[Federal Register Volume 90, Number 156 (Friday, August 15, 2025)]
[Rules and Regulations]
[Pages 39314-39319]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-15566]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-1337]
Schedules of Controlled Substances: Temporary Placement of N-
pyrrolidino metonitazene and N-pyrrolidino protonitazene in Schedule I
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Temporary amendment; temporary scheduling order.
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SUMMARY: The Drug Enforcement Administration issues this temporary
order to schedule two benzimidazole-opioids in schedule I of the
Controlled Substances Act. DEA bases this action on a finding that
placing these substances in schedule I is necessary to avoid imminent
hazard to public safety. This order imposes 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, or possess) or propose
to handle these substances.
DATES: This temporary order is effective August 15, 2025, until August
15, 2027. If this order is extended or made permanent, DEA will publish
a document in the Federal Register.
ADDRESSES: 8701 Morrissette Drive, Springfield, Virginia 22152.
FOR FURTHER INFORMATION CONTACT: Terrence L. Boos, Drug and Chemical
Evaluation Section, Diversion Control Division, Drug Enforcement
Administration; Mailing Address: 8701 Morrissette Drive, Springfield,
Virginia 22152; Telephone: (571) 362-3249.
As required by 5 U.S.C. 553(b)(4), a summary of this rule may be
found in the docket for this rulemaking at www.regulations.gov.
SUPPLEMENTARY INFORMATION: The Drug Enforcement Administration (DEA)
issues a temporary scheduling order \1\
[[Page 39315]]
(in the form of a temporary amendment) to add the following two
synthetic benzimidazole-opioid substances, 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, to schedule I under the Controlled Substances Act (CSA):
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\1\ Though DEA has used the term ``final order'' with respect to
temporary scheduling orders in the past, this action adheres to the
statutory language of 21 U.S.C. 811(h), which refers to a
``temporary scheduling order.'' No substantive change is intended.
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2-(4-methoxybenzyl)-5-nitro-1-(2-(pyrrolidin-1-yl)ethyl)-
1H-benzimidazole (commonly known as, N-pyrrolidino metonitazene or
metonitazepyne), and
5-nitro-2-(4-propoxybenzyl)-1-(2-(pyrrolidin-1-yl)ethyl)-
1H-benzimidazole (commonly known as, N-pyrrolidino protonitazene or
protonitazepyne).
Legal Authority
Under 21 U.S.C. 811(h)(1), the CSA provides the Attorney General
(as delegated to the Administrator of DEA (Administrator) pursuant to
28 CFR 0.100) with the authority to temporarily place a substance in
schedule I of the CSA for two years without regard to the evaluation
requirements of 21 U.S.C. 811(b), if she finds that such action is
necessary to avoid an imminent hazard to the public safety.\2\ In
addition, if proceedings to control a substance are initiated under 21
U.S.C. 811(a)(1) while the substance is temporarily controlled under
section 811(h), the Attorney General may extend the temporary
scheduling for up to one year.\3\
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\2\ 21 U.S.C. 811(h)(1).
\3\ 21 U.S.C. 811(h)(2).
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Where the necessary findings are made, a substance may be
temporarily scheduled if it is not listed in any other schedule under
21 U.S.C. 812, or if there is no exemption or approval in effect for
the substance under section 505 of the Federal Food, Drug, and Cosmetic
Act, 21 U.S.C. 355.\4\
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\4\ 21 U.S.C. 811(h)(1); 21 CFR part 1308.
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Background
The CSA requires the Administrator to notify the Secretary of the
Department of Health and Human Services (HHS) of an intent to
temporarily place a substance in schedule I of the CSA (i.e., to issue
a temporary scheduling order).\5\ By letter dated March 24, 2025, the
then-Acting Administrator transmitted the required notice to place N-
pyrrolidino metonitazene and N-pyrrolidino protonitazene in schedule I
on a temporary basis to the Acting Assistant Secretary for Health of
HHS (Assistant Secretary).\6\ On June 11, 2025, the Acting Assistant
Secretary responded to this notice and advised DEA that based on a
review by the Food and Drug Administration (FDA), there are currently
no investigational new drug applications (IND) or approved new drug
applications (NDA) for N-pyrrolidino metonitazene or N-pyrrolidino
protonitazene. The Acting Assistant Secretary also stated that HHS had
no objection to the temporary placement of these substances in schedule
I of the CSA. N-Pyrrolidino metonitazene and N-pyrrolidino
protonitazene currently are not listed in any schedule under the CSA,
and no exemptions or approvals under 21 U.S.C. 355 are in effect for
these substances.\7\
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\5\ 21 U.S.C. 811(h)(4).
\6\ The Secretary of HHS has delegated to the Assistant
Secretary for Health of HHS the authority to make domestic drug
scheduling recommendations. 58 FR 35460 (July 1, 1993).
\7\ By letter dated December 7, 2023, the then-Administrator
transmitted the required notice to place N-pyrrolidino metonitazene
and N-pyrrolidino protonitazene in schedule I on a temporary basis
to the Acting Assistant Secretary for Health of HHS. On December 22,
2023, the then-Assistant Secretary responded to this notice and
advised DEA that based on a review by the FDA, there are currently
no investigational new IND or approved NDA for N-pyrrolidino
metonitazene or N-pyrrolidino protonitazene. The then-Assistant
Secretary also stated that HHS had no objection to the temporary
placement of these substances in schedule I of the CSA.
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DEA has taken into consideration the Acting Assistant Secretary's
comments as required by 21 U.S.C. 811(h)(4). DEA has found the control
of N-pyrrolidino metonitazene and N-pyrrolidino protonitazene in
schedule I on a temporary basis is necessary to avoid an imminent
hazard to the public safety.
As required by 21 U.S.C. 811(h)(1)(A), DEA published a notice of
intent (NOI) to temporarily schedule N-pyrrolidino metonitazene and N-
pyrrolidino protonitazene on September 17, 2024.\8\ That NOI discussed
findings from DEA's three-factor analysis dated August 2024, which DEA
made available on www.regulations.gov.
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\8\ Schedules of Controlled Substances: Temporary Placement of
N-Pyrrolidino Metonitazene and N-Pyrrolidino Protonitazene in
Schedule I, 89 FR 75979 (Sept. 17, 2024).
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To find that temporarily placing a substance in schedule I of the
CSA is necessary to avoid an imminent hazard to the public safety, the
Administrator must consider three of the eight factors set forth in 21
U.S.C. 811(c): the substance's history and current pattern of abuse;
the scope, duration, and significance of abuse; and what, if any, risk
there is to the public health.\9\ Considerations of these factors
includes any information indicating actual abuse, diversion from
legitimate channels, and clandestine importation, manufacture, or
distribution of N-pyrrolidino metonitazene and N-pyrrolidino
protonitazene.\10\ Substances meeting the statutory requirements for
temporary scheduling may only be placed in schedule I.\11\ Substances
in schedule I have high potential for abuse, no currently accepted
medical use in treatment in the United States,\12\ and a lack of
accepted safety for use under medical supervision.\13\
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\9\ 21 U.S.C. 811(h)(3).
\10\ 21 U.S.C. 811(h)(3).
\11\ 21 U.S.C. 811(h)(1).
\12\ When finding schedule I placement on a temporary basis is
necessary to avoid imminent hazard to the public, 21 U.S.C. 811(h)
does not require DEA to consider whether the substance has a
currently accepted medical use in treatment in the United States.
Nonetheless, 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: 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 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 temporary 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 December 22, 2023, and 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.
\13\ 21 U.S.C. 812(b)(1).
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[[Page 39316]]
Two Benzimidazole-Opioids: N-pyrrolidino metonitazene and N-pyrrolidino
protonitazene
The continued encounter of novel synthetic opioids on the
recreational drug market poses a threat to public safety. Beginning in
2019, a new class of synthetic opioids known as benzimidazole-opioids,
commonly referred to as ``nitazenes,'' emerged on the recreational drug
market. This class of substances has a similar pharmacological profile
to fentanyl, morphine, and other mu-opioid receptor agonists. Between
August 2020 and March 2024, DEA temporarily controlled ten
benzimidazole-opioids because they posed a threat to public safety.\14\
N-Pyrrolidino metonitazene and N-pyrrolidino protonitazene are some of
the recently encountered ``nitazene'' synthetic opioids identified on
the illicit drug market.
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\14\ 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); Schedules of Controlled
Substances: Temporary Placement of Isotonitazene in Schedule I, 85
FR 51342 (Aug. 20, 2020); Schedules of Controlled Substances:
Temporary Placement of N-Desethyl Isotonitazene and N-Piperidinyl
Etonitazene in Schedule I, 89 FR 60817 (Jul. 29, 2024).
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The continued trafficking and identification of benzimidazole-
opioids in toxicology cases poses a significant threat to public health
and safety. Adverse health effects associated with the misuse and abuse
of synthetic opioids have led to devastating consequences including
death. Preclinical pharmacology data demonstrate that N-pyrrolidino
metonitazene and N-pyrrolidino protonitazene have pharmacological
profiles similar to those of the potent benzimidazole-opioids
metonitazene and protonitazene, schedule I opioid substances. N-
Pyrrolidino metonitazene and N-pyrrolidino protonitazene have been
positively identified in at least 26 toxicology cases. As the United
States continues to experience a high number of opioid-involved
overdoses and mortalities, the introduction of new designer opioids
further exacerbates the current opioid epidemic.
Available data and information for N-pyrrolidino metonitazene and
N-pyrrolidino protonitazene, summarized below, indicate that these
substances have high potentials for abuse, no currently accepted
medical uses in treatment in the United States, and a lack of accepted
safety for use under medical supervision. DEA's three-factor analysis
is available in its entirety under ``Supporting and Related Material''
of the public docket for this action at www.regulations.gov under
Docket Number DEA-1337.
Factor 4. History and Current Pattern of Abuse
Since 2019, there has been an emergence of benzimidazole-opioid
compounds on the illicit drug market, which have been positively
identified in numerous cases of fatal overdose events. The
benzimidazole-opioids were originally synthesized and studied in the
1950s by the pharmaceutical research laboratories of the Swiss chemical
company Chemical Industries Basel. The research produced a group of
structurally unique benzimidazole derivatives with analgesic
properties; however, the research effort did not produce any medically
approved analgesic products. These benzimidazole derivatives include
schedule I substances, such as synthetic opioids clonitazene,
etonitazene, and isotonitazene.
In August 2020, isotonitazene was placed in schedule I of the CSA
(85 FR 51342). Subsequently, nine additional benzimidazole-opioids \15\
have been placed in schedule I of the CSA (87 FR 21556 and 89 FR
60817). Recently, N-pyrrolidino metonitazene and N-pyrrolidino
protonitazene have emerged on the illicit drug market. Law enforcement
officers have encountered N-pyrrolidino metonitazene and N-pyrrolidino
protonitazene in several solid forms (e.g., powder and tablets). These
substances are not approved pharmaceutical products and are not
approved for medical use anywhere in the world. The appearance of
benzimidazole-opioids on the illicit drug market is similar to other
designer opioid drugs that are trafficked for their psychoactive
effects. These substances are likely to be abused in the same manner as
schedule I opioids, such as etonitazene, isotonitazene, and heroin. In
2023, N-pyrrolidino metonitazene and N-pyrrolidino protonitazene
emerged on the illicit synthetic drug market as evidenced by their
identification in forensic drug seizures and in biological samples.\16\
Based on NFLIS-Drug data, law enforcement encounters of N-pyrrolidino
metonitazene and N-pyrrolidino protonitazene were found in combination
with other substances of abuse such as heroin, designer
benzodiazepines, cocaine, fentanyl, methamphetamine, and xylazine.
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\15\ Butonitazene, etodesnitazene, flunitazene, metodesnitazene,
metonitazene, N-pyrrolidino etonitazene, and protonitazene (87 FR
21556, Apr. 12, 2022). N-desethyl isotonitazene and N-piperidinyl
etonitazene (89 FR 60817, Jul. 29 2024).
\16\ NMS Labs, in collaboration with the Center for Forensic
Science Research and Education at the Fredric Rieders Family
Foundation and the Organized Crime Drug Enforcement Task Force at
the United States Department of Justice, has received funding from
the Centers for Disease Control and Prevention to develop systems
for the early identification and notification of novel psychoactive
substances in the drug supply within the United States.
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Factor 5. Scope, Duration and Significance of Abuse
N-Pyrrolidino metonitazene and N-pyrrolidino protonitazene, similar
to etonitazene, metonitazene and protonitazene (schedule I substances),
have been described as potent synthetic opioids, and evidence suggests
they are abused for their opioidergic effects (see Factor 6). The abuse
of these benzimidazole-opioids, similar to other synthetic opioids, has
resulted in serious adverse health effects. According to a public alert
report \17\ published in August 2023, N-pyrrolidino protonitazene has
been positively confirmed in 20 medicolegal death investigation cases
in the United States (n =16) and United Kingdom (n = 4). The cases that
occurred in the United States originated from seven states including
California, Illinois, Maine, Massachusetts, Minnesota, Wisconsin, and
Wyoming. N-Pyrrolidino metonitazene has been identified in six
toxicology cases as of June 2023 in the United States. The cases
occurred in at least three states including Ohio, Illinois, and West
Virginia.\18\
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\17\ Krotulski, AJ; Walton, SE; Papsun, DM; DeBord, J; Fogarty,
MF; Logan, BK. (2023) New Nitazene Analogue N-Pyrrolidino
Protonitazene Impacting Drug Markets In North America and Europe,
Center for Forensic Science Research and Education, United States.
CSFRE Public Alert. August 2023.
\18\ Krotulski, AJ; Horton, KB; Walton, SE; Papsun, DM; DeBord,
J; Fogarty, MF; Logan, BK. (2023) N-Pyrrolidino Metonitazene--NPS
Discovery New Drug Monograph, Center for Forensic Science Research
and Education, United States.
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Data from law enforcement suggest that N-pyrrolidino metonitazene
and N-pyrrolidino protonitazene are being abused in the United States
as recreational drugs.\19\ Since 2023, there have been 123 exhibits
reported to the NFLIS-Drug (Federal, State and local laboratories)
database pertaining to the trafficking, distribution, and abuse of
these substances. There were 10 encounters of N-pyrrolidino
metonitazene from four states in NFLIS-Drug: Florida (n = 1), Maine (n
= 1), Missouri (n = 2) and Ohio (n = 6). N-Pyrrolidino protonitazene
has been identified in 113 exhibits in NFLIS-Drug
[[Page 39317]]
from 16 states: California (n = 3), Colorado (n = 3), District of
Columbia (n = 1), Florida (n = 47), Illinois (n = 1), Iowa (n = 10),
Kentucky (n = 1), Mississippi (n = 1), Missouri (n = 1), New Jersey (n
= 1), New York (n = 1), Ohio (n = 14), Pennsylvania (n = 2), Texas (n =
23), Virginia (n = 3), and Washington (n = 1).\20\
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\19\ While law enforcement data are not direct evidence of
abuse, they can lead to an inference that a drug has been diverted
and abused. See 76 FR 77330, 77332 (Dec. 12, 2011).
\20\ NFLIS-Drug was queried on November 13, 2024.
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Because abusers of N-pyrrolidino metonitazene and N-pyrrolidino
protonitazene are likely to obtain these substances through unregulated
sources, the identity, purity, and quantity of these substances are
uncertain and inconsistent, thus posing significant adverse health
risks to the end user. The misuse and abuse of opioids have been
demonstrated and are well-characterized.\21\ Individuals who initiate
(i.e., use a drug for the first time) use of these benzimidazole-
opioids are likely to be at risk of developing substance use disorder,
an overdose event, or death, similar to that of other opioid analgesics
(e.g., fentanyl, morphine, etc.). Law enforcement and toxicology
reports demonstrate that N-pyrrolidino metonitazene and N-pyrrolidino
protonitazene are being illicitly distributed and abused.
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\21\ Jones CM, Logan J, Gladden RM, Bohm MK. Vital Signs:
Demographic and Substance Use Trends Among Heroin Users--United
States, 2002-2013. MMWR Morb Mortal Wkly Rep. 2015 Jul
10;64(26):719-25.
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Factor 6. What, if Any, Risk There Is to the Public Health
The increase in opioid overdose deaths in the United States has
been exacerbated recently by the availability of potent synthetic
opioids on the illicit drug market. Data obtained from pre-clinical
studies demonstrate that N-pyrrolidino metonitazene and N-pyrrolidino
protonitazene exhibit pharmacological profiles similar to that of
etonitazene, metonitazene, protonitazene, and other mu-opioid receptor
agonists. These two benzimidazole-opioids bind to and act as agonists
at the mu-opioid receptors.\22\ It is well established that substances
that act as mu-opioid receptor agonists have a high potential for
addiction and can induce dose-dependent respiratory depression.\23\
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\22\ DEA-VA Interagency Agreement. ``In Vitro Receptor and
Transporter Assays for Abuse Liability Testing for the DEA by the
VA''. Binding and Functional Activity at Delta, Kappa and Mu Opioid
Receptors. 2022.
\23\ Fox LM, Hoffman RS, Vlahov D, Manini AF. Risk factors for
severe respiratory depression from prescription opioid overdose.
Addiction. 2018 Jan;113(1):59-66.
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Consistent with any mu-opioid receptor agonist, the potential
health and safety risks for users of N-pyrrolidino metonitazene and N-
pyrrolidino protonitazene are high. N-Pyrrolidino metonitazene and N-
pyrrolidino protonitazene have been positively identified in forensic
toxicology and postmortem cases. According to a public alert, N-
pyrrolidino protonitazene has been positively identified in 20
medicolegal death investigations in the United States and United
Kingdom as of August 2023. Of the cases, 16 occurred across seven
states in the United States. Decedent ages ranged from mid-20s to mid-
70s. N-Pyrrolidino protonitazene was co-identified with additional
novel psychoactive substances (70 percent), quinine (60 percent), other
benzimidazole-opioids (55 percent), methamphetamine/cocaine (55
percent), fentanyl (55 percent), xylazine (35 percent) and designer
benzodiazepines (30 percent).\24\ Also, N-pyrrolidino metonitazene has
been identified in six toxicology cases in the United States as of June
2023. The introduction of potent synthetic opioids such as N-
pyrrolidino metonitazene and N-pyrrolidino protonitazene into the
illicit market may serve as a portal to problematic opioid use for
those seeking these powerful opioids. As documented by toxicology
reports, polysubstance abuse remains common in fatalities associated
with the abuse of some of these benzimidazole-opioids.
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\24\ Krotulski, AJ; Walton, SE; Papsun, DM; DeBord, J; Fogarty,
MF; Logan, BK. (2023) New Nitazene Analogue N-Pyrrolidino
Protonitazene Impacting Drug Markets in North America and Europe,
Center for Forensic Science Research and Education, United States.
CSFRE Public Alert. August 2023.
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The United States is currently experiencing an opioid epidemic, and
the presence of synthetic opioids on the illicit drug market further
exacerbates the problem. The trafficking and abuse of new synthetic
opioids are deadly trends which pose imminent hazard to the public
safety. Adverse health effects associated with the abuse of synthetic
opioids and the continued evolution and increased popularity of these
substances have been a serious concern in recent years. Because of the
pharmacological similarities of N-pyrrolidino metonitazene and N-
pyrrolidino protonitazene to metonitazene and protonitazene, the use of
these substances presents high risk of abuse and may negatively affect
users and communities. The positive identification of these substances
in toxicology cases is of serious concern to the public safety. Thus,
N-pyrrolidino metonitazene and N-pyrrolidino protonitazene pose
imminent hazard to public safety.
Finding of Necessity of Schedule I Placement To Avoid Imminent Hazard
to Public Safety
In accordance with 21 U.S.C. 811(h)(3), based on the available data
and information summarized above, the uncontrolled manufacture,
distribution, reverse distribution, importation, exportation, conduct
of research and chemical analysis, possession, and abuse of N-
pyrrolidino metonitazene and N-pyrrolidino protonitazene pose imminent
hazards to public safety. DEA is not aware of any currently accepted
medical uses for these substances in the United States. A substance
meeting the statutory requirements for temporary scheduling, found in
21 U.S.C. 811(h)(1), may only be placed in schedule I. Substances in
schedule I must have a high potential for abuse, no currently accepted
medical use in treatment in the United States, and a lack of accepted
safety for use under medical supervision. Available data and
information for N-pyrrolidino metonitazene and N-pyrrolidino
protonitazene indicate that these substances meet the three statutory
criteria. As required by 21 U.S.C. 811(h)(4), the then-Administrator
transmitted to the then-Assistant Secretary, via letter dated December
7, 2023, notice of DEA's intent to place N-pyrrolidino metonitazene and
N-pyrrolidino protonitazene in schedule I on a temporary basis. By
letter dated December 22, 2023, the then-Assistant Secretary had no
objection to the temporary placement of these substances in schedule I.
DEA subsequently published this NOI in the Federal Register on
September 17, 2024. However, due to the time lapse between HHS's
December 22, 2023, response, the then-Acting DEA Administrator by
letter dated March 24, 2025, provided notification to the Acting
Assistant Secretary per 21 U.S.C. 811(h)(4) of his intent to finalize
the placement of N-pyrrolidino metonitazene and N-pyrrolidino
protonitazene in schedule I on a temporary basis. HHS had no objection
to the temporary placement of these substances in schedule I.
Conclusion
In accordance with 21 U.S.C. 811(h)(1) and (3), the Administrator
considered available data and information, herein set forth the grounds
for his determination that it is necessary to temporarily schedule N-
pyrrolidino metonitazene and N-pyrrolidino protonitazene in schedule I
of the CSA, and finds that placement of
[[Page 39318]]
these substances in schedule I is necessary to avoid an imminent hazard
to the public safety.
The temporary placement of N-pyrrolidino metonitazene and N-
pyrrolidino protonitazene in schedule I of the CSA will take effect on
the date the order is published in the Federal Register and will remain
in effect for two years, with a possible extension of one year, pending
completion of the regular (permanent) scheduling process.\25\
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\25\ 21 U.S.C. 811(h)(1) and (2).
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The CSA sets forth specific criteria for scheduling drugs or other
substances. Regular scheduling actions in accordance with 21 U.S.C.
811(a) are subject to formal rulemaking procedures ``on the record
after opportunity for a hearing'' conducted pursuant to the provisions
of 5 U.S.C. 556 and 557.\26\ The regular scheduling process of formal
rulemaking affords interested parties appropriate process and the
government any additional relevant information needed to make a
determination. Final decisions that conclude the regular scheduling
process of formal rulemaking are subject to judicial review.\27\
Temporary scheduling orders are not subject to judicial review.\28\
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\26\ 21 U.S.C. 811.
\27\ 21 U.S.C. 877.
\28\ 21 U.S.C. 811(h)(6).
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Requirements for Handling
Upon the effective date of this temporary order, N-pyrrolidino
metonitazene and N-pyrrolidino protonitazene will be subject to the
regulatory controls and administrative, civil, and criminal sanctions
applicable to the manufacture, distribution, reverse distribution,
importation, exportation, possession of, and engagement in research and
conduct of instructional activities or chemical analysis with, schedule
I controlled substances, including but not limited to the following:
1. Registration. Any person who handles (possesses, manufactures,
distributes, reverse distributes, imports, exports, engages in
research, or conducts instructional activities or chemical analysis
with) or 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, as of August 15, 2025. Any person who
thereafter handles N-pyrrolidino metonitazene or N-pyrrolidino
protonitazene and is not registered with DEA must submit an application
for registration and may not continue to handle N-pyrrolidino
metonitazene or N-pyrrolidino protonitazene as of August 15, 2025,
unless DEA has approved that application for registration 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 on
or after August 15, 2025 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. Any person who does not desire or is unable
to obtain a schedule I registration to handle N-pyrrolidino
metonitazene or N-pyrrolidino protonitazene must surrender all
currently held quantities of these substances.
3. Security. N-Pyrrolidino metonitazene and N-pyrrolidino
protonitazene are subject to schedule I security requirements and must
be handled in accordance with 21 CFR 1301.71-1301.93, as of August 15,
2025.
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 21 CFR part
1302. Current DEA registrants will have 30 calendar days from August
15, 2025 to comply with all labeling and packaging requirements.
5. Inventory. Every DEA registrant who possesses any quantity of N-
pyrrolidino metonitazene or N-pyrrolidino protonitazene on the
effective date of this order must take an inventory of all stocks of
these substances on hand pursuant to 21 U.S.C. 827 and 958, and in
accordance with 21 CFR 1304.03, 1304.04, and 1304.11. Current DEA
registrants will have 30 calendar days from the effective date of this
order to comply with all inventory requirements. After the initial
inventory, every DEA registrant must take an inventory of all
controlled substances (including N-pyrrolidino metonitazene and N-
pyrrolidino protonitazene) on hand on a biennial basis pursuant to 21
U.S.C. 827 and 958 and in accordance with 21 CFR 1304.03, 1304.04, and
1304.11.
6. Records. All DEA registrants must maintain records 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 parts 1304,
1312, and 1317, and section 1307.11. Current DEA registrants authorized
to handle these two substances shall have 30 calendar days from the
effective date of this order to comply with all recordkeeping
requirements.
7. Reports. All DEA registrants must submit reports with respect to
N-pyrrolidino metonitazene and N-pyrrolidino protonitazene pursuant to
21 U.S.C. 827 and in accordance with 21 CFR parts 1304, 1312, and 1317,
and sections 1301.74(c) and 1301.76(b), as of August 15, 2025.
Manufacturers and distributors must also submit reports regarding these
substances 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 N-pyrrolidino
metonitazene or N-pyrrolidino protonitazene must comply with order form
requirements pursuant to 21 U.S.C. 828 and in accordance with 21 CFR
part 1305 as of August 15, 2025.
9. Importation and Exportation. All importation and exportation of
N-pyrrolidino metonitazene and N-pyrrolidino protonitazene must be in
compliance with 21 U.S.C. 952, 953, 957, and 958, and in accordance
with 21 CFR part 1312 as of August 15, 2025.
10. Quota. Only DEA-registered manufacturers may 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, as of August 15, 2025.
11. Liability. Any activity involving N-pyrrolidino metonitazene or
N-pyrrolidino protonitazene not authorized by or in violation of the
CSA, occurring as of August 15, 2025, is unlawful, and may subject the
person to administrative, civil, and/or criminal sanctions.
Regulatory Analyses
The CSA provides for expedited temporary scheduling actions where
necessary to avoid an imminent hazard to the public safety. Under 21
U.S.C. 811(h)(1), the Administrator, as delegated by the Attorney
General, may, by order, temporarily place substances in schedule I.
Such orders may not be issued before the expiration of 30 days from:
(1) The publication of a notice in the Federal Register of the intent
to issue such order and the grounds upon which such order is to be
issued, and (2) the date that notice of the proposed temporary
scheduling order is transmitted to the Assistant Secretary, as
delegated by the Secretary of HHS.\29\
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\29\ 21 U.S.C. 811(h)(1).
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[[Page 39319]]
Inasmuch as section 811(h) directs that temporary scheduling
actions be issued by order (as distinct from a rule) and sets forth the
procedures by which such orders are to be issued, DEA believes the
notice-and-comment requirements of section 553 of the Administrative
Procedure Act (APA), 5 U.S.C. 553, do not apply to this temporary
scheduling order. The APA expressly differentiates between orders and
rules, as it defines an ``order'' to mean a ``final disposition,
whether affirmative, negative, injunctive, or declaratory in form, of
an agency in a matter other than rule making.'' \30\ (Emphasis added).
This contrasts with permanent scheduling actions, which are subject to
formal rulemaking procedures done ``on the record after opportunity for
a hearing,'' and final decisions that conclude the scheduling process
and are subject to judicial review. 21 U.S.C. 811(a) and 877. The
specific language chosen by Congress indicates its intent that DEA
issue orders instead of proceeding by rulemaking when temporarily
scheduling substances. Given that Congress specifically requires the
Administrator (as delegated by the Attorney General) to follow
rulemaking procedures for other kinds of scheduling actions, see 21
U.S.C. 811(a), it is noteworthy that, in section 811(h)(1), Congress
authorized the issuance of temporary scheduling actions by order rather
than by rule.
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\30\ 5 U.S.C. 551(6).
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Even assuming that this action is subject to section 553 of the
APA, the Administrator finds that there is good cause to forgo its
notice-and-comment requirements, as any further delays in the process
for issuing temporary scheduling orders would be impracticable and
contrary to the public interest given the manifest urgency to avoid an
imminent hazard to the public safety.
Although DEA believes this temporary scheduling order is not
subject to the notice-and-comment requirements of section 553 of the
APA, DEA notes that in accordance with 21 U.S.C. 811(h)(4), the
Administrator took into consideration comments submitted by the Acting
Assistant Secretary in response to the notices that DEA transmitted to
the Acting Assistant Secretary pursuant to such subsection.
Further, DEA believes that this temporary scheduling action is not
a ``rule'' as defined by 5 U.S.C. 601(2), and, accordingly, is not
subject to the requirements of the Regulatory Flexibility Act (RFA).
The requirements for the preparation of an initial regulatory
flexibility analysis in 5 U.S.C. 603(a) are not applicable where, as
here, DEA is not required by section 553 of the APA or any other law to
publish a general notice of proposed rulemaking. Therefore, in this
instance, since DEA believes this temporary scheduling action is not a
``rule,'' it is not subject to the requirements of the RFA when issuing
this temporary action.
In accordance with the principles of Executive Orders (E.O.) 12866,
13563, and 14192, this action is not a significant regulatory action.
E.O. 12866 directs agencies to assess all costs and benefits of
available regulatory alternatives and, if regulation is necessary, to
select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health, and safety effects;
distributive impacts; and equity). E.O. 13563 is supplemental to and
reaffirms the principles, structures, and definitions governing
regulatory review as established in E.O. 12866. E.O. 12866, sec. 3(f),
provides the definition of a ``significant regulatory action,''
requiring review by the Office of Management and Budget. Because this
is not a rulemaking action, this is not a significant regulatory action
as defined in Section 3(f) of E.O. 12866. DEA scheduling actions are
not subject to either E.O. 14192, Unleashing Prosperity Through
Deregulation, or E.O. 14294, Fighting Overcriminalization in Federal
Regulations.
This action will 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. Therefore, in accordance with E.O. 13132, it is
determined that this action does not have sufficient federalism
implications to warrant the preparation of a Federalism Assessment.
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 proposes to amend 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, add paragraphs (h)(77) and (78) to read as
follows:
Sec. 1308.11 Schedule I
* * * * *
(h) * * *
------------------------------------------------------------------------
------------------------------------------------------------------------
(77) 2-(4-methoxybenzyl)-5-nitro-1-(2-(pyrrolidin-1- 9762
yl)ethyl)-1H-benzimidazole, its isomers, esters,
ethers, salts, and salts of isomers, esters and ethers
(Other names: N-pyrrolidino metonitazene;
metonitazepyne)........................................
(78) 5-nitro-2-(4-propoxybenzyl)-1-(2-(pyrrolidin-1- 9763
yl)ethyl)-1H-benzimidazole, its isomers, esters,
ethers, salts, and salts of isomers, esters and ethers
(Other names: N-pyrrolidino protonitazene;
protonitazepyne).......................................
* * * * * * *
------------------------------------------------------------------------
Signing Authority
This document of the Drug Enforcement Administration was signed on
August 12, 2025, by Administrator Terrance 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. 2025-15566 Filed 8-14-25; 8:45 am]
BILLING CODE 4410-09-P