Food and Drug Regulations

C.01.001 (1) In this Part

acetaminophen product

acetaminophen product has the same meaning as in Division 9; (produit d’acétaminophène)

adult standard dosage unit

adult standard dosage unit has, with reference to a drug, the same meaning as in Division 9; (dose normale pour adultes)

adverse drug reaction

adverse drug reaction means a noxious and unintended response to a drug, which occurs at doses normally used or tested for the diagnosis, treatment or prevention of a disease or the modification of an organic function; (réaction indésirable à une drogue)

antibiotic

antibiotic means any drug or combination of drugs such as those named in C.01.410 to C.01.592 which is prepared from certain micro-organisms, or which formerly was prepared from micro-organisms but is now made synthetically and which possesses inhibitory action on the growth of other micro-organisms; (antibiotique)

authorization holder

authorization holder[Repealed, SOR/2017-259, s. 1]

brand name

brand name means, with reference to a drug, the name, whether or not including the name of any manufacturer, corporation, partnership or individual, in English or French,

• (a) that is assigned to the drug by its manufacturer,

• (b) under which the drug is sold or advertised, and

• (c) that is used to distinguish the drug; (marque nominative)

case report

case report means a detailed record of all relevant data associated with the use of a drug in a subject; (fiche d’observation)

children’s standard dosage unit

children’s standard dosage unit has, with reference to a drug, the same meaning as in Division 9; (dose normale pour enfants)

child resistant package

child resistant package means a package that meets the requirements of subsection (2); (emballage protège-enfants)

common name

common name means, with reference to a drug, the name in English or French by which the drug is

• (a) commonly known, and

• (b) designated in scientific or technical journals, other than the publications referred to in Schedule B to the Act; (nom usuel)

discontinue

discontinue means, in respect of the sale of a drug by the manufacturer to whom a document was issued under subsection C.01.014.2(1) that sets out the drug identification number assigned for the drug, to permanently cease the sale of the drug; (cesser)

expiration date

expiration date means

• (a) in the case of a drug in dosage form, the earlier of the following dates, expressed at minimum as a year and month:

  • (i) the date up to and including which the drug maintains its labelled potency, purity and physical characteristics, and

  • (ii) the date after which the manufacturer recommends that the drug not be used; and

• (b) in the case of an active ingredient, whichever of the following dates is applicable, expressed at minimum as a year and month:

  • (i) the retest date, or

  • (ii) the date after which the manufacturer recommends that the active ingredient not be used; (date limite d’utilisation)

flavour

flavour means a non-medicinal ingredient or combination of non-medicinal ingredients added to a drug solely to produce or mask a particular taste. It does not include an ingredient or combination of ingredients that impart only a sweet taste to the drug; (saveur)

fragrance

fragrance means a non-medicinal ingredient or combination of non-medicinal ingredients added to a drug to produce or mask a particular odour; (parfum)

immediate container

immediate container means the receptacle that is in direct contact with a drug; (récipient immédiat)

internal use

internal use means ingestion by mouth or application for systemic effect to any part of the body in which the drug comes into contact with mucous membrane; (usage interne)

List A

List A means the document, entitled List of Certain Antimicrobial Active Pharmaceutical Ingredients, that is published by the Government of Canada on its website, as amended from time to time; (Liste A)

List B

List B means the document, entitled List of Certain Veterinary Drugs Which May Be Imported But Not Sold, that is published by the Government of Canada on its website, as amended from time to time; (Liste B)

List C

List C means the document, entitled Veterinary Health Products, that is published by the Government of Canada on its website, as amended from time to time; (Liste C)

non-medicinal ingredient

non-medicinal ingredient means a substance — other than the pharmacologically active drug — that is added during the manufacturing process and that is present in the finished drug product; (ingrédient non médicinal)

official drug

official drug means any drug

• (a) for which a standard is provided in these Regulations, or

• (b) for which no standard is provided in these Regulations but for which a standard is provided in any of the publications mentioned in Schedule B to the Act; (drogue officielle)

parenteral use

parenteral use means administration of a drug by means of a hypodermic syringe, needle or other instrument through or into the skin or mucous membrane; (usage parentéral)

per cent

per cent means per cent by weight unless otherwise stated; (pour cent)

pharmaceutical ink

pharmaceutical ink means a non-medicinal ingredient or combination of non-medicinal ingredients used to imprint the drug with marks or symbols; (encre pharmaceutique)

pharmacist

pharmacist means a person who

• (a) is registered or otherwise entitled under the laws of a province to practise pharmacy, and

• (b) is practising pharmacy in that province; (pharmacien)

pharmacy technician

pharmacy technician means a person who

• (a) is registered or otherwise entitled under the laws of a province to practise as a pharmacy technician; and

• (b) is practising as a pharmacy technician in that province; (technicien en pharmacie)

practitioner

practitioner means a person who

• (a) is entitled under the laws of a province to treat patients with a prescription drug, and

• (b) is practising their profession in that province; (praticien)

prescription

prescription means an order given by a practitioner directing that a stated amount of any drug or mixture of drugs specified therein be dispensed for the person named in the order; (ordonnance)

proper name

proper name means, with reference to a drug, the name in English or French

• (a) assigned to the drug in section C.01.002,

• (b) that appears in bold-face type for the drug in these Regulations and, where the drug is dispensed in a form other than that described in this Part, the name of the dispensing form,

• (c) specified in the Canadian licence in the case of drugs included in Schedule C or Schedule D to the Act, or

• (d) assigned in any of the publications mentioned in Schedule B to the Act in the case of drugs not included in paragraph (a), (b) or (c); (nom propre)

salicylate product

salicylate product has the same meaning as in Division 9; (produit de salicylate)

serious adverse drug reaction

serious adverse drug reaction means a noxious and unintended response to a drug that occurs at any dose and that requires in-patient hospitalization or prolongation of existing hospitalization, causes congenital malformation, results in persistent or significant disability or incapacity, is life-threatening or results in death; (réaction indésirable grave à une drogue)

serious unexpected adverse drug reaction

serious unexpected adverse drug reaction means a serious adverse drug reaction that is not identified in nature, severity or frequency in the risk information set out on the label of the drug; (réaction indésirable grave et imprévue à une drogue)

teaspoon

teaspoon means, for the purpose of calculation of dosage, a volume of 5 cubic centimetres; (cuillerée à thé)

test group

test group means a group that meets the requirements of subsection (3); (groupe d’essai)

veterinary health product

veterinary health product means any of the following drugs that is in dosage form and that is not manufactured, sold or represented for use in the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms:

• (a) a substance set out in Column I of Part 1 of List C that is consistent with the descriptive information set out in Columns II to V, or any combination of any substances in which all the medicinal ingredients are substances set out in Column I of Part 1 of that list if that combination is, in respect of each of those substances, consistent with the descriptive information set out in Columns II and III and the descriptive information set out in Columns IV and V that is, within each of those columns, common to those substances;

• (b) a homeopathic medicine set out in Column I of Part 2 of List C that is consistent with the descriptive information set out in Columns II to V, or any combination of homeopathic medicines set out in Column I of Part 2 of that list if that combination is, in respect of each of those homeopathic medicines, consistent with the descriptive information set out in Columns II and III and the descriptive information set out in Columns IV and V that is, within each of those columns, common to those homeopathic medicines; and

• (c) a traditional medicine set out in Column I of Part 3 of List C that is consistent with the descriptive information set out in Columns II to V, or any combination of traditional medicines set out in Column I of Part 3 of that list if that combination is, in respect of each of those traditional medicines, consistent with the descriptive information set out in Columns II and III and the descriptive information set out in Columns IV and V that is, within each of those columns, common to those traditional medicines; (produit de santé animale)

withdrawal period

withdrawal period means the length of time between the last administration of a drug to an animal and the time when tissues or products collected from the treated animal for consumption as food contain a level of residue of the drug that would not likely cause injury to human health. (délai d’attente)

(1.1) For the purposes of the Act, serious adverse drug reaction has the same meaning as in subsection (1).

(2) A child resistant package is a package that

• (a) when tested in accordance with an acceptable method,

  • (i) in the case of a test group comprising children, cannot be opened

    • (A) by at least 85 per cent of those children prior to a demonstration to them of the proper means of opening the package, and

    • (B) by at least 80 per cent of those children after the demonstration, and

  • (ii) in the case of a test group comprising adults

    • (A) can be opened by at least 90 per cent of those adults, and

    • (B) where the package is designed so that, once opened and reclosed, it continues to meet the requirements of subparagraph (i), can be so reclosed by at least 90 per cent of those adults; or

• (b) complies with the requirements of one of the following standards, namely,

  • (i) Canadian Standards Association Standard CAN/CSA-Z76.1-M90, entitled Recloseable Child-Resistant Packages, published January 1990, as amended from time to time,

  • (ii) European Standard EN 28317:1992, entitled Child-resistant packaging — Requirements and testing procedures for reclosable packages, as adopted by the European Committee for Standardization on October 30, 1992, recognized by the British Standards Institution, and effective February 15, 1993 and by the Association française de normalisation, and effective December 20, 1992, and which reiterates fully the international standard ISO 8317:1989, as amended from time to time, and

  • (iii) Code of Federal Regulations (United States), Title 16, Section 1700.15, entitled Poison prevention packaging standards, as amended from time to time.

(3) For the purposes of this section, test group means

• (a) in relation to children, a group of at least 200 children who

  • (i) are healthy and have no obvious physical or mental disability,

  • (ii) are between 42 and 51 months of age, and

  • (iii) represent evenly, within plus or minus 10 per cent, each monthly age between 42 and 51 months calculated to the nearest month; and

• (b) in relation to adults, a group of at least 100 adults who

  • (i) are healthy and have no obvious physical or mental disability,

  • (ii) are between 18 and 45 years of age, and

  • (iii) represent evenly, within plus or minus 10 per cent, each yearly age between 18 and 45 years calculated to the nearest year.

(4) For the purpose of this section, an amendment from time to time to a standard referred to in paragraph (2)(b) becomes effective 18 months after the date designated by the competent authority as the effective date for the amendment.