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FDA Guidance for Industry: Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act



For a drug product compounded by an outsourcing facility to qualify for the exemptions under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act or Act), it must not be “essentially a copy of one or more approved drug products,” and must meet the other conditions in section 503B. This guidance sets forth the FDA’s or policies concerning the essentially a copy provision of section 503B

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