I 
118TH CONGRESS 
2D SESSION H. R. 10239 
To amend the Federal Food, Drug, and Cosmetic Act to expand drug shortage 
notification practices to include surges in demand for a drug, and for 
other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
NOVEMBER 21, 2024 
Ms. SPANBERGER (for herself and Mr. SMITH of Nebraska) 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 
expand drug shortage notification practices to include 
surges in demand for a drug, and for other purposes. 
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 ‘‘End Drug Shortages 
Act’’. 
SEC. 2. DRUG SHORTAGE NOTIFICATION PRACTICES. 
Section 506C of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 356c) is amended— 
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(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’’; and 
(D) by striking ‘‘such discontinuation or 
interruption; the expected duration of the inter-
ruption;’’ and inserting ‘‘such discontinuation, 
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— 
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‘‘(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’’; 
(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— 
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‘‘(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 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. 3. OUTSOURCING FACILITY COMPOUNDING. 
Section 503B of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 353b) is amended— 
(1) by redesignating the 2 subsections (d) (re-
lating to definitions and relating to obligation to pay 
fees) as subsections (e) and (f), respectively; and 
(2) 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).’’. 
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SEC. 4. HOSPITAL AND HEALTH SYSTEM COMPOUNDING. 
Not later than 1 year after the date of enactment 
of this Act, the Secretary of Health and Human Services 
shall finalize the draft guidance entitled ‘‘Hospital and 
Health System Compounding Under Section 503A of the 
Federal Food, Drug, and Cosmetic Act: Guidance for In-
dustry’’ issued in October 2021, and ensure that such 
guidance is consistent with the most current research and 
best clinical practices for pharmacy compounding relating 
to implementing section 503A of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 353a). 
Æ 
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