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Federal Register / Vol. 86, No. 138 / Thursday, July 22, 2021 / Proposed Rules
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South America. However, amineptine was later withdrawn from the majority of countries due to its abuse potential and lack of safety. Therefore, there is a lack of accepted safety for the use of amineptine under medical supervision.
Although the first finding shows amineptine to have similar effects to schedule II substances such as cocaine and amphetamine, it bears reiterating that there is only one possible schedule in the CSAschedule Ito place amineptine since it has no currently accepted medical use in treatment in the United States. See the background section for additional discussion.
Based on these findings, the Administrator of DEA concludes that amineptine warrants control in schedule I of the CSA. 21 U.S.C. 812b1. More precisely, because of its stimulant effects, DEA proposes placing substance amineptine, including its salts, isomers, and salts of isomers, in 21 CFR
1308.11f the stimulants category of schedule I.
Requirements for Handling Amineptine If this rule is finalized as proposed, amineptine 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 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 amineptine, or who desires to handle amineptine, would need to be registered with DEA
to conduct such activities pursuant to 21 U.S.C. 822, 823, 957, 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 amineptine and is not registered with DEA would need to submit an application for registration and may not continue to handle amineptine 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 to transfer all quantities of currently held amineptine to a person registered with DEA before the effective date of a final scheduling
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action in accordance with all applicable Federal, State, local, and tribal laws. As of the effective date of a final scheduling action, amineptine 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. Amineptine would be subject to schedule I security requirements and would need to be handled and stored pursuant to 21
U.S.C. 821 and 823 and in accordance with 21 CFR 1301.711301.93, as of the effective date of a final scheduling action. Non-practitioners handling amineptine would also need to comply with the employee screening requirements of 21 CFR 1301.90
1301.93.
4. Labeling and Packaging. All labels, labeling, and packaging for commercial containers of amineptine would need to be in compliance with 21 U.S.C. 825
and 958e and 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 amineptine 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.
6. Inventory. Every DEA registrant who possesses any quantity of amineptine on the effective date of a final scheduling action would be required to take an inventory of amineptine on hand at that time, pursuant to 21 U.S.C. 827 and 958 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 amineptine on hand on the date the registrant first engages in the handling of controlled substances, pursuant to 21 U.S.C. 827 and 958 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 amineptine on hand every two years, pursuant to 21
U.S.C. 827 and 958 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 amineptine, or products containing amineptine, pursuant to 21 U.S.C. 827
and 958 and in accordance with 21 CFR
parts 1304, 1312, and 1317, as of the
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effective date of a final scheduling action. Manufacturers and distributors would be required to submit reports regarding amineptine 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 amineptine would be required to comply with order form requirements, pursuant to 21 U.S.C. 828
and in accordance with 21 CFR part 1305, as of the effective date of a final scheduling action.
9. Importation and Exportation. All importation and exportation of amineptine 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 amineptine 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.
Regulatory Analyses Executive Orders 12866 and 13563, Regulatory Planning and Review, and Improving Regulation and Regulatory Review.
In accordance with 21 U.S.C. 811a, this proposed 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 procedures and criteria for scheduling a drug or other substance.
Such actions are exempt from review by the Office of Management and Budget 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 proposed regulation meets the applicable standards set forth in Sections 3a and 3b2 of E.O. 12988, Civil Justice Reform, 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 proposed rulemaking does not have federalism implications warranting the application of E.O. 13132. The proposed rule does not have substantial direct effects on the States, on the
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