GENERAL

CONTENTS PART I INTERPRETATION 1. Definitions PART II CONTROLLED ACTS 2. General 3. Standards of practice, s. 4 (1) of the Act 4. Internal examinations 5. Administering substances by injection or inhalation 6. Moving the joints of the spine 7. Communicating a naturopathic diagnosis 8. Taking blood samples for performing prescribed naturopathic examinations 9. Prescribing a drug 10. Dispensing a drug 11. Compounding a drug 12. Selling a drug 13. Mandatory referral PART III DELEGATION 14. Definitions 15. Limits on delegation 16. Responsibility 17. Conditions before delegating 18. How made 19. Records, etc. 20. Accepting delegation, etc. 21. Contents of record 22. Delegation of communication of diagnosis PART IV INSPECTION OF PREMISES WHERE CERTAIN PROCEDURES ARE PERFORMED 23. Interpretation, etc. 24. Standard of practice re procedures 25. Reporting of occurrences 26. Inspection 27. Power of inspector 28. Duty of member 29. Direct observation 30. Designated member 31. Requirements before using premises 32. Timing of inspections 33. Results of inspection Table 1 Prescribed substances that may be administered by inhalation Table 2 Prescribed substances that may be administered by injection Table 3 Drugs that may be prescribed Table 4 Drugs that may be dispensed Table 5 Drugs that may be compounded Table 6 Drugs that may be sold Part I Interpretation Definitions 1. In this Regulation, “controlled act” means a controlled act set out in subsection 27 (2) of the Regulated Health Professions Act, 1991; (“acte autorisé”) “drug” means a drug as defined in the Drug and Pharmacies Regulation Act. (“médicament”) Part II Controlled Acts General 2. (1) A member shall not perform a controlled act under the authority of subsection 4 (1) of the Act except in accordance with this Part. (2) Where the provisions of this Part are inconsistent with a law of Canada respecting the sale, dispensing, compounding, prescribing or injection of a drug or other substance, including a drug or substance related to a targeted substance, the law of Canada shall prevail and the provisions of this Part, to the extent they are inconsistent with that law, shall not apply. (3) Where the provisions of this Part are inconsistent with the provisions of the Narcotics Safety and Awareness Act, 2010, the provisions of that Act shall prevail and the provisions of this Part, to the extent they are inconsistent with that Act, shall not apply. Standards of practice, s. 4 (1) of the Act 3. (1) A member shall not perform any controlled act under the authority of paragraph 1, 2, 3, 4 or 6 of subsection 4 (1) of the Act unless he or she performs it in accordance with all of the following standards of practice of the profession: 1. The member must have a naturopath-patient relationship with the patient and, before performing the controlled act, must record the patient’s health history. 2. Before performing the controlled act, the member must inform the patient or the patient’s authorized representative about, i. the purpose of the controlled act, ii. the risks inherent in performing it, iii. alternative treatments that the member knows or ought to know are available within the practice of the profession, and iv. treatments that the member knows or ought to know are available to the patient if he or she were to be treated by a member of another College under the Regulated Health Professions Act, 1991. 3. Before performing the controlled act, the member must receive an informed consent from the patient or his or her authorized representative. 4. Before performing the controlled act, the member must determine that the patient’s condition warrants performing the controlled act, having considered, i. the known risks and benefits to the patient of performing the controlled act, ii. the predictability of the outcome, iii. the safeguards and resources available in the circumstances to safely manage the outcome of performing the controlled act, and iv. other relevant circumstances specific to the patient. 5. The member must ensure that appropriate infection control procedures are in place at all times and that the controlled act is performed in an environment that is clean, safe, private and comfortable for the patient. 6. The member must have the knowledge, skill and judgment, i. to perform the controlled act safely and ethically, and ii. to determine whether the patient’s condition warrants performance of the controlled act. (2) It is a further standard of practice of the profession that a member is prohibited from taking or collecting a specimen from the human body for examination to obtain information for diagnosis, prophylaxis or treatment, unless the specimen that is taken or collected is identified in the regulations made under the Laboratory and Specimen Collection Centre Licensing Act and related to a specific laboratory test set out in the regulations made under that Act. (3) It is a further standard of practice of the profession that a member is prohibited from performing a laboratory test or taking blood samples or other specimens from a patient for the purpose of performing a laboratory test, unless the laboratory test that the member performs is specified in the regulations made under the Laboratory and Specimen Collection Centre Licensing Act and the blood samples or other specimens taken from a patient are identified in and related to a specific test in the regulations made under that Act. (4) It is a further standard of practice of the profession that a member is prohibited from ordering a laboratory test unless the test is one specified in the regulations made under the Laboratory and Specimen Collection Centre Licensing Act. Internal examinations 4. (1) For the purposes of paragraphs 1 and 2 of subsection 4 (1) of the Act, a member who meets all of the standards of practice of the profession in this section and section 3 of this Regulation is authorized to perform the following controlled acts: 1. Putting an instrument, hand or finger beyond the labia majora but not beyond the cervix. 2. Putting an instrument, hand or finger beyond the anal verge but not beyond the rectal-sigmoidal junction. (2) It is a standard of practice of the profession that a member may only perform a controlled act described in subsection (1) for one or more of the following purposes: 1. Examining a patient in the course of an assessment or to formulate a naturopathic diagnosis. 2. Treating the patient with naturopathic treatments or remedies. 3. Taking or collecting a specimen. Administering substances by injection or inhalation 5. (1) For the purposes of paragraph 3 of subsection 4 (1) of the Act, a member who meets all of the standards of practice of the profession in this section and section 3 of this Regulation is authorized to perform the following controlled acts: 1. Administering a substance specified in Table 1 by inhalation to a patient, in accordance with any limitations respecting the substance set out in the Table. 2. Administering a substance specified in Table 2 by injection to a patient using the routes of administration respecting the substance that are set out in the Table and in accordance with any limitations respecting the substance that are set out in the Table. (2) It is a standard of practice of the profession that a member who performs the controlled act referred to in paragraph 1 of subsection (1) and who, in doing so, mixes, prepares, packages or labels two or more substances specified in Table 1 for the purpose of administering a customized therapeutic product to a patient by inhalation must comply with all the standards of practice set out in subsection 11 (2), with any necessary modifications. (3) It is a standard of practice of the profession that a member who performs the controlled act referred to in paragraph 2 of subsection (1) and who, in doing so, reconstitutes, dilutes, mixes, prepares, packages or labels two or more substances specified in Table 2 for the purpose of administering a customized therapeutic product to a patient by injection must comply with all the standards of practice set out in subsection 11 (2), with any necessary modifications. (4) It is a standard of practice of the profession that a member may only perform a controlled act described in subsection (1) if he or she has successfully completed, (a) a course on prescribing that has been approved by the Council; and (b) an examination on prescribing that is administered or approved by the Council. (5) Where the administration of a substance referred to in paragraph 2 of subsection (1) is by intravenous injection, it is a standard of practice of the profession that a member may only perform the controlled act if he or she has successfully completed, in addition to the requirements under clauses (4) (a) and (b), (a) a course on administering a substance by intravenous injection that is approved by the Council; and (b) an examination on administering a substance by intravenous injection that is administered or approved by the Council. (6) A member who, immediately before section 6 of the Act came into force, was registered to practice under the Drugless Practitioners Act by The Board of Directors of Drugless Therapy and authorized by The Board to administer a substance by intravenous injection to a patient shall be deemed to have met the standards of practice in subsections (4) and (5), subject to subsection (7). (7) It is a standard of practice of the profession that a member described in subsection (6) shall successfully complete the course and examination mentioned in subsection (4) within six months of the coming into force of section 6 of the Act. (8) Despite anything in this section, a member may perform a controlled act described in subsection (1) if he or she does so while taking part in a course or examination required under clause (4) (a) or (b) or (5) (a) or (b). Moving the joints of the spine 6. (1) For the purposes of paragraph 4 of subsection 4 (1) of the Act, a member who meets all of the standards of practice of the profession in this section and section 3 of this Regulation is authorized to move the thoracic, lumbar and sacral joints of the spine and the cervical joints of the spine. (2) A member may perform an act described in subsection (1) only if he or she meets all of the following standards of practice: 1. The member shall use only one or more of the following low amplitude thrust procedures when he or she manipulates a patient’s cervical joints of the spine: i. Supine lateral flexion. ii. Supine rotary. iii. C2-C7 seated rotary. 2. The member shall not perform a controlled act described in subsection (1) if, at the time that the controlled act is proposed, i. the patient has or may have one or more of the contraindications listed in subsection (3), or ii. the member is in doubt about the accuracy of the patient’s health status or health history respecting any of the contraindications listed in subsection (3). (3) The contraindications mentioned in subparagraphs 2 i and ii of subsection (2) are the following: 1. Anomalies, including dens hypoplasia, unstable os odontoideum and similar diseases, disorders or dysfunctions. 2. Acute fracture. 3. Spinal cord tumour. 4. Acute infection of the spine, including osteomyelitis, septic discitis and tuberculosis of the spine. 5. Meningeal tumour. 6. Haematomas, whether spinal or intracanalicular. 7. Malignancy of the spine. 8. Frank disc herniation with accompanying signs of progressive neurological deficit. 9. Basilar invagination of the upper cervical spine (vertebrobasilar ischemia). 10. Symptomatic Arnold-Chiari malformation of the upper cervical spine. 11. Dislocation of a vertebra. 12. Aggressive types of benign tumours, such as an aneurismal bone cyst, giant cell tumour, osteoblastoma or osteoid osteoma. 13. Internal fixation/stabilization devices. 14. Neoplastic disease of muscle or other soft tissue. 15. Positive Kernig’s or Lhermitte’s signs. 16. Congenital, generalized hypermobility. 17. Syringomyelia. 18. Hydrocephalus of unknown aetiology. 19. Diastematomyelia. 20. Cauda equina syndrome. 21. Any other disease, disorder or dysfunction that the member knows or ought to know contraindicates performance of the controlled act in the relevant circumstances of the patient. Communicating a naturopathic diagnosis 7. (1) For the purposes of paragraph 5 of subsection 4 (1) of the Act, a member who meets all of the standards of practice in this section may communicate a naturopathic diagnosis to a patient that identifies the cause of his or her symptoms as being a disease, disorder or dysfunction that may be identified through an assessment using one or more of the following: 1. The patient’s health history. 2. The findings of an objective patient evaluation, including a physical examination of the patient. 3. The results of any relevant tests or investigations. (2) The member shall perform the controlled act described in subsection (1) only if he or she meets all of the following standards of practice: 1. The member must have a naturopath-patient relationship with the patient. 2. The member must have the knowledge, skill and judgment to perform the controlled act safely, accurately and ethically. Taking blood samples for performing prescribed naturopathic examinations 8. (1) For the purposes of paragraph 6 of subsection 4 (1) of the Act, a member who meets all of the standards of practice of the profession in this section and section 3 of this Regulation is authorized to take blood samples from veins or by skin pricking for the purpose of performing one or more of the following naturopathic examinations on a patient’s blood sample: 1. BTA Bioterrain Assessment. 2. Glucose. 3. Live blood cell analysis. 4. Hemoglobin – A1C. 5. Mononuclear Heterophile Antibodies (monospot). 6. Fatty acids, free. 7. Blood Group – ABO and RhD. (2) The member shall perform the controlled act described in subsection (1) only if he or she meets all of the following standards of practice: 1. The member shall perform the controlled act only for the purpose of, i. assessing the patient’s health status, ii. communicating a naturopathic diagnosis, or iii. monitoring or evaluating the patient’s response to treatment. 2. Subject to paragraph 3, the member shall only perform the specified naturopathic examination on a patient’s blood sample using a Class III medical device that has been approved by Health Canada. 3. Where no Health Canada approved Class III medical device exists for the purpose of performing a specified naturopathic examination, but another Health Canada approved medical device exists that can be used for the purpose, the member must use such a device, in accordance with the purpose intended by the manufacturer of the device, and in accordance with the manufacturer’s instructions. 4. The member shall ensure that any instrument or device used for taking, collecting or examining a blood sample is used solely for the purpose intended by the manufacturer of the device and in compliance with the manufacturer’s specifications. 5. The member is prohibited from taking a blood sample from a patient except for the purpose of performing the controlled act mentioned in subsection (1). Prescribing a drug 9. (1) For the purposes of paragraph 7 of subsection 4 (1) of the Act, a member may prescribe a drug designated in Table 3 only if all of the standards of practice of the profession in this section are met. (2) The following are standards of practice for the purposes of subsection (1): 1. The member must have a naturopath-patient relationship with the patient for whom the drug is prescribed. 2. The member must prescribe the drug for therapeutic purposes only. 3. The member must possess sufficient knowledge, skill and judgment respecting the drug and the patient’s condition to prescribe the drug for the patient. 4. The member must have determined that the patient’s condition warrants prescribing the drug, having considered the known risks and benefits to the patient of prescribing the drug and other circumstances relevant to the patient. 5. The member must give a written prescription for the drug to the patient or his or her authorized representative. 6. The member must notify the patient’s other primary health care providers, if any, within a reasonable time that the member prescribed a drug for the patient and provide details respecting the prescription, unless the patient refuses to consent to the notification. 7. Where a limitation, a route of administration or a dosage is indicated in the column opposite the drug in Table 3, a member shall only prescribe that drug in compliance with the limitation and in accordance with the route of administration and dosage specified. (3) It is an additional standard of practice of the profession that a member who prescribes a drug to a patient as described in subsection (1) must ensure that the following information is recorded on the prescription: 1. The name and address of the patient for whom the drug is prescribed. 2. The name, strength (where applicable) and quantity of the prescribed drug. 3. Directions for the use of the drug, including its dose, frequency, route of administration and any special instructions. 4. The name, signature, address, telephone number and College registration number of the member issuing the prescription. 5. The date the prescription was issued by the member. 6. The number of refills that the member authorized, if applicable. 7. Any other information required by law. (4) It is an additional standard of practice of the profession that a member who prescribes a drug under this section must maintain a patient record that includes details of the member’s rationale for his or her decision to prescribe the drug to the patient and the following information, if applicable: 1. A copy of the prescription that the member gave to the patient or the patient’s authorized representative. 2. A record of the results of any laboratory or other tests that the member considered in making the decision to prescribe the drug. 3. The names and addresses of the patient’s other primary health care providers, the date on which the member notified those other providers about the prescription and the method by which the notification occurred. (5) It is an additional standard of practice of the profession that a member may only perform the controlled act described in subsection (1) if he or she has successfully completed, (a) a course on prescribing that has been approved by the Council; and (b) an examination on prescribing that is administered or approved by the Council. (6) Despite anything in this section, a member may perform the controlled act described in subsection (1) if he or she does so while taking part in a course or examination required under clauses (5) (a) and (b). Dispensing a drug 10. (1) For the purposes of paragraph 7 of subsection 4 (1) of the Act, a member may dispense a drug designated in Table 4 only if all of the standards of practice of the profession in this section are met. (2) The following are standards of practice for the purposes of subsection (1); 1. Unless subsection (3) applies, the member must have a naturopath-patient relationship with the patient for whom the drug is dispensed. 2. The member must dispense the drug for therapeutic purposes only. 3. Unless subsection (3) applies, the member must provide the drug directly to the patient or the patient’s authorized representative. 4. The member must advise the patient or his or her authorized representative that the drug may be available at a pharmacy. 5. The member must have the knowledge, skill and judgment to dispense the drug safely and ethically. 6. The member must have ensured that the drug has been obtained and stored in accordance with any applicable laws. 7. The member must have ensured that the drug has not expired and will not expire before the date on which the patient is expected to take the last of the drug. 8. Where a limitation, a route of administration or a dosage is indicated in the column opposite the drug in Table 4, a member shall only dispense that drug in compliance with the limitation and in accordance with the route of administration and dosage specified. 9. The member must dispense a reasonable quantity of the drug having regard to the patient’s condition, availability of the drug and the patient’s ability to obtain the drug elsewhere. 10. The member must ensure that the container in which the drug is dispensed, or, if there is insufficient space on the container, a document attached to the container, lists the following information: i. An identification number, if applicable. ii. The member’s name and title. iii. The name, address and telephone number of the place from which the drug is dispensed. iv. The identification of the drug as to its name, its strength (where applicable) and, if available, its manufacturer. v. The quantity of the drug dispensed. vi. The date the drug is dispensed. vii. The expiry date of the drug, if applicable. viii. The name of the patient for whom the drug is dispensed. ix. The directions for use of the drug, including its dose, frequency, route of administration and any special instructions. 11. The member must retain a copy of the information set out under paragraph 10 in the patient’s record, and, if applicable, a copy of the prescription required under clause (3) (d). (3) It is a further standard of practice of the profession that if the member does not have a naturopath-patient relationship with the person for whom the drug is dispensed, the member must not dispense the drug unless, (a) at the time the drug is dispensed, the member possesses the prescription for the drug; (b) the person who prescribed the drug is another member; (c) the prescription contains all the information required under subsection 9 (3); and (d) the member retains a copy of the prescription in the member’s records. (4) It is a further standard of practice of the profession that a member may only perform the controlled act described in subsection (1) if he or she has successfully completed, (a) a course on prescribing that has been approved by the Council; and (b) an examination on prescribing that is administered or approved by the Council. (5) Despite anything in this section, a member may perform the controlled act described in subsection (1) if he or she does so while taking part in a course or examination required under clauses (4) (a) and (b). Compounding a drug 11. (1) For the purposes of paragraph 7 of subsection 4 (1) of the Act, a member may compound a drug designated in Table 5 only if all of the standards of practice of the profession in this section are met. (2) The following are standards of practice for the purposes of subsection (1): 1. The member must have a naturopath-patient relationship with the patient for whom the drug is compounded. 2. The member must have the knowledge, skill and judgment to engage in the controlled act safely, competently and ethically. 3. Before performing the controlled act, the member must have considered the patient’s condition, the risks and benefits to the patient and any other relevant circumstances specific to the patient. 4. The member must ensure that the controlled act is performed in an aseptic preparation area using aseptic techniques to minimize the risk of contamination. 5. The member must provide the compounded drug directly to the patient or the patient’s authorized representative. 6. Where a limitation, a route of administration or a dosage is indicated in the column opposite the drug in Table 5, a member shall only compound that drug in compliance with the limitation and in accordance with the route of administration and dosage specified. 7. The member must compound the drug for the purpose of providing a customized therapeutic solution for a particular patient. 8. The member must advise the patient or his or her authorized representative that the drug may be compounded at a pharmacy. 9. The member shall only engage in the controlled act when a supply of a Health Canada approved, commercially prepared product that meets the patient’s needs is not reasonably available. 10. The member must have ensured that the drugs or other substances used in the compounding have been obtained and stored in accordance with any applicable laws. 11. The member must have ensured that the drugs or other substances used in the compounding have not expired and will not expire before the date on which the patient is expected to take or use the last of the compounded drug. 12. The member must ensure that the container holding the compounded drug, or if there is insufficient space on the container, a document attached to the container, lists the following information: i. An identification number, if applicable. ii. The member’s name and title. iii. The name, address and telephone number of the place where the drug was compounded. iv. The identification of the drugs, substances and any other ingredients used in the compounding, their names and strength and, if available, their manufacturer. v. The amount or percentage of each of the drugs, substances and any other ingredients used to make the compounded product and the quantity of the compounded product in the container. vi. The date that the compounded drug was prepared and the date that the compounded drug was dispensed to the patient. vii. The expiry date of the compounded drug. viii. The name of the patient for whom the drug was compounded. ix. The directions for the storage and use of the compounded drug, including its dose, frequency, route of administration and any special instructions. 13. The member must retain a copy of the information described in paragraph 12 in the patient’s record. (3) It is a further standard of practice of the profession that a member may only perform a controlled act described in subsection (1) if he or she has successfully completed, (a) a course on prescribing that has been approved by the Council; and (b) an examination on prescribing that is administered or approved by the Council. (4) Despite anything in this section, a member may perform a controlled act described in subsection (1) if he or she does so while taking part in a course or examination required under clause (3) (a) or (b). Selling a drug 12. (1) For the purposes of paragraph 7 of subsection 4 (1) of the Act, a member may sell a drug designated in Table 6 only if all of the standards of practice of the profession in this section are met. (2) The following are standards of practice for the purposes of subsection (1): 1. Unless subsection (3) applies, the member must have a naturopath-patient relationship with the patient for whom the drug is sold. 2. Unless subsection (3) applies, the member must sell the drug directly to the patient or the patient’s authorized representative. 3. The member must sell the drug for therapeutic purposes only. 4. Where a limitation, a route of administration or a dosage is indicated in the column opposite the drug in Table 6, a member shall only sell that drug in compliance with the limitation and in accordance with the route of administration and dosage specified. 5. The member must advise the patient or his or her authorized representative that the drug may be purchased at a pharmacy. 6. The member must have made reasonable inquiries and be satisfied that, i. the patient does not have reasonable or timely access to a pharmacy, ii. the patient would not otherwise buy the drug, iii. the patient does not have the financial resources to obtain the drug if not sold by the member, or iv. the drug is not reasonably available in a pharmacy. 7. The member must not sell the drug if the selling provides a profit to him or her or a direct or indirect personal or financial benefit. 8. The member must have ensured that the drug to be sold has been obtained and stored in accordance with any applicable laws. 9. The member must have ensured that the drug to be sold has not expired and will not expire before the date on which the patient is expected to take the last of the drug. 10. Unless subsection (3) applies, the member must retain in the patient’s record a record that the drug was sold to the patient or his or her authorized representative and the price charged, and where subsection (3) does apply, a copy of the prescription required under clause (3) (d). (3) If the member does not have a naturopath-patient relationship with the person to whom the drug is sold, the member must not sell the drug unless, (a) at the time the drug is sold, the member possesses the prescription for the drug; (b) the person who prescribed the drug is another member; (c) the prescription contains all the information required under subsection 9 (3); and (d) the member retains a copy of the prescription in the member’s records. (4) Paragraphs 5 to 9 of subsection (2) apply, with necessary modification, to the member mentioned in clause (3) (b). (5) It is a further standard of practice of the profession that a member may only perform a controlled act described in subsection (1) if he or she has successfully completed, (a) a course on prescribing that has been approved by the Council; and (b) an examination on prescribing that is administered or approved by the Council. (6) Despite anything in this section, a member may perform a controlled act described in subsection (1) if he or she does so while taking part in a course or examination required under clause (5) (a) or (b). Mandatory referral 13. (1) If a patient’s life is or may be at risk, it is a standard of practice of the profession that the member shall immediately call emergency services to transfer the patient to a hospital. (2) If the patient’s condition prevents the member from communicating a naturopathic diagnosis because the condition is beyond the scope of practice of the profession, it is a standard of practice of the profession that the member shall refer the patient to, (a) a member of the College of Physicians and Surgeons of Ontario; (b) a member of the College of Nurses of Ontario who holds a certificate of registration as a registered nurse in the extended class; or (c) a member of another health profession College where the patient’s condition would fall within that member’s scope of practice under his or her health profession Act. (3) If treatment of the patient’s condition is beyond the scope of practice of the profession, it is a standard of practice of the profession that the member shall refer the patient to, (a) a member of the College of Physicians and Surgeons of Ontario; (b) a member of the College of Nurses of Ontario who holds a certificate of registration as a registered nurse in the extended class; or (c) a member of another health profession College where the patient’s condition would fall within that member’s scope of practice under his or her health profession Act. (4) If the treatment of the patient’s condition requires diagnostic, monitoring or treatment related technology that is beyond the scope of practice of the profession, it is a standard of practice of the profession that the member shall refer the patient to, (a) a member of the College of Physicians and Surgeons of Ontario; or (b) a member of another health profession College where the diagnostic, monitoring or treatment related technology would fall within that member’s scope of practice. (5) If the patient or the patient’s authorized representative asks the member to refer the patient to another member or a member of another health profession College, it is a standard of practice of the profession that the member shall immediately make the referral in accordance with the request of the patient or his or her authorized representative. (6) It is a standard of practice of the profession that the member must immediately refer the patient to a member of the College of Physicians and Surgeons of Ontario or a member of the College of Nurses of Ontario who holds a certificate of registration as a registered nurse in the extended class if the patient’s laboratory test result from a laboratory licensed under the Laboratory Specimen Centre Collection Licensing Act is a critical value test result. (7) It is a standard of practice of the profession that the member must refer the patient to a member of the College of Physicians and Surgeons of Ontario or a member of the College of Nurses of Ontario who holds a certificate of registration as a registered nurse in the extended class if the response of a patient to the treatment offered by a member is not adequate and is not likely to improve based on alternative treatments available from the member, or if the patient’s condition significantly deteriorates and is likely to continue to do so without a referral. (8) Nothing in this section prohibits a member who has referred a patient from providing that patient with supportive or other health services within the member’s scope of practice after the patient has been referred, as long as the member works in collaboration with the person to whom the patient was referred and the patient. (9) In this section, “critical value test result” means a laboratory test result that shows a marked deviation from the reference ranges, with no clear indication to the laboratory that these are expected deviations. Part III Delegation Definitions 14. In this Part, “delegatee” means a person to whom a controlled act is delegated; (“délégataire”) “delegator” means a person who delegates a controlled act. (“délégant”) Limits on delegation 15. A member shall not, except in accordance with this Part, delegate a controlled act or perform a controlled act that was delegated to him or her. Responsibility 16. (1) A member who delegates a controlled act is responsible for the decision to delegate the controlled act. (2) A member who performs a controlled act that is delegated to him or her is responsible for the decision to carry out the controlled act and for its performance. Conditions before delegating 17. (1) A member shall ensure, before delegating any controlled act, that he or she, (a) has the authority under the Act and its regulations to perform the controlled act himself or herself; (b) has the knowledge, skill and judgment to perform the controlled act safely and ethically; (c) has a naturopath-patient relationship with the patient for whom the controlled act will be performed; (d) has considered whether delegation of the controlled act is appropriate, bearing in mind the best interests and needs of the patient; (e) after taking reasonable steps, is satisfied that sufficient safeguards and resources are available to the delegatee so that the controlled act may be performed safely and ethically; (f) has considered whether delegation of the controlled act should be subject to any conditions to ensure that it is performed safely and ethically and has made the delegation subject to conditions, if necessary; (g) has put in place a communication plan between himself or herself and the delegatee that deals with the appropriate management of any adverse events that may occur as a result of the delegation. (h) after taking reasonable steps, is satisfied that the delegatee is a person who is permitted to accept the delegation; (i) after taking reasonable steps, is satisfied that the delegatee is a health care provider who has a professional relationship with the patient, a person in the patient’s household or a person who routinely provides assistance or treatment to the patient; and (j) after taking reasonable steps, is satisfied, (i) that the delegatee has the knowledge, skill and judgment to perform the controlled act safely and ethically, where the delegatee is a member of a health profession other than the profession of naturopathy, or (ii) that the delegation is appropriate for the patient and that the delegatee has the knowledge, skill and judgment to perform the controlled act safely and ethically where the delegatee is not a member of a health profession set out in Schedule 1 to the Regulated Health Professions Act, 1991. (2) A member shall not delegate a controlled act that was delegated to him or her to perform. (3) A member who has delegated a controlled act but has reasonable grounds to believe that the delegatee no longer has the ability to perform the controlled act safely and ethically shall immediately cease to delegate the controlled act to that delegatee and shall take measures to ensure that the delegatee ceases to perform any controlled acts previously delegated by the delegator but not yet completed. How made 18. The delegation of a controlled act may be made orally or in writing. Records, etc. 19. (1) A member who delegates a controlled act shall, (a) ensure that a written record of the particulars of the delegation is available in the place where the controlled act is to be performed before it is performed; (b) ensure that a written record of the particulars of the delegation, or a copy of the record, is placed in the patient’s record at the time the delegation takes place or within a reasonable period of time afterwards; or (c) record the particulars of the delegation in the patient record either at the time the delegation takes place or within a reasonable period of time afterwards. (2) A record created under subsection (1) must include a copy of the communication plan required under clause 17 (1) (g). Accepting delegation, etc. 20. (1) A member shall not accept the delegation of a controlled act unless the person delegating the controlled act was, at the time of the delegation, a member of another health profession set out in Schedule 1 to the Regulated Health Professions Act, 1991 who is authorized to perform that controlled act by a health profession Act governing his or her profession. (2) A member shall not perform a controlled act that was delegated to him or her by a person to whom the controlled act was delegated. (3) A member shall only perform a controlled act delegated to him or her if, before performing the controlled act, the member ensures that he or she, (a) has the knowledge, skill and judgment to perform the controlled act safely and ethically; (b) has a naturopath-patient relationship with the patient for whom the controlled act is to be performed; (c) has considered whether performing the controlled act is appropriate, bearing in mind the best interests and needs of the patient; (d) after taking reasonable steps, is satisfied that there are sufficient safeguards and resources available to ensure that the controlled act can be performed safely and ethically; (e) has no reason to believe that the delegator is not permitted to delegate that controlled act; and (f) has ensured that any conditions have been met, if the delegation is subject to any conditions. (4) A member who performs a controlled act that was delegated to him or her shall record the particulars of the delegation in the patient’s record, unless, (a) a written record of the particulars of the delegation is available in the place where the controlled act is to be performed; (b) a written record of the particulars of the delegation, or a copy of the record, is present in the patient’s record; or (c) the particulars of the delegation have already been recorded in the patient’s record. Contents of record 21. Any record of the particulars of a delegation must include, (a) the date of the delegation; (b) the delegator’s name, if the controlled act was delegated to the member; (c) the delegatee’s name, if the controlled act was delegated by the member; and (d) the conditions, if any, applicable to the delegation. Delegation of communication of diagnosis 22. It is a standard of practice of the profession that a member shall not delegate the controlled act described in paragraph 5 of subsection 4 (1) of the Act. Part iv inspection of premises where Certain procedures are performed Interpretation, etc. 23. (1) In this Part, “designated member” means, (a) the member designated for a premises in accordance with section 30, or (b) where only one member performs or may perform a procedure in a premises, that member; (“membre désigné”) “inspector” means a person designated by the College to carry out an inspection under this Part on behalf of the College; (“inspecteur”) “premises” means any place where a member performs or may perform a procedure; (“locaux”) “procedure” means, (a) any procedure by which any two or more drugs or substances listed in Table 2 or Table 5, in any combination, are mixed, reconstituted, or by any other means made into a customized therapeutic product by a member for the purpose of administration by intravenous injection to a patient, and includes the labelling of such a customized therapeutic product, or (b) the administration of a customized therapeutic product described in clause (a) by intravenous injection to a patient by a member; (“acte”) “Type 1 occurrence” means, with respect to a premises, (a) the death of a patient at the premises after a procedure was performed, (b) the death of a patient occurring within five days after a procedure was performed at the premises, (c) any referral of a patient to emergency services within five days after a procedure was performed at the premises, (d) any procedure performed on the wrong patient at the premises, (e) the administration of an emergency drug to a patient immediately after a procedure was performed at the premises, (f) the diagnosis of a patient with shock or convulsions occurring within five days after a procedure was performed at the premises, (g) the diagnosis of a patient as being infected with a disease or any disease-causing agent after a procedure was performed at the premises, if the member forms the opinion that the patient is or may have been infected as a result of the performance of a procedure; (“situation de type 1”) “Type 2 occurrence” means, (a) any infection occurring in a patient in the premises after a procedure was performed at the premises, (b) an unscheduled treatment of a patient by a member occurring within five days after a procedure was performed at the premises, or (c) any adverse drug reaction occurring in a patient after a procedure was performed at the premises. (“situation de type 2”) O. Reg. 415/16, s. 1. (2) Anything that may be done by the College under this Part may be done by the Council or by a committee established under clause 94 (1) (i) of the Health Professions Procedural Code. O. Reg. 415/16, s. 1. Standard of practice re procedures 24. It is a standard of practice of the profession that a member who practises the profession in a premises where procedures are performed shall comply with the requirements of this Part with regard to the reporting of Type 1 and Type 2 occurrences. O. Reg. 415/16, s. 1. Reporting of occurrences 25. Every member shall report to the College, in the form and manner required by the College, (a) every Type 1 occurrence that follows the performance of a procedure in the premises by the member or another member, with the report being provided to the College no later than 24 hours after the member learns of the occurrence; and (b) the total number of Type 2 occurrences following the performance of procedures, with the report provided to the College by the designated member on an annual basis, together with, for every Type 2 occurrence that involved an infection, the type of infection. O. Reg. 415/16, s. 1. Inspection 26. (1) All premises where a procedure is or may be performed by a member in connection with his or her practice are subject to inspection by the College in accordance with this Part. O. Reg. 415/16, s. 1. (2) In carrying out an inspection of a premises under subsection (1), the College may also require any or all of the following: 1. Inspection, examination or tests regarding any equipment, instrument, materials or any other thing that may be used in the performance of a procedure. 2. Examination and copying of books, accounts, reports, records or similar documents that are, in the opinion of the College, relevant to the performance of a procedure in the practice of the member. 3. Inquiries or questions to be answered by the member that are relevant to the performance of a procedure. 4. Information that establishes whether a member who performs or may perform a procedure in a premises has met the standard of practice set out in section 24. 5. Direct observation of a member in his or her practice, including direct observation by an inspector of the member performing a procedure and performing a procedure on a patient. O. Reg. 415/16, s. 1. Power of inspector 27. An inspector may, on the production of information identifying him or her as an inspector, enter and have access to any premises where a procedure is or may be performed by a member at reasonable times and may inspect the premises and do any of the things mentioned in subsection 26 (2) on behalf of the College. O. Reg. 415/16, s. 1. Duty of member 28. (1) It is the duty of every member whose premises are subject to an inspection to, (a) submit to an inspection of the premises where he or she performs or may perform a procedure in accordance with this Part; (b) submit to being directly observed performing a procedure in his or her practice; (c) promptly answer a question or comply with a requirement of the inspector that is relevant to an inspection under this Part; (d) co-operate fully with the inspector who is conducting an inspection of a premises in accordance with this Part; (e) provide the inspector with a copy of any report that was given to the College in accordance with clause 25 (a); and, (f) co-operate fully with the College in accordance with this Part. O. Reg. 415/16, s. 1. (2) A member shall not perform a procedure at a premises subject to an inspection under this Part where an inspector has been denied entry or access. O. Reg. 415/16, s. 1. Direct observation 29. Where, as part of the inspection, an inspector directly observes the member performing a procedure on a patient, before the observation occurs, the inspector shall, (a) identify himself or herself to the patient as an inspector appointed by the College; (b) explain the purpose of the direct observation to the patient; (c) inform the patient that information obtained from the direct observation, including personally identifiable information about the patient, may be used in proceedings under this Part or any other proceeding under the Act; (d) answer any questions that the patient asks; and (e) obtain the patient’s written consent to the direct observation of the patient by the inspector. O. Reg. 415/16, s. 1. Designated member 30. Where two or more members perform or may perform a procedure in a premises, the members shall, (a) designate a member as the designated member for the premises, and immediately notify the College of the designated member’s identity; (b) immediately notify the College, on every occasion when a different member is designated as designated member for the premises, of the identity of the new designated member. O. Reg. 415/16, s. 1. Requirements before using premises 31. (1) No member shall commence using any premises for the purpose of performing a procedure unless the member has previously given notice in writing to the College in accordance with subsection (5) of the member’s intention to do so and the premises pass an inspection or pass an inspection with conditions. O. Reg. 415/16, s. 1. (2) The College shall ensure that an inspection of the premises of a member referred to in subsection (1) is performed within 180 days from the day the College receives the member’s notice. O. Reg. 415/16, s. 1.

(3) A member whose practice includes the performance of a procedure in any premises on the day this section comes into force shall give notice in writing to the College in accordance with subsection (5) within 60 days from the day this section comes into force, and the member may continue to use the premises for the performance of procedures until such time as the College has inspected the premises and delivered a report in accordance with section 33. O. Reg. 415/16, s. 1. (4) The College shall ensure that an inspection of the premises of a member referred to in subsection (3) is performed within 24 months from the day this section comes into force. O. Reg. 415/16, s. 1. (5) The notice submitted by the member required in subsections (1) and (3) shall include the following information, submitted in the form and manner required by the College: 1. The full name of the member giving the notice and the full name of the owner or occupier of the premises, if he or she is not the member who is required to give notice under this section. 2. The full name of any other member who is practising or may practise in the premises with the member giving the notice. 3. The name of any health profession corporation that is practising at the premises. 4. The full name of any other regulated health professional who is practising or may practise in the premises with a member at the premises, along with the name of the College where the regulated health professional is a member. 5. The full address of the premises. 6. The date when any member first performed a procedure in the premises or the proposed date when any member or another member intends to perform a procedure at the premises. 7. A description of any procedure that is or may be performed by a member or other members at the premises and of any procedure that may be delegated by the member or other members at the premises. 8. A description of any equipment or materials to be used in the performance of a procedure. 9. Any other information the College requires that is relevant to an inspection conducted at the premises in accordance with this Part. O. Reg. 415/16, s. 1. Timing of inspections 32. All premises where a member performs or may perform a procedure are subject to an inspection by the College once every five years after its initial inspection or more often if, in the opinion of the College, it is necessary or advisable to do so. O. Reg. 415/16, s. 1. Results of inspection 33. (1) After an inspection of a premises, the College shall determine, in accordance with the accepted standards of practice, whether the premises passes, passes with conditions, or fails the inspection. O. Reg. 415/16, s. 1. (2) In determining whether a premises passes, passes with conditions or fails an inspection, the College may consider, (a) the inspection results provided to the College by the inspector; (b) information provided by one or more members who perform or may perform a procedure in the premises respecting the inspection, including the answers given by them in response to inquiries or questions asked by the inspector; (c) the information contained in a notice given by a member under subsection 31 (1) or (3); (d) any submissions made by a member or members practising in the premises that are relevant to the inspection; and (e) any other information that is directly relevant to the inspection of the premises conducted under this Part. O. Reg. 415/16, s. 1. (3) The College shall deliver a report, in writing and in accordance with section 39 of the Regulated Health Professions Act, 1991, to the designated member for the premises, within a reasonable time after the inspection is completed. O. Reg. 415/16, s. 1. (4) Any report made by the College respecting an inspection of a premises where a procedure is or may be performed shall make a finding that the premises passed, passed with conditions, or failed the inspection and shall provide reasons where the premises passed with conditions or failed the inspection. O. Reg. 415/16, s. 1. (5) Any report made by the College that makes a finding that the premises failed an inspection or passed with conditions is effective on the day when the report is received in accordance with section 39 of the Regulated Health Professions Act, 1991, by the designated member for the premises. O. Reg. 415/16, s. 1. (6) The designated member who receives a report made by the College that finds that a premises failed an inspection or passed with conditions shall promptly provide copies of the report to all members who perform or may perform a procedure in the premises. O. Reg. 415/16, s. 1. (7) A member shall not perform a procedure in a premises that fails an inspection until, (a) the College delivers a report, in accordance with section 39 of the Regulated Health Professions Act, 1991, indicating that the premises passed a subsequent inspection, or passed with conditions; or (b) the College substitutes a finding that the premises passed or passed with conditions, after considering the written submissions, if any, under subsection (9). O. Reg. 415/16, s. 1. (8) A member shall not perform a procedure in a premises that passed an inspection with conditions except in accordance with the conditions set out in the report until, (a) the College delivers a report, in accordance with section 39 of the Regulated Health Professions Act, 1991, indicating that the premises passed a subsequent inspection; or (b) the College substitutes a finding that the premises passed the inspection, after considering the written submissions, if any, under subsection (9). O. Reg. 415/16, s. 1. (9) A member may make submissions in writing to the College within 14 days from the day the designated member receives the report under subsection (5). O. Reg. 415/16, s. 1. (10) The College may or may not elect to re-inspect the premises after receiving a member’s written submissions, but no more than 60 days after a member provides his or her written submissions, the College shall do one or more of the following: 1. Confirm its finding that the premises failed the inspection or passed with conditions. 2. Make a report and find that the premises passed with conditions. 3. Make a report and find that the premises passed the inspection. O. Reg. 415/16, s. 1. (11) Premises that fail an inspection or pass with conditions may be subject to one or more further inspections within a reasonable time after the College delivers its report, at the request of a member or any other person to whom the College gave the report, or at any time at the discretion of the College. O. Reg. 415/16, s. 1. (12) Where, as a result of an inspection carried out under this Part, a report made by the College finds that a member’s knowledge, skill or judgment is unsatisfactory, the College may direct the Registrar to refer the report to the Quality Assurance Committee. O. Reg. 415/16, s. 1. (13) Where, as a result of an inspection carried out under this Part, a report made by the College finds that a member may have committed an act of professional misconduct or may be incompetent or incapacitated, the College may direct the Registrar to refer the report to the Inquiries, Complaints and Reports Committee. O. Reg. 415/16, s. 1. Table 1 prescribed Substances that may be Administered by Inhalation Substance Limitations Acetylcysteine No limitation specified. Glutathione No limitation specified. Ipratropium Bromide Administered to a patient by the member in his or her office only in emergency circumstances. In an emergency, administer a maximum daily dose of 0.5 mg but only after the member has administered Salbutamol to the patient. Salbutamol Administered to a patient by the member in his or her office only in emergency circumstances. In an emergency, administer a maximum of two doses, each dose 2.5 mg. Saline No limitation specified. Therapeutic Oxygen No limitation specified. Table 2 prescribed Substances that may be Administered by Injection Substance Route of Administration Limitation Acetylcysteine Intravenous Must be in combination with other amino acids. Adenosine triphosphate Intravenous No limitation specified. Alanine Intravenous Must be in combination with other amino acids. Alpha Lipoic Acid Intravenous Maximum daily dose of 600 mg for racemic form or 300 mg for R form. Arginine Intravenous Must be in combination with other amino acids. Aspartic Acid Intravenous Must be in combination with other amino acids. Atropine Intravenous Administered to a patient by the member in his or her office only in emergency circumstances. In an emergency, administer 0.5-1 mg q3-5 min. Dose must be 0.5 mg or higher but must not exceed 2 mg. Biotin Intravenous No limitation specified. Calcium Chloride Intravenous No limitation specified. Calcium Gluconate Intravenous No limitation specified. Calcium Glycerophosphate Intravenous No limitation specified. Carbohydrates in sodium chloride solution Intravenous No limitation specified. Chromium Intravenous No limitation specified. Copper Sulfate Intravenous No limitation specified. Cupric Chloride Intravenous No limitation specified. Dextrose Injection Intravenous No limitation specified. Diphenhydramine Hydrochloride Intravenous, Intramuscular Administered to a patient by the member in his or her office only in emergency circumstances with a maximum dose of 100 mg. Epinephrine Hydrochloride Intramuscular Administered to a patient by the member in his or her office only in emergency circumstances with a maximum dose of 1.5 mg. Ferrous Sulphate Intramuscular Must be administered by z-track only. Folic Acid Intravenous, Intramuscular No limitation specified. Glutamine Intravenous Must be in combination with other amino acids. Glutamic Acid Intravenous Must be in combination with other amino acids. Glycine Intravenous Must be in combination with other amino acids. Glutathione Intravenous, Intramuscular No limitation specified. Histidine Intravenous Must be in combination with other amino acids. Hydrochloric Acid Intravenous In ratio of 1:1000 or 1:500. Isoleucine Intravenous Must be in combination with other amino acids. L-Tryptophan Intravenous No limitation specified. Lactated Ringer’s Solution Intravenous No limitation specified. Leucine Intravenous Must be in combination with other amino acids. Levocarnitine and its salts Intravenous No limitation specified. Lysine Intravenous Must be in combination with other amino acids. Magnesium Sulfate Intravenous, Intramuscular Must never be administered by the member for the treatment of eclampsia or pre-eclampsia. Magnesium Chloride Intravenous, Intramuscular Must never be administered by the member for the treatment of eclampsia or pre-eclampsia. Manganese Intravenous No limitation specified. Methionine Intravenous Must be in combination with other amino acids. Molybdenum Intravenous No limitation specified. Ornithine Intravenous Must be in combination with other amino acids. Phenylalanine Intravenous Must be in combination with other amino acids. Potassium Chloride Intravenous In dosage form not more than 0.3 mEq/kg/hr. Must never be administered as a single agent or by intravenous push. Potassium Phosphate Intravenous In dosage form not more than 0.3 mEq/kg/hr. Must never be administered as a single agent or by intravenous push. Proline Intravenous Must be in combination with other amino acids. Ringer’s Solution (sodium, chloride, potassium and calcium) Intravenous No limitation specified. Saline Solution Intravenous, Intramuscular No limitation specified. Selenium Intravenous No limitation specified. Serine Intravenous Must be in combination with other amino acids. Sodium Bicarbonate Intravenous No limitation specified. Sodium Iodide Intravenous Must be in combination with other minerals. Sterile Water Intravenous, Intramuscular Must be in combination with other substances. Strontium and its salts Intravenous No limitation specified. Taurine Intravenous No limitation specified. Threonine Intravenous Must be in combination with other amino acids. Tyrosine (L-tyrosine) Intravenous Must be in combination with other amino acids. Vanadium Intravenous Must be in combination with other minerals. Viscum Album Intravenous, Subcutaneous No limitation specified. Vitamin A Intravenous Maximum daily dose of 10,000 International Units. Vitamin B1 Intravenous, Intramuscular No limitation specified. Vitamin B2 Intravenous, Intramuscular No limitation specified. Vitamin B3 Intravenous, Intramuscular No limitation specified. Vitamin B5 Intravenous, Intramuscular No limitation specified. Vitamin B6 Intravenous, Intramuscular, Subcutaneous No limitation specified. Vitamin B12 Intravenous, Intramuscular No limitation specified. Vitamin C Intravenous Must administer no more than 15 g per day when patient’s G6PD is deficient. Vitamin D Intravenous, Intramuscular No limitation specified. Vitamin E Intravenous No limitation specified. Vitamin K1 Intramuscular No limitation specified. Zinc Chloride Intravenous No limitation specified. Zinc Sulphate Intravenous No limitation specified. O. Reg. 168/15, Table 2; O. Reg. 94/23, s. 1. Table 3 Drugs that may be Prescribed Drug Limitations, routes of administration, dosages Adenosine triphosphate Only if prescribed for intravenous injection to be administered by the member in his or her office to the patient. Calcium Chloride Only if prescribed in injectable form for intravenous injection to be administered by the member to the patient. Calcium Gluconate Only if prescribed in injectable form for intravenous injection to be administered by the member to the patient. Colchicine Must not be prescribed unless the drug is botanical colchicine, compounded from the corm of colchicum autumnale. Dextrose Injection May only be prescribed when in concentrated solutions for intravenous injection to be administered by the member to the patient. Digitalis Purpurea and its glycosides Only if prescribed in conjunction with monitoring of patient’s serum levels by member. Estrogen (bioidentical) Only if prescribed in topical or suppository form. Folic Acid Only if prescribed in oral dosage containing more than 1.0 mg of folic acid per dosage or, where the largest recommended daily dosage would, if consumed by a patient, result in the daily intake by that patient of more than 1.0 mg of folic acid. L-Tryptophan Only if prescribed for patient’s use in oral dosage form at a concentration of more than 220 mg per dosage unit or per daily dose. Recommended daily dose must not exceed 12g and must be provided. May be prescribed as a single ingredient intended for intravenous injection. Levocarnitine and its Salts Only if prescribed for the treatment of primary or secondary levocarnitine deficiency. Nitroglycerin Administered to a patient by the member in his or her office only in emergency circumstances and only for angina pectoris. Dosage: 1 to 2 metered doses (0.4 or 0.8 mg nitroglycerin) administered on or under the tongue, without inhaling. The mouth must be closed immediately after each dose (up to 3 doses in total, at least 5 minutes apart). A sublingual tablet may be used (0.3 or 0.6 mg for initial dose). Maximum dose of 1.8 mg. Pancreatin Only if prescribed in a dosage form that provides more than 20,000 USP units of lipase activity per dosage unit or for the treatment of pancreatic exocrine insufficiency. Pancrelipase Only if prescribed in a dosage form that provides more than 20,000 USP units of lipase activity per dosage unit or for the treatment of pancreatic exocrine insufficiency. Pilocarpine and its salts Must not be prescribed unless, 1. the drug is botanical pilocarpus, compounded from the leaves of pilocarpus microphyllus, 2. the member monitors his or her patient’s drug levels during treatment with the drug and, 3. the drug is never prescribed to treat a patient with glaucoma. Podophyllotoxin Must not be prescribed unless, 1. the drug is botanical podophyllotoxin compounded from podophyllum peltatum and, 2. the drug is never prescribed to treat a patient with rheumatoid arthritis. Progesterone (bioidentical form) Only if prescribed in a topical or suppository form. Rauwolfia No limitation, etc., specified. Thyroid No limitation, etc., specified. Vitamin A Only if prescribed in oral dosage form containing more than 10,000 International Units of Vitamin A per dosage or, where the largest daily dosage would, if consumed by a patient, result in the daily intake by that patient of more than 10,000 International Units of Vitamin A. Vitamin D Only if prescribed in oral dosage form containing more than 2,500 International Units of Vitamin D per dosage form or where the largest recommended daily dosage shown on the label would result in the daily intake by that patient of more than 2,500 International Units of Vitamin D. Vitamin K1 Only if prescribed in oral dosage when the maximum daily dose is more than 0.120 mg. Vitamin K2 Only if prescribed in oral dosage when the maximum daily dose is more than 0.120 mg. Yohimbine and its salts Must not be prescribed unless the drug is botanical yohimbine, compounded from the bark of pausinystalia yohimbine. O. Reg. 168/15, Table 3; O. Reg. 94/23, s. 2. Table 4 Drugs That May be Dispensed Drug Limitations, routes of administration, dosages Colchicine Must not be dispensed unless the drug is botanical colchicine, compounded from the corm of the colchicum autumanle. Digitalis Purpurea and its glycosides Only if dispensed in conjunction with monitoring of patient’s serum level by the member. Estrogen (bioidentical) Only if dispensed in topical or suppository form. Folic Acid Only if dispensed in oral dosage containing more than 1.0 mg of folic acid per dosage or, where the largest daily dosage would, if consumed by a patient, result in the daily intake by that patient of more than 1.0 mg of folic acid. L-Tryptophan Only if dispensed for patient’s use in oral dosage form at a concentration of more than 220 mg per dosage unit or per daily dose. Recommended daily dose must not exceed 12g and must be provided in 3 to 4 equally divided doses. Levocarnitine and its salts Only if dispensed for the treatment of primary or secondary levocarnitine deficiency. Pancreatin Only if dispensed in a dosage form that provides more than 20,000 USP units of lipase activity per dosage unit or for the treatment of pancreatic exocrine insufficiency. Pancrelipase Only if dispensed in a dosage form that provides more than 20,000 USP units of lipase activity per dosage unit or for the treatment of pancreatic exocrine insufficiency. Pilocarpine and its salts Must not be dispensed unless, 1. the dispensed drug botanical pilocarpus compounded from the leaves of pilocarpus microphyllus, 2. the member monitors his or her patient’s drug levels during treatment with the drug and, 3. the drug is never dispensed to treat a patient with glaucoma. Podophyllotoxin Must not be dispensed unless, 1. the dispensed drug is botanical podophyllotoxin compounded from podophyllum peltatum and, 2. the drug is never dispensed to treat a patient with rheumatoid arthritis. Progesterone (bioidentical form) Only if dispensed in a topical or suppository form. Rauwolfia No limitation, etc., specified. Thyroid No limitation, etc., specified. Vitamin A Only if dispensed in oral dosage containing more than 10,000 International Units of Vitamin A per dosage or, where the largest daily dosage would, if consumed by a patient, result in the daily intake by that patient of more than 10,000 International Units of Vitamin A. Vitamin D Only if dispensed in oral dosage form containing more than 2,500 International Units of Vitamin D per dosage form or where the largest recommended daily dosage shown on the label would result in the daily intake by that patient of more than 2,500 International Units of Vitamin D. Vitamin K1 Only if dispensed in oral dosage when the maximum daily dose is more than 0.120 mg. Vitamin K2 Only if dispensed in oral dosage when the maximum daily dose is more than 0.120 mg. Yohimbine and its salts Must not be dispensed unless the dispensed drug is botanical yohimbine compounded from the bark of pausinystalia yohimbine. O. Reg. 168/15, Table 4; O. Reg. 94/23, s. 3. Table 5 Drugs that may be Compounded Drug Limitations, routes of administration, dosages. Adenosine triphosphate Only if compounded for intravenous injection. Colchicine Must not be compounded unless the drug is botanical colchicine compounded from the corm of colchicum autumnale. Dextrose Injection Only if compounded when in concentrated solution for intravenous injection. Digitalis Purpurea and its glycosides Only if compounded in conjunction with monitoring of the patient’s serum levels by the member. Estrogen (bioidentical) Only if compounded in topical or suppository form. Folic Acid Only if compounded in oral dosage containing more than 1.0 mg of folic acid per dosage or, where the largest daily dosage would, if consumed by a patient, result in the daily intake by that patient of more than 1.0 mg of folic acid. L-Tryptophan Only if compounded for patient’s use in oral dosage form at a concentration of more than 220 mg per dosage unit or per daily dose. Recommended daily dose must not exceed 12g and must be provided in 3 to 4 equally divided doses. May also be compounded as a single ingredient intended for intravenous injection. Levocarnitine and its Salts Only if compounded for the treatment of primary or secondary levocarnitine deficiency. Pancreatin Only if compounded in a dosage that provides more than 20,000 USP units of lipase activity per dosage unit or for the treatment of pancreatic exocrine insufficiency. Pancrelipase Only if compounded in a dosage that provides more than 20,000 USP units of lipase activity per dosage unit or for the treatment of pancreatic exocrine insufficiency. Pilocarpine and its salts Must not be compounded unless, 1. the drug is botanical pilocarpine, compounded from the leaves of pilocarpus microphyllus, 2. the member monitors his or her patient’s serum levels during treatment with the drug and, 3. the drug is never compounded to treat a patient with glaucoma. Podophyllotoxin Must not be compounded unless, 1. the drug is botanical podophyllotoxin, compounded from podophyllum peltatum and, 2. the drug is never compounded to treat a patient with rheumatoid arthritis. Progesterone (bioidentical ) Only if compounded in topical or suppository form. Rauwolfia No limitation, etc., specified. Thyroid No limitation, etc., specified. Vitamin A Only if compounded in oral dosage containing more than 10,000 International Units of Vitamin A per dosage or, where the largest daily dosage would, if consumed by a patient, result in the daily intake by that patient of more than 10,000 International Units of Vitamin A. Vitamin D Only if compounded in oral dosage form containing more than 2,500 International Units of Vitamin D per dosage form or where the largest recommended daily dosage shown on the label would result in the daily intake by that patient of more than 2,500 International Units of Vitamin D. Vitamin K1 Only if compounded in oral dosage where the maximum daily dose is more than 0.120 mg. Vitamin K2 Only if compounded in oral dosage where the maximum daily dose is more than 0.120 mg. Yohimbine and its salts Must not be compounded unless the drug is botanical yohimbine, compounded from the bark of pausinystalia yohimbine. O. Reg. 168/15, Table 5; O. Reg. 94/23, s. 4. Table 6 Drugs That May be Sold Drug Limitations, routes of administration, dosages. Colchicine Must not be sold unless the drug is botanical colchicine, compounded from the corm of colchicum autumnale. Digitalis Purpurea and its glycosides Only if sold in conjunction with monitoring of the patient’s serum levels by the member. Estrogen (bioidentical) Only if sold in topical or suppository form. Folic Acid Only if sold in oral dosage containing more than 1.0 mg of folic acid per dosage or, where the largest daily dosage would, if consumed by a patient, result in the daily intake by that patient of more than 1.0 mg of folic acid. L-Tryptophan Only if sold for patient’s use in oral dosage form at a concentration of more than 220 mg per dosage unit or per daily dose. Recommended daily dose must not exceed 12g and must be provided in three to four equally divided doses. Levocarnitine and its Salts Only if sold for the treatment of primary or secondary levocarnitine deficiency. Pancreatin Only if sold in a dosage form that provides more than 20,000 USP units of lipase activity per dosage unit or for the treatment of pancreatic exocrine insufficiency. Pancrelipase Only if sold in a dosage form that provides more than 20,000 USP units of lipase activity per dosage unit or for the treatment of pancreatic exocrine insufficiency. Pilocarpine and its salts Must not be sold unless, 1. the drug is botanical pilocarpine, compounded from the leaves of pilocarpus microphyllus, 2. the member monitors his or her patient’s serum levels during treatment with the drug and, 3. the drug is never sold to treat a patient with glaucoma. Podophyllotoxin Must not be sold unless, 1. the drug is botanical podophyllotoxin, compounded from podophyllum peltatum and, 2. the drug is never sold to treat a patient with rheumatoid arthritis. Progesterone (bioidentical form) Only if sold in topical or suppository form. Rauwolfia No limitation, etc., specified. Thyroid No limitation, etc., specified. Vitamin A Only if sold in oral dosage containing more than 10,000 International Units of Vitamin A per dosage or, where the largest daily dosage would, if consumed by a patient, result in the daily intake by that patient of more than 10,000 International Units of Vitamin A. Vitamin D Only if sold in oral dosage form containing more than 2,500 International Units of Vitamin D per dosage form or where the largest recommended daily dosage shown on the label would result in the daily intake by that patient of more than 2,500 International Units of Vitamin D. Vitamin K1 Only if sold in oral dosage where the maximum daily dose is more than 0.120 mg. Vitamin K2 Only if sold in oral dosage where the maximum daily dose is more than 0.120 mg. Yohimbine and its salts Must not be sold unless the drug is botanical yohimbine compounded from the bark of pausinystalia yohimbine. O. Reg. 168/15, Table 6; O. Reg. 94/23, s. 5.