I 
119TH CONGRESS 
1ST SESSION H. R. 5316 
To amend the Federal Food, Drug, and Cosmetic Act to ensure patients 
have access to certain shortage and urgent-use compounded medications, 
and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
SEPTEMBER 11, 2025 
Mrs. HARSHBARGER (for herself and Mr. CARTER of Georgia) introduced the 
following bill; which was referred to the Committee on Energy and Commerce 
A BILL 
To amend the Federal Food, Drug, and Cosmetic Act to 
ensure patients have access to certain shortage and ur-
gent-use compounded medications, and for other pur-
poses. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Drug Shortage 
Compounding Patient Access Act of 2025’’. 
SEC. 2. PHARMACY COMPOUNDING. 
(a) COMPOUNDING FOR URGENT ADMINISTRATION 
TO PATIENTS.—Section 503A(a) of the Federal Food, 
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Drug, and Cosmetic Act (21 U.S.C. 353a(a)) is amend-
ed— 
(1) in paragraph (1), by striking ‘‘or’’ at the 
end; 
(2) in paragraph (2)(B)(ii)(II), by striking the 
period at the end and inserting ‘‘; or’’; and 
(3) by adding at the end the following: 
‘‘(3) notwithstanding the requirement in the 
matter preceding paragraph (1) that the drug prod-
uct is compounded for an identified individual pa-
tient based on a valid prescription order or notation 
described in such matter, is by a licensed pharmacist 
or licensed physician and the compounded drug 
product is compounded for distribution in limited 
quantities to a licensed prescriber for urgent admin-
istration to a patient in a hospital or other clinical 
setting, provided that all of the following are met: 
‘‘(A) The drug product appeared on the 
drug shortage list in effect under section 506E 
at any time during the 60-day period ending on 
the date of the compounding, distribution, or 
dispensing of the drug product. 
‘‘(B) The licensed prescriber certifies by 
notation on the order to the compounding phar-
macist or physician that the licensed prescriber 
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has made reasonable attempts to obtain, and 
has not been able to obtain, to address the ur-
gent medical need a drug product that is com-
pounded by an outsourcing facility in accord-
ance with section 503B with the same active in-
gredient and the same route of administration. 
‘‘(C) The compounded drug product is la-
beled with a beyond-use-date in accordance with 
applicable United States Pharmacopeia stand-
ards. 
‘‘(D) The licensed pharmacist or licensed 
physician marks the packaging of the com-
pounded drug product with text— 
‘‘(i) indicating that the drug product 
is provided to the hospital or other clinical 
setting only for urgent administration to a 
patient; and 
‘‘(ii) requesting that the hospital or 
other clinical setting provide to the 
compounding pharmacist or physician the 
records that identify the patient or pa-
tients to whom the drug products were ad-
ministered within— 
‘‘(I) 7 days of each such patient 
receiving such medication; or 
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‘‘(II) 7 days of each such patient 
being discharged. 
‘‘(E) Upon receipt of records requested 
pursuant to subparagraph (D)(ii), the licensed 
pharmacist or licensed physician ensures that 
the patient information in such records is 
linked with the respective order. 
‘‘(F) The licensed pharmacist or licensed 
physician reports adverse events associated with 
the compounded drug product as soon as pos-
sible but not later than 15 days after becoming 
aware of such events to the MedWatch Adverse 
Event Reporting program of the Food and 
Drug Administration (or any successor pro-
gram).’’. 
(b) DEFINITION.—Paragraph (2) of section 503A(b) 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
353a(b)(2)) is amended to read as follows: 
‘‘(2) DEFINITION.—For purposes of paragraph 
(1)(D), the term ‘essentially a copy of a commer-
cially available drug product’ does not include— 
‘‘(A) a drug product in which there is a 
change, made for an identified individual pa-
tient, which produces for that patient a signifi-
cant difference, as determined by the pre-
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scribing practitioner, between the compounded 
drug and the comparable commercially available 
drug product; or 
‘‘(B) a drug product that meets each of 
the following conditions: 
‘‘(i) At any time during the 60-day 
period 
ending 
on 
the 
date 
of 
the 
compounding, distribution, or dispensing, 
the drug product appeared on the drug 
shortage list in effect under section 506E. 
‘‘(ii) If the drug product is not com-
pounded for an identified individual patient 
based on a valid prescription order or nota-
tion, notwithstanding such requirement in 
the matter preceding paragraph (1) of sub-
section (a), the drug product— 
‘‘(I) is labeled in accordance sub-
paragraphs (C) and (D) of subsection 
(a)(3); and 
‘‘(II) is documented by the 
compounding pharmacist or physician 
in accordance with subparagraphs (E) 
and (F) of subsection (a)(3).’’. 
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SEC. 3. MITIGATING DRUG SHORTAGES THROUGH IM-
PROVED REPORTING. 
Section 506C of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 356c) is amended— 
(1) in the section heading, by inserting ‘‘OR 
SURGE IN DEMAND FOR’’ after ‘‘PRODUCTION 
OF’’; 
(2) in subsection (a), in the matter following 
paragraph (2)— 
(A) by striking ‘‘or an interruption of the 
manufacture of the drug’’ and inserting ‘‘, an 
interruption of the manufacture of the drug, or 
a surge in demand for the drug’’; 
(B) by striking ‘‘such discontinuance or 
interruption’’ and inserting ‘‘such discontinu-
ance, interruption, or surge in demand’’; 
(C) by striking ‘‘the discontinuation or 
interruption’’ and inserting ‘‘the discontinu-
ation, interruption, or surge in demand’’; 
(D) by striking ‘‘such discontinuation or 
interruption, the source’’ and inserting ‘‘such 
discontinuation, interruption, or surge in de-
mand, the source’’; and 
(E) by striking ‘‘such discontinuation or 
interruption; the expected duration of the inter-
ruption;’’ and inserting ‘‘such discontinuation, 
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interruption, or surge in demand; the expected 
duration of the interruption or surge in de-
mand’’; 
(3) in subsection (b), by striking paragraphs 
(1) and (2) and inserting the following: 
‘‘(1) in the case of a notice of a discontinuance 
or interruption in the manufacture of a drug— 
‘‘(A) at least 6 months prior to the date of 
the discontinuance or interruption; or 
‘‘(B) if compliance with subparagraph (A) 
is not possible, as soon as practicable; or 
‘‘(2) in the case of a notice of a surge in de-
mand for a drug, as soon as practicable.’’; 
(4) in subsection (c)— 
(A) by striking ‘‘discontinuance or inter-
ruption’’ and inserting ‘‘discontinuance, inter-
ruption, or surge in demand’’; and 
(B) by inserting ‘‘and outsourcing facilities 
(as defined in section 503B(d))’’ after ‘‘patient 
organizations’’; and 
(5) in subsection (h)— 
(A) in paragraph (1), by striking ‘‘and 
that is subject to section 503(b)(1)’’ and insert-
ing ‘‘or the active pharmaceutical ingredient of 
such a drug’’; 
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(B) by amending paragraph (2) to read as 
follows: 
‘‘(2) the term ‘drug shortage’ or ‘shortage’, 
with respect to a drug, means a period of time with 
the demand or projected demand for the drug within 
the United States exceeds the supply of the drug, 
taking into consideration— 
‘‘(A) how the drug is prepared or dis-
pensed, including the route of administration 
and dosage form; and 
‘‘(B) information reported by manufactur-
ers, health care professionals, and patients;’’. 
(C) in paragraph (3)(B), by striking the 
period at the end and inserting ‘‘; and’’; and 
(D) by adding at the end the following: 
‘‘(4) the term ‘surge’ means an increase in de-
mand or projected demand for a drug that the man-
ufacturer likely will be unable to meet without mean-
ingful shortfall or delay.’’. 
SEC. 4. OUTSOURCING FACILITY COMPOUNDING. 
Section 503B of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 353b) is amended— 
(1) in subsection (a)(2)(A)(ii)— 
(A) by striking ‘‘appears’’ and inserting 
‘‘appeared’’; and 
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(B) by striking ‘‘at the time of’’ and in-
serting ‘‘at any time during the 180-day period 
ending on the date of’’; 
(2) in subsection (a)(10)(A)(iii)— 
(A) in subclause (VIII), by striking the 
semicolon at the end and inserting ‘‘; and’’; 
(B) by striking subclause (IX); and 
(C) by redesignating subclause (X) as sub-
clause (IX); 
(3) by redesignating the 2 subsections (d) (re-
lating to definitions and relating to obligation to pay 
fees) as subsections (e) and (f), respectively; and 
(4) by inserting after subsection (c) the fol-
lowing: 
‘‘(d) LIST
OF
IDENTIFIED
BULK
DRUG
SUB-
STANCES.—The Secretary shall make publicly available 
annual updates on the evaluation of bulk drug substances 
for purposes of the list maintained under subsection 
(a)(2)(A)(i).’’; 
SEC. 5. CLARIFYING PROVISIONS; LABELING REQUIRE-
MENT. 
Section 503A of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 353a) is amended— 
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(1) by striking subsection (b)(3)(B) and the 
matter following such subsection and inserting the 
following: 
‘‘(B) such drug product is labeled as fol-
lows: ‘This medication has been compounded 
for dispensing to an individual patient and has 
not been approved by the Food and Drug Ad-
ministration’.’’; and 
(2) in subsection (b)(1)(A)(i)(I) by striking 
‘‘National Formulary monograph’’ and inserting 
‘‘National Formulary drug or dietary supplement 
monograph’’. 
Æ 
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