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FDA Commissioner Outlines Priorities For Tightening Oversight Of Drug Compounding Facilities

Executive Summary

To encourage drug compounding pharmacies to register as 503B drug outsourcing facilities, FDA plans to propose assigning these pharmacies a lower risk category, thus subjecting them to less stringent GMP controls if they make limited volumes of drugs as part of a “2018 Compounding Policy Priorities Plan” announced by FDA Commissioner Scott Gottlieb.

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