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S. 2292: Over-the-Counter Monograph Drug User Fee Amendments

119th Congress · introduced 2025-07-15 · Health · Latest: Placed on Senate Legislative Calendar under General Orders. Calendar No. 152.

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Official title

Over-the-Counter Monograph Drug User Fee Amendments

Plain summary

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.

Congressional Research Service summary (Reported to Senate), quoted unchanged (nonpartisan). Read the source.

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Alternatives

Needs sources: no published alternatives yet (for example a different bill, a law instead of an amendment, or keeping current law). We only show items backed by a published source. Suggest one.

Officials and money

Sponsor: Sen. Banks, Jim [R-IN] · 3 cosponsors

Money: No cost estimate published yet. No linked contracts or vendors yet.

Sources

• Congressional Research Service summary (Reported to Senate)
• Congress.gov
• Data: GovInfo BILLSTATUS bulk data (Library of Congress), BILLSTATUS-119s2292.xml <https://www.govinfo.gov/bulkdata/BILLSTATUS/119/s>

Record fed-us-cong119-s2292 · catalog fed-us-congress-bills-cong119 · updated 2026-11-03 by psicol fed-bills