Rule2025-14037
Schedules of Controlled Substances: Extension of Temporary Placement of Clonazolam, Diclazepam, Etizolam, Flualprazolam, and Flubromazolam in Schedule I of the Controlled Substances Act
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
July 25, 2025
Effective
July 26, 2025
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
The Acting Administrator of the Drug Enforcement Administration (DEA) is issuing this temporary scheduling order to extend the temporary schedule I status of five designer benzodiazepines--clonazolam, diclazepam, etizolam, flualprazolam, and flubromazolam. In an order dated July 26, 2023, DEA temporarily placed these five substances in schedule I of the Controlled Substances Act. This temporary order will extend the temporary scheduling of five designer benzodiazepines for one year, or until the permanent scheduling action for these substances is completed, whichever occurs first. As a result of this order, the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances will continue to be imposed on persons who handle (manufacture, distribute, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis with, or possess) or propose to handle these five specified controlled substances.
Full Text
<html>
<head>
<title>Federal Register, Volume 90 Issue 141 (Friday, July 25, 2025)</title>
</head>
<body><pre>
[Federal Register Volume 90, Number 141 (Friday, July 25, 2025)]
[Rules and Regulations]
[Pages 35236-35238]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-14037]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-989]
Schedules of Controlled Substances: Extension of Temporary
Placement of Clonazolam, Diclazepam, Etizolam, Flualprazolam, and
Flubromazolam in Schedule I of the Controlled Substances Act
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Temporary scheduling order; extension.
-----------------------------------------------------------------------
SUMMARY: The Acting Administrator of the Drug Enforcement
Administration (DEA) is issuing this temporary scheduling order to
extend the temporary schedule I status of five designer
benzodiazepines--clonazolam, diclazepam, etizolam, flualprazolam, and
flubromazolam. In an order dated July 26, 2023, DEA temporarily placed
these five substances in schedule I of the Controlled Substances Act.
This temporary order will extend the temporary scheduling of five
designer benzodiazepines for one year, or until the permanent
scheduling action for these substances is completed, whichever occurs
first. As a result of this order, the regulatory controls and
administrative, civil, and criminal sanctions applicable to schedule I
controlled substances will continue to be imposed on persons who handle
(manufacture, distribute, reverse distribute, import, export, engage in
research, conduct instructional activities or chemical analysis with,
or possess) or propose to handle these five specified controlled
substances.
DATES: This temporary scheduling order, which extends schedule I
control of five specific substances covered by an order (88 FR 48112,
July 26, 2023), is effective July 26, 2025, and expires on July 26,
2026. If DEA publishes a final rule making this scheduling action
permanent, this order will expire on the effective date of that rule,
if the effective date is earlier than July 26, 2026.
FOR FURTHER INFORMATION CONTACT: Terrence L. Boos, Drug and Chemical
Evaluation Section, Diversion Control Division, Drug Enforcement
Administration; Mailing Address: 8701 Morrissette Drive, Springfield,
Virginia 22152; Telephone: (571) 362-3249.
SUPPLEMENTARY INFORMATION: In this order, the Drug Enforcement
Administration (DEA) extends the temporary scheduling of the following
five controlled substances in schedule I of the Controlled Substances
Act (CSA), including their salts, isomers, and salts of isomers,
whenever the existence of such salts, isomers, and salts of isomers is
possible within the specific chemical designation:
<bullet> clonazolam (6-(2-chlorophenyl)-1-methyl-8-nitro-4H-
benzo[f][1,2,4]triazolo[4,3-a][1,4]diazepine),
<bullet> diclazepam (7-chloro-5-(2-chlorophenyl)-1-methyl-1,3-
dihydro-2H-benzo[e][1,4]diazepin-2-one),
<bullet> etizolam (4-(2-chlorophenyl)-2-ethyl-9-methyl-6H-
thieno[3,2-f][1,2,4]triazolo[4,3-a][1,4]diazepine),
<bullet> flualprazolam (8-chloro-6-(2-fluorophenyl)-1-methyl-4H-
benzo[f][1,2,4]triazolo[4,3-a][1,4]diazepine), and
<bullet> flubromazolam (8-bromo-6-(2-fluorophenyl)-1-methyl-4H-
benzo[f][1,2,4]triazolo[4,3-a][1,4]diazepine).
Background and Legal Authority
On July 26, 2023, pursuant to 21 U.S.C. 811(h)(1), DEA published an
order in the Federal Register temporarily placing the five designer
benzodiazepines referenced above in schedule I of the CSA based upon a
finding that these substances pose an imminent hazard to the public
safety.\1\ That temporary order was effective upon the date of
publication. Pursuant to 21 U.S.C. 811(h)(2), the temporary scheduling
of a substance expires at the end of two years from the date of
issuance of the scheduling order, except that DEA may extend temporary
scheduling of that substance for up to one year during the pendency of
proceedings under 21 U.S.C. 811(a)(1) with the respect to the
temporarily controlled substance. In this instance, the temporary
scheduling of these five designer benzodiazepines expires on July 26,
2025, unless extended.
---------------------------------------------------------------------------
\1\ Schedules of Controlled Substances: Temporary Placement of
Etizolam, Flualprazolam, Clonazolam, Flubromazolam, and Diclazepam
in Schedule I, 88 FR 48112 (July 26, 2023).
---------------------------------------------------------------------------
Proceedings for the issuance, amendment, or repeal of the
scheduling of any drug or other substance under 21 U.S.C. 811(a) may be
initiated by the Attorney General (delegated to the Administrator of
DEA pursuant to 28 CFR 0.100) on her own motion, at the request of the
Secretary of the Department of Health and Human Services (HHS), or on
the petition of any interested party.\2\ The Acting
[[Page 35237]]
Administrator of DEA, on his own motion pursuant to 21 U.S.C. 811(a),
has initiated proceedings under 21 U.S.C. 811(a)(1) to permanently
schedule the following designer benzodiazepines: clonazolam,
diclazepam, etizolam, flualprazolam, and flubromazolam. DEA is
publishing a notice of proposed rulemaking elsewhere in this issue of
the Federal Register for the permanent placement of these five
benzodiazepines in schedule I. If that proposed rule is finalized, DEA
will publish a final rule in the Federal Register to make permanent the
schedule I status of these substances.
---------------------------------------------------------------------------
\2\ 21 U.S.C. 811(a). As discussed in a memorandum of
understanding entered into by the Food and Drug Administration (FDA)
and the National Institute on Drug Abuse (NIDA), FDA acts as the
lead agency within HHS in carrying out the Secretary's scheduling
responsibilities under the CSA, with the concurrence of NIDA.
Memorandum of Understanding with the National Institute on Drug
Abuse, 50 FR 9518 (Mar. 8, 1985). Because the Secretary has
delegated to the Assistant Secretary for Health of HHS the authority
to make domestic drug scheduling recommendations, see Comprehensive
Drug Abuse Prevention and Control Act of 1970, Public Law 91-513, As
Amended; Delegation of Authority, 58 FR 35460 (July 1, 1993), for
purposes of this temporary order, all subsequent references to
``Secretary'' have been replaced with ``Assistant Secretary.''
---------------------------------------------------------------------------
Pursuant to 21 U.S.C. 811(h)(2), the Acting Administrator orders
that the temporary scheduling of these five benzodiazepines--
clonazolam, diclazepam, etizolam, flualprazolam, and flubromazolam--and
their salts, isomers, and salts of isomers whenever the existence of
such salts, isomers, and salts of isomers is possible, be extended for
one year, or until the permanent scheduling proceeding is completed,
whichever occurs first.
Regulatory Matters
The CSA provides for an expedited temporary scheduling action where
such action is necessary to avoid an imminent hazard to the public
safety.\3\ This provision of the CSA allows the Attorney General, by
order, to temporarily place substances in schedule I.\4\ The same
subsection also provides that the temporary scheduling of a substance
shall expire at the end of two years from the date of the issuance of
the order scheduling such substance, except that the Attorney General
may, during the pendency of proceedings to permanently schedule the
substance under 21 U.S.C. 811(a)(1), extend the temporary scheduling
for up to one year.
---------------------------------------------------------------------------
\3\ 21 U.S.C. 811(h).
\4\ Id.
---------------------------------------------------------------------------
To the extent that 21 U.S.C. 811(h) directs that temporary
scheduling actions be issued by order and sets forth the procedures by
which such orders are to be issued and extended, the notice and comment
requirements of section 553 of the Administrative Procedure Act
(APA),\5\ do not apply to this extension of the temporary scheduling
action. The APA expressly differentiates between orders and rules, as
it defines an ``order'' to mean a ``final disposition, whether
affirmative, negative, injunctive, or declaratory in form, of an agency
in a matter other than rule making.'' \6\ This contrasts with permanent
scheduling actions, which are subject to formal rulemaking procedures
done ``on the record after opportunity for a hearing,'' and final
decisions that conclude the scheduling process and are subject to
judicial review.\7\ The specific language chosen by Congress indicates
an intention for DEA to proceed through the issuance of an order
instead of proceeding by rulemaking. Given that Congress specifically
requires the Attorney General to follow rulemaking procedures for other
kinds of scheduling actions,\8\ it is noteworthy that, in subsection
811(h), Congress authorized the issuance of temporary scheduling
actions by order rather than by rule.
---------------------------------------------------------------------------
\5\ 5 U.S.C. 553.
\6\ 5 U.S.C. 551(6) (emphasis added).
\7\ 21 U.S.C. 811(a) and 877.
\8\ See 21 U.S.C. 811(a).
---------------------------------------------------------------------------
In the alternative, even if this action were subject to 5 U.S.C.
553, the Acting Administrator finds that there is good cause under 5
U.S.C. 553(b)(B) and (d)(3) to forgo the notice-and-comment
requirements and the delayed effective date requirements of such
section, as any further delays in the process for extending the
temporary scheduling order would be impracticable and contrary to the
public interest in view of the manifest urgency to avoid an imminent
hazard to the public safety that these substances would present if
scheduling expired, for the reasons expressed in the temporary
scheduling order.\9\
---------------------------------------------------------------------------
\9\ See Schedules of Controlled Substances: Temporary Placement
of Etizolam, Flualprazolam, Clonazolam, Flubromazolam, and
Diclazepam in Schedule I, 88 FR 48112 (July 26, 2023).
---------------------------------------------------------------------------
Further, DEA believes that this order extending the temporary
scheduling action is not a ``rule'' as defined by 5 U.S.C. 601(2) and,
accordingly, is not subject to the requirements of the Regulatory
Flexibility Act (RFA). The requirements for the preparation of an
initial regulatory flexibility analysis in 5 U.S.C. 603(a) are not
applicable where, as here, DEA is not required by section 553 of the
APA or any other law to publish a general notice of proposed
rulemaking. Therefore, in this instance, since DEA believes this
temporary scheduling action is not a ``rule,'' it is not subject to the
requirements of the RFA when issuing this temporary action.
In addition, in accordance with the principles of Executive Orders
(E.O.) 12866 and 13563, this action is not a significant regulatory
action. E.O. 12866 directs agencies to assess all costs and benefits of
available regulatory alternatives and, if regulation is necessary, to
select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health, and safety effects;
distributive impacts; and equity). E.O. 13563 is supplemental to and
reaffirms the principles, structures, and definitions governing
regulatory review as established in E.O. 12866. E.O. 12866, sec. 3(f),
provides the definition of a ``significant regulatory action,''
requiring review by the Office of Management and Budget. Because this
is not a rulemaking action, this is not a significant regulatory action
as defined in section 3(f) of E.O. 12866. DEA scheduling actions are
not subject to either E.O. 14192, Unleashing Prosperity Through
Deregulation, or E.O. 14294, Fighting Overcriminalization in Federal
Regulations.
This action will not have substantial direct effects on the States,
on the relationship between the National Government and the States, or
on the distribution of power and responsibilities among the various
levels of government. Therefore, in accordance with E.O. 13132
(Federalism), it is determined that this action does not have
sufficient federalism implications to warrant the preparation of a
Federalism Assessment.
As noted above, this action is an order, not a rule. Accordingly,
the Congressional Review Act (CRA) is inapplicable, as it applies only
to rules. However, if this were a rule, pursuant to the CRA, ``any rule
for which an agency for good cause finds that notice and public
procedure thereon are impracticable, unnecessary, or contrary to the
public interest, shall take effect at such time as the federal agency
promulgating the rule determines.'' \10\
---------------------------------------------------------------------------
\10\ 5 U.S.C. 808(2).
---------------------------------------------------------------------------
It is in the public interest to maintain the temporary placement of
these five substances in schedule I because they pose a public health
risk. These substances are clonazolam, diclazepam, etizolam,
flualprazolam, and flubromazolam, including their salts, isomers, and
salts of isomers. The temporary scheduling action was taken pursuant to
21 U.S.C. 811(h), which is specifically designed to enable DEA to act
in an expeditious manner to avoid
[[Page 35238]]
an imminent hazard to the public safety. Under 21 U.S.C. 811(h),
temporary scheduling orders are not subject to notice and comment
rulemaking procedures. For the same reasons that underlie 21 U.S.C.
811(h), that is, the need to keep these five substances in schedule I
because they pose an imminent hazard to public safety, it would be
contrary to the public interest to delay implementation of this
extension of the temporary scheduling order. Further, public notice and
comment is impracticable in the amount of time remaining before
expiration of the temporary scheduling order and considering the
manifest urgency to avoid an imminent hazard to the public safety that
these substances would present if scheduling expired, for the reasons
expressed in the temporary scheduling order. Therefore, in accordance
with section 808(2) of the CRA, this order extending the temporary
scheduling order for five designer benzodiazepines, currently covered
under the temporary order, shall take effect immediately upon its
publication.
Nonetheless, DEA has submitted a copy of this temporary order to
both Houses of Congress and to the Comptroller General, although such
filing is not required under the Small Business Regulatory Enforcement
Fairness Act of 1996 (Congressional Review Act), 5 U.S.C. 801-808
because, as noted above, this action is an order, not a rule.
Signing Authority
This document of the Drug Enforcement Administration was signed on
July 22, 2025, by Acting Administrator Robert J. Murphy. That document
with the original signature and date is maintained by DEA. For
administrative purposes only, and in compliance with requirements of
the Office of the Federal Register, the undersigned DEA Federal
Register Liaison Officer has been authorized to sign and submit the
document in electronic format for publication, as an official document
of DEA. This administrative process in no way alters the legal effect
of this document upon publication in the Federal Register.
Heather Achbach,
Federal Register Liaison Officer, Drug Enforcement Administration.
[FR Doc. 2025-14037 Filed 7-24-25; 8:45 am]
BILLING CODE 4410-09-P
</pre></body>
</html>Indexed from Federal Register on July 25, 2025.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.