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Guidance Documents/Guidance-Document/Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act Guidance for Industry: Draft Guidance for Industry

Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act Guidance for Industry: Draft Guidance for Industry

Detailed guidance document from FDA and regulatory agencies.

Document Details

Guidance Document

January 22, 2020

January 7, 2021

Center for Drug Evaluation and Research

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