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Sections 503A and 503B of the FD&C Act allow pharmacies and registered outsourcing facilities (facilities registered with the FDA under Section 503B that may compound larger volumes of drugs without individual patient prescriptions), respectively, to compound customized medications but not copies of commercially available drugs, unless those drugs are on the FDAs shortage list (a publicly available, regularly updated database identifying drugs whose national supply cannot meet current demand)

Nutr Rev 75(2):7382

De Rose V, Burgel PR, Gaggar A, Greene C

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