Groups Say GMPs for Compounding Pharmacies are Unworkable
This article was originally published in The Gold Sheet
Pharmacy groups and pharmaceutical manufacturers are at odds over the applicability of GMPs to outsourced pharmacy compounding operations. In the meantime, FDA is going full steam ahead and taking an aggressive enforcement approach to compounding pharmacies that violate GMPs, issuing 19 warning letters so far this year.
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FDA’s revised draft guidance on GMPs for outsourcing pharmacy compounding operations responds to calls to allow the compounding of small quantities of drugs presumably for office use. The IACP applauds the move.
Will lessons from New England Compounding Center ever be learned? Top FDA officials say that compounding pharmacies need up their game and do a better job of producing quality sterile drugs as way too many facilities are failing GMP inspections and producing drugs that are sickening – and even killing – patients. Officials say forthcoming final guidance and final USP standard should turn this situation around.
FDA’s Woodcock says large-scale compounders would not be subject to all current Good Manufacturing Practices, but would be given separate regulations tailored specifically for them, similar to how it handled PET drug requirements.