Health and Safety Code — Part 9 | HSC — United States — California law | Esheria

Health and Safety Code

Part 9 of 87 · provisions 1,601–1,800

This section says the act is to be known as the Health and Safety Code.

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About this statute

The Legislature states findings supporting a unified, single-payer-style health care financing system for all Californians. The State Department of Health Services is renamed the State Department of Health Care Services, and its retained functions continue with the renamed department. The Director of Health Care Services is appointed by the Governor with Senate confirmation, the director receives a salary set by law, and the Governor may appoint up to two chief deputies on the director’s recommendation. The director has the powers of a department head under the cited Government Code chapter. The Department of Health Services has a Division of Rural Health, and that division must administer specified chapters and sections.

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Provisions of Health and Safety Code

Showing 200 of 17,333

  1. 111220.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 5. Food [110425 - 111224.6] ( Chapter 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 13. Hamburger and Imitation Hamburger [111200 - 111220] ( Article 13 added by Stats. 1995, Ch. 415, Sec. 6. )

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    This section says Article 13 is enforced by the same persons, and in the same manner, as Article 7 in Chapter 11 of Division 22.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 5. Food [110425 - 111224.6] ( Chapter 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 13. Hamburger and Imitation Hamburger [111200 - 111220] ( Article 13 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111220. This article shall be enforced by the same persons and in the same manner as provided in Article 7 (commencing with Section 28690) of Chapter 11 of Division 22. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  2. 111222.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 5. Food [110425 - 111224.6] ( Chapter 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 14. Asian Rice Noodles, Korean Rice Cakes, and Vietnamese Rice Cakes [111222 - 111223] ( Heading of Article 14 amended by Stats. 2016, Ch. 193, Sec. 1. )

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    This section defines Asian rice-based noodles, Korean rice cakes, and Vietnamese rice cakes, and sets ingredient, cooking, handling, and refrigeration requirements for them.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 5. Food [110425 - 111224.6] ( Chapter 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 14. Asian Rice Noodles, Korean Rice Cakes, and Vietnamese Rice Cakes [111222 - 111223] ( Heading of Article 14 amended by Stats. 2016, Ch. 193, Sec. 1. ) ## 111222. For purposes of this article the following definitions shall apply: (a) “Asian rice-based noodle” is defined as a rice-based pasta that contains rice powder, water, wheat starch, vegetable cooking oil, and optional ingredients to modify the pH or water activity, or to provide a preservative effect. The ingredients shall not include any animal fats or any other products derived from animals. An Asian rice-based noodle is prepared by using a traditional method that includes cooking by steaming at not less than 130 degrees Fahrenheit, for not less than four minutes. (b) “Korean rice cake” is defined as a confection that contains rice powder, salt, sugar, various edible seeds, oil, dried beans, nuts, dried fruits, and dried pumpkin. The ingredients may not include any animal fats or any other products derived from animals. A Korean rice cake is prepared by using a traditional Korean method that includes cooking by steaming at not less than 275 degrees Fahrenheit, for not less than five minutes, nor more than 15 minutes. (c) “Vietnamese rice cake,” also known as Bánh Tét or Bánh Chưng, is defined as a confection that contains a combination of rice, beans, and meat or fruit wrapped tightly in banana leaves for cooking. Bánh Tét is a rice cake in a cylindrical shape, and Bánh Chưng is a rice cake in a square shape. A Vietnamese rice cake is prepared using a traditional Vietnamese method that includes cooking by boiling in water for not less than 10 hours. Vietnamese rice cakes are required to be handled, prepared, and stored under sanitary conditions both when they are kept at no more than 70 degrees Fahrenheit upon completion of cooking and after the rice cakes have been cooled to below 70 degrees Fahrenheit. Any Vietnamese rice cakes that are unwrapped from the banana leaves after cooking shall be refrigerated. (Amended by Stats. 2016, Ch. 193, Sec. 2. (SB 969) Effective January 1, 2017.)
  3. 111223.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 5. Food [110425 - 111224.6] ( Chapter 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 14. Asian Rice Noodles, Korean Rice Cakes, and Vietnamese Rice Cakes [111222 - 111223] ( Heading of Article 14 amended by Stats. 2016, Ch. 193, Sec. 1. )

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    Manufacturers of certain Asian rice-based noodles, Korean rice cakes, and Vietnamese rice cakes must label the product packaging with specific date, time, and consumption statements, subject to stated exemptions.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 5. Food [110425 - 111224.6] ( Chapter 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 14. Asian Rice Noodles, Korean Rice Cakes, and Vietnamese Rice Cakes [111222 - 111223] ( Heading of Article 14 amended by Stats. 2016, Ch. 193, Sec. 1. ) ## 111223. (a) (1) All manufacturers of Asian rice-based noodles shall place a label on the packaging of Asian rice-based noodles that indicates the date and time that the product first came out of hot holding at temperatures above 135 degrees Fahrenheit and includes a statement that the Asian rice-based noodles are perishable. (2) The product packaging shall only be labeled once. (3) Notwithstanding paragraphs (1) and (2), this section shall not apply to Asian rice-based noodles that have a pH of 4.6 or below, have a water activity of 0.85 or below, or have been determined by the department to be nonpotentially hazardous foods based on formulation and supporting laboratory documentation submitted to the department by the manufacturer. (b) All manufacturers of Korean rice cakes shall place a label issued by the Korean Rice Cake Association Corporation on the Korean rice cake that indicates the date of manufacture. The Korean rice cakes label shall include a statement that the rice cake must be consumed within one day of manufacture. (c) (1) All manufacturers of Vietnamese rice cakes shall place a label, designed by the Vietnamese Rice Cake Association, Inc., on the Vietnamese rice cake that indicates the date and time the cooking process was completed. The Vietnamese rice cakes label shall include a statement that the rice cake must be consumed within 24 hours of the date and time printed on the label. (2) Notwithstanding paragraph (1), this section does not apply to Vietnamese rice cakes that have been determined by the department to be nonpotentially hazardous foods based on formulation and supporting laboratory documentation submitted to the department by the manufacturer. (Amended by Stats. 2016, Ch. 193, Sec. 3. (SB 969) Effective January 1, 2017.)
  4. 111224.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 5. Food [110425 - 111224.6] ( Chapter 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 15. Eviscerated Crab [111224 - 111224.6] ( Article 15 added by Stats. 2021, Ch. 757, Sec. 10. )

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    This section defines key terms for eviscerated crab rules, including “eviscerate,” “eviscerated crab,” “HACCP plan,” and “processor.”

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 5. Food [110425 - 111224.6] ( Chapter 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 15. Eviscerated Crab [111224 - 111224.6] ( Article 15 added by Stats. 2021, Ch. 757, Sec. 10. ) ## 111224. For purposes of this article, the following terms have the following meanings: (a) “Eviscerate” or “evisceration” means the processor’s action of removing and discarding the entire intestinal tract, hepatopancreas, and all associated abdominal organs in accordance with this article. (b) “Eviscerated crab” means Dungeness crab or rock crab in which the viscera have been removed in accordance with regulations adopted pursuant to this section. (c) “Hazard Analysis Critical Control Point plan” means a hazard analysis critical control point plan as described in Section 123.6 of Title 21 of the Code of Federal Regulations or a successor federal definition. (d) “Processor” means any person engaged in commercial, custom, or institutional processing of fish or fishery products in California, in another state, or in a foreign country. A processor includes any person engaged in the production of foods that are to be used in market or consumer tests. (Added by Stats. 2021, Ch. 757, Sec. 10. (SB 80) Effective October 9, 2021.)
  5. 111224.5.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 5. Food [110425 - 111224.6] ( Chapter 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 15. Eviscerated Crab [111224 - 111224.6] ( Article 15 added by Stats. 2021, Ch. 757, Sec. 10. )

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    The department must issue an order authorizing evisceration of Dungeness or rock crab when the stated domoic acid conditions are met.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 5. Food [110425 - 111224.6] ( Chapter 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 15. Eviscerated Crab [111224 - 111224.6] ( Article 15 added by Stats. 2021, Ch. 757, Sec. 10. ) ## 111224.5. The department shall issue an order authorizing the evisceration of Dungeness crab or rock crab pursuant to this article if the domoic acid for Dungeness crab or rock crab exceeds the allowable levels for viscera in a specified area, when all of the following criteria exist: (a) The Director of Fish and Wildlife has closed waters or otherwise restricted the take of Dungeness crab or rock crab for commercial purposes pursuant to Section 5523 of the Fish and Game Code due to the viscera of the Dungeness crab or rock crab exceeding the allowable levels of domoic acid. (b) The department has determined the viscera of the Dungeness crab or rock crab exceed the allowable levels of domoic acid. (c) The department has determined the corresponding meat of the Dungeness crab or rock crab does not exceed the allowable levels of domoic acid. (Added by Stats. 2021, Ch. 757, Sec. 10. (SB 80) Effective October 9, 2021.)
  6. 111224.6.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 5. Food [110425 - 111224.6] ( Chapter 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 15. Eviscerated Crab [111224 - 111224.6] ( Article 15 added by Stats. 2021, Ch. 757, Sec. 10. )

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    The department may authorize eviscerating Dungeness or rock crab only for licensed processors with department-approved HACCP plans, and it must set related fees, labeling rules, recall procedures, and notice/comment steps.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 5. Food [110425 - 111224.6] ( Chapter 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 15. Eviscerated Crab [111224 - 111224.6] ( Article 15 added by Stats. 2021, Ch. 757, Sec. 10. ) ## 111224.6. (a) (1) The department shall only authorize the evisceration of Dungeness crab or rock crab pursuant to this article by a processor that is licensed pursuant to Article 2 (commencing with Section 110460) and that has a Hazard Analysis Critical Control Point plan approved by the department for handling and preparing eviscerated crab. (2) The department shall collect from a processor a fee of three hundred fifty dollars ($350) for the cost of reviewing the processor’s Hazard Analysis Critical Control Point plan for handling and preparing eviscerated crab. This fee shall not exceed the cost of reviewing the Hazard Analysis Critical Control Point plan and shall be adjusted pursuant to Section 100425. All moneys collected by the department from this fee shall be deposited in the Food Safety Fund established pursuant to Section 110050 for expenditure by the department, upon appropriation by the Legislature, for the costs of reviewing Hazard Analysis Critical Control Point plans for handling and preparing eviscerated crab. (3) The department shall establish requirements for labeling eviscerated crab to identify harvest location, harvest date, or lot code, or any combination of these things. (4) The department shall require the processor to maintain written recall procedures. (b) (1) The department shall consult with the Dungeness crab task force established pursuant to Section 8276.4 of the Fish and Game Code or a successor task force or committee to establish the criteria for the manufacture, sale, delivery, holding, or offering for sale of Dungeness crab or rock crab that is subject to Section 111224.5. (2) The Dungeness crab or rock crab criteria established under this subdivision shall become effective by operation of law as a regulation adopted under this article 90 days after the department publishes the notice required by paragraph (3). (3) The department shall publish a notice in the California Regulatory Notice Register of the department’s proposed Dungeness crab or rock crab criteria. The notice shall include the proposed text and justification for the addition, change, or deletion of the Dungeness crab or rock crab criteria to allow public comment. The department shall consider the public comments. (c) This section shall not be subject to Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code. (Added by Stats. 2021, Ch. 757, Sec. 10. (SB 80) Effective October 9, 2021.)
  7. 111225.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 1. General Provisions [111225 - 111246] ( Article 1 added by Stats. 1995, Ch. 415, Sec. 6. )

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    This section defines “established name” for a drug or drug ingredient.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 1. General Provisions [111225 - 111246] ( Article 1 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111225. As used in this chapter, with respect to a drug or drug ingredient, “established name” means either of the following: (a) The name designated pursuant to Section 508 of the federal act (21 U.S.C. Sec. 358). (b) If there is no such name and the drug or ingredient is an article recognized in an official compendium, then the official title in the compendium is the established name. If neither subdivision (a) or (b) of this section applies, the common or usual name, if any, of the drug or of the ingredient is the established name. When an article is recognized in the United States Pharmacopoeia and in the Homeopathic Pharmacopoeia under different official titles, the official title used in the United States Pharmacopoeia shall apply unless it is labeled and offered for sale as a homeopathic drug. If it is labeled and offered for sale as a homeopathic drug, the official title used in the Homeopathic Pharmacopoeia shall apply. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  8. 111230.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 1. General Provisions [111225 - 111246] ( Article 1 added by Stats. 1995, Ch. 415, Sec. 6. )

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    A drug labeled or advertised as an antiseptic is treated as a germicide, except when it is an antiseptic for inhibitory use such as a wet dressing, ointment, dusting powder, or other prolonged-contact use.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 1. General Provisions [111225 - 111246] ( Article 1 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111230. Any drug represented in its labeling or advertisement as an antiseptic shall be considered to be represented as a germicide, except in the case of a drug that is purported to be or represented as, an antiseptic for inhibitory use as a wet dressing, ointment, dusting powder, or other use involving prolonged contact with the body. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  9. 111235.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 1. General Provisions [111225 - 111246] ( Article 1 added by Stats. 1995, Ch. 415, Sec. 6. )

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    A drug listed in both pharmacopoeias follows the United States Pharmacopoeia unless it is labeled and sold as a homeopathic drug.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 1. General Provisions [111225 - 111246] ( Article 1 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111235. Whenever a drug is recognized in both the United States Pharmacopoeia and the Homeopathic Pharmacopoeia of the United States, it shall be subject to the requirements of the United States Pharmacopoeia unless it is labeled and offered for sale as a homeopathic drug. If it is labeled and offered for sale as a homeopathic drug, it shall be subject to the provisions of the Homeopathic Pharmacopoeia of the United States and not to those of the United States Pharmacopoeia. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  10. 111240.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 1. General Provisions [111225 - 111246] ( Article 1 added by Stats. 1995, Ch. 415, Sec. 6. )

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    Added poisonous or deleterious substances and color additives are treated as unsafe for use in drugs or devices unless a Section 110090 regulation allows that use.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 1. General Provisions [111225 - 111246] ( Article 1 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111240. Any added poisonous or deleterious substance, or color additive, shall be considered unsafe for use with respect to any drug or device unless there is in effect a regulation adopted pursuant to Section 110090 that prescribes its use in or on drugs or devices. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  11. 111245.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 1. General Provisions [111225 - 111246] ( Article 1 added by Stats. 1995, Ch. 415, Sec. 6. )

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    The department may set performance standards for devices, and those standards may include labeling requirements when appropriate.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 1. General Provisions [111225 - 111246] ( Article 1 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111245. The department may establish performance standards for devices, that shall be designed to provide reasonable assurance of safe and effective performance and, where appropriate, requiring the use and prescribing the form and content of labeling for the proper installation, maintenance, operation, or use of the device. However, if a performance standard is established for a device pursuant to Section 514 of the federal act (21 U.S.C. Sec. 360d) or Section 521 of the federal act (21 U.S.C. Sec. 360k), it shall be the performance standard of this state for device. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  12. 111246.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 1. General Provisions [111225 - 111246] ( Article 1 added by Stats. 1995, Ch. 415, Sec. 6. )

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    Beginning January 1, 2002, a product used to treat lice or scabies in humans that contains Lindane must not be used or sold in the state.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 1. General Provisions [111225 - 111246] ( Article 1 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111246. Commencing January 1, 2002, any product used for the treatment of lice or scabies in human beings that contains the pesticide Lindane shall not be used or sold in the state. (Added by Stats. 2000, Ch. 326, Sec. 2. Effective January 1, 2001.)
  13. 111250.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 2. Adulterated Drugs or Devices [111250 - 111325] ( Article 2 added by Stats. 1995, Ch. 415, Sec. 6. )

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    A drug or device is adulterated if it contains any filthy, putrid, or decomposed substance, in whole or in part.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 2. Adulterated Drugs or Devices [111250 - 111325] ( Article 2 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111250. Any drug or device is adulterated if it consists, in whole or in part, of any filthy, putrid, or decomposed substance. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  14. 111255.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 2. Adulterated Drugs or Devices [111250 - 111325] ( Article 2 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    A drug or device is adulterated if it was handled in conditions that may have contaminated it with filth or made it injurious to health.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 2. Adulterated Drugs or Devices [111250 - 111325] ( Article 2 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111255. Any drug or device is adulterated if it has been produced, prepared, packed, or held under conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  15. 111260.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 2. Adulterated Drugs or Devices [111250 - 111325] ( Article 2 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    A drug or device is adulterated if its manufacturing, processing, packing, or holding practices do not meet current good manufacturing practice.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 2. Adulterated Drugs or Devices [111250 - 111325] ( Article 2 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111260. Any drug or device is adulterated if the methods, facilities, or controls used for its manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with current good manufacturing practice to assure that the drug or device meets the requirements of this part as to safety and has the identity and strength, and meets the quality and purity characteristics that it purports or is represented to possess. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  16. 111265.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 2. Adulterated Drugs or Devices [111250 - 111325] ( Article 2 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    A packaged drug or device is adulterated if its container contains a poisonous or deleterious substance that could make the contents harmful to health.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 2. Adulterated Drugs or Devices [111250 - 111325] ( Article 2 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111265. Any drug or device is adulterated if it is packaged and its container is composed, in whole or in part, of any poisonous or deleterious substance that may render the contents injurious to health. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  17. 111270.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 2. Adulterated Drugs or Devices [111250 - 111325] ( Article 2 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    A drug or device is adulterated if it contains an unsafe color additive used only for coloring.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 2. Adulterated Drugs or Devices [111250 - 111325] ( Article 2 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111270. Any drug or device is adulterated if it bears or contains for the purpose of coloring only a color additive that is unsafe within the meaning of Section 111240. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  18. 111275.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 2. Adulterated Drugs or Devices [111250 - 111325] ( Article 2 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    A drug or device is adulterated if it is a color additive used only for coloring and is unsafe under Section 111240.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 2. Adulterated Drugs or Devices [111250 - 111325] ( Article 2 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111275. Any drug or device is adulterated if it is a color additive, the intended use of which in or on drugs or devices is for the purpose of coloring only, and it is unsafe within the meaning of Section 111240. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  19. 111280.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 2. Adulterated Drugs or Devices [111250 - 111325] ( Article 2 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    A drug is adulterated if it claims to be an official-compendium drug but falls below the compendium’s strength, quality, or purity standards.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 2. Adulterated Drugs or Devices [111250 - 111325] ( Article 2 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111280. Any drug is adulterated if it purports to be, or is represented as, a drug that is recognized in an official compendium, and its strength differs from, or its quality or purity falls below, the standards set forth in the compendium. Such determination as to strength, quality, or purity shall be made in accordance with the tests or methods of assay set forth in the compendium, or in the absence of or inadequacy of the tests or methods of assay, those prescribed under authority of this part. No drug defined in an official compendium shall be deemed to be adulterated under this section because it differs from the standard of strength, quality, or purity set forth in the compendium, if its difference in strength, quality, or purity from the standard is plainly stated on the label. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  20. 111285.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 2. Adulterated Drugs or Devices [111250 - 111325] ( Article 2 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    A drug or device is adulterated if its strength, purity, or quality is below what it is represented to be.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 2. Adulterated Drugs or Devices [111250 - 111325] ( Article 2 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111285. Any drug or device is adulterated if its strength differs from, or its purity or quality is below, that which it is represented to possess. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  21. 111290.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 2. Adulterated Drugs or Devices [111250 - 111325] ( Article 2 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    A drug or device is adulterated if it has been mixed or packed to reduce its quality or strength, or if something has been substituted for it in whole or in part.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 2. Adulterated Drugs or Devices [111250 - 111325] ( Article 2 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111290. Any drug or device is adulterated if any substance has been mixed or packed with it so as to reduce its quality or strength or if any substance has been substituted, wholly or in part, for the drug or device. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  22. 111295.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 2. Adulterated Drugs or Devices [111250 - 111325] ( Article 2 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    A person must not manufacture, sell, deliver, hold, or offer for sale any adulterated drug or device.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 2. Adulterated Drugs or Devices [111250 - 111325] ( Article 2 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111295. It is unlawful for any person to manufacture, sell, deliver, hold, or offer for sale any drug or device that is adulterated. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  23. 111300.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 2. Adulterated Drugs or Devices [111250 - 111325] ( Article 2 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    A person must not adulterate any drug or device.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 2. Adulterated Drugs or Devices [111250 - 111325] ( Article 2 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111300. It is unlawful for any person to adulterate any drug or device. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  24. 111305.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 2. Adulterated Drugs or Devices [111250 - 111325] ( Article 2 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    Any person may not receive adulterated drugs or devices in commerce, and may not deliver or offer them for delivery.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 2. Adulterated Drugs or Devices [111250 - 111325] ( Article 2 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111305. It is unlawful for any person to receive in commerce any drug or device that is adulterated or to deliver or proffer for delivery any drug or device. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  25. 111310.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 2. Adulterated Drugs or Devices [111250 - 111325] ( Article 2 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    A drug or device that contains a color additive in line with an applicable Section 110090 regulation is not treated as adulterated while that regulation is in effect.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 2. Adulterated Drugs or Devices [111250 - 111325] ( Article 2 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111310. While any regulation described in Section 110090 relating to any color additive is in effect, any drug or device that bears or contains the color additive in accordance with the regulation shall not be considered adulterated. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  26. 111315.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 2. Adulterated Drugs or Devices [111250 - 111325] ( Article 2 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    Certain drugs or devices intended for export are not treated as adulterated if they meet listed export conditions.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 2. Adulterated Drugs or Devices [111250 - 111325] ( Article 2 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111315. Any drug or device intended for export shall not be deemed to be adulterated under this part if it satisfies all of the following requirements: (a) It accords to the specifications of the foreign purchaser. (b) It is not in conflict with the laws of the importing country. (c) It is labeled on the outside of the shipping package to show that it is intended for export. If the article is sold or offered for sale in domestic commerce, this section shall not exempt it from any of the provisions of this part. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  27. 111320.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 2. Adulterated Drugs or Devices [111250 - 111325] ( Article 2 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    A device is adulterated if it does not meet the applicable performance standard, if one applies, under Section 111245.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 2. Adulterated Drugs or Devices [111250 - 111325] ( Article 2 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111320. Any device is adulterated that fails to meet the applicable performance standard, if any, as provided in Section 111245. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  28. 111325.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 2. Adulterated Drugs or Devices [111250 - 111325] ( Article 2 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    A drug or device is treated as adulterated if it is covered by certain FDA tamper-resistant packaging regulations and does not comply with them.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 2. Adulterated Drugs or Devices [111250 - 111325] ( Article 2 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111325. A drug or device is deemed adulterated under the laws of this state if it is subject to regulations issued by the United States Food and Drug Administration as set forth in Parts 200, 211, 314, and 800 of Volume 21 of the Code of Federal Regulations, as amended, relating to tamper-resistant packaging, but is not in compliance therewith. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  29. 111330.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3. Misbranded Drugs or Devices [111330 - 111510] ( Article 3 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    A drug or device is misbranded if its labeling is false or misleading in any way.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3. Misbranded Drugs or Devices [111330 - 111510] ( Article 3 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111330. Any drug or device is misbranded if its labeling is false or misleading in any particular. (Amended by Stats. 2000, Ch. 796, Sec. 7. Effective January 1, 2001.)
  30. 111335.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3. Misbranded Drugs or Devices [111330 - 111510] ( Article 3 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    A drug or device is misbranded if its labeling or packaging does not meet Chapter 4 requirements starting at Section 110290.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3. Misbranded Drugs or Devices [111330 - 111510] ( Article 3 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111335. Any drug or device is misbranded if its labeling or packaging does not conform to the requirements of Chapter 4 (commencing with Section 110290). (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  31. 111340.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3. Misbranded Drugs or Devices [111330 - 111510] ( Article 3 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    A drug or device is misbranded unless its label includes the required business name/address and a quantity statement.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3. Misbranded Drugs or Devices [111330 - 111510] ( Article 3 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111340. Any drug or device is misbranded unless it bears a label containing all of the following information: (a) The name and place of business of the manufacturer, packer, or distributor. (b) An accurate statement of the quantity of the contents in terms of weight, measure, or numerical count. Reasonable variations from the requirements of subdivision (b) shall be permitted. Requirements for placement and prominence of the information and exemptions as to small packages shall be established in accordance with regulations adopted pursuant to Section 110380. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  32. 111345.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3. Misbranded Drugs or Devices [111330 - 111510] ( Article 3 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    A drug or device is misbranded if required label or labeling information is not prominently placed and clear enough for an ordinary person to read and understand under customary purchase and use conditions.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3. Misbranded Drugs or Devices [111330 - 111510] ( Article 3 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111345. Any drug or device is misbranded if any word, statement, or other information required by or under this part to appear on the label or labeling is not prominently placed on the label or labeling with conspicuousness, as compared with other words, statements, designs, or devices in the labeling, and in terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  33. 111355.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3. Misbranded Drugs or Devices [111330 - 111510] ( Article 3 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    Drugs are misbranded unless their labels include required name and ingredient information; the department may exempt some nonprescription drugs from part of the quantity-disclosure rule.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3. Misbranded Drugs or Devices [111330 - 111510] ( Article 3 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111355. (a) Any drug is misbranded unless its label bears, to the exclusion of any other nonproprietary name except the applicable, systematic chemical name or the chemical formula, all of the following information: (1) The established name of the drug, if any. (2) If it is fabricated from two or more ingredients, the established name and quantity of each active ingredient, including the kind and quantity or proportion of any alcohol, and also including, whether active or not, the established name and quantity or proportion of any bromides, ether, chloroform, acetanilide, acetophenetidin, antipyrine, atropine, hyoscine, hyoscyamine, codeine, arsenic, digitalis, digitalis glycosides, mercury, ouabain, strophanthin, strychnine, barbituric acid, or any derivative or preparation of any substances contained therein. (3) For nonprescription drugs, the quantity or proportion of each active ingredient and the established name of each inactive ingredient in accordance with Sections 502(e)(1)(A)(ii) and (iii) of the federal act (21 U.S.C. 352(e)(1)(A)(ii) and (iii)). (b) The requirement for stating the quantity of the active ingredients of any drug, including the quantity or proportion of any alcohol, and also including, whether active or not, the quantity or proportion of any bromides, ether, chloroform, acetanilide, acetophenetidin, antipyrine, atropine, hyoscine, hyoscyamine, codeine, arsenic, digitalis, digitalis glycosides, mercury, ouabain, strophanthin, strychnine, barbituric acid, or any derivative or preparation of any substances contained therein, shall apply to all drugs, including prescription drugs and nonprescription drugs. However, the requirement for declaration of quantity shall not apply to nonprescription drugs that are also cosmetics, as defined in Section 201(i) of the federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 321(i)) and that are labeled in compliance with federal labeling requirements concerning declaration of ingredients including active ingredients and also the quantity and proportion of any alcohol, except that the quantity or proportion of the following ingredients, whether active or not, shall be declared: bromides, ether, chloroform, acetanilide, acetophenetidin, antipyrine, atropine, hyoscine, hyoscyamine, codeine, arsenic, digitalis, digitalis glycosides, mercury, ouabain, strophanthin, strychnine, barbituric acid, or any derivative or preparation of any substances contained therein. The department may exempt any nonprescription drug from the requirement of stating the quantity of the active ingredients, other than those specifically named in this subdivision, upon a showing by the applicant through evidence satisfactory to the department that the granting of the exemption will not endanger the public health. For any prescription drug the established name of the drug or ingredient, as the case may be, on the label and on any labeling on which a name for the drug or ingredient is used shall be printed prominently and in type at least half as large as that used thereon for any proprietary name or designation for the drug or ingredient. The changes made in this section by Chapter 943 of the Statutes of 1978 shall not apply to any drug shipped by a manufacturer or packer to a retailer or wholesaler before January 1, 1980. Any such drugs so shipped shall comply with this section on and after January 1, 1981. (Amended by Stats. 2000, Ch. 796, Sec. 9. Effective January 1, 2001.)
  34. 111360.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3. Misbranded Drugs or Devices [111330 - 111510] ( Article 3 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    Drugs covered by Section 111470 are misbranded unless their manufacturer, packer, or distributor includes required true statements in all related advertisements and descriptive materials.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3. Misbranded Drugs or Devices [111330 - 111510] ( Article 3 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111360. Any drug subject to Section 111470 is misbranded unless the manufacturer, packer, or distributor of the drug includes, in all advertisements and other descriptive matter issued or caused to be issued by the manufacturer, packer, or distributor with respect to that drug, a true statement of all of the following: (a) The established name, printed prominently and in a type at least half as large as that used for any proprietary name of the drug. (b) The formula showing quantitatively each ingredient of the drug to the extent required for labels under Section 111355. (c) The name and place of business of the manufacturer that produced the finished dosage form of the drug, as prescribed by regulations issued by the department. This subdivision applies only to advertisements or descriptive matter issued for drugs manufactured in finished dosage form on or after April 1, 1973. (d) Such other information, in brief summary relating to side effects, contraindications, and effectiveness as shall be required by regulations promulgated by the department. Regulations relating to side effects, contraindications, and effectiveness issued pursuant to Section 502(n) of the federal act (21 U.S.C. Sec. 352(n)) are the regulations establishing information requirements relating to side effects, contraindications and effectiveness in this state. The department may, by regulation, make other requirements relating to side effects, contraindications, and effectiveness whether or not in accordance with the regulations adopted under the federal act. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  35. 111365.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3. Misbranded Drugs or Devices [111330 - 111510] ( Article 3 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    A drug covered by Section 111470 is misbranded unless the prescription drug’s established name is shown prominently and in type at least half as large as the proprietary name on the label, labeling, or advertising.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3. Misbranded Drugs or Devices [111330 - 111510] ( Article 3 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111365. Any drug subject to Section 111470 is misbranded unless the established name of the prescription drug or prescription drug ingredient is printed on the label prominently and in type at least half as large as that used for the proprietary name or designation on the label, labeling, or advertising. The department may, by regulation, establish exemptions from the requirements of this section when compliance with this section is not considered necessary for the protection of health and safety. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  36. 111375.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3. Misbranded Drugs or Devices [111330 - 111510] ( Article 3 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    A drug or device is misbranded unless its labeling includes required directions and warnings.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3. Misbranded Drugs or Devices [111330 - 111510] ( Article 3 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111375. Any drug or device is misbranded unless its labeling bears all of the following information: (a) Adequate directions for use. (b) Such adequate warnings against use in pathological conditions or by children where its use may be dangerous to health. (c) Adequate warning against unsafe dosage or methods or duration of administration or application. Warnings shall be in a manner and form as are necessary for the protection of users. If the department determines that any requirement of subdivision (a), as applied to any drug or device, is not necessary for the protection of the public health, the department may adopt regulations exempting the drug or device from these requirements. Any drug or device exempted under Section 502(f) of the federal act (21 U.S.C. Sec. 352(f)) is exempt from the requirement of this section. The department, however, may adopt any regulation including a drug or device within, or excluding a drug or device from the requirements of this section, whether or not the inclusion or exclusion of the drug or device is in accord with the federal act. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  37. 111376.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3. Misbranded Drugs or Devices [111330 - 111510] ( Article 3 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    The department may issue regulations about brand name or generic mifepristone and drugs used for medication abortion, including rules that bring them within or exclude them from this article’s requirements.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3. Misbranded Drugs or Devices [111330 - 111510] ( Article 3 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111376. (a) The department may adopt regulations relating to brand name or generic mifepristone or any drug used for medication abortion by including brand name or generic mifepristone or any drug used for medication abortion within, or excluding brand name or generic mifepristone or any drug used for medication abortion from, the requirements of this article, whether or not the inclusion or exclusion of the drug is in accordance with federal law. (b) Notwithstanding any other state law, and consistent with Sections 1 and 1.1 of Article I of the California Constitution, this article shall not apply to brand name or generic mifepristone in the event of a labeling change or in the absence of its United States Food and Drug Administration approval if it is recommended for use by the World Health Organization and its labeling was true and accurate at the time of manufacture, except if the state deems it necessary to address an imminent health or safety concern regarding brand name or generic mifepristone. (Added by Stats. 2025, Ch. 136, Sec. 17. (AB 260) Effective September 26, 2025.)
  38. 111380.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3. Misbranded Drugs or Devices [111330 - 111510] ( Article 3 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    A drug is misbranded if it claims to be an official-compendium drug but is not packaged and labeled as required; the department can consent to a packaging change.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3. Misbranded Drugs or Devices [111330 - 111510] ( Article 3 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111380. Any drug is misbranded if it purports to be a drug that is recognized in an official compendium and it is not packaged and labeled as prescribed in the official compendium. The method of packaging, however, may be modified with the consent of the department. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  39. 111385.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3. Misbranded Drugs or Devices [111330 - 111510] ( Article 3 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    A drug or device is misbranded if the department determines it is liable to deterioration, unless it is packaged and labeled with the precautions the department requires by regulation.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3. Misbranded Drugs or Devices [111330 - 111510] ( Article 3 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111385. Any drug or device is misbranded if the department determines that the drug or device is liable to deterioration, unless it is packaged in that form and manner and its label bears a statement of the precautions, as the department, by regulation, may require as necessary for the protection of public health. Such regulations shall not be established for any drug or device recognized in an official compendium, unless the department has informed the appropriate body, charged with the revision of the official compendium, of the need for that packaging or labeling requirements and that body has not prescribed the requirements in a reasonable length of time. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  40. 111390.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3. Misbranded Drugs or Devices [111330 - 111510] ( Article 3 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    A drug or device is misbranded if its container is made, formed, or filled in a way that is misleading.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3. Misbranded Drugs or Devices [111330 - 111510] ( Article 3 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111390. Any drug or device is misbranded if its container is so made, formed, or filled as to be misleading. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  41. 111395.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3. Misbranded Drugs or Devices [111330 - 111510] ( Article 3 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    A drug is misbranded if it imitates another drug, is sold under another drug’s name, or has had the original package’s contents removed and replaced.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3. Misbranded Drugs or Devices [111330 - 111510] ( Article 3 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111395. Any drug is misbranded in any of the following cases: (a) It is an imitation of another drug. (b) It is offered for sale under the name of another drug. (c) The contents of the original package have been, wholly or partly, removed and replaced with other material in the package. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  42. 111397.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3. Misbranded Drugs or Devices [111330 - 111510] ( Article 3 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    A foreign dangerous drug is misbranded if it is not FDA-approved or is obtained outside the licensed supply chain; lawfully imported drugs or drugs covered by FDA enforcement discretion are not misbranded.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3. Misbranded Drugs or Devices [111330 - 111510] ( Article 3 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111397. (a) Any foreign dangerous drug that is not approved by the United States Food and Drug Administration or that is obtained outside of the licensed supply chain regulated by the United States Food and Drug Administration, California State Board of Pharmacy, or State Department of Public Health is misbranded. (b) Any foreign dangerous drug that is imported lawfully under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 301 et seq.) or pursuant to an announcement by the United States Food and Drug Administration of the exercise of enforcement discretion for instances including, but not limited to, clinical research purposes, drug shortages, development of countermeasures against chemical, biological, radiological, and nuclear terrorism agents, or pandemic influenza preparedness and response is not misbranded. (Added by Stats. 2014, Ch. 492, Sec. 13. (SB 600) Effective January 1, 2015.)
  43. 111400.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3. Misbranded Drugs or Devices [111330 - 111510] ( Article 3 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    A drug or device is misbranded if its labeled dosage, frequency, or duration makes it dangerous to health.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3. Misbranded Drugs or Devices [111330 - 111510] ( Article 3 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111400. Any drug or device is misbranded if it is dangerous to health when used in the dosage, or with the frequency or duration prescribed, recommended, or suggested in its labeling. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  44. 111415.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3. Misbranded Drugs or Devices [111330 - 111510] ( Article 3 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    A drug is misbranded if it is a color additive for coloring drugs only and its packaging or labeling does not meet the requirements adopted under Section 110090.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3. Misbranded Drugs or Devices [111330 - 111510] ( Article 3 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111415. Any drug is misbranded if it is a color additive, intended for use in or on drugs for the purpose of coloring only and its packaging and labeling fail to conform to the packaging and labeling requirements adopted pursuant to Section 110090. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  45. 111420.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3. Misbranded Drugs or Devices [111330 - 111510] ( Article 3 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    A drug or device is misbranded if someone else’s trademark, trade name, or other identifying mark is placed on it or its container.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3. Misbranded Drugs or Devices [111330 - 111510] ( Article 3 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111420. A drug or device is misbranded if a trademark, trade name, or other identifying mark, imprint, or device of another person, or any likeness of the trademark, trade name, or other identifying mark, imprint, or device of another person, has been placed on the drug or device, or upon its container. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  46. 111425.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3. Misbranded Drugs or Devices [111330 - 111510] ( Article 3 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    A drug or device is misbranded if it was made in California in an establishment that is not duly licensed under this part.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3. Misbranded Drugs or Devices [111330 - 111510] ( Article 3 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111425. A drug or device is misbranded if it was manufactured in this state in an establishment not duly licensed as provided in this part. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  47. 111430.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3. Misbranded Drugs or Devices [111330 - 111510] ( Article 3 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    A drug or device is misbranded if it was made in an establishment that was not duly registered with the named federal secretary.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3. Misbranded Drugs or Devices [111330 - 111510] ( Article 3 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111430. A drug or device is misbranded if it was manufactured in an establishment not duly registered with the Secretary of Health, Education, and Welfare of the United States. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  48. 111435.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3. Misbranded Drugs or Devices [111330 - 111510] ( Article 3 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    A drug is misbranded if its packaging or labeling violates an applicable regulation issued under Section 108685 or 108700.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3. Misbranded Drugs or Devices [111330 - 111510] ( Article 3 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111435. Any drug is misbranded if its packaging or labeling is in violation of an applicable regulation issued pursuant to Section 108685 or 108700. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  49. 111440.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3. Misbranded Drugs or Devices [111330 - 111510] ( Article 3 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    It is unlawful for any person to manufacture, sell, deliver, hold, or offer for sale a misbranded drug or device.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3. Misbranded Drugs or Devices [111330 - 111510] ( Article 3 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111440. It is unlawful for any person to manufacture, sell, deliver, hold, or offer for sale any drug or device that is misbranded. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  50. 111445.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3. Misbranded Drugs or Devices [111330 - 111510] ( Article 3 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    A person must not misbrand any drug or device.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3. Misbranded Drugs or Devices [111330 - 111510] ( Article 3 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111445. It is unlawful for any person to misbrand any drug or device. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  51. 111450.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3. Misbranded Drugs or Devices [111330 - 111510] ( Article 3 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    A person must not receive in commerce any misbranded drug or device, and must not deliver or offer for delivery any drug or device.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3. Misbranded Drugs or Devices [111330 - 111510] ( Article 3 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111450. It is unlawful for any person to receive in commerce any drug or device that is misbranded or to deliver or proffer for delivery any drug or device. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  52. 111455.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3. Misbranded Drugs or Devices [111330 - 111510] ( Article 3 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    A person must not alter, mutilate, destroy, obliterate, or remove any label or labeling from a drug or device if doing so makes the product misbranded.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3. Misbranded Drugs or Devices [111330 - 111510] ( Article 3 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111455. It is unlawful for any person to alter, mutilate, destroy, obliterate, or remove the label or any part of the labeling of any drug or device if the act results in the drug or device being misbranded. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  53. 111460.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3. Misbranded Drugs or Devices [111330 - 111510] ( Article 3 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    A drug or device intended for export is not misbranded if it matches the foreign purchaser’s specifications, does not conflict with the importing country’s laws, and is labeled on the outside of the shipping package as intended for export.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3. Misbranded Drugs or Devices [111330 - 111510] ( Article 3 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111460. Any drug or device intended for export shall not be deemed to be misbranded under this part if it satisfies all of the following requirements: (a) It accords to the specifications of the foreign purchaser. (b) It is not in conflict with the laws of the importing country. (c) It is labeled on the outside of the shipping package to show that it is intended for export. If the article is sold or offered for sale in domestic commerce, this section shall not exempt it from any of the provisions of this part. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  54. 111465.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3. Misbranded Drugs or Devices [111330 - 111510] ( Article 3 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    A drug or device is misbranded if it is covered by FDA tamper-resistant packaging rules and does not comply with them.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3. Misbranded Drugs or Devices [111330 - 111510] ( Article 3 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111465. A drug or device is deemed misbranded under the laws of this state if it is subject to regulations issued by the United States Food and Drug Administration relating to tamper-resistant packaging, as set forth in Parts 200, 211, 314, and 800 of Volume 21 of the Code of Federal Regulations, as amended, but is not in compliance therewith. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  55. 111470.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3. Misbranded Drugs or Devices [111330 - 111510] ( Article 3 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    Certain listed drugs or devices for human use may be sold only under a prescription, and a refill cannot be made without a new practitioner order if the prescription does not state refill counts.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3. Misbranded Drugs or Devices [111330 - 111510] ( Article 3 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111470. The following drugs or devices, that are intended for use by man, shall be sold only upon a written prescription of a practitioner licensed by law to prescribe the drug or device, or upon an oral prescription of the licensee that is reduced promptly to writing and filed by the pharmacist, or by refilling the written or oral prescription if the refilling is authorized by the prescriber either in the original prescription or by oral order that is reduced promptly to writing and filed by the pharmacist: (a) A habit forming drug to which Section 111350 applies. (b) A drug or device that, because of its toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use, is not safe for use except under the supervision of a practitioner licensed by law to administer the drug or device. (c) A drug or device for which adequate directions cannot be written for persons, who are not practitioners licensed by law to prescribe the drug or device, for safe and effective self-medication or treatment by those persons, who are not practitioners licensed by law to prescribe the drug or device. (d) A drug or device that is limited by an effective application under Section 505 of the federal act (21 U.S.C. Sec. 355) or Section 111550 to use under the professional supervision of a practitioner licensed by law to administer the drug or device. If any prescription for the drug does not indicate the number of times it may be refilled, if any, the prescription may not be refilled unless the pharmacist obtains a new order from the practitioner. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  56. 111475.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3. Misbranded Drugs or Devices [111330 - 111510] ( Article 3 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    Selling a drug or device contrary to Section 111470 is treated as misbranding while it is held for sale.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3. Misbranded Drugs or Devices [111330 - 111510] ( Article 3 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111475. The act of selling a drug or device contrary to Section 111470 shall be deemed to be an act that results in the drug or device being misbranded while held for sale. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  57. 111480.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3. Misbranded Drugs or Devices [111330 - 111510] ( Article 3 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    Some prescription drugs and devices are exempt from certain labeling rules if the label includes the listed information.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3. Misbranded Drugs or Devices [111330 - 111510] ( Article 3 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111480. (a) A drug or device sold by filling or refilling a written or oral prescription of a practitioner licensed to prescribe the drug or device shall be exempt from the labeling requirements of Sections 111335, 111340, 111355, 111360, 111365, 111375, 111380, 111385, 111395, 111415, and 111420, if the drug or device bears a label displaying all of the following: (1) Except when the prescriber orders otherwise, either the manufacturer’s trade name of the drug, or the generic name and the name of the manufacturer. Commonly used abbreviations may be used. Preparations containing two or more active ingredients may be identified by the manufacturer’s trade name or the commonly used name or the principal active ingredients. (2) The directions for the use of the drug or device. (3) The name of the patient(s). (4) The name of the prescriber. (5) The date of issue. (6) The name, address of the furnisher, and prescription number or other means of identifying the prescription. (7) The strength of the drug or drugs dispensed. (8) The quantity of the drug or drugs dispensed. (9) The expiration date of the effectiveness of the drug or device if the information is included on the original label of the manufacturer of the drug or device. (b) Brand name or generic mifepristone or any drug used for medication abortion sold by filling or refilling a written or oral prescription of a practitioner licensed to prescribe the drug or device shall be exempt from the labeling requirements of Sections 111335, 111340, 111355, 111360, 111365, 111375, 111380, 111385, 111395, 111415, and 111420, if the label complies with subdivision (g) of Section 4076 of the Business and Professions Code. (c) If a pharmacist dispenses a prescribed drug by means of a unit dose medication system, as defined by administrative regulation, for a patient in a skilled nursing, intermediate care or other health care facility, the requirements of subdivision (a) shall be satisfied if the unit dose medication system contains the information required pursuant to subdivision (a) or the information is otherwise readily available at the time of drug administration. (d) The exemption in subdivision (a) shall not apply to any drug or device dispensed in the course of the conduct of a business of dispensing drugs or devices pursuant to diagnosis by mail, or to a drug or device dispensed in violation of Section 111470. (Amended by Stats. 2025, Ch. 136, Sec. 18. (AB 260) Effective September 26, 2025.)
  58. 111485.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3. Misbranded Drugs or Devices [111330 - 111510] ( Article 3 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    The department may use regulation to remove certain drugs or devices from Section 111470’s requirements, or keep Section 111470 applying to them.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3. Misbranded Drugs or Devices [111330 - 111510] ( Article 3 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111485. The department may, by regulation, remove any drug or device subject to Sections 111350 and 111550 from the requirements of Section 111470, when the requirements are not necessary for the protection of the public health. Any drug removed from the prescription requirements of the federal act by regulations adopted pursuant to the federal act is removed from the requirements of Section 111470. The department may, however, by regulation, continue the applicability of Section 111470 for any drug or device, or make these sections inapplicable to any drug or device, whether or not the inclusion or exclusion of the drug or device is in accordance with the regulations adopted pursuant to the federal act. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  59. 111490.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3. Misbranded Drugs or Devices [111330 - 111510] ( Article 3 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    A drug or device can be misbranded if its label does not show the required caution statement before dispensing, or if it shows a prohibited caution statement when Section 111470 does not apply.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3. Misbranded Drugs or Devices [111330 - 111510] ( Article 3 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111490. (a) A drug or device that is subject to Section 111470 is misbranded if at any time prior to dispensing, its label fails to bear the statement “Caution: federal law prohibits dispensing without prescription,” or “Caution: state law prohibits dispensing without prescription,” or “R x only.” A drug or device to which Section 111470 does not apply is misbranded if at any time prior to dispensing its label bears the caution statement or “R x only” quoted in the preceding sentence. (b) A device that is subject to Section 111470 is misbranded if, at any time prior to dispensing, its label fails to bear the statement “Caution: federal law restricts this device to sale by or on the order of a ____ ,” the blank to be filled in with the designation of the practitioner licensed to use or order use of the device. A device to which Section 111470 does not apply is misbranded if, at any time prior to dispensing, its label bears the caution statement quoted in the preceding sentence. (Amended by Stats. 2000, Ch. 796, Sec. 12. Effective January 1, 2001.)
  60. 111495.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3. Misbranded Drugs or Devices [111330 - 111510] ( Article 3 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    This article does not remove any legal requirements that apply to drugs covered by Division 10 or applicable federal controlled-substances law.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3. Misbranded Drugs or Devices [111330 - 111510] ( Article 3 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111495. Nothing in this article shall be construed to relieve any person from any requirement prescribed by or under authority of law with respect to drugs now included or that may hereafter be included within the classification stated in Division 10 (commencing with Section 11000) or in the applicable federal law relating to controlled substances. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  61. 11150.

    ## Health and Safety Code - HSC ## DIVISION 10. UNIFORM CONTROLLED SUBSTANCES ACT [11000 - 11651] ( Division 10 repealed and added by Stats. 1972, Ch. 1407. ) ## CHAPTER 4. Prescriptions [11150 - 11209] ( Chapter 4 added by Stats. 1972, Ch. 1407. ) ## ARTICLE 1. Requirements of Prescriptions [11150 - 11180] ( Article 1 added by Stats. 1972, Ch. 1407. )

    Verify source ↗

    Only listed health professionals and certain authorized prescribers may write or issue a prescription.

    ## Health and Safety Code - HSC ## DIVISION 10. UNIFORM CONTROLLED SUBSTANCES ACT [11000 - 11651] ( Division 10 repealed and added by Stats. 1972, Ch. 1407. ) ## CHAPTER 4. Prescriptions [11150 - 11209] ( Chapter 4 added by Stats. 1972, Ch. 1407. ) ## ARTICLE 1. Requirements of Prescriptions [11150 - 11180] ( Article 1 added by Stats. 1972, Ch. 1407. ) ## 11150. No person other than a physician, dentist, podiatrist, or veterinarian, or naturopathic doctor acting pursuant to Section 3640.7 of the Business and Professions Code, or pharmacist acting within the scope of a project authorized under Article 1 (commencing with Section 128125) of Chapter 3 of Part 3 of Division 107 or within the scope of Section 4052.1, 4052.2, or 4052.6 of the Business and Professions Code, a registered nurse acting within the scope of a project authorized under Article 1 (commencing with Section 128125) of Chapter 3 of Part 3 of Division 107, a certified nurse-midwife acting within the scope of Section 2746.51 of the Business and Professions Code, a nurse practitioner acting within the scope of Section 2836.1 of the Business and Professions Code, a physician assistant acting within the scope of a project authorized under Article 1 (commencing with Section 128125) of Chapter 3 of Part 3 of Division 107 or Section 3502.1 of the Business and Professions Code, a naturopathic doctor acting within the scope of Section 3640.5 of the Business and Professions Code, or an optometrist acting within the scope of Section 3041 of the Business and Professions Code, or an out-of-state prescriber acting pursuant to Section 4005 of the Business and Professions Code shall write or issue a prescription. (Amended by Stats. 2014, Ch. 319, Sec. 5. (SB 1039) Effective January 1, 2015.)
  62. 11150.2.

    ## Health and Safety Code - HSC ## DIVISION 10. UNIFORM CONTROLLED SUBSTANCES ACT [11000 - 11651] ( Division 10 repealed and added by Stats. 1972, Ch. 1407. ) ## CHAPTER 4. Prescriptions [11150 - 11209] ( Chapter 4 added by Stats. 1972, Ch. 1407. ) ## ARTICLE 1. Requirements of Prescriptions [11150 - 11180] ( Article 1 added by Stats. 1972, Ch. 1407. )

    Verify source ↗

    This section says certain cannabinoid products may be handled under state law if federal law has moved them out of Schedule I or FDA-approved them in a way that allows prescribing or dispensing.

    ## Health and Safety Code - HSC ## DIVISION 10. UNIFORM CONTROLLED SUBSTANCES ACT [11000 - 11651] ( Division 10 repealed and added by Stats. 1972, Ch. 1407. ) ## CHAPTER 4. Prescriptions [11150 - 11209] ( Chapter 4 added by Stats. 1972, Ch. 1407. ) ## ARTICLE 1. Requirements of Prescriptions [11150 - 11180] ( Article 1 added by Stats. 1972, Ch. 1407. ) ## 11150.2. (a) Notwithstanding any other law, if cannabinoids are excluded from Schedule I of the federal Controlled Substances Act and placed on a schedule of the act other than Schedule I, or if a product composed of cannabinoids is approved by the federal Food and Drug Administration and either placed on a schedule of the act other than Schedule I, or exempted from one or more provisions of the act, so as to permit a physician, pharmacist, or other authorized healing arts licensee acting within their scope of practice, to prescribe, furnish, or dispense that product, the physician, pharmacist, or other authorized healing arts licensee who prescribes, furnishes, or dispenses that product in accordance with federal law shall be deemed to be in compliance with state law governing those acts. (b) For purposes of this chapter, upon the effective date of one of the changes in federal law described in subdivision (a), notwithstanding any other state law, a product composed of cannabinoids may be prescribed, furnished, dispensed, transferred, transported, possessed, or used in accordance with federal law and is authorized pursuant to state law. (c) This section does not apply to any product containing cannabinoids that is made or derived from industrial hemp, as defined in Section 11018.5 and regulated pursuant to that section. (Amended by Stats. 2021, Ch. 618, Sec. 4. (AB 527) Effective January 1, 2022.)
  63. 11150.3.

    ## Health and Safety Code - HSC ## DIVISION 10. UNIFORM CONTROLLED SUBSTANCES ACT [11000 - 11651] ( Division 10 repealed and added by Stats. 1972, Ch. 1407. ) ## CHAPTER 4. Prescriptions [11150 - 11209] ( Chapter 4 added by Stats. 1972, Ch. 1407. ) ## ARTICLE 1. Requirements of Prescriptions [11150 - 11180] ( Article 1 added by Stats. 1972, Ch. 1407. )

    Verify source ↗

    Certain licensed health professionals who follow federal law when prescribing, furnishing, or dispensing a covered product are treated as complying with state law.

    ## Health and Safety Code - HSC ## DIVISION 10. UNIFORM CONTROLLED SUBSTANCES ACT [11000 - 11651] ( Division 10 repealed and added by Stats. 1972, Ch. 1407. ) ## CHAPTER 4. Prescriptions [11150 - 11209] ( Chapter 4 added by Stats. 1972, Ch. 1407. ) ## ARTICLE 1. Requirements of Prescriptions [11150 - 11180] ( Article 1 added by Stats. 1972, Ch. 1407. ) ## 11150.3. (a) Notwithstanding any other law, if a substance listed in Schedule I of Section 11054 is excluded from Schedule I of the federal Controlled Substances Act and placed on a schedule of the act other than Schedule I, or if a product composed of one of these substances is approved by the federal Food and Drug Administration and either placed on a schedule of the act other than Schedule I, or exempted from one or more provisions of the act, so as to permit a physician, pharmacist, or other authorized healing arts licensee acting within their scope of practice, to prescribe, furnish, or dispense that product, the physician, pharmacist, or other authorized healing arts licensee who prescribes, furnishes, or dispenses that product in accordance with federal law shall be deemed to be in compliance with state law governing those acts. (b) For purposes of this chapter, upon the effective date of any of the changes in federal law described in subdivision (a), notwithstanding any other state law, a product composed of the excluded substance may be prescribed, furnished, dispensed, transferred, transported, possessed, or used in accordance with federal law and is authorized pursuant to state law. (c) This section does not apply to cannabis or a cannabis product, as defined in Section 26001 of the Business and Professions Code. However, cannabis or cannabis products may be authorized pursuant to Section 11150.2. (Added by Stats. 2023, Ch. 274, Sec. 1. (AB 1021) Effective January 1, 2024.)
  64. 11150.6.

    ## Health and Safety Code - HSC ## DIVISION 10. UNIFORM CONTROLLED SUBSTANCES ACT [11000 - 11651] ( Division 10 repealed and added by Stats. 1972, Ch. 1407. ) ## CHAPTER 4. Prescriptions [11150 - 11209] ( Chapter 4 added by Stats. 1972, Ch. 1407. ) ## ARTICLE 1. Requirements of Prescriptions [11150 - 11180] ( Article 1 added by Stats. 1972, Ch. 1407. )

    Verify source ↗

    Methaqualone and related forms are treated as Schedule I substances for this chapter.

    ## Health and Safety Code - HSC ## DIVISION 10. UNIFORM CONTROLLED SUBSTANCES ACT [11000 - 11651] ( Division 10 repealed and added by Stats. 1972, Ch. 1407. ) ## CHAPTER 4. Prescriptions [11150 - 11209] ( Chapter 4 added by Stats. 1972, Ch. 1407. ) ## ARTICLE 1. Requirements of Prescriptions [11150 - 11180] ( Article 1 added by Stats. 1972, Ch. 1407. ) ## 11150.6. Notwithstanding Section 11150.5 or subdivision (a) of Section 11054, methaqualone, its salts, isomers, and salts of its isomers shall be deemed to be classified in Schedule I for the purposes of this chapter. (Added by Stats. 1984, Ch. 22, Sec. 1. Effective March 1, 1984.)
  65. 111500.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3. Misbranded Drugs or Devices [111330 - 111510] ( Article 3 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    A physician, dentist, podiatrist, or veterinarian may personally provide necessary drugs to their own patient if the drugs are properly labeled, except for the prescription number.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3. Misbranded Drugs or Devices [111330 - 111510] ( Article 3 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111500. A physician, dentist, podiatrist, or veterinarian may personally furnish his or her own patient with drugs as are necessary in the treatment of the condition for which he or she attends the patient provided that the drug is properly labeled to show all the information required in Section 111480 except the prescription number. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  66. 111505.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3. Misbranded Drugs or Devices [111330 - 111510] ( Article 3 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    This section defines several terms used for Section 111510.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3. Misbranded Drugs or Devices [111330 - 111510] ( Article 3 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111505. For purposes of Section 111510, the following definitions shall apply: (a) “Distributor” means any corporation, person, or other entity, not engaged in the manufacture of a legend drug product, who distributes for resale and distribution a legend drug product under the label of the corporation, person, or entity. (b) “Legend drug” means any controlled substance subject to the Federal Controlled Substances Act (Title II, P.L. 91-513) or subject to the Uniform Controlled Substances Act, Division 10 (commencing with Section 11000), and any drug described in Section 4211 of the Business and Professions Code or Section 111470. (c) “Solid dosage forms” means capsules or tablets intended for oral administration. (d) “Code imprint” means a series of letters or numbers assigned by the manufacturer or distributor to a specific drug, or marks or monograms unique to the manufacturer, distributor, or both. The National Drug Code may be used as a code imprint. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  67. 11151.

    ## Health and Safety Code - HSC ## DIVISION 10. UNIFORM CONTROLLED SUBSTANCES ACT [11000 - 11651] ( Division 10 repealed and added by Stats. 1972, Ch. 1407. ) ## CHAPTER 4. Prescriptions [11150 - 11209] ( Chapter 4 added by Stats. 1972, Ch. 1407. ) ## ARTICLE 1. Requirements of Prescriptions [11150 - 11180] ( Article 1 added by Stats. 1972, Ch. 1407. )

    Verify source ↗

    A prescription written by an unlicensed person practicing medicine under the cited code section may be filled only at a hospital-maintained pharmacy that employs that person.

    ## Health and Safety Code - HSC ## DIVISION 10. UNIFORM CONTROLLED SUBSTANCES ACT [11000 - 11651] ( Division 10 repealed and added by Stats. 1972, Ch. 1407. ) ## CHAPTER 4. Prescriptions [11150 - 11209] ( Chapter 4 added by Stats. 1972, Ch. 1407. ) ## ARTICLE 1. Requirements of Prescriptions [11150 - 11180] ( Article 1 added by Stats. 1972, Ch. 1407. ) ## 11151. A prescription written by an unlicensed person lawfully practicing medicine pursuant to Section 2065 of the Business and Professions Code, shall be filled only at a pharmacy maintained in the hospital which employs such unlicensed person. (Amended by Stats. 1986, Ch. 248, Sec. 144.)
  68. 111510.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3. Misbranded Drugs or Devices [111330 - 111510] ( Article 3 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    Legend drugs in solid dosage form sold in California generally must be marked with a code imprint identifying the drug and the manufacturer or distributor, with reporting, disclosure, and exemption rules.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3. Misbranded Drugs or Devices [111330 - 111510] ( Article 3 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111510. (a) No legend drug in solid dosage form may be manufactured or distributed for sale in this state unless it is clearly marked or imprinted with a code imprint identifying the drug and the manufacturer or distributor of the drug. Manufacturers or distributors who only repack an already finished dosage form of a legend drug shall not have the responsibility to do the imprint. (b) On or before July 1, 1982, manufacturers or distributors of legend drugs, depending on whether the manufacturer’s or distributor’s code imprint will appear on the surface of the solid dosage form, shall provide to the department a list of their legend drugs and the intended code imprints. The department shall provide for the distribution of the information required to be submitted under this subdivision to all poison control centers in the state. Manufacturers, distributors, and the department shall provide to any licensed health care provider, upon request, lists of legend drugs and code imprints provided to the department under this section, but may charge a reasonable fee to cover copying and postage costs. Updated lists shall be provided to the department annually or as changes or revisions occur. (c) The department may grant exemptions from the requirements of this section upon application of a manufacturer or distributor indicating size or other characteristics that render the product impractical for the imprinting required by this section. (d) A legend drug that does not meet the requirements is misbranded. (e) It is the intent of the Legislature that all legend drugs having solid dosage forms be imprinted regardless of by whom they are distributed. (f) This section shall apply to all legend drugs sold in California on or after January 1, 1983. (g) Pharmacists, pharmacies, and licensed wholesalers shall only be liable for knowing and willful violations of this section, except that no liability shall accrue if the pharmacist acts pursuant to Section 4229.5 of the Business and Professions Code. (h) The provisions of subdivisions (a) to (g), inclusive, shall not apply to any of the following: (1) Drugs purchased by a pharmacy, pharmacist, or licensed wholesaler prior to January 1, 1983, and held in stock for resale. (2) Drugs that are the subject of an investigation pursuant to Section 111590 or 111595. (3) Drugs that are manufactured by or upon the order of a practitioner licensed by law to prescribe or administer drugs and that are to be used solely by the patient for whom prescribed. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  69. 111515.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 4. Experimental Use of Drugs [111515 - 111545] ( Article 4 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    This section defines “experimental drug” for this article.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 4. Experimental Use of Drugs [111515 - 111545] ( Article 4 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111515. As used in this article, “experimental drug” means any of the following: A drug intended for investigational use under Section 111595. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  70. 11152.

    ## Health and Safety Code - HSC ## DIVISION 10. UNIFORM CONTROLLED SUBSTANCES ACT [11000 - 11651] ( Division 10 repealed and added by Stats. 1972, Ch. 1407. ) ## CHAPTER 4. Prescriptions [11150 - 11209] ( Chapter 4 added by Stats. 1972, Ch. 1407. ) ## ARTICLE 1. Requirements of Prescriptions [11150 - 11180] ( Article 1 added by Stats. 1972, Ch. 1407. )

    Verify source ↗

    No person may write, issue, fill, compound, or dispense a prescription unless it conforms to this division.

    ## Health and Safety Code - HSC ## DIVISION 10. UNIFORM CONTROLLED SUBSTANCES ACT [11000 - 11651] ( Division 10 repealed and added by Stats. 1972, Ch. 1407. ) ## CHAPTER 4. Prescriptions [11150 - 11209] ( Chapter 4 added by Stats. 1972, Ch. 1407. ) ## ARTICLE 1. Requirements of Prescriptions [11150 - 11180] ( Article 1 added by Stats. 1972, Ch. 1407. ) ## 11152. No person shall write, issue, fill, compound, or dispense a prescription that does not conform to this division. (Added by Stats. 1972, Ch. 1407.)
  71. 111520.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 4. Experimental Use of Drugs [111515 - 111545] ( Article 4 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    No person may prescribe or knowingly administer an experimental drug to another person if doing so violates this article.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 4. Experimental Use of Drugs [111515 - 111545] ( Article 4 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111520. No person shall prescribe or knowingly administer an experimental drug to another person in violation of this article. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  72. 111525.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 4. Experimental Use of Drugs [111515 - 111545] ( Article 4 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    Before prescribing or administering an experimental drug, consent to its use must be obtained in the manner required by Division 20, Chapter 1.3.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 4. Experimental Use of Drugs [111515 - 111545] ( Article 4 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111525. Prior to prescribing or administering an experimental drug, consent to the use of the drug shall be obtained in the method and manner specified in Chapter 1.3 (commencing with Section 24170) of Division 20. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  73. 11153.

    ## Health and Safety Code - HSC ## DIVISION 10. UNIFORM CONTROLLED SUBSTANCES ACT [11000 - 11651] ( Division 10 repealed and added by Stats. 1972, Ch. 1407. ) ## CHAPTER 4. Prescriptions [11150 - 11209] ( Chapter 4 added by Stats. 1972, Ch. 1407. ) ## ARTICLE 1. Requirements of Prescriptions [11150 - 11180] ( Article 1 added by Stats. 1972, Ch. 1407. )

    Verify source ↗

    Controlled-substance prescriptions may be issued only for a legitimate medical purpose by a practitioner acting in the usual course of professional practice.

    ## Health and Safety Code - HSC ## DIVISION 10. UNIFORM CONTROLLED SUBSTANCES ACT [11000 - 11651] ( Division 10 repealed and added by Stats. 1972, Ch. 1407. ) ## CHAPTER 4. Prescriptions [11150 - 11209] ( Chapter 4 added by Stats. 1972, Ch. 1407. ) ## ARTICLE 1. Requirements of Prescriptions [11150 - 11180] ( Article 1 added by Stats. 1972, Ch. 1407. ) ## 11153. (a) A prescription for a controlled substance shall only be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of their professional practice. The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription. Except as authorized by this division, the following are not legal prescriptions: (1) an order purporting to be a prescription which is issued not in the usual course of professional treatment or in legitimate and authorized research; or (2) an order for a person with substance use disorder or habitual user of controlled substances, which is issued not in the course of professional treatment or as part of an authorized narcotic treatment program, for the purpose of providing the user with controlled substances, sufficient to keep them comfortable by maintaining customary use. (b) Any person who knowingly violates this section shall be punished by imprisonment pursuant to subdivision (h) of Section 1170 of the Penal Code, or in a county jail not exceeding one year, or by a fine not exceeding twenty thousand dollars ($20,000), or by both that fine and imprisonment. (c) No provision of the amendments to this section enacted during the second year of the 1981–82 Regular Session shall be construed as expanding the scope of practice of a pharmacist. (Amended by Stats. 2023, Ch. 21, Sec. 4. (AB 1130) Effective January 1, 2024.)
  74. 11153.5.

    ## Health and Safety Code - HSC ## DIVISION 10. UNIFORM CONTROLLED SUBSTANCES ACT [11000 - 11651] ( Division 10 repealed and added by Stats. 1972, Ch. 1407. ) ## CHAPTER 4. Prescriptions [11150 - 11209] ( Chapter 4 added by Stats. 1972, Ch. 1407. ) ## ARTICLE 1. Requirements of Prescriptions [11150 - 11180] ( Article 1 added by Stats. 1972, Ch. 1407. )

    Verify source ↗

    Wholesalers, manufacturers, and their agents or employees must not furnish controlled substances for non-legitimate medical purposes.

    ## Health and Safety Code - HSC ## DIVISION 10. UNIFORM CONTROLLED SUBSTANCES ACT [11000 - 11651] ( Division 10 repealed and added by Stats. 1972, Ch. 1407. ) ## CHAPTER 4. Prescriptions [11150 - 11209] ( Chapter 4 added by Stats. 1972, Ch. 1407. ) ## ARTICLE 1. Requirements of Prescriptions [11150 - 11180] ( Article 1 added by Stats. 1972, Ch. 1407. ) ## 11153.5. (a) No wholesaler or manufacturer, or agent or employee of a wholesaler or manufacturer, shall furnish controlled substances for other than legitimate medical purposes. (b) Anyone who violates this section knowing, or having a conscious disregard for the fact, that the controlled substances are for other than a legitimate medical purpose shall be punishable by imprisonment pursuant to subdivision (h) of Section 1170 of the Penal Code, or in a county jail not exceeding one year, or by a fine not exceeding twenty thousand dollars ($20,000), or by both that fine and imprisonment. (c) Factors to be considered in determining whether a wholesaler or manufacturer, or agent or employee of a wholesaler or manufacturer, furnished controlled substances knowing or having a conscious disregard for the fact that the controlled substances are for other than legitimate medical purposes shall include, but not be limited to, whether the use of controlled substances was for purposes of increasing athletic ability or performance, 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 the product. (Amended by Stats. 2011, Ch. 15, Sec. 149. (AB 109) Effective April 4, 2011. Operative October 1, 2011, by Sec. 636 of Ch. 15, as amended by Stats. 2011, Ch. 39, Sec. 68.)
  75. 111530.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 4. Experimental Use of Drugs [111515 - 111545] ( Article 4 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    For a minor, consent must come from a parent or guardian, and the minor must also consent if age 7 or older.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 4. Experimental Use of Drugs [111515 - 111545] ( Article 4 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111530. (a) Notwithstanding the provisions of Section 24175, if the subject is a minor, consent shall be provided by a parent or guardian of the subject and shall also be provided by the subject if the subject is seven years of age or older. (b) Consent given pursuant to this section shall only be for the prescribing or administering of an experimental drug that is related to maintaining or improving the health of the subject or related to obtaining information about a pathological condition of the subject. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  76. 111535.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 4. Experimental Use of Drugs [111515 - 111545] ( Article 4 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    A person who gave consent under Section 111525 may revoke that consent at any time by telling the supervising practitioner verbally or in writing.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 4. Experimental Use of Drugs [111515 - 111545] ( Article 4 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111535. Consent given pursuant to Section 111525 may be revoked at any time by either verbal or written communication to the practitioner supervising the administration of the experimental drug. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  77. 11154.

    ## Health and Safety Code - HSC ## DIVISION 10. UNIFORM CONTROLLED SUBSTANCES ACT [11000 - 11651] ( Division 10 repealed and added by Stats. 1972, Ch. 1407. ) ## CHAPTER 4. Prescriptions [11150 - 11209] ( Chapter 4 added by Stats. 1972, Ch. 1407. ) ## ARTICLE 1. Requirements of Prescriptions [11150 - 11180] ( Article 1 added by Stats. 1972, Ch. 1407. )

    Verify source ↗

    A person may not knowingly prescribe, administer, dispense, or furnish a controlled substance outside the regular practice of their profession, or help a practitioner do so unlawfully.

    ## Health and Safety Code - HSC ## DIVISION 10. UNIFORM CONTROLLED SUBSTANCES ACT [11000 - 11651] ( Division 10 repealed and added by Stats. 1972, Ch. 1407. ) ## CHAPTER 4. Prescriptions [11150 - 11209] ( Chapter 4 added by Stats. 1972, Ch. 1407. ) ## ARTICLE 1. Requirements of Prescriptions [11150 - 11180] ( Article 1 added by Stats. 1972, Ch. 1407. ) ## 11154. (a) Except in the regular practice of his or her profession, no person shall knowingly prescribe, administer, dispense, or furnish a controlled substance to or for any person or animal which is not under his or her treatment for a pathology or condition other than addiction to a controlled substance, except as provided in this division. (b) No person shall knowingly solicit, direct, induce, aid, or encourage a practitioner authorized to write a prescription to unlawfully prescribe, administer, dispense, or furnish a controlled substance. (Amended by Stats. 1982, Ch. 1403, Sec. 1.)
  78. 111540.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 4. Experimental Use of Drugs [111515 - 111545] ( Article 4 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    Before an experimental drug is given, the experiment must be reviewed and approved by an acceptable human subjects committee, and a copy of the approved consent procedures must be filed with the department before the experiment starts.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 4. Experimental Use of Drugs [111515 - 111545] ( Article 4 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111540. Prior to administering an experimental drug, the experimental activity as a whole, including the consent procedures required by Section 111525, shall be reviewed and approved by a committee for the protection of human subjects that is acceptable, as determined by the department. A committee for the protection of human subjects that operates under a general or special assurance approved by the federal Department of Health, Education, and Welfare pursuant to Part 46 of Title 45 of the Code of Federal Regulations shall be an acceptable committee for purposes of this section. A copy of the consent procedures approved by a committee for the protection of human subjects shall be filed with the department prior to the commencement of the experiment. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  79. 111545.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 4. Experimental Use of Drugs [111515 - 111545] ( Article 4 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    A person with an ownership interest in a skilled nursing facility or intermediate care facility may not prescribe an experimental drug to a patient in that facility.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 4. Experimental Use of Drugs [111515 - 111545] ( Article 4 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111545. A person having an ownership interest in a skilled nursing facility or intermediate care facility, as those terms are defined in Section 1250, may not prescribe an experimental drug for a patient in the facility. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  80. 111548.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 4.5. Right to Try Act [111548 - 111548.5] ( Article 4.5 added by Stats. 2016, Ch. 684, Sec. 1. )

    Verify source ↗

    This section names the article the Right to Try Act and says it may be cited by that name.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 4.5. Right to Try Act [111548 - 111548.5] ( Article 4.5 added by Stats. 2016, Ch. 684, Sec. 1. ) ## 111548. This article shall be known and may be cited as the Right to Try Act. (Added by Stats. 2016, Ch. 684, Sec. 1. (AB 1668) Effective January 1, 2017.)
  81. 111548.1.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 4.5. Right to Try Act [111548 - 111548.5] ( Article 4.5 added by Stats. 2016, Ch. 684, Sec. 1. )

    Verify source ↗

    This section defines key terms used in the Right to Try Act, including who counts as a consulting physician, eligible patient, primary physician, state regulatory board, and what counts as written informed consent.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 4.5. Right to Try Act [111548 - 111548.5] ( Article 4.5 added by Stats. 2016, Ch. 684, Sec. 1. ) ## 111548.1. For purposes of this article, unless the context otherwise requires, the following definitions shall apply: (a) “Consulting physician” means a physician and surgeon licensed under the Medical Practice Act or an osteopathic physician and surgeon licensed under the Osteopathic Act who performs all of the following: (1) Examines the qualified individual and his or her relevant medical records. (2) Confirms, in writing, the primary physician’s diagnosis and prognosis. (3) Verifies, in the opinion of the consulting physician, that the eligible patient is competent, acting voluntarily, and has made an informed decision. (b) “Eligible patient” means a person who meets all of the following conditions: (1) Has an immediately life-threatening disease or condition. (2) Has considered all other treatment options currently approved by the United States Food and Drug Administration. (3) Has not been accepted to participate in the nearest clinical trial to his or her home for the immediately life-threatening disease or condition identified in paragraph (1) within one week of completion of the clinical trial application process, or, in the treating physician’s medical judgment, it is unreasonable for the patient to participate in that clinical trial due to the patient’s current condition and stage of disease. (4) Has received a recommendation from his or her primary physician and a consulting physician for an investigational drug, biological product, or device. (5) Has given written informed consent for the use of the investigational drug, biological product, or device, or, if he or she lacks the capacity to consent, his or her legally authorized representative has given written informed consent on his or her behalf. (6) Has documentation from his or her primary physician and a consulting physician attesting that the patient has met the requirements of this subdivision. (c) “Health benefit plan” means a plan or program that provides, arranges, pays for, or reimburses the cost of health benefits. “Health benefit plan” includes, but is not limited to, a health care service plan contract issued by a health care service plan, as defined in Section 1345, and a policy of health insurance, as defined in Section 106 of the Insurance Code, issued by a health insurer. (d) “Immediately life-threatening disease or condition” means a stage of disease in which there is a reasonable likelihood that death will occur within a matter of months. (e) “Investigational drug, biological product, or device” means a drug, biological product, or device that has successfully completed phase one of a clinical trial approved by the United States Food and Drug Administration, but has not been approved for general use by the United States Food and Drug Administration and remains under investigation in a clinical trial approved by the United States Food and Drug Administration. (f) “Primary physician” means a physician and surgeon licensed under the Medical Practice Act or an osteopathic physician and surgeon licensed under the Osteopathic Act. (g) “State regulatory board” means the Medical Board of California or the Osteopathic Medical Board of California. (h) (1) “Written, informed consent” means a written document that has been approved by the primary physician’s institutional review board or an accredited independent institutional review board, is signed by an eligible patient, or his or her legally authorized representative when the patient lacks the capacity to consent, and attested to by the patient’s primary physician and a witness that, at a minimum, does all of the following: (A) Explains the currently approved products and treatments for the immediately life-threatening disease or condition from which the patient suffers. (B) Attests to the fact that the patient, or when the patient lacks the capacity to consent his or her legally authorized representative, concurs with the patient’s primary physician in believing that all currently approved and conventionally recognized treatments are unlikely to prolong the patient’s life. (C) Clearly identifies the specific proposed investigational drug, biological product, or device that the patient is seeking to use. (D) Describes the potentially best and worst outcomes of using the investigational drug, biological product, or device and describes the most likely outcome. This description shall include the possibility that new, unanticipated, different, or worse symptoms might result and that death could be hastened by the proposed treatment. The description shall be based on the primary physician’s knowledge of the proposed treatment in conjunction with an awareness of the patient’s condition. (E) Clearly states that the patient’s health benefit plan, if any, and health care provider are not obligated to pay for the investigational drug, biological product, or device or any care or treatments consequent to use of the investigational drug, biological product, or device. (F) Clearly states that the patient’s eligibility for hospice care may be withdrawn if the patient begins curative treatment and that care may be reinstated if the curative treatment ends and the patient meets hospice eligibility requirements. (G) Clearly states that in-home health care may be denied if treatment begins. (H) States that the patient understands that he or she is liable for all expenses consequent to the use of the investigational drug, biological product, or device, and that this liability extends to the patient’s estate, except as otherwise provided in the patient’s health benefit plan or a contract between the patient and the manufacturer of the drug, biological product, or device. (2) Written, informed consent for purposes of this article shall be consistent with the informed consent requirements of the Protection of Human Subjects in Medical Experimentation Act (Chapter 1.3 (commencing with Section 24170) of Division 20). (Added by Stats. 2016, Ch. 684, Sec. 1. (AB 1668) Effective January 1, 2017.)
  82. 111548.2.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 4.5. Right to Try Act [111548 - 111548.5] ( Article 4.5 added by Stats. 2016, Ch. 684, Sec. 1. )

    Verify source ↗

    Manufacturers may make investigational drugs, biological products, or devices available to eligible patients, but the article does not require it and limits coverage obligations.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 4.5. Right to Try Act [111548 - 111548.5] ( Article 4.5 added by Stats. 2016, Ch. 684, Sec. 1. ) ## 111548.2. (a) Notwithstanding Section 110280, 111520, or 111550, a manufacturer of an investigational drug, biological product, or device may make available the manufacturer’s investigational drug, biological product, or device to an eligible patient pursuant to this article. This article does not require that a manufacturer make available an investigational drug, biological product, or device to an eligible patient. (b) A manufacturer may do both of the following: (1) Provide an investigational drug, biological product, or device to an eligible patient without receiving compensation. (2) Require an eligible patient to pay the costs of, or associated with, the manufacture of the investigational drug, biological product, or device. (c) (1) This article does not expand the coverage provided under Sections 1370.4 and 1370.6 of this code, Sections 10145.3 and 10145.4 of the Insurance Code, or Sections 14087.11 and 14132.98 of the Welfare and Institutions Code. (2) This article does not require a health benefit plan to provide coverage for the cost of any investigational drug, biological product, or device, or the costs of services related to the use of an investigational drug, biological product, or device under this article. A health benefit plan may provide coverage for an investigational drug, biological product, or device made available pursuant to this section. (d) If the clinical trial for an investigational drug, biological product, or device is closed due to the lack of efficacy or for toxicity, the investigational drug, biological product, or device shall not be offered. If notice of closure of a clinical trial is given for an investigational drug, biological product, or device taken by a patient outside of a clinical trial, the manufacturer and the patient’s primary physician shall notify the patient of the information from the safety committee of the clinical trial. (e) If an eligible patient dies while being treated by an investigational drug, biological product, or device made available pursuant to this article, the patient’s heirs and health benefit plan, except to the extent the plan provided coverage pursuant to paragraph (2) of subdivision (c), are not liable for any outstanding debt related to the treatment or lack of insurance for the treatment. (Added by Stats. 2016, Ch. 684, Sec. 1. (AB 1668) Effective January 1, 2017.)
  83. 111548.3.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 4.5. Right to Try Act [111548 - 111548.5] ( Article 4.5 added by Stats. 2016, Ch. 684, Sec. 1. )

    Verify source ↗

    A state regulatory board may not discipline a physician’s license for qualifying investigational-drug recommendations or treatment, and certain review boards must report related treatment information twice a year.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 4.5. Right to Try Act [111548 - 111548.5] ( Article 4.5 added by Stats. 2016, Ch. 684, Sec. 1. ) ## 111548.3. (a) Notwithstanding any other law, a state regulatory board shall not revoke, fail to renew, or take any other disciplinary action against a physician’s license based on the physician’s recommendation to an eligible patient regarding, or prescription for or treatment with, an investigational drug, biological product, or device if the recommendation or prescription is consistent with protocol approved by the physician’s institutional review board or an accredited independent institutional review board. (b) The physician’s institutional review board or an accredited institutional review board shall biannually report the following information to the State Department of Public Health, the Medical Board of California, and the Osteopathic Medical Board of California: (1) The number of requests made for an investigational drug, biological product, or device. (2) The status of the requests made. (3) The duration of the treatment. (4) The costs of the treatment paid by eligible patients. (5) The success or failure of the investigational drug, biological product, or device in treating the immediately life-threatening disease or condition from which the patient suffers. (6) Any adverse event for each investigational drug, biological product, or device. (c) A state agency shall not alter any recommendation made to the federal Centers for Medicare and Medicaid Services regarding a health care provider’s certification to participate in the Medicare or Medicaid program based solely on the recommendation from an individual health care provider that a patient have access to an investigational drug, biological product, or device. (d) A violation of this section shall not be subject to Chapter 8 (commencing with Section 111825). (Added by Stats. 2016, Ch. 684, Sec. 1. (AB 1668) Effective January 1, 2017.)
  84. 111548.5.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 4.5. Right to Try Act [111548 - 111548.5] ( Article 4.5 added by Stats. 2016, Ch. 684, Sec. 1. )

    Verify source ↗

    This section says the article does not create a private lawsuit right, and actions under it cannot be used as the basis for certain claims against listed drug, biological product, or device-related parties if they complied with the article, except where reasonable care was not exercised.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 4.5. Right to Try Act [111548 - 111548.5] ( Article 4.5 added by Stats. 2016, Ch. 684, Sec. 1. ) ## 111548.5. This article does not create a private cause of action, and actions taken pursuant to this article shall not serve as a basis for a civil, criminal, or disciplinary claim or cause of action, including, but not limited to, product liability, medical negligence, or wrongful death, against a manufacturer of an investigational drug, biological product, or device, or against any other person or entity involved in the care of an eligible patient for harm done to the eligible patient or his or her heirs resulting from the investigational drug, biological product, or device, or the use or nonuse thereof, if the manufacturer or other person or entity has complied with the terms of this article in relation to the eligible patient, unless there was a failure to exercise reasonable care. (Added by Stats. 2016, Ch. 684, Sec. 1. (AB 1668) Effective January 1, 2017.)
  85. 11155.

    ## Health and Safety Code - HSC ## DIVISION 10. UNIFORM CONTROLLED SUBSTANCES ACT [11000 - 11651] ( Division 10 repealed and added by Stats. 1972, Ch. 1407. ) ## CHAPTER 4. Prescriptions [11150 - 11209] ( Chapter 4 added by Stats. 1972, Ch. 1407. ) ## ARTICLE 1. Requirements of Prescriptions [11150 - 11180] ( Article 1 added by Stats. 1972, Ch. 1407. )

    Verify source ↗

    A physician whose controlled substance privileges have been taken away or voluntarily surrendered must not possess, administer, dispense, or prescribe controlled substances unless the privileges are restored and current federal registration is obtained.

    ## Health and Safety Code - HSC ## DIVISION 10. UNIFORM CONTROLLED SUBSTANCES ACT [11000 - 11651] ( Division 10 repealed and added by Stats. 1972, Ch. 1407. ) ## CHAPTER 4. Prescriptions [11150 - 11209] ( Chapter 4 added by Stats. 1972, Ch. 1407. ) ## ARTICLE 1. Requirements of Prescriptions [11150 - 11180] ( Article 1 added by Stats. 1972, Ch. 1407. ) ## 11155. Any physician, who by court order or order of any state or governmental agency, or who voluntarily surrenders his controlled substance privileges, shall not possess, administer, dispense, or prescribe a controlled substance unless and until such privileges have been restored, and he has obtained current registration from the appropriate federal agency as provided by law. (Added by Stats. 1972, Ch. 1407.)
  86. 111550.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 5. New Drugs or Devices [111550 - 111610] ( Article 5 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    A person may not sell, deliver, or give away a new drug or new device unless it meets one of the listed approval or exemption paths. Applicants to the department must also submit specified safety, composition, manufacturing, samples, and labeling information.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 5. New Drugs or Devices [111550 - 111610] ( Article 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111550. No person shall sell, deliver, or give away any new drug or new device unless it satisfies either of the following: (a) It is one of the following: (1) A new drug, and a new drug application has been approved for it and that approval has not been withdrawn, terminated, or suspended under Section 505 of the federal act (21 U.S.C. Sec. 355). (2) A new biologic product for which a license has been issued as required by the federal Public Health Service Act (42 U.S.C. Sec. 262). (3) A device that is reported under Section 510(k) of the federal act (21 U.S.C. Sec. 360(k)), or is a device exempted pursuant to subsection (l) or (m) of Section 360 of Title 21 of the United States Code, or it is a new device for which a premarket approval application has been approved, and that approval has not been withdrawn, terminated, or suspended under Section 515 of the federal act (21 U.S.C. Sec. 360e). (b) The department has approved a new drug or device application for that new drug or new device and that approval has not been withdrawn, terminated, or suspended. Any person who files a new drug or device application with the department shall submit, as part of the application, all of the following information: (1) Full reports of investigations that have been made to show whether or not the new drug or device is safe for use and whether the new drug or device is effective in use under the conditions prescribed, recommended, or suggested in the labeling or advertising of the new drug or device. (2) A full list of the articles used as components of the new drug or device. (3) A full statement of the composition of the new drug or device. (4) A full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of the new drug, or in the case of a new device, a full statement of its composition, properties, and construction, and the principles of its operation. (5) Samples of the new drug or device and of the articles used as components of the drug or device as the department may require. (6) Specimens of the labeling and advertisements proposed to be used for the new drug or device. (Amended by Stats. 2012, Ch. 688, Sec. 1. (AB 1277) Effective January 1, 2013.)
  87. 111555.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 5. New Drugs or Devices [111550 - 111610] ( Article 5 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    The department must act on a new-drug-or-device application within 180 days, unless the department and applicant agree to more time.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 5. New Drugs or Devices [111550 - 111610] ( Article 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111555. Within 180 days after the filing of an application provided for in Section 111550, or an additional period as shall be agreed upon by the department and the applicant, the department shall do either of the following: (a) Approve the application, if it finds that none of the grounds for denying approval specified in Section 111550 apply. (b) Give the applicant written notice for an opportunity for a hearing before the department on the question of whether the application is approvable. If the applicant elects to accept the opportunity for hearing by written request within 30 days after the notice, the hearing shall commence not more than 90 days after the expiration of the 30 days unless the department and the applicant otherwise agree. Any such hearing shall thereafter be conducted on an expedited basis and the department’s order thereon shall be issued within 90 days after the date fixed by the department for filing final briefs. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  88. 11156.

    ## Health and Safety Code - HSC ## DIVISION 10. UNIFORM CONTROLLED SUBSTANCES ACT [11000 - 11651] ( Division 10 repealed and added by Stats. 1972, Ch. 1407. ) ## CHAPTER 4. Prescriptions [11150 - 11209] ( Chapter 4 added by Stats. 1972, Ch. 1407. ) ## ARTICLE 1. Requirements of Prescriptions [11150 - 11180] ( Article 1 added by Stats. 1972, Ch. 1407. )

    Verify source ↗

    Generally, no person may prescribe, administer, or dispense a controlled substance to a person with substance use disorder, except as allowed by Section 2241 or this division.

    ## Health and Safety Code - HSC ## DIVISION 10. UNIFORM CONTROLLED SUBSTANCES ACT [11000 - 11651] ( Division 10 repealed and added by Stats. 1972, Ch. 1407. ) ## CHAPTER 4. Prescriptions [11150 - 11209] ( Chapter 4 added by Stats. 1972, Ch. 1407. ) ## ARTICLE 1. Requirements of Prescriptions [11150 - 11180] ( Article 1 added by Stats. 1972, Ch. 1407. ) ## 11156. (a) Except as provided in Section 2241 of the Business and Professions Code, no person shall prescribe for, or administer, or dispense a controlled substance to, a person with substance use disorder, or to any person representing themselves as such, except as permitted by this division. (b) (1) For purposes of this section, “person with substance use disorder” means a person whose actions are characterized by craving in combination with one or more of the following: (A) Impaired control over drug use. (B) Compulsive use. (C) Continued use despite harm. (2) Notwithstanding paragraph (1), a person whose drug-seeking behavior is primarily due to the inadequate control of pain is not a person with substance use disorder within the meaning of this section. (Amended by Stats. 2023, Ch. 21, Sec. 5. (AB 1130) Effective January 1, 2024.)
  89. 111560.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 5. New Drugs or Devices [111550 - 111610] ( Article 5 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    The department must refuse to approve a new drug or device application if, after notice and a hearing, it makes one of the listed findings.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 5. New Drugs or Devices [111550 - 111610] ( Article 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111560. The department shall issue an order refusing to approve an application if, after written notice to the applicant and after giving him or her an opportunity for a hearing, the department makes any of the following findings: (a) That the reports of investigation, that are required to be submitted to the department pursuant to Section 111550, do not include adequate tests by all methods reasonably applicable to show whether or not the new drug or device is safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling and advertisement of the new drug or device. (b) That the results of the tests submitted pursuant to Section 111550 to show whether or not the new drug or device is safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling and advertisement of the new drug or device show that the drug or device is unsafe for use under these conditions or do not show that the new drug or device is safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling and advertisement. (c) That the methods, facilities, and controls used in the manufacture, processing, or packing of the new drug or device are inadequate to preserve its identity, strength, quality, purity, composition, or other characteristics. (d) That upon the basis of information submitted as part of the application, or upon the basis of any other information before it with respect to the new drug or device, that the department has insufficient information to determine whether the drug or device is safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling and advertisement. (e) That evaluated on the basis of the information submitted as part of the application and any other information before it with respect to the new drug or device, that there is a lack of substantial evidence that the new drug or device will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the proposed labeling or advertisement of the new drug or device. (f) That based on an evaluation by the department of all material facts, that the proposed labeling or advertising of the new drug or device is false or misleading in any particular. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  90. 111565.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 5. New Drugs or Devices [111550 - 111610] ( Article 5 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    The department must revoke a Section 111560 order refusing approval of a new drug or new device application when the facts justify doing so.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 5. New Drugs or Devices [111550 - 111610] ( Article 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111565. An order pursuant to Section 111560 refusing approval of a new drug application or a new device application shall be revoked whenever the department finds that the facts justify the action. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  91. 11157.

    ## Health and Safety Code - HSC ## DIVISION 10. UNIFORM CONTROLLED SUBSTANCES ACT [11000 - 11651] ( Division 10 repealed and added by Stats. 1972, Ch. 1407. ) ## CHAPTER 4. Prescriptions [11150 - 11209] ( Chapter 4 added by Stats. 1972, Ch. 1407. ) ## ARTICLE 1. Requirements of Prescriptions [11150 - 11180] ( Article 1 added by Stats. 1972, Ch. 1407. )

    Verify source ↗

    No person may issue a prescription that is false or fictitious in any respect.

    ## Health and Safety Code - HSC ## DIVISION 10. UNIFORM CONTROLLED SUBSTANCES ACT [11000 - 11651] ( Division 10 repealed and added by Stats. 1972, Ch. 1407. ) ## CHAPTER 4. Prescriptions [11150 - 11209] ( Chapter 4 added by Stats. 1972, Ch. 1407. ) ## ARTICLE 1. Requirements of Prescriptions [11150 - 11180] ( Article 1 added by Stats. 1972, Ch. 1407. ) ## 11157. No person shall issue a prescription that is false or fictitious in any respect. (Added by Stats. 1972, Ch. 1407.)
  92. 111570.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 5. New Drugs or Devices [111550 - 111610] ( Article 5 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    If a new drug or device has an approved application, the applicant must keep records, make reports to the department, and allow record access when requested by an authorized department agent.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 5. New Drugs or Devices [111550 - 111610] ( Article 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111570. In the case of any new drug or device for which an approval of an application filed pursuant to Section 111550 is in effect, the applicant shall establish and maintain records, and make reports to the department, of data relating to clinical experience and other data or information, received or otherwise obtained by the applicant with respect to the new drug or device, as the department may by general regulation, or by order with respect to the application, prescribe. Any regulation or order issued pursuant to this section or pursuant to Section 111595 shall have due regard for the professional ethics of the medical profession and the interest of patients and shall provide, where the department determines that it is reasonably necessary, for the examination upon request, by the persons to whom the regulation or order is applicable, of similar information received or otherwise obtained by the department. Every person required pursuant to this section to maintain records, and every person in charge or in custody of the records, shall, upon request of an authorized agent of the department, permit the agent at all reasonable time to have access to, and copy and verify, the records. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  93. 111575.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 5. New Drugs or Devices [111550 - 111610] ( Article 5 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    The department must withdraw approval of a new drug or device application if, after notice and a hearing, it makes one of the listed findings.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 5. New Drugs or Devices [111550 - 111610] ( Article 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111575. The department shall issue an order withdrawing approval of an application concerning any new drug or device if, after giving written notice to the applicant and an opportunity for a hearing, the department makes any of the following findings: (a) That clinical or other experience, tests, or other scientific data show that the new drug or device is unsafe for use under the conditions of use upon the basis of which the application was approved. (b) That new evidence of clinical experience, not contained in the application or not available to the department until after the application was approved, or tests by new methods, or tests by methods not deemed reasonably applicable when the application was approved, evaluated together with the evidence available to the department when the application was approved, shows that the new drug or device is not shown to be safe for use under the conditions of use upon the basis of which the application was approved. (c) On the basis of new information with respect to the new drug or device, evaluated together with the evidence available to the department when the application was approved, that there is a lack of substantial evidence that the new drug or device will have the effect it purports or is represented to have, under the conditions of use prescribed, recommended, or suggested in the labeling or advertising of the new drug or device. (d) That the application contains any untrue statement of a material fact. (e) That the applicant has failed to establish a system for maintaining required records, or has repeatedly or deliberately failed to maintain the records or to make required reports, or the applicant has refused to permit access to, or copying or verification of, the records. (f) That on the basis of new information before the department, evaluated together with the evidence before it when the application was approved, the methods used in, or the facilities and controls used for, the manufacture, processing, and packing of the new drug or device are inadequate to assure and preserve its identity, strength, quality, purity, composition, and characteristics as determined by qualified experts selected by the department, and were not made adequate within a reasonable time after receipt of written notice from the department specifying the matter complained of. (g) That on the basis of new information before it, evaluated together with the evidence before it when the application was approved, the labeling or advertisement of the new drug or device, based on an evaluation of all material facts, is false or misleading in any particular and is not corrected within a reasonable time after receipt of written notice from the department specifying the matter complained of. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  94. 11158.

    ## Health and Safety Code - HSC ## DIVISION 10. UNIFORM CONTROLLED SUBSTANCES ACT [11000 - 11651] ( Division 10 repealed and added by Stats. 1972, Ch. 1407. ) ## CHAPTER 4. Prescriptions [11150 - 11209] ( Chapter 4 added by Stats. 1972, Ch. 1407. ) ## ARTICLE 1. Requirements of Prescriptions [11150 - 11180] ( Article 1 added by Stats. 1972, Ch. 1407. )

    Verify source ↗

    Certain controlled substances may not be dispensed without a qualifying prescription, but practitioners specified in Section 11150 may dispense Schedule II drugs in limited cases and may administer controlled substances in regular practice unless other law prohibits it.

    ## Health and Safety Code - HSC ## DIVISION 10. UNIFORM CONTROLLED SUBSTANCES ACT [11000 - 11651] ( Division 10 repealed and added by Stats. 1972, Ch. 1407. ) ## CHAPTER 4. Prescriptions [11150 - 11209] ( Chapter 4 added by Stats. 1972, Ch. 1407. ) ## ARTICLE 1. Requirements of Prescriptions [11150 - 11180] ( Article 1 added by Stats. 1972, Ch. 1407. ) ## 11158. (a) Except as provided in Section 11159 or in subdivision (b) of this section, no controlled substance classified in Schedule II shall be dispensed without a prescription meeting the requirements of this chapter. Except as provided in Section 11159 or when dispensed directly to an ultimate user by a practitioner, other than a pharmacist or pharmacy, no controlled substance classified in Schedule III, IV, or V may be dispensed without a prescription meeting the requirements of this chapter. (b) A practitioner specified in Section 11150 may dispense a controlled substance classified in Schedule II, which may be from a hospital pharmacy inventory, directly to an ultimate user in either of the following circumstances: (1) In an amount not to exceed a 72-hour supply for the patient in accordance with directions for use given by the dispensing practitioner only where the patient is not expected to require any additional amount of the controlled substance beyond the 72 hours. (2) For the purpose of initiating maintenance treatment or detoxification treatment, or both, for a person with an opioid use disorder. Not more than a three-day supply of such medication may be dispensed to the person at one time while arrangements are being made for referral for treatment. Such emergency treatment may not be renewed or extended. (c) Except as otherwise prohibited or limited by law, a practitioner specified in Section 11150, may administer controlled substances in the regular practice of their profession. (Amended by Stats. 2024, Ch. 634, Sec. 2. (AB 2115) Effective September 27, 2024.)
  95. 11158.1.

    ## Health and Safety Code - HSC ## DIVISION 10. UNIFORM CONTROLLED SUBSTANCES ACT [11000 - 11651] ( Division 10 repealed and added by Stats. 1972, Ch. 1407. ) ## CHAPTER 4. Prescriptions [11150 - 11209] ( Chapter 4 added by Stats. 1972, Ch. 1407. ) ## ARTICLE 1. Requirements of Prescriptions [11150 - 11180] ( Article 1 added by Stats. 1972, Ch. 1407. )

    Verify source ↗

    A prescriber must discuss specified opioid risks with the patient before the first opioid prescription in a treatment course, unless an exception applies.

    ## Health and Safety Code - HSC ## DIVISION 10. UNIFORM CONTROLLED SUBSTANCES ACT [11000 - 11651] ( Division 10 repealed and added by Stats. 1972, Ch. 1407. ) ## CHAPTER 4. Prescriptions [11150 - 11209] ( Chapter 4 added by Stats. 1972, Ch. 1407. ) ## ARTICLE 1. Requirements of Prescriptions [11150 - 11180] ( Article 1 added by Stats. 1972, Ch. 1407. ) ## 11158.1. (a) Except when a patient is being treated as set forth in Sections 11159, 11159.2, and 11167.5, and Article 2 (commencing with Section 11215) of Chapter 5, pertaining to the treatment of persons with substance use disorder, except when a patient is currently receiving hospice care, a prescriber shall discuss all of the following information with the patient, or if the patient is a minor, the minor, the minor’s parent or guardian, or another adult authorized to consent to the minor’s medical treatment, before directly dispensing or issuing to a patient the first prescription in a single course of treatment for a controlled substance containing an opioid: (1) The risks of addiction and overdose associated with the use of opioids. (2) The increased risk of addiction to an opioid for an individual who is suffering from both mental and substance abuse disorders. (3) The danger of taking an opioid with a benzodiazepine, alcohol, or another central nervous system depressant. (4) Any other information required by law. (b) This section does not apply in any of the following circumstances: (1) If the patient’s treatment includes emergency services and care as defined in Section 1317.1. (2) If the patient’s treatment is associated with, or incidental to, an emergency surgery, regardless of whether the surgery is performed on an inpatient or outpatient basis. (3) If, in the prescriber’s professional judgment, fulfilling the requirements of subdivision (a) would be detrimental to the patient’s health or safety, or in violation of the patient’s legal rights regarding confidentiality. (c) Notwithstanding any other law, including Section 11374, failure to comply with this section shall not constitute a criminal offense. (Amended by Stats. 2024, Ch. 862, Sec. 1. (SB 607) Effective January 1, 2025.)
  96. 111580.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 5. New Drugs or Devices [111550 - 111610] ( Article 5 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    If the department finds an imminent hazard to public health, it may immediately suspend approval of the application.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 5. New Drugs or Devices [111550 - 111610] ( Article 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111580. When the department finds that there is an imminent hazard to the public health, it may suspend the approval for the application immediately. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  97. 111585.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 5. New Drugs or Devices [111550 - 111610] ( Article 5 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    An order withdrawing approval of an application for a new drug or device must be revoked when the department finds the facts justify doing so.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 5. New Drugs or Devices [111550 - 111610] ( Article 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111585. An order pursuant to Section 111575 or 111580 withdrawing approval of an application concerning any new drug or device shall be revoked whenever the department finds that the facts justify the action. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  98. 11159.

    ## Health and Safety Code - HSC ## DIVISION 10. UNIFORM CONTROLLED SUBSTANCES ACT [11000 - 11651] ( Division 10 repealed and added by Stats. 1972, Ch. 1407. ) ## CHAPTER 4. Prescriptions [11150 - 11209] ( Chapter 4 added by Stats. 1972, Ch. 1407. ) ## ARTICLE 1. Requirements of Prescriptions [11150 - 11180] ( Article 1 added by Stats. 1972, Ch. 1407. )

    Verify source ↗

    An order for controlled substances used for a patient in a county or licensed hospital is exempt from this article’s requirements, but the order must be written in the patient’s record, signed, dated, and include the drug name, quantity ordered, and quantity actually given.

    ## Health and Safety Code - HSC ## DIVISION 10. UNIFORM CONTROLLED SUBSTANCES ACT [11000 - 11651] ( Division 10 repealed and added by Stats. 1972, Ch. 1407. ) ## CHAPTER 4. Prescriptions [11150 - 11209] ( Chapter 4 added by Stats. 1972, Ch. 1407. ) ## ARTICLE 1. Requirements of Prescriptions [11150 - 11180] ( Article 1 added by Stats. 1972, Ch. 1407. ) ## 11159. An order for controlled substances for use by a patient in a county or licensed hospital shall be exempt from all requirements of this article, but shall be in writing on the patient’s record, signed by the prescriber, dated, and shall state the name and quantity of the controlled substance ordered and the quantity actually administered. The record of such orders shall be maintained as a hospital record for a minimum of seven years. (Added by Stats. 1972, Ch. 1407.)
  99. 11159.1.

    ## Health and Safety Code - HSC ## DIVISION 10. UNIFORM CONTROLLED SUBSTANCES ACT [11000 - 11651] ( Division 10 repealed and added by Stats. 1972, Ch. 1407. ) ## CHAPTER 4. Prescriptions [11150 - 11209] ( Chapter 4 added by Stats. 1972, Ch. 1407. ) ## ARTICLE 1. Requirements of Prescriptions [11150 - 11180] ( Article 1 added by Stats. 1972, Ch. 1407. )

    Verify source ↗

    Certain controlled-substance orders for permitted clinics are exempt from this article’s prescription rules, but they must be documented on the patient record and kept for at least seven years.

    ## Health and Safety Code - HSC ## DIVISION 10. UNIFORM CONTROLLED SUBSTANCES ACT [11000 - 11651] ( Division 10 repealed and added by Stats. 1972, Ch. 1407. ) ## CHAPTER 4. Prescriptions [11150 - 11209] ( Chapter 4 added by Stats. 1972, Ch. 1407. ) ## ARTICLE 1. Requirements of Prescriptions [11150 - 11180] ( Article 1 added by Stats. 1972, Ch. 1407. ) ## 11159.1. An order for controlled substances furnished to a patient in a clinic which has a permit issued pursuant to Article 13 (commencing with Section 4180) of Chapter 9 of Division 2 of the Business and Professions Code, except an order for a Schedule II controlled substance, shall be exempt from the prescription requirements of this article and shall be in writing on the patient’s record, signed by the prescriber, dated, and shall state the name and quantity of the controlled substance ordered and the quantity actually furnished. The record of the order shall be maintained as a clinic record for a minimum of seven years. This section shall apply only to a clinic that has obtained a permit under the provisions of Article 13 (commencing with Section 4180) of Chapter 9 of Division 2 of the Business and Professions Code. Clinics that furnish controlled substances shall be required to keep a separate record of the furnishing of those drugs which shall be available for review and inspection by all properly authorized personnel. (Amended by Stats. 2004, Ch. 695, Sec. 52. Effective January 1, 2005.)
  100. 11159.2.

    ## Health and Safety Code - HSC ## DIVISION 10. UNIFORM CONTROLLED SUBSTANCES ACT [11000 - 11651] ( Division 10 repealed and added by Stats. 1972, Ch. 1407. ) ## CHAPTER 4. Prescriptions [11150 - 11209] ( Chapter 4 added by Stats. 1972, Ch. 1407. ) ## ARTICLE 1. Requirements of Prescriptions [11150 - 11180] ( Article 1 added by Stats. 1972, Ch. 1407. )

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    This section allows certain controlled-substance prescriptions for terminally ill patients to be written on a form that does not meet Section 11162.1 if specified information is included and the prescriber certifies terminal illness.

    ## Health and Safety Code - HSC ## DIVISION 10. UNIFORM CONTROLLED SUBSTANCES ACT [11000 - 11651] ( Division 10 repealed and added by Stats. 1972, Ch. 1407. ) ## CHAPTER 4. Prescriptions [11150 - 11209] ( Chapter 4 added by Stats. 1972, Ch. 1407. ) ## ARTICLE 1. Requirements of Prescriptions [11150 - 11180] ( Article 1 added by Stats. 1972, Ch. 1407. ) ## 11159.2. (a) Notwithstanding any other provision of law, a prescription for a controlled substance for use by a patient who has a terminal illness may be written on a prescription form that does not meet the requirements of Section 11162.1 if the prescription meets the following requirements: (1) Contain the information specified in subdivision (a) of Section 11164. (2) Indicate that the prescriber has certified that the patient is terminally ill by the words “11159.2 exemption.” (b) A pharmacist may fill a prescription pursuant to this section when there is a technical error in the certification required by paragraph (2) of subdivision (a), provided that he or she has personal knowledge of the patient’s terminal illness, and subsequently returns the prescription to the prescriber for correction within 72 hours. (c) For purposes of this section, “terminally ill” means a patient who meets all of the following conditions: (1) In the reasonable medical judgment of the prescribing physician, the patient has been determined to be suffering from an illness that is incurable and irreversible. (2) In the reasonable medical judgment of the prescribing physician, the patient’s illness will, if the illness takes its normal course, bring about the death of the patient within a period of one year. (3) The patient’s treatment by the physician prescribing a controlled substance pursuant to this section primarily is for the control of pain, symptom management, or both, rather than for cure of the illness. (d) This section shall become operative on July 1, 2004. (Amended by Stats. 2005, Ch. 487, Sec. 1. Effective January 1, 2006.)
  101. 11159.3.

    ## Health and Safety Code - HSC ## DIVISION 10. UNIFORM CONTROLLED SUBSTANCES ACT [11000 - 11651] ( Division 10 repealed and added by Stats. 1972, Ch. 1407. ) ## CHAPTER 4. Prescriptions [11150 - 11209] ( Chapter 4 added by Stats. 1972, Ch. 1407. ) ## ARTICLE 1. Requirements of Prescriptions [11150 - 11180] ( Article 1 added by Stats. 1972, Ch. 1407. )

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    During certain emergencies, a pharmacist may fill a controlled-substance prescription under special conditions, but must review the patient’s CURES report, limit Schedule II dispensing to a seven-day supply, verify the patient cannot access medications, and not refill the prescription.

    ## Health and Safety Code - HSC ## DIVISION 10. UNIFORM CONTROLLED SUBSTANCES ACT [11000 - 11651] ( Division 10 repealed and added by Stats. 1972, Ch. 1407. ) ## CHAPTER 4. Prescriptions [11150 - 11209] ( Chapter 4 added by Stats. 1972, Ch. 1407. ) ## ARTICLE 1. Requirements of Prescriptions [11150 - 11180] ( Article 1 added by Stats. 1972, Ch. 1407. ) ## 11159.3. (a) Notwithstanding any other law, during a declared local, state, or federal emergency, if the California State Board of Pharmacy issues a notice that the board is waiving the application of the provisions of, or regulations adopted pursuant to, the Pharmacy Law, as specified in subdivision (b) of Section 4062 of the Business and Professions Code, a pharmacist may fill a prescription for a controlled substance for use by a patient who cannot access medications as a result of the declared local, state, or federal emergency, regardless of whether the prescription form meets the requirements of Section 11162.1, if the prescription meets the following requirements: (1) Contains the information specified in subdivision (a) of Section 11164. (2) Indicates that the patient is affected by a declared emergency with the words “11159.3 exemption” or a similar statement. (3) Is written and dispensed within the first two weeks of the notice issued by the board. (b) A pharmacist filling a prescription pursuant to this section shall do all of the following: (1) Exercise appropriate professional judgment, including reviewing the patient’s activity report from the CURES Prescription Drug Monitoring Program before dispensing the medication. (2) If the prescription is for a Schedule II controlled substance, dispense no greater than the amount needed for a seven-day supply. (3) Require the patient to first demonstrate, to the satisfaction of the pharmacist, their inability to access medications. This demonstration may include, but is not limited to, verification of residency within an evacuation area. (c) A pharmacist shall not refill a prescription that has been dispensed pursuant to this section. (Added by Stats. 2019, Ch. 705, Sec. 1. (SB 569) Effective January 1, 2020.)
  102. 111590.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 5. New Drugs or Devices [111550 - 111610] ( Article 5 added by Stats. 1995, Ch. 415, Sec. 6. )

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    Section 111550 does not apply to certain drugs or devices used only for investigational purposes by qualified experts, if the investigation follows specified federal requirements and regulations.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 5. New Drugs or Devices [111550 - 111610] ( Article 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111590. Section 111550 does not apply to a drug or device intended solely for investigational use by experts qualified by scientific training and experience to investigate the safety and effectiveness of drugs or devices if the investigation is conducted in accordance with the requirements of Section 505(i) of the federal act (21 U.S.C. Sec. 355(i)) or Section 520(g) thereof (21 U.S.C. Secs. 352 and 360) and the regulations adopted pursuant to the federal act. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  103. 111595.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 5. New Drugs or Devices [111550 - 111610] ( Article 5 added by Stats. 1995, Ch. 415, Sec. 6. )

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    Section 111550 does not apply to certain investigational drugs or devices if listed conditions are met.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 5. New Drugs or Devices [111550 - 111610] ( Article 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111595. Section 111550 does not apply to any drug or device intended solely for investigational use by experts qualified by scientific training and experience to investigate the safety and effectiveness of drugs or devices if all the following conditions are complied with: (a) The submission to the department, before any clinical testing of a drug or device is undertaken, of reports, by the manufacturer or the sponsor of the investigation of the drug or device, of preclinical tests including tests on animals, of the drug or device adequate to justify the proposed clinical testing. (b) The manufacturer or the sponsor of the investigation of a drug or a device proposed to be distributed to investigators for clinical testing obtaining a signed, notarized agreement from each of the investigators that patients to whom the drug or device is administered will be under his or her personal supervision, or under the supervision of investigators responsible to him or her, and that he or she will not supply the drug or device to any other investigator, or to clinics, for administration to human beings. (c) The establishment and maintenance of the records, and the making of the reports to the department, by the manufacturer or the sponsor of the investigation of the drug or device, of data, including but not limited to, analytical reports by investigators, obtained as a result of the investigational use of the drug or device, as the department finds will enable it to evaluate the safety and effectiveness of the drug or device in the event of the filing of an application pursuant to Section 111550. (d) The manufacturer, or the sponsor of the investigation, require experts using the drugs or devices for investigational purposes to certify to the manufacturer or sponsor that they will comply with the requirements of Article 4 (commencing with Section 111515). (e) Any other conditions as the department shall adopt as regulations necessary for the protection of the public health. The federal regulations adopted pursuant to Section 505(i) of the federal act (21 U.S.C. Sec. 355(i)) or Section 520(g) thereof (21 U.S.C. Secs. 352 and 360) shall be the regulations for exemptions from Section 111550 in this state. However, the department may prescribe, by regulation, any condition for exemption from Section 111550 whether or not the condition is in accordance with regulations adopted under the federal act. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  104. 111605.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 5. New Drugs or Devices [111550 - 111610] ( Article 5 added by Stats. 1995, Ch. 415, Sec. 6. )

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    The department must use people to review AIDS-related drug approval requests and related exemptions, the advisory committee must review and advise, and conflicts of interest block contracting for the review.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 5. New Drugs or Devices [111550 - 111610] ( Article 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111605. (a) In making determinations on requests for approval of AIDS-related drugs, as defined in subdivision (b), in accordance with Section 111550, or for exemptions from these requirements, for purposes of investigations of these drugs, pursuant to Section 111595, the department shall employ persons to conduct reviews of requests for drug marketing approval for AIDS-related drugs, or exemptions from the approval requirements as specified in that section. The AIDS Vaccine Research and Development Advisory Committee shall review and advise the department in its actions under this section. Where necessary, the department shall enter into contracts with appropriate and qualified persons or entities for the review of these requests, including persons with significant experience in conducting or reviewing clinical trials of drugs or physicians with significant experience in treating AIDS patients. No person may contract with the department for the review of a request under this subdivision if the person has a financial interest or a conflict of interest involving the drug being evaluated. (b) “AIDS-related drug” means either of the following: (1) A vaccine to protect against human immunodeficiency virus (HIV) infection. (2) Antiviral agent, immune modulator, or other agent to be administered to persons who have been infected with HIV, to counteract the effects of this infection, or any drug to treat opportunistic infections associated with AIDS. (c) The immunities provided for in Sections 818.4 and 821.6 of the Government Code shall apply whenever the department grants approval pursuant to Section 111550 or an exemption from the approval requirements pursuant to Section 111595, for an AIDS-related drug. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  105. 11161.

    ## Health and Safety Code - HSC ## DIVISION 10. UNIFORM CONTROLLED SUBSTANCES ACT [11000 - 11651] ( Division 10 repealed and added by Stats. 1972, Ch. 1407. ) ## CHAPTER 4. Prescriptions [11150 - 11209] ( Chapter 4 added by Stats. 1972, Ch. 1407. ) ## ARTICLE 1. Requirements of Prescriptions [11150 - 11180] ( Article 1 added by Stats. 1972, Ch. 1407. )

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    A court or magistrate must order certain practitioners to surrender controlled substance prescription forms and stop getting, ordering, or using more forms when the practitioner is named in a warrant or charged with specified felony drug offenses, if law enforcement shows reasonable cause.

    ## Health and Safety Code - HSC ## DIVISION 10. UNIFORM CONTROLLED SUBSTANCES ACT [11000 - 11651] ( Division 10 repealed and added by Stats. 1972, Ch. 1407. ) ## CHAPTER 4. Prescriptions [11150 - 11209] ( Chapter 4 added by Stats. 1972, Ch. 1407. ) ## ARTICLE 1. Requirements of Prescriptions [11150 - 11180] ( Article 1 added by Stats. 1972, Ch. 1407. ) ## 11161. (a) When a practitioner is named in a warrant of arrest or is charged in an accusatory pleading with a felony violation of Section 11153, 11154, 11156, 11157, 11170, 11173, 11350, 11351, 11352, 11353, 11353.5, 11377, 11378, 11378.5, 11379, 11379.5, or 11379.6, the court in which the accusatory pleading is filed or the magistrate who issued the warrant of arrest shall, upon the motion of a law enforcement agency which is supported by reasonable cause, issue an order which requires the practitioner to surrender to the clerk of the court all controlled substance prescription forms in the practitioner’s possession at a time set in the order and which prohibits the practitioner from obtaining, ordering, or using any additional prescription forms. The law enforcement agency obtaining the order shall notify the Department of Justice of this order. Except as provided in subdivisions (b) and (e) of this section, the order shall remain in effect until further order of the court. Any practitioner possessing prescription forms in violation of the order is guilty of a misdemeanor. (b) The order provided by subdivision (a) shall be vacated if the court or magistrate finds that the underlying violation or violations are not supported by reasonable cause at a hearing held within two court days after the practitioner files and personally serves upon the prosecuting attorney and the law enforcement agency that obtained the order, a notice of motion to vacate the order with any affidavits on which the practitioner relies. At the hearing, the burden of proof, by a preponderance of the evidence, is on the prosecution. Evidence presented at the hearing shall be limited to the warrant of arrest with supporting affidavits, the motion to require the defendant to surrender controlled substance prescription forms and to prohibit the defendant from obtaining, ordering, or using controlled substance prescription forms, with supporting affidavits, the sworn complaint together with any documents or reports incorporated by reference thereto which, if based on information and belief, state the basis for the information, or any other documents of similar reliability as well as affidavits and counter affidavits submitted by the prosecution and defense. Granting of the motion to vacate the order is no bar to prosecution of the alleged violation or violations. (c) The defendant may elect to challenge the order issued under subdivision (a) at the preliminary examination. At that hearing, the evidence shall be limited to that set forth in subdivision (b) and any other evidence otherwise admissible at the preliminary examination. (d) If the practitioner has not moved to vacate the order issued under subdivision (a) by the time of the preliminary examination and he or she is held to answer on the underlying violation or violations, the practitioner shall be precluded from afterwards moving to vacate the order. If the defendant is not held to answer on the underlying charge or charges at the conclusion of the preliminary examination, the order issued under subdivision (a) shall be vacated. (e) Notwithstanding subdivision (d), any practitioner who is diverted pursuant to Chapter 2.5 (commencing with Section 1000) of Title 7 of Part 2 of the Penal Code may file a motion to vacate the order issued under subdivision (a). (f) This section shall become operative on November 1, 2004. (Amended by Stats. 2005, Ch. 487, Sec. 2. Effective January 1, 2006.)
  106. 11161.5.

    ## Health and Safety Code - HSC ## DIVISION 10. UNIFORM CONTROLLED SUBSTANCES ACT [11000 - 11651] ( Division 10 repealed and added by Stats. 1972, Ch. 1407. ) ## CHAPTER 4. Prescriptions [11150 - 11209] ( Chapter 4 added by Stats. 1972, Ch. 1407. ) ## ARTICLE 1. Requirements of Prescriptions [11150 - 11180] ( Article 1 added by Stats. 1972, Ch. 1407. )

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    Security printers for controlled substance prescription forms must follow DOJ approval, verification, delivery, recordkeeping, and theft-reporting rules.

    ## Health and Safety Code - HSC ## DIVISION 10. UNIFORM CONTROLLED SUBSTANCES ACT [11000 - 11651] ( Division 10 repealed and added by Stats. 1972, Ch. 1407. ) ## CHAPTER 4. Prescriptions [11150 - 11209] ( Chapter 4 added by Stats. 1972, Ch. 1407. ) ## ARTICLE 1. Requirements of Prescriptions [11150 - 11180] ( Article 1 added by Stats. 1972, Ch. 1407. ) ## 11161.5. (a) Prescription forms for controlled substance prescriptions shall be obtained from security printers approved by the Department of Justice. (b) The department may approve security printer applications after the applicant has provided the following information: (1) Name, address, and telephone number of the applicant. (2) Policies and procedures of the applicant for verifying the identity of the prescriber ordering controlled substance prescription forms. (3) Policies and procedures of the applicant for verifying delivery of controlled substance prescription forms to prescribers. (4) (A) The location, names, and titles of the applicant’s agent for service of process in this state; all principal corporate officers, if any; all managing general partners, if any; and any individual owner, partner, corporate officer, manager, agent, representative, employee, or subcontractor of the applicant who has direct access to, or management or control of, controlled substance prescription forms. (B) A report containing this information shall be made on an annual basis and within 30 days after any change of office, principal corporate officers, managing general partner, or of any person described in subparagraph (A). (5) (A) A signed statement indicating whether the applicant, any principal corporate officer, any managing general partner, or any individual owner, partner, corporate officer, manager, agent, representative, employee, or subcontractor of the applicant who has direct access to, or management or control of, controlled substance prescription forms, has ever been convicted of, or pled no contest to, a violation of any law of a foreign country, the United States, or any state, or of any local ordinance. (B) The department shall provide the applicant and any individual owner, partner, corporate officer, manager, agent, representative, employee, or subcontractor of the applicant who has direct access to, or management or control of, controlled substance prescription forms, with the means and direction to provide fingerprints and related information, in a manner specified by the department, for the purpose of completing state, federal, or foreign criminal background checks. (C) Any applicant described in subdivision (b) shall submit his or her fingerprint images and related information to the department, for the purpose of the department obtaining information as to the existence and nature of a record of state, federal, or foreign level convictions and state, federal, or foreign level arrests for which the department establishes that the applicant was released on bail or on his or her own recognizance pending trial, as described in subdivision (l) of Section 11105 of the Penal Code. Requests for federal level criminal offender record information received by the department pursuant to this section shall be forwarded to the Federal Bureau of Investigation by the department. (D) The department shall assess against each security printer applicant a fee determined by the department to be sufficient to cover all processing, maintenance, and investigative costs generated from or associated with completing state, federal, or foreign background checks and inspections of security printers pursuant to this section with respect to that applicant; the fee shall be paid by the applicant at the time he or she submits the security printer application, fingerprints, and related information to the department. (E) The department shall retain fingerprint impressions and related information for subsequent arrest notification pursuant to Section 11105.2 of the Penal Code for all applicants. (c) The department may, within 60 calendar days of receipt of the application from the applicant, deny the security printer application. (d) The department may deny a security printer application on any of the following grounds: (1) The applicant, any individual owner, partner, corporate officer, manager, agent, representative, employee, or subcontractor for the applicant, who has direct access, management, or control of controlled substance prescription forms, has been convicted of a crime. A conviction within the meaning of this paragraph means a plea or verdict of guilty or a conviction following a plea of nolo contendere. Any action which a board is permitted to take following the establishment of a conviction may be taken when the time for appeal has elapsed, 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 the provisions of Section 1203.4 of the Penal Code. (2) The applicant committed any act involving dishonesty, fraud, or deceit with the intent to substantially benefit himself, herself, or another, or substantially injure another. (3) The applicant committed any act that would constitute a violation of this division. (4) The applicant knowingly made a false statement of fact required to be revealed in the application to produce controlled substance prescription forms. (5) The department determines that the applicant failed to demonstrate adequate security procedures relating to the production and distribution of controlled substance prescription forms. (6) The department determines that the applicant has submitted an incomplete application. (7) As a condition for its approval as a security printer, an applicant shall authorize the Department of Justice to make any examination of the books and records of the applicant, or to visit and inspect the applicant during business hours, to the extent deemed necessary by the board or department to properly enforce this section. (e) An approved applicant shall submit an exemplar of a controlled substance prescription form, with all security features, to the Department of Justice within 30 days of initial production. (f) The department shall maintain a list of approved security printers and the department shall make this information available to prescribers and other appropriate government agencies, including the Board of Pharmacy. (g) Before printing any controlled substance prescription forms, a security printer shall verify with the appropriate licensing board that the prescriber possesses a license and current prescribing privileges which permits the prescribing of controlled substances with the federal Drug Enforcement Administration (DEA). (h) Controlled substance prescription forms shall be provided directly to the prescriber either in person, by certified mail, or by a means that requires a signature signifying receipt of the package and provision of that signature to the security printer. Controlled substance prescription forms provided in person shall be restricted to established customers. Security printers shall obtain a photo identification from the customer and maintain a log of this information. Controlled substance prescription forms shall be shipped only to the prescriber’s address on file and verified with the federal Drug Enforcement Administration or the Medical Board of California. (i) Security printers shall retain ordering and delivery records in a readily retrievable manner for individual prescribers for three years. (j) Security printers shall produce ordering and delivery records upon request by an authorized officer of the law as defined in Section 4017 of the Business and Professions Code. (k) Security printers shall report any theft or loss of controlled substance prescription forms to the Department of Justice via fax or email within 24 hours of the theft or loss. (l) (1) The department shall impose restrictions, sanctions, or penalties, subject to subdivisions (m) and (n), against security printers who are not in compliance with this division pursuant to regulations implemented pursuant to this division and shall revoke its approval of a security printer for a violation of this division or action that would permit a denial pursuant to subdivision (d) of this section. (2) When the department revokes its approval, it shall notify the appropriate licensing boards and remove the security printer from the list of approved security printers. (m) The following violations by security printers shall be punishable pursuant to subdivision (n): (1) Failure to comply with the Security Printer Guidelines established by the Security Printer Program as a condition of approval. (2) Failure to take reasonable precautions to prevent any dishonest act or illegal activity related to the access and control of security prescription forms. (3) Theft or fraudulent use of a prescriber’s identity in order to obtain security prescription forms. (n) A security printer approved pursuant to subdivision (b) shall be subject to the following penalties for actions leading to the denial of a security printer application specified in subdivision (d) or for a violation specified in subdivision (m): (1) For a first violation, a fine not to exceed one thousand dollars ($1,000). (2) For a second or subsequent violation, a fine not to exceed two thousand five hundred dollars ($2,500) for each violation. (3) For a third or subsequent violation, a filing of an administrative disciplinary action seeking to suspend or revoke security printer approval. (o) In order to facilitate the standardization of all prescription forms and the serialization of prescription forms with unique identifiers, the Department of Justice may cease issuing new approvals of security printers to the extent necessary to achieve these purposes. The department may, pursuant to regulation, reduce the number of currently approved security printers to no fewer than three vendors. The department shall ensure that any reduction or limitation of approved security printers does not impact the ability of vendors to meet demand for prescription forms. (Amended by Stats. 2018, Ch. 479, Sec. 2. (AB 1753) Effective January 1, 2019.)
  107. 11161.7.

    ## Health and Safety Code - HSC ## DIVISION 10. UNIFORM CONTROLLED SUBSTANCES ACT [11000 - 11651] ( Division 10 repealed and added by Stats. 1972, Ch. 1407. ) ## CHAPTER 4. Prescriptions [11150 - 11209] ( Chapter 4 added by Stats. 1972, Ch. 1407. ) ## ARTICLE 1. Requirements of Prescriptions [11150 - 11180] ( Article 1 added by Stats. 1972, Ch. 1407. )

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    When a prescriber’s authority is restricted, the agency or board that obtained the restriction must give identifying restriction details to security printers, the Department of Justice, and the Board of Pharmacy. The Board of Pharmacy must then share that information with pharmacies and security printers.

    ## Health and Safety Code - HSC ## DIVISION 10. UNIFORM CONTROLLED SUBSTANCES ACT [11000 - 11651] ( Division 10 repealed and added by Stats. 1972, Ch. 1407. ) ## CHAPTER 4. Prescriptions [11150 - 11209] ( Chapter 4 added by Stats. 1972, Ch. 1407. ) ## ARTICLE 1. Requirements of Prescriptions [11150 - 11180] ( Article 1 added by Stats. 1972, Ch. 1407. ) ## 11161.7. (a) When a prescriber’s authority to prescribe controlled substances is restricted by civil, criminal, or administrative action, or by an order of the court issued pursuant to Section 11161, the law enforcement agency or licensing board that sought the restrictions shall provide the name, category of licensure, license number, and the nature of the restrictions imposed on the prescriber to security printers, the Department of Justice, and the Board of Pharmacy. (b) The Board of Pharmacy shall make available the information required by subdivision (a) to pharmacies and security printers to prevent the dispensing of controlled substance prescriptions issued by the prescriber and the ordering of additional controlled substance prescription forms by the restricted prescriber. (Added by Stats. 2003, Ch. 406, Sec. 7. Effective January 1, 2004.)
  108. 111610.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 5. New Drugs or Devices [111550 - 111610] ( Article 5 added by Stats. 1995, Ch. 415, Sec. 6. )

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    Section 111550 does not apply to certain drugs and devices that meet listed conditions.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 5. New Drugs or Devices [111550 - 111610] ( Article 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111610. Section 111550 does not apply to any of the following: (a) A drug or device that is sold in this state, or introduced into interstate commerce, at any time prior to the enactment of the federal act, if its labeling and advertising contained the same representations concerning the conditions of its use. (b) Any drug that is licensed under the Public Health Service Act of July 1, 1944 (58 Stats. 682, as amended; 42 U.S.C. Sec. 201 et seq.) or under the eighth paragraph of the heading of Bureau of Animal Industry of the act of March 4, 1913 (37 Stat. 832–833; 21 U.S.C. Sec. 151 et seq.), commonly known as the “Virus-Serum-Toxin Act.” (Amended by Stats. 2000, Ch. 796, Sec. 13. Effective January 1, 2001.)
  109. 111615.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 6. Licenses [111615 - 111656.13] ( Article 6 added by Stats. 1995, Ch. 415, Sec. 6. )

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    Manufacturing any drug or device in the state requires a valid department license.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 6. Licenses [111615 - 111656.13] ( Article 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111615. No person shall manufacture any drug or device in this state unless he or she has a valid license from the department. The license is valid for two calendar years from the date of issue, unless it is revoked. The license is not transferable. The department may require any manufacturer, wholesaler, or importer of any prescription ophthalmic device in this state to obtain a license. (Amended by Stats. 2006, Ch. 74, Sec. 34. Effective July 12, 2006.)
  110. 11162.1.

    ## Health and Safety Code - HSC ## DIVISION 10. UNIFORM CONTROLLED SUBSTANCES ACT [11000 - 11651] ( Division 10 repealed and added by Stats. 1972, Ch. 1407. ) ## CHAPTER 4. Prescriptions [11150 - 11209] ( Chapter 4 added by Stats. 1972, Ch. 1407. ) ## ARTICLE 1. Requirements of Prescriptions [11150 - 11180] ( Article 1 added by Stats. 1972, Ch. 1407. )

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    Controlled substance prescription forms must include specified security features and information, with some limited exceptions.

    ## Health and Safety Code - HSC ## DIVISION 10. UNIFORM CONTROLLED SUBSTANCES ACT [11000 - 11651] ( Division 10 repealed and added by Stats. 1972, Ch. 1407. ) ## CHAPTER 4. Prescriptions [11150 - 11209] ( Chapter 4 added by Stats. 1972, Ch. 1407. ) ## ARTICLE 1. Requirements of Prescriptions [11150 - 11180] ( Article 1 added by Stats. 1972, Ch. 1407. ) ## 11162.1. (a) The prescription forms for controlled substances shall be printed with the following features: (1) A latent, repetitive “void” pattern shall be printed across the entire front of the prescription blank; if a prescription is scanned or photocopied, the word “void” shall appear in a pattern across the entire front of the prescription. (2) A watermark shall be printed on the backside of the prescription blank; the watermark shall consist of the words “California Security Prescription.” (3) A chemical void protection that prevents alteration by chemical washing. (4) A feature printed in thermochromic ink. (5) An area of opaque writing so that the writing disappears if the prescription is lightened. (6) A description of the security features included on each prescription form. (7) (A) Six quantity check off boxes shall be printed on the form so that the prescriber may indicate the quantity by checking the applicable box where the following quantities shall appear: 1–24 25–49 50–74 75–100 101–150 151 and over. (B) In conjunction with the quantity boxes, a space shall be provided to designate the units referenced in the quantity boxes when the drug is not in tablet or capsule form. (8) Prescription blanks shall contain a statement printed on the bottom of the prescription blank that the “Prescription is void if the number of drugs prescribed is not noted.” (9) The preprinted name, category of licensure, license number, federal controlled substance registration number, and address of the prescribing practitioner. (10) Check boxes shall be printed on the form so that the prescriber may indicate the number of refills ordered. (11) The date of origin of the prescription. (12) A check box indicating the prescriber’s order not to substitute. (13) An identifying number assigned to the approved security printer by the Department of Justice. (14) (A) A check box by the name of each prescriber when a prescription form lists multiple prescribers. (B) Each prescriber who signs the prescription form shall identify themselves as the prescriber by checking the box by the prescriber’s name. (15) A uniquely serialized number, in a manner prescribed by the Department of Justice in accordance with Section 11162.2. (b) Each batch of controlled substance prescription forms shall have the lot number printed on the form and each form within that batch shall be numbered sequentially beginning with the numeral one. (c) (1) A prescriber designated by a licensed health care facility, a clinic specified in Section 1200, or a clinic specified in subdivision (a) of Section 1206 that has 25 or more physicians or surgeons may order controlled substance prescription forms for use by prescribers when treating patients in that facility without the information required in paragraph (9) of subdivision (a) or paragraph (3). (2) Forms ordered pursuant to this subdivision shall have the name, category of licensure, license number, and federal controlled substance registration number of the designated prescriber and the name, address, category of licensure, and license number of the licensed health care facility the clinic specified in Section 1200, or the clinic specified in Section 1206 that has 25 or more physicians or surgeons preprinted on the form. Licensed health care facilities or clinics exempt under Section 1206 are not required to preprint the category of licensure and license number of their facility or clinic. (3) Forms ordered pursuant to this section shall not be valid prescriptions without the name, category of licensure, license number, and federal controlled substance registration number of the prescriber on the form. (4) (A) Except as provided in subparagraph (B), the designated prescriber shall maintain a record of the prescribers to whom the controlled substance prescription forms are issued, that shall include the name, category of licensure, license number, federal controlled substance registration number, and quantity of controlled substance prescription forms issued to each prescriber. The record shall be maintained in the health facility for three years. (B) Forms ordered pursuant to this subdivision that are printed by a computerized prescription generation system shall not be subject to subparagraph (A) or paragraph (7) of subdivision (a). Forms printed pursuant to this subdivision that are printed by a computerized prescription generation system may contain the prescriber’s name, category of professional licensure, license number, federal controlled substance registration number, and the date of the prescription. (d) Within the next working day following delivery, a security printer shall submit via web-based application, as specified by the Department of Justice, all of the following information for all prescription forms delivered: (1) Serial numbers of all prescription forms delivered. (2) All prescriber names and Drug Enforcement Administration Controlled Substance Registration Certificate numbers displayed on the prescription forms. (3) The delivery shipment recipient names. (4) The date of delivery. (Amended by Stats. 2019, Ch. 4, Sec. 1. (AB 149) Effective March 11, 2019.)
  111. 11162.2.

    ## Health and Safety Code - HSC ## DIVISION 10. UNIFORM CONTROLLED SUBSTANCES ACT [11000 - 11651] ( Division 10 repealed and added by Stats. 1972, Ch. 1407. ) ## CHAPTER 4. Prescriptions [11150 - 11209] ( Chapter 4 added by Stats. 1972, Ch. 1407. ) ## ARTICLE 1. Requirements of Prescriptions [11150 - 11180] ( Article 1 added by Stats. 1972, Ch. 1407. )

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    The Department of Justice must prescribe specifications for the serialized number used on new prescription forms, and the number is not required on those forms until a DOJ-set date no later than January 1, 2020.

    ## Health and Safety Code - HSC ## DIVISION 10. UNIFORM CONTROLLED SUBSTANCES ACT [11000 - 11651] ( Division 10 repealed and added by Stats. 1972, Ch. 1407. ) ## CHAPTER 4. Prescriptions [11150 - 11209] ( Chapter 4 added by Stats. 1972, Ch. 1407. ) ## ARTICLE 1. Requirements of Prescriptions [11150 - 11180] ( Article 1 added by Stats. 1972, Ch. 1407. ) ## 11162.2. (a) Notwithstanding any other law, the uniquely serialized number described in paragraph (15) of subdivision (a) of Section 11162.1 shall not be a required feature in the printing of new prescription forms produced by approved security printers until a date determined by the Department of Justice, which shall be no later than January 1, 2020. (b) Specifications for the serialized number shall be prescribed by the Department of Justice and shall meet the following minimum requirements: (1) The serialized number shall be compliant with all state and federal requirements. (2) The serialized number shall be utilizable as a barcode that may be scanned by dispensers. (3) The serialized number shall be compliant with current National Council for Prescription Drug Program Standards. (Added by Stats. 2019, Ch. 4, Sec. 2. (AB 149) Effective March 11, 2019.)
  112. 11162.5.

    ## Health and Safety Code - HSC ## DIVISION 10. UNIFORM CONTROLLED SUBSTANCES ACT [11000 - 11651] ( Division 10 repealed and added by Stats. 1972, Ch. 1407. ) ## CHAPTER 4. Prescriptions [11150 - 11209] ( Chapter 4 added by Stats. 1972, Ch. 1407. ) ## ARTICLE 1. Requirements of Prescriptions [11150 - 11180] ( Article 1 added by Stats. 1972, Ch. 1407. )

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    It is an offence to counterfeit an official prescription blank or to possess counterfeited prescription blanks beyond the stated limits.

    ## Health and Safety Code - HSC ## DIVISION 10. UNIFORM CONTROLLED SUBSTANCES ACT [11000 - 11651] ( Division 10 repealed and added by Stats. 1972, Ch. 1407. ) ## CHAPTER 4. Prescriptions [11150 - 11209] ( Chapter 4 added by Stats. 1972, Ch. 1407. ) ## ARTICLE 1. Requirements of Prescriptions [11150 - 11180] ( Article 1 added by Stats. 1972, Ch. 1407. ) ## 11162.5. (a) Every person who counterfeits a prescription blank purporting to be an official prescription blank prepared and issued pursuant to Section 11161.5, or knowingly possesses more than three counterfeited prescription blanks, shall be punished by imprisonment pursuant to subdivision (h) of Section 1170 of the Penal Code or by imprisonment in a county jail for not more than one year. (b) Every person who knowingly possesses three or fewer counterfeited prescription blanks purporting to be official prescription blanks prepared and issued pursuant to Section 11161.5, shall be guilty of a misdemeanor punishable by imprisonment in a county jail not exceeding six months, or by a fine not exceeding one thousand dollars ($1,000), or by both that fine and imprisonment. (Amended by Stats. 2011, Ch. 15, Sec. 150. (AB 109) Effective April 4, 2011. Operative October 1, 2011, by Sec. 636 of Ch. 15, as amended by Stats. 2011, Ch. 39, Sec. 68.)
  113. 11162.6.

    ## Health and Safety Code - HSC ## DIVISION 10. UNIFORM CONTROLLED SUBSTANCES ACT [11000 - 11651] ( Division 10 repealed and added by Stats. 1972, Ch. 1407. ) ## CHAPTER 4. Prescriptions [11150 - 11209] ( Chapter 4 added by Stats. 1972, Ch. 1407. ) ## ARTICLE 1. Requirements of Prescriptions [11150 - 11180] ( Article 1 added by Stats. 1972, Ch. 1407. )

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    It is a misdemeanor to counterfeit, knowingly possess, obtain by false pretenses, or fraudulently produce a controlled substance prescription form.

    ## Health and Safety Code - HSC ## DIVISION 10. UNIFORM CONTROLLED SUBSTANCES ACT [11000 - 11651] ( Division 10 repealed and added by Stats. 1972, Ch. 1407. ) ## CHAPTER 4. Prescriptions [11150 - 11209] ( Chapter 4 added by Stats. 1972, Ch. 1407. ) ## ARTICLE 1. Requirements of Prescriptions [11150 - 11180] ( Article 1 added by Stats. 1972, Ch. 1407. ) ## 11162.6. (a) Every person who counterfeits a controlled substance prescription form shall be guilty of a misdemeanor punishable by imprisonment in a county jail for not more than one year, by a fine not exceeding one thousand dollars ($1,000), or by both that imprisonment and fine. (b) Every person who knowingly possesses a counterfeited controlled substance prescription form shall be guilty of a misdemeanor punishable by imprisonment in a county jail not exceeding six months, by a fine not exceeding one thousand dollars ($1,000), or by both that imprisonment and fine. (c) Every person who attempts to obtain or obtains a controlled substance prescription form under false pretenses shall be guilty of a misdemeanor punishable by imprisonment in a county jail not exceeding six months, by a fine not exceeding one thousand dollars ($1,000), or by both that imprisonment and fine. (d) Every person who fraudulently produces controlled substance prescription forms shall be guilty of a misdemeanor punishable by imprisonment in a county jail not exceeding six months, by a fine not exceeding one thousand dollars ($1,000), or by both that imprisonment and fine. (e) This section shall become operative on July 1, 2004. (Added by Stats. 2003, Ch. 406, Sec. 10. Effective January 1, 2004. Section operative July 1, 2004, by its own provisions.)
  114. 111620.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 6. Licenses [111615 - 111656.13] ( Article 6 added by Stats. 1995, Ch. 415, Sec. 6. )

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    A separate license is required for each place of manufacture.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 6. Licenses [111615 - 111656.13] ( Article 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111620. A separate license is required for each place of manufacture. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  115. 111625.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 6. Licenses [111615 - 111656.13] ( Article 6 added by Stats. 1995, Ch. 415, Sec. 6. )

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    License applications must be completed every two years and filed with the required fee. If the license is refused, the fee is not refundable.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 6. Licenses [111615 - 111656.13] ( Article 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111625. A license application shall be completed biennially and accompanied by an application fee as prescribed in Section 111630. This fee is not refundable if the license is refused. (Amended by Stats. 2006, Ch. 74, Sec. 35. Effective July 12, 2006.)
  116. 111630.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 6. Licenses [111615 - 111656.13] ( Article 6 added by Stats. 1995, Ch. 415, Sec. 6. )

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    The department must set the application form and fee for licensure and renewal, and licensed persons must promptly report changes in their application information.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 6. Licenses [111615 - 111656.13] ( Article 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111630. The department shall by regulation establish the application form and set the fee for licensure and renewal of a license. The penalty for failure to apply for renewal of a license within 30 days after its expiration is ten dollars ($10) and shall be added to the renewal fee and be paid by the applicant before the renewal license may be issued. All moneys collected as fees shall be expended when appropriated by the Legislature in the carrying out of the provisions of this part and the regulations adopted pursuant to this part. Any person licensed pursuant to this section shall immediately notify the department of any change in the information reported in the license application. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  117. 111633.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 6. Licenses [111615 - 111656.13] ( Article 6 added by Stats. 1995, Ch. 415, Sec. 6. )

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    An applicant for a human prescription drug manufacturing license must provide fingerprints and related information to the Department of Justice, and the Department of Justice must provide a state- or federal-level response.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 6. Licenses [111615 - 111656.13] ( Article 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111633. The State Department of Public Health shall require that an applicant for a human prescription drug manufacturing license submit fingerprints to the Department of Justice, and related information as required by the Department of Justice, as required by this chapter, pursuant to subdivision (u) of Section 11105 of the Penal Code. The Department of Justice shall provide a state- or federal-level response pursuant to subdivision (p) of Section 11105 of the Penal Code. (Added by Stats. 2023, Ch. 198, Sec. 17. (SB 152) Effective September 13, 2023.)
  118. 111635.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 6. Licenses [111615 - 111656.13] ( Article 6 added by Stats. 1995, Ch. 415, Sec. 6. )

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    Before issuing certain manufacturing licenses, the department must review specified ownership and compliance documentation, and it may or may not inspect depending on what it receives.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 6. Licenses [111615 - 111656.13] ( Article 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111635. (a) Prior to issuing a license required by Section 111615 to any place of business where a drug or device is manufactured, the department shall receive from each place of business documentation that evidences ownership and any of the following: (1) The place of business is operating pursuant to a valid biologics license issued by the United States Food and Drug Administration in compliance with Section 351 of the federal Public Health Service Act (42 U.S.C. Sec. 262). (2) The place of business is operating with a valid establishment registration pursuant to Section 510 of the federal act (21 U.S.C. Sec. 360). This documentation shall include an attestation from an officer of the place of business that a federal inspection was completed within the two years prior to the date of the attestation. (3) The place of business is operating in compliance with audits conducted pursuant to the International Standards Organization (ISO) 9000 series, ISO 13485:2003 quality management systems standards, ISO 15378:2006 quality management systems standards, pursuant to Parts 210 and 211 of Title 21 of the Code of Federal Regulations, or pursuant to Part 820 of Title 21 of the Code of Federal Regulations. (4) The place of business is operating pursuant to an approved investigational new drug issued by the federal Food and Drug Administration pursuant to Section 312.20 of Title 21 of the Code of Federal Regulations or pursuant to an approved investigational device exemption issued by the federal Food and Drug Administration pursuant to Section 812.20 of Title 21 of the Code of Federal Regulations. (b) If the department receives documentation that satisfies the requirements of subdivision (a), the department shall not inspect the place of business prior to issuing a license required by Section 111615. If the department does not receive the documentation required, the department shall inspect the place of business prior to issuing a license required by Section 111615. (c) Upon request by a place of business licensed under Section 111615, the department shall provide an official copy of the valid license to the place of business in accordance with Sections 110230 and 110235. (d) Notwithstanding Section 111640, for any place of business where a drug or device is manufactured and the manufacturer has received a license pursuant to this section, the department shall make investigations or inspections authorized by Article 2 (commencing with Section 110140) of Chapter 2 only when any of the following occur: (1) The department becomes aware of an issue and makes a determination that the health and safety of the public is at risk. (2) A complaint has been registered with the department and the department makes a determination that the health and safety of the public is at risk. (3) A notification has been sent by the United States Food and Drug Administration to the department that requests assistance regarding any Class I or II recall action memorandum. (4) The United States Food and Drug Administration has requested assistance for enforcement activities, including, but not limited to, embargoes, seizures, or injunctions. (e) Inspections made pursuant to subdivision (d) shall be limited to inspections for compliance with, or violations of, Chapter 4 (commencing with Section 110290) or this chapter. (Amended by Stats. 2012, Ch. 688, Sec. 2. (AB 1277) Effective January 1, 2013.)
  119. 11164.

    ## Health and Safety Code - HSC ## DIVISION 10. UNIFORM CONTROLLED SUBSTANCES ACT [11000 - 11651] ( Division 10 repealed and added by Stats. 1972, Ch. 1407. ) ## CHAPTER 4. Prescriptions [11150 - 11209] ( Chapter 4 added by Stats. 1972, Ch. 1407. ) ## ARTICLE 1. Requirements of Prescriptions [11150 - 11180] ( Article 1 added by Stats. 1972, Ch. 1407. )

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    This section limits how controlled-substance prescriptions may be written, transmitted, filled, compounded, or dispensed, and sets specific form, record, and security requirements.

    ## Health and Safety Code - HSC ## DIVISION 10. UNIFORM CONTROLLED SUBSTANCES ACT [11000 - 11651] ( Division 10 repealed and added by Stats. 1972, Ch. 1407. ) ## CHAPTER 4. Prescriptions [11150 - 11209] ( Chapter 4 added by Stats. 1972, Ch. 1407. ) ## ARTICLE 1. Requirements of Prescriptions [11150 - 11180] ( Article 1 added by Stats. 1972, Ch. 1407. ) ## 11164. Except as provided in Section 11167, no person shall prescribe a controlled substance, nor shall any person fill, compound, or dispense a prescription for a controlled substance, unless it complies with the requirements of this section. (a) Each prescription for a controlled substance classified in Schedule II, III, IV, or V, except as authorized by subdivision (b), shall be made on a controlled substance prescription form as specified in Section 11162.1 and shall meet the following requirements: (1) The prescription shall be signed and dated by the prescriber in ink and shall contain the prescriber’s address and telephone number; the name of the ultimate user or research subject, or contact information as determined by the Secretary of the United States Department of Health and Human Services; refill information, such as the number of refills ordered and whether the prescription is a first-time request or a refill; and the name, quantity, strength, and directions for use of the controlled substance prescribed. (2) The prescription shall also contain the address of the person for whom the controlled substance is prescribed. If the prescriber does not specify this address on the prescription, the pharmacist filling the prescription or an employee acting under the direction of the pharmacist shall write or type the address on the prescription or maintain this information in a readily retrievable form in the pharmacy. (b) (1) Notwithstanding paragraph (1) of subdivision (a) of Section 11162.1, any controlled substance classified in Schedule III, IV, or V may be dispensed upon an oral or electronically transmitted prescription, which shall be produced in hard copy form and signed and dated by the pharmacist filling the prescription or by any other person expressly authorized by provisions of the Business and Professions Code. Any person who transmits, maintains, or receives any electronically transmitted prescription shall ensure the security, integrity, authority, and confidentiality of the prescription. (2) The date of issue of the prescription and all the information required for a written prescription by subdivision (a) shall be included in the written record of the prescription; the pharmacist need not include the address, telephone number, license classification, or federal registry number of the prescriber or the address of the patient on the hard copy, if that information is readily retrievable in the pharmacy. (3) Pursuant to an authorization of the prescriber, any agent of the prescriber on behalf of the prescriber may orally or electronically transmit a prescription for a controlled substance classified in Schedule III, IV, or V, if in these cases the written record of the prescription required by this subdivision specifies the name of the agent of the prescriber transmitting the prescription. (c) The use of commonly used abbreviations shall not invalidate an otherwise valid prescription. (d) Notwithstanding subdivisions (a) and (b), prescriptions for a controlled substance classified in Schedule V may be for more than one person in the same family with the same medical need. (e) (1) Notwithstanding any other law, a prescription written on a prescription form that was otherwise valid prior to January 1, 2019, but that does not comply with paragraph (15) of subdivision (a) of Section 11162.1, or a valid controlled substance prescription form approved by the Department of Justice as of January 1, 2019, is a valid prescription that may be filled, compounded, or dispensed until January 1, 2021. (2) If the Department of Justice determines that there is an inadequate availability of compliant prescription forms to meet demand on or before the date described in paragraph (1), the department may extend the period during which prescriptions written on noncompliant prescription forms remain valid for a period no longer than an additional six months. (Amended by Stats. 2019, Ch. 4, Sec. 3. (AB 149) Effective March 11, 2019.)
  120. 11164.1.

    ## Health and Safety Code - HSC ## DIVISION 10. UNIFORM CONTROLLED SUBSTANCES ACT [11000 - 11651] ( Division 10 repealed and added by Stats. 1972, Ch. 1407. ) ## CHAPTER 4. Prescriptions [11150 - 11209] ( Chapter 4 added by Stats. 1972, Ch. 1407. ) ## ARTICLE 1. Requirements of Prescriptions [11150 - 11180] ( Article 1 added by Stats. 1972, Ch. 1407. )

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    California pharmacies may dispense certain out-of-state controlled-substance prescriptions if the prescription meets the prescribing state’s requirements, and some dispensed prescriptions must be reported to the Department of Justice.

    ## Health and Safety Code - HSC ## DIVISION 10. UNIFORM CONTROLLED SUBSTANCES ACT [11000 - 11651] ( Division 10 repealed and added by Stats. 1972, Ch. 1407. ) ## CHAPTER 4. Prescriptions [11150 - 11209] ( Chapter 4 added by Stats. 1972, Ch. 1407. ) ## ARTICLE 1. Requirements of Prescriptions [11150 - 11180] ( Article 1 added by Stats. 1972, Ch. 1407. ) ## 11164.1. (a) (1) Notwithstanding any other law, a prescription for a controlled substance issued by a prescriber in another state for delivery to a patient in another state may be dispensed by a California pharmacy, if the prescription conforms with the requirements for controlled substance prescriptions in the state in which the controlled substance was prescribed. (2) A prescription for a Schedule II, Schedule III, Schedule IV, or Schedule V controlled substance dispensed pursuant to this subdivision shall be reported by the dispensing pharmacy to the Department of Justice in the manner prescribed by subdivision (d) of Section 11165. (b) A pharmacy may dispense a prescription for a Schedule III, Schedule IV, or Schedule V controlled substance from an out-of-state prescriber pursuant to Section 4005 of the Business and Professions Code and Section 1717 of Title 16 of the California Code of Regulations. (c) This section shall become operative on January 1, 2021. (Repealed (in Sec. 3) and added by Stats. 2019, Ch. 677, Sec. 4. (AB 528) Effective January 1, 2020. Section operative January 1, 2021, by its own provisions.)
  121. 11164.5.

    ## Health and Safety Code - HSC ## DIVISION 10. UNIFORM CONTROLLED SUBSTANCES ACT [11000 - 11651] ( Division 10 repealed and added by Stats. 1972, Ch. 1407. ) ## CHAPTER 4. Prescriptions [11150 - 11209] ( Chapter 4 added by Stats. 1972, Ch. 1407. ) ## ARTICLE 1. Requirements of Prescriptions [11150 - 11180] ( Article 1 added by Stats. 1972, Ch. 1407. )

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    Pharmacy or hospital computer systems must preserve electronic controlled-substance records and cannot let them be altered or destroyed; corrections after dispensing may be made only by or with a pharmacist’s approval.

    ## Health and Safety Code - HSC ## DIVISION 10. UNIFORM CONTROLLED SUBSTANCES ACT [11000 - 11651] ( Division 10 repealed and added by Stats. 1972, Ch. 1407. ) ## CHAPTER 4. Prescriptions [11150 - 11209] ( Chapter 4 added by Stats. 1972, Ch. 1407. ) ## ARTICLE 1. Requirements of Prescriptions [11150 - 11180] ( Article 1 added by Stats. 1972, Ch. 1407. ) ## 11164.5. (a) Notwithstanding Section 11164, if only recorded and stored electronically, on magnetic media, or in any other computerized form, the pharmacy’s or hospital’s computer system shall not permit the received information or the controlled substance dispensing information required by this section to be changed, obliterated, destroyed, or disposed of, for the record maintenance period required by law, once the information has been received by the pharmacy or the hospital and once the controlled substance has been dispensed, respectively. Once the controlled substance has been dispensed, if the previously created record is determined to be incorrect, a correcting addition may be made only by or with the approval of a pharmacist. After a pharmacist enters the change or enters his or her approval of the change into the computer, the resulting record shall include the correcting addition and the date it was made to the record, the identity of the person or pharmacist making the correction, and the identity of the pharmacist approving the correction. (b) Nothing in this section shall be construed to exempt any pharmacy or hospital dispensing Schedule II controlled substances pursuant to electronic transmission prescriptions from existing reporting requirements. (Amended by Stats. 2016, Ch. 484, Sec. 55. (SB 1193) Effective January 1, 2017.)
  122. 111640.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 6. Licenses [111615 - 111656.13] ( Article 6 added by Stats. 1995, Ch. 415, Sec. 6. )

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    The department must make any investigations or inspections authorized by Article 2 when it considers them necessary to carry out this chapter.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 6. Licenses [111615 - 111656.13] ( Article 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111640. The department shall make investigations or inspections authorized by Article 2 (commencing with Section 110410) of Chapter 2 as it deems necessary to carry out this chapter. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  123. 111645.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 6. Licenses [111615 - 111656.13] ( Article 6 added by Stats. 1995, Ch. 415, Sec. 6. )

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    A license may be denied, suspended, or revoked if there is a violation of this part or a regulation adopted under it.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 6. Licenses [111615 - 111656.13] ( Article 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111645. Any violation of any provision of this part or any regulation adopted pursuant to this part shall be grounds for denying a license or for suspending or revoking a license. Proceedings for the denial, suspension, or revocation of a license shall be conducted pursuant to Section 100171. (Amended by Stats. 1997, Ch. 220, Sec. 28. Effective August 4, 1997.)
  124. 11165.

    ## Health and Safety Code - HSC ## DIVISION 10. UNIFORM CONTROLLED SUBSTANCES ACT [11000 - 11651] ( Division 10 repealed and added by Stats. 1972, Ch. 1407. ) ## CHAPTER 4. Prescriptions [11150 - 11209] ( Chapter 4 added by Stats. 1972, Ch. 1407. ) ## ARTICLE 1. Requirements of Prescriptions [11150 - 11180] ( Article 1 added by Stats. 1972, Ch. 1407. )

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    This section requires the Department of Justice to maintain CURES, sets reporting and privacy rules for controlled-substance prescription data, and makes unauthorized access or sharing a misdemeanor.

    ## Health and Safety Code - HSC ## DIVISION 10. UNIFORM CONTROLLED SUBSTANCES ACT [11000 - 11651] ( Division 10 repealed and added by Stats. 1972, Ch. 1407. ) ## CHAPTER 4. Prescriptions [11150 - 11209] ( Chapter 4 added by Stats. 1972, Ch. 1407. ) ## ARTICLE 1. Requirements of Prescriptions [11150 - 11180] ( Article 1 added by Stats. 1972, Ch. 1407. ) ## 11165. (a) To assist health care practitioners in their efforts to ensure appropriate prescribing, ordering, administering, furnishing, and dispensing of controlled substances, law enforcement and regulatory agencies in their efforts to control the diversion and resultant abuse of Schedule II, Schedule III, Schedule IV, and Schedule V controlled substances, and for statistical analysis, education, and research, the Department of Justice shall, contingent upon the availability of adequate funds in the CURES Fund, maintain the Controlled Substance Utilization Review and Evaluation System (CURES) for the electronic monitoring of, and internet access to information regarding, the prescribing and dispensing of Schedule II, Schedule III, Schedule IV, and Schedule V controlled substances by all practitioners authorized to prescribe, order, administer, furnish, or dispense these controlled substances. (b) The department may seek and use grant funds to pay the costs incurred by the operation and maintenance of CURES. The department shall annually report to the Legislature and make available to the public the amount and source of funds it receives for support of CURES. (c) (1) The operation of CURES shall comply with all applicable federal and state privacy and security laws and regulations. (2) (A) CURES shall operate under existing provisions of law to safeguard the privacy and confidentiality of patients. Data obtained from CURES shall only be provided to appropriate state, local, and federal public agencies for disciplinary, civil, or criminal purposes and to other agencies or entities, as determined by the department, for the purpose of educating practitioners and others in lieu of disciplinary, civil, or criminal actions. Data may be provided to public or private entities, as approved by the department, for educational, peer review, statistical, or research purposes, if patient information, including information that may identify the patient, is not compromised. The University of California shall be provided access to identifiable data for research purposes if the requirements of subdivision (t) of Section 1798.24 of the Civil Code are satisfied. Further, data disclosed to an individual or agency as described in this subdivision shall not be disclosed, sold, or transferred to a third party, unless authorized by, or pursuant to, state and federal privacy and security laws and regulations. The department shall establish policies, procedures, and regulations regarding the use, access, evaluation, management, implementation, operation, storage, disclosure, and security of the information within CURES, consistent with this subdivision. (B) Notwithstanding subparagraph (A), a regulatory board whose licensees do not prescribe, order, administer, furnish, or dispense controlled substances shall not be provided data obtained from CURES. (C) (i) Notwithstanding subparagraph (A) or any other law, a state or local agency or employee, appointee, officer, contractor, or official or any other person acting on behalf of a public agency shall not knowingly provide any CURES data or knowingly expend or use time, money, facilities, property, equipment, personnel, or other resources in furtherance of any interstate investigation or proceeding seeking to impose civil, criminal, or disciplinary liability based on another state’s laws for the provision or receipt of legally protected health care activity, as defined in Section 1798.300 of the Civil Code. (ii) This section does not prohibit the investigation of any activity that is punishable as a crime under the laws of this state so long as CURES data related to any legally protected health care activity, as defined in Section 1798.300 of the Civil Code, is not knowingly shared with any individual or entity from another state. (iii) This section does not prohibit compliance with an audit or investigation of activity that is unlawful under the laws of this state or federal law, or with an audit, review, or investigation conducted for purposes of licensure, registration, accreditation, or certification under the laws of this state or federal law or pursuant to an accrediting organization recognized by the State Department of Public Health or the federal Centers for Medicare and Medicaid Services. (3) The department may adopt regulations regarding the access and use of the information within CURES. The department shall consult with all stakeholders identified by the department during the rulemaking process. The regulations shall, at a minimum, address all of the following in a manner consistent with this chapter: (A) The process for approving, denying, and disapproving individuals or entities seeking access to information in CURES. (B) The purposes for which a health care practitioner may access information in CURES. (C) The conditions under which a warrant, subpoena, or court order is required for a law enforcement agency to obtain information from CURES as part of a criminal investigation. (D) The process by which information in CURES may be provided for educational, peer review, statistical, or research purposes. (4) In accordance with federal and state privacy laws and regulations, a health care practitioner may provide a patient with a copy of the patient’s CURES patient activity report as long as no additional CURES data are provided and the health care practitioner keeps a copy of the report in the patient’s medical record in compliance with subdivision (d) of Section 11165.1. (d) Except as provided in subdivision (k), for each prescription for a Schedule II, Schedule III, Schedule IV, or Schedule V controlled substance, as defined in the controlled substances schedules in federal law and regulations, specifically Sections 1308.12, 1308.13, 1308.14, and 1308.15, respectively, of Title 21 of the Code of Federal Regulations, the dispensing pharmacy, clinic, or other dispenser shall report the following information to the department or contracted prescription data processing vendor as soon as reasonably possible, but not more than one working day after the date a controlled substance is released to the patient or patient’s representative, in a format specified by the department: (1) Full name, address, and, if available, telephone number of the ultimate user or research subject, or contact information as determined by the Secretary of the United States Department of Health and Human Services, and the gender and date of birth of the ultimate user. (2) The prescriber’s category of licensure, license number, national provider identifier (NPI) number, if applicable, the federal controlled substance registration number, and the state medical license number of a prescriber using the federal controlled substance registration number of a government-exempt facility. (3) Pharmacy prescription number, license number, NPI number, and federal controlled substance registration number. (4) National Drug Code (NDC) number of the controlled substance dispensed. (5) Quantity of the controlled substance dispensed. (6) The International Statistical Classification of Diseases (ICD) Code contained in the most current ICD revision, or any revision deemed sufficient by the State Board of Pharmacy, if available. (7) Number of refills ordered. (8) Whether the drug was dispensed as a refill of a prescription or as a first-time request. (9) Prescribing date of the prescription. (10) Date of dispensing of the prescription. (11) The serial number for the corresponding prescription form, if applicable. (e) The department may invite stakeholders to assist, advise, and make recommendations on the establishment of rules and regulations necessary to ensure the proper administration and enforcement of the CURES database. A prescriber or dispenser invitee shall be licensed by one of the boards or committees identified in subdivision (d) of Section 208 of the Business and Professions Code, in active practice in California, and a regular user of CURES. (f) The department shall, prior to upgrading CURES, consult with prescribers licensed by one of the boards or committees identified in subdivision (d) of Section 208 of the Business and Professions Code, one or more of the boards or committees identified in subdivision (d) of Section 208 of the Business and Professions Code, and any other stakeholder identified by the department, for the purpose of identifying desirable capabilities and upgrades to the CURES Prescription Drug Monitoring Program (PDMP). (g) The department may establish a process to educate authorized subscribers of the CURES PDMP on how to access and use the CURES PDMP. (h) (1) The department may enter into an agreement with an entity operating an interstate data sharing hub, or an agency operating a prescription drug monitoring program in another state, for purposes of interstate data sharing of prescription drug monitoring program information. An out-of-state authorized user who obtains CURES data through the interstate data sharing hub shall not provide any CURES data in furtherance of any investigation or proceeding seeking to impose civil, criminal, or disciplinary liability based on another state’s laws for the provision or receipt of legally protected health care activity, as defined in Section 1798.300 of the Civil Code. (2) Data obtained from CURES may be provided to authorized users of another state’s prescription drug monitoring program, as determined by the department pursuant to subdivision (c), if the entity operating the interstate data sharing hub, and the prescription drug monitoring program of that state, as applicable, have entered into an agreement with the department for interstate data sharing of prescription drug monitoring program information. (3) An agreement entered into by the department for purposes of interstate data sharing of prescription drug monitoring program information shall ensure that all access to data obtained from CURES and the handling of data contained within CURES comply with California law, including regulations, and meet the same patient privacy, audit, and data security standards employed and required for direct access to CURES. (4) For purposes of interstate data sharing of CURES information pursuant to this subdivision, an authorized user of another state’s prescription drug monitoring program shall not be required to register with CURES, if the authorized user is registered and in good standing with that state’s prescription drug monitoring program. (5) The department shall not enter into an agreement pursuant to this subdivision until the department has issued final regulations regarding the access and use of the information within CURES as required by paragraph (3) of subdivision (c). (6) Notwithstanding subdivision (c), the department shall not provide CURES data to out-of-state law enforcement absent a warrant, subpoena, or court order, issued pursuant to Section 2029.300 or 2029.350 of the Code of Civil Procedure, or Section 1326 of the Penal Code. (i) Notwithstanding subdivision (d), a veterinarian shall report the information required by that subdivision to the department as soon as reasonably possible, but not more than seven days after the date a controlled substance is dispensed. (j) If the dispensing pharmacy, clinic, or other dispenser experiences a temporary technological or electrical failure, it shall, without undue delay, seek to correct any cause of the temporary technological or electrical failure that is reasonably within its control. The deadline for transmitting prescription information to the department or contracted prescription data processing vendor pursuant to subdivision (d) shall be extended until the failure is corrected. If the dispensing pharmacy, clinic, or other dispenser experiences technological limitations that are not reasonably within its control, or is impacted by a natural or manmade disaster, the deadline for transmitting prescription information to the department or contracted prescription data processing vendor shall be extended until normal operations have resumed. (k) (1) Notwithstanding subdivision (d), a prescription for or the dispensing of testosterone or mifepristone shall not be reported to the department, CURES, or a contracted prescription data processing vendor. (2) On or before January 1, 2027, the department shall remove existing records of a prescription described in this subdivision created or maintained prior to January 1, 2026. (l) (1) Any person who accesses the CURES database and who is not authorized by law to do so is guilty of a misdemeanor. (2) Any person authorized by law to access the CURES database and who knowingly furnishes the information from the CURES database to a person who is not authorized by law to receive that information is guilty of a misdemeanor. (3) This subdivision does not apply to a provider of health care as defined in Section 56.06 of the Civil Code that is subject to applicable state and federal medical privacy laws. (Amended by Stats. 2025, Ch. 764, Sec. 5.5. (SB 497) Effective October 13, 2025. Operative January 1, 2026, pursuant to Sec. 8 of Stats. 2025, Ch. 764.)
  125. 11165.1.

    ## Health and Safety Code - HSC ## DIVISION 10. UNIFORM CONTROLLED SUBSTANCES ACT [11000 - 11651] ( Division 10 repealed and added by Stats. 1972, Ch. 1407. ) ## CHAPTER 4. Prescriptions [11150 - 11209] ( Chapter 4 added by Stats. 1972, Ch. 1407. ) ## ARTICLE 1. Requirements of Prescriptions [11150 - 11180] ( Article 1 added by Stats. 1972, Ch. 1407. )

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    This section sets rules for obtaining, using, and controlling access to CURES controlled-substance history data.

    ## Health and Safety Code - HSC ## DIVISION 10. UNIFORM CONTROLLED SUBSTANCES ACT [11000 - 11651] ( Division 10 repealed and added by Stats. 1972, Ch. 1407. ) ## CHAPTER 4. Prescriptions [11150 - 11209] ( Chapter 4 added by Stats. 1972, Ch. 1407. ) ## ARTICLE 1. Requirements of Prescriptions [11150 - 11180] ( Article 1 added by Stats. 1972, Ch. 1407. ) ## 11165.1. (a) (1) (A) (i) A health care practitioner authorized to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, Schedule IV, or Schedule V controlled substances pursuant to Section 11150 shall, upon receipt of a federal Drug Enforcement Administration (DEA) registration, submit an application developed by the department to obtain approval to electronically access information regarding the controlled substance history of a patient that is maintained by the department. Upon approval, the department shall release to the practitioner or their delegate the electronic history of controlled substances dispensed to an individual under the practitioner’s care based on data contained in the CURES Prescription Drug Monitoring Program (PDMP). (ii) A pharmacist shall, upon licensure, submit an application developed by the department to obtain approval to electronically access information regarding the controlled substance history of a patient that is maintained by the department. Upon approval, the department shall release to the pharmacist or their delegate the electronic history of controlled substances dispensed to an individual under the pharmacist’s care based on data contained in the CURES PDMP. (iii) A licensed physician and surgeon who does not hold a DEA registration may submit an application developed by the department to obtain approval to electronically access information regarding the controlled substance history of the patient that is maintained by the department. Upon approval, the department shall release to the physician and surgeon or their delegate the electronic history of controlled substances dispensed to a patient under their care based on data contained in the CURES PDMP. (iv) The department shall implement its duties described in clauses (i), (ii), and (iii) upon completion of any technological changes to the CURES database necessary to support clauses (i), (ii), and (iii), or by October 1, 2022, whichever is sooner. (B) The department may deny an application or suspend a subscriber, for reasons that include, but are not limited to, the following: (i) Materially falsifying an application to access information contained in the CURES database. (ii) Failing to maintain effective controls for access to the patient activity report. (iii) Having their federal DEA registration suspended or revoked. (iv) Violating a law governing controlled substances or another law for which the possession or use of a controlled substance is an element of the crime. (v) Accessing information for a reason other than to diagnose or treat a patient, or to document compliance with the law. (C) An authorized subscriber shall notify the department within 30 days of a change to the subscriber account. (D) An approved health care practitioner, pharmacist, or a person acting on behalf of a health care practitioner or pharmacist pursuant to subdivision (b) of Section 209 of the Business and Professions Code may use the department’s online portal or a health information technology system that meets the criteria required in subparagraph (E) to access information in the CURES database pursuant to this section. A subscriber who uses a health information technology system that meets the criteria required in subparagraph (E) to access the CURES database may submit automated queries to the CURES database that are triggered by predetermined criteria. (E) An approved health care practitioner or pharmacist may submit queries to the CURES database through a health information technology system if the entity that operates the health information technology system certifies all of the following: (i) The entity will not use or disclose data received from the CURES database for a purpose other than delivering the data to an approved health care practitioner or pharmacist or performing data processing activities that may be necessary to enable the delivery unless authorized by, and pursuant to, state and federal privacy and security laws and regulations. (ii) The health information technology system will authenticate the identity of an authorized health care practitioner or pharmacist initiating queries to the CURES database and, at the time of the query to the CURES database, the health information technology system submits the following data regarding the query to CURES: (I) The date of the query. (II) The time of the query. (III) The first and last name of the patient queried. (IV) The date of birth of the patient queried. (V) The identification of the CURES user for whom the system is making the query. (iii) The health information technology system meets applicable patient privacy and information security requirements of state and federal law. (iv) The entity has entered into a memorandum of understanding with the department that solely addresses the technical specifications of the health information technology system to ensure the security of the data in the CURES database and the secure transfer of data from the CURES database. The technical specifications shall be universal for all health information technology systems that establish a method of system integration to retrieve information from the CURES database. The memorandum of understanding shall not govern, or in any way impact or restrict, the use of data received from the CURES database or impose any additional burdens on covered entities in compliance with the regulations promulgated pursuant to the federal Health Insurance Portability and Accountability Act of 1996 found in Parts 160 and 164 of Title 45 of the Code of Federal Regulations. (F) No later than October 1, 2018, the department shall develop a programming interface or other method of system integration to allow health information technology systems that meet the requirements in subparagraph (E) to retrieve information in the CURES database on behalf of an authorized health care practitioner or pharmacist. (G) The department shall not access patient-identifiable information in an entity’s health information technology system. (H) An entity that operates a health information technology system that is requesting to establish an integration with the CURES database shall pay a reasonable fee to cover the cost of establishing and maintaining integration with the CURES database. (I) The department may prohibit integration or terminate a health information technology system’s ability to retrieve information in the CURES database if the health information technology system fails to meet the requirements of subparagraph (E), or the entity operating the health information technology system does not fulfill its obligation under subparagraph (H). (2) A health care practitioner authorized to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, Schedule IV, or Schedule V controlled substances pursuant to Section 11150 or a pharmacist shall be deemed to have complied with paragraph (1) if the licensed health care practitioner or pharmacist has been approved to access the CURES database through the process developed pursuant to subdivision (a) of Section 209 of the Business and Professions Code. (b) A request for, or release of, a controlled substance history pursuant to this section shall be made in accordance with guidelines developed by the department. (c) In order to prevent the inappropriate, improper, or illegal use of Schedule II, Schedule III, Schedule IV, or Schedule V controlled substances, the department may initiate the referral of the history of controlled substances dispensed to an individual based on data contained in CURES to licensed health care practitioners, pharmacists, or both, providing care or services to the individual. (d) The history of controlled substances dispensed to an individual based on data contained in CURES that is received by a practitioner or pharmacist from the department pursuant to this section is medical information subject to the provisions of the Confidentiality of Medical Information Act contained in Part 2.6 (commencing with Section 56) of Division 1 of the Civil Code. (e) Information concerning a patient’s controlled substance history provided to a practitioner or pharmacist pursuant to this section shall include prescriptions for controlled substances listed in Sections 1308.12, 1308.13, 1308.14, and 1308.15 of Title 21 of the Code of Federal Regulations. (f) A health care practitioner, pharmacist, or a person acting on behalf of a health care practitioner or pharmacist, when acting with reasonable care and in good faith, is not subject to civil or administrative liability arising from false, incomplete, inaccurate, or misattributed information submitted to, reported by, or relied upon in the CURES database or for a resulting failure of the CURES database to accurately or timely report that information. (g) For purposes of this section, the following terms have the following meanings: (1) “Automated basis” means using predefined criteria to trigger an automated query to the CURES database, which can be attributed to a specific health care practitioner or pharmacist. (2) “Department” means the Department of Justice. (3) “Entity” means an organization that operates, or provides or makes available, a health information technology system to a health care practitioner or pharmacist. (4) “Health information technology system” means an information processing application using hardware and software for the storage, retrieval, sharing of or use of patient data for communication, decisionmaking, coordination of care, or the quality, safety, or efficiency of the practice of medicine or delivery of health care services, including, but not limited to, electronic medical record applications, health information exchange systems, or other interoperable clinical or health care information system. (h) This section shall become operative on July 1, 2021, or upon the date the department promulgates regulations to implement this section and posts those regulations on its internet website, whichever date is earlier. (Amended (as added by Stats. 2019, Ch. 677, Sec. 8) by Stats. 2021, Ch. 77, Sec. 20. (AB 137) Effective July 16, 2021.)
  126. 11165.2.

    ## Health and Safety Code - HSC ## DIVISION 10. UNIFORM CONTROLLED SUBSTANCES ACT [11000 - 11651] ( Division 10 repealed and added by Stats. 1972, Ch. 1407. ) ## CHAPTER 4. Prescriptions [11150 - 11209] ( Chapter 4 added by Stats. 1972, Ch. 1407. ) ## ARTICLE 1. Requirements of Prescriptions [11150 - 11180] ( Article 1 added by Stats. 1972, Ch. 1407. )

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    The Department of Justice may audit the CURES program and create a citation system for subscriber violations, with fines capped at $2,500 per violation and set procedures for hearings, informal conferences, abatement, and discipline.

    ## Health and Safety Code - HSC ## DIVISION 10. UNIFORM CONTROLLED SUBSTANCES ACT [11000 - 11651] ( Division 10 repealed and added by Stats. 1972, Ch. 1407. ) ## CHAPTER 4. Prescriptions [11150 - 11209] ( Chapter 4 added by Stats. 1972, Ch. 1407. ) ## ARTICLE 1. Requirements of Prescriptions [11150 - 11180] ( Article 1 added by Stats. 1972, Ch. 1407. ) ## 11165.2. (a) The Department of Justice may conduct audits of the CURES Prescription Drug Monitoring Program system and its users. (b) The Department of Justice may establish, by regulation, a system for the issuance to a CURES Prescription Drug Monitoring Program subscriber of a citation which may contain an order of abatement, or an order to pay an administrative fine assessed by the Department of Justice if the subscriber is in violation of any provision of this chapter or any regulation adopted by the Department of Justice pursuant to this chapter. (c) The system shall contain the following provisions: (1) Citations shall be in writing and shall describe with particularity the nature of the violation, including specific reference to the provision of law or regulation of the department determined to have been violated. (2) Whenever appropriate, the citation shall contain an order of abatement establishing a reasonable time for abatement of the violation. (3) In no event shall the administrative fine assessed by the department exceed two thousand five hundred dollars ($2,500) for each violation. In assessing a fine, due consideration shall be given to the appropriateness of the amount of the fine with respect to such factors as the gravity of the violation, the good faith of the subscribers, and the history of previous violations. (4) An order of abatement or a fine assessment issued pursuant to a citation shall inform the subscriber that if the subscriber desires a hearing to contest the finding of a violation, a hearing shall be requested by written notice to the CURES Prescription Drug Monitoring Program within 30 days of the date of issuance of the citation or assessment. Hearings shall be held pursuant to Chapter 5 (commencing with Section 11500) of Part 1 of Division 3 of Title 2 of the Government Code. (5) In addition to requesting a hearing, the subscriber may, within 10 days after service of the citation, request in writing an opportunity for an informal conference with the department regarding the citation. At the conclusion of the informal conference, the department may affirm, modify, or dismiss the citation, including any fine levied or order of abatement issued. The decision shall be deemed to be a final order with regard to the citation issued, including the fine levied or the order of abatement which could include permanent suspension to the system, a monetary fine, or both, depending on the gravity of the violation. However, the subscriber does not waive its right to request a hearing to contest a citation by requesting an informal conference. If the citation is affirmed, a formal hearing may be requested within 30 days of the date the citation was affirmed. If the citation is dismissed after the informal conference, the request for a hearing on the matter of the citation shall be deemed to be withdrawn. If the citation, including any fine levied or order of abatement, is modified, the citation originally issued shall be considered withdrawn and a new citation issued. If a hearing is requested for a subsequent citation, it shall be requested within 30 days of service of that subsequent citation. (6) Failure of a subscriber to pay a fine within 30 days of the date of assessment or comply with an order of abatement within the fixed time, unless the citation is being appealed, may result in disciplinary action taken by the department. If a citation is not contested and a fine is not paid, the subscriber account will be terminated: (A) A citation may be issued without the assessment of an administrative fine. (B) Assessment of administrative fines may be limited to only particular violations of law or department regulations. (d) Notwithstanding any other provision of law, if a fine is paid to satisfy an assessment based on the finding of a violation, payment of the fine shall be represented as a satisfactory resolution of the matter for purposes of public disclosure. (e) Administrative fines collected pursuant to this section shall be deposited in the CURES Program Special Fund, available upon appropriation by the Legislature. These special funds shall provide support for costs associated with informal and formal hearings, maintenance, and updates to the CURES Prescription Drug Monitoring Program. (f) The sanctions authorized under this section shall be separate from, and in addition to, any other administrative, civil, or criminal remedies; however, a criminal action may not be initiated for a specific offense if a citation has been issued pursuant to this section for that offense, and a citation may not be issued pursuant to this section for a specific offense if a criminal action for that offense has been filed. (g) Nothing in this section shall be deemed to prevent the department from serving and prosecuting an accusation to suspend or revoke a subscriber if grounds for that suspension or revocation exist. (Added by Stats. 2011, Ch. 418, Sec. 5. (SB 360) Effective January 1, 2012.)
  127. 11165.3.

    ## Health and Safety Code - HSC ## DIVISION 10. UNIFORM CONTROLLED SUBSTANCES ACT [11000 - 11651] ( Division 10 repealed and added by Stats. 1972, Ch. 1407. ) ## CHAPTER 4. Prescriptions [11150 - 11209] ( Chapter 4 added by Stats. 1972, Ch. 1407. ) ## ARTICLE 1. Requirements of Prescriptions [11150 - 11180] ( Article 1 added by Stats. 1972, Ch. 1407. )

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    Security printers or affected prescribers must report theft or loss of prescription forms right away, and no later than 3 days after discovery.

    ## Health and Safety Code - HSC ## DIVISION 10. UNIFORM CONTROLLED SUBSTANCES ACT [11000 - 11651] ( Division 10 repealed and added by Stats. 1972, Ch. 1407. ) ## CHAPTER 4. Prescriptions [11150 - 11209] ( Chapter 4 added by Stats. 1972, Ch. 1407. ) ## ARTICLE 1. Requirements of Prescriptions [11150 - 11180] ( Article 1 added by Stats. 1972, Ch. 1407. ) ## 11165.3. The theft or loss of prescription forms shall be reported immediately by the security printer or affected prescriber to the CURES Prescription Drug Monitoring Program, but no later than three days after the discovery of the theft or loss. This notification may be done in writing utilizing the approved Department of Justice form or may be reported by the authorized subscriber through the CURES Prescription Drug Monitoring Program. (Amended by Stats. 2012, Ch. 867, Sec. 7. (SB 1144) Effective January 1, 2013.)
  128. 11165.4.

    ## Health and Safety Code - HSC ## DIVISION 10. UNIFORM CONTROLLED SUBSTANCES ACT [11000 - 11651] ( Division 10 repealed and added by Stats. 1972, Ch. 1407. ) ## CHAPTER 4. Prescriptions [11150 - 11209] ( Chapter 4 added by Stats. 1972, Ch. 1407. ) ## ARTICLE 1. Requirements of Prescriptions [11150 - 11180] ( Article 1 added by Stats. 1972, Ch. 1407. )

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    Health care practitioners must check the CURES database before prescribing certain controlled substances, and must document or update the review in specified situations.

    ## Health and Safety Code - HSC ## DIVISION 10. UNIFORM CONTROLLED SUBSTANCES ACT [11000 - 11651] ( Division 10 repealed and added by Stats. 1972, Ch. 1407. ) ## CHAPTER 4. Prescriptions [11150 - 11209] ( Chapter 4 added by Stats. 1972, Ch. 1407. ) ## ARTICLE 1. Requirements of Prescriptions [11150 - 11180] ( Article 1 added by Stats. 1972, Ch. 1407. ) ## 11165.4. (a) (1) (A) (i) A health care practitioner authorized to prescribe, order, administer, or furnish a controlled substance shall consult the patient activity report or information from the patient activity report obtained from the CURES database to review a patient’s controlled substance history for the past 12 months before prescribing a Schedule II, Schedule III, or Schedule IV controlled substance to the patient for the first time and at least once every six months thereafter if the prescriber renews the prescription and the substance remains part of the treatment of the patient. (ii) If a health care practitioner authorized to prescribe, order, administer, or furnish a controlled substance is not required, pursuant to an exemption described in subdivision (c), to consult the patient activity report from the CURES database the first time the health care practitioner prescribes, orders, administers, or furnishes a controlled substance to a patient, the health care practitioner shall consult the patient activity report from the CURES database to review the patient’s controlled substance history before subsequently prescribing a Schedule II, Schedule III, or Schedule IV controlled substance to the patient and at least once every six months thereafter if the prescriber renews the prescription and the substance remains part of the treatment of the patient. (iii) A health care practitioner who did not directly access the CURES database to perform the required review of the controlled substance use report shall document in the patient’s medical record that they reviewed the CURES database generated report within 24 hours of the controlled substance prescription that was provided to them by another authorized user of the CURES database. (B) For purposes of this paragraph, “first time” means the initial occurrence in which a health care practitioner, in their role as a health care practitioner, intends to prescribe, order, administer, or furnish a Schedule II, Schedule III, or Schedule IV controlled substance to a patient and has not previously prescribed a controlled substance to the patient. (2) A health care practitioner shall review a patient’s controlled substance history that has been obtained from the CURES database no earlier than 24 hours, or the previous business day, before the health care practitioner prescribes, orders, administers, or furnishes a Schedule II, Schedule III, or Schedule IV controlled substance to the patient. (b) The duty to consult the CURES database, as described in subdivision (a), does not apply to veterinarians or pharmacists. (c) The duty to consult the CURES database, as described in subdivision (a), does not apply to a health care practitioner in any of the following circumstances: (1) If a health care practitioner prescribes, orders, or furnishes a controlled substance to be administered to a patient in any of the following facilities or during a transfer between any of the following facilities, or for use while on facility premises: (A) A licensed clinic, as described in Chapter 1 (commencing with Section 1200) of Division 2. (B) An outpatient setting, as described in Chapter 1.3 (commencing with Section 1248) of Division 2. (C) A health facility, as described in Chapter 2 (commencing with Section 1250) of Division 2. (D) A county medical facility, as described in Chapter 2.5 (commencing with Section 1440) of Division 2. (E) Another medical facility, including, but not limited to, an office of a health care practitioner and an imaging center. (F) A correctional clinic, as described in Section 4187 of the Business and Professions Code, or a correctional pharmacy, as described in Section 4021.5 of the Business and Professions Code. (2) If a health care practitioner prescribes, orders, administers, or furnishes a controlled substance in the emergency department of a general acute care hospital and the quantity of the controlled substance does not exceed a nonrefillable seven-day supply of the controlled substance to be used in accordance with the directions for use. (3) If a health care practitioner prescribes, orders, administers, or furnishes buprenorphine or other controlled substance containing buprenorphine in the emergency department of a general acute care hospital. (4) If a health care practitioner prescribes, orders, administers, or furnishes a controlled substance to a patient as part of the patient’s treatment for a surgical, radiotherapeutic, therapeutic, or diagnostic procedure and the quantity of the controlled substance does not exceed a nonrefillable seven-day supply of the controlled substance to be used in accordance with the directions for use, in any of the following facilities: (A) A licensed clinic, as described in Chapter 1 (commencing with Section 1200) of Division 2. (B) An outpatient setting, as described in Chapter 1.3 (commencing with Section 1248) of Division 2. (C) A health facility, as described in Chapter 2 (commencing with Section 1250) of Division 2. (D) A county medical facility, as described in Chapter 2.5 (commencing with Section 1440) of Division 2. (E) A place of practice, as defined in Section 1658 of the Business and Professions Code. (F) Another medical facility where surgical procedures are permitted to take place, including, but not limited to, the office of a health care practitioner. (5) If a health care practitioner prescribes, orders, administers, or furnishes a controlled substance to a patient who is terminally ill, as defined in subdivision (c) of Section 11159.2. (6) (A) If all of the following circumstances are satisfied: (i) It is not reasonably possible for a health care practitioner to access the information in the CURES database in a timely manner. (ii) Another health care practitioner or designee authorized to access the CURES database is not reasonably available. (iii) The quantity of controlled substance prescribed, ordered, administered, or furnished does not exceed a nonrefillable seven-day supply of the controlled substance to be used in accordance with the directions for use and no refill of the controlled substance is allowed. (B) A health care practitioner who does not consult the CURES database under subparagraph (A) shall document the reason they did not consult the database in the patient’s medical record. (7) If the CURES database is not operational, as determined by the department, or cannot be accessed by a health care practitioner because of a temporary technological or electrical failure. A health care practitioner shall, without undue delay, seek to correct the cause of the temporary technological or electrical failure that is reasonably within the health care practitioner’s control. (8) If the CURES database cannot be accessed because of technological limitations that are not reasonably within the control of a health care practitioner. (9) If consultation of the CURES database would, as determined by the health care practitioner, result in a patient’s inability to obtain a prescription in a timely manner and thereby adversely impact the patient’s medical condition, provided that the quantity of the controlled substance does not exceed a nonrefillable seven-day supply if the controlled substance were used in accordance with the directions for use. (d) (1) A health care practitioner who fails to consult the CURES database, as described in subdivision (a), shall be referred to the appropriate state professional licensing board solely for administrative sanctions, as deemed appropriate by that board. (2) This section does not create a private cause of action against a health care practitioner. This section does not limit a health care practitioner’s liability for the negligent failure to diagnose or treat a patient. (e) All applicable state and federal privacy laws govern the duties required by this section. (f) The provisions of this section are severable. If any provision of this section or its application is held invalid, that invalidity shall not affect other provisions or applications that can be given effect without the invalid provision or application. (g) This section shall become operative on July 1, 2021, or upon the date the department promulgates regulations to implement this section and posts those regulations on its internet website, whichever date is earlier. (Amended by Stats. 2023, Ch. 144, Sec. 1. (AB 1731) Effective January 1, 2024.)
  129. 11165.5.

    ## Health and Safety Code - HSC ## DIVISION 10. UNIFORM CONTROLLED SUBSTANCES ACT [11000 - 11651] ( Division 10 repealed and added by Stats. 1972, Ch. 1407. ) ## CHAPTER 4. Prescriptions [11150 - 11209] ( Chapter 4 added by Stats. 1972, Ch. 1407. ) ## ARTICLE 1. Requirements of Prescriptions [11150 - 11180] ( Article 1 added by Stats. 1972, Ch. 1407. )

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    The Department of Justice may seek voluntary private funding for CURES, donors may contribute through the Controller, and the department must publicly disclose the amount and source of private funds received.

    ## Health and Safety Code - HSC ## DIVISION 10. UNIFORM CONTROLLED SUBSTANCES ACT [11000 - 11651] ( Division 10 repealed and added by Stats. 1972, Ch. 1407. ) ## CHAPTER 4. Prescriptions [11150 - 11209] ( Chapter 4 added by Stats. 1972, Ch. 1407. ) ## ARTICLE 1. Requirements of Prescriptions [11150 - 11180] ( Article 1 added by Stats. 1972, Ch. 1407. ) ## 11165.5. (a) The Department of Justice may seek voluntarily contributed private funds from insurers, health care service plans, qualified manufacturers, and other donors for the purpose of supporting CURES. Insurers, health care service plans, qualified manufacturers, and other donors may contribute by submitting their payment to the Controller for deposit into the CURES Fund established pursuant to subdivision (c) of Section 208 of the Business and Professions Code. The department shall make information about the amount and the source of all private funds it receives for support of CURES available to the public. Contributions to the CURES Fund pursuant to this subdivision shall be nondeductible for state tax purposes. (b) For purposes of this section, the following definitions apply: (1) “Controlled substance” means a drug, substance, or immediate precursor listed in any schedule in Section 11055, 11056, or 11057 of the Health and Safety Code. (2) “Health care service plan” means an entity licensed pursuant to 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). (3) “Insurer” means an admitted insurer writing health insurance, as defined in Section 106 of the Insurance Code, and an admitted insurer writing workers’ compensation insurance, as defined in Section 109 of the Insurance Code. (4) “Qualified manufacturer” means a manufacturer of a controlled substance, but does not mean a wholesaler or nonresident wholesaler of dangerous drugs, regulated pursuant to Article 11 (commencing with Section 4160) of Chapter 9 of Division 2 of the Business and Professions Code, a veterinary food-animal drug retailer, regulated pursuant to Article 15 (commencing with Section 4196) of Chapter 9 of Division 2 of the Business and Professions Code, or an individual regulated by the Medical Board of California, the Dental Board of California, the California State Board of Pharmacy, the Veterinary Medical Board, the Board of Registered Nursing, the Physician Assistant Committee of the Medical Board of California, the Osteopathic Medical Board of California, the State Board of Optometry, or the California Board of Podiatric Medicine. (Added by Stats. 2013, Ch. 400, Sec. 8. (SB 809) Effective January 1, 2014.)
  130. 11165.6.

    ## Health and Safety Code - HSC ## DIVISION 10. UNIFORM CONTROLLED SUBSTANCES ACT [11000 - 11651] ( Division 10 repealed and added by Stats. 1972, Ch. 1407. ) ## CHAPTER 4. Prescriptions [11150 - 11209] ( Chapter 4 added by Stats. 1972, Ch. 1407. ) ## ARTICLE 1. Requirements of Prescriptions [11150 - 11180] ( Article 1 added by Stats. 1972, Ch. 1407. )

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    A prescriber may access the CURES database for a list of patients for whom that prescriber is listed as a prescriber.

    ## Health and Safety Code - HSC ## DIVISION 10. UNIFORM CONTROLLED SUBSTANCES ACT [11000 - 11651] ( Division 10 repealed and added by Stats. 1972, Ch. 1407. ) ## CHAPTER 4. Prescriptions [11150 - 11209] ( Chapter 4 added by Stats. 1972, Ch. 1407. ) ## ARTICLE 1. Requirements of Prescriptions [11150 - 11180] ( Article 1 added by Stats. 1972, Ch. 1407. ) ## 11165.6. A prescriber shall be allowed to access the CURES database for a list of patients for whom that prescriber is listed as a prescriber in the CURES database. (Added by Stats. 2018, Ch. 274, Sec. 1. (AB 2086) Effective January 1, 2019.)
  131. 111650.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 6. Licenses [111615 - 111656.13] ( Article 6 added by Stats. 1995, Ch. 415, Sec. 6. )

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    Drug manufacturers with, or applying for, a license must give the California State Board of Pharmacy information the Board reasonably needs, including drug inventory or restricted dangerous drug information.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 6. Licenses [111615 - 111656.13] ( Article 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111650. Drug manufacturers who have obtained a license or who are applying for a license pursuant to this article shall submit to the California State Board of Pharmacy information as the Board of Pharmacy deems reasonably necessary to carry out its drug distribution responsibilities including, but not limited to, information on drug inventories or restricted dangerous drugs. Failure of any manufacturer to report the information to the Board of Pharmacy in a timely fashion shall be grounds for the department to deny, suspend, or revoke the manufacturer’s license. The California State Board of Pharmacy may adopt regulations that are reasonably necessary to implement this section. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  132. 111655.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 6. Licenses [111615 - 111656.13] ( Article 6 added by Stats. 1995, Ch. 415, Sec. 6. )

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    This section says the chapter’s licensing rules do not apply to several listed kinds of pharmacies, licensed practitioners, wholesalers, and certain other exempt classes.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 6. Licenses [111615 - 111656.13] ( Article 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111655. The licensing provisions of this chapter shall not apply to any of the following: (a) Any pharmacy that maintains establishments in conformance with provisions of the Pharmacy Law, Chapter 9 (commencing with Section 4000) of Division 2 of the Business and Professions Code, regulating the practice of pharmacy, and that is regularly engaged in dispensing prescription drugs or devices, upon prescriptions of any person licensed to administer the drugs or devices to patients under the care of the person in the course of his or her professional practice, and that does not manufacture, prepare, propagate, compound, or process drugs or devices for sale other than in the regular course of his or her business of dispensing or selling drugs or devices at retail. (b) Any pharmacy that solely engages in providing drugs or devices to a person licensed by law to administer the drug or device for his or her use in the course of his or her professional practice. (c) Any pharmacy that solely provides drugs or devices to another pharmacy in order to meet a temporary inventory shortage. (d) Any person who is licensed by law to prescribe or administer drugs or devices and who manufactures, prepares, propagates, compounds, or processes drugs or devices solely for use in the course of his or her professional practice. (e) Any person who manufactures, prepares, propagates, compounds, or processes any drug or device solely for use in nonclinical research, teaching, or chemical analysis and not for sale. (f) Any wholesaler, as defined in Section 4038 of the Business and Professions Code. (g) Any such other class of persons as the department may by regulation exempt from the application of this article upon a finding that licensing by a class of persons in accordance with this article is not necessary for the protection of the public health. (h) Any registered dispensing optician licensed pursuant to the provisions of Chapter 5.5 (commencing with Section 2550) of Division 2 of the Business and Professions Code, who is regularly engaged in dispensing or selling prescription lenses and frames, and not engaged in the manufacture, preparation, processing or assembling of lenses or frames for sale other than in the regular course of his or her business of dispensing or selling lenses or frames at retail. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  133. 111656.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 6. Licenses [111615 - 111656.13] ( Article 6 added by Stats. 1995, Ch. 415, Sec. 6. )

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    A person may not run a home medical device retail facility business in California without a department license. Licenses must be renewed yearly, are nontransferable, and the licensee is responsible for compliance.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 6. Licenses [111615 - 111656.13] ( Article 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111656. (a) No person shall conduct a home medical device retail facility business in the State of California unless he or she has obtained a license from the department. A license shall be required for each home medical device retail facility owned or operated by a specific person. A separate license shall be required for each of the premises of any person operating a home medical device retail facility in more than one location. The license shall be renewed annually and shall not be transferable. The licensee shall be responsible for assuring compliance with all requirements of this article pertaining to home medical device retail facilities. (b) Applications for a home medical device retail facility license shall be made on a form furnished by the department. The department may require any information it deems reasonably necessary to carry out the purposes of this section. (c) A warehouse owned by a home medical device retail facility the primary purpose of which is storage, not dispensing of home medical devices to patients, shall be licensed at a fee one-half of that for a home medical device retail facility. There shall be no separate or additional license fee for warehouse premises owned by a home medical device retail facility that are physically connected to the retail premises or that share common access. (d) The department may, at its discretion, issue a temporary license when the ownership of a home medical device retail facility is transferred from one person to another upon any conditions and for the periods of time as the department determines to be in the public interest. A temporary license fee shall be established by the department at an amount not to exceed the annual fee for renewal of a license to conduct a home medical device retail facility. (e) Notwithstanding any other provision of law, a licensed home medical device retail facility may furnish a prescription 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 Health Services set forth in Title 22 of the California Code of Regulations. (f) The licensure requirements of this section shall not apply to the following entities or practitioners, unless the entities or practitioners furnish home medical devices or home medical device services through a separate entity including, but not limited to, a corporate entity, division, or other business entity: (1) Home health agencies that do not have a Part B Medicare supplier number. (2) Hospitals, excluding providers of home medical devices that are owned or related to a hospital. (3) Manufacturers and wholesale distributors, if not selling directly to the patient. (4) Health care practitioners authorized to prescribe or order home medical devices or who use home medical devices or who use home medical devices to treat their patients. (5) Licensed pharmacists and pharmacies. Pharmacies that sell or rent home medical devices shall be governed by the provisions of Chapter 9 (commencing with Section 4000) of Division 2 of the Business and Professions Code and any rules and regulations adopted by the California State Board of Pharmacy. (6) Licensed hospice programs. (7) Licensed nursing homes. (8) Licensed veterinarians. (9) Licensed dentists. (10) Emergency medical services provider. (11) Breast feeding support programs. (Amended by Stats. 2001, Ch. 728, Sec. 71. Effective January 1, 2002.)
  134. 111656.10.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 6. Licenses [111615 - 111656.13] ( Article 6 added by Stats. 1995, Ch. 415, Sec. 6. )

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    The department may void a home medical device retail facility’s license if the premises stay closed, and the licensee must transfer prescription devices after voidance or closure-related notice.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 6. Licenses [111615 - 111656.13] ( Article 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111656.10. (a) The department may void the license of a home medical device retail facility, if the licensed premises remain closed, as defined in subdivision (e), other than by order of the department. For good cause shown, the department may void a license after a shorter period of closure. To void a license pursuant to this subdivision, the department shall make a diligent, good faith effort to give notice by personal service on the licensee. If no written objection is 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 department may void the license without the necessity of a hearing. If the licensee files a written objection, the department 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 department shall have all the powers granted in that chapter. (b) In the event that the license of a home medical device retail facility is voided pursuant to subdivision (a) or revoked or a home medical device retail facility notifies the department of its intent to remain closed or to discontinue business, the licensee shall, within 10 days thereafter, arrange for the transfer of all prescription devices to another licensee authorized to possess the prescription devices. The licensee transferring the prescription devices shall immediately confirm in writing to the department that the transfer has taken place. (c) If a home medical device retail facility fails to comply with subdivision (b), the department may seek and obtain an order from the superior court in the county in which the home medical device retail facility is located, authorizing the department to enter the home medical device retail facility and inventory and store, transfer, sell, or arrange for the sale of, prescription devices found in the home medical device retail facility. (d) In the event that the department sells or arranges for the sale of any prescription devices pursuant to subdivision (c), the department may retain from the proceeds of the sale an amount equal to the cost to the department of obtaining and enforcing an order issued pursuant to subdivision (c), including the cost of disposing of the prescription devices. The remaining proceeds, if any, shall be returned to the licensee from whose premises the prescription devices were removed. (1) The licensee shall be notified of his or her right to the remaining proceeds by personal service or by certified mail, postage prepaid. (2) Where a statute or regulation requires the licensee to file with the department his or her 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 department, 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 department for the remaining proceeds within 30 calendar days after the personal service has been made or service by certified mail, postage prepaid, is deemed completed, the remaining proceeds shall be deposited by the department into the Drug and Device Safety 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 home medical device retail facility to be open seven days a week. (Added by Stats. 2000, Ch. 837, Sec. 42. Effective January 1, 2001.)
  135. 111656.11.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 6. Licenses [111615 - 111656.13] ( Article 6 added by Stats. 1995, Ch. 415, Sec. 6. )

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    Only a licensed pharmacist or exemptee may take charge of a home medical device retail facility or furnish prescription devices, and licensed operators must place one in charge.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 6. Licenses [111615 - 111656.13] ( Article 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111656.11. (a) It is unlawful for any person who is neither a licensed pharmacist nor an exemptee to take charge of a home medical device retail facility or to furnish prescription devices except as otherwise provided in this article. (b) It is unlawful for any person who has obtained a license to conduct a home medical device retail facility to fail to place a licensed pharmacist or exemptee in charge of that home medical device retail facility or for any person to, by himself or herself, or by any other person, permit the compounding or dispensing of prescriptions, except by a licensed pharmacist or exemptee or as otherwise provided in this article. (Added by Stats. 2000, Ch. 837, Sec. 43. Effective January 1, 2001.)
  136. 111656.12.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 6. Licenses [111615 - 111656.13] ( Article 6 added by Stats. 1995, Ch. 415, Sec. 6. )

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    This section sets three fees: $100 for examination and investigation for an exemptee license, $150 for an exemptee license and annual renewal, and $150 for certain registrations related to out-of-state home medical device retail facilities.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 6. Licenses [111615 - 111656.13] ( Article 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111656.12. (a) The fee for examination and investigation for an exemptee license under Section 111656.4 shall be one hundred dollars ($100). (b) The fee for an exemptee license and annual renewal under Section 111656.4 shall be one hundred fifty dollars ($150). (c) The fee for registration as an out-of-state home medical device retail facility or as the principal or agent of an out-of-state home medical device retail facility shall be one hundred fifty dollars ($150). (Added by Stats. 2000, Ch. 837, Sec. 44. Effective January 1, 2001.)
  137. 111656.13.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 6. Licenses [111615 - 111656.13] ( Article 6 added by Stats. 1995, Ch. 415, Sec. 6. )

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    Some entities are treated as licensed home medical device retail facilities, and some must apply for that license by July 1, 2001.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 6. Licenses [111615 - 111656.13] ( Article 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111656.13. (a) Any entity that prior to July 1, 2001, held a current, valid license as a medical device retailer pursuant to Section 4130 of the Business and Professions Code, shall be deemed to be a licensed home medical device retail facility until the expiration of that license if the entity is in compliance with all applicable criteria for obtaining a license as a home medical device retail facility. (b) Any entity that was not required to obtain a license as a medical device retailer in order to provide equipment or services prior to July 1, 2001, and that is required to obtain a license as a home medical device retail facility pursuant to Section 111656, shall apply for a license as a home medical device retail facility by July 1, 2001; however, the requirement for licensure shall only apply to those entities on and after January 1, 2002. (Amended by Stats. 2001, Ch. 159, Sec. 136. Effective January 1, 2002.)
  138. 111656.2.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 6. Licenses [111615 - 111656.13] ( Article 6 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    Home medical device retail facilities must keep prescription devices out of direct customer access, and keep their premises, fixtures, and equipment clean, orderly, dry, and well ventilated.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 6. Licenses [111615 - 111656.13] ( Article 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111656.2. (a) The following standards shall apply to all home medical device retail facilities: (1) Each retail facility shall store prescription devices in a manner that does not allow a customer direct access or self-service. (2) Each retail facility shall maintain the premises, fixtures, and equipment in a clean and orderly condition. (3) Each retail facility shall maintain the premises in a dry, well-ventilated condition, free from contamination or other conditions that may render home medical devices unfit for their intended use. (b) The department may by regulation impose any other standards pertaining to the acquisition, storage, and maintenance of prescription devices or other goods or to the maintenance or condition of the licensed premises of any home medical device retail facility as the department determines are reasonably necessary. (Amended by Stats. 2001, Ch. 728, Sec. 72. Effective January 1, 2002.)
  139. 111656.3.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 6. Licenses [111615 - 111656.13] ( Article 6 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    Home medical device retail facilities must maintain written policies, train staff, provide consultation, keep records, run quality assurance, and make certain records available for inspection.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 6. Licenses [111615 - 111656.13] ( Article 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111656.3. (a) Each home medical device retail facility shall have written policies and procedures related to home medical device handling and, if authorized by the department pursuant to Section 111656.4, the dispensing of prescription devices. Those written policies and procedures shall be adequate to assure compliance with this article and shall include, but not be limited to: (1) Training of staff, patients, and caregivers. (2) Cleaning, storage, and maintenance of home medical devices necessary to prevent damage or contamination and to assure their operation in accordance with manufacturer specifications. (3) Emergency services. If home medical device malfunction may threaten a patient’s health, access to emergency services 24 hours per day, 365 days per year shall be available for device maintenance or replacement. (4) Maintaining all records required by this article and any regulations adopted pursuant to the provisions of this article. (5) Storage and security requirements to assure that prescription devices are dispensed in accordance with this article. (6) Quality assurance. (b) The home medical device retail facility shall make consultation available to the patient or primary caregiver about the proper use of devices and related supplies furnished by the home medical device retail facility. The home medical device retail facility shall notify the patient or primary care giver that this consultation is available. (c) Each home medical device retail facility shall ensure all personnel who engage in the taking of orders for, the selling of, or the fitting of prescription devices, if authorized by the department pursuant to Section 111656.4, shall have training and demonstrate initial and continuing competence in the order-taking, fitting, and sale of prescription devices that the home medical device retail facility furnishes pursuant to Section 111656.4. (d) Each home medical device retail facility shall prepare and maintain records of training and demonstrated employee competence required under this article for employees of the home medical device retail facility. The records shall be maintained for three years from and after the last date of employment. (e) Each home medical device retail facility shall have an ongoing, documented quality assurance program that includes, but is not limited to, the following: (1) Monitoring personnel performance to assure compliance with this article. (2) Storage, maintenance, and dispensing of prescription devices to assure that prescription devices are dispensed in accordance with this article. (f) The records and documents specified in subdivisions (a) and (e) shall be maintained for three years from the date of making. The records and documents described in subdivisions (a), (d), and (e), shall be open to inspection at all times during business hours by authorized agents of the department or an inspector from the California State Board of Pharmacy for the purpose of investigating a pharmacist. (Added by Stats. 2000, Ch. 837, Sec. 35. Effective January 1, 2001.)
  140. 111656.4.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 6. Licenses [111615 - 111656.13] ( Article 6 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    A home medical device retail facility may sell or dispense prescription devices only if the department finds sufficient qualified supervision, and the facility must meet listed staffing, training, presence, licensing, and storage requirements.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 6. Licenses [111615 - 111656.13] ( Article 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111656.4. Section 4051 of the Business and Professions Code shall not prohibit a home medical device retail facility from selling or dispensing prescription devices if the department finds that sufficient qualified supervision is employed by the home medical device retail facility to adequately safeguard and protect the public health. Each person applying to the department for this exemption shall meet the following requirements to obtain and maintain the exemption: (a) A licensed pharmacist or an exemptee who meets the requirements set forth in paragraphs (1) to (5), inclusive, and whose license of exemption is currently valid, shall be in charge of the home medical device retail facility. (1) He or she shall be a high school graduate or possess a general education development equivalent. (2) He or she shall have a minimum of one year of paid work experience related to the distribution or dispensing of dangerous drugs or dangerous devices. (3) He or she shall complete a training program that addresses each of the following subjects that are applicable to his or her duties: (A) Knowledge and understanding of state and federal laws relating to the distribution of dangerous drugs and dangerous devices. (B) Knowledge and understanding of state and federal laws relating the distribution of controlled substances. (C) Knowledge and understanding of quality control systems. (D) Knowledge and understanding of the United States Pharmacopoeia standards relating to the safe storage and handling of drugs. (E) Knowledge and understanding relating to the safe storage and handling of home medical devices. (F) Knowledge and understanding of prescription terminology, abbreviations, and format. (4) The department may, by regulation, require training programs that include additional material. (5) The department shall not issue an exemptee a license until the applicant provides proof of completion of the required training that the department determines is adequate to fulfill these requirements. (b) The licensed pharmacist or exemptee shall be on the premises at all times that prescription devices are available for sale or fitting unless the prescription devices are stored separately from other merchandise and are under the exclusive control of the licensed pharmacist or exemptee. A licensed pharmacist or an exemptee need not be present in the warehouse facility of a home medical device retail facility unless the department establishes that requirement by regulation based upon the need to protect the public. (c) The department may require an exemptee to complete a designated number of hours of coursework in department-approved courses of home health education in the disposition of any disciplinary action taken against the exemptee. (d) Each premises maintained by a home medical device retail facility shall have a license issued by the department and shall have a licensed pharmacist or exemptee on the premises if prescription devices are furnished, sold, or dispensed. (e) A home medical device retail facility may establish locked storage (a lock box or locked area) for emergency or after working hours furnishing of prescription devices. Locked storage may be installed or placed in a service vehicle of the home medical device retail facility for emergency or after hours service to patients having prescriptions for prescription devices. (f) The department may by regulation authorize a licensed pharmacist or exemptee to direct an employee of the home medical device retail facility who operates the service vehicle equipped with locked storage described in subdivision (e) to deliver a prescription device from the locked storage to patients having prescriptions for prescription devices. These regulations shall establish inventory requirements for the locked storage by a licensed pharmacist or exemptee to take place shortly after a prescription device has been delivered from the locked storage to a patient. (Amended by Stats. 2002, Ch. 1013, Sec. 88. Effective January 1, 2003.)
  141. 111656.5.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 6. Licenses [111615 - 111656.13] ( Article 6 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    Only certain authorized people may enter the licensed area where prescription devices are handled, and a licensed pharmacist or exemptee must be present during fitting or consultation visits.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 6. Licenses [111615 - 111656.13] ( Article 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111656.5. (a) A person other than a licensed pharmacist, an intern pharmacist, an exemptee, as specified in Section 111656.4, or an authorized agent of the department or a person authorized to prescribe, may not be permitted in that area, place, or premises described in the license issued by the department wherein prescription devices are stored, possessed, prepared, manufactured, or repacked, except that a licensed pharmacist or exemptee shall be responsible for any individual who enters the medical device retail facility for the purposes of receiving, fitting, or consultation from the licensed pharmacist or exemptee or any person performing clerical, inventory control, housekeeping, delivery, maintenance, or similar functions relating to the home medical device retail facility. The licensed pharmacist or exemptee shall remain present in the home medical device retail facility any time an individual is present who is seeking a fitting or consultation. However, a licensed pharmacist or an exemptee need not be present on the premises of a home medical device retail facility at all times of its operation and need not be present in a warehouse facility owned by a home medical device retail facility unless the department establishes that requirement by regulation based upon the need to protect the public. The exemptee need not be present if the prescription devices are stored in a secure locked area under the exclusive control of the exemptee and unavailable for dispensing. This subdivision shall apply only to prescription devices. (b) A “warehouse” as used in this section, is a facility owned by a home medical device retail facility that is used for storage only. There may not be fitting, display, or sales at that location. A licensed pharmacist or exemptee shall be designated as “in charge” of a warehouse but need not be present during its operation. The licensed pharmacist or exemptee may permit others to possess a key to the warehouse. (c) Notwithstanding the remainder of this section, a home medical device retail facility may establish a locked facility, meeting the requirements of Section 111656.4, for furnishing prescription devices to patients having prescriptions for prescription devices in emergencies or after working hours. (d) The department may establish reasonable security measures consistent with this section as a condition of licensing in order to prevent unauthorized persons from gaining access to the area, place, or premises, or to the prescription devices therein. (e) The department may by regulation establish labeling requirements for prescription devices sold, fitted, or dispensed by a home medical device retail facility as it deems necessary for the protection of the public. (Amended by Stats. 2001, Ch. 159, Sec. 135. Effective January 1, 2002.)
  142. 111656.6.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 6. Licenses [111615 - 111656.13] ( Article 6 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    Home medical device retail facilities must keep rental home medical devices clean, sanitary, and in good working order, following manufacturer specifications when available.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 6. Licenses [111615 - 111656.13] ( Article 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111656.6. Home medical devices for rental purposes shall at all times while under the control of the home medical device retail facility, be maintained in a clean and sanitary condition and in good working order following, where available, manufacturer specifications. (Added by Stats. 2000, Ch. 837, Sec. 38. Effective January 1, 2001.)
  143. 111656.7.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 6. Licenses [111615 - 111656.13] ( Article 6 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    An out-of-state home medical device retail facility must register before selling or distributing prescription devices in this state, and sales or distribution must go through a licensed wholesaler.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 6. Licenses [111615 - 111656.13] ( Article 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111656.7. (a) Without registering as an out-of-state home medical device retail facility, an out-of-state home medical device retail facility shall not sell or distribute prescription devices in this state through any person or media other than a wholesaler who is licensed pursuant to Chapter 9 (commencing with Section 4000) of Division 2 of the Business and Professions Code. (b) Applications for an out-of-state home medical device retail facility registration shall be made on a form furnished by the department. The department may require any information it deems reasonably necessary to carry out the purposes of this section. (c) The Legislature by enacting this section does not intend a registration issued to any out-of-state home medical device retail facility 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 out-of-state home medical device retail facility. (d) The Legislature by enacting this section does not intend a registration issued to any out-of-state home medical device retail facility pursuant to this section to serve as any evidence that the out-of-state home medical device retail facility is doing business within this state. (Added by Stats. 2000, Ch. 837, Sec. 39. Effective January 1, 2001.)
  144. 111656.8.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 6. Licenses [111615 - 111656.13] ( Article 6 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    Out-of-state home medical device retail facility principals or agents must register before selling or distributing prescription devices in California, and the department can require information, renew registrations annually, and discipline registrations for violations.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 6. Licenses [111615 - 111656.13] ( Article 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111656.8. (a) No person acting as principal or agent for any out-of-state home medical device retail facility who has not obtained a registration from the department pursuant to this article and who sells or distributes prescription devices in this state that are not obtained through a wholesaler who has obtained a license pursuant to Chapter 9 (commencing with Section 4000) of Division 2 of the Business and Professions Code, or that are not obtained through a selling or distribution outlet of an out-of-state manufacturer that is licensed as a wholesaler pursuant to Chapter 9 (commencing with Section 4000) of Division 2 of the Business and Professions Code, shall conduct the business of selling or distributing prescription devices within this state without registering with the department pursuant to this article. (b) Registration of persons under this section shall be made on a form furnished by the department. The department may require any information as the department deems reasonably necessary to carry out the purposes of this section including, but not limited to, the name and address of the registrant and the name and address of the manufacturer whose prescription devices he or she is selling or distributing. (c) The department may deny, revoke, or suspend the registration of persons registered under this article for any violation of this article or Chapter 9 (commencing with Section 4000) of Division 2 of the Business and Professions Code or for any violation of Part 5 (commencing with Section 109875) of Division 104. The department may deny, revoke, or suspend the person’s registration if the manufacturer whose prescription devices he or she is selling or distributing violates this article or Chapter 9 (commencing with Section 4000) of Division 2 of the Business and Professions Code or Part 5 (commencing with Section 109875) of Division 104. (d) Registration under this section shall be renewed annually. (Added by Stats. 2000, Ch. 837, Sec. 40. Effective January 1, 2001.)
  145. 111656.9.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 6. Licenses [111615 - 111656.13] ( Article 6 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    The department may waive licensing requirements for a medical device retail facility if it believes patient safety and good care can still be maintained.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 6. Drugs and Devices [111225 - 111656.13] ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 6. Licenses [111615 - 111656.13] ( Article 6 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111656.9. When, in the opinion of the department, a high standard of patient safety, consistent with good patient care, can be provided by the licensure of a home medical device retail facility that does not meet all of the requirements for licensure as a home medical device retail facility, the department may waive any licensing requirements for that medical device retail facility. (Added by Stats. 2000, Ch. 837, Sec. 41. Effective January 1, 2001.)
  146. 11166.

    ## Health and Safety Code - HSC ## DIVISION 10. UNIFORM CONTROLLED SUBSTANCES ACT [11000 - 11651] ( Division 10 repealed and added by Stats. 1972, Ch. 1407. ) ## CHAPTER 4. Prescriptions [11150 - 11209] ( Chapter 4 added by Stats. 1972, Ch. 1407. ) ## ARTICLE 1. Requirements of Prescriptions [11150 - 11180] ( Article 1 added by Stats. 1972, Ch. 1407. )

    Verify source ↗

    A person must not fill a controlled-substance prescription more than six months after it was written, and must not knowingly fill a mutilated, forged, or altered prescription except for adding the patient’s address as allowed by Section 11164.

    ## Health and Safety Code - HSC ## DIVISION 10. UNIFORM CONTROLLED SUBSTANCES ACT [11000 - 11651] ( Division 10 repealed and added by Stats. 1972, Ch. 1407. ) ## CHAPTER 4. Prescriptions [11150 - 11209] ( Chapter 4 added by Stats. 1972, Ch. 1407. ) ## ARTICLE 1. Requirements of Prescriptions [11150 - 11180] ( Article 1 added by Stats. 1972, Ch. 1407. ) ## 11166. No person shall fill a prescription for a controlled substance after six months has elapsed from the date written on the prescription by the prescriber. No person shall knowingly fill a mutilated or forged or altered prescription for a controlled substance except for the addition of the address of the person for whom the controlled substance is prescribed as provided by paragraph (3) of subdivision (b) of Section 11164. (Amended by Stats. 2003, Ch. 406, Sec. 19. Effective January 1, 2004.)
  147. 111660.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 7. Cosmetics [111660 - 111820] ( Chapter 7 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 1. General Provisions and Definitions [111660 - 111665] ( Article 1 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    In this chapter, “hair dye” does not include eyelash dye or eyebrow dye.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 7. Cosmetics [111660 - 111820] ( Chapter 7 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 1. General Provisions and Definitions [111660 - 111665] ( Article 1 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111660. As used in this chapter, “hair dye” does not include any eyelash dye or eyebrow dye. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  148. 111665.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 7. Cosmetics [111660 - 111820] ( Chapter 7 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 1. General Provisions and Definitions [111660 - 111665] ( Article 1 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    A color additive is treated as unsafe for cosmetic use unless a regulation under Section 110090 is in effect that allows that use.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 7. Cosmetics [111660 - 111820] ( Chapter 7 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 1. General Provisions and Definitions [111660 - 111665] ( Article 1 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111665. Any color additive shall be considered unsafe for use with respect to any cosmetic unless there is in effect a regulation adopted pursuant to Section 110090 that prescribes its use in cosmetics. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  149. 11167.

    ## Health and Safety Code - HSC ## DIVISION 10. UNIFORM CONTROLLED SUBSTANCES ACT [11000 - 11651] ( Division 10 repealed and added by Stats. 1972, Ch. 1407. ) ## CHAPTER 4. Prescriptions [11150 - 11209] ( Chapter 4 added by Stats. 1972, Ch. 1407. ) ## ARTICLE 1. Requirements of Prescriptions [11150 - 11180] ( Article 1 added by Stats. 1972, Ch. 1407. )

    Verify source ↗

    In an emergency, a controlled-substance order may be dispensed by oral, electronic transmission, or a nonstandard written order, but specific follow-up and recordkeeping rules apply.

    ## Health and Safety Code - HSC ## DIVISION 10. UNIFORM CONTROLLED SUBSTANCES ACT [11000 - 11651] ( Division 10 repealed and added by Stats. 1972, Ch. 1407. ) ## CHAPTER 4. Prescriptions [11150 - 11209] ( Chapter 4 added by Stats. 1972, Ch. 1407. ) ## ARTICLE 1. Requirements of Prescriptions [11150 - 11180] ( Article 1 added by Stats. 1972, Ch. 1407. ) ## 11167. Notwithstanding subdivision (a) of Section 11164, in an emergency where failure to issue a prescription may result in loss of life or intense suffering, an order for a controlled substance may be dispensed on an oral order, an electronic data transmission order, or a written order not made on a controlled substance form as specified in Section 11162.1, subject to all of the following requirements: (a) The order contains all information required by subdivision (a) of Section 11164. (b) Any written order is signed and dated by the prescriber in ink, and the pharmacy reduces any oral or electronic data transmission order to hard copy form prior to dispensing the controlled substance. (c) The prescriber provides a written prescription on a controlled substance prescription form that meets the requirements of Section 11162.1, by the seventh day following the transmission of the initial order; a postmark by the seventh day following transmission of the initial order shall constitute compliance. (d) If the prescriber fails to comply with subdivision (c), the pharmacy shall so notify the Department of Justice in writing within 144 hours of the prescriber’s failure to do so and shall make and retain a hard copy, readily retrievable record of the prescription, including the date and method of notification of the Department of Justice. (e) This section shall become operative on January 1, 2005. (Amended by Stats. 2012, Ch. 867, Sec. 8. (SB 1144) Effective January 1, 2013.)
  150. 11167.5.

    ## Health and Safety Code - HSC ## DIVISION 10. UNIFORM CONTROLLED SUBSTANCES ACT [11000 - 11651] ( Division 10 repealed and added by Stats. 1972, Ch. 1407. ) ## CHAPTER 4. Prescriptions [11150 - 11209] ( Chapter 4 added by Stats. 1972, Ch. 1407. ) ## ARTICLE 1. Requirements of Prescriptions [11150 - 11180] ( Article 1 added by Stats. 1972, Ch. 1407. )

    Verify source ↗

    Certain Schedule II controlled substances for patients in specified care facilities or hospice may be dispensed on an oral or electronic prescription, but the pharmacist must complete specific written or hard-copy steps first.

    ## Health and Safety Code - HSC ## DIVISION 10. UNIFORM CONTROLLED SUBSTANCES ACT [11000 - 11651] ( Division 10 repealed and added by Stats. 1972, Ch. 1407. ) ## CHAPTER 4. Prescriptions [11150 - 11209] ( Chapter 4 added by Stats. 1972, Ch. 1407. ) ## ARTICLE 1. Requirements of Prescriptions [11150 - 11180] ( Article 1 added by Stats. 1972, Ch. 1407. ) ## 11167.5. (a) An order for a controlled substance classified in Schedule II for a patient of a licensed skilled nursing facility, a licensed intermediate care facility, a licensed home health agency, or a licensed hospice may be dispensed upon an oral or electronically transmitted prescription. If the prescription is transmitted orally, the pharmacist shall, prior to filling the prescription, reduce the prescription to writing in ink in the handwriting of the pharmacist on a form developed by the pharmacy for this purpose. If the prescription is transmitted electronically, the pharmacist shall, prior to filling the prescription, produce, sign, and date a hard copy prescription. The prescriptions shall contain the date the prescription was orally or electronically transmitted by the prescriber, the name of the person for whom the prescription was authorized, the name and address of the licensed skilled nursing facility, licensed intermediate care facility, licensed home health agency, or licensed hospice in which that person is a patient, the name and quantity of the controlled substance prescribed, the directions for use, and the name, address, category of professional licensure, license number, and federal controlled substance registration number of the prescriber. The original shall be properly endorsed by the pharmacist with the pharmacy’s state license number, the name and address of the pharmacy, and the signature of the person who received the controlled substances for the licensed skilled nursing facility, licensed intermediate care facility, licensed home health agency, or licensed hospice. A licensed skilled nursing facility, a licensed intermediate care facility, a licensed home health agency, or a licensed hospice shall forward to the dispensing pharmacist a copy of any signed telephone orders, chart orders, or related documentation substantiating each oral or electronically transmitted prescription transaction under this section. (b) This section shall become operative on July 1, 2004. (Repealed (in Sec. 23) and added by Stats. 2003, Ch. 406, Sec. 24. Effective January 1, 2004. Section operative July 1, 2004, by its own provisions.)
  151. 111670.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 7. Cosmetics [111660 - 111820] ( Chapter 7 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 2. Adulterated Cosmetics [111670 - 111725] ( Article 2 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    A cosmetic is adulterated if it contains a poisonous or deleterious substance that may make it harmful to users.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 7. Cosmetics [111660 - 111820] ( Chapter 7 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 2. Adulterated Cosmetics [111670 - 111725] ( Article 2 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111670. A cosmetic is adulterated if it bears or contains any poisonous or deleterious substance that may render it injurious to users under the conditions of use prescribed in the labeling or advertisement of the cosmetic, or under conditions of use as are customary or usual. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  152. 111675.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 7. Cosmetics [111660 - 111820] ( Chapter 7 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 2. Adulterated Cosmetics [111670 - 111725] ( Article 2 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    Coal tar hair dye is exempt from Section 111670 if it is conspicuously labeled with the required warning, and the labeling must include directions for preliminary testing.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 7. Cosmetics [111660 - 111820] ( Chapter 7 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 2. Adulterated Cosmetics [111670 - 111725] ( Article 2 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111675. Section 111670 shall not apply to coal tar hair dye, that is conspicuously labeled as follows: “Caution—this product contains ingredients that may cause skin irritation on certain individuals and a preliminary test according to accompanying directions should first be made. This product must not be used for dyeing the eyelashes or eyebrows; to do so may cause blindness.” The labeling shall also bear adequate directions for such preliminary testing. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  153. 111680.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 7. Cosmetics [111660 - 111820] ( Chapter 7 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 2. Adulterated Cosmetics [111670 - 111725] ( Article 2 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    A cosmetic is adulterated if it contains, in whole or in part, any filthy, putrid, or decomposed substance.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 7. Cosmetics [111660 - 111820] ( Chapter 7 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 2. Adulterated Cosmetics [111670 - 111725] ( Article 2 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111680. Any cosmetic is adulterated if it consists in whole or in part of any filthy, putrid, or decomposed substance. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  154. 111685.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 7. Cosmetics [111660 - 111820] ( Chapter 7 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 2. Adulterated Cosmetics [111670 - 111725] ( Article 2 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    A cosmetic is adulterated if it was produced, prepared, packed, or held in insanitary conditions that may contaminate it with filth or make it injurious to health.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 7. Cosmetics [111660 - 111820] ( Chapter 7 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 2. Adulterated Cosmetics [111670 - 111725] ( Article 2 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111685. Any cosmetic is adulterated if it has been produced, prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  155. 111690.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 7. Cosmetics [111660 - 111820] ( Chapter 7 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 2. Adulterated Cosmetics [111670 - 111725] ( Article 2 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    A cosmetic is adulterated if its container contains poisonous or deleterious material that may make the contents harmful to health.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 7. Cosmetics [111660 - 111820] ( Chapter 7 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 2. Adulterated Cosmetics [111670 - 111725] ( Article 2 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111690. Any cosmetic is adulterated if its container is composed, in whole or in part, of any poisonous or deleterious substance that may render the contents injurious to health. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  156. 111691.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 7. Cosmetics [111660 - 111820] ( Chapter 7 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 2. Adulterated Cosmetics [111670 - 111725] ( Article 2 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    A cosmetic with industrial hemp, raw extract, or raw hemp product is not adulterated if Chapter 9 requirements are met, and its sale cannot be restricted or prohibited solely for that inclusion.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 7. Cosmetics [111660 - 111820] ( Chapter 7 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 2. Adulterated Cosmetics [111670 - 111725] ( Article 2 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111691. A cosmetic is not adulterated because it includes industrial hemp, raw extract, or raw hemp product, as defined in Section 111920, if the industrial hemp, raw extract, or raw hemp product meets the requirements established in Chapter 9 (commencing with Section 111920). The sale of a cosmetic that includes industrial hemp, raw extract, or raw hemp product shall not be restricted or prohibited based solely on the inclusion of industrial hemp provided that the industrial hemp, raw extract, or raw hemp product meets the requirements established in Chapter 9 (commencing with Section 111920). (Amended by Stats. 2025, Ch. 248, Sec. 30. (AB 8) Effective January 1, 2026.)
  157. 111695.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 7. Cosmetics [111660 - 111820] ( Chapter 7 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 2. Adulterated Cosmetics [111670 - 111725] ( Article 2 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    A cosmetic is adulterated if it is not a hair dye and contains an unsafe color additive.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 7. Cosmetics [111660 - 111820] ( Chapter 7 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 2. Adulterated Cosmetics [111670 - 111725] ( Article 2 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111695. Any cosmetic is adulterated if it is not a hair dye and it is, or it bears or contains, a color additive that is unsafe within the meaning of Section 111665. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  158. 11170.

    ## Health and Safety Code - HSC ## DIVISION 10. UNIFORM CONTROLLED SUBSTANCES ACT [11000 - 11651] ( Division 10 repealed and added by Stats. 1972, Ch. 1407. ) ## CHAPTER 4. Prescriptions [11150 - 11209] ( Chapter 4 added by Stats. 1972, Ch. 1407. ) ## ARTICLE 1. Requirements of Prescriptions [11150 - 11180] ( Article 1 added by Stats. 1972, Ch. 1407. )

    Verify source ↗

    No person may prescribe, administer, or furnish a controlled substance for himself.

    ## Health and Safety Code - HSC ## DIVISION 10. UNIFORM CONTROLLED SUBSTANCES ACT [11000 - 11651] ( Division 10 repealed and added by Stats. 1972, Ch. 1407. ) ## CHAPTER 4. Prescriptions [11150 - 11209] ( Chapter 4 added by Stats. 1972, Ch. 1407. ) ## ARTICLE 1. Requirements of Prescriptions [11150 - 11180] ( Article 1 added by Stats. 1972, Ch. 1407. ) ## 11170. No person shall prescribe, administer, or furnish a controlled substance for himself. (Repealed and added by Stats. 1972, Ch. 1407.)
  159. 111700.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 7. Cosmetics [111660 - 111820] ( Chapter 7 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 2. Adulterated Cosmetics [111670 - 111725] ( Article 2 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    A person must not manufacture, sell, deliver, hold, or offer for sale any adulterated cosmetic.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 7. Cosmetics [111660 - 111820] ( Chapter 7 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 2. Adulterated Cosmetics [111670 - 111725] ( Article 2 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111700. It is unlawful for any person to manufacture, sell, deliver, hold, or offer for sale any cosmetic that is adulterated. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  160. 111705.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 7. Cosmetics [111660 - 111820] ( Chapter 7 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 2. Adulterated Cosmetics [111670 - 111725] ( Article 2 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    A person must not adulterate any cosmetic.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 7. Cosmetics [111660 - 111820] ( Chapter 7 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 2. Adulterated Cosmetics [111670 - 111725] ( Article 2 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111705. It is unlawful for any person to adulterate any cosmetic. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  161. 11171.

    ## Health and Safety Code - HSC ## DIVISION 10. UNIFORM CONTROLLED SUBSTANCES ACT [11000 - 11651] ( Division 10 repealed and added by Stats. 1972, Ch. 1407. ) ## CHAPTER 4. Prescriptions [11150 - 11209] ( Chapter 4 added by Stats. 1972, Ch. 1407. ) ## ARTICLE 1. Requirements of Prescriptions [11150 - 11180] ( Article 1 added by Stats. 1972, Ch. 1407. )

    Verify source ↗

    No person may prescribe, administer, or furnish a controlled substance except as allowed by this division.

    ## Health and Safety Code - HSC ## DIVISION 10. UNIFORM CONTROLLED SUBSTANCES ACT [11000 - 11651] ( Division 10 repealed and added by Stats. 1972, Ch. 1407. ) ## CHAPTER 4. Prescriptions [11150 - 11209] ( Chapter 4 added by Stats. 1972, Ch. 1407. ) ## ARTICLE 1. Requirements of Prescriptions [11150 - 11180] ( Article 1 added by Stats. 1972, Ch. 1407. ) ## 11171. No person shall prescribe, administer, or furnish a controlled substance except under the conditions and in the manner provided by this division. (Repealed and added by Stats. 1972, Ch. 1407.)
  162. 111710.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 7. Cosmetics [111660 - 111820] ( Chapter 7 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 2. Adulterated Cosmetics [111670 - 111725] ( Article 2 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    A person may not receive adulterated cosmetics in commerce or deliver or offer them for delivery.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 7. Cosmetics [111660 - 111820] ( Chapter 7 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 2. Adulterated Cosmetics [111670 - 111725] ( Article 2 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111710. It is unlawful for any person to receive in commerce any cosmetic that is adulterated or to deliver or proffer for delivery any such cosmetic. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  163. 111715.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 7. Cosmetics [111660 - 111820] ( Chapter 7 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 2. Adulterated Cosmetics [111670 - 111725] ( Article 2 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    Cosmetics that contain a color additive in line with the applicable regulations are not treated as adulterated while those color-additive regulations remain in effect.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 7. Cosmetics [111660 - 111820] ( Chapter 7 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 2. Adulterated Cosmetics [111670 - 111725] ( Article 2 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111715. While any regulation relating to any color additive referred to in Section 111665 is in effect, any cosmetic that bears or contains a color additive in accordance with these regulations shall not be considered adulterated. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  164. 11172.

    ## Health and Safety Code - HSC ## DIVISION 10. UNIFORM CONTROLLED SUBSTANCES ACT [11000 - 11651] ( Division 10 repealed and added by Stats. 1972, Ch. 1407. ) ## CHAPTER 4. Prescriptions [11150 - 11209] ( Chapter 4 added by Stats. 1972, Ch. 1407. ) ## ARTICLE 1. Requirements of Prescriptions [11150 - 11180] ( Article 1 added by Stats. 1972, Ch. 1407. )

    Verify source ↗

    No person may antedate or postdate a prescription.

    ## Health and Safety Code - HSC ## DIVISION 10. UNIFORM CONTROLLED SUBSTANCES ACT [11000 - 11651] ( Division 10 repealed and added by Stats. 1972, Ch. 1407. ) ## CHAPTER 4. Prescriptions [11150 - 11209] ( Chapter 4 added by Stats. 1972, Ch. 1407. ) ## ARTICLE 1. Requirements of Prescriptions [11150 - 11180] ( Article 1 added by Stats. 1972, Ch. 1407. ) ## 11172. No person shall antedate or postdate a prescription. (Repealed and added by Stats. 1972, Ch. 1407.)
  165. 111720.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 7. Cosmetics [111660 - 111820] ( Chapter 7 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 2. Adulterated Cosmetics [111670 - 111725] ( Article 2 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    Export cosmetics are not treated as adulterated if they meet three listed conditions.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 7. Cosmetics [111660 - 111820] ( Chapter 7 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 2. Adulterated Cosmetics [111670 - 111725] ( Article 2 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111720. Any cosmetic intended for export shall not be deemed to be adulterated under this part if it satisfies all of the following requirements: (a) It accords to the specifications of the foreign purchaser. (b) It is not in conflict with the laws of the importing country. (c) It is labeled on the outside of the shipping package to show that it is intended for export. If the article is sold or offered for sale in domestic commerce, this section shall not exempt it from any of the provisions of this part. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  166. 111725.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 7. Cosmetics [111660 - 111820] ( Chapter 7 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 2. Adulterated Cosmetics [111670 - 111725] ( Article 2 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    A cosmetic is treated as adulterated if it is covered by FDA tamper-resistant packaging regulations and does not comply with them.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 7. Cosmetics [111660 - 111820] ( Chapter 7 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 2. Adulterated Cosmetics [111670 - 111725] ( Article 2 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111725. A cosmetic is deemed adulterated under the laws of this state if it is subject to regulations issued by the United States Food and Drug Administration relating to tamper-resistant packaging, as set forth in Part 700 of Volume 21 of the Code of Federal Regulations, as amended, but is not in compliance therewith. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  167. 11173.

    ## Health and Safety Code - HSC ## DIVISION 10. UNIFORM CONTROLLED SUBSTANCES ACT [11000 - 11651] ( Division 10 repealed and added by Stats. 1972, Ch. 1407. ) ## CHAPTER 4. Prescriptions [11150 - 11209] ( Chapter 4 added by Stats. 1972, Ch. 1407. ) ## ARTICLE 1. Requirements of Prescriptions [11150 - 11180] ( Article 1 added by Stats. 1972, Ch. 1407. )

    Verify source ↗

    No person may use fraud, false statements, false identity, or false labels to obtain controlled substances or related prescriptions and records.

    ## Health and Safety Code - HSC ## DIVISION 10. UNIFORM CONTROLLED SUBSTANCES ACT [11000 - 11651] ( Division 10 repealed and added by Stats. 1972, Ch. 1407. ) ## CHAPTER 4. Prescriptions [11150 - 11209] ( Chapter 4 added by Stats. 1972, Ch. 1407. ) ## ARTICLE 1. Requirements of Prescriptions [11150 - 11180] ( Article 1 added by Stats. 1972, Ch. 1407. ) ## 11173. (a) No person shall obtain or attempt to obtain controlled substances, or procure or attempt to procure the administration of or prescription for controlled substances, (1) by fraud, deceit, misrepresentation , or subterfuge; or (2) by the concealment of a material fact. (b) No person shall make a false statement in any prescription, order, report, or record, required by this division. (c) No person shall, for the purpose of obtaining controlled substances, falsely assume the title of, or represent himself to be, a manufacturer, wholesaler, pharmacist, physician, dentist, veterinarian, registered nurse, physician’s assistant, or other authorized person. (d) No person shall affix any false or forged label to a package or receptacle containing controlled substances. (Amended by Stats. 1977, Ch. 843.)
  168. 111730.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 7. Cosmetics [111660 - 111820] ( Chapter 7 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3. Misbranded Cosmetics [111730 - 111790] ( Article 3 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    A cosmetic is misbranded if its labeling is false or misleading in any particular.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 7. Cosmetics [111660 - 111820] ( Chapter 7 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3. Misbranded Cosmetics [111730 - 111790] ( Article 3 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111730. Any cosmetic is misbranded if its labeling is false or misleading in any particular. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  169. 111735.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 7. Cosmetics [111660 - 111820] ( Chapter 7 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3. Misbranded Cosmetics [111730 - 111790] ( Article 3 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    A cosmetic is misbranded if its labeling or packaging does not meet Chapter 4 requirements.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 7. Cosmetics [111660 - 111820] ( Chapter 7 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3. Misbranded Cosmetics [111730 - 111790] ( Article 3 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111735. Any cosmetic is misbranded if its labeling or packaging does not conform to the requirements of Chapter 4 (commencing with Section 110290). (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  170. 11174.

    ## Health and Safety Code - HSC ## DIVISION 10. UNIFORM CONTROLLED SUBSTANCES ACT [11000 - 11651] ( Division 10 repealed and added by Stats. 1972, Ch. 1407. ) ## CHAPTER 4. Prescriptions [11150 - 11209] ( Chapter 4 added by Stats. 1972, Ch. 1407. ) ## ARTICLE 1. Requirements of Prescriptions [11150 - 11180] ( Article 1 added by Stats. 1972, Ch. 1407. )

    Verify source ↗

    A person must not give a false name or false address when involved in prescribing, furnishing, administering, or dispensing a controlled substance.

    ## Health and Safety Code - HSC ## DIVISION 10. UNIFORM CONTROLLED SUBSTANCES ACT [11000 - 11651] ( Division 10 repealed and added by Stats. 1972, Ch. 1407. ) ## CHAPTER 4. Prescriptions [11150 - 11209] ( Chapter 4 added by Stats. 1972, Ch. 1407. ) ## ARTICLE 1. Requirements of Prescriptions [11150 - 11180] ( Article 1 added by Stats. 1972, Ch. 1407. ) ## 11174. No person shall, in connection with the prescribing, furnishing, administering, or dispensing of a controlled substance, give a false name or false address. (Repealed and added by Stats. 1972, Ch. 1407.)
  171. 111740.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 7. Cosmetics [111660 - 111820] ( Chapter 7 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3. Misbranded Cosmetics [111730 - 111790] ( Article 3 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    A package-form cosmetic is misbranded unless its label includes the manufacturer, packer, or distributor’s name and place of business, plus the quantity of contents.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 7. Cosmetics [111660 - 111820] ( Chapter 7 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3. Misbranded Cosmetics [111730 - 111790] ( Article 3 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111740. Any cosmetic is misbranded if it is in package form and it does not bear a label containing all of the following information: (a) The name and place of business of the manufacturer, packer, or distributor. (b) An accurate statement of the quantity of the contents in terms of weight, measure, or numerical count. Reasonable variations shall be permitted from the requirements of subdivision (b) of this section. Requirements for placement and prominence of the information and exemptions as to small packages shall be established by regulations adopted pursuant to Section 110380. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  172. 111745.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 7. Cosmetics [111660 - 111820] ( Chapter 7 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3. Misbranded Cosmetics [111730 - 111790] ( Article 3 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    A cosmetic is misbranded if required label information is not prominently and conspicuously placed so an ordinary purchaser can read and understand it.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 7. Cosmetics [111660 - 111820] ( Chapter 7 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3. Misbranded Cosmetics [111730 - 111790] ( Article 3 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111745. A cosmetic is misbranded if any word, statement, or other information required pursuant to this part to appear on the label or labeling is not prominently placed upon the label or labeling with conspicuousness, as compared with other words, statements, designs, or devices, in the labeling, and in terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  173. 11175.

    ## Health and Safety Code - HSC ## DIVISION 10. UNIFORM CONTROLLED SUBSTANCES ACT [11000 - 11651] ( Division 10 repealed and added by Stats. 1972, Ch. 1407. ) ## CHAPTER 4. Prescriptions [11150 - 11209] ( Chapter 4 added by Stats. 1972, Ch. 1407. ) ## ARTICLE 1. Requirements of Prescriptions [11150 - 11180] ( Article 1 added by Stats. 1972, Ch. 1407. )

    Verify source ↗

    No person may obtain or possess a noncompliant prescription, or obtain or possess a controlled substance through such a prescription.

    ## Health and Safety Code - HSC ## DIVISION 10. UNIFORM CONTROLLED SUBSTANCES ACT [11000 - 11651] ( Division 10 repealed and added by Stats. 1972, Ch. 1407. ) ## CHAPTER 4. Prescriptions [11150 - 11209] ( Chapter 4 added by Stats. 1972, Ch. 1407. ) ## ARTICLE 1. Requirements of Prescriptions [11150 - 11180] ( Article 1 added by Stats. 1972, Ch. 1407. ) ## 11175. No person shall obtain or possess a prescription that does not comply with this division, nor shall any person obtain a controlled substance by means of a prescription which does not comply with this division or possess a controlled substance obtained by such a prescription. (Amended by Stats. 1976, Ch. 896.)
  174. 111750.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 7. Cosmetics [111660 - 111820] ( Chapter 7 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3. Misbranded Cosmetics [111730 - 111790] ( Article 3 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    A cosmetic is misbranded if its container is made, formed, or filled in a misleading way.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 7. Cosmetics [111660 - 111820] ( Chapter 7 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3. Misbranded Cosmetics [111730 - 111790] ( Article 3 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111750. Any cosmetic is misbranded if its container is so made, formed, or filled as to be misleading. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  175. 111755.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 7. Cosmetics [111660 - 111820] ( Chapter 7 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3. Misbranded Cosmetics [111730 - 111790] ( Article 3 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    A cosmetic is misbranded if it is a color additive, unless its packaging and labeling meet the color-additive requirements in Section 110090.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 7. Cosmetics [111660 - 111820] ( Chapter 7 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3. Misbranded Cosmetics [111730 - 111790] ( Article 3 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111755. A cosmetic is misbranded if it is a color additive, unless its packaging and labeling are in conformity with the packaging and labeling requirements applicable to color additives prescribed under the provisions of Section 110090. This section does not apply to packages of color additives that, with respect to their use for cosmetics, are marketed and intended for use only in or on hair dyes. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  176. 111760.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 7. Cosmetics [111660 - 111820] ( Chapter 7 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3. Misbranded Cosmetics [111730 - 111790] ( Article 3 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    A cosmetic is misbranded if its packaging or labeling violates an applicable regulation issued under Sections 108685 or 108700.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 7. Cosmetics [111660 - 111820] ( Chapter 7 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3. Misbranded Cosmetics [111730 - 111790] ( Article 3 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111760. Any cosmetic is misbranded if its packaging or labeling is in violation of an applicable regulation issued pursuant to Section 108685 or 108700. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  177. 111765.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 7. Cosmetics [111660 - 111820] ( Chapter 7 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3. Misbranded Cosmetics [111730 - 111790] ( Article 3 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    A person must not manufacture or sell a misbranded cosmetic.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 7. Cosmetics [111660 - 111820] ( Chapter 7 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3. Misbranded Cosmetics [111730 - 111790] ( Article 3 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111765. It is unlawful for any person to manufacture, or sell any cosmetic that is misbranded. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  178. 111770.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 7. Cosmetics [111660 - 111820] ( Chapter 7 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3. Misbranded Cosmetics [111730 - 111790] ( Article 3 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    A person must not misbrand any cosmetic.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 7. Cosmetics [111660 - 111820] ( Chapter 7 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3. Misbranded Cosmetics [111730 - 111790] ( Article 3 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111770. It is unlawful for any person to misbrand any cosmetic. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  179. 111775.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 7. Cosmetics [111660 - 111820] ( Chapter 7 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3. Misbranded Cosmetics [111730 - 111790] ( Article 3 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    Any person must not receive in commerce a misbranded cosmetic, and must not deliver or offer for delivery any cosmetic.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 7. Cosmetics [111660 - 111820] ( Chapter 7 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3. Misbranded Cosmetics [111730 - 111790] ( Article 3 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111775. It is unlawful for any person to receive in commerce any cosmetic that is misbranded, or to deliver or proffer for delivery any cosmetic. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  180. 111780.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 7. Cosmetics [111660 - 111820] ( Chapter 7 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3. Misbranded Cosmetics [111730 - 111790] ( Article 3 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    A person must not change or remove cosmetic labeling if doing so would make the cosmetic misbranded while it is held for sale.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 7. Cosmetics [111660 - 111820] ( Chapter 7 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3. Misbranded Cosmetics [111730 - 111790] ( Article 3 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111780. It is unlawful for any person to alter, mutilate, destroy, obliterate, or remove the label or any part of the labeling of any cosmetic if the act results in the cosmetic being misbranded, while held for sale. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  181. 111785.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 7. Cosmetics [111660 - 111820] ( Chapter 7 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3. Misbranded Cosmetics [111730 - 111790] ( Article 3 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    A cosmetic intended for export is not treated as misbranded if it matches the foreign buyer’s specifications, does not conflict with the destination country’s law, and is labeled on the outside of the shipping package as intended for export.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 7. Cosmetics [111660 - 111820] ( Chapter 7 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3. Misbranded Cosmetics [111730 - 111790] ( Article 3 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111785. Any cosmetic intended for export shall not be deemed to be misbranded under this part if it satisfies all of the following requirements: (a) It accords to the specifications of the foreign purchaser. (b) It is not in conflict with the laws of the country to which it is intended for export. (c) It is labeled on the outside of the shipping package to show that it is intended for export. If the article is sold or offered for sale in domestic commerce, this section shall not exempt it from any of the provisions of this part. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  182. 11179.

    ## Health and Safety Code - HSC ## DIVISION 10. UNIFORM CONTROLLED SUBSTANCES ACT [11000 - 11651] ( Division 10 repealed and added by Stats. 1972, Ch. 1407. ) ## CHAPTER 4. Prescriptions [11150 - 11209] ( Chapter 4 added by Stats. 1972, Ch. 1407. ) ## ARTICLE 1. Requirements of Prescriptions [11150 - 11180] ( Article 1 added by Stats. 1972, Ch. 1407. )

    Verify source ↗

    A person who fills a prescription must keep it on file for at least three years after it is filled.

    ## Health and Safety Code - HSC ## DIVISION 10. UNIFORM CONTROLLED SUBSTANCES ACT [11000 - 11651] ( Division 10 repealed and added by Stats. 1972, Ch. 1407. ) ## CHAPTER 4. Prescriptions [11150 - 11209] ( Chapter 4 added by Stats. 1972, Ch. 1407. ) ## ARTICLE 1. Requirements of Prescriptions [11150 - 11180] ( Article 1 added by Stats. 1972, Ch. 1407. ) ## 11179. A person who fills a prescription shall keep it on file for at least three years from the date of filling it. (Amended by Stats. 1976, Ch. 896.)
  183. 111790.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 7. Cosmetics [111660 - 111820] ( Chapter 7 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3. Misbranded Cosmetics [111730 - 111790] ( Article 3 added by Stats. 1995, Ch. 415, Sec. 6. )

    Verify source ↗

    A cosmetic is misbranded if it is covered by FDA tamper-resistant packaging rules and does not comply with them.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 7. Cosmetics [111660 - 111820] ( Chapter 7 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3. Misbranded Cosmetics [111730 - 111790] ( Article 3 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111790. A cosmetic is deemed misbranded under the laws of this state if it is subject to regulations issued by the United States Food and Drug Administration relating to tamper-resistant packaging, as set forth in Part 700 of Volume 21 of the Code of Federal Regulations, as amended, but is not in compliance therewith. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  184. 111791.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 7. Cosmetics [111660 - 111820] ( Chapter 7 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3.5. Chronic Health Effects of Cosmetics [111791 - 111793.5] ( Article 3.5 added by Stats. 2005, Ch. 729, Sec. 2. )

    Verify source ↗

    This article is known as the California Safe Cosmetics Act of 2005 and may be cited by that name.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 7. Cosmetics [111660 - 111820] ( Chapter 7 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3.5. Chronic Health Effects of Cosmetics [111791 - 111793.5] ( Article 3.5 added by Stats. 2005, Ch. 729, Sec. 2. ) ## 111791. This article shall be known, and may be cited, as the California Safe Cosmetics Act of 2005. (Added by Stats. 2005, Ch. 729, Sec. 2. Effective January 1, 2006.)
  185. 111791.5.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 7. Cosmetics [111660 - 111820] ( Chapter 7 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3.5. Chronic Health Effects of Cosmetics [111791 - 111793.5] ( Article 3.5 added by Stats. 2005, Ch. 729, Sec. 2. )

    Verify source ↗

    This section defines key terms used in the article, including authoritative body, chemical identified as causing cancer or reproductive toxicity, division, ingredient, and manufacturer.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 7. Cosmetics [111660 - 111820] ( Chapter 7 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3.5. Chronic Health Effects of Cosmetics [111791 - 111793.5] ( Article 3.5 added by Stats. 2005, Ch. 729, Sec. 2. ) ## 111791.5. For purposes of this article, the following terms have the following meanings: (a) “Authoritative body” means any agency or formally organized program or group recognized pursuant to Section 12306 of Title 22 of the California Code of Regulations as being authoritative for the purpose of identifying chemicals that cause cancer or reproductive toxicity. (b) “Chemical identified as causing cancer or reproductive toxicity” means a chemical identified pursuant to Section 25249.8 or identified by an authoritative body as any of the following: (1) A substance listed as known or reasonably anticipated to be a human carcinogen in a National Toxicology Report on carcinogens. (2) A substance given an overall carcinogenicity evaluation of Group 1, Group 2A, or Group 2B by the International Agency for Research on Cancer. (3) A substance identified as a Group A, Group B1, or Group B2 carcinogen, or as a known or likely carcinogen by the United States Environmental Protection Agency. (4) A substance identified as having some or clear evidence of adverse developmental, male reproductive, or female reproductive toxicity effects in a report by an expert panel of the National Toxicology Program’s Center for the Evaluation of Risks to Human Reproduction. (c) “Division” means the Division of Environmental and Occupational Disease Control within the State Department of Health Services. (d) “Ingredient” has the same meaning as that term is defined in subdivision (e) of Section 700.3 of Part 700 of Chapter 1 of Title 21 of the Code of Federal Regulations and does not include any incidental ingredient as defined in subdivision (l) of Section 701.3 of Part 701 of Chapter 1 of Title 21 of the Code of Federal Regulations. (e) “Manufacturer” means any person whose name appears on the label of a cosmetic product pursuant to the requirements of Section 701.12 of Title 21 of the Code of Federal Regulations. (Added by Stats. 2005, Ch. 729, Sec. 2. Effective January 1, 2006.)
  186. 111792.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 7. Cosmetics [111660 - 111820] ( Chapter 7 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3.5. Chronic Health Effects of Cosmetics [111791 - 111793.5] ( Article 3.5 added by Stats. 2005, Ch. 729, Sec. 2. )

    Verify source ↗

    Cosmetic manufacturers covered by the FDA and selling in California must report certain cancer- or reproductive-toxicity-related ingredients to the division, and the state department must maintain a public searchable website for the collected data.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 7. Cosmetics [111660 - 111820] ( Chapter 7 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3.5. Chronic Health Effects of Cosmetics [111791 - 111793.5] ( Article 3.5 added by Stats. 2005, Ch. 729, Sec. 2. ) ## 111792. (a) The manufacturer of any cosmetic product subject to regulation by the federal Food and Drug Administration that is sold in this state shall, on a schedule and in electronic or other format, as determined by the division, provide the division with a complete and accurate list of its cosmetic products that, as of the date of submission, are sold in the state and that contain any ingredient that is a chemical identified as causing cancer or reproductive toxicity, including any chemical that meets either of the following conditions: (1) A chemical contained in the product for purposes of fragrance or flavoring. (2) A chemical identified by the phrase “and other ingredients” and determined to be a trade secret pursuant to the procedure established in Part 20 and Section 720.8 of Part 720 of Title 21 of the Code of Federal Regulations. Any ingredient identified pursuant to this paragraph shall be considered to be a trade secret and shall be treated by the division in a manner consistent with the requirements of Part 20 and Part 720 of Title 21 of the Code of Federal Regulations. Any ingredients considered to be a trade secret shall not be subject to the California Public Records Act (Division 10 (commencing with Section 7920.000) of Title 1 of the Government Code) for the purposes of this section. (b) Any information submitted pursuant to subdivision (a) shall identify each chemical both by name and Chemical Abstract Service number and shall specify the product or products in which the chemical is contained. (c) If an ingredient identified pursuant to this section subsequently is removed from the product in which it was contained, is removed from the list of chemicals known to cause cancer or reproductive toxicity published under Section 25249.8, or is no longer a chemical identified as causing cancer or reproductive toxicity by an authoritative body, the manufacturer of the product containing the ingredient shall submit the new information to the division. Upon receipt of new information, the division, after verifying the accuracy of that information, shall revise the manufacturer’s information on record with the division to reflect the new information. The manufacturer shall not be under obligation to submit subsequent information on the presence of the ingredient in the product unless subsequent changes require submittal of the information. (d) This section shall not apply to any manufacturer of cosmetic products with annual aggregate sales of cosmetic products, both within and outside of California, of less than one million dollars ($1,000,000), based on the manufacturer’s most recent tax year filing. (e) On or before December 31, 2013, the State Department of Public Health shall develop and make operational a consumer-friendly, public internet website that creates a database of the information collected pursuant to this section. The database shall be searchable to accommodate a wide range of users, including users with limited technical and scientific literacy. Data shall be presented in an educational manner with, among other things, hypertext links that explain the meanings of technical terms, including, but not limited to, “carcinogenic” and “reproductive toxicity.” The internet website shall be designed to be easily navigable and to enable users to compare and contrast products and reportable ingredients. The internet website shall include hypertext links to other educational and informational internet websites to enhance consumer understanding. (Amended by Stats. 2021, Ch. 615, Sec. 277. (AB 474) Effective January 1, 2022. Operative January 1, 2023, pursuant to Sec. 463 of Stats. 2021, Ch. 615.)
  187. 111792.5.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 7. Cosmetics [111660 - 111820] ( Chapter 7 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3.5. Chronic Health Effects of Cosmetics [111791 - 111793.5] ( Article 3.5 added by Stats. 2005, Ch. 729, Sec. 2. )

    Verify source ↗

    The division may investigate certain cosmetic products, manufacturers may submit health data, and the division must set reasonable submission deadlines.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 7. Cosmetics [111660 - 111820] ( Chapter 7 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3.5. Chronic Health Effects of Cosmetics [111791 - 111793.5] ( Article 3.5 added by Stats. 2005, Ch. 729, Sec. 2. ) ## 111792.5. (a) In order to determine potential health effects of exposure to ingredients in cosmetics sold in the state, the division may conduct an investigation of one or more cosmetic products that contain chemicals identified as causing cancer or reproductive toxicity or other ingredients of concern to the division. (b) An investigation conducted pursuant to subdivision (a) may include, but not be limited to, a review of available health effects data and studies, worksite health hazard evaluations, epidemiological studies to determine the health effects of exposures to chemicals in various subpopulations, and exposure assessments to determine total exposures to individuals in various settings. (c) If an investigation is conducted pursuant to subdivision (a), the manufacturer of any product subject to the investigation may submit relevant health effects data and studies to the division. (d) In order to further the purposes of an investigation, the division may require manufacturers of products subject to the investigation to submit to the division relevant health effects data and studies available to the manufacturer and other available information as requested by the division, including, but not limited to, the concentration of the chemical in the product, the amount by volume or weight of the product that comprises the average daily application or use, and sales and use data necessary to determine where the product is used in the occupational setting. (e) The division shall establish reasonable deadlines for the submittal of information required pursuant to subdivision (d). Failure by a manufacturer to submit the information in compliance with the requirements of the division shall constitute a violation of this part. (Added by Stats. 2005, Ch. 729, Sec. 2. Effective January 1, 2006.)
  188. 111792.6.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 7. Cosmetics [111660 - 111820] ( Chapter 7 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3.5. Chronic Health Effects of Cosmetics [111791 - 111793.5] ( Article 3.5 added by Stats. 2005, Ch. 729, Sec. 2. )

    Verify source ↗

    Cosmetic product manufacturers selling in California must disclose certain ingredient and product details to the state health department, and the division must publish the information in the database.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 7. Cosmetics [111660 - 111820] ( Chapter 7 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3.5. Chronic Health Effects of Cosmetics [111791 - 111793.5] ( Article 3.5 added by Stats. 2005, Ch. 729, Sec. 2. ) ## 111792.6. (a) For purposes of this section, the following definitions apply: (1) “Cosmetic product” means an article for retail sale or professional use intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance. (2) “Designated list” means any of the following, including subsequent revisions when adopted by the authoritative body: (A) Chemicals known to the State of California to cause cancer or reproductive toxicity that are listed pursuant to the Safe Drinking Water and Toxic Enforcement Act of 1986 (Chapter 6.6 (commencing with Section 25249.5 of Division 20)). (B) Chemicals classified by the European Union as carcinogens, mutagens, or reproductive toxicants pursuant to Category 1A or 1B in Annex VI to Regulation (EC) 1272/2008. (C) Chemicals included in the European Union Candidate List of Substances of Very High Concern in accordance with Article 59 of Regulation (EC) 1907/2006 on the basis of Article 57(f) for endocrine disrupting properties. (D) Chemicals for which a reference dose or reference concentration has been developed based on neurotoxicity in the federal Environmental Protection Agency’s Integrated Risk Information System. (E) Chemicals that are identified as carcinogenic to humans, likely to be carcinogenic to humans, or as Group A, B1, or B2 carcinogens in the federal Environmental Protection Agency’s Integrated Risk Information System. (F) Chemicals included in the European Chemicals Agency Candidate List of Substances of Very High Concern in accordance with Article 59 of Regulation (EC) 1907/2006 on the basis of Article 57(d), Article 57(e), or Article 57(f) of Regulation (EC) 1907/2006 for persistent, bioaccumulative and toxic, or very persistent and very bioaccumulative, properties. (G) Chemicals that are identified as persistent, bioaccumulative, and inherently toxic to the environment by the Canadian Environmental Protection Act Environmental Registry Domestic Substances List. (H) Chemicals classified by the European Union in Annex VI to Regulation (EC) 1272/2008 as respiratory sensitizer category 1. (I) Group 1, 2A, or 2B carcinogens identified by the International Agency for Research on Cancer. (J) Neurotoxicants that are identified in the federal Agency for Toxic Substances and Disease Registry’s Toxic Substances Portal, Health Effects of Toxic Substances and Carcinogens, Nervous System. (K) Persistent bioaccumulative and toxic priority chemicals that are identified by the federal Environmental Protection Agency National Waste Minimization Program. (L) Reproductive or developmental toxicants identified in Monographs on the Potential Human Reproductive and Developmental Effects published by the federal National Toxicology Program, Office of Health Assessment and Translation. (M) Chemicals identified by the federal Environmental Protection Agency’s Toxics Release Inventory as Persistent, Bioaccumulative and Toxic Chemicals that are subject to reporting under Section 313 of the Emergency Planning and Community Right-to-Know Act of 1986 (42 U.S.C. Sec. 11001, et seq.). (N) The Washington Department of Ecology’s Persistent, Bioaccumulative, Toxic (PBT) Chemicals identified in Chapter 173-333 of Title 173 of the Washington Administrative Code. (O) Chemicals that are identified as known to be, or reasonably anticipated to be, human carcinogens by the 13th Report on Carcinogens prepared by the federal National Toxicology Program. (P) Chemicals for which notification levels, as defined in Section 116455, have been established by the State Department of Public Health or the State Water Resources Control Board. (Q) Chemicals for which primary maximum contaminant levels have been established and adopted under Section 64431 or 64444 of Title 22 of the California Code of Regulations. (R) Chemicals identified as toxic air contaminants under Section 93000 or 93001 of Title 17 of the California Code of Regulations. (S) Chemicals that are identified as priority pollutants in the California water quality control plans pursuant to subdivision (c) of Section 303 of the federal Clean Water Act (33 U.S.C. Sec. 1341) and in Section 131.38 of Title 40 of the Code of Federal Regulations, or identified as pollutants by the state or the federal Environmental Protection Agency for one or more water bodies in the state under subdivision (d) of Section 303 of the federal Clean Water Act (33 U.S.C. Sec. 1341) and Section 130.7 of Title 40 of the Code of Federal Regulations. (T) Chemicals that are identified with noncancer endpoints and listed with an inhalation or oral reference exposure level by the Office of Environmental Health Hazard Assessment pursuant to paragraph (2) of subdivision (b) of Section 44360. (U) Chemicals identified as priority chemicals by the California Environmental Contaminant Biomonitoring Program pursuant to Section 105449. (V) Chemicals that are identified on Part A of the List of Chemicals for Priority Action prepared by the Oslo and Paris Conventions for the Protection of the Marine Environment of the North-East Atlantic. (3) “Flavor ingredient” means any intentionally added substance or complex mixture of aroma chemicals, flavor chemicals, natural essential oils, and other functional ingredient or ingredients for which the purpose is to impart a flavor or taste, or to counteract a flavor or taste. (4) “Fragrance ingredient” means any intentionally added substance or complex mixture of aroma chemicals, natural essential oils, and other functional ingredient or ingredients for which the purpose is to impart an odor or scent, or to counteract an odor. (5) “Manufacturer” means any entity whose name appears on the label of a cosmetic product pursuant to the requirements of Section 701.12 of Title 21 of the Code of Federal Regulations. (6) “Professional cosmetic” has the same meaning as provided in paragraph (3) of subdivision (b) of Section 110371. (b) (1) Commencing January 1, 2022, a manufacturer of a cosmetic product sold in the state shall disclose all of the following information to the Division of Environmental and Occupational Disease Control within the State Department of Public Health: (A) A list of each fragrance ingredient or flavor ingredient that is included on a designated list, as defined in paragraph (2) of subdivision (a), and present in the cosmetic product. This section does not require a manufacturer of a cosmetic product to disclose the presence of any fragrance ingredient or flavor ingredient that is not included on a designated list. (B) A list of each fragrance allergen included in Annex III of the EU Cosmetics Regulation No. 1223/2009, as required to be disclosed pursuant to the EU Detergents Regulation No. 21 648/2004, and subsequent updates to those regulations, that is present in a rinse-off cosmetic product at a concentration at or above 0.01 percent (100 parts per million) or in a leave-on cosmetic product at a concentration at or above 0.001 percent (10 parts per million). Those ingredients shall appear on the database in a unique manner that distinguishes those ingredients from other reportable ingredients and indicates that they are hazardous only to individuals who suffer from fragrance allergies. (C) Whether the cosmetic product is intended for professional use or retail cosmetic use. (D) The Chemical Abstracts Service (CAS) number for each ingredient or allergen that requires disclosure pursuant to subparagraph (A) or (B). (E) The corresponding Universal Product Code (UPC) for the cosmetic product described in subparagraph (A). (2) (A) To protect trade secrets, this section does not require a manufacturer to disclose the weight or amount of an ingredient that requires disclosure pursuant to subparagraph (A) or (B) of paragraph (1) or to disclose the manner in which a cosmetic product or intentionally added fragrance ingredient or flavor ingredient is formulated. A manufacturer may protect as a trade secret, and is not required to disclose, any ingredient or combination of ingredients that is not on a designated list or required to be disclosed pursuant to subparagraph (A) or (B) of paragraph (1). A fragrance ingredient or flavor ingredient that is included in a designated list, or a fragrance allergen that requires disclosure pursuant to subparagraph (B) of paragraph (1), does not constitute a trade secret. (B) Pursuant to Section 7927.705 of the Government Code, a fragrance ingredient or flavor ingredient that constitutes a trade secret is not subject to disclosure under the California Public Records Act (Division 10 (commencing with Section 7920.000) of Title 1 of the Government Code). (3) (A) A manufacturer that is required to disclose a fragrance ingredient or flavor ingredient pursuant to paragraph (1) due to a change in a designated list shall disclose the ingredient no later than six months after the revised list is adopted by the authoritative body, or six months after the revised list becomes effective, whichever is later. (B) The State Department of Public Health shall create a voluntary electronic mailing list for the department to provide updates on the inclusion or deletion of fragrance allergens, fragrance ingredients, and flavor ingredients on the designated lists. (c) (1) Commencing January 1, 2022, the Division of Environmental and Occupational Disease Control shall post on the database created pursuant to Section 111792, in an easily readable format, all of the following information related to a cosmetic product described in, and disclosed pursuant to, subparagraph (A) of paragraph (1) of subdivision (b): (A) A list of all fragrance ingredients and flavor ingredients that are included on a designated list and all fragrance allergens required to be disclosed pursuant to subparagraph (B) of paragraph (1) of subdivision (b). (B) The health hazards associated with each fragrance ingredient or flavor ingredient. (2) The division shall identify whether an ingredient is a fragrance ingredient or a flavor ingredient. (Amended by Stats. 2021, Ch. 615, Sec. 278. (AB 474) Effective January 1, 2022. Operative January 1, 2023, pursuant to Sec. 463 of Stats. 2021, Ch. 615.)
  189. 111793.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 7. Cosmetics [111660 - 111820] ( Chapter 7 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3.5. Chronic Health Effects of Cosmetics [111791 - 111793.5] ( Article 3.5 added by Stats. 2005, Ch. 729, Sec. 2. )

    Verify source ↗

    If an investigation finds a cosmetic ingredient may be toxic, the division must immediately refer the results to two agencies. The Division of Occupational Safety and Health must then act within 180 days unless it makes a timely written finding that no standard is needed.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 7. Cosmetics [111660 - 111820] ( Chapter 7 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3.5. Chronic Health Effects of Cosmetics [111791 - 111793.5] ( Article 3.5 added by Stats. 2005, Ch. 729, Sec. 2. ) ## 111793. (a) If the division determines pursuant to an investigation that an ingredient in a cosmetic product is potentially toxic at the concentrations present in the product or under the conditions used, the division shall immediately refer the results of its investigation to the Division of Occupational Safety and Health in the Department of Industrial Relations and the Office of Environmental Health Hazard Assessment. (b) Within 180 days after it receives the results of an investigation pursuant to subdivision (b), the Division of Occupational Safety and Health shall, pursuant to Section 147.1 of the Labor Code, develop and present one or more proposed occupational health standards to the Occupational Safety and Health Standards Board in the Department of Industrial Relations, unless the Division of Occupational Safety and Health affirmatively determines, in a written finding within 90 days, that a standard is not necessary to protect the health of an employee who has regular exposure to the hazard for the period of his or her working life. The written finding shall identify the reasons for determining the standard is not necessary and the factual basis for the finding. (Added by Stats. 2005, Ch. 729, Sec. 2. Effective January 1, 2006.)
  190. 111793.5.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 7. Cosmetics [111660 - 111820] ( Chapter 7 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3.5. Chronic Health Effects of Cosmetics [111791 - 111793.5] ( Article 3.5 added by Stats. 2005, Ch. 729, Sec. 2. )

    Verify source ↗

    The division may review certain cosmetic products for safety and must refer findings to the Attorney General and FDA if it finds a product is safe but contains an ingredient the CIR says is unsafe for that use.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 7. Cosmetics [111660 - 111820] ( Chapter 7 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 3.5. Chronic Health Effects of Cosmetics [111791 - 111793.5] ( Article 3.5 added by Stats. 2005, Ch. 729, Sec. 2. ) ## 111793.5. (a) The Legislature finds and declares the following: (1) The Cosmetic Ingredient Review (CIR) panel is a nongovernmental body established and funded by the cosmetics industry to review the safety of cosmetic ingredients. (2) According to a 2004 analysis of the 2003 CIR Compendium by the Environmental Working Group, 54 cosmetic products violate the CIR’s own safe use recommendations to manufacturers by containing an ingredient that the CIR has found is not safe for the specific use indicated on the product’s label. (3) Federal regulations (21 C.F.R. 740.10) require every ingredient in a cosmetic product and every finished cosmetic product to be adequately substantiated for safety prior to marketing, and state that any ingredient or product whose safety has not been adequately substantiated prior to marketing is misbranded unless it displays a warning statement declaring, “The safety of this product has not been determined.” (b) The division may, as early as feasible within existing resources, determine whether the products identified in paragraph (2) of subdivision (a) have been adequately substantiated for safety pursuant to Section 740.10 of Title 21 of the Code of Federal Regulations. For any product adequately substantiated for safety, the division shall determine if the product contains any ingredient that the CIR has found is not safe for the specific use indicated on the product’s label. (c) If the division finds that a product has been adequately substantiated for safety despite containing an ingredient that the CIR has found is not safe for the specific use indicated on the product’s label, the division shall refer its findings to the Attorney General and the federal Food and Drug Administration for possible enforcement action pursuant to this part and the federal Food, Drug and Cosmetic Act (21 U.S.C. Sec. 301 et seq.). (Added by Stats. 2005, Ch. 729, Sec. 2. Effective January 1, 2006.)
  191. 111795.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 7. Cosmetics [111660 - 111820] ( Chapter 7 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 4. Voluntary Registration [111795 - 111820] ( Article 4 added by Stats. 1995, Ch. 415, Sec. 6. )

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    Cosmetic manufacturers in this state may register with the department, but the registration is nontransferable and each place of manufacture needs a separate registration.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 7. Cosmetics [111660 - 111820] ( Chapter 7 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 4. Voluntary Registration [111795 - 111820] ( Article 4 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111795. (a) Any person who manufactures a cosmetic in this state may register with the department. Any registration issued under this article shall be valid for one calendar year from the date of issue, unless it is suspended or revoked. The registration shall not be transferable. (b) A separate registration shall be required for each place of manufacture. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  192. 11180.

    ## Health and Safety Code - HSC ## DIVISION 10. UNIFORM CONTROLLED SUBSTANCES ACT [11000 - 11651] ( Division 10 repealed and added by Stats. 1972, Ch. 1407. ) ## CHAPTER 4. Prescriptions [11150 - 11209] ( Chapter 4 added by Stats. 1972, Ch. 1407. ) ## ARTICLE 1. Requirements of Prescriptions [11150 - 11180] ( Article 1 added by Stats. 1972, Ch. 1407. )

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    No person may obtain or possess a controlled substance if the prescription does not comply with this division.

    ## Health and Safety Code - HSC ## DIVISION 10. UNIFORM CONTROLLED SUBSTANCES ACT [11000 - 11651] ( Division 10 repealed and added by Stats. 1972, Ch. 1407. ) ## CHAPTER 4. Prescriptions [11150 - 11209] ( Chapter 4 added by Stats. 1972, Ch. 1407. ) ## ARTICLE 1. Requirements of Prescriptions [11150 - 11180] ( Article 1 added by Stats. 1972, Ch. 1407. ) ## 11180. No person shall obtain or possess a controlled substance obtained by a prescription that does not comply with this division. (Added by Stats. 1972, Ch. 1407.)
  193. 111800.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 7. Cosmetics [111660 - 111820] ( Chapter 7 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 4. Voluntary Registration [111795 - 111820] ( Article 4 added by Stats. 1995, Ch. 415, Sec. 6. )

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    A registration application form must be completed every year and sent with a $350 application fee.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 7. Cosmetics [111660 - 111820] ( Chapter 7 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 4. Voluntary Registration [111795 - 111820] ( Article 4 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111800. A registration application form provided by the department shall be completed annually and accompanied by an application fee of three hundred fifty dollars ($350). This fee shall not be returnable if the registration is denied. The fee amount shall be adjusted annually pursuant to Section 100425. All fees collected pursuant to this section shall be deposited into the Export Document Program Fund established by Section 110240. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  194. 111805.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 7. Cosmetics [111660 - 111820] ( Chapter 7 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 4. Voluntary Registration [111795 - 111820] ( Article 4 added by Stats. 1995, Ch. 415, Sec. 6. )

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    A person registered under this article must immediately tell the department about any change in the information in the registration application.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 7. Cosmetics [111660 - 111820] ( Chapter 7 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 4. Voluntary Registration [111795 - 111820] ( Article 4 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111805. Any person registered pursuant to this article shall immediately notify the department of any change in the information reported in the registration application. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  195. 111810.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 7. Cosmetics [111660 - 111820] ( Chapter 7 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 4. Voluntary Registration [111795 - 111820] ( Article 4 added by Stats. 1995, Ch. 415, Sec. 6. )

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    Before issuing a registration, the department must inspect each place of business, and it must inspect each registrant annually.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 7. Cosmetics [111660 - 111820] ( Chapter 7 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 4. Voluntary Registration [111795 - 111820] ( Article 4 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111810. (a) Prior to issuing a registration under Section 111795, the department shall inspect each place of business to determine ownership, adequacy of facilities, personnel qualifications, and compliance with this part. The department shall annually inspect each registrant. (b) The department shall provide to each registrant a validated copy of the completed registration application form, sent to the mailing address shown on the form, as evidence of valid registration. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  196. 111815.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 7. Cosmetics [111660 - 111820] ( Chapter 7 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 4. Voluntary Registration [111795 - 111820] ( Article 4 added by Stats. 1995, Ch. 415, Sec. 6. )

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    The department must make any investigations or inspections authorized by Article 2 when it deems them necessary to carry out this article.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 7. Cosmetics [111660 - 111820] ( Chapter 7 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 4. Voluntary Registration [111795 - 111820] ( Article 4 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111815. The department shall make any investigations or inspections authorized by Article 2 (commencing with Section 110410) of Chapter 2 as it deems necessary to carry out this article. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  197. 111820.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 7. Cosmetics [111660 - 111820] ( Chapter 7 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 4. Voluntary Registration [111795 - 111820] ( Article 4 added by Stats. 1995, Ch. 415, Sec. 6. )

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    Violations of this part or related regulations can be grounds to deny, suspend, or revoke a registration; related proceedings follow Government Code Chapter 5, and the department has the powers given there.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 7. Cosmetics [111660 - 111820] ( Chapter 7 added by Stats. 1995, Ch. 415, Sec. 6. ) ## ARTICLE 4. Voluntary Registration [111795 - 111820] ( Article 4 added by Stats. 1995, Ch. 415, Sec. 6. ) ## 111820. Any violation of this part or any regulation adopted pursuant to this part shall be grounds for denying a registration or for suspending or revoking a registration. Proceedings for the denial, suspension, or revocation of the registration 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 department shall have all the powers granted in that chapter. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
  198. 111822.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 7.5. Menstrual Products [111822 - 111822.8] ( Chapter 7.5 added by Stats. 2020, Ch. 272, Sec. 1. )

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    This section defines key terms for menstrual product labeling and ingredient disclosure, and requires manufacturers to calculate the total concentration of each fragrance ingredient.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 7.5. Menstrual Products [111822 - 111822.8] ( Chapter 7.5 added by Stats. 2020, Ch. 272, Sec. 1. ) ## 111822. For purposes of this chapter, the following definitions apply: (a) “Confidential business information” means an intentionally added ingredient or combination of ingredients for which a claim has been approved by the federal Environmental Protection Agency for inclusion on the Toxic Substances Control Act (TSCA) Confidential Inventory or for which the manufacturer or its supplier claim protection under the Uniform Trade Secrets Act (Title 5 (commencing with Section 3426) of Part 1 of Division 4 of the Civil Code). “Confidential business information” shall not include any of the following: (1) An intentionally added ingredient or combination of ingredients that is on a designated list, as defined in subdivision (b). (2) A fragrance allergen included on Annex III of the European Union (EU) Cosmetics Regulation No. 1223/2009 or subsequent updates to those regulations, when present in the product at a concentration at or above 0.001 percent (10 parts per million). (b) “Designated list” means any of the following, including subsequent revisions when adopted by the authoritative body: (1) Chemicals known to the State of California to cause cancer or reproductive toxicity that are listed pursuant to the Safe Drinking Water and Toxic Enforcement Act of 1986 (Chapter 6.6 (commencing with Section 25249.5) of Division 20). (2) Chemicals classified by the EU as carcinogens, mutagens, or reproductive toxicants pursuant to Category 1A or 1B in Annex VI to Regulation (EC) 1272/2008. (3) Chemicals included in the EU Candidate List of Substances of Very High Concern in accordance with Article 59 of Regulation (EC) 1907/2006 on the basis of Article 57(f) for endocrine disrupting properties. (4) Chemicals for which a reference dose or reference concentration has been developed based on neurotoxicity in the federal Environmental Protection Agency’s Integrated Risk Information System. (5) Chemicals that are identified as carcinogenic to humans, likely to be carcinogenic to humans, or as Group A, B1, or B2 carcinogens in the federal Environmental Protection Agency’s Integrated Risk Information System. (6) Chemicals included in the EU Candidate List of Substances of Very High Concern in accordance with Article 59 of Regulation (EC) 1907/2006 on the basis of Article 57(d), Article 57(e), or Article 57(f) for persistent, bioaccumulative and toxic, or very persistent and very bioaccumulative, properties. (7) Chemicals that are identified as persistent, bioaccumulative, and inherently toxic to the environment by the Canadian Environmental Protection Act Environmental Registry Domestic Substances List. (8) Chemicals classified by the EU in Annex VI to Regulation (EC) 1272/2008 as respiratory sensitizer category 1. (9) Group 1, 2A, or 2B carcinogens identified by the International Agency for Research on Cancer. (10) Neurotoxicants that are identified in the federal Agency for Toxic Substances and Disease Registry’s Toxic Substances Portal, Health Effects of Toxic Substances and Carcinogens, Nervous System. (11) Persistent bioaccumulative and toxic priority chemicals that are identified by the federal Environmental Protection Agency National Waste Minimization Program. (12) Reproductive or developmental toxicants identified in Monographs on the Potential Human Reproductive and Developmental Effects published by the federal National Toxicology Program, Office of Health Assessment and Translation. (13) Chemicals identified by the federal Environmental Protection Agency’s Toxics Release Inventory as Persistent, Bioaccumulative and Toxic Chemicals that are subject to reporting under Section 313 of the Emergency Planning and Community Right-to-Know Act of 1986 (42 U.S.C. Sec. 11001, et seq.). (14) The Washington Department of Ecology’s Persistent, Bioaccumulative, Toxic (PBT) Chemicals identified in Chapter 173-333 of Title 173 of the Washington Administrative Code. (15) Chemicals that are identified as known to be, or reasonably anticipated to be, human carcinogens by the 13th Report on Carcinogens prepared by the federal National Toxicology Program. (16) Chemicals for which notification levels, as defined in Section 116455, have been established by the State Department of Public Health or the State Water Resources Control Board. (17) Chemicals for which primary maximum contaminant levels have been established and adopted under Section 64431 or 64444 of Title 22 of the California Code of Regulations. (18) Chemicals identified as toxic air contaminants under Section 93000 or 93001 of Title 17 of the California Code of Regulations. (19) Chemicals that are identified as priority pollutants in the California water quality control plans pursuant to subdivision (c) of Section 303 of the federal Clean Water Act (33 U.S.C. Sec. 1341) and in Section 131.38 of Title 40 of the Code of Federal Regulations, or identified as pollutants by the state or the federal Environmental Protection Agency for one or more water bodies in the state under subdivision (d) of Section 303 of the federal Clean Water Act (33 U.S.C. Sec. 1341) and Section 130.7 of Title 40 of the Code of Federal Regulations. (20) Chemicals that are identified with noncancer endpoints and listed with an inhalation or oral reference exposure level by the Office of Environmental Health Hazard Assessment pursuant to paragraph (2) of subdivision (b) of Section 44360. (21) Chemicals identified as priority chemicals by the California Environmental Contaminant Biomonitoring Program pursuant to Section 105449. (22) Chemicals that are identified on Part A of the list of Chemicals for Priority Action prepared by the Oslo and Paris Conventions for the Protection of the Marine Environment of the North-East Atlantic. (c) (1) “Fragrance ingredient” means an intentionally added substance or complex mixture of aroma chemicals, natural essential oils, and other functional ingredient present in a menstrual product for which the sole purpose is to impart an odor or scent, or to counteract odor, and that is any of the following: (A) Present in a menstrual product at a concentration at or above 0.01 percent (100 parts per million), unless the substance is confidential business information, in which case the manufacturer may identify the ingredient by its common name to protect its confidential identity pursuant to subdivision (b) of Section 111822.2. (B) Included on a designated list. (C) A fragrance allergen included in Annex III of the EU Cosmetics Regulation No. 1223/2009 or subsequent updates to that regulation when present in the menstrual product in a concentration at or above 0.001 percent (10 parts per million). (2) The manufacturer shall determine the total concentration of each fragrance ingredient by calculating the total amount of fragrance ingredient as a percentage of the total weight of the menstrual product. (d) “Ingredient” means a fragrance ingredient or other intentionally added substance or combination of substances present in the menstrual product, unless the intentionally added substance or combination of substances is confidential business information, in which case the manufacturer may identify the ingredient by its common name to protect its confidential identity pursuant to subdivision (b) of Section 111822.2. (e) “Intentionally added” means a substance that serves a technical or functional purpose in the finished menstrual product. (f) “Manufacturer” means either of the following: (1) A person or entity that manufactures the menstrual product and whose name appears on the product label. (2) A person or entity for whom the product is manufactured or distributed, as identified on the product label pursuant to the federal Fair Packaging and Labeling Act. (g) “Menstrual product” means a product used to collect menstruation and vaginal discharge, including, but not limited to, tampons, pads, sponges, menstruation underwear, disks, and menstrual cups, whether disposable or reusable. (Added by Stats. 2020, Ch. 272, Sec. 1. (AB 1989) Effective January 1, 2021.)
  199. 111822.2.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 7.5. Menstrual Products [111822 - 111822.8] ( Chapter 7.5 added by Stats. 2020, Ch. 272, Sec. 1. )

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    Menstrual product packages made on or after January 1, 2023 must list all ingredients on the label, and manufacturers must post the ingredient information on a website in electronically readable form.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 7.5. Menstrual Products [111822 - 111822.8] ( Chapter 7.5 added by Stats. 2020, Ch. 272, Sec. 1. ) ## 111822.2. (a) A package or box containing menstrual products that was manufactured on or after January 1, 2023, for sale or distribution in this state shall have printed on the label a plain and conspicuous list of all ingredients in the product. (b) The ingredients shall be listed in order of predominance by weight in the menstrual product, except that ingredients present at a weight below one percent may be listed in any order following the other ingredients. Ingredients shall be identified using a standardized nomenclature, including, but not limited to, the International Nomenclature of Cosmetic Ingredients (INCI), the Household Commercial Products Association’s Consumer Product Ingredient Dictionary (HCPA Dictionary), or common chemical name. If a standardized nomenclature does not otherwise exist for an ingredient, a name established by the Center for Baby and Adult Hygiene Products (BAHP) shall be used by all menstrual product manufacturers. A manufacturer may identify any ingredient that is confidential business information by its common name to protect its confidential identity. (c) Commencing January 1, 2023, a manufacturer of a menstrual product that is manufactured for sale or distribution in the state shall post on an internet website, in an electronically readable format, the ingredient information that is required to be disclosed on a package or box containing menstrual products pursuant to subdivision (a). (d) This section does not prohibit a manufacturer from using technologies, including, but not limited to, digital link, to communicate the information required by this section. (Added by Stats. 2020, Ch. 272, Sec. 1. (AB 1989) Effective January 1, 2021.)
  200. 111822.4.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 7.5. Menstrual Products [111822 - 111822.8] ( Chapter 7.5 added by Stats. 2020, Ch. 272, Sec. 1. )

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    Manufacturers must update online information within 6 months, and change menstrual product labels within 18 months, after certain ingredient or designated-list changes, unless a later effective date is set by the relevant authoritative body.

    ## Health and Safety Code - HSC ## DIVISION 104. ENVIRONMENTAL HEALTH [106500 - 119406] ( Division 104 added by Stats. 1995, Ch. 415, Sec. 6. ) ## PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS [109875 - 111929.5] ( Part 5 added by Stats. 1995, Ch. 415, Sec. 6. ) ## CHAPTER 7.5. Menstrual Products [111822 - 111822.8] ( Chapter 7.5 added by Stats. 2020, Ch. 272, Sec. 1. ) ## 111822.4. (a) When a manufacturer is required to make a revision to information disclosed online due to a change in a designated list or a change in an ingredient or addition of a new ingredient, the manufacturer shall make the revision no later than six months after the change or addition of the ingredient, or after the adoption of the revised designated list by its authoritative body, unless a later effective date for changes to a designated list is imposed by the relevant authoritative body. (b) When a manufacturer is required to change the label on a menstrual product because of a change in a designated list or a change to an ingredient or addition of a new ingredient, the manufacturer shall make the change within 18 months of the change or addition of the ingredient, or after the adoption of the revised designated list by its authoritative body, unless a later effective date is imposed by the relevant authoritative body. (Added by Stats. 2020, Ch. 272, Sec. 1. (AB 1989) Effective January 1, 2021.)

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