II 

116TH CONGRESS 

1ST SESSION S. 1366 

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 

MAY 8, 2019 

Mr. MARKEY (for himself, Mrs. SHAHEEN, Mr. BROWN, Mr. DURBIN, Ms. 

HASSAN, and Mr. MANCHIN) 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 2019’’ or the 

6 ‘‘Opioid QuOTA Act’’. 


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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) Upon a request by a registered manufacturer as5 serting that a document or information described in clause 

6 (i) or (ii) of paragraph (2)(C) is exempt from disclosure 

7 under section 552(b)(4) of title 5, United States Code, and 

8 to the extent that the Attorney General determines that 

9 the document or information is exempt from disclosure 

10 under such section 552(b)(4), the document or informa11 tion may be excluded from public disclosure under para12 graph (2).’’. 

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

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

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

16 this Act— 

17 (1) details— 

18 (A) the number of instances in which a 

19 registered manufacturer made a request de20 scribed in section 306(j)(3) of the Controlled 

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

22 with respect to a document or information; and 

23 (B) the number of instances in which the 

24 Attorney General determined such a document 

25 or information was exempt from disclosure 


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1 under section 552(b)(4) of title 5, United 

2 States Code; and 

3 (2) evaluates the extent of the independent 

4 evaluation conducted by the Attorney General of re5 quests described in section 306(j)(3) of the Con6 trolled Substances Act. 

Æ 


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