Food and Drug Regulations
C.02.022 (1) Every wholesaler, distributor referred to in section C.01A.003 and importer of a drug in dosage form shall retain records of sale of each lot or batch of the drug, which enable them to recall the lot or batch from the market, for one year after the expiration date of that lot or batch unless their establishment licence specifies some other period.
(2) Every distributor of an active ingredient referred to in paragraph C.01A.003(a) and every wholesaler and importer of an active ingredient shall retain records of sale of each lot or batch of the active ingredient, which enable them to recall the lot or batch from the market, for the following period unless the person holds an establishment licence that 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.
- SOR/82-524, s. 3
- SOR/92-654, s. 7
- SOR/97-12, s. 18
- SOR/2013-74, s. 11
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