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Federal Register / Vol. 86, No. 87 / Friday, May 7, 2021 / Rules and Regulations SDX demonstrated no indication of physical dependence after abrupt discontinuation of the drug. In a HAP
study, SDX increased drug-liking scores that were significantly greater than that of placebo and were similar to that of phentermine. In addition, SDX
produced euphoria-related adverse events in a HAP study. These data collectively suggest that SDX abuse may lead to limited psychological dependence relative to drugs in schedule III and largely similar to that of schedule IV stimulants.
Based on these findings, the Acting Administrator of DEA concludes that SDX warrants control in schedule IV of the CSA. 21 U.S.C. 812b4.
Requirements for Handling Serdexmethylphenidate Serdexmethylphenidate is subject to the CSAs 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 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, or who desires to handle, serdexmethylphenidate, 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 currently handles or intends to handle serdexmethylphenidate and is not registered with DEA must submit an application for registration and may not continue to handle serdexmethylphenidate 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 serdexmethylphenidate pursuant to a lawful prescription.
2. Disposal of stocks. Any person who obtains a schedule IV registration to handle serdexmethylphenidate but who subsequently does not desire or is not able to maintain such registration must surrender all quantities of serdexmethylphenidate or may transfer all quantities of serdexmethylphenidate to a person registered with DEA in accordance with 21 CFR part 1317, in
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additional to all other applicable Federal, state, local, and tribal laws.
3. Security. Serdexmethylphenidate is subject to schedule IIIV security requirements for DEA registrants and it must be handled and stored in accordance with 21 CFR 1301.71
1301.77. Non-practitioners handling serdexmethylphenidate must also comply with the employee screening requirements of 21 CFR 1301.90
1301.93. These requirements, however, are not applicable to patients end users who possess serdexmethylphenidate pursuant to a lawful prescription.
4. Labeling and Packaging. All labels, labeling, and packaging for commercial containers of serdexmethylphenidate must comply with 21 U.S.C. 825 and 958e, and be in accordance with 21
CFR part 1302.
5. Inventory. Every DEA registrant who possesses any quantity of serdexmethylphenidate must take an inventory of serdexmethylphenidate on hand, pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 CFR
1304.03, 1304.04, and 1304.11.
Any person who becomes registered with DEA to handle serdexmethylphenidate must take an initial inventory of all stocks of controlled substances including serdexmethylphenidate on hand on the date the registrant first engages in the handling of controlled substances, pursuant to 21 U.S.C. 827 and 958e, 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 serdexmethylphenidate on hand every two years, pursuant to 21
U.S.C. 827 and 958e, and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11. These requirements, however, are not applicable to patients end users who possess serdexmethylphenidate pursuant to a lawful prescription.
6. Records and Reports. DEA
registrants must maintain records and submit reports for serdexmethylphenidate, 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 serdexmethylphenidate, or products containing serdexmethylphenidate, 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
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substances, such registrants should be advised that consistent with the foregoing considerations any manufacturing or distribution of serdexmethylphenidate may only be for the legitimate purposes consistent with the drugs labeling, or for research activities authorized by the FDCA and CSA.
9. Importation and Exportation. All importation and exportation of serdexmethylphenidate 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 serdexmethylphenidate 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 Section 553 of the 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, under section 505c of the FDCA
and 2 HHS recommends control in CSA schedule IIV, DEA shall issue an interim final rule scheduling the drug within 90 days. As stated in the legal authority section, the 90-day time frame is the later of: 1 The date DEA receives HHSs scientific and medical evaluation/scheduling recommendation, or 2 the date DEA receives notice of the NDA approval by HHS.
Additionally, subsection j specifies that the rulemaking shall become immediately effective as an interim final rule without requiring DEA to demonstrate good cause.
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 the 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.

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