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

Regulations are current to 2017-07-03 and last amended on 2017-06-20. Previous Versions

 Both the inner and the outer labels of a drug that carry a recommended single or daily dosage or a statement of concentration in excess of the limits provided by section C.01.021 shall carry a caution that the product is to be used only on the advice of a physician.

 The provisions of section C.01.025 do not apply to

  • (a) a drug sold on prescription, or

  • (b) the inner label of a single-dose container.

  •  (1) Where a person advertises to the general public a drug for human use, the person shall not make any representation other than with respect to the brand name, proper name, common name, price and quantity of the drug if it

    • (a) contains a drug set out in the table to section C.01.021; and

    • (b) carries on its label

      • (i) a statement of the recommended single or daily adult dosage that results in a single or daily adult dosage of the drug referred to in paragraph (a) in excess of the maximum dosage set out in the table to section C.01.021 for that drug, or

      • (ii) a statement that shows a concentration of the drug referred to in paragraph (a) in excess of the maximum limit set out in the table to section C.01.021 for that drug.

  • (2) Subsection (1) does not apply to products containing

    • (a) acetaminophen;

    • (b) acetylsalicylic acid;

    • (c) choline salicylate;

    • (d) magnesium salicylate; or

    • (e) sodium salicylate.

  • (3) [Repealed, SOR/94-409, s. 1]

  • (4) Where a person advertises to the general public a drug for human use that contains acetylsalicylic acid, the person shall not make any representation with respect to its administration to or use by children or teenagers.

  • SOR/81-358, s. 1;
  • SOR/84-145, s. 3;
  • SOR/85-715, s. 4(F);
  • SOR/85-966, s. 3;
  • SOR/93-202, s. 5;
  • SOR/93-411, s. 1;
  • SOR/94-409, s. 1.

Cautionary Statements and Child Resistant Packages

  •  (1) Subject to subsection (2), the inner and outer labels of a drug that contains

    • (a) acetylsalicylic acid or any of its salts or derivatives, salicylic acid or a salt thereof, or salicylamide, where the drug is recommended for children, shall carry a cautionary statement to the effect that the drug should not be administered to a child under two years of age except on the advice of a physician;

    • (b) boric acid or sodium borate as a medicinal ingredient shall carry a cautionary statement to the effect that the drug should not be administered to a child under three years of age;

    • (c) hyoscine (scopolamine) or a salt thereof shall carry a cautionary statement to the effect that the drug should not be used by persons suffering from glaucoma or where it causes blurring of the vision or pressure pain within the eye;

    • (d) phenacetin, either singly or in combination with other drugs, shall carry the following cautionary statement:

      “CAUTION: May be injurious if taken in large doses or for a long time. Do not exceed the recommended dose without consulting a physician.”; or

    • (e) acetylsalicylic acid for internal use shall carry a cautionary statement to the effect that the drug should not be administered to or used by children or teenagers who have chicken pox or manifest flu symptoms before a physician or pharmacist is consulted about Reye’s syndrome, which statement shall also refer to the fact that Reye’s syndrome is a rare and serious illness.

  • (2) Subsection (1) does not apply to a drug that is

  • SOR/86-93, s. 2;
  • SOR/88-323, s. 2(F);
  • SOR/93-411, s. 2;
  • SOR/2013-122, s. 7.
  •  (1) Subject to subsections C.01.031.2(1) and (2), the inner and outer labels of a drug

    • (a) that contains

      • (i) salicylic acid, a salt thereof or salicylamide,

      • (ii) acetylsalicylic acid, or any of its salts or derivatives,

      • (iii) acetaminophen, or

      • (iv) more than five per cent alkyl salicylates, or

    • (b) that is in a package that contains

      • (i) more than the equivalent of 250 mg of elemental iron, or

      • (ii) more than the equivalent of 120 mg of fluoride ion, unless the drug is intended solely for use in dentists’ offices,

    shall carry a cautionary statement to the effect that the drug should be kept out of the reach of children.

  • (2) Subject to subsections C.01.031.2(1) and (2), the inner and outer labels of a drug that is in a package that contains

    • (a) more than 1.5 g of salicylic acid or the equivalent quantity of any of its salts or salicylamide,

    • (b) more than 2 g of acetylsalicylic acid or the equivalent quantity of any of its salts or derivatives,

    • (c) more than 3.2 g of acetaminophen,

    • (d) more than the equivalent of 250 mg of elemental iron, or

    • (e) more than the equivalent of 120 mg of fluoride ion, unless the drug is intended solely for use in dentists’ offices,

    shall carry a cautionary statement to the effect that there is enough drug in the package to seriously harm a child.

  • (3) The cautionary statements required under subsections (1) and (2) shall be preceded by a prominently displayed symbol that is octagonal in shape, conspicuous in colour and on a background of a contrasting colour.

  • SOR/86-93, s. 2;
  • SOR/87-484, s. 2;
  • SOR/88-323, s. 3(F);
  • SOR/90-587, s. 2;
  • SOR/93-468, s. 1.

 [Repealed, SOR/2003-196, s. 104]

  •  (1) Subject to section C.01.031.2,

    • (a) no person shall sell a drug described in subsection C.01.029(1) unless

      • (i) where the drug is recommended solely for children, it is packaged in a child resistant package, or

      • (ii) where the drug is not recommended solely for children, at least one of the sizes of packages available for sale is packaged in a child resistant package; and

    • (b) where a drug described in subsection C.01.029(1) is packaged in a package that is not a child resistant package, the outer label shall carry a statement that the drug is available in a child resistant package.

  • (2) [Repealed, SOR/93-468, s. 2]

  • SOR/86-93, s. 2;
  • SOR/87-16, s. 1;
  • SOR/93-468, s. 2.

 [Repealed, SOR/87-484, s. 3]

  •  (1) Sections C.01.029 to C.01.031 do not apply to a drug that is

    • (a) a prescription drug or a drug that is required to be sold under a prescription by Part G, the Benzodiazepines and Other Targeted Substances Regulations or the Narcotic Control Regulations;

    • (b) intended for parenteral use only;

    • (c) in effervescent or powder form;

    • (d) in suppository form;

    • (e) intended for topical use, unless it is a liquid preparation containing more than five per cent alkyl salicylates;

    • (f) packaged in a non-reclosable package containing not more than two adult standard dosage units per package; or

    • (g) in toothpaste form.

  • (2) Sections C.01.029 to C.01.031 do not apply to a drug that is repackaged by a pharmacist or practitioner at the time of sale.

  • (3) Section C.01.031 does not apply to a drug that is

    • (a) sold only in containers that have roll-on or spray applicators or permanently installed wick applicators;

    • (b) sold for exclusive use in animals other than household pets; or

    • (c) intended solely for use in dentists’ offices, or packaged for hospital use only.

  • SOR/86-93, s. 2;
  • SOR/87-484, s. 4;
  • SOR/88-323, s. 5(F);
  • SOR/93-468, s. 3;
  • SOR/2013-122, s. 8.
 
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