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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

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Their rate of gastrointestinal side effects nearly doubled compared to the group that started at 2 mg and escalated (Jastreboff et al., NEJM 2023)