Over-the-Counter Monograph Drug User Fee Amendments
Official title: To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user fee program for over-the-counter monograph drugs, and for other purposes.
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Placed on the Union Calendar, Calendar No. 254.
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 changes to a monograph.
The bill makes certain changes to OMUFA, including by
- revising the total facility fee revenue amount to be collected for FY2026-FY2030,
- revising due dates for facility fees,
- permitting the FDA to implement a one-time adjustment to facility fees if certain conditions exist, and
- requiring the FDA to publish facility and order request fee amounts at least 60 days before the start of each fiscal year.
Finally, the bill adds as a Tier 2 OTC monograph order request a request for the addition or modification of a testing procedure applicable to a monograph drug, provided the testing procedure reflects a voluntary consensus standard with respect to pharmaceutical quality. (Requestors seeking certain kinds of changes to a monograph are awarded a period of market exclusivity if the FDA makes the requested changes; tier 2 requests are not eligible for market exclusivity.)
- Introduced in House Formatted Text PDF Formatted XML
- Reported in House Formatted Text PDF Formatted XML
- AMERICAN ACADEMY OF DERMATOLOGY ASSOCIATION
- NATIONAL TREASURY EMPLOYEES UNION
- CONSUMER HEALTHCARE PRODUCTS ASSOCIATION
- AMERICAN ACADEMY OF DERMATOLOGY ASSOCIATION
- NATIONAL TREASURY EMPLOYEES UNION
- CONSUMER HEALTHCARE PRODUCTS ASSOCIATION
Bodies those filers lobbied
- HOUSE OF REPRESENTATIVES
- SENATE
- Food & Drug Administration (FDA)
- Health & Human Services, Dept of (HHS)
- White House Office
- Treasury, Dept of
- Defense, Dept of (DOD)
- Centers For Medicare and Medicaid Services (CMS)
Cite this page
U.S. Congress. (2026). H.R. 4273: Over-the-Counter Monograph Drug User Fee Amendments. 119th Congress. Open America. https://openamerica.io/bill/119-HR-4273/
"H.R. 4273: Over-the-Counter Monograph Drug User Fee Amendments." 119th Congress, 2026, Open America, https://openamerica.io/bill/119-HR-4273/.
H.R. 4273, 119th Cong. (2026), https://openamerica.io/bill/119-HR-4273/.
[H.R. 4273: Over-the-Counter Monograph Drug User Fee Amendments](https://openamerica.io/bill/119-HR-4273/)