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Federal Register / Vol. 86, No. 232 / Tuesday, December 7, 2021 / Proposed Rules of phencyclidine TCP; schedule I, phencyclidine PCP; schedule II, and ketamine schedule III;
2 Methoxetamine has no currently accepted medical use in treatment in the United States. There are no approved New Drug Applications for methoxetamine and no known therapeutic applications for methoxetamine in the United States.
Therefore, methoxetamine has no currently accepted medical use in treatment in the United States.5
3 There is a lack of accepted safety for use of methoxetamine under medical supervision. Because methoxetamine has no approved medical use and has not been investigated as a new drug, its safety for use under medical supervision has not been determined. Therefore, there is a lack of accepted safety for use of methoxetamine under medical supervision.
Based on these findings, the Acting Administrator of DEA concludes that methoxetamine warrants control in schedule I of the CSA. More precisely, because of its hallucinogenic effects, and because it may produce hallucinogenic-like tolerance and dependence in humans, DEA proposes to placing methoxetamine, including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical description, in 21 CFR 1308.11d the hallucinogenic substances category of schedule I.

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Requirements for Handling Methoxetamine If this rule is finalized as proposed, methoxetamine would be subject to the CSAs schedule I regulatory controls and administrative, civil, and criminal sanctions applicable to the manufacture, distribution, reverse distribution, import, export, engagement in research, conduct instructional activities or 5 Although there is no evidence suggesting that methoxetamine has a 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 FDA, 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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chemical analysis with, and possession of schedule I controlled substances, including the following:
1. Registration. Any person who handles manufactures, distributes, reverse distributes, imports, exports, engages in research, or conducts instructional activities or chemical analysis with, or possesses, or who desires to handle, methoxetamine would be required to 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, as of the effective date of a final scheduling action. Any person who currently handles methoxetamine and is not registered with DEA would need to submit an application for registration and may not continue to handle methoxetamine as of the effective date of a final scheduling action, unless DEA has approved that application for registration pursuant to 21 U.S.C. 822, 823, 957, 958, and in accordance with 21 CFR parts 1301 and 1312.
2. Disposal of stocks. Any person who does not desire or is not able to obtain a schedule I registration would be required to surrender or transfer all quantities of currently held methoxetamine to a person registered with DEA before the effective date of a final scheduling action in accordance with all applicable Federal, State, local, and tribal laws. As of the effective date of a final scheduling action, methoxetamine would be required to be disposed of in accordance with 21 CFR
part 1317, in addition to all other applicable Federal, State, local, and tribal laws.
3. Security. Methoxetamine would be subject to schedule I security requirements and would need to be handled and stored pursuant to 21
U.S.C. 823, and in accordance with 21
CFR 1301.711301.93, as of the effective date of a final scheduling action. Nonpractitioners handling methoxetamine would also need to 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 methoxetamine would need to be in compliance with 21 U.S.C.
825, and be in accordance with 21 CFR
part 1302, as of the effective date of a final scheduling action.
5. Quota. Only registered manufacturers would be permitted to manufacture methoxetamine in accordance with a quota assigned pursuant to 21 U.S.C. 826, and in accordance with 21 CFR part 1303, as of the effective date of a final scheduling action.

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6. Inventory. Every DEA registrant who possesses any quantity of methoxetamine on the effective date of the final scheduling action would be required to take an inventory of methoxetamine on hand at that time, pursuant to 21 U.S.C. 827, and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11a and d.
Any person who becomes registered with DEA on or after the effective date of the final scheduling action would be required to take an initial inventory of all stocks of controlled substances including methoxetamine on hand on the date the registrant first engages in the handling of controlled substances, pursuant to 21 U.S.C. 827 and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11a and b.
After the initial inventory, every DEA
registrant would be required to take a new inventory of all controlled substances including methoxetamine on hand every two years, pursuant to 21
U.S.C. 827 and in accordance with 21
CFR 1304.03, 1304.04, and 1304.11.
7. Records and Reports. Every DEA
registrant would be required to maintain records and submit reports for methoxetamine, or products containing methoxetamine, pursuant to 21 U.S.C.
827 and in accordance with 21 CFR
1301.74b and c and parts 1304, 1312, and 1317, as of the effective date of a final scheduling action. Manufacturers and distributors would need to submit reports regarding methoxetamine 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, as of the effective date of a final scheduling action.
8. Order Forms. Every DEA registrant who distributes methoxetamine would be required to comply with the order form requirements, pursuant to 21
U.S.C. 828, and 21 CFR part 1305, as of the effective date of a final scheduling action.
9. Importation and Exportation. All importation and exportation of methoxetamine would need to be in compliance with 21 U.S.C. 952, 953, 957, and 958, and in accordance with 21
CFR part 1312, as of the effective date of a final scheduling action.
10. Liability. Any activity involving methoxetamine not authorized by, or in violation of, the CSA or its implementing regulations, would be unlawful, and may subject the person to administrative, civil, and/or criminal sanctions.

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