Over-the-Counter Monograph Drug User Fee Amendments
Official title: A bill 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 Senate Legislative Calendar under General Orders. Calendar No. 152.
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.
- Introduced in Senate Formatted Text PDF Formatted XML
- Reported to Senate Formatted Text PDF Formatted XML
- AMERICAN ACADEMY OF DERMATOLOGY ASSOCIATION
- CONSUMER HEALTHCARE PRODUCTS ASSOCIATION
- AMERICAN ACADEMY OF DERMATOLOGY ASSOCIATION
- CONSUMER HEALTHCARE PRODUCTS ASSOCIATION
- AKIN GUMP STRAUSS HAUER & FELD
- AMERICAN ACADEMY OF DERMATOLOGY ASSOCIATION
Bodies those filers lobbied
- HOUSE OF REPRESENTATIVES
- SENATE
- Centers For Medicare and Medicaid Services (CMS)
- Food & Drug Administration (FDA)
- Health & Human Services, Dept of (HHS)
- White House Office
- Defense, Dept of (DOD)
- Drug Enforcement Administration (DEA)
Cite this page
U.S. Congress. (2026). S. 2292: Over-the-Counter Monograph Drug User Fee Amendments. 119th Congress. Open America. https://openamerica.io/bill/119-S-2292/
"S. 2292: Over-the-Counter Monograph Drug User Fee Amendments." 119th Congress, 2026, Open America, https://openamerica.io/bill/119-S-2292/.
S. 2292, 119th Cong. (2026), https://openamerica.io/bill/119-S-2292/.
[S. 2292: Over-the-Counter Monograph Drug User Fee Amendments](https://openamerica.io/bill/119-S-2292/)