Food and Drug Regulations

C.02.018 (1) Each lot or batch of a drug shall, before it is made available for further use in fabrication or for sale, be tested against the specifications for that drug.

(2) No lot or batch of a drug shall be made available for further use in fabrication or 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.