[Federal Register Volume 87, Number 221 (Thursday, November 17, 2022)]
[Rules and Regulations]
[Pages 68895-68898]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-25003]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-371]


Schedules of Controlled Substances: Placement of Amineptine 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 amineptine (chemical name: 7-[(10,11-dihydro-5H-
dibenzo[a,d]cyclohepten-5-yl)amino]heptanoic acid), 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, 
import, export, engage in research, conduct instructional activities or 
chemical analysis, or possess), or propose to handle amineptine.

DATES: Effective date: December 19, 2022.

FOR FURTHER INFORMATION CONTACT: 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.\2\ 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 may, by rule, add 
to such a schedule or transfer between such schedules 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 or other substance is to be placed. The Attorney 
General has delegated this scheduling authority to the Administrator of 
the Drug Enforcement Administration (Administrator).\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 
CSA, 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

    Amineptine (chemical name: 7-[(10,11-dihydro-5H-
dibenzo[a,d]cyclohepten-5-yl)amino]heptanoic acid) is a synthetic 
tricyclic antidepressant with central nervous system (CNS) stimulating 
properties.
    In April 2003, the United Nations Commission on Narcotic Drugs 
(CND), on the advice of the Director-General of the World Health 
Organization (WHO), added amineptine to Schedule II of the 1971 
Convention, thus notifying all parties to the 1971 Convention.

DEA and HHS Eight Factor Analyses

    On November 8, 2011, in accordance with 21 U.S.C. 811(b), and in 
response to the Drug Enforcement Administration's (DEA) August 12, 2008 
request, HHS provided to DEA a scientific and medical evaluation and a 
scheduling recommendation for amineptine. DEA subsequently reviewed 
HHS' evaluation and recommendation for schedule I placement and all 
other relevant data, and conducted its own analysis under the eight 
factors stipulated in 21 U.S.C.

[[Page 68896]]

811(c). DEA found, under 21 U.S.C. 812(b)(1), that this substance 
warrants control in schedule I. Both DEA and HHS analyses are available 
in their entirety under ``Supporting and Related Material'' of the 
public docket for this rule at https://www.regulations.gov under docket 
number DEA-371.

Notice of Proposed Rulemaking to Schedule Amineptine

    On July 22, 2021, DEA published a notice of proposed rulemaking 
(NPRM) entitled ``Schedules of Controlled Substances: Placement of 
amineptine in schedule I.'' \4\ The NPRM provided an opportunity for 
interested persons to file a request for a hearing in accordance with 
DEA regulations on or before August 23, 2021. No requests for such a 
hearing were received by DEA. The NPRM also provided an opportunity for 
interested persons to submit comments on the proposed rule on or before 
September 20, 2021.
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    \4\ 86 FR 38619.
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Comments Received

    DEA received three comments on the proposed rule to control 
amineptine in schedule I of the CSA.
    Support for rulemaking: Two commenters recognized the dangers and 
public health risks, and supported the placement of amineptine in 
schedule I.
    DEA Response: DEA appreciates the comments in support of this 
rulemaking.
    Opposition to rulemaking: One commenter opposed the placement of 
amineptine in schedule I due to the lack of abuse in the United States, 
and contended it showed potential as an ``anti-addictive agent and 
antidepressant'' in clinical settings.
    DEA Response: DEA does not agree. As discussed in DEA and HHS 
eight-factor analyses which accompanied the published NPRM, amineptine 
is not approved by the Food and Drug Administration for use in the 
United States. While amineptine has previously been used in Europe and 
Asia as an antidepressant, its use has been withdrawn from the market 
in 49 of 66 countries. Strong evidence of abuse, severe adverse effects 
including hepatotoxicity, pancreatic injury, and severe acne eruption 
that required hospitalization, and overconsumption, have been 
documented by the WHO's Expert Committee on Drug Dependence report \5\ 
and HHS in their scientific and medical evaluation where amineptine was 
recommended for control in schedule I of the CSA.\6\
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    \5\ World Health Organization (WHO) Critical Review of 
Psychoactive Substances prepared for evaluation by the 33rd Meeting 
of the WHO Expert Committee on Drug Dependence. Annex, 2002.1-14.
    \6\ While HHS's Secretary is the expert on scientific and 
medical matters in scheduling decisions of this type, DEA is not 
bound by HHS's recommendation to schedule a substance. DEA's 
Administrator is obligated to determine ``that these facts and all 
other relevant data constitute substantial evidence of potential for 
abuse such as to warrant control'' prior to following set rulemaking 
proceedings for control. 21 U.S.C. 811(b); see 76 FR 77330, 77334-
77335, Dec. 12, 2011. This is what DEA is doing in this rulemaking.
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    In addition, DEA conducted an eight-factor analysis pursuant to 21 
U.S.C. 811(c), and based its scheduling determination on a 
comprehensive evaluation of all available data. As stated in the 
proposed rulemaking, after careful review of all data, DEA concurred 
with HHS' assessment that amineptine has a high potential for abuse, 
and it has no currently accepted medical use in treatment in the United 
States and lacks accepted safety for use under medical supervision. 
Congress established only one schedule, schedule I, for drugs of abuse 
with ``no currently accepted medical use in treatment in the United 
States'' and ``lack of accepted safety for use under medical 
supervision.'' \7\ DEA is therefore promulgating this final rule 
placing amineptine in schedule I under the CSA.
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    \7\ 21 U.S.C. 812(b).
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Scheduling Conclusion

    After consideration of the public comments, the scientific and 
medical evaluation and accompanying recommendation of HHS, and 
conducting an independent eight-factor analysis, DEA finds substantial 
evidence of potential for abuse of amineptine. As such, DEA is 
permanently scheduling amineptine 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.\8\ After consideration of the analysis and recommendation of 
the Assistant Secretary for HHS and review of all other available data, 
the Administrator, pursuant to 21 U.S.C. 811(a) and 812(b)(1), finds 
that:
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    \8\ 21 U.S.C. 812(b).
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    (1) Amineptine has a high potential for abuse. This potential is 
comparable to certain schedule II substances (e.g., amphetamine or 
cocaine);
    (2) Amineptine has no currently accepted medical use in treatment 
in the United States; \9\ and
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    \9\ Although there is no evidence suggesting that amineptine 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 amineptine under 
medical supervision.
    Based on these findings, the Administrator concludes that 
amineptine, including its salts, isomers, and salts of isomers, 
warrants control in schedule I of the CSA.\10\
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    \10\ 21 U.S.C. 812(b)(1).
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Requirements for Handling Amineptine

    Amineptine is subject to the CSA's schedule I regulatory controls 
and administrative, civil, and criminal sanctions applicable to the 
manufacture, distribution, dispensing, importing, exporting, research, 
and conduct of instructional activities, including the following:
    1. Registration. Any person who handles (manufactures, distributes, 
imports, exports, engages in research, or conducts instructional 
activities or chemical analysis with, or possesses) amineptine, or who 
desires to handle amineptine, 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 amineptine and is not registered with DEA must submit an 
application for registration and may not continue to handle amineptine, 
unless DEA has approved that application, 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 all quantities of currently held 
amineptine, or may transfer all quantities of currently held amineptine 
to a person registered with DEA. Amineptine is required to be disposed 
of in accordance with 21 CFR part 1317, in addition to all other 
applicable Federal, State, local, and tribal laws.
    3. Security. Amineptine is subject to schedule I security 
requirements and

[[Page 68897]]

must be handled and stored pursuant to 21 U.S.C. 821 and 823 and in 
accordance with 21 CFR parts 1301.71-1301.76. Non-practitioners 
handling amineptine must also comply with the employee screening 
requirements of 21 CFR parts 1301.90-1301.93.
    4. Labeling and Packaging. All labels, labeling, and packaging for 
commercial containers of amineptine must comply with 21 U.S.C. 825 and 
958(e), and be in accordance with 21 CFR part 1302.
    5. Quota. Only registered manufacturers are permitted to 
manufacture amineptine 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 
amineptine must take an inventory of amineptine on hand pursuant to 21 
U.S.C. 827 and 958 and in accordance with 21 CFR parts 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 amineptine) on hand on 
the date the registrant first engages in the handling of controlled 
substances, pursuant to 21 U.S.C. 827, 958, 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 amineptine) on hand 
every two years, pursuant to 21 U.S.C. 827 and 958, and in accordance 
with 21 CFR parts 1304.03, 1304.04, and 1304.11.
    7. Records and Reports. Every DEA registrant must maintain records 
and submit reports with respect to amineptine, pursuant to 21 U.S.C. 
827 and 958(e), and in accordance with 21 CFR 1301.74(b) and (c) and 
parts 1304, 1312, and 1317. Manufacturers and distributors must submit 
reports regarding amineptine 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 amineptine 
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 
amineptine 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 amineptine 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 (Regulatory Planning and Review) and 13563 
(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 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.

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.

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 amineptine, 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. 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 amineptine.
    Based on the review of HHS' scientific and medical evaluation and 
all other relevant data, DEA determined that amineptine 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 amineptine in the United States. DEA is not aware 
of any availability or source of amineptine in the United States. 
Therefore, DEA estimates that no United States entity currently handles 
amineptine and does not expect any United States entity to handle 
amineptine 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

    In accordance with the Unfunded Mandates Reform Act (UMRA) of 1995, 
2 U.S.C. 1501 et seq., DEA has determined and certifies 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

    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 final rule to the Government Accountability 
Office, the House, and the Senate under the CRA.

Paperwork Reduction Act of 1995

    This action does not impose a new collection of information under 
the Paperwork Reduction Act of 1995.\11\

[[Page 68898]]

This action would not impose recordkeeping or reporting requirements on 
State or local governments, individuals, businesses, or organizations. 
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.
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    \11\ 44 U.S.C. 3501-3521.
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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 re-designating paragraphs (f)(1) through 
(f)(9) as paragraphs (f)(2) through (f)(10), and adding a new paragraph 
(f)(1) to read as follows:


Sec.  1308.11   Schedule I.

* * * * *
    (f) * * *

(1) Amineptine (7-[(10,11-dihydro-5H-                               1219
 dibenzo[a,d]cyclohepten-5-yl)amino]heptanoic acid).....
 

* * * * *

Signing Authority

    This document of the Drug Enforcement Administration was signed on 
November 9, 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.

Heather Achbach,
Federal Register Liaison Officer, Drug Enforcement Administration.
[FR Doc. 2022-25003 Filed 11-16-22; 8:45 am]
BILLING CODE 4410-09-P