Food and Drug Regulations

C.02.025 (1) Every distributor referred to in paragraph C.01A.003(b) and importer of a drug in dosage form shall retain in Canada a sample of each lot or batch of the packaged/labelled drug for one year after the expiration date of the drug unless their establishment licence specifies otherwise.

(2) Subject to subsection (4), the fabricator of a drug in dosage form shall retain a sample of each lot or batch of raw materials used in the fabrication for two years after the materials were last used in the fabrication unless their establishment licence specifies some other period.

(3) Subject to subsection (4), the fabricator of an active ingredient shall retain a sample of each lot or batch of it for the following period unless their establishment licence specifies some other period:

• (a) in the case of an active ingredient that has a retest date, three years after the lot or batch has been completely distributed; or

• (b) in any other case, one year after the expiration date of the lot or batch.

(4) If a fabricator is required to maintain samples in respect of the same active ingredient under subsections (2) and (3), they shall maintain them for the longest period that is applicable.