Regulations Respecting Food and Drugs
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A.01.003 [Repealed, SOR/94-289, s. 1]
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 means the Food and Drugs Act, except in Parts G and J; (Loi)
- common-law partner
common-law partner has the same meaning as in section 2 of the Criminal Code; (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Director[Repealed, SOR/2018-69, s. 1]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manufacturer[Repealed, SOR/97-12, s. 1]
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)
- SOR/84-300, s. 1(F)
- SOR/85-141, s. 1
- SOR/89-455, s. 1
- SOR/97-12, s. 1
- SOR/2000-353, s. 1
- SOR/2001-272, s. 5
- SOR/2003-135, s. 1
- SOR/2013-122, s. 1
- SOR/2018-69, ss. 1, 27
- SOR/2022-197, s. 1
A.01.011 The Minister shall, upon request, furnish copies of official methods.
- SOR/2018-69, s. 27
A.01.012 The Minister shall, upon request, indicate that a method is acceptable or otherwise upon its submission to him for a ruling.
- SOR/2018-69, s. 27
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
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.
- SOR/85-140, s. 1
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.
- SOR/2014-158, s. 1
- SOR/2022-143, s. 1(F)
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).
- SOR/2014-158, s. 2
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]
- SOR/80-500, s. 1
- SOR/92-626, s. 1
- SOR/95-548, s. 5
- SOR/2000-184, s. 60
- SOR/2018-69, s. 27
A.01.025 If 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 Food and Drugs Act applies, or concerning recommendations for the prevention, treatment or cure of a disease or ailment.
A.01.026 An inspector may, for the proper administration of the Act or these Regulations, take photographs of
(a) any article that is referred to in subsection 23(2) of the Act;
(b) any place where, on reasonable grounds, he believes any article referred to in paragraph (a) is manufactured, prepared, preserved, packaged or stored; and
(c) anything that, on reasonable grounds, he believes is used or capable of being used for the manufacture, preparation, preservation, packaging or storing of any article referred to in paragraph (a).
- SOR/90-814, s. 1
A.01.040 Subject to section A.01.044, no person shall import into Canada for sale a food or drug the sale of which in Canada would constitute a violation of the Act or these Regulations.
- SOR/92-626, s. 2(F)
A.01.041 An inspector may examine and take samples of any food or drug sought to be imported into Canada.
A.01.042 If an inspector examines or takes a sample of a food or drug under section A.01.041, the inspector may submit it to an analyst for analysis or examination.
- SOR/2017-18, s. 1(E)
A.01.043 If an inspector, on examination of a sample of a food or drug or on receipt of a report of an analyst of the result of an analysis or examination of the sample, is of the opinion that the sale of the food or drug in Canada would constitute a violation of the Act or these Regulations, the inspector shall so notify in writing the collector of customs concerned and the importer.
- SOR/84-300, s. 2(E)
- SOR/2017-18, s. 2
A.01.044 (1) Where a person seeks to import a food or drug into Canada for sale and the sale would constitute a violation of the Act or these Regulations, that person may, if the sale of the food or drug would be in conformity with the Act and these Regulations after its relabelling or modification, import it into Canada on condition that
(a) the person gives to an inspector notice of the proposed importation; and
(b) the food or drug will be relabelled or modified as may be necessary to enable its sale to be lawful in Canada.
(2) No person shall sell a food or drug that has been imported into Canada under subsection (1) unless the food or drug has been relabelled or modified within three months after the importation or within such longer period as may be specified by
(a) in the case of a drug, the Minister; or
(b) in the case of food, the Minister or the President of the Canadian Food Inspection Agency.
- SOR/92-626, s. 3
- SOR/95-548, s. 5
- SOR/2000-184, s. 61
- SOR/2000-317, s. 18
- SOR/2018-69, s. 27
A.01.045 A certificate referred to in section 37 of the Act shall be signed and issued by the exporter in the form set out in Appendix III.
- SOR/80-318, s. 1
- SOR/90-814, s. 2
A.01.046 An exporter that issues a certificate referred to in paragraph 37(1)(c) of the Act in respect of a drug shall retain a copy of the certificate for five years after the day on which the drug is exported.
A.01.047 (1) For the purposes of paragraph 37(1)(d) of the Act, a drug that, by virtue of paragraph A.01.048(a), is required to be fabricated, packaged/labelled, tested, distributed or wholesaled in accordance with an establishment licence must be fabricated, packaged/labelled, tested, distributed or wholesaled by the holder of such a licence that has paid fees in connection with the licence in accordance with the Fees in Respect of Drugs and Medical Devices Order.
(2) Words and expressions used in this section have the same meaning as in subsection C.01A.001(1).
A.01.048 For the purposes of subsection 37(1.2) of the Act, the following provisions are prescribed in relation to drugs:
(a) the provisions of Division 1A of Part C;
(b) the provisions of Division 2 of Part C, except section C.02.003.2 and paragraphs C.02.009(5)(b), C.02.016(3)(b) and C.02.018(3)(c);
(c) sections C.03.001 to C.03.013; and
(d) the provisions of Division 4 of Part C, except
(i) sections C.04.003, C.04.019, C.04.020, C.04.054, C.04.055, C.04.080, C.04.082 to C.04.085 and C.04.091,
(ii) sections C.04.101 and C.04.102, paragraph C.04.117(c), sections C.04.118 to C.04.120, C.04.126 and C.04.127, paragraph C.04.128(a) and sections C.04.137, C.04.138, C.04.146, C.04.147, C.04.169, C.04.170, C.04.187 and C.04.190,
(iii) sections C.04.218 to C.04.220 and C.04.239 to C.04.241,
(iv) sections C.04.555, C.04.556, C.04.561, C.04.562, C.04.567, C.04.568, C.04.573, C.04.574, C.04.578, C.04.580, C.04.581, C.04.588, C.04.589, C.04.593, C.04.595 and C.04.596, and
(v) sections C.04.601, C.04.602, C.04.650 to C.04.656, C.04.676, C.04.677 and C.04.680 to C.04.683.
A.01.049 For the purposes of paragraph 38(c) of the Act, all drugs must be in bond.
A.01.050 When taking a sample of an article under paragraph 23(2)(i) of the Act, an inspector shall inform the owner of the article or the person from whom the sample is being obtained of the inspector’s intention to submit the sample or a part of it to an analyst for analysis or examination, and
(a) where, in the opinion of the inspector, division of the procured quantity would not interfere with analysis or examination
(i) divide the quantity into three parts,
(ii) identify the three parts as the owner’s portion, the sample, and the duplicate sample and where only one part bears the label, that part shall be identified as the sample,
(iii) seal each part in such a manner that it cannot be opened without breaking the seal, and
(iv) deliver the part identified as the owner’s portion to the owner or the person from whom the sample was obtained and forward the sample and the duplicate sample to an analyst for analysis or examination; or
(b) where, in the opinion of the inspector, division of the procured quantity would interfere with analysis or examination
(i) identify the entire quantity as the sample,
(ii) seal the sample in such a manner that it cannot be opened without breaking the seal, and
(iii) forward the sample to an analyst for analysis or examination.
- SOR/90-814, s. 3
- SOR/2021-46, s. 1
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