Food and Drug Regulations (C.R.C., c. 870)

Prescription Drugs

C.01.040.3 In deciding whether to amend the Prescription Drug List in respect of a drug, including by adding the drug to it or removing the drug from it, the Minister shall consider whether any of the following criteria apply with respect to the drug:

• (a) supervision by a practitioner is necessary

  • (i) for the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in respect of which the drug is recommended for use, or

  • (ii) to monitor a disease, disorder or abnormal physical state, or its symptoms, in respect of which the drug is recommended for use, or to monitor the use of the drug;

• (b) the level of uncertainty respecting the drug, its use or its effects justifies supervision by a practitioner; or

• (c) use of the drug can cause harm to human or animal health or a risk to public health and the harm or the risk can be mitigated by a practitioner’s supervision.

C.01.040.4 The Minister shall consult the general public on any proposal by the Minister to remove a drug from the Prescription Drug List.

C.01.040.5 Sections C.01.040.3 and C.01.040.4 apply, with any modifications that the circumstances require, in respect of classes of drugs.

• C.01.041 (1) No person shall sell a prescription drug unless

  • (a) they are entitled under the laws of a province to dispense a prescription drug and they sell it in that province under a verbal or written prescription that they received; or

  • (b) they sell it under section C.01.043.

• (2) In the case of a verbal prescription, the person referred to in paragraph (1)(a) or a pharmacy technician shall create a written record of the prescription that includes the following information:

  • (a) the date on which the prescription was received and, if applicable, the number of the prescription;

  • (b) the name and address of the person to whom the prescription was issued;

  • (c) the proper name, common name or brand name of the drug and its quantity;

  • (d) the person’s name and the name of the practitioner who issued the prescription; and

  • (e) the directions for use provided with the prescription, whether or not the practitioner authorized it to be refilled and, if refills are authorized, the number of authorized refills.

• (3) The person referred to in paragraph (1)(a) shall retain the written prescription referred to in subsection (1) or the record referred to in subsection (2) for at least two years after the day on which the prescription is filled.

C.01.041.1 Subject to paragraph C.01.041.3(2)(b), a pharmacist or pharmacy technician may transfer to another pharmacist or pharmacy technician a prescription for a prescription drug.

• C.01.041.2 (1) Before a pharmacist sells a drug under a prescription that was transferred under section C.01.041.1, the pharmacist or a pharmacy technician shall

  • (a) create a written record of the name and address of the pharmacist or pharmacy technician who transferred the prescription and, if applicable, the number of authorized refills remaining and the date of the last refill; and

  • (b) obtain a copy of the written prescription or of the written record that was created under subsection C.01.041(2), as the case may be, or, in the case of a verbal transfer, create a written record that includes the information referred to in that subsection.

• (2) The pharmacist shall retain the documents referred to in subsection (1) for at least two years after the day on which the prescription was filled.

• C.01.041.3 (1) A pharmacist or a pharmacy technician who transfers a prescription under section C.01.041.1 shall indicate the date of transfer on the original of the written prescription or of the written record created under subsection C.01.041(2) or in a record kept under the name of the patient in question, as the case may be.

• (2) When the pharmacist or pharmacy technician has transferred the prescription,

  • (a) the pharmacist shall not make any additional sales under the prescription; and

  • (b) the pharmacist or pharmacy technician shall not transfer the prescription to another pharmacist or pharmacy technician.

C.01.041.4 [Repealed, SOR/2013-122, s. 11]

C.01.042 A person referred to in paragraph C.01.041(1)(a) shall not refill a prescription for a prescription drug unless authorized by the practitioner and, in the case of such an authorization, they shall not refill a prescription more than the number of times specified by the practitioner.

C.01.042.1 A person referred to in paragraph C.01.041(1)(a) shall indicate on the original of or on the copy of the written prescription or the written record created under subsection C.01.041(2) or in a record kept under the name of the patient in question, as the case may be,

• (a) the date on which the prescription was filled;

• (b) the date of each refill, if applicable;

• (c) the quantity of drug sold when the prescription was filled and, if applicable, for each refill; and

• (d) the name of the person who sold the drug.

• C.01.043 (1) A person may sell a prescription drug to

  • (a) a drug manufacturer;

  • (b) a practitioner;

  • (c) a wholesale druggist;

  • (d) a pharmacist; or

  • (e) the Government of Canada or the government of a province, for the use of a department or agency of that government, on receipt of a written order signed by the minister responsible for the department or by the person in charge of the agency, or by their duly authorized representative.

• (2) If a person sells a prescription drug under paragraph (1)(e), they shall retain the written order for the drug for a period of at least two years after the day on which the drug is sold.

C.01.044 If a person advertises a prescription drug to the general public, the person shall not make any representation other than with respect to the brand name, the proper name, the common name and the price and quantity of the drug.

C.01.045 No person, other than one of the following, shall import a prescription drug:

• (a) a practitioner;

• (b) a drug manufacturer;

• (c) a wholesale druggist;

• (d) a pharmacist; or

• (e) a resident of a foreign country while a visitor in Canada.

C.01.046 [Repealed, SOR/2013-122, s. 11]