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Under section 503B of the Federal Food, Drug, and Cosmetic Act, large outsourcing facilities may only compound from bulk active ingredients in two situations: the ingredient appears on the 503B bulks list, meaning FDA has found a clinical need for it, or the finished drug sits on FDA's shortage list at the time of compounding
doi: 10.3389/fendo.2022.974042 80 PrabhakarPMaheyRGuptaMKhadgawatRKachhawaGSharmaJBet al
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