Food and Drug Regulations

C.02.018 (1) Each lot or batch of a drug shall, prior to its availability for sale, be tested against the specifications for that drug.

(2) No lot or batch of a drug shall be available for sale unless it complies with the specifications for that drug.

(3) The specifications referred to in subsections (1) and (2) shall

• (a) be in writing;

• (b) be approved by the person in charge of the quality control department; and

• (c) comply with the Act and these Regulations.