FDA has announced the Outsourcing Facility Fee rates (here) for registered compounding facilities and their reinspection. The fees are broken down into qualified Small Business Establishment which pay a reduced fee, and Non-Small Business Establishment fees which pay a full fee. If there are any issues uncovered during an inspection of an outsourcing facility, and a reinspection of the facility is required to in order to assure compliance and continue operations, then the entity will be charged a reinspection fee.
Outsourcing Facility Fee Rates for FY 2027
According to the Federal Register Notice, FDA estimates that 87 outsourcing facilities (including 8 small businesses) will be registered with FDA in FY 2027. To qualify for a small business reduction of the FY 2027 establishment fee, entities had to submit their exception requests by April 30, 2026.
Discussion of how the fees are established and the factors that influence the fees and the rationale for the calculations are outlined in the FRN. “Once an entity submits registration information and FDA has determined that the information is complete, the entity will incur the annual establishment fee. FDA will send an invoice to the entity via email to the email address indicated in the registration file. The invoice will contain information regarding the obligation incurred, the amount owed, and payment procedures. A facility will not be registered as an outsourcing facility until it has paid the annual establishment fee under section 744K of the FD&C Act. Accordingly, it is important that facilities seeking to operate as outsourcing facilities pay all fees immediately upon receiving an invoice. If an entity does not pay the full invoiced amount within 15 calendar days after FDA issues the invoice, FDA will consider the submission of registration information to have been withdrawn and adjust the invoice to reflect that no fee is due”.
FDA indicates that “outsourcing facilities that registered in FY 2026 and wish to maintain their status as an outsourcing facility in FY 2027 must register during the annual registration period that lasts from October 1, 2026, to December 31, 2026. Failure to register and complete payment by December 31, 2026, will result in a loss of status as an outsourcing facility on January 1, 2027”.
