Government of Canada / Gouvernement du Canada
Symbol of the Government of Canada

Search

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

Regulations are current to 2024-05-28 and last amended on 2023-11-24. Previous Versions

PART CDrugs (continued)

DIVISION 11Public or Canadian Armed Forces Health Emergencies — Drugs for Immediate Use or Stockpiling (continued)

  •  (1) The Minister may, after review of the application, issue an authorization to a manufacturer authorizing the sale of a specified quantity of the drug to the public health official for the use described in the application.

  • (2) In reviewing the application, the Minister must consider whether there is an alternative mechanism that would address the emergency, event or incident.

  • (3) The authorization must

    • (a) set out the date of issue;

    • (b) set out the name and contact information of the public health official;

    • (c) set out the name and contact information of the manufacturer;

    • (d) describe the emergency, event or incident;

    • (e) state whether the drug is for immediate use or stockpiling or both;

    • (f) describe the use for which the sale of the drug is authorized in order to address the emergency, event or incident;

    • (g) set out the civic address of the place to which the drug is to be shipped by the manufacturer;

    • (h) set out the following information about the drug:

      • (i) its brand name, if any, and either its proper name, common name and chemical name or its identifying name, code, number or mark,

      • (ii) its medicinal ingredients,

      • (iii) its strength,

      • (iv) its dosage form,

      • (v) its recommended dosage and route of administration, and

      • (vi) its recommended storage conditions; and

    • (i) specify the quantity of the drug that may be sold.

 The initial public health official must notify the Minister, in writing, of any change to the information provided under paragraph C.11.002(2)(g), subparagraph C.11.002(2)(i)(iv), paragraph C.11.002(2)(j) or subsection C.11.002(3), within 30 days after the day on which they become aware of the change.

  •  (1) Subject to subsection C.11.008(2), these Regulations, other than sections A.01.010, A.01.014 and A.01.045, subsections C.01.001(1) and (1.1) and this Division, do not apply to a drug that is sold in accordance with an authorization.

  • (2) In the case of a drug described in Schedule C or D of the Act, a drug that is sold in accordance with an authorization is exempt from the application of section 12 of the Act.

  •  (1) The initial public health official must ensure that the drug bears a label or is accompanied by a document that clearly sets out the following information in English and French:

    • (a) the name and civic address of the drug’s manufacturer;

    • (b) a statement that the Minister has authorized the sale of the drug to address the emergency, event or incident described in the authorization;

    • (c) a statement that the drug is to be used only for the use described in the authorization;

    • (d) the drug’s brand name, if any, and either its proper name, common name and chemical name or its identifying name, code, number or mark;

    • (e) the drug’s medicinal ingredients;

    • (f) the drug’s strength;

    • (g) the drug’s dosage form;

    • (h) the drug’s recommended dosage and route of administration;

    • (i) the drug’s lot number, if known;

    • (j) all warnings and precautions in respect of the use of the drug, if any;

    • (k) the drug’s expiration date, or, if there is no expiration date, the stability testing date or the date on which the drug should be retested, as specified by the manufacturer;

    • (l) the drug’s recommended storage conditions; and

    • (m) the net contents of the drug’s container, in terms of the weight, volume, size or number of units of the drug in the container.

  • (2) Any subsequent public health official must ensure that the drug bears the label or is accompanied by the document.

  • (3) If the initial public health official becomes aware of a change to any of the information referred to in paragraph (1)(a), (h), (j), (k) or (l), they must

    • (a) ensure that the information on the drug’s label or in the accompanying document is updated; and

    • (b) notify of the change, in writing and without delay, any person to whom they have sold any quantity of the drug.

  • (4) If the person notified under paragraph (3)(b) is a subsequent public health official, they must notify of the change, in writing and without delay, any person to whom they have sold any quantity of the drug.

  • (5) Any person who is notified under paragraph (3)(b) or subsection (4) must ensure that the updated information accompanies, in writing, any quantity of the drug that remains in their possession.

  •  (1) In addition to the information required under subsection C.11.006(1), the initial public health official or any subsequent public health official, as the case may be, must make the following information available to the following persons, in writing, in English and French:

    • (a) to the persons to whom the drug is administered and the persons who administer the drug, the known and potential benefits and risks associated with the use for which the sale of the drug is authorized, the recommended duration of use, if any, of the drug and instructions on how to report serious adverse drug reactions; and

    • (b) to the persons who administer the drug, the information referred to in paragraphs C.11.002(2)(a), (b) and (e) and subparagraphs C.11.002(2)(g)(v), (vii) and (viii), if that information is not set out on the drug’s label or accompanying document.

  • (2) If the initial public health official becomes aware of a change to any of the information referred to in subsection (1), they must, in writing and without delay, notify the relevant persons of the change.

  •  (1) If the initial public health official is a person referred to in paragraph (d) of the definition public health official in subsection C.11.001(1), they must submit a written report to the Minister in respect of any serious adverse drug reaction to the drug, and include in the report the information referred to in paragraphs C.01.020.1(2)(b) to (l), no later than the 30th day after the day on which they become aware of the reaction.

  • (2) If the initial public health official is a person referred to in any of paragraphs (a) to (c) or (e) of the definition public health official in subsection C.11.001(1), the written report is not required and section C.01.020.1 applies in respect of the provision of information relating to serious adverse drug reactions.

  •  (1) The initial public health official must monitor the response to the drug in the emergency, event or incident — including monitoring information they receive relating to serious adverse drug reactions — and must take reasonable steps to obtain information on that response.

  • (2) The initial public health official must, on request of the Minister, submit a written report to the Minister on the monitoring of the response to the drug in the emergency, event or incident during the time period specified by the Minister, as well as on any corrective measures taken as a result of the monitoring.

  •  (1) The initial public health official must maintain all information about the sale and use of the drug in a way that allows them to submit the information, notices and reports referred to in sections C.11.004 and C.11.008 and subsection C.11.009(2).

  • (2) The initial public health official and any subsequent public health official must maintain all information about the sale and use of the drug in a way that allows them to communicate with persons to whom the drug has been administered if the health of those persons may be endangered by its use.

 The initial public health official or any subsequent public health official, as the case may be, must retain the information, notices and reports referred to in sections C.11.004 and C.11.008, subsection C.11.009(2) and section C.11.010, as applicable, for 15 years after the end of the period to which the information, notices and reports relate.

 The initial public health official must account to the Minister for any unused quantity of stockpiled drug remaining in their possession at the end of the preceding calendar year by the January 30 that follows the first full calendar year during which the drug is stockpiled and then by January 30 of each subsequent year.

  •  (1) The Minister may cancel an authorization if the Minister has reasonable grounds to believe that the drug presents a serious or imminent risk of injury to human health.

  • (2) If the Minister cancels an authorization, the initial public health official must, without delay, notify of the cancellation any person to whom they have directly distributed any quantity of the drug.

  • (3) These Regulations apply to any unused quantity of the drug as of the day on which the cancellation takes effect.

  •  (1) The Minister may issue an authorization that permits an initial public health official who is a person referred to in paragraph (a), (d) or (e) of the definition public health official in subsection C.11.001(1) to sell a specified quantity of a stockpiled drug to a practitioner for use in the emergency treatment of a person under the care of that practitioner, if

    • (a) the manufacturer of the drug has been issued a letter of authorization under subsection C.08.010(1) that authorizes the sale of a specified quantity of the drug to that practitioner for the emergency treatment of that person; and

    • (b) the use of the drug specified in the letter of authorization is the same as the use described in the authorization issued to the manufacturer under subsection C.11.003(1).

  • (2) This Division, other than this section, does not apply to a drug sold in accordance with an authorization issued under subsection (1).

PART DVitamins, Minerals and Amino Acids

  •  (1) In this Part,

    advertise

    advertise means to advertise to the general public; (faire de la publicité)

    brand name

    brand name means, with reference to a drug, the name, whether or not including the name of any manufacturer, corporation, partnership or individual, in English or French,

    • (a) that is assigned to the drug by its manufacturer,

    • (b) under which the drug is sold or advertised, and

    • (c) that is used to distinguish the drug; (marque nominative)

    common name

    common name means, with reference to a salt or derivative of a vitamin, the name in English or French by which the salt or derivative is

    • (a) commonly known, and

    • (b) designated in scientific or technical journals; (nom usuel)

    human milk fortifier

    human milk fortifier has the same meaning as in section B.25.001; (fortifiant pour lait humain)

    human milk substitute

    human milk substitute has the same meaning as in section B.25.001; (succédané de lait humain)

    prepackaged product

    prepackaged product means any food that is contained in a package in the manner in which it is ordinarily sold to, or used or purchased by, a person; (produit préemballé)

    reasonable daily intake

    reasonable daily intake, in respect of a food named in an item in Column I of Schedule K, means the amount of that food set out in Column II of that item; (ration quotidienne normale)

    recommended daily intake

    recommended daily intake[Repealed, SOR/2016-305, s. 61]

    supplemental ingredient

    supplemental ingredient has the same meaning as in section B.01.001; (ingrédient supplémentaire)

    supplemented food

    supplemented food has the same meaning as in section B.01.001; (aliment supplémenté)

    supplemented food facts table

    supplemented food facts table has the same meaning as in subsection B.01.001(1); (tableau des renseignements sur les aliments supplémentés)

    Table of Daily Values

    Table of Daily Values has the same meaning as in subsection B.01.001(1); (Tableau des valeurs quotidiennes)

    Table of Reference Amounts

    Table of Reference Amounts has the same meaning as in subsection B.01.001(1); (Tableau des quantités de référence)

    testimonial

    testimonial, with respect to a food or drug that is represented as containing a vitamin, mineral nutrient or mineral, means any dramatized or undramatized pictorial, written or oral representation as to the result that is, has been or may be produced by the addition to a person’s diet of that vitamin, mineral nutrient or mineral, as the case may be; (témoignage)

    weighted recommended nutrient intake

    weighted recommended nutrient intake means, in respect of a vitamin or mineral nutrient, the amount of the vitamin or mineral nutrient set out in Table II to Division 1 and Table II to Division 2. (apport nutritionnel recommandé pondéré)

  • (2) For the purposes of this Part, a serving of stated size of a food shall be

    • (a) based on the food as offered for sale;

    • (b) in either of the following cases, the net quantity of the food in the package:

      • (i) if the quantity of food in the package can reasonably be consumed by one person at a single eating occasion, or

      • (ii) if the package contains less than 200% of the reference amount for the food; and

    • (c) in all other cases, the amount indicated for the food according to the criteria set out in column 3A of the Table of Reference Amounts.

  • (3) A serving of stated size of a food shall be expressed as follows:

    • (a) in the case of a single-serving prepackaged product to which paragraph (2)(b) applies, per package and using the following units:

      • (i) in grams, if the net quantity of the food is shown on the label by weight or by count, and

      • (ii) in millilitres, if the net quantity of the food is shown on the label by volume; and

    • (b) in the case of a multiple-serving prepackaged product to which paragraph (2)(c) applies, according to the following units set out in column 3B of the Table of Reference Amounts and according to the manner set out in that column:

      • (i) the household measure that applies to the product, and

      • (ii) the metric measure that applies to the product.

 

Date modified: