On May 11, 2026, the U.S. Food and Drug Administration published its latest update to the Over-the-Counter Monograph Drug User Fee Program (OMUFA) arrears and paid facilities lists, available on the FDA’s OMUFA programme page under the “OMUFA Arrears and Paid Facilities Lists” tab. For any facility that manufactures or processes finished dosage forms of OTC monograph drugs and has not settled outstanding fee obligations, the FDA OMUFA arrears list carries immediate regulatory consequences.
What the Lists Reflect
The arrears and paid facilities lists are updated periodically to reflect payment activity following each annual fee deadline. The May 11 update covers outstanding obligations from FY 2021 through FY 2025. A facility remains on the arrears list until every outstanding balance across those years is cleared in full.
For FY 2026, facility fees are due June 1, 2026. The fee schedule published in the March 18, 2026 Federal Register notice sets the Monograph Drug Facility (MDF) rate at $19,188 and the Contract Manufacturing Organisation (CMO) rate at $12,792, both significantly reduced from FY 2025 levels.
Consequences of Non-Payment
The stakes of appearing on the FDA OMUFA arrears list are substantial. If a facility does not pay the annual facility fee within 20 calendar days of the due date, the agency places the facility on a publicly available arrears list, and all OTC monograph drug products produced at that facility, or containing an ingredient manufactured at that facility, shall be deemed misbranded under section 502(ff) of the FD&C Act. Additionally, OTC Monograph Order Requests and related meeting requests will not be accepted from any person or affiliate in arrears. Lachmanconsultants
Brand owners using contract manufacturers should also take note. The misbranding determination extends to products containing ingredients from a non-compliant facility, meaning a CMO’s unpaid fees can affect downstream companies even where those companies are fully current on their own obligations.
What This Means for Your Business
The June 1, 2026 deadline is days away. Facilities that have not yet paid their FY 2026 fee should do so immediately through FDA’s user fee system. Those appearing on the May 11 arrears list for prior years should contact CDERCollections@fda.hhs.gov to resolve outstanding balances and, where applicable, dispute any listings they believe are in error. Foreign facilities registered with FDA are subject to the same requirements as domestic manufacturers and should confirm their status before the deadline passes.
Frequently Asked Questions
Our facility appears on the May 11 arrears list but we believe the fee was paid. What should we do?
Payment processing errors can occasionally result in a facility appearing on the list despite a submitted payment. Contact CDERCollections@fda.hhs.gov with your facility name, DUNS number, FDA Establishment Identifier (FEI) number, Payment Identification Number (PIN), and payment method, date, and amount. FDA will review the submission and respond.
Does OMUFA apply to facilities outside the United States?
Yes. OMUFA applies to any facility manufacturing finished dosage forms of OTC monograph drugs for the U.S. market, regardless of where that facility is located. A facility is considered liable if it was registered with FDA at any point between January 1 and December 31 of the previous year.
Key Takeaways
- FDA published updated OMUFA arrears and paid facilities lists on May 11, 2026.
- FY 2026 facility fees are due June 1, 2026: $19,188 for MDFs and $12,792 for CMOs.
- Non-payment within 20 calendar days of the deadline results in a public arrears listing and misbranding of all affected OTC products.
- The arrears list covers unpaid obligations from FY 2021 through FY 2025 and applies to foreign facilities as well as domestic ones.
Confirm Your Status Before June 1
With the FY 2026 payment deadline imminent, facilities and their supply chain partners have limited time to confirm compliance and resolve any outstanding balances. For guidance on U.S. drug registration requirements and OMUFA obligations, contact Quality Smart Solutions to speak with a regulatory specialist. The current arrears and paid facilities lists are available directly on the FDA’s OMUFA programme page.
