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).