HR 4273
· 119th Congress
· Health
Over-the-Counter Monograph Drug User Fee Amendments
Sponsor
Latest action
Placed on the Union Calendar, Calendar No. 254.
Action timeline
Every recorded action on this bill, newest first. Stage badges color-code the legislative path.
Sep 17, 2025
committee
Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 119-300.
Energy and Commerce Committee
Sep 17, 2025
other
Placed on the Union Calendar, Calendar No. 254.
Jul 23, 2025
committee
Committee Consideration and Mark-up Session Held
Energy and Commerce Committee
Jul 23, 2025
committee
Ordered to be Reported (Amended) by the Yeas and Nays: 51 - 0.
Energy and Commerce Committee
Jul 02, 2025
introduced
Introduced in House
Jul 02, 2025
introduced
Referred to the House Committee on Energy and Commerce.
Energy and Commerce Committee
Text versions
Each stage of the bill — official text published by GPO. Click any format to read on congress.gov / govinfo.
CRS summaries
Plain-English summaries written by the Congressional Research Service — neutral, nonpartisan staff who summarize bills as they advance through stages. The authoritative description of what each version of the bill does.
00
Introduced in House
Jul 02, 2025
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.)
via Congressional Research Service · published through congress.gov
Changelog
ⓘ
How a bill moves through Congress. Each stage produces a new official text. The diff between them shows what changed at that step.
ih / is — Introduced in House / Senate. First filed version.rfh / rfs — Referred to a committee for review.rh / rs — Reported back by the committee to the floor (often with amendments — this is where most language changes happen).pcs / pch — Placed on Calendar for floor consideration.eh / es — Engrossed. Passed by the originating chamber. Text is now what was actually voted on.rdh / rds — Received by the other chamber.eah / eas — Engrossed Amendment. The other chamber passed an amended version.ath / ats — Agreed to. Both chambers settled on the same text.enr — Enrolled. Final reconciled text, sent to the President.pl — Public Law. Signed by the President. It's now law.pp — Public Print. Official printing post-enactment.
Most bills die before eh/es. Going from pcs → enr is the full path through both chambers.
ⓘ
How a bill moves through Congress. Each stage produces a new official text. The diff between them shows what changed at that step.
ih/is— Introduced in House / Senate. First filed version.rfh/rfs— Referred to a committee for review.rh/rs— Reported back by the committee to the floor (often with amendments — this is where most language changes happen).pcs/pch— Placed on Calendar for floor consideration.eh/es— Engrossed. Passed by the originating chamber. Text is now what was actually voted on.rdh/rds— Received by the other chamber.eah/eas— Engrossed Amendment. The other chamber passed an amended version.ath/ats— Agreed to. Both chambers settled on the same text.enr— Enrolled. Final reconciled text, sent to the President.pl— Public Law. Signed by the President. It's now law.pp— Public Print. Official printing post-enactment.
Most bills die before eh/es. Going from pcs → enr is the full path through both chambers.
Line-level diff between text versions of this bill — what actually changed at each legislative stage.
+62
−13
57 unchanged
--- Introduced (House)
+++ Reported (House)
@@ -1,12 +1,15 @@
[From the U.S. Government Publishing Office]
-[H.R. 4273 Introduced in House (IH)]
+[H.R. 4273 Reported in House (RH)]
<DOC>
+Union Calendar No. 254
119th CONGRESS
1st Session
H. R. 4273
+[Report No. 119-300]
+
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.
@@ -20,6 +23,15 @@
Mr. Latta (for himself, Ms. DeGette, Mr. Crenshaw, and Mrs. Dingell)
introduced the following bill; which was referred to the Committee on
Energy and Commerce
+
+September 17, 2025
+
+Reported with an amendment, committed to the Committee of the Whole
+House on the State of the Union, and ordered to be printed
+[Strike out all after the enacting clause and insert the part printed
+in italic]
+[For text of introduced bill, see copy of bill as introduced on July 2,
+2025]
_______________________________________________________________________
@@ -74,9 +86,9 @@
a process described in guidance for industry,
initially published in July 2023, or any
successor guidance, publicly available on the
-agency website, which addresses voluntary
-consensus standards for pharmaceutical
-quality.''.
+website of the Food and Drug Administration,
+which addresses voluntary consensus standards
+for pharmaceutical quality.''.
SEC. 4. AUTHORITY TO ASSESS AND USE OTC MONOGRAPH FEES.
@@ -239,10 +251,11 @@
inserting ``the sum of'' after ``is equal to'';
(ii) by striking clause (i);
(iii) by redesignating subclauses (I) and
-(II) as clauses (i) and (ii), respectively, and
-adjusting the margins accordingly;
+(II) of clause (ii) as clauses (i) and (ii),
+respectively, and adjusting the margins
+accordingly;
(iv) by striking ``(ii) for each of fiscal
-years 2024 and 2025, the sum of''; and
+years 2024 and 2025, the sum of--''; and
(v) in clause (ii), as so redesignated, by
striking ``Washington-Baltimore, DC-MD-VA-WV''
and inserting ``Washington-Arlington-
@@ -273,8 +286,8 @@
``(A) $135,000 for fiscal year 2026;
``(B) $300,000 for fiscal year 2027;
``(C) $55,000 for fiscal year 2028;
-``(D) $0 for fiscal year 2029; and
-``(E) $30,000 for fiscal year 2030.''; and
+``(D) $30,000 for fiscal year 2029; and
+``(E) $0 for fiscal year 2030.''; and
(4) by striking paragraph (4) and inserting the following:
``(4) One-time facility fee workload adjustment.--
``(A) In general.--In addition to the adjustments
@@ -363,7 +376,20 @@
(3) in subsection (d), by striking ``2025'' each place it
appears and inserting ``2030''.
-SEC. 6. SUNSET DATES.
+SEC. 6. REGULATION OF CERTAIN NONPRESCRIPTION DRUGS THAT ARE MARKETED
+WITHOUT AN APPROVED DRUG APPLICATION.
+
+(a) Development Advice to Sponsors or Requestors.--Section 505G(h)
+of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355h(h)) is
+amended by striking ``sponsors or requestors'' and inserting
+``sponsors, requestors, or organizations nominated by sponsors or
+requestors to represent their interests in a proceeding''.
+(b) Technical Correction.--Section 505G(b)(2)(A)(iv)(III) of the
+Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355h(b)(2)(A)(iv)(III))
+is amended by striking ``requestors'' and inserting ``sponsors or
+requestors''.
+
+SEC. 7. SUNSET DATES.
(a) Authorization.--Sections 744L and 744M of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379j-71; 379j-72) shall cease to be
@@ -372,7 +398,7 @@
Drug, and Cosmetic Act (21 U.S.C. 379j-73) shall cease to be effective
January 31, 2031.
-SEC. 7. EFFECTIVE DATE.
+SEC. 8. EFFECTIVE DATE.
The amendments made by this Act shall take effect on October 1,
2025, or the date of the enactment of this Act, whichever is later,
@@ -381,7 +407,7 @@
be assessed beginning October 1, 2025, regardless of the date of the
enactment of this Act.
-SEC. 8. SAVINGS CLAUSE.
+SEC. 9. SAVINGS CLAUSE.
Notwithstanding the amendments made by this Act, part 10 of
subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act
@@ -389,4 +415,27 @@
enactment of this Act, shall continue to be in effect with respect to
assessing and collecting any fee required by such part for a fiscal
year prior to fiscal year 2026.
-<all>
+Union Calendar No. 254
+
+119th CONGRESS
+
+1st Session
+
+H. R. 4273
+
+[Report No. 119-300]
+
+_______________________________________________________________________
+
+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.
+
+_______________________________________________________________________
+
+September 17, 2025
+
+Reported with an amendment, committed to the Committee of the Whole
+House on the State of the Union, and ordered to be printed
Lobbying activity
Organizations whose LDA filings reference this bill, ranked by filing count. Position not disclosed — LDA does not require lobbyists to report support / oppose / monitor. Bill-number references can be stale (lobbyists sometimes copy text year-over-year), so verify against the filing description.
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filings · 2026 Q3
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filings · 2025 Q4
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Cosponsors (3)
Members who signed on to support this bill.