Food and Drug Regulations

C.02.025 (1) Every distributor referred to in paragraph C.01A.003(b) and importer of a drug shall retain in Canada a sample of each lot or batch of the packaged/labelled drug for a period of at least one year after the expiration date on the label of the drug, unless otherwise specified in the distributor’s or importer’s establishment licence.

(2) The fabricator shall retain a sample of each lot or batch of raw materials used in the fabrication of a drug for a period of at least two years after the materials were last used in the fabrication of the drug, unless otherwise specified in the fabricator’s establishment licence.