Registration of Human Drug Compounding Outsourcing Facilities

FDA has issued a new document: “The US Food and Drug Administration (USFDA) Registration of Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C 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.

For details see: FDA

Posted by Tim Sandle