[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 2362 Introduced in Senate (IS)]

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118th CONGRESS
  1st Session
                                S. 2362

   To amend the Federal Food, Drug, and Cosmetic Act to provide for 
 notification by manufacturers of critical drugs of increased demand, 
                        and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             July 18, 2023

Ms. Klobuchar (for herself, Ms. Collins, Ms. Smith, Ms. Murkowski, and 
  Ms. Warren) introduced the following bill; which was read twice and 
  referred to the Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
   To amend the Federal Food, Drug, and Cosmetic Act to provide for 
 notification by manufacturers of critical drugs of increased demand, 
                        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 Shortage Prevention Act of 
2023''.

SEC. 2. IMPROVING NOTIFICATION PROCEDURES IN CASE OF INCREASED DEMAND 
              FOR CRITICAL DRUGS.

    (a) In General.--Section 506C of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 356c) is amended--
            (1) in the section heading, by striking ``discontinuance or 
        interruption in the production of life-saving drugs'' and 
        inserting ``notification of issues affecting domestic supply of 
        critical drugs'';
            (2) by striking subsections (a), (b), and (c), and 
        inserting the following:
    ``(a) Notification Required.--
            ``(1) In general.--A manufacturer of a covered drug shall 
        notify the Secretary, in accordance with subsection (b), of--
                    ``(A)(i) a permanent discontinuance in the 
                manufacture of the drug or an interruption of the 
                manufacture of the drug that is likely to lead to a 
                meaningful disruption in the supply of such drug in the 
                United States;
                    ``(ii) a permanent discontinuance in the 
                manufacture of an active pharmaceutical ingredient of 
                such drug, or an interruption in the manufacture of an 
                active pharmaceutical ingredient of such drug that is 
                likely to lead to a meaningful disruption in the supply 
                of the active pharmaceutical ingredient of such drug; 
                or
                    ``(iii) any other circumstance, such as an increase 
                in demand or export restriction, that is likely to 
                leave the manufacturer unable to meet demand for the 
                drug without a meaningful shortfall or delay; and
                    ``(B) the reasons for such discontinuance, 
                interruption, or other circumstance, if known.
            ``(2) Contents.--Notification under this subsection with 
        respect to a covered drug shall include--
                    ``(A) with respect to the reasons for the 
                discontinuation, interruption, or other circumstance 
                described in paragraph (1)(A)(iii), if an active 
                pharmaceutical ingredient is a reason for, or risk 
                factor in, such discontinuation, interruption, or other 
                circumstance, the source of the active pharmaceutical 
                ingredient and any alternative sources for the active 
                pharmaceutical ingredient known to the manufacturer;
                    ``(B) whether any associated device used for 
                preparation or administration included in the drug is a 
                reason for, or a risk factor in, such discontinuation, 
                interruption, or other circumstance described in 
                paragraph (1)(A)(iii);
                    ``(C) the expected duration of the interruption; 
                and
                    ``(D) such other information as the Secretary may 
                require.
    ``(b) Timing.--A notice required under subsection (a) shall be 
submitted to the Secretary--
            ``(1) at least 6 months prior to the date of the 
        discontinuance or interruption;
            ``(2) in the case of such a notice with respect to a 
        circumstance described in subsection (a)(1)(A)(iii), as soon as 
        practicable, or not later than 10 business days after the onset 
        of the circumstance; or
            ``(3) if compliance with paragraph (1) or (2) is not 
        possible, as soon as practicable.
    ``(c) Distribution.--To the maximum extent practicable, the 
Secretary shall distribute, through such means as the Secretary 
determines appropriate, information on the discontinuance or 
interruption of the manufacture of, or other circumstance described in 
subsection (a)(1)(A)(iii) that is likely to lead to a shortage or 
meaningful disruption in the supply of, covered drugs to appropriate 
organizations, including physician, health provider, and patient 
organizations, as described in section 506E.'';
            (3) in subsection (g), in the matter preceding paragraph 
        (1), by striking ``drug described in subsection (a)'' and 
        inserting ``covered drug''; and
            (4) in subsection (j), by striking ``drug described in 
        subsection (a)'' and inserting ``covered drug''.
    (b) Definitions.--Paragraph (1) of section 506C(h) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 356c(h)) is amended to read as 
follows:
            ``(1) the term `covered drug' means a drug that is intended 
        for human use and that--
                    ``(A) is--
                            ``(i) life-supporting;
                            ``(ii) life-sustaining; or
                            ``(iii) intended for use in the prevention 
                        or treatment of a debilitating disease or 
                        condition, including any such drug used in 
                        emergency medical care or during surgery or any 
                        such drug that is critical to the public health 
                        during a public health emergency declared by 
                        the Secretary under section 319 of the Public 
                        Health Service Act;
                    ``(B) is not a radio pharmaceutical drug product or 
                any other product as designated by the Secretary; and
                    ``(C) is not a biological product (as defined in 
                section 351(i) of the Public Health Service Act), 
                unless otherwise provided by the Secretary in the 
                regulations promulgated under subsection (i);''.

SEC. 3. REPORTING ON SUPPLY CHAINS.

    Section 510(j)(3)(A) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360(j)(3)(A)) is amended--
            (1) by striking ``annually to the Secretary'' in the first 
        sentence and inserting ``to the Secretary, once during the 
        month of March each year and once during the month of September 
        each year,'';
            (2) by inserting ``, and the legal names of, and any 
        additional information the Secretary may require, regarding 
        suppliers of active pharmaceutical ingredients and intermediate 
        and in-process materials such person used for the manufacture, 
        preparation, propagation, compounding, or processing of such 
        drug, and the amount of such drug manufactured, prepared, 
        propagated, compounded, or processed using each such active 
        pharmaceutical ingredient or intermediate or in-process 
        material sourced from each such supplier'' before the period at 
        the end of the first sentence; and
            (3) by inserting after the first sentence the following: 
        ``In addition to the reporting required under the preceding 
        sentence, each person who registers with the Secretary under 
        this section with regard to a drug may voluntarily report on 
        the information described in the preceding sentence, at such 
        other times as the Secretary may specify.''.
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