[Federal Register Volume 91, Number 7 (Monday, January 12, 2026)]
[Rules and Regulations]
[Pages 1089-1092]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2026-00362]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-1337]
Schedules of Controlled Substances: Placement of N-Pyrrolidino
Metonitazene and N-Pyrrolidino 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-(4-
methoxybenzyl)-5-nitro-1-(2-(pyrrolidin-1-yl)ethyl)-1H-benzimidazole
(other names: N-pyrrolidino metonitazene or metonitazepyne) and 5-
nitro-2-(4-propoxybenzyl)-1-(2-(pyrrolidin-1-yl)ethyl)-1H-benzimidazole
(other names: N-pyrrolidino protonitazene or protonitazepyne),
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 under the Controlled Substances Act. This
action is being taken, in part, to enable the United States to meet its
obligations under the 1961 Single Convention on Narcotic Drugs. 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 N-pyrrolidino metonitazene and N-pyrrolidino protonitazene.
DATES: Effective February 11, 2026.
ADDRESSES: 8701 Morrissette Drive, Springfield, Virginia 22152.
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 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,
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 she 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.\1\
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\1\ 28 CFR 0.100.
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Background
On November 21, 2024, the Director-General of the World Health
Organization recommended to the Secretary-General that N-pyrrolidino
metonitazene and N-pyrrolidino protonitazene be placed in Schedule I of
the Single Convention, as these substances have pharmacological effects
similar to other opioid drugs that are controlled in Schedule I of the
Single Convention. On June 9, 2025, the Secretariat of the United
Nations informed the United States government, by letter, that the
Commission voted to place N-pyrrolidino metonitazene and N-pyrrolidino
protonitazene in Schedule I of the Single Convention during its 68th
session on March 12, 2025 (CND Mar 68/2 and 68/1).
On August 15, 2025, DEA issued a temporary scheduling order,
placing N-pyrrolidino metonitazene and N-pyrrolidino protonitazene
temporarily in schedule I of the CSA.\2\ That order for N-pyrrolidino
metonitazene and N-pyrrolidino protonitazene (codified at 21 CFR
1308.11(h)(77) and (78)) was based on the Administrator's finding that
the temporary scheduling of these substances was necessary to avoid an
imminent hazard to public safety.\3\
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\2\ Schedules of Controlled Substances: Temporary Placement of
N-pyrrolidino metonitazene and N-pyrrolidino protonitazene in
Schedule I, 90 FR 39314 (August 15, 2025).
\3\ Id.
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N-Pyrrolidino Metonitazene and N-Pyrrolidino Protonitazene
Benzimidazole-opioids, commonly referred to as ``nitazenes,''
emerged on the recreational drug market in 2019. This class of
substances shares a similar pharmacological profile with fentanyl,
morphine, and other mu-opioid receptor agonists. In 2023, N-pyrrolidino
metonitazene and N-pyrrolidino protonitazene emerged on the illicit
opioid drug market. The abuse of N-pyrrolidino metonitazene and N-
pyrrolidino protonitazene has been associated with adverse events to
include their identification in toxicology cases in the United States.
Several substances belonging to the benzimidazole-opioid drug class
have been controlled in the United States, and as a class of drug in
China, Canada, and the United Kingdom.
Law enforcement reports demonstrate that N-pyrrolidino metonitazene
and N-pyrrolidino protonitazene are being illicitly distributed and
abused. According to the National Forensic Laboratory Information
System (NFLIS-Drug) \4\ database, which collects drug identification
results from drug cases submitted to and analyzed by Federal, State and
local forensic laboratories, there have been 284 reports for N-
pyrrolidino metonitazene and N-pyrrolidino protonitazene between
January 2022 and August 2025 (query date: August 13, 2025).
Specifically, there have been 253 encounters of N-pyrrolidino
protonitazene from 22 States and 31 encounters of N-pyrrolidino
metonitazene from 10 States. Benzimidazole-opioids have been identified
in counterfeit prescription tablets in the United States. A report from
the Expert Committee on Drug Dependence Critical Review on N-
pyrrolidino protonitazene indicate this
[[Page 1090]]
substance has been sold online as ``China White'' heroin.\5\
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\4\ NFLIS-Drug represents an important resource in monitoring
illicit drug trafficking, including the diversion of legally
manufactured pharmaceuticals into illegal markets. NFLIS-Drug is a
comprehensive information system that includes data from forensic
laboratories that handle more than 96 percent of an estimated 1
million distinct annual federal, state, and local drug analysis
cases. NFLIS-Drug includes drug chemistry results from completed
analyses only. While NFLIS-Drug data are not direct evidence of
abuse, these can lead to an inference that a drug has been diverted
and abused. See Schedules of Controlled Substances: Placement of
Carisoprodol Into Schedule IV, 76 FR 77330, 77332 (Dec. 12, 2011).
\5\ 47th Expert Committee on Drug Dependence Critical Review on
N-pyrrolidino protonitazene and N-pyrrolidino metonitazene. 14-18
October 2024.
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N-Pyrrolidino metonitazene and N-pyrrolidino protonitazene have no
currently accepted medical use in treatment in the United States. The
Department of Health and Human Services (HHS) advised DEA, by letter
dated June 11, 2025, that based on a review by the Food and Drug
Administration (FDA), there were no investigational new drug
applications (IND) or approved new drug applications (NDA) for N-
pyrrolidino metonitazene and N-pyrrolidino protonitazene in the United
States. Since this letter, HHS has not advised DEA of any new IND or
NDA for these substances. Because N-pyrrolidino metonitazene and N-
pyrrolidino 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 N-
pyrrolidino metonitazene and N-pyrrolidino 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. Because control is
required under the Single Convention, DEA will not be initiating
regular rulemaking proceedings to permanently schedule N-pyrrolidino
metonitazene and N-pyrrolidino protonitazene pursuant to 21
U.S.C.811(a).
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\6\ There is no evidence suggesting that N-pyrrolidino
metonitazene or N-pyrrolidino protonitazene 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: (1) the drug's
chemistry must be known and reproducible; (2) there must be adequate
safety studies; (3) there must be adequate and well-controlled
studies proving efficacy; (4) the drug must be accepted by qualified
experts; and (5) 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 applied the traditional five-part test and concluded
the test was not satisfied. 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 providers 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 scheduling order, there is no evidence
that health care providers have widespread experience with medical
use of N-pyrrolidino metonitazene and N-pyrrolidino protonitazene or
that the use of N-pyrrolidino metonitazene and N-pyrrolidino
protonitazene are recognized by entities that regulate the practice
of medicine, so the two-part test also is not satisfied. By letter
dated June 11, 2025, DEA has been advised by HHS that there are
currently no approved new drug applications or investigational new
drug applications for N-pyrrolidino metonitazene and N-pyrrolidino
protonitazene. Additionally, HHS communicated no objections to the
temporary placement of N-pyrrolidino metonitazene and N-pyrrolidino
protonitazene into schedule I of the CSA.
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Conclusion
In order to meet the United States' obligation under the Single
Convention and because N-pyrrolidino metonitazene and N-pyrrolidino
protonitazene have no currently accepted medical use in treatment in
the United States, the Administrator has determined that N-pyrrolidino
metonitazene and N-pyrrolidino protonitazene including their isomers,
esters, ethers, salts, and salts of isomers, esters, and ethers,
whenever the existence of such isomers, esters, and salts are possible
within the specific 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
As discussed above, N-pyrrolidino metonitazene and N-pyrrolidino
protonitazene have been temporarily controlled in schedule I of the CSA
since August 15, 2025. Upon the effective date of this final order, N-
pyrrolidino metonitazene and N-pyrrolidino protonitazene will be
permanently subject to the CSA's schedule I regulatory controls and
administrative, civil, and criminal sanctions applicable to the
manufacture, distribution, dispensing, importing, exporting, 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,
reverse distributes, imports, exports, engages in research or conducts
instructional activities or chemical analysis with, or possesses), or
who desires to handle, N-pyrrolidino metonitazene or N-pyrrolidino
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. N-Pyrrolidino metonitazene and N-pyrrolidino
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. N-Pyrrolidino metonitazene and N-pyrrolidino
protonitazene are subject to schedule I security requirements and must
be handled and stored pursuant to 21 U.S.C. 821, 823, and in accordance
with 21 CFR 1301.71 through 1301.76. Non-practitioners handling N-
pyrrolidino metonitazene and N-pyrrolidino protonitazene must comply
with the screening requirements of 21 CFR 1301.90 through 1301.93.
4. Labeling and packaging. All labels, labeling, and packaging for
commercial containers of N-pyrrolidino metonitazene and N-pyrrolidino
protonitazene must comply with 21 U.S.C. 825 and 958(e) and be in
accordance with 21 CFR part 1302.
5. Quota. Generally, only registered manufacturers are permitted to
manufacture N-pyrrolidino metonitazene and N-pyrrolidino protonitazene
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 N-
pyrrolidino metonitazene or N-pyrrolidino protonitazene 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(e), 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 N-
pyrrolidino metonitazene and N-pyrrolidino protonitazene) on hand every
two years pursuant to 21 U.S.C. 827 and 958(e) and in accordance
[[Page 1091]]
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 N-pyrrolidino metonitazene and N-
pyrrolidino protonitazene pursuant to 21 U.S.C. 827 and 958(e), 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 N-pyrrolidino metonitazene and N-pyrrolidino
protonitazene 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 N-pyrrolidino
metonitazene or N-pyrrolidino 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
N-pyrrolidino metonitazene and N-pyrrolidino 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 N-pyrrolidino metonitazene or
N-pyrrolidino protonitazene 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, 13563, 14192, and 14294
This action is not a significant regulatory action as defined by
Executive Order (E.O.) 12866 (Regulatory Planning and Review) and the
principles reaffirmed in E.O. 13563 (Improving Regulation and
Regulatory Review). DEA scheduling actions are not subject to E.O.
14192, Unleashing Prosperity Through Deregulations, or E.O. 14294,
Fighting Overcriminalization in Federal Regulations. This action makes
no change in the status quo, as N-pyrrolidino metonitazene and N-
pyrrolidino 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. 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.
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.\7\ 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.
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\7\ 21 U.S.C. 811(d)(1).
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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 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 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.\8\ 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 Office of Management and Budget
(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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\8\ 44 U.S.C. 3501-3521.
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Unfunded Mandates Reform Act of 1995
On the basis of information contained in the ``Regulatory
Flexibility Act'' section above, DEA has determined pursuant to the
Unfunded Mandates Reform Act (UMRA) of 1995 (2 U.S.C. 1501 et seq.)
that this final rule 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 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 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:
[[Page 1092]]
0
a. Redesignate paragraphs (b)(79) through (119) as paragraphs (b)(81)
through (121);
0
b. Add new paragraphs (b)(79) and (80); and
0
c. Remove and reserve paragraphs (h)(77) and (78).
The additions to read as follows:
Sec. 1308.11 Schedule I.
* * * * *
(b) * * *
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* * * * * * *
(79) 2-(4-methoxybenzyl)-5-nitro-1-(2-(pyrrolidin-1- 9762
yl)ethyl)-1H-benzimidazole (Other names: N-pyrrolidino
metonitazene; metonitazepyne).............................
(80) 5-nitro-2-(4-propoxybenzyl)-1-(2-(pyrrolidin-1- 9763
yl)ethyl)-1H-benzimidazole (other names: N-pyrrolidino
protonitazene; protonitazepyne)...........................
* * * * * * *
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* * * * *
Signing Authority
This document of the Drug Enforcement Administration was signed on
January 5, 2025, by Administrator Terrance C. Cole. 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. 2026-00362 Filed 1-9-26; 8:45 am]
BILLING CODE 4410-09-P