I 
117TH CONGRESS 
2D SESSION 
H. R. 7669 
To require guidance on extending expiration dates for certain drugs, and 
for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
MAY 6, 2022 
Ms. MATSUI introduced the following bill; which was referred to the 
Committee on Energy and Commerce 
A BILL 
To require guidance on extending expiration dates for certain 
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, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Drug Shortages Shelf 
Life Extension Act’’. 
SEC. 2. EXTENDING EXPIRATION DATES FOR CERTAIN 
DRUGS. 
(a) IN GENERAL.—Not later than 1 year after the 
date of enactment of this Act, the Secretary of Health and 
Human Services (referred to in this section as the ‘‘Sec-
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retary’’) shall issue draft guidance, or revise existing guid-
ance, to address recommendations for sponsors of applica-
tions submitted under section 505 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355) or section 351 
of the Public Health Service Act (42 U.S.C. 262) regard-
ing— 
(1) the submission of stability testing data in 
such applications, including considerations for data 
requirements that could be streamlined or reduced 
to facilitate faster review of longer proposed expira-
tion dates; 
(2) establishing in the labeling of drugs the 
longest feasible expiration date scientifically sup-
ported by such data, taking into consideration how 
extended expiration dates may— 
(A) help prevent or mitigate drug short-
ages; and 
(B) affect product quality; and 
(3) the use of innovative approaches for drug 
and combination product stability modeling to sup-
port initial product expiration dates and expiration 
date extensions. 
(b) REPORT.—Not later than 2 years after the date 
of enactment of this Act, and again 2 years thereafter, 
the Secretary shall submit to the Committee on Health, 
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Education, Labor, and Pensions of the Senate and the 
Committee on Energy and Commerce of the House of 
Representatives a report that includes— 
(1) the number of drugs for which the Sec-
retary has requested the manufacturer make a label-
ing change regarding the expiration date; and 
(2) for each drug for which the Secretary has 
requested a labeling change with respect to the expi-
ration date, information regarding the circumstances 
of such request, including— 
(A) the name and dose of such drug; 
(B) the rationale for the request; 
(C) whether the drug, at the time of the 
request, was listed on the drug shortage list 
under section 506E of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 356e), or was at 
risk of shortage; 
(D) whether the request was made during 
a public health emergency declared under sec-
tion 319 of the Public Health Service Act (42 
U.S.C. 247d); and 
(E) whether the manufacturer made the 
requested change by the requested date, and for 
instances where the manufacturer does not 
make the requested change, the manufacturer’s 
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justification for not making the change, if the 
manufacturer agrees to provide such justifica-
tion for inclusion in the report. 
Æ 
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