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Federal Register / Vol. 86, No. 211 / Thursday, November 4, 2021 / Rules and Regulations
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at least 48 1 2 fatalities in the United States between August 2019 and July 2020. The positive identification of this substance in post-mortem cases is a serious concern to the public safety.
Isotonitazene in the illicit drug market has been reported in Canada, Estonia, Germany, Latvia, Sweden, and the United States since April 2019.3 Law enforcement reports demonstrate that isotonitazene is being illicitly distributed and abused. The illicit use and distribution of this substance are similar to that of heroin schedule I and prescription opioid analgesics.
According to the National Forensic Laboratory Information System NFLISDrug database, which collects drug identification results from drug cases submitted to and analyzed by Federal, State and local forensic laboratories, there have been 181 reports for isotonitazene between January 2019 and December 2020 4 query date: May 28, 2021.
DEA is not aware of any claims or any medical or scientific literature suggesting that isotonitazene has a currently accepted medical use in treatment in the United States. In addition, the Department of Health and Human Services advised DEA, by letter dated March 31, 2020, that there were no investigational new drug applications or approved new drug applications for isotonitazene in the United States. Because isotonitazene is not formulated or available for clinical use as an approved medicinal product, all current use of this substance 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 a drug.
Therefore, consistent with 21 U.S.C.
811d1, DEA concludes that isotonitazene has no currently accepted medical use in treatment in the United States 5 and is most appropriately 1 Shover CL, Falasinnu TO, Freedman RB, Humphreys K. Emerging Characteristics of Isotonitazene-Involved Overdose Deaths: A CaseControl Study. J Addict Med. 2020 Nov 23:10.1097/
ADM.0000000000000775.
2 Krotulski AJ, Papsun DM, Kacinko SL, Logan BK. Isotonitazene Quantitation and Metabolite Discovery in Authentic Forensic Casework. J Anal Toxicol. 2020 Jul 31;446:521530.
3 European Monitoring Centre for Drugs and Drug Addiction and Europol. 2020. EMCDDA initial report on the new psychoactive substance N,Ndiethyl-2-4-1 methylethoxyphenylmethyl-5nitro-1H-benzimidazole-1-ethanamine isotonitazene. In accordance with Article 5b of Regulation EC No 1920/2006 as amended, Publications Office of the European Union, Luxembourg.
4 Reports to NFLIS-Drug are still pending for 2020.
5 Although, as discussed above, there is no evidence suggesting that isotonitazene has a
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placed in schedule I of the CSA, the same schedule in which it currently resides. Because control is required under the Single Convention, DEA will not be initiating regular rulemaking proceedings to schedule isotonitazene pursuant to 21 U.S.C. 811a.
Conclusion In order to meet the United States obligations under the Single Convention and because isotonitazene has no currently accepted medical use in treatment in the United States, the Administrator has determined that isotonitazene, including its isomers, esters, ethers, salts, and salts of isomers, esters, and ethers, whenever the existence of such isomers, esters, ethers, and salts is possible within the specific chemical designation, should remain in schedule I of the CSA.
Requirements for Handling Isotonitazene has been controlled as a schedule I controlled substance since August 20, 2020. Upon the effective date of the final order contained in this document, isotonitazene will be permanently subject to the CSAs schedule I regulatory controls and administrative, civil, and criminal sanctions applicable to the manufacture of, distribution of, importation of, exportation of, engagement in research or conduct of instructional activities with, and possession of, schedule I
controlled substances, including the following:
1. Registration. Any person who handles manufactures, distributes, imports, exports, engages in research or conducts instructional activities with, or possesses, or who desires to handle, isotonitazene 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. Retail sales of schedule I
controlled substances to the general public are not allowed under the CSA.
Possession of any quantity of these substances in a manner not authorized by the CSA is unlawful and those in currently accepted medical use in treatment in the United States, it bears noting that a drug cannot be found to have such medical use unless DEA
concludes that it satisfies a five-part test.
Specifically, with respect to a drug that has not been approved by the Food and Drug Administration, to have a currently accepted medical use in treatment in the United States, all of the following must be demonstrated: i. The drugs 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. 57 FR 10499 1992, pet.
for rev. denied, Alliance for Cannabis Therapeutics v. DEA, 15 F.3d 1131, 1135 D.C. Cir. 1994.

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possession of any quantity of these substances may be subject to prosecution pursuant to the CSA.
2. Disposal of stocks. Isotonitazene must be disposed of in accordance with 21 CFR part 1317, in addition to all other applicable federal, state, local, and tribal laws.
3. Security. Isotonitazene is subject to schedule I security requirements and must be handled and stored pursuant to 21 U.S.C. 821 and 823, and in accordance with 21 CFR 1301.71
1301.76. Non-practitioners handling isotonitazene must also comply with the employee screening requirements of 21
CFR 1301.901301.93.
4. Labeling and packaging. All labels, labeling, and packaging for commercial containers of isotonitazene must be in compliance with 21 U.S.C. 825 and 958e, and be in accordance with 21
CFR part 1302.
5. Quota. Only registered manufacturers are permitted to manufacture isotonitazene in accordance with a quota assigned pursuant to 21 U.S.C. 826 and in accordance with 21 CFR part 1303.
6. Inventory. Every DEA registrant who possesses any quantity of isotonitazene has been required to keep an inventory of all stocks of this substance on hand as of August 20, 2020, pursuant to 21 U.S.C. 827 and 958e, and in accordance with 21 CFR
1304.03, 1304.04, and 1304.11.
7. Records and Reports. DEA
registrants must maintain records and submit reports with respect to isotonitazene pursuant to 21 U.S.C. 827
and 958e, and in accordance with 21
CFR parts 1304, 1312, and 1317, and 1307.11. Manufacturers and distributors must submit reports regarding isotonitazene to the Automation of Reports and Consolidated Order System pursuant to 21 U.S.C. 827 and in accordance with 21
CFR parts 1304 and 1312.
8. Order Forms. All DEA registrants who distribute isotonitazene must continue to comply with order form requirements pursuant to 21 U.S.C. 828
and in accordance with 21 CFR part 1305.
9. Importation and Exportation. All importation and exportation of isotonitazene must continue to be in compliance with 21 U.S.C. 952, 953, 957, and 958, and in accordance with 21
CFR parts 1304, 1312, and 1317.
10. Liability. Any activity involving isotonitazene not authorized by, or in violation of the CSA, is unlawful, and may subject the person to administrative, civil, and/or criminal sanctions.

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