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

Regulations are current to 2019-02-28 and last amended on 2019-01-15. Previous Versions

PART CDrugs (continued)

DIVISION 1 (continued)

Cautionary Statements and Child Resistant Packages (continued)

 [Repealed, SOR/87-484, s. 3]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.

 No person shall sell a corticosteroid drug for ophthalmic use unless

  • (a) the outer label or the package insert carries, as part of the directions for use, the following statements:

    “Contraindications

    Viral diseases of the cornea and conjunctiva;

    Tuberculosis of the eye;

    Fungal diseases of the eye;

    Acute purulent untreated infections of the eye, which, like other diseases caused by micro-organisms, may be masked or enhanced by the presence of the steroid.

    Side Effects

    Extended ophthalmic use of corticosteroid drugs may cause increased intraocular pressure in certain individuals and in those diseases causing thinning of the cornea, perforation has been known to occur.”;

    and

  • (b) the inner label carries the statements required by paragraph (a) or instructions to see the outer label or package insert for information about contraindications and side effects.

  • SOR/2018-69, s. 18(F).

 Section C.01.032 does not apply to a corticosteroid drug that is sold by a pharmacist under a prescription.

  • SOR/2013-122, s. 9.

 No person shall disseminate to a practitioner promotional literature about corticosteroid drugs for ophthalmic use unless the statements required by paragraph C.01.032(a) are included in that literature.

 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 Minister 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;
  • SOR/2018-69, s. 27.

 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.

 In vitro diagnostic products that are or contain drugs other than drugs listed in Schedule E to the Act, and drugs listed in Schedule D to the Act that are labelled for veterinary use only, are exempt from the application of this Part.

  • SOR/97-12, s. 4.

 No manufacturer or importer shall sell a drug for human use that contains as an ingredient

  • (a) chloroform; or

  • (b) arsenic or any of its salts or derivatives, other than arsenic trioxide.

  • SOR/89-229, s. 4;
  • SOR/2013-113, s. 1.
 
Date modified: