3.0.0 2292 2026-06-03T21:04:50Z 2026-06-03T21:04:50Z Senate S S 2025-07-15 119 https://www.congress.gov/bill/119th-congress/senate-bill/2292 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Reported By 2025-09-08T21:26:24Z Markup By 2025-07-30T14:00:02Z Referred To 2025-07-15T22:02:00Z A bill to increase the clarity and predictability of the process for developing applications for Rx-to-nonprescription switches. 119 2529 S 2025-07-30 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. Related bill CRS Over-the-Counter Monograph Drug User Fee Amendments 119 4273 HR 2025-09-17 Placed on the Union Calendar, Calendar No. 254. Related bill CRS 2025-09-08 Senate Placed on Senate Legislative Calendar under General Orders. Calendar No. 152. Calendars 2025-09-08 sshr00 Health, Education, Labor, and Pensions Committee Senate Committee on Health, Education, Labor, and Pensions. Reported by Senator Cassidy with an amendment in the nature of a substitute. Without written report. Committee 2025-09-08 Committee on Health, Education, Labor, and Pensions. Reported by Senator Cassidy with an amendment in the nature of a substitute. Without written report. Committee 14000 9 Library of Congress sshr00 Health, Education, Labor, and Pensions Committee 2025-07-30 sshr00 Health, Education, Labor, and Pensions Committee Senate Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably. Committee 2025-07-15 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2025-07-15 Introduced in Senate IntroReferral 10000 9 Library of Congress B001299 Sen. Banks, Jim [R-IN] Jim Banks R IN N K000384 Sen. Kaine, Tim [D-VA] Timothy Kaine D VA M. 2025-07-15 True K000394 Sen. Kim, Andy [D-NJ] Andy Kim D NJ 2025-07-29 False H001104 Sen. Husted, Jon [R-OH] Jon Husted R OH 2025-07-29 False Health Congressional oversight 2025-08-08T15:20:28Z Drug safety, medical device, and laboratory regulation 2025-08-08T15:20:28Z Supply chain 2026-04-08T17:11:46Z User charges and fees 2025-08-08T15:20:28Z Health 2026-05-07T13:52:20Z 25 2025-09-08 Reported to Senate 2026-06-03T21:03:38Z 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.

]]> Over-the-Counter Monograph Drug User Fee Amendments Short Title(s) as Reported to Senate 103 Over-the-Counter Monograph Drug User Fee Amendments 2025-09-10T04:23:20Z S Senate Reported to Senate RS Display Title 45 Over-the-Counter Monograph Drug User Fee Amendments 2025-09-09T11:03:23Z Short Title(s) as Introduced 101 Over-the-Counter Monograph Drug User Fee Amendments 2025-07-29T13:23:19Z Introduced in Senate IS Official Title as Introduced 6 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. 2025-07-29T13:18:19Z Introduced in Senate IS Reported to Senate 2025-09-08T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-119s2292rs/xml/BILLS-119s2292rs.xml Introduced in Senate 2025-07-15T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-119s2292is/xml/BILLS-119s2292is.xml 2025-09-08 Placed on Senate Legislative Calendar under General Orders. Calendar No. 152. text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. Congressional Research Service, Library of Congress This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.