II 

117TH CONGRESS 

1ST SESSION S. 3327 

To amend the Controlled Substances Act to require the Attorney General 

to make procurement quotas for opioid analgesics publicly available, 

and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

DECEMBER 7, 2021 

Mr. MARKEY (for himself, Mr. MANCHIN, Mr. BROWN, and Mr. DURBIN) introduced the following bill; which was read twice and referred to the Committee on the Judiciary 

A BILL 

To amend the Controlled Substances Act to require the Attorney General to make procurement quotas for opioid 

analgesics publicly available, 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 ‘‘Opioid Quota Open5 ness, Transparency, and Awareness Act of 2021’’ or the 

6 ‘‘Opioid QuOTA Act of 2021’’. 


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1 SEC. 2. PUBLIC REPORTING OF PROCUREMENT QUOTAS 

2 FOR OPIOID ANALGESICS. 

3 (a) IN GENERAL.—Section 306 of the Controlled 

4 Substances Act (21 U.S.C. 826) is amended by adding at 

5 the end the following: 

6 ‘‘(j)(1) In this subsection, the term ‘opioid procure7 ment quota’ means a quota established by the Attorney 

8 General for the quantity of opioid analgesics that a reg9 istered manufacturer may procure for purposes of manu10 facturing dosage forms or other substances. 

11 ‘‘(2) The Attorney General shall make publicly avail12 able, including through the website of the Drug Enforce13 ment Administration— 

14 ‘‘(A) the quantity of the opioid procurement 

15 quota for each registered manufacturer for each 

16 year; 

17 ‘‘(B) the quantity of opioid analgesics procured 

18 by each registered manufacturer for each year; and 

19 ‘‘(C) except as provided under paragraph (3)— 

20 ‘‘(i) a copy of the form or other applica21 tion, including any attachments or exhibits, 

22 submitted by each registered manufacturer re23 questing an opioid procurement quota; and 

24 ‘‘(ii) a copy of each year-end or annual re25 port relating to the procurement or use of 

26 opioid analgesics submitted to the Attorney 


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1 General by a registered manufacturer to whom 

2 the Attorney General has issued an opioid pro3 curement quota. 

4 ‘‘(3)(A) Upon request by a registered manufacturer, 

5 the Attorney General may redact information identified in 

6 clause (i) or (ii) of paragraph (2)(C) from the publication 

7 required under paragraph (2) if the Attorney General de8 termines that public disclosure of that information is likely 

9 to cause substantial harm to the competitive position of 

10 the registered manufacturer. For purposes of a determina11 tion under this subparagraph, adverse publicity or embar12 rassment shall not constitute competitive harm. 

13 ‘‘(B) A determination of the Attorney General under 

14 subparagraph (A) shall be subject to judicial review in ac15 cordance with chapter 7 of title 5, United States Code. 

16 ‘‘(C) The Attorney General shall annually publish a 

17 report on the website of the Department of Justice con18 taining an accounting of each declination determination 

19 made under subparagraph (A), including the reason for 

20 the declination, during the time period covered by the re21 port.’’. 

22 (b) GAO REPORT.—The Comptroller General of the 

23 United States shall submit to Congress a report that, for 

24 the 1-year period beginning on the date of enactment of 

25 this Act— 


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1 (1) details— 

2 (A) the number of instances in which a 

3 registered manufacturer made a request de4 scribed in section 306(j)(3) of the Controlled 

5 Substances Act, as added by subsection (a), 

6 with respect to a document or information; and 

7 (B) the number of instances in which the 

8 Attorney General redacted information de9 scribed in clause (i) or (ii) of subsection 

10 (j)(2)(C) of the Controlled Substances Act, as 

11 added by subsection (a), from the publication 

12 required under such subsection (j)(2); and 

13 (2) evaluates, in a fair, compliant, and trans14 parent manner, the extent of the independent eval15 uation conducted by the Attorney General of re16 quests described in section 306(j)(3) of the Con17 trolled Substances Act, as added by subsection (a). 

Æ 


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