[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 [www.gpo.gov]
[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.

[[Page 67550]]

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