Over-the-Counter Monograph Drug User Fee Amendments
On calendar: it can still change before the session ends.
- Stage
- On calendar
- Started in
- House
- Sponsors
- 4
- Latest action
- Sep 17, 2025
What it does
Over-the-Counter Monograph Drug User Fee Amendments This bill reauthorizes the Over-the-Counter (OTC) Monograph Drug User Fee Program (OMUFA) through FY2030 and revises certain aspects of the program, including total fees to be collected and fee due dates. Under current law, many OTC drugs are marketed through compliance with an OTC monograph issued by the Food and Drug Administration (FDA), rather than through an approved new drug application. Monographs establish the conditions under which OTC drugs are generally recognized as safe and effective, and include ingredients, dosages, and other requirements. OMUFA permits the FDA to collect fees from OTC drug facilities and entities requesting…
Official summary · Introduced in House · Jul 2, 2025
Titles and provisions can change as the bill moves.
Where it stands
Introduced (Done)
Committee (Current step)
Floor (Not started)
Law (Not started)
What moved
Who is involved
Sponsors
The lawmakers who put their names on it, lead sponsors first.
Where it goes next
While a bill can still move, the questions are about people and money.