FDA issues draft guidance on hospital and health system compounding

Apr 15, 2016 - 03:51 PM

The Food and Drug Administration today issued draft guidance explaining how it intends to apply section 503A of the Federal Food, Drug and Cosmetic Act to drugs compounded in state-licensed hospital or health system pharmacies for use within the hospital or health system. Pharmacies located within a hospital or standalone pharmacies that are part of a health system frequently provide compounded drug products for administration within the hospital or health system. Some of these compounders have registered with the FDA as outsourcing facilities under section 503B of the Act, which was added by the Drug Quality and Security Act of 2013, and others are state-licensed pharmacies subject to section 503A. In addition, FDA issued draft guidance on certain prescription requirements for compounding under section 503A and the meaning of the term “facility” under section 503B. For more information, see the FDA news release. The agency will accept comments on the draft guidance for 90 days after notice of the guidance is published in the April 18 Federal Register.

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