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

Regulations are current to 2017-12-11 and last amended on 2017-11-13. Previous Versions

AMENDMENTS NOT IN FORCE

  • — 2014, c. 20, s. 366(3)

    • Replacement of “trade-mark” in regulations
      • 366 (3) Unless the context requires otherwise, “trade-mark”, “trade-marks”, “Trade-mark”, “Trade-marks”, “trade mark” and “trade marks”, are replaced by “trademark”, “trademarks”, “Trademark” or “Trademarks”, as the case may be, in the English version of any regulation, as defined in subsection 2(1) of the Statutory Instruments Act.

  • — SOR/2017-76, s. 7

    • 7 Subsection C.01A.001(2) of the Regulations is replaced by the following:

      • (2) In this Division and in Division 2, drug does not include any of the following:

        • (a) a dilute drug premix;

        • (b) a medicated feed as defined in subsection 2(1) of the Feeds Regulations, 1983;

        • (c) an active ingredient that is for veterinary use and that is not an active pharmaceutical ingredient;

        • (d) an active pharmaceutical ingredient for veterinary use that is not required to be sold pursuant to a prescription and that is also a natural health product as defined in subsection 1(1) of the Natural Health Products Regulations;

        • (e) a drug that is used only for the purposes of an experimental study in accordance with a certificate issued under section C.08.015.

  • — SOR/2017-76, s. 8(1)

      • (1) The portion of paragraph C.01A.002(1)(b) of the Regulations before subparagraph (i) is replaced by the following:

        • (b) subject to subsection (3), importing or compounding, pursuant to a prescription, a drug that is not commercially available in Canada by one of the following persons:

  • — SOR/2017-76, s. 8(3)

      • (3) Section C.01A.002 of the Regulations is amended by adding the following after subsection (2):

        • (3) This Division applies to the importing, by a pharmacist, a veterinary practitioner or a person who compounds a drug under the supervision of a veterinary practitioner, of an active pharmaceutical ingredient for veterinary use that is for the purpose of compounding, pursuant to a prescription, a drug in dosage form that is not commercially available in Canada, if that ingredient is set out in List A.

  • — SOR/2017-76, s. 9

    • 9 Table II to section C.01A.008 of the Regulations is amended by adding the following after item 6:

      TABLE II

      ItemCategories of Drugs
      7Active pharmaceutical ingredients set out in List A that are for veterinary use
  • — SOR/2017-250, s. 1

    • 1 Item 9 of Part I of the schedule to Part G of the Food and Drug RegulationsFootnote 1 is replaced by the following:

      • 9 
        Aminorex (5-phenyl-4,5-dihydro-1,3-oxazol-2-amine), its salts, derivatives, isomers and analogues and salts of derivatives, isomers and analogues, including
        • (1) 
          4-Methylaminorex (4-methyl-5-phenyl-4,5-dihydro-1,3-oxazol-2-amine)
        • (2) 
          4,4’-Dimethylaminorex (4-methyl-5-(4-methylphenyl)-4,5-dihydro-1,3-oxazol-2-amine)
  • — SOR/2017-250, s. 2

    • 2 Item 14 of Part I of the schedule to Part J of the Regulations is repealed.

  • — SOR/2017-259, s. 1

      • (1) The definition authorization holder in subsection C.01.001(1) of the Food and Drug RegulationsFootnote 1 is repealed.

      • (2) The definition discontinue in subsection C.01.001(1) of the Regulations is replaced by the following:

        discontinue

        discontinue means, in respect of the sale of a drug by the manufacturer to whom a document was issued under subsection C.01.014.2(1) that sets out the drug identification number assigned for the drug, to permanently cease the sale of the drug; (cesser)

  • — SOR/2017-259, s. 2

    • 2 Subsection C.01.005(1) of the Regulations is replaced by the following:

        • C.01.005 (1) The principal display panel of both the inner label and outer label of a drug in dosage form shall show the drug identification number assigned for that drug, preceded by the expression “Drug Identification Number” or “Drogue : identification numérique”, or both, or the abbreviation “DIN”.

  • — SOR/2017-259, s. 3

    • 3 Subsection C.01.014(2) of the Regulations is replaced by the following:

      • (2) Subsection (1) does not apply in respect of a veterinary health product, a study drug as defined in section C.03.301 or a medicated feed as defined in subsection 2(1) of the Feeds Regulations, 1983.

  • — SOR/2017-259, s. 4

      • (1) Subsection C.01.014.1(1) of the Regulations is replaced by the following:

          • C.01.014.1 (1) A manufacturer of a drug may make an application for a drug identification number for that drug.

      • (2) Paragraph C.01.014.1(2)(o) of the Regulations is replaced by the following:

        • (o) in the case of a drug for human use, an assessment as to whether there is a likelihood that the drug will be mistaken for another drug for which a drug identification number has been assigned due to a resemblance between the brand name that is proposed to be used in respect of the drug and the brand name, common name or proper name of the other drug.

  • — SOR/2017-259, s. 5

      • (1) The portion of subsection C.01.014.2(1) of the Regulations before paragraph (a) is replaced by the following:

          • C.01.014.2 (1) Subject to subsection (2), if a manufacturer has provided all the information and material described in subsection C.01.014.1(2) or section C.08.002, C.08.002.01 or C.08.002.1, as the case may be, in respect of a drug, the Director shall issue to the manufacturer a document that

      • (2) Subparagraphs C.01.014.2(1)(a)(i) and (ii) of the English version of the Regulations are replaced by the following:

        • (i) the drug identification number assigned for the drug, preceded by the abbreviation “DIN”, or

        • (ii) if there are two or more brand names for the drug, the drug identification numbers assigned by the Director for the drug, each of which pertains to one of the brand names and is preceded by the abbreviation “DIN”; and

      • (3) The portion of subsection C.01.014.2(2) of the Regulations before paragraph (a) is replaced by the following:

        • (2) The Director may refuse to issue the document referred to in subsection (1) if he or she has reasonable grounds to believe that the product in respect of which an application referred to in section C.01.014.1 has been made

      • (4) Paragraph C.01.014.2(2)(b) of the Regulations is replaced by the following:

        • (b) is a drug but its sale would cause injury to the health of the purchaser or consumer or would be a contravention of the Act or these Regulations.

      • (5) The portion of subsection C.01.014.2(2) of the English version of the Regulations after paragraph (b) is repealed.

      • (6) Subsections C.01.014.2(3) and (4) of the Regulations are replaced by the following:

        • (3) If the Director refuses to issue the document under subsection (2), the manufacturer may submit additional information or material and request the Director to reconsider his or her decision.

        • (4) On the basis of the additional information or material submitted under subsection (3), the Director shall reconsider the grounds on which the refusal to issue the document was made.

  • — SOR/2017-259, s. 6

    • 6 Section C.01.014.3 of the Regulations is replaced by the following:

      • C.01.014.3 The manufacturer to whom a document was issued under subsection C.01.014.2(1) that sets out the drug identification number assigned for a drug shall, within 30 days after the day on which the drug is first sold following the issuance by the Director of the document, date and sign the document and return it to the Director with a statement set out on it that the information it contains is correct and with an indication of the date of that first sale.

  • — SOR/2017-259, s. 7

    • 7 Sections C.01.014.5 and C.01.014.6 of the Regulations are replaced by the following:

        • C.01.014.5 (1) The manufacturer to whom a document was issued under subsection C.01.014.2(1) that sets out the drug identification number assigned for a drug shall, annually before the first day of October and in a form established by the Director, provide the Director with a notification that is signed by them and that

          • (a) indicates whether any of the following circumstances apply in respect of the drug:

            • (i) as of the day on which the notification is sent,

              • (A) the manufacturer sells the drug in Canada, or

              • (B) the manufacturer has discontinued the sale of the drug in Canada, or

            • (ii) the manufacturer has not sold the drug in Canada for a period that is greater than 12 months and a portion of that period is covered by the notification; and

          • (b) subject to subsection (2), confirms that the information that the manufacturer previously submitted with respect to the drug under subsection C.01.014.1(2), paragraph C.01.014.4(b) or section C.08.002, C.08.002.01, C.08.002.1 or C.08.003, as the case may be, is correct as of the day on which the notification is sent.

        • (2) If any of the information that the manufacturer submitted under a provision referred to in paragraph (1)(b) is not correct as of the day on which the notification is sent, the manufacturer shall update that information in the notification.

        • C.01.014.6 (1) The Director shall cancel the assignment of a drug identification number if

          • (a) the manufacturer to whom a document was issued under subsection C.01.014.2(1) that sets out the drug identification number advises under section C.01.014.7 that they discontinued the sale of the drug;

          • (b) the drug is a new drug in respect of which the notice of compliance has been suspended under section C.08.006; or

          • (c) the Director determines that the product for which the drug identification number has been assigned is not a drug.

        • (2) The Director may cancel the assignment of a drug identification number if the manufacturer to whom a document was issued under subsection C.01.014.2(1) that sets out the drug identification number

          • (a) contravenes section C.01.014.5; or

          • (b) has been notified under section C.01.013 that the evidence that they submitted in respect of the drug is not sufficient.

  • — SOR/2017-259, s. 8

    • 8 Sections C.01.014.7 and C.01.014.8 of the Regulations are replaced by the following:

      • C.01.014.7 The manufacturer to whom a document was issued under subsection C.01.014.2(1) that sets out the drug identification number assigned for a drug shall, within 30 days after the day on which they discontinue the sale of the drug, submit the following information to the Minister:

        • (a) the drug identification number assigned for the drug;

        • (b) the date on which the manufacturer discontinued the sale of the drug; and

        • (c) the latest expiration date of the drug that the manufacturer sold and the lot number of that drug.

      • C.01.014.71 If a period of 12 months has elapsed since the day on which the manufacturer to whom a document was issued under subsection C.01.014.2(1) that sets out the drug identification number assigned for a drug as defined in section C.01.014.8 last sold the drug, the manufacturer shall so notify the Minister in writing within 30 days after the day on which that period ends.

      • C.01.014.72 If the manufacturer to whom a document was issued under subsection C.01.014.2(1) that sets out the drug identification number assigned for a drug resumes the sale of the drug after a period of 12 months has elapsed since the day on which they last sold the drug, the manufacturer shall so notify the Minister in writing within 30 days after the day on which they resume the sale of the drug.

      • C.01.014.8 The following definitions apply in this section and in sections C.01.014.9 and C.01.014.10.

        drug

        drug means any of the following drugs for human use for which a drug identification number has been assigned:

        • (a) drugs included in Schedule I, II, III, IV or V to the Controlled Drugs and Substances Act;

        • (b) prescription drugs;

        • (c) drugs that are listed in Schedule C or D to the Act; and

        • (d) drugs that are permitted to be sold without a prescription but that are administered only under the supervision of a practitioner. (drogue)

        shortage

        shortage means, in respect of a drug, a situation in which the manufacturer to whom a document was issued under subsection C.01.014.2(1) that sets out the drug identification number assigned for the drug is unable to meet the demand for the drug. (pénurie)

  • — SOR/2017-259, s. 9

      • (1) The portion of subsection C.01.014.9(1) of the Regulations before paragraph (c) is replaced by the following:

          • C.01.014.9 (1) If a shortage of a drug exists or is likely to occur, the manufacturer to whom a document was issued under subsection C.01.014.2(1) that sets out the drug identification number assigned for the drug shall post the following information in English and French on a website that is operated by a party for that purpose with whom Her Majesty in right of Canada has entered into a contract to make that information available to the public:

            • (a) the manufacturer’s name and their telephone number, email address, website address, postal address or any other information that enables communication with them;

            • (b) the drug identification number assigned for the drug;

      • (2) Paragraph C.01.014.9(1)(k) of the Regulations is replaced by the following:

        • (k) the anticipated date when the manufacturer will be able to meet the demand for the drug, if they can anticipate that date; and

      • (3) The portion of subsection C.01.014.9(2) of the Regulations before paragraph (a) is replaced by the following:

        • (2) The manufacturer shall post the information

      • (4) Subsections C.01.014.9(3) and (4) of the Regulations are replaced by the following:

        • (3) If any of the information that was posted by the manufacturer changes, they shall update that information on the website within two days after the day on which they make or become aware of the change.

        • (4) Within two days after the day on which the manufacturer is able to meet the demand for the drug, they shall post information on the website to that effect.

  • — SOR/2017-259, s. 10

      • 10 (1) The portion of subsection C.01.014.10(1) of the Regulations before paragraph (c) is replaced by the following:

          • C.01.014.10 (1) If the manufacturer to whom a document was issued under subsection C.01.014.2(1) that sets out the drug identification number assigned for a drug decides to discontinue the sale of the drug, they shall post the following information in English and French on the website referred to in subsection C.01.014.9(1):

            • (a) the manufacturer’s name and their telephone number, email address, website address, postal address or any other information that enables communication with them;

            • (b) the drug identification number assigned for the drug;

      • (2) Paragraph C.01.014.10(1)(j) of the Regulations is replaced by the following:

        • (j) the date on which the manufacturer will discontinue the sale of the drug; and

      • (3) The portion of subsection C.01.014.10(2) of the Regulations before paragraph (a) is replaced by the following:

        • (2) The manufacturer shall post the information

      • (4) Subsection C.01.014.10(3) of the Regulations is replaced by the following:

        • (3) If any of the information that was posted by the manufacturer changes, they shall update that information on the website within two days after the day on which they make or become aware of the change.

  • — SOR/2017-259, s. 11

    • 11 Sections C.01.014.11 to C.01.014.13 of the Regulations are replaced by the following:

      • C.01.014.11 The Minister shall ensure that a hyperlink to the website referred to in subsection C.01.014.9(1) is on the Government of Canada website.

  • — SOR/2017-259, s. 12

    • 12 Paragraph C.01A.003(a) of the Regulations is replaced by the following:

      • (a) a distributor of an active ingredient; and

  • — SOR/2017-259, s. 13

    • 13 Paragraphs C.01A.004(1)(c) and (d) of the Regulations are replaced by the following:

      • (c) distribute as a distributor referred to in section C.01A.003 a drug that is not an active pharmaceutical ingredient or an active ingredient that is used in the fabrication of a drug that is of non-biological origin and that is listed in Schedule C to the Act; or

      • (d) wholesale a drug that is not an active pharmaceutical ingredient or an active ingredient that is used in the fabrication of a drug that is of non-biological origin and that is listed in Schedule C to the Act.

  • — SOR/2017-259, s. 14

      • 14 (1) Item 4 of Table I to section C.01A.008 of the Regulations is replaced by the following:

        ItemActivities
        4Distribute as a distributor referred to in paragraph C.01A.003(a) an active ingredient that is not an active pharmaceutical ingredient or an active ingredient that is used in the fabrication of a drug that is of non-biological origin and that is listed in Schedule C to the Act
      • (2) Item 5 of Table I to section C.01A.008 of the English version of the Regulations is replaced by the following:

        ItemActivities
        5Distribute as a distributor referred to in paragraph C.01A.003(b)
      • (3) Item 7 of Table I to section C.01A.008 of the Regulations is replaced by the following:

        ItemActivities
        7Wholesale a drug that is not an active pharmaceutical ingredient or an active ingredient that is used in the fabrication of a drug that is of non-biological origin and that is listed in Schedule C to the Act
  • — SOR/2017-259, s. 15

    • 15 Paragraph C.02.020(1)(a) of the Regulations is replaced by the following:

      • (a) except in the case of an importer of an active pharmaceutical ingredient or an active ingredient that is used in the fabrication of a drug that is of non-biological origin and that is listed in Schedule C to the Act, master production documents for the drug;

  • — SOR/2017-259, s. 16

      • 16 (1) Paragraph C.03.202(1)(a) of the Regulations is amended by striking out “and” at the end of subparagraph (ii) and by adding the following after subparagraph (iii):

        • (iv) the drug identification number assigned for the radiopharmaceutical, preceded by the expression “Drug Identification Number” or “Drogue : identification numérique”, or both, or the abbreviation “DIN”; and

      • (2) Subparagraph C.03.202(1)(b)(v) of the Regulations is repealed.

      • (3) Section C.03.202 of the Regulations is amended by adding the following after subsection (1):

        • (2) Subparagraph (1)(a)(iv) does not apply to a radiopharmaceutical that is

          • (a) compounded by a pharmacist under a prescription or by a practitioner; or

          • (b) sold under a prescription, if the radiopharmaceutical’s label indicates

            • (i) its proper name, common name or brand name,

            • (ii) its potency, and

            • (iii) the name of its manufacturer.

  • — SOR/2017-259, s. 17

      • 17 (1) Paragraph C.03.203(1)(e) of the Regulations is replaced by the following:

        • (e) the drug identification number assigned for the radionuclide generator, preceded by the expression “Drug Identification Number” or “Drogue : identification numérique”, or both, or the abbreviation “DIN”;

      • (2) Section C.03.203 of the Regulations is amended by adding the following after subsection (2):

        • (3) Section C.01.005 does not apply to a radionuclide generator.

  • — SOR/2017-259, s. 18

    • 18 The heading before section C.03.205 of the French version of the Regulations is replaced by the following:

      Drogues, autres que les radionucléides, vendues pour être employées dans la préparation de produits pharmaceutiques radioactifs ou représentées comme pouvant servir à cette fin

  • — SOR/2017-259, s. 19

    • 19 Section C.03.205 of the Regulations is replaced by the following:

      • C.03.205 The following definitions apply in this section and in sections C.03.206 to C.03.209.

        component

        component means

        • (a) a unit of a drug, other than a radionuclide, separately packaged in a kit; or

        • (b) an empty vial or other accessory item in a kit. (constituant)

        kit

        kit means a package that is intended to be used in the preparation of radiopharmaceuticals and that

        • (a) contains one or more separately packaged units of a drug, other than a radionuclide; and

        • (b) may contain empty vials or other accessory items. (trousse)

  • — SOR/2017-259, s. 20

    • 20 Section C.03.207 of the Regulations is renumbered as subsection C.03.207(1) and is amended by adding the following:

      • (2) The component of a kit that is intended to contain the prepared radiopharmaceutical shall be labelled to display the drug identification number assigned for the kit, preceded by the expression “Drug Identification Number” or “Drogue : identification numérique”, or both, or the abbreviation “DIN”.

  • — SOR/2017-259, s. 21

    • 21 Paragraph C.03.208(e) of the Regulations is replaced by the following:

      • (e) the drug identification number assigned for the kit, preceded by the expression “Drug Identification Number” or “Drogue : identification numérique”, or both, or the abbreviation “DIN”;

  • — SOR/2017-259, s. 22

    • 22 Paragraph C.08.002(2)(o) of the Regulations is replaced by the following:

      • (o) in the case of a new drug for human use, an assessment as to whether there is a likelihood that the new drug will be mistaken for another drug for which a drug identification number has been assigned due to a resemblance between the brand name that is proposed to be used in respect of the new drug and the brand name, common name or proper name of the other drug.

  • — SOR/2017-259, s. 23

    • 23 Subparagraph C.08.003(3.1)(b)(i) of the Regulations is replaced by the following:

      • (i) an assessment as to whether there is a likelihood that the new drug will be mistaken for another drug for which a drug identification number has been assigned due to a resemblance between the brand name that is proposed to be used in respect of the new drug and the brand name, common name or proper name of the other drug, and

  • — SOR/2017-259, s. 24

    • 24 In sections 25 and 26, drug means a drug that is listed in Schedule C to the Food and Drugs Act, that is in dosage form and that was available for sale in Canada before the day on which these Regulations come into force.

  • — SOR/2017-259, s. 25

      • 25 (1) Despite these Regulations, if the labels of a drug display information in accordance with one of the following provisions of the Food and Drug Regulations, as they read immediately before the day on which these Regulations come into force, that provision continues to apply in respect of the drug:

        • (a) subsection C.03.202(1);

        • (b) subsection C.03.203(1); or

        • (c) section C.03.208.

      • (2) Subsection (1) ceases to apply in respect of a drug

        • (a) if an application for a drug identification number for the drug is made under subsection C.01.014.1(1) of the Food and Drug Regulations within six months after the day on which these Regulations come into force,

          • (i) in the case of a kit as defined in section C.03.205 of the Food and Drug Regulations, 24 months after the day on which the final decision on the application is made, and

          • (ii) in the case of any other drug, 12 months after the day on which the final decision on the application is made; and

        • (b) if an application for a drug identification number for the drug is not made under subsection C.01.014.1(1) of the Food and Drug Regulations within six months after the day on which these Regulations come into force,

          • (i) in the case of a kit as defined in section C.03.205 of the Food and Drug Regulations, 30 months after the day on which these Regulations come into force, and

          • (ii) in the case of any other drug, 18 months after the day on which these Regulations come into force.

  • — SOR/2017-259, s. 26

      • 26 (1) Despite these Regulations, subsection C.01.014(2) of the Food and Drug Regulations, as it read immediately before the day on which these Regulations come into force, continues to apply in respect of a drug.

      • (2) Subsection (1) ceases to apply in respect of a drug

        • (a) if an application for a drug identification number for the drug is made under subsection C.01.014.1(1) of the Food and Drug Regulations within six months after the day on which these Regulations come into force and a document referred to in subsection C.01.014.2(1) of the Food and Drug Regulations is issued in respect of the drug, on the day on which the document is issued;

        • (b) if an application for a drug identification number for the drug is made under subsection C.01.014.1(1) of the Food and Drug Regulations within six months after the day on which these Regulations come into force and the final decision on the application is a refusal to issue a document referred to in subsection C.01.014.2(1) of the Food and Drug Regulations in respect of the drug,

          • (i) in the case of a kit as defined in section C.03.205 of the Food and Drug Regulations, 24 months after the day on which the final decision is made, and

          • (ii) in the case of any other drug, 12 months after the day on which the final decision is made; and

        • (c) in the cases referred to in paragraph 25(2)(b), at the end of the period referred to in subparagraph 25(2)(b)(i) or (ii), as the case may be.

  • — SOR/2017-278, s. 1

    • 1 Part I of the schedule to Part J of the Food and Drug RegulationsFootnote 1 is amended by adding the following after item 27:

      • 28 
        U-47700 (3,4-dichloro-N-(2-(dimethylamino)cyclohexyl)-N-methylbenzamide), its salts, derivatives, isomers and analogues, and salts of derivatives, isomers and analogues, including
        • (1) 
          Bromadoline (4-bromo-N-(2-(dimethylamino)cyclohexyl)benzamide)
        • (2) 
          U-47109 (3,4-dichloro-N-(2-(dimethylamino)cyclohexyl)benzamide)
        • (3) 
          U-48520 (4-chloro-N-(2-(dimethylamino)cyclohexyl)-N-methylbenzamide)
        • (4) 
          U-50211 (N-(2-(dimethylamino)cyclohexyl)-4-hydroxy-N-methylbenzamide)
        • (5) 
          U-77891 (3,4-dibromo-N-methyl-N-(1-methyl-1-azaspiro[4.5]decan-6-yl)benzamide)
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