[Federal Register Volume 90, Number 219 (Monday, November 17, 2025)]
[Rules and Regulations]
[Pages 51102-51105]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-20004]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-1246]
Schedules of Controlled Substances: Placement of 4-
Chloromethcathinone 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 4-chloromethcathinone (4-CMC, 1-(4-chlorophenyl)-
2-(methylamino)propan-1-one), including its salts, isomers, and salts
of isomers, 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 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 4-
chloromethcathinone.
DATES: Effective date: December 17, 2025.
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:
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 Controlled Substances Act (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.\2\ In the
event that the Secretary did not so 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 Drug Enforcement Administration
(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 he 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
4-Chloromethcathinone (4-CMC) is a central nervous system stimulant
that shares structural and pharmacological similarities with schedule I
synthetic cathinones such as 4-methylethcathinone (4-MEC), 4-
fluoromethcathinone (4-FMC), and 3-fluoromethcathinone (3-FMC), and
schedule II stimulants such as amphetamine and methamphetamine. On May
7, 2020, the Secretary-General of the United Nations advised the
Secretary of State of the United States that the Commission on Narcotic
Drugs (CND) voted to place 4-CMC in Schedule II of the 1971 Convention
during its 63rd session held in March 2020 (CND Dec/63/9).
As a signatory to the 1971 Convention, the United States is
required, by scheduling under the CSA, to place appropriate controls on
4-CMC 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 for 4-CMC, discussed in the above legal authority
section, were not followed, DEA is utilizing the procedures for
permanent scheduling set forth in 21 U.S.C. 811(a) and (b) to control
4-CMC. Such scheduling would satisfy the United States' international
obligations.
DEA and HHS Eight Factor Analyses
In a letter dated December 22, 2022, in accordance with 21 U.S.C.
811(b), and in response to DEA's May 12, 2021, request, Department of
Health and Human Services (HHS) provided to DEA a scientific and
medical evaluation and scheduling recommendation for 4-CMC. 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 this substance warrants
control in schedule I. Both DEA and HHS Eight-Factor analyses are
available in their entirety under the tab Supporting Documents of the
public docket for this action at https://www.regulations.gov under
docket number DEA-1246.
Notice of Proposed Rulemaking to Schedule 4-CMC
On December 30, 2024, DEA published a notice of proposed rulemaking
(NPRM) to permanently control 4-CMC in schedule I.\3\ Specifically, DEA
proposed to add 4-CMC 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 29, 2025. DEA did not receive any requests for such a
hearing. The NPRM also provided an opportunity for interested persons
to submit comments on or before January 29, 2025.
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\3\ Schedules of Controlled Substances: Placement of 4-
Chloromethcathinone in Schedule I, 89 FR 106376 (Dec. 30, 2024).
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Comments Received
DEA received one comment in response to the NPRM for the placement
of 4-CMC into schedule I of the CSA. The submission was from an
[[Page 51103]]
anonymous commenter against the placement of 4-CMC in schedule I of the
CSA in part due to potential medical use of this substance that has yet
to be investigated since it is a new substance. This commenter opined
that adding 4-CMC to schedule I would make it difficult to do future
research for potential medical use. The commenter also made a
comparison of the fewer number of law enforcement encounters to
fentanyl and noted that other substances that are not controlled under
the CSA have a higher prevalence of recreational use.
DEA Response: DEA appreciates this comment and would like to
provide further clarification regarding the control of 4-CMC. 4-CMC has
been placed under international control. In order to comply with treaty
obligations, DEA must place 4-CMC under the most appropriate schedule,
taking into consideration all appropriate scientific data.
Additionally, as set forth in the NPRM, 4-CMC has no currently accepted
medical use in treatment in the United States, nor were there any New
Drug Applications. Therefore, 4-CMC must be placed in schedule I of the
CSA along with other substances which have no currently accepted
medical use, lack accepted safety for use under medical supervision,
and possess a high potential for abuse. With respect to research for
potential medical use, the placement of substances in schedule I of the
CSA does not preclude academic research on these substances.\4\ DEA
registrants wishing to conduct research on schedule I substances may
apply for permission to do so through the schedule I researcher
registration program.\5\
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\4\ 21 U.S.C. 823(g)(2)(A).
\5\ https://apps.deadiversion.usdoj.gov/webforms2/spring/login?execution=e1s1.
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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 4-CMC. As such, DEA is permanently scheduling 4-CMC as a
controlled substance under schedule I of the CSA. The permanent
scheduling of 4-CMC 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) 4-CMC has a high potential for abuse that is comparable to
other scheduled substances, such as schedule I synthetic cathinones,
methamphetamine, and MDMA.
(2) 4-CMC has no currently accepted medical use in treatment in the
United States. In HHS' 2022 recommendation to control 4-CMC, it was
noted there are no approved New Drug Applications for 4-CMC and no
known therapeutic applications for 4-CMC in the United States. DEA is
not aware of any other evidence suggesting that 4-CMC has a currently
accepted medical use in treatment in the United States.\6\
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\6\ When placing a substance in schedule I, 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). There is no
evidence suggesting that 4-CMC has a currently accepted medical use
in treatment in the United States. To determine whether a drug or
other substance has a currently accepted medical use, DEA has
traditionally applied a five-part test to a drug or substance that
has not been approved by the FDA: i. The drug's chemistry must be
known and reproducible; ii. there must be adequate safety studies;
iii. there must be adequate and well-controlled studies proving
efficacy; iv. the drug must be accepted by qualified experts; and v.
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. 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
4-CMC or that the use of 4-CMC is recognized by entities that
regulate the practice of medicine under either the traditional five-
part test or the two-part test.
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(3) There is a lack of accepted safety for use of 4-CMC under
medical supervision. Because 4-CMC 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 4-
CMC, 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 4-CMC
4-CMC 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, 4-CMC 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 4-CMC and is not registered with DEA must submit an application
for registration and may not continue to handle 4-CMC, unless DEA has
approved that application for registration pursuant to 21 U.S.C. 822,
823, 957, 958, and in accordance with 21 CFR parts 1301 and 1312.
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 4-CMC 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. 4-CMC 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. 4-CMC 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, as of the effective date of
this final scheduling action. Non-practitioners handling 4-CMC must
comply with the employee
[[Page 51104]]
screening requirements of 21 CFR 1301.90 through 1301.93.
4. Labeling and Packaging. All labels, labeling, and packaging for
commercial containers of 4-CMC 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 4-CMC 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 4-
CMC must take an inventory of 4-CMC 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 4-CMC) on 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 4-CMC) 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 4-CMC, or products containing 4-CMC, 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 4-CMC 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 4-CMC 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
4-CMC 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 4-CMC 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, and 14192 (Regulatory Review)
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. DEA scheduling actions are not subject to E.O. 14192,
Unleashing Prosperity Through Deregulation.
Executive Order 14294 (Overcriminalization of Federal Regulations)
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.
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 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 4-CMC (chemical name: 1-(4-
chlorophenyl)-2-(methylamino)propan-1-one), 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 4-CMC.
Based on the review of HHS's scientific and medical evaluation and
all other relevant data, DEA determined that 4-CMC 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 4-CMC 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 4-CMC from
legitimate suppliers. Therefore, this final rule will not have a
significant economic impact on a substantial number of small entities.
Paperwork Reduction Act of 1995
This action does not impose a new collection of information
requirement under the Paperwork Reduction Act of 1995.\7\ This action
would not impose recordkeeping or reporting requirements on State or
local governments, individuals, businesses, or organizations. However,
this rule requires 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
[[Page 51105]]
displays a currently valid OMB control number.
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\7\ 44 U.S.C. 3501 through 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 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. Amend Sec. 1308.11 by adding paragraph (d)(106) to read as follows:
Sec. 1308.11 Schedule I.
* * * * *
(d) * * *
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(106) 4-Chloromethcathinone (4-CMC, 1-(4-chlorophenyl)-2- 1239
(methylamino)propan-1-one).............................
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* * * * *
Signing Authority
This document of the Drug Enforcement Administration was signed on
October 1, 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. 2025-20004 Filed 11-14-25; 8:45 am]
BILLING CODE 4410-09-P