Rule2026-05064
Schedules of Controlled Substances: Temporary Placement of Bromazolam in Schedule I
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 16, 2026
Effective
March 16, 2026
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
The Drug Enforcement Administration issues this 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. DEA bases this action on a finding that placing bromazolam in schedule I is necessary to avoid an 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.
Full Text
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[Federal Register Volume 91, Number 50 (Monday, March 16, 2026)]
[Rules and Regulations]
[Pages 12504-12509]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-05064]
[[Page 12504]]
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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: Temporary amendment; temporary scheduling order.
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SUMMARY: The Drug Enforcement Administration issues this 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. DEA bases
this action on a finding that placing bromazolam in schedule I is
necessary to avoid an 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 March 16, 2026, until March
16, 2028. 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: 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 Drug Enforcement Administration (DEA)
issues a temporary scheduling order \1\ (in the form of a temporary
amendment) to add 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 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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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 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 (FD&C 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 Services (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 is temporarily placing 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 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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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 bromazolam in schedule I on a temporary basis is
[[Page 12505]]
necessary to avoid an imminent hazard to public safety.
As required by 21 U.S.C. 811(h)(1)(A), DEA published a notice of
intent (NOI) to temporarily schedule bromazolam in the Federal Register
on December 15, 2025.\8\ That NOI discussed findings from DEA's three-
factor analysis dated December 2025, which DEA made available on
<a href="http://www.regulations.gov">www.regulations.gov</a>.
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\8\ Schedules of Controlled Substances: Temporary Placement of
Bromazolam in Schedule I, 90 FR 57924 (Dec. 15, 2025).
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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\ Consideration of these factors
includes any information indicating actual abuse, diversion from
legitimate channels, and clandestine importation, manufacture, or
distribution of bromazolam.\10\
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\9\ 21 U.S.C. 811(c)(4)-(6), (h)(3).
\10\ 21 U.S.C. 811(h)(3).
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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, and a lack of accepted safety for use
under medical supervision.\12\
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\11\ 21 U.S.C. 811(h)(1).
\12\ 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, in particular 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 on 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 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 on 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 February 2026, DEA is aware of at
least 259 overdose cases involving bromazolam, of which 201 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.\13\
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\13\ <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, and
a lack of accepted safety for use under medical supervision.\14\ 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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\14\ 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 emerged on 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.\15\ The dramatic increase in trafficking and abuse
associated with 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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\15\ 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 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
[[Page 12506]]
from 1 percent in the first quarter of 2021 to 13 percent in the second
quarter of 2022. Similarly, between April 2021 and February 2026, DEA's
toxicology testing program (DEA TOX \16\) has detected bromazolam in
259 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 percent of users were between 21 and 40 years of age. The
increase of bromazolam identifications in toxicology cases demonstrates
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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\16\ DEA TOX is a surveillance program that aims to detect 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, February 26, 2026.
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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 and 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 February 2026,
DEA TOX results reported a total of 259 cases in which bromazolam was
detected in a biological sample. Of these 259 cases, fentanyl was
identified in 202 cases, or 78 percent of the time. Fatal and nonfatal
cases submitted to DEA TOX saw a large increase in bromazolam abuse
since 2021.
Factor 5. Scope, Duration and Significance of Abuse
The first law enforcement encounter of bromazolam, as reported by
National Forensic Laboratory Information System (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 February 26,
2026, for bromazolam case reports. NFLIS registered 16,614 encounters
of bromazolam. Due to the recent emergence of these designer
benzodiazepines on 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 on 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 February 2026, DEA TOX results
reported a total of 259 cases in which bromazolam was detected in a
biological sample. Of these 259 cases, fatality was observed in 201 of
the 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, nonfatal 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 17 of those reports coming in April and May 2023 (8
reports and 9 reports 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 in Alabama first
detected bromazolam in their case work. A study describing 10
bromazolam-involved deaths was published in 2024, in which 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 percent of the
bromazolam-positive deaths, which commonly involved fentanyl (82
percent), methamphetamine (41 percent), and cocaine (28 percent).
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
and information summarized above, the uncontrolled manufacture,
distribution, reverse distribution, importation, exportation, conduct
of research and chemical analysis, possession, and abuse of bromazolam
poses an imminent hazard to public safety. Bromazolam has not been
approved by 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
[[Page 12507]]
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 then-Acting Administrator
transmitted to the Acting Assistant Secretary, via letters dated June
14, 2024, and June 11, 2025, notice of DEA's intent to place bromazolam
in schedule I on a temporary basis. By letters dated June 28, 2024, and
July 10, 2025, the Acting Assistant Secretary had no objection to the
temporary placement of bromazolam in schedule I. DEA subsequently
published this NOI in the Federal Register on December 15, 2025.\17\
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\17\ Schedules of Controlled Substances: Temporary Placement of
Bromazolam in Schedule I, 90 FR 57924 (Dec. 15, 2025).
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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
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's safety.
The temporary placement of bromazolam 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.\18\
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\18\ 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. Permanent 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.\19\ The permanent 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 permanent scheduling
process of formal rulemaking are subject to judicial review.\20\
Temporary scheduling orders are not subject to judicial review.\21\
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\19\ 21 U.S.C. 811.
\20\ 21 U.S.C. 877.
\21\ 21 U.S.C. 811(h)(6).
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Requirements for Handling
Upon the effective date of this temporary order, bromazolam 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, bromazolam 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 March 16,
2026. Any person who currently handles bromazolam and is not registered
with DEA must submit an application for registration and may not
continue to handle bromazolam as of March 16, 2026, 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.
Notwithstanding the foregoing, pursuant to 21 U.S.C. 822(h), if, on
March 16, 2026, a person is conducting research on bromazolam and is
already registered to conduct research with another controlled
substance in schedule I, the person may continue to conduct research on
bromazolam if they submit a completed application for registration or
modification of existing registration, as applicable, to conduct
research with bromazolam not later than 90 calendar days after March
16, 2026. The person may continue to conduct such research until the
person withdraws the application or the Administrator serves on the
person an order to show cause proposing denial of the application
pursuant to 21 U.S.C. 824(c) and in accordance with 21 CFR 1301.37. If
the Administrator serves an order to show cause proposing denial of the
application or modification, the person may not continue to conduct
research with bromazolam and may not receive or otherwise obtain
additional bromazolam. If an order to show cause is served and the
person requests a hearing in accordance with 21 CFR 1301.37(d), the
hearing shall be held in accordance with 21 CFR 1301.41-1301.46 on an
expedited basis and not later than 45 calendar days after the request
is made, except that the hearing may be held at a later time if so
requested by the person. If the person sends a copy of the application
to a manufacturer or distributor of bromazolam, receipt of the copy by
the manufacturer or distributor constitutes sufficient evidence that
the person is authorized to receive bromazolam pursuant to 21 U.S.C.
822(h)(4). Continuation of research under 21 U.S.C. 822(h) does not
authorize any other handling (e.g., distribution) of bromazolam.
Retail sales of schedule I controlled substances to the general
public are not allowed under the CSA. Possession of any quantity of
bromazolam in a manner not authorized by the CSA on or after March 16,
2026 is unlawful, and those in possession of any quantity of bromazolam
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 bromazolam must surrender
all currently held quantities of this substance.
3. Security. Bromazolam is subject to schedule I security
requirements and must be handled in accordance with 21 CFR 1301.71-
1301.93, as of March 16, 2026.
4. Labeling and Packaging. All labels, labeling, and packaging for
commercial containers of bromazolam 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 March 16, 2026 to comply with all labeling and
packaging requirements.
5. Inventory. Every DEA registrant who possesses any quantity of
bromazolam on the effective date of this order must take an inventory
of all stocks of this substance 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 bromazolam) 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 bromazolam 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 bromazolam shall have 30 calendar
days from the effective date of this order to comply with all
recordkeeping requirements.
[[Page 12508]]
7. Reports. All DEA registrants must submit reports with respect to
bromazolam 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 March 16, 2026. Manufacturers and distributors must also submit
reports regarding bromazolam 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 bromazolam must
comply with order form requirements pursuant to 21 U.S.C. 828 and in
accordance with 21 CFR part 1305 as of March 16, 2026.
9. Importation and Exportation. All importation and exportation of
bromazolam must be in compliance with 21 U.S.C. 952, 953, 957, and 958,
and in accordance with 21 CFR part 1312 as of March 16, 2026.
10. Quota. Only DEA-registered manufacturers may manufacture
bromazolam in accordance with a quota assigned pursuant to 21 U.S.C.
826 and in accordance with 21 CFR part 1303, as of March 16, 2026.
11. Liability. Any activity involving bromazolam not authorized by
or in violation of the CSA, occurring as of March 16, 2026, 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 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.\22\
---------------------------------------------------------------------------
\22\ 21 U.S.C. 811(h)(1).
---------------------------------------------------------------------------
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 the Administrative Procedure Act (APA)
at 5 U.S.C. 553, which are applicable to rulemaking, 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.'' \23\ 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.\24\ 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,\25\ it is noteworthy that, in section 811(h)(1),
Congress authorized the issuance of temporary scheduling actions by
order rather than by rule.
---------------------------------------------------------------------------
\23\ 5 U.S.C. 551(6) (emphasis added).
\24\ 21 U.S.C. 811(a) and 877.
\25\ See 21 U.S.C. 811(a).
---------------------------------------------------------------------------
Even assuming that this action is subject to the notice-and-comment
requirements of the APA, the Administrator finds that there is good
cause to forgo these 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 temporary scheduling order is not
subject to the notice-and-comment requirements 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 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
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. 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. 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 amends 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 paragraph (h)(86) to read as follows:
Sec. 1308.11 Schedule I
* * * * *
(h) * * *
[[Page 12509]]
------------------------------------------------------------------------
------------------------------------------------------------------------
* * * * * * *
(86) 8-bromo-1-methyl-6-phenyl-4H-benzo[f][1,2,4]triazolo[4,3- 2778
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
March 10, 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. 2026-05064 Filed 3-13-26; 8:45 am]
BILLING CODE 4410-09-P
</pre></body>
</html>Indexed from Federal Register on March 16, 2026.
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.