S 2292
Advanced toward a vote
Reauthorizes and revises the user fee program that the FDA uses to fund oversight of over-the-counter monograph drugs through fiscal year 2030, setting new fee amounts and collection schedules, and adds requirements on sunscreen rules, Rx-to-nonprescription switch guidance, and supply chain reporting.
Official title: Over-the-Counter Monograph Drug User Fee Amendments
Timeline each lane is a chamber; dates pull from congress.gov actions
Senate
Introduced
15-JUL-2025
Referred
15-JUL-2025
Approved by committee
30-JUL-2025
Reported
08-SEP-2025
On the calendar
08-SEP-2025
- Sets facility and order request fee revenue for fiscal years 2026 through 2030, with fee amounts and due dates changed from prior years
- Allows a one-time fee increase in fiscal years 2028, 2029, or 2030 if facility counts exceed a set threshold
- Requires FDA to report on order request timelines, safety activities, and sunscreen active ingredient review, and to publish negotiation meeting minutes
- Directs the Comptroller General to report on the over-the-counter drug supply chain by September 30, 2027, and sets guidance deadlines for switching prescription drugs to nonprescription use
Current. The Congressional Research Service's summary covers the bill's latest wording (Reported to Senate, 08-SEP-2025).
CRS is the Library of Congress's nonpartisan research office. Read it on congress.govHealth
■ 2 D■ 1 R
1 Republican