Drug Shortages Shelf Life Extension Act
Bill: S.3493 | Sponsor: Sen. Cardin, Benjamin L. (D-MD)
Policy area: Health

Summary:
Drug Shortages Shelf Life Extension Act
This bill requires the Food and Drug Administration (FDA) to issue or revise guidance to address issues relating to extending drug expiration dates.
Specifically, the guidance must address recommendations to drug companies relating to (1) submitting stability testing data in applications for market approval for drugs or biological products; and (2) establishing on drug labels the longest feasible expiration date supported by such data, taking into consideration how extended expiration dates may help prevent or mitigate drug shortages.
The FDA must also periodically report to Congress certain information about requests to change the expiration date on a drug label, including the number of such requests from the FDA to the manufacturer and the rationale for each request.

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

    Be it enacted by the Senate and House of Representatives 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 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(referred to in this section as the ``Secretary'') shall issue draft 
guidance, or revise existing guidance, to address recommendations for 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.
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