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Category 2 of the FDA's 503A list is reserved for bulk drug substances that "raise significant safety concerns." Placement in this category essentially prohibits compounding pharmacies from using the substance to prepare formulations for patients

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Zanin-Zhorov A, Weiss JM, Trzeciak A, Chen W, Zhang J, Nyuydzefe MS, Arencibia C, Polimera S, Schueller O, Fuentes-Duculan J, Bonifacio KM, Kunjravia N, Cueto I, Soung J, Fleischmann RM, Kivitz A, Lebwohl M, Nunez M, Woodson, J.,Waksal, S