3-Methoxyphencyclidine Placed in Schedule I

Content

ACTION:

Final rule.

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

  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.

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.

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)

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

  currently accepted medical use in treatment in the United States. [(6)]()

(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.

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.

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

Regulatory Text 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.

1. Amend § 1308.11 by adding paragraph (d)(109) to read as follows:

§ 1308.11 Schedule I.

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(d) * * *

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| (109) 3-methoxyphencyclidine (Other names: 1-(1-(3-methoxyphenyl)cyclohexyl)piperidine; 3-MeO-PCP) | 7457 |

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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

Footnotes

(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).

(3) Schedules of Controlled Substances: Placement of 3-Methoxyphencyclidine (1-(1-(3-methoxyphenyl)cyclohexyl)piperidine) in Schedule
I, 90 FR 24370 (June 10, 2025).

(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.

(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.

(7) 44 U.S.C. 3501 through 3521.

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