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Groups Say GMPs for Compounding Pharmacies are Unworkable

This article was originally published in The Gold Sheet

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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 19 warning letters so far this year.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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