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GUIDANCE DOCUMENT

Registration for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act November 2014

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2013-N-1429
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance is intended for facilities planning to register or renew registration as human drug
compounding outsourcing facilities (outsourcing facilities). A compounder can elect to register
with FDA as an outsourcing facility under section 503B of the Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 353b), as added by the Drug Quality and Security Act (DQSA), Pub. Law No.
113-54 (November 27, 2013). This guidance describes the process for electronic submission of
establishment registration information for outsourcing facilities. In certain rare cases, FDA may
grant an entity a waiver from submitting registration information electronically.  This guidance
also provides information on how to obtain such a waiver.

Submit Comments

Submit Comments Online

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-2013-N-1429.

 
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