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OMUFA Reauthorization: Fiscal Years 2026 - 2030

On November 12, 2025, the President signed into law the Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act, 2026. This new law includes the second authorization of the Over-the-Counter Monograph User Fee Act (OMUFA) that provides FDA with the necessary resources to maintain a predictable and efficient review process for over-the-counter monograph drug products.

FDA developed the proposed enhancements for OMUFA II in consultation with drug industry representatives from November 2023 through June 2024. FDA also consulted with public stakeholders via public meetings and associated public comment requests. FDA transmitted these proposed enhancements to Congress in January 2025, which are referred to in Title V of the Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act, 2026.

The new law ensures that FDA will continue to receive a source of stable and consistent funding during fiscal years 2026-2030. FDA dedicates this funding to expediting and enhancing the review process for over-the-counter monograph drug products. Over-the-counter monograph drug products represent an important public health benefit, with the potential to offer accessible and affordable treatment options for consumers without requiring a prescription from a health care provider. This page contains the relevant information related to OMUFA II and FDA's implementation of the OMUFA II enhancements. It also includes information related to the negotiations and consultations prior to the agreement..

OMUFA II Commitment Letter

Industry Discussions on Reauthorization

2024 Meeting Summaries

2023 Meeting Summaries

Public Meetings on Reauthorization

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