Rule2025-22496
Schedules of Controlled Substances: Extension of Temporary Placement of CUMYL-PEGACLONE 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
December 11, 2025
Effective
December 12, 2025
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
The Administrator of the Drug Enforcement Administration (DEA) is issuing this temporary scheduling order to extend the temporary schedule I status of CUMYL-PEGACLONE. In an order dated December 12, 2023, DEA temporarily placed CUMYL-PEGACLONE in schedule I of the Controlled Substances Act. This temporary order will extend the temporary scheduling of CUMYL-PEGACLONE for one year, or until the permanent scheduling action for this substance 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 CUMYL-PEGACLONE.
Full Text
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<title>Federal Register, Volume 90 Issue 236 (Thursday, December 11, 2025)</title>
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[Federal Register Volume 90, Number 236 (Thursday, December 11, 2025)]
[Rules and Regulations]
[Pages 57542-57543]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-22496]
Federal Register / Vol. 90, No. 236 / Thursday, December 11, 2025 /
Rules and Regulations
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-1511]
Schedules of Controlled Substances: Extension of Temporary
Placement of CUMYL-PEGACLONE in Schedule I of the Controlled Substances
Act
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Temporary scheduling order; extension.
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SUMMARY: The Administrator of the Drug Enforcement Administration (DEA)
is issuing this temporary scheduling order to extend the temporary
schedule I status of CUMYL-PEGACLONE. In an order dated December 12,
2023, DEA temporarily placed CUMYL-PEGACLONE in schedule I of the
Controlled Substances Act. This temporary order will extend the
temporary scheduling of CUMYL-PEGACLONE for one year, or until the
permanent scheduling action for this substance 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 CUMYL-PEGACLONE.
DATES: This temporary scheduling order, which extends schedule I
control of CUMYL-PEGACLONE covered by an order (88 FR 86040, December
12, 2023), is effective December 12, 2025, and expires on December 12,
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 December 12, 2026.
FOR FURTHER INFORMATION CONTACT: Dr. 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 CUMYL-
PEGACLONE in schedule I of the Controlled Substances Act (CSA),
including its 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> CUMYL-PEGACLONE (SGT-151; 5-pentyl-2-(2-phenylpropan-2-
yl)pyrido[4,3-b]indol-1-one).
Background and Legal Authority
On December 12, 2023, pursuant to 21 U.S.C. 811(h)(1), DEA
published an order in the Federal Register temporarily placing CUMYL-
PEGACLONE in schedule I of the CSA based upon a finding that this
substance poses 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 CUMYL-PEGACLONE expires on
December 12, 2025, unless extended.
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\1\ Schedules of Controlled Substances: Temporary Placement of
MDMB-4en-PINACA, 4F-MDMB-BUTICA, ADB-4en-PINACA, CUMYL-PEGACLONE,
5F-EDMB-PICA, and MMB-FUBICA into Schedule I, 88 FR 86040 (December
12, 2023).
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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 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 CUMYL-PEGACLONE. DEA
is publishing a notice of proposed rulemaking elsewhere in this issue
of the Federal Register for the permanent placement of CUMYL-PEGACLONE
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 this substance.
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\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.''
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Pursuant to 21 U.S.C. 811(h)(2), the Administrator orders that the
temporary scheduling of CUMYL-PEGACLONE and its 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.
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\3\ 21 U.S.C. 811(h).
\4\ Id.
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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 the Administrative Procedure Act (APA) at 5 U.S.C. 553,
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.'' \5\ 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.\6\ 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
[[Page 57543]]
procedures for other kinds of scheduling actions,\7\ it is noteworthy
that, in subsection 811(h), Congress authorized the issuance of
temporary scheduling actions by order rather than by rule.
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\5\ 5 U.S.C. 551(6) (emphasis added).
\6\ 21 U.S.C. 811(a) and 877.
\7\ See 21 U.S.C. 811(a).
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In the alternative, even if this action were subject to 5 U.S.C.
553, the 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 this substance would present if scheduling expired, for the
reasons expressed in the temporary scheduling order.\8\
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\8\ See Schedules of Controlled Substances: Temporary Placement
of MDMB-4en-PINACA, 4F-MDMB-BUTICA, ADB-4en-PINACA, CUMYL-PEGACLONE,
5F-EDMB-PICA, and MMB-FUBICA into Schedule I, 88 FR 86040 (December
12, 2023).
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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 the APA at 5 U.S.C.
553 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 subsection 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.'' \9\
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\9\ 5 U.S.C. 808(2).
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It is in the public interest to maintain the temporary placement of
CUMYL-PEGACLONE, including its salts, isomers, and salts of isomers, in
schedule I because it poses a public health risk. 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 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 this substance in schedule I because
it poses 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 this substance would
present if scheduling expired, for the reasons expressed in the
temporary scheduling order. Therefore, in accordance with subsection
808(2) of the CRA, this order extending the temporary scheduling order,
for CUMYL-PEGACLONE 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
December 8, 2025, by Administrator Terrance C. Cole. 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. 2025-22496 Filed 12-10-25; 8:45 am]
BILLING CODE 4410-09-P
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</html>Indexed from Federal Register on December 11, 2025.
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