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

PART AAdministration

General

A.01.001 These Regulations may be cited as the Food and Drug Regulations.

A.01.002 These Regulations, where applicable, prescribe the standards of composition, strength, potency, purity, quality or other property of the article of food or drug to which they refer.

A.01.003 [Repealed, SOR/94-289, s. 1]

Interpretation

A.01.010 In these Regulations,

acceptable method

acceptable method means a method of analysis or examination designated by the Minister as acceptable for use in the administration of the Act and these Regulations; (méthode acceptable)

Act

Act means the Food and Drugs Act, except in Parts G and J; (Loi)

common-law partner

common-law partner, in relation to an individual, means a person who is cohabiting with the individual in a conjugal relationship, having so cohabited for a period of at least one year; (conjoint de fait)

cubic centimetre

cubic centimetre and its abbreviation cc. shall be deemed to be interchangeable with the term millilitre and its abbreviation ml.; (centimètre cube)

Director

Director[Repealed, SOR/2018-69, s. 1]

inner label

inner label means the label on or affixed to an immediate container of a food or drug; (étiquette intérieure)

Lot number

Lot number means any combination of letters, figures, or both, by which any food or drug can be traced in manufacture and identified in distribution; (numéro de lot)

manufacturer

manufacturer[Repealed, SOR/97-12, s. 1]

manufacturer

manufacturer or distributor means a person, including an association or partnership, who under their own name, or under a trade-, design or word mark, trade name or other name, word or mark controlled by them, sells a food or drug; (fabricant or distributeur)

official method

official method means a method of analysis or examination designated as such by Minister for use in the administration of the Act and these Regulations; (méthode officielle)

outer label

outer label means the label on or affixed to the outside of a package of a food or drug; (étiquette extérieure)

prescription drug

prescription drug means a drug that is set out in the Prescription Drug List, as amended from time to time, or a drug that is part of a class of drugs that is set out in it; (drogue sur ordonnance)

Prescription Drug List

Prescription Drug List means the list established by the Minister under section 29.1 of the Act; (Liste des drogues sur ordonnance)

principal display panel

principal display panel has the same meaning as in the Consumer Packaging and Labelling Regulations; (espace principal)

security package

security package means a package having a security feature that provides reasonable assurance to consumers that the package has not been opened prior to purchase. (emballage de sécurité)

A.01.011 The Minister shall, upon request, furnish copies of official methods.

A.01.012 The Minister shall, upon request, indicate that a method is acceptable or otherwise upon its submission to him for a ruling.

A.01.013 Where a food, drug, vitamin or cosmetic has more than one name, whether proper or common, a reference in these Regulations to the food, drug, vitamin or cosmetic by any of its names is deemed to be a reference to the food, drug or vitamin by all of its names.

A.01.014 When a lot number is required by these Regulations to appear on any article, container, package or label it shall be preceded by one of the following designations:

• (a) “Lot number”;

• (b) “Lot No.”;

• (c) “Lot”; or

• (d) “(L)”.

• A.01.015 (1) Subject to subsection (2), any statement, information or declaration that is required by these Regulations to appear on the label of any drug shall be in either the French or the English language in addition to any other language.

• (2) The adequate directions for use required to be shown on the inner and outer labels of a drug pursuant to subparagraph C.01.004(1)(c)(iii) shall be in both the French and English languages if the drug is available for sale without prescription in an open self-selection area.

A.01.016 All information that is required by these Regulations to appear on a label of a food or a drug, other than a drug for human use in dosage form, shall be

• (a) clearly and prominently displayed on the label; and

• (b) readily discernible to the purchaser or consumer under the customary conditions of purchase and use.

A.01.017 Every label of a drug for human use in dosage form shall meet the following conditions:

• (a) the information that is required by these Regulations to appear on the label shall be

  • (i) prominently displayed on it,

  • (ii) readily discernible to the purchaser or consumer under the customary conditions of purchase and use, and

  • (iii) expressed in plain language; and

• (b) the format of the label, including the manner in which its text and any graphics are displayed on it, shall not impede comprehension of the information referred to in paragraph (a).

Analysts; Inspectors

A.01.020 and A.01.021 [Repealed, SOR/81-935, s. 1]

A.01.022 An inspector shall perform the functions and duties and carry out the responsibilities in respect of foods and drugs prescribed by the Act, and these Regulations.

A.01.023 The authority of an inspector extends to and includes the whole of Canada.

A.01.024 The certificate of designation required pursuant to subsection 22(2) of the Act shall

• (a) certify that the person named therein is an inspector for the purpose of the Act; and

• (b) be signed by

  • (i) the Minister and the person named in the certificate, in the case of an inspector on the staff of the Department.

  • (ii) [Repealed, SOR/2000-184, s. 60]

A.01.025 Where authorized by a regulation made pursuant to the Broadcasting Act, inspectors shall act as representatives of the Canadian Radio-television and Telecommunications Commission for the purpose of enforcing the provisions of regulations made by the Canadian Radio-Television and Telecommunications Commission concerning the advertising of any article to which the Proprietary or Patent Medicine Act or the Food and Drugs Act applies, or concerning recommendations for the prevention, treatment or cure of a disease or ailment.