Rule2022-25003
Schedules of Controlled Substances: Placement of Amineptine 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
November 17, 2022
Effective
December 19, 2022
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 221 (Thursday, November 17, 2022)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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\
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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
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</html>Indexed from Federal Register on November 17, 2022.
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.