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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

One of the most common issues is liver damage, including fatty liver, alcoholic hepatitis, and ultimately cirrhosis, which can be fatal

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Conflicts of interest Both authors declared that there are no conflicts of interest