Rule2026-04112
Schedules of Controlled Substances: Placement of Clonazolam, Diclazepam, Etizolam, Flualprazolam, and Flubromazolam in Schedule I of the Controlled Substances Act
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
March 2, 2026
Effective
April 1, 2026
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
With the issuance of this final rule, the Drug Enforcement Administration places clonazolam, diclazepam, etizolam, flualprazolam, and flubromazolam and their salts, isomers, and salts of isomers, whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation, in schedule I of the Controlled Substances Act. These five substances were temporarily scheduled in an order dated July 26, 2023, and subsequently extended until July 26, 2026, pursuant to an extension published elsewhere in this issue of the Federal Register. This action also enables the United States to meet its obligations under the 1971 Convention on Psychotropic Substances. This action makes permanent the existing 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 five specific controlled substances.
Full Text
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<title>Federal Register, Volume 91 Issue 40 (Monday, March 2, 2026)</title>
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[Federal Register Volume 91, Number 40 (Monday, March 2, 2026)]
[Rules and Regulations]
[Pages 9985-9989]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-04112]
[[Page 9985]]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-989]
Schedules of Controlled Substances: Placement of Clonazolam,
Diclazepam, Etizolam, Flualprazolam, and Flubromazolam in Schedule I of
the Controlled Substances Act
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Final rule.
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SUMMARY: With the issuance of this final rule, the Drug Enforcement
Administration places clonazolam, diclazepam, etizolam, flualprazolam,
and flubromazolam and their salts, isomers, and salts of isomers,
whenever the existence of such salts, isomers, and salts of isomers is
possible within the specific chemical designation, in schedule I of the
Controlled Substances Act. These five substances were temporarily
scheduled in an order dated July 26, 2023, and subsequently extended
until July 26, 2026, pursuant to an extension published elsewhere in
this issue of the Federal Register. This action also enables the United
States to meet its obligations under the 1971 Convention on
Psychotropic Substances. This action makes permanent the existing
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 five specific controlled
substances.
DATES: Effective date: April 1, 2026.
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 places clonazolam, diclazepam,
etizolam, flualprazolam, and flubromazolam and their salts, isomers,
and salts of isomers, whenever the existence of such salts, isomers,
and salts of isomers is possible within the specific chemical
designation, in schedule I of the Controlled Substances Act (CSA).
Legal Authority
The United States is a party to the 1971 United Nations Convention
on Psychotropic Substances (1971 Convention), Feb. 21, 1971, 32 U.S.T.
543, 1019 U.N.T.S. 175, as amended. Procedures respecting changes in
drug schedules under the 1971 Convention are governed domestically by
21 U.S.C. 811(d)(2)-(4). When the United States receives notification
of a scheduling decision pursuant to Article 2 of the 1971 Convention
indicating that a drug or other substance has been added to a schedule
specified in the notification, the Secretary of the Department of
Health and Human Services (HHS),\1\ after consultation with the
Attorney General, shall first determine whether existing legal controls
under subchapter I of the CSA and the Federal Food, Drug, and Cosmetic
Act \2\ meet the requirements of the schedule specified in the
notification with respect to the specific drug or substance.\3\ In the
event that the Secretary did not so consult with the Attorney General,
and the Attorney General did not issue a temporary order, as provided
under 21 U.S.C. 811(d)(4), the procedures for permanent scheduling set
forth in 21 U.S.C. 811(a) and (b) control.
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\1\ As discussed in a memorandum of understanding entered into
by the U.S. Food and Drug Administration (FDA) and the National
Institute on Drug Abuse (NIDA), FDA acts as the lead agency within
HHS in carrying out the Secretary's scheduling responsibilities
under the CSA, with the concurrence of NIDA. Memorandum of
Understanding with the National Institute on Drug Abuse, 50 FR 9518
(Mar. 8, 1985). The Secretary has delegated to the Assistant
Secretary for Health of HHS the authority to make domestic drug
scheduling recommendations. Comprehensive Drug Abuse Prevention and
Control Act of 1970, Public Law 91-513, As Amended; Delegation of
Authority, 58 FR 35460 (July 1, 1993).
\2\ 21 U.S.C. 355.
\3\ 21 U.S.C. 811(d)(3).
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Pursuant to 21 U.S.C. 811(a)(1) and (2), the Attorney General (as
delegated to the Administrator of DEA pursuant to 28 CFR 0.100) may, by
rule, and upon the recommendation of the Secretary, add to such a
schedule or transfer between such schedules any drug or other
substance, if she finds that such drug or other substance has a
potential for abuse, and makes with respect to such drug or other
substance the findings prescribed by 21 U.S.C. 812(b) for the schedule
in which such drug or other substance is to be placed.
Background
Clonazolam, diclazepam, etizolam, flualprazolam, and flubromazolam
are central nervous system depressants that are structurally and
pharmacologically related to classical benzodiazepines, such as
alprazolam. On May 7, 2020, the Secretariat of the United Nations
advised the Secretary of State of the United States that the Commission
on Narcotic Drugs (CND), during its 63rd Session on March 4, 2020,
voted to place etizolam and flualprazolam in Schedule IV of the 1971
Convention (CND Decisions 63/12, 63/13). On June 10, 2021, the
Secretariat advised the Secretary of State that the CND, during its
64th Session, voted to place clonazolam, diclazepam, and flubromazolam
in Schedule IV of the 1971 Convention (CND Decisions 64/6, 64/7, 64/8).
As a signatory to the 1971 Convention, the United States is required,
by scheduling under the CSA, to place appropriate controls on these
five designer benzodiazepines to meet the requirements of this treaty.
To meet the minimum requirements of this treaty and to confront
these emerging substances, DEA published an order in the Federal
Register on July 26, 2023, temporarily placing clonazolam, diclazepam,
etizolam, flualprazolam, and flubromazolam in schedule I of the CSA
based upon a finding that these substances pose an imminent hazard to
the public safety under 21 U.S.C. 811(h)(1).\4\ That temporary order
was effective upon the date of publication. On July 25, 2025, DEA
published a temporary scheduling order to extend the temporary schedule
I status of these five substances for one year, or until the permanent
scheduling action for these substances is completed, whichever occurs
first.\5\
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\4\ Schedules of Controlled Substances: Temporary Placement of
Etizolam, Flualprazolam, Clonazolam, Flubromazolam, and Diclazepam
in Schedule I, 88 FR 48112 (July 26, 2023).
\5\ Schedules of Controlled Substances: Placement of Clonazolam,
Diclazepam, Etizolam, Flualprazolam, and Flubromazolam in Schedule I
of the Controlled Substances Act, 90 FR 35236 (July 25, 2025).
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DEA and HHS Eight-Factor Analyses
In letters dated March 17 and 24, 2022, in accordance with 21
U.S.C. 811(b), the former Administrator requested that the former
Assistant Secretary for Health of HHS provide DEA with a scientific and
medical evaluation of available information and a scheduling
recommendation for clonazolam, diclazepam, etizolam, flualprazolam, and
flubromazolam. In a letter dated June 18, 2025, HHS provided DEA with a
scientific and medical evaluation of available information for these
five substances and a scheduling recommendation for schedule I
placement of these substances under the CSA.
[[Page 9986]]
DEA reviewed HHS's scientific and medical evaluation and scheduling
recommendation, as well as all other relevant data, pursuant to 21
U.S.C. 811(b) and (c), and conducted its own analysis under the eight
factors stipulated in 21 U.S.C. 811(c). DEA found, under 21 U.S.C.
812(b)(1), that these substances warrant control in schedule I. Both
DEA's and HHS's eight-factor analyses are available in their entirety
under the tab Supporting Documents of the public docket for this action
at <a href="https://www.regulations.gov">https://www.regulations.gov</a> under docket number DEA-989.
Notice of Proposed Rulemaking To Schedule Clonazolam, Diclazepam,
Etizolam, Flualprazolam, and Flubromazolam
On July 25, 2025, DEA published a notice of proposed rulemaking
(NPRM) to permanently control clonazolam, diclazepam, etizolam,
flualprazolam, and flubromazolam in schedule I.\6\ Specifically, DEA
proposed to add clonazolam, diclazepam, etizolam, flualprazolam, and
flubromazolam to the list of depressant substances under 21 CFR
1308.11(e). The NPRM provided an opportunity for interested persons to
file a request for a hearing, in accordance with DEA regulations, on or
before August 25, 2025. DEA did not receive any requests for such a
hearing. The NPRM also provided an opportunity for interested persons
to submit comments on or before August 25, 2025.
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\6\ Schedules of Controlled Substances: Placement of Clonazolam,
Diclazepam, Etizolam, Flualprazolam, and Flubromazolam in Schedule I
of the Controlled Substances Act, 90 FR 35253 (July 25, 2025).
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Comments Received
DEA received 19 comments in response to the NPRM for the placement
of clonazolam, diclazepam, etizolam, flualprazolam, and flubromazolam
into schedule I of the CSA. The submissions were from individuals or
anonymous commenters. Of these 19 submissions, 5 commenters provided
support for the NPRM; 6 commenters were against the placement of
clonazolam, diclazepam, etizolam, flualprazolam, or flubromazolam in
schedule I of the CSA; 2 commenters requested placement in another
schedule; and 6 commenters provided statements that were neither
explicitly for nor against the proposed rule.
Support of rulemaking: DEA received five comments, including from
medical professionals, in support of the placement of clonazolam,
diclazepam, etizolam, flualprazolam, and flubromazolam in schedule I of
the CSA.
DEA response: DEA appreciates these comments in support of this
rulemaking.
Opposition to rulemaking: DEA received six comments explicitly
against the placement of clonazolam, diclazepam, etizolam,
flualprazolam, or flubromazolam in schedule I of the CSA. Of these six
comments, three commentors asserted that these five substances are
analogues of benzodiazepines with therapeutic use; four commentors
noted that etizolam is prescribed clinically in other countries; and
two commentors expressed concerns that research would be restricted due
to schedule I status. The following is DEA's response to the comments
against the proposed rulemaking.
DEA response: DEA appreciates these comments and would like to
provide further clarification regarding the control of clonazolam,
diclazepam, etizolam, flualprazolam, and flubromazolam. These five
substances have been internationally controlled. To comply with treaty
obligations, DEA must place these five substances under the most
appropriate schedule, taking into consideration all appropriate
scientific data. As set forth in the NPRM, these five substances have
no currently accepted medical use in treatment in the United States,
nor were there any New Drug Applications. Regarding etizolam
specifically, HHS noted in its scientific and medical evaluation that
etizolam is used as an approved medical drug in other countries for the
treatment of anxiety disorders, insomnia, and neurosis. Nevertheless,
HHS concluded that etizolam lacked a currently accepted medical use in
the United States, finding that the few published clinical studies on
etizolam in particular (1) had important limitations, (2) did not
address the human abuse potential of etizolam, and (3) did not meet the
threshold for findings of safety or efficacy of etizolam for any
medical uses. HHS also stated that no qualified experts or groups have
been identified in the United States who have asserted or supported
that etizolam has a currently accepted medical use in treatment in the
United States. Therefore, these five substances must be placed in
schedule I of the CSA, alongside other substances that have no
currently accepted medical use, lack accepted safety for use under
medical supervision, and possess high potential for abuse. With respect
to research for potential for medical use, the placement of substances
in schedule I of the CSA does not preclude academic research on these
substances.\7\ Those wishing to conduct research on clonazolam,
diclazepam, etizolam, flualprazolam, or flubromazolam must seek
permission to do so with DEA.\8\
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\7\ 21 U.S.C. 822(h); 21 U.S.C. 823(g)(2)(A); 21 U.S.C. 823(n);
see also Grinspoon v. Drug Enforcement Admin., 828 F.2d 881, 897
(1st Cir. 1987).
\8\ <a href="https://apps.deadiversion.usdoj.gov/webforms2/spring/login?execution=e1s1">https://apps.deadiversion.usdoj.gov/webforms2/spring/login?execution=e1s1</a>.
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Considerations for rulemaking: DEA received two comments that did
not oppose scheduling clonazolam, diclazepam, etizolam, flualprazolam,
and flubromazolam under the CSA. Of these two comments, one commentor
requested placement of these five substances in another schedule, such
that research on the therapeutic potential of these substances may be
accomplished; and the other commenter did not oppose placement of four
of the five substances in schedule I, requesting a different schedule
for etizolam specifically. The following is DEA's response to the
comments requesting modifications to the proposed rulemaking.
DEA response: DEA appreciates these comments and would like to
provide further clarification regarding the control of clonazolam,
diclazepam, etizolam, flualprazolam, and flubromazolam. As noted above,
DEA must place these five substances under the most appropriate
schedule, taking into consideration all appropriate scientific data, to
comply with treaty obligations. These five substances have no currently
accepted medical use in treatment in the United States, nor were there
any New Drug Applications. Therefore, these five substances must be
placed in schedule I of the CSA, which does not preclude academic
research, and those who wish to conduct research on the therapeutic
potential of clonazolam, diclazepam, etizolam, flualprazolam, or
flubromazolam must seek permission to do so with DEA.
General comments: DEA received six comments that were neither
explicitly for nor against the proposed rule.
DEA response: DEA appreciates these comments.
Scheduling Conclusion
After consideration of the public comments, scientific and medical
evaluation and accompanying scheduling recommendation from HHS, and its
own eight-factor evaluation, DEA finds that these facts and all
relevant data constitute substantial evidence of potential for abuse of
clonazolam, diclazepam, etizolam, flualprazolam, and flubromazolam. As
such, DEA is permanently scheduling clonazolam,
[[Page 9987]]
diclazepam, etizolam, flualprazolam, and flubromazolam as controlled
substances under schedule I of the CSA. The permanent scheduling of
these five benzodiazepines fulfills the United States' obligations as a
party to the 1971 Convention.
Determination of Appropriate Schedule
The CSA establishes five schedules of controlled substances known
as schedules I, II, III, IV, and V. The CSA also specifies the findings
required to place a drug or other substance in any particular
schedule.\9\ After consideration of the interested persons' comments
above, analysis and recommendation of the Assistant Secretary for
Health of HHS, and all other available data, the Administrator of DEA,
pursuant to 21 U.S.C. 812(b)(1), finds that:
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\9\ 21 U.S.C. 812(b).
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(1) Clonazolam, diclazepam, etizolam, flualprazolam, and
flubromazolam have a high potential for abuse. These five substances
are pharmacologically similar to classical benzodiazepines (e.g.,
diazepam), which have been shown to produce dependence and are abused
by millions of individuals in the United States. In vitro binding
affinity and functional activity studies, as well as in vivo drug
discrimination studies, demonstrate that these substances are highly
potent positive allosteric modulators of GABA<INF>A</INF> receptors--a
mechanism of action that accounts for the inhibitory effects of GABA,
decreased neuronal activity, and result in the pharmacological
properties of the benzodiazepine class. These pharmacological
properties include CNS depressant effects, such as anxiolytic, amnesic,
anticonvulsant, sedative-hypnotic, respiratory depressant, and muscle
relaxant effects. This finding is consistent with drug abuse patterns
and adverse outcomes from epidemiological data sources.
(2) Clonazolam, diclazepam, etizolam, flualprazolam, and
flubromazolam have no currently accepted medical use in treatment in
the United States. According to HHS, FDA has not approved a marketing
application for clonazolam, diclazepam, etizolam, flualprazolam, or
flubromazolam. In addition, these five substances have no known
therapeutic applications in the United States. DEA is not aware of any
evidence suggesting that these five substances have a currently
accepted medical use in treatment in the United States.\10\
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\10\ When placing a drug or other substance in schedule I of 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 clonazolam,
diclazepam, etizolam, flualprazolam, and flubromazolam have a
currently accepted medical use 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 and HHS applied the traditional five-part test for
currently accepted medical use in this matter 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
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 the 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 (Apr. 11, 2024). For
purposes of this final rule, there is no evidence that health care
providers have widespread experience with medical use of clonazolam,
diclazepam, etizolam, flualprazolam, or flubromazolam or that the
use of clonazolam, diclazepam, etizolam, flualprazolam, or
flubromazolam is recognized by entities that regulate the practice
of medicine, so the two-part test also is not satisfied.
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(3) There is a lack of accepted safety for use of clonazolam,
diclazepam, etizolam, flualprazolam, and flubromazolam under medical
supervision. As stated by HHS, because these five substances have no
approved medical use and have not been investigated as new drugs, their
safety for use under medical supervision has not been determined.
Based on these findings, the Administrator of DEA concludes that
clonazolam, diclazepam, etizolam, flualprazolam, and flubromazolam,
including their salts, isomers, and salts of isomers whenever the
existence of such salts, isomers, and salts of isomers is possible,
warrant continued control in schedule I of the CSA.
Requirements for Handling Clonazolam, Diclazepam, Etizolam,
Flualprazolam, and Flubromazolam
Clonazolam, diclazepam, etizolam, flualprazolam, and flubromazolam
are subject to the CSA's schedule I regulatory controls and
administrative, civil, and criminal sanctions applicable to the
manufacture, distribution, reverse distribution, import, export,
engagement in research, conduct instructional activities or chemical
analysis 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, clonazolam, diclazepam, etizolam, flualprazolam,
or flubromazolam 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. Any person who currently handles clonazolam,
diclazepam, etizolam, flualprazolam, or flubromazolam and is not
registered with DEA must submit an application for registration and may
not continue to handle clonazolam, diclazepam, etizolam, flualprazolam,
or flubromazolam, unless DEA has approved that application for
registration pursuant to 21 U.S.C. 822, 823, 957, 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 in a manner not authorized by the CSA
is unlawful and those in possession of any quantity may be subject to
prosecution pursuant to the CSA.
2. Disposal of stocks. Any person unwilling or unable to obtain a
schedule I registration must surrender or transfer all quantities of
currently held clonazolam, diclazepam, etizolam, flualprazolam, and
flubromazolam to a person registered with DEA before the effective date
of a final scheduling action in accordance with all applicable Federal,
State, local, and Tribal laws. Clonazolam, diclazepam, etizolam,
flualprazolam, and flubromazolam 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. Clonazolam, diclazepam, etizolam, flualprazolam, and
flubromazolam are 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, as of the effective date of this final
scheduling action. Non-practitioners handling these five substances
also must comply with the screening requirements of 21 CFR 1301.90-
1301.93.
[[Page 9988]]
4. Labeling and Packaging. All labels, labeling, and packaging for
commercial containers of clonazolam, diclazepam, etizolam,
flualprazolam, or flubromazolam must comply with 21 U.S.C. 825 and be
in accordance with 21 CFR part 1302.
5. Quota. Generally, only registered manufacturers are permitted to
manufacture clonazolam, diclazepam, etizolam, flualprazolam, and
flubromazolam 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
clonazolam, diclazepam, etizolam, flualprazolam, or flubromazolam must
take an inventory of these substances on hand, pursuant to 21 U.S.C.
827 and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11(a) and
(d).
Any person who registers with DEA must take an initial inventory of
all stocks of controlled substances (including these five substances)
on hand on the date the registrant first engages in the handling of
controlled substances, pursuant to 21 U.S.C. 827 and in accordance with
21 CFR 1304.03, 1304.04, and 1304.11(a) and (b).
After the initial inventory, every DEA registrant must take an
inventory of all controlled substances (including these five
substances) on hand every two years, pursuant to 21 U.S.C. 827 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 clonazolam, diclazepam, etizolam,
flualprazolam, and flubromazolam pursuant to 21 U.S.C. 827 and in
accordance with 21 CFR 1301.74(b) and (c), 1301.76(b), and parts 1304,
1312, and 1317. Manufacturers and distributors must submit reports
regarding clonazolam, diclazepam, etizolam, flualprazolam, and
flubromazolam to the Automation of Reports and Consolidated Order
System pursuant 21 U.S.C. 827, and in accordance with 21 CFR parts 1304
and 1312.
8. Order Forms. Every DEA registrant who distributes clonazolam,
diclazepam, etizolam, flualprazolam, or flubromazolam 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
clonazolam, diclazepam, etizolam, flualprazolam, or flubromazolam must
comply with 21 U.S.C. 952, 953, 957, and 958 and in accordance with 21
CFR parts 1304 and 1312.
10. Liability. Any activity involving clonazolam, diclazepam,
etizolam, flualprazolam, or flubromazolam 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
In accordance with 21 U.S.C. 811(a), this final scheduling action
is subject to formal rulemaking procedures performed ``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 procedures
and 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. DEA scheduling actions are not
subject to either E.O. 14192, Unleashing Prosperity Through
Deregulation, or E.O. 14294, Overcriminalization in Federal
Regulations.
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 on 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.
Paperwork Reduction Act of 1995
This action does not impose a new collection or modify an existing
collection of information under the Paperwork Reduction Act of
1995.\11\ Also, this rule does 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.
---------------------------------------------------------------------------
\11\ 44 U.S.C. 3501-3521.
---------------------------------------------------------------------------
Regulatory Flexibility Act
The Administrator of DEA, in accordance with the Regulatory
Flexibility Act, 5 U.S.C. 601-612, has reviewed this final rule, and by
approving it, certifies that it will not have a significant economic
impact on a substantial number of small entities.
DEA is placing clonazolam, diclazepam, etizolam, flualprazolam, and
flubromazolam, including its salts, isomers, and salts of isomers, in
schedule I of the CSA on a permanent basis to enable the United States
to meet its obligations under the 1971 Convention. This action 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 with, or possess) or propose to handle clonazolam, diclazepam,
etizolam, flualprazolam, or flubromazolam.
Based on DEA's review of HHS's scientific and medical evaluation
and all other relevant data, DEA determined that, in agreement with
HHS, the five designer benzodiazepines--clonazolam, diclazepam,
etizolam, flualprazolam, and flubromazolam--have a high potential for
abuse, have no currently accepted medical use in treatment in the
United States, and lack accepted safety for use under medical
supervision. There appear to be no legitimate sources for clonazolam,
diclazepam, etizolam, flualprazolam, or flubromazolam as a marketed
drug in the United States, but DEA notes that these substances are
available for purchase from legitimate suppliers for scientific
research. Significant diversion of these five substances from
legitimate suppliers is not evident. Therefore, this final rule
[[Page 9989]]
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 (UMRA) of 1995,
2 U.S.C. 1532, DEA has determined 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
The Office of Information and Regulatory Affairs has determined
that this rule is not a major rule as defined by the Congressional
Review Act (CRA), 5 U.S.C. 804. However, pursuant to the CRA, DEA is
submitting a copy of the final rule 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, 21 CFR part 1308 is amended 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 (e)(1) through (3) as paragraphs (e)(6)
through (8);
0
b. Add new paragraphs (e)(1) through (5); and
0
c. Remove and reserve paragraphs (h)(57) through (61).
The addition reads as follows:
Sec. 1308.11 Schedule I.
* * * * *
(e) * * *
------------------------------------------------------------------------
------------------------------------------------------------------------
(1) Clonazolam (Other name: 6-(2-chlorophenyl)-1-methyl-8-nitro- 2786
4H-benzo[f][1,2,4]triazolo[4,3-a][1,4]diazepine)..............
(2) Diclazepam (Other name: 7-chloro-5-(2-chlorophenyl)-1- 2789
methyl-1,3-dihydro-2H-benzo[e][1,4]diazepin-2-one)............
(3) Etizolam (Other name: 4-(2-chlorophenyl)-2-ethyl-9-methyl- 2780
6H-thieno[3,2-f][1,2,4]triazolo[4,3-a][1,4]diazepine).........
(4) Flualprazolam (Other name: 8-chloro-6-(2-fluorophenyl)-1- 2785
methyl-4H-benzo[f][1,2,4]triazolo[4,3-a][1,4]diazepine).......
(5) Flubromazolam (Other name: 8-bromo-6-(2-fluorophenyl)-1- 2788
methyl-4H-benzo[f][1,2,4]triazolo[4,3-a][1,4]diazepine).......
* * * * * * *
------------------------------------------------------------------------
* * * * *
Signing Authority
This document of the Drug Enforcement Administration was signed on
February 24, 2026, 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. 2026-04112 Filed 2-27-26; 8:45 am]
BILLING CODE 4410-09-P
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</html>Indexed from Federal Register on March 2, 2026.
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