Rule2026-09566

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
May 13, 2026
Effective
May 13, 2026

Issuing agencies

Justice DepartmentDrug Enforcement Administration

Abstract

With the issuance of this final rule, the Drug Enforcement Administration places 5-pentyl-2-(2-phenylpropan-2-yl)pyrido[4,3- b]indol-1-one (other names: CUMYL-PEGACLONE; SGT-151), including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible, in schedule I of the Controlled Substances Act. This action is being taken, in part, to enable the United States to meet its obligations under the 1971 Convention on Psychotropic Substances. This action imposes 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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<title>Federal Register, Volume 91 Issue 92 (Wednesday, May 13, 2026)</title>
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[Federal Register Volume 91, Number 92 (Wednesday, May 13, 2026)]
[Rules and Regulations]
[Pages 26913-26917]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-09566]


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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: Final rule.

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SUMMARY: With the issuance of this final rule, the Drug Enforcement 
Administration places 5-pentyl-2-(2-phenylpropan-2-yl)pyrido[4,3-
b]indol-1-one (other names: CUMYL-PEGACLONE; SGT-151), including its 
salts, isomers, and salts of isomers whenever the existence of such 
salts, isomers, and salts of isomers is possible, in schedule I of the 
Controlled Substances Act. This action is being taken, in part, to 
enable the United States to meet its obligations under the 1971 
Convention on Psychotropic Substances. This action imposes 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: Effective date: May 13, 2026.

FOR FURTHER INFORMATION CONTACT: Dr. Terrence L. Boos, Drug and 
Chemical Evaluation Section, Diversion Control Division, Drug 
Enforcement Administration; Telephone: (571) 362-3249.

SUPPLEMENTARY INFORMATION: In this final rule, the Drug Enforcement 
Administration (DEA) permanently places CUMYL-PEGACLONE and 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, in schedule I of the Controlled Substances Act (CSA).

Legal Authority

    The United States is a party to the 1971 United Nations Convention 
on Psychotropic Substances (1971 Convention), Feb. 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 governed domestically by 
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 Health and Human 
Services (Secretary),\1\ 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

[[Page 26914]]

drug or substance.\2\ 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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    \1\ 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).
    \2\ 21 U.S.C. 811(d)(3).
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    Pursuant to 21 U.S.C. 811(a)(1) and (2), the Attorney General (as 
delegated to the Administrator of the DEA pursuant to 28 CFR 0.100) 
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

    The neurochemical effects of CUMYL-PEGACLONE occur primarily 
through cannabinoid receptor systems in the brain. CUMYL-PEGACLONE 
binds to cannabinoid subtype 1 (CB1) receptors, functions as a full 
agonist, and has a binding affinity and functional activity profile 
that is similar to that of other schedule I cannabinoids, including 
[Delta]9-THC, JWH-018, XLR11, and AKB-48. 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 voted to 
place CUMYL-PEGACLONE in Schedule II of the 1971 Convention during its 
64th Session held on April 14, 2021.
    As a signatory to this international treaty, 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. Because 
the procedures in 21 U.S.C. 811(d)(3) and (4) for consultation and 
issuance of a temporary order, discussed in the above legal authority 
section, were not followed for CUMYL-PEGACLONE, DEA is utilizing the 
procedures for permanent scheduling set forth in 21 U.S.C. 811(a) and 
(b) to control CUMYL-PEGACLONE. Such scheduling would satisfy the 
United States' international obligations.
    To meet the minimum requirements of this treaty and to confront 
this emerging substance, DEA published an order in the Federal Register 
on December 12, 2023, 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 under 21 U.S.C. 811(h)(1).\3\ That 
temporary order was effective upon the date of publication. On December 
11, 2025, DEA published a temporary scheduling order to extend the 
temporary schedule I status of CUMYL-PEGACLONE for one year, or until 
the permanent scheduling action for this substance is completed, 
whichever occurs first.\4\
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    \3\ 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).
    \4\ Schedules of Controlled Substances: Extension of Temporary 
Placement of CUMYL-PEGACLONE in Schedule I of the Controlled 
Substances Act, 90 FR 57542 (Dec. 11, 2025).
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DEA and HHS Eight-Factor Analyses

    In a letter dated December 11, 2024, in accordance with 21 U.S.C. 
811(b), and in response to DEA's June 12, 2023 request, the Department 
of Health and Human Services (HHS) provided to DEA a scientific and 
medical evaluation and scheduling recommendation for CUMYL-PEGACLONE. 
DEA reviewed the scientific and medical evaluation and scheduling 
recommendation for schedule I placement provided by HHS, and all other 
relevant data, pursuant to 21 U.S.C. 811(b) and (c), and conducted its 
own analysis under the eight factors stipulated in 21 U.S.C. 811(c). 
DEA found, under 21 U.S.C. 811(b)(1), that CUMYL-PEGACLONE warrants 
control in schedule I. Both the DEA and HHS's Eight-Factor Analyses are 
available in their entirety under the tab Supporting Documents of the 
public docket for this action at <a href="https://www.regulations.gov">https://www.regulations.gov</a> under 
docket number DEA-1356.

Notice of Proposed Rulemaking To Schedule CUMYL-PEGACLONE

    On December 11, 2025, DEA published a notice of proposed rulemaking 
(NPRM) to permanently control CUMYL-PEGACLONE in schedule I.\5\ 
Specifically, DEA proposed to add CUMYL-PEGACLONE to the list of 
hallucinogenic substances under 21 CFR 1308.11(d). The NPRM provided an 
opportunity for interested persons to file a request for hearing in 
accordance with DEA regulations on or before January 12, 2026. DEA did 
not receive any requests for a hearing. The NPRM also provided an 
opportunity for interested persons to submit comments on or before 
January 12, 2026.
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    \5\ Schedules of Controlled Substances: Placement of CUMYL-
PEGACLONE in Schedule I, 90 FR 57534 (Dec. 11, 2025).
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Comments Received

    DEA received one comment in response to the NPRM in support of the 
rulemaking for the placement of CUMYL-PEGACLONE into schedule I of the 
CSA.
    Comment in support of the rulemaking: One comment was in support of 
the rulemaking. The response specifically noted the serious adverse 
effects following the ingestion of CUMYL-PEGACLONE and described how 
this rule will help to decrease the availability of CUMYL-PEGACLONE to 
the general public to decrease dependence and addiction to this 
substance.
    DEA Response: DEA appreciates the comment in support of this 
rulemaking.

Scheduling Conclusion

    After consideration of the public comment, scientific and medical 
evaluation and accompanying scheduling recommendation from HHS, and 
after its own eight-factor evaluation, DEA finds that these facts and 
all relevant data constitute substantial evidence of potential for 
abuse of CUMYL-PEGACLONE. As such, DEA is permanently scheduling CUMYL-
PEGACLONE as a controlled substance under schedule I of the CSA. The 
permanent scheduling of CUMYL-PEGACLONE fulfills the United States' 
obligations as a party to the 1971 Convention.

Determination of Appropriate Schedule

    The CSA establishes five schedules of controlled substances known 
as schedules I, II, II, IV, and V. The CSA also specifies the findings 
requires to place a drug or other substance in any particular schedule, 
21 U.S.C. 812(b). After consideration of the analysis and 
recommendation of the then Assistant Secretary for Health of HHS and 
review of all other available data, the Administrator of DEA, pursuant 
to 21 U.S.C. 812(b)(1), finds that:
    (1) CUMYL-PEGACLONE has a high potential for abuse that is 
comparable to other scheduled synthetic cannabinoids, such as JWH-018, 
XLR11, and ABKB-48. In vitro studies demonstrate that CUMYL-PEGACLONE 
binds to CB1 receptors and functions as a full agonist. In drug 
discrimination studies conducted in animals to evaluate its 
discriminative stimulus effects, CUMYL-PEGACLONE was shown to fully 
substitute for the discriminative stimulus effects produced by delta 9-
THC. The ingestion of CUMYL-PEGACLONE has been documented to result in 
serious adverse effects including seizures, sudden collapse of the 
user, and death.
    (2) CUMYL-PEGACLONE has no currently accepted medical use in 
treatment in the United States. In HHS's

[[Page 26915]]

2024 recommendation to control CUMYL-PEGACLONE, it was noted there are 
no approved New Drug Applications for CUMYL-PEGACLONE and no known 
therapeutic applications for CUMYL-PEGACLONE in the United States. DEA 
is not aware of any other evidence suggesting that CUMYL-PEGACLONE has 
a currently accepted medical use in treatment in the United States.\6\
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    \6\ To place a drug or other substance in schedule I under the 
CSA, DEA must consider whether the substance has a currently 
accepted medical use in treatment in the United States. 21 U.S.C. 
812(b)(1)(B). 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 a drug or substance that has not been 
approved by the FDA: (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. See 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 and concluded the test was not 
satisfied. 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 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 (April 11, 2024). For 
purposes of this final rule, there is no evidence that health care 
providers have widespread experience with medical use of CUMYL-
PEGACLONE, or that the use of CUMYL-PEGACLONE is recognized by 
entities that regulate the practice of medicine, so the two-part 
test also is not satisfied.
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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 investigated as a new drug, its safety for 
use under medical supervision has not been determined.
    Based on these findings, the Administrator of DEA concludes that 
CUMYL-PEGACLONE, as well as its salts, isomers, and salts of isomers 
whenever the existence of such salts, isomers, and salts of isomers is 
possible, warrants control in schedule I of the CSA.

Requirements for Handling CUMYL-PEGACLONE

    CUMYL-PEGACLONE is subject to the CSA's schedule I regulatory 
controls and administrative, civil, and criminal sanctions applicable 
to the manufacture, distribution, reverse distribution, import, export, 
engagement in research, conduct instructional activities or chemical 
analysis with, and possession of schedule I controlled substances, 
including the following:
    1. Registration. Any person who handles (manufactures, distributes, 
reverse distributes, imports, exports, engages in research, or conducts 
instructional activities or chemical analysis with, or possesses), or 
who desires to handle, CUMYL-PEGACLONE must register 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.
    Any person who currently handles CUMYL-PEGACLONE and is not 
registered with DEA to conduct research with a schedule I controlled 
substance must submit an application for registration and may not 
continue to handle CUMYL-PEGACLONE as of May 13, 2026, unless DEA has 
approved that application for registration pursuant to 21 U.S.C. 822, 
823, 957, and 958, and in accordance with 21 CFR parts 1301 and 1312.
    Notwithstanding the foregoing, pursuant to 21 U.S.C. 822(h), if, on 
May 13, 2026, a person is conducting research on CUMYL-PEGACLONE and is 
already registered to conduct research with another controlled 
substance in schedule I, the person may continue to conduct research on 
CUMYL-PEGACLONE if they submit a completed application for registration 
or modification of existing registration, as applicable, to conduct 
research with CUMYL-PEGACLONE not later than 90 calendar days after May 
13, 2026. The person may continue to conduct such research until the 
person withdraws the application or the Administrator serves on the 
person an order to show cause proposing denial of the application 
pursuant to 21 U.S.C. 824(c) and in accordance with 21 CFR 1301.37. If 
the Administrator serves an order to show cause proposing denial of the 
application or modification, the person may not continue to conduct 
research with CUMYL-PEGACLONE and may not receive or otherwise obtain 
additional CUMYL-PEGACLONE. If an order to show cause is served and the 
person requests a hearing in accordance with 21 CFR 1301.37(d), the 
hearing shall be held in accordance with 21 CFR 1301.41-1301.46 on an 
expedited basis and not later than 45 calendar days after the request 
is made, except that the hearing may be held at a later time if so 
requested by the person. If the person sends a copy of the application 
to a manufacturer or distributor of CUMYL-PEGACLONE, receipt of the 
copy by the manufacturer or distributor constitutes sufficient evidence 
that the person is authorized to receive CUMYL-PEGACLONE pursuant to 21 
U.S.C. 822(h)(4). Continuation of research under 21 U.S.C. 822(h) does 
not authorize any other handling (e.g., distribution) of CUMYL-
PEGACLONE. Retail sales of schedule I controlled substances to the 
general public are not allowed under the CSA. Possession of any 
quantity in a manner not authorized by the CSA is unlawful and those in 
possession of any quantity may be subject to prosecution pursuant to 
the CSA.
    2. Disposal of stocks. Any person unwilling or unable to obtain a 
schedule I registration must surrender or transfer all quantities of 
currently held CUMYL-PEGACLONE to a person registered with DEA before 
the effective date of the final scheduling action in accordance with 
all applicable Federal, State, local, and Tribal laws. CUMYL-PEGACLONE 
must be disposed of in accordance with 21 CFR part 1317, in addition to 
all other applicable Federal, State, local, and Tribal laws
    3. Security. CUMYL-PEGACLONE is subject to schedule I security 
requirements and must be handled and stored pursuant to 21 U.S.C. 823, 
and in accordance with 21 CFR 1301.71-1301.76. Non-practitioners 
handling CUMYL-PEGACLONE must comply with the employee screening 
requirements of 21 CFR 1301.90 through 1301.93.
    4. Labeling and Packaging. All labels, labeling, and packaging for 
commercial containers of CUMYL-PEGACLONE must comply with 21 U.S.C. 825 
and be in accordance with 21 CFR part 1302.
    5. Quota. Generally, only registered manufacturers are 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.
    6. Inventory. Every DEA registrant who possesses any quantity of 
CUMYL-PEGACLONE must take an inventory of CUMYL-PEGACLONE on hand, 
pursuant to 21 U.S.C. 827 and in accordance with 21 CFR 1304.03, 
1304.04, and 1304.11(a) and (d).
    Any person who registers with DEA must take an initial inventory of 
all stocks of controlled substances (including CUMYL-PEGACLONE) on

[[Page 26916]]

hand on the date the registrant first engages in the handling of 
controlled substances, pursuant to 21 U.S.C. 827 and in accordance with 
21 CFR 1304.03, 1304.04, and 1304.11(a) and (b).
    After the initial inventory, every DEA registrant must take an 
inventory of all controlled substances (including CUMYL-PEGACLONE) on 
hand every two years, pursuant to 21 U.S.C. 827 and in accordance with 
21 CFR 1304.03, 1304.04, and 1304.11.
    7. Records and Reports. Every DEA registrant must maintain records 
and submit reports for CUMYL-PEGACLONE, or products containing CUMYL-
PEGACLONE, pursuant to 21 U.S.C. 827 and in accordance with 21 CFR 
1301.74(b) and (c), 1301.76(b), and parts 1304, 1312 and 1317. 
Manufacturers and distributors must submit reports regarding CUMYL-
PEGACLONE to the Automation of Reports and Consolidated Order System 
pursuant to 21 U.S.C. 827 and in accordance with 21 CFR parts 1304 and 
1312.
    8. 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.
    9. Importation and Exportation. All importation and exportation of 
CUMYL-PEGACLONE must comply with 21 U.S.C. 952, 953, 957, and 958, and 
in accordance with 21 CFR parts 1304 and 1312.
    10. Liability. Any activity involving CUMYL-PEGACLONE not 
authorized by, or in violation of, the CSA or its implementing 
regulations, is 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 final scheduling action 
is subject to formal rulemaking procedures performed ``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 procedures 
and 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, Overcriminalization in Federal 
Regulations.

Executive Order 12988, Civil Justice Reform

    This 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 rulemaking does not have federalism implications warranting 
the application of E.O. 13132. The rule does 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.

Executive Order 13175, Consultation and Coordination With Indian Tribal 
Governments

    This 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.

Paperwork Reduction Act of 1995

    This action does not impose a new collection or modify an existing 
collection of information under the Paperwork Reduction Act of 1995.\7\ 
Also, this rule does not impose new or modify existing recordkeeping or 
reporting requirements on state or local governments, individuals, 
businesses, or organizations. However, this rule would require 
compliance with the following existing OMB collections: 1117-0003, 
1117-0004, 1117-0006, 1117-0008, 1117-0009, 1117-0010, 1117-0012, 1117-
0014, 1117-0021, 1117-0023, 1117-0029, and 1117-0056. 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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    \7\ 44 U.S.C. 3501-3521.
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Regulatory Flexibility Act

    The Administrator of DEA, in accordance with the Regulatory 
Flexibility Act, 5 U.S.C. 601-612, has reviewed this final rule, and by 
approving it, certifies that it will not have a significant economic 
impact on a substantial number of small entities.
    DEA is placing the substance CUMYL-PEGACLONE (chemical name: methyl 
3,3-dimethyl-2-(1-(pent-4-en-1-yl)-1H-indazole-3-
carboxamido)butanoate), including its salts, isomers, and salts of 
isomers, in schedule I of the CSA to enable the United States to meet 
its obligations under the 1971 Convention. This action imposes the 
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.
    Based on the review of HHS's scientific and medical evaluation and 
all other relevant data, DEA determined that CUMYL-PEGACLONE has 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, this final rule 
will not have 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 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.

Congressional Review Act

    This rule is not a major rule as defined by the Congressional 
Review Act (CRA), 5 U.S.C. 804(2). However, pursuant to the CRA, DEA is 
submitting a copy of this rule to both Houses of Congress and to the 
Comptroller General.

Determination To Make Rule Effective Immediately

    The Administrative Procedure Act (APA) generally requires that 
rules enacted in accordance with the procedures of 5 U.S.C. 553 to be 
effective not less than 30 days after publication of the proposed 
rule.\8\ However, the APA provides three

[[Page 26917]]

exceptions for when an agency may make a rule effective sooner than 30 
days after publication, including if the agency finds for good cause 
why the rule should be effective sooner and publishes those reasons 
with the rule.\9\
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    \8\ 5 U.S.C. 553(d).
    \9\ 5 U.S.C. 553(d)(3).
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    DEA finds that there is good cause for this scheduling action to be 
immediately effective upon publication because a delay in the effective 
date is unnecessary and contrary to the public interest. First, it is 
unnecessary because CUMYL-PEGACLONE is currently listed in schedule I 
of the CSA under 21 U.S.C. 811(h).\10\ Second, as discussed in the 
temporary scheduling order and NPRM, CUMYL-PEGACLONE poses imminent 
hazard to public safety. Therefore, DEA believes it is unnecessary and 
contrary to the public interest to delay the effectiveness of this 
final rule by 30 days.\11\
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    \10\ Schedules of Controlled Substances: Temporary Placement of 
CUMYL-PEGACLONE, 4F-MDMB-BUTICA, ADB-4en-PINACA, CUMYL-PEGACLONE, 
5F-EDMB-PICA, and MMB-FUBICA into Schedule I, 88 FR 86040 (Dec. 12, 
2023); Schedules of Controlled Substances: Extension of Temporary 
Placement of CUMYL-PEGACLONE in Schedule I of the Controlled 
Substances Act, 90 FR 57356 (Dec. 11, 2025).
    \11\ See, e.g., Schedules of Controlled Substances: Placement of 
beta-Hydroxythiofentanyl in Schedule I, 84 FR 20023, 20027 (May 8, 
2019); Schedules of Controlled Substances: Placement of UR-144, 
XLR11, and AKB48 into Schedule I, 81 FR 29142, 29144 (May 11, 2016); 
accord Schedules of Controlled Substances: Placement of Seven 
Specific Fentanyl-Related Substances in Schedule I, 90 FR 44979 
(Sept. 18, 2025); Schedules of Controlled Substances: Placement of 
Nine Specific Fentanyl-Related Substances in Schedule I, 88 FR 85104 
(Dec. 7, 2023).
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List of Subjects in 21 CFR Part 1308

    Administrative practice and procedure, Drug traffic control, 
Reporting and record keeping requirements.
    For the reasons set out above, DEA amends 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. Amend Sec.  1308.11 by adding the new paragraph (d)(116) to read as 
follows:


Sec.  1308.11  Schedule I.

* * * * *
    (d) * * *

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                              * * * * * * *
(116) 5-Pentyl-2-(2-phenylpropan-2-yl)pyrido[4,3-b]indol-           7093
 1-one (other names: CUMYL-PEGACLONE; SGT-151)..........
 
                              * * * * * * *
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* * * * *

Signing Authority

    This document of the Drug Enforcement Administration was signed on 
May 6, 2026, by DEA 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. 2026-09566 Filed 5-12-26; 8:45 am]
BILLING CODE 4410-09-P


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Indexed from Federal Register on May 13, 2026.

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.