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

C.01.063. [Repealed, SOR/96-399, s. 2]

C.01.064. Where a drug is prepared for ophthalmic or parenteral use and contains a preservative ingredient, that ingredient

• (a) shall be present only in an amount necessary to obtain the intended action and that does not pose undue risk to humans or animals; and

• (b) shall not interfere with the therapeutic properties of the drug.

C.01.065. No person shall sell a drug that is prepared for ophthalmic or parenteral use unless a representative sample of each lot of the drug in its immediate container

• (a) is tested by an acceptable method for identity, and the drug is found to be true to its proper name, or to its common name if there is no proper name;

• (b) is tested by an acceptable method for sterility, except

  • (i) for living vaccines, or

  • (ii) where the manufacturer has submitted evidence, satisfactory to the Director to prove that processing controls ensure the sterility of the drug in its immediate container,

  and the drug is found to be sterile; and

• (c) is subjected to such further tests satisfactory to the Director to ensure that the drug is safe to use according to directions.

C.01.066. No person shall sell a drug in aqueous solution that is prepared for parenteral use unless it has been prepared with non-pyrogenic water produced by distillation or reverse osmosis.

• C.01.067. (1) Subject to subsection (2), no person shall sell a drug that is prepared for parenteral use unless a representative sample of each lot of the drug in its immediate container

  • (a) is tested by an acceptable method for the presence of pyrogens; and

  • (b) when so tested, is found to be non-pyrogenic.

• (2) Subsection (1) does not apply in respect of a drug that cannot be tested for the presence of pyrogens or that is inherently pyrogenic.

C.01.068. Detailed records of the tests required by sections C.01.065 and C.01.067 shall be retained by the manufacturer for a period of at least one year after the expiration date on the label of the drug.

C.01.069. The packaging of a drug that is prepared for parenteral use shall meet the following requirements:

• (a) the immediate container shall be of such material and construction that

  • (i) no deleterious substance is yielded to the drug,

  • (ii) it is non-reactive with the drug,

  • (iii) visual or electronic inspection of the drug is possible,

  • (iv) protection against environmental factors that cause deterioration or contamination of the drug is provided or, where that protection cannot be provided by the immediate container, it is provided by the secondary packaging, and

  • (v) a sufficient quantity of the drug is contained to allow withdrawal of the labelled amount of the drug; and

• (b) the immediate closures and any material coming into contact with the drug in its immediate container shall meet the requirements of subparagraphs (a)(i) and (ii).