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 Commerce, and in addition to the Committee on the Judiciary, 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 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. 

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. 

4 This Act may be cited as the ‘‘Modernizing Drug En5 forcement Act of 2019’’. 


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•HR 2580 IH

1 SEC. 2. DRUGS OR OTHER SUBSTANCES THAT ACT AS MU 

2 OPIOID RECEPTOR AGONISTS. 

3 (a) DEFINITIONS.—Paragraph (18) of section 102 of 

4 the Controlled Substances Act (21 U.S.C. 802) is amend5 ed to read as follows: 

6 ‘‘(18)(A) The term ‘opiate’or ‘opioid’— 

7 ‘‘(i) means any drug or other substance having 

8 an addiction-forming or addiction-sustaining liability 

9 similar to morphine or being capable of conversion 

10 into a drug having such addiction-forming or addic11 tion-sustaining liability; and 

12 ‘‘(ii) includes any drug or other substance that 

13 acts as a mu opioid receptor agonist. 

14 ‘‘(B) The term ‘mu opioid receptor’ is a molecule that 

15 when bound to, and activated by, a mu opioid receptor 

16 agonist would result in analgesia, euphoria, addiction, or 

17 respiratory depression in the central nervous system. 

18 ‘‘(C) The term ‘mu opioid receptor agonist’ is a sub19 stance that when bound to, and interacting with, the mu 

20 opioid receptor, activates the receptor to result in analge21 sia, euphoria, addiction, or respiratory depression.’’. 

22 (b) SCHEDULING.—Section 201 of the Controlled 

23 Substances Act (21 U.S.C. 811) is amended by adding at 

24 the end the following: 

25 ‘‘(k) MU OPIOID RECEPTOR AGONISTS.— 


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•HR 2580 IH

1 ‘‘(1) IN GENERAL.—Effective as of the date of 

2 enactment of the Modernizing Drug Enforcement 

3 Act of 2019, schedule I under section 202 is deemed 

4 to include, unless specifically exempted or unless 

5 listed in another schedule, any chemical substances, 

6 including their salts, isomers, and salts of isomers 

7 whenever the existence of such salts, isomers, and 

8 salts of isomers is possible, that act as mu opioid re9 ceptor agonists, and any material, compound, mix10 ture, or preparation that contains any quantity of 

11 such substances. 

12 ‘‘(2) EXCEPTIONS.—A chemical substance is ex13 empt from inclusion in schedule I by operation of 

14 paragraph (1)— 

15 ‘‘(A) if the substance is the subject of an 

16 approved application submitted under sub17 section (b) or (j) of section 505 of the Federal 

18 Food, Drug, and Cosmetic Act; 

19 ‘‘(B) to the extent the substance is exempt 

20 from the provisions of section 505 of such Act 

21 relating to new drugs because— 

22 ‘‘(i) the substance is intended solely 

23 for investigational use as described in sec24 tion 505(i) of such Act; and 


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•HR 2580 IH

1 ‘‘(ii) the substance is being used ex2 clusively for purposes of a clinical trial 

3 that is the subject of an effective investiga4 tional new drug application; or 

5 ‘‘(C) to the extent the substance is the 

6 subject of a nonclinical study by researchers 

7 qualified by scientific training to investigate the 

8 safety and effectiveness of drugs. 

9 ‘‘(3) LISTING.—Not later than 180 days after 

10 the date of enactment of the Modernizing Drug En11 forcement Act of 2019, the Attorney General shall 

12 update schedule I in accordance with paragraph (1). 

13 The Attorney General may list substances in sched14 ule I pursuant to paragraph (1) without regard to 

15 the process and considerations that are otherwise 

16 applicable under this section for adding, removing, 

17 or transferring controlled substances to, from, or 

18 among the schedules under section 202.’’. 

Æ 


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