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

Regulations are current to 2013-05-20 and last amended on 2013-03-21. Previous Versions

  • C.01.029. (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.

C.01.030. [Repealed, SOR/2003-196, s. 104]

  • C.01.031. (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.