S. 2292 · Where this bill is now
In committee
Introduced in the Senate, Jul 15, 2025
What this bill does
In plain words · AI-written from the official summaryUpdates rules for over-the-counter drug approvals
This bill keeps funding for how the FDA oversees common over-the-counter drugs through 2030. It also changes how the FDA evaluates topical drugs like sunscreens and pain creams, allowing companies to use real-world evidence instead of just animal testing. The bill also asks the FDA to create clearer rules for switching prescription drugs to over-the-counter status, and requires the government to study how well this process is working.
How it affects you
If you use over-the-counter drugs, you might see these products evaluated using newer testing methods that don't rely only on animals. If a prescription drug becomes available over-the-counter in the future, there will be a clearer process for that switch. The main changes are behind the scenes at the FDA, so most people won't notice direct changes in their daily lives, though the goal is to keep OTC medications safe and available.
Read the official 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 AI (Claude) using only the official summary by the Congressional Research Service, the Library of Congress’s nonpartisan research staff. It can miss nuance, so check the official summary and the bill text for details.
1st SessionS. 2292
A BILL
Over-the-Counter Monograph Drug User Fee Amendments
Sponsor: Sen. Jim Banks (R-IN) · Introduced Jul 15, 2025 · Health · 2 versions of the text
Sources: Congress.gov actions and votes · bill text from GovInfo · latest official action Sep 8, 2025: “Placed on Senate Legislative Calendar under General Orders. Calendar No. 152.”
Sections
The wording of this bill hasn’t changed across its 2 official versions.