FDA Publishes Lists of OTC Companies With Outstanding and Paid User Fees
On July 6, the FDA released updated lists under the Over-the-Counter Monograph User Fee Amendments (OMUFA), identifying companies with unpaid OTC monograph drug facility fees as well as those that have paid in full. If your company appears on the FDA's public OMUFA arrears list, it means the FDA's records show your company has outstanding OTC monograph drug fees. For OTC monograph drug companies, being named on the public arrears list can raise concerns among customers, business partners, and internal compliance stakeholders.
Facility fee payment deadlines were as follows: FY2021 – May 10, 2021; FY2022 – June 1, 2022; FY2023 – June 1, 2023; FY2024 – June 1, 2024; and FY2026 – June 1, 2026. If a company fails to pay its annual facility fee within 20 calendar days after the applicable deadline, the FDA will place the facility on the public arrears list. In addition, all OTC monograph drug products manufactured at that facility (or products containing ingredients made there) will be considered misbranded under Section 502(ff) of the Federal Food, Drug, and Cosmetic Act (FDC Act).
Daniel Hue, a consultant with many years of experience advising on FDA, USDA, and US Customs matters, has an extensive track record of successful cases. He recommends verifying with your business partners that all applicable fees have been paid in full to the FDA. If your company has already been placed on the FDA arrears list, contact Daniel Hue – he can definitely help. The consultation is free, and you won't be disappointed with the results.
