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FDA GMP Warning Letters Review: Compounding Pharmacies Drew The Most Letters In 2016

Executive Summary

More than half of last year’s 110 drug GMP warning letters went to compounding pharmacies as US FDA’s crackdown on poor aseptic practices in sterile compounding continued. The complexity surrounding GMP applicability continued to complicate the enforcement landscape in 2016 despite FDASIA distinction between traditional and outsourcing compounders, final article in our four-part series reports.

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