FDA Commissioner Outlines Priorities For Tightening Oversight Of Drug Compounding Facilities
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 clarifies that drugs in shortage are not considered “essentially a copy” of an approved drug and can be compounded by traditional pharmacies and outsourcing facilities. This clarification is one of several recently announced by the agency.
FDA proposal would allow traditional compounding from five drug substances based on medical need, but not from another 26.
Chronic problem with drug shortages is driving the Cleveland Clinic to consider registering as a 503B “outsourcing” facility. That could be a milestone in FDA’s efforts to encourage the model for high volume compounders.