I 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 

4 (a) SHORT TITLE.—This Act may be cited as the 

5 ‘‘Comprehensive Fentanyl Control Act’’. 

6 (b) TABLE OF CONTENTS.—The table of contents of 

7 this Act is as follows: 

Sec. 1. Short title; table of contents. 

Sec. 2. Findings; sense of Congress. 

Sec. 3. Enhanced penalties. 


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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. 

1 SEC. 2. FINDINGS; SENSE OF CONGRESS. 

2 (a) FINDINGS.—The Congress finds as follows: 

3 (1) Fentanyl is a dangerous, synthetic opioid 

4 that’s 50 to 100 times more potent than heroin and 

5 morphine and lethal in doses as small as approxi6 mately 2 milligrams. Current sentencing enhance7 ments do not reflect the danger fentanyl poses at 

8 lower quantities compared to other illicit substances. 

9 (2) Because a lethal dose of fentanyl can be ac10 cidentally inhaled or absorbed through the skin, it’s 

11 not just deadly to its users, but it also threatens the 

12 lives of law enforcement and customs officials, public 

13 health workers, first responders and postal workers 

14 who risk unknowingly coming into contact with 

15 fentanyl in its different forms. 

16 (3) From 2013 to 2014, the number of drug 

17 seizures by law enforcement that tested positive for 

18 fentanyl increased by 426 percent and synthetic 

19 opioid-related deaths increased by 79 percent, with 

20 over 700 overdose deaths related to fentanyl. How21 ever, due to variations in States’ medical examiner 

22 and coroner testing and reporting techniques, and 


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1 deaths attributed to heroin, this figure is believed to 

2 be significantly higher. 

3 (4) Illicitly manufactured fentanyl, pill press 

4 machines, and other supplies needed to manufacture 

5 counterfeit pills containing fentanyl are primarily 

6 sourced from China and widely available for pur7 chase on the Internet. Traffickers can typically pur8 chase a kilogram of fentanyl powder for as little as 

9 $2,000 from a Chinese supplier, transform it into 

10 hundreds of thousands of pills, and sell the counter11 feit pills for millions of dollars in profit. 

12 (5) In 2015, the Drug Enforcement Adminis13 tration (DEA) and Centers for Disease Control and 

14 Prevention (CDC) issued nationwide alerts identi15 fying fentanyl as a threat to public health and safety 

16 and stating that the rise of counterfeit pills that 

17 contain fentanyl in the illicit drug market will likely 

18 result in more opioid-dependent individuals, 

19 overdoses, and deaths. 

20 (6) The DEA has identified two key challenges 

21 for using the Controlled Substances Analogue En22 forcement Act of 1986 (21 U.S.C. 801 note) to pros23 ecute individuals for violations relating to fentanyl: 

24 (A) The law requires that the substance 

25 have a substantially similar chemical structure 


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1 to a controlled substance in order to be consid2 ered an analogue, yet the threshold for ‘‘sub3 stantially similar’’ has been cited by numerous 

4 courts as difficult to apply. 

5 (B) Each case requires additional inves6 tigation to determine whether the substance in 

7 question was ‘‘intended for human consump8 tion’’ and can therefore be considered an ana9 logue. 

10 (7) Illicit fentanyl manufacturers are continu11 ously manipulating the chemical structures of the 

12 analogues in order to stay ahead of researchers and 

13 law enforcement, thus making prosecuting these 

14 crimes overly onerous. Furthermore, the speed at 

15 which these alterations can be made outpace the cur16 rent authorities of the Department of Justice to 

17 schedule new compounds and analogues under the 

18 Controlled Substances Act (21 U.S.C. 801 et seq.). 

19 (b) SENSE OF CONGRESS.—It is the sense of the 

20 Congress that— 

21 (1) the trafficking in fentanyl and other syn22 thetic opioids represents a public health emergency 

23 in the United States and requires a comprehensive 

24 legislative response; 


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1 (2) the United States Government should use 

2 all available measures to reduce the availability of il3 licit fentanyl, its chemical precursors, and the equip4 ment by which fentanyl may be milled into counter5 feit prescription pills; 

6 (3) the United States Government should make 

7 grants available for State and local medical exam8 iners and coroners to screen for fentanyl in sus9 pected opioid overdose cases in regions reporting in10 creases in fentanyl seizures, fentanyl-related over11 dose fatalities, or unusually high spikes in heroin or 

12 unspecified drug overdose fatalities; 

13 (4) State and local law enforcement should, if 

14 safe and possible, prioritize and expedite testing of 

15 drug samples taken from drug overdose scenes and 

16 share the data on fentanyl drug seizures with local 

17 health departments, coroners, and medical exam18 iners; 

19 (5) grants made available to address the opioid 

20 epidemic should be used to improve States’ surveil21 lance of fentanyl-related deaths and to expand ac22 cess to naloxone for first responders, law enforce23 ment, and health care personnel given that multiple 

24 doses of naloxone must be administered per overdose 

25 event; and 


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1 (6) the United States Government, including 

2 the Secretary of State, the Attorney General, the 

3 Secretary of Homeland Security, and the Director of 

4 the Office of National Drug Control Policy, should 

5 use the broad diplomatic and law enforcement re6 sources of the United States, in partnership with the 

7 Governments of Mexico and China, to stop the traf8 ficking of illicit fentanyl into the United States. 

9 SEC. 3. ENHANCED PENALTIES. 

10 (a) CONTROLLED SUBSTANCES ACT AMEND11 MENTS.—The Controlled Substances Act is amended— 

12 (1) in section 401(b)(1) (21 U.S.C. 

13 841(b)(1))— 

14 (A) in subparagraph (A)(vi)— 

15 (i) by striking ‘‘400 grams’’ and in16 serting ‘‘20 grams’’; and 

17 (ii) by striking ‘‘100 grams’’ and in18 serting ‘‘5 grams’’; and 

19 (B) in subparagraph (B)(vi)— 

20 (i) by striking ‘‘40 grams’’ and insert21 ing ‘‘2 grams’’; and 

22 (ii) by striking ‘‘10 grams’’ and in23 serting ‘‘0.5 grams’’; and 

24 (2) by adding at the end of section 401(b) (21 

25 U.S.C. 841(b)) the following: 


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1 ‘‘(8) In the case of a violation of subsection (a), 

2 if the mixture or substance contains a detectable 

3 amount of N-phenyl-[1–(2-phenylethyl)–4- 

4 piperidinyl] propanamide or any analogue of N5 phenyl-[1–(2-phenylethyl)–4-piperidinyl] 

6 propanamide and also contains a detectable amount 

7 of another controlled substance, then a court shall— 

8 ‘‘(A) not impose a term of probation; 

9 ‘‘(B) in addition to the term of punishment 

10 for the violation of this section, impose a term 

11 of imprisonment not to exceed 5 years; and 

12 ‘‘(C) no term of imprisonment imposed on 

13 a person under subparagraph (B) shall run con14 currently with any term of imprisonment im15 posed on the person under any other provision 

16 of law. 

17 ‘‘(9) In the case of a violation of subsection (a), 

18 if the mixture or substance containing a detectable 

19 amount of N-phenyl-[1–(2-phenylethyl)–4- 

20 piperidinyl] propanamide or any analogue of N21 phenyl-[1–(2-phenylethyl)–4-piperidinyl] 

22 propanamide was represented to be or sold as an23 other controlled substance, then a court shall— 

24 ‘‘(A) not impose a term of probation; 


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1 ‘‘(B) in addition to the term of punishment 

2 for the violation of this section, impose a term 

3 of imprisonment not to exceed 5 years; and 

4 ‘‘(C) no term of imprisonment imposed on 

5 a person under subparagraph (B) shall run con6 currently with any term of imprisonment im7 posed on the person under any other provision 

8 of law.’’. 

9 (b) CONTROLLED SUBSTANCES IMPORT AND EXPORT

10 ACT AMENDMENTS.—Section 1010(b) of the Controlled 

11 Substances Import and Export Act (21 U.S.C. 960(b)) is 

12 amended by adding at the end the following: 

13 ‘‘(8) In the case of a violation of subsection (a), 

14 if the mixture or substance containing a detectable 

15 amount of N-phenyl-[1–(2-phenylethyl)–4- 

16 piperidinyl] propanamide or any analogue of N17 phenyl-[1–(2-phenylethyl)–4-piperidinyl] 

18 propanamide also contains a detectable amount of 

19 another controlled substance, then a court shall— 

20 ‘‘(A) not impose a term of probation; 

21 ‘‘(B) in addition to the term of punishment 

22 for the violation of this section, impose a term 

23 of imprisonment not to exceed 5 years; and 

24 ‘‘(C) no term of imprisonment imposed on 

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1 currently with any term of imprisonment im2 posed on the person under any other provision 

3 of law. 

4 ‘‘(9) In the case of a violation of subsection (a), 

5 if the mixture or substance containing a detectable 

6 amount of N-phenyl-[1–(2-phenylethyl)–4- 

7 piperidinyl] propanamide or any analogue of N8 phenyl-[1–(2-phenylethyl)–4-piperidinyl] 

9 propanamide was represented to be or sold as an10 other controlled substance, then a court shall— 

11 ‘‘(A) not impose a term of probation; 

12 ‘‘(B) in addition to the term of punishment 

13 for the violation of this section, impose a term 

14 of imprisonment not to exceed 5 years; and 

15 ‘‘(C) no term of imprisonment imposed on 

16 a person under subparagraph (B) shall run con17 currently with any term of imprisonment im18 posed on the person under any other provision 

19 of law.’’. 

20 SEC. 4. ENDANGERING HUMAN LIFE WHILE ILLEGALLY 

21 MANUFACTURING CONTROLLED SUBSTANCE. 

22 Section 417 of the Controlled Substances Act (21 

23 U.S.C. 858) is amended to read as follows: 


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1 ‘‘SEC. 417. ENDANGERING HUMAN LIFE WHILE ILLEGALLY 

2 MANUFACTURING CONTROLLED SUBSTANCE. 

3 ‘‘(a) IN GENERAL.—Whoever, while manufacturing a 

4 controlled substance in violation of this title, or attempting 

5 to do so, or transporting or causing to be transported ma6 terials, including chemicals, to do so, creates a substantial 

7 risk of harm to human life shall be fined in accordance 

8 with title 18, United States Code, or imprisoned not more 

9 than 10 years, or both. 

10 ‘‘(b) REBUTTABLE PRESUMPTION.—For purposes of 

11 this section, there shall be rebuttable presumption that 

12 any violation of subsection (a) involving a detectable 

13 amount of N-phenyl-[1–(2-phenylethyl)–4-piperidinyl] 

14 propanamide, any analogue of N-phenyl-[1–(2- 

15 phenylethyl)–4-piperidinyl] propanamide, or the imme16 diate precursor of such a substance, creates a substantial 

17 risk of harm to human life.’’. 

18 SEC. 5. TEMPORARY SCHEDULING OF SYNTHETIC OPIOIDS. 

19 Section 201 of the Controlled Substances Act (21 

20 U.S.C. 811) is amended by adding at the end the fol21 lowing: 

22 ‘‘(k) TEMPORARY AND PERMANENT SCHEDULING OF

23 RECENTLY EMERGED SYNTHETIC OPIOIDS.— 

24 ‘‘(1) IN GENERAL.—The Attorney General may 

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1 stance to the definition of synthetic opioids if the 

2 Attorney General finds that— 

3 ‘‘(A) the drug or other substance satisfies 

4 the criteria for being considered a synthetic 

5 opioid but is not listed in that section or by reg6 ulation of the Attorney General as being a syn7 thetic opioid; and 

8 ‘‘(B) adding such drug or other substance 

9 to the definition of synthetic opioids will assist 

10 in preventing abuse or misuse of the drug or 

11 other substance. 

12 ‘‘(2) EFFECTIVE DATE; DURATION.—An order 

13 issued under paragraph (1) shall not take effect 

14 until 30 days after the date of the publication by the 

15 Attorney General of a notice in the Federal Register 

16 of the intention to issue such order and the grounds 

17 upon which such order is to be issued. The order 

18 shall expire not later than 24 months after the date 

19 it becomes effective, except that the Attorney Gen20 eral may, during the pendency of proceedings under 

21 paragraph (6), extend the temporary scheduling 

22 order for up to 6 months. 

23 ‘‘(3) NOTICE.—The Attorney General shall 

24 transmit notice of an order proposed to be issued 

25 under paragraph (1) to the Secretary of Health and 


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1 Human Services. In issuing an order under para2 graph (1), the Attorney General shall take into con3 sideration any comments submitted by the Secretary 

4 in response to a notice transmitted pursuant to this 

5 paragraph. 

6 ‘‘(4) EFFECT OF PERMANENT SCHEDULING.—A 

7 temporary scheduling order issued under paragraph 

8 (1) shall be vacated upon the issuance of a perma9 nent scheduling order under paragraph (6). 

10 ‘‘(5) JUDICIAL REVIEW.—An order issued 

11 under paragraph (1) is not subject to judicial review. 

12 ‘‘(6) PERMANENT SCHEDULING.—The Attorney 

13 General may, by rule, issue a permanent order add14 ing a drug or other substance to the definition of 

15 synthetic opioids if such drug or other substance 

16 satisfies the criteria for being considered a synthetic 

17 opioid. Such rulemaking may be commenced simulta18 neously with the issuance of the temporary order 

19 issued under paragraph (1).’’. 

20 SEC. 6. TABLETING MACHINES, ENCAPSULATING MA21 CHINES, AND CONTROLLED SUBSTANCE 

22 COUNTERFEITING MATERIALS. 

23 (a) MAILABILITY.— 


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1 (1) IN GENERAL.—Chapter 30 of title 39, 

2 United States Code, is amended by inserting after 

3 section 3002a, the following new section: 

4 ‘‘§ 3002b. Nonmailability of tableting machines, en5 capsulating machines, and controlled 

6 substance counterfeiting materials 

7 ‘‘(a) Any tableting machine, encapsulating machine, 

8 or controlled substance counterfeiting material is non9 mailable matter, shall not be carried or delivered by mail, 

10 and shall be disposed of as the Postal Service directs, un11 less such device or material is mailed— 

12 ‘‘(1) to a regulated person (as defined in section 

13 102(38) of the Controlled Substances Act); or 

14 ‘‘(2) to a person registered to manufacture a 

15 controlled substance by the Attorney General pursu16 ant to section 302 of the Controlled Substances Act. 

17 ‘‘(b) For the purpose of this section— 

18 ‘‘(1) the term ‘controlled substance counter19 feiting material’ means any punch, die, plate, stone, 

20 or other thing described section 403(a)(5) of the 

21 Controlled Substances Act; 

22 ‘‘(2) the term ‘encapsulating machine’ means 

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1 sules with any powdered, granular, semisolid, or liq2 uid material; and 

3 ‘‘(3) the term ‘tableting machine’ means any 

4 manual, semiautomatic, or fully automatic equip5 ment which may be used for the compaction or 

6 molding of powdered or granular solids, or semisolid 

7 material, to produce coherent solid tablets.’’. 

8 (2) CLERICAL AMENDMENT.—The table of sec9 tions for chapter 30 of title 39, United States Code, 

10 is amended by inserting after the item relating to 

11 section 3002a the following new item: 

‘‘3002b. Nonmailability of tableting machines, encapsulating machines, and controlled substance counterfeiting materials.’’. 

12 (b) PENALTY.— 

13 (1) IN GENERAL.—Chapter 83 of title 18, 

14 United States Code, is amended by inserting after 

15 section 1716E the following new section: 

16 ‘‘§ 1716F. Nonmailability of tableting machines, en17 capsulating machines, and controlled 

18 substance counterfeiting materials 

19 ‘‘Whoever knowingly deposits for mailing or delivery, 

20 or knowingly causes to be delivered by mail according to 

21 the direction thereon, or at any place to which it is di22 rected to be delivered by the person to whom it is ad23 dressed, any matter declared to be nonmailable by section 


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1 3002c of title 39, shall be fined under this title or impris2 oned not more than 1 year, or both.’’. 

3 (2) CLERICAL AMENDMENT.—The table of sec4 tions for chapter 83 of title 18, United States Code, 

5 is amended by inserting after the item relating to 

6 section 1716E the following new item: 

‘‘1716F. Nonmailability of tableting machines, encapsulating machines, and controlled substance counterfeiting materials.’’. 

7 SEC. 7. LABELING REQUIREMENTS. 

8 (a) IN GENERAL.—Section 305 of the Controlled 

9 Substances Act (21 U.S.C. 825) is amended by adding at 

10 the end the following: 

11 ‘‘(f) FALSE LABELING OF SYNTHETIC OPIOIDS.— 

12 ‘‘(1) It shall be unlawful to import, export, 

13 manufacture, distribute, dispense, or possess with 

14 intent to manufacture, distribute, or dispense, a syn15 thetic opioid or product containing a synthetic 

16 opioid, unless the opioid or product bears a label 

17 clearly identifying a synthetic opioid or product con18 taining a synthetic opioid by the nomenclature used 

19 by the International Union of Pure and Applied 

20 Chemistry (IUPAC). 

21 ‘‘(2)(A) A product described in subparagraph 

22 (B) is exempt from the International Union of Pure 

23 and Applied Chemistry nomenclature requirement of 

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1 ner required under the Federal Food, Drug, and 

2 Cosmetic Act. 

3 ‘‘(B) A product is described in this subpara4 graph if the product— 

5 ‘‘(i) is the subject of an approved applica6 tion as described in section 505(b) or (j) of the 

7 Federal Food, Drug, and Cosmetic Act; or 

8 ‘‘(ii) is exempt from the provisions of sec9 tion 505 of such Act relating to new drugs be10 cause— 

11 ‘‘(I) it is intended solely for investiga12 tional use as described in section 505(i) of 

13 such Act; and 

14 ‘‘(II) such product is being used ex15 clusively for purposes of a clinical trial 

16 that is the subject of an effective investiga17 tional new drug application.’’. 

18 (b) CLARIFICATION TO IMPORT AND EXPORT STAT19 UTE.—Section 1010 of the Controlled Substances Import 

20 and Export Act (21 U.S.C. 960) is amended, in subsection 

21 (a)(1), by inserting ‘‘305,’’ before ‘‘1002’’. 

22 (c) CIVIL PENALTIES.—Section 402 of the Controlled 

23 Substances Act (21 U.S.C. 842) is amended— 

24 (1) in subsection (a)— 


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1 (A) in paragraph (15), by striking ‘‘or’’ at 

2 the end; 

3 (B) in paragraph (16), by striking the pe4 riod at the end and inserting ‘‘; or’’; and 

5 (C) by inserting, after paragraph (16), the 

6 following: 

7 ‘‘(17) to violate subsection (f) of section 825 of 

8 this title.’’; and 

9 (2) in subsection (c)(1)— 

10 (A) by inserting, in subparagraph (A), 

11 after ‘‘subparagraph (B), (C),’’ striking ‘‘or 

12 (D)’’ and inserting the following: ‘‘, (D), (E), or 

13 (F)’’; and 

14 (B) by inserting after subparagraph (D) 

15 the following: 

16 ‘‘(E) In the case of a violation of paragraph (17) of 

17 subsection (a) of this section by an importer, exporter, 

18 manufacturer, or distributor (other than as provided in 

19 subparagraph (F)), up to $500,000 per violation. For pur20 poses of this subparagraph, a violation is defined as each 

21 instance of importation, exportation, manufacturing, dis22 tribution, or possession with intent to manufacture or dis23 tribute, in violation of paragraph (17) of subsection (a). 

24 ‘‘(F) In the case of a distribution, dispensing, or pos25 session with intent to distribute or dispense in violation 


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1 of paragraph (17) of subsection (a) of this section at the 

2 retail level, up to $1,000 per violation. Each package, con3 tainer or other separate unit containing a synthetic opioid 

4 that is distributed, dispensed, or possessed with intent to 

5 distribute or dispense at the retail level in violation of such 

6 paragraph (17) of subsection (a) shall be considered a sep7 arate violation.’’. 

Æ 


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