Returned drug products (USFDA CFR 211.204 )
Returned drug products shall be identified as such and held.
- If the conditions under which returned drug products have been held, stored or shipped before or during their return, or
- If the condition of the drug product, its container, carton, or labeling, as a result of storage or shipping, casts doubt on the safety, identity, strength, quality, or purity of the drug product.
The returned drug product shall be destroyed unless examination, testing, or other investigations prove the drug product meets appropriate standards of safety, identity, strength, quality, or purity.
A drug product may be reprocessed provided the subsequent drug product meets appropriate standards, specifications, and characteristics.
Records of returned drug products shall be maintained and shall include –
- The names and labels potency of the drug product dosage form
- Lot number (or control number or batch number)
- The reason for the return
- Quantity returned
- Date of disposition, and
- The ultimate disposition of the returned drug product.
If the reason for a drug product being returned implicates associated batches, an appropriate investigation shall be conducted in accordance with the requirements of USFDA CFR 211.192.
Procedures for the holding, testing, and reprocessing of returned drug products shall be in writing and shall be followed.