II 

117TH CONGRESS 

1ST SESSION S. 2595 

To address prescription drug shortages and improve the quality of prescription 

drugs, and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

AUGUST 4, 2021 

Mr. CARDIN (for himself and Ms. SMITH) introduced the following bill; which 

was read twice and referred to the Committee on Health, Education, 

Labor, and Pensions 

A BILL 

To address prescription drug shortages and improve the 

quality of prescription drugs, 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 ‘‘Drug Shortages Pre5 vention and Quality Improvement Act’’. 

6 SEC. 2. LENGTHEN EXPIRATION DATES TO MITIGATE CRIT7 ICAL DRUG SHORTAGES. 

8 (a) IN GENERAL.—The Federal Food, Drug, and 

9 Cosmetic Act is amended by inserting after section 506C– 

10 1 (21 U.S.C. 356c–1) the following: 


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1 ‘‘SEC. 506C–2. EXTENDED SHELF LIFE DATES FOR ESSEN2 TIAL DRUGS. 

3 ‘‘(a) IN GENERAL.—A manufacturer of a drug sub4 ject to notification requirements under section 506C(a) 

5 (referred to in this section as an ‘essential drug’) shall— 

6 ‘‘(1) submit to the Secretary data and informa7 tion as required by subsection (b)(1); 

8 ‘‘(2) conduct and submit the results of any 

9 studies required under subsection (b)(2); and 

10 ‘‘(3) make any labeling change described in 

11 subsection (c) by the date specified by the Secretary 

12 pursuant to such subsection. 

13 ‘‘(b) NOTIFICATION.— 

14 ‘‘(1) IN GENERAL.—The Secretary may issue 

15 an order requiring the manufacturer of any essential 

16 drug to submit, in such manner as the Secretary 

17 may prescribe, data and information from any stage 

18 of development of the drug that are adequate to as19 sess the shelf life stability of the drug to determine 

20 the longest supported expiration date. 

21 ‘‘(2) UNAVAILABLE OR INSUFFICIENT DATA

22 AND INFORMATION.—If the data and information re23 quired pursuant to an order issued under paragraph 

24 (1) are not available or are insufficient, the Sec25 retary may require the manufacturer of the drug 

26 to— 


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1 ‘‘(A) conduct studies adequate to provide 

2 the data and information in accordance with 

3 section 211.166 of title 21, Code of Federal 

4 Regulations (or any successor regulations); and 

5 ‘‘(B) submit to the Secretary the results, 

6 data, and information generated by such studies 

7 when available. 

8 ‘‘(c) LABELING.—The Secretary may issue an order 

9 requiring the manufacturer of an essential drug to, by a 

10 specified date, make any labeling change regarding the ex11 piration period that the Secretary determines to be appro12 priate based on the data and information required to be 

13 submitted under this section or any other data and infor14 mation available to the Secretary in accordance with label15 ing requirements under subpart G of part 211 of title 21, 

16 Code of Federal Regulations (or any successor regula17 tions). 

18 ‘‘(d) CONFIDENTIALITY.—Nothing in this section 

19 shall be construed as authorizing the Secretary to disclose 

20 any information that is a trade secret or confidential infor21 mation subject to section 552(b)(4) of title 5, United 

22 States Code, or section 1905 of title 18, United States 

23 Code.’’. 


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1 (b) CIVIL MONETARY PENALTY.—Section 303(b) of 

2 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

3 333(b)) is amended by adding at the end the following: 

4 ‘‘(9) If a drug manufacturer fails to submit data and 

5 information as required under section 506C–2(b)(1), fails 

6 to conduct or submit the results of studies as required 

7 under section 506C–2(b)(3), or fails to make a labeling 

8 change as required under section 506C–2(c), such manu9 facturer shall be liable to the United States for a civil pen10 alty in an amount not to exceed $10,000 for each such 

11 violation.’’. 

12 (c) GAO STUDY OF SHELF LIFE DATA.—Not later 

13 than 2 years after the date of enactment of this Act, the 

14 Comptroller General of the United States shall conduct 

15 a study examining the process by which prescription drug 

16 manufacturers submit data on shelf life to the Food and 

17 Drug Administration. In carrying out this study, the 

18 Comptroller General shall consider whether manufacturers 

19 adequately test the shelf life stability of their drug prod20 ucts subject to section 211.166 of title 21, Code of Federal 

21 Regulations (or any successor regulations). 

22 (d) SHELF LIFE STABILITY GUIDANCE.—Not later 

23 than 6 months after the date of enactment of this Act, 

24 the Secretary shall publish for notice and comment in the 

25 Federal Register updates to stability testing under section 


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1 211.166 of title 21, Code of Federal Regulations (or any 

2 successor regulations). 

3 SEC. 3. QUALITY MANAGEMENT MATURITY STERILE 

4 INJECTABLE DRUG PILOT PROGRAM. 

5 (a) QUALITY MANAGEMENT MATURITY STERILE

6 INJECTABLE DRUG PILOT PROGRAM.— 

7 (1) IN GENERAL.—Not later than 6 months 

8 after the date of enactment of this Act, the Sec9 retary of Health and Human Services (referred to in 

10 this section as the ‘‘Secretary’’), acting through the 

11 Commissioner of Food and Drugs, shall commence 

12 the Quality Management Maturity (QMM) Sterile 

13 Injectable Drug Pilot Program (referred to in this 

14 section as the ‘‘pilot program’’) under this section. 

15 Under such program, the Secretary shall— 

16 (A) select eligible drug manufacturers to 

17 participate in the program in accordance with 

18 paragraph (2); and 

19 (B) contract with a third-party contractor 

20 to develop a QMM assessment tool and conduct 

21 assessments, in cooperation with staff of the 

22 Food and Drug Administration, of each partici23 pant’s quality management system. 


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1 (2) ELIGIBILITY.—To be eligible to participate 

2 in the pilot program under this section, a manufac3 turer shall— 

4 (A) be a for-profit or nonprofit entity; 

5 (B) manufacture a prescription drug that 

6 is a sterile injectable drug; 

7 (C) manufacture a drug that is deemed an 

8 essential medicine under Executive Order 

9 13944 (85 Fed. Reg. 49929); 

10 (D) have received a final classification of 

11 ‘‘No Action Indicated’’ or ‘‘Voluntary Action 

12 Indicated’’ with respect to all inspections of all 

13 manufacturing facilities of the entity conducted 

14 by the Food and Drug Administration within 

15 the 5-year period immediately preceding the 

16 date of enactment of this Act; 

17 (E) be a person who has registered one or 

18 more establishments under subsection (b)(1) or 

19 (i)(1) of section 510 of the Federal Food, Drug, 

20 and Cosmetic Act (21 U.S.C. 360), with respect 

21 to the manufacture of a prescription drug de22 scribed in subparagraph (B); and 

23 (F) agree to— 

24 (i) permit a third-party contractor to 

25 conduct regular assessments under the 


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1 QMM pilot program, as described in para2 graph (3), either on-site or remotely; 

3 (ii) collect and submit metrics data to 

4 the Food and Drug Administration and the 

5 contractor by an agreed upon date, prior to 

6 each assessment described in clause (i); 

7 and 

8 (iii) be available for consultations with 

9 the third-party contractor and the Food 

10 and Drug Administration prior to and 

11 after each assessment described in clause 

12 (i), including discussions regarding the 

13 participant’s established QMM-related ac14 tivities and the contractor’s post-assess15 ment recommendations regarding these ac16 tivities. 

17 (3) ASSESSMENTS.—Assessments that are con18 ducted jointly by a third-party contractor, in co19 operation with staff of the Food and Drug Adminis20 tration, will regularly conduct manufacturer facility 

21 assessments to determine the manufacturer’s quality 

22 management maturity progress or status. Pilot pro23 gram assessments will cover multiple topics and 

24 shall include— 

25 (A) supply chain management; 


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1 (B) manufacturing strategy and oper2 ations; 

3 (C) safety, environmental, and regulatory 

4 compliance; 

5 (D) inventory management; 

6 (E) performance management and con7 tinual improvement; 

8 (F) risk management; 

9 (G) management review and responsibility; 

10 (H) planning; 

11 (I) workforce management; 

12 (J) quality culture; and 

13 (K) customer experience. 

14 (4) PROGRAM DURATION.—Not later than 6 

15 months after the date of enactment of this Act, the 

16 Secretary shall publish instructions for applicants in 

17 the Federal Register. Such instructions shall include 

18 a timeline for the application period for such pro19 gram, and a 1-year timeline for the pilot program 

20 following such application period. 

21 (b) REPORT TO CONGRESS.—Not later than 6 

22 months after the completion of the pilot program, the Sec23 retary shall submit a report to Congress on such pilot pro24 gram. Such report shall include— 


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1 (1) a summary of third-party assessments of 

2 each participating manufacturer’s quality manage3 ment system; 

4 (2) recommendations on next steps towards de5 veloping a publicly available Food and Drug Admin6 istration rating system for quality management ma7 turity systems of sterile injectable drug manufac8 turing facilities, including specific drugs manufac9 tured at each facility; 

10 (3) considerations the Food and Drug Adminis11 tration may take in updating guidance of current 

12 good manufacturing practice of sterile injectable 

13 drug products; and 

14 (4) recommendations on incorporating pilot pro15 grams (or related work) described in the guidances 

16 entitled, ‘‘Quality Management Maturity for Fin17 ished Dosage Forms Pilot Program for Domestic 

18 Drug Product Manufacturers; Program Announce19 ment’’, issued by the Food and Drug Administration 

20 on October 16, 2020 (85 Fed. Reg. 65824), and 

21 ‘‘Quality Management Maturity for Active Pharma22 ceutical Ingredients Pilot Program for Foreign Fa23 cilities; Program Announcement’’, issued by the 

24 Food and Drug Administration on October 16, 2020 

25 (85 Fed. Reg. 65828), into publicly available Food 


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1 and Drug Administration rating systems for overall 

2 quality management maturity systems. 

3 (c) DEFINITION.—In this section, the term ‘‘sterile 

4 injectable drug’’ means a drug approved under section 505 

5 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

6 355), a biological product licensed under section 351 of 

7 the Public Health Service Act (42 U.S.C. 262), or a com8 bination product (as described in section 503(g) of the 

9 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353(g)) 

10 whose primary mode of action is that of a drug or biologi11 cal product, whose manufacturing, distribution, and ad12 ministration processes require sterile conditions. 

13 SEC. 4. IMPROVED DATA SHARING: ENSURING TIMELY AND 

14 INFORMATIVE NOTIFICATION. 

15 (a) IN GENERAL.—Section 301 of the Federal Food, 

16 Drug, and Cosmetic Act (21 U.S.C. 331) is amended by 

17 adding at the end the following: 

18 ‘‘(fff) FAILURE TO PROVIDE TIMELY AND INFORM19 ATIVE NOTIFICATION.—Any manufacturer who violates a 

20 requirement of this Act that relates to critical drugs by 

21 failing to provide timely, adequate information related to 

22 drug shortages pursuant to section 506C(a) shall be sub23 ject to a civil penalty in an amount not to exceed $50,000 

24 per violation.’’. 


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1 (b) REGULATIONS.—Not later than 1 year after the 

2 date of the enactment of this Act, the Secretary shall pro3 mulgate final regulations to carry out section 301(fff) of 

4 the Federal Food, Drug, and Cosmetic Act, as added by 

5 subsection (a). 

6 SEC. 5. SUPPORTING CONTINUOUS MANUFACTURING TO 

7 PREVENT SHORTAGES FOR SUSCEPTIBLE 

8 DRUGS. 

9 Subtitle B of title III of the 21st Century Cures Act 

10 is amended by inserting after section 3016 (21 U.S.C. 

11 399h) the following: 

12 ‘‘SEC. 3017. GRANTS FOR CONTINUOUS MANUFACTURING 

13 TO PREVENT DRUG SHORTAGES. 

14 ‘‘(a) IN GENERAL.—The Secretary of Health and 

15 Human Services, acting through the Commissioner of 

16 Food and Drugs, shall solicit and, beginning not later than 

17 one year after the date of enactment of the Drug Short18 ages Prevention and Quality Improvement Act, receive, re19 quests from institutions of higher education and nonprofit 

20 entities engaged in the manufacture of sterile injectable 

21 drugs for the purpose of upgrading drug establishment to 

22 continuous manufacturing or other advanced manufac23 turing capabilities. 

24 ‘‘(b) GRANT CRITERIA.—An institution of higher 

25 education or a nonprofit entity shall be eligible for a grant 


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1 under this section if such institution or entity manufac2 tures a drug that— 

3 ‘‘(1) is categorized as an essential medicine 

4 under Executive Order 13944; 

5 ‘‘(2) is a sterile injectable drug; and 

6 ‘‘(3) is vulnerable to shortage. 

7 ‘‘(c) GRANT SELECTION.—As a condition for accept8 ing a grant under this section, an institution of higher 

9 education and nonprofit entity shall agree to participate 

10 in the Quality Management Maturity Sterile Injectable 

11 Drug Pilot Program established under section 3 of the 

12 Drug Shortages Prevention and Quality Improvement Act. 

13 ‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—To 

14 carry out this section, there is authorized to be appro15 priated $1,000,000,000 for the period of fiscal years 2022 

16 through 2027. 

17 ‘‘(e) DEFINITIONS.—In this section: 

18 ‘‘(1) ADVANCED MANUFACTURING.—The term 

19 ‘advanced manufacturing’ means an approach for 

20 the manufacturing of drugs that incorporates novel 

21 technology, or uses an established technique or tech22 nology in a new or innovative way (such as contin23 uous manufacturing where the input materials are 

24 continuously transformed within the process by 2 or 


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1 more unit operations) that enhances drug quality or 

2 improves the manufacturing process. 

3 ‘‘(2) CONTINUOUS MANUFACTURING.—The 

4 term ‘continuous manufacturing’— 

5 ‘‘(A) means a process where the input ma6 terials are continuously fed into and trans7 formed within the process, and the processed 

8 output materials are continuously removed from 

9 the system; and 

10 ‘‘(B) consists of an integrated process that 

11 consists of a series of 2 or more unit oper12 ations. 

13 ‘‘(3) STERILE INJECTABLE DRUG.—The term 

14 ‘sterile injectable drug’ means a drug approved 

15 under section 505 of the Federal Food, Drug, and 

16 Cosmetic Act (21 U.S.C. 355), a biological product 

17 licensed under section 351 of the Public Health 

18 Service Act (42 U.S.C. 262), or a combination prod19 uct (as described in section 503(g) of the Federal 

20 Food, Drug, and Cosmetic Act (21 U.S.C. 353(g)) 

21 whose primary mode of action is that of a drug or 

22 biological product, whose manufacturing, distribu23 tion, and administration processes require sterile 

24 conditions.’’. 

Æ 


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