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

Regulations are current to 2021-11-17 and last amended on 2021-09-16. Previous Versions

PART CDrugs (continued)

DIVISION 1 (continued)

Limits of Variability (continued)

 No person shall sell a drug that is prepared for ophthalmic or parenteral use unless a representative sample of each lot of the drug in its immediate container

  • (a) is tested by an acceptable method for identity, and the drug is found to be true to its proper name, or to its common name if there is no proper name;

  • (b) is tested by an acceptable method for sterility, except

    • (i) for living vaccines, or

    • (ii) where the manufacturer has submitted evidence, satisfactory to the Minister to prove that processing controls ensure the sterility of the drug in its immediate container,

    and the drug is found to be sterile; and

  • (c) is subjected to such further tests satisfactory to the Minister to ensure that the drug is safe to use according to directions.

  • SOR/86-552, s. 1
  • SOR/90-586, s. 3
  • SOR/93-202, s. 12
  • SOR/96-399, s. 3
  • SOR/2018-69, s. 27

 No person shall sell a drug in aqueous solution that is prepared for parenteral use unless it has been prepared with non-pyrogenic water produced by distillation or reverse osmosis.

  •  (1) Subject to subsection (2), no person shall sell a drug that is prepared for parenteral use unless a representative sample of each lot of the drug in its immediate container

    • (a) is tested by an acceptable method for the presence of pyrogens; and

    • (b) when so tested, is found to be non-pyrogenic.

  • (2) Subsection (1) does not apply in respect of a drug that cannot be tested for the presence of pyrogens or that is inherently pyrogenic.

  • SOR/81-335, s. 1
  • SOR/96-399, s. 4

 Detailed records of the tests required by sections C.01.065 and C.01.067 shall be retained by the manufacturer for a period of at least one year after the expiration date on the label of the drug.

  • SOR/85-715, s. 5
  • SOR/92-654, s. 3

 The packaging of a drug that is prepared for parenteral use shall meet the following requirements:

  • (a) the immediate container shall be of such material and construction that

    • (i) no deleterious substance is yielded to the drug,

    • (ii) it is non-reactive with the drug,

    • (iii) visual or electronic inspection of the drug is possible,

    • (iv) protection against environmental factors that cause deterioration or contamination of the drug is provided or, where that protection cannot be provided by the immediate container, it is provided by the secondary packaging, and

    • (v) a sufficient quantity of the drug is contained to allow withdrawal of the labelled amount of the drug; and

  • (b) the immediate closures and any material coming into contact with the drug in its immediate container shall meet the requirements of subparagraphs (a)(i) and (ii).

  • SOR/96-399, s. 5

 No person shall sell a drug that is a hypodermic tablet that does not completely dissolve in and form a clear solution with water.

Mercuric Chloride Tablets

 No person shall sell mercuric chloride tablets for household use that are packaged in lots of 200 or less, unless

  • (a) such tablets are

    • (i) of an irregular or angular shape,

    • (ii) coloured blue, and

    • (iii) packed in an immediate container that is readily distinguishable by touch; and

  • (b) the principal display panel of both the inner and the outer labels carries in prominent type and in a colour contrasting to that of such labels

    • (i) the design of a skull and cross-bones, and

    • (ii) the word “Poison”.

  • SOR/2001-181, s. 2

 [Repealed, SOR/80-544, s. 4]

 [Repealed, SOR/80-544, s. 5]

Synthetic Sweeteners

  •  (1) [Repealed, SOR/78-422, s. 3]

  • (2) [Repealed, SOR/78-800, s. 1]

  • (3) [Repealed, SOR/78-422, s. 3]

 [Repealed, SOR/80-544, s. 6]

Aminopyrine and Dipyrone

 No person shall sell Aminopyrine or Dipyrone (a derivative of Aminopyrine) for oral or parenteral use, unless

  • (a) the inner label carries the statement:

    “WARNING: Fatal agranulocytosis may be associated with the use of Aminopyrine and Dipyrone. It is essential that adequate blood studies be made. (See enclosed warnings and precautions)”; and

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

    “WARNING: Serious and even fatal agranulocytosis is known to occur after the administration of Aminopyrine or Dipyrone. Fatal agranulocytosis has occurred after short term, intermittent and prolonged therapy with the drugs. Therefore, the use of these drugs should be as brief as possible. Bearing in mind the possibility that such reactions may occur, Aminopyrine or Dipyrone should be used only when other less potentially dangerous agents are ineffective.

    PRECAUTIONS: It is essential that frequent white blood cell counts and differential counts be made during treatment with these drugs. However, it is emphasized that agranulocytosis may occur suddenly without prior warning. The drug should be discontinued at the first evidence of any alteration of the blood count or sign of agranulocytosis, and the patient should be instructed to discontinue use of the drug at the first indication of sore throat or sign of other infection in the mouth or throat (pain, swelling, tenderness, ulceration).”

  • SOR/2018-69, s. 34(F)

 No person shall disseminate to a practitioner promotional literature about Aminopyrine or Dipyrone unless the statements set out in section C.01.131 are included in such literature.

 The provisions of sections C.01.131 and C.01.132 do not apply to preparations containing Aminopyrine or Dipyrone that are

  • (a) dispensed by a pharmacist pursuant to a prescription; or

  • (b) sold for veterinary use only.

Coated Potassium Salts

 No person shall sell coated tablets containing potassium salts, with or without thiazide diuretics, unless the inner label thereof or the package insert carries the following statement:

“WARNING: A probable association exists between the use of coated tablets containing potassium salts, with or without thiazide diuretics, and the incidence of serious small bowel ulceration. Such preparations should be used only when adequate dietary supplementation is not practical, and should be discontinued if abdominal pain, distension, nausea, vomiting or gastro-intestinal bleeding occur.”

  • SOR/2018-69, s. 34(F)

 No person shall disseminate to a practitioner promotional literature about coated tablets containing potassium salts, with or without thiazide diuretics, unless the statement set out in section C.01.134 is included in such literature.

 The provisions of sections C.01.134 and C.01.135 do not apply to coated tablets containing potassium salts with or without thiazide diuretics that

  • (a) are sold for veterinary use only;

  • (b) are dispensed by a pharmacist pursuant to a prescription; or

  • (c) contain 100 milligrams or less of elemental potassium per tablet.

Antibiotics

 Except as provided in these Regulations, an antibiotic for other than parenteral use shall, in addition to meeting the requirements of section C.01.004, carry on both the inner label and outer label 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, micrograms or fractions of a gram,

  • (a) per gram in the case of solids or viscous liquids;

  • (b) per millilitre in the case of other liquids; and

  • (c) per individual dosage or dispensing form in the case of antibiotic preparations put up in individual dosage or dispensing form.

  • SOR/80-544, s. 7
  • SOR/92-654, s. 4

 [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.

  • SOR/2018-69, s. 35(F)

 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
 
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