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Guidance Documents/Guidance-Document/Registration for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act

Registration for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act

Detailed guidance document from FDA and regulatory agencies.

Document Details

Guidance Document

November 24, 2014

April 17, 2020

Center for Drug Evaluation and Research

74d2bf28-3d33-408f-9b37-e47a144fa9bc

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