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Federal Register / Vol. 86, No. 104 / Wednesday, June 2, 2021 / Rules and Regulations
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and current pattern of abuse, and the scope, duration, and significance of abuse. Regarding the commenters public safety concerns with remimazolams placement in schedule IV, there is still significant oversight for schedule IV drugs. For both the IFR and this final rule, DEA made the findings required under 21 U.S.C. 812b4 for the placement of remimazolam in schedule IV.
Requirements for Handling Remimazolam As indicated above, remimazolam has been a schedule IV controlled substance by virtue of an IFR issued by DEA in October 2020. Thus, this final rule does not alter the regulatory requirements applicable to handlers of remimazolam that have been in place since that time.
Nonetheless, for informational purposes, we restate here those requirements. Remimazolam is subject to the Controlled Substances Acts CSA schedule IV regulatory controls and administrative, civil, and criminal sanctions applicable to the manufacture, distribution, reverse distribution, dispensing, importing, exporting, research, and conduct of instructional activities and chemical analysis with, and possession involving schedule IV
substances, including, but not limited to, the following:
1. Registration. Any person who handles manufactures, distributes, reverse distributes, dispenses, imports, exports, engages in research, or conducts instructional activities or chemical analysis with, or possesses remimazolam, or who desires to handle remimazolam, 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. Any person who intends to handle remimazolam, and is not registered with DEA, must submit an application for registration and may not continue to handle remimazolam unless DEA has approved that application for registration, pursuant to 21 U.S.C. 822, 823, 957, and 958, and in accordance with 21 CFR parts 1301 and 1312. These registration requirements, however, are not applicable to patients end users who possess remimazolam pursuant to a lawful prescription.
2. Disposal of stocks. Any person who does not desire or is not able to maintain a schedule IV registration must surrender all quantities of currently held remimazolam or may transfer all quantities of remimazolam to a person registered with DEA in accordance with 21 CFR part 1317, in additional to all other applicable Federal, State, local, and tribal laws.

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3. Security. Remimazolam is subject to schedule IIIV security requirements for DEA registrants and it must be handled and stored in accordance with 21 CFR 1301.711301.77. Nonpractitioners handling remimazolam 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 remimazolam must comply with 21 U.S.C. 825 and 958e, and be in accordance with 21 CFR part 1302.
5. Inventory. Since October 6, 2020, every DEA registrant who possesses any quantity of remimazolam must take an inventory of remimazolam on hand, 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. DEA
registrants must maintain records and submit reports for remimazolam, pursuant to 21 U.S.C. 827, 832a, and 958e, and in accordance with 21 CFR
1301.74b and c and parts 1304, 1312, and 1317.
7. Prescriptions. All prescriptions for remimazolam, or products containing remimazolam, must comply with 21
U.S.C. 829, and be issued in accordance with 21 CFR parts 1306 and 1311, subpart C.
8. Manufacturing and Distributing. In addition to the general requirements of the CSA and DEA regulations that are applicable to manufacturers and distributors of schedule IV controlled substances, such registrants should be advised that consistent with the foregoing considerations any manufacturing or distribution of remimazolam may only be for the legitimate purposes consistent with the drugs labeling, or for research activities authorized by the Federal Food, Drug, and Cosmetic Act and the CSA.
9. Importation and Exportation. All importation and exportation of remimazolam must be in compliance with 21 U.S.C. 952, 953, 957, and 958, and in accordance with 21 CFR part 1312.
10. Liability. Any activity involving remimazolam 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 Administrative Procedure Act This final rule, without change, affirms the amendment made by the IFR
that is already in effect. Section 553 of
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the Administrative Procedure Act APA
5 U.S.C. 553 generally requires notice and comment for rulemakings.
However, 21 U.S.C. 811j provides that in cases where a certain new drug is 1
approved by HHS and 2 HHS
recommends control in CSA schedule IIV, DEA shall issue an IFR scheduling the drug within 90 days. Additionally, subsection j specifies that the rulemaking shall become immediately effective as an IFR without requiring DEA to demonstrate good cause. DEA
issued an IFR on October 6, 2020, and solicited public comments on that rule.
Subsection j further provides that after giving interested persons the opportunity to comment and to request a hearing, the Attorney General, as delegated to the Administrator of DEA, shall issue a final rule in accordance with the scheduling criteria of 21 U.S.C.
811b through d and 812b. DEA is now responding to the comments submitted by the public and issuing the final rule in accordance with subsection j.
Executive Orders 12866 Regulatory Planning and Review and 13563
Improving Regulation and Regulatory Review In accordance with 21 U.S.C. 811a and j, this 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 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 on the distribution of power and responsibilities among the various levels of government.

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