II 

Calendar No. 473 

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 

JUNE 19, 2018 

Reported by Mr. GRASSLEY, with an amendment 

[Strike out all after the enacting clause and insert the part printed in italic] 

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’’. 


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1 SEC. 2. STRENGTHENING CONSIDERATIONS FOR DEA 

2 OPIOID QUOTAS. 

3 Section 306 of the Controlled Substances Act (21 

4 U.S.C. 826) is amended— 

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

6 striking ‘‘ and not in terms of individual pharma7 ceutical dosage forms prepared from or containing 

8 such a controlled substance’’; and 

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

10 ‘‘(i)(1) In fixing and adjusting production and manu11 facturing quotas under this section for fentanyl, oxyco12 done, hydrocodone, oxymorphone, and hydromorphone, the 

13 Attorney General shall consider the impact of the produc14 tion and manufacturing quotas on overall public health 

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

16 to these controlled substances in the United States. Any 

17 of the considerations in this subsection or in subsection 

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

19 production and manufacturing quotas in a given year. 

20 ‘‘(2)(A) For any year in which the approved produc21 tion quota for fentanyl, oxycodone, hydrocodone, oxymor22 phone, or hydromorphone is higher than the approved pro23 duction quota for the substance in the previous year, the 

24 Attorney General shall include in its final order an expla25 nation of why the public health benefits of increasing such 

26 quota outweigh the consequences of having an increased 


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1 volume of such substance available for sale, and potential 

2 diversion, in the United States. 

3 ‘‘(B) Not later than 1 year after the date of enact4 ment of this subsection and every year thereafter, the At5 torney General shall provide to the Caucus on Inter6 national Narcotics Control, Committee on the Judiciary, 

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

8 and Committee on Appropriations of the Senate and the 

9 Committee on the Judiciary, Committee on Energy and 

10 Commerce, and Committee on Appropriations of the 

11 House of Representatives, the following information with 

12 regard to each of the substances described in subpara13 graph (A): 

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

15 of manufacturers issued individual manufacturing 

16 quotas that year for that substance. 

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

18 were issued an approved manufacturing quota that 

19 was higher than the quota issued to that manufac20 turer for that substance in the previous year. 

21 ‘‘(3) Not later than 180 days after the date of enact22 ment of this subsection, the Attorney General shall submit 

23 to Congress a report on how the Attorney General will 

24 ensure that the annual process of fixing and adjusting proVerDate Sep 11 2014 23:07 Jun 19, 2018 Jkt 079200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6401 E:\BILLS\S2535.RS S2535

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1 duction and manufacturing quotas under this section 

2 takes into consideration— 

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

4 deaths associated with the diversion and abuse of 

5 prescription opioids and heroin, including changes in 

6 the accepted medical use of certain controlled sub7 stances; and 

8 ‘‘(B) data collection and evaluation of the vol9 ume of controlled substances that are diverted and 

10 collected from approved drug collection receptacles, 

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

12 SECTION 1. SHORT TITLE. 

13 This Act may be cited as the ‘‘Opioid Quota Reform 

14 Act’’. 

15 SEC. 2. STRENGTHENING CONSIDERATIONS FOR DEA 

16 OPIOID QUOTAS. 

17 (a) IN GENERAL.—Section 306 of the Controlled Sub18 stances Act (21 U.S.C. 826) is amended— 

19 (1) in subsection (a)— 

20 (A) by inserting ‘‘(1)’’ after ‘‘(a)’’; 

21 (B) in the second sentence, by striking 

22 ‘‘Production’’ and inserting ‘‘Except as provided 

23 in paragraph (2), production’’; and 

24 (C) by adding at the end the following: 


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1 ‘‘(2) The Attorney General may, if the Attorney Gen2 eral determines it will assist in avoiding the overproduc3 tion, shortages, or diversion of a controlled substance, estab4 lish an aggregate or individual production quota under this 

5 subsection, or a procurement quota established by the Attor6 ney General by regulation, in terms of pharmaceutical dos7 age forms prepared from or containing the controlled sub8 stance.’’; 

9 (2) in subsection (b), in the first sentence, by 

10 striking ‘‘production’’ and inserting ‘‘manufac11 turing’’; 

12 (3) in subsection (c), by striking ‘‘October’’ and 

13 inserting ‘‘December’’; and 

14 (4) by adding at the end the following: 

15 ‘‘(i)(1)(A) In establishing any quota under this sec16 tion, or any procurement quota established by the Attorney 

17 General by regulation, for fentanyl, oxycodone, 

18 hydrocodone, oxymorphone, or hydromorphone (in this sub19 section referred to as a ‘covered controlled substance’), the 

20 Attorney General shall estimate the amount of diversion of 

21 the covered controlled substance that occurs in the United 

22 States. 

23 ‘‘(B) In estimating diversion under this paragraph, 

24 the Attorney General— 


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1 ‘‘(i) shall consider information the Attorney Gen2 eral, in consultation with the Secretary of Health and 

3 Human Services, determines reliable on rates of over4 dose deaths and abuse and overall public health im5 pact related to the covered controlled substance in the 

6 United States; and 

7 ‘‘(ii) may take into consideration whatever other 

8 sources of information the Attorney General deter9 mines reliable. 

10 ‘‘(C) After estimating the amount of diversion of a cov11 ered controlled substance, the Attorney General shall make 

12 appropriate quota reductions, as determined by the Attor13 ney General, from the quota the Attorney General would 

14 have otherwise established had such diversion not been con15 sidered. 

16 ‘‘(2)(A) For any year for which the approved aggregate 

17 production quota for a covered controlled substance is high18 er than the approved aggregate production quota for the 

19 covered controlled substance for the previous year, the Attor20 ney General shall include in the final order an explanation 

21 of why the public health benefits of increasing the quota 

22 clearly outweigh the consequences of having an increased 

23 volume of the covered controlled substance available for sale, 

24 and potential diversion, in the United States. 


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1 ‘‘(B) Not later than 1 year after the date of enactment 

2 of this subsection, and every year thereafter, the Attorney 

3 General shall submit to the Caucus on International Nar4 cotics Control, the Committee on the Judiciary, the Com5 mittee on Health, Education, Labor, and Pensions, and the 

6 Committee on Appropriations of the Senate and the Com7 mittee on the Judiciary, the Committee on Energy and 

8 Commerce, and the Committee on Appropriations of the 

9 House of Representatives the following information with re10 gard to each covered controlled substance: 

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

12 manufacturers issued individual manufacturing 

13 quotas that year for the covered controlled substance. 

14 ‘‘(ii) An anonymized count of how many such 

15 manufacturers were issued an approved manufac16 turing quota that was higher than the quota issued to 

17 that manufacturer for the covered controlled substance 

18 in the previous year. 

19 ‘‘(3) Not later than 1 year after the date of enactment 

20 of this subsection, the Attorney General shall submit to Con21 gress a report on how the Attorney General, when fixing 

22 and adjusting production and manufacturing quotas under 

23 this section for covered controlled substances, will— 


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1 ‘‘(A) take into consideration changes in the ac2 cepted medical use of the covered controlled sub3 stances; and 

4 ‘‘(B) work with the Secretary of Health and 

5 Human Services on methods to appropriately and 

6 anonymously survey opioid patients in order to esti7 mate and evaluate the type and amount of covered 

8 controlled substances that patients are submitting for 

9 collection from approved drug collection receptacles, 

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

11 (b) CONFORMING CHANGE.—The Law Revision Coun12 sel is directed to amend the heading for subsection (b) of 

13 section 826 of title 21, United States Code, by striking 

14 ‘‘PRODUCTION’’ and inserting ‘‘MANUFACTURING’’. 


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amozie on DSK3GDR082PROD with BILLS
Calendar No. 473 

115TH CONGRESS 

2D SESSION S. 2535 

A BILL 

To amend the Controlled Substances Act to 

discretion in setting opioid quotas. strengthen Drug Enforcement Administration 

JUNE 19, 2018 

Reported with an amendment 


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