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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

Next stop Senate floor: awaiting a vote
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
Key points
  • 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
AI-generated from the Reported to Senate text of 08-SEP-2025 · verify · report an error
Official CRS summary

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.gov
Committee referrals (1) Policy area

Health

Sponsor Jim Banks (R-IN) Cosponsors · 3
■ 2 D■ 1 R
2 Democrats
1 Republican