Schedules of Controlled Substances: Temporary Placement of N-pyrrolidino metonitazene and N-pyrrolidino protonitazene in Schedule I

<RULE> DEPARTMENT OF JUSTICE <SUBAGY>Drug Enforcement Administration</SUBAGY> <CFR>21 CFR Part 1308</CFR> <DEPDOC>[Docket No. DEA-1337]</DEPDOC> <SUBJECT> Schedules of Controlled Substances: Temporary Placement of <E T="0714">N</E> -pyrrolidino metonitazene and <E T="0714">N</E> -pyrrolidino protonitazene in Schedule I </SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Drug Enforcement Administration, Department of Justice. <HD SOURCE="HED">ACTION:</HD> Temporary amendment; temporary scheduling order. <SUM> <HD SOURCE="HED">SUMMARY:</HD> The Drug Enforcement Administration issues this temporary order to schedule two benzimidazole-opioids in schedule I of the Controlled Substances Act. DEA bases this action on a finding that placing these substances in schedule I is necessary to avoid 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. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> This temporary order is effective August 15, 2025, until August 15, 2027. If this order is extended or made permanent, DEA will publish a document in the <E T="04">Federal Register</E> . </EFFDATE> <HD SOURCE="HED">ADDRESSES:</HD> 8701 Morrissette Drive, Springfield, Virginia 22152. <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> 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. As required by 5 U.S.C. 553(b)(4), a summary of this rule may be found in the docket for this rulemaking at <E T="03">www.regulations.gov.</E> </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> The Drug Enforcement Administration (DEA) issues a temporary scheduling order  <SU>1</SU> <FTREF/> (in the form of a temporary amendment) to add the following two synthetic benzimidazole-opioid substances, including their isomers, esters, ethers, salts, and salts of isomers, esters, and ethers whenever the existence of such isomers, esters, ethers, and salts 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 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. </FTNT> • 2-(4-methoxybenzyl)-5-nitro-1-(2-(pyrrolidin-1-yl)ethyl)-1 <E T="03">H</E> -benzimidazole (commonly known as, <E T="03">N</E> -pyrrolidino metonitazene or metonitazepyne), and • 5-nitro-2-(4-propoxybenzyl)-1-(2-(pyrrolidin-1-yl)ethyl)-1 <E T="03">H</E> -benzimidazole (commonly known as, <E T="03">N-</E> pyrrolidino protonitazene or protonitazepyne). <HD SOURCE="HD1">Legal Authority</HD> Under 21 U.S.C. 811(h)(1), the CSA provides the Attorney General (as delegated to the Administrator of DEA (Administrator) pursuant to 28 CFR 0.100) 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. <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> <HD SOURCE="HD1">Background</HD> The CSA requires the Administrator to notify the Secretary of the Department of Health and Human Services (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>5</SU> <FTREF/> By letter dated March 24, 2025, the then-Acting Administrator transmitted the required notice to place <E T="03">N</E> -pyrrolidino metonitazene and <E T="03">N</E> -pyrrolidino protonitazene in schedule I on a temporary basis to the Acting Assistant Secretary for Health of HHS (Assistant Secretary). <SU>6</SU> <FTREF/> On June 11, 2025, the Acting Assistant Secretary responded to this notice and advised DEA that based on a review by the Food and Drug Administration (FDA), there are currently no investigational new drug applications (IND) or approved new drug applications (NDA) for <E T="03">N</E> -pyrrolidino metonitazene or <E T="03">N</E> -pyrrolidino protonitazene. The Acting Assistant Secretary also stated that HHS had no objection to the temporary placement of these substances in schedule I of the CSA. <E T="03">N</E> -Pyrrolidino metonitazene and <E T="03">N</E> -pyrrolidino protonitazene currently are not listed in any schedule under the CSA, and no exemptions or approvals under 21 U.S.C. 355 are in effect for these substances. <SU>7</SU> <FTREF/> <FTNT> <SU>5</SU>  21 U.S.C. 811(h)(4). </FTNT> <FTNT> <SU>6</SU>  The Secretary of HHS has delegated to the Assistant Secretary for Health of HHS the authority to make domestic drug scheduling recommendations. 58 FR 35460 (July 1, 1993). </FTNT> <FTNT> <SU>7</SU>  By letter dated December 7, 2023, the then-Administrator transmitted the required notice to place <E T="03">N</E> -pyrrolidino metonitazene and <E T="03">N</E> -pyrrolidino protonitazene in schedule I on a temporary basis to the Acting Assistant Secretary for Health of HHS. On December 22, 2023, the then-Assistant Secretary responded to this notice and advised DEA that based on a review by the FDA, there are currently no investigational new IND or approved NDA for <E T="03">N</E> -pyrrolidino metonitazene or <E T="03">N</E> -pyrrolidino protonitazene. The then-Assistant Secretary also stated that HHS had no objection to the temporary placement of these substances in schedule I of the CSA. </FTNT> 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 <E T="03">N</E> -pyrrolidino metonitazene and <E T="03">N</E> -pyrrolidino protonitazene in schedule I on a temporary basis is necessary to avoid an imminent hazard to the public safety. As required by 21 U.S.C. 811(h)(1)(A), DEA published a notice of intent (NOI) to temporarily schedule <E T="03">N</E> -pyrrolidino metonitazene and <E T="03">N</E> -pyrrolidino protonitazene on September 17, 2024. <SU>8</SU> <FTREF/> That NOI discussed findings from DEA's three-factor analysis dated August 2024, which DEA made available on <E T="03">www.regulations.gov.</E> <FTNT> <SU>8</SU>  Schedules of Controlled Substances: Temporary Placement of <E T="03">N</E> -Pyrrolidino Metonitazene and <E T="03">N</E> -Pyrrolidino Protonitazene in Schedule I, 89 FR 75979 (Sept. 17, 2024). </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): 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>9</SU> <FTREF/> Considerations of these factors includes any information indicating actual abuse, diversion from legitimate channels, and clandestine importation, manufacture, or distribution of <E T="03">N</E> -pyrrolidino metonitazene and <E T="03">N</E> -pyrrolidino protonitazene. <SU>10</SU> <FTREF/> Substances meeting the statutory requirements for temporary scheduling may only be placed in schedule I. <SU>11</SU> <FTREF/> Substances in schedule I have high potential for abuse, no currently accepted medical use in treatment in the United States, <SU>12</SU> <FTREF/> and a lack of accepted safety for use under medical supervision. <SU>13</SU> <FTREF/> <FTNT> <SU>9</SU>  21 U.S.C. 811(h)(3). </FTNT> <FTNT> <SU>10</SU>  21 U.S.C. 811(h)(3). </FTNT> <FTNT> <SU>11</SU>  21 U.S.C. 811(h)(1). </FTNT> <FTNT> <SU>12</SU>  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 <E T="03">N-</E> pyrrolidino metonitazene or <E T="03">N</E> -pyrrolidino protonitazene have a currently accepted medical use in treatment in the United States. To determine whether a drug or other substance has a currently accepted medical use, DEA has traditionally applied a five-part test to a drug or substance that has not been approved by the FDA: i. The drug's chemistry must be known and reproducible; ii. there must be adequate safety studies; iii. there must be adequate and well-controlled studies proving efficacy; iv. the drug must be accepted by qualified experts; and v. the scientific evidence must be widely available. See Marijuana Schedu ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 45k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━