Secondary Packaging of Hormones

(Frank Range) #1

Our company has an opportunity to provide secondary packaging services for a company that manufactures hormones in solid dose format. The project would involve receiving unit dose blisters and manually placing a single unit dose (1 tablet) into a wallet card, place these cards into a carton, and the cartons into a shipping case. Can secondary packaging of a hormone be done outside the WHO and FDA guidance since those regulations are primarily for manufacturing?

(Md.Asif Hussain) #2

As this is secondary packing, the scenerio is just like re-dressing and the risk is very low, so it will not need special requirements.