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

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.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,

SECTION 1. Short title.

This Act may be cited as the “Modernizing Drug Enforcement Act of 2018”.

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 amended 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 addiction-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 substance that when bound to, and interacting with, the opioid mu receptor, activates the receptor to result in analgesia, 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.—

“(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 receptor agonists, and any material, compound, mixture, or preparation that contains any quantity of such substances.

“(2) EXCEPTIONS.—A chemical substance is exempt from inclusion in schedule I by operation of paragraph (1) if the substance—

“(A) is the subject of an approved application submitted under subsection (b) or (j) of section 505 of the Federal Food, Drug, and Cosmetic Act;

“(B) 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 section 505(i) of such Act; and

“(ii) the substance is being used exclusively for purposes of a clinical trial that is the subject of an effective investigational new drug application; or

“(C) is the subject of a nonclinical drug investigation 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 Enforcement Act of 2018, the Attorney General shall update schedule I in accordance with paragraph (1). The Attorney General may list substances in schedule 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.”.