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University of Washington, Seattle Shotelersuk V, Larson D, Anikster Y, McDowell G, Lemons R, Bernardini I, Guo J, Thoene J, Gahl WA (1998) CTNS mutations in an American-based population of cystinosis patients

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