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

DEPARTMENT OF JUSTICE <SUBAGY>Drug Enforcement Administration</SUBAGY> <CFR>21 CFR Part 1308</CFR> <DEPDOC>[Docket No. DEA-1420]</DEPDOC> <SUBJECT>Schedules of Controlled Substances: Temporary Placement of Bromazolam in Schedule I</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Drug Enforcement Administration, Department of Justice. <HD SOURCE="HED">ACTION:</HD> Proposed amendment; notification of intent. <SUM> <HD SOURCE="HED">SUMMARY:</HD> 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-4 <E T="03">H</E> -benzo[ <E T="03">f</E> ][1,2,4]triazolo[4,3- <E T="03">a</E> ][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. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> December 15, 2025. </EFFDATE> <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> 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. </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> 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  <SU>1</SU> <FTREF/> (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): <FTNT> <SU>1</SU>  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. </FTNT> <FP SOURCE="FP-1"> • 8-bromo-1-methyl-6-phenyl-4 <E T="03">H</E> -benzo[ <E T="03">f</E> ][1,2,4]triazolo[4,3- <E T="03">a</E> ][l, 4]diazepine (Other name: bromazolam) </FP> The temporary scheduling order will be published in the <E T="04">Federal Register</E> on or after January 14, 2026. <HD SOURCE="HD1">Legal Authority</HD> 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. <SU>2</SU> <FTREF/> 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. <SU>3</SU> <FTREF/> <FTNT> <SU>2</SU>  21 U.S.C. 811(h)(1). </FTNT> <FTNT> <SU>3</SU>  21 U.S.C. 811(h)(2). </FTNT> 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. <SU>4</SU> <FTREF/> <FTNT> <SU>4</SU>  21 U.S.C. 811(h)(1); 21 CFR part 1308. </FTNT> 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). <SU>5</SU> <FTREF/> <FTNT> <SU>5</SU>  28 CFR 0.100. </FTNT> <HD SOURCE="HD1">Background</HD> 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 ( <E T="03">i.e.,</E> to issue a temporary scheduling order). <SU>6</SU> <FTREF/> 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). <SU>7</SU> <FTREF/> 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. <FTNT> <SU>6</SU>  21 U.S.C. 811(h)(4). </FTNT> <FTNT> <SU>7</SU>  The Secretary of HHS has delegated to the Assistant Secretary for Health of HHS the authority to make domestic drug scheduling recommendations. <E T="03">Comprehensive Drug Abuse Prevention and Control Act of 1970, Public Law 91-513, As Amended; Delegation of Authority,</E> 58 FR 35460 (July 1, 1993). </FTNT> 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. <SU>8</SU> <FTREF/> This consideration includes any information indicating actual abuse, diversion from legitimate channels, and clandestine importation, manufacture, or distribution of bromazolam. <SU>9</SU> <FTREF/> <FTNT> <SU>8</SU>  21 U.S.C. 811(h)(3). </FTNT> <FTNT> <SU>9</SU>   <E T="03">Id.</E> </FTNT> Substances meeting the statutory requirements for temporary scheduling may only be placed in schedule I. <SU>10</SU> <FTREF/> 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. <SU>11</SU> <FTREF/> <FTNT> <SU>10</SU>  21 U.S.C. 811(h)(1). </FTNT> <FTNT> <SU>11</SU>  21 U.S.C. 812(b)(1). </FTNT> <HD SOURCE="HD1">Bromazolam</HD> 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 bromazol ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 35k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━