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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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The formula is straightforward: Concentration (mg/mL) = Total mg in vial Total mL of BAC water added Dose volume (mL) = Target dose (mg) Concentration (mg/mL) The most common approach is adding 2 mL of BAC water, which produces easy-to-measure concentrations

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