Outsourcing facilities are compounders registered with the FDA under Section 503B of the Federal Food Drug and Cosmetic Act. They undergo FDA inspections and must follow cGMPs as they relate to compounded prescription drug products that they are authorized to compound. Good news for the 503B facilities – their fees have not gone up much for FY 2022 and they appear in the chart below with a comparison to the FY 2021 fee schedule.
|Fee Type||FY 2021 Fees||FY 2022 Fees||% Change|
|Qualified Small Business Establishment Fee||$5,695||$5,824||2.3|
|Non-Small Business Establishment Fee||18,837||18,999||0.9|
In arriving at the FY 2022 fees, the FDA applied an inflation calculation and had to estimate the number of total and small business establishments that would be paying fees in FY 2022. “FDA estimates that 80 outsourcing facilities, including 12 small businesses, will be registered with FDA in FY 2022.” In FY 2021, the FDA estimated that there would be eighty-five outsourcing facilities, including fifteen small business operations. Note that, for the reinspection fee, there is no small business adjustment. For a full description of how the FDA calculates the fees, and how and when to pay the fees, please see the FR notice here.