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Bill · HR

H.R. 4273 (119th)

Over-the-Counter Monograph Drug User Fee Amendments

Original

openUnited States· United States Congress· EN

Introduced

2 July 2025

Last action

17 September 2025 · Reported

Status

Placed on the Union Calendar, Calendar No. 254.

Sponsors

Rep. Latta, Robert E. [R-OH-5], Diana DeGette, Rep. Crenshaw, Dan [R-TX-2], Debbie Dingell

Subjects

Healthcare, Taxation

Source updated

18 July 2026

Healthcare · Taxation

Official sourceDownload fileView documentsShare

Summary

Over-the-Counter Monograph Drug User Fee Amendments This 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 by revising 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, and requiring 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.)

This text is taken from the official record. PoliticalRepo does not editorialize.

Timeline

  1. 2 July 2025

    Introduced

    Referred to the House Committee on Energy and Commerce.

    Source: IntroReferral

  2. 2 July 2025

    Introduced

    Introduced in House

    Source: IntroReferral

  3. 2 July 2025

    Introduced

    Introduced in House

    Source: IntroReferral

  4. 23 July 2025

    Committee

    Committee Consideration and Mark-up Session Held

    Source: Committee

  5. 23 July 2025

    Vote

    Ordered to be Reported (Amended) by the Yeas and Nays: 51 - 0.

    Source: Committee

  6. 17 September 2025

    Calendars

    Placed on the Union Calendar, Calendar No. 254.

    Source: Calendars

  7. 17 September 2025

    Reported

    Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 119-300.

    Source: Committee

  8. 17 September 2025

    Reported

    Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 119-300.

    Source: Committee

Votes

No vote records are attached yet.

Versions

No version snapshots stored. Document URLs remain at the source.

Documents

3 official files

Sponsors

Related records

Sources

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