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Federal Register / Vol. 86, No. 112 / Monday, June 14, 2021 / Rules and Regulations
of the CSA. However, this comment was not related to the rule; therefore, DEA
does not respond to the comment.
Scheduling Conclusion After consideration of the relevant matter presented through the scientific and medical evaluation and the accompanying scheduling recommendation of HHS, and after its own eight-factor evaluation, DEA finds that these facts and all other relevant data constitute substantial evidence of potential for abuse of N-ethylpentylone.
Accordingly, DEA is permanently scheduling N-ethylpentylone as a controlled substance under the CSA.

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Determination of Appropriate Schedule The CSA establishes five schedules of controlled substances known as schedules I, II, III, IV, and V. The CSA
also outlines the findings required to place a drug or other substance in any particular schedule. 21 U.S.C. 812b.
After consideration of the analysis and recommendation of the Assistant Secretary and review of all other available data, the Acting Administrator, pursuant to 21 U.S.C.
811a and 812b1, finds that:
1 N-Ethylpentylone has a high potential for abuse;
2 N-Ethylpentylone has no currently accepted medical use in treatment in the United States; 2 and 3 There is a lack of accepted safety for use of N-ethylpentylone under medical supervision.
Based on these findings, the Acting Administrator concludes that 1-1,3benzodioxol-5-yl-2ethylaminopentan-1-one known as Nethylpentylone or ephylone and its optical, positional, and geometric isomers, including its salts, isomers, and salts of isomers, whenever the existence of such salts, isomers, and salts of isomers is possible, warrants continued control in schedule I of the CSA. 21
U.S.C. 812b1.
2 Although there is no evidence suggesting that Nethylpentylone 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 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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Requirements for Handling N-Ethylpentylone N-Ethylpentylone will continue 3 to be subject to the CSAs schedule I
regulatory controls and administrative, civil, and criminal sanctions applicable to the manufacture, distribution, reverse distribution, importation, exportation, engagement in research, and conduct of instructional activities or 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 Nethylpentylone, or who desires to handle N-ethylpentylone, 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.
2. Security. N-Ethylpentylone is subject to schedule I security requirements and must be handled and stored pursuant to 21 U.S.C. 821, 823, 871b, and in accordance with 21 CFR
1301.711301.76. Non-practitioners handling this substance must also comply with the employee screening requirements of 21 CFR 1301.90
1301.93.
3. Labeling and Packaging. All labels, labeling, and packaging for commercial containers of N-ethylpentylone must be in compliance with 21 U.S.C. 825 and 958e, and be in accordance with 21
CFR part 1302.
4. Quota. Only registered manufacturers are permitted to manufacture N-ethylpentylone in accordance with a quota assigned pursuant to 21 U.S.C. 826 and in accordance with 21 CFR part 1303.
5. Inventory. Any person registered with DEA to handle N-ethylpentylone must have an initial inventory of all stocks of controlled substances including N-ethylpentylone on hand on the date the registrant first engages in the handling of the controlled substances pursuant to 21 U.S.C. 827
and 958, and in accordance with 21 CFR
1304.03, 1304.04, and 1304.11. After the initial inventory, every DEA registrant must take a new inventory of all stocks of controlled substances including Nethylpentylone on hand every two years pursuant to 21 U.S.C. 827 and 958, 3 N-Ethylpentylone has been subject to schedule I controls on a temporary basis, pursuant to 21
U.S.C. 811h, by virtue of the August 31, 2018
temporary scheduling order 83 FR 44474 and the subsequent one-year extension of that order August 27, 2020, 85 FR 52915.

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and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11.
6. Records and Reports. Every DEA
registrant must maintain records and submit reports with respect to Nethylpentylone pursuant to 21 U.S.C.
827 and 958e, and in accordance with 21 CFR 1301.74b and c and parts 1304, 1312, and 1317.
7. Order Forms. Every DEA registrant who distributes N-ethylpentylone must continue to comply with the order form requirements, pursuant to 21 U.S.C. 828
and 21 CFR part 1305.
8. Importation and Exportation. All importation and exportation of Nethylpentylone must be in compliance with 21 U.S.C. 952, 953, 957, and 958, and in accordance with 21 CFR part 1312.
9. Liability. Any activity involving Nethylpentylone not authorized by, or in violation of, the CSA or its implementing regulations is unlawful, and may subject the person to administrative, civil, and/or criminal sanctions.
Regulatory Analyses Executive Orders 12866 Regulatory Planning and Review and 13563
Improving Regulation and Regulatory Review In accordance with 21 U.S.C. 811a, this final scheduling action is subject to formal rulemaking procedures performed on the record after opportunity for a hearing, which are conducted pursuant to the provisions of 5 U.S.C. 556 and 557. The CSA sets forth the criteria for scheduling a drug or other substance. Such actions are exempt from review by the Office of Management and Budget OMB
pursuant to section 3d1 of Executive Order E.O. 12866 and the principles reaffirmed in E.O. 13563.
Executive Order 12988, Civil Justice Reform This regulation meets the applicable standards set forth in sections 3a and 3b2 of E.O. 12988 to eliminate drafting errors and ambiguity, minimize litigation, provide a clear legal standard for affected conduct, and promote simplification and burden reduction.
Executive Order 13132, Federalism This rulemaking does not have federalism implications warranting the application of E.O. 13132. The rule does not have substantial direct effects on the States, on the relationship between the National Government and the States, or the distribution of power and responsibilities among the various levels of government.

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