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

Electronic Drug Product Reporting 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

January 3, 2017

April 28, 2022

Center for Drug Evaluation and Research

663cef2e-7472-423d-8bba-249d7de0ea3d

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