Food and Drug Regulations

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.