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[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 5368 Introduced in Senate (IS)]

<DOC>

118th CONGRESS
  2d Session
                                S. 5368

   To amend the Federal Food, Drug, and Cosmetic Act to expand drug 
shortage notification practices to include surges in demand for a drug, 
                        and for other purposes.

_______________________________________________________________________

                   IN THE SENATE OF THE UNITED STATES

                           November 21, 2024

 Mr. Kaine (for himself and Mr. Cotton) 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 expand drug 
shortage notification practices to include surges in demand for a drug, 
                        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 ``End Drug Shortages Act''.

SEC. 2. DRUG SHORTAGE NOTIFICATION PRACTICES.

    Section 506C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
356c) is amended--
            (1) in the section heading, by inserting ``or surge in 
        demand for'' after ``production of'';
            (2) in subsection (a), in the matter following paragraph 
        (2)--
                    (A) by striking ``or an interruption of the 
                manufacture of the drug'' and inserting ``, an 
                interruption of the manufacture of the drug, or a surge 
                in demand for the drug'';
                    (B) by striking ``such discontinuance or 
                interruption'' and inserting ``such discontinuance, 
                interruption, or surge in demand'';
                    (C) by striking ``the discontinuation or 
                interruption'' and inserting ``the discontinuation, 
                interruption, or surge in demand''; and
                    (D) by striking ``such discontinuation or 
                interruption; the expected duration of the 
                interruption;'' and inserting ``such discontinuation, 
                interruption, or surge in demand; the expected duration 
                of the interruption or surge in demand'';
            (3) in subsection (b), by striking paragraphs (1) and (2) 
        and inserting the following:
            ``(1) in the case of a notice of a discontinuance or 
        interruption in the manufacture of a drug--
                    ``(A) at least 6 months prior to the date of the 
                discontinuance or interruption; or
                    ``(B) if compliance with subparagraph (A) is not 
                possible, as soon as practicable; or
            ``(2) in the case of a notice of a surge in demand for a 
        drug, as soon as practicable.'';
            (4) in subsection (c)--
                    (A) by striking ``discontinuance or interruption'' 
                and inserting ``discontinuance, interruption, or surge 
                in demand''; and
                    (B) by inserting ``and outsourcing facilities (as 
                defined in section 503B(d))'' after ``patient 
                organizations''; and
            (5) in subsection (h)--
                    (A) in paragraph (1), by striking ``and that is 
                subject to section 503(b)(1)'' and inserting ``or the 
                active pharmaceutical ingredient of such a drug'';
                    (B) by amending paragraph (2), to read as follows:
            ``(2) the term `drug shortage' or `shortage', with respect 
        to a drug, means a period of time with the demand or projected 
        demand for the drug within the United States exceeds the supply 
        of the drug, taking into consideration--
                    ``(A) how the drug is prepared or dispensed, 
                including the route of administration and dosage form; 
                and
                    ``(B) information reported by manufacturers, health 
                care professionals, and patients;'';
                    (C) in paragraph (3)(B), by striking the period and 
                inserting ``; and''; and
                    (D) by adding at the end the following:
            ``(4) the term `surge' means an increase in demand or 
        projected demand for a drug that the manufacturer likely will 
        be unable to meet without meaningful shortfall or delay.''.

SEC. 3. OUTSOURCING FACILITY COMPOUNDING.

    Section 503B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
353b) is amended--
            (1) by redesignating the 2 subsections (d) (relating to 
        definitions and relating to obligation to pay fees) as 
        subsections (e) and (f), respectively; and
            (2) by inserting after subsection (c) the following:
    ``(d) List of Identified Bulk Drug Substances.--The Secretary shall 
make publicly available annual updates on the evaluation of bulk drug 
substances for purposes of the list maintained under subsection 
(a)(2)(A)(i).''.

SEC. 4. HOSPITAL AND HEALTH SYSTEM COMPOUNDING.

    Not later than 1 year after the date of enactment of this Act, the 
Secretary of Health and Human Services shall finalize the draft 
guidance entitled ``Hospital and Health System Compounding Under 
Section 503A of the Federal Food, Drug, and Cosmetic Act: Guidance for 
Industry'' issued in October 2021, and ensure that such guidance is 
consistent with the most current research and best clinical practices 
for pharmacy compounding relating to implementing section 503A of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353a).
                                 <all>
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