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115th Congress   }                                  {    Rept. 115-713
                        HOUSE OF REPRESENTATIVES
 2d Session      }                                  {           Part 1

======================================================================



 
STOP THE IMPORTATION AND TRAFFICKING OF SYNTHETIC ANALOGUES ACT OF 2017

                                _______
                                

                  June 8, 2018.--Ordered to be printed

                                _______
                                

   Mr. Goodlatte, from the Committee on the Judiciary, submitted the 
                               following

                              R E P O R T

                             together with

                            DISSENTING VIEWS

                        [To accompany H.R. 2851]

      [Including cost estimate of the Congressional Budget Office]

    The Committee on the Judiciary, to whom was referred the 
bill (H.R. 2851) to amend the Controlled Substances Act to 
clarify how controlled substance analogues are to be regulated, 
and for other purposes, having considered the same, report 
favorably thereon with an amendment and recommend that the bill 
as amended do pass.

                                CONTENTS

                                                                   Page
The Amendment....................................................     2
Purpose and Summary..............................................     8
Background and Need for the Legislation..........................     9
Hearings.........................................................     9
Committee Consideration..........................................    10
Committee Votes..................................................    10
Committee Oversight Findings.....................................    10
New Budget Authority and Tax Expenditures........................    10
Congressional Budget Office Cost Estimate........................    10
Duplication of Federal Programs..................................    12
Disclosure of Directed Rule Makings..............................    12
Performance Goals and Objectives.................................    12
Advisory on Earmarks.............................................    12
Section-by-Section Analysis......................................    12
Changes in Existing Law Made by the Bill, as Reported............    17
Dissenting Views.................................................    90

                             The Amendment

    The amendment is as follows:
  Strike all that follows after the enacting clause, and insert 
the following:

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.
          ``(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 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 $2,500,000 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 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 
$1,000,000 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 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 
$2,000,000 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 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.
  ``(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.
  ``(3) If the applicant is currently registered under subsection (f) 
to conduct research with a schedule I controlled substance, the 
applicant will be considered qualified to conduct research with 
controlled substances in schedule A and the Attorney General shall 
modify the applicant's registration to include schedule A controlled 
substances 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 thirty 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. AMENDMENT TO THE SENTENCING GUIDELINES.

  Section 2D1.1 of the Federal Sentencing Guidelines is amended, in 
Application Note 6 (Analogues and Controlled Substances Not Referenced 
in this Guideline) of the Commentary, by striking ``In determining the 
most closely related controlled substance, the court shall, to the 
extent practicable, consider the following:'' and inserting the 
following: ``In determining the most closely related controlled 
substance and the applicable guideline or drug equivalence, the court 
shall--
                  ``(A) if Attorney General has provided guidance on 
                the appropriate sentencing equivalency or ratio to a 
                controlled substance that is referenced in the 
                guidelines through publication in the Federal Register 
                (whether such guidance is included in or separate from 
                any notice of proposed temporary or permanent 
                scheduling of such substance under section 201 of the 
                Controlled Substances Act (21 U.S.C. 811)), apply any 
                such sentencing equivalency or ratio; and
                  ``(B) in the absence of guidance with respect to a 
                substance or group of substances as described in 
                paragraph (A), use equivalencies for the following 
                structural classes of substances as if they were 
                included on the Drug Equivalency Tables:


----------------------------------------------------------------------------------------------------------------
                 ``Drug Class                          Marihuana Equivalency of 1 gm of subject substance
----------------------------------------------------------------------------------------------------------------
Synthetic Opioids............................  1 gm = 10 kg
Synthetic Cannabinoids.......................  1 gm = 167 gm
Synthetic Cathinones.........................  1 gm = 380 gm
Tryptamine...................................  1 gm = 80 gm
Phenethylamines..............................  1 gm = 2.5 kg
Piperazines..................................  1 gm = 2 kg
Benzofurans..................................  1 gm = 500 gm
Arylcyclohexylamines (PCP-like substances)...  1 gm = 1 kg
Methylphenidate analogs......................  1 gm = 100 gm
Benzodiazepines..............................  1 `unit' (as defined in Note (F) to the Drug Quantity Table in
                                                2D1.1) = 0.0625 gm
----------------------------------------------------------------------------------------------------------------

        In the case of a substance for which paragraphs (A) and (B) 
        above are not applicable, the court shall determine an 
        equivalency or ratio by considering the following factors, to 
        the extent practicable:''.

SEC. 10. 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. 11. 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.

                          Purpose and Summary

    H.R. 2851 would modernize the Controlled Substances Act 
(CSA) to provide prompt action to stop the unlawful importation 
and distribution of synthetic drugs. It establishes a mechanism 
by which synthetic drugs can be temporarily and permanently 
controlled to curtail illicit manufacturing, importation and 
distribution.

                Background and Need for the Legislation

    The United States is in the midst of a synthetic drug 
epidemic. Over 52,000 Americans, or about 144 people per day, 
died from drug overdoses in 2015. Nearly one-fifth of these 
deaths resulted from an overdose of synthetic opioids like 
fentanyl. These synthetic opioids can be as much as 100 times 
more powerful than painkillers like morphine. Moreover, 
synthetic analogues, with street names like K2, Spice, Bath 
Salts, or Molly, are designed to mimic other street drugs like 
marijuana, LSD, and Ecstasy and can be more potent than the 
real thing and just as deadly. These drugs have no known 
legitimate industrial or medical use and their misuse and abuse 
represents an emerging and ongoing public health and safety 
crisis in the United States.
    Synthetic drugs are analogues of already-controlled 
substances. Savvy and highly-knowledgeable criminals, and the 
chemists they employ, are able to slightly modify the chemical 
structure of a controlled substance. Their goal is that the new 
(and legal) synthetic drug mimics the effects of a controlled 
substance. Because the drug is only slightly modified, it still 
attaches to receptors in the human brain, causing similar but 
sometimes more intense effects.
    Federal and state drug statutes are designed to list each 
controlled substance by its precise chemical name and 
structure. It is in this way that all authorized manufacturers, 
importers, and distributors have knowledge of the requirements 
for handling that controlled substance under the law. However, 
it is under this law that illicit manufacturers, importers, and 
distributors of synthetic drugs are able to slightly modify the 
chemical structure of substances to avoid responsibility and 
prosecution.
    Illegal drug traffickers and importers are able to 
circumvent the existing scheduling regime by altering a single 
atom or molecule of a currently controlled substance in a 
laboratory, thereby creating a substance that is lawful, but 
often highly dangerous, addictive, and even deadly. These 
synthetic analogues are being trafficked into the United 
States, often from China and Mexico, and pose a grave threat to 
the health and safety of the American people.
    The Controlled Substances Act, enacted over 40 years ago, 
was not designed to handle the magnitude and speed with which 
synthetic drugs have emerged in our communities. The Stop the 
Importation and Trafficking of Synthetic Analogues Act 
modernizes the CSA to provide swifter action to stop the 
unlawful importation and distribution of synthetic drugs and 
gives law enforcement effective tools to help keep our 
communities safe.

                                Hearings

    The Judiciary Committee's Subcommittee on Crime, Terrorism, 
Homeland Security and Investigations held one day of hearings 
on H.R. 2851, the Stop the Trafficking and Importation of 
Synthetic Analogues (SITSA) Act, on June 27, 2017. Testimony 
was received from John Katko, Member of Congress; Demetra 
Ashley, Deputy Assistant Administrator, Drug Enforcement 
Administration (DEA), Diversion Control; Robert E. Perez, 
Acting Executive Assistant Commissioner, U.S. Customs and 
Border Protection, Operations Support; Marcia Lee Taylor, 
President and CEO, Partnership for Drug-Free Kids; Reta Newman, 
Special Advisor to Drug Free America Foundation and Chief 
Chemist and Laboratory Director of the Pinellas County 
(Florida) Forensic Laboratory; and Angela Pacheco, former 
District Attorney, State of New Mexico, First Judicial 
District.

                        Committee Consideration

    On July 12, 2017, the Committee met in open session and 
ordered the bill, H.R. 2851, favorably reported, with an 
amendment, by voice vote, a quorum being present.

                            Committee Votes

    In compliance with clause 3(b) of rule XIII of the Rules of 
the House of Representatives, the Committee advises that there 
were no recorded votes during the Committee's consideration of 
H.R. 2851.

                      Committee Oversight Findings

    In compliance with clause 3(c)(1) of rule XIII of the Rules 
of the House of Representatives, the Committee advises that the 
findings and recommendations of the Committee, based on 
oversight activities under clause 2(b)(1) of rule X of the 
Rules of the House of Representatives, are incorporated in the 
descriptive portions of this report.

               New Budget Authority and Tax Expenditures

    Clause 3(c)(2) of rule XIII of the Rules of the House of 
Representatives is inapplicable because this legislation does 
not provide new budgetary authority or increased tax 
expenditures.

               Congressional Budget Office Cost Estimate

    In compliance with clause 3(c)(3) of rule XIII of the Rules 
of the House of Representatives, the Committee sets forth, with 
respect to H.R. 2851, the following estimate and comparison 
prepared by the Director of the Congressional Budget Office 
under section 402 of the Congressional Budget Act of 1974:

                               Congressional Budget Office,
                                Washington, DC, September 20, 2017.
Hon. Bob Goodlatte, Chairman,
Committee on the Judiciary,
House of Representatives, Washington, DC.
    Dear Mr. Chairman: The Congressional Budget Office has 
prepared the enclosed cost estimate for H.R. 2851, the Stop the 
Importation and Trafficking of Synthetic Analogues Act of 2017.
    If you wish further details on this estimate, we will be 
pleased to provide them. The CBO staff contact is Mark 
Grabowicz, who can be reached at 226-2860.
            Sincerely,
                                                        Keith Hall.
Enclosure.

cc: Honorable John Conyers Jr.
    Ranking Member

H.R. 2851--Stop the Importation and Trafficking of Synthetic Analogues 
                              Act of 2017.


As ordered reported by the House Committee on the Judiciary on July 12, 
                                 2017.




    H.R. 2851 would classify certain drugs, most of which 
include the pain medication fentanyl, as controlled substances. 
Individuals who wish to handle those substances, such as 
researchers or persons conducting chemical analyses, would have 
to register with the Drug Enforcement Administration (DEA) and 
pay a fee (usually a few hundred dollars per year, on average). 
Such fees are treated as reductions in direct spending and DEA 
is authorized to spend them without further appropriation to 
cover the cost of overseeing those who register. Based on 
information from the agency, CBO estimates that DEA would 
collect (and spend) less than $1 million per year from the 
additional fees; thus, the net budgetary effect would be 
negligible.
    H.R. 2851 also would establish new federal crimes related 
to misuse of the controlled substances identified in the bill. 
As a result, the government might be able to pursue cases that 
it otherwise would not be able to prosecute. CBO expects that 
the bill would apply to a relatively small number of offenders, 
however, so any increase in costs for law enforcement, court 
proceedings, or prison operations would not be significant. Any 
such spending would be subject to the availability of 
appropriated funds.
    Because those prosecuted and convicted under H.R. 2851 
could be subject to criminal fines, the federal government 
might collect additional fines under the bill. Criminal fines 
are recorded as revenues, deposited in the Crime Victims Fund, 
and later spent without further appropriation action. CBO 
expects that any additional revenues and associated direct 
spending would not be significant because the legislation would 
probably affect only a small number of cases.
    Because enacting the bill would affect direct spending and 
revenues pay-as-you-go procedures apply. However, we estimate 
that any such effects would be insignificant in any year.
    CBO estimates that enacting H.R. 2851 would not increase 
net direct spending or on-budget deficits in any of the four 
consecutive 10-year periods beginning in 2028.
    By expanding the list of drugs classified as controlled 
substances, H.R. 2851 would impose an intergovernmental and 
private-sector mandate as defined in the Unfunded Mandates 
Reform Act (UMRA). The bill would require individuals and 
facilities, including public research institutions, that wish 
to handle those drugs to register (or update their existing 
registration) with the DEA and comply with any regulatory 
controls. Based on information from DEA, CBO expects that the 
registration requirements would apply to hundreds of entities. 
CBO estimates that the cost to obtain or update a registration 
would be relatively small. Additionally, public institutions 
are exempt from the registration fee. Consequently, CBO 
estimates that the incremental cost of the mandate on public 
and private entities would be small and fall below the annual 
thresholds established in UMRA for intergovernmental and 
private-sector mandates ($78 million and $156 million in 2017, 
respectively, adjusted annually for inflation).
    The CBO staff contacts for this estimate are Mark Grabowicz 
(for federal costs), Zach Byrum (for intergovernmental 
mandates), and Amy Petz (for private-sector mandates). The 
estimate was approved by H. Samuel Papenfuss, Deputy Assistant 
Director for Budget Analysis.

                    Duplication of Federal Programs

    No provision of H.R. 2851 establishes or reauthorizes a 
program of the Federal government known to be duplicative of 
another Federal program, a program that was included in any 
report from the Government Accountability Office to Congress 
pursuant to section 21 of Public Law 111-139, or a program 
related to a program identified in the most recent Catalog of 
Federal Domestic Assistance.

                  Disclosure of Directed Rule Makings

    The Committee finds that H.R. 2851 contains no directed 
rule making within the meaning of 5 U.S.C. Sec. 551.

                    Performance Goals and Objectives

    Pursuant to clause 3(c)(4) of rule XIII of the Rules of the 
House of Representatives, the Committee states that H.R. 2851 
is designed to control the manufacture, importation, and 
distribution of synthetic drugs and restrict possession to 
qualified researchers. Specifically, the bill creates a process 
whereby synthetic drugs which are virtually identical to 
currently scheduled, dangerous drugs can be expeditiously 
identified and scheduled appropriately.

                          Advisory on Earmarks

    In accordance with clause 9 of rule XXI of the Rules of the 
House of Representatives, H.R. 2851 does not contain any 
congressional earmarks, limited tax benefits, or limited tariff 
benefits as defined in clause 9(e), 9(f), or 9(g) of rule XXI.

                      Section-by-Section Analysis

    The following discussion describes the bill as reported by 
the Committee.
    Section 1. Short Title. Section 1 sets forth the short 
title of the bill as the ``Stop the Importation and Trafficking 
of Synthetic Analogues Act (SITSA) of 2017.''
    Section 2. Establishment of Schedule A. The CSA is 
currently comprised of five drug schedules (I, II, III, IV, and 
V). Differentiation among the schedules is based on: 1) 
currently accepted medical use; 2) the degree of potential for 
abuse; and 3) the existence or lack of safety for use of the 
drug under medical supervision. Schedule I drugs have no known 
medical use and cannot be prescribed. Drugs in Schedules II 
through V have well-researched medical uses but have varying 
potentials for addiction and abuse ranging from severe 
(oxycodone and fentanyl) to low (low-dosage codeine 
preparations). Due to the very unique production, 
characteristics, and importation of synthetic drugs, Section 2 
establishes a sixth category of controlled substances known as 
``Schedule A.''
    This section defines a Schedule A substance. The definition 
is nearly identical to the current definition for a controlled 
substance analogue.\1\ The proposed Schedule A substance must 
have a chemical structure that is substantially similar to an 
existing controlled substance in Schedules I through V, and it 
must have an actual or predicted physiological effect on the 
human body equal to or greater than an existing controlled 
substance in Schedules I through V. By definition, it excludes 
new substances which are approved by the Food and Drug 
Administration (FDA) for investigational purposes.
---------------------------------------------------------------------------
    \1\21 U.S.C. Sec. 802(32)(A).
---------------------------------------------------------------------------
    Illicit drug traffickers and importers are able to 
circumvent the CSA by changing just one atom of an existing 
controlled substance. Although the change might be considered 
minor, the physical reaction to each substance can be severe, 
varying from person to person. Moreover, the research and 
chemistry communities have had no time or opportunity to 
analyze the substance's effects. Therefore, this section 
provides specific and detailed criteria by which the Attorney 
General must find that the predicted stimulant, depressant, or 
hallucinogenic effects on the central nervous system are 
substantially similar to or greater than that of an existing 
Schedule I through V controlled substance.
    This section also adds 13 variations of the drug fentanyl 
to Schedule A. Fentanyl is a powerful drug designed to treat 
severe pain (e.g., pain associated with certain late-stage 
cancers), only while under strict medical supervision. However, 
drug trafficking organizations and their chemists modify 
versions of the base fentanyl molecule to create new but 
similar-acting or sometimes more powerful substances, in order 
to circumvent the CSA controls. Law enforcement has encountered 
these modified fentanyls in the United States, Europe, Asia, 
and Africa. These fentanyls have been confirmed as the cause of 
death in at least 162 cases in the United States, with several 
more suspected. Importantly, the bill does not preclude these 
or future Schedule A drugs from becoming Schedule I through V 
drugs. It merely places controls upon the drugs, so the illicit 
trafficking can be halted.
    Section 3. Temporary and Permanent Scheduling of Schedule A 
Substances. Section 3 permits the Attorney General to issue 
temporary and permanent scheduling orders very similar to those 
in a 2014 law enacted to curb the trafficking of recently 
emerged anabolic steroids.\2\ This section provides specific 
criteria upon which the Attorney General must make findings:
---------------------------------------------------------------------------
    \2\Designer Anabolic Steroid Control Act of 2014, Pub. L. No. 113-
260 (enacted December 18, 2014).
---------------------------------------------------------------------------
          1. To issue a temporary order, the Attorney General 
        must find that the substance meets the criteria for 
        inclusion in Schedule A and must find that inclusion in 
        Schedule A will assist in preventing abuse or misuse of 
        the substance.
          2. The temporary order cannot take effect until 30 
        days after the Attorney General publishes notice in the 
        Federal Register and states the grounds for inclusion 
        in Schedule A. The temporary order may not last longer 
        than five years, with the exception that the Attorney 
        General may extend the temporary order for up to 180 
        days if the substance is in the process of being 
        declared a permanent Schedule A substance. One of the 
        purposes being that the research community must have 
        enough time to analyze and investigate these 
        substances.
When the Attorney General publishes notice in the Federal 
Register to include a substance in Schedule A, notice must also 
be transmitted to Congress. Congress has the power to 
disapprove and reverse the temporary scheduling order within 
180 days from the date of the Federal Register notice.
    Section 4. Penalties. Section 4 establishes penalties for 
manufacturing, distributing, or dispensing Schedule A 
controlled substances, or possessing with the intent to 
manufacture, distribute, or dispense Schedule A controlled 
substances. Although the majority of potential Schedule A 
substances are most closely related to those in Schedules I and 
II, the penalties established are the equivalent of those 
associated with Schedule III controlled substances, such as 
anabolic steroids. The crime of simple possession is expressly 
excluded from the possible penalties. Unlike the penalties 
associated with these offenses for Schedule I or II controlled 
substances, these penalties do not include mandatory minimum 
sentences. Penalties for a first offense of trafficking or 
distribution may include imprisonment of not more than 10 
years. Subsequent offenses may include imprisonment of not more 
than 20 years.
    This section also establishes penalties for importing or 
exporting Schedule A controlled substances, as well as 
manufacturing or distributing Schedule A controlled substances 
while intending, knowing, or having reasonable cause to believe 
these substances will be imported into the United States. These 
penalties are the equivalent of those associated with these 
offenses for Schedule I controlled substances, reflecting the 
importance of punishing and deterring drug trafficking 
organizations in China and Mexico that import these substances 
into the United States. Unlike the penalties associated with 
these offenses for Schedule I controlled substances, these 
penalties do not include mandatory minimum sentences.
    Section 5. False Labeling of Schedule A Controlled 
Substances. Section 5 adds a new subsection making it unlawful 
to import, export, manufacture, distribute, dispense, or 
traffic Schedule A substances unless they are properly labeled. 
Similar to the Designer Anabolic Steroid Act of 2014, this 
section requires all entities in the supply chain (e.g. 
retailers, importers, distributers, etc.) to clearly label the 
product with the standardized nomenclature used by the 
International Union of Pure and Applied Chemistry (IUPAC). This 
section exempts drugs or other substances from the IUPAC 
nomenclature requirement if the product is labeled in the 
manner required under the Food, Drug, and Cosmetic Act. IUPAC 
has long been recognized as the world authority on chemical 
nomenclature. This section also provides additional civil tools 
the government can impose to either shut down shops that are in 
violation of this provision or levy civil fines to go after 
organizations, retailers, or individuals who traffic synthetic 
drugs. A substance is exempt from these provisions if it is 
currently undergoing clinical trials or is subject to FDA 
approval. Violation of this subsection may include civil 
penalties of up to $1,000 per violation.
    Section 6. Registration Requirements for Handlers of 
Schedule A Substances. Section 6 requires the Attorney General 
to register applicants to import, export, manufacture, and/or 
possess synthetic drugs, provided it is for approved research, 
analytical, or industrial purposes, and ensures the applicant 
will prevent diversion of the synthetic drugs.
    A practitioner or researcher that is already registered to 
conduct research on Schedule I substances does not need to 
obtain a separate registration for Schedule A substances. 
Similarly, if a person or entity is already registered to 
manufacture, distribute, or import Schedule I or II substances, 
then a separate registration is not required. All persons and 
entities already registered need to comply with security and 
recordkeeping requirements and notify the Attorney General that 
they are handling Schedule A substances.
    Qualified individuals and research entities not currently 
registered must apply for a Schedule A registration. This 
section simplifies the registration requirements and eliminates 
the need for submission of a research protocol. As most 
Schedule A substances are quite powerful, limits are placed on 
the amounts researchers can manufacture and possess, however, a 
procedure provides for requests for increase based on 
scientific need.
    Any practitioner or researcher who is engaged in 
researching a substance that is subsequently placed on Schedule 
A must register within 90 days if not already registered to 
research Schedule I drugs.
    This section also sets strict time limits for action on 
Schedule A applications. The Attorney General must grant, deny, 
or request supplemental information within 60 days of receipt 
of an application. If supplemental information is requested 
from the applicant, the Attorney General must grant or deny a 
registration within 30 days after receipt of the requested 
supplemental information.
    Scientific investigators and qualified research 
institutions shall be registered by the Attorney General to 
conduct research with Schedule A substances dependent upon 
certain factors. Applicants currently registered to conduct 
research on Schedule I substances will be considered qualified 
to conduct research on Schedule A substances and their 
registrations will be modified accordingly. Applications from 
those not currently registered to conduct research on Schedule 
I substances shall be referred by the Attorney General to the 
Secretary of Health and Human Services, who shall determine 
whether the applicant will be engaged in bona fide research and 
is qualified to conduct such research. Approved registrants 
must conform to certain notice, quantity, and transfer 
requirements.
    Section 7. Additional Conforming Amendments. Section 7 
incorporates Schedule A in the Controlled Substances Import and 
Export Act (21 U.S.C. 959). It also incorporates requirements 
and penalties for Schedule A substances into those already 
existing for substances in Schedules I and II, categories 
reserved for the most addictive and potentially harmful of all 
controlled substances. Additions to certain provisions include: 
1) controls on importation; exportation, manufacturing, and 
distribution; 2) setting of production quotas; 3) use of 
approved order forms (to track legitimate shipments); and 4) 
forfeiture (of seized substances only).
    Section 8. Controlled Substance Analogues. Section 8 is a 
technical amendment to the definition of a controlled substance 
analogue\3\ that relates to the Analogue Enforcement Act,\4\ an 
existing tool that would be available for prosecutors even 
after the creation of Schedule A. The current wording of the 
definition in the statute has created confusion among various 
district and appellate courts about whether demonstrating any 
of the three elements of the definition would qualify a 
substance as a controlled substance analogue, which was not the 
intent of Congress when the law was passed. This section 
clarifies that, consistent with the conclusion of a majority of 
courts that have interpreted it, a substance must meet the 
first element of the definition (the substance's chemical 
structure must be substantially similar to that of a controlled 
substance in Schedule I or II) and then either of the remaining 
two elements.
---------------------------------------------------------------------------
    \3\21 U.S.C. Sec. 802(32).
    \4\21 U.S.C. Sec. 813.
---------------------------------------------------------------------------
    Section 9. Amendment of the Sentencing Guidelines. Section 
9 provides guidance in sentencing during the current 
problematic time for courts, prosecutors, and defendants. Under 
current law, after a defendant is convicted of violating 
federal law with regard to a specific controlled substance or 
an analogue of a controlled substance (21 U.S.C. 813), the 
court must then look to the sentencing guidelines to calculate 
the appropriate offense level (and from there, the sentence). 
This sentence is based on a conversion ratio of the quantity of 
the drug at issue (typically in grams) to a quantity of 
marijuana for which a sentencing structure (in months) is 
applied. The U.S. Sentencing Commission (USSC) has set forth 
several ratios in the Sentencing Guidelines Drug Equivalency 
Table.\5\ However, due to the adaptability of criminal drug 
manufacturers, importers, and traffickers, the USSC, the DEA, 
and the government at large are far behind the curve at 
establishing criteria and ratios that courts need to apply at 
sentencing. In a majority of synthetic drug convictions for 
which a sentencing equivalency does not exist, courts must now 
undertake a time and resource-intensive process to determine 
whether the chemical structure and/or physiological effects of 
the drug at issue (which does not have an equivalency) is 
substantially similar to that of a drug already referenced in 
the guidelines.\6\ Section 9 is intended to provide specific 
equivalencies for substances NOT already referenced in the 
sentencing guidelines. Courts will be able to look at three 
sources of information before having to undertake this 
laborious process. These three sources are the U.S. Sentencing 
Guidelines, guidance on a specific synthetic drug published by 
the Attorney General in the Federal Register, and the Drug 
Equivalency Table contained in this section. Courts would then 
be able to follow steps in sentencing defendants for certain 
drug offenses:
---------------------------------------------------------------------------
    \5\Federal Sentencing Guidelines Manual, Sec. 2D1.1, pg. 166, et 
seq. (Nov. 2016).
    \6\Federal Sentencing Guidelines Manual, Sec. 2D1.1, Application 
Note 6.
---------------------------------------------------------------------------
          1. If a substance is referenced in the guidelines, as 
        is currently the case, courts must follow the guideline 
        parameters for amounts and offense levels for that 
        substance.
          2. If a substance is not referenced in the 
        guidelines, and the Attorney General has provided 
        guidance on the appropriate equivalency or ratio in the 
        Federal Register, courts must apply that equivalency or 
        ratio.
          3. If the substance is not referenced in the 
        guidelines, and the Attorney General has not provided 
        guidance on the appropriate equivalency or ratio in the 
        Federal Register, courts must use the equivalency 
        provided in the table contained in this section.
          4. If the substance is not referenced in the 
        guidelines, and the Attorney General has not provided 
        guidance on the appropriate equivalency or ratio in the 
        Federal Register, and courts cannot use the equivalency 
        provided in the table (because the substance is not 
        part of a specified structural class), the court shall 
        determine an equivalency or ratio by applying the 
        factors in application note 6 (as is currently the case 
        for all substances not referenced in the guidelines).
    It is highly important to note that although courts are 
required to consult the guidelines and apply all of its 
provisions and calculate recommended guideline ranges, pursuant 
to U.S. Supreme Court decisions, courts are then free to depart 
from the guidelines.\7\ Moreover, if further evidence over time 
reveals an imbalance in an existing equivalency established by 
the USSC, the Attorney General's guidance, or the table, the 
USSC has the option to add that substance to the sentencing 
guidelines, amend an equivalency, or provide its own quantity 
thresholds and associated offense levels.
---------------------------------------------------------------------------
    \7\U.S. v. Booker, 543 U.S. 220 (2005); see also Blakely v. 
Washington, 542 U.S. 296 (2004).
---------------------------------------------------------------------------
    Currently, the government, in the absence of direct 
guidance, must persuade a judge on the appropriate sentencing 
ratio for each individual case and each substance. This 
sometimes leads to inconsistent sentences and ratios for 
synthetic analogues, even for the same substance. This section 
will help to bring clarity and uniformity to sentencing.
    Section 10. Rules of Construction. Section 10 clarifies 
that nothing in the bill affects the ability of the Attorney 
General to schedule, re-schedule, or decontrol substances under 
the current Controlled Substances Act, or to prosecute offenses 
under the Analogue Enforcement Act,\8\ or any other portion of 
the Controlled Substances Act. Thus, even after a substance is 
placed on Schedule A, the government may still subsequently 
seek to place it on another schedule instead, or to decontrol 
it, after more information about the substance is acquired. In 
addition, even after a substance is placed on Schedule A, the 
government could still attempt to prosecute a trafficker using 
the Analogue Enforcement Act, if appropriate in a given 
circumstance.
---------------------------------------------------------------------------
    \8\U.S.C. 813.
---------------------------------------------------------------------------
    Section 11. Study by Comptroller General. Section 11 
requires the Comptroller General of the United States to 
conduct a study on the costs associated with Section 4 of this 
bill.

         Changes in Existing Law Made by the Bill, as Reported

  In compliance with clause 3(e) of rule XIII of the Rules of 
the House of Representatives, changes in existing law made by 
the bill, as reported, are shown as follows (existing law 
proposed to be omitted is enclosed in black brackets, new 
matter is printed in italics, and existing law in which no 
change is proposed is shown in roman):

                       CONTROLLED SUBSTANCES ACT


                   TITLE II--CONTROL AND ENFORCEMENT


Part A--Short Title; Findings and Declaration; Definitions

           *       *       *       *       *       *       *



                              definitions

  Sec. 102. As used in this title:
  (1) The term ``addict'' means any individual who habitually 
uses any narcotic drug so as to endanger the public morals, 
health, safety, or welfare, or who is so far addicted to the 
use of narcotic drugs as to have lost the power of self-control 
with reference to his addiction.
  (2) The term ``administer'' refers to the direct application 
of a controlled substance to the body of a patient or research 
subject by--
          (A) a practitioner (or, in his presence, by his 
        authorized agent), or
          (B) the patient or research subject at the direction 
        and in the presence of the practitioner,
whether such application be by injection, inhalation, 
ingestion, or any other means.
  (3) The term ``agent'' means an authorized person who acts on 
behalf of or at the direction of a manufacturer, distributor, 
or dispenser; except that such term does not include a common 
or contract carrier, public warehouseman, or employee of the 
carrier or warehouseman, when acting in the usual and lawful 
course of the carrier's or warehouseman's business.
  (4) The term ``Drug Enforcement Administration'' means the 
Drug Enforcement Administration in the Department of Justice.
  (5) The term ``control'' means to add a drug or other 
substance, or immediate precursor, to a schedule under part B 
of this title, whether by transfer from another schedule or 
otherwise.
  (6) The term ``controlled substance'' means a drug or other 
substance, or immediate precursor, included in schedule I, II, 
III, IV, [or V] V, or A of part B of this title. The term does 
not include distilled spirits, wine, malt beverages, or 
tobacco, as those terms are defined or used in subtitle E of 
the Internal Revenue Code of 1954.
  (7) The term ``counterfeit substance'' means a controlled 
substance which, or the container or labeling of which, without 
authorization, bears the trademark, trade name, or other 
identifying mark, imprint, number, or device, or any likeness 
thereof, of a manufacturer, distributor, or dispenser other 
than the person or persons who in fact manufactured, 
distributed, or dispensed such substance and which thereby 
falsely purports or is represented to be the product of, or to 
have been distributed by, such other manufacturer, distributor, 
or dispenser.
  (8) The terms ``deliver'' or ``delivery'' mean the actual, 
constructive, or attempted transfer of a controlled substance 
or a listed chemical, whether or not there exists an agency 
relationship.
  (9) The term ``depressant or stimulant substance'' means--
          (A) a drug which contains any quantity of barbituric 
        acid or any of the salts of barbituric acid; or
          (B) a drug which contains any quantity of (i) 
        amphetamine or any of its optical isomers; (ii) any 
        salt of amphetamine or any salt of an optical isomer of 
        amphetamine; or (iii) any substance which the Attorney 
        General, after investigation, has found to be, and by 
        regulation designated as, habit forming because of its 
        stimulant effect on the central nervous system; or
          (C) lysergic acid diethylamide; or
          (D) any drug which contains any quantity of a 
        substance which the Attorney General, after 
        investigation, has found to have, and by regulation 
        designated as having, a potential for abuse because of 
        its depressant or stimulant effect on the central 
        nervous system or its hallucinogenic effect.
  (10) The term ``dispense'' means to deliver a controlled 
substance to an ultimate user or research subject by, or 
pursuant to the lawful order of, a practitioner, including the 
prescribing and administering of a controlled substance and the 
packaging, labeling, or compounding necessary to prepare the 
substance for such delivery. The term ``dispenser'' means a 
practitioner who so delivers a controlled substance to an 
ultimate user or research subject.
  (11) The term ``distribute'' means to deliver (other than by 
administering or dispensing) a controlled substance or a listed 
chemical. The term ``distributor'' means a person who so 
delivers a controlled substance or a listed chemical.
  (12) The term ``drug'' has the meaning given that term by 
section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act.
  (13) The term ``felony'' means any Federal or State offense 
classified by applicable Federal or State law as a felony.
  (14) The term ``isomer'' means the optical isomer, except as 
used in [schedule I(c) and] schedule I(c), schedule A, and 
schedule II(a)(4). As used in [schedule I(c),] schedule I(c) 
and schedule A, the term ``isomer'' means any optical, 
positional, or geometric isomer. As used in schedule II(a)(4), 
the term ``isomer'' means any optical or geometric isomer.
  (15) The term ``manufacture'' means the production, 
preparation, propagation, compounding, or processing of a drug 
or other substance, either directly or indirectly or by 
extraction from substances of natural origin, or independently 
by means of chemical synthesis or by a combination of 
extraction and chemical synthesis, and includes any packaging 
or repackaging of such substance or labeling or relabeling of 
its container; except that such term does not include the 
preparation, compounding, packaging, or labeling of a drug or 
other substance in conformity with applicable State or local 
law by a practitioner as an incident to his administration or 
dispensing of such drug or substance in the course of his 
professional practice. The term ``manufacturer'' means a person 
who manufactures a drug or other substance.
  (16) The term ``marihuana'' means all parts of the plant 
Cannabis sativa L., whether growing or not; the seeds thereof; 
the resin extracted from any part of such plant; and every 
compound, manufacture, salt, derivative, mixture, or 
preparation of such plant, its seeds or resin. Such term does 
not include the mature stalks of such plant, fiber produced 
from such stalks, oil or cake made from the seeds of such 
plant, any other compound, manufacture, salt, derivative, 
mixture, or preparation of such mature stalks (except the resin 
extracted therefrom), fiber, oil, or cake, or the sterilized 
seed of such plant which is incapable of germination.
  (17) The term ``narcotic drug'' means any of the following 
whether produced directly or indirectly by extraction from 
substances of vegetable origin, or independently by means of 
chemical synthesis, or by a combination of extraction and 
chemical synthesis:
          (A) Opium, opiates, derivatives of opium and opiates, 
        including their isomers, esters, whenever the existence 
        of such isomers, esters, ethers, and salts is possible 
        within the specific chemical designation. Such term 
        does not include the isoquinoline alkaloids of opium.
          (B) Poppy straw and concentrate of poppy straw.
          (C) Coca leaves, except coca leaves and extracts of 
        coca leaves from which cocaine, ecgonine, and 
        derivatives of ecgonine or their salts have been 
        removed.
          (D) Cocaine, its salts, optical and geometric 
        isomers, and salts of isomers.
          (E) Ecgonine, its derivatives, their salts, isomers, 
        and salts of isomers.
          (F) Any compound, mixture, or preparation which 
        contains any quantity of any of the substances referred 
        to in subparagraphs (A) through (E).
  (18) The term ``opiate''or ``opioid'' means any drug or other 
substance having an addiction-forming or addiction-sustaining 
liability similar to morphine or being capable of conversion 
into a drug having such addiction-forming or addiction-
sustaining liability.
  (19) The term ``opium poppy'' means the plant of the species 
Papaver somniferum L., except the seed thereof.
  (20) The term ``poppy straw'' means all parts, except the 
seeds, of the opium poppy, after mowing.
  (21) The term ``practitioner'' means a physician, dentist, 
veterinarian, scientific investigator, pharmacy, hospital, or 
other person licensed, registered, or otherwise permitted, by 
the United States or the jurisdiction in which he practices or 
does research, to distribute, dispense, conduct research with 
respect to, administer, or use in teaching or chemical 
analysis, a controlled substance in the course of professional 
practice or research.
  (22) The term ``production'' includes the manufacture, 
planting, cultivation, growing, or harvesting of a controlled 
substance.
  (23) The term ``immediate precursor'' means a substance--
          (A) which the Attorney General has found to be and by 
        regulation designated as being the principal compound 
        used, or produced primarily for use, in the manufacture 
        of a controlled substance;
          (B) which is an immediate chemical intermediary used 
        or likely to be used in the manufacture of such 
        controlled substance; and
          (C) the control of which is necessary to prevent, 
        curtail, or limit the manufacture of such controlled 
        substance.
  (24) The term ``Secretary'', unless the context otherwise 
indicates, means the Secretary of Health, Education, and 
Welfare.
  (25) The term ``serious bodily injury'' means bodily injury 
which involves--
          (A) a substantial risk of death;
          (B) protracted and obvious disfigurement; or
          (C) protracted loss or impairment of the function of 
        a bodily member, or organ, or mental faculty.
          (26) The term ``State'' means a State of the United 
        States, the District of Columbia, and any commonwealth, 
        territory, or possession of the United States.
  (27) The term ``ultimate user'' means a person who has 
lawfully obtained, and who possesses, a controlled substance 
for his own use or for the use of a member of his household or 
for an animal owned by him or by a member of his household.
  (28) The term ``United States'', when used in a geographic 
sense, means all places and waters, continental or insular, 
subject to the jurisdiction of the United States.
  (29) The term ``maintenance treatment'' means the dispensing, 
for a period in excess of twenty-one days, of a narcotic drug 
in the treatment of an individual for dependence upon heroin or 
other morphine-like drugs.
  (30) The term ``detoxification treatment'' means the 
dispensing, for a period not in excess of one hundred and 
eighty days, of a narcotic drug in decreasing doses to an 
individual in order to alleviate adverse physiological or 
psychological effects incident to withdrawal from the 
continuous or sustained use of a narcotic drug and as a method 
of bringing the individual to a narcotic drug-free state within 
such period.
  (31) The term ``Convention on Psychotropic Substances'' means 
the Convention on Psychotropic Substances signed at Vienna, 
Austria, on February 21, 1971; and the term ``Single Convention 
on Narcotic Drugs'' means the Single Convention on Narcotic 
Drugs signed at New York, New York, on March 30, 1961.
  (32)(A) [Except as provided in subparagraph (C), the term 
``controlled substance analogue'' means a substance--] 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) the chemical structure of which is substantially 
        similar to the chemical structure of a controlled 
        substance in schedule I or II;
          [(ii) 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
          [(iii) 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.]
                  (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.
  (B) The designation of gamma butyrolactone or any other 
chemical as a listed chemical pursuant to paragraph (34) or 
(35) does not preclude a finding pursuant to subparagraph (A) 
of this paragraph that the chemical is a controlled substance 
analogue.
  (C) Such term does not include--
          (i) a controlled substance;
          (ii) any substance for which there is an approved new 
        drug application;
          (iii) with respect to a particular person any 
        substance, if an exemption 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; or
          (iv) any substance to the extent not intended for 
        human consumption before such an exemption takes effect 
        with respect to that substance.
  (33) The term ``listed chemical'' means any list I chemical 
or any list II chemical.
  (34) The term ``list I chemical'' means a chemical specified 
by regulation to the Attorney General as a chemical that is 
used in manufacturing a controlled substance in violation of 
this title and is important to the manufacture of the 
controlled substances, and such term includes (until otherwise 
specified by regulation of the Attorney General, as considered 
appropriate by the Attorney General or upon petition to the 
Attorney General by any person) the following:
          (A) Anthranilic acid, its esters, and its salts.
          (B) Benzyl cyanide.
          (C) Ephedrine, its salts, optical isomers, and salts 
        of optical isomers.
          (D) Ergonovine and its salts.
          (E) Ergotamine and its salts.
          (F) N-Acetylanthranilic acid, its esters, and its 
        salts.
          (G) Norpseudoephedrine, its salts, optical isomers, 
        and salts of
          (H) Phenylacetic acid, its esters, and its salts.
          (I) Phenylpropanolamine, its salts, optical isomers, 
        and salts of optical isomers.
          (J) Piperidine and its salts.
          (K) Pseudoephedrine, its salts, optical isomers, and 
        salts of optical isomers.
          (L) 3,4-Methylenedioxyphenyl-2-propanone.
          (M) Methylamine.
          (N) Ethylamine.
          (O) Propionic anhydride.
          (P) Isosafrole.
          (Q) Safrole.
          (R) Piperonal.
          (S) N-Methylephedrine.
          (T) N-methylpseudoephedrine.
          (U) Hydriodic acid.
          (V) Benzaldehyde.
          (W) Nitroethane.
          (X) Gamma butyrolactone.
          (Y) Any salt, optical isomer, or salt of an optical 
        isomer of the chemicals listed in subparagraphs (M) 
        through (U) of this paragraph.
  (35) The term ``list II chemical'' means a chemical (other 
than a list I chemical) specified by regulation of the Attorney 
General as a chemical that is used in manufacturing a 
controlled substance in violation of this title, and such term 
includes (until otherwise specified by regulation of the 
Attorney General, as considered appropriate by the Attorney 
General or upon petition to the Attorney General by any person) 
the following chemicals:
          (A) Acetic anhydride.
          (B) Acetone.
          (C) Benzyl chloride.
          (D) Ethyl ether.
          (F) Potassium permanaganate.
          (G) 2-Butanone (or Methyl Ethyl Ketone).
          (H) Toluene.
          (I) Iodine.
          (J) Hydrochloric gas.
  (36) The term ``regular customer'' means, with respect to a 
regulated person, a customer with whom the regulated person has 
an established business relationship that is reported to the 
Attorney General.
  (37) The term ``regular importer'' means, with respect to a 
listed chemical, a person that has an established record as an 
importer of that listed chemical that is reported to the 
Attorney General.
  (38) The term ``regulated person'' means a person who 
manufactures, distributes, imports, or exports a listed 
chemical, a tableting machine, or an encapsulating machine or 
who acts as a broker or trader for an international transaction 
involving a listed chemical, a tableting machine, or an 
encapsulating machine.
  (39) The term ``regulated transaction'' means--
          (A) a distribution, receipt, sale, importation, or 
        exportation of, or an international transaction 
        involving shipment of, a listed chemical, or if the 
        Attorney General establishes a threshold amount for a 
        specific listed chemical, a threshold amount, including 
        a cumulative threshold amount for multiple transactions 
        (as determined by the Attorney General, in consultation 
        with the chemical industry and taking into 
        consideration the quantities normally used for lawful 
        purposes), of a listed chemical, except that such term 
        does not include--
                  (i) a domestic lawful distribution in the 
                usual course of business between agents or 
                employees of a single regulated person;
                  (ii) a delivery of a listed chemical to or by 
                a common or contract carrier for carriage in 
                the lawful and usual course of the business of 
                the common or contract carrier, or to or by a 
                warehouseman for storage in the lawful and 
                usual course of the business of the 
                warehouseman, except that if the carriage or 
                storage is in connection with the distribution, 
                importation, or exportation of a listed 
                chemical to a third person, this clause does 
                not relieve a distributor, importer, or 
                exporter from compliance with section 310;
                  (iii) any category of transaction or any 
                category of transaction for a specific listed 
                chemical or chemicals specified by regulation 
                of the Attorney General as excluded from this 
                definition as unnecessary for enforcement of 
                this title or title III;
                  (iv) any transaction in a listed chemical 
                that is contained in a drug that may be 
                marketed or distributed lawfully in the United 
                States under the Federal Food, Drug, and 
                Cosmetic Act, subject to clause (v), unless--
                          (I) the Attorney General has 
                        determined under section 204 that the 
                        drug or group of drugs is being 
                        diverted to obtain the listed chemical 
                        for use in the illicit production of a 
                        controlled substance; and
                          (II) the quantity of the listed 
                        chemical contained in the drug included 
                        in the transaction or multiple 
                        transactions equals or exceeds the 
                        threshold established for that chemical 
                        by the Attorney General;
                  (v) any transaction in a scheduled listed 
                chemical product that is a sale at retail by a 
                regulated seller or a distributor required to 
                submit reports under section 310(b)(3); or
                  (vi) any transaction in a chemical mixture 
                which the Attorney General has by regulation 
                designated as exempt from the application of 
                this title and title III based on a finding 
                that the mixture is formulated in such a way 
                that it cannot be easily used in the illicit 
                production of a controlled substance and that 
                the listed chemical or chemicals contained in 
                the mixture cannot be readily recovered; and
          (B) a distribution, importation, or exportation of a 
        tableting machine or encapsulating machine.
  (40) The term ``chemical mixture'' means a combination of two 
or more chemical substances, at least one of which is not a 
list I chemical or a list II chemical, except that such term 
does not include any combination of a list I chemical or a list 
II chemical with another chemical that is present solely as an 
impurity.
  (41)(A) The term ``anabolic steroid'' means any drug or 
hormonal substance, chemically and pharmacologically related to 
testosterone (other than estrogens, progestins, 
corticosteroids, and dehydroepiandrosterone), and includes--
          (i) androstanediol--
                  (I) 3b,17b-dihydroxy-5a-androstane; and
                  (II) 3a,17b-dihydroxy-5a-androstane;
          (ii) androstanedione (5a-androstan-3,17-dione);
          (iii) androstenediol--
                  (I) 1-androstenediol (3b,17b-dihydroxy-5a-
                androst-1-ene);
                  (II) 1-androstenediol (3a,17b-dihydroxy-5a-
                androst-1-ene);
                  (III) 4-androstenediol (3b,17b-dihydroxy-
                androst-4-ene); and
                  (IV) 5-androstenediol (3b,17b-dihydroxy-
                androst-5-ene);
          (iv) androstenedione--
                  (I) 1-androstenedione ([5a]-androst-1-en-
                3,17-dione);
                  (II) 4-androstenedione (androst-4-en-3,17-
                dione); and
                  (III) 5-androstenedione (androst-5-en-3,17-
                dione);
          (v) bolasterone (7a,17a-dimethyl-17b-hydroxyandrost-
        4-en-3-one);
          (vi) boldenone (17b-hydroxyandrost-1,4,-diene-3-one);
          (vii) calusterone (7b,17a-dimethyl-17b-
        hydroxyandrost-4-en-3-one);
          (viii) clostebol (4-chloro-17b-hydroxyandrost-4-en-3-
        one);
          (ix) dehydrochloromethyltestosterone (4-chloro-17b-
        hydroxy-17a-methyl-androst-1,4-dien-3-one);
          (x) 1-dihydrotestosterone (a.k.a. ``1-
        testosterone'') (17b-hydroxy-5a-androst-1-en-3-one);
          (xi) 4-dihydrotestosterone (17b-hydroxy-androstan-3-
        one);
          (xii) drostanolone (17b-hydroxy-2a-methyl-5a-
        androstan-3-one);
          (xiii) ethylestrenol (17a-ethyl-17b-hydroxyestr-4-
        ene);
          (xiv) fluoxymesterone (9-fluoro-17a-methyl-11b,17b-
        dihydroxyandrost-4-en-3-one);
          (xv) formebolone (2-formyl-17a-methyl-11a,17b-
        dihydroxyandrost-1,4-dien-3-one);
          (xvi) furazabol (17a-methyl-17b-
        hydroxyandrostano[2,3-c]-furazan);
          (xvii) 13b-ethyl-17b-hydroxygon-4-en-3-one;
          (xviii) 4-hydroxytestosterone (4,17b-dihydroxy-
        androst-4-en-3-one);
          (xix) 4-hydroxy-19-nortestosterone (4,17b-dihydroxy-
        estr-4-en-3-one);
          (xx) mestanolone (17a-methyl-17b-hydroxy-5a-
        androstan-3-one);
          (xxi) mesterolone (1a-methyl-17b-hydroxy-[5a]-
        androstan-3-one);
          (xxii) methandienone (17a-methyl-17b-hydroxyandrost-
        1,4-dien-3-one);
          (xxiii) methandriol (17a-methyl-3b,17b-
        dihydroxyandrost-5-ene);
          (xxiv) methenolone (1-methyl-17b-hydroxy-5a-androst-
        1-en-3-one);
          (xxv) 17a-methyl-3b, 17b-dihydroxy-5a-androstane;
          (xxvi) 17a-methyl-3a,17b-dihydroxy-5a-androstane;
          (xxvii) 17a-methyl-3b,17b-dihydroxyandrost-4-ene.
          (xxviii) 17a-methyl-4-hydroxynandrolone (17a-methyl-
        4-hydroxy-17b-hydroxyestr-4-en-3-one);
          (xxix) methyldienolone (17a-methyl-17b-hydroxyestra-
        4,9(10)-dien-3-one);
          (xxx) methyltrienolone (17a-methyl-17b-hydroxyestra-
        4,9-11-trien-3-one);
          (xxxi) methyltestosterone (17a-methyl-17b-
        hydroxyandrost-4-en-3-one);
          (xxxii) mibolerone (7a,17a-dimethyl-17b-hydroxyestr-
        4-en-3-one);
          (xxxiii) 17a-methyl-D1-dihydrotestosterone (17b-
        hydroxy-17a-methyl-5a-androst-1-en-3-one) (a.k.a. ``17-
        a-methyl-1-testosterone'');
          (xxxiv) nandrolone (17b-hydroxyestr-4-en-3-one);
          (xxxv) norandrostenediol--
                  (I) 19-nor-4-androstenediol (3b, 17b-
                dihydroxyestr-4-ene);
                  (II) 19-nor-4-androstenediol (3a, 17b-
                dihydroxyestr-4-ene);
                  (III) 19-nor-5-androstenediol (3b, 17b-
                dihydroxyestr-5-ene); and
                  (IV) 19-nor-5-androstenediol (3a, 17b-
                dihydroxyestr-5-ene);
          (xxxvi) norandrostenedione--
                  (I) 19-nor-4-androstenedione (estr-4-en-3,17-
                dione); and
                  (II) 19-nor-5-androstenedione (estr-5-en-
                3,17-dione;
          (xxxvii) norbolethone (13b,17a-diethyl-17b-
        hydroxygon-4-en-3-one);
          (xxxviii) norclostebol (4-chloro-17b-hydroxyestr-4-
        en-3-one);
          (xxxix) norethandrolone (17a-ethyl-17b-hydroxyestr-4-
        en-3-one);
          (xl) normethandrolone (17a-methyl-17b-hydroxyestr-4-
        en-3-one);
          (xli) oxandrolone (17a-methyl-17b-hydroxy-2-oxa-[5a]-
        androstan-3-one);
          (xlii) oxymesterone (17a-methyl-4,17b-
        dihydroxyandrost-4-en-3-one);
          (xliii) oxymetholone (17a-methyl-2-hydroxymethylene-
        17b-hydroxy-[5a]-androstan-3-one);
          (xliv) stanozolol (17a-methyl-17b-hydroxy-[5a]-
        androst-2-eno[3,2-c]-pyrazole);
          (xlv) stenbolone (17b-hydroxy-2-methyl-[5a]-androst-
        1-en-3-one);
          (xlvi) testolactone (13-hydroxy-3-oxo-13,17-
        secoandrosta-1,4-dien-17-oic acid lactone);
          (xlvii) testosterone (17b-hydroxyandrost-4-en-3-one);
          (xlviii) tetrahydrogestrinone (13b,17a-diethyl-17b-
        hydroxygon-4,9,11-trien-3-one);
          (xlix) trenbolone (17b-hydroxyestr-4,9,11-trien-3-
        one);
          (l) 5a-Androstan-3,6,17-trione;
          (li) 6-bromo-androstan-3,17-dione;
          (lii) 6-bromo-androsta-1,4-diene-3,17-dione;
          (liii) 4-chloro-17a-methyl-androsta-1,4-diene-3,17b-
        diol;
          (liv) 4-chloro-17a-methyl-androst-4-ene-3b,17b-diol;
          (lv) 4-chloro-17a-methyl-17b-hydroxy-androst-4-en-3-
        one;
          (lvi) 4-chloro-17a-methyl-17b-hydroxy-androst-4-ene-
        3,11-dione;
          (lvii) 4-chloro-17a-methyl-androsta-1,4-diene-3,17b-
        diol;
          (lviii) 2a,17a-dimethyl-17b-hydroxy-5a-androstan-3-
        one;
          (lix) 2a,17a-dimethyl-17b-hydroxy-5b-androstan-3-one;
          (lx) 2a,3a-epithio-17a-methyl-5a-androstan-17b-ol;
          (lxi) [3,2-c]-furazan-5a-androstan-17b-ol;
          (lxii) 3b-hydroxy-estra-4,9,11-trien-17-one;
          (lxiii) 17a-methyl-androst-2-ene-3,17b-diol;
          (lxiv) 17a-methyl-androsta-1,4-diene-3,17b-diol;
          (lxv) Estra-4,9,11-triene-3,17-dione;
          (lxvi) 18a-Homo-3-hydroxy-estra-2,5(10)-dien-17-one;
          (lxvii) 6a-Methyl-androst-4-ene-3,17-dione;
          (lxviii) 17a-Methyl-androstan-3-hydroxyimine-17b-ol;
          (lxix) 17a-Methyl-5a-androstan-17b-ol;
          (lxx) 17b-Hydroxy-androstano[2,3-d]isoxazole;
          (lxxi) 17b-Hydroxy-androstano[3,2-c]isoxazole;
          (lxxii) 4-Hydroxy-androst-4-ene-3,17-dione[3,2-
        c]pyrazole-5a-androstan-17b-ol;
          (lxxiii) [3,2-c]pyrazole-androst-4-en-17b-ol;
          (lxxiv) [3,2-c]pyrazole-5a-androstan-17b-ol; and
          (lxxv) any salt, ester, or ether of a drug or 
        substance described in this paragraph.
The substances excluded under this subparagraph may at any time 
be scheduled by the Attorney General in accordance with the 
authority and requirements of subsections (a) through (c) of 
section 201.
          (B)(i) Except as provided in clause (ii), such term 
        does not include an anabolic steroid which is expressly 
        intended for administration through implants to cattle 
        or other nonhuman species and which has been approved 
        by the Secretary of Health and Human Services for such 
        administration.
          (ii) If any person prescribes, dispenses, or 
        distributes such steroid for human use, such person 
        shall be considered to have prescribed, dispensed, or 
        distributed an anabolic steroid within the meaning of 
        subparagraph (A).
  (C)(i) Subject to clause (ii), a drug or hormonal substance 
(other than estrogens, progestins, corticosteroids, and 
dehydroepiandrosterone) that is not listed in subparagraph (A) 
and is derived from, or has a chemical structure substantially 
similar to, 1 or more anabolic steroids listed in subparagraph 
(A) shall be considered to be an anabolic steroid for purposes 
of this Act if--
          (I) the drug or substance has been created or 
        manufactured with the intent of producing a drug or 
        other substance that either--
                  (aa) promotes muscle growth; or
                  (bb) otherwise causes a pharmacological 
                effect similar to that of testosterone; or
          (II) the drug or substance has been, or is intended 
        to be, marketed or otherwise promoted in any manner 
        suggesting that consuming it will promote muscle growth 
        or any other pharmacological effect similar to that of 
        testosterone.
  (ii) A substance shall not be considered to be a drug or 
hormonal substance for purposes of this subparagraph if it--
          (I) is--
                  (aa) an herb or other botanical;
                  (bb) a concentrate, metabolite, or extract 
                of, or a constituent isolated directly from, an 
                herb or other botanical; or
                  (cc) a combination of 2 or more substances 
                described in item (aa) or (bb);
          (II) is a dietary ingredient for purposes of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et 
        seq.); and
          (III) is not anabolic or androgenic.
  (iii) In accordance with section 515(a), any person claiming 
the benefit of an exemption or exception under clause (ii) 
shall bear the burden of going forward with the evidence with 
respect to such exemption or exception.
  (42) The term ``international transaction'' means a 
transaction involving the shipment of a listed chemical across 
an international border (other than a United States border) in 
which a broker or trader located in the United States 
participates.
  (43) The terms ``broker'' and ``trader'' mean a person that 
assists in arranging an international transaction in a listed 
chemical by--
          (A) negotiating contracts;
          (B) serving as an agent or intermediary; or
          (C) bringing together a buyer and seller, a buyer and 
        transporter, or a seller and transporter.
  (44) The term ``felony drug offense'' means an offense that 
is punishable by imprisonment for more than one year under any 
law of the United States or of a State or foreign country that 
prohibits or restricts conduct relating to narcotic drugs, 
marihuana, anabolic steroids, or depressant or stimulant 
substances.
  (45)(A) The term ``scheduled listed chemical product'' means, 
subject to subparagraph (B), a product that--
          (i) contains ephedrine, pseudoephedrine, or 
        phenylpropanolamine; and
          (ii) may be marketed or distributed lawfully in the 
        United States under the Federal, Food, Drug, and 
        Cosmetic Act as a nonprescription drug.
Each reference in clause (i) to ephedrine, pseudoephedrine, or 
phenylpropanolamine includes each of the salts, optical 
isomers, and salts of optical isomers of such chemical.
  (B) Such term does not include a product described in 
subparagraph (A) if the product contains a chemical specified 
in such subparagraph that the Attorney General has under 
section 201(a) added to any of the schedules under section 
202(c). In the absence of such scheduling by the Attorney 
General, a chemical specified in such subparagraph may not be 
considered to be a controlled substance.
  (46) The term ``regulated seller'' means a retail distributor 
(including a pharmacy or a mobile retail vendor), except that 
such term does not include an employee or agent of such 
distributor.
  (47) The term ``mobile retail vendor'' means a person or 
entity that makes sales at retail from a stand that is intended 
to be temporary, or is capable of being moved from one location 
to another, whether the stand is located within or on the 
premises of a fixed facility (such as a kiosk at a shopping 
center or an airport) or whether the stand is located on 
unimproved real estate (such as a lot or field leased for 
retail purposes).
  (48) The term ``at retail'', with respect to the sale or 
purchase of a scheduled listed chemical product, means a sale 
or purchase for personal use, respectively.
          (49)(A) The term ``retail distributor'' means a 
        grocery store, general merchandise store, drug store, 
        or other entity or person whose activities as a 
        distributor relating to ephedrine, pseudoephedrine, or 
        phenylpropanolamine products are limited almost 
        exclusively to sales for personal use, both in number 
        of sales and volume of sales, either directly to walk-
        in customers or in face-to-face transactions by direct 
        sales.
          (B) For purposes of this paragraph, entities are 
        defined by reference to the Standard Industrial 
        Classification (SIC) code, as follows:
                  (i) A grocery store is an entity within SIC 
                code 5411.
                  (ii) A general merchandise store is an entity 
                within SIC codes 5300 through 5399 and 5499.
                  (iii) A drug store is an entity within SIC 
                code 5912.
  (50) The term ``Internet'' means collectively the myriad of 
computer and telecommunications facilities, including equipment 
and operating software, which comprise the interconnected 
worldwide network of networks that employ the Transmission 
Control Protocol/Internet Protocol, or any predecessor or 
successor protocol to such protocol, to communicate information 
of all kinds by wire or radio.
  (51) The term ``deliver, distribute, or dispense by means of 
the Internet'' refers, respectively, to any delivery, 
distribution, or dispensing of a controlled substance that is 
caused or facilitated by means of the Internet.
  (52) The term ``online pharmacy''--
          (A) means a 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 by means of the Internet; and
          (B) does not include--
                  (i) manufacturers or distributors registered 
                under subsection (a), (b), (d), or (e) of 
                section 303 who do not dispense controlled 
                substances to an unregistered individual or 
                entity;
                  (ii) nonpharmacy practitioners who are 
                registered under section 303(f) and whose 
                activities are authorized by that registration;
                  (iii) any hospital or other medical facility 
                that is operated by an agency of the United 
                States (including the Armed Forces), provided 
                such hospital or other facility is registered 
                under section 303(f);
                  (iv) a health care facility owned or operated 
                by an Indian tribe or tribal organization, only 
                to the extent such facility is carrying out a 
                contract or compact under the Indian Self-
                Determination and Education Assistance Act;
                  (v) any agent or employee of any hospital or 
                facility referred to in clause (iii) or (iv), 
                provided such agent or employee is lawfully 
                acting in the usual course of business or 
                employment, and within the scope of the 
                official duties of such agent or employee, with 
                such hospital or facility, and, with respect to 
                agents or employees of health care facilities 
                specified in clause (iv), only to the extent 
                such individuals are furnishing services 
                pursuant to the contracts or compacts described 
                in such clause;
                  (vi) mere advertisements that do not attempt 
                to facilitate an actual transaction involving a 
                controlled substance;
                  (vii) a person, entity, or Internet site that 
                is not in the United States and does not 
                facilitate the delivery, distribution, or 
                dispensing of a controlled substance by means 
                of the Internet to any person in the United 
                States;
                  (viii) a pharmacy registered under section 
                303(f) whose dispensing of controlled 
                substances via the Internet consists solely 
                of--
                          (I) refilling prescriptions for 
                        controlled substances in schedule III, 
                        IV, or V, as defined in paragraph (55); 
                        or
                          (II) filling new prescriptions for 
                        controlled substances in schedule III, 
                        IV, or V, as defined in paragraph (56); 
                        or
                  (ix) any other persons for whom the Attorney 
                General and the Secretary have jointly, by 
                regulation, found it to be consistent with 
                effective controls against diversion and 
                otherwise consistent with the public health and 
                safety to exempt from the definition of an 
                ``online pharmacy''.
  (53) The term ``homepage'' means the opening or main page or 
screen of the website of an online pharmacy that is viewable on 
the Internet.
  (54) The term ``practice of telemedicine'' means, for 
purposes of this title, the practice of medicine in accordance 
with applicable Federal and State laws by a practitioner (other 
than a pharmacist) who is at a location remote from the patient 
and is communicating with the patient, or health care 
professional who is treating the patient, using a 
telecommunications system referred to in section 1834(m) of the 
Social Security Act, which practice--
          (A) is being conducted--
                  (i) while the patient is being treated by, 
                and physically located in, a hospital or clinic 
                registered under section 303(f); and
                  (ii) by a practitioner--
                          (I) acting in the usual course of 
                        professional practice;
                          (II) acting in accordance with 
                        applicable State law; and
                          (III) registered under section 303(f) 
                        in the State in which the patient is 
                        located, unless the practitioner--
                                  (aa) is exempted from such 
                                registration in all States 
                                under section 302(d); or
                                  (bb) is--
                                          (AA) an employee or 
                                        contractor of the 
                                        Department of Veterans 
                                        Affairs who is acting 
                                        in the scope of such 
                                        employment or contract; 
                                        and
                                          (BB) registered under 
                                        section 303(f) in any 
                                        State or is utilizing 
                                        the registration of a 
                                        hospital or clinic 
                                        operated by the 
                                        Department of Veterans 
                                        Affairs registered 
                                        under section 303(f);
          (B) is being conducted while the patient is being 
        treated by, and in the physical presence of, a 
        practitioner--
                  (i) acting in the usual course of 
                professional practice;
                  (ii) acting in accordance with applicable 
                State law; and
                  (iii) registered under section 303(f) in the 
                State in which the patient is located, unless 
                the practitioner--
                          (I) is exempted from such 
                        registration in all States under 
                        section 302(d); or
                          (II) is--
                                  (aa) an employee or 
                                contractor of the Department of 
                                Veterans Affairs who is acting 
                                in the scope of such employment 
                                or contract; and
                                  (bb) registered under section 
                                303(f) in any State or is using 
                                the registration of a hospital 
                                or clinic operated by the 
                                Department of Veterans Affairs 
                                registered under section 
                                303(f);
          (C) is being conducted by a practitioner--
                  (i) who is an employee or contractor of the 
                Indian Health Service, or is working for an 
                Indian tribe or tribal organization under its 
                contract or compact with the Indian Health 
                Service under the Indian Self-Determination and 
                Education Assistance Act;
                  (ii) acting within the scope of the 
                employment, contract, or compact described in 
                clause (i); and
                  (iii) who is designated as an Internet 
                Eligible Controlled Substances Provider by the 
                Secretary under section 311(g)(2);
          (D)(i) is being conducted during a public health 
        emergency declared by the Secretary under section 319 
        of the Public Health Service Act; and
          (ii) involves patients located in such areas, and 
        such controlled substances, as the Secretary, with the 
        concurrence of the Attorney General, designates, 
        provided that such designation shall not be subject to 
        the procedures prescribed by subchapter II of chapter 5 
        of title 5, United States Code;
          (E) is being conducted by a practitioner who has 
        obtained from the Attorney General a special 
        registration under section 311(h);
          (F) is being conducted--
                  (i) in a medical emergency situation--
                          (I) that prevents the patient from 
                        being in the physical presence of a 
                        practitioner registered under section 
                        303(f) who is an employee or contractor 
                        of the Veterans Health Administration 
                        acting in the usual course of business 
                        and employment and within the scope of 
                        the official duties or contract of that 
                        employee or contractor;
                          (II) that prevents the patient from 
                        being physically present at a hospital 
                        or clinic operated by the Department of 
                        Veterans Affairs registered under 
                        section 303(f);
                          (III) during which the primary care 
                        practitioner of the patient or a 
                        practitioner otherwise practicing 
                        telemedicine within the meaning of this 
                        paragraph is unable to provide care or 
                        consultation; and
                          (IV) that requires immediate 
                        intervention by a health care 
                        practitioner using controlled 
                        substances to prevent what the 
                        practitioner reasonably believes in 
                        good faith will be imminent and serious 
                        clinical consequences, such as further 
                        injury or death; and
                  (ii) by a practitioner that--
                          (I) is an employee or contractor of 
                        the Veterans Health Administration 
                        acting within the scope of that 
                        employment or contract;
                          (II) is registered under section 
                        303(f) in any State or is utilizing the 
                        registration of a hospital or clinic 
                        operated by the Department of Veterans 
                        Affairs registered under section 
                        303(f); and
                          (III) issues a controlled substance 
                        prescription in this emergency context 
                        that is limited to a maximum of a 5-day 
                        supply which may not be extended or 
                        refilled; or
          (G) is being conducted under any other circumstances 
        that the Attorney General and the Secretary have 
        jointly, by regulation, determined to be consistent 
        with effective controls against diversion and otherwise 
        consistent with the public health and safety.
  (55) The term ``refilling prescriptions for controlled 
substances in schedule III, IV, or V''--
          (A) means the dispensing of a controlled substance in 
        schedule III, IV, or V in accordance with refill 
        instructions issued by a practitioner as part of a 
        valid prescription that meets the requirements of 
        subsections (b) and (c) of section 309, as appropriate; 
        and
          (B) does not include the issuance of a new 
        prescription to an individual for a controlled 
        substance that individual was previously prescribed.
  (56) The term ``filling new prescriptions for controlled 
substances in schedule III, IV, or V'' means filling a 
prescription for an individual for a controlled substance in 
schedule III, IV, or V, if--
          (A) the pharmacy dispensing that prescription has 
        previously dispensed to the patient a controlled 
        substance other than by means of the Internet and 
        pursuant to the valid prescription of a practitioner 
        that meets the applicable requirements of subsections 
        (b) and (c) of section 309 (in this paragraph referred 
        to as the ``original prescription'');
          (B) the pharmacy contacts the practitioner who issued 
        the original prescription at the request of that 
        individual to determine whether the practitioner will 
        authorize the issuance of a new prescription for that 
        individual for the controlled substance described in 
        subparagraph (A); and
          (C) the practitioner, acting in the usual course of 
        professional practice, determines there is a legitimate 
        medical purpose for the issuance of the new 
        prescription.

         Part B--Authority To Control; Standards and Schedules

SEC. 201. AUTHORITY AND CRITERIA FOR CLASSIFICATION OF SUBSTANCES (A) 
                    THE ATTORNEY GENERAL SHALL APPLY THE PROVISIONS OF 
                    THIS TITLE TO THE CONTROLLED SUBSTANCES LISTED IN 
                    THE SCHEDULES ESTABLISHED BY SECTION 202 OF THIS 
                    TITLE AND TO ANY OTHER DRUG OR OTHER SUBSTANCE 
                    ADDED TO SUCH SCHEDULES UNDER THIS TITLE. EXCEPT AS 
                    PROVIDED IN SUBSECTIONS (D) AND (E), THE ATTORNEY 
                    GENERAL MAY BY RULE--

          (1) add to such a schedule or transfer between such 
        schedules any drug or other substance if he--
                  (A) finds that such drug or other substance 
                has a potential for abuse, and
                  (B) makes with respect to such drug or other 
                substance the findings prescribed by subsection 
                (b) of section 202 for the schedule in which 
                such drug is to be placed; or
          (2) remove any drug or other substance from the 
        schedules if he finds that the drug or other substance 
        does not meet the requirements for inclusion in any 
        schedule.
Rules of the Attorney General under this subsection shall be 
made on the record after opportunity for a hearing pursuant to 
the rulemaking procedures prescribed by subchapter II of 
chapter 5 of title 5 of the United States Code. Proceedings for 
the issuance, amendment, or repeal of such rules may be 
initiated by the Attorney General (1) on his own motion, (2) at 
the request of the Secretary, or (3) on the petition of any 
interested party.
  (b) The Attorney General shall, before initiating proceedings 
under subsection (a) to control a drug or other substance or to 
remove a drug or other substance entirely from the schedules, 
and after gathering the necessary data, request from the 
Secretary a scientific and medical evaluation, and his 
recommendations, as to whether such drug or other substance 
should be so controlled or removed as a controlled substance. 
In making such evaluation and recommendations, the Secretary 
shall consider the factors listed in paragraphs (2), (3), (6), 
(7), and (8) of subsection (c) and any scientific or medical 
considerations involved in paragraphs (1), (4), and (5) of such 
subsection. The recommendations of the Secretary shall include 
recommendations with respect to the appropriate schedule, if 
any, under which such drug or other substance should be listed. 
The evaluation and the recommendations of the Secretary shall 
be made in writing and submitted to the Attorney General within 
a reasonable time. The recommendations of the Secretary to the 
Attorney General shall be binding on the Attorney General as to 
such scientific and medical matters, and if the Secretary 
recommends that a drug or other substance not be controlled, 
the Attorney General shall not control the drug or other 
substance. If the Attorney General determines that these facts 
and all other relevant data constitute substantial evidence of 
potential for abuse such as to warrant control or substantial 
evidence that the drug or other substance should be removed 
entirely from the schedules, he shall initiate proceedings for 
control or removal, as the case may be, under subsection (a).
  (c) In making any finding under subsection (a) of this 
section or under subsection (b) of section 202, the Attorney 
General shall consider the following factors with respect to 
each drug or other substance proposed to be controlled or 
removed from the schedules:
          (1) Its actual or relative potential for abuse.
          (2) Scientific evidence of its pharmacological 
        effect, if known.
          (3) The state of current scientific knowledge 
        regarding the drug or other substance.
          (4) Its history and current pattern of abuse.
          (5) The scope, duration, and significance of abuse.
          (6) What, if any, risk there is to the public health.
          (7) Its psychic or physiological dependence 
        liability.
          (8) Whether the substance is an immediate precursor 
        of a substance already controlled under this title.
  (d)(1) If control is required by United States obligations 
under international treaties, conventions, or protocols in 
effect on the effective date of this part, the Attorney General 
shall issue an order controlling such drug under the schedule 
he deems most appropriate to carry out such obligations, 
without regard to the findings required by subsection (a) of 
this section or section 202(b) and without regard to the 
procedures prescribed by subsections (a) and (b) of this 
section.
  (2) (A) Whenever the Secretary of State receives notification 
from the Secretary-General of the United Nations that 
information has been transmitted by or to the World Health 
Organization, pursuant to article 2 of the Convention on 
Psychotropic Substances, which may justify adding a drug or 
other substance to one of the schedules of the Convention, 
transferring a drug or substance from one schedule to another, 
or deleting it from the schedules, the Secretary of State shall 
immediately transmit the notice to the Secretary of Health, 
Education, and Welfare who shall publish it in the Federal 
Register and provide opportunity to interested persons to 
submit to him comments respecting the scientific and medical 
evaluations which he is to prepare respecting such drug or 
substance. The Secretary of Health, Education, and Welfare 
shall prepare for transmission through the Secretary of State 
to the World Health Organization such medical and scientific 
evaluations as may be appropriate regarding the possible action 
that could be proposed by the World Health Organization 
respecting the drug or substance with respect to which a notice 
was transmitted under this subparagraph.
  (B) Whenever the Secretary of State receives information that 
the Commission on Narcotic Drugs of the United Nations proposes 
to decide whether to add a drug or other substance to one of 
the schedules of the Convention, transfer a drug or substance 
from one schedule to another, or delete it from the schedules, 
the Secretary of State shall transmit timely notice to the 
Secretary of Health, Education, and Welfare of such information 
who shall publish a summary of such information in the Federal 
Register and provide opportunity to interested persons to 
submit to him comments respecting the recommendation which he 
is to furnish, pursuant to this subparagraph, respecting such 
proposal. The Secretary of Health, Education, and Welfare shall 
evaluate the proposal and furnish a recommendation to the 
Secretary of State which shall be binding on the representative 
of the United States in discussions and negotiations relating 
to the proposal.
  (3) When the United States receives notification of a 
scheduling decision pursuant to article 2 of the Convention on 
Psychotropic Substances that a drug or other substance has been 
added or transferred to a schedule specified in the 
notification or receives notification (referred to in this 
subsection as a ``schedule notice'') that existing legal 
controls applicable under this title to a drug or substance and 
the controls required by the Federal Food, Drug, and Cosmetic 
Act do not meet the requirements of the schedule of the 
Convention in which such drug or substance has been placed, the 
Secretary of Health, Education, and Welfare, after consultation 
with the Attorney General, shall first determine whether 
existing legal controls under this title applicable to the drug 
or substance and the controls required by the Federal Food, 
Drug, and Cosmetic Act, meet the requirements of the schedule 
specified in the notification or schedule notice and shall take 
the following action:
          (A) If such requirements are met by such existing 
        controls but the Secretary of Health, Education, and 
        Welfare nonetheless believes that more stringent 
        controls should be applied to the drug or substance, 
        the Secretary shall recommend to the Attorney General 
        that he initiate proceedings for scheduling the drug or 
        substance, pursuant to subsections (a) and (b) of this 
        section, to apply to such controls.
          (B) If such requirements are not met by such existing 
        controls and the Secretary of Health, Education, and 
        Welfare concurs in the scheduling decision or schedule 
        notice transmitted by the notification, the Secretary 
        shall recommend to the Attorney General that he 
        initiate proceedings for scheduling the drug or 
        substance under the appropriate schedule pursuant to 
        subsections (a) and (b) of this section.
          (C) If such requirements are not met by such existing 
        controls and the Secretary of Health, Education, and 
        Welfare does not concur in the scheduling decision or 
        schedule notice transmitted by the notification, the 
        Secretary shall--
                  (i) if he deems that additional controls are 
                necessary to protect the public health and 
                safety, recommend to the Attorney General that 
                he initiate proceedings for scheduling the drug 
                or substance pursuant to subsections (a) and 
                (b) of this section, to apply such additional 
                controls;
                  (ii) request the Secretary of State to 
                transmit a notice of qualified acceptance, 
                within the period specified in the Convention, 
                pursuant to paragraph 7 of article 2 of the 
                Convention, to the Secretary-General of the 
                United Nations;
                  (iii) request the Secretary of State to 
                transmit a notice of qualified acceptance as 
                prescribed in clause (ii) and request the 
                Secretary of State to ask for a review by the 
                Economic and Social Council of the United 
                Nations, in accordance with paragraph 8 of 
                article 2 of the Convention, of the scheduling 
                decision; or
                  (iv) in the case of a schedule notice, 
                request the Secretary of State to take 
                appropriate action under the Convention to 
                initiate proceedings to remove the drug or 
                substance from the schedules under the 
                Convention or to transfer the drug or substance 
                to a schedule under the Convention different 
                from the one specified in the schedule notice.
  (4)(A) If the Attorney General determines, after consultation 
with the Secretary of Health, Education, and Welfare, that 
proceedings initiated under recommendations made under 
paragraph (B) or (C)(i) of paragraph (3) will not be completed 
within the time period required by paragraph 7 of article 2 of 
the Convention, the Attorney General, after consultation with 
the Secretary and after providing interested persons 
opportunity to submit comments respecting the requirements of 
the temporary order to be issued under this sentence, shall 
issue a temporary order controlling the drug or substance under 
schedule IV or V, whichever is most appropriate to carry out 
the minimum United States obligations under paragraph 7 of 
article 2 of the Convention. As a part of such order, the 
Attorney General shall, after consultation with the Secretary, 
except such drug or substance from the application of any 
provision of part C of this title which he finds is not 
required to carry out the United States obligations under 
paragraph 7 of article 2 of the Convention. In the case of 
proceedings initiated under subparagraph (B) of paragraph (3), 
the Attorney General, concurrently with the issuance of such 
order, shall request the Secretary of State to transmit a 
notice of qualified acceptance to the Secretary-General of the 
United Nations pursuant to paragraph 7 of article 2 of the 
Convention. A temporary order issued under this subparagraph 
controlling a drug or other substance subject to proceedings 
initiated under subsections (a) and (b) of this section shall 
expire upon the effective date of the application to the drug 
or substance of the controls resulting from such proceedings.
  (B) After a notice of qualified acceptance of a scheduling 
decision with respect to a drug or other substance is 
transmitted to the Secretary-General of the United Nations in 
accordance with clause (ii) or (iii) of paragraph (3)(C) or 
after a request has been made under clause (iv) of such 
paragraph with respect to a drug or substance described in a 
schedule notice, the Attorney General, after consultation with 
the Secretary of Health, Education, and Welfare and after 
providing interested persons opportunity to submit comments 
respecting the requirements of the order to be issued under 
this sentence, shall issue an order controlling the drug or 
substance under schedule IV or V, whichever is most appropriate 
to carry out the minimum United States obligations under 
paragraph 7 of article 2 of the Convention in the case of a 
drug or substance for which a notice of qualified acceptance 
was transmitted or whichever the Attorney General determines is 
appropriate in the case of a drug or substance described in a 
schedule notice. As a part of such order, the Attorney General 
shall, after consultation with the Secretary, except such drug 
or substance from the application of any provision of part C of 
this title which he finds is not required to carry out the 
United States obligations under paragraph 7 of article 2 of the 
Convention. If, as a result of a review under paragraph 8 of 
article 2 of the Convention of the scheduling decision with 
respect to which a notice of qualified acceptance was 
transmitted in accordance with clause (ii) or (iii) of 
paragraph (3)(C)--
          (i) the decision is reversed, and
          (ii) the drug or substance subject to such decision 
        is not required to be controlled under schedule IV or V 
        to carry out the minimum United States obligations 
        under paragraph 7 of article 2 of the Convention,
the order issued under this subparagraph with respect to such 
drug or substance shall expire upon receipt by the United 
States of the review decision. If, as a result of action taken 
pursuant to action initiated under a request transmitted under 
clause (iv) of paragraph (3)(C), the drug or substance with 
respect to which such action was taken is not required to be 
controlled under schedule IV or V, the order issued under this 
paragraph with respect to such drug or substance shall expire 
upon receipt by the United States of a notice of the action 
taken with respect to such drug or substance under the 
Convention.
  (C) An order issued under subparagraph (A) or (B) may be 
issued without regard to the findings required by subsection 
(a) of this section or by section 202(b) and without regard to 
the procedures prescribed by subsection (a) or (b) of this 
section.
  (5) Nothing in the amendments made by the Psychotropic 
Substances Act of 1978 or the regulations or orders promulgated 
thereunder shall be construed to preclude requests by the 
Secretary of Health, Education, and Welfare or the Attorney 
General through the Secretary of State, pursuant to article 2 
or other applicable provisions of the Convention, for review of 
scheduling decisions under such Convention, based on new or 
additional information.
  (e) The Attorney General may, without regard to the findings 
required by subsection (a) of this section or section 202(b) 
and without regard to the procedures prescribed by subsections 
(a) and (b) of this section, place an immediate precursor in 
the same schedule in which the controlled substance of which it 
is an immediate precursor is placed or in any other schedule 
with a higher numerical designation. If the Attorney General 
designates a substance as an immediate precursor and places it 
in a schedule, other substances shall not be placed in a 
schedule solely because they are its precursors.
  (f) If, at the time a new-drug application is submitted to 
the Secretary for any drug having a stimulant, depressant, or 
hallucinogenic effect on the central nervous system, it appears 
that such drug has an abuse potential, such information shall 
be forwarded by the Secretary to the Attorney General.
  (g)(1) The Attorney General shall by regulation exclude any 
nonnarcotic drug which contains a controlled substance from the 
application of titles II and III of the Comprehensive Drug 
Abuse Prevention and Control Act (21 U.S.C. 802 et seq.) if 
such drug may, under the Federal Food, Drug, and Cosmetic Act, 
be lawfully sold over the counter without a prescription.
  (2) Dextromethorphan shall not be deemed to be included in 
any schedule by reason of enactment of this title unless 
controlled after the date of such enactment pursuant to the 
foregoing provisions of this section.
  (3) The Attorney General may, by regulation, exempt any 
compound, mixture, or preparation containing a controlled 
substance from the application of all or any part of this title 
if he finds such compound, mixture, or preparation meets the 
requirements of one of the following categories:
          (A) A mixture, or preparation containing a 
        nonnarcotic controlled substance, which mixture or 
        preparation is approved for prescription use, and which 
        contains one or more other active ingredients which are 
        not listed in any schedule and which are included there 
        in such combinations, quantity, proportion, or 
        concentration as to vitiate the potential for abuse.
          (B) A compound, mixture, or preparation which 
        contains any controlled substance, which is not for 
        administration to a human being or animal, and which is 
        packaged in such form or concentration, or with 
        adulterants or denaturants, so that as packaged it does 
        not present any significant potential for abuse.
          (C) Upon the recommendation of the Secretary of 
        Health and Human Services, a compound, mixture, or 
        preparation which contains any anabolic steroid, which 
        is intended for administration to a human being or an 
        animal, and which, because of its concentration, 
        preparation, formulation or delivery system, does not 
        present any significant potential for abuse.
  (h)(1) If the Attorney General finds that the scheduling of a 
substance in schedule I on a temporary basis is necessary to 
avoid an imminent hazard to the public safety, he may, by order 
and without regard to the requirements of subsection (b) 
relating to the Secretary of Health and Human Services, 
schedule such substance in schedule I if the substance is not 
listed in any other schedule in section 202 or if no exemption 
or approval is in effect for the substance under section 505 of 
the Federal Food, Drug, and Cosmetic Act. Such an order may not 
be issued before the expiration of thirty days from--
          (A) 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, and
          (B) the date the Attorney General has transmitted the 
        notice required by paragraph (4).
  (2) The scheduling of a substance under this subsection shall 
expire at the end of 2 years from the date of the issuance of 
the order scheduling such substance, except that the Attorney 
General may, during the pendency of proceedings under 
subsection (a)(1) with respect to the substance, extend the 
temporary scheduling for up to 1 year.
  (3) When issuing an order under paragraph (1), the Attorney 
General shall be required to consider, with respect to the 
finding of an imminent hazard to the public safety, only those 
factors set forth in paragraphs (4), (5), and (6) of subsection 
(c), including actual abuse, diversion from legitimate 
channels, and clandestine importation, manufacture, or 
distribution.
  (4) The Attorney General shall transmit notice of an order 
proposed to be issued under paragraph (1) 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 in response to a notice 
transmitted pursuant to this paragraph.
  (5) An order issued under paragraph (1) with respect to a 
substance shall be vacated upon the conclusion of a subsequent 
rulemaking proceeding initiated under subsection (a) with 
respect to such substance.
  (6) An order issued under paragraph (1) is not subject to 
judicial review.
  (i) Temporary and Permanent Scheduling of Recently Emerged 
Anabolic Steroids.--
          (1) The Attorney General may issue a temporary order 
        adding a drug or other substance to the definition of 
        anabolic steroids if the Attorney General finds that--
                  (A) the drug or other substance satisfies the 
                criteria for being considered an anabolic 
                steroid under section 102(41) but is not listed 
                in that section or by regulation of the 
                Attorney General as being an anabolic steroid; 
                and
                  (B) adding such drug or other substance to 
                the definition of anabolic steroids will assist 
                in preventing abuse or misuse of the drug or 
                other substance.
          (2) An 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 order shall expire not later than 24 months after 
        the date it becomes effective, except that the Attorney 
        General may, during the pendency of proceedings under 
        paragraph (6), extend the temporary scheduling order 
        for up to 6 months.
          (3) The Attorney General shall transmit notice of an 
        order proposed to be issued under paragraph (1) 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 in response to a notice transmitted pursuant 
        to this paragraph.
          (4) A temporary scheduling order issued under 
        paragraph (1) shall be vacated upon the issuance of a 
        permanent scheduling order under paragraph (6).
          (5) An order issued under paragraph (1) is not 
        subject to judicial review.
          (6) The Attorney General may, by rule, issue a 
        permanent order adding a drug or other substance to the 
        definition of anabolic steroids if such drug or other 
        substance satisfies the criteria for being considered 
        an anabolic steroid under section 102(41). Such 
        rulemaking may be commenced simultaneously with the 
        issuance of the temporary order issued under paragraph 
        (1).
  (j)(1) With respect to a drug referred to in subsection (f), 
if the Secretary of Health and Human Services recommends that 
the Attorney General control the drug in schedule II, III, IV, 
or V pursuant to subsections (a) and (b), the Attorney General 
shall, not later than 90 days after the date described in 
paragraph (2), issue an interim final rule controlling the drug 
in accordance with such subsections and section 202(b) using 
the procedures described in paragraph (3).
  (2) The date described in this paragraph shall be the later 
of--
          (A) the date on which the Attorney General receives 
        the scientific and medical evaluation and the 
        scheduling recommendation from the Secretary of Health 
        and Human Services in accordance with subsection (b); 
        or
          (B) the date on which the Attorney General receives 
        notification from the Secretary of Health and Human 
        Services that the Secretary has approved an application 
        under section 505(c), 512, or 571 of the Federal Food, 
        Drug, and Cosmetic Act or section 351(a) of the Public 
        Health Service Act, or indexed a drug under section 572 
        of the Federal Food, Drug, and Cosmetic Act, with 
        respect to the drug described in paragraph (1).
  (3) A rule issued by the Attorney General under paragraph (1) 
shall become immediately effective as an interim final rule 
without requiring the Attorney General to demonstrate good 
cause therefor. The interim final rule shall give interested 
persons the opportunity to comment and to request a hearing. 
After the conclusion of such proceedings, the Attorney General 
shall issue a final rule in accordance with the scheduling 
criteria of subsections (b), (c), and (d) of this section and 
section 202(b).
  (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.
          (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 Act of 
        Congress within 180 days from the date of publication 
        of the notice in the Federal Register.

                   schedules of controlled substances

  Sec. 202. (a) There are established [five schedules of 
controlled substances, to be known as schedules I, II, III, IV, 
and V] six schedules of controlled substances, to be known as 
schedules I, II, III, IV, V, and A. Such schedules shall 
initially consist of the substances listed in this section. The 
schedules established by this section shall be updated and 
republished on a semiannual basis during the two-year period 
beginning one year after the date of enactment of this title 
and shall be updated and republished on an annual basis 
thereafter.
  (b) Except where control is required by United States 
obligations under an international treaty, convention, or 
protocol, in effect on the effective date of this part, and 
except in the case of an immediate precursor, a drug or other 
substance may not be placed in any schedule unless the findings 
required for such schedule are made with respect to such drug 
or other substance. The findings required for each of the 
schedules are as follows:
  (1) Schedule I.--
          (A) The drug or other substance has a high potential 
        for abuse.
          (B) The drug or other substance has no currently 
        accepted medical use in treatment in the United States.
          (C) There is a lack of accepted safety for use of the 
        drug or other substance under medical supervision.
  (2) Schedule II.--
          (A) The drug or other substance has a high potential 
        for abuse.
          (B) The drug or other substance has a currently 
        accepted medical use in treatment in the United States 
        or a currently accepted medical use with severe 
        restrictions.
          (C) Abuse of the drug or other substances may lead to 
        severe psychological or physical dependence.
  (3) Schedule III.--
          (A) The drug or other substance has a potential for 
        abuse less than the drugs or other substances in 
        schedules I and II.
          (B) The drug or other substance has a currently 
        accepted medical use in treatment in the United States.
          (C) Abuse of the drug or other substance may lead to 
        moderate or low physical dependence or high 
        psychological dependence.
  (4) Schedule IV.--
          (A) The drug or other substance has a low potential 
        for abuse relative to the drugs or other substances in 
        schedule III.
          (B) The drug or other substance has a currently 
        accepted medical use in treatment in the United States.
          (C) Abuse of the drug or other substance may lead to 
        limited physical dependence or psychological dependence 
        relative to the drugs or other substances in schedule 
        III.
  (5) Schedule V.--
          (A) The drug or other substance has a low potential 
        for abuse relative to the drugs or other substances in 
        schedule IV.
          (B) The drug or other substance has a currently 
        accepted medical use in treatment in the United States.
          (C) Abuse of the drug or other substance may lead to 
        limited physical dependence or psychological dependence 
        relative to the drugs or other substances in schedule 
        IV.
  (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.
  (c) Schedules I, II, III, [IV, and V] IV, V, and A shall, 
unless and until amended pursuant to section 201, consist of 
the following drugs or other substances, by whatever official 
name, common or usual name, chemical name, or brand name 
designated:

                               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.

           *       *       *       *       *       *       *


Part C--Registration of Manufacturers, Distributors, and Dispensers of 
Controlled Substances; Piperidine Reporting

           *       *       *       *       *       *       *


                       registration requirements

  Sec. 303. (a) The Attorney General shall register an 
applicant to manufacture controlled substances in schedule I or 
II if he determines that such registration is consistent with 
the public interest and with United States obligations under 
international treaties, conventions, or protocols in effect on 
the effective date of this part. In determining the public 
interest, the following factors shall be considered:
          (1) maintenance of effective controls against 
        diversion of particular controlled substances and any 
        controlled substance in schedule I or II 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;
          (2) compliance with applicable State and local law;
          (3) promotion of technical advances in the art of 
        manufacturing these substances and the development of 
        new substances;
          (4) prior conviction record of applicant under 
        Federal and State laws relating to the manufacture, 
        distribution, or dispensing of such substances;
          (5) past experience in the manufacture of controlled 
        substances, and the existence in the establishment of 
        effective control against diversion; and
          (6) such other factors as may be relevant to and 
        consistent with the public health and safety.
  (b) The Attorney General shall register an applicant to 
distribute a controlled substance in schedule I or II unless he 
determines that the issuance of such registration is 
inconsistent with the public interest. In determining the 
public interest, the following factors shall be considered:
          (1) maintenance of effective controls against 
        diversion of particular controlled substances into 
        other than legitimate medical, scientific, and 
        industrial channels;
          (2) compliance with applicable State and local law;
          (3) prior conviction record of applicant under 
        Federal or State laws relating to the manufacture, 
        distribution, or dispensing of such substances;
          (4) past experience in the distribution of controlled 
        substances; and
          (5) such other factors as may be relevant to and 
        consistent with the public health and safety.
  (c) Registration granted under [subsections (a) and (b)] 
subsection (a), (b), (k), or (l) of this section shall not 
entitle a registrant to (1) manufacture or distribute 
controlled substances in [schedule I or II] schedule I, II, or 
A other than those specified in the registration, or (2) 
manufacture any quantity of those controlled substances in 
excess of the quota assigned pursuant to section 306.
  (d) The Attorney General shall register an applicant to 
manufacture controlled substances in schedule III, IV, or V, 
unless he determines that the issuance of such registration is 
inconsistent with the public interest. In determining the 
public interest, the following factors shall be considered:
          (1) maintenance of effective controls against 
        diversion of particular controlled substances and any 
        controlled substance in schedule III, IV, or V 
        compounded therefrom into other than legitimate 
        medical, scientific, or industrial channels;
          (2) compliance with applicable State and local law;
          (3) promotion of technical advances in the art of 
        manufacturing these substances and the development of 
        new substances;
          (4) prior conviction record of applicant under 
        Federal or State laws relating to the manufacture, 
        distribution, or dispensing of such substances;
          (5) past experience in the manufacture, distribution, 
        and dispensing of controlled substances, and the 
        existence in the establishment of effective controls 
        against diversion; and
          (6) such other factors as may be relevant to and 
        consistent with the public health and safety.
  (e) The Attorney General shall register an applicant to 
distribute controlled substances in schedule III, IV, or V, 
unless he determines that the issuance of such registration is 
inconsistent with the public interest. In determining the 
public interest, the following factors shall be considered:
          (1) maintenance of effective controls against 
        diversion of particular controlled substances into 
        other than legitimate medical, scientific, and 
        industrial channels;
          (2) compliance with applicable State and local law;
          (3) prior conviction record of applicant under 
        Federal or State laws relating to the manufacture, 
        distribution, or dispensing of such substances;
          (4) past experience in the distribution of controlled 
        substances; and
          (5) such other factors as may be relevant to and 
        consistent with the public health and safety.
  (f) The Attorney General shall register practitioners 
(including pharmacies, as distinguished from pharmacists) to 
dispense, or conduct research with, controlled substances in 
schedule II, III, IV, or V and shall modify the registrations 
of pharmacies so registered to authorize them to dispense 
controlled substances by means of the Internet, if the 
applicant is authorized to dispense, or conduct research with 
respect to, controlled substances under the laws of the State 
in which he practices. The Attorney General may deny an 
application for such registration or such modification of 
registration if the Attorney General determines that the 
issuance of such registration or modification would be 
inconsistent with the public interest. In determining the 
public interest, the following factors shall be considered:
          (1) The recommendation of the appropriate State 
        licensing board or professional disciplinary authority.
          (2) The applicant's experience in dispensing, or 
        conducting research with respect to controlled 
        substances.
          (3) The applicant's conviction record under Federal 
        or State laws relating to the manufacture, 
        distribution, or dispensing of controlled substances.
          (4) Compliance with applicable State, Federal, or 
        local laws relating to controlled substances.
          (5) Such other conduct which may threaten the public 
        health and safety.
Separate registration under this part for practitioners 
engaging in research with controlled substances in schedule II, 
III, IV, or V, who are already registered under this part in 
another capacity, shall not be required. Registration 
applications by practitioners wishing to conduct research with 
controlled substances in schedule I shall be referred to the 
Seretary, who shall determine the qualifications and competency 
of each practitioner requesting registration, as well as the 
merits of the research protocol. The Secretary, in determining 
the merits of each research protocol, shall consult with the 
Attorney General as to effective procedures to adequately 
safeguard against diversion of such controlled substances from 
legitimate medical or scientific use. Registration for the 
purpose of bona fide research with controlled substances in 
schedule I by a practitioner deemed qualified by the Secretary 
may be denied by the Attorney General only on a ground 
specified in section 304(a). Article 7 of the Convention on 
Psychotrophic Substances shall not be construed to prohibit, or 
impose additional restrictions upon, research involving drugs 
or other substances scheduled under the convention which is 
conducted in conformity with this subsection and other 
applicable provisions of this title.
  (g)(1) Except as provided in paragraph (2), practitioners who 
dispense narcotic drugs to individuals for maintenance 
treatment or detoxification treatment shall obtain annually a 
separate registration for that purpose. The Attorney General 
shall register an applicant to dispense narcotic drugs to 
individuals for maintenance treatment or detoxification 
treatment (or both)--
          (A) if the applicant is a practitioner who is 
        determined by the Secretary to be qualified (under 
        standards established by the Secretary) to engage in 
        the treatment with respect to which registration is 
        sought;
          (B) if the Attorney General determines that the 
        applicant will comply with standards established by the 
        Attorney General respecting (i) security of stocks of 
        narcotic drugs for such treatment, and (ii) the 
        maintenance of records (in accordance with section 307) 
        on such drugs; and
          (C) if the Secretary determines that the applicant 
        will comply with standards established by the Secretary 
        (after consultation with the Attorney General) 
        respecting the quantities of narcotic drugs which may 
        be provided for unsupervised use by individuals in such 
        treatment.
  (2)(A) Subject to subparagraphs (D) and (J), the requirements 
of paragraph (1) are waived in the case of the dispensing 
(including the prescribing), by a practitioner, of narcotic 
drugs in schedule III, IV, or V or combinations of such drugs 
if the practitioner meets the conditions specified in 
subparagraph (B) and the narcotic drugs or combinations of such 
drugs meet the conditions specified in subparagraph (C).
  (B) For purposes of subparagraph (A), the conditions 
specified in this subparagraph with respect to a practitioner 
are that, before the initial dispensing of narcotic drugs in 
schedule III, IV, or V or combinations of such drugs to 
patients for maintenance or detoxification treatment, the 
practitioner submit to the Secretary a notification of the 
intent of the practitioner to begin dispensing the drugs or 
combinations for such purpose, and that the notification 
contain the following certifications by the practitioner:
          (i) The practitioner is a qualifying practitioner (as 
        defined in subparagraph (G)).
          (ii) With respect to patients to whom the 
        practitioner will provide such drugs or combinations of 
        drugs, the practitioner has the capacity to provide 
        directly, by referral, or in such other manner as 
        determined by the Secretary--
                  (I) all drugs approved by the Food and Drug 
                Administration for the treatment of opioid use 
                disorder, including for maintenance, 
                detoxification, overdose reversal, and relapse 
                prevention; and
                  (II) appropriate counseling and other 
                appropriate ancillary services.
          (iii)(I) The total number of such patients of the 
        practitioner at any one time will not exceed the 
        applicable number. Except as provided in subclause 
        (II), the applicable number is 30.
          (II) The applicable number is 100 if, not sooner than 
        1 year after the date on which the practitioner 
        submitted the initial notification, the practitioner 
        submits a second notification to the Secretary of the 
        need and intent of the practitioner to treat up to 100 
        patients.
          (III) The Secretary may by regulation change such 
        applicable number.
          (IV) The Secretary may exclude from the applicable 
        number patients to whom such drugs or combinations of 
        drugs are directly administered by the qualifying 
        practitioner in the office setting.
  (C) For purposes of subparagraph (A), the conditions 
specified in this subparagraph with respect to narcotic drugs 
in schedule III, IV, or V or combinations of such drugs are as 
follows:
          (i) The drugs or combinations of drugs have, under 
        the Federal Food, Drug, and Cosmetic Act or section 351 
        of the Public Health Service Act, been approved for use 
        in maintenance or detoxification treatment.
          (ii) The drugs or combinations of drugs have not been 
        the subject of an adverse determination. For purposes 
        of this clause, an adverse determination is a 
        determination published in the Federal Register and 
        made by the Secretary, after consultation with the 
        Attorney General, that the use of the drugs or 
        combinations of drugs for maintenance or detoxification 
        treatment requires additional standards respecting the 
        qualifications of practitioners to provide such 
        treatment, or requires standards respecting the 
        quantities of the drugs that may be provided for 
        unsupervised use.
  (D)(i) A waiver under subparagraph (A) with respect to a 
practitioner is not in effect unless (in addition to conditions 
under subparagraphs (B) and (C)) the following conditions are 
met:
          (I) The notification under subparagraph (B) is in 
        writing and states the name of the practitioner.
          (II) The notification identifies the registration 
        issued for the practitioner pursuant to subsection (f).
          (III) If the practitioner is a member of a group 
        practice, the notification states the names of the 
        other practitioners in the practice and identifies the 
        registrations issued for the other practitioners 
        pursuant to subsection (f).
  (ii) Upon receiving a determination from the Secretary under 
clause (iii) finding that a practitioner meets all requirements 
for a waiver under subparagraph (B), the Attorney General shall 
assign the practitioner involved an identification number under 
this paragraph for inclusion with the registration issued for 
the practitioner pursuant to subsection (f). The identification 
number so assigned shall be appropriate to preserve the 
confidentiality of patients for whom the practitioner has 
dispensed narcotic drugs under a waiver under subparagraph (A).
  (iii) Not later than 45 days after the date on which the 
Secretary receives a notification under subparagraph (B), the 
Secretary shall make a determination of whether the 
practitioner involved meets all requirements for a waiver under 
subparagraph (B) and shall forward such determination to the 
Attorney General. If the Secretary fails to make such 
determination by the end of the such 45-day period, the 
Attorney General shall assign the practitioner an 
identification number described in clause (ii) at the end of 
such period.
  (E)(i) If a practitioner is not registered under paragraph 
(1) and, in violation of the conditions specified in 
subparagraphs (B) through (D), dispenses narcotic drugs in 
schedule III, IV, or V or combinations of such drugs for 
maintenance treatment or detoxification treatment, the Attorney 
General may, for purposes of section 304(a)(4), consider the 
practitioner to have committed an act that renders the 
registration of the practitioner pursuant to subsection (f) to 
be inconsistent with the public interest.
  (ii)(I) Upon the expiration of 45 days from the date on which 
the Secretary receives a notification under subparagraph (B), a 
practitioner who in good faith submits a notification under 
subparagraph (B) and reasonably believes that the conditions 
specified in subparagraphs (B) through (D) have been met shall, 
in dispensing narcotic drugs in schedule III, IV, or V or 
combinations of such drugs for maintenance treatment or 
detoxification treatment, be considered to have a waiver under 
subparagraph (A) until notified otherwise by the Secretary, 
except that such a practitioner may commence to prescribe or 
dispense such narcotic drugs for such purposes prior to the 
expiration of such 45-day period if it facilitates the 
treatment of an individual patient and both the Secretary and 
the Attorney General are notified by the practitioner of the 
intent to commence prescribing or dispensing such narcotic 
drugs.
  (II) For purposes of subclause (I), the publication in the 
Federal Register of an adverse determination by the Secretary 
pursuant to subparagraph (C)(ii) shall (with respect to the 
narcotic drug or combination involved) be considered to be a 
notification provided by the Secretary to practitioners, 
effective upon the expiration of the 30-day period beginning on 
the date on which the adverse determination is so published.
  (F)(i) With respect to the dispensing of narcotic drugs in 
schedule III, IV, or V or combinations of such drugs to 
patients for maintenance or detoxification treatment, a 
practitioner may, in his or her discretion, dispense such drugs 
or combinations for such treatment under a registration under 
paragraph (1) or a waiver under subparagraph (A) (subject to 
meeting the applicable conditions).
  (ii) This paragraph may not be construed as having any legal 
effect on the conditions for obtaining a registration under 
paragraph (1), including with respect to the number of patients 
who may be served under such a registration.
  (G) For purposes of this paragraph:
          (i) The term ``group practice'' has the meaning given 
        such term in section 1877(h)(4) of the Social Security 
        Act.
          (ii) The term ``qualifying physician'' means a 
        physician who is licensed under State law and who meets 
        one or more of the following conditions:
                  (I) The physician holds a board certification 
                in addiction psychiatry or addiction medicine 
                from the American Board of Medical Specialties.
                  (II) The physician holds an addiction 
                certification or board certification from the 
                American Society of Addiction Medicine or the 
                American Board of Addiction Medicine.
                  (III) The physician holds a board 
                certification in addiction medicine from the 
                American Osteopathic Association.
                  (IV) The physician has, with respect to the 
                treatment and management of opiate-dependent 
                patients, completed not less than 8 hours of 
                training (through classroom situations, 
                seminars at professional society meetings, 
                electronic communications, or otherwise) that 
                is provided by the American Society of 
                Addiction Medicine, the American Academy of 
                Addiction Psychiatry, the American Medical 
                Association, the American Osteopathic 
                Association, the American Psychiatric 
                Association, or any other organization that the 
                Secretary determines is appropriate for 
                purposes of this subclause. Such training shall 
                include--
                          (aa) opioid maintenance and 
                        detoxification;
                          (bb) appropriate clinical use of all 
                        drugs approved by the Food and Drug 
                        Administration for the treatment of 
                        opioid use disorder;
                          (cc) initial and periodic patient 
                        assessments (including substance use 
                        monitoring);
                          (dd) individualized treatment 
                        planning, overdose reversal, and 
                        relapse prevention;
                          (ee) counseling and recovery support 
                        services;
                          (ff) staffing roles and 
                        considerations;
                          (gg) diversion control; and
                          (hh) other best practices, as 
                        identified by the Secretary.
                  (V) The physician has participated as an 
                investigator in one or more clinical trials 
                leading to the approval of a narcotic drug in 
                schedule III, IV, or V for maintenance or 
                detoxification treatment, as demonstrated by a 
                statement submitted to the Secretary by the 
                sponsor of such approved drug.
                  (VI) The physician has such other training or 
                experience as the State medical licensing board 
                (of the State in which the physician will 
                provide maintenance or detoxification 
                treatment) considers to demonstrate the ability 
                of the physician to treat and manage opiate-
                dependent patients.
                  (VII) The physician has such other training 
                or experience as the Secretary considers to 
                demonstrate the ability of the physician to 
                treat and manage opiate-dependent patients. Any 
                criteria of the Secretary under this subclause 
                shall be established by regulation. Any such 
                criteria are effective only for 3 years after 
                the date on which the criteria are promulgated, 
                but may be extended for such additional 
                discrete 3-year periods as the Secretary 
                considers appropriate for purposes of this 
                subclause. Such an extension of criteria may 
                only be effectuated through a statement 
                published in the Federal Register by the 
                Secretary during the 30-day period preceding 
                the end of the 3-year period involved.
          (iii) The term ``qualifying practitioner'' means--
                  (I) a qualifying physician, as defined in 
                clause (ii); or
                  (II) during the period beginning on the date 
                of enactment of the Comprehensive Addiction and 
                Recovery Act of 2016 and ending on October 1, 
                2021, a qualifying other practitioner, as 
                defined in clause (iv).
          (iv) The term ``qualifying other practitioner'' means 
        a nurse practitioner or physician assistant who 
        satisfies each of the following:
                  (I) The nurse practitioner or physician 
                assistant is licensed under State law to 
                prescribe schedule III, IV, or V medications 
                for the treatment of pain.
                  (II) The nurse practitioner or physician 
                assistant has--
                          (aa) completed not fewer than 24 
                        hours of initial training addressing 
                        each of the topics listed in clause 
                        (ii)(IV) (through classroom situations, 
                        seminars at professional society 
                        meetings, electronic communications, or 
                        otherwise) provided by the American 
                        Society of Addiction Medicine, the 
                        American Academy of Addiction 
                        Psychiatry, the American Medical 
                        Association, the American Osteopathic 
                        Association, the American Nurses 
                        Credentialing Center, the American 
                        Psychiatric Association, the American 
                        Association of Nurse Practitioners, the 
                        American Academy of Physician 
                        Assistants, or any other organization 
                        that the Secretary determines is 
                        appropriate for purposes of this 
                        subclause; or
                          (bb) has such other training or 
                        experience as the Secretary determines 
                        will demonstrate the ability of the 
                        nurse practitioner or physician 
                        assistant to treat and manage opiate-
                        dependent patients.
                  (III) The nurse practitioner or physician 
                assistant is supervised by, or works in 
                collaboration with, a qualifying physician, if 
                the nurse practitioner or physician assistant 
                is required by State law to prescribe 
                medications for the treatment of opioid use 
                disorder in collaboration with or under the 
                supervision of a physician.
The Secretary may, by regulation, revise the requirements for 
being a qualifying other practitioner under this clause.
  (H)(i) In consultation with the Administrator of the Drug 
Enforcement Administration, the Administrator of the Substance 
Abuse and Mental Health Services Administration, the Director 
of the National Institute on Drug Abuse, and the Commissioner 
of Food and Drugs, the Secretary shall issue regulations 
(through notice and comment rulemaking) or issue practice 
guidelines to address the following:
          (I) Approval of additional credentialing bodies and 
        the responsibilities of additional credentialing 
        bodies.
          (II) Additional exemptions from the requirements of 
        this paragraph and any regulations under this 
        paragraph.
          (III) Such other elements of the requirements under 
        this paragraph as the Secretary determines necessary 
        for purposes of implementing such requirements.
Nothing in such regulations or practice guidelines may 
authorize any Federal official or employee to exercise 
supervision or control over the practice of medicine or the 
manner in which medical services are provided.
  (ii) Not later than 18 months after the date of enactment of 
the Opioid Use Disorder Treatment Expansion and Modernization 
Act, the Secretary shall update the treatment improvement 
protocol containing best practice guidelines for the treatment 
of opioid-dependent patients in office-based settings. The 
Secretary shall update such protocol in consultation with 
experts in opioid use disorder research and treatment.
  (I) Notwithstanding section 708, nothing in this paragraph 
shall be construed to preempt any State law that--
          (i) permits a qualifying practitioner to dispense 
        narcotic drugs in schedule III, IV, or V, or 
        combinations of such drugs, for maintenance or 
        detoxification treatment in accordance with this 
        paragraph to a total number of patients that is more 
        than 30 or less than the total number applicable to the 
        qualifying practitioner under subparagraph (B)(iii)(II) 
        if a State enacts a law modifying such total number and 
        the Attorney General is notified by the State of such 
        modification; or
          (ii) requires a qualifying practitioner to comply 
        with additional requirements relating to the dispensing 
        of narcotic drugs in schedule III, IV, or V, or 
        combinations of such drugs, including requirements 
        relating to the practice setting in which the 
        qualifying practitioner practices and education, 
        training, and reporting requirements.
  (h) The Attorney General shall register an applicant to 
distribute a list I chemical unless the Attorney General 
determines that registration of the applicant is inconsistent 
with the public interest. Registration under this subsection 
shall not be required for the distribution of a drug product 
that is exempted under clause (iv) or (v) of section 
102(39)(A). In determining the public interest for the purposes 
of this subsection, the Attorney General shall consider--
          (1) maintenance by the applicant of effective 
        controls against diversion of listed chemicals into 
        other than legitimate channels;
          (2) compliance by the applicant with applicable 
        Federal, State, and local law;
          (3) any prior conviction record of the applicant 
        under Federal or State laws relating to controlled 
        substances or to chemicals controlled under Federal or 
        State law;
          (4) any past experience of the applicant in the 
        manufacture and distribution of chemicals; and
          (5) such other factors as are relevant to and 
        consistent with the public health and safety.
  (i)(1) For purposes of registration to manufacture a 
controlled substance under subsection (d) for use only in a 
clinical trial, the Attorney General shall register the 
applicant, or serve an order to show cause upon the applicant 
in accordance with section 304(c), not later than 180 days 
after the date on which the application is accepted for filing.
  (2) For purposes of registration to manufacture a controlled 
substance under subsection (a) for use only in a clinical 
trial, the Attorney General shall, in accordance with the 
regulations issued by the Attorney General, issue a notice of 
application not later than 90 days after the application is 
accepted for filing. Not later than 90 days after the date on 
which the period for comment pursuant to such notice ends, the 
Attorney General shall register the applicant, or serve an 
order to show cause upon the applicant in accordance with 
section 304(c), unless the Attorney General has granted a 
hearing on the application under section 1008(i) of the 
Controlled Substances Import and Export Act.
  (j) In this section, the phrase ``factors as may be relevant 
to and consistent with the public health and safety'' means 
factors that are relevant to and consistent with the findings 
contained in section 101.
  (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.
  (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.
  (3) If the applicant is currently registered under subsection 
(f) to conduct research with a schedule I controlled substance, 
the applicant will be considered qualified to conduct research 
with controlled substances in schedule A and the Attorney 
General shall modify the applicant's registration to include 
schedule A controlled substances 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 thirty 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).

           *       *       *       *       *       *       *


                  labeling and packaging requirements

  Sec. 305. (a) It shall be unlawful to distribute a controlled 
substance in a commercial container unless such container, when 
and as required by regulations of the Attorney General, bears a 
label (as defined in section 201(k) of the Federal Food, Drug, 
and Cosmetic Act) containing an identifying symbol for such 
substance in accordance with such regulations. A different 
symbol shall be required for each schedule of controlled 
substances.
  (b) It shall be unlawful for the manufacturer of any 
controlled substance to distribute such substances unless the 
labeling (as defined in section 201(m) of the Federal Food, 
Drug, and Cosmetic Act) of such substance contains, when and as 
required by regulations of the Attorney General, the 
identifying symbol required under subsection (a).
  (c) The Secretary shall prescribe regulations under section 
503(b) of the Federal Food, Drug, and Cosmetic Act which shall 
provide that the label of a drug listed in schedule II, III, or 
IV shall, when dispensed to or for a patient, contain a clear, 
concise warning that it is a crime to transfer the drug to any 
person other than the patient.
  (d) It shall be unlawful to distribute controlled substances 
in schedule I or II, and narcotic drugs in schedule III or IV, 
unless the bottle or other container, stopper, covering, or 
wrapper thereof is securely sealed as required by regulations 
of the Attorney General.
  (e) False Labeling of Anabolic Steroids.--
          (1) It shall be unlawful to import, export, 
        manufacture, distribute, dispense, or possess with 
        intent to manufacture, distribute, or dispense, an 
        anabolic steroid or product containing an anabolic 
        steroid, unless the steroid or product bears a label 
        clearly identifying an anabolic steroid or product 
        containing an anabolic steroid 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.
  (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.

                quotas applicable to certain substances

  Sec. 306. (a) The Attorney General shall determine the total 
quantity and establish production quotas for each basic class 
of controlled substance in [schedules I and II] schedules I, 
II, and A and for ephedrine, pseudoephedrine, and 
phenylpropanolamine to be manufactured each calendar year to 
provide for the estimated medical, scientific, research, and 
industrial needs of the United States, for lawful export 
requirements, and for the establishment and maintenance of 
reserve stocks. Production quotas shall be established in terms 
of quantities of each basic class of controlled substance and 
not in terms of individual pharmaceutical dosage forms prepared 
from or containing such a controlled substance.
  (b) The Attorney General shall limit or reduce individual 
production quotas to the extent necessary to prevent the 
aggregate of individual quotas from exceeding the amount 
determined necessary each year by the Attorney General under 
subsection (a). The quota of each registered manufacturer for 
each basic class of controlled substance in [schedule I or II] 
schedule I, II, or A or for ephedrine, pseudoephedrine, or 
phenylpropanolamine shall be revised in the same proportion as 
the limitation or reduction of the aggregate of the quotas. 
However, if any registrant, before the issuance of a limitation 
or reduction in quota, has manufactured in excess of his 
revised quota, the amount of the excess shall be subtracted 
from his quota for the following year.
  (c) On or before October 1 of each year, upon application 
therefor by a registered manufacturer, the Attorney General 
shall fix a manufacturing quota for the basic classes of 
controlled substances in [schedules I and II] schedules I, II, 
and A and for ephedrine, pseudoephedrine, and 
phenylpropanolamine that the manufacturer seeks to produce. The 
quota shall be subject to the provisions of subsections (a) and 
(b) of this section. In fixing such quotas, the Attorney 
General shall determine the manufacturer's estimated disposal, 
inventory, and other requirements for the calendar year; and, 
in making his determination, the Attorney General shall 
consider the manufacturer's current rate of disposal, the trend 
of the national disposal rate during the preceding calendar 
year, the manufacturer's production cycle and inventory 
position, the economic availability of raw materials, yield and 
stability problems, emergencies such as strikes and fires, and 
other factors.
  (d) The Attorney General shall, upon application and subject 
to the provisions of subsections (a) and (b) of this section, 
fix a quota for a basic class of controlled substance in 
[schedule I or II] schedule I, II, or A for any registrant who 
has not manufactured that basic class of controlled substance 
or ephedrine, pseudoephedrine, or phenylpropanolamine during 
one or more preceding calendar years. In fixing such quota, the 
Attorney General shall take into account the registrant's 
reasonably anticipated requirements for the current year; and, 
in making his determination of such requirements, he shall 
consider such factors specified in subsection (c) of this 
section as may be relevant.
  (e) At any time during the year any registrant who has 
applied for or received a manufacturing quota for a basic class 
of controlled substance in [schedule I or II] schedule I, II, 
or A or for ephedrine, pseudoephedrine, or phenylpropanolamine 
may apply for an increase in that quota to meet his estimated 
disposal, inventory, and other requirements during the 
remainder of that year. In passing upon the application the 
Attorney General shall take into consideration any occurrences 
since the filing of the registrant's initial quota application 
that may require an increased manufacturing rate by the 
registrant during the balance of the year. In passing upon the 
application the Attorney General may also take into account the 
amount, if any, by which the determination of the Attorney 
General under subsection (a) of this section exceeds the 
aggregate of the quotas of all registrants under this section.
  (f) Notwithstanding any other provisions of this title, no 
registration or quota may be required for the manufacture of 
such quantities of controlled substances in [schedules I and 
II] schedules I, II, and A or ephedrine, pseudoephedrine, or 
phenylpropanolamine as incidentally and necessarily result from 
the manufacturing process used for the manufacture of a 
controlled substance or of ephedrine, pseudoephedrine, or 
phenylpropanolamine with respect to which its manufacturer is 
duly registered under this title. The Attorney General may, by 
regulation, prescribe restrictions on the retention and 
disposal of such incidentally produced substances or chemicals.
  (g) Each reference in this section to ephedrine, 
pseudoephedrine, or phenylpropanolamine includes each of the 
salts, optical isomers, and salts of optical isomers of such 
chemical.
  (h)(1) Not later than 30 days after the receipt of a request 
described in paragraph (2), the Attorney General shall--
          (A) complete review of such request; and
          (B)(i) as necessary to address a shortage of a 
        controlled substance, increase the aggregate and 
        individual production quotas under this section 
        applicable to such controlled substance and any 
        ingredient therein to the level requested; or
          (ii) if the Attorney General determines that the 
        level requested is not necessary to address a shortage 
        of a controlled substance, the Attorney General shall 
        provide a written response detailing the basis for the 
        Attorney General's determination.
The Secretary shall make the written response provided under 
subparagraph (B)(ii) available to the public on the Internet 
Web site of the Food and Drug Administration.
  (2) A request is described in this paragraph if--
          (A) the request pertains to a controlled substance on 
        the list of drugs in shortage maintained under section 
        506E of the Federal Food, Drug, and Cosmetic Act;
          (B) the request is submitted by the manufacturer of 
        the controlled substance; and
          (C) the controlled substance is in schedule II.

           *       *       *       *       *       *       *


                              order forms

  Sec. 308. (a) It shall be unlawful for any person to 
distribute a controlled substance in [schedule I or II] 
schedule I, II, or A to another except in pursuance of a 
written order of the person to whom such substance is 
distributed, made on a form to be issued by the Attorney 
General in blank in accordance with subsection (d) and 
regulations prescribed by him pursuant to this section.
  (b) Nothing in subsection (a) shall apply to--
          (1) the exportation of such substances from the 
        United States in conformity with title III;
          (2) the delivery of such a substance to or by a 
        common or contract carrier for carriage in the lawful 
        and usual course of its business, or to or by a 
        warehouseman for storage in the lawful and usual course 
        of its business; but where such carriage or storage is 
        in connection with the distribution by the owner of the 
        substance to a third person, this paragraph shall not 
        relieve the distributor from compliance with subsection 
        (a); or
          (3) the delivery of such a substance for the purpose 
        of disposal by an ultimate user, long-term care 
        facility, or other person acting in accordance with 
        section 302(g).
  (c)(1) Every person who in pursuance of an order required 
under subsection (a) distributes a controlled substance shall 
preserve such order for a period of two years, and shall make 
such order available for inspection and copying by officers and 
employees of the United States duly authorized for that purpose 
by the Attorney General, and by officers or employees of States 
or their political subdivisions who are charged with the 
enforcement of State or local laws regulating the production, 
or regulating the distribution or dispensing, of controlled 
substances and who are authorized under such laws to inspect 
such orders.
  (2) Every person who gives an order required under subsection 
(a) shall, at or before the time of giving such order, make or 
cause to be made a duplicate thereof on a form to be issued by 
the Attorney General in blank in accordance with subsection (d) 
and regulations prescribed by him pursuant to this section, and 
shall, if such order is accepted, preserve such duplicate for a 
period of two years and make it available for inspection and 
copying by the officers and employees mentioned in paragraph 
(1) of this subsection.
  (d)(1) The Attorney General shall issue forms pursuant to 
subsections (a) and (c)(2) only to persons validly registered 
under section 303 (or exempted from registration under section 
302(d)). Whenever any such form is issued to a person, the 
Attorney General shall, before delivery thereof, insert therein 
the name of such person, and it shall be unlawful for any other 
person (A) to use such form for the purpose of obtaining 
controlled substances or (B) to furnishsuch form to any person 
with intent thereby to procure the distribution of such 
substances.
  (2) The Attorney General may charge reasonable fees for the 
issuance of such forms in such amounts as he may prescribe for 
the purpose of covering the cost to the United States of 
issuing such forms, and other necessary activities in 
connection therewith.
  (e) It shall be unlawful for any person to obtain by means of 
order forms issued under this section controlled substances for 
any purpose other than their use, distribution, dispensing, or 
administration in the conduct of a lawful business in such 
substances or in the course of his professional practice or 
research.

           *       *       *       *       *       *       *


                     Part D--Offenses and Penalties

                      prohibited acts a--penalties

  Sec. 401. (a) Except as authorized by this title, it shall be 
unlawful for any person knowingly or intentionally--
          (1) to manufacture, distribute, or dispense, or 
        possess with intent to manufacture, distribute, or 
        dispense, a controlled substance; or
          (2) to create, distribute, or dispense, or possess 
        with intent to distribute or dispense, a counterfeit 
        substance.
  (b) Except as otherwise provided in section 409, 418, 419, or 
420 any person who violates subsection (a) of this section 
shall be sentenced as follows:
  (1)(A) In the case of a violation of subsection (a) of this 
section involving--
          (i) 1 kilogram or more of a mixture or substance 
        containing a detectable amount of heroin;
          (ii) 5 kilograms or more of a mixture or substance 
        containing a detectable amount of--
                  (I) coca leaves, except coca leaves and 
                extracts of coca leaves from which cocaine, 
                ecgonine, and derivatives of ecgonine or their 
                salts have been removed;
                  (II) cocaine, its salts, optical and 
                geometric isomers, and salts of isomers;
                  (III) ecgonine, its derivatives, their salts, 
                isomers, and salts of isomers; or
                  (IV) any compound, mixture, or preparation 
                which contains any quantity of any of the 
                substances referred to in subclauses (I) 
                through (III);
          (iii) 280 grams or more of a mixture or substance 
        described in clause (ii) which contains cocaine base;
          (iv) 100 grams or more of phencyclidine (PCP) or 1 
        kilogram or more of a mixture or substance containing a 
        detectable amount of phencyclidine (PCP);
          (v) 10 grams or more of a mixture or substance 
        containing a detectable amount of lysergic acid 
        diethylamide (LSD);
          (vi) 400 grams or more of a mixture or substance 
        containing a detectable amount of N-phenyl-N-[1-(2-
        phenylethyl)-4-piperidinyl] propanamide or 100 grams or 
        more of a mixture or substance containing a detectable 
        amount of any analogue of N-phenyl-N-[1-(2-
        phenylethyl)-4-piperidinyl] propanamide;
          (vii) 1000 kilograms or more of a mixture or 
        substance containing a detectable amount of marihuana, 
        or 1,000 or more marihuana plants regardless of weight; 
        or
          (viii) 50 grams or more of methamphetamine, its 
        salts, isomers, and salts of its isomers or 500 grams 
        or more of a mixture or substance containing a 
        detectable amount of methamphetamine, its salts, 
        isomers, or salts of its isomers;
such person shall be sentenced to a term of imprisonment which 
may not be less than 10 years or more than life and if death or 
serious bodily injury results from the use of such substance 
shall be not less than 20 years or 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 $10,000,000 if 
the defendant is an individual or $50,000,000 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 which may not be less than 20 years and 
not more than life imprisonment and if death or serious bodily 
injury results from the use of such substance shall be 
sentenced to 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 $20,000,000 if 
the defendant is an individual or $75,000,000 if the defendant 
is other than an individual, or both. If any person commits a 
violation of this subparagraph or of section 409, 418, 419, or 
420 after two or more prior convictions for a felony drug 
offense have become final, such person shall be sentenced to a 
mandatory term of life imprisonment without release and fined 
in accordance with the preceding sentence. Notwithstanding 
section 3583 of title 18, any sentence under this subparagraph 
shall, in the absence of such a prior conviction, impose a term 
of supervised release of at least 5 years in addition to such 
term of imprisonment and shall, if there was such a prior 
conviction, impose a term of supervised release of at least 10 
years in addition to such term of imprisonment. Notwithstanding 
any other provision of law, the court shall not place on 
probation or suspend the sentence of any person sentenced under 
this subparagraph. No person sentenced under this subparagraph 
shall be eligible for parole during the term of imprisonment 
imposed therein.
  (B) In the case of a violation of subsection (a) of this 
section involving--
          (i) 100 grams or more of a mixture or substance 
        containing a detectable amount of heroin;
          (ii) 500 grams or more of a mixture or substance 
        containing a detectable amount of--
                  (I) coca leaves, except coca leaves and 
                extracts of coca leaves from which cocaine, 
                ecgonine, and derivatives of ecgonine or their 
                salts have been removed;
                  (II) cocaine, its salts, optical and 
                geometric isomers, and salts of isomers;
                  (III) ecgonine, its derivatives, their salts, 
                isomers, and salts of isomers; or
                  (IV) any compound, mixture, or preparation 
                which contains any quantity of any of the 
                substances referred to in subclauses (I) 
                through (III);
          (iii) 28 grams or more of a mixture or substance 
        described in clause (ii) which contains cocaine base;
          (iv) 10 grams or more of phencyclidine (PCP) or 100 
        grams or more of a mixture or substance containing a 
        detectable amount of phencyclidine (PCP);
          (v) 1 gram or more of a mixture or substance 
        containing a detectable amount of lysergic acid 
        diethylamide (LSD);
          (vi) 40 grams or more of a mixture or substance 
        containing a detectable amount of N-phenyl-N-[1-(2-
        phenylethyl)-4-piperidinyl] propanamide or 10 grams or 
        more of a mixture or substance containing a detectable 
        amount of any analogue of N-phenyl-N-[1-(2-
        phenylethyl)-4-piperidinyl] propanamide; or
          (vii) 100 kilograms or more of a mixture or substance 
        containing a detectable amount of marihuana, or 100 or 
        more marihuana plants regardless of weight; or
          (viii) 5 grams or more of methamphetamine, its salts, 
        isomers, and salts of its isomers or 50 grams or more 
        of a mixture or substance containing a detectable 
        amount of methamphetamine, its salts, isomers, or salts 
        of its isomers;
such person shall be sentenced to a term of imprisonment which 
may not be less than 5 years and not more than 40 years and if 
death or serious bodily injury results from the use of such 
substance shall be not less than 20 years or 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 
$5,000,000 if the defendant is an individual or $25,000,000 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 which may not be less than 
10 years and not more than life imprisonment and if death or 
serious bodily injury results from the use of such substance 
shall be sentenced to 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 $8,000,000 if 
the defendant is an individual or $50,000,000 if the defendant 
is other than an individual, or both. Notwithstanding section 
3583 of title 18, any sentence under this subparagraph shall, 
in the absence of such a prior conviction, include a term of 
supervised release of at least 4 years in addition to such term 
of imprisonment and shall, if there was such a prior 
conviction, include a term of supervised release of at least 8 
years in addition to such term of imprisonment. Notwithstanding 
any other provision of law, the court shall not place on 
probation or suspend the sentence of any person sentenced under 
this subparagraph. No person sentenced under this subparagraph 
shall be eligible for parole during the term of imprisonment 
imposed therein.
  (C) In the case of a controlled substance in schedule I or 
II, gamma hydroxybutyric acid (including when scheduled as an 
approved drug product for purposes of section 3(a)(1)(B) of the 
Hillory J. Farias and Samantha Reid Date-Rape Drug Prohibition 
Act of 2000), or 1 gram of flunitrazepam, except as provided in 
subparagraphs (A), (B), and (D), 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 
less than twenty years or 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 $1,000,000 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 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 $2,000,000 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, 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 at least 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 at least 6 years in addition to such term of 
imprisonment. 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 subparagraph 
which provide for a mandatory term of imprisonment if death or 
serious bodily injury results, nor shall a person so sentenced 
be eligible for parole during the term of such a sentence.
  (D) In the case of less than 50 kilograms of marihuana, 
except in the case of 50 or more marihuana plants regardless of 
weight, 10 kilograms of hashish, or one kilogram of hashish 
oil, such person shall, except as provided in paragraphs (4) 
and (5) of this subsection, be sentenced to a term of 
imprisonment of not more than 5 years, a fine not to exceed the 
greater of that authorized in accordance with the provisions of 
title 18, United States Code, or $250,000 if the defendant is 
an individual or $1,000,000 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 10 years, a fine not to exceed the greater of 
twice that authorized in accordance with the provisions of 
title 18, United State Code, or $500,000 if the defendant is an 
individual or $2,000,000 if the defendant is other than an 
individual, or both. Notwithstanding section 3583 of title 18, 
any sentence imposing a term of imprisonment under this 
paragraph shall, in the absence of such a prior conviction, 
impose a special parole term of at least 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 at least 4 
years in addition to such term of imprisonment.
  (E)(i) Except as provided in subparagraphs (C) and (D), in 
the case of any controlled substance in schedule III, 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 at least 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 
at least 4 years in addition to such term of imprisonment.
  (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 the case of a controlled substance in schedule IV, 
such person shall be sentenced to a term of imprisonment of not 
more than 5 years, a fine not to exceed the greater of that 
authorized in accordance with the provisions of title 18, 
United States Code, or $250,000 if the defendant is an 
individual or $1,000,000 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 10 years, a fine not to exceed the greater of 
twice the authorized in accordance with the provisions of title 
18, United States Code, or $500,000 if the defendant is an 
individual or $2,000,000 if the defendant is other than an 
individual, or both. 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 at 
least one year in addition to such term of imprisonment and 
shall, if there was such a prior conviction, impose a term of 
supervised release of at least 2 years in addition to such term 
of imprisonment.
  (3) In the case of a controlled substance in schedule V, such 
person shall be sentenced to a term of imprisonment of not more 
than 1 year, a fine not to exceed the greater of that 
authorized in accordance with the provisions of title 18, 
United States Code, or $100,000 if the defendant is an 
individual or $250,000 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 4 years, a fine not to exceed the provisions 
of title 18, United States Code, or $200,000 if the defendant 
is an individual or $500,000 if the defendant is other than an 
individual, or both. Any sentence imposing a term of 
imprisonment under this paragraph may, if there was a prior 
conviction, impose a term of supervised release of not more 
than 1 year, in addition to such term of imprisonment.
  (4) Notwithstanding paragraph (1)(D) of this subsection, any 
person who violates subsection (a) of this section by 
distributing a small amount of marihuana for no remuneration 
shall be treated as provided in section 404 and section 3607 of 
title 18, United States Code.
  (5) Any person who violates subsection (a) of this section by 
cultivating or manufacturing a controlled substance on Federal 
property shall be imprisoned as provided in this subsection and 
shall be fined any amount not to exceed--
          (A) the amount authorized in accordance with this 
        section;
          (B) the amount authorized in accordance with the 
        provisions of title 18, United States Code;
          (C) $500,000 if the defendant is an individual; or
          (D) $1,000,000 if the defendant is other than an 
        individual;
or both.
  (6) Any person who violates subsection (a), or attempts to do 
so, and knowingly or intentionally uses a poison, chemical, or 
other hazardous substance on Federal land, and, by such use--
          (A) creates a serious hazard to humans, wildlife, or 
        domestic animals,
          (B) degrades or harms the environment or natural 
        resources, or
          (C) pollutes an aquifer, spring, stream, river, or 
        body of water,
shall be fined in accordance with title 18, United States Code, 
or imprisoned not more than five years, or both.
  (7) Penalties for distribution.--
          (A) In general.--Whoever, with intent to commit a 
        crime of violence, as defined in section 16 of title 
        18, United States Code (including rape), against an 
        individual, violates subsection (a) by distributing a 
        controlled substance or controlled substance analogue 
        to that individual without that individual's knowledge, 
        shall be imprisoned not more than 20 years and fined in 
        accordance with title 18, United States Code.
          (B) Definition.--For purposes of this paragraph, the 
        term ``without that individual's knowledge'' means that 
        the individual is unaware that a substance with the 
        ability to alter that individual's ability to appraise 
        conduct or to decline participation in or communicate 
        unwillingness to participate in conduct is administered 
        to the individual.
  (c) Any person who knowingly or intentionally--
          (1) possesses a listed chemical with intent to 
        manufacture a controlled substance except as authorized 
        by this title;
          (2) possesses or distributes, a listed chemical 
        knowing, or having reasonable cause to believe, that 
        the listed chemical will be used to manufacture a 
        controlled substance except as authorized by this 
        title; or
          (3) with the intent of causing the evasion of the 
        recordkeeping or reporting requirements of section 310, 
        or the regulations issued under that section, receives 
        or distributes a reportable amount of any listed 
        chemical in units small enough so that the making of 
        records or filing of reports under that section is not 
        required;
shall be fined in accordance with title 18, United States Code, 
or imprisoned not more than 20 years in the case of a violation 
of paragraph (1) or (2) involving a list I chemical or not more 
than 10 years in the case of a violation of this subsection 
other than a violation of paragraph (1) or (2) involving a list 
I chemical, or both.
  (d)(1) Any person who assembles, maintains, places, or causes 
to be placed a boobytrap on Federal property where a controlled 
substance is being manufactured, distributed, or dispensed 
shall be sentenced to a term of imprisonment for not more than 
10 years or fined under title 18, United States Code, or both.
  (2) If any person commits such a violation after 1 or more 
prior convictions for an offense punishable under this 
subsection, such person shall be sentenced to a term of 
imprisonment of not more than 20 years or fined under title 18, 
United States Code, or both.
  (3) For the purposes of this subsection, the term 
``boobytrap'' means any concealed or camouflaged device 
designed to cause bodily injury when triggered by any action of 
any unsuspecting person making contact with the device. Such 
term includes guns, ammunition, or explosive devices attached 
to trip wires or other triggering mechanisms, sharpened stakes, 
and lines or wires with hooks attached.
  (e) In addition to any other applicable penalty, any person 
convicted of a felony violation of this section relating to the 
receipt, distribution, manufacture, exportation, or importation 
of a listed chemical may be enjoined from engaging in any 
transaction involving a listed chemical for not more than ten 
years.
  (f)(1) Whoever knowingly distributes a listed chemical in 
violation of this title (other than in violation of a 
recordkeeping or reporting requirement of section 310) shall, 
except to the extent that paragraph (12), (13), or (14) of 
section 402(a) applies, be fined under title 18, United States 
Code, or imprisoned not more than 5 years, or both.
  (2) Whoever possesses any listed chemical, with knowledge 
that the recordkeeping or reporting requirements of section 310 
have not been adhered to, if, after such knowledge is acquired, 
such person does not take immediate steps to remedy the 
violation shall be fined under title 18, United States Code, or 
imprisoned not more than one year, or both.
  (g) Internet Sales of Date Rape Drugs.--
          (1) Whoever knowingly uses the Internet to distribute 
        a date rape drug to any person, knowing or with 
        reasonable cause to believe that--
                  (A) the drug would be used in the commission 
                of criminal sexual conduct; or
                  (B) the person is not an authorized 
                purchaser;
        shall be fined under this title or imprisoned not more 
        than 20 years, or both.
          (2) As used in this subsection:
                  (A) The term ``date rape drug'' means--
                          (i) gamma hydroxybutyric acid (GHB) 
                        or any controlled substance analogue of 
                        GHB, including gamma butyrolactone 
                        (GBL) or 1,4-butanediol;
                          (ii) ketamine;
                          (iii) flunitrazepam; or
                          (iv) any substance which the Attorney 
                        General designates, pursuant to the 
                        rulemaking procedures prescribed by 
                        section 553 of title 5, United States 
                        Code, to be used in committing rape or 
                        sexual assault.
                The Attorney General is authorized to remove 
                any substance from the list of date rape drugs 
                pursuant to the same rulemaking authority.
                  (B) The term ``authorized purchaser'' means 
                any of the following persons, provided such 
                person has acquired the controlled substance in 
                accordance with this Act:
                          (i) A person with a valid 
                        prescription that is issued for a 
                        legitimate medical purpose in the usual 
                        course of professional practice that is 
                        based upon a qualifying medical 
                        relationship by a practitioner 
                        registered by the Attorney General. A 
                        ``qualifying medical relationship'' 
                        means a medical relationship that 
                        exists when the practitioner has 
                        conducted at least 1 medical evaluation 
                        with the authorized purchaser in the 
                        physical presence of the practitioner, 
                        without regard to whether portions of 
                        the evaluation are conducted by other 
                        heath professionals. The preceding 
                        sentence shall not be construed to 
                        imply that 1 medical evaluation 
                        demonstrates that a prescription has 
                        been issued for a legitimate medical 
                        purpose within the usual course of 
                        professional practice.
                          (ii) Any practitioner or other 
                        registrant who is otherwise authorized 
                        by their registration to dispense, 
                        procure, purchase, manufacture, 
                        transfer, distribute, import, or export 
                        the substance under this Act.
                          (iii) A person or entity providing 
                        documentation that establishes the 
                        name, address, and business of the 
                        person or entity and which provides a 
                        legitimate purpose for using any ``date 
                        rape drug'' for which a prescription is 
                        not required.
          (3) The Attorney General is authorized to promulgate 
        regulations for record-keeping and reporting by persons 
        handling 1,4-butanediol in order to implement and 
        enforce the provisions of this section. Any record or 
        report required by such regulations shall be considered 
        a record or report required under this Act.
  (h) Offenses Involving Dispensing of Controlled Substances by 
Means of the Internet.--
          (1) In general.--It shall be unlawful for any person 
        to knowingly or intentionally--
                  (A) deliver, distribute, or dispense a 
                controlled substance by means of the Internet, 
                except as authorized by this title; or
                  (B) aid or abet (as such terms are used in 
                section 2 of title 18, United States Code) any 
                activity described in subparagraph (A) that is 
                not authorized by this title.
          (2) Examples.--Examples of activities that violate 
        paragraph (1) include, but are not limited to, 
        knowingly or intentionally--
                  (A) delivering, distributing, or dispensing a 
                controlled substance by means of the Internet 
                by an online pharmacy that is not validly 
                registered with a modification authorizing such 
                activity as required by section 303(f) (unless 
                exempt from such registration);
                  (B) writing a prescription for a controlled 
                substance for the purpose of delivery, 
                distribution, or dispensation by means of the 
                Internet in violation of section 309(e);
                  (C) serving as an agent, intermediary, or 
                other entity that causes the Internet to be 
                used to bring together a buyer and seller to 
                engage in the dispensing of a controlled 
                substance in a manner not authorized by 
                sections 303(f) or 309(e);
                  (D) offering to fill a prescription for a 
                controlled substance based solely on a 
                consumer's completion of an online medical 
                questionnaire; and
                  (E) making a material false, fictitious, or 
                fraudulent statement or representation in a 
                notification or declaration under subsection 
                (d) or (e), respectively, of section 311.
          (3) Inapplicability.--
                  (A) This subsection does not apply to--
                          (i) the delivery, distribution, or 
                        dispensation of controlled substances 
                        by nonpractitioners to the extent 
                        authorized by their registration under 
                        this title;
                          (ii) the placement on the Internet of 
                        material that merely advocates the use 
                        of a controlled substance or includes 
                        pricing information without attempting 
                        to propose or facilitate an actual 
                        transaction involving a controlled 
                        substance; or
                          (iii) except as provided in 
                        subparagraph (B), any activity that is 
                        limited to--
                                  (I) the provision of a 
                                telecommunications service, or 
                                of an Internet access service 
                                or Internet information 
                                location tool (as those terms 
                                are defined in section 231 of 
                                the Communications Act of 
                                1934); or
                                  (II) the transmission, 
                                storage, retrieval, hosting, 
                                formatting, or translation (or 
                                any combination thereof) of a 
                                communication, without 
                                selection or alteration of the 
                                content of the communication, 
                                except that deletion of a 
                                particular communication or 
                                material made by another person 
                                in a manner consistent with 
                                section 230(c) of the 
                                Communications Act of 1934 
                                shall not constitute such 
                                selection or alteration of the 
                                content of the communication.
                  (B) The exceptions under subclauses (I) and 
                (II) of subparagraph (A)(iii) shall not apply 
                to a person acting in concert with a person who 
                violates paragraph (1).
          (4) Knowing or intentional violation.--Any person who 
        knowingly or intentionally violates this subsection 
        shall be sentenced in accordance with subsection (b).

                      prohibited acts b--penalties

  Sec. 402. (a) It shall be unlawful for any person--
          (1) who is subject to the requirements of part C to 
        distribute or dispense a controlled substance in 
        violation of section 309;
          (2) who is a registrant to distribute or dispense a 
        controlled substance not authorized by his registration 
        to another registrant or other authorized person or to 
        manufacture a controlled substance not authorized by 
        his registration;
          (3) who is a registrant to distribute a controlled 
        substance in violation of section 305 of this title;
          (4) to remove, alter, or obliterate a symbol or label 
        required by section 305 of this title;
          (5) to refuse or negligently fail to make, keep, or 
        furnish any record, report, notification, declaration, 
        order or order form, statement, invoice, or information 
        required under this title or title III;
          (6) to refuse any entry into any premises or 
        inspection authorized by this title or title III;
          (7) to remove, break, injure, or deface a seal placed 
        upon controlled substances pursuant to section 304(f) 
        or 511 or to remove or dispose of substances so placed 
        under seal;
          (8) to use, to his own advantage, or to reveal, other 
        than to duly authorized officers or employees of the 
        United States, or to the courts when relevant in any 
        judicial proceeding under this title or title III, any 
        information acquired in the course of an inspection 
        authorized by this title concerning any method or 
        process which as a trade secret is entitled to 
        protection, or to use to his own advantage or reveal 
        (other than as authorized by section 310) any 
        information that is confidential under such section;
          (9) who is a regulated person to engage in a 
        regulated transaction without obtaining the 
        identification required by 310(a)(3);
          (10) negligently to fail to keep a record or make a 
        report under section 310 or negligently to fail to 
        self-certify as required under section 310;
          (11) to distribute a laboratory supply to a person 
        who uses, or attempts to use, that laboratory supply to 
        manufacture a controlled substance or a listed 
        chemical, in violation of this title or title III, with 
        reckless disregard for the illegal uses to which such a 
        laboratory supply will be put;
          (12) who is a regulated seller, or a distributor 
        required to submit reports under subsection (b)(3) of 
        section 310--
                  (A) to sell at retail a scheduled listed 
                chemical product in violation of paragraph (1) 
                of subsection (d) of such section, knowing at 
                the time of the transaction involved 
                (independent of consulting the logbook under 
                subsection (e)(1)(A)(iii) of such section) that 
                the transaction is a violation; or
                  (B) to knowingly or recklessly sell at retail 
                such a product in violation of paragraph (2) of 
                such subsection (d);
          (13) who is a regulated seller to knowingly or 
        recklessly sell at retail a scheduled listed chemical 
        product in violation of subsection (e) of such section;
          (14) who is a regulated seller or an employee or 
        agent of such seller to disclose, in violation of 
        regulations under subparagraph (C) of section 
        310(e)(1), information in logbooks under subparagraph 
        (A)(iii) of such section, or to refuse to provide such 
        a logbook to Federal, State, or local law enforcement 
        authorities;
          (15) to distribute a scheduled listed chemical 
        product to a regulated seller, or to a regulated person 
        referred to in section 310(b)(3)(B), unless such 
        regulated seller or regulated person is, at the time of 
        such distribution, currently registered with the Drug 
        Enforcement Administration, or on the list of persons 
        referred to under section 310(e)(1)(B)(v); or
          (16) to violate subsection (e) or subsection (f) of 
        section 825 of this title.
As used in paragraph (11), the term ``laboratory supply'' means 
a listed chemical or any chemical, substance, or item on a 
special surveillance list published by the Attorney General, 
which contains chemicals, products, materials, or equipment 
used in the manufacture of controlled substances and listed 
chemicals. For purposes of paragraph (11), there is a 
rebuttable presumption of reckless disregard at trial if the 
Attorney General notifies a firm in writing that a laboratory 
supply sold by the firm, or any other person or firm, has been 
used by a customer of the notified firm, or distributed further 
by that customer, for the unlawful production of controlled 
substances or listed chemicals a firm distributes and 2 weeks 
or more after the notification the notified firm distributes a 
laboratory supply to the customer. For purposes of paragraph 
(15), if the distributor is temporarily unable to access the 
list of persons referred to under section 310(e)(1)(B)(v), the 
distributor may rely on a written, faxed, or electronic copy of 
a certificate of self-certification submitted by the regulated 
seller or regulated person, provided the distributor confirms 
within 7 business days of the distribution that such regulated 
seller or regulated person is on the list referred to under 
section 310(e)(1)(B)(v).
  (b) It shall be unlawful for any person who is a registrant 
to manufacture a controlled substance in [schedule I or II] 
schedule I, II, or A, or ephedrine, pseudoephedrine, or 
phenylpropanolamine or any of the salts, optical isomers, or 
salts of optical isomers of such chemical, which is--
          (1) not expressly authorized by his registration and 
        by a quota assigned to him pursuant to section 306; or
          (2) in excess of a quota assigned to him pursuant to 
        section 306.
  (c)(1)(A) Except as provided in subparagraph (B), (C), or (D) 
of this paragraph and paragraph (2), any person who violates 
this section shall, with respect to any such violation, be 
subject to a civil penalty of not more than $25,000. The 
district courts of the United States (or, where there is no 
such court in the case of any territory or possession of the 
United States, then the court in such territory or possession 
having the jurisdiction of a district court of the United 
States in cases arising under the Constitution and laws of the 
United States) shall have jurisdiction in accordance with 
section 1355 of title 28 of the United States Code to enforce 
this paragraph.
  (B) In the case of a violation of paragraph (5) or (10) of 
subsection (a), the civil penalty shall not exceed $10,000.
  (C) In the case of a violation of paragraph (16) of 
subsection (a) of this section by an importer, exporter, 
manufacturer, or distributor (other than as provided in 
subparagraph (D)), up to $500,000 per violation. For purposes 
of this subparagraph, a violation is defined as each instance 
of importation, exportation, manufacturing, distribution, or 
possession with intent to manufacture or distribute, in 
violation of paragraph (16) of subsection (a).
  (D) In the case of a distribution, dispensing, or possession 
with intent to distribute or dispense in violation of paragraph 
(16) of subsection (a) of this section at the retail level, up 
to $1000 per violation. For purposes of this paragraph, the 
term ``at the retail level'' refers to products sold, or held 
for sale, directly to the consumer for personal use. Each 
package, container or other separate unit containing an 
anabolic steroid or a schedule A substance that is distributed, 
dispensed, or possessed with intent to distribute or dispense 
at the retail level in violation of such paragraph (16) of 
subsection (a) shall be considered a separate violation.
  (2)(A) If a violation of this section is prosecuted by an 
information or indictment which alleges that the violation was 
committed knowingly and the trier of fact specifically finds 
that the violation was so committed, such person shall, except 
as otherwise provided in subparagraph (B) of this paragraph, be 
sentenced to imprisonment of not more than one year or a fine 
under title 18, United States Code, or both.
  (B) If a violation referred to in subparagraph (A) was 
committed after one or more prior convictions of the offender 
for an offense punishable under this paragraph (2), or for a 
crime under any other provision of this title or title III or 
other law of the United States relating to narcotic drugs, 
marihuana, or depressant or stimulant substances, have become 
final, such person shall be sentenced to a term of imprisonment 
of not more than 2 years, a fine under title 18, United States 
Code, or both.
  (C) In addition to the penalties set forth elsewhere in this 
title or title III, any business that violates paragraph (11) 
of subsection (a) shall, with respect to the first such 
violation, be subject to a civil penalty of not more than 
$250,000, but shall not be subject to criminal penalties under 
this section, and shall, for any succeeding violation, be 
subject to a civil fine of not more than $250,000 or double the 
last previously imposed penalty, whichever is greater.
  (3) Except under the conditions specified in paragraph (2) of 
this subsection, a violation of this section does not 
constitute a crime, and a judgment for the United States and 
imposition of a civil penalty pursuant to paragraph (1) shall 
not give rise to any disability or legal disadvantage based on 
conviction for a criminal offense.
  (4)(A) If a regulated seller, or a distributor required to 
submit reports under section 310(b)(3), violates paragraph (12) 
of subsection (a) of this section, or if a regulated seller 
violates paragraph (13) of such subsection, the Attorney 
General may by order prohibit such seller or distributor (as 
the case may be) from selling any scheduled listed chemical 
product. Any sale of such a product in violation of such an 
order is subject to the same penalties as apply under paragraph 
(2).
  (B) An order under subparagraph (A) may be imposed only 
through the same procedures as apply under section 304(c) for 
an order to show cause.

                      prohibited acts c--penalties

  Sec. 403. (a) It shall be unlawful for any person knowingly 
or intentionally--
          (1) who is a registrant to distribute a controlled 
        substance classified in [schedule I or II] schedule I, 
        II, or A, in the course of his legitimate business, 
        except pursuant to an order or an order form as 
        required by section 308 of this title;
          (2) to use in the course of the manufacture, 
        distribution, or dispensing of a controlled substance, 
        or to use for the purpose of acquiring or obtaining a 
        controlled substance, a registration number which is 
        fictitious, revoked, suspended, expired, or issued to 
        another person;
          (3) to acquire or obtain possession of a controlled 
        substance by misrepresentation, fraud, forgery, 
        deception, or subterfuge;
          (4)(A) to furnish false or fraudulent material 
        information in, or omit any material information from, 
        any application, report, record, or other document 
        required to be made, kept, or filed under this title or 
        title III, or (B) to present false or fraudulent 
        identification where the person is receiving or 
        purchasing a listed chemical and the person is required 
        to present identification under section 310(a);
          (5) to make, distribute, or possess any punch, die, 
        plate, stone, or other thing designed to print, 
        imprint, or reproduce the trademark, trade name, or 
        other identifying mark, imprint, or device of another 
        or any likeness of any of the foregoing upon any drug 
        or container or labeling thereof so as to render such 
        drug a counterfeit substance;
          (6) to possess any three-neck round-bottom flask, 
        tableting machine, encapsulating machine, or gelatin 
        capsule, or any equipment, chemical, product, or 
        material which may be used to manufacture a controlled 
        substance or listed chemical, knowing, intending, or 
        having reasonable cause to believe, that it will be 
        used to manufacture a controlled substance or listed 
        chemical in violation of this title or title III;
          (7) to manufacture, distribute, export, or import any 
        three-neck round-bottom flask, tableting machine, 
        encapsulating machine, or gelatin capsule, or any 
        equipment, chemical, product, or material which may be 
        used to manufacture a controlled substance or listed 
        chemical, knowing, intending, or having reasonable 
        cause to believe, that it will be used to manufacture a 
        controlled substance or listed chemical in violation of 
        this title or title III or, in the case of an 
        exportation, in violation of this title or title III or 
        of the laws of the country to which it is exported;
          (8) to create a chemical mixture for the purpose of 
        evading a requirement of section 310 or to receive a 
        chemical mixture created for that purpose; [or]
          (9) to distribute, import, or export a list I 
        chemical without the registration required by this 
        title or title III[.]; or
          (10) to export a substance in violation of the 
        controlled substance laws of the country to which the 
        substance is exported.
  (b) It shall be unlawful for any person knowingly or 
intentionally to use any communication facility in committing 
or in causing or facilitating the commission of any act or acts 
constituting a felony under any provision of this title or 
title III. Each separate use of a communication facility shall 
be a separate offense under this subsection. For purposes of 
this subsection, the term ``communication facility'' means any 
and all public and private instrumentalities used or useful in 
the transmission of writing, signs, signals, pictures, or 
sounds of all kinds and includes mail, telephone, wire, radio, 
and all other means of communication.
  (c)(1) It shall be unlawful for any person to place in any 
newspaper, magazine, handbill, or other publications, any 
written advertisement knowing that it has the purpose of 
seeking or offering illegally to receive, buy, or distribute a 
Schedule I controlled substance. As used in this section the 
term ``advertisement'' includes, in addition to its ordinary 
meaning, such advertisements as those for a catalog of Schedule 
I controlled substances and any similar written advertisement 
that has the purpose of seeking or offering illegally to 
receive, buy, or distribute a Schedule I controlled substance. 
The term ``advertisement'' does not include material which 
merely advocates the use of a similar material, which advocates 
a position or practice, and does not attempt to propose or 
facilitate an actual transaction in a Schedule I controlled 
substance.
  (2)(A) It shall be unlawful for any person to knowingly or 
intentionally use the Internet, or cause the Internet to be 
used, to advertise the sale of, or to offer to sell, 
distribute, or dispense, a controlled substance where such 
sale, distribution, or dispensing is not authorized by this 
title or by the Controlled Substances Import and Export Act.
  (B) Examples of activities that violate subparagraph (A) 
include, but are not limited to, knowingly or intentionally 
causing the placement on the Internet of an advertisement that 
refers to or directs prospective buyers to Internet sellers of 
controlled substances who are not registered with a 
modification under section 303(f).
  (C) Subparagraph (A) does not apply to material that either--
          (i) merely advertises the distribution of controlled 
        substances by nonpractitioners to the extent authorized 
        by their registration under this title; or
          (ii) merely advocates the use of a controlled 
        substance or includes pricing information without 
        attempting to facilitate an actual transaction 
        involving a controlled substance.
  (d)(1) Except as provided in paragraph (2), any person who 
violates this section shall be sentenced to a term of 
imprisonment of not more than 4 years, a fine under title 18, 
United States Code, or both; except that if any person commits 
such a violation after one or more prior convictions of him for 
violation of this section, or for a felony under any other 
provision of this title or title III or other law of the United 
States relating to narcotic drugs, marihuana, or depressant or 
stimulant substances, have become final, such person shall be 
sentenced to a term of imprisonment of not more than 8 years, a 
fine under title 18, United States Code, or both.
  (2) Any person who, with the intent to manufacture or to 
facilitate the manufacture of methamphetamine, violates 
paragraph (6) or (7) of subsection (a), shall be sentenced to a 
term of imprisonment of not more than 10 years, a fine under 
title 18, United States Code, or both; except that if any 
person commits such a violation after one or more prior 
convictions of that person--
          (A) for a violation of paragraph (6) or (7) of 
        subsection (a);
          (B) for a felony under any other provision of this 
        subchapter or subchapter II of this chapter; or
          (C) under any other law of the United States or any 
        State relating to controlled substances or listed 
        chemicals,
has become final, such person shall be sentenced to a term of 
imprisonment of not more than 20 years, a fine under title 18, 
United States Code, or both.
  (e) In addition to any other applicable penalty, any person 
convicted of a felony violation of this section relating to the 
receipt, distribution, manufacture, exportation, or importation 
of a listed chemical may be enjoined from engaging in any 
transaction involving a listed chemical for not more than ten 
years.
  (f) Injunctions.--(1) In addition to any penalty provided in 
this section, the Attorney General is authorized to commence a 
civil action for appropriate declaratory or injunctive relief 
relating to violations of this section, section 402, or 416.
  (2) Any action under this subsection may be brought in the 
district court of the United States for the district in which 
the defendant is located or resides or is doing business.
  (3) Any order or judgment issued by the court pursuant to 
this subsection shall be tailored to restrain violations of 
this section or section 402.
  (4) The court shall proceed as soon as practicable to the 
hearing and determination of such an action. An action under 
this subsection is governed by the Federal Rules of Civil 
Procedure except that, if an indictment has been returned 
against the respondent, discovery is governed by the Federal 
Rules of Criminal Procedure.

                     penalty for simple possession

  Sec. 404. (a) It shall be unlawful for any person knowingly 
or intentionally to possess a controlled substance unless such 
substance was obtained directly, or pursuant to a valid 
prescription or order, from a practitioner, while acting in the 
course of his professional practice, or except as otherwise 
authorized by this title or title III. It shall be unlawful for 
any person knowingly or intentionally to possess any list I 
chemical obtained pursuant to or under authority of a 
registration issued to that person under section 303 of this 
title or section 1008 of title III if that registration has 
been revoked or suspended, if that registration has expired, or 
if the registrant has ceased to do business in the manner 
contemplated by his registration. It shall be unlawful for any 
person to knowingly or intentionally purchase at retail during 
a 30 day period more than 9 grams of ephedrine base, 
pseudoephedrine base, or phenylpropanolamine base in a 
scheduled listed chemical product, except that, of such 9 
grams, not more than 7.5 grams may be imported by means of 
shipping through any private or commercial carrier or the 
Postal Service. Any person who violates this subsection shall 
be sentenced to a term of imprisonment of not more than 1 year, 
and be fined a minimum of $1,000, or both, except that if he 
commits such offense after a prior conviction under this title 
or title III, or a prior conviction for any drug, narcotic, or 
chemical offense chargeable under the law of any State, has 
become final, he shall be sentenced to a term of imprisonment 
for not less than 15 days but not more than 2 years, and shall 
be fined a minimum of $2,500, except, further, that if he 
commits such offense after two or more prior convictions under 
this title or title III, or two or more prior convictions for 
any drug, narcotic, or chemical offense chargeable under the 
law of any State, or a combination of two or more such offenses 
have become final, he shall be sentenced to a term of 
imprisonment for not less than 90 days but not more than 3 
years, and shall be fined a minimum of $5,000. Notwithstanding 
any penalty provided in this subsection, any person convicted 
under this subsection for the possession of flunitrazepam shall 
be imprisoned for not more than 3 years, shall be fined as 
otherwise provided in this section, or both. The imposition or 
execution of a minimum sentence required to be imposed under 
this subsection shall not be suspended or deferred. Further, 
upon conviction, a person who violates this subsection shall be 
fined the reasonable costs of the investigation and prosecution 
of the offense, including the costs of prosecution of an 
offense as defined in sections 1918 and 1920 of title 28, 
United States Code, except that this sentence shall not apply 
and a fine under this section need not be imposed if the court 
determines under the provision of title 18 that the defendant 
lacks the ability to pay.
  (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.
  (c) As used in this section, the term ``drug, narcotic, or 
chemical offense'' means any offense which proscribes the 
possession, distribution, manufacture, cultivation, sale, 
transfer, or the attempt or conspiracy to possess, distribute, 
manufacture, cultivate, sell or transfer any substance the 
possession of which is prohibited under this title.

           *       *       *       *       *       *       *


Part E--Administrative and Enforcement Provisions

           *       *       *       *       *       *       *


                              forfeitures

  Sec. 511. (a) The following shall be subject to forfeiture to 
the United States and no property right shall exist in them:
          (1) All controlled substances which have been 
        manufactured, distributed, dispensed, or acquired in 
        violation of this title.
          (2) All raw materials, products, and equipment of any 
        kind which are used, or intended for use, in 
        manufacturing, compounding, processing, delivering, 
        importing, or exporting any controlled substance or 
        listed chemical in violation of this title.
          (3) All property which is used, or intended for use, 
        as a container for property described in paragraph (1), 
        (2), or (9).
          (4) All conveyances, including aircraft, vehicles, or 
        vessels, which are used, or are intended for use, to 
        transport, or in any manner to facilitate the 
        transportation, sale, receipt, possession, or 
        concealment of property described in paragraph (1), 
        (2), or (9).
          (5) All books, records, and research, including 
        formulas, microfilm, tapes, and data which are used, or 
        intended for use, in violation of this title.
          (6) All moneys, negotiable instruments, securities, 
        or other things of value furnished or intended to be 
        furnished by any person in exchange for a controlled 
        substance or listed chemical in violation of this 
        title, all proceeds traceable to such an exchange, and 
        all moneys, negotiable instruments, and securities used 
        or intended to be used to facilitate any violation of 
        this title.
          (7) All real property, including any right, title, 
        and interest (including any leasehold interest) in the 
        whole of any lot or tract of land and any appurtenances 
        or improvements, which is used, or intended to be used, 
        in any manner or part, to commit, or to facilitate the 
        commission of, a violation of this title punishable by 
        more than one year's imprisonment.
          (8) All controlled substances which have been 
        possessed in violation of this title.
          (9) All listed chemicals, all drug manufacturing 
        equipment, all tableting machines, all encapsulating 
        machines, and all gelatin capsules, which have been 
        imported, exported, manufactured, possessed, 
        distributed, dispensed, acquired,or intended to be 
        distributed, dispensed, acquired, imported, or 
        exported, in violation of this title or title III.
          (10) Any drug paraphernalia (as defined in section 
        422).
          (11) Any firearm (as defined in section 921 of title 
        18, United States Code) used or intended to be used to 
        facilitate the transportation, sale, receipt, 
        possession, or concealment of property described in 
        paragraph (1) or (2) and any proceeds traceable to such 
        property.
  (b) Seizure Procedures.--Any property subject to forfeiture 
to the United States under this section may be seized by the 
Attorney General in the manner set forth in section 981(b) of 
title 18, United States Code.
  (c) Property taken or detained under this section shall not 
be repleviable, but shall be deemed to be in the custody of the 
Attorney General, subject only to the orders and decrees of the 
court or the official having jurisdiction thereof. Whenever 
property is seized under any of the provisions of this title, 
the Attorney General may--
          (1) place the property under seal;
          (2) remove the property to a place designated by him; 
        or
          (3) require that the General Services Administration 
        take custody of the property and remove it, if 
        practicable, to an appropriate location for disposition 
        in accordance with law.
  (d) The provisions of law relating to the seizure, summary 
and judicial forfeiture, and condemnation of property for 
violation of the customs laws; the disposition of such property 
or the proceeds from the sale thereof; the remission or 
mitigation of such forfeitures; and the compromise of claims 
shall apply to seizures and forfeitures incurred, or alleged to 
have been incurred, under any of the provisions of this title, 
insofar as applicable and not inconsistent with the provisions 
hereof; except that such duties as are imposed upon the customs 
officer or any other person with respect to the seizure and 
forfeiture of property under the customs laws shall be 
performed with respect to seizures and forfeitures of property 
under this title by such officers, agents, or other persons as 
may be authorized or designated for that purpose by the 
Attorney General, except to the extent that such duties arise 
from seizures and forfeitures effected by any customs officer.
  (e)(1) Whenever property is civily or criminally forfeited 
under this title the Attorney General may--
          (A) retain the property for official use or, in the 
        manner provided with respect to transfers under section 
        616 of the Tariff Act of 1930, transfer the property to 
        any Federal agency or to any State or local law 
        enforcement agency which participated directly in the 
        seizure or forfeiture of the property;
          (B) except as provided in paragraph (4), sell, by 
        public sale or any other commercially feasible means, 
        any forfeited property which is not required to be 
        destroyed by law and which is not harmful to the 
        public;
          (C) require that the General Services Administration 
        take custody of the property and dispose of it in 
        accordance with law;
          (D) forward it to the Bureau of Narcotics and 
        Dangerous Drugs for disposition (including delivery for 
        medical or scientific use to any Federal or State 
        agency under regulations of the Attorney General); or
          (E) transfer the forfeited personal property or the 
        proceeds of the sale of any forfeited personal or real 
        property to any foreign country which participated 
        directly or indirectly in the seizure or forfeiture of 
        the property, if such a transfer--
                  (i) has been agreed to by the Secretary of 
                State;
                  (ii) is authorized in an international 
                agreement between the United States and the 
                foreign country; and
                  (iii) is made to a country which, if 
                applicable, has been certified under section 
                490(b) of the Foreign Assistance Act of 1961.
  (2)(A) The proceeds from any sale under subparagraph (B) of 
paragraph (1) and any moneys forfeited under this title shall 
be used to pay--
          (i) all proper expenses of the proceedings for 
        forfeiture and sale including expenses of seizure, 
        maintenance of custody, advertising, and court costs; 
        and
          (ii) awards of up to $100,000 to any individual who 
        provides original information which leads to the arrest 
        and conviction of a person who kills or kidnaps a 
        Federal drug law enforcement agent.
Any award paid for information concerning the killing or 
kidnapping of a Federal drug law enforcement agent, as provided 
in clause (ii), shall be paid at the discretion of the Attorney 
General.
  (B) The Attorney General shall forward to the Treasurer of 
the United States for deposit in accordance with section 524(c) 
of title 28, United States Code, any amounts of such moneys and 
proceeds remaining after payment of the expenses provided in 
subparagraph (A), except that, with respect to forfeitures 
conducted by the Postal Service, the Postal Service shall 
deposit in the Postal Service Fund, under section 2003(b)(7) of 
title 39, United States Code, such moneys and proceeds.
  (3) The Attorney General shall assure that any property 
transferred to a State or local law enforcement agency under 
paragraph (1)(A)--
          (A) has a value that bears a reasonable relationship 
        to the degree of direct participation of the State or 
        local agency in the law enforcement effort resulting in 
        the forfeiture, taking into account the total value of 
        all property forfeited and the total law enforcement 
        effort with respect to the violation of law on which 
        the forfeiture is based; and
          (B) will serve to encourage further cooperation 
        between the recipient State or local agency and Federal 
        law enforcement agencies.
  (4)(A) With respect to real property described in 
subparagraph (B), if the chief executive officer of the State 
involved submits to the Attorney General a request for purposes 
of such subparagraph, the authority established in such 
subparagraph is in lieu of the authority established in 
paragraph (1)(B).
  (B) In the case of property described in paragraph (1)(B) 
that is civilly or criminally forfeited under this title, if 
the property is real property that is appropriate for use as a 
public area reserved for recreational or historic purposes or 
for the preservation of natural conditions, the Attorney 
General, upon the request of the chief executive officer of the 
State in which the property is located, may transfer title to 
the property to the State, either without charge or for a 
nominal charge, through a legal instrument providing that--
          (i) such use will be the principal use of the 
        property; and
          (ii) title to the property reverts to the United 
        States in the event that the property is used 
        otherwise.
  (f)(1) All controlled substances in [schedule I or II] 
schedule I, II, or A that are possessed, transferred, sold, or 
offered for sale in violation of the provisions of this title; 
all dangerous, toxic, or hazardous raw materials or products 
subject to forfeiture under subsection (a)(2) of this section; 
and any equipment or container subject to forfeiture under 
subsection (a)(2) or (3) which cannot be separated safely from 
such raw materials or products shall be deemed contraband and 
seized and summarily forfeited to the United States. Similarly, 
all substances in [schedule I or II] schedule I, II, or A, 
which are seized or come into the possession of the United 
States, the owners of which are unknown, shall be deemed 
contraband and summarily forfeited to the United States.
  (2) The Attorney General may direct the destruction of all 
controlled substances in [schedule I or II] schedule I, II, or 
A seized for violation of this title; all dangerous, toxic, or 
hazardous raw materials or products subject to forfeiture under 
subsection (a)(2) of this section; and any equipment or 
container subject to forfeiture under subsection (a)(2) or (3) 
which cannot be separated safely from such raw materials or 
products under such circumstances as the Attorney General may 
deem necessary.
  (g)(1) All species of plants from which controlled substances 
in schedules I and II may be derived which have been planted or 
cultivated in violation of this title, or of which the owners 
or cultivators are unknown, or which are wild growths, may be 
seized and summarily forfeited to the United States.
  (2) The failure, upon demand by the Attorney General or his 
duly authorized agent, of the person in occupancy or in control 
of land or premises upon which such species of plants are 
growing or being stored, to produce an appropriate 
registration, or proof that he is the holder thereof, shall 
constitute authority for the seizure and forfeiture.
  (3) The Attorney General, or his duly authorized agent, shall 
have authority to enter upon any lands, or into any dwelling 
pursuant to a search warrant, to cut, harvest, carry off, or 
destroy such plants.
  (h) All right, title, and interest in property described in 
subsection (a) shall vest in the United States upon commission 
of the act giving rise to forfeiture under this section.
  (i) The provisions of section 981(g) of title 18, United 
States Code, regarding the stay of a civil forfeiture 
proceeding shall apply to forfeitures under this section.
  (j) In addition to the venue provided for in section 1395 of 
title 28, United States Code, or any other provision of law, in 
the case of property of a defendant charged with a violation 
that is the basis for forfeiture of the property under this 
section, a proceeding for forfeiture under this section may be 
brought in the judicial district in which the defendant owning 
such property is found or in the judicial district in which the 
criminal prosecution is brought.
  (l) The functions of the Attorney General under this section 
shall be carried out by the Postal Service pursuant to such 
agreement as may be entered into between the Attorney General 
and the Postal Service.

           *       *       *       *       *       *       *

                              ----------                              


              CONTROLLED SUBSTANCES IMPORT AND EXPORT ACT



           *       *       *       *       *       *       *
   TITLE III--IMPORTATION AND EXPORTATION; AMENDMENTS AND REPEALS OF 
REVENUE LAWS

           *       *       *       *       *       *       *


Part A--Importation and Exportation

           *       *       *       *       *       *       *


                  importation of controlled substances

  Sec. 1002. (a) It shall be unlawful to import into the 
customs territory of the United States from any place outside 
thereof (but within the United States), or to import into the 
United States from any place outside thereof, any controlled 
substance in [schedule I or II] schedule I, II, or A of title 
II, or ephedrine, pseudoephedrine, or phenylpropanolamine, or 
any narcotic drug in schedule III, IV, or V of title II, except 
that--
          (1) such amounts of crude opium poppy straw, 
        concentrate of poppy straw, and coca leaves, and of 
        ephedrine, pseudoephedrine, and phenylpropanolamine, as 
        the Attorney General finds to be necessary to provide 
        for medical, scientific, or other legitimate purposes, 
        and
          (2) such amounts of any controlled substance in 
        [schedule I or II] schedule I, II, or A or any narcotic 
        drug in schedule III, IV, or V that the Attorney 
        General finds to be necessary to provide for the 
        medical, scientific, or other legitimate needs of the 
        United States--
                  (A) during an emergency in which domestic 
                supplies of such substance or drug are found by 
                the Attorney General to be inadequate,
                  (B) in any case in which the Attorney General 
                finds that competition among domestic 
                manufacturers of the controlled substance is 
                inadequate and will not be rendered adequate by 
                the registration of additional manufacturers 
                under section 303, or
                  (C) in any case in which the Attorney General 
                finds that such controlled substance is in 
                limited quantities exclusively for scientific, 
                analytical, or research uses,
may be so imported under such regulations as the Attorney 
General shall prescribe. No crude opium may be so imported for 
the purpose of manufacturing heroin or smoking opium.
  (b) It shall be unlawful to import into the customs territory 
of the United States from any place outside thereof (but within 
the United States), or to import into the United States from 
any place outside thereof, any nonnarcotic controlled substance 
in schedule III, IV, or V, unless such nonnarcotic controlled 
substance--
          (1) is imported for medical, scientific or other 
        legitimate uses, and
          (2) is imported pursuant to such notification or 
        declaration, or in the case of any nonnarcotic 
        controlled substance in schedule III, such import 
        permit, notification, or declaration, as the Attorney 
        General may by regulation prescribe, except that if a 
        nonnarcotic control substance in schedule IV or V is 
        also listed in schedule I or II of the Convention on 
        Psychotropic Substances it shall be imported pursuant 
        to such import permit requirements, prescribed by 
        regulation of the Attorney General, as are required by 
        the Convention.
  (c) In addition to the amount of coca leaves authorized to be 
imported into the United States under subsection (a), the 
Attorney General may permit the importation of additional 
amounts of coca leaves. All cocaine and ecgonine (and all 
salts, derivatives, and preparations from which cocaine or 
ecgonine may be synthesized or made) contained in such 
additional amounts of coca leaves imported under this 
subsection shall be destroyed under the supervision of an 
authorized representative of the Attorney General.
  (d)(1) With respect to a registrant under section 1008 who is 
authorized under subsection (a)(1) to import ephedrine, 
pseudoephedrine, or phenylpropanolamine, at any time during the 
year the registrant may apply for an increase in the amount of 
such chemical that the registrant is authorized to import, and 
the Attorney General may approve the application if the 
Attorney General determines that the approval is necessary to 
provide for medical, scientific, or other legitimate purposes 
regarding the chemical.
  (2) With respect to the application under paragraph (1):
          (A) Not later than 60 days after receiving the 
        application, the Attorney General shall approve or deny 
        the application.
          (B) In approving the application, the Attorney 
        General shall specify the period of time for which the 
        approval is in effect, or shall provide that the 
        approval is effective until the registrant involved is 
        notified in writing by the Attorney General that the 
        approval is terminated.
          (C) If the Attorney General does not approve or deny 
        the application before the expiration of the 60-day 
        period under subparagraph (A), the application is 
        deemed to be approved, and such approval remains in 
        effect until the Attorney General notifies the 
        registrant in writing that the approval is terminated.
  (e) Each reference in this section to ephedrine, 
pseudoephedrine, or phenylpropanolamine includes each of the 
salts, optical isomers, and salts of optical isomers of such 
chemical.

                  exportation of controlled substances

  Sec. 1003. (a) It shall be unlawful to export from the United 
States any narcotic drug in schedule I, II, III, or IV unless--
          (1) it is exported to a country which is a party to--
                  (A) the International Opium Convention of 
                1912 for the Suppression of the Abuses of 
                Opium, Morphine, Cocaine, and Derivative Drugs, 
                or to the International Opium Convention signed 
                at Geneva on February 19, 1925; or
                  (B) the Convention for Limiting the 
                Manufacture and Regulating the Distribution of 
                Narcotic Drugs concluded at Geneva, July 13, 
                1931, as amended by the protocol signed at Lake 
                Success on December 11, 1946, and the protocol 
                bringing under international control drugs 
                outside the scope of the convention of July 13, 
                1931, for limiting the manufacture and 
                regulating the distribution of narcotic drugs 
                (as amended by the protocol signed at Lake 
                Success on December 11, 1946), signed at Paris, 
                November 19, 1948; or
                  (C) the Single Convention on Narcotic Drugs, 
                1961, signed at New York, March 30, 1961;
          (2) such country has instituted and maintains, in 
        conformity with the conventions to which it is a party, 
        a system for the control of imports of narcotic drugs 
        which the Attorney General deems adequate;
          (3) the narcotic drug is consigned to a holder of 
        such permits or licenses as may be required under the 
        laws of the country of import, and a permit or license 
        to import such drug has been issued by the country of 
        import;
          (4) substantial evidence is furnished to the Attorney 
        General by the exporter that (A) the narcotic drug is 
        to be applied exclusively to medical or scientific uses 
        within the country of import, and (B) there is an 
        actual need for the narcotic drug for medical or 
        scientific uses within such country; and
          (5) a permit to export the narcotic drug in each 
        instance has been issued by the Attorney General.
  (b) Notwithstanding subsection (a), the Attorney General may 
authorize any narcotic drug (including crude opium and coca 
leaves) in schedule I, II, III, or IV to be exported from the 
United States to a country which is a party to any of the 
international instruments mentioned in subsection (a) if the 
particular drug is to be applied to a special scientific 
purpose in the country of destination and the authorities of 
such country will permit the importation of the particular drug 
for such purpose.
  (c) It shall be unlawful to export from the United States any 
nonnarcotic controlled substance in [schedule I or II] schedule 
I, II, or A unless--
          (1) it is exported to a country which has instituted 
        and maintains a system which the Attorney General deems 
        adequate for the control of imports of such substances;
          (2) the controlled substance is consigned to a holder 
        of such permits or licenses as may be required under 
        the laws of the country of import;
          (3) substantial evidence is furnished to the Attorney 
        General that (A) the controlled substance is to be 
        applied exclusively to medical, scientific, or other 
        legitimate uses within the country to which exported, 
        (B) it will not be exported from such country, and (C) 
        there is an actual need for the controlled substance 
        for medical, scientific, or other legitimate uses 
        within the country; and
          (4) a permit to export the controlled substance in 
        each instance has been issued by the Attorney General.
  (d) Notwithstanding subsection (c), the Attorney General may 
authorize any nonnarcotic controlled substance in [schedule I 
or II] schedule I, II, or A to be exported from the United 
States if the particular substance is to be applied to a 
special scientific purpose in the country of destination and 
the authorities of such country will permit the importation of 
the particular drug for such purpose.
  (e) It shall be unlawful to export from the United States to 
any other country any nonnarcotic controlled substances in 
schedule III or IV or any controlled substances in schedule V 
unless--
          (1) there is furnished (before export) to the 
        Attorney General documentary proof that importation is 
        not contrary to the laws or regulations of the country 
        of destination for consumption for medical, scientific, 
        or other legitimate purposes;
          (2) it is exported pursuant to such notification or 
        declaration, or in the case of any nonnarcotic 
        controlled substance in schedule III, such export 
        permit, notification, or declaration as the Attorney 
        General may by regulation prescribe; and
          (3) in the case of a nonnarcotic controlled substance 
        in schedule IV or V which is also listed in schedule I 
        or II of the Convention on Psychotropic Substances, it 
        is exported pursuant to such export permit 
        requirements, prescribed by regulation of the Attorney 
        General, as are required by the Convention.
  (f) Notwithstanding subsections (a)(4) and (c)(3), the 
Attorney General may authorize any controlled substance that is 
in schedule I or II, or is a narcotic drug in schedule III or 
IV, to be exported from the United States to a country for 
subsequent export from that country to another country, if each 
of the following conditions is met:
          (1) Both the country to which the controlled 
        substance is exported from the United States (referred 
        to in this subsection as the ``first country'') and the 
        country to which the controlled substance is exported 
        from the first country (referred to in this subsection 
        as the ``second country'') are parties to the Single 
        Convention on Narcotic Drugs, 1961, and the Convention 
        on Psychotropic Substances, 1971.
          (2) The first country and the second country have 
        each instituted and maintain, in conformity with such 
        Conventions, a system of controls of imports of 
        controlled substances which the Attorney General deems 
        adequate.
          (3) With respect to the first country, the controlled 
        substance is consigned to a holder of such permits or 
        licenses as may be required under the laws of such 
        country, and a permit or license to import the 
        controlled substance has been issued by the country.
          (4) With respect to the second country, substantial 
        evidence is furnished to the Attorney General by the 
        person who will export the controlled substance from 
        the United States that--
                  (A) the controlled substance is to be 
                consigned to a holder of such permits or 
                licenses as may be required under the laws of 
                such country, and a permit or license to import 
                the controlled substance is to be issued by the 
                country; and
                  (B) the controlled substance is to be applied 
                exclusively to medical, scientific, or other 
                legitimate uses within the country.
          (5)(A) The controlled substance will not be exported 
        from the second country, except that the controlled 
        substance may be exported from a second country that is 
        a member of the European Economic Area to another 
        country that is a member of the European Economic Area, 
        provided that the first country is also a member of the 
        European Economic Area.
          (B) Subsequent to any re-exportation described in 
        subparagraph (A), a controlled substance may continue 
        to be exported from any country that is a member of the 
        European Economic Area to any other such country, if--
                  (i) the conditions applicable with respect to 
                the first country under paragraphs (1), (2), 
                (3), (4), (6), and (7) are met by each 
                subsequent country from which the controlled 
                substance is exported pursuant to this 
                paragraph; and
                  (ii) the conditions applicable with respect 
                to the second country under paragraphs (1), 
                (2), (3), (4), (6), and (7) are met by each 
                subsequent country to which the controlled 
                substance is exported pursuant to this 
                paragraph.
          (6)(A) Within 30 days after the controlled substance 
        is exported from the first country to the second 
        country, the person who exported the controlled 
        substance from the United States delivers to the 
        Attorney General documentation certifying that such 
        export from the first country has occurred.
          (B) In the case of re-exportation among members of 
        the European Economic Area, within 30 days after each 
        re-exportation, the person who exported the controlled 
        substance from the United States delivers to the 
        Attorney General--
                  (i) documentation certifying that such re-
                exportation has occurred; and
                  (ii) information concerning the consignee, 
                country, and product.
          (7) A permit to export the controlled substance from 
        the United States has been issued by the Attorney 
        General.
  (g) Limitation.--Subject to paragraphs (5) and (6) of 
subsection (f) in the case of any controlled substance in 
schedule I or II or any narcotic drug in schedule III or IV, 
the Attorney General shall not promulgate nor enforce any 
regulation, subregulatory guidance, or enforcement policy which 
impedes re-exportation of any controlled substance among 
European Economic Area countries, including by promulgating or 
enforcing any requirement that--
          (1) re-exportation from the first country to the 
        second country or re-exportation from the second 
        country to another country occur within a specified 
        period of time; or
          (2) information concerning the consignee, country, 
        and product be provided prior to exportation of the 
        controlled substance from the United States or prior to 
        each re-exportation among members of the European 
        Economic Area.

     transshipment and in-transit shipment of controlled substances

  Sec. 1004. Notwithstanding sections 1002, 1003, and 1007--
          (1) A controlled substance in [schedule I] schedule I 
        or A may--
                  (A) be imported into the United States for 
                transshipment to another country, or
                  (B) be transferred or transshipped from one 
                vessel, vehicle, or aircraft to another vessel, 
                vehicle, or aircraft within the United States 
                for immediate exportation,
        if and only if it is so imported, transferred, or 
        transshipped (i) for scientific, medical, or other 
        legitimate purposes in the country of destination, and 
        (ii) with the prior written approval of the Attorney 
        General (which shall be granted or denied within 21 
        days of the request).
          (2) A controlled substance in schedule II, III, or IV 
        may be so imported, transferred, or transshipped if and 
        only if advance notice is given to the Attorney General 
        in accordance with regulations of the Attorney General.

possession on board vessels, etc., arriving in or departing from united 
                                 states

  Sec. 1005. It shall be unlawful for any person to bring or 
possess on board any vessel or aircraft, or on board any 
vehicle of a carrier, arriving in or departing from the United 
States or the customs territory of the United States, a 
controlled substance in [schedule I or II] schedule I, II, or A 
or a narcotic drug in schedule III or IV, unless such substance 
or drug is a part of the cargo entered in the manifest or part 
of the official supplies of the vessel, aircraft, or vehicle.

           *       *       *       *       *       *       *


                       registration requirements

  Sec. 1008. (a) The Attorney General shall register an 
applicant to import or export a controlled substance in 
schedule I or II if he determines that such registration is 
consistent with the public interest and with United States 
obligations under international treaties, conventions, or 
protocols in effect on the effective date of this section. In 
determining the public interest, the factors enumerated in 
paragraph (1) through (6) of section 303(a) shall be 
considered.
  (b) Registration granted under this section shall not entitle 
a registrant to import or export controlled substances other 
than specified in the registration.
  (c)(1) The Attorney General shall register an applicant to 
import a controlled substance in schedule III, IV, or V or to 
export a controlled substance in schedule III or IV, unless he 
determines that the issuance of such registration is 
inconsistent with the public interest. In determining the 
public interest, the factors enumerated in paragraphs (1) 
through (6) of section 303(d) shall be considered.
  (2)(A) The Attorney General shall register an applicant to 
import or export a list I chemical unless the Attorney General 
determines that registration of the applicant is inconsistent 
with the public interest. Registration under this subsection 
shall not be required for the import or export of a drug 
product that is exempted under section 102(39)(A)(iv).
  (B) In determining the public interest for the purposes of 
subparagraph (A), the Attorney General shall consider the 
factors specified in section 303(h).
  (d)(1) The Attorney General may deny an application for 
registration under subsection (a) if he is unable to determine 
that such registration is consistent with the public interest 
(as defined in subsection (a)) and with the United States 
obligations under international treaties, conventions, or 
protocols in effect on the effective date of this part.
  (2) The Attorney General may deny an application for 
registration under subsection (c), or revoke or suspend a 
registration under subsection (a) or (c), if he determines that 
such registration is inconsistent with the public interest (as 
defined in subsection (a) or (c)) or with the United States 
obligations under international treaties, conventions, or 
protocols in effect on the effective date of this part.
  (3) The Attorney General may limit the revocation or 
suspension of a registration to the particular controlled 
substance, or substances, or list I chemical or chemicals, with 
respect to which grounds for revocation or suspension exist.
  (4) Before taking action pursuant to this subsection, the 
Attorney General shall serve upon the applicant or registrant 
an order to show cause as to why the registration should not be 
denied, revoked, or suspended. The order to show cause shall 
contain a statement of the basis thereof and shall call upon 
the applicant or registrant to appear before the Attorney 
General, or his designee, at a time and place stated in the 
order, but in no event less than thirty days after the date of 
receipt of the order. Proceedings to deny, revoke, or suspend 
shall be conducted pursuant to this subsection in accordance 
with subchapter II of chapter 5 of title 5 of the United States 
Code. Such proceedings shall be independent of, and not in lieu 
of, criminal prosecutions or other proceedings under this title 
or any other law of the United States.
  (5) The Attorney General may, in his discretion, suspend any 
registration simultaneously with the institution of proceedings 
under this subsection, in cases where he finds that there is an 
imminent danger to the public health and safety. Such 
suspension shall continue in effect until the conclusion of 
such proceedings, including judicial review thereof, unless 
sooner withdrawn by the Attorney General or dissolved by a 
court of competent jurisdiction.
  (6) In the event that the Attorney General suspends or 
revokes a registration granted under this section, all 
controlled substances or list I chemicals owned or possessed by 
the registrant pusuant to such registration at the time of 
suspension or the effective date of the revocation order, as 
the case may be, may, in the discretion of the Attorney 
General, be seized or placed under seal. No disposition may be 
made of any controlled substances or list I chemicals under 
seal until the time for taking an appeal has elapsed or until 
all appeals have been concluded, except that a court, upon 
application therefor, may at any time order the sale of 
perishable controlled substances or list I chemicals. Any such 
order shall require the deposit of the proceeds of the sale 
with the court. Upon a revocation order becoming final, all 
such controlled substances or list I chemicals (or proceeds of 
the sale thereof which have been deposited with the court) 
shall be forfeited to the United States; and the Attorney 
General shall dispose of such controlled substances or list I 
chemicals in accordance with section 511(e) of the Controlled 
Substances Act.
  (e) No registration shall be issued under this part for a 
period in excess of one year. Unless the regulations of the 
Attorney General otherwise provide, sections 302(f), 305, 307, 
and 310 shall apply to persons registered under this section to 
the same extent such sections apply to persons registered under 
section 303.
  (f) The Attorney General is authorized to promulgate rules 
and regulations and to charge reasonable fees relating to the 
registration of importers and exporters of controlled 
substances or list I chemicals under this section.
  (g) Persons registered by the Attorney General under this 
section to import or export controlled substances or list I 
chemicals may import or export (and, for the purpose of so 
importing or exporting, may possess) such substances to the 
extent authorized by their registration and in conformity with 
the other provisions of this title and title II.
  (h) A separate registration shall be required at each 
principal place of business where the applicant imports or 
exports controlled substances or list I chemicals.
  (i) Except in emergency situations as described in section 
1002(a)(2)(A), prior to issuing a registration under this 
section to a bulk manufacturer of a controlled substance in 
schedule I or II, and prior to issuing a regulation under 
section 1002(a) authorizing the importation of such a 
substance, the Attorney General shall give manufacturers 
holding registration for the bulk manufacture of the substance 
an opportunity for a hearing.
  (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.

   possession, manufacture or distribution for purposes of unlawful 
                              importation

  Sec. 1009. (a) It shall be unlawful for any person to 
manufacture or distribute a controlled substance in [schedule I 
or II] schedule I, II, or A or flunitrazepam or a listed 
chemical intending, knowing, or having reasonable cause to 
believe that such substance or chemical will be unlawfully 
imported into the United States or into waters within a 
distance of 12 miles of the coast of the United States.
  (b) It shall be unlawful for any person tomanufacture or 
distribute a listed chemical--
          (1) intending or knowing that the listedchemical will 
        be used to manufacture a controlled substance; and
          (2) intending, knowing, or having reasonablecause to 
        believe that the controlled substance will be 
        unlawfully imported intothe UnitedStates.
  (c) It shall be unlawful for any United States citizen on 
board any aircraft, or any person on board an aircraft owned by 
a United States citizen or registered in United States, to--
          (1) manufacture or distribute a controlled substance 
        or listed chemical; or
          (2) possess a controlled substance or listed chemical 
        with intent to distribute.
  (d) This section is intended to reach acts of manufacture or 
distribution committed outside the territorial jurisdiction of 
the United States. Any person who violates this section shall 
be tried in the United States district court at the point of 
entry where such person enters the United States, or in the 
United States District Court for the District of Columbia.

                      prohibited acts a--penalties

  Sec. 1010. (a) Any person who--
          (1) contrary to section 305, 1002, 1003, or 1007, 
        knowingly or intentionally imports or exports a 
        controlled substance,
          (2) contrary to section 1005, knowingly or 
        intentionally brings or possesses on board a vessel, 
        aircraft, or vehicle a controlled substance, or
          (3) contrary to section 1009, manufactures, possesses 
        with intent to distribute, or distributes a controlled 
        substance,
shall be punished as provided in subsection (b).
  (b)(1) In the case of a violation of subsection (a) of this 
section involving--
          (A) 1 kilogram or more of a mixture or substance 
        containing a detectable amount of heroin;
          (B) 5 kilograms or more of a mixture or substance 
        containing a detectable amount of--
                  (i) coca leaves, except coca leaves and 
                extracts of coca leaves from which cocaine, 
                ecgonine, and derivatives of ecgonine or their 
                salts have been removed;
                  (ii) cocaine, its salts, optical and 
                geometric isomers, and salts or isomers;
                  (iii) ecgonine, its derivatives, their salts, 
                isomers, and salts of isomers; or
                  (iv) any compound, mixture, or preparation 
                which contains any quantity of any of the 
                substances referred to in clauses (i) through 
                (iii);
          (C) 280 grams or more of a mixture or substance 
        described in subparagraph (B) which contains cocaine 
        base;
          (D) 100 grams or more of phencyclidine (PCP) or 1 
        kilogram or more of a mixture or substance containing a 
        detectable amount of phencyclidine (PCP);
          (E) 10 grams or more of a mixture or substance 
        containing a detectable amount of lysergic acid 
        diethylamide (LSD);
          (F) 400 grams or more of a mixture or substance 
        containing a detectable amount of N-phenyl-N-[1-(2-
        phenylethyl)-4-piperidinyl] propanamide or 100 grams or 
        more of a mixture or substance containing a detectable 
        amount of any analogue of N-phenyl-N-[1-(2-
        phenylethyl)-4-piperidinyl] propanamide;
          (G) 1000 kilograms or more of a mixture or substance 
        containing a detectable amount of marihuana; or
          (H) 50 grams or more of methamphetamine, its salts, 
        isomers, and salts of its isomers or 500 grams or more 
        of a mixture or substance containing a detectable 
        amount of methamphetamine, its salts, isomers, or salts 
        of its isomers.
the person committing such violation shall be sentenced to a 
term of imprisonment of not less than 10 years and not more 
than life and if death or serious bodily injury results from 
the use of such substance shall be sentenced to a term of 
imprisonment of not less than 20 years and 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 $10,000,000 if the defendant is an individual or $50,000,000 
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 less than 20 years 
and not more than life imprisonment and if death or serious 
bodily injury results from the use of such substance shall be 
sentenced to 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 $20,000,000 if 
the defendant is an individual or $75,000,000 if the defendant 
is other than an individual, or both. Notwithstanding section 
3583 of title 18, any sentence under this paragraph shall, in 
the absence of such a prior conviction, impose a term of 
supervised release of at least 5 years in addition to such term 
of imprisonment and shall, if there was such a prior 
conviction, impose a term of supervised release of at least 10 
years in addition to such term of imprisonment. Notwithstanding 
any other provision of law, the court shall not place on 
probation or suspend the sentence of any person sentenced under 
this paragraph. No person sentenced under this paragraph shall 
be eligible for parole during the term of imprisonment imposed 
therein.
  (2) In the case of a violation of subsection (a) of this 
section involving--
          (A) 100 grams or more of a mixture or substance 
        containing a detectable amount of heroin;
          (B) 500 grams or more of a mixture or substance 
        containing a detectable amount of--
                  (i) coca leaves, except coca leaves and 
                extracts of coca leaves from which cocaine, 
                ecgonine, and derivatives of ecgonine or their 
                salts have been removed;
                  (ii) cocaine, its salts, optical and 
                geometric isomers, and salts or isomers;
                  (iii) ecgonine, its derivatives, their salts, 
                isomers, and salts of isomers; or
                  (iv) any compound, mixture, or preparation 
                which contains any quantity of any of the 
                substances referred to in clauses (i) through 
                (iii);
          (C) 28 grams or more of a mixture or substance 
        described in subparagraph (B) which contains cocaine 
        base;
          (D) 10 grams or more of phencyclidine (PCP) or 100 
        grams or more of a mixture or substance containing a 
        detectable amount of phencyclidine (PCP);
          (E) 1 gram or more of a mixture or substance 
        containing a detectable amount of lysergic acid 
        diethylamide (LSD);
          (F) 40 grams or more of a mixture or substance 
        containing a detectable amount of N-phenyl-N-[1-(2-
        phenylethyl)-4-piperidinyl] propanamide or 10 grams or 
        more of a mixture or substance containing a detectable 
        amount of any analogue of N-phenyl-N-[1-(2-
        phenylethyl)-4-piperidinyl] propanamide;
          (G) 100 kilograms or more of a mixture or substance 
        containing a detectable amount of marihuana; or
          (H) 5 grams or more of methamphetamine, its salts, 
        isomers, and salts of its isomers or 50 grams or more 
        of a mixture or substance containing a detectable 
        amount of methamphetamine, its salts, isomers, or salts 
        of its isomers.
the person committing such violation shall be sentenced to a 
term of imprisonment of not less than 5 years and not more than 
40 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 less than twenty years and 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 $5,000,000 if the defendant is an individual or $25,000,000 
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 less than 10 years 
and not more than life imprisonment and if death or serious 
bodily injury results from the use of such substance shall be 
sentenced to 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 $8,000,000 if 
the defendant is an individual or $50,000,000 if the defendant 
is other than an individual, or both. Notwithstanding section 
3583 of title 18, any sentence imposed under this paragraph 
shall, in the absence of such a prior conviction, include a 
term of supervised release of at least 4 years in addition to 
such term of imprisonment and shall, if there was such a prior 
conviction, include a term of supervised release of at least 8 
years in addition to such term of imprisonment. Notwithstanding 
any other provision of law, the court shall not place on 
probation or suspend the sentence of any person sentenced under 
this paragraph. No person sentenced under this paragraph shall 
be eligible for parole during the term of imprisonment imposed 
therein.
  (3) In the case of a violation under subsection (a) of this 
section involving a controlled substance in schedule I or II, 
gamma hydroxybutyric acid (including when scheduled as an 
approved drug product for purposes of section 3(a)(1)(B) of the 
Hillory J. Farias and Samantha Reid Date-Rape Drug Prohibition 
Act of 2000), or flunitrazepam, the person committing such 
violation shall, except as provided in paragraphs (1), (2), and 
(4), 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 less than twenty years and 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 $1,000,000 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 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 $2,000,000 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, any sentence imposing 
a term of imprisonment under this paragraph shall, in the 
absence of such a prior conviction, impose a term of 
suspervised release of at least 3 years in addition to such 
term of imprisonment and shall, if there was such a prior 
conviction, impose a term of suspervised release of at least 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.
  (4) In the case of a violation under subsection (a) with 
respect to less than 50 kilograms of marihuana except in the 
case of 100 or more marihuana plants regardless of weight, less 
than 10 kilograms of hashish, or less than one kilogram of 
hashish oil, the person committing such violation shall be 
sentenced in accordance with section 401(b)(1)(D).
  (5) In the case of a violation of subsection (a) involving a 
controlled substance in schedule III, such person shall be 
sentenced in accordance with section 401(b)(1).
  (6) In the case of a violation of subsection (a) involving a 
controlled substance in schedule IV, such person shall be 
sentenced in accordance with section 401(b)(2).
  (7) In the case of a violation of subsection (a) involving a 
controlled substance in schedule V, such person shall be 
sentenced in accordance with section 401(b)(3).
  (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 $1,000,000 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 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 $2,000,000 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.
  (c) A special parole term imposed under this section or 
section 1012 may be revoked if its terms and conditions are 
violated. In such circumstances the original term of 
imprisonment shall be increased by the period of the special 
parole term and the resulting new term of imprisonment shall 
not be diminished by the time which was spent on special 
parole. A person whose special parole term has been revoked may 
be required to serve all or part of the remainder of the new 
term of imprisonment. The special term provided for in this 
section and in section 1012 is in addition to, and not in lieu 
of, any other parole provided for by law.
  (d) A person who knowingly or intentionally--
          (1) imports or exports a listed chemical with intent 
        to manufacture a controlled substance in violation of 
        this title or title II;
          (2) exports a listed chemical in violation of the 
        laws of the country to which the chemical is exported 
        or serves as a broker or trader for an international 
        transaction involving a listed chemical, if the 
        transaction is in violation of the laws of the country 
        to which the chemical is exported;
          (3) imports or exports a listed chemical knowing, or 
        having reasonable cause to believe, that the chemical 
        will be used to manufacture a controlled substance in 
        violation of this title or title II;
          (4) exports a listed chemical, or serves as a broker 
        or trader for an international transaction involving a 
        listed chemical, knowing, or having reasonable cause to 
        believe, that the chemical will be used to manufacture 
        a controlled substance in violation of the laws of the 
        country to which the chemical is exported;
          (5) imports or exports a listed chemical, with the 
        intent to evade the reporting or recordkeeping 
        requirements of section 1018 applicable to such 
        importation or exportation by falsely representing to 
        the Attorney General that the importation or 
        exportation qualifies for a waiver of the 15-day 
        notification requirement granted pursuant to paragraph 
        (2) or (3) of section 1018(f) by misrepresenting the 
        actual country of final destination of the listed 
        chemical or the actual listed chemical being imported 
        or exported;
          (6) imports a listed chemical in violation of section 
        1002, imports or exports such a chemical in violation 
        of section 1007 or 1018, or transfers such a chemical 
        in violation of section 1018(d); or
          (7) manufactures, possesses with intent to 
        distribute, or distributes a listed chemical in 
        violation of section 959 of this title.
shall be fined in accordance with title 18, imprisoned not more 
than 20 years in the case of a violation of paragraph (1) or 
(3) involving a list I chemical or not more than 10 years in 
the case of a violation of this subsection other than a 
violation of paragraph (1) or (3) involving a list I chemical, 
or both.

           *       *       *       *       *       *       *


                            Dissenting Views

    H.R. 2851, the ``Stop the Importation and Trafficking of 
Synthetic Analogues Act of 2017'' or ``SITSA'' Act, is well-
intended, but flawed legislation that is designed to enhance 
the ability of federal law enforcement, specifically the 
Department of Justice and the Drug Enforcement Administration 
(DEA), to prohibit the manufacture, distribution, and 
trafficking of analogues of synthetic drugs through temporary 
and permanent scheduling. This legislation will expand 
penalties for drug offenses, concentrate an overwhelming amount 
of unchecked power within the Department of Justice, eliminate 
scientific and medical analysis and interagency collaboration 
from the process of scheduling synthetic analogues, over-
criminalize certain conduct, and punish individuals without 
proof of intent. Not surprisingly, the bill is strongly opposed 
by a broad spectrum of stakeholders, representing many 
different interests.\1\
---------------------------------------------------------------------------
    \1\Letter from David R. Sibley, Ph.D, President, American Society 
for Pharmacology and Experimental Therapeutics, to Rep. Bob Goodlatte, 
Chairman, H. Comm. on the Judiciary, & Rep. John Conyers, Jr., Ranking 
Member, H. Comm. on the Judiciary (June 27, 2017) (on file with 
Democratic staff of the H. Comm. on the Judiciary); Letter from James 
C. Duff, Secretary, Judicial Conference of the United States, to 
Ranking Member Shelia Jackson Lee, Subcomm. on Crime, Terrorism, 
Homeland Security, and Investigations, H. Comm. on the Judiciary (July 
7, 2017) (on file with H. Comm. on the Judiciary Democratic Staff); 
Letter from Vanita Gupta, President & CEO, The Leadership Conference, 
to Rep. Bob Goodlatte, Chairman, H. Comm. on the Judiciary, & Rep. John 
Conyers, Jr., Ranking Member, H. Comm. on the Judiciary (July 11, 2017) 
(on file with Democratic staff of the H. Comm. on the Judiciary); 
Letter from Jason Pye, Vice President of Legislative Affairs, 
FreedomWorks, Pat Nolan, Director of the Center for Criminal Justice 
Reform, American Conservative Union Foundation, David Barnes, Policy 
director, Generation Opportunity & David Williams, President, Taxpayers 
Protection Alliance, to Rep. Bob Goodlatte, Chairman, H. Comm. on the 
Judiciary, & Rep. John Conyers, Jr., Ranking Member, H. Comm. on the 
Judiciary (July 11, 2017) (on file with Democratic staff of the H. 
Comm. on the Judiciary); Letter from coalition of sixty-eight civil and 
human rights, faith, and criminal justice reform organizations, to Rep. 
Bob Goodlatte, Chairman, H. Comm. on the Judiciary, & Rep. John 
Conyers, Jr., Ranking Member, H. Comm. on the Judiciary (July 12, 2017) 
(on file with Democratic staff of the H. Comm. on the Judiciary).
---------------------------------------------------------------------------
    For these reasons and those explained below, we must 
respectfully dissent and urge our colleagues to oppose this 
flawed legislation.

                       DESCRIPTION AND BACKGROUND

                              DESCRIPTION

    H.R. 2851, the ``Stop the Importation and Trafficking of 
Synthetic Analogues Act of 2017,'' amends title 21 of the 
United States Code, the Controlled Substances Act (CSA), to: 
(1) create a new schedule for synthetic analogues--Schedule A; 
(2) place 13 fentanyl analogues on Schedule A upon enactment of 
the bill; and (3) establish an abbreviated procedure to be 
conducted exclusively by the Attorney General (as delegated to 
the DEA) for temporary and permanent placement of drugs or 
substances on Schedule A that have a chemical structure 
substantially and an actual or predicted psychoactive effect 
similar to a controlled substance in Schedules I, II, III, IV, 
or V. Drugs or substances that meet the criteria for Schedule A 
may be permanently scheduled or temporarily placed on the 
schedule by the Attorney General for up to five years with the 
ability to extend temporary placement for 180 days. Other than 
the Department of Health and Human Services (HHS), interested 
parties or agencies would not have the opportunity to comment 
or request a hearing on proposed scheduling orders. The 
Attorney General would only be required to consider comments on 
proposed scheduling orders made by HHS. The bill also 
establishes penalties including mandatory terms of supervised 
release for the offenses of manufacturing, distributing, 
exportation, importation, and dispensing Schedule A substances; 
possession with intent to do such activities involving Schedule 
A substances; and retail-related offenses involving Schedule A 
substances. Finally, the bill establishes procedures, 
requirements, and criteria for registration of practitioners 
seeking to manufacture, distribute, import, export, or conduct 
research with Schedule A substances.

                               BACKGROUND

    Because manufacturers of illicit synthetic drugs change the 
chemical composition slightly by modifying the molecular 
structures of illegal or controlled substances, many of them 
are largely or completely unknown in terms of scientific data 
and human experience. These small variations allow the 
manufacturers to circumvent existing regulatory legislation, 
resulting in profound and often deadly consequences.\2\
---------------------------------------------------------------------------
    \2\K. Finklea, Synthetic Drugs: Overview and Issues for Congress, 
Congressional Research Serv. Rep. No. R42066 (2016).
---------------------------------------------------------------------------
    Although the landscape for these drugs is changing, the 
problem is not new. In response to the emergence of synthetic 
drugs, or ``designer drugs'' such as MDMA (Ecstasy), synthetic 
analogues were added to the CSA in 1986.\3\ The Controlled 
Substance Analogue Enforcement Act of 1986 (AEA) amended the 
CSA to create a legal basis for controlling unscheduled drugs, 
placing more effective controls on new chemical variants of 
already controlled substances and serving as a method of 
criminalizing synthetic drugs without having to ban them 
individually. The Act provides that any chemical 
``substantially similar'' to a controlled substance listed in 
Schedule I or II of the CSA is to be legally treated as though 
it were also listed in Schedule I.\4\ To be treated as an 
analogue under the AEA, a substance must be intended for human 
consumption and have a substantially similar chemical structure 
and cause a substantially similar stimulant, depressant, or 
hallucinogenic effect to that of a controlled substance in 
Schedule I or II of the CSA.\5\
---------------------------------------------------------------------------
    \3\See Gregory Kau, Flashback to the Federal Analog Act of 1986: 
Mixing Rules and Standards in the Cauldron,156 U. PA. L. Rev. 1077 
(2008).
    \4\See 21 U.S.C. Sec. 813 (2017).
    \5\See 21 U.S.C. Sec. 802(32)(A) (2017).
---------------------------------------------------------------------------
    As previously mentioned, the chemical structure of 
synthetic drugs can be manipulated such that it is not 
chemically the same as a controlled substance, but is 
structurally similar and will produce pharmacological effects 
similar to a controlled substance. Theses manipulations occur 
continuously, effectively creating new analogue substances and 
allowing illicit drug manufacturers to remain one step ahead of 
researchers and law enforcement. The DEA reports that 
prosecution of drug cases under the Analogue Act has proven 
challenging primarily because the AEA does not establish per se 
regulation (scheduling) upon identification of an analogue. 
Each criminal prosecution must establish anew that a particular 
substance is a controlled substance analogue under the CSA; 
prosecutors must prove the substance was intended for human 
consumption; and federal courts maintain a high standard when 
interpreting whether a substance is substantially similar. As 
explained by Demetra Ashley, Acting Assistant Administrator of 
the DEA's Diversion Control Division, ``the process is 
workable, but resource-intensive for DEA, federal prosecutors 
serving in United States Attorney's Offices, the defense bar, 
and the court system.'' \6\
---------------------------------------------------------------------------
    \6\Stop the Importation and Trafficking of Synthetic Analogues Act 
of 2017: Hearing on H.R. 2851 Before the Subcomm. on Crime, Terrorism, 
Homeland Security, and Investigations of the H. Comm. on the Judiciary, 
115th Cong. (2017) (prepared statement of Demetra Ashley, Acting 
Assistant Administrator, Diversion Control Division, DEA).
---------------------------------------------------------------------------
    Intended to address concerns about the current mechanisms 
of regulating these synthetic analogues, H.R. 2851 seeks to 
simplify and condense the process of scheduling, regulating, 
and prohibiting synthetic analogues, and provide uniformity in 
the prosecution of cases involving synthetic analogues. It 
would create a new schedule of the Controlled Substances Act--
Schedule A, on which synthetic analogues of drugs and 
substances on Schedules I, II, III, IV, or V could be placed--
and establish abbreviated procedures for placing drugs and 
substances on Schedule A. The bill would authorize the Attorney 
General to order permanent placement on Schedule A if a drug or 
substance is not already scheduled or otherwise regulated; is 
not exempted for research purposes, with respect to licensed 
experts; has a chemical structure that is substantially similar 
to an existing controlled substances in Schedules I through V; 
and has an actual or predicted physiological effect on the body 
equal to or greater than an existing controlled substance in 
Schedules I through V. The legislation would also allow the 
Attorney General to order temporary placement of a drug or 
substance on Schedule A to prevent abuse or misuse of a drug or 
substance. Before initiating temporary or permanent scheduling, 
the Attorney General must provide notice to the HHS and would 
only be required to consider comments submitted by HHS in 
response to such notices when issuing temporary or permanent 
scheduling orders.
    In addition, the bill would establish penalties including 
mandatory minimum terms of supervised release for the offenses 
of manufacturing, distributing, exportation, importation, and 
dispensing Schedule A substances; possession with intent to do 
such activities involving Schedule A substances; and retail-
related offenses involving Schedule A substances. Application 
Note 6 of Section 2D1.1 of the Federal Sentencing Guidelines 
would be amended to outline the procedure for sentencing courts 
to determine the most closely related controlled substance to a 
synthetic analogue and, thus, the applicable guideline or drug 
equivalence for offenses involving analogues and controlled 
substances not referenced in this Guideline. The drug 
equivalencies will be set by the Attorney General and in cases 
where the Attorney General offers no guidance on equivalencies 
for particular substances, this section provides equivalency 
tables.
    Finally, H.R. 2851 would establish procedures, 
requirements, and criteria to be administered by the Attorney 
General for registration of practitioners seeking to 
manufacture, distribute, import, export, or conduct research 
with Schedule A substances. Practitioners already registered to 
engage in research of Schedule I substances would not have to 
obtain a separate registration for Schedule A substances. The 
Attorney General would be required to grant, deny, or request 
supplemental information within 60 days of receiving an 
application; and if supplemental information is requested, the 
Attorney General would be required to grant or deny 
registration within 30 days after receiving the requested 
supplemental information.

                        CONCERNS WITH H.R. 2851

I. H.R. 2851 Would Give the Attorney General Sweeping Authority to 
        Schedule Any Substance.

    H.R. 2851 would give the Attorney General, as likely 
delegated to the DEA, the sole authority to schedule and, thus, 
outlaw synthetic analogues based on vaguely-defined standards 
and set drug equivalencies for sentencing purposes, effectively 
allowing the Department of Justice to define new criminal 
offenses to enforce and to set the penalties for violating 
those offenses. As Michael Collins, Deputy Director of the Drug 
Policy Alliance, observes, the bill ``gives the Attorney 
General a ton of power in terms of scheduling drugs and 
pursuing penalties.''\7\
---------------------------------------------------------------------------
    \7\Christopher Ingram, Congress is considering a bill that would 
expand Jeff Sessions's power to escalate the war on drugs, Wash. Post, 
June 16, 2017, available at https://www.washingtonpost.com/news/wonk/
wp/2017/06/16/congress-is-considering-a-bill-that-would-expand-jeff-
sessions-power-to-escalate-the-war-on-drugs/?utm_term=.23fb6ae9f6d6.
---------------------------------------------------------------------------
    Pursuant to the legislation, the Attorney General would be 
authorized to permanently place a drug or substance on Schedule 
A that has a chemical structure and an actual or predicted 
stimulant, depressant, or hallucinogenic effect on a person 
that is substantially similar to or greater than the effect of 
an already-scheduled controlled substance. Critics of the AEA 
routinely cite the difficulties experienced in proving that an 
analogue is ``substantially similar'' in structure or effect to 
a drug or substance on Schedule I or II.\8\ Yet this bill 
includes the same vague terminology and fails to define or 
clarify the meaning of ``substantially similar.''
---------------------------------------------------------------------------
    \8\The Dangers of Synthetic Cannabinoids and Stimulants: Hearing 
Before the S. Caucus on International Narcotics Control, 112th Cong. 
(2011) (statement of Joseph T. Rannazzisi, Deputy Assistant 
Administrator, Office of Diversion Control, Drug Enforcement 
Administration); Deadly Synthetic Drugs--The Need to Stay Ahead of the 
Poison Peddlers: Hearing Before the S. Comm. on the Judiciary, 113th 
Congress (2016) (statement of Chuck Rosenberg, Acting Administrator, 
Drug Enforcement Administration).
---------------------------------------------------------------------------
    The predicted effect may be based on just one of the 
following factors: (1) the chemical structure, structure 
activity relationships, binding receptor assays, or other 
relevant scientific information about the substance; (2) the 
current or relative potential for abuse of the substance, and 
the clandestine importation, manufacture, or distribution, or 
diversion from legitimate channels, of the substance; or (3) 
the capacity of the substance to cause a state of dependence. 
Despite this troubling authorization to schedule drugs or 
substances based on such speculation, the language of the bill 
that outlines the basis on which such predictions may be based 
is even more concerning. Arguably, the Attorney General would 
not necessarily be required to establish the predicted effect 
of a drug or substance based on any of the factors listed in 
the bill.
    While the Attorney General's authority would go largely 
unchecked, based on an amendment adopted by the Committee, 
Congress would have the ability to object to the placement of a 
substance on Schedule A within 180 days of the filing of a 
scheduling action. Relying on Congress to conduct the analysis 
that should have been conducted by the agencies, ideally 
including HHS and also the FDA, is not an acceptable way to 
address a process in this bill that is flawed in the first 
place. This congressional override would not afford adequate 
oversight of the overwhelming amount of power bestowed upon the 
Attorney General and ensure the reliability of synthetic 
analogue scheduling. It also fails to provide for binding 
review of scheduling actions by any agency or authority outside 
of the DOJ.
    Finally, the bill would require judges to sentence 
offenders convicted of offenses involving analogues or 
substances not referenced in the Guidelines based on 
equivalency amounts unilaterally set by the Attorney General. 
This is particularly problematic because the U.S. Sentencing 
Commission is currently conducting an extensive study of 
analogues and synthetic drugs.\9\ Without direction from 
Congress, it is very likely that the Attorney General will not 
consider the Commission's consultations with experts, chemists, 
law enforcement, and practitioners or resulting conclusions. 
The equivalency tables, which should not be codified in law due 
to the ever-changing nature of synthetic drugs, would be set 
without the benefit of the Commission's vital study.
---------------------------------------------------------------------------
    \9\See U.S. Sentencing Comm'n, Transcript of Testimony from Public 
Hearing: Alternatives to Incarceration Court Programs and Synthetic 
Drugs (Apr. 18, 2017), http://www.ussc.gov/sites/default/files/pdf/
amendment-process/public-hearings-and-meetings/20170418/transcript.pdf.
---------------------------------------------------------------------------

II. H.R. 2851 Would Eliminate Scientific and Medical Analysis of 
        Scheduling Actions.

    Proponents of H.R. 2851 argue that there is often not 
enough information known about newly identified synthetic 
analogues to quickly schedule them. In an effort to speed up 
the process of scheduling synthetic analogues, this bill would 
circumvent the current permanent and temporary inter-agency 
scheduling processes, allowing the placement of drugs or 
substances on Schedule A based purely on the speculation of the 
Attorney General and the DEA. While much of the conversation 
about synthetic analogues focuses on the chemistry of the 
substances--from their manufacture to their effect on the human 
body--this bill would eliminate the longstanding eight-factor 
analysis of drugs and substances established by the CSA and 
simply require the Attorney General to consider scheduling 
recommendations made by HHS. In addition, it would remove HHS's 
binding authority to halt unjustifiable scheduling actions.
    The permanent scheduling process by which drugs are placed 
on Schedules I, II, III, IV, and V through administrative 
rulemaking has existed for nearly fifty years. Ultimately, to 
permanently schedule a drug or substance under the CSA, the 
Attorney General must find that a drug or substance has the 
potential for abuse, and then determine in which schedule to 
place the drug or substance based on the characteristics of the 
drug or substance. The CSA provides eight factors to consider 
when determining whether a drug or substance has a potential 
for abuse, including scientific evidence of the drug or 
substance's pharmacological effect; the scope, duration, and 
significance of abuse; and the history and current pattern of 
abuse. Under the proposed legislation, however, the Attorney 
General would not be required to examine the potential for 
abuse or consider the eight factors to permanently place drugs 
or substances on Schedule A.
    Although the DEA, acting under the authority of the 
Attorney General, is the primary agency responsible for 
regulating controlled substances under the CSA, HHS performs 
various vital functions in the scheduling process, several of 
which are performed by the Food and Drug Administration (FDA). 
``The legislative history of the CSA is replete with hearings, 
discussion and statements that the scientific and medical 
evaluation of DHHS is important and critical to the 
process.''\10\ The FDA conducts the scientific and medical 
evaluations required under the CSA--the eight-factor analysis--
while the National Institute on Drug Abuse (NIDA) consults with 
the FDA and provides concurrent review of the data. The 
evaluations from the FDA and NIDA form the basis of the HHS 
recommendation to the DEA, and the resulting medical and 
scientific evaluations issued by HHS are binding on the DEA. 
Notably, the CSA mandates that the Attorney General not control 
the drug or other substance if HHS recommends that a drug or 
other substance should not be controlled.\11\
---------------------------------------------------------------------------
    \10\Scheduling of Drugs Under the Controlled Substances Act: 
Hearing Before the Subcomm. on Oversight and Investigations of the H. 
Comm. on Commerce, 106th Cong. (1999) (prepared statement of Nicholas 
Reuter, Associate Director for Domestic and International Drug Control, 
Office of Health Affairs, FDA).
    \11\21 U.S.C. Sec. 811(b) (2017).
---------------------------------------------------------------------------
    As previously discussed, this bill would permit temporary 
and permanent placement of a drug or substance on Schedule A 
based on the Attorney General's predictions. H.R. 2851 would 
allow the Attorney General to make such predictions absent any 
requirement to consult with or seek input from HHS, the FDA, 
NIDA, the medical and scientific communities, or other 
authority outside of the Department of Justice. Scheduling 
orders would not be subject to scientific review of any kind. 
The Attorney General would only be required to consider 
recommendations made by the HHS--eliminating the ability of HHS 
to stop unwarranted scheduling actions.
    H.R. 2851 would also establish a diluted version of the 
existing temporary scheduling processes under the CSA or the 
AEA. Temporary scheduling was specifically designed to enable 
the DEA to act in an expeditious manner to avoid an imminent 
hazard to the public safety.\12\ The CSA currently authorizes 
temporary placement of a drug or substance on Schedule I to 
avoid an imminent hazard to public safety for up to two years 
only after the Attorney General demonstrates: (1) the drug's 
history and current pattern of abuse; (2) the scope, duration 
and significance of abuse; and (3) what, if any, risk there is 
to the public health.\13\ This three-factor analysis includes 
consideration of actual abuse; diversion of the drug or 
substance from legitimate channels; and clandestine 
importation, manufacture, or distribution of the drug or 
substance.\14\ As previously discussed, a temporarily scheduled 
drug or substance may be subsequently placed on a schedule 
permanently only after the requisite medical and scientific 
eight-factor analysis has been completed by HHS.
---------------------------------------------------------------------------
    \12\Drug Enforcement Administration, Dept. of Justice, Schedules of 
Controlled Substances: Temporary Placement of Acryl Fentanyl Into 
Schedule I, 82 Fed. Reg. 32453 (July 14, 2017).
    \13\21 U.S.C. Sec. 811(h) (2017).
    \14\21 U.S.C. Sec. 811(h)(3) (2017).
---------------------------------------------------------------------------
    H.R. 2851 would eliminate the requirement to analyze the 
history of a drug's abuse or its potential risk to public 
health, and instead require a simple finding by the Attorney 
General that: a drug or substance meets Schedule A criteria; 
and temporary placement on Schedule A would ``assist in 
preventing abuse or misuse of a drug or other substance''--yet 
another vague use of terminology within the bill.\15\ Following 
the requisite 30-day notice of intent issued to the public and 
HHS, any such drug or substance could remain ``temporarily'' on 
Schedule A for five years, with the Attorney General having 
proven very little medically, scientifically, or 
criminogenically. The lesser burden of proof necessary to place 
substances temporarily on Schedule A would give the Attorney 
General wide latitude to schedule countless substances. The 
subsequent permanent placement under SITSA would require no 
further analysis, review, or evidence.
---------------------------------------------------------------------------
    \15\Stop the Importation and Trafficking of Synthetic Analogues 
Act, H.R. 2851, 115th Cong. Sec. 3 (2017).
---------------------------------------------------------------------------
    Proponents of the bill argue that giving the Attorney 
General the ability to schedule synthetic analogues temporarily 
or permanently within thirty days is necessary to speed up the 
process of outlawing synthetic analogues and, thus, stop the 
importation and distribution of such substances quickly. Ms. 
Ashley testified before the Subcommittee that the process of 
temporarily scheduling drugs or substances under the CSA 
typically takes three to four months and permanent placement 
takes from eighteen months to several years. After praising the 
great partnership between the scientific staff at DEA and HHS 
that involves ``a day-to-day relationship'' and ``exchanging 
information constantly,'' Ms. Ashley stated incorrectly that 
the eight-factor analysis would continue to be included in the 
process of permanently scheduling Schedule A substances under 
SITSA.
    Synthetic analogue abuse undoubtedly presents a potential 
danger to public health, and law enforcement is experiencing 
some difficulty in developing an appropriate and coherent 
response. Nevertheless, Congress must be careful in formulating 
a response to address the dangers these drugs pose and the 
issues encountered by law enforcement. Medical and scientific 
evidence are essential to establish the need to prohibit and, 
thus, criminalize drugs and substances. HHS should be involved 
in the evaluation of synthetic analogues to uphold the 
integrity of the scheduling process. While it might be 
expedient to shave two or three months from the temporary 
scheduling process, it is imprudent to completely eliminate 
medical and scientific analysis and review of drugs and 
substances from the process.

III. H.R. 2851 Conflicts With the Need to Reform Our Drug Laws.

    After four decades of a failed war on drugs, the outcome 
has remained the same. Based in part on excessive, and often 
mandatory, minimum penalties in our drug laws, there has been a 
growing bipartisan movement to reform both the state and 
federal criminal justice systems in recent years. 
Unfortunately, the approach of H.R. 2851 runs counter to these 
efforts to reform these laws. A broad coalition of 
stakeholders--including the Drug Policy Alliance, the American 
Civil Liberties Union, the Leadership Conference on Civil and 
Human Rights, Families Against Mandatory Minimums, the 
Sentencing Project, Human Rights Watch, and the American Bar 
Association--have expressed strong objection to H.R. 2851 for 
several reasons.\16\ These groups collectively argue that this 
legislation undermines the previous progress made to reform the 
criminal justice system.
---------------------------------------------------------------------------
    \16\See Drug Policy Alliance one pager, S. 1327/H.R. 2851: Stop the 
Importation and Trafficking of Synthetic Analogues (SITSA) Act of 2017 
(2017) [hereinafter Drug Policy Alliance one pager]; see also Letter 
from coalition of sixty-five civil and human rights, faith, and 
criminal justice reform organizations, to Rep. Bob Goodlatte, Chairman, 
H. Comm. on the Judiciary, & Rep. John Conyers, Jr., Ranking Member, H. 
Comm. on the Judiciary (June 26, 2017) (on file with Democratic staff 
of the H. Comm. on the Judiciary).
---------------------------------------------------------------------------
    For example, the Pew Center's Public Safety Performance 
Project recently compared data from law enforcement, 
corrections, and health agencies to evaluate the relationship 
between imprisonment and the nature and extent of the country's 
drug problem. The Project reports that ``[a]nalysis of the data 
revealed that there is no statistically significant 
relationship between state drug offender imprisonment rates and 
three measures of state drug problems: rates of illicit drug 
use, drug overdose deaths, and drug arrests.''\17\ With respect 
to the federal penal system, nearly half of all people in 
federal prisons in 2015 were serving time for drug 
offenses.\18\ As stated in a letter to the President's 
Commission on Combating Drug Addiction and the Opioid Crisis, 
the Project stated that federal prison spending grew 
exponentially between 1980 and 2013, ``without a convincing 
public safety return.''\19\
---------------------------------------------------------------------------
    \17\Letter from Adam Gelb, Pew Charitable Trusts, Public Safety 
Performance Project, to the Honorable Chris Christie, President's 
Commission on Combating Drug Addiction and the Opioid Crisis (June 19, 
2017) (on file with H. Comm. on the Judiciary Democratic staff) 
[hereinafter Pew Letter].
    \18\E. Carson & E. Anderson, E., Prisoners in 2015, U.S. Dep't of 
Justice, Bureau of Justice Statistics (Dec. 2016), available at https:/
/www.bjs.gov/content/pub/pdf/p15.pdf.
    \19\Pew Letter.
---------------------------------------------------------------------------
    The 2016 National Drug Threat Assessment suggests that 
traffickers of synthetic cannabinoids and synthetic cathinones 
may continue to distribute these popular substances, regardless 
of their status on the controlled substances list, a premise 
also expressed by Louis J. Milione, the DEA's Assistant 
Administrator.\20\ Synthetic drugs and substances are 
inexpensive, easily accessible to both users and suppliers, 
and, thus, extremely tempting to dealers, traffickers, and 
users. As explained at a Subcommittee hearing held last year, 
the profit margin for these substances is considerably 
high.\21\ The Pew Project suggests that this legislation could 
serve only to force the use of synthetic drugs underground, 
driving profitability up and encouraging dealers, traffickers, 
and manufacturers to continue to produce the drugs despite 
breaking the law.\22\ Based on the lessons learned from the 
crack era to today, a flawed and rushed effort to apply 
criminal penalties for synthetic analogues, H.R. 2851 will have 
very little effect, if any at all, on the supply or demand for 
these drugs.
---------------------------------------------------------------------------
    \20\U.S. Department of Justice, Drug Enforcement Administration, 
National Drug Threat Assessment, (Nov. 2016); Fentanyl: The Next Wave 
of the Opioid Crisis: Hearing Before the Subcommittee on Oversight and 
Investigations of the H. Comm. on the Judiciary, 115th Congress (2017) 
(statement of Louis J. Milione, Assistant Administrator, DEA).
    \21\Synthetic Drugs, Real Danger: Hearing Before the Subcomm. on 
Crime, Terrorism, Homeland Security, and Investigations of the H. Comm. 
on the Judiciary, 114th Cong. (2016).
    \22\Id.
---------------------------------------------------------------------------
    Despite the abundant evidence supporting the need to 
curtail the U.S. criminal justice system's reliance on 
incarceration, particularly with respect to drug offenses, this 
bill would sweep more individuals into the federal criminal 
justice system and allow law enforcement to target substances 
of which very little is known scientifically about their harms 
or benefits. The Subcommittee approved an amendment introduced 
by Subcommittee Chairman Jim Sensenbrenner (R-WI) that removed 
mandatory minimum imprisonment penalties from the bill. 
Nevertheless, mandatory minimum terms of supervised release 
remain and the penalties proposed in the bill would still 
subject offenders to potentially lengthy sentences. James C. 
Duff, Secretary of the Judicial Conference of the United 
States, conveyed the Conference's objection to the mandatory 
minimum terms of supervised release in a letter to Subcommittee 
Members.\23\ He stated, ``Mandatory minimum sentences--
including mandatory minimum term of supervised release--waste 
valuable taxpayer dollars, create injustice in sentencing, 
undermine guideline sentencing, and ultimately foster a lack of 
confidence in the criminal justice system.''\24\ Congress 
should ``avoid the costs associated with mandatory minimum 
sentences'' and restore sentencing discretion to district 
judges, who are in the best position to impose punishments that 
are appropriate and just.''\25\
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    \23\Letter from James C. Duff, Secretary, Judicial Conference of 
the United States, to Ranking Member Shelia Jackson Lee, Subcomm. on 
Crime, Terrorism, Homeland Security, and Investigations, H. Comm. on 
the Judiciary (July 7, 2017) (on file with H. Comm. on the Judiciary 
Democratic Staff).
    \24\Id.
    \25\Id.
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    Furthermore, while the bill excludes prosecution for simple 
possession of synthetic analogues placed on Schedule A, it 
nevertheless fails to set threshold amounts for manufacture, 
distribution, importation, or exportation offenses involving 
synthetic analogues. Thus, even possession of small amounts of 
the drugs could, in some cases, lead to prosecutors bringing 
federal charges.

IV. H.R. 2851 Could Stifle Legitimate Synthetic Analogue Research.

    ``Critics are worried that the bill's language could be 
used to justify bans on all manner of substances that are not 
particularly lethal or dangerous.''\26\ The bill has the 
potential to undermine and stifle the research and development 
of therapeutic uses of synthetic compounds, such as opioids. 
This result is counterproductive from the standpoint of public 
health. For instance, federal law has already unnecessarily 
impeded scientific and medical research into the medical uses 
of marijuana.
---------------------------------------------------------------------------
    \26\Id.
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    Although Chairman Goodlatte offered a substitute amendment, 
which was adopted, that would exempt researchers who hold a 
Schedule I registration from having to obtain a separate 
registration for Schedule A substances or submit a protocol 
review, only a small number of researchers currently hold a 
Schedule I registration. Many more researchers hold Schedule II 
registrations and, thus, would not benefit from this narrow 
improvement to the bill.

                               CONCLUSION

    H.R. 2851 would unwisely and unnecessarily grant broad 
powers to the Attorney General--without the benefit of adequate 
scientific and medical research--to expand the application of 
criminal penalties with respect to analogue synthetic drugs. 
Although we must do more to combat the abuse of synthetic 
drugs, including opioids, this bill is an extreme and unwise 
measure. Therefore, we are unable to support this bill and must 
respectfully dissent.

                                   Mr. Nadler.
                                   Ms. Lofgren.
                                   Ms. Jackson Lee.
                                   Mr. Cohen.
                                   Mr. Johnson, Jr.
                                   Mr. Jeffries.
                                   Ms. Jayapal.

                                  [all]