[Federal Register Volume 87, Number 108 (Monday, June 6, 2022)]
[Rules and Regulations]
[Pages 34166-34169]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-11933]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-568]


Schedules of Controlled Substances: Placement of Methoxetamine 
(MXE) 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 2-(ethylamino)-2-(3-methoxyphenyl)cyclohexan-1-
one (methoxetamine, MXE), 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, in 
schedule I of the Controlled Substances Act 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, methoxetamine.

DATES: Effective July 6, 2022.

FOR FURTHER INFORMATION CONTACT: Terrence L. Boos, Drug & 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), February 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 specific schedule, the Secretary of the Department Health 
and Human Services (HHS),\1\ after consultation with the Attorney 
General, shall 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 of HHS did not consult 
with the Attorney General, and

[[Page 34167]]

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), 
the Attorney General may, by rule, schedule or transfer between any 
schedules any drug or other substance, if he finds that such drug or 
other substance has a potential for abuse, and makes the findings 
prescribed by 21 U.S.C. 812(b) to schedule the drug or other substance. 
The Attorney General has delegated this scheduling authority to the 
Administrator of the Drug Enforcement Administration (DEA).\3\
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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 
Controlled Substances Act, with the concurrence of NIDA. 50 FR 9518 
(March 8, 1985). The Secretary of HHS 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).
    \3\ 28 CFR 0.100.
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Background

    Methoxetamine, also known as 2-(ethylamino)-2-(3-
methoxyphenyl)cyclohexan-1-one or 2-(3-methoxyphenyl)-2-(N-
ethylamino)cyclohexanone or MXE, belongs to the arylcyclohexylamine 
class of drugs with dissociative anesthetic and hallucinogenic 
properties, similar to phencyclidine (PCP), a schedule II controlled 
substance, and ketamine, a schedule III controlled substance. 
Methoxetamine has no approved medical use in the United States. In 
March 2016, the Commission on Narcotic Drugs (CND) voted to place 
methoxetamine in Schedule II of the 1971 Convention (CND Dec/59/6) 
during its 59th Session due to its dependence and abuse potential.

DEA and HHS Eight Factor Analyses

    On April 14, 2018, in accordance with 21 U.S.C. 811(b), and in 
response to DEA's December 30, 2014, request and April 14, 2017, 
submission of additional data, HHS provided to DEA a scientific and 
medical evaluation and scheduling recommendation for methoxetamine. 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-568.

Notice of Proposed Rulemaking To Schedule Methoxetamine

    On December 7, 2021 (86 FR 69187), DEA published a notice of 
proposed rulemaking (NPRM) to permanently control methoxetamine in 
schedule I. Specifically, DEA proposed to add methoxetamine to the 
hallucinogenic substances list 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 February 7, 
2022. No requests for such a hearing were received by DEA. The NPRM 
also provided an opportunity for interested persons to submit comments 
on or before February 7, 2022.

Comments Received

    DEA received one comment that recognized the dangers and public 
health risks, and fully supported the placement of methoxetamine in 
schedule I.
    DEA Response: DEA appreciates this comment in support of this 
rulemaking.

Scheduling Conclusion

    After consideration of the public comment, scientific and medical 
evaluation and accompanying recommendation of 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 
methoxetamine. DEA is permanently scheduling methoxetamine as a 
controlled substance under the CSA.

Determination of Appropriate Schedule

    The CSA establishes five schedules of controlled substances known 
as schedules I, II, III, IV, and V. The CSA also specifies the findings 
required 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 Acting 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) Methoxetamine has a high potential for abuse that is comparable 
to other scheduled 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);
    (2) Methoxetamine has no currently accepted medical use in 
treatment in the United States. There are no approved New Drug 
Applications for methoxetamine and no known therapeutic applications 
for methoxetamine in the United States. Therefore, methoxetamine has no 
currently accepted medical use in treatment in the United States.\4\
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    \4\ Although there is no evidence suggesting that methoxetamine 
has a currently accepted medical use in treatment in the United 
States, it bears noting that a drug cannot be found to have such 
medical use unless DEA concludes that it satisfies a five-part test. 
Specifically, with respect to a drug that has not been approved by 
FDA, to have a currently accepted medical use in treatment in the 
United States, all of the following must be demonstrated: 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. 57 FR 10499 (1992), pet. for rev. denied, Alliance for 
Cannabis Therapeutics v. DEA, 15 F.3d 1131, 1135 (D.C. Cir. 1994).
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    (3) There is a lack of accepted safety for use of methoxetamine 
under medical supervision. Because methoxetamine 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. Therefore, there 
is a lack of accepted safety for use of methoxetamine under medical 
supervision.
    Based on these findings, the Administrator of DEA concludes that 
methoxetamine 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.\5\
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    \5\ 21 U.S.C. 812(b)(1).
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Requirements for Handling Methoxetamine

    Methoxetamine 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, methoxetamine must be registered 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 methoxetamine and is not registered with DEA must 
submit an application for registration and may not continue to handle 
methoxetamine, 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.

[[Page 34168]]

    2. Disposal of stocks. Any person unwilling or unable to obtain a 
schedule I registration must surrender or transfer all quantities of 
currently held methoxetamine to a person registered with DEA before the 
effective date of a final scheduling action in accordance with all 
applicable Federal, State, local, and tribal laws. Methoxetamine 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. Methoxetamine 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 
methoxetamine 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 methoxetamine must comply with 21 U.S.C. 825, 
and be in accordance with 21 CFR part 1302.
    5. Quota. Only registered manufacturers are permitted to 
manufacture methoxetamine 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 
methoxetamine must take an inventory of methoxetamine 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 methoxetamine) 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 methoxetamine) 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 methoxetamine, or products containing 
methoxetamine, pursuant to 21 U.S.C. 827 and in accordance with 21 CFR 
1301.74(b) and (c) and parts 1304, 1312 and 1317. Manufacturers and 
distributors must submit reports regarding methoxetamine 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 methoxetamine 
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 
methoxetamine must comply with 21 U.S.C. 952, 953, 957, and 958, and in 
accordance with 21 CFR part 1312.
    10. Liability. Any activity involving methoxetamine 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 and 13563 (Regulatory Planning and Review; 
Improving Regulation and 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 pursuant to 
section 3(d)(1) of Executive Order (E.O.) 12866 and the principles 
reaffirmed in E.O. 13563.

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 proposed 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 of information 
requirement under the Paperwork Reduction Act of 1995.\6\
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    \6\ 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 methoxetamine (chemical name: 2-
(ethylamino)-2-(3-methoxyphenyl)cyclohexan-1-one)), 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, 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/or 
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 methoxetamine.
    Based on the review of HHS's scientific and medical evaluation and 
all other relevant data, DEA determined that methoxetamine 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. DEA's research confirms that there is no legitimate 
commercial market for methoxetamine in the United States. Therefore, 
this final rule will not have a significant effect on a substantial 
number of small entities.

Unfunded Mandates Reform Act of 1995

    On the basis of information contained in the ``Regulatory 
Flexibility Act'' section above, DEA has determined pursuant to the 
Unfunded Mandates Reform Act (UMRA) of 1995 (2 U.S.C. 1501 et seq.) 
that this final rule 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

[[Page 34169]]

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 the final 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, 21 CFR part 1308 is amended as 
follows:

PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES

0
1. The authority citation for 21 CFR part 1308 continues to read as 
follows:

    Authority:  21 U.S.C. 811, 812, 871(b), 956(b), unless otherwise 
noted.

0
2. In Sec.  1308.11, add paragraph (d)(100) to read as follows:


Sec.  1308.11   Schedule I.

* * * * *
    (d) * * *

(100) 2-(ethylamino)-2-(3-methoxyphenyl)cyclohexan-1-one            7286
 (methoxetamine, MXE)............................................
 

* * * * *

Anne Milgram,
Administrator.
[FR Doc. 2022-11933 Filed 6-3-22; 8:45 am]
BILLING CODE 4410-09-P