I 
118TH CONGRESS 
1ST SESSION H. R. 3793 
To amend the Federal Food, Drug, and Cosmetic Act to require manufactur-
ers of life-saving drugs to submit data and information to assess the 
stability of the drugs and determine their longest supported expiration 
date, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
JUNE 5, 2023 
Ms. SLOTKIN 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 
require manufacturers of life-saving drugs to submit data 
and information to assess the stability of the drugs and 
determine their longest supported expiration date, 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 ‘‘Ensuring Access to 
Lifesaving Drugs Act of 2023’’. 
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SEC. 2. EXTENDED EXPIRATION DATES FOR LIFE-SAVING 
DRUGS. 
(a) IN GENERAL.—The Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 301 et seq.) is amended by in-
serting after section 506L of such Act (21 U.S.C. 356l) 
the following new section: 
‘‘SEC. 506M. EXTENDED EXPIRATION DATES FOR LIFE-SAV-
ING DRUGS. 
‘‘(a) IN GENERAL.—A manufacturer of a life-saving 
drug shall— 
‘‘(1) submit to the Secretary data and informa-
tion as required by subsection (b)(1); 
‘‘(2) conduct and submit the results, data, and 
information generated by any studies required under 
subsection (b)(2); and 
‘‘(3) make any labeling change described in 
subsection (c) by the date specified by the Secretary 
pursuant to such subsection. 
‘‘(b) DATA AND INFORMATION.— 
‘‘(1) IN GENERAL.—The Secretary may issue 
an order requiring the manufacturer of a life-saving 
drug to submit, in such manner as the Secretary 
may prescribe, data and information from any stage 
of development of the drug that are adequate to as-
sess the stability of the drug to determine the long-
est supported expiration date. 
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‘‘(2) LACK OF DATA AND INFORMATION.—If the 
data and information required pursuant to an order 
issued under paragraph (1) are not available or are 
insufficient, as determined by the Secretary, the Sec-
retary may issue an order requiring the manufac-
turer of the drug— 
‘‘(A) to conduct studies, which may be a 
continuation of ongoing studies, to provide data 
and information adequate to assess the stability 
of the drug and to determine the longest sup-
ported expiration date; and 
‘‘(B) to submit such data and information 
to the Secretary in such manner as the Sec-
retary may prescribe in the order. 
‘‘(c) LABELING.—The Secretary may issue an order 
requiring the manufacturer of a life-saving drug, by a date 
determined by the Secretary in consultation with the spon-
sor of the drug, to make any labeling change regarding 
the expiration date or storage and handling of the drug 
that the Secretary determines to be appropriate based on 
the data and information required to be submitted under 
this section or any other data and information available 
to the Secretary. 
‘‘(d) DEFINITIONS.—In this section: 
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