Expiration dating of repackaged medications Naughty 18 chat


16-Apr-2020 22:13

A repackager should provide appropriate labeling of the product identical to the manufacturer's approved market container.

All repackaged products should be labeled with an appropriate BUD in the absence of stability data, or with an expiration date in cases where suitable stability studies, determined in CFR 211.166 (for recommended conditions see ), have been performed on the product using the repackager's container.

Stability studies are performed on the drug product in the original manufacturer's containers to establish an expiration date.The expiration date is the final day that the manufacturer guarantees the full potency and safety of a medication. pharmaceutical manufacturers are required by law to place expiration dates on prescription products prior to marketing.