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

Regulations are current to 2017-11-20 and last amended on 2017-11-13. Previous Versions

 Notwithstanding the provisions of section C.01.401(a), the potency of an antibiotic in in amounts greater than 50 parts per million contained in a medicated feed registered under the Feeds Act may be declared in grams per ton.

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

 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.

  • SOR/85-539, s. 1;
  • SOR/85-685, s. 2;
  • SOR/91-546, s. 1;
  • SOR/94-568, s. 2;
  • SOR/97-510, s. 2;
  • SOR/2003-292, s. 3.

 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.

  • SOR/91-546, s. 1.
  •  (1) The Director 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 Director 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 Director, 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 Director has required a warning to be printed pursuant to paragraph (1)(b) unless the manufacturer has complied with that request.

  • SOR/93-467, s. 2;
  • SOR/2016-74, s. 10.
  •  (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.

  • SOR/2017-76, s. 6.
  •  (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.

  • SOR/2017-76, s. 6.
  •  (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.

  • SOR/2017-76, s. 6.
  •  (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.

  • SOR/2017-76, s. 6.

 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.

  • SOR/2017-76, s. 6.
  •  (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.

  • SOR/2017-76, s. 6.
 
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