HR 4273
Over-the-Counter Monograph Drug User Fee Amendments
Jurisdiction
US Congress
Session
119th Congress (2025-2026)
Last updated at
Jun 14, 2026, 3:08 AM
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Sign in to take action- Introduced
- Passed House
- Passed Senate
- To President
- Became Law
Bill overview
This bill reauthorizes the Over-the-Counter (OTC) Monograph Drug User Fee Program (OMUFA) through fiscal year 2030, ensuring continued funding for the FDA’s oversight of OTC drugs marketed through monographs. It makes several revisions to the program, including adjusting the total revenue collected, modifying fee due dates, and allowing for one-time fee adjustments under specific circumstances. The bill also introduces a new tier of order requests related to testing procedures for monographs, while clarifying that these requests are not eligible for market exclusivity. Finally, it establishes specific fee amounts and timelines for collection.
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