Rule2022-24157
Schedules of Controlled Substances: Placement of Ganaxolone in Schedule V
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
November 9, 2022
Effective
December 9, 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 June 1, 2022, placing ganaxolone (3[alpha]-hydroxy-3[beta]-methyl-5[alpha]- pregnan-20-one) and its salts in schedule V of the Controlled Substances Act. With the issuance of this final rule, the Drug Enforcement Administration maintains ganaxolone, including its salts, in schedule V of the Controlled Substances Act.
Full Text
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<title>Federal Register, Volume 87 Issue 216 (Wednesday, November 9, 2022)</title>
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[Federal Register Volume 87, Number 216 (Wednesday, November 9, 2022)]
[Rules and Regulations]
[Pages 67548-67550]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-24157]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-990]
Schedules of Controlled Substances: Placement of Ganaxolone in
Schedule V
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 June 1,
2022, placing ganaxolone (3[alpha]-hydroxy-3[beta]-methyl-5[alpha]-
pregnan-20-one) and its salts in schedule V of the Controlled
Substances Act. With the issuance of this final rule, the Drug
Enforcement Administration maintains ganaxolone, including its salts,
in schedule V of the Controlled Substances Act.
DATES: The effective date of this rule is December 9, 2022.
FOR FURTHER INFORMATION CONTACT: Terrence L. Boos, Ph.D., Chief, Drug
and 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
(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 subsequently to 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 March 18, 2022, DEA received notification that FDA approved, on
that same date, a new drug application for ZTALMY (ganaxolone oral
suspension) for the treatment of seizures associated with cyclin-
dependent kinase-like 5 deficiency disorder in patients two years or
older. In addition, on March 14, 2022, HHS recommended that DEA place
ganaxolone and its salts in schedule V of the CSA. On June 1, 2022,
DEA, pursuant to 21 U.S.C. 811(j), published an IFR in the Federal
Register to make ganaxolone (including its salts) a schedule V
controlled substance. 87 FR 32991.
The IFR referenced two supporting documents and stated they were
available for viewing on the electronic docket. Specifically, the two
documents cited are as follows: (1) HHS's March 2022 scientific and
medical evaluation and scheduling recommendation (HHS Eight-Factor
analysis), and (2) DEA's May 2022 Eight-Factor analysis. DEA has
discovered that these documents were not posted to the electronic
docket. However, they were available for viewing at DEA headquarters.
Upon publication of this final rule, DEA will post to the docket DEA's
and HHS's analyses that should have accompanied the IFR.
The IFR provided an opportunity for interested persons to submit
comments, as well as file a request for a hearing or waiver of a
hearing, on or before July 1, 2022. DEA did not receive any comments or
requests for a hearing or
[[Page 67549]]
waiver of a hearing. Based on the rationale set forth in the IFR, DEA
adopts the IFR, without change.
Requirements for Handling Ganaxolone
As indicated above, ganaxolone has been a schedule V controlled
substance by virtue of an IFR issued by DEA in June 2022. Thus, this
final rule does not alter the regulatory requirements applicable to
handlers of ganaxolone that have been in place since that time.
Nonetheless, for informational purposes, we restate here those
requirements. Ganaxolone is subject to the CSA's schedule V 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 V
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, ganaxolone 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 ganaxolone and is not registered with DEA
must submit an application for registration and may not handle
ganaxolone 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 ganaxolone pursuant to a lawful
prescription.
2. Disposal of stocks. Any person who obtains a schedule V
registration to handle ganaxolone and subsequently determines they are
no longer willing or able to maintain such registration must surrender
all quantities of ganaxolone, or may transfer all quantities of
ganaxolone to a person registered with DEA. Ganaxolone must be disposed
of in accordance with 21 CFR part 1317, in addition to all other
applicable Federal, State, local, and tribal laws.
3. Security. Ganaxolone is subject to schedule III-V security
requirements for DEA registrants, and it must be handled and stored in
accordance with 21 CFR 1301.71-1301.77. Non-practitioners handling
ganaxolone 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 ganaxolone pursuant to a lawful
prescription.
4. Labeling and Packaging. All labels, labeling, and packaging for
commercial containers of ganaxolone must comply with 21 U.S.C. 825, and
be in accordance with 21 CFR part 1302.
5. Inventory. Since June 1, 2022, every DEA registrant who
possesses any quantity of ganaxolone was required to keep an inventory
of ganaxolone on hand, 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 ganaxolone
pursuant to a lawful prescription.
6. Records and Reports. DEA registrants must maintain records and
submit reports for ganaxolone, 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 ganaxolone, or products
containing ganaxolone, 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 V controlled substances,
such registrants should be advised that (consistent with the foregoing
considerations) any manufacturing or distribution of ganaxolone 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, as applicable, and the CSA.
9. Importation and Exportation. All importation and exportation of
ganaxolone 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 ganaxolone 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 the Administrative
Procedure Act (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
Federal Food, Drug, and Cosmetic Act, 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 June 1, 2022, 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. 811(b) through (d) and 812(b). As
stated above, DEA did not receive any comments or requests for a
hearing or waiver of a hearing. DEA is now 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. 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 (OMB)
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.
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Executive Order 13175, Consultation and Coordination With Indian Tribal
Governments
This 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 of
proposed rulemaking. Consequently, the RFA does not apply to this final
rule.
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.
Congressional Review Act
This 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 both Houses of Congress and to
the Comptroller General.
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
Accordingly, the interim final rule amending 21 CFR part 1308,
which published on June 1, 2022 (87 FR 32991), is adopted as a final
rule without change.
Signing Authority
This document of the Drug Enforcement Administration was signed on
November 1, 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.
Scott Brinks,
Federal Register Liaison Officer, Drug Enforcement Administration.
[FR Doc. 2022-24157 Filed 11-8-22; 8:45 am]
BILLING CODE 4410-09-P
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</html>Indexed from Federal Register on November 9, 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.