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[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1781 Introduced in House (IH)]

<DOC>

115th CONGRESS
  1st Session
                                H. R. 1781

 To improve the ability of the Federal Government to address synthetic 
                    opioids, and for other purposes.

_______________________________________________________________________

                    IN THE HOUSE OF REPRESENTATIVES

                             March 29, 2017

     Mr. Donovan (for himself and Mr. Thomas J. Rooney of Florida) 
 introduced the following bill; which was referred to the Committee on 
     Energy and Commerce, and in addition to the Committees on the 
  Judiciary, and Oversight and Government Reform, for a period to be 
subsequently determined by the Speaker, in each case for consideration 
  of such provisions as fall within the jurisdiction of the committee 
                               concerned

_______________________________________________________________________

                                 A BILL

 
 To improve the ability of the Federal Government to address synthetic 
                    opioids, and for other purposes.

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

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

    (a) Short Title.--This Act may be cited as the ``Comprehensive 
Fentanyl Control Act''.
    (b) Table of Contents.--The table of contents of this Act is as 
follows:

Sec. 1. Short title; table of contents.
Sec. 2. Findings; sense of Congress.
Sec. 3. Enhanced penalties.
Sec. 4. Endangering human life while illegally manufacturing controlled 
                            substance.
Sec. 5. Temporary scheduling of synthetic opioids.
Sec. 6. Tableting machines, encapsulating machines, and controlled 
                            substance counterfeiting materials.
Sec. 7. Labeling requirements.

SEC. 2. FINDINGS; SENSE OF CONGRESS.

    (a) Findings.--The Congress finds as follows:
            (1) Fentanyl is a dangerous, synthetic opioid that's 50 to 
        100 times more potent than heroin and morphine and lethal in 
        doses as small as approximately 2 milligrams. Current 
        sentencing enhancements do not reflect the danger fentanyl 
        poses at lower quantities compared to other illicit substances.
            (2) Because a lethal dose of fentanyl can be accidentally 
        inhaled or absorbed through the skin, it's not just deadly to 
        its users, but it also threatens the lives of law enforcement 
        and customs officials, public health workers, first responders 
        and postal workers who risk unknowingly coming into contact 
        with fentanyl in its different forms.
            (3) From 2013 to 2014, the number of drug seizures by law 
        enforcement that tested positive for fentanyl increased by 426 
        percent and synthetic opioid-related deaths increased by 79 
        percent, with over 700 overdose deaths related to fentanyl. 
        However, due to variations in States' medical examiner and 
        coroner testing and reporting techniques, and deaths attributed 
        to heroin, this figure is believed to be significantly higher.
            (4) Illicitly manufactured fentanyl, pill press machines, 
        and other supplies needed to manufacture counterfeit pills 
        containing fentanyl are primarily sourced from China and widely 
        available for purchase on the Internet. Traffickers can 
        typically purchase a kilogram of fentanyl powder for as little 
        as $2,000 from a Chinese supplier, transform it into hundreds 
        of thousands of pills, and sell the counterfeit pills for 
        millions of dollars in profit.
            (5) In 2015, the Drug Enforcement Administration (DEA) and 
        Centers for Disease Control and Prevention (CDC) issued 
        nationwide alerts identifying fentanyl as a threat to public 
        health and safety and stating that the rise of counterfeit 
        pills that contain fentanyl in the illicit drug market will 
        likely result in more opioid-dependent individuals, overdoses, 
        and deaths.
            (6) The DEA has identified two key challenges for using the 
        Controlled Substances Analogue Enforcement Act of 1986 (21 
        U.S.C. 801 note) to prosecute individuals for violations 
        relating to fentanyl:
                    (A) The law requires that the substance have a 
                substantially similar chemical structure to a 
                controlled substance in order to be considered an 
                analogue, yet the threshold for ``substantially 
                similar'' has been cited by numerous courts as 
                difficult to apply.
                    (B) Each case requires additional investigation to 
                determine whether the substance in question was 
                ``intended for human consumption'' and can therefore be 
                considered an analogue.
            (7) Illicit fentanyl manufacturers are continuously 
        manipulating the chemical structures of the analogues in order 
        to stay ahead of researchers and law enforcement, thus making 
        prosecuting these crimes overly onerous. Furthermore, the speed 
        at which these alterations can be made outpace the current 
        authorities of the Department of Justice to schedule new 
        compounds and analogues under the Controlled Substances Act (21 
        U.S.C. 801 et seq.).
    (b) Sense of Congress.--It is the sense of the Congress that--
            (1) the trafficking in fentanyl and other synthetic opioids 
        represents a public health emergency in the United States and 
        requires a comprehensive legislative response;
            (2) the United States Government should use all available 
        measures to reduce the availability of illicit fentanyl, its 
        chemical precursors, and the equipment by which fentanyl may be 
        milled into counterfeit prescription pills;
            (3) the United States Government should make grants 
        available for State and local medical examiners and coroners to 
        screen for fentanyl in suspected opioid overdose cases in 
        regions reporting increases in fentanyl seizures, fentanyl-
        related overdose fatalities, or unusually high spikes in heroin 
        or unspecified drug overdose fatalities;
            (4) State and local law enforcement should, if safe and 
        possible, prioritize and expedite testing of drug samples taken 
        from drug overdose scenes and share the data on fentanyl drug 
        seizures with local health departments, coroners, and medical 
        examiners;
            (5) grants made available to address the opioid epidemic 
        should be used to improve States' surveillance of fentanyl-
        related deaths and to expand access to naloxone for first 
        responders, law enforcement, and health care personnel given 
        that multiple doses of naloxone must be administered per 
        overdose event; and
            (6) the United States Government, including the Secretary 
        of State, the Attorney General, the Secretary of Homeland 
        Security, and the Director of the Office of National Drug 
        Control Policy, should use the broad diplomatic and law 
        enforcement resources of the United States, in partnership with 
        the Governments of Mexico and China, to stop the trafficking of 
        illicit fentanyl into the United States.

SEC. 3. ENHANCED PENALTIES.

    (a) Controlled Substances Act Amendments.--The Controlled 
Substances Act is amended--
            (1) in section 401(b)(1) (21 U.S.C. 841(b)(1))--
                    (A) in subparagraph (A)(vi)--
                            (i) by striking ``400 grams'' and inserting 
                        ``20 grams''; and
                            (ii) by striking ``100 grams'' and 
                        inserting ``5 grams''; and
                    (B) in subparagraph (B)(vi)--
                            (i) by striking ``40 grams'' and inserting 
                        ``2 grams''; and
                            (ii) by striking ``10 grams'' and inserting 
                        ``0.5 grams''; and
            (2) by adding at the end of section 401(b) (21 U.S.C. 
        841(b)) the following:
            ``(8) In the case of a violation of subsection (a), if the 
        mixture or substance contains a detectable amount of N-phenyl-
        [1-(2-phenylethyl)-4-piperidinyl] propanamide or any analogue 
        of N-phenyl-[1-(2-phenylethyl)-4-piperidinyl] propanamide and 
        also contains a detectable amount of another controlled 
        substance, then a court shall--
                    ``(A) not impose a term of probation;
                    ``(B) in addition to the term of punishment for the 
                violation of this section, impose a term of 
                imprisonment not to exceed 5 years; and
                    ``(C) no term of imprisonment imposed on a person 
                under subparagraph (B) shall run concurrently with any 
                term of imprisonment imposed on the person under any 
                other provision of law.
            ``(9) In the case of a violation of subsection (a), if the 
        mixture or substance containing a detectable amount of N-
        phenyl-[1-(2-phenylethyl)-4-piperidinyl] propanamide or any 
        analogue of N-phenyl-[1-(2-phenylethyl)-4-piperidinyl] 
        propanamide was represented to be or sold as another controlled 
        substance, then a court shall--
                    ``(A) not impose a term of probation;
                    ``(B) in addition to the term of punishment for the 
                violation of this section, impose a term of 
                imprisonment not to exceed 5 years; and
                    ``(C) no term of imprisonment imposed on a person 
                under subparagraph (B) shall run concurrently with any 
                term of imprisonment imposed on the person under any 
                other provision of law.''.
    (b) Controlled Substances Import and Export Act Amendments.--
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 of subsection (a), if the 
        mixture or substance containing a detectable amount of N-
        phenyl-[1-(2-phenylethyl)-4-piperidinyl] propanamide or any 
        analogue of N-phenyl-[1-(2-phenylethyl)-4-piperidinyl] 
        propanamide also contains a detectable amount of another 
        controlled substance, then a court shall--
                    ``(A) not impose a term of probation;
                    ``(B) in addition to the term of punishment for the 
                violation of this section, impose a term of 
                imprisonment not to exceed 5 years; and
                    ``(C) no term of imprisonment imposed on a person 
                under subparagraph (B) shall run concurrently with any 
                term of imprisonment imposed on the person under any 
                other provision of law.
            ``(9) In the case of a violation of subsection (a), if the 
        mixture or substance containing a detectable amount of N-
        phenyl-[1-(2-phenylethyl)-4-piperidinyl] propanamide or any 
        analogue of N-phenyl-[1-(2-phenylethyl)-4-piperidinyl] 
        propanamide was represented to be or sold as another controlled 
        substance, then a court shall--
                    ``(A) not impose a term of probation;
                    ``(B) in addition to the term of punishment for the 
                violation of this section, impose a term of 
                imprisonment not to exceed 5 years; and
                    ``(C) no term of imprisonment imposed on a person 
                under subparagraph (B) shall run concurrently with any 
                term of imprisonment imposed on the person under any 
                other provision of law.''.

SEC. 4. ENDANGERING HUMAN LIFE WHILE ILLEGALLY MANUFACTURING CONTROLLED 
              SUBSTANCE.

    Section 417 of the Controlled Substances Act (21 U.S.C. 858) is 
amended to read as follows:

``SEC. 417. ENDANGERING HUMAN LIFE WHILE ILLEGALLY MANUFACTURING 
              CONTROLLED SUBSTANCE.

    ``(a) In General.--Whoever, while manufacturing a controlled 
substance in violation of this title, or attempting to do so, or 
transporting or causing to be transported materials, including 
chemicals, to do so, creates a substantial risk of harm to human life 
shall be fined in accordance with title 18, United States Code, or 
imprisoned not more than 10 years, or both.
    ``(b) Rebuttable Presumption.--For purposes of this section, there 
shall be rebuttable presumption that any violation of subsection (a) 
involving a detectable amount of N-phenyl-[1-(2-phenylethyl)-4-
piperidinyl] propanamide, any analogue of N-phenyl-[1-(2-phenylethyl)-
4-piperidinyl] propanamide, or the immediate precursor of such a 
substance, creates a substantial risk of harm to human life.''.

SEC. 5. TEMPORARY SCHEDULING OF SYNTHETIC OPIOIDS.

    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 Recently Emerged 
Synthetic Opioids.--
            ``(1) In general.--The Attorney General may issue a 
        temporary order adding a drug or other substance to the 
        definition of synthetic opioids if the Attorney General finds 
        that--
                    ``(A) the drug or other substance satisfies the 
                criteria for being considered a synthetic opioid but is 
                not listed in that section or by regulation of the 
                Attorney General as being a synthetic opioid; and
                    ``(B) adding such drug or other substance to the 
                definition of synthetic opioids will assist in 
                preventing abuse or misuse of the drug or other 
                substance.
            ``(2) Effective date; duration.--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) Notice.--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) Effect of permanent scheduling.--A temporary 
        scheduling order issued under paragraph (1) shall be vacated 
        upon the issuance of a permanent scheduling order under 
        paragraph (6).
            ``(5) Judicial review.--An order issued under paragraph (1) 
        is not subject to judicial review.
            ``(6) Permanent scheduling.--The Attorney General may, by 
        rule, issue a permanent order adding a drug or other substance 
        to the definition of synthetic opioids if such drug or other 
        substance satisfies the criteria for being considered a 
        synthetic opioid. Such rulemaking may be commenced 
        simultaneously with the issuance of the temporary order issued 
        under paragraph (1).''.

SEC. 6. TABLETING MACHINES, ENCAPSULATING MACHINES, AND CONTROLLED 
              SUBSTANCE COUNTERFEITING MATERIALS.

    (a) Mailability.--
            (1) In general.--Chapter 30 of title 39, United States 
        Code, is amended by inserting after section 3002a, the 
        following new section:
``Sec. 3002b. Nonmailability of tableting machines, encapsulating 
              machines, and controlled substance counterfeiting 
              materials
    ``(a) Any tableting machine, encapsulating machine, or controlled 
substance counterfeiting material is nonmailable matter, shall not be 
carried or delivered by mail, and shall be disposed of as the Postal 
Service directs, unless such device or material is mailed--
            ``(1) to a regulated person (as defined in section 102(38) 
        of the Controlled Substances Act); or
            ``(2) to a person registered to manufacture a controlled 
        substance by the Attorney General pursuant to section 302 of 
        the Controlled Substances Act.
    ``(b) For the purpose of this section--
            ``(1) the term `controlled substance counterfeiting 
        material' means any punch, die, plate, stone, or other thing 
        described section 403(a)(5) of the Controlled Substances Act;
            ``(2) the term `encapsulating machine' means any manual, 
        semiautomatic, or fully automatic equipment which may be used 
        to fill shells or capsules with any powdered, granular, 
        semisolid, or liquid material; and
            ``(3) the term `tableting machine' means any manual, 
        semiautomatic, or fully automatic equipment which may be used 
        for the compaction or molding of powdered or granular solids, 
        or semisolid material, to produce coherent solid tablets.''.
            (2) Clerical amendment.--The table of sections for chapter 
        30 of title 39, United States Code, is amended by inserting 
        after the item relating to section 3002a the following new 
        item:

``3002b. Nonmailability of tableting machines, encapsulating machines, 
                            and controlled substance counterfeiting 
                            materials.''.
    (b) Penalty.--
            (1) In general.--Chapter 83 of title 18, United States 
        Code, is amended by inserting after section 1716E the following 
        new section:
``Sec. 1716F. Nonmailability of tableting machines, encapsulating 
              machines, and controlled substance counterfeiting 
              materials
    ``Whoever knowingly deposits for mailing or delivery, or knowingly 
causes to be delivered by mail according to the direction thereon, or 
at any place to which it is directed to be delivered by the person to 
whom it is addressed, any matter declared to be nonmailable by section 
3002c of title 39, shall be fined under this title or imprisoned not 
more than 1 year, or both.''.
            (2) Clerical amendment.--The table of sections for chapter 
        83 of title 18, United States Code, is amended by inserting 
        after the item relating to section 1716E the following new 
        item:

``1716F. Nonmailability of tableting machines, encapsulating machines, 
                            and controlled substance counterfeiting 
                            materials.''.

SEC. 7. LABELING REQUIREMENTS.

    (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 Synthetic Opioids.--
            ``(1) It shall be unlawful to import, export, manufacture, 
        distribute, dispense, or possess with intent to manufacture, 
        distribute, or dispense, a synthetic opioid or product 
        containing a synthetic opioid, unless the opioid or product 
        bears a label clearly identifying a synthetic opioid or product 
        containing a synthetic opioid 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) Clarification To Import and Export Statute.--Section 1010 of 
the Controlled Substances Import and Export Act (21 U.S.C. 960) is 
amended, in subsection (a)(1), by inserting ``305,'' before ``1002''.
    (c) Civil Penalties.--Section 402 of the Controlled Substances Act 
(21 U.S.C. 842) is amended--
            (1) in subsection (a)--
                    (A) in paragraph (15), by striking ``or'' at the 
                end;
                    (B) in paragraph (16), by striking the period at 
                the end and inserting ``; or''; and
                    (C) by inserting, after paragraph (16), the 
                following:
            ``(17) to violate subsection (f) of section 825 of this 
        title.''; and
            (2) in subsection (c)(1)--
                    (A) by inserting, in subparagraph (A), after 
                ``subparagraph (B), (C),'' striking ``or (D)'' and 
                inserting the following: ``, (D), (E), or (F)''; and
                    (B) by inserting after subparagraph (D) the 
                following:
    ``(E) In the case of a violation of paragraph (17) of subsection 
(a) of this section by an importer, exporter, manufacturer, or 
distributor (other than as provided in subparagraph (F)), 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 (17) of subsection (a).
    ``(F) In the case of a distribution, dispensing, or possession with 
intent to distribute or dispense in violation of paragraph (17) of 
subsection (a) of this section at the retail level, up to $1,000 per 
violation. Each package, container or other separate unit containing a 
synthetic opioid that is distributed, dispensed, or possessed with 
intent to distribute or dispense at the retail level in violation of 
such paragraph (17) of subsection (a) shall be considered a separate 
violation.''.
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