I 
114TH CONGRESS 
2D SESSION 
H. R. 6243 
To improve the ability of the Federal Government to address synthetic opioids, 
and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
SEPTEMBER 28, 2016 
Mr. DONOVAN (for himself and Mr. ROONEY of Florida) introduced the fol-
lowing bill; which was referred to the Committee on Energy and Com-
merce, 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 with-
in 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 Representa-
tives of the United States of America in Congress assembled, 
SEC. 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. Controlled substance analogues. 
VerDate Sep 11 2014 
01:15 Oct 06, 2016
Jkt 069200
PO 00000
Frm 00001
Fmt 6652
Sfmt 6211
E:\BILLS\H6243.IH
H6243
rfrederick on DSKBCBPHB2PROD with bills
Sec. 4. Treatment of controlled substance analogues. 
Sec. 5. Enhanced penalties. 
Sec. 6. Endangering human life while illegally manufacturing controlled sub-
stance. 
Sec. 7. Temporary scheduling of synthetic opioid analgesics. 
Sec. 8. Tableting machines, encapsulating machines, and controlled substance 
counterfeiting materials. 
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 approxi-
mately 2 milligrams. Current sentencing enhance-
ments do not reflect the danger fentanyl poses at 
lower quantities compared to other illicit substances. 
(2) Because a lethal dose of fentanyl can be ac-
cidentally 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. How-
ever, due to variations in States’ medical examiner 
and coroner testing and reporting techniques, and 
VerDate Sep 11 2014 
04:14 Oct 06, 2016
Jkt 069200
PO 00000
Frm 00002
Fmt 6652
Sfmt 6201
E:\BILLS\H6243.IH
H6243
rfrederick on DSKBCBPHB2PROD with bills
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 pur-
chase on the Internet. Traffickers can typically pur-
chase 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 counter-
feit pills for millions of dollars in profit. 
(5) In 2015, the Drug Enforcement Adminis-
tration (DEA) and Centers for Disease Control and 
Prevention (CDC) issued nationwide alerts identi-
fying 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 En-
forcement Act of 1986 (21 U.S.C. 801 note) to pros-
ecute individuals for violations relating to fentanyl: 
(A) The law requires that the substance 
have a substantially similar chemical structure 
VerDate Sep 11 2014 
01:15 Oct 06, 2016
Jkt 069200
PO 00000
Frm 00003
Fmt 6652
Sfmt 6201
E:\BILLS\H6243.IH
H6243
rfrederick on DSKBCBPHB2PROD with bills
to a controlled substance in order to be consid-
ered an analogue, yet the threshold for ‘‘sub-
stantially similar’’ has been cited by numerous 
courts as difficult to apply. 
(B) Each case requires additional inves-
tigation to determine whether the substance in 
question was ‘‘intended for human consump-
tion’’ and can therefore be considered an ana-
logue. 
(7) Illicit fentanyl manufacturers are continu-
ously 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 cur-
rent 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 syn-
thetic opioids represents a public health emergency 
in the United States and requires a comprehensive 
legislative response; 
VerDate Sep 11 2014 
01:15 Oct 06, 2016
Jkt 069200
PO 00000
Frm 00004
Fmt 6652
Sfmt 6201
E:\BILLS\H6243.IH
H6243
rfrederick on DSKBCBPHB2PROD with bills
(2) the United States Government should use 
all available measures to reduce the availability of il-
licit fentanyl, its chemical precursors, and the equip-
ment by which fentanyl may be milled into counter-
feit prescription pills; 
(3) the United States Government should make 
grants available for State and local medical exam-
iners and coroners to screen for fentanyl in sus-
pected opioid overdose cases in regions reporting in-
creases in fentanyl seizures, fentanyl-related over-
dose 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 exam-
iners; 
(5) grants made available to address the opioid 
epidemic should be used to improve States’ surveil-
lance of fentanyl-related deaths and to expand ac-
cess to naloxone for first responders, law enforce-
ment, and health care personnel given that multiple 
doses of naloxone must be administered per overdose 
event; and 
VerDate Sep 11 2014 
01:15 Oct 06, 2016
Jkt 069200
PO 00000
Frm 00005
Fmt 6652
Sfmt 6201
E:\BILLS\H6243.IH
H6243
rfrederick on DSKBCBPHB2PROD with bills
(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 re-
sources of the United States, in partnership with the 
Governments of Mexico and China, to stop the traf-
ficking of illicit fentanyl into the United States. 
SEC. 3. CONTROLLED SUBSTANCE ANALOGUES. 
(a) IN GENERAL.—Clauses (i), (ii), and (iii) of sec-
tion 102(32)(A) of the Controlled Substances Act (21 
U.S.C. 802(32)(A)) are amended by striking ‘‘substan-
tially’’ each place it appears. 
(b) RULE OF CONSTRUCTION.—Section 102(32)(A) 
of the Controlled Substances Act (21 U.S.C. 82(32)(A)) 
shall not be construed to require that a substance satisfy 
more than one of the clauses listed in such section 
102(32)(A) to meet the definition of a controlled sub-
stance analogue. 
SEC. 4. TREATMENT OF CONTROLLED SUBSTANCE ANA-
LOGUES. 
Section 203 of the Controlled Substances Act (21 
U.S.C. 813) is amended by striking ‘‘shall, to the extent 
intended for human consumption, be treated, for the pur-
poses of any Federal law as a controlled substance in 
VerDate Sep 11 2014 
01:15 Oct 06, 2016
Jkt 069200
PO 00000
Frm 00006
Fmt 6652
Sfmt 6201
E:\BILLS\H6243.IH
H6243
rfrederick on DSKBCBPHB2PROD with bills
schedule I’’ and inserting ‘‘shall, to the extent to which 
it should be reasonably known to the manufacturer, dis-
tributor, or dispenser that the controlled substance ana-
logue is intended for human consumption, be treated, with 
respect to such manufacturer, distributor, or dispenser, re-
spectively, for the purpose of any Federal law as a con-
trolled substance in schedule I’’. 
SEC. 5. ENHANCED PENALTIES. 
(a) 
CONTROLLED
SUBSTANCES
ACT
AMEND-
MENTS.—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 in-
serting ‘‘20 grams’’; and 
(ii) by striking ‘‘100 grams’’ and in-
serting ‘‘5 grams’’; and 
(B) in subparagraph (B)(vi)— 
(i) by striking ‘‘40 grams’’ and insert-
ing ‘‘2 grams’’; and 
(ii) by striking ‘‘10 grams’’ and in-
serting ‘‘0.5 grams’’; and 
(2) by adding at the end of section 401(b) (21 
U.S.C. 841(b)) the following: 
VerDate Sep 11 2014 
01:15 Oct 06, 2016
Jkt 069200
PO 00000
Frm 00007
Fmt 6652
Sfmt 6201
E:\BILLS\H6243.IH
H6243
rfrederick on DSKBCBPHB2PROD with bills
‘‘(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 con-
currently with any term of imprisonment im-
posed 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 rep-
resented to be or sold as another controlled sub-
stance, then a court shall— 
‘‘(A) not impose a term of probation; 
VerDate Sep 11 2014 
01:15 Oct 06, 2016
Jkt 069200
PO 00000
Frm 00008
Fmt 6652
Sfmt 6201
E:\BILLS\H6243.IH
H6243
rfrederick on DSKBCBPHB2PROD with bills
‘‘(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 con-
currently with any term of imprisonment im-
posed 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 con-
tains a detectable amount of another controlled sub-
stance, 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 con-
VerDate Sep 11 2014 
01:15 Oct 06, 2016
Jkt 069200
PO 00000
Frm 00009
Fmt 6652
Sfmt 6201
E:\BILLS\H6243.IH
H6243
rfrederick on DSKBCBPHB2PROD with bills
currently with any term of imprisonment im-
posed 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 rep-
resented to be or sold as another controlled sub-
stance, 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 con-
currently with any term of imprisonment im-
posed on the person under any other provision 
of law.’’. 
SEC. 6. 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: 
VerDate Sep 11 2014 
01:15 Oct 06, 2016
Jkt 069200
PO 00000
Frm 00010
Fmt 6652
Sfmt 6201
E:\BILLS\H6243.IH
H6243
rfrederick on DSKBCBPHB2PROD with bills
‘‘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 ma-
terials, 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. 7. TEMPORARY SCHEDULING OF SYNTHETIC OPIOID 
ANALGESICS. 
Section 201 of the Controlled Substances Act (21 
U.S.C. 811) is amended by adding at the end the fol-
lowing: 
‘‘(k) TEMPORARY
SCHEDULING
OF
SYNTHETIC 
OPIOID ANALGESICS.— 
‘‘(1) ISSUANCE OF ORDER.—The Attorney Gen-
eral may, by order and without regard to the find-
VerDate Sep 11 2014 
04:14 Oct 06, 2016
Jkt 069200
PO 00000
Frm 00011
Fmt 6652
Sfmt 6201
E:\BILLS\H6243.IH
H6243
rfrederick on DSKBCBPHB2PROD with bills
ings required by subsection (a) of this section or sec-
tion 202(b) and without regard to the procedures 
prescribed by subsections (a) and (b) of this section, 
place a substance in schedule I if— 
‘‘(A) the substance is not listed in any 
other schedule in section 202; 
‘‘(B) no exemption, approval, or licensing 
is in effect for the substance under section 505 
of the Federal Food, Drug, and Cosmetic Act 
or section 351 of the Public Health Service Act; 
and 
‘‘(C) the Attorney General has reason to 
believe that such substance— 
‘‘(i) is a synthetic opioid analgesic; 
‘‘(ii) is the object or intended object of 
clandestine importation, manufacture, or 
distribution; and 
‘‘(iii) poses an imminent hazard to 
public health and safety. 
‘‘(2) EFFECTIVE DATE OF ORDER.—An order 
issued under paragraph (1) may not take effect until 
5 days after its publication in Federal Register. 
‘‘(3) EXPIRATION OF ORDER.—An order issued 
under paragraph (1) shall expire not later than 6 
months after the date on which it becomes effective, 
VerDate Sep 11 2014 
01:15 Oct 06, 2016
Jkt 069200
PO 00000
Frm 00012
Fmt 6652
Sfmt 6201
E:\BILLS\H6243.IH
H6243
rfrederick on DSKBCBPHB2PROD with bills
except that the Attorney General may extend the 
order for up to 6 months. 
‘‘(4) CONCLUSION OF RULEMAKING.—An order 
issued under paragraph (1) with respect to a sub-
stance shall be vacated upon the conclusion of a sub-
sequent rulemaking proceeding initiated under sub-
section (a) with respect to such substance. 
‘‘(5) ORDER NOT SUBJECT TO JUDICIAL RE-
VIEW.—An order issued under paragraph (1) is not 
subject to judicial review.’’. 
SEC. 
8. 
TABLETING 
MACHINES, 
ENCAPSULATING 
MA-
CHINES, 
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: 
‘‘§ 3002b. Nonmailability of tableting machines, en-
capsulating 
machines, 
and 
controlled 
substance counterfeiting materials 
‘‘(a) Any tableting machine, encapsulating machine, 
or controlled substance counterfeiting material is non-
mailable matter, shall not be carried or delivered by mail, 
and shall be disposed of as the Postal Service directs, un-
less such device or material is mailed— 
VerDate Sep 11 2014 
01:15 Oct 06, 2016
Jkt 069200
PO 00000
Frm 00013
Fmt 6652
Sfmt 6201
E:\BILLS\H6243.IH
H6243
rfrederick on DSKBCBPHB2PROD with bills
‘‘(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 pursu-
ant to section 302 of the Controlled Substances Act. 
‘‘(b) For the purpose of this section— 
‘‘(1) the ‘controlled substance counterfeiting 
material’ means any punch, die, plate, stone, or 
other thing described section 403(a)(5) of the Con-
trolled Substances Act; 
‘‘(2) the term ‘encapsulating machine’ means 
any manual, semiautomatic, or fully automatic 
equipment which may be used to fill shells or cap-
sules with any powdered, granular, semisolid, or liq-
uid material; and 
‘‘(3) the term ‘tableting machine’ means any 
manual, semiautomatic, or fully automatic equip-
ment 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 sec-
tions 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 con-
trolled substance counterfeiting materials.’’. 
VerDate Sep 11 2014 
01:15 Oct 06, 2016
Jkt 069200
PO 00000
Frm 00014
Fmt 6652
Sfmt 6211
E:\BILLS\H6243.IH
H6243
rfrederick on DSKBCBPHB2PROD with bills
(b) PENALTY.— 
(1) IN
GENERAL.—Chapter 83 of title 18, 
United States Code, is amended by inserting after 
section 1716E the following new section: 
‘‘§ 1716F. Nonmailability of tableting machines, en-
capsulating 
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 di-
rected to be delivered by the person to whom it is ad-
dressed, any matter declared to be nonmailable by section 
3002c of title 39, shall be fined under this title or impris-
oned not more than 1 year, or both.’’. 
(2) CLERICAL AMENDMENT.—The table of sec-
tions 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 con-
trolled substance counterfeiting materials.’’. 
Æ 
VerDate Sep 11 2014 
01:15 Oct 06, 2016
Jkt 069200
PO 00000
Frm 00015
Fmt 6652
Sfmt 6301
E:\BILLS\H6243.IH
H6243
rfrederick on DSKBCBPHB2PROD with bills