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For more information on the “essentially a copy” condition, including FDA’s recommendations on documenting prescriber determinations of a clinical difference with respect to compounded drugs that would otherwise be copies under section 503B(d)(2)(B), please see FDA’s guidance, “Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act.” We remind you that for a compounded drug product to qualify for the exemptions under section 503B, the labeling of the drug must include certain information, including “the statement ‘This is a compounded drug.’ or a reasonable comparable alternative statement (as specified by the Secretary) that prominently identifies the drug as a compounded drug” (section 503B(a)(10) of the FDCA [21 U.S.C
