Rule2024-07684
Schedules of Controlled Substances: Placement of Etodesnitazene, N-Pyrrolidino Etonitazene, and Protonitazene in Schedule I
Primary source
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Published
April 11, 2024
Effective
April 11, 2024
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
With the issuance of this final order, the Administrator of the Drug Enforcement Administration is permanently placing 2-(2-(4- ethoxybenzyl)-1H-benzimidazol-1-yl)-N,N-diethylethan-1-amine (other names: etodesnitazene; etazene), 2-(4-ethoxybenzyl)-5-nitro-1-(2- (pyrrolidin-1-yl)ethyl)-1H-benzimidazole (other names: N-pyrrolidino etonitazene; etonitazepyne), and N,N-diethyl-2-(5-nitro-2-(4- propoxybenzyl)-1H-benzimidazol-1-yl)ethan-1-amine (other name: protonitazene), including their isomers, esters, ethers, salts, and salts of isomers, esters, and ethers whenever the existence of such isomers, esters, ethers, and salts are possible within the specific chemical designation, in schedule I of the Controlled Substances Act. This scheduling action discharges the United States' obligations under the Single Convention on Narcotic Drugs (1961). This action imposes permanent 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 or conduct instructional activities with, or possess), or handle etodesnitazene, N-pyrrolidino etonitazene, and protonitazene.
Full Text
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<title>Federal Register, Volume 89 Issue 71 (Thursday, April 11, 2024)</title>
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[Federal Register Volume 89, Number 71 (Thursday, April 11, 2024)]
[Rules and Regulations]
[Pages 25514-25517]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-07684]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-900]
Schedules of Controlled Substances: Placement of Etodesnitazene,
N-Pyrrolidino Etonitazene, and Protonitazene in Schedule I
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Final amendment; final order.
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SUMMARY: With the issuance of this final order, the Administrator of
the Drug Enforcement Administration is permanently placing 2-(2-(4-
ethoxybenzyl)-1H-benzimidazol-1-yl)-N,N-diethylethan-1-amine (other
names: etodesnitazene; etazene), 2-(4-ethoxybenzyl)-5-nitro-1-(2-
(pyrrolidin-1-yl)ethyl)-1H-benzimidazole (other names: N-pyrrolidino
etonitazene; etonitazepyne), and N,N-diethyl-2-(5-nitro-2-(4-
propoxybenzyl)-1H-benzimidazol-1-yl)ethan-1-amine (other name:
protonitazene), including their isomers, esters, ethers, salts, and
salts of isomers, esters, and ethers whenever the existence of such
isomers, esters, ethers, and salts are possible within the specific
chemical designation, in schedule I of the Controlled Substances Act.
This scheduling action discharges the United States' obligations under
the Single Convention on Narcotic Drugs (1961). This action imposes
permanent 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 or
conduct instructional activities with, or possess), or handle
etodesnitazene, N-pyrrolidino etonitazene, and protonitazene.
DATES: Effective April 11, 2024.
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 United Nations Single
Convention on Narcotic Drugs, Mar. 30, 1961, 18 U.S.T. 1407, 520
U.N.T.S. 151 (Single Convention), as amended by the 1972 Protocol.
Article 3, paragraph 7 of the Single Convention requires that if the
Commission on Narcotic Drugs (Commission) adds a substance to one of
the schedules of such Convention, and the United States receives
notification of such scheduling decision from the Secretary-General of
the United Nations (Secretary-General), the United States, as a
signatory Member State, is obligated to control the substance under its
national drug control legislation. Under 21 U.S.C. 811(d)(1) of the
Controlled Substances Act (CSA), if control of a substance is required
``by United States obligations under international treaties,
conventions, or protocols in effect on October 27, 1970,'' the Attorney
General must issue an order controlling such drug under the schedule he
deems most appropriate to carry out such obligations, without regard to
the findings required by 21 U.S.C. 811(a) or 812(b), and without regard
to the procedures prescribed by 21 U.S.C. 811(a) and (b). The Attorney
General has delegated scheduling authority under 21 U.S.C. 811 to the
Administrator of the Drug Enforcement Administration (DEA).\1\
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\1\ 28 CFR 0.100.
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Background
On April 12, 2022, DEA issued a temporary scheduling order, placing
etodesnitazene, N-pyrrolidino etonitazene, and protonitazene, along
with four other substances,\2\ temporarily in schedule I of the
Controlled Substances Act (CSA).\3\ That order for etodesnitazene, N-
pyrrolidino etonitazene, and protonitazene (codified at 21 CFR
1308.11(h)(51), (55), and (56)) was based on findings by the
Administrator that the temporary
[[Page 25515]]
scheduling was necessary to avoid an imminent hazard to the public
safety.\4\
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\2\ Those four other substances, [butonitazene, flunitazene,
metodesnitazene, metonitazene], will not be discussed further in
this final order.
\3\ Schedules of Controlled Substances: Temporary Placement of
Butonitazene, Etodesnitazene, flunitazene, Metodesnitazene,
Metonitazene, N-Pyrrolidino etonitazene, and Protonitazene in
Schedule I, 87 FR 21556 (Apr. 12, 2022).
\4\ Id.
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On November 24, 2022, the Director-General of the World Health
Organization recommended to the Secretary-General that etodesnitazene,
N-pyrrolidino etonitazene, and protonitazene be placed in Schedule I of
the Single Convention, as these substances have opioid-agonist
mechanism of action similar to drugs that are controlled in Schedule I
of the Single Convention (i.e., etodesnitazene, N-pyrrolidino
etonitazene, and protonitazene are similar to drugs such as
isotonitazene and fentanyl) and has dependence and abuse potential. On
May 17, 2023, the United States government was informed by the
Secretariat of the United Nations, by letter, that during its 66th
session in March 2023, the Commission voted to place etodesnitazene, N-
pyrrolidino etonitazene, and protonitazene in Schedule I of the Single
Convention (CND Mar/66/2, 66/3, and 66/4).
Etodesnitazene, N-Pyrrolidino Etonitazene, and Protonitazene
As discussed in the background section, etodesnitazene, N-
pyrrolidino etonitazene, and protonitazene are temporarily controlled
in schedule I of the CSA upon the Administrator's finding they pose
imminent hazard to the public safety. Etodesnitazene, N-pyrrolidino
etonitazene, and protonitazene share a pharmacological profile with
etonitazene (schedule I), isotonitazene (schedule I), and other
schedule I and II synthetic opioids that act as mu-opioid receptor
agonists. The use of these substances presents a high risk of abuse and
have negatively affected users and communities due to their
pharmacological similarities with etonitazene and isotonitazene (potent
mu-opioid agonists). The abuse of etodesnitazene, N-pyrrolidino
etonitazene, and protonitazene has been associated with at least 46
toxicology cases in the United States between January 2021 and April
2023. The positive identification of these substances in toxicology
cases is a serious concern to the public safety.
Law enforcement reports demonstrate that etodesnitazene, N-
pyrrolidino etonitazene, and protonitazene are being illicitly
distributed and abused. The illicit use and distribution of these
substances are similar to that of isotonitazene (schedule I) and
prescription opioid analgesics. According to the National Forensic
Laboratory Information System (NFLIS-Drug) database, which collects
drug identification results from drug cases submitted to and analyzed
by Federal, State and local forensic laboratories, there has been 596
reports for etodesnitazene, N-pyrrolidino etonitazene, and
protonitazene between January 2020 and May 2023 \5\ (query date: May
15, 2023).
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\5\ Reports to NFLIS-Drug are still pending for 2023.
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DEA is not aware of any claims or of any medical or scientific
literature suggesting that etodesnitazene, N-pyrrolidino etonitazene,
and protonitazene have a currently accepted medical use in treatment in
the United States. In addition, the Department of Health and Human
Services (HHS) advised DEA, by letters dated July 7 and September 10,
2021, that there were no investigational new drug applications (IND) or
approved new drug applications (NDA) for etodesnitazene, N-pyrrolidino
etonitazene, and protonitazene in the United States. Since September
10, 2021, HHS has not advised DEA of any new IND or NDA for any of
these substances. Because etodesnitazene, N-pyrrolidino etonitazene,
and protonitazene are not formulated or available for clinical use as
approved medicinal products, all current use of these substances by
individuals is based on their own initiative, rather than on the basis
of medical advice from a practitioner licensed by law to administer
such drugs.
Consistent with 21 U.S.C. 811(d)(1), DEA concludes that
etodesnitazene, N-pyrrolidino etonitazene, and protonitazene have no
currently accepted medical use in treatment in the United States \6\
and are most appropriately placed permanently in schedule I of the CSA,
the same schedule in which they temporarily reside at present. Because
control is required under the Single Convention, DEA will not be
initiating regular rulemaking proceedings to permanently schedule
etodesnitazene, N-pyrrolidino etonitazene, and protonitazene pursuant
to 21 U.S.C. 811(a).
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\6\ HHS and DEA both applied a five-part test for currently
accepted medical use as part of this scheduling action. Under that
test, with respect to a drug that has not been approved by the Food
and Drug Administration, 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. Marijuana Scheduling
Petition; Denial of Petition; Remand, 57 FR 10499 (Mar. 26, 1992),
pet. for rev. denied, Alliance for Cannabis Therapeutics v. Drug
Enforcement Admin., 15 F.3d 1131, 1135 (D.C. Cir. 1994).
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Conclusion
In order to meet the United States' obligations under the Single
Convention and because etodesnitazene, N-pyrrolidino etonitazene, and
protonitazene have no currently accepted medical use in treatment in
the United States, the Administrator has determined that
etodesnitazene, N-pyrrolidino etonitazene, and protonitazene, including
their isomers, esters, ethers, salts, and salts of isomers, esters, and
ethers, whenever the existence of such isomers, esters, ethers, and
salts are possible within the specific chemical designation, should be
placed permanently in schedule I of the CSA.
Requirements for Handling
Etodesnitazene, N-pyrrolidino etonitazene, and protonitazene have
been controlled in schedule I of the CSA since April 12, 2022. Upon the
effective date of this final order, etodesnitazene, N-pyrrolidino
etonitazene, and protonitazene will be permanently subject to the CSA's
schedule I regulatory controls and administrative, civil, and criminal
sanctions applicable to the manufacture of, distribution of,
importation of, exportation of, engagement in research or conduct of
instructional activities with, and possession of, schedule I controlled
substances, including the following:
1. Registration. Any person who handles (manufactures, distributes,
imports, exports, engages in research or conducts instructional
activities with, or possesses), or who desires to handle,
etodesnitazene, N-pyrrolidino etonitazene, or protonitazene 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. Retail sales of schedule I controlled substances to the general
public are not allowed under the CSA. Possession of any quantity of
these substances in a manner not authorized by the CSA is unlawful and
those in possession of any quantity of these substances may be subject
to prosecution pursuant to the CSA.
2. Disposal of stocks. Etodesnitazene, N-pyrrolidino etonitazene,
and protonitazene 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. Etodesnitazene, N-pyrrolidino etonitazene, and
protonitazene are subject to schedule I security requirements and must
be handled and stored pursuant to 21 U.S.C. 823, and in accordance with
21
[[Page 25516]]
CFR 1301.71 through 1301.76. Non-practitioners handling etodesnitazene,
N-pyrrolidino etonitazene, or protonitazene must comply with the
employee screening requirements of 21 CFR 1301.90 through 1301.93.
4. Labeling and packaging. All labels, labeling, and packaging for
commercial containers of etodesnitazene, N-pyrrolidino etonitazene, and
protonitazene 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 etodesnitazene, N-pyrrolidino etonitazene, and
protonitazene 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
etodesnitazene, N-pyrrolidino etonitazene, or protonitazene has been
required to keep an inventory of all stocks of these substances on hand
as of April 12, 2022, pursuant to 21 U.S.C. 827, and in accordance with
21 CFR 1304.03, 1304.04, and 1304.11.
7. Records and Reports. DEA registrants must maintain records and
submit reports with respect to etodesnitazene, N-pyrrolidino
etonitazene, and protonitazene pursuant to 21 U.S.C. 827, and in
accordance with 21 CFR 1301.74(b) and (c), 1301.76(b), and 1307.11 and
21 CFR parts 1304, 1312, and 1317. Manufacturers and distributors must
submit reports regarding etodesnitazene, N-pyrrolidino etonitazene, and
protonitazene to the Automation of Reports and Consolidated Order
System (ARCOS) pursuant to 21 U.S.C. 827 and in accordance with 21 CFR
parts 1304 and 1312.
8. Order Forms. All DEA registrants who distribute etodesnitazene,
N-pyrrolidino etonitazene, or protonitazene must continue to comply
with 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
etodesnitazene, N-pyrrolidino etonitazene, and protonitazene must
continue to comply with 21 U.S.C. 952, 953, 957, and 958, and in
accordance with 21 CFR part 1312.
10. Liability. Any activity involving etodesnitazene, N-pyrrolidino
etonitazene, or protonitazene not authorized by, or in violation of the
CSA, is unlawful, and may subject the person to administrative, civil,
and/or criminal sanctions.
Regulatory Analyses
Executive Orders 12866 (Regulatory Planning and Review), 13563
(Improving Regulation and Regulatory Review), and 14094 (Modernizing
Regulatory Review)
This action is not a significant regulatory action as defined by
Executive Order (E.O.) 12866 (Regulatory Planning and Review), section
3(f), as amended by E.O. 14094, section 1(b), and the principles
reaffirmed in E.O. 13563 (Improving Regulation and Regulatory Review);
and, accordingly, this action has not been reviewed by the Office of
Management and Budget (OMB). This action makes no change in the status
quo, as etodesnitazene, N-pyrrolidino etonitazene, and protonitazene
are already listed as schedule I controlled substances.
Executive Order 12988, Civil Justice Reform
This action 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 action does not have federalism implications warranting the
application of E.O. 13132. This action 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 action does not have tribal implications warranting the
application of E.O. 13175. The action 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.
Administrative Procedure Act
The CSA provides for an expedited scheduling action where control
is required by the United States' obligations under international
treaties, conventions, or protocols. 21 U.S.C. 811(d)(1). If control is
required pursuant to such international treaty, convention, or
protocol, the Attorney General, as delegated to the Administrator, must
issue an order controlling such drug under the schedule he deems most
appropriate to carry out such obligations, and ``without regard to''
the findings and rulemaking procedures otherwise required for
scheduling actions in 21 U.S.C. 811(a) and (b). Id.
In accordance with 21 U.S.C. 811(d)(1), scheduling actions for
drugs that are required to be controlled by the United States'
obligations under international treaties, conventions, or protocols in
effect on October 27, 1970, shall be issued by order (as opposed to
scheduling by rule pursuant to 21 U.S.C. 811(a)). Therefore, DEA
believes that the notice and comment requirements of section 553 of the
Administrative Procedure Act (APA), 5 U.S.C. 553, do not apply to this
scheduling action.
Regulatory Flexibility Act
The Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612) applies to
rules that are subject to notice and comment under section 553(b) of
the APA or any other law. As explained above, the CSA exempts this
final order from notice and comment. Consequently, the RFA does not
apply to this action.
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. Also, this action does not impose new or modify existing
recordkeeping or reporting requirements on State or local governments,
individuals, businesses, or organizations. However, this action does
require compliance with the following existing OMB collections: 1117-
0003, 1117-0004, 1117-0006, 1117-0008, 1117-0009, 1117-0010, 1117-0012,
1117-0014, 1117-0021, 1117-0023, 1117-0029, and 1117-0056. 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.
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.
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Congressional Review Act
This order is not a major rule as defined by the Congressional
Review Act (CRA), 5 U.S.C. 804. However, DEA is submitting reports
under the CRA 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.
Signing Authority
This document of the Drug Enforcement Administration was signed on
April 5, 2024, 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.
For the reasons set out above, DEA amends 21 CFR part 1308 as
follows:
PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES
0
1. The authority citation for 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:
0
a. Redesignate paragraphs (b)(95) through (103) as paragraphs (b)(98)
through (106);
0
b. Redesignate paragraphs (b)(69) through (94) as paragraphs (b)(71)
through (96);
0
c. Redesignate paragraphs (b)(40) through (68) as paragraphs (b)(41)
through (69);
0
d. Add new paragraph (b)(40), (70), and (97); and
0
e. Remove and reserve paragraphs (h)(51), (55), and (56).
The addition reads as follows:
Sec. 1308.11 Schedule I.
* * * * *
(b) * * *
* * * * * * *
(40) 2-(2-(4-ethoxybenzyl)-1H-benzimidazol-1-yl)-N,N- 9765
diethylethan-1-amine (Other names: etodesnitazene; etazene)....
* * * * * * *
(70) 2-(4-ethoxybenzyl)-5-nitro-1-(2-(pyrrolidin-1-yl)ethyl)-1H- 9758
benzimidazole (Other names: N-pyrrolidino etonitazene;
etonitazepyne).................................................
* * * * * * *
(97) N,N-diethyl-2-(5-nitro-2-(4-propoxybenzyl)-1H-benzimidazol- 9759
1-yl)ethan-1-amine (Other name: protonitazene).................
* * * * *
[FR Doc. 2024-07684 Filed 4-10-24; 8:45 am]
BILLING CODE 4410-09-P
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</html>Indexed from Federal Register on April 11, 2024.
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.