Issue Date: November 24, 2014
Issued by: Center for Drug Evaluation and Research
Topic(s): Administrative / Procedural, Compounding
Status: Final
Registration for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act
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.
Download the Guidance Document
