Rule2022-21253
Schedules of Controlled Substances: Placement of Daridorexant in Schedule IV
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
September 30, 2022
Effective
October 31, 2022
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
This final rule adopts without change an interim final rule with request for comments published in the Federal Register on April 7, 2022, placing daridorexant ([(S)-2-(5-chloro-4-methyl-1H- benzo[d]imidazol-2-yl)-2-methylpyrrolidin-1-yl](5-methoxy-2-(2H-1,2,3- triazol-2-yl)phenyl)methanone), including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of such isomers is possible, in schedule IV of the Controlled Substances Act (CSA). With the issuance of this final rule, the Drug Enforcement Administration maintains daridorexant in schedule IV of the CSA.
Full Text
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<title>Federal Register, Volume 87 Issue 189 (Friday, September 30, 2022)</title>
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[Federal Register Volume 87, Number 189 (Friday, September 30, 2022)]
[Rules and Regulations]
[Pages 59296-59298]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-21253]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-949]
Schedules of Controlled Substances: Placement of Daridorexant in
Schedule IV
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Final rule.
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SUMMARY: This final rule adopts without change an interim final rule
with request for comments published in the Federal Register on April 7,
2022, placing daridorexant ([(S)-2-(5-chloro-4-methyl-1H-
benzo[d]imidazol-2-yl)-2-methylpyrrolidin-1-yl](5-methoxy-2-(2H-1,2,3-
triazol-2-yl)phenyl)methanone), including its salts, isomers, and salts
of isomers whenever the existence of such salts, isomers, and salts of
such isomers is possible, in schedule IV of the Controlled Substances
Act (CSA). With the issuance of this final rule, the Drug Enforcement
Administration maintains daridorexant in schedule IV of the CSA.
DATES: The effective date of this rulemaking is October 31, 2022.
FOR FURTHER INFORMATION CONTACT: Dr. Terrence L. Boos, Drug & Chemical
Evaluation Section, Diversion Control Division, Drug Enforcement
Administration; Telephone: (571) 362-3249.
SUPPLEMENTARY INFORMATION:
Background and Legal Authority
Under the Controlled Substances Act (CSA), as amended in 2015 by
the Improving Regulatory Transparency for New Medical Therapies Act
(section 2(b) of Pub. L. 114-89), when the Drug Enforcement
Administration (DEA) receives notification from the Department of
Health and Human Services (HHS) that the Secretary has approved a
certain new drug and HHS recommends control in the CSA schedule II-V,
DEA is required to issue an interim final rule (IFR), with opportunity
for public comment and to request a hearing, controlling the drug
within a specified 90-day timeframe and to subsequently issue a final
rule. 21 U.S.C. 811(j). When controlling a drug pursuant to subsection
(j), DEA must apply the scheduling criteria of 21 U.S.C. 811 (b)
through (d) and 812(b). 21 U.S.C. 811(j)(3).
On January 7, 2022, DEA received notification that the United
States Food and Drug Administration (FDA) approved, on the same date, a
new drug application (NDA) for QUVIVIQ (daridorexant) tablets for use
as a treatment of adult patients with insomnia, characterized by
difficulties with sleep onset and/or sleep maintenance. Daridorexant,
chemically known as [(S)-2-(5-chloro-4-methyl-1H-benzo[d]imidazol-2-
yl)-2-methylpyrrolidin-1-yl](5-methoxy-2-(2H-1,2,3-triazol-2-
yl)phenyl)methanone, is a new molecular entity (NME) with central
nervous system activity. Previously, on December 22, 2021, DEA received
HHS's recommendation that DEA place daridorexant and ``its salts'' in
schedule IV of the CSA, in the event that FDA approves the NDA for
daridorexant. On April 7, 2022, DEA, pursuant to 21 U.S.C. 811(j),
published an IFR (87 FR 20313) to place daridorexant (including its
salts, isomers, and salts of isomers) in schedule IV of the CSA; the
regulatory text only listed the chemical name for daridorexant. In the
preamble of the IFR, DEA incorrectly misspelled the proprietary name
for daridorexant's approved drug product as ``QUIVIVIQ.'' The preamble
of this final rule now correctly uses ``QUVIVIQ.'' It bears emphasis
that the regulatory text used in this final rule remains unchanged from
that used in the IFR.
The IFR provided an opportunity for interested persons to submit
comments, as well as to file a request for hearing or waiver of
hearing, on or before May 9, 2022. DEA did not receive any requests for
hearing or waivers of hearing.
Comment Received
In response to the IFR, DEA received one comment. The submission
was from an anonymous commenter. The commenter supported the placement
of daridorexant in schedule IV of the CSA, and noted its safety,
effectiveness, and approved indication for use as a treatment of
patients with insomnia.
DEA Response: DEA appreciates the support for this rulemaking.
Requirements for Handling Daridorexant
As indicated above, daridorexant has been a schedule IV controlled
substance by virtue of an IFR issued by DEA on April 7, 2022. Thus,
this final rule does not alter the regulatory requirements applicable
to handlers of daridorexant that have been in place since that time.
Nonetheless, for informational purposes, DEA restates here those
requirements. Daridorexant is subject to the CSA's schedule IV
regulatory controls and administrative, civil, and criminal sanctions
applicable to the
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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) daridorexant, or who desires to handle daridorexant, 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 daridorexant and is not
registered with DEA must submit an application for registration and may
not handle daridorexant unless DEA has approved that application,
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 daridorexant
pursuant to a lawful prescription.
2. Disposal of stocks. Any person who obtains a schedule IV
registration to handle daridorexant but who subsequently does not
desire or is not able to maintain such registration must surrender all
quantities of daridorexant, or may transfer all quantities of
daridorexant 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. Daridorexant is subject to schedule III-V security
requirements for DEA registrants and must be handled and stored in
accordance with 21 CFR 1301.71-1301.77. Non-practitioners handling
daridorexant 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 daridorexant pursuant to
a lawful prescription.
4. Labeling and Packaging. All labels, labeling, and packaging for
commercial containers of daridorexant must comply with 21 U.S.C. 825
and be in accordance with 21 CFR part 1302.
5. Inventory. Every DEA registrant who possesses any quantity of
daridorexant was required to keep an inventory of daridorexant on hand,
as of April 7, 2022, pursuant to 21 U.S.C. 827 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 daridorexant
pursuant to a lawful prescription.
6. Records and Reports. DEA registrants must maintain records and
submit reports for daridorexant, pursuant to 21 U.S.C. 827 and 832(a),
and in accordance with 21 CFR 1301.74(b) and (c) and 1301.76(b) and
parts 1304, 1312, and 1317.
7. Prescriptions. All prescriptions for daridorexant, or products
containing daridorexant, 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 daridorexant may
only be for the legitimate purposes consistent with the drug's
labeling, or for research activities authorized by the Federal Food,
Drug, and Cosmetic Act (FDCA), as applicable, and the CSA.
9. Importation and Exportation. All importation and exportation of
daridorexant must comply with 21 U.S.C. 952, 953, 957, and 958, and be
in accordance with 21 CFR part 1312.
10. Liability. Any activity involving daridorexant 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 adopts, without change, the amendment made by the
IFR that is already in effect. Section 553 of the Administrative
Procedure Act (APA) (5 U.S.C. 553) generally requires notice and
comment for rulemakings. However, 21 U.S.C. 811(j) provides that in
cases where a certain new drug is (1) approved by HHS, under section
505(c) of the FDCA and (2) HHS recommends control in CSA schedule II-V,
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 April 7, 2022, and solicited public
comments on that rule. Subsection (j) further states 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. 811(b) through (d) and 812(b). DEA is now responding to the
comment submitted by the public and issuing the final rule, in
accordance with 21 U.S.C. 811(j).
Executive Orders 12866 (Regulatory Planning and Review) and 13563
(Improving Regulation and Regulatory Review)
In accordance with 21 U.S.C. 811(a) 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 pursuant to
section 3(d)(1) 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 3(a) and 3(b)(2) 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.
Executive Order 13175, Consultation and Coordination With Indian Tribal
Governments
This final 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 Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612) applies to
rules that are subject to notice and comment under section 553(b) of
the APA. As noted in the above discussion regarding the applicability
of the APA, DEA was not required to publish a general notice
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of proposed rulemaking. Consequently, the RFA does not apply.
Unfunded Mandates Reform Act of 1995
In accordance with the Unfunded Mandates Reform Act (UMRA) of 1995,
2 U.S.C. 1501 et seq., DEA has determined that this action would not
result in any Federal mandate that may result ``in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any 1 year.'' Therefore, neither a Small Government
Agency Plan nor any other action is required under UMRA of 1995.
Paperwork Reduction Act of 1995
This action does not impose a new collection of information
requirement under the Paperwork Reduction Act of 1995. 44 U.S.C. 3501-
3521.
Congressional Review Act
This final rule is not a major rule as defined by the Congressional
Review Act (CRA), 5 U.S.C. 804. However, pursuant to the CRA, DEA is
submitting a copy of this final rule to the Government Accountability
Office, the House, and the Senate under the CRA.
Signing Authority
This document of the Drug Enforcement Administration was signed on
September 26, 2022, by Administrator Anne Milgram. That document with
the original signature and date is maintained by DEA. For
administrative purposes only, and in compliance with requirements of
the Office of the Federal Register, the undersigned DEA Federal
Register Liaison Officer has been authorized to sign and submit the
document in electronic format for publication, as an official document
of DEA. This administrative process in no way alters the legal effect
of this document upon publication in the Federal Register.
List of Subjects in 21 CFR Part 1308
Administrative practice and procedure, Drug traffic control,
Reporting and recordkeeping requirements.
PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES
0
Accordingly, the interim final rule (87 FR 20313) amending 21 CFR part
1308, which published on April 7, 2022, is adopted as a final rule
without change.
Scott Brinks,
Federal Register Liaison Officer, Drug Enforcement Administration.
[FR Doc. 2022-21253 Filed 9-29-22; 8:45 am]
BILLING CODE 4410-09-P
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</html>Indexed from Federal Register on September 30, 2022.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.