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While 503B outsourcing facilities are subject to federal Current Good Manufacturing Practice (CGMP) regulations and must register with the FDA, traditional 503A compounders are exempt from CGMP regulations and are instead overseen primarily by state boards of pharmacy, potentially resulting in a patchwork of manufacturing regulation and oversight across states (Lisi, 2021

Potential confounders included in the regression models included age, sex, race, etiology of acute liver failure, primary payer (Medicaid vs

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The 7 Peptides Under Review The July 23-24 meeting will evaluate these specific peptides for inclusion on the FDA's 503A bulks list: These 7 were among the 19 peptides the FDA removed from compounding pharmacy access in 2023