Schedules of Controlled Substances: Temporary Placement of N-Pyrrolidino Metonitazene and N-Pyrrolidino Protonitazene in Schedule I

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 N-Pyrrolidino Metonitazene and N-Pyrrolidino Protonitazene in Schedule I</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Drug Enforcement Administration, Department of Justice. <HD SOURCE="HED">ACTION:</HD> Proposed amendment; notice of intent. <SUM> <HD SOURCE="HED">SUMMARY:</HD> The Administrator of the Drug Enforcement Administration is issuing this notice of intent to publish a temporary order to schedule two synthetic benzimidazole-opioid substances, <E T="03">N</E> -pyrrolidino metonitazene and <E T="03">N</E> -pyrrolidino protonitazene, 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, 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 these two specified substances. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> This notice of intent is effective September 17, 2024. </EFFDATE> <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. </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 the 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 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> • 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). The temporary scheduling order will be published in the <E T="04">Federal Register</E> on or after October 17, 2024. <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) has 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 he 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 December 15, 2023, the 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 Assistant Secretary for Health of HHS (Assistant Secretary). <SU>6</SU> <FTREF/> On December 22, 2023, the 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 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. <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> 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>7</SU> <FTREF/> This consideration 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>8</SU> <FTREF/> <FTNT> <SU>7</SU>  21 U.S.C. 811(h)(3). </FTNT> <FTNT> <SU>8</SU>  21 U.S.C. 811(h)(3). </FTNT> Substances meeting the statutory requirements for temporary scheduling may only be placed in schedule I. <SU>9</SU> <FTREF/> Substances in schedule I have high potential for abuse, no currently accepted medical use in treatment in the United States, <SU>10</SU> <FTREF/> and a lack of accepted safety for use under medical supervision. <SU>11</SU> <FTREF/> <FTNT> <SU>9</SU>  21 U.S.C. 811(h)(1). </FTNT> <FTNT> <SU>10</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 <E T="03">Marijuana Scheduling Petition; Denial of Petition; Remand</E> , 57 FR 10499 (Mar. 26, 1992), pet. for rev. denied, <E T="03">Alliance for Cannabis Therapeutics</E> v. <E T="03">Drug Enforcement Admin.</E> , 15 F.3d 1131, 1135 (D.C. Cir. 1994). DEA and HHS applied the traditional five-part test for currently accepted medical use in this matter. 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 <E T="03">N</E> -pyrrolidino metonitazene and <E T="03">N</E> -pyrrolidino protonitazene or that the use of <E T="03">N</E> -pyrrolidino metonitazene or <E T="03">N</E> ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 37k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━