Life Science Compliance Update



The Wheels of Time Grind Slowly – FDA Issues Draft Guidance For Compound Pharmacy Outsourcing Facilities

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Carolyn Greene

In response to concerns about the safety of compounded drugs, particularly those produced in bulk, Congress passed the DQSA which amended the FFDCA to create a new category of compound pharmacies referred to as “outsourcing facilities.” Outsourcing facilities are subject to heightened FDA regulatory authority compared to traditional compound pharmacies. The FDA has just issued a Draft Guidance outlining some of the new regulations relevant to outsourcing facilities. These regulations limit the drugs that outsourcing facilities may produce in bulk quantities.


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