Business and Professions Code
Part 32 of 52 · provisions 6,201–6,400
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This part may be cited as the Real Estate Law. This section says chapter definitions apply only to this part, unless the text says otherwise. “Commissioner” means the Real Estate Commissioner. “Department” means the Department of Real Estate in the Business and Consumer Services Agency. This section says certain references like “bureau” and “Real Estate Division” mean the Department of Real Estate, and it states the section becomes operative on July 1, 2018.
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- 4081. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 5. Authority of Inspectors [4080 - 4086] ( Article 5 added by Stats. 1996, Ch. 890, Sec. 3. )
Records about dangerous drugs or dangerous devices must be open to inspection during business hours and kept for at least three years; covered businesses must also keep a current inventory.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 5. Authority of Inspectors [4080 - 4086] ( Article 5 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4081. (a) All records of manufacture and of sale, acquisition, receipt, shipment, or disposition of dangerous drugs or dangerous devices shall be at all times during business hours open to inspection by authorized officers of the law, and shall be preserved for at least three years from the date of making. A current inventory shall be kept by every manufacturer, wholesaler, third-party logistics provider, pharmacy, veterinary food-animal drug retailer, outsourcing facility, physician, dentist, podiatrist, veterinarian, laboratory, licensed correctional clinic, as defined in Section 4187, clinic, hospital, institution, or establishment holding a currently valid and unrevoked certificate, license, permit, registration, or exemption under Division 2 (commencing with Section 1200) of the Health and Safety Code or under Part 4 (commencing with Section 16000) of Division 9 of the Welfare and Institutions Code who maintains a stock of dangerous drugs or dangerous devices. (b) The owner, officer, and partner of a pharmacy, wholesaler, third-party logistics provider, or veterinary food-animal drug retailer shall be jointly responsible, with the pharmacist-in-charge, responsible manager, or designated representative-in-charge, for maintaining the records and inventory described in this section. (c) The pharmacist-in-charge, responsible manager, or designated representative-in-charge shall not be criminally responsible for acts of the owner, officer, partner, or employee that violate this section and of which the pharmacist-in-charge, responsible manager, or designated representative-in-charge had no knowledge, or in which they did not knowingly participate. (d) Pharmacies that dispense nonprescription diabetes test devices pursuant to prescriptions shall retain records of acquisition and sale of those nonprescription diabetes test devices for at least three years from the date of making. The records shall be at all times during business hours open to inspection by authorized officers of the law. (e) (1) In addition to the records described in subdivision (a), records that shall be maintained include policies and procedures related to pharmacy personnel and pharmacy operations. Such records shall be maintained in a readily retrievable format. (2) Records described in paragraph (1) that are maintained electronically shall provide an audit trail for revisions and updates of each record. (3) Prior versions of each electronically maintained record described in paragraph (2) shall be maintained in a readily retrievable format and include changes to the document, identification of the individual who made the change, and the date of each change. (Amended by Stats. 2025, Ch. 196, Sec. 27. (AB 1503) Effective January 1, 2026.) - 4082. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 5. Authority of Inspectors [4080 - 4086] ( Article 5 added by Stats. 1996, Ch. 890, Sec. 3. )
When an inspector asks, the owner or manager of certain licensed or drug/device-related premises must give the inspector the names of the owner(s), manager(s), and employees, plus a brief statement of each person’s job capacity on the premises.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 5. Authority of Inspectors [4080 - 4086] ( Article 5 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4082. When called upon by an inspector, the owner or manager of any entity licensed by the board, or other store, shop, building, or premises retailing, wholesaling, or storing drugs or devices shall furnish the inspector with the names of the owner or owners, manager or managers, and employees together with a brief statement of the capacity in which these persons are employed on the premises. (Amended by Stats. 1997, Ch. 549, Sec. 55. Effective January 1, 1998.) - 4083. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 5. Authority of Inspectors [4080 - 4086] ( Article 5 added by Stats. 1996, Ch. 890, Sec. 3. )
Inspectors may issue correction orders to licensees, and licensees can request an office conference or comply and file a corrective action plan.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 5. Authority of Inspectors [4080 - 4086] ( Article 5 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4083. (a) An inspector may issue an order of correction to a licensee directing the licensee to comply with this chapter or regulations adopted pursuant to this chapter. (b) The order of correction shall be in writing and shall describe in detail the nature and facts of the violation, including a reference to the statute or regulations violated. (c) The order of correction shall inform the licensee that within 30 days of service of the order of correction, the licensee may do either of the following: (1) Submit a written request for an office conference with the board’s executive officer to contest the order of correction. (A) Upon a timely request, the executive officer, or designee of the executive officer, shall hold an office conference with the licensee or the licensee’s legal counsel or authorized representative. Unless so authorized by the executive officer, or designee of the executive officer, no individual other than the licensee’s legal counsel or authorized representative may accompany the licensee to the office conference. (B) Prior to or at the office conference, the licensee may submit to the executive officer declarations and documents pertinent to the subject matter of the order of correction. (C) The office conference is intended to be an informal proceeding and shall not be subject to the provisions of the Administrative Procedure Act (Chapter 3.5 (commencing with Section 11340), Chapter 4 (commencing with Section 11370), Chapter 4.5 (commencing with Section 11400), and Chapter 5 (commencing with Section 11500) of Part 1 of Division 3 of Title 2 of the Government Code). (D) The executive officer, or designee of the executive officer, may affirm, modify, or withdraw the order of correction. Within 14 calendar days from the date of the office conference, the executive officer, or designee of the executive officer, shall personally serve or send by certified mail to the licensee’s address of record with the board a written decision. This decision shall be deemed the final administrative decision concerning the order of correction. (E) Judicial review of the decision may be had by filing a petition for a writ of mandate in accordance with the provisions of Section 1094.5 of the Code of Civil Procedure within 30 days of the date the decision was personally served or sent by certified mail. The judicial review shall extend to the question of whether or not there was a prejudicial abuse of discretion in the issuance of the order of correction. (2) Comply with the order of correction and submit a written corrective action plan to the inspector documenting compliance. If an office conference is not requested pursuant to this section, compliance with the order of correction shall not constitute an admission of the violation noted in the order of correction. (d) The order of correction shall be served upon the licensee personally or by certified mail at the licensee’s address of record with the board. If the licensee is served by certified mail, service shall be effective upon deposit in the United States mail. (e) The licensee shall maintain and have readily available on the pharmacy premises a copy of the order of correction and corrective action plan for at least three years from the date of issuance of the order of correction. (f) Nothing in this section shall in any way limit the board’s authority or ability to do any of the following: (1) Issue a citation pursuant to Section 125.9, 148, or 4067 or pursuant to Section 1775, 1775.15, 1777, or 1778 of Title 16 of the California Code of Regulations. (2) Issue a letter of admonishment pursuant to Section 4315. (3) Institute disciplinary proceedings pursuant to Article 19 (commencing with Section 4300). (g) Unless a writ of mandate is filed, a citation issued, a letter of admonishment issued, or a disciplinary proceeding instituted, an order of correction shall not be considered a public record and shall not be disclosed pursuant to a request under the California Public Records Act (Division 10 (commencing with Section 7920.000) of Title 1 of the Government Code). (Amended by Stats. 2021, Ch. 615, Sec. 6. (AB 474) Effective January 1, 2022. Operative January 1, 2023, pursuant to Section 463 of Stats. 2021, Ch. 615.) - 4084. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 5. Authority of Inspectors [4080 - 4086] ( Article 5 added by Stats. 1996, Ch. 890, Sec. 3. )
Board inspectors must tag and give notice for dangerous drugs or devices they find, or have probable cause to believe, are adulterated, misbranded, or counterfeit; they must remove the tag if the item is later found not to be adulterated, misbranded, or counterfeit.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 5. Authority of Inspectors [4080 - 4086] ( Article 5 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4084. (a) When a board inspector finds, or has probable cause to believe, that any dangerous drug or dangerous device is adulterated, misbranded, or counterfeit, the board inspector shall affix a tag or other marking to that dangerous drug or dangerous device. The board inspector shall give notice to the person that the dangerous drug or dangerous device bearing the tag or marking has been embargoed. (b) When a board inspector has found that an embargoed dangerous drug or dangerous device is not adulterated, misbranded, or counterfeit, a board inspector shall remove the tag or other marking. (c) A board inspector may secure a sample or specimen of a dangerous drug or dangerous device. If the board inspector obtains a sample prior to leaving the premises, the board inspector shall leave a receipt describing the sample. (d) For the purposes of this article, “counterfeit” shall have the meaning defined in Section 109905 of the Health and Safety Code. (e) For the purposes of this article, “adulterated” shall have the meaning defined in Article 2 (commencing with Section 111250) of Chapter 6 of Part 5 of Division 104 of the Health and Safety Code. (f) For the purposes of this article, “misbranded” shall have the meaning defined in Article 3 (commencing with Section 111330) of Chapter 6 of Part 5 of Division 104 of the Health and Safety Code. (Amended by Stats. 2007, Ch. 588, Sec. 44. Effective January 1, 2008.) - 4084.1. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 5. Authority of Inspectors [4080 - 4086] ( Article 5 added by Stats. 1996, Ch. 890, Sec. 3. )
The board may embargo certain nonprescription diabetes test devices if there is reason to believe they were not bought from the manufacturer or authorized distributors.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 5. Authority of Inspectors [4080 - 4086] ( Article 5 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4084.1. The board may embargo any nonprescription diabetes test device that a board inspector finds or has probable cause to believe was not purchased either directly from the manufacturer or from the nonprescription diabetes test device manufacturer’s authorized distributors as identified in Section 4160.5. For the purposes of this section, the board shall embargo these products following the same procedures and protections used for adulterated, misbranded, or counterfeit drugs or dangerous devices in Sections 4084, 4085, and 4086. (Added by Stats. 2017, Ch. 139, Sec. 4. (AB 602) Effective July 31, 2017.) - 4085. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 5. Authority of Inspectors [4080 - 4086] ( Article 5 added by Stats. 1996, Ch. 890, Sec. 3. )
A person may not remove, sell, or dispose of an embargoed dangerous drug or dangerous device unless the board gives permission. A board inspector may remove the embargoed item from the premises if the inspector has reasonable cause to believe the embargo will be violated.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 5. Authority of Inspectors [4080 - 4086] ( Article 5 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4085. (a) It is unlawful for any person to remove, sell, or dispose of an embargoed dangerous drug or dangerous device without permission of the board. (b) When a board inspector has reasonable cause to believe, that the embargo will be violated, a board inspector may remove the embargoed dangerous drug or dangerous device from the premises. (Added by Stats. 2004, Ch. 857, Sec. 15. Effective January 1, 2005.) - 4086. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 5. Authority of Inspectors [4080 - 4086] ( Article 5 added by Stats. 1996, Ch. 890, Sec. 3. )
If a dangerous drug or device is alleged to be adulterated or counterfeit, the board must start court proceedings for condemnation. If the court finds it is adulterated or counterfeit, it must be destroyed, and the claimant or owner must pay the costs.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 5. Authority of Inspectors [4080 - 4086] ( Article 5 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4086. (a) If a dangerous drug or dangerous device is alleged to be adulterated or counterfeit, the board shall commence proceedings in the superior court in whose jurisdiction the dangerous drug or dangerous device is located, for condemnation of the dangerous drug or dangerous device. (b) If the court finds that an embargoed dangerous drug or dangerous device is adulterated or counterfeit, the dangerous drug or dangerous device shall, after entry of the judgment, be destroyed at the expense of the claimant or owner, under the supervision of the board. All court costs and fees and all reasonable costs incurred by the board in investigating and prosecuting the action, including, but not limited to, the costs of storage and testing, shall be paid by the claimant or owner of the dangerous drug or dangerous device. (c) A superior court of this state may condemn any dangerous drug or dangerous device pursuant to this article. In the absence of an order, the dangerous drug or dangerous device may be destroyed under the supervision of the board who has the written consent of the owner, his or her attorney, or authorized representative. If the board cannot ascertain ownership of the dangerous drug or dangerous device within 30 days of establishing an embargo, the board may destroy the dangerous drug or dangerous device. (Added by Stats. 2004, Ch. 857, Sec. 16. Effective January 1, 2005.) - 4100. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 6. General Requirements [4100 - 4107.5] ( Article 6 added by Stats. 1996, Ch. 890, Sec. 3. )
Certain pharmacy-related licensees and representatives must tell the board’s executive officer within 30 days when they change their address of record or their legal name.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 6. General Requirements [4100 - 4107.5] ( Article 6 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4100. Within 30 days after changing his or her address of record with the board or after changing his or her name according to law, a pharmacist, intern pharmacist, technician, designated representative, designated representative-3PL, or designated representative-reverse distributor shall notify the executive officer of the board of the change of address or change of name. (Amended by Stats. 2017, Ch. 598, Sec. 6. (SB 752) Effective January 1, 2018.) - 4101. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 6. General Requirements [4100 - 4107.5] ( Article 6 added by Stats. 1996, Ch. 890, Sec. 3. )
Section 4101 lets certain pharmacy and distribution personnel serve in specified charge roles if the relevant entity applies and the board approves, and it requires notice to the board within 30 days after a person stops serving in one of those roles.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 6. General Requirements [4100 - 4107.5] ( Article 6 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4101. (a) A pharmacist may take charge of and act as the pharmacist-in-charge of a pharmacy upon application by the pharmacy and approval by the board. A pharmacist-in-charge who ceases to act as the pharmacist-in-charge of the pharmacy shall notify the board in writing within 30 days of the date of that change in status. (b) A designated representative or a pharmacist may take charge of, and act as, the designated representative-in-charge of a wholesaler or veterinary food-animal drug retailer upon application by the wholesaler or veterinary food-animal drug retailer and approval by the board. A designated representative-in-charge who ceases to act as the designated representative-in-charge at that entity shall notify the board in writing within 30 days of the date of that change in status. (c) A designated representative-3PL may take charge of, and act as, the responsible manager of a third-party logistics provider upon application by the third-party logistics provider and approval by the board. A responsible manager who ceases to act as the responsible manager at that entity shall notify the board in writing within 30 days of the date of that change in status. (Amended by Stats. 2014, Ch. 507, Sec. 11. (AB 2605) Effective January 1, 2015.) - 4102. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 6. General Requirements [4100 - 4107.5] ( Article 6 added by Stats. 1996, Ch. 890, Sec. 3. )
Licensed facilities must complete a board-prescribed self-assessment on the required schedule and keep the completed form on file.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 6. General Requirements [4100 - 4107.5] ( Article 6 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4102. (a) (1) As provided in this section, all facilities licensed by the board shall complete the self-assessment process by July 1 of every odd-numbered year, unless otherwise established in this section. (2) The self-assessment process shall be completed on a form provided by the board pursuant to this section. (b) The form shall be completed to assess the facility’s compliance with federal and state laws identified on the form. For each “no” response, the facility shall undertake a written corrective action or action plan to come into compliance with the law. (c) (1) The form shall be signed under penalty of perjury by the designated individual, pursuant to this section, and cosigned by the owner or authorized officer of the facility acknowledging they have read, reviewed, and completed the self-assessment to the best of their professional ability and acknowledge that failure to correct any deficiency identified could result in action by the board. (2) The completed form shall be kept on file in the facility and made available to the board or its designee upon request. (d) The facility shall use the appropriate designated form based on the type of license, as described in this subdivision and as posted on the board’s internet website. (1) The Community Pharmacy Self-Assessment/Hospital Outpatient Self-Assessment form shall be completed by the pharmacist-in-charge. In addition to the requirements in subdivision (a), the form shall be completed within 30 days of any of the following: (A) A new pharmacy license is issued. (B) There is a change of pharmacist-in-charge, and they become the new pharmacist-in-charge of a pharmacy. (C) There is a change in the location of a pharmacy to a new address. (2) The Hospital Pharmacy Self-Assessment form shall be completed by the pharmacist-in-charge. In addition to the requirements in subdivision (a), the form shall be completed within 30 days of any of the following: (A) A new pharmacy license is issued. (B) There is a change of pharmacist-in-charge, and they become the new pharmacist-in-charge of a pharmacy. (C) There is a change in the location of a pharmacy to a new address. (3) The Automated Drug Delivery System Self-Assessment form shall be completed by the pharmacist-in-charge of the pharmacy operating the system. In addition to the requirements in subdivision (a), the form shall be completed within 30 days of any of the following: (A) A new pharmacy license is issued. (B) There is a change of pharmacist-in-charge, and they become the new pharmacist-in-charge of a pharmacy. (C) There is a change in the location of a pharmacy to a new address. (4) The Compounding Self-Assessment form shall be completed by the pharmacist-in-charge of each pharmacy that compounds drug products. In addition to the requirements in subdivision (a), the form shall be completed within 30 days of any of the following: (A) A new pharmacy license is issued. (B) There is a change of pharmacist-in-charge, and they become the new pharmacist-in-charge of a pharmacy. (C) There is a change in the location of a pharmacy to a new address. (5) The Surgical Clinic Self-Assessment form shall be completed by the consulting pharmacist of the surgical clinic and cosigned by the professional director. (6) The Wholesaler/Third-Party Logistics Provider Self-Assessment form shall be completed by the designated representative-in-charge or the wholesaler or responsible manager of the third-party logistics provider. In addition to the requirements in subdivision (a), the form shall be completed within 30 days of any of the following: (A) A new license is issued. (B) There is a change of designated representative-in-charge or responsible manager, and they become the new designated representative-in-charge or responsible manager. (C) There is a change in the location to a new address. (7) The Outsourcing Facility Self-Assessment form shall be completed by the designated quality control personnel. In addition to the requirements in subdivision (a), the form shall be completed within 30 days of any of the following: (A) A new license is issued. (B) There is a change in the designated quality control personnel. (C) There is a change in the location to a new address. (Added by Stats. 2025, Ch. 196, Sec. 28. (AB 1503) Effective January 1, 2026.) - 4103. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 6. General Requirements [4100 - 4107.5] ( Article 6 added by Stats. 1996, Ch. 890, Sec. 3. )
A pharmacist may check a person’s blood pressure and discuss the results, but must use commonly accepted community standards when giving opinions or referrals.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 6. General Requirements [4100 - 4107.5] ( Article 6 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4103. Notwithstanding Section 2038, or any other provision of law, a pharmacist may take a person’s blood pressure and may inform the person of the results, render an opinion as to whether the reading is within a high, low, or normal range, and may advise the person to consult a physician of the person’s choice. Pharmacists rendering this service shall utilize commonly accepted community standards in rendering opinions and referring patients to physicians. Enforcement of this section is vested in the Board of Pharmacy of the State of California. Any pharmacist who performs this service shall not be in violation of Section 2052. (Amended by Stats. 1997, Ch. 549, Sec. 59. Effective January 1, 1998.) - 4104. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 6. General Requirements [4100 - 4107.5] ( Article 6 added by Stats. 1996, Ch. 890, Sec. 3. )
Every pharmacy must have procedures and written policies for impaired or drug-diverting licensed individuals, report specified information to the board within 14 days, and provide an audit on request.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 6. General Requirements [4100 - 4107.5] ( Article 6 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4104. (a) Every pharmacy shall have in place procedures for taking action to protect the public when a licensed individual employed by or with the pharmacy is discovered or known to be chemically, mentally, or physically impaired to the extent it affects his or her ability to practice the profession or occupation authorized by his or her license, or is discovered or known to have engaged in the theft, diversion, or self-use of dangerous drugs. (b) Every pharmacy shall have written policies and procedures for addressing chemical, mental, or physical impairment, as well as theft, diversion, or self-use of dangerous drugs, among licensed individuals employed by or with the pharmacy. (c) Every pharmacy shall report and provide to the board, within 14 days of the receipt or development thereof, the following information with regard to any licensed individual employed by or with the pharmacy: (1) Any admission by a licensed individual of chemical, mental, or physical impairment affecting his or her ability to practice. (2) Any admission by a licensed individual of theft, diversion, or self-use of dangerous drugs. (3) Any video or documentary evidence demonstrating chemical, mental, or physical impairment of a licensed individual to the extent it affects his or her ability to practice. (4) Any video or documentary evidence demonstrating theft, diversion, or self-use of dangerous drugs by a licensed individual. (5) Any termination based on chemical, mental, or physical impairment of a licensed individual to the extent it affects his or her ability to practice. (6) Any termination of a licensed individual based on theft, diversion, or self-use of dangerous drugs. (d) The report required in subdivision (c) shall include sufficient detail to inform the board of the facts upon which the report is based, including an estimate of the type and quantity of all dangerous drugs involved, the timeframe over which the losses are suspected, and the date of the last controlled substances inventory. Upon request of the board, the pharmacy shall prepare and submit an audit involving the dangerous drugs suspected to be missing. (e) Anyone making a report authorized or required by this section shall have immunity from any liability, civil or criminal, that might otherwise arise from the making of the report. Any participant shall have the same immunity with respect to participation in any administrative or judicial proceeding resulting from the report. (Amended by Stats. 2011, Ch. 646, Sec. 1. (SB 431) Effective January 1, 2012.) - 4105. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 6. General Requirements [4100 - 4107.5] ( Article 6 added by Stats. 1996, Ch. 890, Sec. 3. )
Licensed entities must keep required pharmacy records on the licensed premises, retain them for three years, and provide requested records promptly when asked by authorized officials or the board.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 6. General Requirements [4100 - 4107.5] ( Article 6 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4105. (a) All records or other documentation required to be maintained pursuant to this chapter by any entity licensed by the board shall be retained on the licensed premises in a readily retrievable form. (b) The licensee may remove the original records or documentation from the licensed premises on a temporary basis for license-related purposes. However, a duplicate set of those records or other documentation shall be retained on the licensed premises. (c) The records required by this chapter shall be retained on the licensed premises for a period of three years from the date of making. Paper records may be converted into a digital format and maintained only in a noneditable format. Certification that the digitized documents have not been altered may be required by the board. (d) (1) Any records that are maintained electronically shall be maintained so that the pharmacist-in-charge, or the pharmacist on duty if the pharmacist-in-charge is not on duty, shall, at all times during which the licensed premises are open for business, be able to produce a hardcopy, digitized copy, or electronic copy of all records required by this chapter to be maintained electronically. (2) In the case of a veterinary food-animal drug retailer, wholesaler, or third-party logistics provider, any records that are maintained electronically shall be maintained so that the designated representative-in-charge or the responsible manager, or the designated representative on duty or the designated representative-3PL on duty if the designated representative-in-charge or responsible manager is not on duty, shall, at all times during which the licensed place of business is open for business, be able to produce a hardcopy, digitized copy, or electronic copy of all records of acquisition or disposition or other drug or dispensing-related records maintained electronically. (e) (1) Notwithstanding subdivisions (a), (b), and (c), the board may, upon written request, grant to a licensee a waiver of the requirements that the records described in subdivisions (a), (b), and (c) be kept on the licensed premises. (2) A waiver granted pursuant to this subdivision shall not affect the board’s authority under this section or any other provision of this chapter. (f) When requested by an authorized officer of the law or by an authorized representative of the board, the owner, corporate officer, or manager of an entity licensed by the board shall provide the board with the requested records within three business days of the time the request was made. The entity may request in writing an extension of this timeframe for a period not to exceed 14 calendar days from the date the records were requested. A request for an extension of time is subject to the approval of the board. An extension shall be deemed approved if the board fails to deny the extension request within two business days of the time the extension request was made directly to the board. (Amended by Stats. 2025, Ch. 196, Sec. 29. (AB 1503) Effective January 1, 2026.) - 4106. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 6. General Requirements [4100 - 4107.5] ( Article 6 added by Stats. 1996, Ch. 890, Sec. 3. )
For license verification, a person may rely on licensing information shown on the board’s website if it includes issuance and expiration dates for the license.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 6. General Requirements [4100 - 4107.5] ( Article 6 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4106. For purposes of license verification, a person may rely upon the licensing information as it is displayed on the board’s Internet Web site that includes the issuance and expiration dates of any license issued by the board. (Amended by Stats. 2005, Ch. 621, Sec. 51. Effective January 1, 2006.) - 4107. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 6. General Requirements [4100 - 4107.5] ( Article 6 added by Stats. 1996, Ch. 890, Sec. 3. )
The board may not issue more than one site license to a single premises, unless one of the listed exceptions applies.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 6. General Requirements [4100 - 4107.5] ( Article 6 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4107. (a) The board shall not issue more than one site license to a single premises except as follows: (1) To issue a veterinary food-animal drug retailer license to a wholesaler pursuant to Section 4196. (2) To issue a license to compound sterile drugs to a pharmacy pursuant to Section 4127.1 or 4127.2. (3) To issue a centralized hospital packaging license pursuant to Section 4128. (4) To issue licenses to two independently owned clinics that share a clinic office space pursuant to Section 4180.5. (b) For the purposes of this subdivision, “premises” means a location with its own address and an independent means of ingress and egress. (Amended by Stats. 2017, Ch. 548, Sec. 6. (AB 401) Effective January 1, 2018.) - 4107.5. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 6. General Requirements [4100 - 4107.5] ( Article 6 added by Stats. 1996, Ch. 890, Sec. 3. )
Certain manufacturers, wholesalers, third-party logistics providers, and pharmacies must notify the board within 72 hours after learning a dangerous drug or device in their possession may be counterfeit or tied to a fraudulent transaction.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 6. General Requirements [4100 - 4107.5] ( Article 6 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4107.5. If a manufacturer, wholesaler, third-party logistics provider, or pharmacy has reasonable cause to believe that a dangerous drug or dangerous device in, or having been in, its possession is counterfeit or the subject of a fraudulent transaction, the manufacturer, wholesaler, third-party logistics provider, or pharmacy shall notify the board within 72 hours of obtaining that knowledge. This section shall apply to any dangerous drug or dangerous device that has been sold or distributed in or through this state. (Added by Stats. 2014, Ch. 507, Sec. 13. (AB 2605) Effective January 1, 2015.) - 4110. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7. Pharmacies [4110 - 4126.10] ( Article 7 added by Stats. 1996, Ch. 890, Sec. 3. )
A pharmacy in California generally must be licensed by the board, with separate licenses required for each pharmacy and location.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7. Pharmacies [4110 - 4126.10] ( Article 7 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4110. (a) No person shall conduct a pharmacy in the State of California unless they have obtained a license from the board. A license shall be required for each pharmacy owned or operated by a specific person. A separate license shall be required for each of the premises of any person operating a pharmacy in more than one location. The license shall be renewed annually. The license shall not be renewed unless the applicant includes necessary matters identified by the board in the renewal application, including, but not limited to, notification to the board regarding compounding practices, including compounded human drug preparations distributed outside of the state. The board may, by regulation, determine the circumstances under which a license may be transferred. (b) The board may, at its discretion, issue a temporary permit upon the conditions and for any periods of time as the board determines to be in the public interest. A temporary permit fee shall be required in an amount established by the board as specified in subdivision (a) of Section 4400. When needed to protect public safety, a temporary permit may be issued for a period not to exceed 180 days, and may be issued subject to terms and conditions the board deems necessary. If the board determines a temporary permit was issued by mistake or denies the application for a permanent license or registration, the temporary license or registration shall terminate upon either personal service of the notice of termination upon the permitholder or service by certified mail, return receipt requested, at the permitholder’s address of record with the board, whichever comes first. Neither for purposes of retaining a temporary permit nor for purposes of any disciplinary or license denial proceeding before the board shall the temporary permitholder be deemed to have a vested property right or interest in the permit. (c) The board may allow the temporary use of a mobile pharmacy when a pharmacy is destroyed or damaged, the mobile pharmacy is necessary to protect the health and safety of the public, and the following conditions are met: (1) The mobile pharmacy shall provide services only on or immediately contiguous to the site of the damaged or destroyed pharmacy. (2) The mobile pharmacy is under the control and management of the pharmacist-in-charge of the pharmacy that was destroyed or damaged. (3) A licensed pharmacist is on the premises while drugs are being dispensed. (4) Reasonable security measures are taken to safeguard the drug supply maintained in the mobile pharmacy. (5) The pharmacy operating the mobile pharmacy provides the board with records of the destruction of, or damage to, the pharmacy and an expected restoration date. (6) Within three calendar days of restoration of the pharmacy services, the board is provided with notice of the restoration of the permanent pharmacy. (7) The mobile pharmacy is not operated for more than 48 hours following the restoration of the permanent pharmacy. (Amended by Stats. 2021, Ch. 629, Sec. 16. (AB 1533) Effective January 1, 2022.) - 4110.5. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7. Pharmacies [4110 - 4126.10] ( Article 7 added by Stats. 1996, Ch. 890, Sec. 3. )
Certain counties, city and counties, and special hospital authorities may run mobile units to provide prescription medication, if they meet listed pharmacy and notice requirements.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7. Pharmacies [4110 - 4126.10] ( Article 7 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4110.5. Notwithstanding any other provision of this article, a county, city and county, or special hospital authority described in Chapter 5 (commencing with Section 101850) or Chapter 5.5 (commencing with Section 101852) of Part 4 of Division 101 of the Health and Safety Code may operate one or more mobile units to provide prescription medication within its jurisdiction to those individuals without fixed addresses, individuals living in county-owned or city-and-county-owned or operated housing facilities, and those enrolled in Medi-Cal plans operated by the county or a city and county, a health district, or a joint powers authority pursuant to Chapter 7 (commencing with Section 14000) or Chapter 8 (commencing with Section 14200) of Part 3 of Division 9 of the Welfare and Institutions Code. The mobile unit shall be operated as an extension of a pharmacy license held by the county, city and county, or special hospital authority. The pharmacist-in-charge shall determine the number of mobile units that are appropriate for a particular pharmacy license. The mobile unit may dispense prescription medication pursuant to a valid prescription, including a prescription of a physician who practices in the mobile unit, if the county, city and county, or special hospital authority meets all of the following requirements: (a) A licensed pharmacist is on the premises and the mobile unit is under the control and management of a pharmacist while prescription medications are being dispensed. (b) All activities of the pharmacist, including the furnishing of medication by the pharmacist, are consistent with Article 3 (commencing with Section 4050). (c) If a physician is practicing in the mobile unit, all prescribing by the physician meets the requirements of the Medical Practice Act (Chapter 5 (commencing with Section 2000)). (d) (1) The mobile unit does not carry or dispense controlled substances. (2) Paragraph (1) does not apply to Schedule III, Schedule IV, or Schedule V controlled substances approved by the United States Food and Drug Administration for the treatment of opioid use disorder. Any controlled substance for the treatment of opioid use disorder carried or dispensed in accordance with this paragraph shall be carried in reasonable quantities based on prescription volume and stored securely in the mobile pharmacy unit. (e) Dangerous drugs shall not be left in the mobile unit during the hours that the mobile unit is not in operation. (f) A county, city and county, or special hospital authority shall notify the board of its intention to operate a mobile unit as soon as possible, and no later than five business days after commencing operation of a mobile unit. A county, city and county, or special hospital authority shall also notify the board of its intention to discontinue operation of a mobile unit as soon as possible, and at least one business day before discontinuing operation of a mobile unit. (Amended by Stats. 2023, Ch. 539, Sec. 1. (AB 663) Effective January 1, 2024.) - 4111. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7. Pharmacies [4110 - 4126.10] ( Article 7 added by Stats. 1996, Ch. 890, Sec. 3. )
This section restricts who the board may license for a pharmacy and requires certain pharmacist duties when issuing drug orders.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7. Pharmacies [4110 - 4126.10] ( Article 7 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4111. (a) Except as otherwise provided in paragraph (2), or in subdivision (b), (d), or (e), the board shall not issue or renew a license to conduct a pharmacy to any of the following: (1) A person or persons authorized to prescribe or write a prescription, as specified in Section 4040, in the State of California. (2) (A) Except as provided in subparagraph (B), a person or persons with whom a person or persons specified in paragraph (1) shares a community or other financial interest in the license sought. (B) Subparagraph (A) shall not preclude the issuance of a new or renewal license to conduct a pharmacy if both of the following conditions are met: (i) Both the person or persons specified in paragraph (1) and the person seeking the license provide statements that the person or persons specified in paragraph (1) disavow any community or financial interest in the license. (ii) Any interest in the license that is shared community property, as defined in Section 65 of the Family Code, of a person specified in paragraph (1) and the person seeking the license is transmuted into the separate property of the person seeking the license. (C) A pharmacy that is granted a license pursuant to the exception in subparagraph (B) shall not fill any prescriptions, emergency or otherwise, issued or prescribed by either of the following persons: (i) A person specified in paragraph (1) who shares a community or other financial interest with the licensee. (ii) A prescriber at the same place of business as a person specified in clause (i) if the prescriber owns an interest greater than 10 percent in the practice issuing the prescription. (3) Any corporation that is controlled by, or in which 10 percent or more of the stock is owned by a person or persons prohibited from pharmacy ownership by paragraph (1) or (2). (b) Subdivision (a) shall not preclude the issuance of a permit for an inpatient hospital pharmacy to the owner of the hospital in which it is located. (c) The board may require any information the board deems is reasonably necessary for the enforcement of this section. (d) Subdivision (a) shall not preclude the issuance of a new or renewal license for a pharmacy to be owned or owned and operated by a person licensed on or before August 1, 1981, under the Knox-Keene Health Care Service Plan Act of 1975 (Chapter 2.2 (commencing with Section 1340) of Division 2 of the Health and Safety Code) and qualified on or before August 1, 1981, under subsection (d) of Section 1310 of Title XIII of the federal Public Health Service Act, as amended, whose ownership includes persons defined pursuant to paragraphs (1) and (2) of subdivision (a). (e) (1) Subdivision (a) shall not preclude the issuance of a new or renewal license for a pharmacy to be owned or owned and operated by a pharmacist. (2) If the board issues a license pursuant to paragraph (1), the pharmacist owning or owning and operating the pharmacy shall do both of the following when issuing a drug order pursuant to Section 4052, 4052.1, 4052.2, or 4052.6: (A) Offer to provide a prescription to the patient that the patient may elect to have filled by a pharmacy of the patient’s choice unless prohibited by the collaborative practice agreement. (B) Provide a full patient consultation before issuing the drug order. (Amended by Stats. 2025, Ch. 196, Sec. 30. (AB 1503) Effective January 1, 2026.) - 4113. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7. Pharmacies [4110 - 4126.10] ( Article 7 added by Stats. 1996, Ch. 890, Sec. 3. )
Pharmacies must designate a pharmacist-in-charge and report the designation to the board within the stated deadline; the board must approve the pharmacist-in-charge before licensing or renewal.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7. Pharmacies [4110 - 4126.10] ( Article 7 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4113. (a) (1) Every pharmacy shall designate a pharmacist-in-charge. (2) A pharmacy licensed pursuant to Section 4110 shall, within 30 days of the designation in paragraph (1), notify the board in writing of the identity and license number of that pharmacist and the date they were designated. (3) A pharmacy licensed pursuant to Section 4112 shall, within 90 days of the designation in paragraph (1), notify the board in writing of the identify and license number of that pharmacist and the date they were designated. (b) The proposed pharmacist-in-charge shall be subject to approval by the board. The board shall not issue or renew a pharmacy license without identification of an approved pharmacist-in-charge for the pharmacy. (c) (1) The pharmacist-in-charge shall be responsible for a pharmacy’s compliance with all state and federal laws and regulations pertaining to the practice of pharmacy. (2) The pharmacist-in-charge shall make staffing decisions to ensure sufficient personnel are present in the pharmacy to prevent fatigue, distraction, or other conditions that may interfere with a pharmacist’s ability to practice competently and safely. If the pharmacist-in-charge is not available, a pharmacist on duty may adjust staffing according to workload if needed. This paragraph does not apply to facilities of the Department of Corrections and Rehabilitation. (3) The determination of the appropriate pharmacist-to-technician ratio shall be made by the pharmacist-in-charge, provided that the ratio does not exceed the maximum ratio established in subdivision (g) of Section 4115. No other person, permittee, or licensee shall interfere with the exercise of the pharmacist-in-charge’s independent professional judgment in setting the pharmacist-to-technician ratio. (d) (1) The pharmacist-in-charge or pharmacist on duty shall immediately notify store management or the building owner or a similar entity of any conditions that present an immediate risk of death, illness, or irreparable harm to patients, personnel, or pharmacy staff. Store management shall take immediate and reasonable steps to address and resolve the conditions that present an immediate risk of death, illness, or irreparable harm to patients, personnel, or pharmacy staff. If the conditions are not resolved within 24 hours, the pharmacist-in-charge or pharmacist on duty shall ensure the board is timely notified. (2) Nothing in this subdivision shall be construed as presenting, limiting, or restraining a pharmacist-in-charge, pharmacy technician, or member of the public from communication with the board, including filing a complaint. (3) The conditions that present an immediate risk of death, illness, or irreparable harm to patients, personnel, or pharmacy staff may include, but are not limited to, any of the following: (A) Workplace safety and health hazards that present an immediate risk of death, illness, or irreparable harm to patients, personnel, or pharmacy staff. (B) Sustained temperatures that could impact ambient temperature drug stability according to manufacturer data on acceptable drug storage conditions. (C) Vermin infestation that poses a risk to the safety or efficacy of medicine. (4) If, after receipt of a notice described in paragraph (1) and an evaluation and assessment of the relevant evidence, the executive officer has a reasonable belief that conditions within a pharmacy exist that present an immediate risk of death, illness, or irreparable harm to patients, personnel, or pharmacy staff, the executive officer may, in conformance with the processes set forth in subdivisions (b) and (c) of Section 4127.3, issue an order to the pharmacy to immediately cease and desist those pharmacy operations that are affected by the conditions at issue. The cease and desist order shall remain in effect until either the executive officer determines the conditions that presented an immediate risk of death, illness, or irreparable harm to patients, personnel, or pharmacy staff have been abated or for no more than 30 days, whichever is earlier. Evidence of corrective actions taken shall be submitted by the pharmacy to correct the conditions at issue. Failure to comply with a cease and desist order issued pursuant to this section shall be unprofessional conduct pursuant to Section 4156. (5) Nothing in this paragraph shall prevent the owner of the licensed premises from closing a pharmacy to mitigate against a perceived immediate risk of death, illness, or irreparable harm to patients, personnel, or pharmacy staff. (6) Facilities of the Department of Corrections and Rehabilitation shall be exempt from this subdivision. (e) (1) Every pharmacy licensed pursuant to Section 4110 shall notify the board in writing, on a form designed by the board, within 30 days of the date when a pharmacist-in-charge ceases to act as the pharmacist-in-charge, and shall on the same form propose another pharmacist to take over as the pharmacist-in-charge. (2) Every pharmacy licensed pursuant to Section 4112 shall notify the board in writing, on a form designed by the board, within 90 days of the date when a pharmacist-in-charge ceases to act as the pharmacist-in-charge, and shall on the same form propose another pharmacist to take over as the pharmacist-in-charge. (3) The proposed replacement pharmacist-in-charge shall be subject to approval by the board. If disapproved, the pharmacy shall propose another replacement within 15 days of the date of disapproval and shall continue to name proposed replacements until a pharmacist-in-charge is approved by the board. (f) If a pharmacy is unable, in the exercise of reasonable diligence, to identify within 30 days a permanent replacement pharmacist-in-charge to propose to the board on the notification form, the pharmacy may instead provide on that form the name of any pharmacist who is an employee, officer, or administrator of the pharmacy or the entity that owns the pharmacy and who is actively involved in the management of the pharmacy on a daily basis, to act as the interim pharmacist-in-charge for a period not to exceed 120 days. The pharmacy, or the entity that owns the pharmacy, shall be prepared during normal business hours to provide a representative of the board with the name of the interim pharmacist-in-charge with documentation of the active involvement of the interim pharmacist-in-charge in the daily management of the pharmacy, and with documentation of the pharmacy’s good faith efforts prior to naming the interim pharmacist-in-charge to obtain a permanent pharmacist-in-charge. By no later than 120 days following the identification of the interim pharmacist-in-charge, the pharmacy shall propose to the board the name of a pharmacist to serve as the permanent pharmacist-in-charge. The proposed permanent pharmacist-in-charge shall be subject to approval by the board. If disapproved, the pharmacy shall propose another replacement within 15 days of the date of disapproval, and shall continue to name proposed replacements until a pharmacist-in-charge is approved by the board. (Amended by Stats. 2025, Ch. 196, Sec. 33. (AB 1503) Effective January 1, 2026.) - 4113.1. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7. Pharmacies [4110 - 4126.10] ( Article 7 added by Stats. 1996, Ch. 890, Sec. 3. )
Community pharmacies must report medication errors to a board-approved entity within 14 days, keep compliance records for three years, and make those records available to an inspector on request.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7. Pharmacies [4110 - 4126.10] ( Article 7 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4113.1. (a) Except as specified in subdivision (e), a community pharmacy licensed pursuant to this article shall report, either directly or through a designated third party, including a component patient safety organization as defined in Section 3.20 of Title 42 of the Code of Federal Regulations, all medication errors to an entity approved by the board. A community pharmacy shall submit the report no later than 14 days following the date of discovery of the error. These reports are deemed confidential and are not subject to discovery, subpoena, or disclosure pursuant to the California Public Records Act (Division 10 (commencing with Section 7920.000) of Title 1 of the Government Code), except that the board may publish deidentified case summary information compiled from the data in the reports so long as deidentification is done in accordance with the requirements set forth in Section 164.514(b)(2) of Title 45 of the Code of Federal Regulations, and includes omitting the name of the reporting pharmacy. The community pharmacy shall maintain records demonstrating compliance with this requirement for three years and shall make these records immediately available at the request of an inspector. A medication error report made pursuant to this section shall not be subject to investigation, discipline, or other enforcement action by the board based solely on a report received pursuant to this section. However, if the board receives other information regarding the medication error independent of the medication error report, that information may serve as basis for discipline or other enforcement by the board. (b) Any entity approved by the board shall have experience with the analysis of medication errors that occur in the outpatient setting. (c) For purposes of this section, “community pharmacy” includes any pharmacy that dispenses medication to an outpatient, but does not include facilities of the Department of Corrections and Rehabilitation. (d) For purposes of this section, “medication error” includes any variation from a prescription drug order not authorized by the prescriber, including, but not limited to, errors involving the wrong drug, the wrong dose, the wrong patient, the wrong directions, the wrong preparation, or the wrong route of administration. A medication error does not include any variation that is corrected prior to dispensing to the patient or patient’s agent or any variation allowed by law. (e) An outpatient hospital pharmacy shall not be required to report a medication error that meets the requirements of an adverse event, as specified in subdivision (a), that has been reported to the State Department of Public Health pursuant to Section 1279.1 of the Health and Safety Code. The State Department of Public Health may share a report with the California State Board of Pharmacy. (f) A pharmacy licensed pursuant to Section 4112 shall only be required to report medication errors related to prescriptions dispensed to California residents. (Amended by Stats. 2025, Ch. 196, Sec. 34. (AB 1503) Effective January 1, 2026.) - 4113.5. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7. Pharmacies [4110 - 4126.10] ( Article 7 added by Stats. 1996, Ch. 890, Sec. 3. )
A community pharmacy generally may not require a pharmacist employee to work on pharmacy tasks while the pharmacy is open to the public unless another employee is always available to help.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7. Pharmacies [4110 - 4126.10] ( Article 7 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4113.5. (a) A community pharmacy shall not require a pharmacist employee to engage in the practice of pharmacy at any time the pharmacy is open to the public, unless either another employee of the pharmacy or, if the pharmacy is located within another establishment, an employee of the establishment within which the pharmacy is located, is made available to assist the pharmacist at all times. (b) This section shall not apply to any of the following: (1) A hospital pharmacy, as defined in Section 4029 or 4056. (2) A pharmacy located in a hospital facility, including, but not limited to, a building where outpatient services are provided in accordance with the hospital’s license. (3) A pharmacy owned or operated by a federal, state, local, or tribal government entity, including, but not limited to, a correctional pharmacy, a University of California pharmacy, or a pharmacy operated by the State Department of State Hospitals. (4) A pharmacy owned by a person or persons who, collectively, control the majority of the beneficial interest in no more than four pharmacies in California. (5) A pharmacy entirely owned and operated by a health care service plan that exclusively contracts with no more than two medical groups in the state to provide, or arrange for the provision of, professional medical services to the enrollees of the plan. (6) A pharmacy that permits patients to receive medications at a drive-through window when both of the following conditions are met: (A) A pharmacist is working during the times when patients may receive medication only at the drive-through window. (B) The pharmacist’s employer does not require the pharmacist to retrieve items for sale to patients if the items are located outside the pharmacy. These items include, but are not limited to, items for which a prescription is not required. (7) Any other pharmacy from which controlled substances, dangerous drugs, or dangerous devices are not furnished, sold, or dispensed at retail. (c) A violation of subdivision (a) is not subject to subdivision (a) of Section 4321. (d) The board shall not take action against a pharmacy for a violation of this section if both of the following apply: (1) Another employee is unavailable to assist the pharmacist due to reasonably unanticipated circumstances, including, but not limited to, illness, injury, family emergency, or the employee’s termination or resignation. (2) The pharmacy takes all reasonable action to make another employee available to assist the pharmacist. (e) This section shall not be construed to permit an employee who is not licensed under this chapter to engage in any act for which a license is required under this chapter. (Added by Stats. 2018, Ch. 569, Sec. 2. (SB 1442) Effective January 1, 2019.) - 4113.6. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7. Pharmacies [4110 - 4126.10] ( Article 7 added by Stats. 1996, Ch. 890, Sec. 3. )
A chain community pharmacy must keep at least one clerk or pharmacy technician dedicated to pharmacy-related services on staff at all times, and it must also post complaint information and, when pharmacist hours do not overlap enough, post and announce lunch closures.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7. Pharmacies [4110 - 4126.10] ( Article 7 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4113.6. (a) A chain community pharmacy subject to Section 4113.5 shall be staffed at all times with at least one clerk or pharmacy technician fully dedicated to performing pharmacy-related services. The board shall not take action against a pharmacy for a violation of this subdivision if any of the following conditions apply: (1) The pharmacist on duty waives the requirement in writing during specified hours based on workload need. (2) The pharmacy is open beyond normal business hours, which is before 8:00 a.m. and after 7:00 p.m. During the hours before 8:00 a.m. and after 7:00 p.m., the requirement shall not apply. (3) The pharmacy’s prescription volume per day on average is less than 75 prescriptions per day based on the average daily prescription volume for the past calendar year. However, if the pharmacist is also expected to provide additional pharmacy services such as immunizations, tests classified as waived under the federal Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. Sec. 263a), or any other ancillary services provided by law, this paragraph does not apply. (b) Where staffing of pharmacist hours within a chain community pharmacy does not overlap sufficiently, scheduled closures for lunch time for all pharmacy staff shall be established and publicly posted and included on the outgoing telephone message. (c) A chain community pharmacy shall post, in a prominent place for pharmacy personnel, a notice that provides information on how to file a complaint with the board. (Amended by Stats. 2025, Ch. 196, Sec. 35. (AB 1503) Effective January 1, 2026.) - 4113.7. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7. Pharmacies [4110 - 4126.10] ( Article 7 added by Stats. 1996, Ch. 890, Sec. 3. )
A chain community pharmacy may not set quota-based work targets for pharmacist or pharmacy technician duties, and may not tell those workers about illegal quotas through employees, contractors, or third parties.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7. Pharmacies [4110 - 4126.10] ( Article 7 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4113.7. (a) A chain community pharmacy, as defined in subdivision (c) of Section 4001, shall not establish a quota related to the duties for which a pharmacist or pharmacy technician license is required. (b) A chain community pharmacy shall not, through employees, contractors, or third parties, communicate the existence of quotas, that are illegal pursuant to this section, to pharmacists or pharmacy technicians who are employees of the chain community pharmacy or with whom the chain community pharmacy contracts. (c) (1) For purposes of this section, “quota” means a fixed number or formula related to the duties for which a pharmacist or pharmacy technician license is required, against which the chain community pharmacy or its agent measures or evaluates the number of times either an individual pharmacist or pharmacy technician performs tasks or provides services while on duty. “Quota” includes a fixed number or formula related to any of the following: (A) Prescriptions filled. (B) Services rendered to patients. (C) Programs offered to patients. (D) Revenue obtained. (2) For purposes of this section, “quota” does not mean any of the following: (A) A measurement of the revenue earned by a particular licensed chain community pharmacy not calculated in relation to, or measured by, the tasks performed, or services provided by, individual pharmacists or pharmacy technicians. (B) Any evaluation or measurement of the competence, performance, or quality of care provided to patients of a pharmacist or pharmacy technician if the evaluation does not use quotas, as defined in paragraph (1). (C) Any performance metric required by state or federal regulators that does not use quotas, as defined in paragraph (1). (d) This section does not prohibit a chain community pharmacy from establishing policies and procedures that assist in assessing the competency and performance of a pharmacist or pharmacy technician in providing care to patients if the measurements used are not, or do not include, quotas, as defined in subdivision (c). (Added by Stats. 2021, Ch. 334, Sec. 2. (SB 362) Effective January 1, 2022.) - 4114. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7. Pharmacies [4110 - 4126.10] ( Article 7 added by Stats. 1996, Ch. 890, Sec. 3. )
An intern pharmacist may do a pharmacist’s functions only under a pharmacist’s direct supervision and control, and a pharmacist may supervise no more than two intern pharmacists at a time.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7. Pharmacies [4110 - 4126.10] ( Article 7 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4114. (a) An intern pharmacist may perform all functions of a pharmacist at the discretion of and under the direct supervision and control of a pharmacist whose license is in good standing with the board. (b) A pharmacist may not supervise more than two intern pharmacists at any one time. (Amended by Stats. 2005, Ch. 621, Sec. 52. Effective January 1, 2006.) - 4115. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7. Pharmacies [4110 - 4126.10] ( Article 7 added by Stats. 1996, Ch. 890, Sec. 3. )
Pharmacy technicians may do only the tasks allowed here, and must work under pharmacist supervision and control.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7. Pharmacies [4110 - 4126.10] ( Article 7 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4115. (a) A pharmacy technician may perform packaging, manipulative, repetitive, or other nondiscretionary tasks only while assisting, and while under the direct supervision and control of, a pharmacist. The pharmacist shall be responsible for the duties performed under their supervision by a technician. (b) (1) In addition to the tasks specified in subdivision (a), and where the pharmacy has scheduled another pharmacy technician to assist the pharmacist by performing the tasks provided in subdivision (a), a certified pharmacy technician as defined in Section 4202 may, under the direct supervision and control of a pharmacist, do any of the following: (A) Prepare and administer influenza and COVID-19 vaccines via injection or intranasally, and prepare and administer epinephrine, provided that both of the following conditions are met: (i) The pharmacy technician has successfully completed at least six hours of practical training approved by the Accreditation Council for Pharmacy Education and includes hands-on injection technique, the recognition and treatment of emergency reactions to vaccines, and an assessment of the pharmacy technician’s injection technique prior to performing administration of vaccines. (ii) The pharmacy technician is certified in basic life support. (B) (i) Perform specimen collection for tests that are classified as CLIA. (ii) “CLIA” means the federal Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. Sec. 263a; Public Law 100-578). (C) Initiate and receive prescription transfers and accept clarification on prescriptions. (c) This section does not authorize the performance of any tasks specified in subdivisions (a) and (b) by a pharmacy technician without a pharmacist on duty. (d) This section does not authorize a pharmacy technician to perform any act requiring the exercise of professional judgment by a pharmacist. (e) The board shall adopt regulations to specify tasks pursuant to subdivision (a) that a pharmacy technician may perform under the supervision of a pharmacist. Any pharmacy that employs a pharmacy technician shall do so in conformity with the regulations adopted by the board. (f) A person shall not act as a pharmacy technician without first being licensed by the board as a pharmacy technician. (g) (1) A pharmacy with only one pharmacist shall have no more than three pharmacy technicians performing the tasks specified in subdivision (a). A pharmacy with only one pharmacist shall have no more than one pharmacy technician performing the tasks specified in subdivision (b). If a pharmacy technician is performing the tasks specified in subdivision (b), a second pharmacy technician shall be assisting a pharmacist with performing tasks specified in subdivision (a). The ratio of pharmacy technicians performing the tasks specified in subdivision (a) to any additional pharmacist shall not exceed 3 to 1 except that this ratio shall not apply to personnel performing clerical functions pursuant to Section 4116 or 4117. This ratio is applicable to all practice settings, except for an inpatient of a licensed health facility, a patient of a licensed home health agency, as specified in paragraph (2), an inmate of a correctional facility of the Department of Corrections and Rehabilitation, and for a person receiving treatment in a facility operated by the State Department of State Hospitals, the State Department of Developmental Services, or the Department of Veterans Affairs. (2) The board may adopt regulations establishing the ratio of pharmacy technicians performing the tasks specified in subdivision (a) to pharmacists applicable to the filling of prescriptions of an inpatient of a licensed health facility and for a patient of a licensed home health agency. Any ratio established by the board pursuant to this subdivision shall allow, at a minimum, at least one pharmacy technician for a single pharmacist in a pharmacy and two pharmacy technicians for each additional pharmacist, except that this ratio shall not apply to personnel performing clerical functions pursuant to Section 4116 or 4117. (3) A pharmacist scheduled to supervise a second pharmacy technician may refuse to supervise a second pharmacy technician if the pharmacist determines, in the exercise of their professional judgment, that permitting the second pharmacy technician to be on duty would interfere with the effective performance of the pharmacist’s responsibilities under this chapter. A pharmacist assigned to supervise a second pharmacy technician shall notify the pharmacist-in-charge in writing of their determination, specifying the circumstances of concern with respect to the pharmacy or the pharmacy technician that have led to the determination, within a reasonable period, but not to exceed 24 hours, after the posting of the relevant schedule. An entity employing a pharmacist shall not discharge, discipline, or otherwise discriminate against any pharmacist in the terms and conditions of employment for exercising or attempting to exercise in good faith the right established pursuant to this paragraph. (h) Notwithstanding subdivisions (a) to (c), inclusive, the board shall by regulation establish conditions to permit the temporary absence of a pharmacist for breaks and lunch periods pursuant to Section 512 of the Labor Code and the orders of the Industrial Welfare Commission without closing the pharmacy. During these temporary absences, a pharmacy technician may, at the discretion of the pharmacist, remain in the pharmacy but may only perform nondiscretionary tasks. The pharmacist shall be responsible for a pharmacy technician and shall review any task performed by a pharmacy technician during the pharmacist’s temporary absence. This subdivision shall not be construed to authorize a pharmacist to supervise pharmacy technicians in greater ratios than those described in subdivision (g). (i) The pharmacist on duty shall be directly responsible for the conduct of a pharmacy technician supervised by that pharmacist. (j) In a health care facility licensed under subdivision (a) of Section 1250 of the Health and Safety Code, a pharmacy technician’s duties may include any of the following: (1) Packaging emergency supplies for use in the health care facility and the hospital’s emergency medical system or as authorized under Section 4119. (2) Sealing emergency containers for use in the health care facility. (3) Performing monthly checks of the drug supplies stored throughout the health care facility. Irregularities shall be reported within 24 hours to the pharmacist-in-charge and the director or chief executive officer of the health care facility in accordance with the health care facility’s policies and procedures. (k) Notwithstanding subdivision (a) of Section 4038, a pharmacy technician may, outside of a licensed pharmacy, do both of the following: (1) Perform compounding activities only under the direct supervision and control of a pharmacist. The supervising pharmacist of the location where such compounding activities occur shall notify the board in writing. (2) Administer vaccinations only under the direct supervision and control of a pharmacist. (Amended by Stats. 2025, Ch. 196, Sec. 36. (AB 1503) Effective January 1, 2026.) - 4115.5. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7. Pharmacies [4110 - 4126.10] ( Article 7 added by Stats. 1996, Ch. 890, Sec. 3. )
Pharmacy technician trainees may do externships in a pharmacy, but their work must be directly supervised by a pharmacist and the trainee must wear trainee identification.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7. Pharmacies [4110 - 4126.10] ( Article 7 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4115.5. (a) Notwithstanding any other law, a pharmacy technician trainee may be placed in a pharmacy to complete an externship for the purpose of obtaining practical training required to become licensed as a pharmacy technician. (b) (1) A pharmacy technician trainee participating in an externship as described in subdivision (a) may perform the duties described in subdivision (a) of Section 4115 only under the direct supervision and control of a pharmacist. (2) A pharmacist supervising a pharmacy technician trainee participating in an externship as described in subdivision (a) shall be directly responsible for the conduct of the trainee. (3) A pharmacist supervising a pharmacy technician trainee participating in an externship as described in subdivision (a) shall verify any prescription prepared by the trainee under supervision of the pharmacist by initialing the prescription label before the medication is disbursed to a patient or by engaging in other verification procedures that are specifically approved by board regulations. (4) A pharmacist may only supervise one pharmacy technician trainee at any given time. (5) A pharmacist supervising a pharmacy technician trainee participating in an externship as described in subdivision (a) shall certify attendance for the pharmacy technician trainee and certify that the pharmacy technician trainee has met the educational objectives established by the training program. (c) (1) Except as described in paragraph (2), an externship in which a pharmacy technician trainee is participating as described in subdivision (a) shall be for a period of no fewer than 120 hours and no more than 140 hours. (2) When an externship in which a pharmacy technician trainee is participating as described in subdivision (a) involves rotation between a community and hospital pharmacy for the purpose of training the student in distinct practice settings, the externship may be for a period of up to 340 hours. (d) An externship in which a pharmacy technician trainee may participate as described in subdivision (a) shall be for a period of no more than six consecutive months in a community pharmacy and for a total of no more than 12 months if the externship involves rotation between a community and hospital pharmacy. The externship shall be completed while the trainee is enrolled in the training program. (e) A pharmacy technician trainee participating in an externship as described in subdivision (a) shall wear identification that indicates the pharmacy technician trainee’s status as a trainee. (Amended by Stats. 2025, Ch. 196, Sec. 37. (AB 1503) Effective January 1, 2026.) - 4116. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7. Pharmacies [4110 - 4126.10] ( Article 7 added by Stats. 1996, Ch. 890, Sec. 3. )
This section limits who may be in certain pharmacy areas and gives the board power to set security rules and pharmacist-absence conditions by regulation.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7. Pharmacies [4110 - 4126.10] ( Article 7 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4116. (a) No person other than a pharmacist, an intern pharmacist, an authorized officer of the law, or a person authorized to prescribe shall be permitted in that area, place, or premises described in the license issued by the board wherein controlled substances or dangerous drugs or dangerous devices are stored, possessed, prepared, manufactured, derived, compounded, dispensed, or repackaged. However, a pharmacist shall be responsible for any individual who enters the pharmacy for the purposes of receiving consultation from the pharmacist or performing clerical, inventory control, housekeeping, delivery, maintenance, or similar functions relating to the pharmacy if the pharmacist remains present in the pharmacy during all times as the authorized individual is present. (b) (1) The board may, by regulation, establish reasonable security measures consistent with this section in order to prevent unauthorized persons from gaining access to the area, place, or premises or to the controlled substances or dangerous drugs or dangerous devices therein. (2) The board shall, by regulation, establish conditions for the temporary absence of a pharmacist for breaks and lunch periods pursuant to Section 512 of the Labor Code and the orders of the Industrial Welfare Commission without closing the pharmacy and removing authorized personnel from the pharmacy. These conditions shall ensure the security of the pharmacy and its operations during the temporary absence of the pharmacist and shall allow, at the discretion of the pharmacist, nonpharmacist personnel to remain and perform any lawful activities during the pharmacist’s temporary absence. (Amended by Stats. 1999, Ch. 900, Sec. 4. Effective October 10, 1999.) - 4117. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7. Pharmacies [4110 - 4126.10] ( Article 7 added by Stats. 1996, Ch. 890, Sec. 3. )
Only specified authorized people may be in the licensed hospital pharmacy area where controlled substances and related drugs or devices are handled.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7. Pharmacies [4110 - 4126.10] ( Article 7 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4117. No person other than a pharmacist, an intern pharmacist, a pharmacy technician, an authorized officer of the law, a person authorized to prescribe, a registered nurse, a licensed vocational nurse, a person who enters the pharmacy for purposes of receiving consultation from a pharmacist, or a person authorized by the pharmacist in charge to perform clerical, inventory control, housekeeping, delivery, maintenance, or similar functions relating to the pharmacy shall be permitted in that area, place, or premises described in the license issued by the board to a licensed hospital wherein controlled substances, dangerous drugs, or dangerous devices are stored, possessed, prepared, manufactured, derived, compounded, dispensed, or repackaged. (Amended by Stats. 1997, Ch. 549, Sec. 69. Effective January 1, 1998.) - 4118. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7. Pharmacies [4110 - 4126.10] ( Article 7 added by Stats. 1996, Ch. 890, Sec. 3. )
The board may waive pharmacy licensing requirements, including for hospital pharmacies, when patient safety and good care can still be maintained.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7. Pharmacies [4110 - 4126.10] ( Article 7 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4118. (a) When, in the opinion of the board, a high standard of patient safety, consistent with good patient care, can be provided by the licensure of a pharmacy that does not meet all of the requirements for licensure as a pharmacy, the board may waive any licensing requirements. (b) When, in the opinion of the board, a high standard of patient safety, consistent with good patient care, can be provided by the licensure of a hospital pharmacy, as defined by subdivision (a) of Section 4029, that does not meet all of the requirements for licensure as a hospital pharmacy, the board may waive any licensing requirements. However, when a waiver of any requirements is granted by the board, the pharmaceutical services to be rendered by this pharmacy shall be limited to patients registered for treatment in the hospital, whether or not they are actually staying in the hospital, or to emergency cases under treatment in the hospital. (Amended by Stats. 1997, Ch. 549, Sec. 70. Effective January 1, 1998.) - 4118.5. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7. Pharmacies [4110 - 4126.10] ( Article 7 added by Stats. 1996, Ch. 890, Sec. 3. )
Hospital pharmacy staff must obtain medication profiles or lists for high-risk patients, and hospitals must set the high-risk criteria and completion timeframe.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7. Pharmacies [4110 - 4126.10] ( Article 7 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4118.5. (a) A pharmacist at a hospital pharmacy shall obtain an accurate medication profile or list for each high-risk patient upon admission and discharge of the high-risk patient under the following conditions: (1) The hospital has more than 100 beds. (2) The accurate medication profile or list may be acquired by the pharmacist during the hospital pharmacy’s hours of operation. (b) Notwithstanding any other law, a pharmacy technician or an intern pharmacist may perform the task of obtaining an accurate medication profile or list for a high-risk patient if both of the following conditions are satisfied: (1) The hospital pharmacy has a quality assurance program to monitor competency. (2) The hospital has established policies and procedures for training and proctoring pharmacy technicians or intern pharmacists by the hospital pharmacy department and the pharmacy technician or intern pharmacist has completed that training and proctoring. (c) The hospital shall establish criteria regarding who is a high-risk patient for purposes of this section, and shall determine the timeframe for completion of the medication profile or list, based on the patient populations served by the hospital. (d) The board may adopt rules and regulations to carry out the purposes and objectives of this section. (e) This section shall not apply to the State Department of State Hospitals. (f) Nothing in this section shall be construed to prohibit a healing arts licensee licensed pursuant to this division from obtaining an accurate medication profile or list. (Amended by Stats. 2025, Ch. 196, Sec. 38. (AB 1503) Effective January 1, 2026.) - 4119. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7. Pharmacies [4110 - 4126.10] ( Article 7 added by Stats. 1996, Ch. 890, Sec. 3. )
A pharmacy may supply certain dangerous drugs or devices to licensed health care facilities or approved EMS service providers if the storage, use, and local policy requirements are met.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7. Pharmacies [4110 - 4126.10] ( Article 7 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4119. (a) Notwithstanding any other law, a pharmacy may furnish a dangerous drug or dangerous device to a licensed health care facility for storage in a secured emergency pharmaceutical supplies container maintained within the facility in accordance with facility regulations of the State Department of Public Health set forth in Title 22 of the California Code of Regulations and the requirements set forth in Section 1261.5 of the Health and Safety Code. These emergency supplies shall be approved by the facility’s patient care policy committee or pharmaceutical service committee and shall be readily available to each nursing station. Section 1261.5 of the Health and Safety Code limits the number of oral dosage form or suppository form drugs in these emergency supplies to 48. (b) Notwithstanding any other law, a pharmacy may furnish a dangerous drug or a dangerous device to an approved service provider within an emergency medical services system for storage in a secured emergency pharmaceutical supplies container, in accordance with the policies and procedures of the local emergency medical services agency, if all of the following are met: (1) The dangerous drug or dangerous device is furnished exclusively for use in conjunction with services provided in an ambulance, or other approved emergency medical services service provider, that provides prehospital emergency medical services. (2) The requested dangerous drug or dangerous device is within the licensed or certified emergency medical technician’s scope of practice as established by the Emergency Medical Services Authority and set forth in Title 22 of the California Code of Regulations. (3) The approved service provider within an emergency medical services system provides a written request that specifies the name and quantity of dangerous drugs or dangerous devices. (4) The approved emergency medical services provider administers dangerous drugs and dangerous devices in accordance with the policies and procedures of the local emergency medical services agency. (5) The approved emergency medical services provider documents, stores, and restocks dangerous drugs and dangerous devices in accordance with the policies and procedures of the local emergency medical services agency. Records of each request by, and dangerous drugs or dangerous devices furnished to, an approved service provider within an emergency medical services system, shall be maintained by both the approved service provider and the dispensing pharmacy for a period of at least three years. The furnishing of controlled substances to an approved emergency medical services provider shall be in accordance with the California Uniform Controlled Substances Act (Division 10 (commencing with Section 11000) of the Health and Safety Code). (Amended by Stats. 2017, Ch. 647, Sec. 2. (SB 443) Effective January 1, 2018.) - 4119.01. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7. Pharmacies [4110 - 4126.10] ( Article 7 added by Stats. 1996, Ch. 890, Sec. 3. )
This section allows certain providers to restock dangerous drugs or devices into a licensed EMSADDS, but only if licensing, access, recordkeeping, inventory, and security rules are followed.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7. Pharmacies [4110 - 4126.10] ( Article 7 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4119.01. (a) Notwithstanding any other law, a pharmacy, or a licensed wholesaler that is also an emergency medical services provider agency, may restock dangerous drugs or dangerous devices into an emergency medical services automated drug delivery system (EMSADDS) that is licensed by the board under this section. Dangerous drugs and dangerous devices stored or maintained in an EMSADDS shall be used for the sole purpose of restocking a secured emergency pharmaceutical supplies container as authorized in subdivision (b) of Section 4119. The EMSADDS may be used only if all of the following conditions are met: (1) The emergency medical services provider agency obtains a license from the board to operate the EMSADDS. As a requirement for licensure, the EMSADDS shall be located on the premises of a fire department headquarters, a fire station, or at an emergency medical services provider agency’s location. A separate license shall be required for each location. As part of its license application, the emergency medical services provider agency shall provide: the address where the EMSADDS will be located; the name of the medical director responsible for overseeing the emergency medical services provider agency; the name of any designated pharmacist or licensed designated paramedic who is responsible for performing the duties as required under this section; the policies and procedures detailing the provisions under which the EMSADDS will operate; and the name and license number of the pharmacy or emergency medical services provider agency wholesaler that will furnish the dangerous drugs and dangerous devices through the EMSADDS. (2) Each EMSADDS shall collect, control, and maintain all transaction information necessary to accurately track the movement of drugs into and out of the system for purposes of security, accuracy, and accountability. (3) The medical director and designated pharmacist, or the medical director and the licensed designated paramedic, shall develop, adopt, and maintain policies and procedures detailing the provisions under which the EMSADDS will operate. At a minimum, the policies and procedures shall address (A) inventory controls, (B) training, (C) storage and security of the dangerous drugs and dangerous devices, and (D) safeguards to limit access to the EMSADDS to authorized staff only. (4) The licensed EMSADDS operator shall limit access to the EMSADDS only to employees of the operator who are licensed by the state and as authorized in this section. (A) An EMSADDS may only be restocked by the medical director, a pharmacist, or a licensed designated paramedic, each of whom may possess and transport dangerous drugs or dangerous devices for that purpose. The transport of dangerous drugs or dangerous devices for restocking into an EMSADDS shall be done in a secured manner to prevent theft or unauthorized access, and shall be done under conditions appropriate to meet storage and handling requirements of the dangerous drugs or dangerous devices. While the dangerous drugs or dangerous devices may be transported, representatives shall not store a dangerous drug or dangerous device at an unlicensed location. (B) Only a medical director, a pharmacist, or a paramedic may remove dangerous drugs or dangerous devices from an EMSADDS to fill a secured emergency pharmaceutical supplies container. This access shall be observed by a second person who is also a paramedic, a pharmacist, or a medical director. Both the individual who removes dangerous drugs or dangerous devices from the EMSADDS and the observer shall record their participation in the removal of the dangerous drugs or dangerous devices via their signatures or use of biometric identifiers. The restocking of the secured emergency pharmaceutical supplies container from the EMSADDS shall occur at the licensed location of the EMSADDS. (C) A medical director, a pharmacist, or a licensed designated paramedic may remove outdated dangerous drugs or dangerous devices from an EMSADDS. Any outdated dangerous drugs or dangerous devices shall be provided to a licensed reverse distributor for destruction. (5) Every EMSADDS operator shall perform monthly inventory and inventory reconciliation functions. The medical director, designated pharmacist, or licensed designated paramedic shall perform a reconciliation and prepare a written report based on written policies and procedures developed to maintain the security and quality of the dangerous drugs and dangerous devices. The written inventory reconciliation report shall include all of the following: (A) A physical count of all quantities of dangerous drugs and dangerous devices stored in the EMSADDS. (B) A review of all dangerous drugs and dangerous devices added into and removed from each EMSADDS since the last monthly inventory. (C) A comparison of subparagraphs (A) and (B), and identification of any variances. (D) A review of all individuals who accessed the EMSADDS since the last inventory and identification of unauthorized individuals accessing the EMSADDS or suspicious activity. (E) Identification of possible causes of shortages and overages. (6) The medical director and designated pharmacist, or medical director and licensed designated paramedic, shall be jointly responsible for monthly review of the inventory reconciliation report, the training, storage, and security of dangerous drugs and dangerous devices, and the restocking of the EMSADDS. Any inventory losses from an EMSADDS shall be reported to the board within seven days from identification of the loss. (7) In order for an individual to perform the functions of a licensed designated paramedic described in this section, that individual shall be licensed by the board pursuant to Section 4202.5. A paramedic who only restocks a secured emergency pharmaceutical supplies container from an EMSADDS need not be licensed with the board. (8) A record of each access to the EMSADDS, as well as all records used to compile an inventory reconciliation report, shall be maintained at the operator’s location for at least three years in a readily retrievable form. The records shall include the identity of every individual who accessed the system or witnessed such access; the date of each access; and the drug, dosage, form, strength, and quantity of dangerous drugs or dangerous devices added or removed. (b) A violation of any of the provisions of this section shall constitute unprofessional conduct and provides the board the authority to take action against the EMSADDS operator’s license. (c) This section shall become operative on January 1, 2025. (Repealed (in Sec. 4) and added by Stats. 2023, Ch. 723, Sec. 5. (SB 816) Effective January 1, 2024. Operative January 1, 2025, by its own provisions.) - 4119.10. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7. Pharmacies [4110 - 4126.10] ( Article 7 added by Stats. 1996, Ch. 890, Sec. 3. )
A California pharmacy may use pharmacists to do certain waived FDA-approved or authorized tests if it meets listed licensing, policy, reporting, safety, and recordkeeping conditions.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7. Pharmacies [4110 - 4126.10] ( Article 7 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4119.10. A pharmacy located in the state may use pharmacists to perform FDA-approved or -authorized tests that are classified as waived pursuant to the federal Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. Sec. 263a) and the regulations adopted thereunder by the federal Health Care Financing Administration, under all of the following conditions: (a) The pharmacy is appropriately licensed as a laboratory under Section 1265. (b) The pharmacy maintains policies and procedures that do all of the following: (1) Establish the initial training requirements, including specimen collection techniques relevant to a test being performed at the pharmacy, and ongoing training. (2) Establish safety precautions necessary to protect pharmacy staff and consumers and to reduce the risk of transmission, consistent with Cal-OSHA and CDC requirements, including, but not limited to, provisions for the use of personal protective equipment, cleaning and sanitizing procedures, appropriate biohazard waste requirements, and space requirements for pharmacy staff and consumers. (3) Ensure the availability of dedicated physically distanced space or other segregated space that provides for privacy during the testing process and private consultation with the pharmacist, and limits potential contamination of other consumers in the pharmacy. (4) Establish requirements for providing test results to the patient in a nonverbal manner, complying with mandatory reporting requirements to local and state reporting systems, and notifying the patient’s health care providers if consent is provided, and referral to licensed sources of care for confirmation, diagnosis, and treatment as appropriate for followup to positive test results. A health care provider shall not be held personally liable for test results, or for any actions or inactions related to test results they did not receive, have knowledge of, or otherwise have access to. (5) Establish requirements for the pharmacist-in-charge serving as the pharmacy laboratory director to report any reportable disease or condition identified in Section 120130 of the Health and Safety Code or the regulations adopted under that section. (6) Ensure documentation of testing equipment maintenance and calibration. (7) Ensure appropriate storage and handling of specimens, testing reagents, and other supplies or equipment that require specialized storage or handling. Specimen collection shall not include vaginal swab, venipuncture, or the collection of seminal fluid. (c) The test is authorized to be administered by a pharmacist pursuant to paragraph (1) of subdivision (b) of Section 4052.4. (d) The pharmacist-in-charge does both of the following: (1) Annually reviews the policies and procedures maintained pursuant to subdivision (b), assesses the pharmacy’s compliance with its policies, and documents corrective actions to be taken when noncompliance is found. (2) Maintains documentation of the annual review and assessment in a readily retrievable format for a period of three years from the date of completion. (e) The pharmacy maintains documentation related to performing tests that demonstrates compliance with this section, which shall include the name of the pharmacist performing the test, the results of the test, and communication of results to a patient’s primary medical provider, and is maintained in a readily retrievable format for a period of three years from the date of creation. (Added by Stats. 2021, Ch. 604, Sec. 4. (SB 409) Effective January 1, 2022.) - 4119.11. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7. Pharmacies [4110 - 4126.10] ( Article 7 added by Stats. 1996, Ch. 890, Sec. 3. )
This section allows a California pharmacy to use an automated patient dispensing system for covered-entity patients only if licensing, contract, recordkeeping, security, supervision, and notice requirements are met.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7. Pharmacies [4110 - 4126.10] ( Article 7 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4119.11. (a) A pharmacy located in the state may provide pharmacy services to the patients of a “covered entity,” as defined in Section 256b of Title 42 of the United States Code, through the use of an automated patient dispensing system located on the premises of the covered entity or on the premises of medical professional practices under contract to provide medical services to covered entity patients, which need not be the same location as the pharmacy, if all of the following conditions are met: (1) The pharmacy obtains a license from the board to operate the automated patient dispensing system at the covered entity or affiliated site. As part of the application, the pharmacy shall provide the address at which the automated patient dispensing system shall be placed and identify the covered entity. A separate license shall be required for each location and shall be renewed annually concurrent with the pharmacy license. (2) The pharmacy providing the pharmacy services to the patients of the covered entity, including, unless otherwise prohibited by any other law, patients enrolled in the Medi-Cal program, shall be under contract with that covered entity as described in Section 4126 to provide those pharmacy services through the use of the automated patient dispensing system. (3) Drugs stored in an automated patient dispensing system shall be part of the inventory of the pharmacy providing pharmacy services to the patients of the covered entity and drugs dispensed from the automated patient dispensing system shall be considered to have been dispensed by that pharmacy. (4) The pharmacy shall maintain records of the acquisition and disposition of dangerous drugs stored in the automated patient dispensing system separate from other pharmacy records. (5) The pharmacy shall be solely responsible for the security, operation, and maintenance of the automated patient dispensing system. (6) The pharmacy shall provide training regarding the operation and use of the automated patient dispensing system to both pharmacy and covered entity personnel using the system. (7) The operation of the automated patient dispensing system shall be under the supervision of a licensed pharmacist acting on behalf of the pharmacy providing services to the patients of the covered entity. The pharmacist need not be physically present at the site of the automated patient dispensing system and may supervise the system electronically. (8) Notwithstanding Section 4107, the board may issue a license for the operation of an automated patient dispensing system at an address for which it has issued another site license. (9) The board, within 30 days after receipt of an application for an automated patient dispensing system license, shall conduct a prelicensure inspection at the proposed location of the automated patient dispensing system. Relocation of the automated patient dispensing system shall require a new application for licensure. Replacement of an automated patient dispensing system shall require notice to the board within 30 days. (10) The automated patient dispensing system license shall be canceled by operation of law if the underlying pharmacy license is not current, valid, and active. Upon reissuance or reinstatement of the underlying pharmacy license, a new application for an automated patient dispensing system license may be submitted to the board. (11) A pharmacy that holds an automated patient dispensing system license shall advise the board in writing within 30 days if use of the automated patient dispensing system is discontinued. (b) For purposes of this section, the following definitions shall apply: (1) An “automated drug delivery system” (ADDS) means a mechanical system that performs operations or activities, other than compounding or administration, relative to the storage, dispensing, or distribution of drugs. An ADDS shall collect, control, and maintain all transaction information to accurately track the movement of drugs into and out of the system for security, accuracy, and accountability. (2) An “automated patient dispensing system” (APDS) is an ADDS for storage and dispensing of prescribed drugs directly to patients pursuant to prior authorization by a pharmacist. (3) An “automated unit dose system” (AUDS) is an ADDS for storage and retrieval of unit doses of drugs for administration to patients by persons authorized to perform these functions. (c) (1) An automated patient dispensing system shall collect, control, and maintain all transaction information to accurately track the movement of drugs into and out of the system for security, accuracy, and accountability. (2) Transaction information shall be made readily available in a downloadable format for review and inspection by individuals authorized by law. These records shall be maintained by the pharmacy for a minimum of three years. (d) Drugs from the automated patient dispensing system may be dispensed directly to the patient, if all of the following requirements are met: (1) The pharmacy shall develop, implement, and annually review written policies and procedures with respect to all of the following: (A) Maintaining the security of the automated patient dispensing system and the dangerous drugs and devices within that automated patient dispensing system. (B) Determining and applying inclusion criteria regarding which drugs and devices are appropriate for placement in the automated patient dispensing system and for which patients. (C) Ensuring that patients are aware that consultation with a pharmacist is available for any prescription medication, including those delivered via the automated patient dispensing system. (D) Describing assignment of responsibilities to, and training of, pharmacy personnel, and other personnel using the automated patient dispensing system at the location where the automated patient dispensing system is placed, regarding maintenance and filing procedures for the automated patient dispensing system. (E) Orienting participating patients on the use of the automated patient dispensing system, notifying patients when expected prescription medications are not available in the automated patient dispensing system, and ensuring that patient use of the automated patient dispensing system does not interfere with delivery of drugs and devices. (F) Ensuring delivery of drugs and devices to patients expecting to receive them from the automated patient dispensing system if the automated patient dispensing system is disabled or malfunctions. (2) The automated patient dispensing system shall only be used for patients who have signed a written consent demonstrating their informed consent to receive prescribed drugs and devices from an automated patient dispensing system and whose use of the automated patient dispensing system meet the criteria pursuant to paragraph (1). (3) The automated patient dispensing system shall have a means to identify each patient and only release the identified patient’s drugs and devices to the patient or the patient’s agent. (4) A pharmacist shall perform all clinical services conducted as part of the dispensing process, including, but not limited to, drug utilization review and consultation. (5) Drugs shall be dispensed from the automated patient dispensing system only upon authorization from a pharmacist after the pharmacist has reviewed the prescription and the patient’s profile for potential contraindications and adverse drug reactions. (6) All prescribed drugs and devices dispensed from the automated patient dispensing system for the first time shall be accompanied by a consultation conducted by a pharmacist licensed by the board via a telecommunications link that has two-way audio and video. (7) The automated patient dispensing system shall include a notice, prominently posted on the automated patient dispensing system, that provides the name, address, and telephone number of the pharmacy that holds the automated patient dispensing system license for that automated patient dispensing system. (8) The labels on all drugs dispensed by the automated patient dispensing system shall comply with Section 4076 of this code and with Section 1707.5 of Title 16 of the California Code of Regulations. (9) Any complaint, error, or omission involving the automated patient dispensing system shall be reviewed as part of the pharmacy’s quality assurance program pursuant to Section 4125. (10) The board shall not issue a pharmacy more than 15 licenses for automated patient dispensing system units under this section. Consistent with Section 4001.1, the board may adopt regulations to reduce the number of automated patient dispensing system licenses that may be issued to a pharmacy. (11) The pharmacy holding the license for the automated patient dispensing system shall maintain the policies and procedures developed pursuant to paragraph (1) for three years after the last date of use of that automated patient dispensing system. (e) Access to the automated patient dispensing system shall be controlled and tracked using an identification or password system or biosensor. A system that is accessed via a password system shall include a camera that records a picture of the individual accessing the machine. Picture records shall be maintained for a minimum of 180 days. (f) The automated patient dispensing system shall make a complete and accurate record of all transactions that will include all users accessing the system and all drugs added to, or removed from, the system. (g) The stocking of an automated patient dispensing system shall be performed by a pharmacist. If the automated patient dispensing system utilizes removable pockets, cards, drawers, similar technology, or unit of use or single dose containers as defined by the United States Pharmacopeia, the stocking system may be done outside of the facility and be delivered to the facility, if all of the following conditions are met: (1) The task of placing drugs into the removable pockets, cards, drawers, similar technology, or unit of use or single dose containers is performed by a pharmacist, or by an intern pharmacist or a pharmacy technician working under the direct supervision of a pharmacist. (2) The removable pockets, cards, drawers, similar technology, or unit of use or single dose containers are transported between the pharmacy and the facility in a secure tamper-evident container. (3) The pharmacy, in conjunction with the covered entity, has developed policies and procedures to ensure that the removable pockets, cards, drawers, similar technology, or unit of use or single dose containers are properly placed into the automated patient dispensing system. (h) Review of the drugs contained within, and the operation and maintenance of, the automated patient dispensing system shall be done in accordance with law and shall be the responsibility of the pharmacy. A pharmacist shall conduct the review on a monthly basis, which shall include a physical inspection of the drugs in the automated patient dispensing system, an inspection of the automated patient dispensing system machine for cleanliness, and a review of all transaction records in order to verify the security and accountability of the system. (i) A pharmacy holding an automated patient dispensing system license shall complete a self-assessment, performed pursuant to Section 1715 of Title 16 of the California Code of Regulations, evaluating the pharmacy’s compliance with pharmacy law relating to the use of the automated patient dispensing system. All information regarding operation, maintenance, compliance, error, omissions, or complaints pertaining to the automated patient dispensing system shall be included in the self-assessment. (j) The pharmacy shall comply with all recordkeeping and quality assurance requirements pursuant to this chapter, and shall maintain those records within the pharmacy holding the automated patient dispensing system license and separately from other pharmacy records. (k) This section shall become operative on January 1, 2025. (Repealed (in Sec. 6) and added by Stats. 2023, Ch. 723, Sec. 7. (SB 816) Effective January 1, 2024. Operative January 1, 2025, by its own provisions.) - 4119.2. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7. Pharmacies [4110 - 4126.10] ( Article 7 added by Stats. 1996, Ch. 890, Sec. 3. )
A pharmacy may furnish epinephrine delivery systems to a local educational agency if the systems are for school use only and a physician and surgeon provides a written order stating the quantity.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7. Pharmacies [4110 - 4126.10] ( Article 7 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4119.2. (a) Notwithstanding any other law, a pharmacy may furnish epinephrine delivery systems to a local educational agency pursuant to Section 49414 of the Education Code if all of the following are met: (1) The epinephrine delivery systems are furnished exclusively for use at a local educational agency, as that term is defined in Section 49414 of the Education Code, including at any state or federally subsidized childcare program operated by or under contract with the local educational agency. (2) A physician and surgeon provides a written order that specifies the quantity of epinephrine delivery systems to be furnished. (b) Records regarding the acquisition and disposition of epinephrine delivery systems furnished pursuant to subdivision (a) shall be maintained by the local educational agency for a period of three years from the date the records were created. The local educational agency shall be responsible for monitoring the supply of epinephrine delivery systems and ensuring the destruction of expired epinephrine delivery systems. (Amended by Stats. 2025, Ch. 322, Sec. 1. (SB 568) Effective January 1, 2026.) - 4119.3. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7. Pharmacies [4110 - 4126.10] ( Article 7 added by Stats. 1996, Ch. 890, Sec. 3. )
A pharmacy may repackage a previously dispensed drug at the patient’s request, but repackaging pharmacies must maintain repackaging policies and procedures and label the container with specified information.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7. Pharmacies [4110 - 4126.10] ( Article 7 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4119.3. (a) A pharmacy may, at a patient’s request, repackage a drug previously dispensed to the patient or to the patient’s agent pursuant to a prescription. (b) Any pharmacy providing repackaging services shall have in place policies and procedures for repackaging these drugs and shall label the repackaged prescription container with the following: (1) All the information required by Section 4076. (2) The name and address of the pharmacy repackaging the drug and the name and address of the pharmacy that initially dispensed the drug to the patient. (c) The repackaging pharmacy and the pharmacy that initially dispensed the drug shall only be liable for its own actions in providing the drug to the patient or the patient’s agent. (Added by renumbering Section 4052.7 by Stats. 2025, Ch. 196, Sec. 20. (AB 1503) Effective January 1, 2026.) - 4119.4. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7. Pharmacies [4110 - 4126.10] ( Article 7 added by Stats. 1996, Ch. 890, Sec. 3. )
A pharmacy may furnish epinephrine auto-injectors to an authorized entity if the listed conditions are met, and the pharmacy and authorized entity must follow labeling, recordkeeping, and supply-monitoring rules.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7. Pharmacies [4110 - 4126.10] ( Article 7 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4119.4. (a) Notwithstanding any other law, a pharmacy may furnish epinephrine auto-injectors to an authorized entity, for the purpose of rendering emergency care in accordance with Section 1797.197a of the Health and Safety Code, if both of the following requirements are met: (1) The epinephrine auto-injectors are furnished exclusively for use by, or in connection with, an authorized entity. (2) An authorized health care provider provides a prescription that specifies the quantity of epinephrine auto-injectors to be furnished to an authorized entity described in subdivision (a) of Section 1797.197a of the Health and Safety Code. A new prescription shall be written for any additional epinephrine auto-injectors required for use. (b) The pharmacy shall label each epinephrine auto-injector dispensed with all of the following: (1) The name of the person or entity to whom the prescription was issued. (2) The designations “Section 1797.197a Responder” and “First Aid Purposes Only.” (3) The dosage, use, and expiration date. (c) Each dispensed prescription shall include the manufacturer’s product information sheet for the epinephrine auto-injector. (d) Records regarding the acquisition and disposition of epinephrine auto-injectors furnished pursuant to subdivision (a) shall be maintained by the authorized entity for a period of three years from the date the records were created. The authorized entity shall be responsible for monitoring the supply of epinephrine auto-injectors and ensuring the destruction of expired epinephrine auto-injectors. (e) The epinephrine auto-injector dispensed pursuant to this section may be used only for the purpose, and under the circumstances, described in Section 1797.197a of the Health and Safety Code. (f) For purposes of this section, “epinephrine auto-injector” means a disposable delivery device designed for the automatic injection of a premeasured dose of epinephrine into the human body to prevent or treat a life-threatening allergic reaction. (Added by Stats. 2016, Ch. 374, Sec. 1. (AB 1386) Effective January 1, 2017.) - 4119.5. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7. Pharmacies [4110 - 4126.10] ( Article 7 added by Stats. 1996, Ch. 890, Sec. 3. )
A pharmacy may transfer a reasonable supply of dangerous drugs to another pharmacy and may repackage and furnish a reasonable quantity of dangerous drugs and devices to a prescriber for office use.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7. Pharmacies [4110 - 4126.10] ( Article 7 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4119.5. (a) A pharmacy can transfer a reasonable supply of dangerous drugs to another pharmacy. (b) A pharmacy may repackage and furnish to a prescriber a reasonable quantity of dangerous drugs and dangerous devices for prescriber office use. (Added by Stats. 1997, Ch. 549, Sec. 72. Effective January 1, 1998.) - 4119.6. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7. Pharmacies [4110 - 4126.10] ( Article 7 added by Stats. 1996, Ch. 890, Sec. 3. )
An intern pharmacist may stock, replenish, and inspect certain emergency supplies at a licensed health care facility if acting under a pharmacist’s direct supervision and control.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7. Pharmacies [4110 - 4126.10] ( Article 7 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4119.6. An intern pharmacist under the direct supervision and control, as defined in Section 4023.5, of a pharmacist may stock, replenish, and inspect the emergency pharmaceutical supplies container and the emergency medical system supplies of a health care facility licensed under subdivision (a) of Section 1250 of the Health and Safety Code. (Added by Stats. 2014, Ch. 319, Sec. 2. (SB 1039) Effective January 1, 2015.) - 4119.7. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7. Pharmacies [4110 - 4126.10] ( Article 7 added by Stats. 1996, Ch. 890, Sec. 3. )
A hospital pharmacy may furnish certain dangerous drugs or devices under approved standing orders if the patient record is dated, timed, and authenticated; health care facilities must follow storage standards and written inspection policies; an intern pharmacist may inspect drugs at least monthly under supervision.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7. Pharmacies [4110 - 4126.10] ( Article 7 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4119.7. (a) Notwithstanding any other law, a hospital pharmacy serving a health care facility licensed under subdivision (a) of Section 1250 of the Health and Safety Code may furnish a dangerous drug or dangerous device pursuant to preprinted or electronic standing orders, order sets, and protocols established under the policies and procedures of the health care facility, as approved according to the policies of the health care facility’s governing body, if the order is dated, timed, and authenticated in the medical record of the patient to whom the dangerous drug or dangerous device will be provided. (b) A health care facility shall store and maintain drugs in accordance with national standards regarding the storage area and refrigerator or freezer temperature, and otherwise pursuant to the manufacturer’s guidelines. The health care facility’s policies and procedures shall specify these storage parameters. (c) An intern pharmacist under the direct supervision and control, as defined in Section 4023.5, of a pharmacist, may inspect the drugs maintained in the health care facility at least once per month. The health care facility shall establish specific written policies and procedures for inspections pursuant to this subdivision. (d) For purposes of this section, “health care facility” means a health facility licensed under subdivision (a) of Section 1250 of the Health and Safety Code. (Added by Stats. 2014, Ch. 319, Sec. 3. (SB 1039) Effective January 1, 2015.) - 4119.8. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7. Pharmacies [4110 - 4126.10] ( Article 7 added by Stats. 1996, Ch. 890, Sec. 3. )
A pharmacy may furnish naloxone or another opioid antagonist to certain schools if the drug is for schoolsite use and a physician and surgeon gives a written order; the school must keep related records for three years and monitor supply and expired stock.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7. Pharmacies [4110 - 4126.10] ( Article 7 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4119.8. (a) Notwithstanding any other law, a pharmacy may furnish naloxone hydrochloride or another opioid antagonist to a school district, county office of education, or charter school pursuant to Section 49414.3 of the Education Code if all of the following are met: (1) The naloxone hydrochloride or another opioid antagonist is furnished exclusively for use at a school district schoolsite, county office of education schoolsite, or charter school. (2) A physician and surgeon provides a written order that specifies the quantity of naloxone hydrochloride or another opioid antagonist to be furnished. (b) Records regarding the acquisition and disposition of naloxone hydrochloride or another opioid antagonist furnished pursuant to subdivision (a) shall be maintained by the school district, county office of education, or charter school for a period of three years from the date the records were created. The school district, county office of education, or charter school shall be responsible for monitoring the supply of naloxone hydrochloride or another opioid antagonist and ensuring the destruction of expired naloxone hydrochloride or another opioid antagonist. (Added by Stats. 2016, Ch. 557, Sec. 1. (AB 1748) Effective January 1, 2017.) - 4119.9. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7. Pharmacies [4110 - 4126.10] ( Article 7 added by Stats. 1996, Ch. 890, Sec. 3. )
A pharmacy, wholesaler, or manufacturer may supply naloxone or another opioid antagonist to a law enforcement agency if the drug is for trained employees only, and the agency keeps related records for three years.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7. Pharmacies [4110 - 4126.10] ( Article 7 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4119.9. Notwithstanding any other law, a pharmacy, wholesaler, or manufacturer may furnish naloxone hydrochloride or other opioid antagonists to a law enforcement agency if both of the following are met: (a) The naloxone hydrochloride or other opioid antagonist is furnished exclusively for use by employees of the law enforcement agency who have completed training, provided by the law enforcement agency, in administering naloxone hydrochloride or other opioid antagonists. (b) Records regarding the acquisition and disposition of naloxone hydrochloride or other opioid antagonists furnished pursuant to this section shall be maintained by the law enforcement agency for a period of three years from the date the records were created. The law enforcement agency shall be responsible for monitoring the supply of naloxone hydrochloride or other opioid antagonists and ensuring the destruction of expired naloxone hydrochloride or other opioid antagonists. (Added by Stats. 2018, Ch. 259, Sec. 1. (AB 2256) Effective January 1, 2019.) - 4120. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7. Pharmacies [4110 - 4126.10] ( Article 7 added by Stats. 1996, Ch. 890, Sec. 3. )
A nonresident pharmacy must register before selling or distributing dangerous drugs or dangerous devices in the state outside the listed licensed channels. Registration applications must use a board-furnished form, and the board may require needed information.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7. Pharmacies [4110 - 4126.10] ( Article 7 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4120. (a) A nonresident pharmacy shall not sell or distribute dangerous drugs or dangerous devices in this state through any person or media, other than a wholesaler or third-party logistics provider who has obtained a license pursuant to this chapter or through a selling or distribution outlet that is licensed as a wholesaler or third-party logistics provider pursuant to this chapter, without registering as a nonresident pharmacy. (b) Applications for a nonresident pharmacy registration shall be made on a form furnished by the board. The board may require any information the board deems reasonably necessary to carry out the purposes of this section. (c) The Legislature, by enacting this section, does not intend a license issued to any nonresident pharmacy pursuant to this section to change or affect the tax liability imposed by Chapter 3 (commencing with Section 23501) of Part 11 of Division 2 of the Revenue and Taxation Code on any nonresident pharmacy. (d) The Legislature, by enacting this section, does not intend a license issued to any nonresident pharmacy pursuant to this section to serve as any evidence that the nonresident pharmacy is doing business within this state. (Amended by Stats. 2015, Ch. 303, Sec. 6. (AB 731) Effective January 1, 2016.) - 4121. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7. Pharmacies [4110 - 4126.10] ( Article 7 added by Stats. 1996, Ch. 890, Sec. 3. )
Retail price ads for prescription drugs must stay within medically appropriate quantities and must show the strength, dosage form, and exact dates the price applies; the section does not apply to certain hospital pharmacies.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7. Pharmacies [4110 - 4126.10] ( Article 7 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4121. (a) Notwithstanding Section 651, an advertisement of the retail price for a drug that requires a prescription shall be limited to quantities of the drug that are consistent with good medical practice and shall include the strength, dosage form, and the exact dates during which the advertised price will be in effect. (b) This section shall not apply to a pharmacy that is located in a licensed hospital and that is accessible only to hospital medical staff and personnel. (Repealed and added by Stats. 1996, Ch. 890, Sec. 3. Effective January 1, 1997.) - 4122. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7. Pharmacies [4110 - 4126.10] ( Article 7 added by Stats. 1996, Ch. 890, Sec. 3. )
Pharmacies must post a board notice about price and service information, and pharmacists or employees must give current retail drug prices when consumers ask.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7. Pharmacies [4110 - 4126.10] ( Article 7 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4122. (a) In every pharmacy there shall be prominently posted in a place conspicuous to, and readable by, prescription drug consumers a notice provided by the board concerning the availability of prescription price information, the possibility of generic drug product selection, the type of services provided by pharmacies, and a statement describing patients’ rights relative to the requirements imposed on pharmacists pursuant to Section 733. The format and wording of the notice shall be adopted by the board by regulation. A written receipt that contains the required information on the notice may be provided to consumers as an alternative to posting the notice in the pharmacy. (b) A pharmacist, or a pharmacist’s employee, shall give the current retail price for any drug sold at the pharmacy upon request from a consumer, however that request is communicated to the pharmacist or employee. (c) If a requester requests price information on more than five prescription drugs and does not have valid prescriptions for all of the drugs for which price information is requested, a pharmacist may require the requester to meet any or all of the following requirements: (1) The request shall be in writing. (2) The pharmacist shall respond to the written request within a reasonable period of time. A reasonable period of time is deemed to be 10 days, or the time period stated in the written request, whichever is later. (3) A pharmacy may charge a reasonable fee for each price quotation, as long as the requester is informed that there will be a fee charged. (4) No pharmacy shall be required to respond to more than three requests as described in this subdivision from any one person or entity in a six-month period. (d) This section shall not apply to a pharmacy that is located in a licensed hospital and that is accessible only to hospital medical staff and personnel. (e) Notwithstanding any other provision of this section, no pharmacy shall be required to do any of the following: (1) Provide the price of any controlled substance in response to a telephone request. (2) Respond to a request from a competitor. (3) Respond to a request from an out-of-state requester. (Amended by Stats. 2007, Ch. 130, Sec. 11. Effective January 1, 2008.) - 4123. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7. Pharmacies [4110 - 4126.10] ( Article 7 added by Stats. 1996, Ch. 890, Sec. 3. )
Some pharmacies must report certain compounding arrangements to the board, and the pharmacy doing the compounding must report the information within 30 days of starting the compounding.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7. Pharmacies [4110 - 4126.10] ( Article 7 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4123. Any pharmacy that contracts to compound a drug for parenteral therapy, pursuant to a prescription, for delivery to another pharmacy shall report that contractual arrangement to the board. That information shall be reported by the pharmacy performing the compounding services within 30 days of commencing that compounding. (Repealed and added by Stats. 1996, Ch. 890, Sec. 3. Effective January 1, 1997.) - 4124. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7. Pharmacies [4110 - 4126.10] ( Article 7 added by Stats. 1996, Ch. 890, Sec. 3. )
Pharmacists may dispense replacement contact lenses only under the section’s conditions, and pharmacies must follow specific prescription, warning, registration, advertising, and recordkeeping rules.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7. Pharmacies [4110 - 4126.10] ( Article 7 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4124. (a) Notwithstanding Section 2543, a pharmacist may dispense replacement contact lenses pursuant to a valid prescription of a physician or optometrist. Nothing in this section authorizes a pharmacist to conduct an examination of the eyes or to fit or adjust contact lenses. For purposes of this section, “replacement contact lenses” means soft contact lenses that require no fitting or adjustment, and that are dispensed as packaged and sealed by the manufacturer. (b) No replacement contact lenses may be sold or dispensed except pursuant to a prescription that meets all of the following requirements: (1) Conforms to state and federal statutes and regulations governing those prescriptions and includes the name, address, and state license number of the prescribing practitioner. (2) Explicitly states an expiration date of not more than one year from the date of the last prescribing examination. (3) Explicitly states that the prescription is for contact lenses and includes the lens brand name, type, and tint, including all specifications necessary for the ordering of lenses. (c) The contact lenses that are dispensed shall be the exact contact lenses that have been prescribed, and no substitutions shall be made. (d) Any pharmacist and pharmacy that dispenses replacement contact lenses shall direct the patient to confer with his or her eyecare practitioner in the event of any eye problem or reaction to the lenses. (e) Any pharmacist and pharmacy that sells replacement contact lenses shall provide the following or substantially equivalent written notification to the patient whenever contact lenses are supplied: WARNING: IF YOU ARE HAVING ANY UNEXPLAINED EYE DISCOMFORT, WATERING, VISION CHANGE, OR REDNESS, REMOVE YOUR LENSES IMMEDIATELY AND CONSULT YOUR EYE CARE PRACTITIONER BEFORE WEARING YOUR LENSES AGAIN. (f) Any pharmacy and pharmacist dispensing replacement contact lenses shall be subject to all statutes, regulations, and ordinances governing the advertisement of contact lenses. In addition, any advertisement by a pharmacy or pharmacist that mentions replacement contact lenses shall include within the advertisement all fees, charges, and costs associated with the purchase of the lenses from that pharmacy and pharmacist. (g) Any pharmacy dispensing replacement contact lenses shall register with the Medical Board of California at the time of initial application for a license or at the time of annual renewal of that license. (h) All nonresident pharmacies shall maintain records of replacement contact lenses shipped, mailed, or delivered to persons in California for a period of at least three years. The records shall be available for inspection upon request by the board or the Division of Licensing of the Medical Board of California. (i) The requirements of this section are applicable to nonresident pharmacies as defined in subdivision (a) of Section 4112. A nonresident pharmacy may dispense contact lenses only as provided in this section. (Repealed and added by Stats. 1996, Ch. 890, Sec. 3. Effective January 1, 1997.) - 4125. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7. Pharmacies [4110 - 4126.10] ( Article 7 added by Stats. 1996, Ch. 890, Sec. 3. )
Every pharmacy must run a quality assurance program that records medication errors and helps the pharmacy prevent repeat errors.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7. Pharmacies [4110 - 4126.10] ( Article 7 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4125. (a) Every pharmacy shall establish a quality assurance program that shall, at a minimum, document medication errors attributable, in whole or in part, to the pharmacy or its personnel. The purpose of the quality assurance program shall be to assess errors that occur in the pharmacy in dispensing or furnishing prescription medications so that the pharmacy may take appropriate action to prevent a recurrence. (b) Records generated for and maintained as a component of a pharmacy’s ongoing quality assurance program shall be considered peer review documents and not subject to discovery in any arbitration, civil, or other proceeding, except as provided hereafter. That privilege shall not prevent review of a pharmacy’s quality assurance program and records maintained as part of that system by the board as necessary to protect the public health and safety or if fraud is alleged by a government agency with jurisdiction over the pharmacy. Nothing in this section shall be construed to prohibit a patient from accessing his or her own prescription records. Nothing in this section shall affect the discoverability of any records not solely generated for and maintained as a component of a pharmacy’s ongoing quality assurance program. (c) This section shall become operative on January 1, 2002. (Added by Stats. 2000, Ch. 677, Sec. 1. Effective January 1, 2001. Section operative January 1, 2002, by its own provisions.) - 4126. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7. Pharmacies [4110 - 4126.10] ( Article 7 added by Stats. 1996, Ch. 890, Sec. 3. )
A covered entity may contract with a pharmacy for pharmacy services, but the contract must follow HRSA guidelines and be available for board staff inspection. Pharmacies must separate covered drugs, keep records retrievable, return undeliverable drugs to the distributor, and a participating licensee may not hold both pharmacy and wholesaler licenses.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7. Pharmacies [4110 - 4126.10] ( Article 7 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4126. (a) Notwithstanding any other provision of law, a covered entity may contract with a pharmacy to provide pharmacy services to patients of the covered entity, as defined in Section 256b of Title 42 of the United States Code, including dispensing preferentially priced drugs obtained pursuant to Section 256b of Title 42 of the United States Code. Contracts between those covered entities and pharmacies shall comply with guidelines published by the Health Resources and Services Administration and shall be available for inspection by board staff during normal business hours. (b) Drugs purchased pursuant to Section 256b of Title 42 of the United States Code and received by a pharmacy shall be segregated from the pharmacy’s other drug stock by either physical or electronic means. All records of acquisition and disposition of these drugs shall be readily retrievable in a form separate from the pharmacy’s other records. (c) Drugs obtained by a pharmacy to be dispensed to patients of a covered entity pursuant to Section 256b of Title 42 of the United States Code that cannot be distributed because of a change in circumstances for the covered entity or the pharmacy shall be returned to the distributor from which they were obtained. For the purposes of this section, a change in circumstances includes, but is not limited to, the termination or expiration of the contract between the pharmacy and the covered entity, the closure of a pharmacy, disciplinary action against the pharmacy, or closure of the covered entity. (d) A licensee that participates in a contract to dispense preferentially priced drugs pursuant to this section shall not have both a pharmacy and a wholesaler license. (e) Neither a covered entity nor a pharmacy shall be required to obtain a license as a wholesaler based on acts reasonably necessary to fully participate in the drug purchase program established by Section 256b of Title 42 of the United States Code. (Added by Stats. 2001, Ch. 631, Sec. 2. Effective January 1, 2002.) - 4126.10. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7. Pharmacies [4110 - 4126.10] ( Article 7 added by Stats. 1996, Ch. 890, Sec. 3. )
A California pharmacy may distribute compounded human drug preparations interstate only if it files required annual data, the pharmacist-in-charge certifies compliance at renewal, and adverse drug or product quality issues are reported to the board within 12 hours.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7. Pharmacies [4110 - 4126.10] ( Article 7 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4126.10. (a) A pharmacy located in California may distribute compounded human drug preparations interstate only if all of the following conditions are met: (1) Between January 1 and March 31 of each year, the pharmacy reports all required data for the previous calendar year into the Information Sharing Network established by the National Association of Boards of Pharmacy in conjunction with the United States Food and Drug Administration (FDA) to implement the Memorandum of Understanding Addressing Certain Distributions of Compounded Human Drug Products. (2) On an annual basis, in connection with and as a condition of renewal of the pharmacy’s license, the pharmacist-in-charge of the pharmacy certifies that the reporting requirements of paragraph (1) have been satisfied. (3) The pharmacy reports any adverse drug experience and product quality issue for any compounded product to the board within 12 hours after the pharmacy receives notice of the adverse drug experience or product quality issue. (b) Information reported by the board to the FDA directly or through the Information Sharing Network established by the National Association of Boards of Pharmacy in conjunction with the FDA to implement the Memorandum of Understanding Addressing Certain Distributions of Compounded Human Drug Products shall not be subject to public disclosure under the California Public Records Act (Division 10 (commencing with Section 7920.000) of Title 1 of the Government Code). (Amended by Stats. 2022, Ch. 28, Sec. 5. (SB 1380) Effective January 1, 2023.) - 4126.5. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7. Pharmacies [4110 - 4126.10] ( Article 7 added by Stats. 1996, Ch. 890, Sec. 3. )
Pharmacies may furnish dangerous drugs only to listed recipients, and licensed clinics may do so during a proclaimed state of emergency subject to listed limits.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7. Pharmacies [4110 - 4126.10] ( Article 7 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4126.5. (a) A pharmacy may furnish dangerous drugs only to the following: (1) A wholesaler owned or under common control by the wholesaler from whom the dangerous drug was acquired. (2) The pharmaceutical manufacturer from whom the dangerous drug was acquired. (3) A licensed wholesaler acting as a reverse distributor. (4) Another pharmacy or wholesaler to alleviate a temporary shortage of a dangerous drug that could result in the denial of health care. A pharmacy furnishing dangerous drugs pursuant to this paragraph may only furnish a quantity sufficient to alleviate the temporary shortage. (5) A patient or to another pharmacy pursuant to a prescription or as otherwise authorized by law. (6) A health care provider that is not a pharmacy but that is authorized to purchase dangerous drugs. (7) To another pharmacy under common control. During a proclaimed state of emergency, “another pharmacy” as used in this paragraph shall include a mobile pharmacy, as described in subdivision (c) of Section 4062. (b) Notwithstanding subdivision (a), or any other law, a clinic licensed under Section 4180 may furnish dangerous drugs to any of the following during a proclaimed state of emergency: (1) Another clinic or wholesaler to alleviate a temporary shortage of a dangerous drug that could result in the denial of health care. A clinic furnishing dangerous drugs pursuant to this paragraph may only furnish a quantity sufficient to alleviate the temporary shortage. (2) A patient pursuant to a prescription or as otherwise authorized by law. (3) A health care provider that is not a clinic but that is authorized to purchase dangerous drugs. (4) To another clinic under common control, including a mobile clinic, as described in subdivision (c) of Section 4062. (c) Notwithstanding any other law, a violation of this section may subject the person or persons who committed the violation to a fine not to exceed the amount specified in Section 125.9 for each occurrence pursuant to a citation issued by the board. (d) Amounts due from any person under this section on or after January 1, 2005, shall be offset as provided under Section 12419.5 of the Government Code. Amounts received by the board under this section shall be deposited into the Pharmacy Board Contingent Fund. (e) For purposes of this section, “common control” means the power to direct or cause the direction of the management and policies of another person whether by ownership, by voting rights, by contract, or by other means. (Amended by Stats. 2018, Ch. 716, Sec. 4. (AB 2576) Effective January 1, 2019.) - 4126.8. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7. Pharmacies [4110 - 4126.10] ( Article 7 added by Stats. 1996, Ch. 890, Sec. 3. )
A pharmacy compounding drug preparations for use in this state must follow the current USP-NF compounding standards, including relevant testing and quality assurance.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7. Pharmacies [4110 - 4126.10] ( Article 7 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4126.8. The compounding of drug preparations by a pharmacy for furnishing, distribution, or use in this state shall be consistent with standards established in the pharmacy compounding chapters of the current version of the United States Pharmacopeia-National Formulary, including relevant testing and quality assurance. The board may adopt regulations to impose additional standards for compounding drug preparations. (Added by Stats. 2019, Ch. 184, Sec. 1. (AB 973) Effective January 1, 2020.) - 4126.9. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7. Pharmacies [4110 - 4126.10] ( Article 7 added by Stats. 1996, Ch. 890, Sec. 3. )
A pharmacy that issues a recall notice for a nonsterile compounded drug product must notify the recipient pharmacy, prescriber, or patient and the board within 12 hours if the drug may cause serious harm or death and was dispensed or intended for use in this state.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7. Pharmacies [4110 - 4126.10] ( Article 7 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4126.9. (a) A pharmacy that issues a recall notice regarding a nonsterile compounded drug product shall, in addition to any other duties, contact the recipient pharmacy, prescriber, or patient of the recalled drug and the board within 12 hours of the recall notice if both of the following apply: (1) Use of or exposure to the recalled drug may cause serious adverse health consequences or death. (2) The recalled drug was dispensed, or is intended for use, in this state. (b) A recall notice issued pursuant to subdivision (a) shall be made as follows: (1) If the recalled drug was dispensed directly to the patient, the notice shall be made to the patient. (2) If the recalled drug was dispensed directly to the prescriber, the notice shall be made to the prescriber, who shall ensure the patient is notified. (3) If the recalled drug was dispensed directly to a pharmacy, the notice shall be made to the pharmacy, which shall notify the prescriber or patient, as appropriate. If the pharmacy notifies the prescriber, the prescriber shall ensure the patient is notified. (c) A pharmacy that has been advised that a patient has been harmed by using a nonsterile compounded product potentially attributable to the pharmacy shall report the event to MedWatch within 72 hours of the pharmacy being advised. (Added by Stats. 2016, Ch. 484, Sec. 22. (SB 1193) Effective January 1, 2017.) - 4127. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7.5. Sterile Drug Products [4127 - 4127.8] ( Heading of Article 7.5 amended by Stats. 2013, Ch. 565, Sec. 1. )
Pharmacies that compound sterile drug products must hold a sterile compounding pharmacy license. The board must also adopt implementing regulations and review official revisions to USP–NF Chapter 797 within 90 days to see whether the regulations need changes.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7.5. Sterile Drug Products [4127 - 4127.8] ( Heading of Article 7.5 amended by Stats. 2013, Ch. 565, Sec. 1. ) ## 4127. (a) A pharmacy that compounds sterile drug products shall possess a sterile compounding pharmacy license as provided in this article. (b) The board shall adopt regulations in accordance with the Administrative Procedure Act (Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code) to establish policies, guidelines, and procedures to implement this article. (c) The board shall review any formal revision to General Chapter 797 of the United States Pharmacopeia and The National Formulary (USP–NF), relating to the compounding of sterile preparations, not later than 90 days after the revision becomes official, to determine whether amendments are necessary for the regulations adopted by the board pursuant to subdivision (b). (Amended by Stats. 2016, Ch. 484, Sec. 23. (SB 1193) Effective January 1, 2017.) - 4127.1. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7.5. Sterile Drug Products [4127 - 4127.8] ( Heading of Article 7.5 amended by Stats. 2013, Ch. 565, Sec. 1. )
Pharmacies may not compound sterile drug products unless they have the required board license, and licensed pharmacies must follow reporting and renewal rules.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7.5. Sterile Drug Products [4127 - 4127.8] ( Heading of Article 7.5 amended by Stats. 2013, Ch. 565, Sec. 1. ) ## 4127.1. (a) A pharmacy shall not compound sterile drug products unless the pharmacy has obtained a sterile compounding pharmacy license from the board pursuant to this section. The license shall be renewed annually and is not transferable. (b) A license to compound sterile drug products shall be issued only to a location that is licensed as a pharmacy and shall be issued only to the owner of the pharmacy licensed at that location. (c) A license to compound sterile drug products shall not be issued or renewed until the location is inspected by the board and found in compliance with this article and regulations adopted by the board. (d) A license to compound sterile drug products shall not be issued or renewed until the board does all of the following: (1) Reviews a current copy of the pharmacy’s policies and procedures for sterile compounding. (2) Reviews the pharmacy’s completed self-assessment form required by Section 1735.2 of Title 16 of the California Code of Regulations. (3) Is provided with copies of all inspection reports conducted of the pharmacy’s premises, and any reports from a private accrediting agency, conducted in the prior 12 months documenting the pharmacy’s operations. (4) Receives a list of all sterile medications compounded by the pharmacy since the last license renewal. (e) A pharmacy licensed pursuant to this section shall do all of the following: (1) Provide to the board a copy of any disciplinary or other action taken by another state within 10 days of the action. (2) Notify the board within 10 days of the suspension of any accreditation held by the pharmacy. (3) Provide to the board, within 12 hours, any recall notice issued by the pharmacy for sterile drug products it has compounded. (f) Adverse effects reported or potentially attributable to a pharmacy’s sterile drug product shall be reported to the board within 12 hours and immediately reported to the MedWatch program of the federal Food and Drug Administration. (g) The reconstitution of a sterile powder shall not require a license pursuant to this section if both of the following requirements are met: (1) The sterile powder was obtained from a manufacturer. (2) The drug is reconstituted for administration to patients by a health care professional licensed to administer drugs by injection pursuant to this division. (h) This section shall become operative on July 1, 2014. (Repealed (in Sec. 4) and added by Stats. 2013, Ch. 565, Sec. 5. (SB 294) Effective January 1, 2014. Section operative July 1, 2014, by its own provisions.) - 4127.15. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7.5. Sterile Drug Products [4127 - 4127.8] ( Heading of Article 7.5 amended by Stats. 2013, Ch. 565, Sec. 1. )
The board may issue a license for a hospital satellite compounding pharmacy, but only if section requirements are met; the license is not transferable and cannot be issued or renewed until the location is inspected and compliant.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7.5. Sterile Drug Products [4127 - 4127.8] ( Heading of Article 7.5 amended by Stats. 2013, Ch. 565, Sec. 1. ) ## 4127.15. Subject to the requirements of this section, the board may issue a license to a hospital satellite compounding pharmacy. The license fee and annual renewal fee shall be in an amount established by the board in subdivision (u) of Section 4400. The license shall not be transferable. (a) A hospital satellite compounding pharmacy license shall not be issued or renewed until the location is inspected by the board and found to be in compliance with this article and regulations adopted by the board. (1) A hospital satellite compounding pharmacy shall compound sterile drug products for administration only to registered hospital patients who are on the premises of the same physical plant in which the hospital satellite compounding pharmacy is located. (2) The services provided shall be directly related to the services or treatment plan administered in the physical plant. (b) A hospital satellite compounding pharmacy license shall not be issued or renewed until the board does all of the following: (1) Reviews a current copy of the hospital satellite compounding pharmacy’s policies and procedures for sterile compounding. (2) Reviews the hospital satellite compounding pharmacy’s completed self-assessment form as described in Section 1735.2 of Title 16 of the California Code of Regulations. (3) Receives a list of all products compounded by the hospital satellite compounding pharmacy since the last license renewal. (c) A hospital satellite compounding pharmacy shall do all of the following: (1) Purchase, procure, or otherwise obtain all components through the license of the hospital pharmacy as defined in subdivision (a) of Section 4029. (2) Satisfy the ratio of not less than one pharmacist on duty for a total of two pharmacy technicians on duty. (3) Ensure immediate supervision, as defined in Section 70065 of Title 22 of the California Code of Regulations, by a pharmacist of licensed ancillary staff involved in sterile compounding. (4) Provide to the board, within 12 hours, any recall notice issued by the hospital satellite compounding pharmacy for sterile drug products it has compounded. (5) Report to the board, within 12 hours, adverse effects reported or potentially attributable to the sterile drug products compounded by the hospital satellite compounding pharmacy. Unexpected adverse effects shall also be, within 12 hours, reported to the MedWatch program of the federal Food and Drug Administration. (Added by Stats. 2017, Ch. 623, Sec. 2. (SB 351) Effective January 1, 2018.) - 4127.2. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7.5. Sterile Drug Products [4127 - 4127.8] ( Heading of Article 7.5 amended by Stats. 2013, Ch. 565, Sec. 1. )
Nonresident pharmacies may not compound sterile drug products for shipment into California unless they have the required license, and licensed pharmacies must meet inspection, reporting, and renewal requirements.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7.5. Sterile Drug Products [4127 - 4127.8] ( Heading of Article 7.5 amended by Stats. 2013, Ch. 565, Sec. 1. ) ## 4127.2. (a) A nonresident pharmacy shall not compound sterile drug products for shipment into this state without a sterile compounding pharmacy license issued by the board pursuant to this section. The license shall be renewed annually and shall not be transferable. (b) A license to compound sterile drug products shall be issued only to a location that is licensed as a nonresident pharmacy and shall be issued only to the owner of the nonresident pharmacy licensed at that location. (c) A license to compound sterile drug products shall not be issued or renewed until the location is inspected by the board and found in compliance with this article and any regulations adopted by the board. The nonresident pharmacy shall reimburse the board for all actual and necessary costs incurred by the board in conducting an inspection of the pharmacy at least once annually pursuant to subdivision (v) of Section 4400. (d) A license to compound sterile drug products shall not be issued or renewed until the board does all of the following: (1) Reviews a current copy of the nonresident pharmacy’s policies and procedures for sterile compounding. (2) Reviews the pharmacy’s completed self-assessment form required by Section 1735.2 of Title 16 of the California Code of Regulations. (3) Is provided with copies of all inspection reports conducted of the nonresident pharmacy’s premises, and any reports from a private accrediting agency, conducted in the prior 12 months documenting the nonresident pharmacy’s operations. (4) Receives a list of all sterile drug products compounded by the pharmacy within the prior 12 months. (e) A pharmacy licensed pursuant to this section shall do all of the following: (1) Provide to the board a copy of any disciplinary or other action taken by its state of residence or another state within 10 days of the action. (2) Notify the board within 10 days of the suspension of any accreditation held by the pharmacy. (3) Provide to the board, within 12 hours, any recall notice issued by the pharmacy for sterile drug products it has compounded that have been shipped into, or dispensed in, California. (4) Advise the board of any complaint it receives from a provider, pharmacy, or patient in California. (f) Adverse effects reported or potentially attributable to a nonresident pharmacy’s sterile compounded drug product shall be reported to the board within 12 hours and immediately reported to the MedWatch program of the federal Food and Drug Administration. (g) On or before January 1, 2018, the board shall provide a report to the Legislature regarding the regulation of nonresident pharmacies. The report shall be submitted to the Legislature in the manner required pursuant to Section 9795 of the Government Code. At a minimum, the report shall address all of the following: (1) A detailed description of board activities related to the inspection and licensure of nonresident pharmacies. (2) Whether fee revenue collected pursuant to subdivision (v) of Section 4400 and travel cost reimbursements collected pursuant to subdivision (c) of this section provide revenue in an amount sufficient to support the board’s activities related to the inspection and licensure of nonresident pharmacies. (3) The status of proposed changes to federal law that are under serious consideration and that would govern compounding pharmacies, including legislation pending before the United States Congress, administrative rules, regulations, or orders under consideration by the federal Food and Drug Administration or other appropriate federal agency, and cases pending before the courts. (4) If applicable, recommended modifications to the board’s statutory duties related to nonresident pharmacies as a result of changes to federal law or any additional modifications necessary to protect the health and safety of the public. (h) The requirement for submitting a report imposed under subdivision (g) is inoperative on January 1, 2022, pursuant to Section 10231.5 of the Government Code. (i) This section shall become operative on July 1, 2014. (Repealed (in Sec. 6) and added by Stats. 2013, Ch. 565, Sec. 7. (SB 294) Effective January 1, 2014. Section operative July 1, 2014, by its own provisions.) - 4127.3. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7.5. Sterile Drug Products [4127 - 4127.8] ( Heading of Article 7.5 amended by Stats. 2013, Ch. 565, Sec. 1. )
If the board believes a sterile drug product compounding pharmacy poses an immediate threat, the executive officer may order it to stop, and the board must give notice and hearing rights.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7.5. Sterile Drug Products [4127 - 4127.8] ( Heading of Article 7.5 amended by Stats. 2013, Ch. 565, Sec. 1. ) ## 4127.3. (a) Whenever the board has a reasonable belief, based on information obtained during an inspection or investigation by the board, that a pharmacy compounding sterile drug products poses an immediate threat to the public health or safety, the executive officer of the board may issue an order to the pharmacy to immediately cease and desist from compounding sterile drug products. The cease and desist order shall remain in effect for no more than 30 days or the date of a hearing seeking an interim suspension order, whichever is earlier. (b) Whenever the board issues a cease and desist order pursuant to subdivision (a), the board shall immediately issue the owner a notice setting forth the acts or omissions with which the owner is charged, specifying the pertinent code section or sections. (c) The order shall provide that the owner, within 15 days of receipt of the notice, may request a hearing before the president of the board to contest the cease and desist order. Consideration of the owner’s contest of the cease and desist order shall comply with Section 11425.10 of the Government Code. The hearing shall be held no later than five business days from the date the request of the owner is received by the board. The president shall render a written decision within five business days of the hearing. In the absence of the president of the board, the vice president of the board may conduct the hearing permitted by this subdivision. The owner or person in possession or control of the pharmacy may seek review of the decision of the president of the board pursuant to Section 1094.5 of the Code of Civil Procedure. (d) Failure to comply with a cease and desist order issued pursuant to this section shall be unprofessional conduct. (Amended by Stats. 2021, Ch. 629, Sec. 19. (AB 1533) Effective January 1, 2022.) - 4127.4. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7.5. Sterile Drug Products [4127 - 4127.8] ( Heading of Article 7.5 amended by Stats. 2013, Ch. 565, Sec. 1. )
A person or entity that violates this article or related regulations may be fined up to $2,500 for each violation, through a citation issued by the board.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7.5. Sterile Drug Products [4127 - 4127.8] ( Heading of Article 7.5 amended by Stats. 2013, Ch. 565, Sec. 1. ) ## 4127.4. Notwithstanding any other provision of law, a violation of this article, or regulations adopted pursuant thereto, may subject the person or entity that committed the violation to a fine of up to two thousand five hundred dollars ($2,500) per occurrence pursuant to a citation issued by the board. (Added by Stats. 2001, Ch. 827, Sec. 2. Effective January 1, 2002. Section operative September 5, 2002, pursuant to Section 4127.6.) - 4127.6. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7.5. Sterile Drug Products [4127 - 4127.8] ( Heading of Article 7.5 amended by Stats. 2013, Ch. 565, Sec. 1. )
This article takes effect only when positions are allocated to the board in the annual Budget Act for implementing the article.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7.5. Sterile Drug Products [4127 - 4127.8] ( Heading of Article 7.5 amended by Stats. 2013, Ch. 565, Sec. 1. ) ## 4127.6. This article shall become operative upon the allocation of positions to the board for the implementation of the provisions of this article in the annual Budget Act. (Added by Stats. 2001, Ch. 827, Sec. 2. Effective January 1, 2002. Note: The condition in this section for operation of Article 7.5 (comm. with Section 4127), was satisfied on September 5, 2002, when Stats. 2002, Ch. 379, took effect.) - 4127.7. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7.5. Sterile Drug Products [4127 - 4127.8] ( Heading of Article 7.5 amended by Stats. 2013, Ch. 565, Sec. 1. )
The board may issue a temporary license for compounding sterile drug products, set its conditions and duration, and require a fee.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7.5. Sterile Drug Products [4127 - 4127.8] ( Heading of Article 7.5 amended by Stats. 2013, Ch. 565, Sec. 1. ) ## 4127.7. The board may, at its discretion, issue a temporary license to compound sterile drug products upon the conditions and for any periods of time as the board determines to be in the public interest. A temporary license fee shall be required in an amount established by the board as specified in subdivision (u) of Section 4400. When needed to protect public safety, a temporary license may be issued for a period not to exceed 180 days, and may be issued subject to terms and conditions the board deems necessary. If the board determines a temporary license was issued by mistake or denies the application for a permanent license, the temporary license shall terminate upon either personal service of the notice of termination upon the licenseholder or service by certified mail, return receipt requested at the licenseholder’s address of record with the board, whichever comes first. Neither for purposes of retaining a temporary license nor for purposes of any disciplinary or license denial proceeding before the board shall the temporary licenseholder be deemed to have a vested property right or interest in the license. (Added by renumbering Section 4127.8 by Stats. 2017, Ch. 649, Sec. 2. (SB 510) Effective January 1, 2018.) - 4127.8. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7.5. Sterile Drug Products [4127 - 4127.8] ( Heading of Article 7.5 amended by Stats. 2013, Ch. 565, Sec. 1. )
A pharmacy that recalls a sterile compounded drug must quickly notify the recipient pharmacy, prescriber or patient, and the board within 12 hours if the drug may cause serious harm or death and was dispensed or intended for use in California.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7.5. Sterile Drug Products [4127 - 4127.8] ( Heading of Article 7.5 amended by Stats. 2013, Ch. 565, Sec. 1. ) ## 4127.8. (a) A pharmacy licensed pursuant to Section 4127.1 or 4127.2 that issues a recall notice regarding a sterile compounded drug shall, in addition to any other duties, contact the recipient pharmacy, prescriber, or patient of the recalled drug and the board as soon as possible within 12 hours of the recall notice if both of the following apply: (1) Use of or exposure to the recalled drug may cause serious adverse health consequences or death. (2) The recalled drug was dispensed, or is intended for use, in this state. (b) A recall notice issued pursuant to subdivision (a) shall be made as follows: (1) If the recalled drug was dispensed directly to the patient, the notice shall be made to the patient. (2) If the recalled drug was dispensed directly to the prescriber, the notice shall be made to the prescriber, who shall ensure the patient is notified. (3) If the recalled drug was dispensed directly to a pharmacy, the notice shall be made to the pharmacy, who shall notify the prescriber or patient, as appropriate. If the pharmacy notifies the prescriber, the prescriber shall ensure the patient is notified. (Added by renumbering Section 4127.9 by Stats. 2017, Ch. 649, Sec. 3. (SB 510) Effective January 1, 2018.) - 4128. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7.6. Centralized Hospital Packaging Pharmacies [4128 - 4128.7] ( Article 7.6 added by Stats. 2012, Ch. 687, Sec. 2. )
A centralized hospital packaging pharmacy may prepare certain medications for inpatient use, subject to location, ownership, and barcoding conditions.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7.6. Centralized Hospital Packaging Pharmacies [4128 - 4128.7] ( Article 7.6 added by Stats. 2012, Ch. 687, Sec. 2. ) ## 4128. (a) Notwithstanding Section 4029, a centralized hospital packaging pharmacy may prepare medications, by performing the following specialized functions, for administration only to inpatients within its own general acute care hospital and one or more general acute care hospitals if the hospitals are under common ownership and located within a 75-mile radius of each other: (1) Preparing unit dose packages for single administration to inpatients from bulk containers, if each unit dose package is barcoded pursuant to Section 4128.4. (2) Preparing sterile compounded unit dose drugs for administration to inpatients, if each compounded unit dose drug is barcoded pursuant to Section 4128.4. (3) Preparing compounded unit dose drugs for administration to inpatients, if each unit dose package is barcoded pursuant to Section 4128.4. (b) For purposes of this article, “common ownership” means that the ownership information on file with the board pursuant to Section 4201 for the licensed pharmacy is consistent with the ownership information on file with the board for the other licensed pharmacy or pharmacies for purposes of preparing medications pursuant to this section. (Amended by Stats. 2015, Ch. 241, Sec. 1. (AB 486) Effective September 2, 2015.) - 4128.2. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7.6. Centralized Hospital Packaging Pharmacies [4128 - 4128.7] ( Article 7.6 added by Stats. 2012, Ch. 687, Sec. 2. )
A centralized hospital packaging pharmacy must get a specialty license from the board before doing the Section 4128 functions, and the license must be renewed yearly and is nontransferable.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7.6. Centralized Hospital Packaging Pharmacies [4128 - 4128.7] ( Article 7.6 added by Stats. 2012, Ch. 687, Sec. 2. ) ## 4128.2. (a) In addition to the pharmacy license requirement described in Section 4110, a centralized hospital packaging pharmacy shall obtain a specialty license from the board prior to engaging in the functions described in Section 4128. (b) An applicant seeking a specialty license pursuant to this article shall apply to the board on forms established by the board. (c) Before issuing the specialty license, the board shall inspect the pharmacy and ensure that the pharmacy is in compliance with this article and regulations established by the board. (d) A license to perform the functions described in Section 4128 may only be issued to a pharmacy that is licensed by the board as a hospital pharmacy. (e) A license issued pursuant to this article shall be renewed annually and is not transferrable. (f) An applicant seeking renewal of a specialty license shall apply to the board on forms established by the board. (g) A license to perform the functions described in Section 4128 shall not be renewed until the pharmacy has been inspected by the board and found to be in compliance with this article and regulations established by the board. (h) This section shall become operative on January 1, 2025. (Repealed (in Sec. 8) and added by Stats. 2023, Ch. 723, Sec. 9. (SB 816) Effective January 1, 2024. Operative January 1, 2025, by its own provisions.) - 4128.3. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7.6. Centralized Hospital Packaging Pharmacies [4128 - 4128.7] ( Article 7.6 added by Stats. 2012, Ch. 687, Sec. 2. )
A centralized hospital packaging pharmacy may prepare and store a limited quantity of certain unit dose drugs before getting a patient-specific prescription.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7.6. Centralized Hospital Packaging Pharmacies [4128 - 4128.7] ( Article 7.6 added by Stats. 2012, Ch. 687, Sec. 2. ) ## 4128.3. A centralized hospital packaging pharmacy may prepare and store a limited quantity of the unit dose drugs authorized by Section 4128 in advance of receipt of a patient-specific prescription in a quantity as is necessary to ensure continuity of care for an identified population of inpatients of the general acute care hospital based on a documented history of prescriptions for that patient population. (Added by Stats. 2012, Ch. 687, Sec. 2. (AB 377) Effective January 1, 2013.) - 4128.4. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7.6. Centralized Hospital Packaging Pharmacies [4128 - 4128.7] ( Article 7.6 added by Stats. 2012, Ch. 687, Sec. 2. )
Unit dose medication made by a centralized hospital packaging pharmacy must be barcoded so it can be read at the inpatient’s bedside.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7.6. Centralized Hospital Packaging Pharmacies [4128 - 4128.7] ( Article 7.6 added by Stats. 2012, Ch. 687, Sec. 2. ) ## 4128.4. (a) Any unit dose medication produced by a centralized hospital packaging pharmacy shall be barcoded to be machine readable at the inpatient’s bedside using barcode medication administration software. (b) The barcode medication administration software shall permit health care practitioners to ensure that, before a medication is administered to an inpatient, it is the right medication, for the right inpatient, in the right dose, and via the right route of administration. The software shall verify that the medication satisfies these criteria by reading the barcode on the medication and comparing the information retrieved to the electronic medical record of the inpatient. (c) For purposes of this section, “barcode medication administration software” means a computerized system designed to prevent medication errors in health care settings. (Amended by Stats. 2015, Ch. 241, Sec. 2. (AB 486) Effective September 2, 2015.) - 4128.5. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7.6. Centralized Hospital Packaging Pharmacies [4128 - 4128.7] ( Article 7.6 added by Stats. 2012, Ch. 687, Sec. 2. )
Centralized hospital packaging pharmacies must put specific information on each unit-dose medication label, and pharmacists must be able to retrieve certain product details using the lot or control number.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7.6. Centralized Hospital Packaging Pharmacies [4128 - 4128.7] ( Article 7.6 added by Stats. 2012, Ch. 687, Sec. 2. ) ## 4128.5. (a) Any label for each unit dose medication produced by a centralized hospital packaging pharmacy shall display a human-readable label that contains all of the following: (1) The date that the medication was prepared. (2) The beyond-use date. (3) The established name of the drug. (4) The quantity of each active ingredient. (5) Special storage or handling requirements. (6) The lot number or control number assigned by the centralized hospital packaging pharmacy. (7) The name of the centralized hospital packaging pharmacy. (b) For quality control and investigative purposes, a pharmacist shall be able to retrieve all of the following information using the lot number or control number described in subdivision (a): (1) The components used in the drug product. (2) The expiration date of each of the drug’s components. (3) The National Drug Code Directory number. (Amended by Stats. 2015, Ch. 241, Sec. 3. (AB 486) Effective September 2, 2015.) - 4128.6. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7.6. Centralized Hospital Packaging Pharmacies [4128 - 4128.7] ( Article 7.6 added by Stats. 2012, Ch. 687, Sec. 2. )
Compounding and packaging functions must be done only in the licensed centralized hospital packaging pharmacy, and that pharmacy must follow applicable federal and state rules.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7.6. Centralized Hospital Packaging Pharmacies [4128 - 4128.7] ( Article 7.6 added by Stats. 2012, Ch. 687, Sec. 2. ) ## 4128.6. All compounding and packaging functions specified in Section 4128 shall be performed only in the licensed centralized hospital packaging pharmacy and that pharmacy shall comply with all applicable federal and state statutes and regulations, including, but not limited to, regulations regarding compounding and, when appropriate, sterile compounding. (Amended by Stats. 2016, Ch. 484, Sec. 28. (SB 1193) Effective January 1, 2017.) - 4128.7. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7.6. Centralized Hospital Packaging Pharmacies [4128 - 4128.7] ( Article 7.6 added by Stats. 2012, Ch. 687, Sec. 2. )
A centralized hospital packaging pharmacy and its pharmacists must ensure unit dose drug products they prepare are accurate in integrity, potency, quality, and labeled strength.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7.6. Centralized Hospital Packaging Pharmacies [4128 - 4128.7] ( Article 7.6 added by Stats. 2012, Ch. 687, Sec. 2. ) ## 4128.7. A centralized hospital packaging pharmacy and the pharmacists working in the pharmacy shall be responsible for the integrity, potency, quality, and labeled strength of any unit dose drug product prepared by the centralized hospital packaging pharmacy. (Added by Stats. 2012, Ch. 687, Sec. 2. (AB 377) Effective January 1, 2013.) - 4129. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7.7. Outsourcing Facilities [4129 - 4129.9] ( Article 7.7 added by Stats. 2016, Ch. 484, Sec. 29. )
This section requires certain FDA-registered outsourcing facilities to also be licensed by the board, bars dual licensing at the same location for sterile compounding pharmacies, lets the board adopt implementing regulations, and sets a 90-day FDA-guidance review duty.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7.7. Outsourcing Facilities [4129 - 4129.9] ( Article 7.7 added by Stats. 2016, Ch. 484, Sec. 29. ) ## 4129. (a) A facility registered as an outsourcing facility with the federal Food and Drug Administration (FDA) shall be concurrently licensed with the board as an outsourcing facility if it compounds sterile medication or nonsterile medication for nonpatient-specific distribution within or into California. (b) A facility premises licensed with the board as a sterile compounding pharmacy shall not be concurrently licensed with the board as an outsourcing facility at the same location. (c) The board may adopt regulations in accordance with the Administrative Procedure Act (Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code) to establish policies, guidelines, and procedures to implement this article. (d) The board shall review any formal requirements or guidance documents developed by the FDA regarding outsourcing facilities within 90 days after their release in order to determine whether revisions are necessary for any regulations promulgated by the board. (e) An outsourcing facility licensed by the board dispensing patient-specific compounded preparations pursuant to a prescription for an individual patient shall not be required to be licensed as a pharmacy, but shall otherwise comply with the same requirements of a pharmacy. (Amended by Stats. 2021, Ch. 629, Sec. 20. (AB 1533) Effective January 1, 2022.) - 4129.1. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7.7. Outsourcing Facilities [4129 - 4129.9] ( Article 7.7 added by Stats. 2016, Ch. 484, Sec. 29. )
Outsourcing facilities with an FDA license and a California address must also get a board license before doing business in California, renew it yearly, and follow board and federal manufacturing rules.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7.7. Outsourcing Facilities [4129 - 4129.9] ( Article 7.7 added by Stats. 2016, Ch. 484, Sec. 29. ) ## 4129.1. (a) An outsourcing facility that is licensed with the federal Food and Drug Administration (FDA) and with an address in this state shall also be licensed by the board as an outsourcing facility before doing business within this state. The license shall be renewed annually and is not transferable. (b) An outsourcing facility shall compound all sterile products and nonsterile products in compliance with regulations issued by the board and with federal current good manufacturing practices applicable to outsourcing facilities. (c) An outsourcing facility license shall not be issued or renewed until the location is inspected by the board and found in compliance with this article and regulations adopted by the board. (d) An outsourcing facility license shall not be issued or renewed until the board does all of the following: (1) Prior to inspection, reviews a current copy of the outsourcing facility’s policies and procedures for sterile compounding and nonsterile compounding. (2) Is provided with copies of all federal and state regulatory agency inspection reports, as well as accreditation reports, and certification reports of facilities or equipment of the outsourcing facility’s premises conducted in the prior 12 months. (3) Prior to inspection, receives a list of all sterile drugs and nonsterile drugs compounded by the outsourcing facility as reported to the FDA in the last 12 months. (e) An outsourcing facility licensed pursuant to this section shall provide the board with all of the following: (1) A copy of any disciplinary or other action taken by another state or the FDA within 10 days of the action. (2) Notice within 24 hours of any recall notice issued by the outsourcing facility. (3) A copy of any clinically related complaint it receives involving an outsourcing facility’s compounded products from or involving any provider, pharmacy, or patient in California within 72 hours of receipt. (4) Notice within 24 hours after learning of adverse effects reported or potentially attributable to the outsourcing facility’s products. (Added by Stats. 2016, Ch. 484, Sec. 29. (SB 1193) Effective January 1, 2017.) - 4129.2. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7.7. Outsourcing Facilities [4129 - 4129.9] ( Article 7.7 added by Stats. 2016, Ch. 484, Sec. 29. )
A nonresident outsourcing facility may not compound sterile or nonsterile drug products for California without the required license, must meet compounding and reporting rules, and the board must inspect and review documents before issuing or renewing the license.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7.7. Outsourcing Facilities [4129 - 4129.9] ( Article 7.7 added by Stats. 2016, Ch. 484, Sec. 29. ) ## 4129.2. (a) An outsourcing facility that is licensed with the federal Food and Drug Administration (FDA) as an outsourcing facility and has an address outside of this state but in the United States of America is a nonresident outsourcing facility. A nonresident outsourcing facility shall not compound sterile drug products or nonsterile drug products for distribution or use into this state without an outsourcing license issued by the board pursuant to this section. The license shall be renewed annually and shall not be transferable. (b) A nonresident outsourcing facility shall compound all sterile products and nonsterile products to be distributed or used in this state in compliance with regulations of the board and with federal current good manufacturing practices applicable to outsourcing facilities. (c) A license for a nonresident outsourcing facility shall not be issued or renewed until the location is inspected by the board and found in compliance with this article and any regulations adopted by the board. The nonresident outsourcing facility shall reimburse the board for all actual and necessary costs incurred by the board in conducting an inspection of the nonresident outsourcing facility at least once annually pursuant to subdivision (x) of Section 4400. (d) A license for a nonresident outsourcing facility shall not be issued or renewed until the board: (1) Prior to inspection, reviews a current copy of the nonresident outsourcing facility’s policies and procedures for sterile compounding and nonsterile compounding. (2) (A) Is provided with copies of all federal and state regulatory agency inspection reports, as well as accreditation reports, and certification reports of facilities or equipment of the nonresident outsourcing facility’s premises conducted in the prior 12 months. (B) For purposes of this paragraph, “state” refers to the state in which the nonresident outsourcing facility resides. (3) Prior to inspection, receives a list of all sterile drug products and nonsterile drug products compounded by the pharmacy as reported to the FDA within the prior 12 months. (e) A nonresident outsourcing facility licensed pursuant to this section shall provide the board with all of the following: (1) A copy of any disciplinary or other action taken by another state or the FDA within 10 days of the action. (2) Notice within 24 hours of any recall notice issued by the nonresident outsourcing facility. (3) A copy of any complaint it receives involving an outsourcing facility’s compounded products from or involving any provider, pharmacy, or patient in California within 72 hours of receipt. (4) Notice within 24 hours after learning of adverse effects reported or potentially attributable to a nonresident outsourcing facility’s products. (Added by Stats. 2016, Ch. 484, Sec. 29. (SB 1193) Effective January 1, 2017.) - 4129.3. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7.7. Outsourcing Facilities [4129 - 4129.9] ( Article 7.7 added by Stats. 2016, Ch. 484, Sec. 29. )
The board must report to the Legislature by January 1, 2018 on regulation of nonresident outsourcing facilities.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7.7. Outsourcing Facilities [4129 - 4129.9] ( Article 7.7 added by Stats. 2016, Ch. 484, Sec. 29. ) ## 4129.3. (a) On or before January 1, 2018, the board shall provide a report to the Legislature regarding the regulation of nonresident outsourcing facilities. The report shall be submitted to the Legislature in the manner required pursuant to Section 9795 of the Government Code. At a minimum, the report shall address all of the following: (1) A detailed description of board activities related to the inspection and licensure of nonresident outsourcing facilities. (2) Whether fee revenue collected pursuant to subdivision (x) of Section 4400 and travel cost reimbursements collected pursuant to subdivision (c) of Section 4129.2 provide revenue in an amount sufficient to support the board’s activities related to the inspection and licensure of nonresident outsourcing facilities. (3) The status of proposed changes to federal law that are under serious consideration and that would govern outsourcing facilities and compounding pharmacies, including, but not limited to, legislation pending before Congress, administrative rules, regulations or orders under consideration by the FDA or other appropriate federal agency, and cases pending before the courts. (4) If applicable, recommended modifications to the board’s statutory duties related to nonresident outsourcing facilities as a result of changes to federal law or any additional modifications necessary to protect the health and safety of the public. (b) The requirement for submitting a report imposed under subdivision (a) is inoperative on January 1, 2022, pursuant to Section 10231.5 of the Government Code. (Added by Stats. 2016, Ch. 484, Sec. 29. (SB 1193) Effective January 1, 2017.) - 4129.4. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7.7. Outsourcing Facilities [4129 - 4129.9] ( Article 7.7 added by Stats. 2016, Ch. 484, Sec. 29. )
The board may order an outsourcing facility to stop compounding sterile or nonsterile drug products if it believes the facility poses an immediate public health or safety threat.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7.7. Outsourcing Facilities [4129 - 4129.9] ( Article 7.7 added by Stats. 2016, Ch. 484, Sec. 29. ) ## 4129.4. (a) Whenever the board has a reasonable belief, based on information obtained during an inspection or investigation by the board, that an outsourcing facility compounding sterile drug products or nonsterile drug products poses an immediate threat to the public health or safety, the executive officer of the board may issue an order to the outsourcing facility to immediately cease and desist compounding sterile drug products or nonsterile drug products. The cease and desist order shall remain in effect for no more than 30 days or the date of a hearing seeking an interim suspension order, whichever is earlier. (b) Whenever the board issues a cease and desist order pursuant to subdivision (a), the board shall immediately issue a notice to the owner setting forth the acts or omissions with which the owner is charged, specifying the pertinent code section or sections and any regulations. (c) The cease and desist order shall state that the owner, within 15 days of receipt of the notice, may request a hearing before the president of the board to contest the cease and desist order. Consideration of the owner’s contest of the cease and desist order shall comply with Section 11425.10 of the Government Code. The hearing shall be held no later than five business days after the date the request of the owner is received by the board. The president shall render a written decision within five business days after the hearing. In the absence of the president of the board, the vice president of the board may conduct the hearing permitted by this subdivision. The owner or person in possession or control of the outsourcing facility may seek review of the decision pursuant to Section 1094.5 of the Code of Civil Procedure. (d) Failure to comply with a cease and desist order issued pursuant to this section shall be unprofessional conduct. (Amended by Stats. 2021, Ch. 629, Sec. 21. (AB 1533) Effective January 1, 2022.) - 4129.5. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7.7. Outsourcing Facilities [4129 - 4129.9] ( Article 7.7 added by Stats. 2016, Ch. 484, Sec. 29. )
A violation of this article or its regulations can lead to a citation by the board and a fine of up to $5,000 per occurrence.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7.7. Outsourcing Facilities [4129 - 4129.9] ( Article 7.7 added by Stats. 2016, Ch. 484, Sec. 29. ) ## 4129.5. Notwithstanding any other law, a violation of this article, or regulation adopted pursuant thereto, may subject the person or entity that committed the violation to a fine of up to five thousand dollars ($5,000) per occurrence pursuant to a citation issued by the board. (Added by Stats. 2016, Ch. 484, Sec. 29. (SB 1193) Effective January 1, 2017.) - 4129.8. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7.7. Outsourcing Facilities [4129 - 4129.9] ( Article 7.7 added by Stats. 2016, Ch. 484, Sec. 29. )
The board may issue a temporary license to an outsourcing facility, and it may set the conditions and duration.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7.7. Outsourcing Facilities [4129 - 4129.9] ( Article 7.7 added by Stats. 2016, Ch. 484, Sec. 29. ) ## 4129.8. The board, at its discretion, may issue a temporary license to an outsourcing facility upon the conditions and for any periods of time as the board determines to be in the public interest. A temporary license fee shall be required as specified in subdivision (w) of Section 4400. When needed to protect public safety, a temporary license may be issued for a period not to exceed 180 days, and may be issued subject to terms and conditions the board deems necessary. If the board determines a temporary license was issued by mistake or denies the application for a permanent license, the temporary license shall terminate upon the earlier of personal service of the notice of termination upon the licenseholder or service by certified mail with return receipt requested at the licenseholder’s address of record with the board. The temporary licenseholder shall not be deemed to have a vested property right or interest in the license for purposes of retaining a temporary license or for purposes of any disciplinary or license denial proceeding before the board. (Added by Stats. 2016, Ch. 484, Sec. 29. (SB 1193) Effective January 1, 2017.) - 4129.9. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7.7. Outsourcing Facilities [4129 - 4129.9] ( Article 7.7 added by Stats. 2016, Ch. 484, Sec. 29. )
Outsourcing facilities that issue certain drug recall notices must notify the recipient pharmacy, prescriber or patient, and the board within 24 hours when the recall involves a serious-risk drug used or intended for use in this state.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 7.7. Outsourcing Facilities [4129 - 4129.9] ( Article 7.7 added by Stats. 2016, Ch. 484, Sec. 29. ) ## 4129.9. (a) An outsourcing facility licensed pursuant to Section 4129.1 or 4129.2 that issues a recall notice for a sterile drug or nonsterile drug compounded by the outsourcing facility, in addition to any other duties, shall contact the recipient pharmacy, prescriber, or patient of the recalled drug and the board as soon as possible within 24 hours of the recall notice if both of the following apply: (1) Use of or exposure to the recalled drug may cause serious adverse health consequences or death. (2) The recalled drug was dispensed, or is intended for use, in this state. (b) A recall notice issued pursuant to subdivision (a) shall be made as follows: (1) If the recalled drug was dispensed directly to the prescriber, the notice shall be made to the prescriber and the prescriber shall ensure the patient is notified. (2) If the recalled drug was dispensed directly to a pharmacy, the notice shall be made to the pharmacy and that pharmacy shall notify the prescriber or patient, as appropriate. If the pharmacy notifies the prescriber, the prescriber shall ensure the patient is notified. (Added by Stats. 2016, Ch. 484, Sec. 29. (SB 1193) Effective January 1, 2017.) - 4130. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 8. Telepharmacy Systems and Remote Dispensing Site Pharmacies [4130 - 4135] ( Article 8 added by Stats. 2017, Ch. 548, Sec. 7. )
This section requires telepharmacy use at remote dispensing site pharmacies, limits where they may be located and staffed, and sets a 225-prescriptions-per-day threshold that changes their status.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 8. Telepharmacy Systems and Remote Dispensing Site Pharmacies [4130 - 4135] ( Article 8 added by Stats. 2017, Ch. 548, Sec. 7. ) ## 4130. (a) A telepharmacy system shall be used for the dispensing of prescription drugs and providing related drug regimen review and patient counseling services at a remote dispensing site pharmacy. (b) If all of the requirements of this article and other relevant provisions of this chapter are met, the board shall issue a remote dispensing site pharmacy license for the purpose of increasing access to dispensing or pharmaceutical care services in the geographic area in which the remote dispensing site pharmacy is to be located. (c) (1) A remote dispensing site pharmacy shall only be located in a medically underserved area unless otherwise approved by the board. For purposes of this section, a “medically underserved area” means a location that does not have a pharmacy that serves the general public within 10 road miles of the remote dispensing site. (2) Notwithstanding paragraph (1), if a pharmacy serving the general public is later established within 10 road miles of a remote dispensing site pharmacy, the remote dispensing site pharmacy may continue to operate. (d) A remote dispensing site pharmacy shall only be staffed by pharmacists or pharmacy technicians, or both, and shall not employ any unlicensed personnel. (e) A remote dispensing site pharmacy license shall be issued only to the supervising pharmacy. A supervising pharmacy shall not obtain more than one remote dispensing site pharmacy license. (f) A remote dispensing site pharmacy shall not be operated by the state and shall not be located in any state facility, including, but not limited to, correctional facilities, state hospitals, or developmental centers. This section shall not be construed to preclude a pharmacist who is otherwise eligible to operate a remote dispensing site pharmacy pursuant to this section from leasing space in property owned by the state, provided it is not for the purpose of serving individuals otherwise served by pharmacists and pharmacy technicians employed by the state. (g) A remote dispensing site pharmacy shall not be located or operated for the purpose of displacing state employees. (h) If a remote dispensing site pharmacy dispenses more than 225 prescriptions per day, calculated each calendar year, it shall cease to be a remote dispensing site pharmacy and may become a full-service pharmacy licensed under Section 4110 with a pharmacist onsite if it meets all the requirements for licensure for a pharmacy. (Added by Stats. 2017, Ch. 548, Sec. 7. (AB 401) Effective January 1, 2018.) - 4131. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 8. Telepharmacy Systems and Remote Dispensing Site Pharmacies [4130 - 4135] ( Article 8 added by Stats. 2017, Ch. 548, Sec. 7. )
A supervising pharmacy may serve only one remote dispensing site pharmacy, must stay within 150 road miles unless the board approves otherwise, and the remote site must be commonly owned and properly staffed and supervised.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 8. Telepharmacy Systems and Remote Dispensing Site Pharmacies [4130 - 4135] ( Article 8 added by Stats. 2017, Ch. 548, Sec. 7. ) ## 4131. (a) A supervising pharmacy shall provide telepharmacy services for only one remote dispensing site pharmacy. (b) A supervising pharmacy shall not be located greater than 150 road miles from a remote dispensing site pharmacy, unless otherwise approved by the board. (c) A supervising pharmacy and remote dispensing site pharmacy shall be under common ownership. (d) Unless staffed by a pharmacist, a remote dispensing site pharmacy shall be staffed by at least one registered pharmacy technician meeting the qualifications of Section 4132. A technician shall remain under the direct supervision and control of a pharmacist at the supervising pharmacy at all times that the remote dispensing site pharmacy is operational. For the purposes of this article, direct supervision and control does not require the pharmacist to be physically present at the remote dispensing site pharmacy, but the pharmacist shall use a telepharmacy system to supervise operations through audio and visual technology from the supervising pharmacy. (e) Notwithstanding any other law, a pharmacist may serve as the pharmacist-in-charge for a pharmacy in addition to serving as pharmacist-in-charge of a supervising pharmacy. The designated pharmacist-in-charge of the supervising pharmacy shall also serve as the designated pharmacist-in-charge at the remote dispensing site pharmacy. (f) Notwithstanding any other law, the pharmacist-in-charge of the remote dispensing site pharmacy and the pharmacist-on-duty at the supervising pharmacy shall be responsible for ensuring that both the supervising pharmacy and remote dispensing site pharmacy are sufficiently staffed to allow for appropriate supervision, which is supervision that would not be reasonably expected to result in an unreasonable risk of harm to public health, safety, or welfare. (Added by Stats. 2017, Ch. 548, Sec. 7. (AB 401) Effective January 1, 2018.) - 4132. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 8. Telepharmacy Systems and Remote Dispensing Site Pharmacies [4130 - 4135] ( Article 8 added by Stats. 2017, Ch. 548, Sec. 7. )
A pharmacy technician must meet specified qualifications before working at a remote dispensing site pharmacy, and technicians there are barred from several clinical and dispensing tasks.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 8. Telepharmacy Systems and Remote Dispensing Site Pharmacies [4130 - 4135] ( Article 8 added by Stats. 2017, Ch. 548, Sec. 7. ) ## 4132. (a) In addition to the requirements of Section 4202, a pharmacy technician shall satisfy each of the following requirements before working at a remote dispensing site pharmacy: (1) Possess a pharmacy technician license that is in good standing. (2) Possess and maintain a certification issued by a board-approved pharmacy technician certification program. (3) Possess one of the following: (A) A minimum of an associate degree in pharmacy technology. (B) A minimum of a bachelor’s degree in any subject. (C) A certificate of completion from a course of training specified by regulations adopted by the board pursuant to Section 4202. (4) Complete a minimum of 2,000 hours of experience working as a pharmacy technician within the two years preceding first commencing work in the remote dispensing site pharmacy. (b) Notwithstanding Section 4115, a registered pharmacy technician may perform order entry, packaging, manipulative, repetitive, and other nondiscretionary tasks at a remote dispensing site pharmacy under the supervision of a pharmacist at a supervising pharmacy using a telepharmacy system. (c) A pharmacy technician at a remote dispensing site pharmacy shall not do any of the following: (1) Receive a new prescription order orally from a prescriber or other person authorized to prescribe by law. (2) Consult with a patient or their agent regarding a prescription, either before or after dispensing, or regarding any medical information contained in a patient medication record system or patient chart. (3) Identify, evaluate, or interpret a prescription. (4) Interpret the clinical data in a patient medication record system or patient chart. (5) Consult with any prescriber, nurse, or other health care professional or authorized agent thereof. (6) Supervise the packaging of drugs and check the packaging procedure and product upon completion. (7) Perform any function that requires the professional judgment of a licensed pharmacist. (8) Compound drug preparations. (d) Notwithstanding Section 4115, a pharmacist at a supervising pharmacy may supervise up to two pharmacy technicians at each remote dispensing site pharmacy. This subdivision shall not be construed to alter a pharmacist’s ability to also supervise pharmacy technicians at the supervising pharmacy. (Amended by Stats. 2019, Ch. 679, Sec. 2. (AB 690) Effective October 9, 2019.) - 4133. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 8. Telepharmacy Systems and Remote Dispensing Site Pharmacies [4130 - 4135] ( Article 8 added by Stats. 2017, Ch. 548, Sec. 7. )
Telepharmacy systems must support secure audio-video communication, pharmacist supervision, prescription verification, patient counseling, and record retention.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 8. Telepharmacy Systems and Remote Dispensing Site Pharmacies [4130 - 4135] ( Article 8 added by Stats. 2017, Ch. 548, Sec. 7. ) ## 4133. (a) A telepharmacy system shall maintain a video and audio communication system that provides for effective communication between the supervising pharmacy and the remote dispensing site pharmacy’s personnel and patients. (b) A telepharmacy system shall facilitate adequate pharmacist supervision and allow the appropriate exchange of visual, verbal, and written communications for patient counseling and other matters involved in the lawful dispensing of drugs. (c) Patient counseling shall be provided using audio-visual communication prior to all prescriptions being dispensed from a remote dispensing site pharmacy. (d) A telepharmacy system shall be able to do all of the following: (1) Identify and record the pharmacy technician preparing each prescription and the supervising pharmacist who reviewed and authorized the dispensing of the prescription. (2) Require a pharmacist to review and compare the electronic image of any new prescription presented at the remote dispensing site pharmacy with the data entry record of the prescription. (3) Require the pharmacy technician to use barcode technology to verify the accuracy of the drug to be dispensed. (4) Require remote visual confirmation by a pharmacist at the supervising pharmacy of the drug stock bottle and the drug to be dispensed prior to dispensing. (5) Ensure that a prescription is not sold or delivered to a patient prior to a pharmacist performing final verification of the accuracy of the prescription and releasing the prescription for sale and delivery. (e) The video and audio communication system used to counsel and interact with each patient or patient’s caregiver shall be secure and compliant with the federal Health Insurance Portability and Accountability Act (Public Law 104-191). (f) All records of prescriptions dispensed including the records of the actions performed through the telepharmacy system shall be maintained at the remote dispensing site pharmacy and shall be maintained for three years after the filling of the prescription. (Added by Stats. 2017, Ch. 548, Sec. 7. (AB 401) Effective January 1, 2018.) - 4134. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 8. Telepharmacy Systems and Remote Dispensing Site Pharmacies [4130 - 4135] ( Article 8 added by Stats. 2017, Ch. 548, Sec. 7. )
Remote dispensing site pharmacies and supervising pharmacists must follow specific controlled-substance inventory, storage, inspection, reporting, and record-retention rules.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 8. Telepharmacy Systems and Remote Dispensing Site Pharmacies [4130 - 4135] ( Article 8 added by Stats. 2017, Ch. 548, Sec. 7. ) ## 4134. (a) A pharmacist from the supervising pharmacy shall complete a monthly in-person, self-inspection of each remote dispensing site pharmacy using a form designated by the board and shall retain all inspection reports. (b) A perpetual inventory shall be kept for all controlled substances stored at a remote dispensing site pharmacy. (c) All controlled substances at a remote dispensing site pharmacy shall be stored in a secure cabinet or safe that is locked. (d) A pharmacist from the supervising pharmacy shall perform inventory and inventory reconciliation functions at a remote dispensing site pharmacy to detect and prevent the loss of any controlled substance. (e) The pharmacist-in-charge of a remote dispensing site pharmacy shall review all inventory and inventory reconciliation reports taken and shall establish and maintain secure methods to prevent losses of any controlled substance. The board shall develop written policies and procedures for performing the inventory reconciliation reports required by this section. (f) A pharmacist from the supervising pharmacy shall compile an inventory reconciliation report of all Schedule II controlled substances at a remote dispensing site pharmacy at least once every three months. This compilation shall require all of the following: (1) A physical count, not an estimate, of all quantities of Schedule II controlled substances at the remote dispensing site pharmacy. The biennial inventory of controlled substances as required under federal law may serve as one of the mandated inventories under this section in the year that the federal biennial inventory is performed, provided that the biennial inventory was taken no more than three months from the last inventory required by this section. (2) A review of all acquisitions and dispositions of Schedule II controlled substances since the last inventory reconciliation report. (3) A comparison of paragraphs (1) and (2) in order to determine if there are any variances. (4) All records used to compile each inventory reconciliation report shall be maintained in the remote dispensing site pharmacy for at least three years in a readily retrievable form. (g) A remote dispensing site pharmacy shall report to the board, in writing, any identified losses of controlled substances and possible causes of the loss within 30 days of discovering the loss unless the cause of loss is theft, diversion, or self-use in which case the report shall be made within 14 days of discovering the loss. If the remote dispensing site pharmacy is unable to identify the cause of the loss, the remote dispensing site pharmacy shall undertake further investigation to identify the cause of the loss and security improvements necessary to prevent any additional losses of controlled substances. The pharmacist-in-charge shall be responsible for submitting the report to the board. (h) Possible causes of overages shall be identified in writing and incorporated into the inventory reconciliation report. (i) The inventory reconciliation report shall be dated and signed by the individual or individuals performing the inventory and countersigned by the pharmacist-in-charge of the remote dispensing site pharmacy. A countersignature shall not be required if the pharmacist-in-charge personally completed the inventory reconciliation report. The inventory reconciliation report shall be maintained in the remote dispensing site pharmacy for at least three years in a readily retrievable form. (Added by Stats. 2017, Ch. 548, Sec. 7. (AB 401) Effective January 1, 2018.) - 4135. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 8. Telepharmacy Systems and Remote Dispensing Site Pharmacies [4130 - 4135] ( Article 8 added by Stats. 2017, Ch. 548, Sec. 7. )
Remote dispensing site pharmacies must use security monitoring when closed, restrict access when the supervising pharmacy is closed unless a pharmacist is present, pause pharmacy services if telepharmacy is unavailable, and keep surveillance recordings for at least 120 days.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 8. Telepharmacy Systems and Remote Dispensing Site Pharmacies [4130 - 4135] ( Article 8 added by Stats. 2017, Ch. 548, Sec. 7. ) ## 4135. (a) While closed, a remote dispensing site pharmacy shall utilize an alarm or other comparable monitoring system to protect its equipment, records, and supply of drugs, devices, and other restricted sale items from unauthorized access, acquisition, or use. (b) Unless a pharmacist is present at the remote dispensing site pharmacy, a remote dispensing site pharmacy shall not be open or its employees allowed access to it during times the supervising pharmacy is closed. The security system shall allow for tracking of entries into the remote dispensing site pharmacy and the pharmacist-in-charge shall periodically review the record of entries. Pharmacy services shall not be provided at a remote dispensing site pharmacy if the telepharmacy system is unavailable. (c) The remote dispensing site pharmacy shall retain a recording of facility surveillance, excluding patient communications, for a minimum of 120 days. (Added by Stats. 2017, Ch. 548, Sec. 7. (AB 401) Effective January 1, 2018.) - 4141. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 9. Hypodermic Needles and Syringes [4141 - 4149] ( Article 9 added by Stats. 1996, Ch. 890, Sec. 3. )
A person may not furnish hypodermic needles or syringes, by sale or otherwise, without a board-issued license, unless another part of this article allows it.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 9. Hypodermic Needles and Syringes [4141 - 4149] ( Article 9 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4141. No person shall furnish hypodermic needles or syringes, by sale or otherwise, without a license issued by the board, except as otherwise provided by this article. (Repealed and added by Stats. 1996, Ch. 890, Sec. 3. Effective January 1, 1997.) - 4143. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 9. Hypodermic Needles and Syringes [4141 - 4149] ( Article 9 added by Stats. 1996, Ch. 890, Sec. 3. )
This article does not apply to certain wholesale sales of hypodermic syringes and needles.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 9. Hypodermic Needles and Syringes [4141 - 4149] ( Article 9 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4143. This article shall not apply to the sale of hypodermic syringes and needles at wholesale by pharmacies, drug wholesalers, drug manufacturers or manufacturers and dealers in surgical instruments to pharmacies, physicians, dentists, podiatrists, veterinarians, or persons to whom a license has been issued under this article. (Amended by Stats. 1997, Ch. 549, Sec. 85. Effective January 1, 1998.) - 4144.5. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 9. Hypodermic Needles and Syringes [4141 - 4149] ( Article 9 added by Stats. 1996, Ch. 890, Sec. 3. )
A person may sell or obtain hypodermic needles and syringes without a prescription or permit if the board determines the use is industrial.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 9. Hypodermic Needles and Syringes [4141 - 4149] ( Article 9 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4144.5. A person may sell or obtain hypodermic needles and hypodermic syringes without a prescription or permit, for uses that the board determines are industrial, and that person shall not be required to comply with Section 4145.5 or 4146. (Amended by Stats. 2014, Ch. 331, Sec. 2. (AB 1743) Effective January 1, 2015.) - 4145.5. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 9. Hypodermic Needles and Syringes [4141 - 4149] ( Article 9 added by Stats. 1996, Ch. 890, Sec. 3. )
This section lets certain people furnish or obtain hypodermic needles and syringes without a prescription in specified situations, and it requires pharmacies/programs that provide nonprescription needles or syringes to store them securely, counsel on safe disposal, and give disposal options.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 9. Hypodermic Needles and Syringes [4141 - 4149] ( Article 9 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4145.5. (a) Notwithstanding any other provision of law, a pharmacist or physician may, without a prescription or a permit, furnish hypodermic needles and syringes for human use, and a person may, without a prescription or license, obtain hypodermic needles and syringes from a pharmacist or physician for human use, if the furnisher has previously been provided a prescription or other proof of a legitimate medical need requiring a hypodermic needle or syringe to administer a medicine or treatment. (b) Notwithstanding any other provision of law, as a public health measure intended to prevent the transmission of HIV, viral hepatitis, and other bloodborne diseases among persons who use syringes and hypodermic needles, and to prevent subsequent infection of sexual partners, newborn children, or other persons, a physician or pharmacist may, without a prescription or a permit, furnish hypodermic needles and syringes for human use to a person 18 years of age or older, and a person 18 years of age or older may, without a prescription or license, obtain hypodermic needles and syringes solely for personal use from a physician or pharmacist. (c) Notwithstanding any other provision of law, a pharmacist, veterinarian, or person licensed pursuant to Section 4141 may, without a prescription or license, furnish hypodermic needles and syringes for use on animals, and a person may, without a prescription or license, obtain hypodermic needles and syringes from a pharmacist, veterinarian, or person licensed pursuant to Section 4141 for use on animals. (d) A pharmacy that furnishes nonprescription hypodermic needles and syringes shall store hypodermic needles and syringes in a manner that ensures that they are available only to authorized personnel, and are not accessible to other persons. (e) In order to provide for the safe disposal of hypodermic needles and syringes, a pharmacy or hypodermic needle and syringe exchange program that furnishes nonprescription hypodermic needles and syringes shall counsel consumers on safe disposal and provide consumers with one or more of the following disposal options: (1) It shall establish an onsite, safe, hypodermic needle and syringe collection and disposal program that meets applicable state and federal standards for collection and disposal of medical sharps waste. (2) It shall furnish, or make available, mail-back sharps containers authorized by the United States Postal Service that meet applicable state and federal requirements for the transport of medical sharps waste, and shall provide tracking forms to verify destruction at a certified disposal facility. (3) It shall furnish, or make available, a sharps container that meets applicable state and federal standards for collection and disposal of medical sharps waste. (f) A pharmacy that furnishes nonprescription syringes shall provide written information or verbal counseling to consumers at the time of furnishing or sale of nonprescription hypodermic needles or syringes on how to do the following: (1) Access drug treatment. (2) Access testing and treatment for HIV and hepatitis C. (3) Safely dispose of sharps waste. (Amended by Stats. 2025, Ch. 685, Sec. 1. (AB 309) Effective January 1, 2026.) - 4146. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 9. Hypodermic Needles and Syringes [4141 - 4149] ( Article 9 added by Stats. 1996, Ch. 890, Sec. 3. )
A pharmacy may accept returned needles and syringes from the public, but only if they are in a sharps container.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 9. Hypodermic Needles and Syringes [4141 - 4149] ( Article 9 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4146. A pharmacy may accept the return of needles and syringes from the public if contained in a sharps container, as defined in Section 117750 of the Health and Safety Code. (Added by Stats. 2009, Ch. 307, Sec. 40. (SB 821) Effective January 1, 2010.) - 4147. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 9. Hypodermic Needles and Syringes [4141 - 4149] ( Article 9 added by Stats. 1996, Ch. 890, Sec. 3. )
You may not discard or dispose of hypodermic needles or syringes on playgrounds, beaches, parks, or public or private schools.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 9. Hypodermic Needles and Syringes [4141 - 4149] ( Article 9 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4147. (a) For the purposes of this section, “playground” means any park or outdoor recreational area specifically designed to be used by children that has play equipment installed or any similar facility located on public or private school grounds or county parks. (b) Any hypodermic needle or syringe that is to be disposed of, shall be contained, treated, and disposed of, pursuant to Part 14 (commencing with Section 117600) of Division 104 of the Health and Safety Code. (c) It is unlawful to discard or dispose of a hypodermic needle or syringe upon the grounds of a playground, beach, park, or any public or private elementary, vocational, junior high, or high school. (d) A person who knowingly violates subdivision (c) is guilty of a misdemeanor, and upon conviction shall be punished by a fine of not less than two hundred dollars ($200) and not more than two thousand dollars ($2,000), or by imprisonment in a county jail for up to six months, or by both that fine and imprisonment. (e) Subdivision (c) does not apply to the containment, treatment, and disposal of medical sharps waste from medical care or first aid services rendered on school grounds, nor to the containment, treatment, and disposal of hypodermic needles or syringes used for instructional or educational purposes on school grounds. (Amended by Stats. 2004, Ch. 608, Sec. 3. Effective January 1, 2005.) - 4148.5. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 9. Hypodermic Needles and Syringes [4141 - 4149] ( Article 9 added by Stats. 1996, Ch. 890, Sec. 3. )
Stocks of hypodermic needles or syringes found outside licensed premises must be confiscated unless they are in the possession or control of a person entitled to an exemption.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 9. Hypodermic Needles and Syringes [4141 - 4149] ( Article 9 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4148.5. All stocks of hypodermic needles or syringes shall be confiscated if found outside the licensed premises of any person holding a permit under Section 4141 and found not in the possession or under the control of a person entitled to an exemption under Section 4143, 4144.5, or 4145.5, or under Section 11364, 121349, or 121349.1 of the Health and Safety Code. (Amended by Stats. 2014, Ch. 331, Sec. 6. (AB 1743) Effective January 1, 2015.) - 4149. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 9. Hypodermic Needles and Syringes [4141 - 4149] ( Article 9 added by Stats. 1996, Ch. 890, Sec. 3. )
A nonresident distributor may not sell or distribute hypodermic needles or syringes in this state unless it gets a license from the board, unless the sales are made solely through a licensed wholesaler or third-party logistics provider.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 9. Hypodermic Needles and Syringes [4141 - 4149] ( Article 9 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4149. (a) A nonresident distributor shall not sell or distribute hypodermic needles or syringes in this state without obtaining a license from the board pursuant to Section 4141. (b) Notwithstanding subdivision (a), a license is not required if the nonresident distributor sells or distributes solely through a person who is licensed as a wholesaler or third-party logistics provider pursuant to Section 4160. (c) The Legislature, by enacting this section, does not intend a license issued to any nonresident distributor pursuant to this article to serve as evidence that the entity is doing business within this state. (Amended by Stats. 2014, Ch. 507, Sec. 15. (AB 2605) Effective January 1, 2015.) - 4150. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 10. Pharmacy Corporations [4150 - 4156] ( Article 10 added by Stats. 1996, Ch. 890, Sec. 3. )
A pharmacy corporation is a corporation authorized to provide professional services, if it and specified pharmacist-related persons comply with the listed laws and regulations.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 10. Pharmacy Corporations [4150 - 4156] ( Article 10 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4150. (a) A pharmacy corporation means a corporation that is authorized to render professional services, as defined in Section 13401 of the Corporations Code, so long as that corporation and its shareholders, officers, directors, and employees rendering professional services who are pharmacists are in compliance with the Moscone-Knox Professional Corporation Act, this article, and all other statutes and regulations now or hereafter enacted or adopted pertaining to the corporation and the conduct of its affairs. (b) With respect to a pharmacy corporation, the governmental agency referred to in the Moscone-Knox Professional Corporation Act is the Board of Pharmacy of the State of California. (Amended by Stats. 1997, Ch. 549, Sec. 87. Effective January 1, 1998.) - 4151. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 10. Pharmacy Corporations [4150 - 4156] ( Article 10 added by Stats. 1996, Ch. 890, Sec. 3. )
Most shareholders, directors, and officers of a pharmacy corporation must be licensed persons, except assistant secretaries and assistant treasurers.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 10. Pharmacy Corporations [4150 - 4156] ( Article 10 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4151. Each shareholder, director, and officer of a pharmacy corporation, except an assistant secretary and an assistant treasurer, shall be a licensed person as defined in Section 13401 of the Corporations Code. (Repealed and added by Stats. 1996, Ch. 890, Sec. 3. Effective January 1, 1997.) - 4152. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 10. Pharmacy Corporations [4150 - 4156] ( Article 10 added by Stats. 1996, Ch. 890, Sec. 3. )
A pharmacy corporation’s name, including any name it uses for professional services, must include “pharmacist,” “pharmacy,” or “pharmaceutical” plus words or abbreviations showing corporate existence.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 10. Pharmacy Corporations [4150 - 4156] ( Article 10 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4152. The name of a pharmacy corporation and any name or names under which it may render professional services shall contain the word “pharmacist,” “pharmacy,” or “pharmaceutical” and wording or abbreviations denoting corporate existence. (Repealed and added by Stats. 1996, Ch. 890, Sec. 3. Effective January 1, 1997.) - 4153. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 10. Pharmacy Corporations [4150 - 4156] ( Article 10 added by Stats. 1996, Ch. 890, Sec. 3. )
A pharmacy corporation’s income from professional services cannot be used to benefit a shareholder’s shares when the shareholder is a disqualified person.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 10. Pharmacy Corporations [4150 - 4156] ( Article 10 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4153. The income of a pharmacy corporation attributable to professional services rendered while a shareholder is a disqualified person, as defined in Section 13401 of the Corporations Code, shall not in any manner accrue to the benefit of the shareholder or his or her shares in the pharmacy corporation. (Added by Stats. 1996, Ch. 890, Sec. 3. Effective January 1, 1997.) - 4154. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 10. Pharmacy Corporations [4150 - 4156] ( Article 10 added by Stats. 1996, Ch. 890, Sec. 3. )
The board may adopt regulations for pharmacy corporations, including rules requiring bylaws to provide for sale of certain stock and requiring adequate security for patient or client claims.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 10. Pharmacy Corporations [4150 - 4156] ( Article 10 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4154. The board may adopt and enforce regulations to carry out the purposes and objectives of this article, including regulations requiring (a) that the bylaws of a pharmacy corporation shall include a provision whereby the capital stock of the corporation owned by a disqualified person, as defined in Section 13401 of the Corporations Code, or a deceased person, shall be sold to the corporation or to the remaining shareholders of the corporation within the time as the regulations may provide, and (b) that a pharmacy corporation shall provide adequate security by insurance or otherwise for claims against it by its patients or clients arising out of the rendering of professional services. (Added by Stats. 1996, Ch. 890, Sec. 3. Effective January 1, 1997.) - 4155. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 10. Pharmacy Corporations [4150 - 4156] ( Article 10 added by Stats. 1996, Ch. 890, Sec. 3. )
This section says it must not be read to require a pharmacy permit applicant or holder under Section 4110 to be a pharmacy corporation.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 10. Pharmacy Corporations [4150 - 4156] ( Article 10 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4155. Nothing in this article shall be construed as requiring the applicant or holder of a pharmacy permit pursuant to Section 4110 to be a pharmacy corporation. (Added by Stats. 1996, Ch. 890, Sec. 3. Effective January 1, 1997.) - 4156. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 10. Pharmacy Corporations [4150 - 4156] ( Article 10 added by Stats. 1996, Ch. 890, Sec. 3. )
A pharmacy corporation must not engage in, or omit, any act that would amount to unprofessional conduct under another statute or regulation, and it must follow the laws and regulations that apply to licensed persons under the chapter.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 10. Pharmacy Corporations [4150 - 4156] ( Article 10 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4156. A pharmacy corporation shall not do, or fail to do, any act where doing or failing to do the act would constitute unprofessional conduct under any statute or regulation. In the conduct of its practice, a pharmacy corporation shall observe and be bound by the laws and regulations that apply to a person licensed under this chapter. (Added by Stats. 1996, Ch. 890, Sec. 3. Effective January 1, 1997.) - 4160. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 11. Wholesalers, Third-Party Logistics Providers, and Manufacturers [4160 - 4169.1] ( Heading of Article 11 amended by Stats. 2014, Ch. 507, Sec. 16. )
Wholesalers and third-party logistics providers need board licenses, separate licenses for each business location, and required designated staff present while open.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 11. Wholesalers, Third-Party Logistics Providers, and Manufacturers [4160 - 4169.1] ( Heading of Article 11 amended by Stats. 2014, Ch. 507, Sec. 16. ) ## 4160. (a) A person shall not act as a wholesaler or third-party logistics provider of any dangerous drug or dangerous device unless he or she has obtained a license from the board. (b) Upon approval by the board and the payment of the required fee, the board shall issue a license to the applicant. (c) (1) A separate license shall be required for each place of business owned or operated by a wholesaler or third-party logistics provider. Each place of business may only be issued a single license by the board, except as provided in paragraph (2). Each license shall be renewed annually and shall not be transferable. At all times during which a place of business is open for business, at least one designated representative, in the case of a wholesaler, or designated representative-3PL in the case of a third-party logistics provider, shall be present. A wholesaler that only acts as a reverse distributor may use either a designated representative or a designated representative-reverse distributor to fulfill this requirement. (2) A wholesaler and a third-party logistics provider under common ownership may be licensed at the same place of business provided that all of the following requirements are satisfied: (A) The wholesaler and the third-party logistics provider each separately maintain the records required under Section 4081. (B) Dangerous drugs and dangerous devices owned by the wholesaler are not commingled with the dangerous drugs and dangerous devices handled by the third-party logistics provider. (C) Any individual acting as a designated representative for the wholesaler is not concurrently acting as a designated representative-3PL on behalf of the third-party logistics provider. Nothing in this subparagraph shall be construed to prohibit an individual from concurrently holding a license to act as a designated representative and to act as a designated representative-3PL. (D) The wholesaler has its own designated representative-in-charge responsible for the operations of the wholesaler and the third-party logistics provider has its own responsible manager responsible for the operations of the third-party logistics provider. The same individual shall not concurrently serve as the responsible manager and the designated representative-in-charge for a wholesaler and a third-party logistics provider licensed at the same place of business. (E) The third-party logistics provider does not handle the prescription drugs or prescription devices owned by a prescriber. (F) The third-party logistics provider is not a reverse third-party logistics provider. (G) The wholesaler is not acting as a reverse distributor. (d) Every wholesaler shall be supervised or managed by a designated representative-in-charge. The designated representative-in-charge shall be responsible for the wholesaler’s compliance with state and federal laws governing wholesalers. As part of its initial application for a license, and for each renewal, each wholesaler shall, on a form designed by the board, provide identifying information and the California license number for a designated representative or pharmacist proposed to serve as the designated representative-in-charge. The proposed designated representative-in-charge shall be subject to approval by the board. The board shall not issue or renew a wholesaler license without identification of an approved designated representative-in-charge for the wholesaler. The designated representative-in-charge shall maintain an active license as a designated representative with the board at all times during which he or she is designated as the designated representative-in-charge. A wholesaler that only acts as a reverse distributor may identify and allow a designated representative-reverse distributor to perform in this capacity. That individual shall maintain an active license as a designated representative-reverse distributor. (e) Each place of business of a third-party logistics provider shall be supervised and managed by a responsible manager. The responsible manager shall be responsible for the compliance of the place of business with state and federal laws governing third-party logistics providers and with the third-party logistics provider’s customer specifications, except where the customer’s specifications conflict with state or federal laws. As part of its initial application for a license, and for each renewal, each third-party logistics provider shall, on a form designated by the board, provide identifying information and the California license number for a designated representative-3PL proposed to serve as the responsible manager. The proposed responsible manager shall be subject to approval by the board. The board shall not issue or renew a third-party logistics provider license without identification of an approved responsible manager for the third-party logistics provider. The responsible manager shall maintain an active license as a designated representative-3PL with the board at all times during which he or she is designated as the responsible manager. (f) A wholesaler shall notify the board in writing, on a form designed by the board, within 30 days of the date when a designated representative-in-charge ceases to act as the designated representative-in-charge, and shall on the same form propose another authorized licensee to take over as the designated representative-in-charge. The proposed replacement designated representative-in-charge shall be subject to approval by the board. If disapproved, the wholesaler shall propose another replacement within 15 days of the date of disapproval, and shall continue to name proposed replacements until a designated representative-in-charge is approved by the board. (g) A third-party logistics provider shall notify the board in writing, on a form designed by the board, within 30 days of the date when a responsible manager ceases to act as the responsible manager, and shall on the same form propose another designated representative-3PL to take over as the responsible manager. The proposed replacement responsible manager shall be subject to approval by the board. If disapproved, the third-party logistics provider shall propose another replacement within 15 days of the date of disapproval, and shall continue to name proposed replacements until a responsible manager is approved by the board. (h) A drug manufacturer premises licensed by the Food and Drug Administration or licensed pursuant to Section 111615 of the Health and Safety Code that only distributes dangerous drugs and dangerous devices of its own manufacture is exempt from this section and Section 4161. (i) The board may issue a temporary license, upon conditions and for periods of time as the board determines to be in the public interest. A temporary license fee shall be required in an amount established by the board as specified in subdivision (f) of Section 4400. When needed to protect public safety, a temporary license may be issued for a period not to exceed 180 days, subject to terms and conditions that the board deems necessary. If the board determines that a temporary license was issued by mistake or denies the application for a permanent license, the temporary license shall terminate upon either personal service of the notice of termination upon the licenseholder or service by certified mail, return receipt requested, at the licenseholder’s address of record with the board, whichever occurs first. For purposes of retaining a temporary license, or for purposes of any disciplinary or license denial proceeding before the board, the temporary licenseholder shall not be deemed to have a vested property right or interest in the license. (Amended by Stats. 2017, Ch. 598, Sec. 7. (SB 752) Effective January 1, 2018.) - 4160.5. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 11. Wholesalers, Third-Party Logistics Providers, and Manufacturers [4160 - 4169.1] ( Heading of Article 11 amended by Stats. 2014, Ch. 507, Sec. 16. )
Manufacturers of nonprescription diabetes test devices must publish authorized distributor names on their website, give the board the names, and update both after changes; the board must post the list on its website.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 11. Wholesalers, Third-Party Logistics Providers, and Manufacturers [4160 - 4169.1] ( Heading of Article 11 amended by Stats. 2014, Ch. 507, Sec. 16. ) ## 4160.5. Within 30 days of the effective date of the act adding this section, a manufacturer of a nonprescription diabetes test device shall make the names of its authorized distributors available on its Internet Web site and shall provide the board with the names of its authorized distributors. Within 30 days of receiving that information from a manufacturer of a nonprescription diabetes test device, the board shall post the names of authorized distributors of nonprescription diabetes test devices on the board’s Internet Web site. A manufacturer of a nonprescription diabetes test device shall, within 30 days of making changes to its authorized distributors, update its Internet Web site and inform the board of changes to its authorized distributors. Within 30 days of receiving notice of any change from a manufacturer of a nonprescription diabetes test device, the board shall post the updated list of the manufacturer’s authorized distributors on its Internet Web site. (Added by Stats. 2017, Ch. 139, Sec. 5. (AB 602) Effective July 31, 2017.) - 4161. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 11. Wholesalers, Third-Party Logistics Providers, and Manufacturers [4160 - 4169.1] ( Heading of Article 11 amended by Stats. 2014, Ch. 507, Sec. 16. )
Nonresident wholesalers and nonresident third-party logistics providers must be licensed by the board before doing covered drug and device business in the state.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 11. Wholesalers, Third-Party Logistics Providers, and Manufacturers [4160 - 4169.1] ( Heading of Article 11 amended by Stats. 2014, Ch. 507, Sec. 16. ) ## 4161. (a) A person located outside this state that (1) ships, sells, mails, warehouses, distributes, or delivers dangerous drugs or dangerous devices into this state or (2) sells, brokers, warehouses, or distributes dangerous drugs or devices within this state shall be considered a nonresident wholesaler or a nonresident third-party logistics provider. (b) A nonresident wholesaler or nonresident third-party logistics provider shall be licensed by the board prior to shipping, selling, mailing, warehousing, distributing, or delivering dangerous drugs or dangerous devices to a site located in this state or selling, brokering, warehousing, or distributing dangerous drugs or devices within this state. (c) (1) A separate license shall be required for each place of business owned or operated by a nonresident wholesaler or nonresident third-party logistics provider from or through which dangerous drugs or dangerous devices are shipped, sold, mailed, warehoused, distributed, or delivered to a site located in this state or sold, brokered, warehoused, or distributed within this state. Each place of business may only be issued a single license by the board, except as provided in paragraph (2). A license shall be renewed annually and shall not be transferable. (2) A nonresident wholesaler and a nonresident third-party logistics provider under common ownership may be licensed at the same place of business provided that all of the following requirements are satisfied: (A) The wholesaler and the third-party logistics provider each separately maintain the records required under Section 4081. (B) Dangerous drugs and dangerous devices owned by the wholesaler are not commingled with the dangerous drugs and dangerous devices handled by the third-party logistics provider. (C) Any individual acting as a designated representative for the wholesaler is not concurrently acting as a designated representative-3PL on behalf of the third-party logistics provider. Nothing in this subparagraph shall be construed to prohibit an individual from concurrently holding a license to act as a designated representative and to act as a designated representative-3PL. (D) The wholesaler has its own designated representative-in-charge responsible for the operations of the wholesaler and the third-party logistics provider has its own responsible manager responsible for the operations of the third-party logistics provider. The same individual shall not concurrently serve as the responsible manager and the designated representative-in-charge for a wholesaler and a third-party logistics provider licensed at the same place of business. (E) The third-party logistics provider does not handle the prescription drugs or prescription devices owned by a prescriber. (F) The third-party logistics provider is not a reverse third-party logistics provider. (G) The wholesaler is not acting as a reverse distributor. (d) The following information shall be reported, in writing, to the board at the time of initial application for licensure by a nonresident wholesaler or a nonresident third-party logistics provider, on renewal of a nonresident wholesaler or nonresident third-party logistics provider license, or within 30 days of a change in that information: (1) Its agent for service of process in this state. (2) Its principal corporate officers, as specified by the board, if any. (3) Its general partners, as specified by the board, if any. (4) Its owners if the applicant is not a corporation or partnership. (e) A report containing the information in subdivision (d) shall be made within 30 days of any change of ownership, office, corporate officer, or partner. (f) A nonresident wholesaler or nonresident third-party logistics provider shall comply with all directions and requests for information from the regulatory or licensing agency of the state in which it is licensed, as well as with all requests for information made by the board. (g) A nonresident wholesaler or nonresident third-party logistics provider shall maintain records of dangerous drugs and dangerous devices sold, traded, transferred, warehoused, or distributed to persons in this state or within this state, so that the records are in a readily retrievable form. (h) A nonresident wholesaler or nonresident third-party logistics provider shall at all times maintain a valid, unexpired license, permit, or registration to conduct the business of the wholesaler or nonresident third-party logistics provider in compliance with the laws of the state in which it is a resident. An application for a nonresident wholesaler or nonresident third-party logistics provider license in this state shall include a license verification from the licensing authority in the applicant’s state of residence. The board may waive the home state licensure requirement for a nonresident third-party logistics provider if the board inspects the location and finds it to be in compliance with this article and any regulations adopted by the board or the applicant provides evidence of its accreditation by the Drug Distributor Accreditation program of the National Association of Boards of Pharmacy. The nonresident third-party logistics provider shall reimburse the board for all actual and necessary costs incurred by the board in conducting an inspection of the location, pursuant to subdivision (v) of Section 4400. (i) (1) The board shall not issue or renew a nonresident wholesaler license until the nonresident wholesaler identifies a designated representative-in-charge and notifies the board in writing of the identity and license number of the designated representative-in-charge. (2) The board shall not issue or renew a nonresident third-party logistics provider license until the nonresident third-party logistics provider identifies a responsible manager and notifies the board in writing of the identity and license number of the designated representative-3PL who will be the responsible manager. (j) The designated representative-in-charge shall be responsible for the compliance of the nonresident wholesaler with state and federal laws governing wholesalers. The responsible manager shall be responsible for the compliance of the nonresident third-party logistics provider’s place of business with state and federal laws governing third-party logistics providers. A nonresident wholesaler or nonresident third-party logistics provider shall identify and notify the board of a new designated representative-in-charge or responsible manager within 30 days of the date that the prior designated representative-in-charge or responsible manager ceases to be the designated representative-in-charge or responsible manager. (k) The board may issue a temporary license, upon conditions and for periods of time as the board determines to be in the public interest. When needed to protect public safety, a temporary license may be issued for a period not to exceed 180 days, subject to terms and conditions that the board deems necessary. If the board determines that a temporary license was issued by mistake or denies the application for a permanent license, the temporary license shall terminate upon either personal service of the notice of termination upon the licenseholder or service by certified mail, return receipt requested, at the licenseholder’s address of record with the board, whichever occurs first. Neither for purposes of retaining a temporary license, nor for purposes of any disciplinary or license denial proceeding before the board, shall the temporary licenseholder be deemed to have a vested property right or interest in the license. (l) The registration fee shall be the fee specified in subdivision (f) of Section 4400. (m) This section shall become operative on January 1, 2025. (Repealed (in Sec. 10) and added by Stats. 2023, Ch. 723, Sec. 11. (SB 816) Effective January 1, 2024. Operative January 1, 2025, by its own provisions.) - 4161.5. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 11. Wholesalers, Third-Party Logistics Providers, and Manufacturers [4160 - 4169.1] ( Heading of Article 11 amended by Stats. 2014, Ch. 507, Sec. 16. )
When federal regulations are issued to implement the cited federal law, the board must quickly identify conflicting California interstate-commerce rules and remove the conflict as allowed by law.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 11. Wholesalers, Third-Party Logistics Providers, and Manufacturers [4160 - 4169.1] ( Heading of Article 11 amended by Stats. 2014, Ch. 507, Sec. 16. ) ## 4161.5. At such time as federal regulations are promulgated to implement Section 584 of the federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 360eee-3), the board shall immediately identify any standard, requirement, or regulation in California law governing interstate commerce that is in conflict with the federal regulations and act to remove the conflict in the manner permitted by law. (Added by Stats. 2014, Ch. 507, Sec. 19. (AB 2605) Effective January 1, 2015.) - 4162. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 11. Wholesalers, Third-Party Logistics Providers, and Manufacturers [4160 - 4169.1] ( Heading of Article 11 amended by Stats. 2014, Ch. 507, Sec. 16. )
Certain wholesaler and third-party logistics provider applicants must post a surety bond, unless a stated exemption applies.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 11. Wholesalers, Third-Party Logistics Providers, and Manufacturers [4160 - 4169.1] ( Heading of Article 11 amended by Stats. 2014, Ch. 507, Sec. 16. ) ## 4162. (a) (1) An applicant for the issuance or renewal of a wholesaler license, which is not government owned and operated, shall submit a surety bond of one hundred thousand dollars ($100,000) or other equivalent means of security acceptable to the board payable to the Pharmacy Board Contingent Fund. The purpose of the surety bond is to secure payment of any administrative fine imposed by the board and any cost recovery ordered pursuant to Section 125.3. (2) An applicant for the issuance or renewal of a third-party logistics provider license, which is not government owned and operated, shall submit a surety bond of ninety thousand dollars ($90,000) or other equivalent means of security acceptable to the board payable to the Pharmacy Board Contingent Fund. The purpose of the surety bond is to secure payment of any administrative fine imposed by the board and any cost recovery ordered pursuant to Section 125.3. (3) For purposes of paragraphs (1) and (2), the board may accept a surety bond less than the amount required under paragraph (1) or (2) if the annual gross receipts of the previous tax year for the wholesaler or third-party logistics provider is ten million dollars ($10,000,000) or less, in which case the surety bond shall be twenty-five thousand dollars ($25,000). (4) A person to whom an approved new drug application has been issued by the United States Food and Drug Administration who engages in the wholesale distribution of only the dangerous drug specified in the new drug application, and is licensed or applies for licensure as a wholesaler or third-party logistics provider, shall not be required to post a surety bond as provided in paragraph (1) or (2). (5) For licensees subject to paragraph (3) or (4), the board may require a bond up to one hundred thousand dollars ($100,000) for any licensee who has been disciplined by any state or federal agency or has been issued an administrative fine pursuant to this chapter. (b) The board may make a claim against the bond if the licensee fails to pay a fine within 30 days after the order imposing the fine, or costs become final. (c) A single surety bond or other equivalent means of security acceptable to the board shall satisfy the requirement of subdivision (a) for all licensed sites under common control as defined in Section 4126.5. (Amended by Stats. 2014, Ch. 507, Sec. 20. (AB 2605) Effective January 1, 2015.) - 4162.5. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 11. Wholesalers, Third-Party Logistics Providers, and Manufacturers [4160 - 4169.1] ( Heading of Article 11 amended by Stats. 2014, Ch. 507, Sec. 16. )
Some nonresident pharmacy-related license applicants must submit a surety bond, but the board can accept reduced security in some cases and certain FDA application holders are exempt.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 11. Wholesalers, Third-Party Logistics Providers, and Manufacturers [4160 - 4169.1] ( Heading of Article 11 amended by Stats. 2014, Ch. 507, Sec. 16. ) ## 4162.5. (a) (1) An applicant for the issuance or renewal of a nonresident wholesaler license shall submit a surety bond of one hundred thousand dollars ($100,000), or other equivalent means of security acceptable to the board, such as an irrevocable letter of credit, or a deposit in a trust account or financial institution, payable to the Pharmacy Board Contingent Fund. The purpose of the surety bond is to secure payment of any administrative fine imposed by the board and any cost recovery ordered pursuant to Section 125.3. (2) An applicant for the issuance or renewal of a nonresident third-party logistics provider license shall submit a surety bond of ninety thousand dollars ($90,000), or other equivalent means of security acceptable to the board, such as an irrevocable letter of credit, or a deposit in a trust account or financial institution, payable to the Pharmacy Board Contingent Fund. The purpose of the surety bond is to secure payment of any administrative fine imposed by the board and any cost recovery ordered pursuant to Section 125.3. (3) For purposes of paragraphs (1) and (2), the board may accept a surety bond less than the amount required under paragraph (1) or (2) if the annual gross receipts of the previous tax year for the nonresident wholesaler or the nonresident third-party logistics provider is ten million dollars ($10,000,000) or less, in which case the surety bond shall be twenty-five thousand dollars ($25,000). (4) For applicants who satisfy paragraph (3), the board may require a bond up to one hundred thousand dollars ($100,000) for any nonresident wholesaler or nonresident third-party logistics provider who has been disciplined by any state or federal agency or has been issued an administrative fine pursuant to this chapter. (5) A person to whom an approved new drug application or a biologics license application has been issued by the United States Food and Drug Administration who engages in the wholesale distribution of only the dangerous drug specified in the new drug application or biologics license application, and is licensed or applies for licensure as a nonresident wholesaler or a nonresident third-party logistics provider, shall not be required to post a surety bond as provided in this section. (b) The board may make a claim against the bond if the licensee fails to pay a fine within 30 days of the issuance of the fine or when the costs become final. (c) A single surety bond or other equivalent means of security acceptable to the board shall satisfy the requirement of subdivision (a) for all licensed sites under common control as defined in Section 4126.5. (Amended by Stats. 2014, Ch. 507, Sec. 21. (AB 2605) Effective January 1, 2015.) - 4163. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 11. Wholesalers, Third-Party Logistics Providers, and Manufacturers [4160 - 4169.1] ( Heading of Article 11 amended by Stats. 2014, Ch. 507, Sec. 16. )
Certain licensed drug handlers must not furnish dangerous drugs or devices to unauthorized people, and acquisitions generally must come from legally authorized sources.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 11. Wholesalers, Third-Party Logistics Providers, and Manufacturers [4160 - 4169.1] ( Heading of Article 11 amended by Stats. 2014, Ch. 507, Sec. 16. ) ## 4163. (a) A manufacturer, wholesaler, repackager, or pharmacy shall not furnish a dangerous drug or dangerous device to an unauthorized person. (b) Except as provided in subdivision (c), dangerous drugs or dangerous devices shall be acquired from a person authorized by law to possess or furnish dangerous drugs or dangerous devices. If the person acquiring the dangerous drugs or dangerous devices is a wholesaler, the obligation of the wholesaler shall be limited to obtaining confirmation of licensure of those sources from whom it has not previously acquired dangerous drugs or dangerous devices. (c) Upon approval of the board, a reverse distributor licensed as a wholesaler may acquire a dangerous drug or dangerous device from an unlicensed source that was previously licensed with the board for the sole purpose of destruction of the dangerous drug or dangerous device. (Amended by Stats. 2019, Ch. 213, Sec. 2. (SB 655) Effective January 1, 2020.) - 4164. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 11. Wholesalers, Third-Party Logistics Providers, and Manufacturers [4160 - 4169.1] ( Heading of Article 11 amended by Stats. 2014, Ch. 507, Sec. 16. )
Wholesalers and licensed third-party logistics providers must report certain abuse-prone distributions to the board, and wholesalers must track specified sales and provide the tracked data to the board on request.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 11. Wholesalers, Third-Party Logistics Providers, and Manufacturers [4160 - 4169.1] ( Heading of Article 11 amended by Stats. 2014, Ch. 507, Sec. 16. ) ## 4164. (a) A wholesaler or third-party logistics provider licensed by the board that distributes controlled substances, dangerous drugs, or dangerous devices within or into this state shall report to the board all distributions of dangerous drugs and controlled substances that are subject to abuse, as determined by the board. (b) Each wholesaler shall develop and maintain a system for tracking individual sales of dangerous drugs at preferential or contract prices to pharmacies that primarily or solely dispense prescription drugs to patients of long-term care facilities. The system shall be capable of identifying purchases of any dangerous drug at preferential or contract prices by customers that vary significantly from prior ordering patterns for the same customer, including by identifying purchases in the preceding 12 calendar months by that customer or similar customers and identifying current purchases that exceed prior purchases by either that customer or similar customers by a factor of 20 percent. (c) Upon written, oral, or electronic request by the board, a wholesaler shall furnish data tracked pursuant to subdivision (b) to the board in written, hardcopy, or electronic form. The board shall specify the dangerous drugs, the customers, or both the dangerous drugs and customers for which data are to be furnished, and the wholesaler shall have 30 calendar days to comply with the request. (d) As used in this section, “preferential or contract prices” means and refers to purchases by contract of dangerous drugs at prices below the market wholesale price for those drugs. (Amended by Stats. 2014, Ch. 507, Sec. 22. (AB 2605) Effective January 1, 2015.) - 4165. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 11. Wholesalers, Third-Party Logistics Providers, and Manufacturers [4160 - 4169.1] ( Heading of Article 11 amended by Stats. 2014, Ch. 507, Sec. 16. )
A licensed wholesaler or third-party logistics provider must provide records of certain dangerous drug or device sales or transfers to an authorized law officer if requested.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 11. Wholesalers, Third-Party Logistics Providers, and Manufacturers [4160 - 4169.1] ( Heading of Article 11 amended by Stats. 2014, Ch. 507, Sec. 16. ) ## 4165. A wholesaler or third-party logistics provider licensed by the board who sells or transfers any dangerous drug or dangerous device into this state or who receives, by sale or otherwise, any dangerous drug or dangerous device from any person in this state shall, on request, furnish an authorized officer of the law with all records or other documentation of that sale or transfer. (Amended by Stats. 2014, Ch. 507, Sec. 23. (AB 2605) Effective January 1, 2015.) - 4166. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 11. Wholesalers, Third-Party Logistics Providers, and Manufacturers [4160 - 4169.1] ( Heading of Article 11 amended by Stats. 2014, Ch. 507, Sec. 16. )
Wholesalers and third-party logistics providers must keep dangerous drugs or devices secure, and the logistics provider must have written procedures and verify carrier obligations and recipient authorization.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 11. Wholesalers, Third-Party Logistics Providers, and Manufacturers [4160 - 4169.1] ( Heading of Article 11 amended by Stats. 2014, Ch. 507, Sec. 16. ) ## 4166. (a) A wholesaler that uses the services of a third-party logistics provider or carrier, including, but not limited to, the United States Postal Service or a common carrier, shall be liable for the security and integrity of any dangerous drugs or dangerous devices through that provider or carrier until the drugs or devices are delivered to the transferee at its board-licensed premises. (b) A third-party logistics provider that uses the services of a carrier, including, but not limited to, the United States Postal Service or a common carrier, shall have in place and comply with written policies and procedures that provide for both of the following: (1) Verification that the third-party logistics provider, or the owner of the dangerous drugs or dangerous devices stored at the third-party logistics provider, has imposed obligations on the carrier that provide for the security and integrity of any dangerous drugs or dangerous devices transported by the carrier until the drugs or devices are delivered to the transferee at its premises. (2) Confirmation, prior to shipping a dangerous drug or dangerous device, that the intended recipient is legally authorized to receive the dangerous drug or dangerous device. (c) Nothing in this section is intended to affect the liability of a wholesaler, third-party logistics provider, or other distributor for dangerous drugs or dangerous devices after their delivery to the transferee. (Amended by Stats. 2014, Ch. 507, Sec. 24. (AB 2605) Effective January 1, 2015.) - 4167. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 11. Wholesalers, Third-Party Logistics Providers, and Manufacturers [4160 - 4169.1] ( Heading of Article 11 amended by Stats. 2014, Ch. 507, Sec. 16. )
A wholesaler or third-party logistics provider must not obtain dangerous drugs or dangerous devices unless they can be kept securely at the board-licensed place of business.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 11. Wholesalers, Third-Party Logistics Providers, and Manufacturers [4160 - 4169.1] ( Heading of Article 11 amended by Stats. 2014, Ch. 507, Sec. 16. ) ## 4167. A wholesaler or third-party logistics provider shall not obtain, by purchase or otherwise, any dangerous drugs or dangerous devices that it cannot maintain, in a secure manner, at the place of business licensed by the board. (Amended by Stats. 2014, Ch. 507, Sec. 25. (AB 2605) Effective January 1, 2015.) - 4168. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 11. Wholesalers, Third-Party Logistics Providers, and Manufacturers [4160 - 4169.1] ( Heading of Article 11 amended by Stats. 2014, Ch. 507, Sec. 16. )
A county or municipality may not issue a business license for an establishment that needs a wholesaler or third-party logistics provider license unless the establishment has a current license issued by the board.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 11. Wholesalers, Third-Party Logistics Providers, and Manufacturers [4160 - 4169.1] ( Heading of Article 11 amended by Stats. 2014, Ch. 507, Sec. 16. ) ## 4168. A county or municipality shall not issue a business license for any establishment that requires a wholesaler or third-party logistics provider license unless the establishment possesses a current wholesaler or third-party logistics provider license issued by the board. For purposes of this section, an “establishment” is the licensee’s physical location in California. (Amended by Stats. 2014, Ch. 507, Sec. 26. (AB 2605) Effective January 1, 2015.) - 4169. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 11. Wholesalers, Third-Party Logistics Providers, and Manufacturers [4160 - 4169.1] ( Heading of Article 11 amended by Stats. 2014, Ch. 507, Sec. 16. )
A person or entity must not wholesale, handle, or transfer certain dangerous drugs or devices in prohibited circumstances, and must keep acquisition or disposition records for at least three years.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 11. Wholesalers, Third-Party Logistics Providers, and Manufacturers [4160 - 4169.1] ( Heading of Article 11 amended by Stats. 2014, Ch. 507, Sec. 16. ) ## 4169. (a) A person or entity shall not do any of the following: (1) Purchase, trade, sell, warehouse, distribute, or transfer dangerous drugs or dangerous devices at wholesale with a person or entity that is not licensed with the board as a wholesaler, third-party logistics provider, or pharmacy. (2) Purchase, trade, sell, or transfer dangerous drugs that the person knew or reasonably should have known were adulterated, as set forth in Article 2 (commencing with Section 111250) of Chapter 6 of Part 5 of Division 104 of the Health and Safety Code. (3) Purchase, trade, sell, or transfer dangerous drugs that the person knew or reasonably should have known were misbranded, as defined in Section 111335 of the Health and Safety Code. (4) Purchase, trade, sell, or transfer dangerous drugs or dangerous devices after the beyond use date on the label. (5) Fail to maintain records of the acquisition or disposition of dangerous drugs or dangerous devices for at least three years. (b) Notwithstanding any other law, a violation of this section may subject the person or entity that has committed the violation to a fine not to exceed the amount specified in Section 125.9 for each occurrence, pursuant to a citation issued by the board. (c) Amounts due from any person under this section shall be offset as provided under Section 12419.5 of the Government Code. Amounts received by the board under this section shall be deposited into the Pharmacy Board Contingent Fund. (d) This section shall not apply to a pharmaceutical manufacturer licensed by the Food and Drug Administration or by the State Department of Public Health. (Amended by Stats. 2014, Ch. 507, Sec. 27. (AB 2605) Effective January 1, 2015.) - 4169.1. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 11. Wholesalers, Third-Party Logistics Providers, and Manufacturers [4160 - 4169.1] ( Heading of Article 11 amended by Stats. 2014, Ch. 507, Sec. 16. )
A wholesaler must promptly notify the board in writing when it discovers suspicious orders of controlled substances placed by a California-licensed pharmacy or wholesaler.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 11. Wholesalers, Third-Party Logistics Providers, and Manufacturers [4160 - 4169.1] ( Heading of Article 11 amended by Stats. 2014, Ch. 507, Sec. 16. ) ## 4169.1. A wholesaler, upon discovery, shall notify the board in writing of any suspicious orders of controlled substances placed by a California-licensed pharmacy or wholesaler by providing the board a copy of the information that the wholesaler provides to the United States Drug Enforcement Administration. Suspicious orders include, but are not limited to, orders of unusual size, orders deviating substantially from a normal pattern, and orders of unusual frequency. (Added by Stats. 2017, Ch. 548, Sec. 8. (AB 401) Effective January 1, 2018.) - 4169.5. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 11.5. Surplus Medication Collection and Distribution Intermediaries [4169.5- 4169.5.] ( Article 11.5 added by Stats. 2014, Ch. 10, Sec. 2. )
Surplus medication collection and distribution intermediaries must be licensed by the board, pay a $300 fee unless exempt, and keep complete records for three years.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 11.5. Surplus Medication Collection and Distribution Intermediaries [4169.5- 4169.5.] ( Article 11.5 added by Stats. 2014, Ch. 10, Sec. 2. ) ## 4169.5. (a) A surplus medication collection and distribution intermediary established for the purpose of facilitating the donation of medications to or transfer of medications between participating entities under a program established pursuant to Division 116 (commencing with Section 150200) of the Health and Safety Code shall be licensed by the board. The board shall enforce the requirements set forth in Section 150208 of the Health and Safety Code. The license shall be renewed annually. (b) An application for licensure as a surplus medication collection and distribution intermediary shall be made on a form furnished by the board, and shall state the name, address, usual occupation, and professional qualifications, if any, of the applicant. If the applicant is an entity other than a natural person, the application shall state the information as to each person beneficially interested in that entity. (c) As used in this section, and subject to subdivision (e), the term “person beneficially interested” means and includes: (1) If the applicant is a partnership or other unincorporated association, each partner or member. (2) If the applicant is a corporation, each of its officers, directors, and stockholders, provided that no natural person shall be deemed to be beneficially interested in a nonprofit corporation. (3) If the applicant is a limited liability company, each officer, manager, or member. (d) If the applicant is a charitable organization described in Section 501(c)(3) of the Internal Revenue Code, the applicant shall furnish the board with the organization’s articles of incorporation. The applicant shall also furnish the board with the names of the controlling members. (e) If the applicant is a partnership or other unincorporated association, a limited liability company, or a corporation, and if the number of partners, members, or stockholders, as the case may be, exceeds five, the application shall so state, and shall further state the information required by subdivision (b) as to each of the five partners, members, or stockholders who own the five largest interests in the applicant’s entity. Upon request by the executive officer of the board, the applicant shall furnish the board with the information required by subdivision (b) as to partners, members, or stockholders not named in the application, or shall refer the board to an appropriate source of that information. (f) The application shall contain a statement to the effect that the applicant or persons beneficially interested have not been convicted of a felony and have not violated any of the provisions of this chapter. If the applicant cannot make this statement, the application shall contain a statement of the violation, if any, or reasons which will prevent the applicant from being able to comply with the requirements with respect to the statement. (g) Upon the approval of the application by the board and payment of a fee in the amount of three hundred dollars ($300), the executive officer of the board shall issue or renew a license to operate as a surplus medication collection and distribution intermediary, if all of the provisions of this chapter have been complied with. Fees received by the board pursuant to this section shall be deposited into the Pharmacy Board Contingent Fund. An applicant for licensure as a surplus medication collection and distribution intermediary that is government owned or is a nonprofit organization pursuant to subdivision (d) is exempt from the fee requirement. (h) A surplus medication collection and distribution intermediary licensed pursuant to this section is exempt from licensure as a wholesaler. (i) A surplus medication collection and distribution intermediary licensed pursuant to this section shall keep and maintain for three years complete records for which the intermediary facilitated the donation of medications to or transfer of medications between participating entities. (Added by Stats. 2014, Ch. 10, Sec. 2. (AB 467) Effective April 9, 2014.) - 4170. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 12. Prescriber Dispensing [4170 - 4175] ( Article 12 added by Stats. 1996, Ch. 890, Sec. 3. )
Prescribers generally may not dispense drugs or dangerous devices in their office unless specific conditions are met.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 12. Prescriber Dispensing [4170 - 4175] ( Article 12 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4170. (a) A prescriber shall not dispense drugs or dangerous devices to patients in the prescriber’s office or place of practice unless all of the following conditions are met: (1) The dangerous drugs or dangerous devices are dispensed to the prescriber’s own patient, and the drugs or dangerous devices are not furnished by a nurse or physician attendant. (2) The dangerous drugs or dangerous devices are necessary in the treatment of the condition for which the prescriber is attending the patient. (3) The prescriber does not keep a pharmacy, open shop, or drugstore, advertised or otherwise, for the retailing of dangerous drugs, dangerous devices, or poisons. (4) The prescriber fulfills all of the labeling requirements imposed upon pharmacists by Section 4076, all of the recordkeeping requirements of this chapter, and all of the packaging requirements of good pharmaceutical practice, including the use of childproof containers. (5) The prescriber does not use a dispensing device unless the prescriber personally owns the device and the contents of the device, and personally dispenses the dangerous drugs or dangerous devices to the patient packaged, labeled, and recorded in accordance with paragraph (4). (6) The prescriber, before dispensing, offers to give a written prescription to the patient that the patient may elect to have filled by the prescriber or by any pharmacy. (7) The prescriber provides the patient with written disclosure that the patient has a choice between obtaining the prescription from the dispensing prescriber or obtaining the prescription at a pharmacy of the patient’s choice. (b) A certified nurse-midwife who functions pursuant to a mutually agreed-upon policy or protocol described in Section 2746.5, a nurse practitioner who functions pursuant to a standardized procedure described in Section 2836.1, or protocol, a physician assistant who functions pursuant to Section 3502.1, or a naturopathic doctor who functions pursuant to Section 3640.5, may hand to a patient of the supervising physician and surgeon a properly labeled prescription drug prepackaged by a physician and surgeon, a manufacturer as defined in this chapter, or a pharmacist. (c) The Medical Board of California, the California State Board of Optometry, the California Board of Naturopathic Medicine, the Dental Board of California, the Podiatric Medical Board of California, the Osteopathic Medical Board of California, the Board of Registered Nursing, the Veterinary Medical Board, and the Physician Assistant Board shall have authority with the California State Board of Pharmacy to ensure compliance with this section, and those boards are specifically charged with the enforcement of this chapter with respect to their respective licensees. (d) “Prescriber,” as used in this section, means a person who holds a physician’s and surgeon’s certificate, a license to practice optometry, a license to practice naturopathic medicine, a license to practice dentistry, a license to practice veterinary medicine, a certificate to practice podiatry, a certificate to practice as a nurse practitioner practicing pursuant to Section 2837.103 or 2837.104, or a certificate to practice as a nurse-midwife, and who is duly registered by the Medical Board of California, the Osteopathic Medical Board of California, the California State Board of Optometry, the California Board of Naturopathic Medicine, the Dental Board of California, the Veterinary Medical Board, the Podiatric Medical Board of California, or the Board of Registered Nursing. (Amended by Stats. 2023, Ch. 497, Sec. 4. (SB 667) Effective January 1, 2024.) - 4170.5. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 12. Prescriber Dispensing [4170 - 4175] ( Article 12 added by Stats. 1996, Ch. 890, Sec. 3. )
Veterinary teaching hospitals with an accredited veterinary medical school may let veterinarians dispense and administer certain drugs from common stock, and must assign pharmacist responsibilities for ordering and for safe handling policies.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 12. Prescriber Dispensing [4170 - 4175] ( Article 12 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4170.5. (a) Veterinarians in a veterinary teaching hospital operated by an accredited veterinary medical school may dispense and administer dangerous drugs and devices and controlled substances from a common stock. (b) The veterinary teaching hospital shall designate a pharmacist to be responsible for ordering the drugs for the common stock and the designated pharmacist-in-charge shall be professionally responsible to insure that inventories, security procedures, training, protocol development, recordkeeping, packaging, labeling, and dispensing occur in a manner that is consistent with the promotion and protection of the health and safety of the public. (c) The veterinary teaching hospital’s pharmacist-in-charge shall develop policies, procedures, and guidelines that recognize the unique relationship between the institution’s pharmacists and veterinarians in the control, management, dispensation, and administration of drugs. (d) The board may inspect a veterinary teaching hospital dispensing or administering drugs pursuant to this section. (Added by Stats. 2004, Ch. 695, Sec. 37. Effective January 1, 2005.) - 4171. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 12. Prescriber Dispensing [4170 - 4175] ( Article 12 added by Stats. 1996, Ch. 890, Sec. 3. )
Section 4170 does not bar a prescriber from giving a limited quantity of samples if the samples stay in the manufacturer’s package, the patient is not charged, and the patient chart is updated. It also does not apply to certain clinics, licensed programs, or cancer-treatment dispensing by a prescriber.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 12. Prescriber Dispensing [4170 - 4175] ( Article 12 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4171. (a) Section 4170 shall not prohibit the furnishing of a limited quantity of samples by a prescriber, if the prescriber dispenses the samples to the patient in the package provided by the manufacturer, no charge is made to the patient therefor, and an appropriate record is entered in the patient’s chart. (b) Section 4170 shall not apply to clinics, as defined in subdivision (a) of Section 1204 or subdivision (b) or (c) of Section 1206 of the Health and Safety Code, to programs licensed pursuant to Sections 11876, 11877, and 11877.5 of the Health and Safety Code, or to a prescriber dispensing parenteral chemotherapeutic agents, biologicals, or delivery systems used in the treatment of cancer. (Amended by Stats. 2003, Ch. 250, Sec. 4. Effective January 1, 2004.) - 4172. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 12. Prescriber Dispensing [4170 - 4175] ( Article 12 added by Stats. 1996, Ch. 890, Sec. 3. )
A prescriber dispensing drugs under Section 4170 must store those drugs in a secure area.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 12. Prescriber Dispensing [4170 - 4175] ( Article 12 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4172. A prescriber who dispenses drugs pursuant to Section 4170 shall store all drugs to be dispensed in an area that is secure. The Medical Board of California shall, by regulation, define the term “secure” for purposes of this section. (Added by Stats. 1996, Ch. 890, Sec. 3. Effective January 1, 1997.) - 4173. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 12. Prescriber Dispensing [4170 - 4175] ( Article 12 added by Stats. 1996, Ch. 890, Sec. 3. )
This chapter does not stop registered nurses acting under Section 2725.1 from dispensing drugs or devices.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 12. Prescriber Dispensing [4170 - 4175] ( Article 12 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4173. This chapter does not prevent the dispensing of drugs or devices by registered nurses functioning pursuant to Section 2725.1. (Added by Stats. 1996, Ch. 890, Sec. 3. Effective January 1, 1997.) - 4174. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 12. Prescriber Dispensing [4170 - 4175] ( Article 12 added by Stats. 1996, Ch. 890, Sec. 3. )
A pharmacist may dispense drugs or devices when acting on the specified orders of certain licensed practitioners.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 12. Prescriber Dispensing [4170 - 4175] ( Article 12 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4174. Notwithstanding any other law, a pharmacist may dispense drugs or devices upon the drug order of a nurse practitioner practicing pursuant to Section 2836.1, 2837.103, or 2837.104, or a certified nurse-midwife functioning pursuant to Section 2746.51, a drug order of a physician assistant functioning pursuant to Section 3502.1 or a naturopathic doctor functioning pursuant to Section 3640.5, or the order of a pharmacist acting under Section 4052, 4052.04, 4052.1, 4052.2, or 4052.6. (Amended by Stats. 2025, Ch. 196, Sec. 40. (AB 1503) Effective January 1, 2026.) - 4175. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 12. Prescriber Dispensing [4170 - 4175] ( Article 12 added by Stats. 1996, Ch. 890, Sec. 3. )
The California State Board of Pharmacy must promptly send certain complaints to the appropriate licensing entity, and serious bodily injury complaints must be handled by the listed boards as highest-risk patient-harm cases.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 12. Prescriber Dispensing [4170 - 4175] ( Article 12 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4175. (a) The California State Board of Pharmacy shall promptly forward to the appropriate licensing entity, including the Medical Board of California, the California Veterinary Medical Board, the Dental Board of California, the California State Board of Optometry, the Podiatric Medical Board of California, the Osteopathic Medical Board of California, the Board of Registered Nursing, the California Board of Naturopathic Medicine, or the Physician Assistant Board, all complaints received related to dangerous drugs or dangerous devices dispensed by a prescriber, certified nurse-midwife, nurse practitioner, naturopathic doctor, or physician assistant pursuant to Section 4170. (b) All complaints involving serious bodily injury due to dangerous drugs or dangerous devices dispensed by prescribers, certified nurse-midwives, nurse practitioners, naturopathic doctors, or physician assistants pursuant to Section 4170 shall be handled by the Medical Board of California, the Dental Board of California, the California State Board of Optometry, the Podiatric Medical Board of California, the Osteopathic Medical Board of California, the California Board of Naturopathic Medicine, the Board of Registered Nursing, the California Veterinary Medical Board, or the Physician Assistant Board as a case of greatest potential harm to a patient. (Amended by Stats. 2024, Ch. 497, Sec. 54. (SB 1526) Effective January 1, 2025.) - 4180. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 13. Nonprofit or Free Clinics [4180 - 4186] ( Article 13 added by Stats. 1996, Ch. 890, Sec. 3. )
Certain clinics may buy drugs at wholesale for dispensing or administration to registered patients, but only under a physician and surgeon’s direction and only if they have a board license.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 13. Nonprofit or Free Clinics [4180 - 4186] ( Article 13 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4180. (a) (1) Notwithstanding any provision of this chapter, any of the following clinics may purchase drugs at wholesale for administration or dispensing, under the direction of a physician and surgeon, to patients registered for care at the clinic: (A) A licensed nonprofit community clinic or free clinic as defined in paragraph (1) of subdivision (a) of Section 1204 of the Health and Safety Code. (B) A primary care clinic owned or operated by a county as referred to in subdivision (b) of Section 1206 of the Health and Safety Code. (C) A clinic operated by a federally recognized Indian tribe or tribal organization as referred to in subdivision (c) of Section 1206 of the Health and Safety Code. (D) A clinic operated by a primary care community or free clinic, operated on separate premises from a licensed clinic, and that is open no more than the number of hours per week as referred to in subdivision (h) of Section 1206 of the Health and Safety Code. (E) A student health center clinic operated by a public institution of higher education as referred to in subdivision (j) of Section 1206 of the Health and Safety Code. (F) A nonprofit multispecialty clinic as referred to in subdivision (l) of Section 1206 of the Health and Safety Code. (2) The clinic shall keep records of the kind and amounts of drugs purchased, administered, and dispensed, and the records shall be available and maintained for a minimum of three years for inspection by all properly authorized personnel. (b) No clinic shall be entitled to the benefits of this section until it has obtained a license from the board. A separate license shall be required for each clinic location. A clinic shall notify the board of any change in the clinic’s address on a form furnished by the board. (c) The board shall synchronize license renewal dates and aggregate fees for multiple clinics under common nonprofit ownership at the request of the parent organization. (Amended by Stats. 2019, Ch. 323, Sec. 1. (AB 1723) Effective January 1, 2020.) - 4181. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 13. Nonprofit or Free Clinics [4180 - 4186] ( Article 13 added by Stats. 1996, Ch. 890, Sec. 3. )
Before a clinic license is issued, the clinic must comply with public health rules for drug distribution, and only authorized people may dispense drugs in the clinic.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 13. Nonprofit or Free Clinics [4180 - 4186] ( Article 13 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4181. (a) Prior to the issuance of a clinic license authorized under Section 4180, the clinic shall comply with all applicable laws and regulations of the State Department of Public Health relating to the drug distribution service to ensure that inventories, security procedures, training, protocol development, recordkeeping, packaging, labeling, dispensing, and patient consultation occur in a manner that is consistent with the promotion and protection of the health and safety of the public. The policies and procedures to implement the laws and regulations shall be developed and approved by the consulting pharmacist, the professional director, and the clinic administrator. (b) The dispensing of drugs in a clinic shall be performed only by a physician, a pharmacist, or other person lawfully authorized to dispense drugs, and only in compliance with all applicable laws and regulations. (Amended by Stats. 2010, Ch. 653, Sec. 30. (SB 1489) Effective January 1, 2011.) - 4182. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 13. Nonprofit or Free Clinics [4180 - 4186] ( Article 13 added by Stats. 1996, Ch. 890, Sec. 3. )
Clinics applying for a license must show the professional director is responsible for safe, orderly, and lawful pharmacy services, and licensed clinics must notify the board of changes in the professional director within 30 days.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 13. Nonprofit or Free Clinics [4180 - 4186] ( Article 13 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4182. (a) Each clinic that makes an application for a license under Section 4180 shall show evidence that the professional director is responsible for the safe, orderly, and lawful provision of pharmacy services. In carrying out the professional director’s responsibilities, a consulting pharmacist shall be retained to approve the policies and procedures in conjunction with the professional director and the administrator. In addition, the consulting pharmacist shall be required to visit the clinic regularly and at least quarterly. However, nothing in this section shall prohibit the consulting pharmacist from visiting more than quarterly to review the application of policies and procedures based on the agreement of all the parties approving the policies and procedures. (b) The consulting pharmacist shall certify in writing quarterly that the clinic is, or is not, operating in compliance with the requirements of this article. Each completed written certification shall be kept on file in the clinic for three years and shall include recommended corrective actions, if appropriate. (c) For the purposes of this article, “professional director” means a physician and surgeon acting in his or her capacity as medical director or a dentist or podiatrist acting in his or her capacity as a director in a clinic where only dental or podiatric services are provided. (d) Licensed clinics shall notify the board within 30 days of any change in professional director on a form furnished by the board. (Amended by Stats. 2006, Ch. 659, Sec. 13. Effective January 1, 2007.) - 4183. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 13. Nonprofit or Free Clinics [4180 - 4186] ( Article 13 added by Stats. 1996, Ch. 890, Sec. 3. )
Clinics dispensing drugs under this article are not eligible for a professional dispensing fee under Medi-Cal.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 13. Nonprofit or Free Clinics [4180 - 4186] ( Article 13 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4183. No clinic dispensing drugs pursuant to this article shall be eligible for any professional dispensing fee that may be authorized under the Medi-Cal program (Chapter 7 (commencing with Section 14000) of Part 3 of Division 9 of the Welfare and Institutions Code). (Added by Stats. 1996, Ch. 890, Sec. 3. Effective January 1, 1997.) - 4184. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 13. Nonprofit or Free Clinics [4180 - 4186] ( Article 13 added by Stats. 1996, Ch. 890, Sec. 3. )
This section limits clinic dispensing of Schedule II controlled substances, allows certain authorized practitioners to dispense a narcotic drug from clinic supply for acute withdrawal treatment, and requires dispensing policies, lawful dispensers, and compliance safeguards.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 13. Nonprofit or Free Clinics [4180 - 4186] ( Article 13 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4184. (a) Except as described in subdivision (b), a Schedule II controlled substance shall not be dispensed by the clinic. This limitation does not prohibit a physician dispensing a Schedule II drug to the extent permitted by law. (b) A practitioner authorized to prescribe a narcotic drug at a clinic registered with the board pursuant to this chapter and with any necessary federal agencies may dispense that narcotic drug from clinic supply for the purpose of relieving acute withdrawal symptoms when necessary while arrangements are being made for referral for treatment consistent with Section 1306.07(b) of Title 21 of the Code of Federal Regulations. (c) A narcotic drug that is dispensed from a clinic’s supply pursuant to subdivision (b) is subject to the requirements of subdivision (d) of Section 11165 of the Health and Safety Code, the labeling requirements imposed upon pharmacists by Section 4076, the recordkeeping requirements of this chapter, and all of the packaging requirements of good pharmaceutical practice, including, but not limited to, the use of childproof containers. (d) A clinic with a supply of narcotic drugs that is being dispensed pursuant to subdivision (b) shall establish policies or procedures for dispensing, including, but not limited to, all of the following: (1) Assessment of the patient’s ability to safely manage and self-administer a narcotic drug for the purposes of treating withdrawal. (2) Assessment of the patient’s appropriateness for medications for opioid use disorder. (3) Connecting patients to ongoing treatment for opioid use disorder. (4) Limiting dispensing to patients who return for repeated withdrawal medication to ensure treatment is not renewed or extended. (e) The dispensing of a narcotic drug shall be performed only by a physician, a pharmacist, or other person lawfully authorized to dispense drugs, and only in compliance with all applicable laws and regulations. (f) It is the intent of the Legislature that a clinic from which narcotic drugs are dispensed operate under appropriate registration and licensing and prioritize safe and secure storage, including any inventory reconciliation methodology, consistent with regulations, to prevent loss or diversion of controlled substances. (Amended by Stats. 2024, Ch. 634, Sec. 1. (AB 2115) Effective September 27, 2024.) - 4185. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 13. Nonprofit or Free Clinics [4180 - 4186] ( Article 13 added by Stats. 1996, Ch. 890, Sec. 3. )
The board may inspect a clinic at any time to check whether it complies with this article.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 13. Nonprofit or Free Clinics [4180 - 4186] ( Article 13 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4185. The board shall have the authority to inspect a clinic at any time in order to determine whether a clinic is, or is not, operating in compliance with this article. (Added by Stats. 1996, Ch. 890, Sec. 3. Effective January 1, 1997.) - 4186. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 13. Nonprofit or Free Clinics [4180 - 4186] ( Article 13 added by Stats. 1996, Ch. 890, Sec. 3. )
Clinics that use automated drug delivery systems must have written safety and security procedures, keep those procedures on site, and ensure pharmacist-controlled handling and review of drugs.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 13. Nonprofit or Free Clinics [4180 - 4186] ( Article 13 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4186. (a) Automated drug delivery systems, as defined in Section 4017.3, may be located in any clinic licensed by the board pursuant to Section 4180. If an automated drug delivery system is located in a clinic, the clinic shall develop and implement written policies and procedures to ensure safety, accuracy, accountability, security, patient confidentiality, and maintenance of the quality, potency, and purity of drugs. All policies and procedures shall be maintained at the location where the automated drug system is being used. (b) Drugs shall be removed from the automated drug delivery system only upon authorization by a pharmacist after the pharmacist has reviewed the prescription and the patient’s profile for potential contraindications and adverse drug reactions. Drugs removed from the automated drug delivery system shall be provided to the patient by a health professional licensed pursuant to this division. (c) The stocking of an automated drug delivery system shall be performed by a pharmacist. (d) Review of the drugs contained within, and the operation and maintenance of, the automated drug delivery system shall be the responsibility of the clinic. The review shall be conducted on a monthly basis by a pharmacist and shall include a physical inspection of the drugs in the automated drug delivery system, an inspection of the automated drug delivery system machine for cleanliness, and a review of all transaction records in order to verify the security and accountability of the system. (e) The automated drug delivery system used at the clinic shall provide for patient consultation pursuant to Section 1707.2 of Title 16 of the California Code of Regulations with a pharmacist via a telecommunications link that has two-way audio and video. (f) The pharmacist operating the automated drug delivery system shall be located in California. (g) Drugs dispensed from the automated drug delivery system shall comply with the labeling requirements in Section 4076 and with Section 1707.5 of Title 16 of the California Code of Regulations. (h) This section shall become operative on July 1, 2019. (Repealed and added by Stats. 2018, Ch. 666, Sec. 7. (SB 1447) Effective January 1, 2019. Section operative July 1, 2019, by its own provisions.) - 4187. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 13.5. Correctional Clinics [4187 - 4187.5] ( Article 13.5 added by Stats. 2018, Ch. 36, Sec. 6. )
This section defines several terms used in the correctional clinics article.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 13.5. Correctional Clinics [4187 - 4187.5] ( Article 13.5 added by Stats. 2018, Ch. 36, Sec. 6. ) ## 4187. For purposes of this article the following terms shall have the following meanings: (a) “Correctional clinic” means a primary care clinic, as referred to in subdivision (b) of Section 1206 of the Health and Safety Code, conducted, maintained, or operated by the state to provide health care to eligible patients of the Department of Corrections and Rehabilitation. (b) “Chief executive officer” means the highest ranking health care administrator at a correctional institution. (c) “Chief medical executive” means a physician and surgeon acting in the capacity of medical director within the correctional institution. (d) “Chief nurse executive” means the highest ranking nurse within the correctional institution. (e) “Licensed correctional clinic” means a correctional clinic that is licensed pursuant to this article. (f) “Supervising dentist” means the highest ranking dentist within the correctional institution. (Added by Stats. 2018, Ch. 36, Sec. 6. (AB 1812) Effective June 27, 2018.) - 4187.1. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 13.5. Correctional Clinics [4187 - 4187.5] ( Article 13.5 added by Stats. 2018, Ch. 36, Sec. 6. )
A licensed correctional clinic may obtain and use drugs under specified prescriptions or protocols, but it must keep records, notify the board of address changes, and cannot use this section’s benefits without a board license.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 13.5. Correctional Clinics [4187 - 4187.5] ( Article 13.5 added by Stats. 2018, Ch. 36, Sec. 6. ) ## 4187.1. (a) Notwithstanding any other provision of this chapter, a correctional clinic licensed by the board under this article may obtain drugs from a licensed correctional pharmacy, the Department of Corrections and Rehabilitation’s Central Fill Pharmacy, or from another correctional clinic licensed by the board under this article within the same institution for the administration or dispensing of drugs or devices to patients eligible for care at the correctional facility if under either: (1) The direction of a physician and surgeon, dentist, or other person lawfully authorized to prescribe. (2) An approved protocol as identified within the statewide Inmate Medical Services Policies and Procedures. (b) The dispensing or administering of drugs in a correctional clinic may be performed pursuant to a chart order, as defined in Section 4019, a valid prescription consistent with this chapter, or pursuant to an approved protocol as identified within the statewide Inmate Medical Services Policies and Procedures. The dispensing of drugs in a correctional clinic shall only be performed by a physician and surgeon, a dentist, a pharmacist, or other person lawfully authorized to dispense drugs. Medications dispensed to patients that are to be kept on the patient’s person for use shall meet the labeling requirements of Section 4076 and all recordkeeping requirements of this chapter. (c) A correctional clinic shall keep records of the kind and amounts of drugs acquired, administered, transferred, and dispensed. The records shall be available and maintained for a minimum of three years for inspection by all properly authorized personnel. (d) (1) A correctional clinic shall not be entitled to the benefits of this section until it has obtained a license from the board. (2) A separate license shall be required for each correctional clinic location and shall not be transferrable. (3) A correctional clinic’s location and address shall be identified by correctional institution and building within that correctional institution. (4) A clinic shall notify the board in advance of any change in the clinic’s address on a form furnished by the board. (Amended by Stats. 2019, Ch. 497, Sec. 6. (AB 991) Effective January 1, 2020.) - 4187.2. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 13.5. Correctional Clinics [4187 - 4187.5] ( Article 13.5 added by Stats. 2018, Ch. 36, Sec. 6. )
Correctional clinics have to follow approved pharmacy policies, get required acknowledgments before licensure, report chief executive officer changes within 30 days, and undergo at least quarterly inspections.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 13.5. Correctional Clinics [4187 - 4187.5] ( Article 13.5 added by Stats. 2018, Ch. 36, Sec. 6. ) ## 4187.2. (a) The policies and procedures to implement the laws and regulations of this article within a correctional clinic shall be developed and approved by the statewide Correctional Pharmacy and Therapeutics Committee referenced in Section 5024.2 of the Penal Code. Prior to the issuance of a correctional clinic license by the board, an acknowledgment shall be signed by the correctional facility pharmacist-in-charge servicing that institution, the pharmacist-in-charge for the Department of Corrections and Rehabilitation’s Central Fill Pharmacy, and the correctional clinic’s chief medical executive, supervising dentist, chief nurse executive, and chief executive officer. (b) (1) The chief executive officer shall be responsible for the safe, orderly, and lawful provision of pharmacy services. The pharmacist-in-charge of servicing the correctional facility shall implement the policies and procedures developed and approved by the statewide Correctional Pharmacy and Therapeutics Committee referenced in Section 5024.2 of the Penal Code and the California Correctional Health Care Services Health Care Department Operations Manual in conjunction with the chief executive officer, the chief medical executive, the supervising dentist, and the chief nurse executive. (2) A licensed correctional clinic shall notify the board within 30 days of any change in the chief executive officer on a form furnished by the board. (c) A correctional clinic shall be inspected at least quarterly by a pharmacist of the correctional pharmacy assigned to service that facility. (Amended by Stats. 2020, Ch. 29, Sec. 2. (SB 118) Effective August 6, 2020.) - 4187.3. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 13.5. Correctional Clinics [4187 - 4187.5] ( Article 13.5 added by Stats. 2018, Ch. 36, Sec. 6. )
Health care staff of a licensed correctional clinic may administer Schedule II, III, IV, or V controlled substances if they are lawfully authorized under a chart order, valid prescription, or approved protocol.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 13.5. Correctional Clinics [4187 - 4187.5] ( Article 13.5 added by Stats. 2018, Ch. 36, Sec. 6. ) ## 4187.3. A Schedule II, III, IV, or V controlled substance may be administered by health care staff of the licensed correctional clinic lawfully authorized to administer pursuant to a chart order, as defined in Section 4019, a valid prescription consistent with this chapter, or pursuant to an approved protocol as identified within the statewide Inmate Medical Services Policies and Procedures. (Added by Stats. 2018, Ch. 36, Sec. 6. (AB 1812) Effective June 27, 2018.) - 4187.4. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 13.5. Correctional Clinics [4187 - 4187.5] ( Article 13.5 added by Stats. 2018, Ch. 36, Sec. 6. )
The board may inspect a correctional clinic at any time to check whether it is complying with this article.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 13.5. Correctional Clinics [4187 - 4187.5] ( Article 13.5 added by Stats. 2018, Ch. 36, Sec. 6. ) ## 4187.4. The board shall have the authority to inspect a correctional clinic at any time in order to determine whether a correctional clinic is, or is not, operating in compliance with this article. (Added by Stats. 2018, Ch. 36, Sec. 6. (AB 1812) Effective June 27, 2018.) - 4187.5. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 13.5. Correctional Clinics [4187 - 4187.5] ( Article 13.5 added by Stats. 2018, Ch. 36, Sec. 6. )
This section allows automated drug delivery systems in correctional clinics and sets rules for how drugs are stored, removed, stocked, reviewed, documented, and tracked.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 13.5. Correctional Clinics [4187 - 4187.5] ( Article 13.5 added by Stats. 2018, Ch. 36, Sec. 6. ) ## 4187.5. (a) An automated drug delivery system, as defined in subdivision (h), may be located in a correctional clinic licensed by the board under this article. If an automated drug delivery system is located in a correctional clinic, the correctional clinic shall implement the statewide Correctional Pharmacy and Therapeutics Committee’s policies and procedures and the California Correctional Health Care Services Health Care Department Operations Manual to ensure safety, accuracy, accountability, security, patient confidentiality, and maintenance of the quality, potency, and purity of drugs. All policies and procedures shall be maintained either in electronic form or paper form at the location where the automated drug system is being used. (b) Drugs shall be removed from the automated drug delivery system upon authorization by a pharmacist after the pharmacist has reviewed the prescription and the patient profile for potential contraindications and adverse drug reactions. Where administration of the drug is necessary before a pharmacist has reviewed the prescription, and if, in the prescriber’s professional judgment, delay in therapy may cause patient harm, a medication may be removed from the automated drug delivery system and administered or furnished to a patient under the direction of the prescriber. Where the drug is otherwise unavailable, a medication may be removed and administered or furnished to the patient pursuant to an approved protocol as identified within the California Correctional Health Care Services Health Care Department Operations Manual. Any removal of medication from an automated drug delivery system shall be documented and provided to the correctional pharmacy when it reopens. (c) Drugs removed from the automated drug delivery system shall be provided to the patient by a health professional licensed pursuant to this division who is lawfully authorized to perform that task. (d) The stocking of an automated drug delivery system shall be performed by either: (1) A pharmacist. (2) An intern pharmacist or pharmacy technician, acting under the supervision of a pharmacist. (e) Review of the drugs contained within, and the operation and maintenance of, the automated drug delivery system shall be the responsibility of the correctional clinic. The review shall be conducted on a monthly basis by a pharmacist and shall include a physical inspection of the drugs in the automated drug delivery system, an inspection of the automated drug delivery system machine for cleanliness, and a review of all transaction records in order to verify the security and accountability of the system. (f) The automated drug delivery system shall be operated by a licensed correctional pharmacy. Any drugs within an automated drug delivery system are considered owned by the licensed correctional pharmacy until they are dispensed from the automated drug delivery system. (g) Drugs from the automated drug delivery system in a correctional clinic shall only be removed by a person authorized to stock the automated drug delivery system, or by a person lawfully authorized to administer or dispense the drugs. (h) For purposes of this section, an “automated drug delivery system” means a mechanical system controlled remotely by a pharmacist that performs operations or activities, other than compounding or administration, relative to the storage, dispensing, or distribution of prepackaged dangerous drugs or dangerous devices. An automated drug delivery system shall collect, control, and maintain all transaction information to accurately track the movement of drugs into and out of the system for security, accuracy, and accountability. (Amended by Stats. 2020, Ch. 29, Sec. 3. (SB 118) Effective August 6, 2020.) - 4190. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 14. Clinics [4190 - 4195] ( Heading of Article 14 amended by Stats. 2012, Ch. 454, Sec. 2. )
Clinics licensed by the board may buy drugs wholesale for patient care, but must follow limits on use, recordkeeping, reporting, and dispensing quantities.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 14. Clinics [4190 - 4195] ( Heading of Article 14 amended by Stats. 2012, Ch. 454, Sec. 2. ) ## 4190. (a) For the purposes of this article, “clinic” means a surgical clinic licensed pursuant to paragraph (1) of subdivision (b) of Section 1204 of the Health and Safety Code, an outpatient setting accredited by an accreditation agency, as defined in Section 1248 of the Health and Safety Code, or an ambulatory surgical center certified to participate in the Medicare Program under Title XVIII of the federal Social Security Act (42 U.S.C. Sec. 1395 et seq.). (b) A clinic licensed by the board may purchase drugs at wholesale for administration or dispensing, under the direction of a physician and surgeon, to patients registered for care at the clinic, as provided in subdivision (c). A separate license shall be required for each clinic location. A clinic licensed by the board shall notify the board of any change in the clinic’s address on a form furnished by the board. The clinic shall keep records of the kind and amounts of drugs purchased, administered, and dispensed, and the records shall be available and maintained for a minimum of three years for inspection by all properly authorized personnel. (c) The drug distribution service of a clinic shall be limited to the use of drugs for administration to the patients of the clinic and to the dispensing of drugs for the control of pain and nausea for patients of the clinic. Drugs shall not be dispensed in an amount greater than that required to meet the patient’s needs for 72 hours. Drugs for administration shall be those drugs directly applied, whether by injection, inhalation, ingestion, or any other means, to the body of a patient for his or her immediate needs. (d) No clinic shall be entitled to the benefits of this section until it has obtained a license from the board. (e) If a clinic is licensed by the board, any proposed change in ownership or beneficial interest in the licensee shall be reported to the board, on a form to be furnished by the board, at least 30 days prior to the execution of any agreement to purchase, sell, exchange, gift or otherwise transfer any ownership or beneficial interest or prior to any transfer of ownership or beneficial interest, whichever occurs earlier. (f) Nothing in this section shall limit the ability of a physician and surgeon to prescribe, dispense, administer, or furnish drugs at a clinic as provided in Sections 2241.5, 2242, and 4170. (Amended by Stats. 2012, Ch. 454, Sec. 3. (SB 1095) Effective January 1, 2013.) - 4191. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 14. Clinics [4190 - 4195] ( Heading of Article 14 amended by Stats. 2012, Ch. 454, Sec. 2. )
Before a clinic license is issued, the clinic must comply with drug-distribution laws and regulations, and its policies and procedures must be developed and approved by specified clinic professionals. After licensing, drugs in the clinic may be dispensed only by authorized persons and only in compliance with applicable laws and regulations.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 14. Clinics [4190 - 4195] ( Heading of Article 14 amended by Stats. 2012, Ch. 454, Sec. 2. ) ## 4191. (a) Prior to the issuance of a clinic license authorized under this article, the clinic shall comply with all applicable laws and regulations of the State Department of Public Health and the board relating to drug distribution to ensure that inventories, security procedures, training, protocol development, recordkeeping, packaging, labeling, dispensing, and patient consultation are carried out in a manner that is consistent with the promotion and protection of the health and safety of the public. The policies and procedures to implement the laws and regulations shall be developed and approved by the consulting pharmacist, the professional director, and the clinic administrator. (b) The dispensing of drugs in a clinic that has received a license under this article shall be performed only by a physician, a pharmacist, or other person lawfully authorized to dispense drugs, and only in compliance with all applicable laws and regulations. (Amended by Stats. 2010, Ch. 653, Sec. 31. (SB 1489) Effective January 1, 2011.) - 4192. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 14. Clinics [4190 - 4195] ( Heading of Article 14 amended by Stats. 2012, Ch. 454, Sec. 2. )
Clinics seeking a license must show that the professional director is responsible for safe, orderly, lawful pharmacy services, and the consulting pharmacist must do quarterly reviews, certifications, self-assessments, recordkeeping, and reporting.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 14. Clinics [4190 - 4195] ( Heading of Article 14 amended by Stats. 2012, Ch. 454, Sec. 2. ) ## 4192. (a) Each clinic that makes an application for a license under this article shall show evidence that the professional director is responsible for the safe, orderly, and lawful provision of pharmacy services. In carrying out the professional director’s responsibilities, a consulting pharmacist shall be retained to approve the policies and procedures in conjunction with the professional director and the administrator. In addition, the consulting pharmacist shall be required to visit the clinic regularly and at least quarterly. However, nothing in this section shall prohibit the consulting pharmacist from visiting more than quarterly to review the application of policies and procedures based on the agreement of all the parties approving the policies and procedures. (b) The consulting pharmacist shall certify in writing quarterly that the clinic is, or is not, operating in compliance with the requirements of this article. Each completed written certification shall be kept on file in the clinic for three years and shall include recommended corrective actions, if appropriate. Before July 1 of every odd-numbered year, the consulting pharmacist shall complete a Surgical Clinic Self-Assessment Form as determined by the board as a means to promote compliance through self-examination and education. The self-assessment shall assess the clinic’s compliance with current laws and regulations and include information on compounding practices as specified on the most recent version of the Surgical Clinic Self-Assessment Form approved by the board and posted on its internet website. The professional director of the clinic and consulting pharmacist shall certify on the final page of the Surgical Clinic Self-Assessment Form that they have read, reviewed, and completed self-assessment to the best of their professional ability and acknowledge that failure to correct any deficiency identified could result in action by the board. The completed form shall be signed under penalty of perjury, kept on file in the clinic for three years, and made available to the board or its designee, upon request. (c) For the purposes of this article, “professional director” means a physician and surgeon acting in their capacity as medical director or a dentist or podiatrist acting in their capacity as a director in a clinic where only dental or podiatric services are provided. (d) Licensed clinics shall notify the board within 30 days of any change in professional director on a form furnished by the board. (Amended by Stats. 2023, Ch. 470, Sec. 5. (AB 1286) Effective January 1, 2024.) - 4193. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 14. Clinics [4190 - 4195] ( Heading of Article 14 amended by Stats. 2012, Ch. 454, Sec. 2. )
Clinics licensed under this article cannot receive certain Medi-Cal dispensing fees, and they cannot sell drugs or bill for professional services tied to dispensing or administering drugs.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 14. Clinics [4190 - 4195] ( Heading of Article 14 amended by Stats. 2012, Ch. 454, Sec. 2. ) ## 4193. No clinic holding a license pursuant to this article shall be eligible for any professional dispensing fee that may be authorized under the Medi-Cal program (Chapter 7 (commencing with Section 14000) of Part 3 of Division 9 of the Welfare and Institutions Code). No clinic holding a license pursuant to this article shall offer drugs for sale or shall charge or bill for professional services for the dispensing or administering of drugs. (Added by Stats. 1996, Ch. 890, Sec. 3. Effective January 1, 1997.) - 4194. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 14. Clinics [4190 - 4195] ( Heading of Article 14 amended by Stats. 2012, Ch. 454, Sec. 2. )
Schedule II controlled substances may not be dispensed in the clinic.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 14. Clinics [4190 - 4195] ( Heading of Article 14 amended by Stats. 2012, Ch. 454, Sec. 2. ) ## 4194. No Schedule II controlled substance shall be dispensed in the clinic. This limitation does not prohibit a physician from dispensing a Schedule II drug to the extent permitted by subdivision (b) of Section 11158 of the Health and Safety Code and all other provisions of law, nor does it prevent the lawful administration of Schedule II drugs on the premises of the clinic. (Added by Stats. 1996, Ch. 890, Sec. 3. Effective January 1, 1997.) - 4195. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 14. Clinics [4190 - 4195] ( Heading of Article 14 amended by Stats. 2012, Ch. 454, Sec. 2. )
The board may inspect a licensed clinic at any time to check compliance with this article and other law.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 14. Clinics [4190 - 4195] ( Heading of Article 14 amended by Stats. 2012, Ch. 454, Sec. 2. ) ## 4195. The board shall have the authority to inspect a clinic that is licensed pursuant to this article at any time in order to determine whether the clinic is, or is not, operating in compliance with this article and all other provisions of the law. (Amended by Stats. 2012, Ch. 454, Sec. 4. (SB 1095) Effective January 1, 2013.) - 4196. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 15. Veterinary Food-Animal Drug Retailers [4196 - 4199] ( Article 15 added by Stats. 1996, Ch. 890, Sec. 3. )
Veterinary food-animal drug retailers need a board license, must have an approved designated representative-in-charge, and must follow board approval and notice rules.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 15. Veterinary Food-Animal Drug Retailers [4196 - 4199] ( Article 15 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4196. (a) No person shall conduct a veterinary food-animal drug retailer in the State of California unless he or she has obtained a license from the board. A license shall be required for each veterinary food-animal drug retailer owned or operated by a specific person. A separate license shall be required for each of the premises of any person operating a veterinary food-animal drug retailer in more than one location. The license shall be renewed annually and shall not be transferable. (b) The board may issue a temporary license, upon conditions and for periods of time as the board determines to be in the public interest. A temporary license fee shall be fixed by the board at an amount not to exceed the annual fee for renewal of a license to conduct a veterinary food-animal drug retailer. (c) No person other than a pharmacist, an intern pharmacist, a designated representative, an authorized officer of the law, or a person authorized to prescribe, shall be permitted in that area, place, or premises described in the permit issued by the board pursuant to Section 4041, wherein veterinary food-animal drugs are stored, possessed, or repacked. A pharmacist or designated representative shall be responsible for any individual who enters the veterinary food-animal drug retailer for the purpose of performing clerical, inventory control, housekeeping, delivery, maintenance, or similar functions relating to the veterinary food-animal drug retailer. (d) Every veterinary food-animal drug retailer shall be supervised or managed by a designated representative-in-charge. The designated representative-in-charge shall be responsible for the veterinary food-animal drug retailer’s compliance with state and federal laws governing veterinary food-animal drug retailers. As part of its initial application for a license, and for each renewal, each veterinary food-animal drug retailer shall, on a form designed by the board, provide identifying information and the California license number for a designated representative or pharmacist proposed to serve as the designated representative-in-charge. The proposed designated representative-in-charge shall be subject to approval by the board. The board shall not issue or renew a veterinary food-animal drug retailer license without identification of an approved designated representative-in-charge for the veterinary food-animal drug retailer. (e) Every veterinary food-animal drug retailer shall notify the board in writing, on a form designed by the board, within 30 days of the date when a designated representative-in-charge who ceases to act as the designated representative-in-charge, and shall on the same form propose another designated representative or pharmacist to take over as the designated representative-in-charge. The proposed replacement designated representative-in-charge shall be subject to approval by the board. If disapproved, the veterinary food-animal drug retailer shall propose another replacement within 15 days of the date of disapproval, and shall continue to name proposed replacements until a designated representative-in-charge is approved by the board. (f) For purposes of this section, designated representative-in-charge means a person granted a designated representative license pursuant to Section 4053, or a registered pharmacist, who is the supervisor or manager of the facility. (Amended by Stats. 2010, Ch. 653, Sec. 32. (SB 1489) Effective January 1, 2011.) - 4197. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 15. Veterinary Food-Animal Drug Retailers [4196 - 4199] ( Article 15 added by Stats. 1996, Ch. 890, Sec. 3. )
Veterinary food-animal drug retailers licensed by the board must keep drugs in a secure, lockable area, keep fixtures and equipment clean and orderly, and maintain dry, well-ventilated premises with adequate lighting. The board may also impose additional standards by regulation and may waive licensing requirements in some cases.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 15. Veterinary Food-Animal Drug Retailers [4196 - 4199] ( Article 15 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4197. (a) The following minimum standards shall apply to all veterinary food-animal drug retailers licensed by the board: (1) Each retailer shall store veterinary food-animal drugs in a secure, lockable area. (2) Each retailer shall maintain on the premises fixtures and equipment in a clean and orderly condition. The premises shall be dry, well-ventilated, and have adequate lighting. (b) The board may, by regulation, impose any other minimum standards pertaining to the acquisition, storage, and maintenance of veterinary food-animal drugs, or other goods, or to the maintenance or condition of the licensed premises of any veterinary food-animal drug retailer as the board determines are reasonably necessary. (c) When, in the opinion of the board, a high standard of patient safety consistent with good animal safety and care in the case of an animal patient can be provided by the licensure of a veterinary food-animal drug retailer that does not meet all of the requirements for licensure as a veterinary food-animal drug retailer, the board may waive any licensing requirements. (Amended by Stats. 1997, Ch. 549, Sec. 104. Effective January 1, 1998.) - 4198. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 15. Veterinary Food-Animal Drug Retailers [4196 - 4199] ( Article 15 added by Stats. 1996, Ch. 890, Sec. 3. )
Veterinary food-animal drug retailers must keep written policies, training and quality records, and make those records available for inspection. A consulting pharmacist must visit at least quarterly, review and certify compliance, and the latest certification must be filed with annual renewal.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 15. Veterinary Food-Animal Drug Retailers [4196 - 4199] ( Article 15 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4198. (a) Each veterinary food-animal drug retailer shall have written policies and procedures related to the handling and dispensing of veterinary food-animal drugs by veterinary food-animal drug retailers. These written policies and procedures shall include, but not be limited to, the following: (1) Training of staff. (2) Cleaning, storage, and maintenance of veterinary food-animal drugs and equipment. (3) Recordkeeping requirements. (4) Storage and security requirements. (5) Quality assurance. (b) Each retailer shall prepare and maintain records of training and demonstrated competence for each individual employed or retained by the retailer. These records shall be maintained for three years from and after the last date of employment. (c) Each retailer shall have an ongoing, documented quality assurance program which includes, but is not limited to: (1) Monitoring personnel performance. (2) Storage, maintenance, and dispensing of veterinary food-animal drugs. (d) The records and documents specified in subdivisions (a) and (b) shall be maintained for three years from the date of making. The records and documents in subdivisions (a), (b), and (c) shall be, at all times during business hours, open to inspection by authorized officers of the law. (e) To assure compliance with the requirements of this chapter regarding operations of the veterinary food-animal drug retailer, a consulting pharmacist shall visit the veterinary food-animal drug retailer regularly and at least quarterly. The consulting pharmacist shall be retained either on a volunteer or paid basis to review, approve, and revise the policies and procedures of the veterinary food-animal drug retailer, and assure compliance with California and federal law regarding the labeling, storage, and dispensing of veterinary food-animal drugs. The consulting pharmacist shall certify in writing at least twice a year whether or not the veterinary food-animal drug retailer is operating in compliance with the requirements of this chapter. The most recent of the written certifications shall be submitted with the annual renewal application of a veterinary food-animal drug retailer license. (Added by Stats. 1996, Ch. 890, Sec. 3. Effective January 1, 1997.) - 4199. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 15. Veterinary Food-Animal Drug Retailers [4196 - 4199] ( Article 15 added by Stats. 1996, Ch. 890, Sec. 3. )
Veterinary food-animal drug retailers must keep filled prescriptions on file for at least three years, and drugs dispensed under a veterinarian’s prescription are subject to specified labeling requirements.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 15. Veterinary Food-Animal Drug Retailers [4196 - 4199] ( Article 15 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4199. (a) Any veterinary food-animal drug dispensed pursuant to a prescription from a licensed veterinarian for food producing animals from a veterinary food-animal drug retailer pursuant to this chapter is subject to the labeling requirements of Sections 4076, 4076.6, and 4077. (b) All prescriptions filled by a veterinary food-animal drug retailer shall be kept on file and maintained for at least three years in accordance with Section 4333. (Amended by Stats. 2015, Ch. 784, Sec. 3. (AB 1073) Effective January 1, 2016.) - 4200. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 16. Applications [4200 - 4211] ( Article 16 added by Stats. 1996, Ch. 890, Sec. 3. )
The board may license a pharmacist applicant who meets specified education, experience, examination, and age requirements, and applicants must pay the required fees and prove their qualifications to the board.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 16. Applications [4200 - 4211] ( Article 16 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4200. (a) The board may license as a pharmacist an applicant who meets all the following requirements: (1) Is at least 18 years of age. (2) (A) Has graduated from a college of pharmacy or department of pharmacy of a university recognized by the board; or (B) If the applicant graduated from a foreign pharmacy school, the foreign-educated applicant has been certified by the Foreign Pharmacy Graduate Examination Committee. (3) Has completed at least 150 semester units of collegiate study in the United States, or the equivalent thereof in a foreign country. No less than 90 of those semester units shall have been completed while in resident attendance at a school or college of pharmacy. (4) Has earned at least a baccalaureate degree in a course of study devoted to the practice of pharmacy. (5) Has completed 1,500 hours of pharmacy practice experience or the equivalent in accordance with Section 4209. (6) Has passed a version of the California Practice Standards and Jurisprudence Examination for Pharmacists that, at the time of application for licensure, was based on an occupational analysis that is either current or that was replaced by another occupational analysis no more than one year before the application for licensure and the applicant meets either of the following requirements: (A) Has passed the North American Pharmacist Licensure Examination on or after January 1, 2004, and holds an active pharmacist license in another state or territory of the United States. (B) Has passed the North American Pharmacist Licensure Examination that, at the time of application for licensure, was based on an occupational analysis that is either current or that was replaced by another occupational analysis no more than one year before the application for licensure. (b) Proof of the qualifications of an applicant for licensure as a pharmacist shall be made to the satisfaction of the board and shall be substantiated by affidavits or other evidence as may be required by the board. (c) Each person, upon application for licensure as a pharmacist under this chapter, shall pay to the executive officer of the board the fees provided by this chapter. The fees shall be compensation to the board for investigation or examination of the applicant. (Amended by Stats. 2019, Ch. 213, Sec. 3. (SB 655) Effective January 1, 2020.) - 4200.1. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 16. Applications [4200 - 4211] ( Article 16 added by Stats. 1996, Ch. 890, Sec. 3. )
An applicant may take each of the two pharmacist exams four times, and may get four more attempts each after completing at least 16 board-approved semester units in pharmacy.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 16. Applications [4200 - 4211] ( Article 16 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4200.1. (a) Notwithstanding Section 135, an applicant may take the North American Pharmacist Licensure Examination four times, and may take the California Practice Standards and Jurisprudence Examination for Pharmacists four times. (b) Notwithstanding Section 135, an applicant may take the North American Pharmacist Licensure Examination and the California Practice Standards and Jurisprudence Examination for Pharmacists four additional times each if he or she successfully completes, at a minimum, 16 additional semester units of education in pharmacy as approved by the board.(c) The applicant shall comply with the requirements of Section 4200 for each application for reexamination made pursuant to subdivision (b). (d) An applicant may use the same coursework to satisfy the additional educational requirement for each examination under subdivision (b), if the coursework was completed within 12 months of the date of his or her application for reexamination. (e) For purposes of this section, the board shall treat each failing score on the pharmacist licensure examination administered by the board prior to January 1, 2004, as a failing score on both the North American Pharmacist Licensure Examination and the California Practice Standards and Jurisprudence Examination for Pharmacists. (Added by Stats. 2010, Ch. 653, Sec. 33. (SB 1489) Effective January 1, 2011.) - 4200.2. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 16. Applications [4200 - 4211] ( Article 16 added by Stats. 1996, Ch. 890, Sec. 3. )
When developing the California Practice Standards and Jurisprudence Examination for Pharmacists, the board must include specified content.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 16. Applications [4200 - 4211] ( Article 16 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4200.2. When developing the California Practice Standards and Jurisprudence Examination for Pharmacists, the board shall include all of the following: (a) Examination items to demonstrate the candidate’s proficiency in patient communication skills. (b) Aspects of contemporary standards of practice for pharmacists in California, including, but not limited to, the provision of pharmacist care and the application of clinical knowledge to typical pharmacy practice situations that are not evaluated by the North American Pharmacy Licensure Examination. (Amended by Stats. 2007, Ch. 588, Sec. 52. Effective January 1, 2008.) - 4200.3. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 16. Applications [4200 - 4211] ( Article 16 added by Stats. 1996, Ch. 890, Sec. 3. )
The board must regularly review the examination process, ensure it meets listed testing standards, work on the state jurisprudence exam, publish pass/fail rates annually, and report comparison pass rates at the next scheduled review. If the department finds the process fails the standards, the board must stop using the North American Pharmacy Licensure Examination and use only its own written and practical exam.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 16. Applications [4200 - 4211] ( Article 16 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4200.3. (a) The examination process shall be regularly reviewed pursuant to Section 139. (b) The examination process shall meet the standards and guidelines set forth in the Standards for Educational and Psychological Testing and the Federal Uniform Guidelines for Employee Selection Procedures. The board shall work with the Office of Professional Examination Services of the department or with an equivalent organization who shall certify at minimum once every five years that the examination process meets these national testing standards. If the department determines that the examination process fails to meet these standards, the board shall terminate its use of the North American Pharmacy Licensure Examination and shall use only the written and practical examination developed by the board. (c) The examination shall meet the mandates of subdivision (a) of Section 12944 of the Government Code. (d) The board shall work with the Office of Professional Examination Services or with an equivalent organization to develop the state jurisprudence examination to ensure that applicants for licensure are evaluated on their knowledge of applicable state laws and regulations. (e) The board shall annually publish the pass and fail rates for the pharmacist’s licensure examination administered pursuant to Section 4200, including a comparison of historical pass and fail rates before utilization of the North American Pharmacist Licensure Examination. (f) The board shall report to the Joint Committee on Boards, Commissions, and Consumer Protection and the department as part of its next scheduled review, the pass rates of applicants who sat for the national examination compared with the pass rates of applicants who sat for the prior state examination. This report shall be a component of the evaluation of the examination process that is based on psychometrically sound principles for establishing minimum qualifications and levels of competency. (Amended by Stats. 2009, Ch. 307, Sec. 44. (SB 821) Effective January 1, 2010.) - 4200.4. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 16. Applications [4200 - 4211] ( Article 16 added by Stats. 1996, Ch. 890, Sec. 3. )
An applicant who fails either named pharmacy exam may not retake it for at least 45 days. The board may adopt a different waiting period by regulation, if it consults the department’s Office of Professional Examination Services.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 16. Applications [4200 - 4211] ( Article 16 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4200.4. An applicant who fails either the North American Pharmacist Licensure Examination or the California Practice Standards and Jurisprudence Examination for Pharmacists may not retake that examination for at least 45 days. The board may, in consultation with the Office of Professional Examination Services of the department, adopt a regulation establishing a different waiting period to retake the examination. (Amended by Stats. 2017, Ch. 598, Sec. 8. (SB 752) Effective January 1, 2018.) - 4200.5. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 16. Applications [4200 - 4211] ( Article 16 added by Stats. 1996, Ch. 890, Sec. 3. )
The board must issue retired pharmacist licenses if the application and fee requirements are met, but not to pharmacists whose licenses have been revoked.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 16. Applications [4200 - 4211] ( Article 16 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4200.5. (a) The board shall issue, upon application and payment of the fee established by Section 4400, a retired license to a pharmacist who has been licensed by the board. The board shall not issue a retired license to a pharmacist whose license has been revoked. (b) The holder of a retired license issued pursuant to this section shall not engage in any activity for which an active pharmacist’s license is required. A pharmacist holding a retired license shall be permitted to use the titles “retired pharmacist” or “pharmacist, retired.” (c) The holder of a retired license shall not be required to renew that license. (d) (1) The holder of a retired license may request to restore their pharmacist license to active status within three years of issuance of the retired license. (2) A request made pursuant to paragraph (1) shall be accompanied by the renewal fee established in subdivision (e) of Section 4400 and demonstration that, within the two years preceding the request for restoration, the pharmacist has successfully completed continuing education consistent with the requirements set forth in subdivision (b) of Section 4231. (3) If more than three years have elapsed since the issuance of the retired license, in order for the holder of a retired license issued pursuant to this section to restore their license to active status, they shall reapply for licensure as a pharmacist consistent with the provisions of Section 4200. (Amended by Stats. 2025, Ch. 196, Sec. 41. (AB 1503) Effective January 1, 2026.) - 4201. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 16. Applications [4200 - 4211] ( Article 16 added by Stats. 1996, Ch. 890, Sec. 3. )
Applications for certain pharmacy-related licenses must use a board-furnished form and include specified ownership and background information; approved licenses are issued, renewed annually, and generally cannot be transferred.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 16. Applications [4200 - 4211] ( Article 16 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4201. (a) Each application to conduct a pharmacy, wholesaler, third-party logistics provider, veterinary food-animal drug retailer, or outsourcing facility shall be made on a form furnished by the board and shall state the name, address, usual occupation, and professional qualifications, if any, of the applicant. If the applicant is other than a natural person, the application shall state the information as to each person beneficially interested therein or any person with management or control over the license. (b) As used in this section, and subject to subdivision (c), the term “person beneficially interested” means and includes: (1) If the applicant is a partnership or other unincorporated association, each partner or member. (2) If the applicant is a corporation, each of its officers, directors, and stockholders, provided that a natural person shall not be deemed to be beneficially interested in a nonprofit corporation. (3) If the applicant is a limited liability company, each officer, manager, or member. (c) If the applicant is a partnership or other unincorporated association, a limited liability company, or a corporation, and the number of partners, members, or stockholders, as the case may be, exceeds five, the application shall so state, and shall further state the information required by subdivision (a) as to each of the five partners, members, or stockholders who own the five largest interests in the applicant entity. Upon request by the executive officer, the applicant shall furnish the board with the information required by subdivision (a) as to partners, members, or stockholders not named in the application, or shall refer the board to an appropriate source of that information. (d) The application shall contain a statement to the effect that the applicant has not been convicted of a felony and has not violated any of the provisions of this chapter. If the applicant cannot make this statement, the application shall contain a statement of the violation, if any, or reasons which will prevent the applicant from being able to comply with the requirements with respect to the statement. (e) Upon the approval of the application by the board and payment of the fee required by this chapter for each pharmacy, wholesaler, third-party logistics provider, or veterinary food-animal drug retailer, the executive officer of the board shall issue a license to conduct a pharmacy, wholesaler, third-party logistics provider, veterinary food-animal drug retailer, or outsourcing facility if all of the provisions of this chapter have been complied with. (f) Notwithstanding any other law, the pharmacy license shall authorize the holder to conduct a pharmacy. The license shall be renewed annually and shall not be transferable. (g) Notwithstanding any other law, the wholesaler license shall authorize the holder to wholesale dangerous drugs and dangerous devices. The license shall be renewed annually and shall not be transferable. (h) Notwithstanding any other law, the third-party logistics provider license shall authorize the holder to provide or coordinate warehousing, distribution, or other similar services of dangerous drugs and dangerous devices. The license shall be renewed annually and shall not be transferable. (i) Notwithstanding any other law, the veterinary food-animal drug retailer license shall authorize the holder to conduct a veterinary food-animal drug retailer and to sell and dispense veterinary food-animal drugs as defined in Section 4042. (j) For licenses referred to in subdivisions (f), (g), (h), and (i), any change in the proposed beneficial ownership interest shall be reported to the board within 30 days thereafter upon a form to be furnished by the board. (Amended by Stats. 2016, Ch. 484, Sec. 32. (SB 1193) Effective January 1, 2017.) - 4202. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 16. Applications [4200 - 4211] ( Article 16 added by Stats. 1996, Ch. 890, Sec. 3. )
The board may issue, renew, suspend, or revoke pharmacy technician licenses, but applicants and renewal applicants must meet specified education, training, background check, and cultural competency requirements.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 16. Applications [4200 - 4211] ( Article 16 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4202. (a) The board may issue a pharmacy technician license to an individual if the applicant is a high school graduate or possesses a general educational development certificate equivalent, and meets any one of the following requirements: (1) Has obtained an associate’s degree in pharmacy technology. (2) Has completed a course of training specified by the board. (3) Has graduated from a school of pharmacy recognized by the board. (4) Is certified by a pharmacy technician certifying organization offering a pharmacy technician certification program accredited by the National Commission for Certifying Agencies that is approved by the board. (b) The board shall adopt regulations pursuant to this section for the licensure of pharmacy technicians and for the specification of training courses as set out in paragraph (2) of subdivision (a). Proof of the qualifications of any applicant for licensure as a pharmacy technician shall be made to the satisfaction of the board and shall be substantiated by any evidence required by the board. (c) The board shall conduct a criminal background check of the applicant to determine if an applicant has committed acts that would constitute grounds for denial of licensure, pursuant to this chapter or Chapter 2 (commencing with Section 480) of Division 1.5. (d) The board shall not renew a pharmacy technician license unless the applicant submits proof satisfactory to the board that the applicant has successfully completed at least one hour of participation in a cultural competency course, as defined in Section 4231, during the two years preceding the application for renewal. (e) The board may suspend or revoke a license issued pursuant to this section on any ground specified in Section 4301. (f) Once an individual is licensed as a pharmacist, the pharmacy technician registration is no longer valid and the pharmacy technician license shall be returned to the board within 15 days. (g) This section shall become operative on January 1, 2024. (Repealed (in Sec. 1) and added by Stats. 2022, Ch. 958, Sec. 2. (AB 2194) Effective January 1, 2023. Operative January 1, 2024, by its own provisions.) - 4202.5. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 16. Applications [4200 - 4211] ( Article 16 added by Stats. 1996, Ch. 890, Sec. 3. )
The board may issue a designated paramedic license, must run a criminal background check, may suspend or revoke the license on specified grounds, and the license is automatically suspended if the underlying paramedic license is no longer valid.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 16. Applications [4200 - 4211] ( Article 16 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4202.5. (a) The board may issue a designated paramedic license to an individual if they hold a license as a paramedic in this state and meets the criteria of this section. (b) The board shall conduct a criminal background check of the applicant to determine if the applicant has committed acts that would constitute grounds for denial of licensure, pursuant to this chapter or Chapter 2 (commencing with Section 480) of Division 1.5. (c) The board may suspend or revoke a license issued pursuant to this section on any ground specified in Section 4301. (d) A license issued under this section is dependent on the validity of the holder’s paramedic license and shall be automatically suspended if the individual’s paramedic license is expired, revoked, or otherwise invalidated by the issuing authority. (e) This section shall become operative on January 1, 2025. (Repealed (in Sec. 12) and added by Stats. 2023, Ch. 723, Sec. 13. (SB 816) Effective January 1, 2024. Operative January 1, 2025, by its own provisions.) - 4202.6. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 16. Applications [4200 - 4211] ( Article 16 added by Stats. 1996, Ch. 890, Sec. 3. )
The board may deny a licensure application under this chapter if specified disqualifying criminal or disciplinary conditions apply.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 16. Applications [4200 - 4211] ( Article 16 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4202.6. Notwithstanding Section 480, the board may deny an application for licensure under this chapter if any of the following conditions apply: (a) The applicant has been convicted of a crime or subjected to formal discipline that would be grounds for denial of a federal registration to distribute controlled substances. (b) The applicant has been convicted of a crime involving fraud in violation of state or federal laws related to health care. (c) The applicant has been convicted of a crime involving financial identify theft. (Amended by Stats. 2025, Ch. 196, Sec. 42. (AB 1503) Effective January 1, 2026.) - 4203. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 16. Applications [4200 - 4211] ( Article 16 added by Stats. 1996, Ch. 890, Sec. 3. )
License applications under Section 4180 must be filed on the board’s form, include specified applicant and clinic information, and are reviewed by the board. The board must investigate eligibility and related licensing issues, may not probe most operating details, must deny unqualified applications, and must issue and renew qualifying licenses under specified conditions.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 16. Applications [4200 - 4211] ( Article 16 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4203. (a) Each application for a license under Section 4180 shall be made on a form furnished by the board. The form of application for a license under Section 4180 shall contain the name and address of the applicant, whether the applicant is licensed as a primary care clinic as defined in this code, the name of its professional director, the name of its administrator, and the name of its consulting pharmacist. (b) Upon the filing of the application and payment of the fee prescribed in subdivision (s) of Section 4400, the board shall make a thorough investigation to determine whether the applicant and the premises for which application for a permit is made qualify for a license. The board shall also determine whether this article has been complied with, and shall investigate all matters directly related to the issuance of the license. The board shall not, however, investigate any matters connected with the operation of a premises, including operating hours, parking availability, or operating noise, except those matters relating to the furnishing, sale, or dispensing of drugs or devices. The board shall deny an application for a license if either the applicant or the premises for which application for a license is made do not qualify for a license under this article. (c) If the board determines that the applicant and the premises for which application for a license is made qualify for a license under this article, the executive officer of the board shall issue a license authorizing the clinic to which it is issued to purchase drugs at wholesale pursuant to Section 4180. The license shall be renewed annually on or before December 31 of each year upon payment of the renewal fee prescribed in subdivision (s) of Section 4400 and shall not be transferable. (Added by Stats. 1996, Ch. 890, Sec. 3. Effective January 1, 1997.) - 4203.5. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 16. Applications [4200 - 4211] ( Article 16 added by Stats. 1996, Ch. 890, Sec. 3. )
The board must issue a clinic license or record reported changes within 30 days after receiving a completed application and required fees.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 16. Applications [4200 - 4211] ( Article 16 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4203.5. (a) Notwithstanding any other law, when a clinic applicant submits either type of application described in subdivision (b), the board shall issue a license or incorporate the reported changes, as appropriate, within 30 days of receipt of a completed application and payment of any prescribed fees. (b) This section applies to the following types of applications: (1) A new clinic license application filed under Section 4180. (2) Applications to report changes to an existing site licensed under Section 4180, including, but not limited to, changes in professional director, clinic administrator, corporate officers, change of location, or change of address. (c) This section shall not be construed to limit the board’s authority to conduct an investigation to determine whether applicants and the premises for which an application is made qualify for a license. (Added by Stats. 2016, Ch. 484, Sec. 33. (SB 1193) Effective January 1, 2017.) - 4203.6. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 16. Applications [4200 - 4211] ( Article 16 added by Stats. 1996, Ch. 890, Sec. 3. )
Applicants for a correctional clinic license must use the board’s form, include specified names and addresses, and pay the applicable fee when filing; the board investigates qualification and must deny unqualified applications; qualifying clinics get a license that is renewed yearly by December 31 and is not transferable.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 16. Applications [4200 - 4211] ( Article 16 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4203.6. (a) Each application for a license as a correctional clinic under Article 13.5 (commencing with Section 4187) shall be made on a form furnished by the board. The application form shall contain the name and address of the applicant, the name of its chief executive officer, as defined in Section 4187, and the name of the pharmacist-in-charge of the correctional pharmacy that provides drugs to the clinic. (b) Upon the filing of the application and payment of the fee prescribed in Section 4400, where applicable, the board shall make a thorough investigation to determine whether the applicant and the premises for which application for a license is made qualify for licensure. The board shall also determine whether this article has been complied with and shall investigate all matters directly related to the issuance of the license. The board shall not, however, investigate any matters connected with the operation of a premises, including, but not limited to, operating hours, parking availability, or operating noise, except those matters relating to the furnishing or dispensing of drugs or devices. The board shall deny an application for a license if either the applicant or the premises for which application for a license is made does not qualify for a license under this article. (c) If the board determines that the applicant and the premises for which application for a license is made qualify for a license under this article, the executive officer of the board shall issue a license authorizing the correctional clinic to which it is issued to obtain drugs pursuant to Article 13.5 (commencing with Section 4187). The license shall be renewed annually on or before December 31 of each year upon payment of the renewal fee prescribed in Section 4400, if applicable. A license shall not be transferable. (Added by Stats. 2018, Ch. 36, Sec. 7. (AB 1812) Effective June 27, 2018.) - 4204. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 16. Applications [4200 - 4211] ( Article 16 added by Stats. 1996, Ch. 890, Sec. 3. )
License applicants must use a board-furnished form and include specified information; initial applications need a consulting pharmacist’s certification; the board must investigate and can deny nonqualifying applications; issued licenses are renewed annually and are nontransferable.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 16. Applications [4200 - 4211] ( Article 16 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4204. (a) Each application for a license under Section 4190 shall be made on a form furnished by the board. The form of application for a license under this article shall contain the name and address of the applicant, whether the applicant is licensed, the type of services the facility will offer, the name of its professional director, the name of its administrator, and the name of its consulting pharmacist. (b) Each initial application shall contain a statement from a consulting pharmacist certifying that the policies and procedures of the clinic’s drug distribution service, relative to inventories, security procedures, training, protocol development, recordkeeping, packaging, labeling, dispensing, and patient consultation are consistent with the promotion and protection of health and safety of the public. Upon the filing of the application and the payment of a fee in subdivision (s) of Section 4400, the board shall make a thorough investigation to determine whether the applicant and the premises for which application for a license is made qualify for a license. The board shall also determine whether this article has been complied with, and shall investigate all matters directly related to the issuance of the license. The board shall not however, investigate any matters connected with the operation of a premises, including operating hours, parking availability, or operating noise, except those matters relating to the furnishing, sale, or dispensing of drugs or devices. The board shall deny an application for a license if either the applicant or the premises for which application for a license is made do not qualify for a license under this article. (c) If the board determines that the applicant and the premises for which application for a license is made qualify for a license under Section 4190, the executive officer of the board shall issue a license authorizing the clinic to which it is issued to purchase drugs at wholesale pursuant to Section 4190. The license shall be renewed annually upon payment of a renewal fee prescribed in subdivision (s) of Section 4400 and shall not be transferable. As part of the renewal process the consulting pharmacist shall certify compliance with the quarterly inspections as required in Section 4192. Further, as part of the renewal process of every odd-numbered year, the most recent self-assessment form completed as provided in Section 4192 shall also be provided to the board. (Amended by Stats. 2023, Ch. 470, Sec. 6. (AB 1286) Effective January 1, 2024.) - 4205. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 16. Applications [4200 - 4211] ( Article 16 added by Stats. 1996, Ch. 890, Sec. 3. )
The board can issue these licenses, but applications must be in writing, each premises needs a separate license if sales occur at more than one location, and licenses must be renewed annually and cannot be transferred.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 16. Applications [4200 - 4211] ( Article 16 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4205. (a) A license issued pursuant to Section 4110, 4120, 4160, or 4161 shall be considered a license within the meaning of Section 4141. (b) The board may, in its discretion, issue a license to any person authorizing the sale and dispensing of hypodermic syringes and needles for animal use. (c) The application for a license shall be made in writing on a form to be furnished by the board. The board may require any information as the board deems reasonably necessary to carry out the purposes of Article 9 (commencing with Section 4140) of this chapter. (d) A separate license shall be required for each of the premises of any person who sells or dispenses hypodermic syringes or needles at more than one location. (e) A license shall be renewed annually and shall not be transferable. (f) The board may deny, revoke, or suspend any license issued pursuant to this article for any violation of this chapter. (Amended by Stats. 2005, Ch. 621, Sec. 58. Effective January 1, 2006.) - 4207. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 16. Applications [4200 - 4211] ( Article 16 added by Stats. 1996, Ch. 890, Sec. 3. )
The board must investigate license applications, check whether the applicant qualifies, and deny the application if the applicant does not qualify.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 16. Applications [4200 - 4211] ( Article 16 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4207. (a) Upon receipt of an application for a license and the applicable fee, the board shall make a thorough investigation to determine whether the applicant is qualified for the license being sought. The board shall also determine whether this article has been complied with, and shall investigate all matters directly related to the issuance of the license that may affect the public welfare. (b) The board shall not investigate matters connected with the operation of a premises other than those matters solely related to the furnishing of dangerous drugs or dangerous devices that might adversely affect the public welfare. (c) The board shall deny an application for a license if the applicant does not qualify for the license being sought. (d) Notwithstanding any other provision of law, the board may request any information it deems necessary to complete the application investigation required by this section, and a request for information that the board deems necessary in carrying out this section in any application or related form devised by the board shall not be required to be adopted by regulation pursuant to the Administrative Procedure Act (Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code). (Amended by Stats. 2011, Ch. 296, Sec. 6. (AB 1023) Effective January 1, 2012.) - 4208. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 16. Applications [4200 - 4211] ( Article 16 added by Stats. 1996, Ch. 890, Sec. 3. )
The board may issue and extend intern pharmacist licenses, and intern pharmacists must report address changes and return certain licenses when they stop being enrolled in pharmacy school.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 16. Applications [4200 - 4211] ( Article 16 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4208. (a) At the discretion of the board, an intern pharmacist license may be issued for a period of: (1) One to six years to a person who is currently enrolled in a school of pharmacy recognized by the board. (2) Two years to a person who is a graduate of a school of pharmacy recognized by the board and who has applied to become licensed as a pharmacist in California. (3) Two years to a foreign graduate who has met educational requirements described in paragraphs (1) and (2) of subdivision (a) of Section 4200. (4) One year to a person who has failed the pharmacist licensure examination four times and has reenrolled in a school of pharmacy to satisfy the requirements of Section 4200.1. (b) The board may issue an intern pharmacist license to an individual for the period of time specified in a decision of reinstatement adopted by the board. (c) An intern pharmacist shall notify the board within 30 days of any change of address. (d) An intern pharmacist whose license has been issued pursuant to paragraph (1) or (4) of subdivision (a) shall return his or her license, by registered mail, within 30 days of no longer being enrolled in a school of pharmacy. The intern pharmacist license shall be canceled by the board. Notwithstanding subdivision (c), an intern pharmacist license may be reinstated if the student reenrolls in a school of pharmacy recognized by the board to fulfill the education requirements of paragraphs (1) to (4), inclusive, of subdivision (a) of Section 4200. (e) A person who has not completed the experience requirements necessary to be eligible for the licensure examination may have his or her intern license extended for a period of up to two years at the discretion of the board if he or she is able to demonstrate his or her inability to exercise the privileges of the intern license during the initial license period. (Amended by Stats. 2007, Ch. 588, Sec. 53. Effective January 1, 2008.) - 4209. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 16. Applications [4200 - 4211] ( Article 16 added by Stats. 1996, Ch. 890, Sec. 3. )
An intern pharmacist must complete 1,500 hours of pharmacy practice experience before applying for the pharmacist licensure examination, and must document that experience in the form required by the board.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 16. Applications [4200 - 4211] ( Article 16 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4209. (a) (1) An intern pharmacist shall complete 1,500 hours of pharmacy practice experience before applying for the pharmacist licensure examination. (2) This pharmacy practice experience shall comply with the Standards of Curriculum established by the Accreditation Council for Pharmacy Education (ACPE) or with regulations adopted by the board. (3) This pharmacy practice experience shall include 900 hours of pharmacy practice experience in a pharmacy as a pharmacist and shall include pharmacy practice experience in both a community and institutional pharmacy practice setting. (b) An intern pharmacist shall submit proof of his or her pharmacy practice experience on board-approved affidavits, or another form specified by the board, which shall be certified under penalty of perjury by a pharmacist under whose supervision the experience was obtained or by the pharmacist-in-charge at the pharmacy while the pharmacist intern obtained the experience. Pharmacy practice experience earned in another state may be certified by the licensing agency of that state to document proof of those hours. (c) An applicant for the examination who has been licensed as a pharmacist in any state for at least one year, as certified by the licensing agency of that state, may submit this certification to satisfy the required 1,500 hours of pharmacy practice experience, provided that the applicant has obtained a minimum of 900 hours of pharmacy practice experience in a pharmacy as a pharmacist and has pharmacy practice experience in both a community and institutional pharmacy practice setting. Certification of an applicant’s licensure in another state shall be submitted in writing and signed, under oath, by a duly authorized official of the state in which the license is held. (d) An applicant for the examination who has graduated after January 1, 2016, from an ACPE accredited college of pharmacy or school of pharmacy recognized by the board shall be deemed to have satisfied the pharmacy practice experience requirements specified in subdivisions (a) and (b). (Amended by Stats. 2015, Ch. 147, Sec. 1. (SB 590) Effective January 1, 2016.) - 4210. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 16. Applications [4200 - 4211] ( Article 16 added by Stats. 1996, Ch. 890, Sec. 3. )
A person seeking recognition as an advanced pharmacist practitioner must hold a current good-standing pharmacy license, meet two of the listed qualification criteria, apply to the board, and pay the fee.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 16. Applications [4200 - 4211] ( Article 16 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4210. (a) A person who seeks recognition as an advanced pharmacist practitioner shall meet all of the following requirements: (1) Hold an active license to practice pharmacy issued pursuant to this chapter that is in good standing. (2) (A) Satisfy any two of the following criteria: (i) Earn certification in a relevant area of practice, including, but not limited to, ambulatory care, critical care, geriatric pharmacy, nuclear pharmacy, nutrition support pharmacy, oncology pharmacy, pediatric pharmacy, pharmacotherapy, or psychiatric pharmacy, from an organization recognized by the Accreditation Council for Pharmacy Education or another entity recognized by the board. (ii) Complete a postgraduate residency through an accredited postgraduate institution where at least 50 percent of the experience includes the provision of direct patient care services with interdisciplinary teams. (iii) Have provided clinical services to patients for at least one year under a collaborative practice agreement or protocol with a physician, advanced pharmacist practitioner, pharmacist practicing collaborative drug therapy management, or health system. (B) For purposes of this paragraph, if, as a condition of completion of one of the required criteria fulfillment of a second criterion is also required, that completion shall be deemed to satisfy this paragraph. (3) File an application with the board for recognition as an advanced pharmacist practitioner. (4) Pay the applicable fee to the board. (b) An advanced pharmacist practitioner recognition issued pursuant to this section shall be valid for two years, coterminous with the certificate holder’s license to practice pharmacy. (c) The board shall adopt regulations establishing the means of documenting completion of the requirements in this section. (d) This section shall become operative on January 1, 2025. (Amended by Stats. 2025, Ch. 196, Sec. 43. (AB 1503) Effective January 1, 2026.) - 4211. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 16. Applications [4200 - 4211] ( Article 16 added by Stats. 1996, Ch. 890, Sec. 3. )
To renew an advanced pharmacist practitioner recognition, the applicant must keep an active pharmacist license, file the renewal application and fee, and provide proof of 10 hours of continuing education. The board cannot require that continuing education for the first renewal cycle.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 16. Applications [4200 - 4211] ( Article 16 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4211. (a) An applicant for renewal of an advanced pharmacist practitioner recognition shall maintain a current and active pharmacist license, and shall submit all of the following as part of the renewal: (1) Application and payment of the renewal fees. (2) (A) Proof satisfactory to the board that the licensee has completed 10 hours of continuing education pursuant to Section 4233. (B) The 10 hours shall be in addition to the continuing education requirements necessary for a pharmacist license renewal pursuant to Section 4231. (C) An advanced pharmacist practitioner shall retain documentation of completion of continuing education for four years. (b) Notwithstanding subdivision (a), the board shall not require completion of continuing education for the first renewal cycle of an advanced pharmacist practitioner recognition. (c) The board may issue an inactive advanced pharmacist practitioner recognition under any of the following conditions: (1) The pharmacist’s license becomes inactive. (2) The advanced pharmacist practitioner fails to provide documentation of the completion of the required continuing education. (3) As part of an investigation or audit conducted by the board, the advanced pharmacist practitioner fails to provide documentation substantiating the completion of continuing education. (d) The board shall reactivate an inactive advanced pharmacist practitioner recognition only if the advanced pharmacist practitioner pays the required renewal fees pursuant to Section 4210, submits satisfactory proof to the board of completion of the continuing education requirements under Section 4233, and meets all renewal requirements in this section. (Amended by Stats. 2025, Ch. 196, Sec. 44. (AB 1503) Effective January 1, 2026.) - 4231. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 17. Continuing Education [4231 - 4234] ( Article 17 added by Stats. 1996, Ch. 890, Sec. 3. )
The board cannot renew a pharmacist license unless the applicant shows 30 hours of approved continuing pharmacy education, including at least one hour in a cultural competency course, except for the first renewal.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 17. Continuing Education [4231 - 4234] ( Article 17 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4231. (a) For purposes of this section, “cultural competency course” means a cultural competency and humility course that meets the following criteria: (1) The course focuses on patients who identify as lesbian, gay, bisexual, transgender, gender nonconforming, or queer, or who question their sexual orientation or gender identity and expression. (2) The course is approved from an accreditation agency approved by the board. (3) The course covers recognized health disparities faced by Black, Indigenous, and people of color. (4) The course contains elements demonstrating how sexual identity is directly impacted through intersectionality. (b) The board shall not renew a pharmacist license unless the applicant submits proof satisfactory to the board that the applicant has successfully completed 30 hours of approved courses of continuing pharmacy education, including at least one hour of participation in a cultural competency course, during the two years preceding the application for renewal. (c) Notwithstanding subdivision (b), the board shall not require completion of continuing education for the first renewal of a pharmacist license. (d) If an applicant for renewal of a pharmacist license submits the renewal application and payment of the renewal fee but does not submit proof satisfactory to the board that the licensee has completed 30 hours of continuing pharmacy education, the board shall not renew the license and shall issue the applicant an inactive pharmacist license. A licensee with an inactive pharmacist license issued pursuant to this section may obtain an active pharmacist license by paying the renewal fees due and submitting satisfactory proof to the board that the licensee has completed 30 hours of continuing pharmacy education. (e) If, as part of an investigation or audit conducted by the board, a pharmacist fails to provide documentation substantiating the completion of continuing education as required in subdivision (b), the board shall cancel the active pharmacist license and issue an inactive pharmacist license in its place. A licensee with an inactive pharmacist license issued pursuant to this section may obtain an active pharmacist license by paying the renewal fees due and submitting satisfactory proof to the board that the licensee has completed 30 hours of continuing pharmacy education. (f) This section shall become operative on January 1, 2024. (Repealed (in Sec. 3) and added by Stats. 2022, Ch. 958, Sec. 4. (AB 2194) Effective January 1, 2023. Operative January 1, 2024, by its own provisions.) - 4232. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 17. Continuing Education [4231 - 4234] ( Article 17 added by Stats. 1996, Ch. 890, Sec. 3. )
Continuing pharmacy education courses must use specified educational formats and cover subject matter relevant to health care and drugs.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 17. Continuing Education [4231 - 4234] ( Article 17 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4232. (a) The courses shall be in the form of postgraduate studies, institutes, seminars, lectures, conferences, workshops, extension studies, correspondence courses, and other similar methods of conveying continuing professional pharmacy education. (b) The subject matter shall be pertinent to the socioeconomic and legal aspects of health care, the properties and actions of drugs and dosage forms and the etiology, and characteristics and therapeutics of the disease state. (c) The subject matter of the courses may include, but shall not be limited to, the following: pharmacology, biochemistry, physiology, pharmaceutical chemistry, pharmacy administration, pharmacy jurisprudence, public health and communicable diseases, professional practice management, anatomy, histology, and any other subject matter as represented in curricula of accredited colleges of pharmacy. (Amended by Stats. 2005, Ch. 621, Sec. 61. Effective January 1, 2006.) - 4232.5. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 17. Continuing Education [4231 - 4234] ( Article 17 added by Stats. 1996, Ch. 890, Sec. 3. )
A pharmacist who prescribes a Schedule II controlled substance under this chapter must complete an education course on addiction risks.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 17. Continuing Education [4231 - 4234] ( Article 17 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4232.5. (a) A pharmacist who, pursuant to any authority of this chapter, prescribes a Schedule II controlled substance, shall have completed an education course on the risks of addiction associated with the use of Schedule II drugs. (b) A pharmacist who has completed such a course within the last four years shall be deemed to have satisfied this requirement. (c) This section shall become operative July 1, 2022. (Added by Stats. 2021, Ch. 629, Sec. 25. (AB 1533) Effective January 1, 2022. Operative July 1, 2022, by its own provisions.) - 4233. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 17. Continuing Education [4231 - 4234] ( Article 17 added by Stats. 1996, Ch. 890, Sec. 3. )
An advanced pharmacist practitioner must complete 10 hours of continuing education each renewal cycle, and the subject matter must be relevant to the pharmacist’s clinical practice.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 17. Continuing Education [4231 - 4234] ( Article 17 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4233. A pharmacist who is recognized as an advanced pharmacist practitioner shall complete 10 hours of continuing education each renewal cycle in addition to the requirements of Section 4231. The subject matter shall be in one or more areas of practice relevant to the pharmacist’s clinical practice. (Amended by Stats. 2025, Ch. 196, Sec. 45. (AB 1503) Effective January 1, 2026.) - 4234. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 17. Continuing Education [4231 - 4234] ( Article 17 added by Stats. 1996, Ch. 890, Sec. 3. )
The board may grant exceptions to this article’s requirements in emergency or hardship cases.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 17. Continuing Education [4231 - 4234] ( Article 17 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4234. The board may, in accordance with the intent of this article, make exceptions from the requirements of this article in emergency or hardship cases. (Repealed and added by Stats. 1996, Ch. 890, Sec. 3. Effective January 1, 1997.) - 4240. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 18. Poisons [4240- 4240.] ( Article 18 added by Stats. 1996, Ch. 890, Sec. 3. )
This section applies the California Hazardous Substances Act to pharmacies, pharmacists, and other persons or places under the board’s jurisdiction, and lets the board enforce the Act and clarify the meaning of “poison” by regulation.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 18. Poisons [4240- 4240.] ( Article 18 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4240. (a) The California Hazardous Substances Act, Chapter 4 (commencing with Section 108100) of Part 3 of Division 104 of the Health and Safety Code, applies to pharmacies and pharmacists and any other person or place subject to the jurisdiction of the board. (b) The board may enforce that act when necessary for the protection of the health and safety of the public if prior regulatory notice is given in accordance with the rulemaking provisions of the Administrative Procedure Act (Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code). Board enforcement shall focus on those hazardous substances that relate significantly to or overlap the practice of pharmacy. (c) “Poison” as used in this chapter refers to a category of hazardous substances defined in Section 108125 of the Health and Safety Code. The board may by regulation make the category more specific. (Repealed and added by Stats. 1996, Ch. 890, Sec. 3. Effective January 1, 1997.) - 4300. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 19. Disciplinary Proceedings [4300 - 4318] ( Article 19 added by Stats. 1996, Ch. 890, Sec. 3. )
The board can discipline license holders and applicants, including suspension, probation, revocation, or other disciplinary action, and may set conditions on probationary licenses.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 19. Disciplinary Proceedings [4300 - 4318] ( Article 19 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4300. (a) Every license issued may be suspended or revoked. (b) The board shall discipline the holder of any license issued by the board, whose default has been entered or whose case has been heard by the board and found guilty, by any of the following methods: (1) Suspending judgment. (2) Placing him or her upon probation. (3) Suspending his or her right to practice for a period not exceeding one year. (4) Revoking his or her license. (5) Taking any other action in relation to disciplining him or her as the board in its discretion may deem proper. (c) The board may refuse a license to any applicant guilty of unprofessional conduct. The board may, in its sole discretion, issue a probationary license to any applicant for a license who is guilty of unprofessional conduct and who has met all other requirements for licensure. The board may issue the license subject to any terms or conditions not contrary to public policy, including, but not limited to, the following: (1) Medical or psychiatric evaluation. (2) Continuing medical or psychiatric treatment. (3) Restriction of type or circumstances of practice. (4) Continuing participation in a board-approved rehabilitation program. (5) Abstention from the use of alcohol or drugs. (6) Random fluid testing for alcohol or drugs. (7) Compliance with laws and regulations governing the practice of pharmacy. (d) The board may initiate disciplinary proceedings to revoke or suspend any probationary certificate of licensure for any violation of the terms and conditions of probation. Upon satisfactory completion of probation, the board shall convert the probationary certificate to a regular certificate, free of conditions. (e) The proceedings under this article shall be conducted in accordance with Chapter 5 (commencing with Section 11500) of Part 1 of Division 3 of the Government Code, and the board shall have all the powers granted therein. The action shall be final, except that the propriety of the action is subject to review by the superior court pursuant to Section 1094.5 of the Code of Civil Procedure. (Amended by Stats. 1997, Ch. 549, Sec. 113. Effective January 1, 1998.) - 4300.1. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 19. Disciplinary Proceedings [4300 - 4318] ( Article 19 added by Stats. 1996, Ch. 890, Sec. 3. )
The board keeps jurisdiction to investigate or take disciplinary action even if a board-issued license has expired, been cancelled, forfeited, suspended, retired, or voluntarily surrendered.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 19. Disciplinary Proceedings [4300 - 4318] ( Article 19 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4300.1. The expiration, cancellation, forfeiture, or suspension of a board-issued license by operation of law or by order or decision of the board or a court of law, the placement of a license on a retired status, or the voluntary surrender of a license by a licensee shall not deprive the board of jurisdiction to commence or proceed with any investigation of, or action or disciplinary proceeding against, the licensee or to render a decision suspending or revoking the license. (Added by Stats. 2012, Ch. 799, Sec. 23. (SB 1575) Effective January 1, 2013.) - 4301. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 19. Disciplinary Proceedings [4300 - 4318] ( Article 19 added by Stats. 1996, Ch. 890, Sec. 3. )
The board must take action against a license holder who has engaged in unprofessional conduct or whose license was issued by mistake.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 19. Disciplinary Proceedings [4300 - 4318] ( Article 19 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4301. The board shall take action against any holder of a license who is guilty of unprofessional conduct or whose license has been issued by mistake. Unprofessional conduct includes, but is not limited to, any of the following: (a) Procurement of a license by fraud or misrepresentation. (b) Incompetence. (c) Gross negligence. (d) The clearly excessive furnishing of controlled substances in violation of subdivision (a) of Section 11153 of the Health and Safety Code. (e) The clearly excessive furnishing of controlled substances in violation of subdivision (a) of Section 11153.5 of the Health and Safety Code. Factors to be considered in determining whether the furnishing of controlled substances is clearly excessive shall include, but not be limited to, the amount of controlled substances furnished, the previous ordering pattern of the customer (including size and frequency of orders), the type and size of the customer, and where and to whom the customer distributes its product. (f) The commission of any act involving moral turpitude, dishonesty, fraud, deceit, or corruption, whether the act is committed in the course of relations as a licensee or otherwise, and whether the act is a felony or misdemeanor or not. (g) Knowingly making or signing any certificate or other document that falsely represents the existence or nonexistence of a state of facts. (h) The administering to oneself, of any controlled substance, or the use of any dangerous drug or of alcoholic beverages to the extent or in a manner as to be dangerous or injurious to oneself, to a person holding a license under this chapter, or to any other person or to the public, or to the extent that the use impairs the ability of the person to conduct with safety to the public the practice authorized by the license. (i) Except as otherwise authorized by law, knowingly selling, furnishing, giving away, or administering, or offering to sell, furnish, give away, or administer, any controlled substance to a person with substance use disorder. (j) The violation of any of the statutes of this state, of any other state, or of the United States regulating controlled substances and dangerous drugs. (k) The conviction of more than one misdemeanor or any felony involving the use, consumption, or self-administration of any dangerous drug or alcoholic beverage, or any combination of those substances. (l) The conviction of a crime substantially related to the qualifications, functions, and duties of a licensee under this chapter. The record of conviction of a violation of Chapter 13 (commencing with Section 801) of Title 21 of the United States Code regulating controlled substances or of a violation of the statutes of this state regulating controlled substances or dangerous drugs shall be conclusive evidence of unprofessional conduct. In all other cases, the record of conviction shall be conclusive evidence only of the fact that the conviction occurred. The board may inquire into the circumstances surrounding the commission of the crime, in order to fix the degree of discipline or, in the case of a conviction not involving controlled substances or dangerous drugs, to determine if the conviction is of an offense substantially related to the qualifications, functions, and duties of a licensee under this chapter. A plea or verdict of guilty or a conviction following a plea of nolo contendere is deemed to be a conviction within the meaning of this provision. The board may take action when the time for appeal has elapsed, or the judgment of conviction has been affirmed on appeal or when an order granting probation is made suspending the imposition of sentence, irrespective of a subsequent order under Section 1203.4 of the Penal Code allowing the person to withdraw their plea of guilty and to enter a plea of not guilty, or setting aside the verdict of guilty, or dismissing the accusation, information, or indictment. (m) The cash compromise of a charge of violation of Chapter 13 (commencing with Section 801) of Title 21 of the United States Code regulating controlled substances or of Chapter 7 (commencing with Section 14000) of Part 3 of Division 9 of the Welfare and Institutions Code relating to the Medi-Cal program. (n) The revocation, suspension, or other discipline by another state of a license to practice pharmacy, operate a pharmacy, or do any other act for which a license is required by this chapter that would be grounds for revocation, suspension, or other discipline under this chapter. Any disciplinary action taken by the board pursuant to this section shall be coterminous with action taken by another state, except that the term of any discipline taken by the board may exceed that of another state, consistent with the board’s enforcement guidelines. The evidence of discipline by another state is conclusive proof of unprofessional conduct. (o) Violating or attempting to violate, directly or indirectly, or assisting in or abetting the violation of or conspiring to violate any provision or term of this chapter or of the applicable federal and state laws and regulations governing pharmacy, including regulations established by the board or by any other state or federal regulatory agency. (p) Actions or conduct that would have warranted denial of a license. (q) Engaging in any conduct that subverts or attempts to subvert an investigation of the board. (r) The selling, trading, transferring, or furnishing of drugs obtained pursuant to Section 256b of Title 42 of the United States Code to any person a licensee knows or reasonably should have known, not to be a patient of a covered entity, as defined in Section 256b(a)(4) of Title 42 of the United States Code. (s) The clearly excessive furnishing of dangerous drugs by a wholesaler to a pharmacy that primarily or solely dispenses prescription drugs to patients of long-term care facilities. Factors to be considered in determining whether the furnishing of dangerous drugs is clearly excessive shall include, but not be limited to, the amount of dangerous drugs furnished to a pharmacy that primarily or solely dispenses prescription drugs to patients of long-term care facilities, the previous ordering pattern of the pharmacy, and the general patient population to whom the pharmacy distributes the dangerous drugs. That a wholesaler has established, and employs, a tracking system that complies with the requirements of subdivision (b) of Section 4164 shall be considered in determining whether there has been a violation of this subdivision. This provision shall not be interpreted to require a wholesaler to obtain personal medical information or be authorized to permit a wholesaler to have access to personal medical information except as otherwise authorized by Section 56 and following of the Civil Code. For purposes of this section, “long-term care facility” has the same meaning given the term in Section 1418 of the Health and Safety Code. (t) The acquisition of a nonprescription diabetes test device from a person that the licensee knew or should have known was not the nonprescription diabetes test device’s manufacturer or the manufacturer’s authorized distributor as identified in Section 4160.5. (u) The submission of a reimbursement claim for a nonprescription diabetes test device to a pharmaceutical benefit manager, health insurer, government agency, or other third-party payor when the licensee knew or reasonably should have known that the diabetes test device was not purchased either directly from the manufacturer or from the nonprescription diabetes test device manufacturer’s authorized distributors as identified in Section 4160.5. (v) Actions or conduct that would subvert the efforts of a pharmacist to comply with laws and regulations, or exercise professional judgment, including creating or allowing conditions that may interfere with a pharmacist’s ability to practice with competency and safety or creating or allowing an environment that may jeopardize patient care. This subdivision does not apply to facilities of the Department of Corrections and Rehabilitation. (w) Actions or conduct that would subvert the efforts of a pharmacist-in-charge to comply with laws and regulations, exercise professional judgment, or make determinations about adequate staffing levels to safely fill prescriptions of the pharmacy or provide other patient care services in a safe and competent manner. This subdivision does not apply to facilities of the Department of Corrections and Rehabilitation. (x) Actions or conduct that would subvert the efforts of a pharmacist intern or a pharmacy technician to comply with laws or regulations. (y) Establishing policies and procedures related to time guarantees to fill prescriptions within a specified time unless those guarantees are required by law or to meet contractual requirements. This subdivision does not apply to facilities of the Department of Corrections and Rehabilitation. (Amended by Stats. 2023, Ch. 470, Sec. 7. (AB 1286) Effective January 1, 2024.) - 4301.1. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 19. Disciplinary Proceedings [4300 - 4318] ( Article 19 added by Stats. 1996, Ch. 890, Sec. 3. )
The board must prioritize investigative and prosecutorial resources toward pharmacists who pose the greatest threat of patient harm.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 19. Disciplinary Proceedings [4300 - 4318] ( Article 19 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4301.1. In order to ensure that the board’s resources are maximized for the protection of the public health and safety, the board shall prioritize its investigative and prosecutorial resources to ensure that pharmacists representing the greatest threat of patient harm are identified and disciplined expeditiously. (Added by Stats. 2016, Ch. 484, Sec. 35. (SB 1193) Effective January 1, 2017.) - 4301.5. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 19. Disciplinary Proceedings [4300 - 4318] ( Article 19 added by Stats. 1996, Ch. 890, Sec. 3. )
If a pharmacist’s out-of-state or federal pharmacy license is suspended or revoked, California’s board must automatically suspend the pharmacist’s license, with notice and a penalty hearing process.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 19. Disciplinary Proceedings [4300 - 4318] ( Article 19 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4301.5. (a) If a pharmacist possesses a license or is otherwise authorized to practice pharmacy in any other state or by an agency of the federal government, and that license or authority is suspended or revoked, the pharmacist’s license shall be suspended automatically for the duration of the suspension or revocation, unless terminated or rescinded as provided in subdivision (c). The board shall notify the pharmacist of the license suspension and of his or her right to have the issue of penalty heard as provided in this section. (b) Upon its own motion or for good cause shown, the board may decline to impose or may set aside the suspension when it appears to be in the interest of justice to do so, with due regard to maintaining the integrity of and confidence in the pharmacy profession. (c) The issue of penalty shall be heard by an administrative law judge sitting alone, by a committee of the board sitting with an administrative law judge, or by the board sitting with an administrative law judge, at the board’s discretion. A pharmacist may request a hearing on the penalty and that hearing shall be held within 90 days from the date of the request. If the order suspending or revoking the pharmacist’s license or authority to practice pharmacy is overturned on appeal, any discipline ordered pursuant to this section shall automatically cease. Upon the showing to the administrative law judge, board, or committee of the board by the pharmacist that the out-of-state action is not a basis for discipline in California, the suspension shall be rescinded. If an accusation for permanent discipline is not filed within 90 days of the suspension imposed pursuant to this section, the suspension shall automatically terminate. (d) The record of the proceedings that resulted in the suspension or revocation of the pharmacist’s license or authority to practice pharmacy, including a transcript of the testimony therein, may be received in evidence. (e) If a summary suspension has been issued pursuant to this section, the pharmacist may request that the hearing on the penalty conducted pursuant to subdivision (c) be held at the same time as a hearing on the accusation. (Added by Stats. 1998, Ch. 878, Sec. 30. Effective January 1, 1999.) - 4302. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 19. Disciplinary Proceedings [4300 - 4318] ( Article 19 added by Stats. 1996, Ch. 890, Sec. 3. )
The board may deny, suspend, or revoke a license if certain disqualifying conditions exist for a 10%+ owner, officer, director, or other person who controls the license.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 19. Disciplinary Proceedings [4300 - 4318] ( Article 19 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4302. The board may deny, suspend, or revoke any license where conditions exist in relation to any person holding 10 percent or more of the ownership interest or where conditions exist in relation to any officer, director, or other person with management or control of the license that would constitute grounds for disciplinary action against a licensee. (Amended by Stats. 2016, Ch. 484, Sec. 36. (SB 1193) Effective January 1, 2017.) - 4303. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 19. Disciplinary Proceedings [4300 - 4318] ( Article 19 added by Stats. 1996, Ch. 890, Sec. 3. )
The board may take disciplinary action against a nonresident pharmacy and related licenses.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 19. Disciplinary Proceedings [4300 - 4318] ( Article 19 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4303. (a) The board may report any violation by a nonresident pharmacy of the laws and regulations of this state, any other state, or of the United States, including, but not limited to, any violation of this chapter or of the regulations established by the board, to any appropriate state or federal regulatory or licensing agency, including, but not limited to, the regulatory or licensing agency of the state in which the nonresident pharmacy is a resident or in which the pharmacist is licensed. (b) The board may cancel, deny, revoke, or suspend a nonresident pharmacy registration, issue a citation or letter of admonishment to a nonresident pharmacy, or take any other action against a nonresident pharmacy that the board may take against a resident pharmacy license, on any of the same grounds upon which such action might be taken against a resident pharmacy. (c) If the home state pharmacy license of a nonresident pharmacy is canceled, revoked, or suspended for any reason, any license issued pursuant to Section 4112 or 4127.2 shall be immediately canceled, revoked, or suspended by operation of law. (Amended by Stats. 2025, Ch. 196, Sec. 46. (AB 1503) Effective January 1, 2026.) - 4303.1. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 19. Disciplinary Proceedings [4300 - 4318] ( Article 19 added by Stats. 1996, Ch. 890, Sec. 3. )
If the FDA cancels, revokes, or suspends an outsourcing facility’s registration, any related Section 4129.2 license is immediately canceled, revoked, or suspended by operation of law.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 19. Disciplinary Proceedings [4300 - 4318] ( Article 19 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4303.1. If the federal Food and Drug Administration (FDA) cancels, revokes, or suspends an outsourcing facility’s registration for any reason, any license issued pursuant to Section 4129.2 shall be immediately canceled, revoked, or suspended by operation of law. (Added by Stats. 2016, Ch. 484, Sec. 37. (SB 1193) Effective January 1, 2017.) - 4304. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 19. Disciplinary Proceedings [4300 - 4318] ( Article 19 added by Stats. 1996, Ch. 890, Sec. 3. )
The board may deny, revoke, or suspend a Section 4161 license for violations of this chapter or specified Health and Safety Code provisions.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 19. Disciplinary Proceedings [4300 - 4318] ( Article 19 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4304. The board may deny, revoke, or suspend any license issued pursuant to Section 4161 for any violation of this chapter or for any violation of Part 5 (commencing with Section 109875) of Division 104 of the Health and Safety Code. (Added by Stats. 1996, Ch. 890, Sec. 3. Effective January 1, 1997.) - 4305. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 19. Disciplinary Proceedings [4300 - 4318] ( Article 19 added by Stats. 1996, Ch. 890, Sec. 3. )
Pharmacists and pharmacies must notify the board in writing within 30 days when a pharmacist-in-charge stops serving; operating a pharmacy more than 30 days without pharmacist-in-charge supervision can trigger discipline.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 19. Disciplinary Proceedings [4300 - 4318] ( Article 19 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4305. (a) Failure by any pharmacist to notify the board in writing that he or she has ceased to act as the pharmacist-in-charge of a pharmacy, or by any pharmacy to notify the board in writing that a pharmacist-in-charge is no longer acting in that capacity, within the 30-day period specified in Sections 4101 and 4113 shall constitute grounds for disciplinary action. (b) Operation of a pharmacy for more than 30 days without supervision or management by a pharmacist-in-charge shall constitute grounds for disciplinary action. (c) Any person who has obtained a license to conduct a pharmacy, who willfully fails to timely notify the board that the pharmacist-in-charge of the pharmacy has ceased to act in that capacity, and who continues to permit the compounding or dispensing of prescriptions, or the furnishing of drugs or poisons, in his or her pharmacy, except by a pharmacist subject to the supervision and management of a responsible pharmacist-in-charge, shall be subject to summary suspension or revocation of his or her license to conduct a pharmacy. (Amended by Stats. 2009, Ch. 308, Sec. 58. (SB 819) Effective January 1, 2010.) - 4305.5. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 19. Disciplinary Proceedings [4300 - 4318] ( Article 19 added by Stats. 1996, Ch. 890, Sec. 3. )
Licensed wholesalers, third-party logistics providers, and veterinary food-animal drug retailers must notify the board within 30 days when the designated representative-in-charge or responsible manager stops working there.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 19. Disciplinary Proceedings [4300 - 4318] ( Article 19 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4305.5. (a) A person that is licensed as a wholesaler, third-party logistics provider, or veterinary food-animal drug retailer, shall notify the board within 30 days of the termination of employment of the designated representative-in-charge or responsible manager. Failure to notify the board within the 30-day period shall constitute grounds for disciplinary action. (b) A person that is licensed as a wholesaler, third-party logistics provider, or veterinary food-animal drug retailer, that willfully fails to notify the board of the termination of employment of the designated representative-in-charge or responsible manager at its licensed place of business, and that continues to operate the place of business in the absence of the designated representative-in-charge or responsible manager for that place of business shall be subject to summary suspension or revocation of its license as a wholesaler, third-party logistics provider, or veterinary food-animal drug retailer at that place of business. (c) A designated representative-in-charge of a wholesaler or veterinary food-animal drug retailer, or a responsible manager of a third-party logistics provider, who terminates his or her employment at the licensed place of business, shall notify the board within 30 days of the termination of employment. Failure to notify the board within the 30-day period shall constitute grounds for disciplinary action. (Amended by Stats. 2014, Ch. 507, Sec. 29. (AB 2605) Effective January 1, 2015.) - 4306. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 19. Disciplinary Proceedings [4300 - 4318] ( Article 19 added by Stats. 1996, Ch. 890, Sec. 3. )
Licensees under this chapter must not violate, try to violate, help violate, or conspire to violate this article, the Moscone-Knox Professional Corporation Act, or related regulations.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 19. Disciplinary Proceedings [4300 - 4318] ( Article 19 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4306. It shall constitute unprofessional conduct and a violation of this chapter for any person licensed under this chapter to violate, attempt to violate, directly or indirectly, or assist in or abet the violation of, or conspire to violate, any provision or term of this article, the Moscone-Knox Professional Corporation Act, or any regulations duly adopted under those laws. (Added by Stats. 1996, Ch. 890, Sec. 3. Effective January 1, 1997.) - 4306.5. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 19. Disciplinary Proceedings [4300 - 4318] ( Article 19 added by Stats. 1996, Ch. 890, Sec. 3. )
A pharmacist’s unprofessional conduct may include certain inappropriate acts or omissions, including failures involving professional judgment, record consultation, and maintaining patient-specific information.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 19. Disciplinary Proceedings [4300 - 4318] ( Article 19 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4306.5. Unprofessional conduct for a pharmacist may include any of the following: (a) Acts or omissions that involve, in whole or in part, the inappropriate exercise of his or her education, training, or experience as a pharmacist, whether or not the act or omission arises in the course of the practice of pharmacy or the ownership, management, administration, or operation of a pharmacy or other entity licensed by the board. (b) Acts or omissions that involve, in whole or in part, the failure to exercise or implement his or her best professional judgment or corresponding responsibility with regard to the dispensing or furnishing of controlled substances, dangerous drugs, or dangerous devices, or with regard to the provision of services. (c) Acts or omissions that involve, in whole or in part, the failure to consult appropriate patient, prescription, and other records pertaining to the performance of any pharmacy function. (d) Acts or omissions that involve, in whole or in part, the failure to fully maintain and retain appropriate patient-specific information pertaining to the performance of any pharmacy function. (Amended by Stats. 2006, Ch. 777, Sec. 11. Effective January 1, 2007.) - 4306.6. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 19. Disciplinary Proceedings [4300 - 4318] ( Article 19 added by Stats. 1996, Ch. 890, Sec. 3. )
If the board disciplines a pharmacist-in-charge for a violation committed by someone else, it must treat the pharmacist-in-charge’s report as a mitigating factor when the stated conditions are met.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 19. Disciplinary Proceedings [4300 - 4318] ( Article 19 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4306.6. If the board disciplines a pharmacist-in-charge for the violation of a state or federal law or regulation committed by another person and the pharmacist-in-charge reported to the board that violation or suspected violation, the board shall use the report as a mitigating factor if all of the following conditions are met: (a) The pharmacist-in-charge did not engage, either directly or indirectly, in any conduct that violated any state or federal law or regulation pertaining to the practice of pharmacy. (b) The pharmacist-in-charge did not permit, encourage, approve of, either tacitly or implicitly or through willful ignorance, any conduct committed by another person that violated state or federal law or regulation pertaining to the practice of pharmacy. (c) The pharmacist-in-charge reported the violation, or suspected violation, of any state or federal law or regulation pertaining to the practice of pharmacy to the board as soon as reasonably possible following the discovery of the violation. (d) The pharmacist-in-charge took all actions reasonably necessary to stop and remedy the violation, or suspected violation, of any state or federal law or regulation pertaining to the practice of pharmacy as soon as reasonably possible following the discovery of the violation. (Added by Stats. 2002, Ch. 562, Sec. 1. Effective January 1, 2003.) - 4307. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 19. Disciplinary Proceedings [4300 - 4318] ( Article 19 added by Stats. 1996, Ch. 890, Sec. 3. )
Some people connected to a denied, suspended, revoked, or probationary license cannot serve in management or control roles for a licensee.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 19. Disciplinary Proceedings [4300 - 4318] ( Article 19 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4307. (a) Any person who has been denied a license or whose license has been revoked or is under suspension, or who has failed to renew his or her license while it was under suspension, or who has been a manager, administrator, owner, member, officer, director, associate, partner, or any other person with management or control of any partnership, corporation, trust, firm, or association whose application for a license has been denied or revoked, is under suspension or has been placed on probation, and while acting as the manager, administrator, owner, member, officer, director, associate, partner, or any other person with management or control had knowledge of or knowingly participated in any conduct for which the license was denied, revoked, suspended, or placed on probation, shall be prohibited from serving as a manager, administrator, owner, member, officer, director, associate, partner, or in any other position with management or control of a licensee as follows: (1) Where a probationary license is issued or where an existing license is placed on probation, this prohibition shall remain in effect for a period not to exceed five years. (2) Where the license is denied or revoked, the prohibition shall continue until the license is issued or reinstated. (b) “Manager, administrator, owner, member, officer, director, associate, partner, or any other person with management or control of a license” as used in this section and Section 4308, may refer to a pharmacist or to any other person who serves in such capacity in or for a licensee. (c) The provisions of subdivision (a) may be alleged in any pleading filed pursuant to Chapter 5 (commencing with Section 11500) of Part 1 of Division 3 of the Government Code. However, no order may be issued in that case except as to a person who is named in the caption, as to whom the pleading alleges the applicability of this section, and where the person has been given notice of the proceeding as required by Chapter 5 (commencing with Section 11500) of Part 1 of Division 3 of the Government Code. The authority to proceed as provided by this subdivision shall be in addition to the board’s authority to proceed under Section 4339 or any other provision of law. (Amended by Stats. 2016, Ch. 484, Sec. 38. (SB 1193) Effective January 1, 2017.) - 4308. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 19. Disciplinary Proceedings [4300 - 4318] ( Article 19 added by Stats. 1996, Ch. 890, Sec. 3. )
If the board knows a person is prohibited from serving in management or control of a licensee, it must notify the affected licensee in writing. The licensee then has 30 days from the notice date to remove and replace that person and, where appropriate, file a permit change.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 19. Disciplinary Proceedings [4300 - 4318] ( Article 19 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4308. Whenever a person is prohibited from serving as a manager, administrator, owner, member, officer, director, associate, partner, or in any other position with management or control of a licensee as provided by Section 4307, the board shall, in each case where it has that information, notify in writing each licensee for whom the person is a manager, administrator, owner, member, officer, director, associate, partner, or in any other position with management or control of the prohibition. The board shall send the notification to the licensee’s address of record. The licensee shall have 30 days from the date that the notice is sent to remove and replace the prohibited person and, where appropriate, file a change of permit to reflect that change. (Amended by Stats. 2016, Ch. 484, Sec. 39. (SB 1193) Effective January 1, 2017.) - 4309. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 19. Disciplinary Proceedings [4300 - 4318] ( Article 19 added by Stats. 1996, Ch. 890, Sec. 3. )
A disciplined licensee may ask the board to reinstate the license or change the penalty, but only after waiting the required minimum time and submitting the required recommendations.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 19. Disciplinary Proceedings [4300 - 4318] ( Article 19 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4309. (a) A person whose license has been revoked or suspended or who has been placed on probation may petition the board for reinstatement or modification of penalty, including modification or termination of probation, after not less than the following minimum periods have elapsed from the effective date of the decision ordering disciplinary action: (1) At least three years for reinstatement of a revoked license. (2) At least two years for early termination of probation of three years or more. (3) At least one year for modification of a condition, or reinstatement of a license revoked for mental or physical illness, or termination of probation of less than three years. (b) The petition shall state any facts required by the board, and the petition shall be accompanied by two or more verified recommendations from holders of licenses issued by the board to which the petition is addressed, and two or more recommendations from citizens, each having personal knowledge of the disciplinary penalty imposed by the board and the activities of the petitioner since the disciplinary penalty was imposed. (c) The petition may be heard by the board sitting with an administrative law judge, or a committee of the board sitting with an administrative law judge, or the board may assign the petition to an administrative law judge. Where the petition is heard by a committee of the board sitting with an administrative law judge or by an administrative law judge sitting alone, the decision shall be subject to review by the board pursuant to Section 11517 of the Government Code. (d) In considering reinstatement or modification of penalty, the board, committee of the board, or the administrative law judge hearing the petition may consider factors including, but not limited to, all of the following: (1) All the activities of the petitioner since the disciplinary action was taken. (2) The offense for which the petitioner was disciplined. (3) The petitioner’s activities during the time the license was in good standing. (4) The petitioner’s documented rehabilitative efforts. (5) The petitioner’s general reputation for truth and professional ability. (e) The hearing may be continued from time to time as the board, committee of the board, or the administrative law judge designated in Section 11371 of the Government Code finds necessary. (f) The board, committee of the board, or administrative law judge may impose necessary terms and conditions on the licensee in reinstating the license. (g) No petition under this section shall be considered while the petitioner is under sentence for any criminal offense, including any period during which the petitioner is on court-imposed probation or parole. No petition shall be considered while there is an accusation or petition to revoke probation pending against the person. The board may deny without a hearing or argument any petition filed pursuant to this section within a period of two years from the effective date of the prior decision following a hearing under this section. (h) Nothing in this section shall be deemed to amend or otherwise change the effect or application of Sections 822 and 823. (i) The board may investigate any and all matters pertaining to the petition and documents submitted with or in connection with the application. (Amended by Stats. 1997, Ch. 549, Sec. 120. Effective January 1, 1998.) - 4310. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 19. Disciplinary Proceedings [4300 - 4318] ( Article 19 added by Stats. 1996, Ch. 890, Sec. 3. )
If a license application is denied, the board must notify the applicant in writing right away, and the applicant may submit a written petition within 10 days after the notice is mailed.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 19. Disciplinary Proceedings [4300 - 4318] ( Article 19 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4310. Immediately upon the denial of any application for a license the board shall notify the applicant in writing. Within 10 days after the board mails the notice, the applicant may present his or her written petition for a license to the board. Upon receipt by the board of the written petition, proceedings shall be conducted in accordance with Chapter 5 (commencing with Section 11500) of Part 1 of Division 3 of Title 2 of the Government Code. (Added by Stats. 1996, Ch. 890, Sec. 3. Effective January 1, 1997.) - 4311. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 19. Disciplinary Proceedings [4300 - 4318] ( Article 19 added by Stats. 1996, Ch. 890, Sec. 3. )
The board must automatically suspend a board-issued license during felony incarceration, and it must also suspend licenses for certain qualifying felony convictions, with notice and hearing rights.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 19. Disciplinary Proceedings [4300 - 4318] ( Article 19 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4311. (a) Any license issued by the board, or the holder thereof, shall be suspended automatically during any time that the person is incarcerated after conviction of a felony, regardless of whether the conviction has been appealed. The board, immediately upon receipt of a certified copy of a record of a criminal conviction, shall determine whether the person has been automatically suspended by virtue of incarceration pursuant to a felony conviction and, if so, the duration of that suspension. The board shall notify the person so suspended of the suspension and that the person has a right to request a hearing, solely as to whether he or she is incarcerated pursuant to a felony conviction, in writing at that person’s address of record with the board and at the facility in which the person is incarcerated. (b) In addition to any suspension under subdivision (a), the board shall summarily suspend any license issued by the board where a conviction of the holder of the license meets the requirements of paragraphs (1) and (2). (1) A felony that was either of the following: (A) Committed in the course of a business or practice for which the board issues a license. (B) Committed in a manner that a client, customer, or patient of the licensee was a victim. (2) Where an element of the offense involves either of the following: (A) The specific intent to deceive, defraud, steal, or make a false statement. (B) The illegal sale or possession for sale of or trafficking in any controlled substance. (3) The suspension shall continue until the time for appeal has elapsed, if no appeal is taken, or until the judgment of conviction has been affirmed on appeal or has otherwise become final, and until further order of the board. (4) The board shall immediately send notice in writing of the suspension to the licensee, or the holder of any other board-issued license, at his or her address of record and, if incarcerated at the time, at the facility in which the person is incarcerated. The notice shall include notification of that person’s right to elect to have the issue of penalty heard as provided in paragraph (2) of subdivision (d), and of the right to request a hearing to contest the summary suspension. Any request for a hearing under this paragraph must be received by the board within 15 days following receipt of the notice provided for by this paragraph. (5) The hearing shall be before an administrative law judge, a committee of the board sitting with an administrative law judge, or the board sitting with an administrative law judge, at the board’s discretion, and shall be subject to review by the board, at its discretion. The hearing shall be limited to (A) whether there has been a felony conviction as stated in the board’s notice, and (B) whether the conviction meets the criteria of this subdivision, except where the licensee chooses to proceed as provided by paragraph (2) of subdivision (d), or where the board has also filed and served an accusation as provided in Chapter 5 (commencing with Section 11500) of Part 1 of Division 3 of Title 2 of the Government Code and given notice of the hearing as required by that chapter; provided that if an accusation under Chapter 5 (commencing with Section 11500) of Part 1 of Division 3 of Title 2 of the Government Code is also to be heard, only an administrative law judge sitting alone or the board, sitting with an administrative law judge, may hear the case. (c) In addition to any suspension under subdivision (a), the board shall also suspend any license issued by the board, or the holder thereof, if the board determines that the felony conviction of the holder of the license is substantially related to the qualifications, functions, or duties of the licensee. (1) Notice of the board’s determination shall be sent to the licensee, or the holder thereof, at that person’s address of record with the board and, if the person is incarcerated at the time, the facility in which the person is incarcerated. The notice shall advise the person that the license shall be suspended without hearing unless, within 15 days following receipt of the notice, a written request for hearing is delivered to the board. (2) Upon receipt of a timely request for hearing, a notice of hearing shall be sent to the person at least 10 days before the date scheduled for the hearing. The notice of hearing shall include notification of that person’s right to elect to have the issue of penalty heard as provided in paragraph (2) of subdivision (d). (3) The hearing to determine whether a felony conviction is substantially related for purposes of an interim suspension under this subdivision shall be separate from any hearing on an accusation under the Administrative Procedure Act, except where the licensee elects to proceed under paragraph (2) of subdivision (d), or where the board has filed and served an accusation as provided by Chapter 5 (commencing with Section 11500) of Part 1 of Division 3 of Title 2 of the Government Code and given notice of hearing as required by that chapter. The hearing on whether the felony conviction is substantially related shall be heard either by an administrative law judge sitting alone, by a committee of the board sitting with an administrative law judge, or by the board sitting with an administrative law judge, at the board’s discretion, and shall be subject to review by the board, at its discretion. However, if an accusation under Chapter 5 (commencing with Section 11500) of Part 1 of Division 3 of Title 2 of the Government Code is also to be heard, only an administrative law judge sitting alone or the board, sitting with an administrative law judge, may hear the case. Except where a person proceeds under paragraph (2) of subdivision (d), or the board proceeds with an accusation at the same time, any suspension imposed under this subdivision shall continue until an accusation is filed under Chapter 5 (commencing with Section 11500) of Part 1 of Division 3 of Title 2 of the Government Code and a final decision is rendered by the board. (4) A conviction of any crime referred to in Section 4301, or for violation of Section 187, 261, or 288 of the Penal Code, shall be conclusively presumed to be substantially related to the qualifications, functions, or duties of a licensee of the board. Upon its own motion or for good cause shown the board may decline to impose a suspension under this subdivision or may set aside a suspension previously imposed when it appears to be in the interest of justice to do so, with due regard to maintaining the integrity of and confidence in the practice of pharmacy and the handling of dangerous drugs and devices. (d) (1) Discipline may be ordered in accordance with Section 4300 or an application denied when the time for appeal has elapsed, the judgment of conviction has been affirmed on appeal, or an order granting probation is made suspending the imposition of sentence, irrespective of a subsequent order under Section 1203.4 of the Penal Code allowing the person to withdraw his or her plea of guilty and to enter a plea of not guilty, setting aside the verdict of guilty, or dismissing the accusation, complaint, information, or indictment. (2) The issue of penalty shall be heard by an administrative law judge sitting alone or with a committee of the board or with the board itself, at the board’s discretion, and any decision shall be subject to review by the board, at its discretion. The hearing shall not be held until the judgment of conviction has become final or, irrespective of a subsequent order under Section 1203.4 of the Penal Code, an order granting probation has been made suspending the imposition of sentence, provided that a licensee may, at his or her option, elect to have the issue of penalty decided before those time periods have elapsed. Where the licensee so elects, the issue of penalty shall be heard in the manner described in this section at the hearing to determine whether the conviction was substantially related to the qualifications, functions, or duties of the licensee. If the conviction of a licensee who has made this election is overturned on appeal, any discipline ordered pursuant to this section shall automatically cease. Nothing in this subdivision shall prohibit the board from pursuing disciplinary action based on any cause, including the facts underlying the conviction, other than the overturned conviction. (3) The record of the proceedings resulting in the criminal conviction, including a transcript of any testimony taken in connection with the proceeding, may be received in evidence in any administrative proceeding to the extent the testimony would otherwise be admissible under Chapter 5 (commencing with Section 11500) of Part 1 of Division 3 of Title 2 of the Government Code. A certified copy of the criminal conviction shall be conclusive proof of the fact of the conviction. (e) Other provisions of this chapter setting forth procedures for the suspension or revocation of a license issued by the board shall not apply to proceedings conducted pursuant to this section, except as specifically provided in this section. (f) For purposes of this section, a crime is a felony if it is specifically declared to be so or is made a felony by subdivision (a) of Section 17 of the Penal Code, unless it is charged as a misdemeanor pursuant to paragraph (4) or (5) of subdivision (b) of Section 17 of the Penal Code, irrespective of whether in a particular case the crime may be considered a misdemeanor as a result of postconviction proceedings. For purposes of this section, a felony also includes a conviction under federal law, or the law of any other state of the United States, of the District of Columbia, or of any territory or possession of the United States. A conviction includes a plea or verdict of guilty or a conviction following a plea of nolo contendere. (g) The board may delegate the authority to issue a suspension under subdivision (a) or (b) or a notice of suspension under subdivision (c) to the executive officer of the board. (Amended by Stats. 2004, Ch. 183, Sec. 7. Effective January 1, 2005.) - 4312. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 19. Disciplinary Proceedings [4300 - 4318] ( Article 19 added by Stats. 1996, Ch. 890, Sec. 3. )
The board may cancel a facility license if the facility stays closed, and the licensee must transfer drugs and devices within 10 days after closure-related events.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 19. Disciplinary Proceedings [4300 - 4318] ( Article 19 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4312. (a) The board may cancel the license of a facility that is licensed by the board if the licensed premises remain closed, as defined in subdivision (e), other than by order of the board. For good cause shown, the board may cancel a license after a shorter period of closure. To cancel a license pursuant to this subdivision, the board shall make a diligent, good faith effort to give notice by personal service on the licensee. If a written objection is not received within 10 days after personal service is made or a diligent, good faith effort to give notice by personal service on the licensee has failed, the board may cancel the license without the necessity of a hearing. If the licensee files a written objection, the board shall file an accusation based on the licensee remaining closed. Proceedings shall be conducted in accordance with Chapter 5 (commencing with Section 11500) of Part 1 of Division 3 of Title 2 of the Government Code, and the board shall have all the powers granted in that chapter. (b) If a facility license is canceled pursuant to subdivision (a) or revoked pursuant to this article, or a facility notifies the board of its intent to remain closed or to discontinue business, the licensee shall, within 10 days thereafter, arrange for the transfer of all dangerous drugs and controlled substances or dangerous devices to another licensee authorized to possess the dangerous drugs and controlled substances or dangerous devices. The licensee transferring the dangerous drugs and controlled substances or dangerous devices shall immediately confirm in writing to the board that the transfer has taken place. (c) If a licensed facility fails to comply with subdivision (b), the board may seek and obtain an order from the superior court in the county in which the facility licensed by the board is located, authorizing the board to enter the facility and inventory and store, transfer, sell, or arrange for the sale of, all dangerous drugs and controlled substances and dangerous devices found in the facility. (d) If the board sells or arranges for the sale of any dangerous drugs, controlled substances, or dangerous devices pursuant to subdivision (c), the board may retain from the proceeds of the sale an amount equal to the cost to the board of obtaining and enforcing an order issued pursuant to subdivision (c), including the cost of disposing of the dangerous drugs, controlled substances, or dangerous devices. The remaining proceeds, if any, shall be returned to the licensee from whose premises the dangerous drugs or controlled substances or dangerous devices were removed. (1) The licensee shall be notified of the licensee’s right to the remaining proceeds by personal service or by certified mail, postage prepaid. (2) If a statute or regulation requires the licensee to file with the board the licensee’s address, and any change of address, the notice required by this subdivision may be sent by certified mail, postage prepaid, to the latest address on file with the board and service of notice in this manner shall be deemed completed on the 10th day after the mailing. (3) If the licensee is notified as provided in this subdivision, and the licensee fails to contact the board for the remaining proceeds within 30 calendar days after personal service has been made or service by certified mail, postage prepaid, is deemed completed, the remaining proceeds shall be deposited by the board into the Pharmacy Board Contingent Fund. These deposits shall be deemed to have been received pursuant to Chapter 7 (commencing with Section 1500) of Title 10 of Part 3 of the Code of Civil Procedure and shall be subject to claim or other disposition as provided in that chapter. (e) For the purposes of this section, “closed” means not engaged in the ordinary activity for which a license has been issued for at least one day each calendar week during any 120-day period. (f) Nothing in this section shall be construed as requiring a pharmacy to be open seven days a week. (Amended by Stats. 2021, Ch. 629, Sec. 27. (AB 1533) Effective January 1, 2022.) - 4313. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 19. Disciplinary Proceedings [4300 - 4318] ( Article 19 added by Stats. 1996, Ch. 890, Sec. 3. )
The board must consider evidence of rehabilitation when deciding whether to grant licensure, discipline a license, or reinstate a license, but public protection comes first if there is a conflict.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 19. Disciplinary Proceedings [4300 - 4318] ( Article 19 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4313. In determining whether to grant an application for licensure or whether to discipline or reinstate a license, the board shall give consideration to evidence of rehabilitation. However, public protection shall take priority over rehabilitation and, where evidence of rehabilitation and public protection are in conflict, public protection shall take precedence. (Added by Stats. 1997, Ch. 549, Sec. 123. Effective January 1, 1998.) - 4314. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 19. Disciplinary Proceedings [4300 - 4318] ( Article 19 added by Stats. 1996, Ch. 890, Sec. 3. )
The board may issue citations with fines and abatement orders for certain violations, and may require corrective steps and up to six hours of continuing education.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 19. Disciplinary Proceedings [4300 - 4318] ( Article 19 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4314. (a) The board may issue citations containing fines and orders of abatement for any violation of Section 733, for any violation of this chapter or regulations adopted pursuant to this chapter, or for any violation of Division 116 (commencing with Section 150200) of the Health and Safety Code, in accordance with Sections 125.9, 148, and 4005 and the regulations adopted pursuant to those sections. (b) Where appropriate, a citation issued by the board, as specified in this section, may subject the person or entity to whom the citation is issued to an administrative fine. (c) Notwithstanding any other provision of law, where appropriate, a citation issued by the board may contain an order of abatement. The order of abatement shall fix a reasonable time for abatement of the violation. It may also require the person or entity to whom the citation is issued to demonstrate how future compliance with the Pharmacy Law, and the regulations adopted pursuant thereto, will be accomplished. A demonstration may include, but is not limited to, submission of a corrective action plan, and requiring completion of up to six hours of continuing education courses in the subject matter specified in the order of abatement. Any continuing education courses required by the order of abatement shall be in addition to those required for license renewal. (d) Nothing in this section shall in any way limit the board from issuing a citation, fine, and order of abatement pursuant to Section 4067 or Section 56.36 of the Civil Code, and the regulations adopted pursuant to those sections. (e) The issuance of a citation pursuant to subdivision (b) shall not be construed as a disciplinary action or discipline for purposes of licensure or the reporting of discipline for licensure. (Amended by Stats. 2021, Ch. 629, Sec. 28. (AB 1533) Effective January 1, 2022.) - 4315. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 19. Disciplinary Proceedings [4300 - 4318] ( Article 19 added by Stats. 1996, Ch. 890, Sec. 3. )
The board’s executive officer may issue a written letter of admonishment to certain licensees or applicants, and the recipient may request an office conference or comply and keep records for at least three years.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 19. Disciplinary Proceedings [4300 - 4318] ( Article 19 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4315. (a) The executive officer, or his or her designee, may issue a letter of admonishment to a licensee for failure to comply with Section 733, for failure to comply with this chapter or regulations adopted pursuant to this chapter, or for failure to comply with Division 116 (commencing with Section 150200) of the Health and Safety Code, directing the licensee to come into compliance. (b) The executive officer, or his or her designee, may issue a letter of admonishment to an applicant for licensure who has committed any violation of law that the board deems, in its discretion, does not merit the denial of a license or require probationary status under Section 4300. The letter of admonishment may be issued concurrently with a license. (c) The letter of admonishment shall be in writing and shall describe in detail the nature and facts of the violation, including a reference to the statutes or regulations violated. (d) The letter of admonishment shall inform the licensee or applicant that within 30 days of service of the order of admonishment the licensee or applicant may do either of the following: (1) Submit a written request for an office conference to the executive officer of the board to contest the letter of admonishment. (A) Upon a timely request, the executive officer, or his or her designee, shall hold an office conference with the licensee or applicant or his or her legal counsel or authorized representative. Unless so authorized by the executive officer, or his or her designee, no individual other than the legal counsel or authorized representative of the licensee or applicant may accompany the licensee or applicant to the office conference. (B) Prior to or at the office conference, the licensee or applicant may submit to the executive officer declarations and documents pertinent to the subject matter of the letter of admonishment. (C) The office conference is intended to be an informal proceeding and shall not be subject to the Administrative Procedure Act (Chapter 3.5 (commencing with Section 11340), Chapter 4 (commencing with Section 11370), Chapter 4.5 (commencing with Section 11400), or Chapter 5 (commencing with Section 11500) of Part 1 of Division 3 of Title 2 of the Government Code). (D) The executive officer, or his or her designee, may affirm, modify, or withdraw the letter of admonishment. Within 14 calendar days from the date of the office conference, the executive officer, or his or her designee, shall personally serve or send the board’s written decision by certified mail to the licensee’s or applicant’s address of record. This decision shall be deemed the final administrative decision concerning the letter of admonishment. (E) Judicial review of the decision may be had by filing a petition for a writ of mandate in accordance with the provisions of Section 1094.5 of the Code of Civil Procedure within 30 days of the date the decision was personally served or sent by certified mail. The judicial review shall extend to the question of whether or not there was a prejudicial abuse of discretion in the issuance of the letter of admonishment. (2) Comply with the letter of admonishment and, if required, submit a written corrective action plan to the executive officer documenting compliance. If an office conference is not requested pursuant to this section, compliance with the letter of admonishment shall not constitute an admission of the violation noted in the letter of admonishment. (e) The letter of admonishment shall be served upon the licensee or applicant personally or by certified mail at his or her address of record with the board. If the licensee or applicant is served by certified mail, service shall be effective upon deposit in the United States mail. (f) The licensee or applicant shall maintain and have readily available a copy of the letter of admonishment and corrective action plan, if any, for at least three years from the date of issuance of the letter of admonishment. (g) Nothing in this section shall in any way limit the board’s authority or ability to do either of the following: (1) Issue a citation pursuant to Section 125.9, 148, or 4067, or pursuant to Section 1775 of Title 16 of the California Code of Regulations. (2) Institute disciplinary proceedings pursuant to this article. (h) The issuance of a letter of admonishment pursuant to subdivision (b) shall not be construed as a disciplinary action or discipline for purposes of licensure or the reporting of discipline for licensure. (Amended by Stats. 2014, Ch. 247, Sec. 1. (SB 960) Effective January 1, 2015.) - 4316. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 19. Disciplinary Proceedings [4300 - 4318] ( Article 19 added by Stats. 1996, Ch. 890, Sec. 3. )
The board may issue a cease and desist order for unlicensed facility operation or unlicensed practice, and must then notify the facility and follow a short hearing-and-decision process.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 19. Disciplinary Proceedings [4300 - 4318] ( Article 19 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4316. (a) The board, through its executive officer, is authorized to issue a cease and desist order for operating any facility under this chapter that requires licensure or for practicing any activity under this chapter that requires licensure without obtaining that licensure. (b) Whenever the board issues a cease and desist order pursuant to subdivision (a), the board shall immediately issue the facility a notice setting forth the acts or omissions with which it is charged, specifying the pertinent code section or sections and any regulations. (c) The order shall provide that the facility, within 15 days of receipt of the notice, may request a hearing before the president of the board to contest the cease and desist order. Consideration of the facility’s contest of the cease and desist order shall comply with Section 11425.10 of the Government Code. The hearing shall be held no later than five business days from the date the request of the owner is received by the board. The president shall render a written decision within five business days of the hearing. In the absence of the president of the board, the vice president of the board may conduct the hearing permitted by this subdivision. The owner or person in possession or control of the facility may seek review of the decision of the president of the board pursuant to Section 1094.5 of the Code of Civil Procedure. (Amended by Stats. 2021, Ch. 629, Sec. 29. (AB 1533) Effective January 1, 2022.) - 4316.5. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 19. Disciplinary Proceedings [4300 - 4318] ( Article 19 added by Stats. 1996, Ch. 890, Sec. 3. )
The board may fine an unlicensed entity and order abatement when it engages in conduct that requires licensure under the board’s jurisdiction, up to $5,000 per occurrence and only through a board-issued citation.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 19. Disciplinary Proceedings [4300 - 4318] ( Article 19 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4316.5. Notwithstanding any other law, the board may assess administrative fines and issue orders of abatement to any unlicensed entity who engages in any action that requires licensure under the jurisdiction of the board, not to exceed five thousand dollars ($5,000) for each occurrence pursuant to a citation issued by the board. (Added by Stats. 2023, Ch. 470, Sec. 8. (AB 1286) Effective January 1, 2024.) - 4317. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 19. Disciplinary Proceedings [4300 - 4318] ( Article 19 added by Stats. 1996, Ch. 890, Sec. 3. )
The board may take enforcement action against a chain community pharmacy that violates Section 4113.7, unless the pharmacy shows by clear and convincing evidence that the violation was contrary to its policy.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 19. Disciplinary Proceedings [4300 - 4318] ( Article 19 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4317. The board may take an enforcement action against a chain community pharmacy, as defined in subdivision (c) of Section 4001, that violates Section 4113.7 unless, by clear and convincing evidence, the chain community pharmacy demonstrates that the violation was contrary to its policy. (Added by Stats. 2021, Ch. 334, Sec. 3. (SB 362) Effective January 1, 2022.) - 4317.5. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 19. Disciplinary Proceedings [4300 - 4318] ( Article 19 added by Stats. 1996, Ch. 890, Sec. 3. )
The board may seek fines against certain pharmacy chains for repeated or policy-driven violations, but it generally must wait at least six months after finding a violation before filing a fines action under subdivision (a).
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 19. Disciplinary Proceedings [4300 - 4318] ( Article 19 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4317.5. (a) The board may bring an action for fines for repeated violations of materially similar provisions of this chapter within five years by three or more pharmacies operating under common ownership or management within a chain community pharmacy for a third or subsequent violation, which may be punished by an administrative fine not to exceed one hundred thousand dollars ($100,000) per violation. (b) The board may bring an action against a chain community pharmacy operating under common ownership or management for fines not to exceed one hundred fifty thousand dollars ($150,000) for any violation of this chapter demonstrated to be the result of a written policy or that was expressly encouraged by any owner or manager. (c) The board shall not bring an action for fines pursuant to subdivision (a) until at least six months have elapsed from the date the board determines that a violation has occurred unless the violation giving rise to the action resulted in actual harm to any consumer or serious potential harm to the public. (d) In an action brought by the board pursuant to subdivision (a), it shall be a defense for any pharmacy to establish either of the following: (1) That the violation was contrary to a written policy that was communicated by any owner or manager to all employees of the pharmacies where the violation occurred, and that the pharmacy has complied with the policy. (2) That, within six months after the violation, any owner or manager corrected all unlawful policies, communicated the change in policy or policies in writing to all pharmacies under its ownership or management, and provided proof of abatement of the violation to the board, so long as the violation did not result in actual harm to any consumer or serious potential harm to the public. (e) In determining the amount of the fine sought in an action brought pursuant to this section, the board shall consider relevant mitigating and aggravating factors, including, but not limited to, the good faith of the licensee, the communication of written changes to unlawful policies, the gravity of the violation, the potential harm to patients, whether the violation affects the professional judgment or independence of pharmacists and pharmacy technicians, and the history of previous violations by the common owner or manager. (f) The authority granted by this section is in addition to the authority of the board to institute any other administrative, civil, or criminal action. (g) For purposes of this section, “chain community pharmacy” shall have the same meaning as defined in Section 4001. (h) The fines in subdivisions (a) and (b) shall be imposed in accordance with Section 4314. (Amended by Stats. 2025, Ch. 196, Sec. 47. (AB 1503) Effective January 1, 2026.) - 4317.6. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 19. Disciplinary Proceedings [4300 - 4318] ( Article 19 added by Stats. 1996, Ch. 890, Sec. 3. )
The board may fine certain mail order pharmacies for repeated similar violations, but generally must wait at least six months after finding a violation before starting a fine action unless there is actual consumer harm or serious public harm.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 19. Disciplinary Proceedings [4300 - 4318] ( Article 19 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4317.6. (a) For the purposes of this section, “mail order pharmacy” is defined as a nonresident pharmacy that dispenses medications and ships them to patients via the postal service or other mail delivery method. (b) The board may bring an action for fines for repeated violations of materially similar provisions of this chapter within five years for a single mail order pharmacy, or multiple mail order pharmacies operating under common ownership or management for a third or subsequent violation, which may be punished by an administrative fine not to exceed one hundred thousand dollars ($100,000) per violation. (c) The board shall not bring an action for fines pursuant to subdivision (b) until at least six months have elapsed from the date the board determines that a violation has occurred unless the violation giving rise to the action resulted in actual harm to any consumer or serious potential harm to the public. (d) In determining the amount of the fine sought in an action brought pursuant to this section, the board shall consider relevant mitigating and aggregating factors, including, but not limited to, the good faith of the licensee, the communication of written changes to unlawful policies, the gravity of the violation, the potential harm to a patient, whether the violation affects the professional judgment or independence of pharmacists, and the history of previous violations by the mail order pharmacy, or in the case of multiple mail order pharmacies operating under common ownership or management, the history of the previous violations by the common ownership or control. (e) The authority granted by this section is in addition to the authority of the board to institute any other administrative, civil, or criminal action. (f) The fines in subdivision (b) shall be imposed in accordance with Section 4314. (Added by Stats. 2025, Ch. 196, Sec. 48. (AB 1503) Effective January 1, 2026.) - 4318. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 19. Disciplinary Proceedings [4300 - 4318] ( Article 19 added by Stats. 1996, Ch. 890, Sec. 3. )
This section bars certain officials and the board from taking criminal, civil, disciplinary, licensing, or licensure-denial actions based solely on lawful mifepristone or medication-abortion-related activities.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 19. Disciplinary Proceedings [4300 - 4318] ( Article 19 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4318. (a) Notwithstanding any other state law, and consistent with Sections 1 and 1.1 of Article I of the California Constitution, an individual or state or local officer shall not commence a criminal, civil, professional discipline, or licensing action concerning the manufacture, transport, distribution, delivery, receipt, acquisition, sale, possession, furnishment, dispensation, repackaging, or storage of brand name or generic mifepristone or any drug used for medication abortion that is lawful under the laws of the state. (b) The board shall not suspend a license, revoke a license, or otherwise take disciplinary action against a licensee solely on the basis that the licensee manufactured, transported, distributed, delivered, received, acquired, sold, possessed, furnished, dispensed, repackaged, or stored brand name or generic mifepristone or any drug used for medication abortion that is lawful under the laws of the state. (c) The board shall not deny an application for licensure, or suspend a license, revoke a license, or otherwise impose discipline upon a licensee solely because the licensee is licensed in another state and was convicted or disciplined in that state solely for an activity related to brand name or generic mifepristone or any drug used for medication abortion that, if performed in this state, would not be grounds for denial, suspension, revocation, or other discipline. (Added by Stats. 2025, Ch. 136, Sec. 9. (AB 260) Effective September 26, 2025.) - 4320. Verify source ↗
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 20. Prohibitions and Offenses [4320 - 4343] ( Article 20 added by Stats. 1996, Ch. 890, Sec. 3. )
The board may recover chapter penalties through civil action or criminal prosecution, and local prosecutors must handle prosecutions at the board’s request.
## Business and Professions Code - BPC ## DIVISION 2. HEALING ARTS [500 - 4999.202] ( Division 2 enacted by Stats. 1937, Ch. 399. ) ## CHAPTER 9. Pharmacy [4000 - 4427.8] ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. ) ## ARTICLE 20. Prohibitions and Offenses [4320 - 4343] ( Article 20 added by Stats. 1996, Ch. 890, Sec. 3. ) ## 4320. (a) The penalties prescribed in this chapter may be recovered in any court having jurisdiction, by a civil action instituted by the board in the name of the State of California, or by criminal prosecution upon complaint being made. (b) The district attorney of the county wherein violations of this chapter occur shall conduct all felony prosecutions at the request of the board. The district attorney of the county or city attorney of the city wherein violations of this chapter occur shall conduct all other actions and prosecutions at the request of the board. (Amended by Stats. 1997, Ch. 549, Sec. 124. Effective January 1, 1998.)
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