Comments on the FDA’s Draft Guidance on Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B

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Public Citizen, in general, supports the policies expressed in the Food and Drug Administration’s (FDA’s) draft guidance document.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 503B, pharmacy compounding of drug products that are essentially copies of approved drug products. Stringent limits on such pharmacy compounding under section 503B are critically important to protecting public health. We suggest some minor changes to strengthen the guidance.

View our other work related to pharmacy compounding.