Over-the-Counter Monograph Drug User Fee Amendments
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Progress
Where this bill stands in the legislative process.
- Introduced
- Passed House
- Passed Senate
- To President
- Became Law
Overview
This bill reauthorizes the Over-the-Counter (OTC) Monograph Drug User Fee Program (OMUFA) through fiscal year 2030. It makes revisions to the program, including adjusting the total revenue collected and modifying fee due dates. Specifically, the bill updates how fees are assessed and collected, introduces a new type of monograph order request, and includes provisions for a one-time adjustment to facility fees under certain circumstances. It also establishes specific revenue targets for each fiscal year from 2026 through 2030.
Key provisions
- Reauthorizes the OMUFA program through FY2030.
- Adjusts the total facility fee revenue amount to be collected for FY2026-FY2030.
- Introduces a new Tier 2 OTC monograph order request for testing procedure additions/modifications.
- Permits a one-time adjustment to facility fees if certain conditions are met.
- Modifies the timing and method of fee assessment and collection.
- Establishes specific revenue targets for each fiscal year (2026-2030).
- Updates the reporting requirements for the program.
- Extends the authorization period for the program.
Who is affected
- Food and Drug Administration (FDA)
- Pharmaceutical manufacturers (OTC drug facilities)
- Drug reviewers at the FDA
- Healthcare providers
- Consumers
Notable changes
Bill text
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Sponsors
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4 on record
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Cosponsors
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