Food and Drug Regulations

C.02.014 (1) Except in the case of a wholesaler, no lot or batch of a drug shall be made available for sale unless the sale of that lot or batch is approved by the person in charge of the quality control department.

(2) A drug that is returned to the fabricator, packager/labeller, wholesaler, distributor referred to in paragraph C.01A.003(b) or importer shall not be made available for further sale unless the sale of that drug is approved by the person in charge of the quality control department.

(3) No lot or batch of raw material or of packaging/labelling material shall be used in the fabrication or packaging/labelling of a drug unless the material is approved for that use by the person in charge of the quality control department.

(4) No lot or batch of a drug shall be reprocessed without the approval of the person in charge of the quality control department.