[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