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Why These 7 Substances Are Being Reviewed Under section 503A of the Federal Food, Drug, and Cosmetic Act, a compounded human drug product is exempt from new drug approval, labeling, and current good manufacturing practice requirements only if, among other conditions, the bulk drug substance used complies with a USP or National Formulary monograph, is a component of an FDA-approved drug, or appears on the 503A Bulks List

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10.1155/2015/287401 13 FriedmanS