[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2851 Referred in Senate (RFS)]

<DOC>
115th CONGRESS
  2d Session
                                H. R. 2851


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             June 18, 2018

  Received; read twice and referred to the Committee on the Judiciary

_______________________________________________________________________

                                 AN ACT


 
   To amend the Controlled Substances Act to clarify how controlled 
    substance analogues are to be regulated, and for other purposes.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Stop the Importation and Trafficking 
of Synthetic Analogues Act of 2017'' or the ``SITSA Act''.

SEC. 2. ESTABLISHMENT OF SCHEDULE A.

    Section 202 of the Controlled Substances Act (21 U.S.C. 812) is 
amended--
            (1) in subsection (a), by striking ``five schedules of 
        controlled substances, to be known as schedules I, II, III, IV, 
        and V'' and inserting ``six schedules of controlled substances, 
        to be known as schedules I, II, III, IV, V, and A'';
            (2) in subsection (b), by adding at the end the following:
    ``(6) Schedule A.--
            ``(A) In general.--The drug or substance--
                    ``(i) has--
                            ``(I) a chemical structure that is 
                        substantially similar to the chemical structure 
                        of a controlled substance in schedule I, II, 
                        III, IV, or V; and
                            ``(II) an actual or predicted stimulant, 
                        depressant, or hallucinogenic effect on the 
                        central nervous system that is substantially 
                        similar to or greater than the stimulant, 
                        depressant, or hallucinogenic effect on the 
                        central nervous system of a controlled 
                        substance in schedule I, II, III, IV, or V; and
                    ``(ii) is not--
                            ``(I) listed or otherwise included in any 
                        other schedule in this section or by regulation 
                        of the Attorney General; and
                            ``(II) with respect to a particular person, 
                        subject to an exemption that is in effect for 
                        investigational use, for that person, under 
                        section 505 of the Federal Food, Drug, and 
                        Cosmetic Act (21 U.S.C. 355) to the extent 
                        conduct with respect to such substance is 
                        pursuant to such exemption.
            ``(B) Predicted stimulant, depressant, or hallucinogenic 
        effect.--For purpose of this paragraph, a predicted stimulant, 
        depressant, or hallucinogenic effect on the central nervous 
        system may be based on--
                    ``(i) the chemical structure and--
                            ``(I) the structure activity relationships; 
                        or
                            ``(II) binding receptor assays and other 
                        relevant scientific information about the 
                        substance;
                    ``(ii)(I) the current or relative potential for 
                abuse of the substance; and
                    ``(II) the clandestine importation, manufacture, or 
                distribution, or diversion from legitimate channels, of 
                the substance; or
                    ``(iii) the capacity of the substance to cause a 
                state of dependence, including physical or 
                psychological dependence that is similar to or greater 
                than that of a controlled substance in schedule I, II, 
                III, IV, or V.''; and
            (3) in subsection (c), in the matter preceding schedule I, 
        by striking ``IV, and V'' and inserting ``IV, V, and A''.

SEC. 3. TEMPORARY AND PERMANENT SCHEDULING OF SCHEDULE A SUBSTANCES.

    Section 201 of the Controlled Substances Act (21 U.S.C. 811) is 
amended by adding at the end the following:
    ``(k) Temporary and Permanent Scheduling of Schedule A 
Substances.--
            ``(1) The Attorney General may issue a temporary order 
        adding a drug or substance to schedule A if the Attorney 
        General finds that--
                    ``(A) the drug or other substance satisfies the 
                criteria for being considered a schedule A substance; 
                and
                    ``(B) adding such drug or substance to schedule A 
                will assist in preventing abuse of the drug or other 
                substance.
            ``(2) A temporary scheduling order issued under paragraph 
        (1) shall not take effect until 30 days after the date of the 
        publication by the Attorney General of a notice in the Federal 
        Register of the intention to issue such order and the grounds 
        upon which such order is to be issued. The temporary scheduling 
        order shall expire not later than 5 years after the date it 
        becomes effective, except that the Attorney General may, during 
        the pendency of proceedings under paragraph (5), extend the 
        temporary scheduling order for up to 180 days.
            ``(3) A temporary scheduling order issued under paragraph 
        (1) shall be vacated upon the issuance of a permanent order 
        issued under paragraph (5) with regard to the same substance, 
        or upon the subsequent issuance of any scheduling order under 
        this section.
            ``(4) A temporary scheduling order issued under paragraph 
        (1) shall not be subject to judicial review.
            ``(5)(A) Beginning no earlier than 3 years after issuing an 
        order temporarily scheduling a drug or other substance under 
        this subsection, the Attorney General may, by rule, issue a 
        permanent order adding a drug or other substance to schedule A 
        if such drug or substance satisfies the criteria for being 
        considered a controlled substance in schedule A under this 
        subsection, except as provided in subparagraph (B).
            ``(B) If the Secretary has determined, based on relevant 
        scientific studies and necessary data requested by the 
        Secretary and gathered by the Attorney General, that a drug or 
        other substance that has been temporarily placed in schedule A 
        does not have sufficient potential for abuse to warrant control 
        in any schedule, and so advises the Attorney General in 
        writing, the Attorney General may not issue a permanent 
        scheduling order under subparagraph (A) and shall, within 30 
        days of receiving the Secretary's advice issue an order 
        immediately terminating the temporary scheduling order.
            ``(6) Before initiating proceedings under paragraph (1), 
        the Attorney General shall transmit notice of a temporary order 
        proposed to be issued to the Secretary of Health and Human 
        Services. In issuing an order under paragraph (1), the Attorney 
        General shall take into consideration any comments submitted by 
        the Secretary of Health and Human Services in response to a 
        notice transmitted pursuant to this paragraph.
            ``(7) On the date of the publication of a notice in the 
        Federal Register pursuant to paragraph (2), the Attorney 
        General shall transmit the same notice to Congress. The 
        temporary scheduling order shall take effect according to 
        paragraph (2), except that the temporary scheduling order may 
        be disapproved by an Act of Congress within 180 days from the 
        date of publication of the notice in the Federal Register.''.

SEC. 4. PENALTIES.

    (a) Controlled Substances Act.--The Controlled Substances Act (21 
U.S.C. 801 et seq.) is amended--
            (1) in section 401(b)(1) (21 U.S.C. 841(b)(1)), by adding 
        at the end the following:
    ``(F)(i) In the case of any controlled substance in schedule A, 
such person shall be sentenced to a term of imprisonment of not more 
than 10 years and if death or serious bodily injury results from the 
use of such substance shall be sentenced to a term of imprisonment of 
not more than 15 years, a fine not to exceed the greater of that 
authorized in accordance with the provisions of title 18, United States 
Code, or $500,000 if the defendant is an individual or $2.5 million if 
the defendant is other than an individual, or both.
    ``(ii) If any person commits such a violation after a prior 
conviction for a felony drug offense has become final, such person 
shall be sentenced to a term of imprisonment of not more than 20 years 
and if death or serious bodily injury results from the use of such 
substance shall be sentenced to a term of imprisonment of not more than 
30 years, a fine not to exceed the greater of twice that authorized in 
accordance with the provisions of title 18, United States Code, or $1 
million if the defendant is an individual or $5 million if the 
defendant is other than an individual, or both.
    ``(iii) Any sentence imposing a term of imprisonment under this 
subparagraph shall, in the absence of such a prior conviction, impose a 
term of supervised release of not less than 2 years in addition to such 
term of imprisonment and shall, if there was such a prior conviction, 
impose a term of supervised release of not less than 4 years in 
addition to such term of imprisonment.'';
            (2) in section 403(a) (21 U.S.C. 843(a))--
                    (A) in paragraph (8), by striking ``or'' at the 
                end;
                    (B) in paragraph (9), by striking the period at the 
                end and inserting ``; or''; and
                    (C) by inserting after paragraph (9) the following:
            ``(10) to export a substance in violation of the controlled 
        substance laws of the country to which the substance is 
        exported.''; and
            (3) in section 404 (21 U.S.C. 844), by inserting after 
        subsection (a) the following:
    ``(b) A person shall not be subject to a criminal or civil penalty 
under this title or under any other Federal law solely for possession 
of a schedule A controlled substance.''.
    (b) Controlled Substances Import and Export Act.--Section 1010(b) 
of the Controlled Substances Import and Export Act (21 U.S.C. 960(b)) 
is amended by adding at the end the following:
    ``(8) In the case of a violation under subsection (a) involving a 
controlled substance in schedule A, the person committing such 
violation shall be sentenced to a term of imprisonment of not more than 
20 years and if death or serious bodily injury results from the use of 
such substance shall be sentenced to a term of imprisonment of not more 
than life, a fine not to exceed the greater of that authorized in 
accordance with the provisions of title 18, United States Code, or $1 
million if the defendant is an individual or $5 million if the 
defendant is other than an individual, or both. If any person commits 
such a violation after a prior conviction for a felony drug offense has 
become final, such person shall be sentenced to a term of imprisonment 
of not more than 30 years and if death or serious bodily injury results 
from the use of such substance shall be sentenced to not more than life 
imprisonment, a fine not to exceed the greater of twice that authorized 
in accordance with the provisions of title 18, United States Code, or 
$2 million if the defendant is an individual or $10 million if the 
defendant is other than an individual, or both. Notwithstanding section 
3583 of title 18, United States Code, any sentence imposing a term of 
imprisonment under this paragraph shall, in the absence of such a prior 
conviction, impose a term of supervised release of not less than 3 
years in addition to such term of imprisonment and shall, if there was 
such a prior conviction, impose a term of supervised release of not 
less than 6 years in addition to such term of imprisonment. 
Notwithstanding the prior sentence, and notwithstanding any other 
provision of law, the court shall not place on probation or suspend the 
sentence of any person sentenced under the provisions of this paragraph 
which provide for a mandatory term of imprisonment if death or serious 
bodily injury results.''.

SEC. 5. FALSE LABELING OF SCHEDULE A CONTROLLED SUBSTANCES.

    (a) In General.--Section 305 of the Controlled Substances Act (21 
U.S.C. 825) is amended by adding at the end the following:
    ``(f) False Labeling of Schedule A Controlled Substances.--
            ``(1) It shall be unlawful to import, export, manufacture, 
        distribute, dispense, or possess with intent to manufacture, 
        distribute, or dispense, a schedule A substance or product 
        containing a schedule A substance, unless the substance or 
        product bears a label clearly identifying a schedule A 
        substance or product containing a schedule A substance by the 
        nomenclature used by the International Union of Pure and 
        Applied Chemistry (IUPAC).
            ``(2)(A) A product described in subparagraph (B) is exempt 
        from the International Union of Pure and Applied Chemistry 
        nomenclature requirement of this subsection if such product is 
        labeled in the manner required under the Federal Food, Drug, 
        and Cosmetic Act.
            ``(B) A product is described in this subparagraph if the 
        product--
                    ``(i) is the subject of an approved application as 
                described in section 505(b) or (j) of the Federal Food, 
                Drug, and Cosmetic Act; or
                    ``(ii) is exempt from the provisions of section 505 
                of such Act relating to new drugs because--
                            ``(I) it is intended solely for 
                        investigational use as described in section 
                        505(i) of such Act; and
                            ``(II) such product is being used 
                        exclusively for purposes of a clinical trial 
                        that is the subject of an effective 
                        investigational new drug application.''.
    (b) Penalties.--Section 402 of the Controlled Substances Act (21 
U.S.C. 842) is amended--
            (1) in subsection (a)(16), by inserting ``or subsection 
        (f)'' after ``subsection (e)''; and
            (2) in subsection (c)(1)(D), by inserting ``or a schedule A 
        substance'' after ``anabolic steroid''.

SEC. 6. REGISTRATION REQUIREMENTS FOR HANDLERS OF SCHEDULE A 
              SUBSTANCES.

    (a) Controlled Substances Act.--Section 303 of the Controlled 
Substances Act (21 U.S.C. 823) is amended by adding at the end the 
following:
    ``(k)(1) The Attorney General shall register an applicant to 
manufacture schedule A substances if--
            ``(A) the applicant demonstrates that the schedule A 
        substances will be used for research, analytical, or industrial 
        purposes approved by the Attorney General; and
            ``(B) the Attorney General determines that such 
        registration is consistent with the public interest and with 
        the United States obligations under international treaties, 
        conventions, or protocols in effect on the date of enactment of 
        this subsection.
    ``(2) In determining the public interest under paragraph (1)(B), 
the Attorney General shall consider--
            ``(A) maintenance of effective controls against diversion 
        of particular controlled substances and any controlled 
        substance in schedule A compounded therefrom into other than 
        legitimate medical, scientific, research, or industrial 
        channels, by limiting the importation and bulk manufacture of 
        such controlled substances to a number of establishments which 
        can produce an adequate and uninterrupted supply of these 
        substances under adequately competitive conditions for 
        legitimate medical, scientific, research, and industrial 
        purposes;
            ``(B) compliance with applicable State and local law;
            ``(C) promotion of technical advances in the art of 
        manufacturing substances described in subparagraph (A) and the 
        development of new substances;
            ``(D) prior conviction record of applicant under Federal 
        and State laws relating to the manufacture, distribution, or 
        dispensing of substances described in paragraph (A);
            ``(E) past experience in the manufacture of controlled 
        substances, and the existence in the establishment of effective 
        control against diversion; and
            ``(F) such other factors as may be relevant to and 
        consistent with the public health and safety.
    ``(3) If an applicant is registered to manufacture controlled 
substances in schedule I or II under subsection (a), the applicant 
shall not be required to apply for a separate registration under this 
subsection.
    ``(l)(1) The Attorney General shall register an applicant to 
distribute schedule A substances--
            ``(A) if the applicant demonstrates that the schedule A 
        substances will be used for research, analytical, or industrial 
        purposes approved by the Attorney General; and
            ``(B) unless the Attorney General determines that the 
        issuance of such registration is inconsistent with the public 
        interest.
    ``(2) In determining the public interest under paragraph (1)(B), 
the Attorney General shall consider--
            ``(A) maintenance of effective control against diversion of 
        particular controlled substances into other than legitimate 
        medical, scientific, and industrial channels;
            ``(B) compliance with applicable State and local law;
            ``(C) prior conviction record of applicant under Federal or 
        State laws relating to the manufacture, distribution, or 
        dispensing of substances described in subparagraph (A);
            ``(D) past experience in the distribution of controlled 
        substances; and
            ``(E) such other factors as may be relevant to and 
        consistent with the public health and safety.
    ``(3) If an applicant is registered to distribute a controlled 
substance in schedule I or II under subsection (b), the applicant shall 
not be required to apply for a separate registration under this 
subsection.
    ``(m)(1)(A) Not later than 90 days after the date on which a 
substance is placed in schedule A, any practitioner who was engaged in 
research on the substance before the placement of the substance in 
schedule A and any manufacturer or distributor who was handling the 
substance before the placement of the substance in schedule A shall 
register with the Attorney General.
    ``(B)(i) If an applicant described in subparagraph (A) is 
registered pursuant to subsection (f) to conduct research with a 
controlled substance in schedule I or II on the date on which another 
substance is placed in schedule A, the applicant may, subject to clause 
(iii), conduct research with that other controlled substance in 
schedule A while the application for registration pursuant to 
subparagraph (A) is pending.
    ``(ii) If an applicant described in subparagraph (A) is registered 
pursuant to subsection (f) as described in clause (i) to conduct 
research with a controlled substance in schedule III, IV, or V on the 
date on which another substance is placed in schedule A, the applicant 
may, subject to clause (iii), conduct research with that other 
controlled substance in schedule A while the application for 
registration pursuant to subparagraph (A) is pending, provided the 
substance for which the applicant is registered to conduct research is 
in the same schedule as, or a less-restricted schedule than, the 
controlled substance whose similarity in chemical structure and actual 
or predicted effect to the controlled substance in schedule A formed 
the basis for placement of the substance in schedule A, as set forth in 
the order published in the Federal Register placing the substance in 
schedule A.
    ``(iii) The permission to conduct research pursuant to clause (i) 
or clause (ii) is conditional on the applicant's complying with the 
registration and other requirements for controlled substances in 
schedule A.
    ``(iv) This subparagraph does not apply to applicants registered 
pursuant to subsection (f) whose authorization to conduct research with 
any controlled substances is limited to doing so as a coincident 
activity pursuant to applicable regulations of the Attorney General.
    ``(2)(A) Not later than 60 days after the date on which the 
Attorney General receives an application for registration to conduct 
research on a schedule A substance, the Attorney General shall--
            ``(i) grant, or initiate proceedings under section 304(c) 
        to deny, the application; or
            ``(ii) request supplemental information from the applicant.
    ``(B) Not later than 30 days after the date on which the Attorney 
General receives supplemental information requested under subparagraph 
(A)(ii) in connection with an application described in subparagraph 
(A), the Attorney General shall grant or deny the application.
    ``(n)(1) The Attorney General shall register a scientific 
investigator or a qualified research institution to conduct research 
with controlled substances in schedule A in accordance with this 
subsection. In evaluating applications for such registration, the 
Attorney General shall apply the criteria set forth in subsection (f) 
of this section that apply to practitioners seeking a registration to 
conduct research with a schedule I controlled substance, except that 
the applicant shall not be required to submit a research protocol.
    ``(2) If the applicant is not currently registered under subsection 
(f) to conduct research with a schedule I controlled substance, the 
Attorney General shall refer the application to the Secretary, who 
shall determine whether the applicant will be engaged in bona fide 
research and is qualified to conduct such research. The 60-day period 
under subsection (m)(2)(A) shall be tolled during the period beginning 
on the date on which the Attorney General refers an application to the 
Secretary under this paragraph, and ending on the date on which the 
Secretary submits a determination related to such referral to the 
Attorney General.
    ``(3) An applicant who meets the criteria under subsection 
(m)(1)(B) with respect to a particular schedule A controlled substance 
shall be considered qualified to conduct research with that substance. 
The Attorney General shall modify such applicant's registration to 
include such schedule A controlled substance in accordance with this 
paragraph. The applicant shall notify the Attorney General of his 
intent to conduct research with a controlled substance in schedule A. 
Upon receiving such notification, the Attorney General shall modify the 
practitioner's existing registration to authorize research with 
schedule A controlled substances, unless the Attorney General 
determines that the registration modification would be inconsistent 
with the public interest based on the criteria of subsection (f).
    ``(4) Registrations issued under this subsection to a qualified 
research institution will apply to all agents and employees of that 
institution acting within the scope of their professional practice.
    ``(5) At least 30 days prior to conducting any research with a 
controlled substance in schedule A, the registrant shall provide the 
Attorney General with written notification of the following:
            ``(A) The name of and drug code for each substance.
            ``(B) The name of each individual with access to each 
        substance.
            ``(C) The amount of each substance.
            ``(D) Other similar information the Attorney General may 
        require.
    ``(6) The quantity of a schedule A controlled substance possessed 
by a person registered under this subsection shall be appropriate for 
the research being conducted, subject to the additional limitations set 
forth in this paragraph. To reduce the risk of diversion, the Attorney 
General may establish limitations on the quantity of schedule A 
controlled substances that may be manufactured or possessed for 
purposes of research under this subsection and shall publish such 
limitations on the website of the Drug Enforcement Administration. A 
person registered under this subsection may, based on legitimate 
research needs, apply to the Attorney General to manufacture or possess 
an amount greater than that so specified by the Attorney General. The 
Attorney General shall specify the manner in which such applications 
shall be submitted. The Attorney General shall act on an application 
filed under this subparagraph within 30 days of receipt of such 
application. If the Attorney General fails to act within 30 days, the 
registrant shall be allowed to manufacture and possess up to the amount 
requested. The Attorney General shall have the authority to reverse the 
increase for cause.
    ``(7) The Attorney General shall by regulation specify the manner 
in which applications for registration under this subsection shall be 
submitted.
    ``(8) Registrants authorized under this subsection may manufacture 
and possess schedule A controlled substances up to the approved amounts 
only for use in their own research setting or institution. 
Manufacturing for use in any other setting or institution shall require 
a manufacturer's registration under section 303(a).''.
    (b) Controlled Substances Import and Export Act.--Section 1008 of 
the Controlled Substances Import and Export Act (21 U.S.C. 958) is 
amended by adding at the end the following:
    ``(j)(1) The Attorney General shall register an applicant to import 
or export a schedule A substance if--
            ``(A) the applicant demonstrates that the schedule A 
        substances will be used for research, analytical, or industrial 
        purposes approved by the Attorney General; and
            ``(B) the Attorney General determines that such 
        registration is consistent with the public interest and with 
        the United States obligations under international treaties, 
        conventions, or protocols in effect on the date of enactment of 
        this subsection.
    ``(2) In determining the public interest under paragraph (1)(B), 
the Attorney General shall consider the factors described in 
subparagraphs (A) through (F) of section 303(k)(2).
    ``(3) If an applicant is registered to import or export a 
controlled substance in schedule I or II under subsection (a), the 
applicant shall not be required to apply for a separate registration 
under this subsection.''.

SEC. 7. ADDITIONAL CONFORMING AMENDMENTS.

    (a) Controlled Substances Act.--The Controlled Substances Act (21 
U.S.C. 801 et seq.) is amended--
            (1) in section 303(c) (21 U.S.C. 823(c))--
                    (A) by striking ``subsections (a) and (b)'' and 
                inserting ``subsection (a), (b), (k), or (l)''; and
                    (B) by striking ``schedule I or II'' and inserting 
                ``schedule I, II, or A'';
            (2) in section 306 (21 U.S.C. 826)--
                    (A) in subsection (a), in the first sentence, by 
                striking ``schedules I and II'' and inserting 
                ``schedules I, II, and A'';
                    (B) in subsection (b), in the second sentence, by 
                striking ``schedule I or II'' and inserting ``schedule 
                I, II, or A'';
                    (C) in subsection (c), in the first sentence, by 
                striking ``schedules I and II'' and inserting 
                ``schedules I, II, and A'';
                    (D) in subsection (d), in the first sentence, by 
                striking ``schedule I or II'' and inserting ``schedule 
                I, II, or A'';
                    (E) in subsection (e), in the first sentence, by 
                striking ``schedule I or II'' and inserting ``schedule 
                I, II, or A''; and
                    (F) in subsection (f), in the first sentence, by 
                striking ``schedules I and II'' and inserting 
                ``schedules I, II, and A'';
            (3) in section 308(a) (21 U.S.C. 828(a)), by striking 
        ``schedule I or II'' and inserting ``schedule I, II, or A'';
            (4) in section 402(b) (21 U.S.C. 842(b)), in the matter 
        preceding paragraph (1), by striking ``schedule I or II'' and 
        inserting ``schedule I, II, or A'';
            (5) in section 403(a)(1) (21 U.S.C. 843(a)(1)), by striking 
        ``schedule I or II'' and inserting ``schedule I, II, or A''; 
        and
            (6) in section 511(f) (21 U.S.C. 881(f)), by striking 
        ``schedule I or II'' each place it appears and inserting 
        ``schedule I, II, or A''.
    (b) Controlled Substances Import Export Act.--The Controlled 
Substances Import and Export Act (21 U.S.C. 951 et seq.) is amended--
            (1) in section 1002(a) (21 U.S.C. 952(a))--
                    (A) in the matter preceding paragraph (1), by 
                striking ``schedule I or II'' and inserting ``schedule 
                I, II, or A''; and
                    (B) in paragraph (2), by striking ``schedule I or 
                II'' and inserting ``schedule I, II, or A'';
            (2) in section 1003 (21 U.S.C. 953)--
                    (A) in subsection (c), in the matter preceding 
                paragraph (1), by striking ``schedule I or II'' and 
                inserting ``schedule I, II, or A''; and
                    (B) in subsection (d), by striking ``schedule I or 
                II'' and inserting ``schedule I, II, or A'';
            (3) in section 1004(1) (21 U.S.C. 954(1)), by striking 
        ``schedule I'' and inserting ``schedule I or A'';
            (4) in section 1005 (21 U.S.C. 955), by striking ``schedule 
        I or II'' and inserting ``schedule I, II, or A''; and
            (5) in section 1009(a) (21 U.S.C. 959(a)), by striking 
        ``schedule I or II'' and inserting ``schedule I, II, or A''.

SEC. 8. CONTROLLED SUBSTANCE ANALOGUES.

    Section 102 of the Controlled Substances Act (21 U.S.C. 802) is 
amended--
            (1) in paragraph (6), by striking ``or V'' and inserting 
        ``V, or A'';
            (2) in paragraph (14)--
                    (A) by striking ``schedule I(c) and'' and inserting 
                ``schedule I(c), schedule A, and''; and
                    (B) by striking ``schedule I(c),'' and inserting 
                ``schedule I(c) and schedule A,''; and
            (3) in paragraph (32)(A), by striking ``(32)(A)'' and all 
        that follows through clause (iii) and inserting the following:
    ``(32)(A) Except as provided in subparagraph (C), the term 
`controlled substance analogue' means a substance whose chemical 
structure is substantially similar to the chemical structure of a 
controlled substance in schedule I or II--
            ``(i) which has a stimulant, depressant, or hallucinogenic 
        effect on the central nervous system that is substantially 
        similar to or greater than the stimulant, depressant, or 
        hallucinogenic effect on the central nervous system of a 
        controlled substance in schedule I or II; or
            ``(ii) with respect to a particular person, which such 
        person represents or intends to have a stimulant, depressant, 
        or hallucinogenic effect on the central nervous system that is 
        substantially similar to or greater than the stimulant, 
        depressant, or hallucinogenic effect on the central nervous 
        system of a controlled substance in schedule I or II.''.

SEC. 9. RULES OF CONSTRUCTION.

    Nothing in this Act, or the amendments made by this Act, may be 
construed to limit--
            (1) the prosecution of offenses involving controlled 
        substance analogues under the Controlled Substances Act (21 
        U.S.C. 801 et seq.); or
            (2) the authority of the Attorney General to temporarily or 
        permanently schedule, reschedule, or decontrol controlled 
        substances under provisions of section 201 of the Controlled 
        Substances Act (21 U.S.C. 811) that are in effect on the day 
        before the date of enactment of this Act.

SEC. 10. STUDY BY COMPTROLLER GENERAL.

    Not later than 2 years after the date of enactment of this Act, the 
Comptroller General of the United States shall complete a study and 
submit a report to the Committees on the Judiciary of the House of 
Representatives and of the Senate regarding the costs associated with 
the amendments made by section 4, including--
            (1) the annual amounts expended by Federal agencies in 
        carrying out the amendments;
            (2) the costs associated with arrests, trials, convictions, 
        imprisonment, or imposition of other sanctions in accordance 
        with the amendments; and
            (3) the impact (including the fiscal impact) of the 
        amendments on existing correctional facilities and the 
        likelihood that those amendments will create a need for 
        additional capacity for housing prisoners.

SEC. 11. REPORT ON CONTROLLED SUBSTANCE ANALOGUES SOLD BY MEANS OF THE 
              INTERNET.

    Not later than 1 year after the date of the enactment of this Act, 
and annually thereafter, the Administrator of the Drug Enforcement 
Administration shall make publicly available on the website of the Drug 
Enforcement Administration a report on, for the previous year, the 
lawful and unlawful sale of controlled substance analogues (as defined 
in section 102 of the Controlled Substances Act (21 U.S.C. 802)) by 
means of the Internet, including the following information:
            (1) The types of controlled substance analogues that were 
        sold, and the number of sales for each such substance.
            (2) The name of each person, entity, or Internet site, 
        whether in the United States or abroad, that knowingly or 
        intentionally delivers, distributes, or dispenses, or offers or 
        attempts to deliver, distribute, or dispense, a controlled 
        substance analogue by means of the Internet, whether lawfully 
        or unlawfully.
            (3) An estimate of the total revenue for all of the vendors 
        described in paragraph (2) for all of the sales described in 
        paragraph (1).

SEC. 12. CONTROLLED SUBSTANCE ANALOGUES.

    Section 203 of the Controlled Substances Act (21 U.S.C. 813) is 
amended--
            (1) by striking ``A controlled'' and inserting ``(a) In 
        General.--A controlled''; and
            (2) by adding at the end the following:
    ``(b) Determination.--In determining whether a controlled substance 
analogue was intended for human consumption under subsection (a), the 
following factors may be considered, along with any other relevant 
factors:
            ``(1) The marketing, advertising, and labeling of the 
        substance.
            ``(2) The known efficacy or usefulness of the substance for 
        the marketed, advertised or labeled purpose.
            ``(3) The difference between the price at which the 
        substance is sold and the price at which the substance it is 
        purported to be or advertised as is normally sold.
            ``(4) The diversion of the substance from legitimate 
        channels and the clandestine importation, manufacture, or 
        distribution of the substance.
            ``(5) Whether the defendant knew or should have known the 
        substance was intended to be consumed by injection, inhalation, 
        ingestion, or any other immediate means.
            ``(6) Any controlled substance analogue that is 
        manufactured, formulated, sold, distributed, or marketed with 
        the intent to avoid the provisions of existing drug laws.
    ``(c) Limitation.--For purposes of this section, evidence that a 
substance was not marketed, advertised, or labeled for human 
consumption, by itself, shall not be


              

 sufficient to establish that the substance was not intended for human 
consumption.''.

            Passed the House of Representatives June 15, 2018.

            Attest:

                                                 KAREN L. HAAS,

                                                                 Clerk.