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Federal Register / Vol. 86, No. 40 / Wednesday, March 3, 2021 / Rules and Regulations is no evidence to suggest that such control of lemborexant creates undue regulatory restrictions increasing the risk of addiction. Furthermore, a HAP
study of lemborexant was conducted, the results of which indicate that lemborexant has an abuse potential that is greater than placebo and statistically similar to other controlled sedatives in schedule IV of the CSA. Therefore, DEA
asserts that by adopting the interim final rule placing lemborexant in schedule IV
of the CSA, there is no risk of restricting its prescribing and limiting treatment options for insomnia to more dangerous and addictive molecules.
Rather, lemborexant is being placed in a schedule with other sedative/
hypnotics that have similar abuse potential such as benzodiazepines, barbiturates, and muscle relaxants.
Regarding the commenters point that lemborexant is a new molecular entity with unknown actual or potential for abuse, and the commenters request for DEA to either not place lemborexant in schedule IV or to postpone such scheduling until there is evidence showing the requisite abuse potential, DEAs determination of the abuse liability of lemborexant in the interim final rule, and again in this final rule, is in agreement with that of HHS. In a clinical HAP study investigating the abuse potential of lemborexant, HHS
concluded that lemborexant produced subjective responses that were similar to those for the schedule IV sedative suvorexant. In the context of drug development, HAP studies are conducted as a component of the safety evaluation of a new molecular entity.
These studies are utilized by HHS, FDA, and the scientific community. They are accepted as repeatable and follow rigorous scientific guidelines. In effect, the HAP studies are indeed evidence showing the requisite abuse potential of lemborexant; therefore, no additional studies are necessary to prove potential for abuse. Additionally, HHS
evaluation of a HAP study conducted by the Sponsor concluded that lemborexant produces positive subjective effects and has abuse potential similar to that of schedule IV sedatives, such as suvorexant and zolpidem, which were used as positive controls in the study.
DEA asserts that when the evidence of actual abuse is not available, both HHS
and DEA rely upon data from preclinical and clinical studies to inform determinations on potential for abuse of a given substance. Therefore, upon evaluation of the above-mentioned clinical studies and other preclinical data, DEA concurred with HHS
findings that the abuse liability of
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lemborexant is similar to other substances placed in schedule IV i.e., benzodiazepines, barbiturates, and muscle relaxants and therefore supportedand continues to support through this final ruleplacement of lemborexant in schedule IV.
Finally, we address the commenters claim that the control of lemborexant is improper because there is another substance, that is not controlled, which the commenter asserts has similar pharmacological properties to those of lemborexant. DEA contends that while both drugs are classified as sedatives with similar FDA-approved indications, they do not share the same pharmacological mechanism of action or abuse liability. Even assuming this assertion were correct, this is not a legal basis to decline to control a substance.
The CSA does not require, as a condition of control under 21 U.S.C.
811, that every other substance with similar properties be simultaneously controlled.
Based on the rationale set forth in the interim final rule, DEA adopts the interim final rule without change.
Requirements for Handling Lemborexant As indicated above, lemborexant has been a schedule IV controlled substance by virtue of the interim final rule issued by DEA in April 2020. Thus, this final rule does not alter the regulatory requirements applicable to handlers of lemborexant that have been in place since that date. Nonetheless, for informational purposes, we re-state here those requirements. Lemborexant 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, 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 lemborexant, or who desires to handle lemborexant, 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 lemborexant, and is not registered with DEA, must submit an application for registration and may not handle lemborexant, unless DEA
approves that application for
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registration, pursuant to 21 U.S.C. 822, 823, 957, and 958, and in accordance with 21 CFR parts 1301 and 1312.
2. Disposal of stocks. Any person who obtains a schedule IV registration to handle lemborexant but who subsequently does not desire or is not able to maintain such registration must surrender all quantities of lemborexant, or may transfer all quantities of lemborexant to a person registered with DEA in accordance with 21 CFR part 1317, in addition to all other applicable Federal, State, local, and tribal laws.
3. Security. Lemborexant is subject to schedule IIIV security requirements and must be handled and stored in accordance with 21 CFR 1301.71
1301.93. Non-practitioners handling lemborexant 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 lemborexant must comply with 21 U.S.C. 825 and 958f, and be in accordance with 21 CFR part 1302.
5. Inventory. Every DEA registrant who possesses any quantity of lemborexant was required to keep an inventory of lemborexant on hand, as of April 7, 2020, pursuant to 21 U.S.C. 827
and 958e, 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 lemborexant, or products containing lemborexant, pursuant to 21 U.S.C. 827 and 958f, and in accordance with 21 CFR parts 1304, 1312, and 1317.
7. Prescriptions. All prescriptions for lemborexant or products containing lemborexant 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 lemborexant 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 lemborexant 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 lemborexant not authorized by, or in
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