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

Regulations are current to 2022-05-02 and last amended on 2022-03-02. Previous Versions

PART CDrugs (continued)

DIVISION 1 (continued)

Prescription Drugs

 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.

  • SOR/2013-122, s. 10
  • SOR/2017-18, s. 21(F)

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

  • SOR/2013-122, s. 10

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

  • SOR/2013-122, s. 10
  •  (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.

  • SOR/78-424, s. 2
  • SOR/80-543, s. 3
  • SOR/93-202, s. 6
  • SOR/93-407, s. 2
  • SOR/2013-122, s. 11

 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.

  • SOR/78-424, s. 3
  • SOR/2013-122, s. 11
  •  (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.

  • SOR/78-424, s. 3
  • SOR/2013-122, s. 11
  •  (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.

  • SOR/78-424, s. 3
  • SOR/2013-122, s. 11

 [Repealed, SOR/2013-122, s. 11]

 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.

  • SOR/78-424, s. 4
  • SOR/2013-122, s. 11

 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.

  • SOR/2013-122, s. 11
  •  (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.

  • SOR/2013-122, s. 11

 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.

  • SOR/78-424, s. 5
  • SOR/93-202, s. 7
  • SOR/93-407, s. 3
  • SOR/2013-122, s. 11

 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.

  • SOR/93-407, s. 4
  • SOR/2013-122, s. 11

 [Repealed, SOR/2013-122, s. 11]

 [Repealed, SOR/80-543, s. 4]

Distribution of Drugs as Samples

[
  • SOR/2020-74, s. 2
]
  •  (1) If a practitioner or pharmacist has signed an order specifying the proper name or common name, the brand name and the quantity of a drug, other than the following, the person who receives the order may distribute or cause to be distributed the drug, in dosage form, as a sample to that practitioner or pharmacist if the drug meets the requirements of these Regulations:

  • (1.1) A person may distribute or cause to be distributed a prescription drug as a sample under subsection (1) only to a practitioner or pharmacist who is entitled, under the laws of the province in which they are practising, to prescribe or dispense that drug, as the case may be.

  • (2) An order referred to in subsection (1) may provide that the order be repeated at specified intervals during any period not exceeding six months.

  • (3) Despite subsection (1), a person may distribute or cause to be distributed a drug, in dosage form, as a sample to a practitioner or pharmacist without a signed order if that drug is not a prescription drug and is part of a class of drugs that is set out in column 1 of List D, and if all of the following conditions are met:

    • (a) the drug contains, as its only medicinal ingredients, one or more of those set out in column 2, each of which corresponds to that class, in the corresponding quantity set out in column 3, and the drug is consistent with the descriptive information set out in columns 4 to 6;

    • (b) the expiration date of the drug falls on a day that is

      • (i) at least 30 days after the day on which it is distributed, if the expiration date consists of a day, month and year, or

      • (ii) in a month that follows the month in which it is distributed, if the expiration date consists only of a month and year;

    • (c) the drug meets the requirements of these Regulations.

 A person who, under subsection C.01.048(1), receives an order for and distributes or causes to be distributed a drug as a sample shall

  • (a) maintain records showing

    • (i) the name, address and description of each person to whom the drug is distributed,

    • (ii) the brand name, quantity and form of the drug distributed, and

    • (iii) the date upon which each such distribution was made; and

  • (b) keep those records and all orders received for drugs in accordance with section C.01.048 for a period of not less than two years from the date upon which the distribution referred to in the records was made.

 A person may distribute or cause to be distributed a drug, in dosage form, as a sample to any consumer that is 18 years of age or older if that drug is not a prescription drug and is part of a class of drugs that is set out in column 1 of List D, and if all of the following conditions are met:

  • (a) the drug contains, as its only medicinal ingredients, one or more of those set out in column 2, each of which corresponds to that class, in the corresponding quantity set out in column 3, and the drug is consistent with the descriptive information set out in columns 4 to 6;

  • (b) the expiration date of the drug falls on a day that is

    • (i) at least 30 days after the day on which it is distributed, if the expiration date consists of a day, month and year, or

    • (ii) in a month that follows the month in which it is distributed, if the expiration date consists only of a month and year;

  • (c) the drug meets the requirements of these Regulations.

Information — Serious Risk of Injury to Human Health

  •  (1) This section applies to a holder of one or more of the following therapeutic product authorizations:

    • (a) a drug identification number that has been assigned under subsection C.01.014.2(1); and

    • (b) a notice of compliance that has been issued under section C.08.004 or C.08.004.01.

  • (2) The holder of a therapeutic product authorization in respect of a drug that is part of a class of drugs set out in subsection (4) shall provide the Minister with information in respect of any serious risk of injury to human health that the holder receives or becomes aware of and that is relevant to the safety of the drug, regarding

    • (a) risks that have been communicated by any foreign regulatory authority that is set out in Part A of the List of Foreign Regulatory Authorities for the Purposes of Section C.01.050 of the Food and Drug Regulations, published by the Government of Canada on its website, as amended from time to time, or by any person who is authorized to manufacture or sell a drug within the jurisdiction of such an authority, and the manner of the communication;

    • (b) changes that have been made to the labelling of any drug and that have been communicated to or requested by any foreign regulatory authority that is set out in Part B of the list referred to in paragraph (a); and

    • (c) recalls, reassessments and suspensions or revocations of authorizations, including licences, in respect of any drug, that have taken place within the jurisdiction of any foreign regulatory authority that is set out in Part C of the list referred to in paragraph (a).

  • (3) The information shall be provided to the Minister within 72 hours after the holder receives or becomes aware of it, whichever occurs first.

  • (4) The classes of drugs are

  • (5) Despite subsection (2), a holder of a therapeutic product authorization who provided information in accordance with

    • (a) paragraph (2)(a) is not required to provide the same information again under that paragraph in the case where the holder receives or becomes aware of that information in respect of a foreign regulatory authority or person referred to in that paragraph; or

    • (b) paragraph (2)(b) or (c) is not required to provide the same information again under that paragraph in the case where the holder receives or becomes aware of that information in respect of a foreign regulatory authority referred to in that paragraph.

  • (6) In this section, foreign regulatory authority means a government agency or other entity outside Canada that has a legal right to control the manufacturing, use or sale of drugs within its jurisdiction and that may take enforcement action to ensure that drugs marketed within its jurisdiction comply with the applicable legal requirements.

 
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