Modernizing Drug Enforcement Act of 2019

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- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Modernizing Drug En- 4 forcement Act of 2019’’. 5 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 2 •HR 2580 IH SEC. 2. DRUGS OR OTHER SUBSTANCES THAT ACT AS MU 1 OPIOID RECEPTOR AGONISTS. 2 (a) DEFINITIONS.—Paragraph (18) of section 102 of 3 the Controlled Substances Act (21 U.S.C. 802) is amend- 4 ed to read as follows: 5 ‘‘(18)(A) The term ‘opiate’or ‘opioid’— 6 ‘‘(i) means any drug or other substance having 7 an addiction-forming or addiction-sustaining liability 8 similar to morphine or being capable of conversion 9 into a drug having such addiction-forming or addic- 10 tion-sustaining liability; and 11 ‘‘(ii) includes any drug or other substance that 12 acts as a mu opioid receptor agonist. 13 ‘‘(B) The term ‘mu opioid receptor’ is a molecule that 14 when bound to, and activated by, a mu opioid receptor 15 agonist would result in analgesia, euphoria, addiction, or 16 respiratory depression in the central nervous system. 17 ‘‘(C) The term ‘mu opioid receptor agonist’ is a sub- 18 stance that when bound to, and interacting with, the mu 19 opioid receptor, activates the receptor to result in analge- 20 sia, euphoria, addiction, or respiratory depression.’’. 21 (b) SCHEDULING.—Section 201 of the Controlled 22 Substances Act (21 U.S.C. 811) is amended by adding at 23 the end the following: 24 ‘‘(k) MU OPIOID RECEPTOR AGONISTS.— 25 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 3 •HR 2580 IH ‘‘(1) IN GENERAL.—Effective as of the date of 1 enactment of the Modernizing Drug Enforcement 2 Act of 2019, schedule I under section 202 is deemed 3 to include, unless specifically exempted or unless 4 listed in another schedule, any chemical substances, 5 including their salts, isomers, and salts of isomers 6 whenever the existence of such salts, isomers, and 7 salts of isomers is possible, that act as mu opioid re- 8 ceptor agonists, and any material, compound, mix- 9 ture, or preparation that contains any quantity of 10 such substances. 11 ‘‘(2) EXCEPTIONS.—A chemical substance is ex- 12 empt from inclusion in schedule I by operation of 13 paragraph (1)— 14 ‘‘(A) if the substance is the subject of an 15 approved application submitted under sub- 16 section (b) or (j) of section 505 of the Federal 17 Food, Drug, and Cosmetic Act; 18 ‘‘(B) to the extent the substance is exempt 19 from the provisions of section 505 of such Act 20 relating to new drugs because— 21 ‘‘(i) the substance is intended solely 22 for investigational use as described in sec- 23 tion 505(i) of such Act; and 24 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 4 •HR 2580 IH ‘‘(ii) the substance is being used ex- 1 clusively for purposes of a clinical trial 2 that is the subject of an effective investiga- 3 tional new drug application; or 4 ‘‘(C) to the extent the substance is the 5 subject of a nonclinical study by researchers 6 qualified by scientific training to investigate the 7 safety and effectiveness of drugs. 8 ‘‘(3) LISTING.—Not later than 180 days after 9 the date of enactment of the Modernizing Drug En- 10 forcement Act of 2019, the Attorney General shall 11 update schedule I in accordance with paragraph (1). 12 The Attorney General may list substances in sched- 13 ule I pursuant to paragraph (1) without regard to 14 the process and considerations that are otherwise 15 applicable under this section for adding, removing, 16 or transferring controlled substances to, from, or 17 among the schedules under section 202.’’. 18 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