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

C.01.031.1. [Repealed, SOR/87-484, s. 3]

• C.01.031.2. (1) Sections C.01.029 to C.01.031 do not apply to a drug that is

  • (a) required by these Regulations or the Narcotic Control Regulations to be sold on prescription;

  • (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.

C.01.032. 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.

C.01.033. Section C.01.032 does not apply to a corticosteroid drug that is dispensed by a registered pharmacist pursuant to a prescription.

C.01.034. 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.