II 

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. 

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 ‘‘End Drug Shortages 

5 Act’’. 

6 SEC. 2. DRUG SHORTAGE NOTIFICATION PRACTICES. 

7 Section 506C of the Federal Food, Drug, and Cos8 metic Act (21 U.S.C. 356c) is amended— 


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1 (1) in the section heading, by inserting ‘‘OR

2 SURGE IN DEMAND FOR’’ after ‘‘PRODUCTION

3 OF’’; 

4 (2) in subsection (a), in the matter following 

5 paragraph (2)— 

6 (A) by striking ‘‘or an interruption of the 

7 manufacture of the drug’’ and inserting ‘‘, an 

8 interruption of the manufacture of the drug, or 

9 a surge in demand for the drug’’; 

10 (B) by striking ‘‘such discontinuance or 

11 interruption’’ and inserting ‘‘such discontinu12 ance, interruption, or surge in demand’’; 

13 (C) by striking ‘‘the discontinuation or 

14 interruption’’ and inserting ‘‘the discontinu15 ation, interruption, or surge in demand’’; and 

16 (D) by striking ‘‘such discontinuation or 

17 interruption; the expected duration of the inter18 ruption;’’ and inserting ‘‘such discontinuation, 

19 interruption, or surge in demand; the expected 

20 duration of the interruption or surge in de21 mand’’; 

22 (3) in subsection (b), by striking paragraphs 

23 (1) and (2) and inserting the following: 

24 ‘‘(1) in the case of a notice of a discontinuance 

25 or interruption in the manufacture of a drug— 


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1 ‘‘(A) at least 6 months prior to the date of 

2 the discontinuance or interruption; or 

3 ‘‘(B) if compliance with subparagraph (A) 

4 is not possible, as soon as practicable; or 

5 ‘‘(2) in the case of a notice of a surge in de6 mand for a drug, as soon as practicable.’’; 

7 (4) in subsection (c)— 

8 (A) by striking ‘‘discontinuance or inter9 ruption’’ and inserting ‘‘discontinuance, inter10 ruption, or surge in demand’’; and 

11 (B) by inserting ‘‘and outsourcing facilities 

12 (as defined in section 503B(d))’’ after ‘‘patient 

13 organizations’’; and 

14 (5) in subsection (h)— 

15 (A) in paragraph (1), by striking ‘‘and 

16 that is subject to section 503(b)(1)’’ and insert17 ing ‘‘or the active pharmaceutical ingredient of 

18 such a drug’’; 

19 (B) by amending paragraph (2), to read as 

20 follows: 

21 ‘‘(2) the term ‘drug shortage’ or ‘shortage’, 

22 with respect to a drug, means a period of time with 

23 the demand or projected demand for the drug within 

24 the United States exceeds the supply of the drug, 

25 taking into consideration— 


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1 ‘‘(A) how the drug is prepared or dis2 pensed, including the route of administration 

3 and dosage form; and 

4 ‘‘(B) information reported by manufactur5 ers, health care professionals, and patients;’’; 

6 (C) in paragraph (3)(B), by striking the 

7 period and inserting ‘‘; and’’; and 

8 (D) by adding at the end the following: 

9 ‘‘(4) the term ‘surge’ means an increase in de10 mand or projected demand for a drug that the man11 ufacturer likely will be unable to meet without mean12 ingful shortfall or delay.’’. 

13 SEC. 3. OUTSOURCING FACILITY COMPOUNDING. 

14 Section 503B of the Federal Food, Drug, and Cos15 metic Act (21 U.S.C. 353b) is amended— 

16 (1) by redesignating the 2 subsections (d) (re17 lating to definitions and relating to obligation to pay 

18 fees) as subsections (e) and (f), respectively; and 

19 (2) by inserting after subsection (c) the fol20 lowing: 

21 ‘‘(d) LIST OF IDENTIFIED BULK DRUG SUB22 STANCES.—The Secretary shall make publicly available 

23 annual updates on the evaluation of bulk drug substances 

24 for purposes of the list maintained under subsection 

25 (a)(2)(A)(i).’’. 


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1 SEC. 4. HOSPITAL AND HEALTH SYSTEM COMPOUNDING. 

2 Not later than 1 year after the date of enactment 

3 of this Act, the Secretary of Health and Human Services 

4 shall finalize the draft guidance entitled ‘‘Hospital and 

5 Health System Compounding Under Section 503A of the 

6 Federal Food, Drug, and Cosmetic Act: Guidance for In7 dustry’’ issued in October 2021, and ensure that such 

8 guidance is consistent with the most current research and 

9 best clinical practices for pharmacy compounding relating 

10 to implementing section 503A of the Federal Food, Drug, 

11 and Cosmetic Act (21 U.S.C. 353a). 

Æ 


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