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FDA Commissioner Outlines Priorities For Tightening Oversight Of Drug Compounding Facilities

 
• By Joanne S. Eglovitch

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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The US FDA plans to issue guidance soon that aims to encourage traditional 503A pharmacies to register as 503B outsourcing facilities by according them a lower level of risk, and thus a lower level of GMP oversight. This is one element of a five-point plan announced by FDA Commissioner Scott Gottlieb to tighten its oversight of drug compounding pharmacies.

The November 2013 Drug Quality and Security Act gave FDA clearer authority to regulate drug compounding facilities

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