‘‘(II) recognized by the Secretary 
through a process described in guidance 
for industry, initially published in July 
2023, or any successor guidance, publicly 
available on the website of the Food and 
Drug Administration, which addresses vol-
untary consensus standards for pharma-
ceutical quality.’’. 
SEC. 504. AUTHORITY TO ASSESS AND USE OTC MONO-
GRAPH 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 insert-
ing the following: 
‘‘(i) ASSESSMENT
OF
FEES.—Each 
person’’; and 
(C) by adding at the end the following:
‘‘(ii) APPLICABLE PERIOD.—For pur-
poses 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 September 30 
of the preceding fiscal year.’’; 
(2) in subparagraph (B)(i), by amending sub-
clause (I) to read as follows: 
‘‘(I) has ceased all activities re-
lated 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 pre-
ceding 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 rep-
resenting 50 percent of such fee, on 
the later of—
‘‘(aa) October 1, 2026; or 
‘‘(bb) the first business day 
after the enactment of an appro-
priations Act providing for the 
collection and obligation of fees 
under this section for such year; 
and 
‘‘(II) in a second installment rep-
resenting 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 Feb-
ruary 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 appro-
priations Act providing for the collec-
tion 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 generate 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 infla-
tion adjustment for the fiscal year (as deter-
mined under subsection (c)(1)); 
‘‘(C) the dollar amount equal to the oper-
ating 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 adjustment. 
‘‘(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 adjust-
ments 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 pre-
vious fiscal year, not including any adjustments 
made for such previous fiscal year under sub-
section (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 subsequent fiscal year’’ and inserting 
‘‘each fiscal year’’; 
(B) in subparagraph (B), by striking ‘‘fis-
cal 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 subsection (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 sub-
section (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 mar-
gins 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 insert-
ing ‘‘10 weeks’’; 
(B) by striking subparagraph (B); 
(C) by redesignating subparagraphs (C) 
and (D) as subparagraphs (B) and (C), respec-
tively; and 
(D) in subparagraph (C), as so redesig-
nated, 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 in-
serting ‘‘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 AD-
JUSTMENT.—
‘‘(A) IN GENERAL.—In addition to the ad-
justments under paragraphs (1), (2), and (3), 
the Secretary may further increase the fee reve-
nues 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
ADJUST-
MENT.—An adjustment under this para-
graph 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 subsection (a)(1) 
over the period of the preceding 3 fis-
cal years exceeds 1,625; and
‘‘(III) with respect to facilities 
described in subclause (II), the aver-
age number of such facilities (ex-
pressed as a percentage) that ap-
peared on the arrears lists pursuant 
to subsection (e)(1)(A)(i) over the pe-
riod of the preceding 3 fiscal years is 
less than 30 percent. 
‘‘(ii) AMOUNT OF ADJUSTMENT.—An 
adjustment under this paragraph for a fis-
cal year shall equal the product of—
‘‘(I) the total facility revenue 
amount determined under subsection 
(b) for the fiscal year, exclusive of the 
adjustment under this paragraph for 
such fiscal year; and 
‘‘(II) the excess facility percent-
age described in clause (iii). 
‘‘(iii) EXCESS
FACILITY
PERCENT-
AGE.—The excess facility percentage de-
scribed in this clause is—
‘‘(I) the amount by which the av-
erage 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—
‘‘(A) establish for such fiscal year, based 
on the revenue amounts under subsection (b) 
and the adjustments provided under this sub-
section—
‘‘(i) OTC monograph drug facility fees 
under subsection (a)(1); and 
‘‘(ii) OTC monograph order request 
fees under subsection (a)(2); and 
‘‘(B) publish such fee revenue amounts, fa-
cility fees, and OTC monograph order request 
fees in the Federal Register.’’. 
(d) CREDITING AND AVAILABILITY OF FEES.—Sec-
tion 744M(f) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 379j–72(f)) is amended—
(1) in paragraph (2)(D)—
(A) in the subparagraph heading, by strik-
ing ‘‘IN SUBSEQUENT YEARS’’; and 
(B) by striking ‘‘(after fiscal year 2021)’’; 
and
(2) in paragraph (3), by striking ‘‘2021 
through 2025’’ and inserting ‘‘2026 through 2030’’. 
SEC. 505. REAUTHORIZATION; REPORTING REQUIREMENTS. 
(a) PERFORMANCE REPORT.—Section 744N of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–
73) is amended—
(1) in subsection (a)—
(A) by striking ‘‘Beginning with fiscal year 
2021, and not later than 120 calendar days 
after the end of each fiscal year thereafter’’ and 
inserting the following: 
‘‘(1) IN
GENERAL.—Not later than 120 cal-
endar days after the end of each fiscal year’’; 
(B) by striking ‘‘section 3861(b) of the 
CARES Act’’ and inserting ‘‘section 2 of the 
Over-the-Counter Monograph Drug User Fee 
Amendments’’; and 
(C) by adding at the end the following: 
‘‘(2) ADDITIONAL
INFORMATION.—Beginning 
with fiscal year 2026, the annual report under this 
subsection shall include—
‘‘(A) the progress of the Food and Drug 
Administration in achieving the goals, and fu-
ture plans for meeting the goals, including—
‘‘(i) the number of Tier 1 OTC mono-
graph order requests for which a proposed 
order was issued, and the number of such 
requests for which a final order was issued, 
in the previous fiscal year; 
‘‘(ii) the number of Tier 2 OTC 
monograph order requests for which a pro-
posed order was issued, and the number of 
such requests for which a final order was 
issued, in the previous fiscal year; 
‘‘(iii) the number of specified safety 
OTC monograph order requests for which 
a proposed order was issued, and the num-
ber of such requests for which a final order 
was issued, in the previous fiscal year; 
‘‘(iv) the number of generally recog-
nized as safe and effective finalization 
OTC monograph order requests for which 
a proposed order was issued, and the num-
ber of such requests for which a final order 
was issued, in the previous fiscal year; 
‘‘(v) the average timeline for proc-
essing OTC monograph order requests, in 
the aggregate and by submission type, in 
the previous fiscal year; and
‘‘(vi) postmarket safety activities with 
respect to OTC monograph drugs, includ-
ing—
‘‘(I) collecting, developing, and 
reviewing safety information on OTC 
monograph drugs, including adverse 
event reports; 
‘‘(II) developing and using im-
proved analytical tools, adverse event 
data-collection systems, including in-
formation technology systems, to as-
sess potential safety problems, includ-
ing access to external databases; and 
‘‘(III) activities under section 
760; 
‘‘(B) information regarding registration of 
OTC monograph drug facilities and contract 
manufacturing organization facilities and pay-
ment of registration fees by such facilities, in-
cluding—
‘‘(i) the OTC monograph drug facili-
ties and contract manufacturing organiza-
tion facilities that were first registered 
under section 510(c) or 510(i) in the fiscal 
year; and
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 ap-
pears and inserting ‘‘2030’’; and 
(B) by adding at the end the following: 
‘‘(4) MINUTES OF NEGOTIATION MEETINGS.—
‘‘(A) PUBLIC
AVAILABILITY.—The Sec-
retary shall make publicly available, on the pub-
lic website of the Food and Drug Administra-
tion, robust written minutes of all negotiation 
meetings conducted under this subsection be-
tween the Food and Drug Administration and 
the regulated industry, not later than 30 days 
after each such negotiation meeting. 
‘‘(B) CONTENT.—The robust written min-
utes described under subparagraph (A) shall 
contain, in detail, any substantive proposal 
made by any party to the negotiations as well 
as significant controversies or differences of 
opinion during the negotiations and their reso-
lution.’’.
(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 sup-
ply 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 Administra-
tion uses information collected on the supply 
chain of over-the-counter monograph drugs to 
inform regulatory decisions; 
(D) how the Food and Drug Administra-
tion coordinates with other Federal agencies to 
monitor and mitigate disruptions 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 authorities or information the 
Food and Drug Administration may need to en-
sure the stability of the supply chain of over-
the-counter monograph drugs. 
SEC. 506. TREATMENT OF ACTIVE INGREDIENTS FOR TOP-
ICAL 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 AC-
TIVE INGREDIENTS FOR TOPICAL ADMINISTRATION.—
‘‘(1) EVIDENCE AND TESTING STANDARDS FOR 
ACTIVE
INGREDIENTS
FOR
TOPICAL
ADMINISTRA-
TION.—The Secretary shall—
‘‘(A) in evaluating the generally recognized 
as safe and effective status of active ingredients 
used in nonprescription drugs intended for top-
ical 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 com-
prehensive evaluation of scientific evidence to 
demonstrate the safety and effectiveness of such
active ingredients, to supplement evidence from 
traditional clinical trials, provided that such 
standards allow the Secretary to evaluate 
whether the benefits of such active ingredients 
outweigh the risks; and 
‘‘(B) apply subsection (b)(6)(C) to the reg-
ulation of active ingredients used in drugs in-
tended for topical administration. 
‘‘(2) NON-ANIMAL TESTING METHODS FOR TOP-
ICAL ACTIVE INGREDIENTS.—
‘‘(A) IN
GENERAL.—The Secretary shall 
consider the types of nonclinical tests described 
in paragraphs (1) through (4) of the first sub-
section (z) of section 505 (as inserted by sec-
tion 3209(a)(2) of the Health Extenders, Im-
proving 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 consid-
eration of drugs intended for topical adminis-
tration 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 alter-
natives to animal testing, as appropriate, to 
meet safety and efficacy standards under this 
section for drugs intended for topical adminis-
tration. 
‘‘(3) CLARIFICATION.—Nothing in this sub-
section 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 effectiveness of drugs.’’. 
(b) SUNSCREEN FINAL ADMINISTRATIVE ORDER.—
A final administrative order on nonprescription sunscreen 
active ingredients issued under section 3854 of the 
Coronavirus Aid, Relief, and Economic Security Act (Pub-
lic Law 116–136; 21 U.S.C. 360fff–3 note) shall—
(1) account for historical data regarding the 
safety of sunscreen active ingredients that have pre-
viously been accepted for marketing in the United 
States; 
(2) account for the role of broad spectrum sun-
screens with a Sun Protection Factor of 15 or high-
er in effective skin cancer prevention; and