I 
118TH CONGRESS 
1ST SESSION H. R. 3008 
To amend the Federal Food, Drug, and Cosmetic Act to provide for notifica-
tion by manufacturers of critical essential medicines of increased demand 
of such drugs, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
APRIL 28, 2023 
Ms. JACOBS (for herself, Mr. ALLRED, Ms. CLARKE of New York, Mr. DOG-
GETT, Mr. GARCI´A of Illinois, Mr. GRIJALVA, Mr. HUFFMAN, Mr. 
KHANNA, Mr. LARSON of Connecticut, Ms. LEE of California, Mr. 
MCGOVERN, Ms. OCASIO-CORTEZ, Ms. PRESSLEY, Mr. VEASEY, Ms. 
VELA´ZQUEZ, Mrs. WATSON COLEMAN, Mr. CARTER of Louisiana, Ms. 
NORTON, Mr. COHEN, Mr. CLEAVER, Mr. SMITH of Washington, Ms. 
BLUNT ROCHESTER, Ms. CROCKETT, Ms. KUSTER, Ms. TOKUDA, Ms. 
CARAVEO, Mr. SCHIFF, Ms. JACKSON LEE, Mr. KIM of New Jersey, and 
Mr. MILLS) introduced the following bill; which was referred to the Com-
mittee on Energy and Commerce 
A BILL 
To amend the Federal Food, Drug, and Cosmetic Act to 
provide for notification by manufacturers of critical es-
sential medicines of increased demand of such drugs, 
and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
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SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Drug Shortage Preven-
tion Act of 2023’’. 
SEC. 2. IMPROVING NOTIFICATION PROCEDURES IN CASE 
OF INCREASED DEMAND FOR CRITICAL ES-
SENTIAL MEDICINES. 
(a) IN GENERAL.—Section 506C of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 356c) is amend-
ed— 
(1) in the section heading, by striking ‘‘DIS-
CONTINUANCE OR INTERRUPTION IN THE PRO-
DUCTION OF LIFE-SAVING DRUGS’’ and inserting 
‘‘NOTIFICATION OF ISSUES AFFECTING DOMES-
TIC
SUPPLY
OF
CRITICAL
ESSENTIAL
MEDI-
CINES’’; 
(2) by striking subsections (a), (b), and (c), and 
inserting the following: 
‘‘(a) NOTIFICATION REQUIRED.— 
‘‘(1) IN GENERAL.—A manufacturer of a crit-
ical essential medicine shall notify the Secretary, in 
accordance with subsection (b), of— 
‘‘(A)(i) a permanent discontinuance in the 
manufacture of the drug or an interruption of 
the manufacture of the drug that is likely to 
lead to a meaningful disruption in the supply of 
such drug in the United States; 
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‘‘(ii) a permanent discontinuance in the 
manufacture of an active pharmaceutical ingre-
dient, an excipient, or any other input in the 
final dosage form of such drug or an interrup-
tion in the manufacture of the active pharma-
ceutical ingredient, an excipient, or any other 
input in the final dosage form of such drug of 
such drug that is likely to lead to a meaningful 
disruption in the supply of the active pharma-
ceutical ingredient of such drug; 
‘‘(iii) an increased demand (other than an 
anticipated seasonal surge) for such drug or an 
active pharmaceutical ingredient, an excipient, 
or any other input in the final dosage form of 
such drug that is likely to lead to a shortage of 
the drug or the active pharmaceutical ingre-
dient, an excipient, or any other input in the 
final dosage form of such drug; and 
‘‘(B) the reasons for such discontinuance, 
interruption, or increased demand. 
‘‘(2) CONTENTS.—Notification under this sub-
section with respect to a critical essential medicine 
shall include— 
‘‘(A) with respect to the reasons for the 
discontinuation, interruption, or increased de-
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mand referred to in paragraph (1)(C), if an ac-
tive pharmaceutical ingredient, an excipient, or 
any other input in the final dosage form of such 
drug is a reason for, or risk factor in, such dis-
continuation, interruption, or increased de-
mand, the source of the active pharmaceutical 
ingredient, excipient, or other input and any al-
ternative sources for the an active pharma-
ceutical ingredient, an excipient, or any other 
input by the manufacturer; 
‘‘(B) whether any associated device used 
for preparation or administration included in 
the drug is a reason for, or a risk factor in, 
such discontinuation, interruption, or increased 
demand; 
‘‘(C) the expected duration of the interrup-
tion or increased demand; and 
‘‘(D) such other information as the Sec-
retary may require. 
‘‘(b) TIMING.— 
‘‘(1) IN
GENERAL.—A notice required under 
subsection (a) shall be submitted to the Secretary— 
‘‘(A) at least 6 months prior to the date of 
the discontinuance or interruption; 
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‘‘(B) in the case of such a notice with re-
spect to increased demand for a critical essen-
tial medicine, not later than 30 days after the 
submission of the initial notification under 
paragraph (2); or 
‘‘(C) if compliance with subparagraph (A) 
or (B) is not possible, as soon as practicable. 
‘‘(2) INITIAL NOTIFICATION WITH RESPECT TO 
INCREASED DEMAND.—In the case a notification re-
quired under subsection (a) with respect to increased 
demand for a critical essential medicine, the manu-
facturer of the drug involved shall submit to the 
Secretary an initial notification not later than 48 
hours after the date on which there has been in-
creased demand for the critical essential medicine 
for a period of at least 6 consecutive weeks. 
‘‘(c) DISTRIBUTION.—To the maximum extent prac-
ticable, the Secretary shall distribute, through such means 
as the Secretary deems appropriate, information on the 
discontinuance or interruption of the manufacture of, or 
the increased demand for, critical essential medicines to 
appropriate organizations, including physician, health pro-
vider, and patient organizations, as described in section 
506E.’’; 
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(3) in subsection (g), in the matter preceding 
paragraph (1), by striking ‘‘drug described in sub-
section (a)’’ and inserting ‘‘critical essential medi-
cine’’; and 
(4) in subsection (j), by striking ‘‘drug de-
scribed in subsection (a)’’ and inserting ‘‘critical es-
sential medicine’’. 
(b) APPLICATION TO NONPRESCRIPTION DRUGS.— 
Section 506C(h) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 356c(h)) is amended— 
(1) by redesignating paragraphs (1), (2), and 
(3) as paragraphs (2), (3), and (4), respectively; 
(2) in paragraph (2)(A) (as so redesignated), by 
striking ‘‘and that is subject to section 503(b)(1)’’ 
and inserting ‘‘, including a drug that is not subject 
to section 503(b)(1)’’; and 
(3) by inserting before paragraph (2) (as so re-
designated) the following: 
‘‘(1) the term ‘critical essential medicine’ means 
a drug that— 
‘‘(A) is— 
‘‘(i) life-supporting; 
‘‘(ii) life-sustaining; or 
‘‘(iii) intended for use in the preven-
tion or treatment of a debilitating disease 
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