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But, the reality is that 503A pharmacies are also under FDA jurisdiction for compliance with requirements under the Federal Food, Drug and Cosmetic Act (FD&C Act) for the compounded products they produce, noting that they are exempt from certain labeling requirements and current good manufacturing practices (cGMPs) applicable to FDA-approved drugs and 503B compounded drugs

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Garber A, Henry R, Ratner R, Garcia-Hernandez PA, Rodriguez-Pattzi H, Olvera-Alvarez I, et al