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

C.01.606 No person shall sell an antibiotic preparation for the treatment of animals, other than an antibiotic preparation that is a new drug sold pursuant to section C.08.013, unless,

• (a) where the preparation is not to be used for lactating animals providing milk to be consumed as food, the inner and outer labels of the preparation carry a statement to that effect; or

• (b) where the preparation may be used for lactating animals providing milk to be consumed as food,

  • (i) there has been submitted, on request, to the Minister, acceptable evidence to show the period of time, not exceeding 96 hours, that must elapse after the last treatment with the preparation in order that the milk from treated lactating animals will contain no residue of antibiotics that would cause injury to human health, and

  • (ii) the principal display panel of the outer label of the preparation, the inner label and the packaging insert, if any, describing the antibiotic preparation carry the warning “WARNING: MILK TAKEN FROM TREATED ANIMALS DURING TREATMENT AND WITHIN ... HOURS AFTER THE LATEST TREATMENT MUST NOT BE USED AS FOOD”, where the number of hours to be inserted is determined according to evidence submitted pursuant to subparagraph (i).

C.01.606.1 No person shall sell a product intended for the prevention or treatment of foot rot of cattle if that product contains Ethylenediamine Dihydroiodide (EDDI).

C.01.607 Notwithstanding subparagraph C.01.004(1)(c)(ii), the declaration of a lot number is not required on the label of an animal feeding-stuff containing a drug.

C.01.608 The provisions of section C.01.604 do not apply to medicated feeds registered under the Feeds Act.

C.01.609 Despite paragraph C.01.401(a), the potency of an antibiotic in amounts greater than 50 parts per million contained in a medicated feed registered under the Feeds Act may be declared in grams per tonne.

C.01.610 No person shall sell any substance having oestrogenic activity for administration to poultry that may be consumed as food.

C.01.610.1 No person shall sell a drug for administration to animals that produce food or that are intended for consumption as food if that drug contains

• (a) chloramphenicol or its salts or derivatives;

• (b) a 5-nitrofuran compound;

• (c) clenbuterol or its salts or derivatives;

• (d) a 5-nitroimidazole compound; or

• (e) diethylstilbestrol or other stilbene compounds.

C.01.610.2 No person shall sell an antibiotic preparation containing chloramphenicol, its salts or derivatives, for administration to animals that do not produce food and that are not intended for consumption as food unless

• (a) both the inner label and outer label of the preparation carry the words “WARNING: FEDERAL LAW PROHIBITS THE ADMINISTRATION OF THIS PREPARATION TO ANIMALS THAT PRODUCE FOOD OR ANIMALS THAT ARE INTENDED FOR CONSUMPTION AS FOOD / MISE EN GARDE : EN VERTU DES LOIS FÉDÉRALES, IL EST INTERDIT D’ADMINISTRER CETTE PRÉPARATION AUX ANIMAUX QUI PRODUISENT DES ALIMENTS OU AUX ANIMAUX DESTINÉS À ÊTRE CONSOMMÉS COMME ALIMENTS”;

• (b) where the preparation is for parenteral use, the preparation contains, in the form of chloramphenicol sodium succinate, not more than one gram of chloramphenicol per vial;

• (c) where the preparation is for ophthalmic use, the preparation contains not more than one per cent chloramphenicol; and

• (d) where the preparation is for oral use, the preparation

  • (i) is in tablet or capsule form and contains not more than one gram of chloramphenicol per tablet or capsule, or

  • (ii) is in the form of a chloramphenicol palmitate suspension and contains not more than three grams of chloramphenicol per container.

• C.01.611 (1) The Minister may, in writing, from time to time require the manufacturer of a drug recommended for administration to animals that may be consumed as food

  • (a) to file with the Minister in respect of that drug a submission describing in detail tests carried out to verify that the administration of the drug to an animal does not result in a substance named in column II of the List referred to in the Marketing Authorization for Maximum Residue Limits for Veterinary Drugs in Foods being present in a food set out in column III of the List, except in an amount within the maximum residue limit set out in column IV of the List in respect of the food and the substance; and

  • (b) to print on the principal display panel of the outer label, the inner label and the packaging insert, if any, that describes the drug, a warning that food derived from animals to which the drug has been administered must not be sold for human consumption unless there has elapsed since the administration of the drug a period of time specified by the Minister, based on a review of the available data with respect to drug residues.

• (2) No manufacturer shall sell a drug in respect of which the Minister has required a warning to be printed pursuant to paragraph (1)(b) unless the manufacturer has complied with that request.

• C.01.612 (1) Every manufacturer or importer who sells a veterinary drug in dosage form that contains an active pharmaceutical ingredient that is set out in List A, or every person who compounds such a drug, shall, in a form established by the Minister, submit to the Minister an annual report identifying for each drug, the total quantity sold or compounded and an estimate of the quantity sold or compounded for each intended animal species.

• (2) The annual report described in subsection (1) is for a period of one calendar year and shall be submitted on or before March 31 of the year following the calendar year covered by the report, beginning with the first full calendar year after the day on which this section comes into force.

• C.01.613 (1) No person shall import a drug into Canada for the purpose of administering it to an animal that produces food or an animal that is intended for consumption as food if the sale of the drug in Canada would constitute a violation of the Act or these Regulations.

• (2) Subsection (1) does not apply to a drug that is described in List B.

• C.01.614 (1) Sections 43 to 58 of the Natural Health Products Regulations apply in relation to a veterinary health product, as if that product were a natural health product as defined in subsection 1(1) of those Regulations.

• (2) A veterinary health product shall display, on the principal display panel of the inner and outer label, the statement: “Veterinary Health Product / Produit de santé animale” or “Produit de santé animale / Veterinary Health Product”.

• (3) Section C.01.600 and paragraph C.01.604(b) do not apply in respect of a veterinary health product.

• C.01.615 (1) Every manufacturer or importer of a veterinary health product shall notify the Minister of the sale of that product in Canada at least 30 days before the day on which that sale is commenced.

• (2) The notification shall be in a form established by the Minister and contain the following information:

  • (a) the name, mailing address, telephone number and email address of the manufacturer or importer;

  • (b) the brand name under which the veterinary health product is sold;

  • (c) the pharmaceutical form in which the veterinary health product is sold;

  • (d) the strength per dosage unit;

  • (e) the route of administration;

  • (f) a quantitative list of the medicinal ingredients and a qualitative list of the non-medicinal ingredients;

  • (g) the species of animal for which the veterinary health product is recommended; and

  • (h) the use or purpose for which the veterinary health product is recommended.

• (3) A manufacturer or importer who has provided the Minister with a notification under subsection (1) shall provide the Minister with any changes to the information required under subsection (2), in a form established by the Minister, at least 30 days before the day on which the veterinary health product to which the changes relate is sold.

C.01.616 If the Minister has reasonable grounds to believe that a veterinary health product may no longer be safe, the Minister may request that the manufacturer or importer of the veterinary health product provide the Minister, within 15 days after the day on which the request is received, with information and documents demonstrating that the veterinary health product is safe.

• C.01.617 (1) The Minister may direct the manufacturer or importer to stop the sale of a veterinary health product if

  • (a) the manufacturer or importer does not, within the required period, provide the Minister with the information and documents requested under section C.01.616;

  • (b) the information and documents provided by the manufacturer or importer in accordance with section C.01.616 do not demonstrate that the veterinary health product is safe; or

  • (c) the Minister has reasonable grounds to believe that the sale of the veterinary health product would be a violation of the Act or these Regulations.

• (2) The Minister shall lift a direction to stop the sale of a veterinary health product if the manufacturer or importer provides the Minister with information and documents demonstrating that

  • (a) in the case of a direction to stop a sale under either paragraph (1)(a) or (b), the veterinary health product is safe;

  • (b) in the case of a direction to stop a sale under paragraph 1(c), the sale of the veterinary health product would no longer be a violation of the Act or these Regulations; or

  • (c) the situation giving rise to the direction to stop the sale of the veterinary health product did not exist.

Contraceptive Drugs

C.01.625 Contraceptive drugs that are manufactured, sold or represented for use in the prevention of conception and that are not prescription drugs may be advertised to the general public.

DIVISION 1AEstablishment Licences

Interpretation

• C.01A.001 (1) The definitions in this subsection apply in this Division and in Divisions 2 to 4.

  active ingredient

  active ingredient means a drug that, when used as a raw material in the fabrication of a drug in dosage form, provides its intended effect. (ingrédient actif)

  active pharmaceutical ingredient

  active pharmaceutical ingredient means an active ingredient that is used in the fabrication of a pharmaceutical. (ingrédient actif pharmaceutique)

  antimicrobial agent

  antimicrobial agent means a drug that is capable of destroying pathogenic micro-organisms and that is labelled as being for use in the disinfection of environmental surfaces or medical devices, as defined in the Medical Devices Regulations, that

  • (a) are not invasive devices as defined in those Regulations; and

  • (b) are intended to come into contact with intact skin only. (agent antimicrobien)

  batch certificate

  batch certificate means a certificate issued by the fabricator of a lot or batch of a drug that is either imported within the framework of a mutual recognition agreement or referred to on the List of Non-prescription Drugs Not Subject to Certain Testing Requirements, and in which the fabricator

  • (a) identifies the master production document for the drug and certifies that the lot or batch has been fabricated, packaged/labelled and tested in accordance with the procedures described in that document;

  • (b) provides a detailed description of the drug, including

    • (i) a statement of all properties and qualities of the drug, including the identity, potency and purity of the drug, and

    • (ii) a statement of tolerances for the properties and qualities of the drug;

  • (c) identifies the analytical methods used in testing the lot or batch and provides details of the analytical results obtained;

  • (d) sets out the addresses of the buildings at which the lot or batch was fabricated, packaged/labelled and tested; and

  • (e) certifies that the lot or batch was fabricated, packaged/labelled and tested

    • (i) in the case of a drug that is imported within the framework of a mutual recognition agreement, in accordance with the good manufacturing practices of the regulatory authority that has recognized those buildings as meeting its good manufacturing practices standards, or

    • (ii) in the case of a drug that is not imported within the framework of a mutual recognition agreement and that is referred to on the List of Non-prescription Drugs Not Subject to Certain Testing Requirements, in accordance with the requirements of Division 2. (certificat de lot)

  bulk process intermediate

  bulk process intermediate means an active ingredient that is used in the fabrication of either a drug of biological origin that is listed in Schedule C to the Act or a drug that is listed in Schedule D to the Act. (produit intermédiaire en vrac)

  class monograph

  class monograph means a document prepared by the Department of Health that

  • (a) lists the types and strengths of medicinal ingredients that may be contained in drugs of a specified class; and

  • (b) sets out labelling and other requirements that apply to those drugs. (monographie de classe)

  dilute drug premix

  dilute drug premix means a drug for veterinary use that results from mixing a drug premix with a feed as defined in section 2 of the Feeds Act, to such a level that at least 10 kg of the resulting mixture is required to medicate one tonne of complete feed, as defined in section 2 of the Feeds Regulations, 1983, with the lowest approved dosage level of the drug. (prémélange médicamenteux dilué)

  dosage form class

  dosage form class means a parenteral, tablet, capsule, solution, suspension, aerosol, powder, suppository, medical gas or drug premix, or any other dosage form class designated by the Minister. (classe de forme posologique)

  drug premix

  drug premix means a drug for veterinary use to which a drug identification number has been assigned, where the directions on its label specify that it is to be mixed with feed as defined in section 2 of the Feeds Act. (prémélange médicamenteux)

  fabricate

  fabricate means to prepare and preserve a drug for the purposes of sale. (manufacturer)

  import

  import means to import into Canada a drug for the purpose of sale. (importer)

  List of Non-prescription Drugs Not Subject to Certain Testing Requirements

  List of Non-prescription Drugs Not Subject to Certain Testing Requirements means the document entitled List of Non-prescription Drugs for Which the Testing Requirements Set Out in Subsections C.02.019(1) and (2) of the Food and Drug Regulations Do Not Apply that is published by the Government of Canada on its website, as amended from time to time. (Liste de drogues vendues sans ordonnance et non soumises à certaines analyses)

  MRA country

  MRA country means a country that is a participant in a mutual recognition agreement with Canada. (pays participant)

  mutual recognition agreement

  mutual recognition agreement means an international agreement that provides for the mutual recognition of compliance certification for good manufacturing practices for drugs. (accord de reconnaisance mutuelle)

  package/label

  package/label means to put a drug in its immediate container or to affix the inner or outer label to the drug. (emballer-étiqueter)

  pharmaceutical

  pharmaceutical means a drug other than a drug listed in Schedule C or D to the Act. (produit pharmaceutique)

  recognized building

  recognized building means, in respect of the fabrication, packaging/labelling or testing of a drug, a building that a regulatory authority that is designated under subsection C.01A.019(1) in respect of that activity for that drug has recognized as meeting its good manufacturing practices standards in respect of that activity for that drug. (bâtiment reconnu)

  recognized country or region

  recognized country or region means a country or region that is set out in the document entitled List of Foreign Countries or Regions and Their Regulatory Authorities for the Application of Subsection C.02.019(5) of the Food and Drug Regulations, published by the Government of Canada on its website, as amended from time to time. (pays ou régions reconnus)

  regulatory authority

  regulatory authority means a government agency or other entity in an MRA country that has a legal right to control the use or sale of drugs within that country and that may take enforcement action to ensure that drugs marketed within its jurisdiction comply with legal requirements. (autorité réglementaire)

  site

  site[Repealed, SOR/2002-368, s. 1]

  wholesale

  wholesale[Repealed, SOR/2013-74, s. 2]

  wholesaler

  wholesaler means a person who is not a distributor described in section C.01A.003 and who sells any of the following drugs other than at retail sale:

  • (a) a drug in dosage form that is listed in Schedule C or D to the Act, a drug that is a prescription drug or a controlled drug as defined in section G.01.001;

  • (b) an active ingredient;

  • (c) a narcotic as defined in the Narcotic Control Regulations; or

  • (d) a drug containing cannabis as defined in subsection 2(1) of the Cannabis Act. (grossiste)

• (2) In this Division and in Division 2, drug does not include any of the following:

  • (a) a dilute drug premix;

  • (b) a medicated feed as defined in subsection 2(1) of the Feeds Regulations, 1983;

  • (c) an active ingredient that is for veterinary use and that is not an active pharmaceutical ingredient;

  • (d) an active pharmaceutical ingredient for veterinary use that is not required to be sold pursuant to a prescription and that is also a natural health product as defined in subsection 1(1) of the Natural Health Products Regulations;

  • (e) a drug that is used only for the purposes of an experimental study in accordance with a certificate issued under section C.08.015.

• (3) Where the Minister designates additional dosage form classes, the Minister shall make a list of those classes available on request.