Issue Date: May 10, 2018
Issued by: Center for Drug Evaluation and Research
Topic(s): Compounding
Status: Final
Facility Definition Under Section 503B of the Federal Food, Drug, and Cosmetic Act
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.
Download the Guidance Document
