[Federal Register Volume 91, Number 55 (Monday, March 23, 2026)]
[Rules and Regulations]
[Pages 13733-13736]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2026-05618]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-1146]
Schedules of Controlled Substances: Placement of 3-
Methoxyphencyclidine (1-(1-(3-Methoxyphenyl)cyclohexyl)piperidine) 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 substance 3-methoxyphencyclidine (1-(1-(3-
methoxyphenyl)cyclohexyl)piperidine; 3-MeO-PCP), 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 3-MeO-PCP.
DATES: Effective date: April 22, 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 schedules 3-methoxyphencyclidine (1-
(1-(3-methoxyphenyl)cyclohexyl)piperidine; 3-MeO-PCP) in schedule I of
the Controlled Substances Act (CSA), including its salts, isomers, and
salts of isomers whenever the existence of such salts, isomers, and
salts of isomers is possible within the specific chemical designation.
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 13734]]
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 Food and Drug Administration (FDA) and the National Institute
on Drug Abuse (NIDA), FDA acts as the lead agency within HHS in
carrying out the Secretary's scheduling responsibilities under the
CSA, with the concurrence of NIDA. Memorandum of Understanding with
the National Institute on Drug Abuse, 50 FR 9518 (Mar. 8, 1985). The
Secretary has delegated to the Assistant Secretary for Health of HHS
(Assistant Secretary) the authority to make domestic drug scheduling
recommendations. Comprehensive Drug Abuse Prevention and Control Act
of 1970, Public Law 91-513, As Amended; Delegation of Authority, 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 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
3-MeO-PCP is an arylcyclohexylamine that has been identified in the
United States' illicit drug market. It is a 3-methoxy derivative of
phencyclidine (PCP; schedule II substance) and produces similar
hallucinogenic effects as PCP. 3-MeO-PCP has no approved medical use in
the United States.
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 in April 2021, voted
to place 3-MeO-PCP in Schedule II of the 1971 Convention (CND Decision
64/4). As a signatory to the 1971 Convention, the United States is
required, by scheduling under the CSA, to place appropriate controls on
3-MeO-PCP 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 3-MeO-PCP, 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 3-MeO-PCP. Such scheduling would
satisfy the United States' international obligations.
DEA and HHS Eight-Factor Analyses
In a letter dated November 15, 2022, in accordance with 21 U.S.C.
811(b), and in response to DEA's October 25, 2021, request, the
Department of Health and Human Services (HHS) provided to DEA a
scientific and medical evaluation and scheduling recommendation for 3-
MeO-PCP. 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. 812(b)(1), that this
substance warrants control in schedule I. Both DEA's 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-1146.
Notice of Proposed Rulemaking to Schedule 3-MeO-PCP
On June 10, 2025, DEA published a notice of proposed rulemaking
(NPRM) to permanently control 3-MeO-PCP in schedule I.\3\ Specifically,
DEA proposed to add 3-MeO-PCP 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's regulations on or before July 10, 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 July 10, 2025.
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\3\ Schedules of Controlled Substances: Placement of 3-
Methoxyphencyclidine (1-(1-(3-methoxyphenyl)cyclohexyl)piperidine)
in Schedule I, 90 FR 24370 (June 10, 2025).
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Comments Received
DEA received one anonymous comment in response to the NPRM for the
placement of 3-MeO-PCP into schedule I of the CSA. The commenter
asserted that the recreational use of 3-MeO-PCP was ``very small'' and
that the current ``primary use seems to be for legitimate research.''
The commenter suggested that DEA should wait until there is more
information and research into the potential medical use before making
the determination for placement into schedule I.
DEA Response: DEA appreciates this comment and would like to
provide further clarification regarding the control of 3-MeO-PCP. 3-
MeO-PCP has been placed under international control. In order to comply
with treaty obligations, DEA must place 3-MeO-PCP under the most
appropriate schedule, taking into consideration all appropriate
scientific data. Additionally, as set forth in the NPRM, 3-MeO-PCP has
no currently accepted medical use in treatment in the United States.
Therefore, 3-MeO-PCP 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 research on these substances.\4\ Those wishing to conduct
research on schedule I substances must comply with the processes and
requirements for registration with DEA involving schedule I
substances.\5\
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\4\ 21 U.S.C. 822(h); 21 U.S.C. 823(g)(2)(A); 21 U.S.C. 823(n).
\5\ https://apps.deadiversion.usdoj.gov/webforms2/spring/login?execution=e1s1.
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Scheduling Conclusion
After consideration of the public comment, the scientific and
medical evaluation and accompanying scheduling recommendations from
HHS, and its own eight-factor evaluation, DEA finds that these facts
and all relevant data constitute substantial evidence of potential for
abuse of 3-MeO-PCP. As such, DEA is permanently scheduling 3-MeO-PCP as
a controlled substance under schedule I of the CSA. The permanent
scheduling of 3-MeO-PCP 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, III, IV, and V. The CSA also outlines the findings
required to place a drug or other substance in any particular schedule,
per 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) 3-MeO-PCP has a high potential for abuse that is comparable to
other controlled substances, such as the ethylamine analog of
phencyclidine (PCE; schedule I), the thiophene analog of phencyclidine
(TCP; schedule I), phencyclidine (PCP, schedule II), and ketamine
(schedule III). 3-MeO-PCP, similar to PCP and ketamine, produces
dissociative anesthetic and hallucinogenic effects.
(2) 3-MeO-PCP has no currently accepted medical use in treatment in
the United States. In HHS' 2022 recommendation to control 3-MeO-PCP, it
was noted there are no approved New Drug Applications for 3-MeO-PCP and
no known therapeutic applications for 3-MeO-PCP in the United States.
DEA is not aware of any other evidence suggesting that 3-MeO-PCP has a
[[Page 13735]]
currently accepted medical use in treatment in the United States.\6\
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\6\ 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 substance
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.
See Marijuana Scheduling Petition; Denial of Petition; Remand, 57 FR
10499 (Mar. 26, 1992), pet. for rev. denied, All. 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'
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 3-MeO-PCP
or that the use of 3-MeO-PCP 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 3-MeO-PCP under
medical supervision. Because 3-MeO-PCP 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 3-
MeO-PCP, 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 3-MeO-PCP
3-MeO-PCP 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, 3-MeO-PCP 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 3-MeO-PCP and is not registered with DEA must submit an
application for registration and may not continue to handle 3-MeO-PCP,
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 3-MeO-PCP 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. 3-MeO-PCP 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. 3-MeO-PCP 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 3-MeO-PCP
must comply with the employee screening requirements of 21 CFR 1301.90-
1301.93.
4. Labeling and Packaging. All labels, labeling, and packaging for
commercial containers of 3-MeO-PCP 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 3-MeO-PCP 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 3-
MeO-PCP must take an inventory of 3-MeO-PCP 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 3-MeO-PCP) 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 3-MeO-PCP) 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 3-MeO-PCP, or products containing 3-MeO-PCP,
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 3-MeO-PCP to the Automation
of Reports and Consolidated Orders 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 3-MeO-PCP 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
3-MeO-PCP 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 3-MeO-PCP 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 of Federal
Regulations.
[[Page 13736]]
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 through 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 3-MeO-PCP (chemical name: 1-(1-(3-
methoxyphenyl)cyclohexyl)piperidine), 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 3-MeO-PCP.
Based on the review of HHS' scientific and medical evaluation and
all other relevant data, DEA determined that 3-MeO-PCP 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 3-MeO-PCP 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 3-MeO-PCP
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 rule does not impose a new collection or modify an existing
collection of information requirement under the Paperwork Reduction Act
of 1995.\7\ This action does not impose new or modify existing
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 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
The Office of Information and Regulatory Affairs has determined
that 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)(109) to read as follows:
Sec. 1308.11 Schedule I.
* * * * *
(d) * * *
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(109) 3-methoxyphencyclidine (Other names: 1-(1-(3- 7457
methoxyphenyl)cyclohexyl)piperidine; 3-MeO-PCP)...............
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* * * * *
Signing Authority
This document of the Drug Enforcement Administration was signed on
March 17, 2026, 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.
Gregory Aul,
Federal Register Liaison Officer, Drug Enforcement Administration.
[FR Doc. 2026-05618 Filed 3-20-26; 8:45 am]
BILLING CODE 4410-09-P