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Rule

You may be interested in this older document that published on 12/15/2025 with action 'Proposed amendment; notification of intent.' View Document

Schedules of Controlled Substances: Temporary Placement of Bromazolam in Schedule I

A Rule by the Drug Enforcement Administration on 03/16/2026

• 1.

1.

• Document Details Published Content - Document Details Agencies Department of Justice Drug Enforcement Administration Agency/Docket Number Docket No. DEA-1420 CFR 21 CFR 1308 Document Citation 91 FR 12504 Document Number 2026-05064 Document Type Rule Pages 12504-12509
  (6 pages) Publication Date 03/16/2026 Published Content - Document Details

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• Document Details Published Content - Document Details Agencies Department of Justice Drug Enforcement Administration Agency/Docket Number Docket No. DEA-1420 CFR 21 CFR 1308 Document Citation 91 FR 12504 Document Number 2026-05064 Document Type Rule Pages 12504-12509
  (6 pages) Publication Date 03/16/2026 Published Content - Document Details

• Document Dates Published Content - Document Dates Effective Date 2026-03-16 Dates Text 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. Published Content - Document Dates

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  • AGENCY:
  • ACTION:
  • SUMMARY:
  • DATES:
  • ADDRESSES:
  • FOR FURTHER INFORMATION CONTACT:
  • SUPPLEMENTARY INFORMATION:
  • Legal Authority
  • Background
  • Bromazolam
  • Factor 4. History and Current Pattern of Abuse
  • Factor 5. Scope, Duration and Significance of Abuse
  • Factor 6. What, if Any, Risk There Is to the Public Health
  • Finding of Necessity of Schedule I Placement To Avoid Imminent Hazard to Public Safety
  • Conclusion
  • Requirements for Handling
  • Regulatory Analyses
  • List of Subjects in 21 CFR Part 1308
  • PART 1308—SCHEDULES OF CONTROLLED SUBSTANCES
  • Signing Authority
  • Footnotes Enhanced Content - Table of Contents

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| Docket No. DEA-1420
(2 Documents) | | | |
| --- | | | |
| Date | | Action | Title |
| | 2026-03-16 | Temporary amendment; temporary scheduling order. | Schedules of Controlled Substances: Temporary Placement of Bromazolam in Schedule I |
| | 2025-12-15 | Proposed amendment; notification of intent. | Schedules of Controlled Substances: Temporary Placement of Bromazolam in Schedule I |

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Department of Justice

Drug Enforcement Administration

1. 21 CFR Part 1308
2. Docket No. DEA-1420 # AGENCY:

Drug Enforcement Administration, Department of Justice.

ACTION:

Temporary amendment; temporary scheduling order.

SUMMARY:

The Drug Enforcement Administration issues this temporary order to schedule 8-bromo-1-methyl-6-phenyl-4 H -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 to add 8-bromo-1-methyl-6-phenyl-4 H -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).

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 ]

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 ]

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 ]

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.

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 ( printed 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 www.regulations.gov.

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 ]

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 ]

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 ]

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 www.regulations.gov under Docket Number DEA-1420.

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.

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 ( printed 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.

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 ( printed 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 ]

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 ]

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 ]

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.

1. 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.

2. 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.

3. 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.

4. 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.

5. 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. ( printed page 12508)

6. 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.

7. 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.

8. 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.

9. 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.

10. 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 ]

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.

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

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.

1. In § 1308.11, add paragraph (h)(86) to read as follows:

§ 1308.11 Schedule I * * * * * (h) * * * ( printed page 12509)

| | |
|                                                       * | |
| (86) 8-bromo-1-methyl-6-phenyl-4 H -benzo[f ][1,2,4]triazolo[4,3- a ][l ,4]diazepine, its salts, isomers, and salts of isomers (Other names: bromazolam) | 2778 |

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.

Footnotes

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)](https://www.govinfo.gov/link/uscode/21/811), which refers to a “temporary scheduling order.” No substantive change is intended.

Back to Citation 2. 21 U.S.C. 811(h)(1).

Back to Citation 3. 21 U.S.C. 811(h)(2).

Back to Citation 4. 21 U.S.C. 811(h)(1); 21 CFR part 1308.

Back to Citation 5. 28 CFR 0.100.

Back to Citation 6. 21 U.S.C. 811(h)(4).

Back to Citation 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](https://www.federalregister.gov/citation/58-FR-35460) (July 1, 1993).

Back to Citation 8. Schedules of Controlled Substances: Temporary Placement of Bromazolam in Schedule I, 90 FR 57924 (Dec. 15, 2025).

Back to Citation 9. 21 U.S.C. 811(c)(4)-(6), (h)(3).

Back to Citation 10. 21 U.S.C. 811(h)(3).

Back to Citation 11. 21 U.S.C. 811(h)(1).

Back to Citation 12. 21 U.S.C. 812(b)(1).

Back to Citation 13. https://www.kentucky.gov/​Pages/​Activity-stream.aspx?​n=​AttorneyGeneral&​prId=​1805.

Back to Citation 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)](https://www.govinfo.gov/link/uscode/21/811) 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](https://www.federalregister.gov/citation/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.

Back to Citation 15. Schedules of Controlled Substances: Temporary Placement of Etizolam, Flualprazolam, Clonazolam, Flubromazolam, and Diclazepam in Schedule I, 88 FR 48112 (July 26, 2023).

Back to Citation 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.

Back to Citation 17. Schedules of Controlled Substances: Temporary Placement of Bromazolam in Schedule I, 90 FR 57924 (Dec. 15, 2025).

Back to Citation 18. 21 U.S.C. 811(h)(1) and (2).

Back to Citation 19. 21 U.S.C. 811.

Back to Citation 20. 21 U.S.C. 877.

Back to Citation 21. 21 U.S.C. 811(h)(6).

Back to Citation 22. 21 U.S.C. 811(h)(1).

Back to Citation 23. 5 U.S.C. 551(6) (emphasis added).

Back to Citation 24. 21 U.S.C. 811(a) and 877.

Back to Citation 25.

                     
                    See [21 U.S.C. 811(a)](https://www.govinfo.gov/link/uscode/21/811).

Back to Citation [FR Doc. 2026-05064 Filed 3-13-26; 8:45 am]

BILLING CODE 4410-09-P

Published Document: 2026-05064 (91 FR 12504)