Outsourcing facilties are compounding facilities that are registered by the FDA and subject to inspection. The fee structure is rather simple, with facility fees and reinspection fees only. The fee rates for FY 2023 will go into effect on October 1, 2022. A chart comparing the FY 2022 and FY 2023 fees is provided below:
|FY 2022||FY 2023||Change|
|Oualified Small Business Establisment Fee||$5,824||$5,941||+ $117|
|Non-Small Business Establishment Fee||$18,999||$18,661||– $338|
|Reinspection fee||$17,472||$17,823||+ $351|
Fee changes are the result of both the number of each type of entity and an adjustment made for inflationary items. The complete explanation of how the FY 2023 fees were calculated appeared in the pre‑publication Federal Register Notice today (here).