FDA: 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). 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 in formation on how to obtain such a waiver.