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

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Regulations are current to 2025-10-28 and last amended on 2025-07-01. Previous Versions

PART CDrugs (continued)

DIVISION 4Schedule D Drugs (continued)

Prevention of Contamination

C.04.005 (1) Every person who fabricates a drug and every person who packages a drug in an immediate container must
- (a) segregate all work involving infectious agents that require special handling, including spore-bearing pathogenic micro-organisms; and
- (b) minimize the possibility of contamination of biological source material and drugs at the premises where the person fabricates or packages the drug, including by taking measures to protect against infection any individual who has access to the area where the person fabricates or packages the drug.
(2) It is prohibited for a person to conduct laboratory procedures of a diagnostic nature in their premises unless the conduct of those procedures is segregated from the fabrication, packaging/labelling and testing of drugs.

SOR/2024-238, s. 23

Reference Preparations

C.04.006 Reference preparations that are used to test the purity or potency of a drug must allow for the control of the quality of the drug.

SOR/2024-238, s. 23

Lot Release

C.04.007 (1) In this section, suitable for sale, in respect of a lot of a drug, means that the lot has been fabricated, packaged/labelled and tested in accordance with these Regulations and in a manner that is consistent with information provided to the Minister regarding the quality and safety of the drug.
(2) The Minister may, for the purpose of assessing whether a lot of a drug in dosage form is suitable for sale, request that the following persons provide the Minister with any information, samples of the drug or its active ingredients, or material to be used to test the samples:
- (a) a fabricator of the drug;
- (b) a packager/labeller of the drug;
- (c) an importer of the drug; or
- (d) the holder of the drug identification number.
(3) It is prohibited for a person who is requested to provide information, samples or material under subsection (2), and any other person whom the Minister notifies of the request, to sell drugs from the lot to which the request relates unless the Minister notifies the person that the lot is suitable for sale.

SOR/2024-238, s. 23

Previous Version

Periodic Quality Reporting

C.04.008 The holder of the drug identification number for a drug in dosage form must, at the request of the Minister, provide the Minister, on an annual basis or at any longer interval specified by the Minister, with information regarding the quality of the drug and its active ingredients, including information regarding the consistency of the fabrication and packaging processes for the drug and the ingredients.

SOR/2024-238, s. 23

Labelling

C.04.009 (1) The principal display panel of both the inner and outer labels of a drug in dosage form must show
- (a) the drug’s brand name, if any;
- (b) the drug’s proper name, if any, which, if there is a brand name, must immediately precede or follow the brand name in type not less than one-half the size of that of the brand name;
- (c) if there is no proper name, the drug’s common name, which, if there is a brand name, must immediately precede or follow the brand name in type not less than one-half the size of that of the brand name;
- (d) the net quantity of the drug in the immediate container for the purpose of the inner label and the net quantity of the drug in the outer package for the purpose of the outer label;
- (e) if the drug is sterile, an indication to that effect;
- (f) if any of the drug’s medicinal ingredients are sourced or derived from human biological source material, an indication to that effect; and
- (g) if any of the drug’s medicinal ingredients are sourced or derived from animal biological source material, the animal species from which each of those ingredients is sourced or derived.
(2) The inner and outer labels of a drug in dosage form must show on any panel
- (a) the name of the holder of the drug identification number assigned for the drug;
- (b) the potency of the drug, if applicable;
- (c) the recommended dose of the drug;
- (d) the lot number of the drug;
- (e) the expiration date of the drug;
- (f) adequate directions for use of the drug; and
- (g) any other information that is necessary to prevent injury to human health.
(3) Paragraph (2)(f) does not apply if adequate directions for use of the drug must be displayed on the label in accordance with section C.01.004.02 or C.01.004.03.
(4) Despite paragraph (2)(g), if another provision of these Regulations requires that information referred to in that paragraph be shown on a particular panel of a label, the information must be shown on that panel.
(5) The outer label of a drug in dosage form must show on any panel
- (a) the address of the holder of the drug identification number assigned for the drug;
- (b) a quantitative list of any preservatives contained in the drug, by their proper names, or if a preservative has no proper name, by its common name;
- (c) the approved storage conditions for the drug;
- (d) any other information that is necessary for the proper storage and handling of the drug, accompanied, as the case may be, by any designated space for the addition of supplementary information in this regard by the person who stores or handles the drug; and
- (e) 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.”
(6) The inner label requirements of these Regulations do not apply in respect of a drug in dosage form whose immediate container is too small to accommodate an inner label that meets those requirements if
- (a) the inner label shows
  - (i) the drug’s brand name, if any,
  - (ii) the drug’s proper name, if any,
  - (iii) the drug’s common name, if there is no proper name,
  - (iv) 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”,
  - (v) the name of the holder of the drug identification number assigned for the drug,
  - (vi) the net quantity of the drug in the container,
  - (vii) the drug’s potency, if applicable, unless the drug contains more than one medicinal ingredient and the drug’s brand name is unique for a particular potency of the drug,
  - (viii) the drug’s lot number,
  - (ix) the drug’s expiration date,
  - (x) the drug’s route of administration, and
  - (xi) any other information that is necessary to prevent injury to human health; and
- (b) the outer label meets the applicable requirements of these Regulations.
(7) The expiration date referred to in paragraph (2)(e) and subparagraph (6)(a)(ix) may be omitted from the label of a drug that is to be stockpiled by the following entities for use in emergency situations if the date is communicated by an alternative means to the individuals who administer the drug:
- (a) the Government of Canada or the government of a province for the use of a department or agency of that government; or
- (b) a municipal government or an institution of a municipal government.

SOR/2024-238, s. 23

Labelling — Prescription Drugs

C.04.010 (1) In the case of a drug in dosage form that is a prescription drug, the symbol “Pr” must be shown on
- (a) the upper left quarter of the principal display panel of both the inner and the outer labels; or
- (b) if the drug is packaged in a single-dose container, on the upper left quarter of the principal display panel of the outer label.
(2) Subsection (1) does not apply to a drug that is
- (a) sold to a person who holds an establishment licence under Division 1A; or
- (b) sold by a pharmacist under a prescription or by a practitioner, if its label shows suitable directions for use and meets the requirements set out in section C.01.005.