I 
115TH CONGRESS 
2D SESSION 
H. R. 5298 
To amend the Controlled Substances Act to deem drugs or other substances 
that act as opioid mu receptor agonists to be in schedule I, subject 
to exceptions for substances intended for legitimate medical or research 
use, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
MARCH 15, 2018 
Mr. ROE of Tennessee (for himself and Mr. SUOZZI) introduced the following 
bill; which was referred to the Committee on Energy and Commerce, and 
in addition to the Committee on the Judiciary, for a period to be subse-
quently determined by the Speaker, in each case for consideration of such 
provisions as fall within the jurisdiction of the committee concerned 
A BILL 
To amend the Controlled Substances Act to deem drugs 
or other substances that act as opioid mu receptor 
agonists to be in schedule I, subject to exceptions for 
substances intended for legitimate medical or research 
use, and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Modernizing Drug En-
forcement Act of 2018’’. 
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SEC. 2. DRUGS OR OTHER SUBSTANCES THAT ACT AS 
OPIOID MU RECEPTOR AGONISTS. 
(a) DEFINITIONS.—Paragraph (18) of section 102 of 
the Controlled Substances Act (21 U.S.C. 802) is amend-
ed to read as follows: 
‘‘(18)(A) The term ‘opiate’or ‘opioid’— 
‘‘(i) 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 addic-
tion-sustaining liability; and 
‘‘(ii) includes any drug or other substance that 
acts as an opioid mu receptor agonist. 
‘‘(B) The term ‘opioid mu receptor’ is a molecule that 
when bound to, and activated by, an opioid mu receptor 
agonist would result in analgesia, euphoria, addiction, or 
respiratory depression in the central nervous system. 
‘‘(C) The term ‘opioid mu receptor agonist’ is a sub-
stance that when bound to, and interacting with, the 
opioid mu receptor, activates the receptor to result in anal-
gesia, euphoria, addiction, or respiratory depression.’’. 
(b) SCHEDULING.—Section 201 of the Controlled 
Substances Act (21 U.S.C. 811) is amended by adding at 
the end the following: 
‘‘(k) OPIOID MU RECEPTOR AGONISTS.— 
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‘‘(1) IN GENERAL.—Effective as of the date of 
enactment of the Modernizing Drug Enforcement 
Act of 2018, schedule I under section 202 is deemed 
to include, unless specifically exempted or unless 
listed in another schedule, any chemical substances, 
including their salts, isomers, and salts of isomers 
whenever the existence of such salts, isomers, and 
salts of isomers is possible, that act as opioid mu re-
ceptor agonists, and any material, compound, mix-
ture, or preparation that contains any quantity of 
such substances. 
‘‘(2) EXCEPTIONS.—A chemical substance is ex-
empt from inclusion in schedule I by operation of 
paragraph (1) if the substance— 
‘‘(A) is the subject of an approved applica-
tion submitted under subsection (b) or (j) of 
section 505 of the Federal Food, Drug, and 
Cosmetic Act; 
‘‘(B) is exempt from the provisions of sec-
tion 505 of such Act relating to new drugs be-
cause— 
‘‘(i) the substance is intended solely 
for investigational use as described in sec-
tion 505(i) of such Act; and 
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‘‘(ii) the substance is being used ex-
clusively for purposes of a clinical trial 
that is the subject of an effective investiga-
tional new drug application; or 
‘‘(C) is the subject of a nonclinical drug in-
vestigation by experts qualified by scientific 
training and experience to investigate the safety 
and effectiveness of drugs. 
‘‘(3) LISTING.—Not later than 180 days after 
the date of enactment of the Modernizing Drug En-
forcement Act of 2018, the Attorney General shall 
update schedule I in accordance with paragraph (1). 
The Attorney General may list substances in sched-
ule I pursuant to paragraph (1) without regard to 
the process and considerations that are otherwise 
applicable under this section for adding, removing, 
or transferring controlled substances to, from, or 
among the schedules under section 202.’’. 
Æ 
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