Temporary Schedule I Control of Two Synthetic Opioids

Summary

The Administrator of the Drug Enforcement Administration is issuing this temporary order to schedule two synthetic benzimidazole- opioid substances, as identified in this order, in schedule I of the Controlled Substances Act. This action is based on a finding by the Administrator that the placement of these two substances in schedule I is necessary to avoid imminent hazard to the 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 with, or possess) or propose to handle these two specified controlled substances.

Compliance Requirements

1. #1

   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, N-desethyl isotonitazene or N-piperidinyl etonitazene 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; Any person who does not desire or is unable to obtain a schedule I registration to handle N-desethyl isotonitazene or N-piperidinyl etonitazene must surrender all currently held quantities of these substances; N-Desethyl isotonitazene and N-piperidinyl etonitazene are subject to schedule I security requirements and must be handled in accordance with 21 CFR 1301.71-1301.93; All labels, labeling, and packaging for commercial containers of N-desethyl isotonitazene and N-piperidinyl etonitazene must comply with 21 U.S.C. 825 and 958(e) and 21 CFR part 1302; Every DEA registrant who possesses any quantity of N-desethyl isotonitazene or N-piperidinyl etonitazene on the effective date of this order must take an inventory of all stocks of these substances on hand pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11; All DEA registrants must maintain records with respect to N-desethyl isotonitazene and N-piperidinyl etonitazene 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; All DEA registrants must submit reports with respect to N-desethyl isotonitazene and N-piperidinyl etonitazene 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); All DEA registrants who distribute N-desethyl isotonitazene or N-piperidinyl etonitazene must comply with order form requirements pursuant to 21 U.S.C. 828 and in accordance with 21 CFR part 1305; All importation and exportation of N-desethyl isotonitazene and N-piperidinyl etonitazene must be in compliance with 21 U.S.C. 952, 953, 957, and 958, and in accordance with 21 CFR part 1312; Only DEA-registered manufacturers may manufacture N-desethyl isotonitazene and N-piperidinyl etonitazene in accordance with a quota assigned pursuant to 21 U.S.C. 826 and in accordance with 21 CFR part 1303

   Deadline: 2024-07-29(July 29, 2024)

Market Impacts

• Complete prohibition of manufacturing, distribution, importation, exportation, and possession of N-desethyl isotonitazene and N-piperidinyl etonitazene without DEA registration. Retail sales to general public are prohibited.; Mandatory DEA registration requirement for all entities conducting research, instructional activities, or chemical analysis involving these substances. Strict security, labeling, packaging, and reporting requirements imposed.; All importation and exportation of these substances must comply with 21 U.S.C. 952, 953, 957, and 958, and 21 CFR part 1312 requirements.; Only DEA-registered manufacturers may manufacture these substances in accordance with assigned quotas pursuant to 21 U.S.C. 826 and 21 CFR part 1303.

Validated Company Impacts