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

AMENDMENTS NOT IN FORCE

• — SOR/2024-110, s. 76

  • 76 The Food and Drug RegulationsFootnote ¹ are amended by adding the following after section A.01.068:

    • Return to footnote ¹C.R.C., c. 870

    Non-application

    • A.01.069 These Regulations do not apply to a drug referred to in paragraph (b) or (c) of the definition biocide in subsection 1(1) of the Biocides Regulations.

• — SOR/2024-110, s. 77

  • 77 Subsection C.01.004.02(6) of the Regulations is amended by adding “and” at the end of paragraph (a), by striking out “and” at the end of paragraph (b) and by repealing paragraph (c).

• — SOR/2024-110, s. 78

  • 78 Paragraphs C.01.014.1(2)(c) and (d) of the Regulations are replaced by the following:

    • (c) the recommended route of administration;

• — SOR/2024-110, s. 79

  • 79 Subsection C.01.040.2(5) of the Regulations is repealed.

• — SOR/2024-110, s. 80

  • 80 The definition antimicrobial agent in subsection C.01A.001(1) of the Regulations is repealed.

• — SOR/2024-110, s. 81

  • 81 Subsection C.01A.002(1) of the Regulations is amended by adding “and” at the end of paragraph (c), by striking out “and” at the end of paragraph (d) and by repealing paragraph (e).

• — SOR/2024-110, s. 82

  • 82 Section C.02.002.1 of the Regulations is repealed.

• — SOR/2024-136, s. 1

  • 1 Section C.01.051 of the Food and Drug RegulationsFootnote ¹ and the heading before it are replaced by the following:

    • Return to footnote ¹C.R.C., c. 870

    Recall Reporting

    • • C.01.051 (1) If a manufacturer who sells a drug in dosage form or an active ingredient or a person who imports into and sells a drug in dosage form or an active ingredient in Canada decides to recall any of those drugs without being ordered to do so by the Minister, the manufacturer or importer shall, within 24 hours after making the decision, provide the Minister with the following information in writing:

        • (a) the drug’s proper name or the common name, if there is no proper name;

        • (b) an indication as to whether the drug is a drug in dosage form or an active ingredient;

        • (c) in the case of a drug in dosage form,

          • (i) the brand name,

          • (ii) the drug identification number assigned under subsection C.01.014.2(1),

          • (iii) the dosage form,

          • (iv) the strength,

          • (v) the names of the persons in Canada, other than consumers that purchased the drug at the retail level, to whom the drug was sold by the manufacturer or importer and the quantity sold to each of the named persons, and

          • (vi) an assessment of the effect that the recall may have on the manufacturer’s or importer’s ability to meet demand for the drug in Canada;

        • (d) the lot numbers of the drug;

        • (e) the dates of fabrication of the drug;

        • (f) the expiration dates of the drug;

        • (g) the quantity of the drug that was fabricated in Canada;

        • (h) the quantity of the drug that was imported;

        • (i) the quantity of the drug that the manufacturer or importer sold to persons in Canada and the period during which it was sold;

        • (j) the quantity of the drug that the manufacturer or importer exported, as well as the quantity exported, by country;

        • (k) the quantity of the drug in Canada that is in the possession or control of the manufacturer or importer;

        • (l) an assessment of the risk of injury to human health posed by the drug, including because of a failure of its effectiveness;

        • (m) the names and civic addresses of the manufacturer and fabricator of the drug and of any importers of the drug;

        • (n) the name and contact information of the individual who is responsible for the recall;

        • (o) the expected dates for the start and completion of the recall; and

        • (p) the reasons for the recall and the date on which and manner in which the situation that prompted the recall was discovered.

      • (2) The manufacturer or importer shall

        • (a) before starting the recall, provide the Minister with a copy of any communications that the manufacturer or importer intends to use in connection with the start of the recall; and

        • (b) after starting the recall, provide the Minister, on request and within the time specified by the Minister, with a copy of any additional communications that the manufacturer or importer uses, or intends to use, in connection with the recall.

      • (3) The manufacturer or importer shall, within 72 hours after making the decision to recall the drug, provide the Minister with the following information in writing:

        • (a) the strategy for conducting the recall, including the time and manner in which the Minister will be informed of the progress of the recall; and

        • (b) a description of the measures that are intended to be taken to prevent a recurrence of the situation that prompted the recall.

      • (4) The manufacturer or importer shall, within 30 days after completing the recall, provide the Minister with the following information in writing:

        • (a) the results of the recall; and

        • (b) a description of the measures that have been or will be taken to prevent a recurrence of the situation that prompted the recall.

      • (5) In this section and in section C.01.051.1, active ingredient and fabricate have the same meaning as in subsection C.01A.001(1).

    • • C.01.051.1 (1) A person who is ordered by the Minister under section 21.3 of the Act to recall a drug in dosage form, or an active ingredient, shall provide the Minister with the following information in the time and manner specified by the Minister:

        • (a) the quantity of the drug that has been sold by the person at the retail level to consumers in Canada;

        • (b) if the person has sold the drug to persons in Canada other than consumers referred to in paragraph (a),

          • (i) the names of those persons and the quantity that has been sold to each of them, and

          • (ii) the period during which the drug was sold to those persons;

        • (c) the quantity of the drug that the person has exported from Canada, as well as the quantity exported by country;

        • (d) the quantity of the drug in Canada that is in the possession or control of the person;

        • (e) the name, title and contact information of an individual from whom the Minister may obtain additional information concerning the recall;

        • (f) the strategy for conducting the recall;

        • (g) any other information that the Minister has reasonable grounds to believe is necessary to mitigate the risk of injury to human health; and

        • (h) if the person is in a position to prevent a recurrence of the situation that prompted the recall, a description of the measures that they intend to take to prevent a recurrence.

      • (2) The person shall notify the Minister without delay of any change to the information referred to in paragraph (1)(e).

      • (3) The person shall

        • (a) before starting the recall, provide the Minister with a copy of any communications that the person intends to use in connection with the start of the recall; and

        • (b) after starting the recall, provide the Minister with, on request and within the time specified by the Minister, a copy of any additional communications that the person uses, or intends to use, in connection with the recall.

      • (4) The person shall notify the Minister in writing, within 24 hours, of the start and completion of the recall.

      • (5) The person shall, within 30 days after completing the recall, provide the Minister with the following information in writing:

        • (a) the results of the recall; and

        • (b) if the person is in a position to prevent a recurrence of the situation that prompted the recall, a description of the measures that they have taken or will take to prevent a recurrence.

• — SOR/2024-136, s. 3

  • 3 Paragraph C.02.012(1)(a) of the French version of the Regulations is replaced by the following:

    • a) un système de contrôle qui permet le rappel rapide et complet de tout lot ou tout lot de fabrication de la drogue se trouvant sur le marché;

• — SOR/2024-136, s. 5

  • • 5 (1) Subsection C.02.022(1) of the French version of the Regulations is replaced by the following:

      • • C.02.022 (1) Le grossiste, le distributeur visé à l’article C.01A.003 et l’importateur d’une drogue sous forme posologique conservent les dossiers sur la vente de chaque lot ou lot de fabrication de la drogue pendant un an après sa date limite d’utilisation afin de pouvoir en faire le rappel, à moins que la licence d’établissement de l’intéressé ne prévoie une autre période.

    • (2) The portion of subsection C.02.022(2) of the French version of the Regulations before paragraph (a) is replaced by the following:

      • (2) Le distributeur d’un ingrédient actif visé à l’alinéa C.01A.003a) et le grossiste et l’importateur d’un ingrédient actif conservent les dossiers sur la vente de chaque lot ou lot de fabrication de l’ingrédient actif pendant celle des périodes ci-après qui s’applique afin de pouvoir en faire le rappel, à moins que l’intéressé ne détienne une licence d’établissement qui prévoit une autre période :