Food and Drug Regulations

C.01.036 (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.