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With branded products commanding having experienced intermittent supply constraints, compounding pharmacies stepped in to fill the gap—operating under Section 503A of the Federal Food, Drug, and Cosmetic Act, which exempts qualifying compounders from certain FDA requirements, including CGMP compliance, labeling requirements, and premarket approval

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doi: 10.1016/j.metabol.2019.04.014 [DOI] [PubMed] [Google Scholar] 12.Girard J