While the fees for outsourcing facilities all went up this year, at least the increases in these fees won’t break the bank (at least not yet). These fees represent the inspection fees associated with outsourcing facilities (better known as compounding facilities) under section 503B of the Federal Food, Drug, and Cosmetic Act. They are designed to recoup the costs of FDA inspection of these facilities.
Comparison of FY 2024 and FY 2025 503B Outsourcing Facility Fees
Also note that the amount of the fees depends on the number of outsourcing facilities registered each year. As the number of these entities changes, the value of the fees can go up or down. While there are currently eighty-three outsourcing facilities registered with the FDA as of July 31, 2024, for the FY 2025 fee calculation, the FDA estimated that there will be eighty outsourcing facilities, eleven of which will quality for the small business facility fee. The estimates of the number of facilities are based on the previous three years’ registration data (FYI, the first year of registration began in December 2013).
The pre-publication Federal Register Notice announcing these fees provides further background on the fees and how they were derived; it can be found here. Also, we have a previous post that further explains the landscape of outsourcing facilities that can be found here.
