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

Regulations are current to 2017-05-11 and last amended on 2017-05-05. Previous Versions

 [Repealed, SOR/92-654, s. 4]

 [Repealed, SOR/80-544, s. 8]

 [Repealed, SOR/80-544, s. 8]

Chloramphenicol

 [Repealed, SOR/80-544, s. 8]

 No person shall sell chloramphenicol and its salts and derivatives, for oral or parenteral use, unless

  • (a) the inner label carries a warning statement to the effect that

    • (i) bone marrow depression has been associated with the use of chloramphenicol, and

    • (ii) the enclosed warnings and precautions should be read carefully; and

  • (b) the outer label or the package insert carries the following:

    • (i) a warning statement to the effect that chloramphenicol should not be used in the treatment or prophylaxis of minor infections or where it is not indicated, as in cold, influenza, or infections of the upper respiratory tract; that there are two types of bone marrow depression associated with the use of chloramphenicol; that some degree of depression of the bone marrow is commonly seen during therapy, is dose-related and is potentially reversible; that blood studies may detect early changes and; that the other type of bone marrow depression, a sudden, delayed and usually fatal bone marrow hypoplasia that may occur without warning, is very rare, and

    • (ii) a statement of precautions to be taken to the effect that it is essential that appropriate blood studies be made during treatment with chloramphenicol and that while blood studies may detect early peripheral blood changes, such studies cannot be relied on to detect the rare and generally irreversible bone marrow depression prior to development of aplastic anemia.

 Section C.01.433 does not apply to chloramphenicol and its salts or derivatives that are sold by a pharmacist under a prescription.

  • SOR/2013-122, s. 12.

 No person shall disseminate to a practitioner promotional literature about chloramphenicol and its salts or derivatives for oral or parenteral use unless the statements set out in paragraph C.01.433(b) are included in such literature.

 The provisions of sections C.01.433 and C.01.435 do not apply to a drug sold solely for veterinary use.

 [Repealed, SOR/80-544, s. 8]

 [Repealed, SOR/80-544, s. 8]

 [Repealed, SOR/80-544, s. 8]

 [Repealed, SOR/80-544, s. 8]

 [Repealed, SOR/80-544, s. 8]

 [Repealed, SOR/80-544, s. 8]

 [Repealed, SOR/80-544, s. 8]

 [Repealed, SOR/80-544, s. 8]

 [Repealed, SOR/80-544, s. 8]

 [Repealed, SOR/80-544, s. 8]

 [Repealed, SOR/80-544, s. 8]

 [Repealed, SOR/80-544, s. 8]

 [Repealed, SOR/80-544, s. 8]

 [Repealed, SOR/80-544, s. 8]

 [Repealed, SOR/80-544, s. 8]

Veterinary Drugs

 No person shall sell for veterinary use a drug listed in the Table of Limits of Drug Dosage for Adults, other than a drug in a form not suitable for human use, unless both the inner and outer labels carry the statement “For Veterinary Use Only” or “Veterinary Use Only”.

  • SOR/80-543, s. 5.

 [Repealed, SOR/93-407, s. 6]

 The provisions of sections C.01.401 and C.01.402 do not apply to an antibiotic in amounts less than 50 parts per million contained in an animal food.

 The provisions of paragraphs C.01.401 (b) and (c) and section C.01.402 do not apply to an antibiotic in amounts greater than 50 parts per million contained in an animal food.

 Both the inner and outer labels of a veterinary drug represented as containing a vitamin shall carry

  • (a) a statement of the amount of each vitamin present in the drug, expressed in terms of the proper name only of the vitamin in

    • (i) International Units per gram or per millilitre for vitamin A, provitamin A, vitamin D, and vitamin E,

    • (ii) milligrams per gram in the case of solids or viscous liquids, or per millilitre in the case of other liquids, for thiamine, riboflavin, niacin, niacinamide, pyridoxine, d-pantothenic acid, d-panthenol, folic acid, ascorbic acid, and vitamin K,

    • (iii) micrograms per gram in the case of solids or viscous liquids, or per millilitre in the case of other liquids, for biotin, and vitamin B12,

    • (iv) Oral Units for vitamin B12 with intrinsic factor concentrate, or

    • (v) for vitamin products put up in individual dosage or dispensing form, the specified units per individual dosage or dispensing form;

  • (b) except for drugs in a form not suitable for human use, the statement “For Veterinary Use Only” or “Veterinary Use Only”.

  • SOR/80-543, s. 6.

 An antibiotic for parenteral use that is recommended for veterinary use only shall carry on both the inner and outer labels

  • (a) the potency of the drug expressed in terms of International Units where established, or, if no International Unit has been established, in terms of units, milligrams or fractions of a gram, per gram in the case of solids or viscous liquids, per millilitre in the case of other liquids, or per individual dosage or dispensing form for antibiotic preparations put up in individual dosage or dispensing form; and

  • (b) [Repealed, SOR/92-654, s. 5]

  • (c) the statement “For Veterinary Use Only” or “Veterinary Use Only”.

  • SOR/80-543, s. 7;
  • SOR/92-654, s. 5.

 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 Director, 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).

  • SOR/88-378, s. 1;
  • SOR/92-664, s. 2;
  • SOR/93-467, s. 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).

  • SOR/90-327, s. 1.

 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.

  • SOR/80-543, s. 8.

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

 
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