Registration for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act November 2014
- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter 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.
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:
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.