‘‘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 imme-
diate 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 fol-
lowing: 
‘‘(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 sub-
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stance 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 reg-
ulation of the Attorney General as being a syn-
thetic 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 Gen-
eral 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 
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Human Services. In issuing an order under para-
graph (1), the Attorney General shall take into con-
sideration 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 perma-
nent 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 add-
ing 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 simulta-
neously with the issuance of the temporary order 
issued under paragraph (1).’’. 
SEC. 
6. 
TABLETING 
MACHINES, 
ENCAPSULATING 
MA-
CHINES, 
AND 
CONTROLLED 
SUBSTANCE 
COUNTERFEITING MATERIALS. 
(a) MAILABILITY.— 
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(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— 
‘‘(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 term ‘controlled substance counter-
feiting 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 cap-
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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.’’. 
(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 
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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.’’. 
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 syn-
thetic opioid or product containing a synthetic 
opioid, unless the opioid or product bears a label 
clearly identifying a synthetic opioid or product con-
taining 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 man-
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ner required under the Federal Food, Drug, and 
Cosmetic Act. 
‘‘(B) A product is described in this subpara-
graph if the product— 
‘‘(i) is the subject of an approved applica-
tion as described in section 505(b) or (j) of the 
Federal Food, Drug, and Cosmetic Act; or 
‘‘(ii) is exempt from the provisions of sec-
tion 505 of such Act relating to new drugs be-
cause— 
‘‘(I) it is intended solely for investiga-
tional use as described in section 505(i) of 
such Act; and 
‘‘(II) such product is being used ex-
clusively for purposes of a clinical trial 
that is the subject of an effective investiga-
tional new drug application.’’. 
(b) CLARIFICATION TO IMPORT AND EXPORT STAT-
UTE.—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)— 
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(A) in paragraph (15), by striking ‘‘or’’ at 
the end; 
(B) in paragraph (16), by striking the pe-
riod 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 pur-
poses of this subparagraph, a violation is defined as each 
instance of importation, exportation, manufacturing, dis-
tribution, or possession with intent to manufacture or dis-
tribute, in violation of paragraph (17) of subsection (a). 
‘‘(F) In the case of a distribution, dispensing, or pos-
session with intent to distribute or dispense in violation 
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of paragraph (17) of subsection (a) of this section at the 
retail level, up to $1,000 per violation. Each package, con-
tainer 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 sep-
arate violation.’’. 
Æ 
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