[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[S. 2535 Reported in Senate (RS)]

<DOC>





                                                       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.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

<DELETED>SECTION 1. SHORT TITLE.</DELETED>

<DELETED>    This Act may be cited as the ``Opioid Quota Reform 
Act''.</DELETED>

<DELETED>SEC. 2. STRENGTHENING CONSIDERATIONS FOR DEA OPIOID 
              QUOTAS.</DELETED>

<DELETED>    Section 306 of the Controlled Substances Act (21 U.S.C. 
826) is amended--</DELETED>
        <DELETED>    (1) in the last sentence of subsection (a), by 
        striking `` and not in terms of individual pharmaceutical 
        dosage forms prepared from or containing such a controlled 
        substance''; and</DELETED>
        <DELETED>    (2) by adding at the end the following:</DELETED>
<DELETED>    ``(i)(1) In fixing and adjusting production and 
manufacturing quotas under this section for fentanyl, oxycodone, 
hydrocodone, oxymorphone, and hydromorphone, the Attorney General shall 
consider the impact of the production and manufacturing quotas on 
overall public health and rates of diversion, abuse, and overdose 
deaths related to these controlled substances in the United States. Any 
of the considerations in this subsection or in subsection (a) may be 
used to determine changes to levels of such production and 
manufacturing quotas in a given year.</DELETED>
<DELETED>    ``(2)(A) For any year in which the approved production 
quota for fentanyl, oxycodone, hydrocodone, oxymorphone, or 
hydromorphone is higher than the approved production quota for the 
substance in the previous year, the Attorney General shall include in 
its final order an explanation of why the public health benefits of 
increasing such quota outweigh the consequences of having an increased 
volume of such substance available for sale, and potential diversion, 
in the United States.</DELETED>
<DELETED>    ``(B) Not later than 1 year after the date of enactment of 
this subsection and every year thereafter, the Attorney General shall 
provide to the Caucus on International Narcotics Control, Committee on 
the Judiciary, Committee on Health, Education, Labor, and Pensions, and 
Committee on Appropriations of the Senate and the Committee on the 
Judiciary, Committee on Energy and Commerce, and Committee on 
Appropriations of the House of Representatives, the following 
information with regard to each of the substances described in 
subparagraph (A):</DELETED>
        <DELETED>    ``(i) An anonymized count of the total number of 
        manufacturers issued individual manufacturing quotas that year 
        for that substance.</DELETED>
        <DELETED>    ``(ii) A count of how many such manufacturers were 
        issued an approved manufacturing quota that was higher than the 
        quota issued to that manufacturer for that substance in the 
        previous year.</DELETED>
<DELETED>    ``(3) Not later than 180 days after the date of enactment 
of this subsection, the Attorney General shall submit to Congress a 
report on how the Attorney General will ensure that the annual process 
of fixing and adjusting production and manufacturing quotas under this 
section takes into consideration--</DELETED>
        <DELETED>    ``(A) efforts to reduce the costs, injuries, and 
        deaths associated with the diversion and abuse of prescription 
        opioids and heroin, including changes in the accepted medical 
        use of certain controlled substances; and</DELETED>
        <DELETED>    ``(B) data collection and evaluation of the volume 
        of controlled substances that are diverted and collected from 
        approved drug collection receptacles, mail-back programs, and 
        take-back events.''.</DELETED>

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Opioid Quota Reform Act''.

SEC. 2. STRENGTHENING CONSIDERATIONS FOR DEA OPIOID QUOTAS.

    (a) In General.--Section 306 of the Controlled Substances Act (21 
U.S.C. 826) is amended--
            (1) in subsection (a)--
                    (A) by inserting ``(1)'' after ``(a)'';
                    (B) in the second sentence, by striking 
                ``Production'' and inserting ``Except as provided in 
                paragraph (2), production''; and
                    (C) by adding at the end the following:
    ``(2) The Attorney General may, if the Attorney General determines 
it will assist in avoiding the overproduction, shortages, or diversion 
of a controlled substance, establish an aggregate or individual 
production quota under this subsection, or a procurement quota 
established by the Attorney General by regulation, in terms of 
pharmaceutical dosage forms prepared from or containing the controlled 
substance.'';
            (2) in subsection (b), in the first sentence, by striking 
        ``production'' and inserting ``manufacturing'';
            (3) in subsection (c), by striking ``October'' and 
        inserting ``December''; and
            (4) by adding at the end the following:
    ``(i)(1)(A) In establishing any quota under this section, or any 
procurement quota established by the Attorney General by regulation, 
for fentanyl, oxycodone, hydrocodone, oxymorphone, or hydromorphone (in 
this subsection referred to as a `covered controlled substance'), the 
Attorney General shall estimate the amount of diversion of the covered 
controlled substance that occurs in the United States.
    ``(B) In estimating diversion under this paragraph, the Attorney 
General--
            ``(i) shall consider information the Attorney General, in 
        consultation with the Secretary of Health and Human Services, 
        determines reliable on rates of overdose deaths and abuse and 
        overall public health impact related to the covered controlled 
        substance in the United States; and
            ``(ii) may take into consideration whatever other sources 
        of information the Attorney General determines reliable.
    ``(C) After estimating the amount of diversion of a covered 
controlled substance, the Attorney General shall make appropriate quota 
reductions, as determined by the Attorney General, from the quota the 
Attorney General would have otherwise established had such diversion 
not been considered.
    ``(2)(A) For any year for which the approved aggregate production 
quota for a covered controlled substance is higher than the approved 
aggregate production quota for the covered controlled substance for the 
previous year, the Attorney General shall include in the final order an 
explanation of why the public health benefits of increasing the quota 
clearly outweigh the consequences of having an increased volume of the 
covered controlled substance available for sale, and potential 
diversion, in the United States.
    ``(B) Not later than 1 year after the date of enactment of this 
subsection, and every year thereafter, the Attorney General shall 
submit to the Caucus on International Narcotics Control, the Committee 
on the Judiciary, the Committee on Health, Education, Labor, and 
Pensions, and the Committee on Appropriations of the Senate and the 
Committee on the Judiciary, the Committee on Energy and Commerce, and 
the Committee on Appropriations of the House of Representatives the 
following information with regard to each covered controlled substance:
            ``(i) An anonymized count of the total number of 
        manufacturers issued individual manufacturing quotas that year 
        for the covered controlled substance.
            ``(ii) An anonymized count of how many such manufacturers 
        were issued an approved manufacturing quota that was higher 
        than the quota issued to that manufacturer for the covered 
        controlled substance in the previous year.
    ``(3) Not later than 1 year after the date of enactment of this 
subsection, the Attorney General shall submit to Congress a report on 
how the Attorney General, when fixing and adjusting production and 
manufacturing quotas under this section for covered controlled 
substances, will--
            ``(A) take into consideration changes in the accepted 
        medical use of the covered controlled substances; and
            ``(B) work with the Secretary of Health and Human Services 
        on methods to appropriately and anonymously survey opioid 
        patients in order to estimate and evaluate the type and amount 
        of covered controlled substances that patients are submitting 
        for collection from approved drug collection receptacles, mail-
        back programs, and take-back events.''.
    (b) Conforming Change.--The Law Revision Counsel is directed to 
amend the heading for subsection (b) of section 826 of title 21, United 
States Code, by striking ``Production'' and inserting 
``Manufacturing''.
                                                       Calendar No. 473

115th CONGRESS

  2d Session

                                S. 2535

_______________________________________________________________________

                                 A BILL

 To amend the Controlled Substances Act to strengthen Drug Enforcement 
          Administration discretion in setting opioid quotas.

_______________________________________________________________________

                             June 19, 2018

                       Reported with an amendment