I 
116TH CONGRESS 
1ST SESSION H. R. 2580 
To amend the Controlled Substances Act to deem drugs or other substances 
that act as mu opioid 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 
MAY 8, 2019 
Mr. DAVID P. ROE of Tennessee (for himself and Mr. SUOZZI) introduced the 
following bill; which was referred to the Committee on Energy and Com-
merce, and in addition to the Committee on the Judiciary, for a period 
to be subsequently determined by the Speaker, in each case for consider-
ation 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 mu opioid 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 2019’’. 
VerDate Sep 11 2014 
05:26 May 14, 2019
Jkt 089200
PO 00000
Frm 00001
Fmt 6652
Sfmt 6201
\\ALPHA3\E\BILLS\H2580.IH
H2580
kjohnson on DSK79L0C42 with BILLS
SEC. 2. DRUGS OR OTHER SUBSTANCES THAT ACT AS MU 
OPIOID 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 a mu opioid receptor agonist. 
‘‘(B) The term ‘mu opioid receptor’ is a molecule that 
when bound to, and activated by, a mu opioid receptor 
agonist would result in analgesia, euphoria, addiction, or 
respiratory depression in the central nervous system. 
‘‘(C) The term ‘mu opioid receptor agonist’ is a sub-
stance that when bound to, and interacting with, the mu 
opioid receptor, activates the receptor to result in analge-
sia, 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) MU OPIOID RECEPTOR AGONISTS.— 
VerDate Sep 11 2014 
05:26 May 14, 2019
Jkt 089200
PO 00000
Frm 00002
Fmt 6652
Sfmt 6201
\\ALPHA3\E\BILLS\H2580.IH
H2580
kjohnson on DSK79L0C42 with BILLS
‘‘(1) IN GENERAL.—Effective as of the date of 
enactment of the Modernizing Drug Enforcement 
Act of 2019, 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 mu opioid 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)— 
‘‘(A) if the substance is the subject of an 
approved application submitted under sub-
section (b) or (j) of section 505 of the Federal 
Food, Drug, and Cosmetic Act; 
‘‘(B) to the extent the substance is exempt 
from the provisions of section 505 of such Act 
relating to new drugs because— 
‘‘(i) the substance is intended solely 
for investigational use as described in sec-
tion 505(i) of such Act; and 
VerDate Sep 11 2014 
05:26 May 14, 2019
Jkt 089200
PO 00000
Frm 00003
Fmt 6652
Sfmt 6201
\\ALPHA3\E\BILLS\H2580.IH
H2580
kjohnson on DSK79L0C42 with BILLS
‘‘(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) to the extent the substance is the 
subject of a nonclinical study by researchers 
qualified by scientific training 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 2019, 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 
VerDate Sep 11 2014 
05:26 May 14, 2019
Jkt 089200
PO 00000
Frm 00004
Fmt 6652
Sfmt 6301
\\ALPHA3\E\BILLS\H2580.IH
H2580
kjohnson on DSK79L0C42 with BILLS