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

Regulations are current to 2013-06-10 and last amended on 2013-05-31. Previous Versions

 Sections C.01.032 and C.01.034 do not apply to a drug sold solely for veterinary use.

Miscellaneous

  •  (1) No manufacturer or importer shall sell

    • (a) a drug that contains phenacetin in combination with any salt or derivative of salicylic acid;

    • (b) a drug for human use that contains

      • (i) oxyphenisatin,

      • (ii) oxyphenisatin acetate, or

      • (iii) phenisatin; or

    • (c) a drug for human use that contains mercury or a salt or derivative thereof, unless the drug is

      • (i) a drug described in Schedule C or D to the Act, or

      • (ii) one of the following drugs, namely,

        • (A) an ophthalmic drug or other drug to be used in the area of the eye,

        • (B) a drug for nasal administration,

        • (C) a drug for otic administration, or

        • (D) a drug for parenteral administration that is packaged in a multi-dose container,

      in which the mercury or the salt or derivative thereof is present as a preservative and the manufacturer or importer has submitted evidence to the Director demonstrating that the only satisfactory way to maintain the sterility or stability of the drug is to use that preservative.

  • (2) For the purpose of clause (1)(c)(ii)(A), “area of the eye” means the area bounded by the supraorbital and infraorbital ridges and includes the eyebrows, the skin underlying the eyebrows, the eyelids, the eyelashes, the conjunctival sac of the eye, the eyeball and the soft tissue that lies below the eye and within the infraorbital ridge.

  • SOR/78-423, s. 2;
  • SOR/86-93, s. 3;
  • SOR/89-229, s. 3.

 No person shall sell, or advertise for sale, nitrous oxide to the general public.

  • SOR/78-875, s. 1.
  •  (1) No person shall sell to the general public a drug that is recommended solely for children if the package in which the drug is sold contains

    • (a) more than 1.92 g of salicylamide or salicylic acid or the equivalent quantity of a salt of salicylic acid;

    • (b) more than 1.92 g of acetylsalicylic acid or the equivalent quantity of a salt or derivative thereof;

    • (c) more than 3.2 g of acetaminophen in 160 mg dosage units; or

    • (d) more than 1.92 g of acetaminophen in 80 mg dosage units.

  • (2) Subsection (1) does not apply to a drug dispensed pursuant to a prescription.

  • SOR/86-93, s. 4;
  • SOR/87-484, s. 5;
  • SOR/88-323, s. 6;
  • SOR/90-587, s. 3.

 A drug for human use is adulterated if it contains

  • (a) Strychnine or any of its salts;

  • (b) extracts or tinctures of

    • (i) Strychnos nux vomica,

    • (ii) Strychnos Ignatii, or

    • (iii) a Strychnos species containing strychnine, other than those species mentioned in subparagraphs (i) and (ii);

  • (c) Methapyrilene or any of its salts;

  • (d) Echimidine or any of its salts; or

  • (e) any of the following plant species or extracts or tinctures thereof:

    • (i) Symphytum asperum,

    • (ii) Symphytum x uplandicum, or

    • (iii) any other plant species containing echimidine.

  • SOR/79-512, s. 1;
  • SOR/88-173, s. 1.