S. 2292 · 119th Congress
Over-the-Counter Monograph Drug User Fee Amendments
Key: what the circles and colors mean
Each circle is a bill. The ring fills as it moves through Congress:
Under the number: the Yea · Nay count of its final (or latest) recorded vote. On a member's page, the small badge is how that member voted: Y Yea / Aye, N Nay / No, P Present, – Not voting.
Gold and violet are only for Yea and Nay; they never mean a party. A member's party is the letter on their photo.
Not yet voted on. This bill is still a proposal: it hasn't reached a floor vote, and its text can change in committee or on the floor before any vote.
R
BanksSponsor3 cosponsors · 2 D, 1 R
1 signed on when it was introduced; the rest joined later. Cosponsors who withdrew aren't shown.
This bill reauthorizes the Over-the-Counter (OTC) Monograph Drug User Fee Program (OMUFA); revises procedures used by the Food and Drug Administration (FDA) to evaluate topical, nonprescription drugs (e.g., sunscreens); and requires the FDA to clarify the process through which a prescription drug may be switched to nonprescription status.
What it does: CRS summary · Reported to Senate · Sep 8, 2025
Over-the-Counter Monograph Drug User Fee Amendments
This bill reauthorizes the Over-the-Counter (OTC) Monograph Drug User Fee Program (OMUFA); revises procedures used by the Food and Drug Administration (FDA) to evaluate topical, nonprescription drugs (e.g., sunscreens); and requires the FDA to clarify the process through which a prescription drug may be switched to nonprescription status.
Under current law, many OTC drugs are marketed through compliance with an OTC monograph issued by the FDA, rather than through an approved new drug application. Monographs establish the conditions under which OTC drugs are generally recognized as safe and effective. The bill reauthorizes the collection of OMUFA fees from OTC drug facilities through FY2030 and revises methods for calculating such fees.
Separately, the bill requires the FDA to allow for the use of real-world evidence to demonstrate the safety and effectiveness of active ingredients in topical, nonprescription drugs. The FDA must consider nonclinical tests and other alternatives to animal testing in evaluating such drugs.
The FDA must also issue guidance to clarify the application process for nonprescription drugs, including applications to switch a prescription drug to nonprescription status. The FDA must plan to engage stakeholders in identifying drugs that are promising candidates for a switch. Moreover, applicants seeking a switch may request to meet with the FDA to develop a plan for the requisite application.
Finally, the Government Accountability Office must report on (1) the OTC monograph drug supply chain, and (2) the FDA’s handling of applications to switch a prescription drug to nonprescription status.
Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov
About this bill and sources
Official title: Over-the-Counter Monograph Drug User Fee Amendments
Latest action (Sep 8, 2025): Placed on Senate Legislative Calendar under General Orders. Calendar No. 152.
Policy area: Health · Origin: Senate · Introduced: Jul 15, 2025
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.