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[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[S. 1327 Introduced in Senate (IS)]

<DOC>

115th CONGRESS
  1st Session
                                S. 1327

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

_______________________________________________________________________

                   IN THE SENATE OF THE UNITED STATES

                              June 8, 2017

Mr. Grassley (for himself 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 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, structure activity 
                relationships, binding receptor assays, or 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)--
                    (A) in the matter preceding schedule I, by striking 
                ``IV, and V'' and inserting ``IV, V, and A''; and
                    (B) by adding at the end the following:

                              ``schedule a

    ``(a) Unless specifically excepted or unless listed in another 
schedule, any of the following substances, as scheduled in accordance 
with section 201(k)(5):
            ``(1) 4-fluoroisobutyryl fentanyl.
            ``(2) Valeryl fentanyl.
            ``(3) 4-methoxybutyryl fentanyl.
            ``(4) 4-methylphenethyl acetyl fentanyl.
            ``(5) 3-furanyl fentanyl.
            ``(6) Ortho-fluorofentanyl.
            ``(7) Tetrahydrofuranyl fentanyl.
            ``(8) Ocfentanil.
            ``(9) 4-fluorobutyryl fentanyl.
            ``(10) Methoxyacetyl fentanyl.
            ``(11) Meta-fluorofentanyl.
            ``(12) Isobutyryl fentanyl.
            ``(13) Acryl fentanyl.''.

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 or misuse 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) 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 
        schedule A substance. Such rulemaking may be commenced 
        simultaneously with the issuance of the temporary scheduling 
        order issued under paragraph (1) with regard to the same 
        substance.
            ``(6) Before initiating proceedings under paragraph (1) or 
        (5), the Attorney General shall transmit notice of an order 
        proposed to be issued to the Secretary of Health and Human 
        Services. In issuing an order under paragraph (1) or (5), 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.''.

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 $2,500,000 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 
$1,000,000 if the defendant is an individual or $5,000,000 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 for any 
term of years or for life, a fine not to exceed the greater of that 
authorized in accordance with the provisions of title 18, United States 
Code, or $1,000,000 if the defendant is an individual or $5,000,000 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 a 
term of imprisonment for any term of years or for life, a fine not to 
exceed the greater of twice that authorized in accordance with the 
provisions of title 18, United States Code, or $2,000,000 if the 
defendant is an individual or $10,000,000 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--
            (1) in subsection (f), in the undesignated matter following 
        paragraph (5)--
                    (A) by inserting ``or A'' after ``schedule I'' each 
                place it appears; and
                    (B) by adding at the end the following: ``A 
                separate registration for engaging in research with a 
                controlled substance in schedule A for practitioners 
                already registered under this part to engage in 
                research with controlled substances in schedule I shall 
                not be required. The Secretary shall determine the 
                merits of the research protocol submitted by the 
                practitioner registering to engage in research with a 
                controlled substance in schedule A, and the Attorney 
                General may deny or revoke the registration only on a 
                ground specified in section 304.''; and
            (2) 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) 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.
    ``(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.''.
    (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. CLARIFICATION OF THE DEFINITION OF CONTROLLED SUBSTANCE 
              ANALOGUE UNDER THE ANALOGUE ENFORCEMENT ACT.

    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.
                                 <all>
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