Tuesday, September 30, 2014

Groups Say GMPs for Compounding Pharmacies are Unworkable

Groups Say GMPs for Compounding Pharmacies are Unworkable


Executive Summary

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 16 warning letters so far this year.


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