[Federal Register Volume 89, Number 207 (Friday, October 25, 2024)]
[Rules and Regulations]
[Pages 85047-85050]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-24635]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-900N]


Schedules of Controlled Substances: Placement of Butonitazene, 
Flunitazene, and Metodesnitazene Substances in Schedule I

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Final rule.

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SUMMARY: The Drug Enforcement Administration places butonitazene, 
flunitazene, and metodesnitazene including their isomers, esters, 
ethers, salts and salts of isomers, esters and ethers in schedule I of 
the Controlled Substances Act. 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 these three specific controlled substances will 
continue to apply as a result of this action.

DATES: Effective October 25, 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: In this final rule, the Drug Enforcement 
Administration (DEA) permanently schedules the following three 
controlled substances in schedule I of the Controlled Substances Act 
(CSA), including their 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:
    <bullet> Butonitazene (2-(2-(4-butoxybenzyl)-5-nitro-1H-
benzimidazol-1-yl)-N,N-diethylethan-1-amine),
    <bullet> Flunitazene (N,N-diethyl-2-(2-(4-fluorobenzyl)-5-nitro-1H-
benzimidazol-1-yl)ethan-1-amine),
    <bullet> Metodesnitazene (N,N-diethyl-2-(2-(4-methoxybenzyl)-1H-
benzimidazol-1-yl)ethan-1-amine).

Legal Authority

    The CSA provides that proceedings for the issuance, amendment, or 
repeal of the scheduling of any drug or other substance may be 
initiated by the Attorney General (delegated to the Administrator of 
DEA pursuant to 28 CFR 0.100) on his own motion, at the request of the 
Secretary of Health and Human Services (HHS), or on the petition of any 
interested party.\1\ This action is supported, inter alia, by a 
recommendation from the Assistant Secretary for Health of HHS 
(Assistant Secretary for HHS or Assistant Secretary) and an evaluation 
of all other relevant data by DEA. This action continues the imposition 
of the regulatory controls and administrative, civil, and criminal 
sanctions of schedule I controlled substances on any person who handles 
(manufactures, distributes, imports, exports, engages in research, or 
conducts instructional activities or chemical analysis with, or 
possesses) or proposes to handle butonitazene, flunitazene, and 
metodesnitazene.
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    \1\ 21 U.S.C. 811(a).
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Background

    On April 12, 2022, pursuant to 21 U.S.C. 811(h)(1), DEA published 
an order in the Federal Register temporarily placing butonitazene, 
flunitazene, metodesnitazene, and four additional benzimidazole-opioids 
in schedule I of the Controlled Substances Act (CSA) based upon a 
finding that these substances pose an imminent hazard to the public 
safety.\2\ That temporary order was effective upon the date of 
publication. Under 21 U.S.C. 811(h)(2), the temporary scheduling of a 
substance expires at the end of two years from the date of issuance of 
the scheduling order, except that DEA may extend temporary scheduling 
of that substance for up to one year during the pendency of permanent 
scheduling proceedings under 21 U.S.C. 811(a)(1) with respect to the 
substance. Pursuant to 21 U.S.C. 811(h)(2), the temporary scheduling of 
butonitazene, flunitazene, and metodesnitazene was set to expire on 
April 12, 2024. However, on April 11, 2024, the DEA Administrator 
extended the temporary order in a separate action.\3\ On the same day, 
the Administrator, on her own motion pursuant to 21 U.S.C. 811(a), 
initiated scheduling proceedings and published a notice of proposed 
rulemaking (NPRM) to permanently control butonitazene, flunitazene, and 
metodesnitazene in schedule I of the CSA.\4\ Specifically, DEA proposed 
to add these substances to the opiates list under 21 CFR 1308.11(b).
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    \2\ See 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). The four additional 
benzimidazole-opioids were etodesnitazene, metonitazene, N-
pyrrolidino etonitazene, and protonitazene. DEA pursued separate 
scheduling actions for metonitazene, see 88 FR 56466 (Aug. 18, 2023) 
and for etodesnitazene, N-pyrrolidino etonitazene, and 
protonitazene, see 89 FR 25514 (Apr. 11, 2024) to remain as schedule 
I substances under the CSA in order to meet the United States' 
obligations under 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.
    \3\ See Schedules of Controlled Substances: Extension of 
Temporary Placement of Butonitazene, Flunitazene, and 
Metodesnitazene in Schedule I of the Controlled Substances Act, 89 
FR 25517 (Apr. 11, 2024).
    \4\ See Schedules of Controlled Substances: Placement of 
Butonitazene, Flunitazene, and Metodesnitazene Substances in 
Schedule I, 89 FR 25544 (Apr. 11, 2024).
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DEA and HHS Eight Factor Analyses

    On November 15, 2023, the Assistant Secretary submitted HHS's 
scientific and medical evaluation and scheduling recommendation for 
butonitazene, flunitazene, metodesnitazene, and three other 
benzimidazole-opioids and their salts to the Administrator,\5\ which 
recommended placing butonitazene, flunitazene, and metodesnitazene and 
their salts in schedule I of the CSA. In accordance with 21 U.S.C. 
811(c), upon receipt of the scientific and medical evaluation and 
scheduling

[[Page 85048]]

recommendation from HHS, DEA reviewed the documents and all other 
relevant data, and conducted its own eight-factor analysis of the abuse 
potential of these three substances. Please note that both the DEA and 
HHS eight-factor analyses are available in their entirety under the tab 
``Supporting Documents'' of the public docket for this action at http://www.regulations.gov under Docket Number ``DEA-900N.''
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    \5\ DEA published a final order to permanently place the three 
other benzimidazole-opioids (etodesnitazene, N-pyrrolidino 
etonitazene, and protonitazene) in schedule I of the CSA. See 
Schedules of Controlled Substances: Placement of Etodesnitazene, N-
Pyrrolidino Etonitazene, and Protonitazene in Schedule I, 89 FR 
25514 (Apr. 11, 2024).
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Determination To Permanently Schedule Butonitazene, Flunitazene, and 
Metodesnitazene

    After review of the available data including the scientific and 
medical evaluation and the scheduling recommendation from HHS, DEA 
published an NPRM in the Federal Register on April 11, 2024, which 
proposed the placement of butonitazene, flunitazene, and 
metodesnitazene in schedule I of the CSA.\6\ The NPRM provided an 
opportunity for interested persons to file a request for a hearing in 
accordance with DEA regulations on or before May 13, 2024. DEA received 
no hearing requests. The NPRM also provided an opportunity for 
interested persons to submit comments on the proposed rule on or before 
May 13, 2024.
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    \6\ See Schedules of Controlled Substances: Placement of 
Butonitazene, Flunitazene, and Metodesnitazene Substances in 
Schedule I, 89 FR 25544 (Apr. 11, 2024).
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Comments Received

    DEA received two comments on the proposed rule to control 
butonitazene, flunitazene, and metodesnitazene in schedule I of the 
CSA. One commenter provided support for the rule. This commenter noted 
that permanent placement of these substances would be beneficial to the 
community safety. DEA appreciates the support for this rulemaking. The 
second commenter commended the proposed rule but noted that a class 
control action for the nitazene drug class would be more appropriate as 
opposed to individually scheduling substances in the benzimidazole-
opioid drug class. DEA appreciates this comment as a potential 
alternative for consideration. However, due to the current threat of 
these specific substances, DEA will continue with solely scheduling 
these three substances.

Scheduling Conclusion

    After consideration of the relevant matters presented through 
public comments, the scientific and medical evaluation and accompanying 
scheduling recommendation of HHS, and DEA's own eight-factor analysis, 
DEA finds that these facts and all relevant data constitute substantial 
evidence of potential for abuse of butonitazene, flunitazene, and 
metodesnitazene. DEA is therefore permanently scheduling these three 
benzimidazole-opioids as schedule I controlled substances 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.\7\ After consideration of the analysis and recommendation of 
the Assistant Secretary for HHS and review of all other available data, 
the Administrator of DEA, pursuant to 21 U.S.C. 811(a) and 21 U.S.C. 
812(b)(1), finds that:
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    \7\ 21 U.S.C. 812(b).
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    (1) Butonitazene, flunitazene, and metodesnitazene have a high 
potential for abuse. Butonitazene, flunitazene, and metodesnitazene, 
similar to etonitazene and fentanyl, are mu-opioid receptor agonists. 
These three benzimidazole-opioids have analgesic effects, and these 
effects are mediated by mu-opioid receptor agonism. HHS states that 
substances that produce mu-opioid receptor agonist effects in the 
central nervous system are considered as having a high potential for 
abuse (e.g. morphine and fentanyl). Data obtained from drug 
discrimination studies indicate that butonitazene, flunitazene, and 
metodesnitazene fully substituted for the discriminative stimulus 
effects of morphine.
    (2) Butonitazene, flunitazene, and metodesnitazene have no 
currently accepted medical use in the United States. There are no FDA-
approved drug products for butonitazene, flunitazene, and 
metodesnitazene in the United States. There are no known therapeutic 
applications for these benzimidazole-opioids, and DEA is not aware of 
any currently accepted medical uses for these substances in the United 
States.\8\
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    \8\ To place a drug or other substance in schedule I under the 
CSA, DEA must consider whether the substance has a currently 
accepted medical use in treatment in the United States. 21 U.S.C. 
812(b)(1)(B). There is no evidence suggesting that butonitazene, 
flunitazene, and metodesnitazene have a currently accepted medical 
use in treatment in the United States. To determine whether a drug 
or other substance has a currently accepted medical use, DEA has 
traditionally applied a five-part test to a drug or substance that 
has not been approved by the FDA: 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. See 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). DEA 
and HHS applied the traditional five-part test for currently 
accepted medical use in this matter. In a recent published letter in 
a different context, HHS applied an additional two-part test to 
determine currently accepted medical use for substances that do not 
satisfy the five-part test: (1) whether there exists widespread, 
current experience with medical use of the substance by licensed 
health care practitioners operating in accordance with implemented 
jurisdiction-authorized programs, where medical use is recognized by 
entities that regulate the practice of medicine, and, if so, (2) 
whether there exists some credible scientific support for at least 
one of the medical conditions for which part (1) is satisfied. On 
April 11, 2024, the Department of Justice's Office of Legal Counsel 
(OLC) issued an opinion, which, among other things, concluded that 
HHS's two-part test would be sufficient to establish that a drug has 
a currently accepted medical use. Office of Legal Counsel, 
Memorandum for Merrick B. Garland Attorney General Re: Questions 
Related to the Potential Rescheduling of Marijuana at 3 (April 11, 
2024). For purposes of this final rule, there is no evidence that 
health care providers have widespread experience with medical use of 
butonitazene, flunitazene, and metodesnitazene, or that the use of 
butonitazene, flunitazene, and metodesnitazene are recognized by 
entities that regulate the practice of medicine under either the 
traditional five-part test or the two-part test.
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    (3) There is a lack of accepted safety for use of butonitazene, 
flunitazene, and metodesnitazene under medical supervision. Because 
these substances have no FDA-approved medical use and have not been 
investigated as new drugs, their safety for use under medical 
supervision is not determined.
    Based on these findings, the Administrator of DEA concludes that 
butonitazene, flunitazene, and metodesnitazene, including their 
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, warrant 
continued control in schedule I of the CSA.\9\
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    \9\ 21 U.S.C. 812(b)(1).
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Requirements for Handling Butonitazene, Flunitazene, and 
Metodesnitazene

    As discussed above, these three substances are currently subject to 
a temporary scheduling order, which added them to schedule I. 
Butonitazene, flunitazene, and metodesnitazene will continue to be 
subject to the CSA's schedule I regulatory controls and administrative, 
civil, and criminal sanctions applicable to the manufacture, 
distribution, reverse distribution, dispensing, importation, 
exportation, engagement in research, and conduct of instructional 
activities or chemical analysis with, and possession of schedule I 
substances, including the following:

[[Page 85049]]

    1. Registration. Any person who handles (manufactures, distributes, 
reverse distributes, dispenses, imports, exports, engages in research, 
or conducts instructional activities or chemical analysis with, or 
possesses) or who desires to handle butonitazene, flunitazene, and 
metodesnitazene 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. Butonitazene, flunitazene, and 
metodesnitazene 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. Butonitazene, flunitazene, and metodesnitazene are 
subject to schedule I security requirements and must be handled and 
stored pursuant to 21 U.S.C. 821, 823, and 871(b), and in accordance 
with 21 CFR 1301.71-1301.76. Non-practitioners handling these three 
substances also must comply with the screening requirements of 21 CFR 
1301.90-1301.93.
    4. Labeling and Packaging. All labels and labeling for commercial 
containers of butonitazene, flunitazene, and metodesnitazene 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 butonitazene, flunitazene, and metodesnitazene in 
accordance with a quota assigned pursuant to 21 U.S.C. 826, and in 
accordance with 21 CFR part 1303.
    6. Inventory. Any person registered with DEA to handle 
butonitazene, flunitazene, and metodesnitazene must have an initial 
inventory of all stocks of controlled substances (including these 
substances) on hand on the date the registrant first engages in the 
handling of controlled substances pursuant to 21 U.S.C. 827 and 958, 
and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11.
    After the initial inventory, every DEA registrant must take a new 
inventory of all stocks of controlled substances (including 
butonitazene, flunitazene, and metodesnitazene) on hand every two years 
pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 CFR 
1304.03, 1304.04, and 1304.11.
    7. Records and Reports. Every DEA registrant must maintain records 
and submit reports with respect to butonitazene, flunitazene, and 
metodesnitazene, pursuant to 21 U.S.C. 827, 832(a), and 958(e), and in 
accordance with 21 CFR 1301.74(b) and (c) and 1301.76(b) and parts 
1304, 1312, and 1317. Manufacturers and distributors would be required 
to submit reports regarding butonitazene, flunitazene, and 
metodesnitazene 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 butonitazene, 
flunitazene, and metodesnitazene must comply with the order form 
requirements, pursuant to 21 U.S.C. 828 and 21 CFR part 1305.
    9. Importation and Exportation. All importation and exportation of 
butonitazene, flunitazene, and metodesnitazene must comply with 21 
U.S.C. 952, 953, 957, and 958, and be in accordance with 21 CFR part 
1312.
    10. Liability. Any activity involving butonitazene, flunitazene, 
and metodesnitazene 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), 13563 
(Improving Regulation and Regulatory Review), and 14094 (Modernizing 
Regulatory Review)

    In accordance with 21 U.S.C. 811(a), this final scheduling action 
is subject to formal rulemaking procedures done ``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. E.O. 14094 modernizes the regulatory review process to 
advance policies that promote the public interest and address national 
priorities.

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 rule and, by approving it, 
certifies that it will not have a significant economic impact on a 
substantial number of small entities.
    On April 12, 2022, DEA published an order to temporarily place 
seven benzimidazole-opioids in schedule I of the CSA pursuant to the 
temporary scheduling provisions of 21 U.S.C. 811(h). DEA estimates that 
all entities handling or planning to handle butonitazene, flunitazene, 
and metodesnitazene have already established and implemented systems 
and processes required to handle these substances.
    There are currently 45 registrations authorized to specifically 
handle butonitazene, flunitazene, or metodesnitazene, as well as 1,239 
registered analytical labs and 861 researchers that are authorized to 
handle schedule I controlled substances generally. These 45 
registrations represent 31 entities. A review of the 45 registrations 
indicates that all entities that currently handle butonitazene, 
flunitazene, and metodesnitazene also handle other schedule I 
controlled substances and have established and implemented (or 
maintained) systems and processes required to handle these substances. 
Therefore, DEA anticipates this final rule will impose minimal or no 
economic impact on any affected entities; and thus, will not have a 
significant economic impact on any affected small entity. Therefore, 
DEA

[[Page 85050]]

has concluded that this rule will not have a significant economic 
impact on a substantial number of small entities.

Unfunded Mandates Reform Act of 1995

    In accordance with the Unfunded Mandates Reform Act of 1995 (UMRA), 
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 the UMRA.

Paperwork Reduction Act of 1995

    This rule would not impose a new collection or modify an existing 
collection of information under the Paperwork Reduction Act of 
1995.\10\ Also, this rule would not impose new or modify existing 
recordkeeping or reporting requirements on state or local governments, 
individuals, businesses, or organizations. However, this rule would 
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.
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    \10\ 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, DEA amends 21 CFR part 1308 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. In Sec.  1308.11:
0
a. Redesignate paragraphs (b)(62) through (106) as (b)(65) through 
(109)
0
b. Redesignate paragraphs (b)(44) through (61) as (b)(46) through (63);
0
c. Redesignate paragraphs (b)(24) through (43) as (b)(25) through (44);
0
d. Add new paragraphs (b)(24), (b)(45), and (b)(64); and
0
e. Remove and reserve paragraphs (h)(50), (52), and (53).
    The additions to read as follows:


Sec.  1308.11  Schedule I.

* * * * *
    (b) * * *

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                              * * * * * * *
(24) Butonitazene (2-(2-(4-butoxybenzyl)-5-nitro-1H-                9751
 benzimidazol-1-yl)-N,N-diethylethan-1-amine)...........
 
                              * * * * * * *
(45) Flunitazene (N,N-diethyl-2-(2-(4-fluorobenzyl)-5-              9756
 nitro-1H-benzimidazol-1-yl)ethan-1-amine)..............
 
                              * * * * * * *
(64) Metodesnitazene (N,N-diethyl-2-(2-(4-methoxybenzyl)-           9764
 1H-benzimidazol-1-yl)ethan-1-amine)....................
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* * * * *

Signing Authority

    This document of the Drug Enforcement Administration was signed on 
October 15, 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.

Heather Achbach,
Federal Register Liaison Officer, Drug Enforcement Administration.
[FR Doc. 2024-24635 Filed 10-24-24; 8:45 am]
BILLING CODE 4410-09-P