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

Regulations are current to 2017-04-12 and last amended on 2017-03-14. 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/2014-158, s. 3

      • (1) Subparagraphs C.01.004(1)(c)(iii) and (iv) of the Regulations are replaced by the following:

        • (iii) adequate directions for use of the drug, except in the case of a drug to which section C.01.004.02 applies,

        • (iv) a quantitative list of the medicinal ingredients of the drug by their proper names or, if they have no proper names, by their common names, except in the case of a drug to which section C.01.004.02 applies,

      • (2) Subsections C.01.004(1.1) to (1.5) of the Regulations are repealed.

      • (3) The portion of subsection C.01.004(2) of the Regulations before paragraph (a) is replaced by the following:

        • (2) In addition to the requirements of subsection (1), the outer label of a drug shall display the following information:

  • — SOR/2014-158, s. 4(2)

      • (2) Subsection C.01.004.01(2) of the Regulations is replaced by the following:

        • (2) Subsection (1) does not apply to

          • (a) the labels of a drug that is listed in Schedule C or D to the Act and that is in dosage form; or

          • (b) the inner and outer labels of a drug to which section C.01.004.02 applies.

  • — SOR/2014-158, s. 5, as amended by SOR/2017-18, s. 23

    • 5 The Regulations are amended by adding the following after section C.01.004.01:

        • C.01.004.02 (1) In addition to the requirements of section C.01.004, the outer label of a drug for human use in dosage form shall display, either one bilingual table, placed on any panel, that contains only the following information in both English and French or one table in English and one table in French, each of which is placed on any panel, that contains only the following information:

          • (a) adequate directions for use of the drug;

          • (b) a quantitative list of the drug’s medicinal ingredients by their proper names or, if they have no proper names, by their common names;

          • (c) the drug’s non-medicinal ingredients listed in alphabetical order or in descending order of predominance by their proportion in the drug, preceded by words that clearly distinguish them from the medicinal ingredients; and

          • (d) the information referred to in subsection C.01.004.01(1).

        • (2) If a package is too small to accommodate an outer label that displays one bilingual table that lists all of the drug’s non-medicinal ingredients or two unilingual tables, each of which lists all of the drug’s non-medicinal ingredients, the list of non-medicinal ingredients shall be displayed in both English and French on a tag, tape or card that is attached to the package.

        • (3) If pharmaceutical ink, a fragrance or a flavour has been added to the drug, the following expressions may be included in the list of non-medicinal ingredients to indicate that those ingredients have been added to the drug, instead of listing them or combinations of them individually:

          • (a) in the case where a bilingual table referred to in subsection (1) is displayed, the expressions “flavour/saveur”, “fragrance/parfum” and “pharmaceutical ink/encre pharmaceutique”; or

          • (b) in the case where two unilingual tables referred to in subsection (1) are displayed, the expressions

            • (i) “encre pharmaceutique”, “parfum” and “saveur” in the table in French, and

            • (ii) “flavour”, “fragrance” and “pharmaceutical ink” in the table in English.

        • (4) If the composition of the drug varies from one lot to another with respect to its non-medicinal ingredients,

          • (a) in the case where a bilingual table referred to in subsection (1) is displayed, the table shall include a reference to all non-medicinal ingredient alternatives that may be present in the drug, preceded by the symbol “+/–” or “±” or the expression “or/ou” or “may contain/peut contenir”; or

          • (b) in the case where two unilingual tables referred to in subsection (1) are displayed,

            • (i) the table in French shall list all non-medicinal ingredient alternatives that may be present in the drug, preceded by the symbol “+/–” or “±” or the expression “ou” or “peut contenir”, and

            • (ii) the table in English shall list all non-medicinal ingredient alternatives that may be present in the drug, preceded by the symbol “+/–” or “±” or the expression “or” or “may contain”.

        • (5) For the purposes of paragraphs (3)(a) and (4)(a), the French terms in the expressions may appear first.

        • (6) Subsections (1) to (5) do not apply to

          • (a) prescription drugs;

          • (b) drugs that are permitted to be sold without a prescription but that are administered only under the supervision of a practitioner; and

          • (c) drugs that are represented as being solely for use as a disinfectant on hard non-porous surfaces.

      • C.01.004.03 In addition to the requirements of section C.01.004, the inner label of a drug to which section C.01.004.02 applies shall display on any panel

        • (a) adequate directions for use of the drug;

        • (b) a quantitative list of the drug’s medicinal ingredients by their proper names or, if they have no proper names, by their common names; and

        • (c) the information referred to in subsection C.01.004.01(1).

  • — SOR/2017-43, s. 1

    • 1 Item 2 of Part I of the schedule to Part G of the Food and Drug RegulationsFootnote 1 is replaced by the following:

      • 2 
        Methylphenidate (methyl 2-phenyl-2-(piperidin-2-yl)acetate), its salts, derivatives, isomers and analogues and salts of derivatives, isomers and analogues, including:
        • (1) 
          Ethylphenidate (ethyl 2-phenyl-2-(piperidin-2-yl)acetate)
        • (2) 
          Isopropylphenidate (isopropyl 2-phenyl-2-(piperidin-2-yl)acetate)
        • (3) 
          Propylphenidate (propyl 2-phenyl-2-(piperidin-2-yl)acetate)
        • (4) 
          3,4-Dichloromethylphenidate (methyl 2-(3,4-dichlorophenyl)-2-(piperidin-2-yl)acetate)
        • (5) 
          4-Methylmethylphenidate (methyl 2-(4-methylphenyl)-2-(piperidin-2-yl)acetate)
        • (6) 
          4-Fluoromethylphenidate (methyl 2-(4-fluorophenyl)-2-(piperidin-2-yl)acetate)
        • (7) 
          Methylnaphthidate (methyl 2-(naphthalen-2-yl)-2-(piperidin-2-yl)acetate)
        • (8) 
          Ethylnaphthidate (ethyl 2-(naphthalen-2-yl)-2-(piperidin-2-yl)acetate)
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