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GUIDANCE DOCUMENT

Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act October 2015

Final
Docket Number:
FDA-2014-D-2138
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance is intended for firms that have registered with the Food and Drug Administration (FDA) under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as human drug compounding outsourcing facilities (outsourcing facilities).  Under section 503B(b)(5) of the FD&C Act, an outsourcing facility must submit adverse event reports to FDA “in accordance with the content and format requirements established through guidance or regulation under section 310.305 of title 21, Code of Federal Regulations (or any successor regulations).”  This
guidance explains FDA’s current thinking on adverse event reporting for outsourcing facilities.
 


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2014-D-2138.

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