Rule2022-27400
Schedules of Controlled Substances: Removal of Fenfluramine From Control
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
December 23, 2022
Effective
December 23, 2022
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
With the issuance of this final rule, the Drug Enforcement Administration removes fenfluramine (chemical name: N-ethyl-[alpha]- methyl-3-(trifluoromethyl)phenethylamine), including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts is possible, from the schedules of the Controlled Substances Act. Prior to the effective date of this rule, fenfluramine was a schedule IV controlled substance. This action removes the regulatory controls and administrative, civil, and criminal sanctions applicable to controlled substances, including those specific to schedule IV controlled substances, on persons who handle (manufacture, distribute, reverse distribute, dispense, engage in research, import, export, conduct instructional activities or chemical analysis with, or possess) or propose to handle fenfluramine.
Full Text
<html>
<head>
<title>Federal Register, Volume 87 Issue 246 (Friday, December 23, 2022)</title>
</head>
<body><pre>
[Federal Register Volume 87, Number 246 (Friday, December 23, 2022)]
[Rules and Regulations]
[Pages 78857-78859]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-27400]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-945]
Schedules of Controlled Substances: Removal of Fenfluramine From
Control
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: With the issuance of this final rule, the Drug Enforcement
Administration removes fenfluramine (chemical name: N-ethyl-[alpha]-
methyl-3-(trifluoromethyl)phenethylamine), including its salts,
isomers, and salts of isomers whenever the existence of such salts,
isomers, and salts is possible, from the schedules of the Controlled
Substances Act. Prior to the effective date of this rule, fenfluramine
was a
[[Page 78858]]
schedule IV controlled substance. This action removes the regulatory
controls and administrative, civil, and criminal sanctions applicable
to controlled substances, including those specific to schedule IV
controlled substances, on persons who handle (manufacture, distribute,
reverse distribute, dispense, engage in research, import, export,
conduct instructional activities or chemical analysis with, or possess)
or propose to handle fenfluramine.
DATES: Effective December 23, 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:
Legal Authority
Under the Controlled Substances Act (CSA), each controlled
substance is classified into one of five schedules based upon its
potential for abuse, its currently accepted medical use in treatment in
the United States, and the degree of dependence the drug or other
substance may cause.\1\ The initial schedules of controlled substances
established by Congress are found at 21 U.S.C. 812(c) and the current
list of scheduled substances is published at 21 CFR part 1308.
---------------------------------------------------------------------------
\1\ 21 U.S.C. 812.
---------------------------------------------------------------------------
Pursuant to 21 U.S.C. 811(a)(2), the Attorney General may, by rule,
``remove any drug or other substance from the schedules if he finds
that the drug or other substance does not meet the requirements for
inclusion in any schedule.'' The Attorney General has delegated
scheduling authority under 21 U.S.C. 811 to the Administrator of the
Drug Enforcement Administration (DEA).\2\
---------------------------------------------------------------------------
\2\ 28 CFR 0.100.
---------------------------------------------------------------------------
The CSA provides that proceedings for the issuance, amendment, or
repeal of the scheduling of any drug or other substance may be
initiated by the Attorney General on the petition of any interested
party.\3\ This action was initiated by a petition to remove
fenfluramine from the list of scheduled controlled substances of the
CSA, and is supported by, inter alia, a recommendation from the
Assistant Secretary for Health of the Department of Health and Human
Services (HHS) and an evaluation of all relevant data by DEA. This
action removes the regulatory controls and administrative, civil, and
criminal sanctions applicable to controlled substances, including those
specific to schedule IV controlled substances, on persons who handle or
propose to handle fenfluramine.
---------------------------------------------------------------------------
\3\ 21 U.S.C. 811(a).
---------------------------------------------------------------------------
Background
Fenfluramine (chemical name: N-ethyl-[alpha]-methyl-3-
(trifluoromethyl)phenethylamine), including its salts, isomers, and
salts of such isomers, has been controlled under 21 CFR 1308.14(d) as a
schedule IV substance of the CSA since June 15, 1973.\4\ On September
25, 2019, Zogenix, Inc. (Zogenix; the Sponsor) submitted to the Food
and Drug Administration (FDA) a New Drug Application (NDA) for Fintepla
(fenfluramine), for the treatment of seizures associated with Dravet
syndrome (DS) in patients two years of age and older. FDA approved the
NDA on June 25, 2020, with the labelling listing fenfluramine as a
schedule IV controlled substance.
---------------------------------------------------------------------------
\4\ 38 FR 15719, May 9, 1973.
---------------------------------------------------------------------------
On October 18, 2018, Zogenix submitted to DEA a petition requesting
that fenfluramine be removed from schedule IV of the CSA. The petition
complied with the requirements of 21 CFR 1308.43(b) and DEA accepted
the petition for filing on November 13, 2018.
Notice of Proposed Rulemaking To Decontrol Fenfluramine
On July 19, 2022, DEA published a notice of proposed rulemaking
(NPRM) to remove fenfluramine from the schedules of the CSA.\5\ The
NPRM provided an opportunity for interested persons to file a request
for a hearing in accordance with DEA regulations by August 18, 2022. No
requests for such a hearing were received by DEA. The NPRM also
provided an opportunity for interested persons to submit comments on
the proposal on or before August 18, 2022.
---------------------------------------------------------------------------
\5\ 87 FR 42979.
---------------------------------------------------------------------------
Comment Received
DEA received one comment on the NPRM to remove fenfluramine from
control.
Opposition to rulemaking: One commenter opposed decontrol of
fenfluramine, however the comment was at times ambiguous. The commenter
seemed to be concerned about children using fenfluramine illicitly and
the potential harm related to the combined use with a stimulant,
specifically noting the fenfluramine-phentermine (``fen-phen'')
combination and noting ``Stimulants+Psychedelics=Psychosis.''
DEA Response: DEA acknowledges the commenter's concerns about
relative harm, especially related to children. DEA notes FDA approved
Fintepla (fenfluramine) on June 25, 2020, for the treatment of DS in
patients two years of age and older. Currently Fintepla is the only
FDA-approved drug product with fenfluramine. HHS considered the harms
the fenfluramine-phentermine combination produced in their April 2021
scientific and medical evaluation, which was provided to DEA as part of
this rulemaking process, pursuant to 21 U.S.C. 811(b).
DEA notes that the combination historically produced serious
cardiac effects, not psychological effects. The FDA-approved labeling
for Fintepla indicates that patients must be enrolled in the Fintepla
risk evaluation and mitigation strategy (REMS) program and undergo
cardiac monitoring before, during, and after treatment with Fintepla to
monitor for serious heart valve changes or high blood pressure in the
arteries of the lungs. The FDA-required REMS program for Fintepla,
including ongoing cardiac monitoring, would still be applicable under
the FDA rules even after fenfluramine is decontrolled by DEA.
Based on FDA's scientific and medical review of the eight factors
and findings related to the substance's abuse potential, legitimate
medical use, and dependence liability, HHS recommended that
fenfluramine and its salts be removed from all schedules of the CSA.
Pursuant to 21 U.S.C. 811(b), the recommendations of HHS shall be
binding on DEA as to such scientific and medical matters and if the
Secretary recommends that a drug or other substance not be controlled,
DEA shall not control the drug or other substances. As stated in the
NPRM, after careful review of all relevant data including HHS'
scientific and medical evaluation and scheduling recommendation, DEA is
therefore promulgating this final rule to remove fenfluramine,
including its salts, isomers, and salts of such isomers whenever the
existence of such salts, isomers, and salts of isomers is possible,
from control under the CSA.
Determination To Decontrol Fenfluramine
Based on consideration of the comment, and the rationale set forth
in the NPRM, the Administrator finds that fenfluramine does not meet
the requirements for inclusion in any schedule. As such, DEA is
removing fenfluramine, including its salts, isomers, and salts of such
isomers whenever the existence of such salts, isomers, and salts of
isomers is possible, from control under the CSA.
[[Page 78859]]
Regulatory Analyses
Executive Orders 12866 (Regulatory Planning and Review) and 13563
(Improving Regulation and Regulatory Review)
In accordance with 21 U.S.C. 811(a), this scheduling action is
subject to formal rulemaking procedures done ``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 criteria for
removing a drug or other substance from the list of controlled
substances. 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. This rule does not have substantial
direct effects on the States, on the relationship between the Federal
government and the States, or the distribution of power and
responsibilities among the various levels of government.
Executive Order 13175, Consultation and Coordination With Indian Tribal
Governments
This rule does not have tribal implications warranting the
application of E.O. 13175. This rule 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 Administrator, in accordance with the Regulatory Flexibility
Act (5 U.S.C. 601-612), has reviewed this rule and by approving it
certifies that it will not have a significant economic impact on a
substantial number of small entities. The purpose of this rule is to
remove fenfluramine from the list of schedules of the CSA. This action
will remove regulatory controls and administrative, civil, and criminal
sanctions applicable to controlled substances for handlers and proposed
handlers of fenfluramine. Accordingly, it has the potential for some
economic impact in the form of cost savings.
Fenfluramine as a pharmaceutical product (Fintepla) is currently
available and marketed in the U.S. Because fenfluramine is currently a
schedule IV drug, all legal handling of fenfluramine is currently done
under appropriate DEA license. In such instances, DEA's knowledge of
its registrant population forms the basis for estimating the number of
affected entities and small entities that are affected by this
rulemaking. There are currently 40 unique registrations authorized to
handle fenfluramine specifically, as well as a number of registered
analytical labs that are authorized to handle schedule IV controlled
substances generally. From review of entity names, DEA estimates these
40 registrations represent 27 entities. Some of these entities are
likely to be small entities. However, since DEA does not have
information of registrant size and the majority of DEA registrants are
small entities or are employed by small entities, DEA estimates a
maximum of 27 entities are small entities. Therefore, DEA
conservatively estimates as many as 27 small entities are affected by
this final rule. However, because this rule would remove fenfluramine
from regulatory controls of the CSA, it is likely to result in some
cost savings. Any person planning to handle fenfluramine will realize
cost savings in the form of saved DEA registration fees, and the
elimination of physical security, recordkeeping, and reporting
requirements. Because of these factors, DEA projects that this rule
will not result in a significant economic impact on a substantial
number of small entities.
Administrative Procedure Act
The Administrative Procedure Act requires the publication of a
substantive rule to be made not less than 30 days before its effective
date.\6\ However, this requirement need not apply for ``a substantive
rule which . . . relieves a restriction.'' \7\ Therefore, DEA makes
this rule effective immediately upon publication.
---------------------------------------------------------------------------
\6\ 5 U.S.C. 553(d).
\7\ 5 U.S.C. 553(d)(1).
---------------------------------------------------------------------------
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 the 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.
For the reasons set out above, 21 CFR part 1308 is amended to read
as follows:
PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES
0
1. The authority citation for 21 CFR part 1308 continues to read as
follows:
Authority: 21 U.S.C. 811, 812, 871(b), 956(b), unless otherwise
noted.
Sec. 1308.14 [Amended]
0
2. In Sec. 1308.14, remove and reserve paragraph (d).
Signing Authority
This document of the Drug Enforcement Administration was signed on
December 12, 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. 2022-27400 Filed 12-22-22; 8:45 am]
BILLING CODE 4410-09-P
</pre></body>
</html>Indexed from Federal Register on December 23, 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.