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Section 503B outsourcing facilities compound in larger volumes and are subject to FDA registration and inspections

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N Engl J Med 380:347357 Cannon CP, Pratley R, Dagogo-Jack S, Mancuso J, Huyck S, Masiukiewicz U, Charbonnel B, Frederich R, Gallo S, Cosentino F, Shih WJ, Gantz I, Terra SG, Cherney DZI, McGuire DK (2020) VERTIS CV Investigators

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