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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

Final

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

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 on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

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

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.