Proposed Rule2025-22763
Schedules of Controlled Substances: Temporary Placement of Bromazolam in Schedule I
Primary source
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Published
December 15, 2025
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
The Administrator of the Drug Enforcement Administration is issuing this notification of intent to publish a temporary order to schedule 8-bromo-1-methyl-6-phenyl-4H-benzo[f][1,2,4]triazolo[4,3-a][l, 4]diazepine (commonly known as bromazolam), including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers are possible, in schedule I of the Controlled Substances Act. When it is issued, the temporary scheduling order will impose 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 bromazolam.
Full Text
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[Federal Register Volume 90, Number 238 (Monday, December 15, 2025)]
[Proposed Rules]
[Pages 57924-57928]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-22763]
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Proposed Rules
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
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Federal Register / Vol. 90, No. 238 / Monday, December 15, 2025 /
Proposed Rules
[[Page 57924]]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-1420]
Schedules of Controlled Substances: Temporary Placement of
Bromazolam in Schedule I
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Proposed amendment; notification of intent.
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SUMMARY: The Administrator of the Drug Enforcement Administration is
issuing this notification of intent to publish a temporary order to
schedule 8-bromo-1-methyl-6-phenyl-4H-benzo[f][1,2,4]triazolo[4,3-a][l,
4]diazepine (commonly known as bromazolam), including its salts,
isomers, and salts of isomers whenever the existence of such salts,
isomers, and salts of isomers are possible, in schedule I of the
Controlled Substances Act. When it is issued, the temporary scheduling
order will impose 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 bromazolam.
DATES: December 15, 2025.
FOR FURTHER INFORMATION CONTACT: Dr. 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.
SUPPLEMENTARY INFORMATION: The notice of intent contained in this
document is issued pursuant to the temporary scheduling provisions of
21 U.S.C. 811(h). The Drug Enforcement Administration (DEA) intends to
issue a temporary scheduling order \1\ (in the form of a temporary
amendment) to add bromazolam, including its salts, isomers, and salts
of isomers, whenever the existence of such salts, isomers, and salts of
isomers 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 notice of intent
adheres to the statutory language of 21 U.S.C. 811(h), which refers
to a ``temporary scheduling order.'' No substantive change is
intended.
<bullet> 8-bromo-1-methyl-6-phenyl-4H-benzo[f][1,2,4]triazolo[4,3-a][l,
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4]diazepine (Other name: bromazolam)
The temporary scheduling order will be published in the Federal
Register on or after January 14, 2026.
Legal Authority
The CSA provides the Attorney General with the authority to
temporarily place a substance in schedule I of the CSA for two years
without regard to the 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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In addition, 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 set
forth in 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 Safety (HHS), after consultation with
the Attorney General, shall first determine whether existing legal
controls under subchapter I of the CSA and the FD&C Act meet the
requirements of the schedule specified in the notification with respect
to the specific drug or substance. In the event that the Secretary did
not 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. The Attorney General has delegated scheduling authority
under 21 U.S.C. 811 to the Administrator of DEA (Administrator).\5\
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\5\ 28 CFR 0.100.
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Background
On June 6, 2024, the Secretariat of the United Nations advised the
Secretary of State of the United States that the Commission on Narcotic
Drugs (CND), during its 67th session on March 19, 2024, voted to place
bromazolam in Schedule IV of the Convention on Psychotropic Substances
of 1971 (CND Decisions 67/5). As a signatory to this international
treaty, the United States is required to place appropriate controls
within the CSA on bromazolam to meet the requirements of the treaty. To
meet the minimum requirements of this treaty and to confront these
emerging substances, DEA intends to temporarily place bromazolam in
schedule I of the CSA.
The CSA requires the Administrator to notify the Secretary of HHS
of an intent to temporarily place a substance in schedule I of the CSA
(i.e., to issue a temporary scheduling order).\6\ By letter dated June
14, 2024, the previous Administrator transmitted the required notice to
place bromazolam in schedule I on a temporary basis to the then-
Assistant Secretary for Health of HHS (Assistant Secretary).\7\ On June
28, 2024, the previous Assistant Secretary responded to this notice and
advised
[[Page 57925]]
DEA that, based on a review by the Food and Drug Administration (FDA),
there were currently no investigational new drug applications or
approved new drug applications for bromazolam. The previous Assistant
Secretary also stated that HHS had no objection to the temporary
placement of this substance in schedule I of the CSA. DEA requested an
updated response from HHS, by letter dated June 11, 2025. By letter
dated July 10, 2025, the Acting Assistant Secretary of HHS responded
that, based on an updated review by FDA, there were currently no
approved drug applications or investigational new drug applications for
bromazolam. Therefore, HHS had no objections to the temporary placement
of bromazolam in schedule I. Bromazolam is not currently listed in any
schedule under the CSA, and no exemptions or approvals under FDA's new
drug statute, at 21 U.S.C. 355, are in effect for this substance.
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\6\ 21 U.S.C. 811(h)(4).
\7\ The Secretary of HHS 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).
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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)(4-6): 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.\8\ This consideration includes
any information indicating actual abuse, diversion from legitimate
channels, and clandestine importation, manufacture, or distribution of
bromazolam.\9\
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\8\ 21 U.S.C. 811(h)(3).
\9\ Id.
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Substances meeting the statutory requirements for temporary
scheduling may only be placed in schedule I.\10\ Substances in schedule
I have high potential for abuse, no currently accepted medical use in
treatment in the United States, and a lack of accepted safety for use
of the drug under medical supervision.\11\
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\10\ 21 U.S.C. 811(h)(1).
\11\ 21 U.S.C. 812(b)(1).
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Bromazolam
The dramatic increase in trafficking and abuse of novel
psychoactive substances (NPS) in the United States, and particularly
the benzodiazepine class of substances, has become a national public
health concern in recent years. The availability of benzodiazepine
substances, with no currently accepted medical use in the illicit drug
market, continues to pose an imminent hazard to public safety. Adverse
health effects including slurred speech, ataxia, altered mental state,
and respiratory depression associated with the abuse of such drugs
known collectively as the ``designer benzodiazepines,'' their continued
evolution, and the increased popularity of these substances, have been
a serious concern in recent years. The increase in the co-abuse of
opioids with the designer benzodiazepines has become a particular
concern as the United States continues to experience an unprecedented
epidemic of opioid misuse and abuse. The identification of bromazolam
in the illicit drug market has been reported in the United States and
is currently one of the most commonly identified benzodiazepines in
drug seizures. Between April 2021 and July 2025, DEA is aware of at
least 240 overdose cases involving bromazolam, of which 189 of these
cases were associated with a fatality (see Factors 4 and 5). While the
cases were often reported in combination with opioids, at least four
fatal cases involved bromazolam either alone or in the absence of other
psychoactive substances. Additional sources of information demonstrate
additional overdoses, which would suggest that this statistic is likely
subject to underreporting in the United States.\12\
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\12\ <a href="https://www.kentucky.gov/Pages/Activity-stream.aspx?n=AttorneyGeneral&prId=1805">https://www.kentucky.gov/Pages/Activity-stream.aspx?n=AttorneyGeneral&prId=1805</a>.
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Available data and information for bromazolam, summarized below,
indicate that this substance has a high potential for abuse, no
currently accepted medical uses in treatment in the United States,\13\
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
<a href="http://www.regulations.gov">www.regulations.gov</a> under Docket Number DEA-1420.
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\13\ 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 bromazolam has a
currently accepted medical use in treatment in the United States.
First, DEA looks to whether the drug or substance has FDA approval
for marketing in interstate commerce. When no FDA approval exists,
DEA has traditionally applied a five-part test to determine whether
a drug or substances has a currently accepted medical use: (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 notice of intent, there is no
evidence that health care providers have widespread experience with
medical use of bromazolam or that the use of bromazolam is
recognized by entities that regulate the practice of medicine, so
the two-part test also is not satisfied. By letter dated June 28,
2024, DEA has been advised by HHS that there are currently no
approved new drug applications or investigational new drug
applications for bromazolam. Additionally, HHS communicated no
objections to the temporary placement of bromazolam into Schedule I
of the CSA. In its July 10, 2025 letter, HHS reaffirmed its position
and advised DEA that there are currently no approved new drug
applications or investigational new drug applications for
bromazolam. Additionally, HHS reaffirmed that it had no objections
to the temporary placement of bromazolam in schedule I of the CSA.
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Factor 4. History and Current Pattern of Abuse
Since 2012, numerous synthetic drugs belonging to the
benzodiazepine class began to emerge in the illicit drug market as
evidenced by the identification of these drugs in forensic drug
exhibits and toxicology samples. Consequently, on July 26, 2023, DEA
temporarily scheduled five synthetic benzodiazepine substances
(etizolam, flualprazolam, clonazolam, flubromazolam, and diclazepam) in
schedule I of the CSA.\14\ The dramatic increase in trafficking and
abuse associated with these substances, also known as designer
benzodiazepines, has become a national public health concern in recent
years. According to the Centers for Disease Control and Prevention
(CDC), benzodiazepines were involved in 12,499 overdose deaths in the
United States between 2019 and 2021.
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\14\ Schedules of Controlled Substances: Temporary Placement of
Etizolam, Flualprazolam, Clonazolam, Flubromazolam, and Diclazepam
in Schedule I, 88 FR 48112 (July 26, 2023).
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Bromazolam, a novel designer benzodiazepine, was first encountered
by law enforcement in the United States in 2016. Since that time there
has been a dramatic rise in its trafficking and abuse. In addition,
various health alerts and overdose data have been issued relating to
the identification of bromazolam in toxicology samples. The
[[Page 57926]]
Center for Forensic Science Research and Education's (CFSRE) NPS
Discovery first reported identifying bromazolam in overdose samples in
a June 2022 alert. Within this alert, it was noted that bromazolam had
been identified in more than 250 toxicology cases submitted to NMS
Labs, including both antemortem and postmortem investigations. Between
the first quarter of 2019 and June 2022, bromazolam was identified in
more than 190 toxicology samples tested at CFSRE, displaying an
increase in the detection of bromazolam from 1% in the first quarter of
2021 to 13% in the second quarter of 2022. Similarly, between April
2021 and July 2025, DEA's toxicology testing program (DEA TOX) \15\ has
detected bromazolam in 240 separate cases submitted for expanded
analysis. Within these cases, the average age of the user was between
31-40 years old, while greater than 50% of users were between 21 and 40
years of age. The increase of bromazolam identifications in toxicology
cases demonstrate the continued rise and serious public health concern
related to the abuse of this substance since it was first detected in
2016.
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\15\ DEA TOX is a surveillance program that aims to detect novel
psychoactive substances (NPS) in fatal and nonfatal overdose cases
within the United States. From these cases, biological samples, as
well as drug paraphernalia (on limited occasions), are submitted for
analysis by hospitals, medical examiners, poison centers, and law
enforcement nationwide. DEA TOX data include confirmed detections of
NPS through the data query date, July 21, 2025.
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Bromazolam, like other designer benzodiazepines, is often
encountered in pill form and can be made to mimic the appearance of
legitimately prescribed substances such as alprazolam or other
prescription drugs like oxycodone. Designer benzodiazepines have also
been encountered in powder or liquid form.
Designer benzodiazepines like bromazolam have been co-abused with
other substances, especially fentanyl, according to toxicology
reporting. As stated above, between April 2021 through July 2025, DEA
TOX results reported a total of 240 cases where bromazolam was detected
in a biological sample. Of these 240 cases, fentanyl was identified in
178 cases, or 74.2% of the time. Similar to the large increase in law
enforcement encounters observed via the National Forensic Laboratory
Information System (NFLIS), fatal and non-fatal cases submitted to DEA
TOX saw a large increase in bromazolam abuse.
Factor 5. Scope, Duration and Significance of Abuse
The first law enforcement encounter of bromazolam, as reported by
NFLIS, was in the second quarter of 2016. While encounters remained low
through 2020, a substantial increase in NFLIS reports was observed in
2021, continuing through the present. The NFLIS database was queried on
November 24, 2025, for bromazolam case reports. NFLIS registered 15,241
encounters of bromazolam. Due to the recent emergence of these designer
benzodiazepines in the illicit market, it is likely that bromazolam is
under-reported as forensic laboratories secure reference standards for
use in analyzing these novel substances. Bromazolam has been
encountered throughout all 50 states.
Factor 6. What, if Any, Risk There Is to the Public Health
The increase in benzodiazepine-related overdoses in the United
States has been exacerbated recently by the availability of designer
benzodiazepines in the illicit drug market. Bromazolam has
pharmacological effects that are similar to other benzodiazepines
currently temporarily controlled in schedule I of the CSA. Public
health risks associated with bromazolam abuse relate to its
pharmacological similarities with known benzodiazepines. Thus, risk to
public health is associated with adverse reactions in humans, which are
expected to include central nervous system depressant-like effects,
such as slurred speech, ataxia, altered mental state, and respiratory
depression. While those who abuse bromazolam are likely to obtain it
through unregulated sources, the identity, purity, dosage, and
adulteration of this substance is uncertain and inconsistent, thus
posing significant adverse health risks to the end user. As stated
above, between April 2021 through July 2025, DEA TOX results reported a
total of 240 cases where bromazolam was detected in a biological
sample. Of these 240 cases, a fatality was observed in 189 of these
overdose cases.
This rise in bromazolam identifications in toxicology cases has
prompted a number of states, including Florida, Ohio, and Indiana, to
alert the public of the harms of bromazolam use by issuing public
health alerts reporting deaths, non-fatal overdoses, and effects of
intoxication. In August 2023, the Indiana Department of Health issued
an emerging drug notification to alert law enforcement, first
responders, clinicians, and public health professionals about
bromazolam. Toxicology results of Indiana decedents from January
through June 2023 showed that 35 individuals tested positive for
bromazolam, with 8 and 9 results coming in April and May of 2023
respectively. Pharmacological testing has been conducted on bromazolam,
showing its activity at the gamma amino butyric acid receptors and
ability to substitute for midazolam, an FDA-approved benzodiazepine.
While designer benzodiazepines are often detected in toxicology
samples with other substances, especially opioids, evidence of their
use alone resulting in serious adverse events have also been
encountered. A publication by the CDC's Morbidity and Mortality Weekly
Report described three previously healthy young adults who ingested
pressed tablets of bromazolam that they reported they believed to be
alprazolam (see Factor 6 of the Three Factor Analysis on the docket for
more information). In these specific cases, adverse effects following
the ingestion of bromazolam included hypertension, tachycardia,
hyperthermia, multiple generalized seizures, and myocardial injury as
demonstrated by elevated troponin levels. Bromazolam has also been
associated with impaired driving which is a hazard to public health and
safety. Multiple studies demonstrated either the use of bromazolam
alone or in conjunction with polydrug abuse, namely with opioids (e.g.,
fentanyl) or stimulants (e.g., methamphetamine, cocaine).
In May 2022, the Jefferson County Medical Examiner first detected
bromazolam in their case work. A study describing 10 bromazolam-
involved deaths was published in 2024, where the results demonstrated
that fentanyl was also detected in eight of the ten decedents.
Bromazolam was detected alongside the benzimidazole opioid metonitazene
in an August 2023 drug overdose in Los Angeles County, California. In a
retrospective study evaluating bromazolam-related deaths in Travis
County, Texas, bromazolam was identified in 112 deaths from 2021 to
2023. Polydrug use was present in 99% of the bromazolam-positive
deaths, which commonly involved fentanyl (82%), methamphetamine (41%),
and cocaine (28%).
In summary, bromazolam has been reported to cause serious adverse
effects, including death, following its use.
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
[[Page 57927]]
and information summarized above, the uncontrolled manufacture,
distribution, reverse distribution, importation, exportation, conduct
of research and chemical analysis, possession, and abuse of bromazolam
pose an imminent hazard to public safety. Bromazolam has not been
approved by the FDA and has not been marketed in the United States, and
DEA is not aware of any currently accepted medical uses for bromazolam
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 bromazolam indicate
that this substance meets the three statutory criteria.
As required by 21 U.S.C. 811(h)(4), the previous Administrator
transmitted to the Assistant Secretary, via letter dated June 14, 2024,
notice of her intent to place bromazolam in schedule I on a temporary
basis. In a letter dated July 28, 2024, the previous Assistant
Secretary did not object to the temporary placement of bromazolam in
schedule I. DEA requested an updated response from HHS on June 10,
2025. The Acting Assistant Secretary reaffirmed on July 11, 2025, that
HHS had no objection to the temporary placement of bromazolam in
schedule I.
Conclusion
This notice of intent provides the 30-day notice pursuant to 21
U.S.C. 811(h)(1) of DEA's intent to issue a temporary scheduling order.
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
bromazolam in schedule I of the CSA, and finds that placement of this
substance in schedule I is necessary to avoid an imminent hazard to the
public safety.
The temporary placement of bromazolam in schedule I of the CSA will
take effect upon publication of a temporary scheduling order in the
Federal Register, which will not be issued before January 14, 2026.
Because the Administrator hereby finds this temporary scheduling order
necessary to avoid an imminent hazard to the public safety, it will
take effect on the date the order is published in the Federal Register,
and it will remain in effect for two years, with a possible extension
of one year, pending completion of the regular (permanent) scheduling
process.\16\ The Administrator intends to issue a temporary scheduling
order as soon as possible after the expiration of 30 days from the date
of publication of this document. Upon the temporary order's
publication, bromazolam will then be subject to the CSA's schedule I
regulatory controls and to administrative, civil, and criminal
sanctions applicable to their manufacture, distribution, reverse
distribution, importation, exportation, research, conduct of
instructional activities and chemical analysis, and possession.
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\16\ 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.\17\ 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.\18\
Temporary scheduling orders are not subject to judicial review.\19\
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\17\ 21 U.S.C. 811.
\18\ 21 U.S.C. 877.
\19\ 21 U.S.C. 811(h)(6).
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Regulatory Analyses
The CSA provides for expedited temporary scheduling actions where
necessary to avoid an imminent hazard to public safety. Under 21 U.S.C.
811(h)(1), the Administrator (as delegated by the Attorney General)
may, by order, temporarily schedule 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.\20\
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\20\ 21 U.S.C. 811(h)(1).
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Inasmuch as section 811(h) directs that temporary scheduling
actions be issued by order and sets forth the procedures by which such
orders are to be issued, including the requirement to publish in the
Federal Register a notice of intent, the notice-and-comment
requirements of section 553 of the Administrative Procedure Act (APA),
5 U.S.C. 553, do not apply to this notice of intent. The APA expressly
differentiates between an order and a rule, 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.'' \21\ (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.\22\ 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,\23\ 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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\21\ 5 U.S.C. 551(6) (emphasis added).
\22\ 21 U.S.C. 811(a) and 877.
\23\ See 21 U.S.C. 811(a).
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Even assuming that this notice of intent is subject to section 553
of the APA, the Administrator finds that there is good cause to forgo
the notice-and-comment requirements pursuant to 5 U.S.C. 553(b)(B), 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 public safety.
Although DEA believes this notice of intent to issue a 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 notice 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.
[[Page 57928]]
As discussed above, DEA is issuing this notice of intent pursuant to
DEA's authority to issue a temporary scheduling order.\24\ 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.
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\24\ 21 U.S.C. 811(h)(1).
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In accordance with the principles of Executive Orders (E.O.) 12866
and 13563, 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. Because this is not a
rulemaking action, this is not a significant regulatory action as
defined in Section 3(f) of E.O. 12866. In addition, 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)(79) to read as follows:
Sec. 1308.11 Schedule I
* * * * *
(h) * * *
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* * * * * * *
(79) 8-bromo-1-methyl-6-phenyl-4H- 2778
benzo[f][1,2,4]triazolo[4,3-a][l ,4]diazepine, its salts,
isomers, and salts of isomers (Other names: bromazolam)...
* * * * * * *
------------------------------------------------------------------------
* * * * *
Signing Authority
This document of the Drug Enforcement Administration was signed on
December 7, 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. 2025-22763 Filed 12-12-25; 8:45 am]
BILLING CODE 4410-09-P
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</html>Indexed from Federal Register on December 15, 2025.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.