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

Regulations are current to 2020-07-28 and last amended on 2020-07-01. Previous Versions

PART CDrugs (continued)

DIVISION 1 (continued)

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.

  • SOR/93-202, s. 9
  • SOR/97-228, s. 2
  • SOR/2018-144, s. 366
  • SOR/2019-171, s. 24
  • SOR/2020-74, s. 3

 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.

  • SOR/93-202, s. 10
  • SOR/2020-74, s. 4

 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.

  • SOR/2020-74, s. 5

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.

  • SOR/2018-84, s. 2

Recalls

 Where a manufacturer who sells a drug in dosage form or a person who imports into and sells in Canada a drug in dosage form commences a recall of the drug, the manufacturer or importer shall forthwith submit to the Minister the following information:

  • (a) the proper name of the drug, the common name of the drug if there is no proper name, the brand name of the drug and the lot number;

  • (b) in the case of an imported drug, the names of the manufacturer and importer;

  • (c) the quantity of the drug manufactured or imported;

  • (d) the quantity of the drug distributed;

  • (e) the quantity of the drug remaining on the premises of the manufacturer or importer;

  • (f) the reasons for initiating the recall; and

  • (g) a description of any other action taken by the manufacturer or importer with respect to the recall.

  • SOR/82-524, s. 2
  • SOR/93-202, s. 11
  • SOR/2018-69, s. 27
 
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