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Comments on the FDA’s Draft Guidance on Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A

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Public Citizen, in general, supports the policies expressed in the Food and Drug Administration’s (FDA’s) draft guidance document. In particular, the proposed guidance appropriately seeks to tightly limit, under section 503A, pharmacy compounding of drug products that are essentially copies of a commercially available drug product. Stringent limits on such pharmacy compounding under section 503A are critically important to protecting public health. We suggest some minor changes to strengthen the guidance.

View our other work related to pharmacy compounding.