Rule2025-15177
Specific Listing for Dipentylone, a Currently Controlled Schedule I Substance
Primary source
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Published
August 8, 2025
Effective
August 8, 2025
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
The Drug Enforcement Administration (DEA) is establishing a specific listing and DEA Controlled Substances Code Number (drug code) for 1-(1,3-benzodioxol-5-yl)-2-(dimethylamino)pentan-1-one (dipentylone; N,N-dimethylpentylone) in schedule I of the Controlled Substances Act (CSA). Although dipentylone is not specifically listed in schedule I of the CSA with its own unique drug code, it is a schedule I controlled substances in the United States because it is a positional isomer of N-ethylpenthylone (controlled August 31, 2018), which is a schedule I hallucinogen. Therefore, DEA is simply amending the schedule I hallucinogenic substances list in its regulations to separately include dipentylone.
Full Text
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<title>Federal Register, Volume 90 Issue 151 (Friday, August 8, 2025)</title>
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[Federal Register Volume 90, Number 151 (Friday, August 8, 2025)]
[Rules and Regulations]
[Pages 38396-38398]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-15177]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-1390]
Specific Listing for Dipentylone, a Currently Controlled Schedule
I Substance
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Final rule.
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SUMMARY: The Drug Enforcement Administration (DEA) is establishing a
specific listing and DEA Controlled Substances Code Number (drug code)
for 1-(1,3-benzodioxol-5-yl)-2-(dimethylamino)pentan-1-one
(dipentylone; N,N-dimethylpentylone) in schedule I of the Controlled
Substances Act (CSA). Although dipentylone is not specifically listed
in schedule I of the CSA with its own unique drug code, it is a
schedule I controlled substances in the United States because it is a
positional isomer of N-ethylpenthylone (controlled August 31, 2018),
which is a schedule I hallucinogen. Therefore, DEA is simply amending
the schedule I hallucinogenic substances list in its regulations to
separately include dipentylone.
DATES: Effective August 8, 2025.
FOR FURTHER INFORMATION CONTACT: Dr. Terrence L. Boos, Drug and
Chemical Evaluation, Diversion Control Division, Drug Enforcement
Administration; Telephone: (571) 362-3249. As required by 5 U.S.C.
553(b)(4), a summary of this rule may be found in the docket for this
rulemaking at <a href="http://www.regulations.gov">www.regulations.gov</a>.
SUPPLEMENTARY INFORMATION:
Dipentylone Control
Dipentylone (also known as, 1-(1,3-benzodioxol-5-yl)-2-
(dimethylamino)pentan-1-one and N,N-dimethylpentylone) is a chemical
substance that is structurally related to N-ethylpentylone (also known
as, 1-(1,3-benzodioxol-5-yl)-2-(ethylamino)pentan-1-one). N-
Ethylpentylone is listed as a hallucinogenic substance in schedule I at
21 CFR 1308.11(d)(86). As stated in subsection 1308.11(d), a listed
hallucinogenic substance includes ``any of 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,'' and the term ``isomer'' includes the ``optical,
position[al,] and geometric isomers.''
When compared to the chemical structure of N-ethylpentylone,
dipentylone meets the definition of a ``positional isomer'' in 21 CFR
1300.01(b), which cross-references the term ``positional isomer'' in 21
CFR 1308.11(d). Both N-ethylpentylone and dipentylone possess the same
molecular formula and core structure, and they have the same functional
groups. They only differ from one another by a rearrangement of an
alkyl moiety between functional groups that does not create new
chemical functionalities or destroy existing chemical functionalities.
Accordingly, under 21 CFR 1308.11(d), dipentylone, as a positional
isomer of N-ethylpentylone, has been and continues to be a schedule I
controlled substance.\1\
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\1\ N-Ethylpentylone (and its isomers) has been subject to
schedule I controls since August 31, 2018, see Schedules of
Controlled Substances: Temporary Placement of N-Ethylpentylone in
Schedule I, 83 FR 44474 (Aug. 31, 2018), a one-year extension of
that order, see Schedules of Controlled Substances: Extension of
Temporary Placement of N-Ethylpentylone in Schedule I of the
Controlled Substances Act, 85 FR 52915 (Aug. 31, 2020), and then
permanently placed under schedule I, see Schedules of Controlled
Substances: Placement of N-Ethylpentylone in Schedule I, 86 FR
31427-31429 (June 14, 2021).
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Legal Authority
This rule is prompted by a letter dated June 6, 2024, in which the
Secretariat of the United Nations informed the United States government
that dipentylone had
[[Page 38397]]
been added to Schedule II of the Convention on Psychotropic Substances
of 1971 (1971 Convention), February 21, 1971, 32 U.S.T. 543, 1019
U.N.T.S. 175, as amended. This letter was provoked by a decision at the
67th Session of the Commission on Narcotic Drugs (CND) in March 2024 to
schedule dipentylone under Schedule II of the 1971 Convention (CND
Decision 67/3). Preceding this decision, the Food and Drug
Administration (FDA), on behalf of the Secretary of Health and Human
Services and pursuant to 21 U.S.C. 811(d)(2), published two notices in
the Federal Register with an opportunity to submit domestic information
and opportunity to comment on this action.\2\ In the February 8, 2024
notice, FDA noted that dipentylone was already controlled in schedule I
of the Controlled Substances Act (CSA) as a positional isomer,\3\ and
the February 2024 notice stated that no additional permanent controls
for dipentylone under the CSA would be necessary to fulfill the United
States' obligations as a party to the 1971 Convention.
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\2\ See International Drug Scheduling; Convention on
Psychotropic Substances; Single Convention on Narcotic Drugs;
Bromazolam; Flubromazepam; Butonitazene; 3-Chloromethcathinone (3-
CMC); Dipentylone; 2-Fluorodeschloroketamine (2-FDCK); Nitrous Oxide
(N2O); Carisoprodol; Request for Comments, 88 FR 52179 (Aug. 7,
2023); International Drug Scheduling; Convention on Psychotropic
Substances; Single Convention on Narcotic Drugs; World Health
Organization; Scheduling Recommendations; Butonitazene; 3-
Chloromethcathinone; Dipentylone; 2-Fluorodeschloroketamine;
Bromazolam; Request for Comments, 89 FR 8683 (Feb. 8, 2024).
\3\ In the Feb. 8, 2024 notice (89 FR 8683), dipentylone was
incorrectly identified as a positional isomer of Pentylone.
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As discussed above in this final rule, dipentylone--by virtue of
being a positional isomer of N-ethylpentylone--has been controlled in
schedule I of the CSA temporarily since August 31, 2018,\4\ and
permanently since June 14, 2021.\5\ Therefore, all regulations and
criminal sanctions applicable to schedule I substances have been and
remain applicable to dipentylone. Drugs controlled in schedule I of the
CSA satisfy and exceed the required domestic controls of Schedule II
under Article 2 of the 1971 Convention.
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\4\ See Schedules of Controlled Substances: Temporary Placement
of N-Ethylpentylone in Schedule I, 83 FR 44474 (Aug. 31, 2018).
\5\ See Schedules of Controlled Substances: Placement of N-
Ethylpentylone in Schedule I, 86 FR 31427 (June 14, 2021).
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Effect of Action
As discussed above, this rule does not affect the continuing status
of dipentylone as a schedule I controlled substance in any way. This
action, as an administrative matter, establishes a separate, specific
listing for dipentylone in schedule I of the CSA and assigns a DEA
controlled substances code number (drug code) for this substance. This
action will allow DEA to establish an aggregate production quota and
grant individual manufacturing and procurement quotas to DEA-registered
manufacturers of dipentylone, who had previously been granted
individual quotas for such purposes under the drug code for N-
ethylpentylone.
Regulatory Analyses
Administrative Procedure Act
An agency may find good cause to exempt a rule from certain
provisions of the Administrative Procedure Act (APA), including notice
of proposed rulemaking and the opportunity for public comment, if it is
determined to be unnecessary, impracticable, or contrary to the public
interest.\6\
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\6\ 5 U.S.C. 553.
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Pursuant to 5 U.S.C. 553(b)(B), DEA finds that notice-and-comment
rulemaking is unnecessary as dipentylone is currently controlled in
schedule I as a positional isomer of N-ethylpentylone. The addition of
a separate listing for dipentylone and its DEA controlled substances
code number in the list of schedule I substances in 21 CFR 1308.11(d)
makes no substantive difference in the status of this drug as a
schedule I controlled substance, but instead is ``a minor or merely
technical amendment in which the public is not particularly
interested.'' \7\ This rule is a ``technical amendment'' to 21 CFR
1308.11(d) as it is ``insignificant in nature and impact, and
inconsequential to the industry and public.'' Therefore, DEA finds that
publishing a notice of proposed rulemaking and soliciting public
comment are unnecessary and good cause exists to dispense with these
procedures.
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\7\ National Nutritional Foods Ass'n v. Kennedy, 572 F.2d 377,
385 (2d Cir. 1978) (quoting S. Rep. No. 79-752, at 200 (1945)). See
also Utility Solid Waste Activities Group v. E.P.A., 236 F.3d 749,
755 (D.C. Cir. 2001) (the ``unnecessary'' prong ``is confined to
those situations in which the administrative rule is a routine
determination, insignificant in nature and impact, and
inconsequential to the industry and public'') (internal quotations
and citation omitted).
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In addition, DEA is concerned that delaying the effective date of
this rule potentially could cause confusion regarding the regulatory
status of dipentylone. With dipentylone currently controlled as a
schedule I controlled substance as a positional isomer, and with no
additional requirements being imposed through this action, DEA finds
good cause exists to make this rule effective immediately upon
publication in accordance with 5 U.S.C. 553(d)(3).
Executive Orders 12866, 13563, 14192, and 14294 (Regulatory Review)
This regulation has been drafted and reviewed in accordance with
the principles of Executive Orders (E.O.) 12866, 13563, and 14192. This
rule is not a significant regulatory action under section 3(f) of E.O.
12866. Dipentylone is already a controlled substance in the United
States under schedule I, as it is a positional isomer of the schedule I
hallucinogen N-ethylpentylone. In this final rule, DEA is making an
administrative change by amending its regulations to separately list
dipentylone in schedule I and to assign a DEA controlled substances
code number to this substance. A separate listing for dipentylone and
its DEA controlled substances code number will not alter the status of
this substance as a schedule I controlled substance. Accordingly, this
rule has not been reviewed by the Office of Management and Budget
(OMB). DEA scheduling actions are not subject to E.O. 14192, Unleashing
Prosperity Through Deregulation.
Executive Order 14294 specifies that all notices of proposed
rulemaking (NPRMs) and final rules published in the Federal Register,
the violation of which may constitute criminal regulatory offenses,
should include a statement identifying that the rule or proposed rule
is a criminal regulatory offense, the authorizing statute, and the mens
rea requirement for each element of the offense. This final rule does
not involve a criminal regulatory offense and thus E.O. 14294 does not
apply.
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, 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.
[[Page 38398]]
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.
Regulatory Flexibility Act
The Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612) applies to
rules that are subject to notice and comment under section 553(b) of
the APA or other laws. As noted in the above section regarding the
applicability of the APA, DEA determined that there was good cause to
exempt this final rule from notice and comment. Consequently, the RFA
does not apply.
Paperwork Reduction Act of 1995
This action does not impose a new collection of information
requirement under the Paperwork Reduction Act of 1995.\8\ This action
would not impose recordkeeping or reporting requirements on State or
local governments, individuals, businesses, or organizations. 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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\8\ 44 U.S.C. 3501-3521.
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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. However, pursuant to the CRA, DEA is
submitting a copy of this rule to both Houses of Congress and to the
Comptroller General.
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 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 paragraph (d)(105) to read as follows:
Sec. 1308.11 Schedule I.
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(105) 1-(1,3-benzodioxol-5-yl)-2-(dimethylamino)pentan-1- 7552
one (other names: dipentylone; N,N-dimethylpentylone)..
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Signing Authority
This document of the Drug Enforcement Administration was signed on
August 5, 2025, by Administrator Terrance 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. 2025-15177 Filed 8-7-25; 8:45 am]
BILLING CODE 4410-09-P
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</html>Indexed from Federal Register on August 8, 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.