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Federal Register / Vol. 86, No. 59 / Tuesday, March 30, 2021 / Proposed Rules
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control in schedule I of the CSA. 21
U.S.C. 812b1.
Requirements for Handling 5F-EDMBPINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA and FUB-144
If this rule is finalized as proposed, 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA and FUB-144 would continue 6 to 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, or who desires to handle, 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5FCUMYL-PINACA or FUB-144 is 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.
2. Security. 5F-EDMB-PINACA, 5FMDMB-PICA, FUB-AKB48, 5F-CUMYLPINACA and FUB-144 are subject to schedule I security requirements and must be handled and stored pursuant to 21 U.S.C. 821, 823 and in accordance with 21 CFR 1301.711301.76. Nonpractitioners handling these five substances must also comply with the employee screening requirements of 21
CFR 1301.901301.93.
3. Labeling and Packaging. All labels, labeling, and packaging for commercial containers of 5F-EDMB-PINACA, 5FMDMB-PICA, FUB-AKB48, 5F-CUMYLPINACA or FUB-144 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 5F-EDMB-PINACA, 5FMDMB-PICA, FUB-AKB48, 5F-CUMYLPINACA or FUB-144 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 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5FCUMYL-PINACA or FUB-144 must have 6 5F-EDMB-PINACA, 5F-MDMB-PICA, FUBAKB48, 5F-CUMYL-PINACA and FUB-144 are currently subject to schedule I controls on a temporary basis, pursuant to 21 U.S.C. 811h. 84
FR 15505, April 16, 2019.

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an initial inventory of all stocks of controlled substances including 5FEDMB-PINACA, 5F-MDMB-PICA, FUBAKB48, 5F-CUMYL-PINACA and FUB144 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 1304.11.
After the initial inventory, every DEA
registrant must take a new inventory of all stocks of controlled substances including 5F-EDMB-PINACA, 5FMDMB-PICA, FUB-AKB48, 5F-CUMYLPINACA and FUB-144 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.
6. Records and Reports. Every DEA
registrant is required to maintain records and submit reports with respect to 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA and FUB-144 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 5F-EDMB-PINACA, 5FMDMB-PICA, FUB-AKB48, 5F-CUMYLPINACA or FUB-144 is required 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 5FEDMB-PINACA, 5F-MDMB-PICA, FUBAKB48, 5F-CUMYL-PINACA or FUB144 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 5FEDMB-PINACA, 5F-MDMB-PICA, FUBAKB48, 5F-CUMYL-PINACA or FUB144 not authorized by, or in violation of, the CSA or its implementing regulations is unlawful, and could 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 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 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
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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
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 relationship between the national government and the States, or the distribution of power and responsibilities among the various levels of government.
Executive Order 13175, Consultation and Coordination With Indian Tribal Governments This proposed rule does not have tribal implications warranting the application of E.O. 13175. It does not have substantial direct effects on one or more Indian tribes, on the relationship between the Federal government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes.
Regulatory Flexibility Act The Acting Administrator, in accordance with the Regulatory Flexibility Act, 5 U.S.C. 601602, has reviewed this proposed rule and by approving it certifies that it will not have a significant economic impact on a substantial number of small entities.
On April 16, 2019, DEA published an order to temporarily place 5F-EDMBPINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA and FUB-144 in schedule I of the CSA pursuant to the temporary scheduling provisions of 21
U.S.C. 811h. DEA estimates that all entities handling or planning to handle 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA or FUB-144 have already established and implemented the systems and processes required to handle these substances.
There are currently 28 unique registrations authorized to specifically handle 5F-EDMB-PINACA, 5F-MDMBPICA, FUB-AKB48, 5F-CUMYL-PINACA
or FUB-144, as well as a number of registered analytical labs that are authorized to handle schedule I
controlled substances generally. From a review of entity names, DEA estimates
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