Rule2023-17778
Schedules of Controlled Substances: Placement of Metonitazene 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
August 18, 2023
Effective
September 18, 2023
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
With the issuance of this final order, the Administrator of the Drug Enforcement Administration is permanently placing N,N-diethyl- 2-(2-(4-methoxybenzyl)-5-nitro-1H-benzimidazol-1-yl)ethan-1-amine (metonitazene), including its isomers, esters, ethers, salts, and salts of isomers, esters, and ethers whenever the existence of such isomers, esters, ethers, and salts is 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 continues to impose 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 or conduct instructional activities with, or possess), or propose to handle metonitazene.
Full Text
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<title>Federal Register, Volume 88 Issue 159 (Friday, August 18, 2023)</title>
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[Federal Register Volume 88, Number 159 (Friday, August 18, 2023)]
[Rules and Regulations]
[Pages 56466-56469]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-17778]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-900]
Schedules of Controlled Substances: Placement of Metonitazene 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 N,N-diethyl-
2-(2-(4-methoxybenzyl)-5-nitro-1H-benzimidazol-1-yl)ethan-1-amine
(metonitazene), including its isomers, esters, ethers, salts, and salts
of isomers, esters, and ethers whenever the existence of such isomers,
esters, ethers, and salts is 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 continues to
impose 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 or
conduct instructional activities with, or possess), or propose to
handle metonitazene.
DATES: Effective September 18, 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 1961 United Nations Single
Convention
[[Page 56467]]
on Narcotic Drugs (Single Convention), March 30, 1961, 18 U.S.T. 1407,
570 U.N.T.S. 151, as amended. 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 (Administrator of DEA or
Administrator). 28 CFR 0.100.
Background
On April 12, 2022, DEA issued a temporary scheduling order, placing
metonitazene (N,N-diethyl-2-(2-(4-methoxybenzyl)-5-nitro-1H-
benzimidazol-1-yl)ethan-1-amine), along with six other substances,\1\
in schedule I of the Controlled Substances Act (CSA). 87 FR 21556. That
order for metonitazene was based on findings by the Administrator that
the temporary scheduling was necessary to avoid an imminent hazard to
the public safety; the order was codified at 21 CFR 1308.11(h)(54).
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\1\ Those six other substances, [butonitazene, etodesnitazene,
flunitazene, metodesnitazene, N-pyrrolidino etonitazene, and
protonitazene], will not be discussed further in this final order.
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In November 2021, the Director-General of the World Health
Organization recommended to the Secretary-General that metonitazene be
placed in Schedule I of the Single Convention, as this substance has an
opioid mechanism of action and similarity to drugs that are controlled
in Schedule I of the Single Convention (i.e., metonitazene is similar
to drugs such as isotonitazene and fentanyl) and has dependence and
abuse potential. On May 27, 2022, the United States government was
informed by the Secretariat of the United Nations, by letter, that
during its 65th session in March 2022, the Commission voted to place
metonitazene in Schedule I of the Single Convention (CND Mar/65/2).
Metonitazene
As discussed in the background section, metonitazene is temporarily
controlled in schedule I of the CSA upon the Administrator's finding it
poses imminent hazard to the public safety. Metonitazene has a
pharmacological profile similar to etonitazene (schedule I),
isotonitazene (schedule I), and other schedule I and II synthetic
opioids that act as mu-opioid receptor agonists. Because of the
pharmacological similarities of metonitazene to etonitazene and
isotonitazene (potent mu-opioid agonists), the use of metonitazene
presents a high risk of abuse and has negatively affected users and
communities. The abuse of metonitazene has been associated with at
least 51 fatalities in the United States between July 2020 and August
2021.<SUP>2 3</SUP> The positive identification of this substance in
post-mortem cases is a serious concern to the public safety.
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\2\ Trecki J, Gerona RR, Ellison R, Thomas C, Mileusnic-Polchan
D. Notes from the Field: Increased Incidence of Fentanyl-Related
Deaths Involving Para-fluorofentanyl or Metonitazene--Knox County,
Tennessee, November 2020-August 2021. MMWR Morb Mortal Wkly Rep.
2022 Jan 28;71(4):153-155.
\3\ Walton SE, Krotulski AJ, Logan BK. A Forward-Thinking
Approach to Addressing the New Synthetic Opioid 2-
Benzylbenzimidazole Nitazene Analogs by Liquid Chromatography-Tandem
Quadrupole Mass Spectrometry (LC-QQQ-MS). J Anal Toxicol. 2022 Mar
21;46(3):221-231.
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In July 2020, metonitazene was first reported in a drug seizure
case in North Carolina and identified as a white powdery substance.\4\
Law enforcement reports demonstrate that metonitazene is being
illicitly distributed and abused. The illicit use and distribution of
this substance are similar to that of heroin (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 have been
1,158 reports for metonitazene between January 2020 and June 2022 \5\
(query date: July 18, 2022).
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\4\ Krotulski AJ, Papsun DM, Walton SE, Logan BK. Metonitazene
in the United States-Forensic toxicology assessment of a potent new
synthetic opioid using liquid chromatography mass spectrometry. Drug
Test Anal. 2021 Oct;13(10):1697-1711.
\5\ Reports to NFLIS-Drug are still pending for 2022.
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DEA is not aware of any claims or any medical or scientific
literature suggesting that metonitazene has a currently accepted
medical use in treatment in the United States. In addition, the
Department of Health and Human Services advised DEA, by letter dated
July 7, 2021, that there were no investigational new drug applications
or approved new drug applications for metonitazene in the United
States. Because metonitazene is not formulated or available for
clinical use as an approved medicinal product, all current use of this
substance 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 a drug.
Therefore, consistent with 21 U.S.C. 811(d)(1), DEA concludes that
metonitazene has no currently accepted medical use in treatment in the
United States \6\ and is most appropriately placed in schedule I of the
CSA, the same schedule in which it currently resides. Because control
is required under the Single Convention, DEA will not be initiating
regular rulemaking proceedings to permanently schedule metonitazene
pursuant to 21 U.S.C. 811(a).
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\6\ Although, as discussed above, there is no evidence
suggesting that metonitazene 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 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. 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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Conclusion
In order to meet the United States' obligations under the Single
Convention and because metonitazene has no currently accepted medical
use in treatment in the United States, the Administrator has determined
that metonitazene, including its isomers, esters, ethers, salts, and
salts of isomers, esters, and ethers, whenever the existence of such
isomers, esters, ethers, and salts is possible within the specific
chemical designation, should remain in schedule I of the CSA.
Requirements for Handling
Metonitazene has been controlled as a schedule I controlled
substance since April 12, 2022. Upon the effective date of the final
order contained in this
[[Page 56468]]
document, metonitazene 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, metonitazene
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 this substance in a manner not authorized by the CSA is
unlawful and those in possession of any quantity of this substance may
be subject to prosecution pursuant to the CSA.
2. Disposal of stocks. Metonitazene 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. Metonitazene is subject to schedule I security
requirements and must be handled and stored pursuant to 21 U.S.C. 823,
and in accordance with 21 CFR 1301.71-1301.76. Non-practitioners
handling metonitazene must 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 metonitazene 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 metonitazene 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
metonitazene has been required to keep an inventory of all stocks of
this substance 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 metonitazene 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 parts 1304, 1312, and 1317. Manufacturers and distributors
must submit reports regarding metonitazene 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. All DEA registrants who distribute metonitazene
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
metonitazene 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 metonitazene 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) and 13563
(Improving Regulation and 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), 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 metonitazene is already listed as
a schedule I controlled substance.
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.
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
[[Page 56469]]
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 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.
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)(55) through (b)(93) as paragraphs (b)(56)
through (b)(94), respectively;
0
b. Add new paragraph (b)(55); and
0
c. Remove and reserve paragraph (h)(54).
The addition reads as follows:
Sec. 1308.11 Schedule I.
* * * * *
(b) * * *
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* * * * * * *
(55) Metonitazene (N,N-diethyl-2-(2-(4-methoxybenzyl)-5- 9757
nitro-1H-benzimidazol-1-yl)ethan-1-amine)..............
* * * * * * *
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Signing Authority
This document of the Drug Enforcement Administration was signed on
August 14, 2023, 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. 2023-17778 Filed 8-17-23; 8:45 am]
BILLING CODE 4410-09-P
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</html>Indexed from Federal Register on August 18, 2023.
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.