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 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 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. 

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 2018’’. 


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

2 OPIOID MU 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 an opioid mu receptor agonist. 

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

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

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

17 respiratory depression in the central nervous system. 

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

20 opioid mu receptor, activates the receptor to result in anal21 gesia, 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) OPIOID MU RECEPTOR AGONISTS.— 


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

2 enactment of the Modernizing Drug Enforcement 

3 Act of 2018, 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 opioid mu 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) if the substance— 

15 ‘‘(A) is the subject of an approved applica16 tion submitted under subsection (b) or (j) of 

17 section 505 of the Federal Food, Drug, and 

18 Cosmetic Act; 

19 ‘‘(B) is exempt from the provisions of sec20 tion 505 of such Act relating to new drugs be21 cause— 

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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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) is the subject of a nonclinical drug in6 vestigation by experts qualified by scientific 

7 training and experience to investigate the safety 

8 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 2018, 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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