H. R. 5371—143
and ending January 30, 2026, shall be $17,748,493, which 
may be claimed as fiscal year 2026 uncompensated care costs’’ 
before the period. 
(b) DELAYING DSH ALLOTMENT REDUCTIONS.—Section 1923(f) 
of the Social Security Act (42 U.S.C. 1396r–4(f)) is amended—
(1) in paragraph (7)(A)—
(A) in clause (i)—
(i) in the matter preceding subclause (I), by 
striking ‘‘For each of fiscal years 2026 through 2028’’ 
and inserting ‘‘For the period beginning January 31, 
2026, and ending September 30, 2026, and for each 
of fiscal years 2027 and 2028’’; 
(ii) in subclause (I), by inserting ‘‘or period’’ after 
‘‘the fiscal year’’; and 
(iii) in subclause (II), by inserting ‘‘or period’’ after 
‘‘in the fiscal year’’; and 
(B) in clause (ii), by striking ‘‘for each of fiscal years 
2026 through 2028’’ and inserting ‘‘for the period beginning 
January 31, 2026, and ending September 30, 2026, and 
for each of fiscal years 2027 and 2028’’; and 
(2) in paragraph (8), by striking ‘‘2027’’ and inserting 
‘‘2028’’. 
TITLE V—FOOD AND DRUG 
ADMINISTRATION 
SEC. 6501. SHORT TITLE. 
This title may be cited as the ‘‘Over-the-Counter Monograph 
Drug User Fee Amendments’’. 
SEC. 6502. FINDING. 
Congress finds that the fees authorized by the amendments 
made in this title will be dedicated to over-the-counter (OTC) mono-
graph drug activities, as set forth in the goals identified for purposes 
of part 10 of subchapter C of chapter VII of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379j–71 et seq.), in the letters 
from the Secretary of Health and Human Services to the Chairman 
of the Committee on Energy and Commerce of the House of Rep-
resentatives and the Chairman of the Committee on Health, Edu-
cation, Labor, and Pensions of the Senate, as set forth in the 
Congressional Record. 
SEC. 6503. DEFINITIONS. 
Section 744L(9)(A) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 379j–71(9)(A)) is amended—
(1) in clause (v), by striking ‘‘; or’’ and inserting a semicolon; 
(2) in clause (vi)—
(A) by striking ‘‘addition’’ and inserting ‘‘the addition’’; 
and 
(B) by striking the period and inserting ‘‘; or’’; and 
(3) by adding at the end the following: 
‘‘(vii) the addition or modification of a testing procedure 
applicable to one or more OTC monograph drugs, provided 
that such additional or modified testing procedure reflects 
a voluntary consensus standard with respect to pharma-
ceutical quality that is—
H. R. 5371—144
‘‘(I) established by a national or international 
standards development organization; and 
‘‘(II) recognized by the Secretary through a process 
described in guidance for industry, initially published 
in July 2023, or any successor guidance, publicly avail-
able on the website of the Food and Drug Administra-
tion, which addresses voluntary consensus standards 
for pharmaceutical quality.’’. 
SEC. 6504. AUTHORITY TO ASSESS AND USE OTC MONOGRAPH FEES. 
(a) TYPES OF FEES.—Section 744M(a)(1) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379j–72(a)(1)) is amended—
(1) in subparagraph (A)—
(A) by striking ‘‘on December 31 of the fiscal year 
or at any time during the preceding 12-month period’’ 
and inserting ‘‘at any time during the applicable period 
specified in clause (ii) for a fiscal year’’; 
(B) by striking ‘‘Each person’’ and inserting the fol-
lowing: 
‘‘(i) ASSESSMENT OF FEES.—Each person’’; and 
(C) by adding at the end the following: 
‘‘(ii) APPLICABLE PERIOD.—For purposes of clause 
(i), the applicable period is—
‘‘(I) for fiscal year 2026, the 12-month period 
ending on December 31, 2025; 
‘‘(II) for fiscal year 2027, the 9-month period 
ending on September 30, 2026; and 
‘‘(III) for fiscal year 2028 and each subsequent 
fiscal year, the 12-month period ending on Sep-
tember 30 of the preceding fiscal year.’’; 
(2) in subparagraph (B)(i), by amending subclause (I) to 
read as follows: 
‘‘(I) has ceased all activities related to OTC 
monograph drugs prior to—
‘‘(aa) for purposes of fiscal year 2026, 
January 1, 2025; 
‘‘(bb) for purposes of fiscal year 2027, 
January 1, 2026; and 
‘‘(cc) for purposes of fiscal year 2028 and 
each subsequent fiscal year, October 1 of the 
preceding fiscal year; and’’; and 
(3) by amending subparagraph (D) to read as follows: 
‘‘(D) DUE DATE.—
‘‘(i) FISCAL YEAR 2026.—For fiscal year 2026, the 
facility fees required under subparagraph (A) shall be 
due on the later of—
‘‘(I) the first business day of June of such 
year; or 
‘‘(II) the first business day after the enactment 
of an appropriations Act providing for the collection 
and obligation of fees under this section for such 
year. 
‘‘(ii) FISCAL YEAR 2027.—For fiscal year 2027, the 
facility fees required under subparagraph (A) shall be 
due—
‘‘(I) in a first installment representing 50 per-
cent of such fee, on the later of—
H. R. 5371—145
‘‘(aa) October 1, 2026; or 
‘‘(bb) the first business day after the enact-
ment of an appropriations Act providing for 
the collection and obligation of fees under this 
section for such year; and 
‘‘(II) in a second installment representing the 
remaining 50 percent of such fee, on—
‘‘(aa) February 1, 2027; or 
‘‘(bb) if an appropriations Act described 
in subclause (I)(bb) is not in effect on February 
1, 2027, the first business day after enactment 
of such an appropriations Act. 
‘‘(iii) SUBSEQUENT FISCAL YEARS.—For fiscal year 
2028 and each subsequent fiscal year, the facility fees 
required under subparagraph (A) shall be due on the 
later of—
‘‘(I) the first business day on or after October 
1 of the fiscal year; or 
‘‘(II) the first business day after the date of 
enactment of an appropriations Act providing for 
the collection and obligation of fees under this 
section for the fiscal year.’’. 
(b) FEE REVENUE AMOUNTS.—Section 744M(b) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379j–72(b)) is amended 
to read as follows: 
‘‘(b) FEE REVENUE AMOUNTS.—
‘‘(1) IN GENERAL.—For each of the fiscal years 2026 through 
2030, fees under subsection (a)(1) shall be established to gen-
erate a total facility fee revenue amount equal to the sum 
of—
‘‘(A) the annual base revenue for the fiscal year (as 
determined under paragraph (2)); 
‘‘(B) the dollar amount equal to the inflation adjust-
ment for the fiscal year (as determined under subsection 
(c)(1)); 
‘‘(C) the dollar amount equal to the operating reserve 
adjustment for the fiscal year, if applicable (as determined 
under subsection (c)(2)); 
‘‘(D) additional direct cost adjustments (as determined 
under subsection (c)(3)); 
‘‘(E) an additional dollar amount equal to—
‘‘(i) $2,373,000 for fiscal year 2026; 
‘‘(ii) $1,233,000 for fiscal year 2027; and 
‘‘(iii) $854,000 for fiscal year 2028; and 
‘‘(F) in the case of a fiscal year for which the Secretary 
applies the one-time facility fee workload adjustment under 
subsection (c)(4), the dollar amount equal to such adjust-
ment. 
‘‘(2) ANNUAL BASE REVENUE.—For purposes of paragraph 
(1), the dollar amount of the annual base revenue for a fiscal 
year shall be—
‘‘(A) for fiscal year 2026, the dollar amount of the 
total revenue amount established for fiscal year 2025 under 
this subsection as in effect on the day before the date 
of enactment of the Over-the-Counter Monograph Drug 
User Fee Amendments, not including any adjustments
H. R. 5371—146
made for such fiscal year 2025 under subsection (c)(2), 
as so in effect; and 
‘‘(B) for fiscal years 2027 through 2030, the dollar 
amount of the total revenue amount established under 
this subsection for the previous fiscal year, not including 
any adjustments made for such previous fiscal year under 
subsection (c)(2) or (c)(3).’’. 
(c) ADJUSTMENTS; ANNUAL FEE SETTING.—Section 744M(c) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–72(c)) 
is amended—
(1) in paragraph (1)—
(A) in subparagraph (A), in the matter preceding clause 
(i)—
(i) by striking ‘‘subsection (b)(2)(B)’’ and inserting 
‘‘subsection (b)(1)(B)’’; and 
(ii) by striking ‘‘fiscal year 2022 and each subse-
quent fiscal year’’ and inserting ‘‘each fiscal year’’; 
(B) in subparagraph (B), by striking ‘‘fiscal year 2022’’ 
and all that follows through the period at the end and 
inserting the following: ‘‘a fiscal year shall be equal to 
the product of—
‘‘(i) for fiscal year 2026—
‘‘(I) the fee for fiscal year 2025 under sub-
section (a)(2); and 
‘‘(II) the inflation adjustment percentage under 
subparagraph (C); and 
‘‘(ii) for each of fiscal years 2027 through 2030—
‘‘(I) the applicable fee under subsection (a)(2) 
for the preceding fiscal year; and 
‘‘(II) the inflation adjustment percentage under 
subparagraph (C).’’; and 
(C) in subparagraph (C)—
(i) in the matter preceding clause (i), by inserting 
‘‘the sum of’’ after ‘‘is equal to’’; 
(ii) by striking clause (i); 
(iii) by redesignating subclauses (I) and (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 
(v) in clause (ii), as so redesignated, by striking 
‘‘Washington-Baltimore, 
DC–MD–VA–WV’’ 
and 
inserting ‘‘Washington–Arlington–Alexandria–DC–VA–
MD–WV’’; 
(2) in paragraph (2)—
(A) in subparagraph (A)—
(i) by striking ‘‘fiscal year 2021 and subsequent 
fiscal years’’ and inserting ‘‘each fiscal year’’; 
(ii) by striking ‘‘subsections (b)(1)(B) and (b)(2)(C)’’ 
and inserting ‘‘subsection (b)(1)(C)’’; and 
(iii) by striking ‘‘the number of weeks specified 
in subparagraph (B)’’ and inserting ‘‘10 weeks’’; 
(B) by striking subparagraph (B); 
(C) by redesignating subparagraphs (C) and (D) as 
subparagraphs (B) and (C), respectively; and
H. R. 5371—147
(D) in subparagraph (C), as so redesignated, by striking 
‘‘paragraph (4) establishing’’ and inserting ‘‘paragraph (5) 
publishing’’; 
(3) in paragraph (3)—
(A) in the matter preceding subparagraph (A), by 
striking ‘‘subsection (b)(2)(D)’’ and inserting ‘‘subsection 
(b)(1)(D)’’; and 
(B) by striking subparagraphs (A) through (E) and 
inserting the following: 
‘‘(A) $135,000 for fiscal year 2026; 
‘‘(B) $300,000 for fiscal year 2027; 
‘‘(C) $55,000 for fiscal year 2028; 
‘‘(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 
under paragraphs (1), (2), and (3), the Secretary may fur-
ther increase the fee revenues and fees through a one-
time adjustment made for fiscal year 2028, 2029, or 2030, 
in accordance with this paragraph. 
‘‘(B) ADJUSTMENT DESCRIBED.—
‘‘(i) CONDITIONS FOR ADJUSTMENT.—An adjustment 
under this paragraph may be made for a fiscal year 
only if—
‘‘(I) an adjustment under this paragraph had 
not been made for any prior fiscal year; 
‘‘(II) the average number of OTC monograph 
drug facilities subject to a facility fee under sub-
section (a)(1) over the period of the preceding 3 
fiscal years exceeds 1,625; and 
‘‘(III) with respect to facilities described in sub-
clause (II), the average number of such facilities 
(expressed as a percentage) that appeared on the 
arrears lists pursuant to subsection (e)(1)(A)(i) over 
the period of the preceding 3 fiscal years is less 
than 30 percent. 
‘‘(ii) AMOUNT
OF
ADJUSTMENT.—An adjustment 
under this paragraph for a fiscal year shall equal the 
product of—
‘‘(I) the total facility revenue amount deter-
mined under subsection (b) for the fiscal year, 
exclusive of the adjustment under this paragraph 
for such fiscal year; and 
‘‘(II) the excess facility percentage described 
in clause (iii). 
‘‘(iii) EXCESS
FACILITY
PERCENTAGE.—The excess 
facility percentage described in this clause is—
‘‘(I) the amount by which the average number 
of OTC monograph drug facilities subject to a 
facility fee under subsection (a)(1) over the pre-
ceding 3 fiscal years exceeds 1,625; divided by 
‘‘(II) 1,625. 
‘‘(5) ANNUAL FEE SETTING.—The Secretary shall, not later 
than 60 days before the first day of each fiscal year—
H. R. 5371—149
‘‘(v) the average timeline for processing OTC mono-
graph order requests, in the aggregate and by submis-
sion type, in the previous fiscal year; and 
‘‘(vi) postmarket safety activities with respect to 
OTC monograph drugs, including—
‘‘(I) collecting, developing, and reviewing safety 
information on OTC monograph drugs, including 
adverse event reports; 
‘‘(II) developing and using improved analytical 
tools, 
adverse 
event 
data-collection 
systems, 
including information technology systems, to 
assess potential safety problems, including access 
to external databases; and 
‘‘(III) activities under section 760; 
‘‘(B) information regarding registration of OTC mono-
graph drug facilities and contract manufacturing organiza-
tion facilities and payment of registration fees by such 
facilities, including—
‘‘(i) the OTC monograph drug facilities and con-
tract manufacturing organization facilities that were 
first registered under section 510(c) or 510(i) in the 
fiscal year; and 
‘‘(ii) for each OTC monograph drug facility and 
contract manufacturing organization facility that was 
assessed a facility fee under section 744M(a) in the 
fiscal year, whether the facility paid such fee; 
‘‘(C) the status of implementation of evidence and 
testing standards under section 505G(r) for nonprescription 
drugs intended for topical administration, including—
‘‘(i) the application of evidence or testing stand-
ards; and 
‘‘(ii) the number of active ingredient requests for 
nonprescription drugs intended for topical administra-
tion reviewed using the standards under section 
505G(b); and 
‘‘(D) the progress of the Food and Drug Administration 
in allowing nonclinical testing alternatives to animal 
testing for the consideration of sunscreen active ingredi-
ents. 
‘‘(3) CONFIDENTIALITY.—Nothing in paragraph (2) shall be 
construed to authorize the disclosure of information that is 
prohibited from disclosure under section 301(j) of this Act or 
section 1905 of title 18, United States Code, or that is subject 
to withholding under section 552(b)(4) of title 5, United States 
Code.’’; 
(2) in subsection (b), by striking ‘‘fiscal year 2021 and 
each subsequent fiscal year’’ and inserting ‘‘each fiscal year’’; 
and 
(3) in subsection (d)—
(A) by striking ‘‘2025’’ each place it appears and 
inserting ‘‘2030’’; and 
(B) by adding at the end the following: 
‘‘(4) MINUTES OF NEGOTIATION MEETINGS.—
‘‘(A) PUBLIC AVAILABILITY.—The Secretary shall make 
publicly available, on the public website of the Food and 
Drug Administration, robust written minutes of all negotia-
tion meetings conducted under this subsection between
H. R. 5371—150
the Food and Drug Administration and the regulated 
industry, not later than 30 days after each such negotiation 
meeting. 
‘‘(B) CONTENT.—The robust written minutes described 
under subparagraph (A) shall contain, in detail, any sub-
stantive proposal made by any party to the negotiations 
as well as significant controversies or differences of opinion 
during the negotiations and their resolution.’’. 
(b) GAO REPORT.—
(1) IN GENERAL.—Not later than September 30, 2027, the 
Comptroller General of the United States shall submit to the 
Committee on Health, Education, Labor, and Pensions of the 
Senate and the Committee on Energy and Commerce of the 
House of Representatives a report assessing the supply chain 
of over-the-counter monograph drugs. 
(2) CONTENTS.—The report required under paragraph (1) 
shall include an assessment of—
(A) the overall stability of the supply chain of over-
the-counter monograph drugs; 
(B) what information is collected by the Food and Drug 
Administration with respect to the supply chain of over-
the-counter monograph drugs; 
(C) how the Food and Drug Administration uses 
information collected on the supply chain of over-the-
counter monograph drugs to inform regulatory decisions; 
(D) how the Food and Drug Administration coordinates 
with other Federal agencies to monitor and mitigate disrup-
tions to the supply chain of over-the-counter monograph 
drugs; and 
(E) the unique characteristics of the over-the-counter 
monograph drug marketplace and what additional authori-
ties or information the Food and Drug Administration may 
need to ensure the stability of the supply chain of over-
the-counter monograph drugs. 
SEC. 6506. TREATMENT OF ACTIVE INGREDIENTS FOR TOPICAL 
ADMINISTRATION. 
(a) IN GENERAL.—Section 505G of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 355h) is amended by adding at the 
end the following: 
‘‘(r) EVIDENCE AND TESTING STANDARDS FOR ACTIVE INGREDI-
ENTS FOR TOPICAL ADMINISTRATION.—
‘‘(1) EVIDENCE
AND
TESTING
STANDARDS
FOR
ACTIVE 
INGREDIENTS
FOR
TOPICAL
ADMINISTRATION.—The Secretary 
shall—
‘‘(A) in evaluating the generally recognized as safe 
and effective status of active ingredients used in non-
prescription drugs intended for topical administration for 
purposes of subsection (a), utilize standards that allow 
for the use of real world evidence (as defined in section 
505F(b)), as appropriate, as part of a comprehensive evalua-
tion of scientific evidence to demonstrate the safety and 
effectiveness of such active ingredients, to supplement evi-
dence from traditional clinical trials, provided that such 
standards allow the Secretary to evaluate whether the 
benefits of such active ingredients outweigh the risks; and
H. R. 5371—151
‘‘(B) apply subsection (b)(6)(C) to the regulation of 
active ingredients used in drugs intended for topical 
administration. 
‘‘(2) NON-ANIMAL TESTING METHODS FOR TOPICAL ACTIVE 
INGREDIENTS.—
‘‘(A) IN GENERAL.—The Secretary shall consider the 
types of nonclinical tests described in paragraphs (1) 
through (4) of the first subsection (z) of section 505 (as 
inserted by section 3209(a)(2) of the Health Extenders, 
Improving Access to Medicare, Medicaid, and CHIP, and 
Strengthening Public Health Act of 2022 (division FF of 
Public Law 117–328)), or any other alternative to animal 
testing that the Secretary determines appropriate, in the 
consideration of drugs intended for topical administration 
under this section. 
‘‘(B) GUIDANCE.—Not later than 1 year after the date 
of enactment of this subsection, the Secretary shall issue 
new draft guidance on how sponsors can use nonclinical 
testing alternatives to animal testing, as appropriate, to 
meet safety and efficacy standards under this section for 
drugs intended for topical administration. 
‘‘(3) CLARIFICATION.—Nothing in this subsection shall be 
construed to alter, supersede, or limit the standards for making 
determinations of whether a drug is generally recognized as 
safe and effective under section 201(p) or the standards set 
forth under section 505 for determining the safety and effective-
ness of drugs.’’. 
(b) 
SUNSCREEN
FINAL
ADMINISTRATIVE
ORDER.—A 
final 
administrative order on nonprescription sunscreen active ingredi-
ents issued under section 3854 of the Coronavirus Aid, Relief, 
and Economic Security Act (Public Law 116–136; 21 U.S.C. 360fff–
3 note) shall—
(1) account for historical data regarding the safety of sun-
screen active ingredients that have previously been accepted 
for marketing in the United States; 
(2) account for the role of broad spectrum sunscreens with 
a Sun Protection Factor of 15 or higher in effective skin cancer 
prevention; and 
(3) incorporate the evidence and testing standards for sun-
screen active ingredients detailed in section 505G(r) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355h) (as 
added by subsection (a)). 
SEC. 6507. INCREASING THE CLARITY AND PREDICTABILITY OF THE 
PROCESS FOR DEVELOPING APPLICATIONS FOR RX-TO-
NONPRESCRIPTION SWITCHES. 
(a) IN GENERAL.—Section 505(b) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 355(b)) is amended by adding at 
the end the following: 
‘‘(7) RX-TO-NONPRESCRIPTION SWITCHES.—
‘‘(A) MEETINGS.—Any person planning to submit an 
application for an Rx-to-nonprescription switch may submit 
to the Secretary a written request for a meeting, for pur-
poses of developing a plan for such application that 
addresses the potential risks to public health of such switch 
and the evidence necessary to support such application, 
including the design of any necessary studies, and the
H. R. 5371—152
format and content of the planned application. The Sec-
retary may grant such a meeting, as appropriate, consistent 
with established procedures for granting meetings with, 
and providing written responses to, applications under this 
section. Each such meeting shall be documented in meeting 
minutes. 
‘‘(B) GUIDANCE.—
‘‘(i) IN GENERAL.—Not later than 18 months after 
the date of enactment of this paragraph, the Secretary 
shall issue guidance to increase the clarity and predict-
ability of the process and standards for approval of 
applications for nonprescription drugs under this sec-
tion, including in the case of applications for an Rx-
to-nonprescription switch, especially with respect to 
prescription drugs with well-established safety profiles 
for which an applicant may seek approval for non-
prescription use. 
‘‘(ii) CONTENTS.—The guidance under clause (i) 
shall—
‘‘(I) describe how published reports in medical 
literature, any previous finding of safety or 
effectiveness for the drug under this section, the 
results of significant human experience with the 
drug, unpublished studies and other data, and 
other sources of information may be used to sup-
port an application for a nonprescription drug, 
including in the context of an application for an 
Rx-to-nonprescription switch; 
‘‘(II) set forth procedures for sponsors to 
request meetings described in subparagraph (A) 
and document the recommendations made in such 
meetings; 
‘‘(III) describe evidentiary expectations to sup-
port approval of an application for a nonprescrip-
tion drug, including in the context of an application 
for an Rx-to-nonprescription switch, including how 
sponsors can demonstrate that consumers can 
appropriately self-select and use the drug and com-
prehend the nonprescription drug label; and 
‘‘(IV) provide recommendations for how mecha-
nisms, in addition to the required Drug Facts 
Label, such as mobile applications and decisions 
aids, can be incorporated into the information sub-
mitted in support of an application for an Rx-
to-nonprescription switch. 
‘‘(C) PLAN TO ENGAGE WITH STAKEHOLDERS.—Not later 
than 1 year after the date of enactment of this paragraph, 
the Secretary shall develop and make publicly available 
on the website of the Food and Drug Administration a 
plan to engage stakeholders on steps and factors for 
application holders and other stakeholders to consider in 
identifying approved prescription drugs that may be prom-
ising candidates for applications for an Rx-to-nonprescrip-
tion switch. 
‘‘(D) DEFINITION.—For purposes of this paragraph, the 
term ‘Rx-to-nonprescription switch’ means the approval of 
an application, or supplemental application, as applicable,