Proposed Rule2025-22495
Schedules of Controlled Substances: Placement of CUMYL-PEGACLONE in Schedule I
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
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
The Drug Enforcement Administration proposes placing the substance CUMYL-PEGACLONE (SGT-151; 5-pentyl-2-(2-phenylpropan-2- yl)pyrido[4,3-b]indol-1-one), including its salts, isomers (including optical, positional, and geometric isomers), and salts of isomers, in schedule I of the Controlled Substances Act. CUMYL-PEGACLONE was temporarily scheduled in an order dated December 12, 2023. This action is being taken, in part, to enable the United States to meet its obligations under the 1971 Convention on Psychotropic Substances. If finalized, this action would make permanent the existing regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances 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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[Federal Register Volume 90, Number 236 (Thursday, December 11, 2025)]
[Proposed Rules]
[Pages 57534-57541]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-22495]
[[Page 57533]]
Vol. 90
Thursday,
No. 236
December 11, 2025
Part II
Department of Justice
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Drug Enforcement Administration
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21 CFR Part 1308
Schedules of Controlled Substances: Placement of CUMYL-PEGACLONE in
Schedule I; Proposed Rule; Schedules of Controlled Substances:
Extension of Temporary Placement of CUMYL-PEGACLONE in Schedule I of
the Controlled Substances Act; Rule
Federal Register / Vol. 90, No. 236 / Thursday, December 11, 2025 /
Proposed Rules
[[Page 57534]]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-1511]
Schedules of Controlled Substances: Placement of CUMYL-PEGACLONE
in Schedule I
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Notice of proposed rulemaking.
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SUMMARY: The Drug Enforcement Administration proposes placing the
substance CUMYL-PEGACLONE (SGT-151; 5-pentyl-2-(2-phenylpropan-2-
yl)pyrido[4,3-b]indol-1-one), including its salts, isomers (including
optical, positional, and geometric isomers), and salts of isomers, in
schedule I of the Controlled Substances Act. CUMYL-PEGACLONE was
temporarily scheduled in an order dated December 12, 2023. This action
is being taken, in part, to enable the United States to meet its
obligations under the 1971 Convention on Psychotropic Substances. If
finalized, this action would make permanent the existing regulatory
controls and administrative, civil, and criminal sanctions applicable
to schedule I controlled substances 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: Comments must be submitted electronically or postmarked on or
before January 12, 2026. The electronic Federal Docket Management
System will not accept comments after 11:59 p.m. Eastern Time on the
last day of the comment period.
Interested persons may file a request for a hearing or waiver of
hearing pursuant to 21 CFR 1308.44 and in accordance with 21 CFR
1316.47 and/or 1316.49, as applicable. Requests for a hearing and
waivers of an opportunity for a hearing or to participate in a hearing,
together with a written statement of position on the matters of fact
and law asserted in the hearing, must be received or postmarked on or
before January 12, 2026.
ADDRESSES: Interested persons may file written comments on this
proposal in accordance with 21 CFR 1308.43(g). To ensure proper
handling of comments, please reference ``Docket No. DEA1356'' on all
electronic and written correspondence, including any attachments.
<bullet> Electronic comments: The Drug Enforcement Administration
(DEA) encourages commenters to submit comments electronically through
the Federal eRulemaking Portal, which provides the ability to type
short comments directly into the comment field on the web page or
attach a file for lengthier comments. Please go to <a href="http://www.regulations.gov">www.regulations.gov</a>
and follow the online instructions at that site for submitting
comments. Upon completion of your submission, you will receive a
Comment Tracking Number. If you have received a Comment Tracking
Number, your comment has been successfully submitted and there is no
need to resubmit the same comment. Commenters should be aware that the
electronic Federal Docket Management System will not accept comments
after 11:59 p.m. Eastern Time on the last day of the comment period.
<bullet> Paper comments: Paper comments that duplicate the
electronic submissions are not necessary and are discouraged. Should
you wish to mail a paper comment in lieu of an electronic comment, it
should be sent via regular or express mail to: Drug Enforcement
Administration, Attn: DEA Federal Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia 22152.
<bullet> Hearing requests: All requests for a hearing and waivers
of participation, together with a written statement of position on the
matters of fact and law asserted in the hearing, must be filed with the
DEA Administrator, who will make the determination of whether a hearing
will be needed to address such matters of fact and law in the
rulemaking. Such requests must be sent to: Drug Enforcement
Administration, Attn: Administrator, 8701 Morrissette Drive,
Springfield, Virginia 22152. For informational purposes, a courtesy
copy of requests for hearing and waivers of participation should also
be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/
OALJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug
Enforcement Administration, Attn: DEA Federal Register Representative/
DPW, 8701 Morrissette Drive, Springfield, Virginia 22152.
FOR FURTHER INFORMATION CONTACT: Dr. Terrence L. Boos, Drug and
Chemical Evaluation Section, Diversion Control Division, Drug
Enforcement Administration; Telephone: (571) 362-3249.
As required by 5 U.S.C. 553(b)(4), a summary of this proposed rule
may be found in the docket for this rulemaking at <a href="http://www.regulations.gov">www.regulations.gov</a>.
SUPPLEMENTARY INFORMATION: The Drug Enforcement Administration (DEA)
proposes to permanently schedule CUMYL-PEGACLONE (SGT-151; 5-pentyl-2-
(2-phenylpropan-2-yl)pyrido[4,3-b]indol-1-one) in schedule I of the
Controlled Substances Act (CSA), including its salts, isomers
(including optical, positional, and geometric isomers), and salts of
isomers whenever the existence of such salts, isomers, and salts of
isomers is possible within the specific chemical designation.
Posting of Public Comments
All comments received in response to this docket are considered
part of the public record. DEA will make comments available for public
inspection online at <a href="http://www.regulations.gov">http://www.regulations.gov</a>, unless reasonable
cause is given. Such information includes personal or business
identifiers (such as name, address, state of federal identifiers, etc.)
voluntarily submitted by the commenter.
Commenters submitting comments which include personal identifying
information (PII), confidential, or proprietary business information
that the commenter does not want to be made publicly available should
submit two copies of the comment. One copy must be marked ``CONTAINS
CONFIDENTIAL INFORMATION'' and should clearly identify all PII or
business information the commenter does not want to be made publicly
available, including any supplemental materials. DEA will review this
copy, including the claimed PII and confidential business information,
in its consideration of comments. The second copy should be marked ``TO
BE PUBLICLY POSTED'' and must have all claimed confidential PII and
business information already redacted. DEA will post only the redacted
comment on <a href="http://www.regulations.gov">http://www.regulations.gov</a> for public inspection. DEA
generally will not redact additional information contained in the
comment marked ``TO BE PUBLICLY POSTED.'' The Freedom of Information
Act applies to all comments received.
For easy reference, an electronic copy of this document and
supplemental information to this proposed scheduling action are
available at <a href="http://www.regulations.gov">http://www.regulations.gov</a>.
Request for Hearing or Appearance; Waiver
Pursuant to 21 U.S.C. 811(a), this action is a formal rulemaking
``on the record after opportunity for a hearing.'' Such proceedings are
conducted pursuant to the provisions of the
[[Page 57535]]
Administrative Procedure Act (APA).\1\ Interested persons, as defined
in 21 CFR 1300.01(b), may file requests for a hearing in conformity
with the requirements of 21 CFR 1308.44(a) and 1316.47(a), and such
requests must:
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\1\ 5 U.S.C. 551-559; 21 CFR 1308.41-1308.45; 21 CFR part 1316,
subpart D.
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(1) state with particularity the interest of the person in the
proceeding;
(2) state with particularity the objections or issues concerning
which the person desires to be heard; and
(3) state briefly the position of the person regarding the
objections or issues.
Any interested person may file a waiver of an opportunity for a
hearing or to participate in a hearing in conformity with the
requirements of 21 CFR 1308.44(c), together with a written statement of
position on the matters of fact and law involved in any hearing.\2\
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\2\ 21 CFR 1316.49.
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All requests for a hearing and waivers of participation, together
with a written statement of position on the matters of fact and law
involved in such hearing, must be sent to DEA using the address
information provided above. The decision whether a hearing will be
needed to address such matters of fact and law in the rulemaking will
be made by the Administrator. If a hearing is needed, DEA will publish
a notice of hearing on the proposed rulemaking in the Federal
Register.\3\ Further, once the Administrator determines a hearing is
needed to address such matters of fact and law in rulemaking, he will
then designate an Administrative Law Judge (ALJ) to preside over the
hearing. The ALJ's functions shall commence upon designation, as
provided in 21 CFR 1316.52.
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\3\ 21 CFR 1308.44(b), 1316.53.
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In accordance with 21 U.S.C. 811 and 812, the purpose of a hearing
would be to determine whether CUMYL-PEGACLONE meets the statutory
criteria for placement in schedule I, as proposed in this rulemaking.
Legal Authority
The CSA provides that proceedings for the issuance, amendment, or
repeal of the scheduling of any drug or other substance 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 Health and Human Services (HHS), or on the petition of an
interested party.\4\ This proposed action is initiated on the
Administrator's own motion and supported by, inter alia, a
recommendation from the then-Assistant Secretary for Health of the HHS
(Assistant Secretary) and an evaluation of all other relevant data by
DEA. If finalized, this action would make permanent the existing
temporary regulatory controls and administrative, civil, and criminal
sanctions of schedule I controlled substances on any person who handles
or proposes to handle CUMYL-PEGACLONE.
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\4\ 21 U.S.C. 811(a).
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In addition, the United States is a party to the 1971 United
Nations Convention on Psychotropic Substances (1971 Convention),
February 21, 1971, 32 U.S.T. 543, 1019 U.N.T.S. 175, as amended.
Procedures respecting changes in drug schedules under the 1971
Convention are set forth in 21 U.S.C. 811(d)(2)-(4). When the United
States receives notification of a scheduling decision pursuant to
Article 2 of the 1971 Convention indicating that a drug or other
substance has been added to a schedule specified in the notification,
the Secretary of HHS (Secretary),\5\ after consultation with the
Attorney General, shall first determine whether existing legal controls
under subchapter I of the CSA and the Federal Food, Drug, and Cosmetic
Act meet the requirements of the schedule specified in the notification
with respect to the specific drug or substance.\6\ In the event that
the Secretary did not consult with the Attorney General, and the
Attorney General did not issue a temporary order, as provided under 21
U.S.C. 811(d)(4), the procedures for permanent scheduling set forth in
21 U.S.C. 811(a) and (b) control.
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\5\ As discussed in a memorandum of understanding entered into
by the 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. 50 FR 9518 (Mar. 8, 1985). The Secretary has delegated to the
Assistant Secretary for Health of HHS the authority to make domestic
drug scheduling recommendations. 58 FR 35460 (July 1, 1993).
\6\ 21 U.S.C. 811(d)(3).
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Pursuant to 21 U.S.C. 811(a)(1), the Attorney General (as delegated
to the Administrator of DEA) may, by rule, and upon the recommendation
of the Secretary, add to such a schedule or transfer between such
schedules any drug or other substance, if she finds that such drug or
other substance has a potential for abuse, and makes with respect to
such drug or other substance the findings prescribed by 21 U.S.C.
812(b) for the schedule in which such drug or other substance is to be
placed.
Background
On June 10, 2021, the Secretary-General of the United Nations
advised the Secretary of State of the United States that the Commission
on Narcotic Drugs (CND), during its 64th Session on April 14, 2021,
voted to place CUMYL-PEGACLONE in Schedule II of the 1971 Convention
(CND Decision 64/2). As a signatory to the 1971 Convention, the United
States is required, by scheduling under the CSA, to place appropriate
controls on CUMYL-PEGACLONE to meet the minimum requirements of the
treaty. The relevant treaty provisions and domestic statutes executing
those provisions are below.
To begin, Article 2, paragraph 7(b), of the 1971 Convention sets
forth the minimum requirements that the United States must meet when a
substance has been added to Schedule II of the 1971 Convention.
Pursuant to the 1971 Convention, the United States must require
licenses for the manufacture, export and import, and distribution of
CUMYL-PEGACLONE. The CSA's registration requirement as set forth in 21
U.S.C. 822, 823, 957, and 958, as well as implementing regulations in
21 CFR parts 1301 and 1312, set forth this licensing requirement.
In addition, the United States must adhere to specific export and
import provisions set forth in the 1971 Convention. The CSA's export
and import provisions established in 21 U.S.C. 952, 953, 957, and 958,
and implemented in 21 CFR part 1312, execute these requirements.
Likewise, under Article 13, paragraphs 1 and 2 of the 1971
Convention, a party to the 1971 Convention may notify through the U.N.
Secretary-General that it prohibits the importation of a substance in
Schedule II, III, or IV of the 1971 Convention. If such notice is
presented to the United States, the United States shall take measures
to ensure that the named substance is not exported to the notifying
country. The CSA's above-mentioned export provisions set forth these
procedures.
Further, under Article 16, paragraph 4, of the 1971 Convention, the
United States is required to provide annual statistical reports to the
International Narcotics Control Board (INCB). Using INCB Form P, the
United States shall provide the following information: (1) In regard to
each substance in Schedule I and II of the 1971 Convention, quantities
manufactured, exported to, and imported from each country or region as
well as stocks held by manufacturers; (2) in regard to each substance
in Schedule III and IV of the 1971 Convention, quantities manufactured,
as well as quantities exported and imported; (3) in regard to each
substance in Schedule II and III of the 1971 Convention, quantities
used in
[[Page 57536]]
the manufacture of exempt preparations; and (4) in regard to each
substance in Schedule II-IV of the 1971 Convention, quantities used for
the manufacture of non-psychotropic substances or products.
Lastly, under Article 2 of the 1971 Convention, the United States
must adopt measures in accordance with Article 22 to address violations
of any statutes or regulations that are adopted pursuant to its
obligations under the 1971 Convention. Persons acting outside the legal
framework established by the CSA are subject to administrative, civil,
and/or criminal action.
DEA notes that there are differences between the schedules of
substances in the 1971 Convention and the CSA. The CSA has five
schedules (schedules I-V) with specific criteria set forth for each
schedule. Schedule I is the only possible schedule in which a drug or
other substance may be placed if it has high potential for abuse and no
currently accepted medical use in treatment in the United States.\7\ In
contrast, the 1971 Convention has four schedules (Schedules I-IV) but
does not have specific criteria for each schedule. The 1971 Convention
simply defines its four schedules, in Article 1, to mean the
correspondingly numbered lists of psychotropic substances annexed to
the Convention and altered in accordance with Article 2.
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\7\ See 21 U.S.C. 812(b).
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Proposed Determination To Schedule CUMYL-PEGACLONE
Pursuant to 21 U.S.C. 811(b), DEA gathered the necessary data on
CUMYL-PEGACLONE and, on June 12, 2023, submitted it to the then-
Assistant Secretary for Health of HHS with a request for a scientific
and medical evaluation of available information and a scheduling
recommendation for CUMYL-PEGACLONE.
On December 12, 2023, the previous Administrator published a
temporary scheduling order in the Federal Register temporarily placing
six synthetic cannabinoids (SCs) in schedule I of the CSA based on the
finding that these substances pose an imminent threat to public
safety.\8\ The six SCs temporarily controlled under the CSA were (1)
MDMB-4en-PINACA; (2) methyl 2-[[1-(4-fluorobutyl)indole-3-
carbonyl]amino]-3,3-dimethyl-butanoate (other name: 4F-MDMB- BUTICA);
(3) 4F-MDMB-BICA); N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(pent-4-
en-1-yl)-1H-indazole-3-carboxamide (other name: ADB-4en-PINACA); (4) 5-
pentyl-2-(2-phenylpropan-2-yl)pyrido[4,3-b]indol-1-one (other names:
CUMYL-PEGACLONE; SGT-151); (5) ethyl 2-[[1-(5-fluoropentyl)indole-3-
carbonyl]amino]-3,3-dimethyl-butanoate (other names: 5F-EDMB-PICA; 5F-
EDMB-2201); and (6) methyl 2-(1-(4-fluorobenzyl)-1H-indole-3-
carboxamido)-3-methyl butanoate (other name: MMB-FUBICA). These six SCs
have not been investigated for medical use. Nor are they intended for
human use.
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\8\ 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 (Dec. 12,
2023).
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On December 11, 2024, HHS provided DEA a scientific and medical
evaluation entitled, ``Basis for the Recommendation to Place CUMYL-
PEGACLONE and its salts in Schedule I of the Controlled Substances
Act,'' and a scheduling recommendation. Pursuant to 21 U.S.C. 811(b),
following consideration of the eight factors and findings related to
the substance's abuse potential, legitimate medical use, and dependence
liability, HHS recommended that CUMYL-PEGACLONE be controlled in
schedule I of the CSA under 21 U.S.C. 812(b). HHS noted that CUMYL-
PEGACLONE is a full agonist at the cannabinoid type 1 (CB1) receptor,
has no known medical use in the United States, has no approved new drug
applications, and is not known to be marketed anywhere in the world as
an approved drug product. HHS also noted that health care practitioners
and medical examiners have reported cases of severe clinical adverse
events and even death when CUMYL-PEGACLONE was ingested.
In response, DEA reviewed the scientific and medical evaluation and
scheduling recommendation provided by HHS, and all other relevant data,
and conducted its own eight-factor analysis in accordance with 21
U.S.C. 811(c). Included below is a brief summary of each factor as
analyzed by HHS and DEA in their respective eight-factor analyses, and
as considered by DEA in this proposed scheduling determination. Please
note that both the DEA and HHS analyses, including the evaluation of
the eight factors determinative of control along with their supporting
data and citations, are available in their entirety under the tab
``Supporting Documents'' of the public docket of this proposed rule at
<a href="https://www.regulations.gov">https://www.regulations.gov</a>, under docket number ``DEA1356.''
1. The Drug's Actual or Relative Potential for Abuse
In addition to considering the information HHS provided in its
scientific and medical evaluation document for CUMYL-PEGACLONE, DEA
also considered all other relevant data regarding actual or relative
potential for abuse of CUMYL-PEGACLONE. The term ``abuse'' is not
defined in the CSA; however, the legislative history of the CSA
suggests the following four prongs in determining whether a particular
drug or substances has a potential for abuse: \9\
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\9\ Comprehensive Drug Abuse Prevention and Control Act of 1970,
H.R. Rep. No. 91-1444, 91st Cong., Sess. 1 (1970); reprinted in 1970
U.S.C.C.A.N. 4566, 4603.
a. There is evidence that individuals are taking the drug or
drugs containing such a substance in amounts sufficient to create a
hazard to their health or to the safety of other individuals or of
the community; or
b. There is a significant diversion of the drug or substance
from legitimate drug channels; or
c. Individuals are taking the drug or drugs containing such a
substance on their own initiative rather than on the basis of
medical advice from a practitioner licensed by law to administer
such drugs in the course of his professional practice; or
d. The drug or drugs containing such a substance are new drugs
so related in their action to a drug or drugs already listed as
having a potential for abuse to make it likely that the drug will
have the same potentiality for abuse as such drugs, thus making it
reasonable to assume that there may be significant diversions from
legitimate channels, significant use contrary to or without medical
advice, or that it has a substantial capability of creating hazards
to the health of the user or to the safety of the community.
Both DEA and HHS eight-factor analyses found that CUMYL-PEGACLONE
produces pharmacological effects that are similar to those produced by
schedule I SCs, such as JWH-018 and AM2201. CUMYL-PEGACLONE has been
associated with numerous reports of severe health effects and
intoxications including seizures followed by collapse, and deaths.
CUMYL-PEGACLONE does not have an approved medical use in the United
States, but evidence indicates that CUMYL-PEGACLONE is being abused and
trafficked in the United States. Because this substance is not an
approved drug product, a practitioner may not legally prescribe it, and
it cannot be dispensed to an individual. However, case reports,
coroner/medical examiner reports, and law enforcement data \10\
demonstrate that CUMYL-PEGACLONE is being used without medical advice.
CUMYL-PEGACLONE has been identified during the toxicological screening
in both fatal and non-fatal overdoses. Law enforcement
[[Page 57537]]
data show that CUMYL-PEGACLONE has been encountered in the United
States illicit drug market.
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\10\ While law enforcement data is not direct evidence of abuse,
it can lead to an inference that a drug has been diverted and
abused. See Schedules of Controlled Substances: Placement of
Carisoprodol Into Schedule IV, 76 FR 77330, 77332 (Dec. 12, 2011).
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Overall, these data demonstrate that CUMYL-PEGACLONE has a high
potential for abuse. Thus, based on these data, it is reasonable to
conclude that CUMYL-PEGACLONE, having no medical use, and thus no
therapeutic value, presents a hazard to the health and safety of
individuals and the community.
2. Scientific Evidence of the Drug's Pharmacological Effects, if Known
As explained in the 8-factor analyses by HHS and by DEA, the
available pharmacology data indicate that CUMYL-PEGACLONE produces
pharmacological effects that are similar to those produced by schedule
I substances, such as JWH-018 and AM2201. In vitro results indicate
that CUMYL-PEGACLONE, similar to other schedule I SCs, binds to CB1
receptors and acts as an agonist at CB1 receptors. Data also
demonstrates that CUMYL-PEGACLONE produces discriminative stimulus
effects that are similar to those of the schedule I JWH-018 and AM2201.
These pharmacological characteristics of CUMYL-PEGACLONE are predictive
of substances that have a high potential for abuse. Overall, these data
indicate that CUMYL-PEGACLONE produces pharmacological effects and
hallucinogen-like behaviors that are similar to those of the JWH-018
and AM2201.
3. The State of Current Scientific Knowledge Regarding the Drug or
Other Substance
CUMYL-PEGACLONE is a CB1 receptor agonist that is pharmacologically
similar to JWH-018 and AM2201 that is often smoked for recreational
purposes. Neither DEA nor HHS are aware of any currently accepted
medical use for CUMYL-PEGACLONE. There are no well-controlled clinical
studies showing safety or efficacy for this substance. In addition,
there is no evidence by qualified experts that CUMYL-PEGACLONE is
accepted as having therapeutic uses. In the HHS report, the Food and
Drug Administration (FDA) concluded that CUMYL-PEGACLONE has no
currently accepted medical use in the United States. Similarly, DEA
concludes CUMYL-PEGACLONE has no currently accepted medical use
according to established DEA procedure and case law.
4. History and Current Pattern of Abuse
In their review, HHS described how the history and current pattern
of abuse of CUMYL-PEGACLONE was evidenced by law enforcement data from
DEA regarding drug seizures and poison control center reports,
indicating the substance is used for abuse purposes. HHS noted that
while law enforcement data is not direct evidence of abuse, it can be
inferred that CUMYL-PEGACLONE has been consumed for its psychoactive
and intoxicating effects as with other SCs. CUMYL-PEGACLONE was
described in a patent from 2014. In addition, CUMYL-PEGACLONE was first
reported as an adulterated plant material in Germany in December 2016
and appeared in the United States in September 2018.
5. Scope, Duration and Significance of Abuse
Evidence shows that CUMYL-PEGACLONE is a recreational drug of
abuse. HHS noted in their recommendation that SCs continue to be
encountered on the illicit market despite scheduling actions that
attempt to safeguard the public from the adverse effects and safety
issues associated with these substances. Novel substances continue to
be encountered that differ only by small chemical structural
modifications intended to avoid prosecution, while maintaining the
pharmacological effects. Law enforcement and health care professionals
continue to report the abuse of these substances and their associated
products. These encounters of CUMYL-PEGACLONE by law enforcement
indicate that this substance is being trafficked and abused in the
United States. Furthermore, evidence also indicates that CUMYL-
PEGACLONE is abused internationally.
6. What, if Any, Risk There Is to the Public Health
Available evidence on the overall public health risks associated
with the use of CUMYL-PEGACLONE suggests that CUMYL-PEGACLONE can cause
acute health problems leading to emergency department admissions and
death. Case reports detailing serious adverse effects have been
reported in the literature (see additional details at
<a href="http://www.regulations.gov">www.regulations.gov</a> contained within DEA's 8-factor analysis at docket
DEA-1356). Following the ingestion of products containing CUMYL-
PEGACLONE, individuals have experienced seizures followed by collapse
and death. Serious adverse effects and previously discussed data
showing that CUMYL-PEGACLONE shares pharmacological similarities with
schedule I substances, including JWH-018 and AM2201, demonstrate that
CUMYL-PEGACLONE is a serious public health threat.
7. Its Psychic or Physiological Dependence Liability
In their recommendation, HHS noted that there are no clinical
studies evaluating dependence liabilities specific for CUMYL-PEGACLONE.
However, scientific data indicate that CUMYL-PEGACLONE has a
pharmacological profile that is similar to other schedule I SCs. It is
reasonable to assume that CUMYL-PEGACLONE would retain a physiological
and psychological dependence liability that is similar to that of other
schedule I SCs such as JWH-018 and AM2201. Thus, it is reasonable to
conclude that the cannabinoid-like properties of CUMYL-PEGACLONE may
produce a psychic and/or physiological dependence liability that is
similar to other SCs already controlled in schedule I under the CSA.
8. Whether the Substance is an Immediate Precursor of a Substance
Already Controlled Under the CSA
CUMYL-PEGACLONE is not an immediate precursor of any substance
controlled under the CSA, as defined in 21 U.S.C. 802(23).
Conclusion
After considering the scientific and medical evaluation conducted
and accompanying recommendation of HHS, and DEA's own eight-factor
analysis, DEA finds that the facts and all relevant data constitute
substantial evidence of the potential for abuse of CUMYL-PEGACLONE. As
such, DEA hereby proposes to permanently schedule CUMYL-PEGACLONE as a
schedule I controlled substance under the CSA. This action would also
enable the United States to meet its obligations under the 1971
Convention.
Proposed Determination of Appropriate Schedule
The CSA establishes five schedules of controlled substances known
as schedules I, II, III, IV, and V. The CSA also outlines the findings
required to place a drug or other substance in any particular
schedule.\11\ After consideration of the analysis and recommendation of
the Assistant Secretary for Health of HHS and review of all other
available data, the Administrator of DEA, pursuant to 21 U.S.C. 811(a)
and 812(b)(1), finds that:
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\11\ 21 U.S.C. 812(b).
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[[Page 57538]]
1. CUMYL-PEGACLONE Has a High Potential for Abuse
CUMYL-PEGACLONE has a high potential for abuse, evidenced in part
by data from in vitro binding affinity and functional activity studies,
as well as by data from in vivo drug discrimination tests in animals.
In these studies, CUMYL-PEGACLONE is demonstrated to be an agonist at
CB1 receptors, which is a mechanism of action shared with other SCs,
substances with a high potential for abuse and controlled in schedule I
under the CSA. This finding is also consistent with the drug abuse
patterns of CUMYL-PEGACLONE and adverse outcomes evident from
epidemiological data sources. In summary, CUMYL-PEGACLONE has similar
patterns of drug abuse, as well as similar adverse outcomes from its
use, as have been observed with other SCs currently controlled in
schedule I of the CSA.
2. CUMYL-PEGACLONE Has No Currently Accepted Medical Use in Treatment
in the United States
CUMYL-PEGACLONE is not legally marketed in the United States, as
FDA has not approved a marketing application for a drug product
containing CUMYL-PEGACLONE for any indication. There are no known
medically approved uses worldwide at this time. Moreover, there are no
clinical studies or petitioners, of which FDA is aware, that claim an
accepted medical use in the United States. There is no evidence that
CUMYL-PEGACLONE has a currently accepted medical use in treatment in
the United States.\12\
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\12\ Pursuant to 21 U.S.C. 812(b)(1)(B), when placing a drug or
other substance in schedule I of the CSA, DEA must consider whether
the substance has a currently accepted medical use in treatment in
the United States. First, DEA looks to whether the drug or substance
has FDA approval. When no FDA approval exists, DEA has traditionally
applied a five-part test to determine whether a drug or substances
has a currently accepted medical use: (1) the drug's chemistry must
be known and reproducible; (2) there must be adequate safety
studies; (3) there must be adequate and well-controlled studies
proving efficacy; (4) the drug must be accepted by qualified
experts; and (5) the scientific evidence must be widely available.
Marijuana Scheduling Petition; Denial of Petition; Remand, 57 FR
10499 (Mar. 26, 1992), pet. for rev. denied, Alliance for Cannabis
Therapeutics v. Drug Enforcement Admin., 15 F.3d 1131, 1135 (D.C.
Cir. 1994). DEA and HHS applied the traditional five-part test for
currently accepted medical use in this matter. In a recent published
letter in a different context, HHS applied an additional two-part
test to determine currently accepted medical use for substances that
do not satisfy the five-part test: (1) whether there exists
widespread, current experience with medical use of the substance by
licensed health care practitioners operating in accordance with
implemented jurisdiction-authorized programs, where medical use is
recognized by entities that regulate the practice of medicine, and,
if so, (2) whether there exists some credible scientific support for
at least one of the medical conditions for which the part 1 is
satisfied. On April 11, 2024, the Department of Justice's Office of
Legal Counsel (OLC) issued an opinion, which, among other things,
concluded that HHS's two-part test would be sufficient to establish
that a drug has a currently accepted medical use. Office of Legal
Counsel, Memorandum for Merrick B. Garland Attorney General Re:
Questions Related to the Potential Rescheduling of Marijuana at 3
(Apr. 11, 2024). In its eight-factor assessment, HHS determined that
CUMYL-PEGACLONE does not satisfy this two-part test. Therefore,
since both DEA and HHS have determined that this substance does not
satisfy the five-part test, and HHS has determined that this
substance does not satisfy the additional two-part test, DEA
concludes that CUMYL-PEGACLONE does not have a currently accepted
medical use.
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3. There is a Lack of Accepted Safety for Use of CUMYL-PEGACLONE Under
Medical Supervision
Because CUMYL-PEGACLONE has no approved medical use and has not
been thoroughly investigated as new drugs, its safety for use under
medical supervision is not determined. Thus, there is a lack of
accepted safety for use of these substances under medical supervision.
Based on these findings, the Administrator concludes that CUMYL-
PEGACLONE (SGT-151; 5-pentyl-2-(2-phenylpropan-2-yl)pyrido[4,3-b]indol-
1-one), including its salts, isomers (including optical, positional,
and geometric isomers), and salts of isomers, warrants control in
schedule I of the CSA. More precisely, because of its hallucinogenic-
like effects, DEA is proposing to place CUMYL-PEGACLONE in 21 CFR
1308.11(d) (the hallucinogens category of schedule I).
Requirements for Handling CUMYL-PEGACLONE
If this rule is finalized as proposed, CUMYL-PEGACLONE would
continue \13\ to be subject to the CSA's schedule I regulatory controls
and administrative, civil, and criminal sanctions applicable to the
manufacture, distribution, reverse distribution, dispensing, import,
export, engagement in research, conduct of instructional actitities or
chemical analysis with, and possession of schedule I controlled
substances, including the following:
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\13\ CUMLY-PEGACLONE is curently subject to schedule 1 controls
on a temporary basis, pursuant to 21 U.S.C. 811(h). See Schedule of
Controled Substances: Temporary Placement of MDMB-4en PINACA, 4f-
MDMB-BUTICA, ADB-4en-PINACA, CUMLY-PEGACLONE, 5F-EDMB-PICA and MMB-
FUBICA into Schedule I, 88 FR 86040 (Dec. 12, 2023).
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1. 1. Registration. Any person who handles (manufactures,
distributes, dispenses, imports, exports, engages in research, or
conducts instructional activities or chemical analysis with, or
possesses) CUMYL-PEGACLONE must be registered with DEA to conduct such
activities pursuant to 21 U.S.C. 822, 823, 957, and 958, and in
accordance with 21 CFR parts 1301 and 1312.
2. Security. CUMYL-PEGACLONE is subject to schedule I security
requirements and must be handled and stored pursuant to 21 U.S.C. 821,
823, and in accordance with 21 CFR 1301.71-1301.76. Non-practitioners
handling these three substances also must comply with the screening
requirements of 21 CFR 1301.90-1301.93.
3. Labeling and Packaging. All labels and labeling for commercial
containers of CUMYL-PEGACLONE must comply with 21 U.S.C. 825 and
958(e), and be in accordance with 21 CFR part 1302.
4. Quota. Only registered manufacturers would be permitted to
manufacture CUMYL-PEGACLONE in accordance with a quota assigned,
pursuant to 21 U.S.C. 826, and in accordance with 21 CFR part 1303.
5. Inventory. Any person registered with DEA to handle CUMYL-
PEGACLONE must have an initial inventory of all stocks of controlled
substances (including this substance) on hand on the date the
registrant first engages in the handling of controlled substances
pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 CFR
1304.03, 1304.04, and 1304.11.
After the initial inventory, every DEA registrant must take a new
inventory of all stocks of controlled substances (including CUMYL-
PEGACLONE) on hand every two years pursuant to 21 U.S.C. 827 and
958(e), and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11.
6. Records and Reports. Every DEA registrant must maintain records
and submit reports with respect to CUMYL-PEGACLONE, pursuant to 21
U.S.C. 827, 832(a), and 958(e), and in accordance with 21 CFR 1301.74
and 1301.76, and parts 1304, 1312, and 1317. Manufacturers and
distributors would be required to submit reports regarding CUMYL-
PEGACLONE to the Automation of Reports and Consolidated Order System
pursuant 21 U.S.C. 827, and in accordance with 21 CFR parts 1304 and
1312.
7. Order Forms. Every DEA registrant who distributes CUMYL-
PEGACLONE must comply with the order form requirements, pursuant to 21
U.S.C. 828 and 21 CFR part 1305.
[[Page 57539]]
8. Importation and Exportation. All importation and exportation of
CUMYL-PEGACLONE must be in compliance with 21 U.S.C. 952, 953, 957, and
958, and in accordance with 21 CFR part 1312.
9. Liability. Any activity involving CUMYL-PEGACLONE not authorized
by, or in violation of, the CSA or its implementing regulations would
be unlawful, and may subject the person to administrative, civil, and/
or criminal sanctions.
Regulatory Analyses
Executive Orders 12866, 13563, 14192, and 14294
In accordance with 21 U.S.C. 811(a), this proposed scheduling
action is subject to formal rulemaking procedures done ``on the record
after opportunity for a hearing,'' which are conducted pursuant to the
provisions of 5 U.S.C. 556 and 557. The CSA sets forth the criteria for
scheduling a drug or other substance. Such actions are exempt from
review by the Office of Management and Budget (OMB) pursuant to section
3(d)(1) of Executive Order (E.O.) 12866 and the principles reaffirmed
in E.O. 13563. DEA scheduling actions are not subject to either E.O.
14192, Unleashing Prosperity Through Deregulation, or E.O. 14294,
Fighting Overcriminalization in Federal Regulations.
Executive Order 12988, Civil Justice Reform
This proposed regulation meets the applicable standards set forth
in sections 3(a) and 3(b)(2) of E.O. 12988 to eliminate drafting errors
and ambiguity, minimize litigation, provide a clear legal standard for
affected conduct, and promote simplification and burden reduction.
Executive Order 13132, Federalism
This proposed rulemaking does not have federalism implications
warranting the application of E.O. 13132. The proposed rule does not
have substantial direct effects on the States, on the relationship
between the National Government and the States, or the distribution of
power and responsibilities among the various levels of government.
Executive Order 13175, Consultation and Coordination With Indian Tribal
Governments
This proposed rule does not have Tribal implications warranting the
application of E.O. 13175. It does not have substantial direct effects
on one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.
Regulatory Flexibility Act
The Administrator, in accordance with the Regulatory Flexibility
Act, 5 U.S.C. 601-602, has reviewed this proposed rule and, by
approving it, certifies that it will not have a significant economic
impact on a substantial number of small entities.
On December 12, 2023, DEA published an order to temporarily place
CUMYL-PEGACLONE, including its salts, isomers (including optical,
positional, and geometric isomers), and salts of isomers, in schedule I
of the CSA pursuant to the temporary scheduling provisions of 21 U.S.C.
811(h). DEA estimates that all entities handling or planning to handle
CUMYL-PEGACLONE have already established and implemented systems and
processes required to handle these substances. This action was taken to
enable the United States to meet its obligations under the 1971
Convention on Psychotropic Substances. If finalized, this action would
make permanent the existing regulatory controls and administrative,
civil, and criminal sanctions applicable to schedule I controlled
substances on persons who handle (manufacture, distribute, reverse
distribute, dispense, import, export, engage in research, conduct
instructional activities or chemical analysis with, or possess), or
propose to handle CUMYL-PEGACLONE.
According to HHS, CUMYL-PEGACLONE has a high potential for abuse,
has no currently accepted medical use in treatment in the United
States, and lacks accepted safety for use under medical supervision.
There appear to be no legitimate sources for CUMYL-PEGACLONE as a
marketed drug in the United States, but DEA notes that this substance
is available for purchase from legitimate suppliers for scientific
research. There is no evidence of significant diversion of CUMYL-
PEGACLONE from legitimate suppliers. Therefore, DEA has concluded that
this proposed rule, if finalized, will not have a significant economic
impact on a substantial number of small entities.
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\14\ Executive Office of the President Office of Management and
Budget, North American Industry Classification System, United
States, 2022, <a href="https://www.census.gov/naics/reference_files_tools/2022_NAICS_Manual.pdf">https://www.census.gov/naics/reference_files_tools/2022_NAICS_Manual.pdf</a>.
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The entities affected by this proposed rule include the
manufacturers, distributors, importers, exporters, and researchers of
CUMYL-PEGACLONE. DEA determines the North American Industry
Classification System (NAICS) industries that best represent these
business activities. Table 1 lists the business activities and
corresponding NAICS industries.\14\
Table 1--Business Activity and Corresponding NAICS Industries
------------------------------------------------------------------------
NAICS industry
Business activity NAICS code description
------------------------------------------------------------------------
Manufacturer..................... 325412 Pharmaceutical
Preparation
Manufacturing.
Distributor, Importer, Exporter.. 424210 Drugs and Druggists'
424690 Sundries Merchant
Wholesalers.
Other Chemical and
Allied Products
Merchant Wholesalers.
Researcher....................... 541715 Research and Development
611310 in Physical,
Engineering, and Life
Sciences (except
Nanotechnology and
Biotechnology).
Colleges, Universities
and Professional
Schools.
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[[Page 57540]]
From Statistics of U.S. Businesses (SUSB) data, DEA determined the
number of firms and small firms for each of the affected industries,
and by comparing the number of affected small entities to the number of
small entities for each industry, DEA determined whether a substantial
number of small entities are affected in any of the industries. Table 2
lists the number of firms, small firms, and percent small firms in each
affected industry.
Table 2--Percent Affected Small Entities by Industry
----------------------------------------------------------------------------------------------------------------
Percent of
Small small
NAICS industry Firms \15\ SBA size standard \16\ firms \17\ entities
(%)
----------------------------------------------------------------------------------------------------------------
325412--Pharmaceutical Preparation 1,179 1,300 employees.................. 1,099 93.2
Manufacturing.
424210--Drugs and Druggists' Sundries 7,012 250 employees.................... 6,760 96.4
Merchant Wholesalers.
424690--Other Chemical and Allied 5,487 175 employees.................... 5,197 94.7
Products Merchant Wholesalers.
541715--Research and Development in 10,042 1,000 employees.................. 9,599 95.6
the Physical, Engineering, and Life
Sciences (except Nanotechnology and
Biotechnology).
611310--Colleges, Universities and 2,494 $34.5 million.................... 1,515 60.8
Professional Schools.
----------------------------------------------------------------------------------------------------------------
Based on the American Chemical Society's SciFinder database,\18\
DEA identified three entities supplying CUMYL-PEGACLONE across the
industries 325412, 424210, and 424690. However, one entity has already
registered with DEA to handle controlled substances. Hence, DEA expects
only two of the entities in the 325412, 424210, and 424690 industries
will be affected by this rule. Assuming that all affected suppliers
were small entities and concentrated in the smallest NAICS industry,
325412--Pharmaceutical Preparation Manufacturing, they would account
for insubstantial number of small entities in that industry, 0.18
percent.\19\
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\15\ Statistics of U.S. Businesses, 2022 SUSB Annual Data Tables
by Establishment Industry, <a href="https://www.census.gov/data/tables/2021/econ/susb/2021-susb-annual.html">https://www.census.gov/data/tables/2021/econ/susb/2021-susb-annual.html</a> (Accessed 6/24/2025).
\16\ U.S. Small Business Administration, Table of size
standards, Version March 2023, Effective: March 17, 2023, <a href="https://www.sba.gov/sites/default/files/2023-06/Table%20of%20Size%20Standards_Effective%20March%2017%2C%202023%20%282%29.pdf">https://www.sba.gov/sites/default/files/2023-06/Table%20of%20Size%20Standards_Effective%20March%2017%2C%202023%20%282%29.pdf</a> (Accessed 6/24/2025).
\17\ Based on the estimated number of firms below the SBA size
standard for each industry.
\18\ SciFinder; Chemical Abstracts Service: Columbus, OH; CAS
2504100-70-1; <a href="https://scifinder.cas.org">https://scifinder.cas.org</a> (accessed May 14, 2024).
\19\ 2/1,099 = 0.18%.
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Additionally, DEA expects that the number of researchers working
with CUMYL-PEGACLONE is small, because CUMYL-PEGACLONE is not approved
for medical use and has a substantial capability to be a hazard to the
health of the user and to the safety of the community. Also, DEA
believes that the researchers working with CUMYL-PEGACLONE may also
work with other controlled substances; hence, these researchers are
likely already registered with DEA and are qualified to handle
controlled substances. For these reasons, DEA believes the number of
affected researchers that are small entities is not a substantial
number of small entities in 541715 and 611310 industries.
In summary, the small entities affected by this proposed rule are
those in 325412--Pharmaceutical Preparation Manufacturing, 424210--
Drugs and Druggists' Sundries Merchant Wholesalers, and 424690--Other
Chemical and Allied Products Merchant Wholesalers. The affected small
entities account for less than 0.18 percent of the small businesses and
are not likely to manufacture or carry inventory of CUMYL-PEGACLONE. As
such, the proposed rule, if finalized, is not expected to result in a
significant economic impact on a substantial number of small entities.
Unfunded Mandates Reform Act of 1995
In accordance with the Unfunded Mandates Reform Act (UMRA) of 1995,
2 U.S.C. 1532, DEA has determined and certifies that this action would
not result in any Federal mandate that may result ``in the expenditure
by State, local, and Tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any 1 year . . . .'' Therefore, neither a Small
Government Agency Plan nor any other action is required under UMRA of
1995.
Paperwork Reduction Act of 1995
This proposed rule would not impose a new collection or modify an
existing collection of information under the Paperwork Reduction Act of
1995.\20\ Also, this propsed rule would not impose new or modify
existing recordkeeping or reporting requirements on State or local
governments, individuals, businesses, or organizations. However, this
proposed rule would require compliance with the following existing OMB
collections: 1117-0003, 1117-0004, 1117-0006, 1117-0008, 1117-0009,
1117-00010, 1117-00012, 1117-00014, 1117-00021, 1117-00023, 1117-00029,
1117-00056. An agency may not conduct or sponsor, and a person is not
required to respond to a collection of information unless it displays a
currently valid OMB control number.
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\20\ 44 U.S.C. 3501-3521.
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List of Subjects in 21 CFR Part 1308
Administrative practice and procedure, Drug traffic control,
Reporting and recordkeeping requirements.
For the reasons set out above, DEA proposes to amend 21 CFR part
1308 as follows:
PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES
0
1. The authority citation for part 1308 continues to read as follows:
Authority: 21 U.S.C. 811, 812, 871(b), 956(b), unless otherwise
noted.
0
2. In Sec. 1308.11:
0
a. Add a new paragraph (d)(107) to read as follows:
Sec. 1308.11 Schedule I.
* * * * *
[[Page 57541]]
(d) * * *
* * * * * * *
(106) 5-Pentyl-2-(2-phenylpropan-2-yl)pyrido[4,3-b]indol-1-one 7093
(other names: CUMYL-PEGACLONE; SGT-151).......................
* * * * * * *
------------------------------------------------------------------------
* * * * *
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. 2025-22495 Filed 12-10-25; 8:45 am]
BILLING CODE 4410-09-P
</pre></body>
</html>Indexed from Federal Register on December 11, 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.