Schedules of Controlled Substances: 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: 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> Final amendment; final order. <SUM> <HD SOURCE="HED">SUMMARY:</HD> With the issuance of this final order, the Administrator of the Drug Enforcement Administration is permanently placing 2-(4-methoxybenzyl)-5-nitro-1-(2-(pyrrolidin-1-yl)ethyl)-1 <E T="03">H</E> -benzimidazole (other names: <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 (other names: <E T="03">N-</E> pyrrolidino protonitazene or protonitazepyne), including their isomers, esters, ethers, salts, and salts of isomers, esters, and ethers whenever the existence of such isomers, esters, ethers, and salts are possible within the specific chemical designation, in schedule I under the Controlled Substances Act. This action is being taken, in part, to enable the United States to meet its obligations under the 1961 Single Convention on Narcotic Drugs. This action imposes permanent regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on persons who handle (manufacture, distribute, import, export, engage in research or conduct instructional activities with or possess), or handle <E T="03">N-</E> pyrrolidino metonitazene and <E T="03">N-</E> pyrrolidino protonitazene. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> Effective February 11, 2026. </EFFDATE> <HD SOURCE="HED">ADDRESSES:</HD> 8701 Morrissette Drive, Springfield, Virginia 22152. <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> Dr. Terrence L. Boos, Drug and Chemical Evaluation Section, Diversion Control Division, Drug Enforcement Administration; Telephone: (571) 362-3249. </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <HD SOURCE="HD1">Legal Authority</HD> The United States is a party to the United Nations Single Convention on Narcotic Drugs, Mar. 30, 1961, 18 U.S.T. 1407, 520 U.N.T.S. 151 (Single Convention), as amended by the 1972 Protocol. Article 3, paragraph 7 of the Single Convention requires that if the Commission on Narcotic Drugs adds a substance to one of the schedules of such Convention, and the United States receives notification of such scheduling decision from the Secretary-General of the United Nations, the United States, as a signatory Member State, is obligated to control the substance under its national drug control legislation. Under 21 U.S.C. 811(d)(1) of the Controlled Substances Act (CSA), if control of a substance is required “by United States obligations under international treaties, conventions, or protocols in effect on October 27, 1970,” the Attorney General must issue an order controlling such drug under the schedule she deems most appropriate to carry out such obligations, without regard to the findings required by 21 U.S.C. 811(a) or 812(b), and without regard to the procedures prescribed by 21 U.S.C. 811(a) and (b). The Attorney General has delegated scheduling authority under 21 U.S.C. 811 to the Administrator of the Drug Enforcement Administration. <SU>1</SU> <FTREF/> <FTNT> <SU>1</SU>  28 CFR 0.100. </FTNT> <HD SOURCE="HD1">Background</HD> On November 21, 2024, the Director-General of the World Health Organization recommended to the Secretary-General that <E T="03">N-</E> pyrrolidino metonitazene and <E T="03">N-</E> pyrrolidino protonitazene be placed in Schedule I of the Single Convention, as these substances have pharmacological effects similar to other opioid drugs that are controlled in Schedule I of the Single Convention. On June 9, 2025, the Secretariat of the United Nations informed the United States government, by letter, that the Commission voted to place <E T="03">N-</E> pyrrolidino metonitazene and <E T="03">N-</E> pyrrolidino protonitazene in Schedule I of the Single Convention during its 68th session on March 12, 2025 (CND Mar 68/2 and 68/1). On August 15, 2025, DEA issued a temporary scheduling order, placing <E T="03">N-</E> pyrrolidino metonitazene and <E T="03">N-</E> pyrrolidino protonitazene temporarily in schedule I of the CSA. <SU>2</SU> <FTREF/> That order for <E T="03">N-</E> pyrrolidino metonitazene and <E T="03">N-</E> pyrrolidino protonitazene (codified at 21 CFR 1308.11(h)(77) and (78)) was based on the Administrator's finding that the temporary scheduling of these substances was necessary to avoid an imminent hazard to public safety. <SU>3</SU> <FTREF/> <FTNT> <SU>2</SU>   <E T="03">Schedules of Controlled Substances: Temporary Placement of N-pyrrolidino metonitazene and N-pyrrolidino protonitazene in Schedule I</E> , 90 FR 39314 (August 15, 2025). </FTNT> <FTNT> <SU>3</SU>   <E T="03">Id.</E> </FTNT> <HD SOURCE="HD1">N-Pyrrolidino Metonitazene and N-Pyrrolidino Protonitazene</HD> Benzimidazole-opioids, commonly referred to as “nitazenes,” emerged on the recreational drug market in 2019. This class of substances shares a similar pharmacological profile with fentanyl, morphine, and other mu-opioid receptor agonists. In 2023, <E T="03">N</E> -pyrrolidino metonitazene and <E T="03">N</E> -pyrrolidino protonitazene emerged on the illicit opioid drug market. The abuse of <E T="03">N</E> -pyrrolidino metonitazene and <E T="03">N</E> -pyrrolidino protonitazene has been associated with adverse events to include their identification in toxicology cases in the United States. Several substances belonging to the benzimidazole-opioid drug class have been controlled in the United States, and as a class of drug in China, Canada, and the United Kingdom. Law enforcement reports demonstrate that <E T="03">N</E> -pyrrolidino metonitazene and <E T="03">N</E> -pyrrolidino protonitazene are being illicitly distributed and abused. According to the National Forensic Laboratory Information System (NFLIS-Drug)  <SU>4</SU> <FTREF/> database, which collects drug identification results from drug cases submitted to and analyzed by Federal, State and local forensic laboratories, there have been 284 reports for <E T="03">N</E> -pyrrolidino metonitazene and <E T="03">N</E> -pyrrolidino protonitazene between January 2022 and August 2025 (query date: August 13, 2025). Specifically, there have been 253 encounters of <E T="03">N</E> -pyrrolidino protonitazene from 22 States and 31 encounters of <E T="03">N</E> -pyrrolidino metonitazene from 10 States. Benzimidazole-opioids have been identified in counterfeit prescription tablets in the United States. A report from the Expert Committee on Drug Dependence Critical Review on <E T="03">N</E> -pyrrolidino protonitazene indicate this substance has been sold online as “China White” heroin. <SU>5</SU> <FTREF/> <FTNT> <SU>4</SU>  NFLIS-Drug represents an important resource in monitoring illicit drug trafficking, including the diversion of legally manufactured pharmaceuticals into illegal markets. NFLIS-Drug is a comprehensive information system that includes data from forensic laboratories that handle more than 96 percent of an estimated 1 million distinct annual federal, state, and local drug analysis cases. NFLIS-Drug includes drug chemistry results from completed analyses only. While NFLIS-Drug data are not direct evidence of abuse, these can lead to an inference that a drug has been diverted and abused. <E T="03">See Schedules of Controlled Substances: Placement of Carisoprodol Into Schedule IV,</E> 76 FR 77330, 77332 (Dec. 12, 2011). </FTNT> <FTNT> <SU>5</SU>  47th Expert Committee on Drug Dependence Critical Review on <E T="03">N</E> -pyrrolidino protonitazene and <E T="03">N</E> -pyrrolidino metonitazene. 14-18 October 2024. </FTNT> <E T="03">N</E> -Pyrrolidino metonitazene and <E T="03">N</E> -pyrrolidino protonitazene have no currently accepted medical use in treatment in the United States. The Department of Health and Human Services (HHS) advised DEA, by letter dated June 11, 2025, that based on a review by the Food and Drug Administration (FDA), there were no investigational new drug applications (IND) or approved new drug applications (NDA) for <E T="03">N</E> -pyrrolidino metonitazene and <E T="03">N</E> -pyrrolidino protonitazene in the United States. Since this letter, HHS has not advised DEA of any new IND or NDA for these substances. Because <E T="03">N</E> -pyrrolidino metonitazene and <E T="03">N</E> -pyrrolidino protonitazene are not formulated or available for clinical use as approved medicinal products, all current use of these substances by individuals is based on their own initiative, rather than on the basis of medical advice from a practitioner licensed by law to administer such drugs. Consistent with 21 U.S.C. 811(d)(1), DEA concludes that <E T="03">N</E> -pyrrolidino metonitazene and <E T="03">N</E> -pyrrolidino protonitazene have no currently accepted medical use in treatment in the United States  <SU>6</SU> <FTREF/> and are most appropriately placed permanently in schedule I of the CSA, the same schedule in which they temporarily reside. Because control is required under the Single Convention, DEA will not be initiating regular rulemaking proceedings to permanently schedule <E T="03">N</E> -pyrrolidino metonitazene and <E T="03">N</E> -pyrrolidino protonitazene pursuant to 21 U.S.C.811(a). <FTNT> <SU>6</SU>  There is no evidence suggesting that <E T="03">N</E> -pyrrolidino metonitazene or <E T="03">N</E> -pyrrolidino protonitazene have a c ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 27k characters. 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