Schedules of Controlled Substances: Placement of Methiopropamine in Schedule I, 75470-75473 [2022-26805]

Agencies

• Drug Enforcement Administration
• Department of Justice

[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 [www.gpo.gov]
[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 https://www.regulations.gov, 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

[[Page 75473]]

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