[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 [www.gpo.gov]
[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 
2021.2 3 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