HR 4273 119th Congress
Over-the-Counter Monograph Drug User Fee Amendments
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.
Official Title as Introduced Congress.gov
Open official Congress.gov recordSource-linked procedural record
Bill journey
This is a chronology, not a progress score. Politically.com does not classify stages or infer what comes next. Records sharing a date are grouped because not every source field supplies a time.
Congress.gov Recently refreshed
U.S. Senate XML Recently refreshed
-
Introduction Congress.gov
Introduced
Introduced in the House.
Open bill recordOfficial action Congress.gov
Referred to the House Committee on Energy and Commerce.
Open bill recordOfficial action Congress.gov
Introduced in House
Open bill recordOfficial action Congress.gov
Introduced in House
Open bill recordText version Congress.gov
Introduced in House
A dated text-version record is available.
Open text record -
Official action Congress.gov
Ordered to be Reported (Amended) by the Yeas and Nays: 51 - 0.
Open bill recordOfficial action Congress.gov
Committee Consideration and Mark-up Session Held
Open bill record -
Official action Congress.gov
Placed on the Union Calendar, Calendar No. 254.
Open bill recordOfficial action Congress.gov
Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 119-300.
Open bill recordOfficial action Congress.gov
Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 119-300.
Open bill recordText version Congress.gov
Reported in House
A dated text-version record is available.
Open text record
View the complete bill journey as an accessible table
| Date and time | Record | Official detail | Source |
|---|---|---|---|
| IntroductionIntroduced | Introduced in the House. | Congress.gov | |
| Official actionReferred to the House Committee on Energy and Commerce. | No additional detail supplied.IntroReferral · House floor actions · Code H11100 | Congress.gov | |
| Official actionIntroduced in House | No additional detail supplied.IntroReferral · Library of Congress · Code Intro-H | Congress.gov | |
| Official actionIntroduced in House | No additional detail supplied.IntroReferral · Library of Congress · Code 1000 | Congress.gov | |
| Text versionIntroduced in House | A dated text-version record is available. | Congress.gov | |
| Official actionOrdered to be Reported (Amended) by the Yeas and Nays: 51 - 0. | No additional detail supplied.Committee · House committee actions · Code H19000 | Congress.gov | |
| Official actionCommittee Consideration and Mark-up Session Held | No additional detail supplied.Committee · House committee actions · Code H15001 | Congress.gov | |
| Official actionPlaced on the Union Calendar, Calendar No. 254. | No additional detail supplied.Calendars · House floor actions · Code H12410 | Congress.gov | |
| Official actionReported (Amended) by the Committee on Energy and Commerce. H. Rept. 119-300. | No additional detail supplied.Committee · House floor actions · Code H12200 | Congress.gov | |
| Official actionReported (Amended) by the Committee on Energy and Commerce. H. Rept. 119-300. | No additional detail supplied.Committee · Library of Congress · Code 5000 | Congress.gov | |
| Text versionReported in House | A dated text-version record is available. | Congress.gov |
House roll calls join only on matching Congress, legislation type, and number. Senate roll calls join only on matching source-supplied document type and number, not question text. Committee and related-measure relationships have no date in their relationship records and therefore are counted above but never placed on the chronology.
Congressional Research Service
CRS summary
Over-the-Counter Monograph Drug User Fee AmendmentsThis bill reauthorizes the Over-the-Counter (OTC) Monograph Drug User Fee Program (OMUFA) through FY2030 and revises certain aspects of the program, including total fees to be collected and fee due dates.Under current law, many OTC drugs are marketed through compliance with an OTC monograph issued by the Food and Drug Administration (FDA), rather than through an approved new drug application. Monographs establish the conditions under which OTC drugs are generally recognized as safe and effective, and include ingredients, dosages, and other requirements. OMUFA permits the FDA to collect fees from OTC drug facilities and entities requesting changes to a monograph.The bill makes certain changes to OMUFA, including byrevising the total facility fee revenue amount to be collected for FY2026-FY2030,revising due dates for facility fees,permitting the FDA to implement a one-time adjustment to facility fees if certain conditions exist, andrequiring the FDA to publish facility and order request fee amounts at least 60 days before the start of each fiscal year.Finally, the bill adds as a Tier 2 OTC monograph order request a request for the addition or modification of a testing procedure applicable to a monograph drug, provided the testing procedure reflects a voluntary consensus standard with respect to pharmaceutical quality. (Requestors seeking certain kinds of changes to a monograph are awarded a period of market exclusivity if the FDA makes the requested changes; tier 2 requests are not eligible for market exclusivity.)
Official documents
Text versions
- Reported in HouseSep 17, 2025
- Introduced in HouseJul 2, 2025