II 

115TH CONGRESS 

2D SESSION S. 2535 

To amend the Controlled Substances Act to strengthen Drug Enforcement 

Administration discretion in setting opioid quotas. 

IN THE SENATE OF THE UNITED STATES 

MARCH 12, 2018 

Mr. DURBIN (for himself, Mr. KENNEDY, Mr. GRASSLEY, and Mrs. FEINSTEIN) 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 strengthen Drug 

Enforcement Administration discretion in setting opioid 

quotas. 

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 Reform 

5 Act’’. 

6 SEC. 2. STRENGTHENING CONSIDERATIONS FOR DEA 

7 OPIOID QUOTAS. 

8 Section 306 of the Controlled Substances Act (21 

9 U.S.C. 826) is amended— 


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1 (1) in the last sentence of subsection (a), by 

2 striking ‘‘ and not in terms of individual pharma3 ceutical dosage forms prepared from or containing 

4 such a controlled substance’’; and 

5 (2) by adding at the end the following: 

6 ‘‘(i)(1) In fixing and adjusting production and manu7 facturing quotas under this section for fentanyl, oxyco8 done, hydrocodone, oxymorphone, and hydromorphone, the 

9 Attorney General shall consider the impact of the produc10 tion and manufacturing quotas on overall public health 

11 and rates of diversion, abuse, and overdose deaths related 

12 to these controlled substances in the United States. Any 

13 of the considerations in this subsection or in subsection 

14 (a) may be used to determine changes to levels of such 

15 production and manufacturing quotas in a given year. 

16 ‘‘(2)(A) For any year in which the approved produc17 tion quota for fentanyl, oxycodone, hydrocodone, oxymor18 phone, or hydromorphone is higher than the approved pro19 duction quota for the substance in the previous year, the 

20 Attorney General shall include in its final order an expla21 nation of why the public health benefits of increasing such 

22 quota outweigh the consequences of having an increased 

23 volume of such substance available for sale, and potential 

24 diversion, in the United States. 


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1 ‘‘(B) Not later than 1 year after the date of enact2 ment of this subsection and every year thereafter, the At3 torney General shall provide to the Caucus on Inter4 national Narcotics Control, Committee on the Judiciary, 

5 Committee on Health, Education, Labor, and Pensions, 

6 and Committee on Appropriations of the Senate and the 

7 Committee on the Judiciary, Committee on Energy and 

8 Commerce, and Committee on Appropriations of the 

9 House of Representatives, the following information with 

10 regard to each of the substances described in subpara11 graph (A): 

12 ‘‘(i) An anonymized count of the total number 

13 of manufacturers issued individual manufacturing 

14 quotas that year for that substance. 

15 ‘‘(ii) A count of how many such manufacturers 

16 were issued an approved manufacturing quota that 

17 was higher than the quota issued to that manufac18 turer for that substance in the previous year. 

19 ‘‘(3) Not later than 180 days after the date of enact20 ment of this subsection, the Attorney General shall submit 

21 to Congress a report on how the Attorney General will 

22 ensure that the annual process of fixing and adjusting pro23 duction and manufacturing quotas under this section 

24 takes into consideration— 


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1 ‘‘(A) efforts to reduce the costs, injuries, and 

2 deaths associated with the diversion and abuse of 

3 prescription opioids and heroin, including changes in 

4 the accepted medical use of certain controlled sub5 stances; and 

6 ‘‘(B) data collection and evaluation of the vol7 ume of controlled substances that are diverted and 

8 collected from approved drug collection receptacles, 

9 mail-back programs, and take-back events.’’. 

Æ 


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