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

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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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