Returned drug products

Returned drug products 21 CFR 211.204— Records of returned drug products shall be maintained and shall include the name and label potency of the drug product dosage form, lot number (or control number or batch number), reason for the return, quantity returned, date of disposition, and ultimate disposition of the returned drug... 

Returned products are expected to be labeled as such and segregated from other stock to prevent reuse. Returned products should be destroyed unless examination, testing, or other investigations prove that the returned drug product still meets appropriate standards of safety, identity, strength, quality, or purity. 

A manufacturer should establish procedures for holding investigating and analyzing returned drug products and determining whether such products should be reprocessed or destroyed. Products may be returned because of complaints, damage, expiration, or other reasons which cast doubt on the safety, and quality of drug products. 

Subpart K—Returned and Salvaged Drug Products 211.204 Returned drug products. 

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