Registered Outsourcing Facilities

Facilities Registered As Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act)

Updated as of 8/30/2024

• Information Concerning Outsourcing Facility Registration
• Outsourcing Facility Product Reporting Information

This table lists the outsourcing facilities that have submitted registration information that has been determined to be complete by the data lock date for the latest weekly update of the table.

Notes

1. The "initial date of registration as an outsourcing facility"is the datethe facility was first registered (i.e., the date FDA determined that the initial registration information submitted for the facility was complete, and for firms first registering on or after October 1, 2014, the establishment fee was paid in full).

Under section 503B(b) of the FD&C Act, after the initial registration, a facility that elects to continue to be registered with FDA as an outsourcing facility must re-register annually.Beginning in fiscal year (FY) 2015 (October 1, 2014 to September 30, 2015), a facility that elects to register (or re-register) with FDA as an outsourcing facility must pay an annual establishment fee.The “date of most recent registration as an outsourcing facility” reflects the date FDA determined the most recently submitted registration information was complete and the annual establishment fee for that fiscal year paid in full.

Inspections identified in this table are associated with the facility at the listed address. A company may own or operate more than one registered outsourcing facility. FDA’s web page Compounding: Inspections, Recalls, and Other Actions may contain information about compounding facilities under the same ownership as the listed registered outsourcing facility.