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GUIDANCE DOCUMENT

Facility Definition Under Section 503B of the Federal Food, Drug, and Cosmetic Act May 2018

Final
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance is intended for entities that are registered or are considering registering 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). Section 503B defines an outsourcing facility, in part, as “a facility at
one geographic location or address.” FDA has received questions from outsourcing facilities and
other stakeholders about the meaning of this term, such as whether multiple suites used for
compounding human drugs at a single street address constitute one or multiple facilities,
or whether a single location where human drugs are compounded can be subdivided into separate
operations compounding under different standards. FDA is issuing this guidance to provide the
agency’s current thinking on these issues, and related issues regarding how to ensure that the
compounding of drugs in an outsourcing facility occurs only in accordance with section 503B.
 


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:

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

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