119-hr5032

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5032 Introduced in House

    (IH) ]

<DOC>

119th CONGRESS
 1st Session
 H. R. 5032

 To amend the Controlled Substances Act to permanently schedule the 
 class of benzimidazole-opioids known as nitazenes, and for other 
 purposes.

_______________________________________________________________________

 IN THE HOUSE OF REPRESENTATIVES

 August 22, 2025

Mr. Vindman (for himself and Mr. Baumgartner) 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 permanently schedule the 
 class of benzimidazole-opioids known as nitazenes, 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 ``Nitazene Control Act''.

SEC. 2. FINDINGS.

 Congress finds the following:

    (1) Nitazenes are a class of synthetic opioids first 
 synthesized in the 1950s that exhibit extreme potency at the 
 mu-opioid receptor, with some analogs exceeding the potency of 
 fentanyl.

    (2) The Drug Enforcement Administration

    (DEA) has 
 temporarily or permanently scheduled multiple nitazene 
 compounds under Schedule I of the Controlled Substances Act due 
 to their high abuse potential and lack of accepted medical use.

    (3) Nitazenes and nitazene analogues have emerged in the 
 illicit drug supply as designer drugs and contribute to 
 overdose and fatal poisonings in the United States.

    (4) A class-wide permanent scheduling of nitazenes is 
 necessary to preemptively address the proliferation of new 
 analogs, streamline enforcement, and protect public health.

SEC. 3. SCHEDULE I CLASSIFICATION OF NITAZENES.

    (a) Amendment.--

Section 202
            (c) of the Controlled Substances Act (21 
U.S.C. 812
            (c) ) is amended by adding at the end of Schedule I the 
following:
 ``

    (f) Benzimidazole-opioids, commonly referred to as nitazenes, 
including any substance (including its salts, isomers, and salts of 
isomers) that has a chemical structure that is substantially similar to 
that of etonitazene or isotonitazene, including:
 ``

    (1) A benzimidazole core substituted at the 2-position 
 with a benzyl or substituted benzyl group; and
 ``

    (2) A basic nitrogen-containing side chain at the 1-
 position; and
 ``

    (3) Exhibits agonist activity at the mu-opioid receptor.
Such substances include, but are not limited to: etonitazene, 
clonitazene, metonitazene, isotonitazene, protonitazene, butonitazene, 
etodesnitazene, flunitazene, N-pyrrolidino etonitazene, N-desethyl 
isotonitazene, and N-piperidinyl etonitazene.''.

    (b) Removal of Temporary Status.--Any substance included in the 
amendment to 

section 202
            (c) of the Controlled Substances Act made by 
this section that was temporarily scheduled under 

section 201

    (h) of the 
Controlled Substances Act shall be deemed permanently scheduled and 
subject to the requirements of Schedule I as of the date of enactment 
of this Act.
            (c) Rulemaking Authority.--The Attorney General, in consultation 
with the Secretary of Health and Human Services, may issue rules to 
clarify the scope of the nitazene class as necessary to enforce this 
section, provided such rules are consistent with the chemical 
definition in subsection

    (a)

    (1) .
            (d) Research Exemption.--

    (1) Notwithstanding the amendments made by subsection

    (a) , 
 a researcher who, as of the date of enactment of this Act, is 
 conducting research involving a substance described in 
 subsection

    (a) that was not previously listed in Schedule I of 
 

section 202
            (c) of the Controlled Substances Act (21 U.S.C. 
 812
            (c) ), shall not be required to obtain a registration under 
 

section 303

    (f) of such Act (21 U.S.C. 823

    (f) ) solely due to the 
 inclusion of that substance in Schedule I, provided that:
        (A) the research is being conducted pursuant to an 
 active investigational new drug

    (IND) application or 
 other applicable regulatory exemption recognized by the 
 Food and Drug Administration or Drug Enforcement 
 Administration;
        (B) the research was approved by an institutional 
 review board

    (IRB) prior to the enactment of this Act; 
 and
            (C) the researcher notifies the Attorney General, 
 in a manner determined by the Attorney General, within 
 90 days of enactment of this Act.

    (2) The exemption under paragraph

    (1) shall remain in 
 effect for a period not to exceed 18 months from the date of 
 enactment, during which time the researcher may apply for a 
 registration under 

section 303

    (f) , and the Attorney General 
 shall expedite such applications to ensure continuity of 
 research.

    (3) Nothing in this subsection shall be construed to 
 authorize the initiation of new research using substances 
 described in subsection

    (a) without proper registration and 
 scheduling compliance.
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