S. 3493Senate117th Congress (2021-2023)In Committee

Drug Shortages Shelf Life Extension Act

Introduced January 12, 2022

AI-Generated Summary

Updated February 8, 2026 at 8:49 AM UTC

The Drug Shortages Shelf Life Extension Act directs the Health and Human Services Secretary to create guidance on extending drug expiration dates to help reduce shortages. It requires the guidance to cover stability testing data and labeling the longest feasible shelf life. The law also mandates periodic reporting to Congress on how many drugs receive expiration‑date changes and the details of each request.

Key Provisions

  • Within 180 days of enactment, HHS must issue or update guidance for drug applicants on submitting stability data and on labeling drugs with the longest feasible expiration date, considering shortage prevention.
  • Every two years, HHS must report to Senate and House committees the number of drugs for which expiration‑date labeling changes were requested, including drug name, dose, reason for the request, shortage status, any public‑health emergency context, and whether the manufacturer complied or provided justification.

Legislative Activity

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1 earlier action
SenateIntro Referral Latest Action

Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (Sponsor introductory remarks on measure: CR S191-192)

January 12, 2022

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SenateIntro Referral

Introduced in Senate

January 12, 2022

SenateIntro Referral

Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (Sponsor introductory remarks on measure: CR S191-192)

January 12, 2022

Floor Debate

1 member

What members said about S. 3493 on the floor

1 Democrat
Benjamin L. Cardin
Sen. Benjamin L. CardinD-MD · Jan 12, 2022

Mr. President, I rise today to introduce an act, co- sponsored by Senator Hagerty, that addresses the importance of foreign affairs training to national security and, more specifically, intends to…

Benjamin L. Cardin
Sen. Benjamin L. CardinD-MD · Jan 12, 2022

Mr. President, I rise today to highlight legislation I am introducing with the senior Senator from Maine, Ms. Collins, to address prescription drug shortages. We rely on prescription drugs to battle…

Bill Text

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Introduced in SenateIssued January 12, 2022

II

117th CONGRESS

2d Session

S. 3493

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.

Short title

This Act may be cited as the Drug Shortages Shelf Life Extension Act.

2.

Extending expiration dates for certain drugs

(a)

In general

Not later than 180 days after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this section as the Secretary) shall issue draft guidance, or revise existing guidance, to address recommendations for sponsors of applications 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) regarding—

(1)

the submission of stability testing data in such applications; and

(2)

establishing in the labeling of drugs the longest feasible expiration date supported by such data, taking into consideration how extended expiration dates may help prevent or mitigate drug shortages.

(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, 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 Secretary has requested the manufacturer make a labeling change regarding the expiration date; and

(2)

for each drug for which the Secretary has requested a labeling change with respect to the expiration 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 section 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 justification for not making the change, if the manufacturer agrees to provide such justification for inclusion in the report.