II 

117TH CONGRESS 

2D SESSION S. 3493 

To require guidance on extending expiration dates for certain drugs, and 

for other purposes. 

IN THE SENATE OF THE UNITED STATES 

JANUARY 12 (legislative day, JANUARY 10), 2022 

Mr. CARDIN (for himself and Ms. COLLINS) introduced the following bill; 

which was read twice and referred to the Committee on Health, Education, Labor, and Pensions 

A BILL 

To require guidance on extending expiration dates for certain 

drugs, and for other purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Drug Shortages Shelf 

5 Life Extension Act’’. 

6 SEC. 2. EXTENDING EXPIRATION DATES FOR CERTAIN 

7 DRUGS. 

8 (a) IN GENERAL.—Not later than 180 days after the 

9 date of enactment of this Act, the Secretary of Health and 

10 Human Services (referred to in this section as the ‘‘SecVerDate Sep 11 2014 03:27 Jan 13, 2022 Jkt 029200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S3493.IS S3493

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1 retary’’) shall issue draft guidance, or revise existing guid2 ance, to address recommendations for sponsors of applica3 tions under section 505 of the Federal Food, Drug, and 

4 Cosmetic Act (21 U.S.C. 355) or section 351 of the Public 

5 Health Service Act (42 U.S.C. 262) regarding— 

6 (1) the submission of stability testing data in 

7 such applications; and 

8 (2) establishing in the labeling of drugs the 

9 longest feasible expiration date supported by such 

10 data, taking into consideration how extended expira11 tion dates may help prevent or mitigate drug short12 ages. 

13 (b) REPORT.—Not later than 2 years after the date 

14 of enactment of this Act, and again 2 years thereafter, 

15 the Secretary shall submit to the Committee on Health, 

16 Education, Labor, and Pensions of the Senate and the 

17 Committee on Energy and Commerce of the House of 

18 Representatives a report that includes— 

19 (1) the number of drugs for which the Sec20 retary has requested the manufacturer make a label21 ing change regarding the expiration date; and 

22 (2) for each drug for which the Secretary has 

23 requested a labeling change with respect to the expi24 ration date, information regarding the circumstances 

25 of such request, including— 


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1 (A) the name and dose of such drug; 

2 (B) the rationale for the request; 

3 (C) whether the drug, at the time of the 

4 request, was listed on the drug shortage list 

5 under section 506E of the Federal Food, Drug, 

6 and Cosmetic Act (21 U.S.C. 356e), or was at 

7 risk of shortage; 

8 (D) whether the request was made during 

9 a public health emergency declared under sec10 tion 319 of the Public Health Service Act (42 

11 U.S.C. 247d); and 

12 (E) whether the manufacturer made the 

13 requested change by the requested date, and for 

14 instances where the manufacturer does not 

15 make the requested change, the manufacturer’s 

16 justification for not making the change, if the 

17 manufacturer agrees to provide such justifica18 tion for inclusion in the report. 

Æ 


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