Rule2022-26805
Schedules of Controlled Substances: Placement of Methiopropamine in Schedule I
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
December 9, 2022
Effective
January 9, 2023
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
With the issuance of this final rule, the Drug Enforcement Administration places N-methyl-1-(thiophen-2-yl)propan-2-amine (methiopropamine), including its salts, isomers, and salts of isomers in schedule I of the Controlled Substances Act. This action is being taken 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 methiopropamine.
Full Text
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<title>Federal Register, Volume 87 Issue 236 (Friday, December 9, 2022)</title>
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[Federal Register Volume 87, Number 236 (Friday, December 9, 2022)]
[Rules and Regulations]
[Pages 75470-75473]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-26805]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-737]
Schedules of Controlled Substances: Placement of Methiopropamine
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 N-methyl-1-(thiophen-2-yl)propan-2-amine
(methiopropamine), including its salts, isomers, and salts of isomers
in schedule I of the Controlled Substances Act. This action is being
taken 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 methiopropamine.
DATES: Effective date: January 9, 2023.
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), 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 adding a drug or other substance to a specific
schedule, the Secretary of the Department of Health and Human Services
(HHS),\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. 21 U.S.C.
811(d)(3). In the event that the Secretary of HHS (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 are set forth in 21 U.S.C. 811(a)
and (b). Pursuant to 21 U.S.C. 811(a)(1), the Attorney General, by
rule, may add to such a schedule 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 is
to be placed. The Attorney General has delegated this scheduling
authority to the Administrator of the Drug Enforcement Administration
(DEA Administrator or Administrator). 28 CFR 0.100.
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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).
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Background
Methiopropamine is a central nervous system (CNS) stimulant and is
structurally related to the schedule II stimulants methamphetamine and
amphetamine. Methiopropamine is not approved by the Food and Drug
Administration for use in the United States. On March 16, 2017, the
Commission on Narcotic Drugs voted to place N-methyl-1-(thiophen-2-
yl)propan-2-amine (methiopropamine) in Schedule II of the 1971
Convention (CND Dec/60/8) during its 60th session.
DEA and HHS Eight Factor Analyses
On August 27, 2020, in accordance with 21 U.S.C. 811(b), and in
response to DEA's November 20, 2018, request, HHS provided to DEA a
scientific and medical evaluation and scheduling recommendation for
methiopropamine. DEA reviewed HHS's evaluation and recommendation for
schedule I placement, and all other relevant data, and conducted its
own eight-factor analysis 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 and HHS eight-factor analyses are available in
their entirety under the tab ``Supporting Documents'' of the public
docket of this rulemaking action at <a href="https://www.regulations.gov">https://www.regulations.gov</a>, under
docket number ``DEA-737.''
Notice of Proposed Rulemaking To Schedule Methiopropamine
On September 2, 2021 (86 FR 49267), DEA published a notice of
proposed rulemaking (NPRM) to permanently control methiopropamine in
schedule I. Specifically, DEA proposed to add methiopropamine to 21 CFR
1308.11(f) (the stimulants category of schedule I). The NPRM provided
an opportunity for interested persons to file a request for hearing in
accordance with DEA regulations on or before October 4, 2021. No
requests for such a hearing were
[[Page 75471]]
received by DEA. The NPRM also provided an opportunity for interested
persons to submit comments on or before October 4, 2021.
Comments Received
In response to the NPRM, DEA received four comments. Three of the
submissions were from individuals or anonymous commenters. Of these
three, two commenters provided support for the NPRM, and one opposed
the NPRM. A fourth comment was either submitted or posted to the wrong
docket as it involved a different DEA rulemaking. As such, the fourth
comment is outside the scope of this current scheduling action.
Support for NPRM
Two commenters were in support of this rulemaking. One stated that
methiopropamine is a stimulant and a user can get high from it, so it
should be a controlled substance. The second commenter stated that if
there is not an accepted medical use, then it should be a schedule I
substance.
DEA Response: DEA appreciates the comments in support of this
rulemaking.
Opposition to NPRM
One commenter opposed the NPRM to control methiopropamine as a
schedule I drug. The commenter stated that scheduling methiopropamine
will only expand the number of people in the United States who can be
captured in the mass incarceration net. The commenter thought the
approach should not be a criminal issue but a public health issue.
DEA Response: Substances are scheduled to protect the public health
and provide safety for individuals. Thus, pursuant to 21 U.S.C. 811(a),
the CSA authorizes DEA's Administrator, under authority delegated by
the Attorney General, to control any drug or other substance if the
Administrator finds that the 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).
Scheduling Conclusion
After consideration of the public comments, scientific and medical
evaluation and accompanying recommendation of HHS, and after its own
eight-factor evaluation, DEA finds that these facts and all other
relevant data constitute substantial evidence of the potential for
abuse of methiopropamine. DEA is permanently scheduling methiopropamine
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 outlines 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 Assistant Secretary for Health of HHS and review
of all other available data, the Administrator, pursuant to 21 U.S.C.
811(a) and 812(b)(1), finds that:
1. Methiopropamine has a high potential for abuse.
Methiopropamine, similar to the schedule II stimulants amphetamine
and methamphetamine, is a CNS stimulant with a high potential for
abuse. Data from animal behavioral locomotor studies show that
methiopropamine produces stimulation similar to that of
methamphetamine. As HHS mentions, methiopropamine abuse in humans has
been reported in at least 16 countries, including some countries in
North America and Europe. Additionally, typical stimulant effects such
as euphoria, psychomotor stimulation, and anxiety have been described
from self-reports of methiopropamine abusers. These effects are similar
to those of schedule II stimulants such as methamphetamine and
amphetamine. These data collectively indicate that methiopropamine has
a high potential for abuse similar to other schedule II stimulants such
as amphetamine and methamphetamine.
2. Methiopropamine currently has no accepted medical use in
treatment in the United States.
According to HHS, FDA has not approved a marketing application for
a drug product containing methiopropamine for any therapeutic
indication. As HHS states, there are also no clinical studies or
petitioners that claim an accepted medical use in the United States.
Thus, methiopropamine has no currently accepted medical use in
treatment in the United States.\2\
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\2\ Although there is no evidence suggesting that
methiopropamine 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 methiopropamine
under medical supervision.
The safety of methiopropamine or use under medical supervision has
not been determined because it has no approved medical use in treatment
in the United States and has not been investigated as a new drug.
Therefore, there is a lack of accepted safety for use of
methiopropamine under medical supervision.
Based on these findings, the Administrator concludes that
methiopropamine (chemical name: N-methyl-1-(thiophen-2-yl)propan-2-
amine), including its salts, isomers, and salts of isomers, warrants
control in schedule I of the CSA. 21 U.S.C. 812(b)(1).
Requirements for Handling Methiopropamine
Methiopropamine is subject to the CSA's schedule I regulatory
controls and administrative, civil, and criminal sanctions applicable
to the manufacture, distribution, reverse distribution, importation,
exportation, engagement in research, and conduct of 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)
methiopropamine, or who desires to handle methiopropamine 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 methiopropamine and is not
registered with DEA must submit an application for registration and may
not continue to handle methiopropamine, unless DEA has approved that
application for registration pursuant to 21 U.S.C. 822, 823, 957, and
958, and in accordance with 21 CFR parts 1301 and 1312.
2. Disposal of Stocks. Any person unwilling or unable to obtain a
schedule I registration must surrender or transfer all quantities of
currently held methiopropamine 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. Methiopropamine 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. Methiopropamine is subject to schedule I security
[[Page 75472]]
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
methiopropamine must also 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 methiopropamine 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 methiopropamine 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
methiopropamine must take an inventory of methiopropamine on hand at
that time, 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 methiopropamine) 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 methiopropamine) 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 methiopropamine, or products containing
methiopropamine, pursuant to 21 U.S.C. 827 and in accordance with 21
CFR 1301.74(b) and (c) and 1301.76(b) and parts 1304, 1312, and 1317.
Manufacturers and distributors must submit reports regarding
methiopropamine 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
methiopropamine must comply with the order form requirements, pursuant
to 21 U.S.C. 828 and in accordance with 21 CFR part 1305.
9. Importation and Exportation. All importation and exportation of
methiopropamine must comply with 21 U.S.C. 952, 953, 957, and 958, and
be in accordance with 21 CFR part 1312.
10. Liability. Any activity involving methiopropamine 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 rule does not have substantial
direct effects on the States, on the relationship between the national
government and the States, or 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. 44 U.S.C. 3501-
3521.
Regulatory Flexibility Act
The Administrator, 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 methiopropamine (chemical name: N-
methyl-1-(thiophen-2-yl)propan-2-amine), including its salts, isomers,
and salts of isomers, in schedule I of the CSA. This action is being
taken 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 methiopropamine.
According to HHS, methiopropamine has a 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 methiopropamine in the United States. Therefore, DEA estimates that
no United States entity currently handles methiopropamine and does not
expect any United States entity to handle methiopropamine in the
foreseeable future. DEA concludes that no legitimate United States
entity would be affected by this rule. As such, this 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 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
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a copy of the final rule to the Government Accountability Office, the
House, and the Senate.
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. Amend Sec. 1308.11 by:
0
a. Redesignating paragraphs (f)(9) through (11) as (f)(10) through
(12); and
0
b. Adding a new paragraph (f)(9).
The addition reads as follows:
Sec. 1308.11 Schedule I.
* * * * *
(f) * * *
(9) Methiopropamine (N-methyl-1-(thiophen-2-yl)propan-2-amine).. 1478
* * * * *
Signing Authority
This document of the Drug Enforcement Administration was signed on
November 14, 2022, by Administrator Anne Milgram. 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.
Scott Brinks,
Federal Register Liaison Officer, Drug Enforcement Administration.
[FR Doc. 2022-26805 Filed 12-8-22; 8:45 am]
BILLING CODE 4410-09-P
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This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.