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

C.01.003 No person shall sell a drug that is not labelled as required by these Regulations.

• C.01.004 (1) The inner and outer labels of a drug shall show

  • (a) on the principal display panel

    • (i) the proper name, if any, of the drug which, if there is a brand name for the drug, shall immediately precede or follow the brand name in type not less than one-half the size of that of the brand name,

    • (ii) if there is no proper name, the common name of the drug,

    • (iii) where a standard for the drug is prescribed in Division 6 of this Part, a statement that the drug is a Canadian Standard Drug, for which the abbreviation C.S.D. may be used,

    • (iv) where a standard for the drug is not prescribed in Division 6 of this Part but is contained in a publication mentioned in Schedule B to the Act, the name of the publication containing the standard used or its abbreviation as provided in Schedule B or, if a manufacturer’s standard is used, a statement setting forth the fact that such a standard is used, and

    • (v) in both official languages, the notation “sterile” “stérile” if the drug is required to be sterile by these Regulations;

  • (b) on the upper left quarter of the principal display panel

    • (i) the symbol “Pr” in the case of a prescription drug, but the symbol “Pr” shall not appear on the label of any other drug,

    • (ii) the symbol “” in a clear manner and a conspicuous colour and size, in the case of a controlled drug, other than a controlled drug contained in an agricultural implant and set out in Part III of the schedule to Part G,

    • (iii) the symbol “N” in a colour contrasting with the rest of the label or in type not less than half the size of any letters used thereon, in the case of a narcotic as defined in the Narcotic Control Regulations, and

    • (iv) in the case of a targeted substance as defined in section 1 of the Benzodiazepines and Other Targeted Substances Regulations, the following symbol in a colour contrasting with the rest of the label and in type not less than half the size of any other letter used on the main panel, namely,

      

  • (c) on any panel

    • (i) the name and address of the manufacturer of the drug,

    • (ii) the lot number of the drug,

    • (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,

    • (v) the expiration date of the drug, and

    • (vi) in the case of a new drug for extraordinary use in respect of which a notice of compliance has been issued under section C.08.004.01, the following statement, displayed in capital letters and in a legible manner:

      “HEALTH CANADA HAS AUTHORIZED THE SALE OF THIS EXTRAORDINARY USE NEW DRUG FOR [naming purpose] BASED ON LIMITED CLINICAL TESTING IN HUMANS.

      SANTÉ CANADA A AUTORISÉ LA VENTE DE CETTE DROGUE NOUVELLE POUR USAGE EXCEPTIONNEL AUX FINS DE [indication de la fin] EN SE FONDANT SUR DES ESSAIS CLINIQUES RESTREINTS CHEZ L’ÊTRE HUMAIN.”.

• (1.1) to (1.5) [Repealed, SOR/2014-158, s. 3]

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

  • (a) the net amount of the drug in the container in terms of weight, measure or number;

  • (b) in the case of a drug intended for parenteral use, a quantitative list of any preservatives present therein by their proper names or, if they have no proper names, by their common names; and

  • (c) in the case of a drug for human use that contains mercury or a salt or derivative thereof as a preservative, a quantitative list of all mercurial preservatives present therein by their proper names or, if they have no proper names, by their common names.

• (3) Where the container of a drug is too small to accommodate an inner label that conforms to the requirements of these Regulations, the inner label requirements of these Regulations do not apply to the drug in that container if

  • (a) there is an outer label that complies with the labelling requirements of these Regulations; and

  • (b) the inner label shows

    • (i) the proper name of the drug, the common name of the drug if there is no proper name or, in the case of a drug with more than one medicinal ingredient, the brand name of the drug,

    • (ii) the potency of the drug except where, in the case of a drug with more than one medicinal ingredient, the name used pursuant to subparagraph (i) for that drug is unique for a particular potency of the drug,

    • (iii) the net contents of the drug if it is not in a discrete dosage form,

    • (iv) the route of administration of the drug if other than oral,

    • (v) the lot number of the drug,

    • (vi) the name of the manufacturer of the drug,

    • (vii) the expiration date of the drug, and

    • (viii) the identification of special characteristics of the dosage form if they are not evident from the name of the drug under subparagraphs (i) or (ii).

• (4) [Repealed, SOR/92-654, s. 2]

• (5) This section does not apply to

  • (a) a drug sold to a drug manufacturer; or

  • (b) a drug dispensed pursuant to a prescription, if its label carries adequate directions for use and complies with the requirements of section C.01.005.

• C.01.004.01 (1) Every label of a drug for human use in dosage form shall display the following:

  • (a) a telephone number, email address, website address, postal address or any other information that enables communication with a contact person in Canada; and

  • (b) a statement to the effect that any injury to a person’s health that is suspected of being associated with the use of the drug may be reported to the contact person.

• (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.

• 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 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 to be 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).

• C.01.004.1 (1) No person shall import a drug in dosage form into Canada for the purpose of sale unless they have in Canada a person who is responsible for the sale of the drug.

• (2) No person who imports a drug in dosage form into Canada shall sell any lot or batch of the drug unless the name of the person who imports it, and the address of the principal place of business in Canada of the person responsible for its sale, appears on the inner and outer labels of the drug.

• 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”.

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

  • (a) a drug in dosage form that is compounded by a pharmacist under a prescription or by a practitioner; or

  • (b) a drug in dosage form that is sold under a prescription if the following information appears on the drug’s label:

    • (i) the drug’s proper name, common name or brand name,

    • (ii) the drug’s potency, and

    • (iii) the name of the drug’s manufacturer.

• (3) In this section and in sections C.01.005.1 and C.01.014, drug in dosage form means a drug in a form in which it is ready for use by the consumer without requiring any further manufacturing.

• (4) and (5) [Repealed, SOR/81-248, s. 1]

• C.01.005.1 (1) No pharmacist or practitioner shall sell a Class A opioid — including one that is compounded by a pharmacist under a prescription or by a practitioner — unless

  • (a) the drug’s package has applied to it a warning sticker that meets the specifications set out in the source document; and

  • (b) the drug is accompanied by a patient information handout that meets the specifications set out in the source document.

• (2) Subsection (1) does not apply in respect of the sale of a Class A opioid by a pharmacist or practitioner if

  • (a) the opioid will be, or is, administered under the supervision of a practitioner; or

  • (b) the sale is to a pharmacist or practitioner.

• (3) The following definitions apply in this section.

  Class A opioid

  Class A opioid means a drug in dosage form set out in Part A of the List of Opioids, published by the Government of Canada on its website, as amended from time to time. (opioïde de catégorie A)

  source document

  source document means the document entitled Information for Patients Concerning Opioids, published by the Government of Canada on its website, as amended from time to time. (document source)