Rule2022-13538
Schedules of Controlled Substances: Placement of Serdexmethylphenidate 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
June 24, 2022
Effective
July 25, 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 May 7, 2021, placing serdexmethylphenidate, including its salts, isomers, and salts of isomers, in schedule IV of the Controlled Substances Act.
Full Text
<html>
<head>
<title>Federal Register, Volume 87 Issue 121 (Friday, June 24, 2022)</title>
</head>
<body><pre>
[Federal Register Volume 87, Number 121 (Friday, June 24, 2022)]
[Rules and Regulations]
[Pages 37733-37735]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-13538]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-808]
Schedules of Controlled Substances: Placement of
Serdexmethylphenidate in Schedule IV
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This final rule adopts, without change, an interim final rule
with request for comments published in the Federal Register on May 7,
2021, placing serdexmethylphenidate, including its salts, isomers, and
salts of isomers, in schedule IV of the Controlled Substances Act.
DATES: Effective July 25, 2022.
FOR FURTHER INFORMATION CONTACT: Dr. Terrence L. Boos, Drug and
Chemical Evaluation Section, Diversion Control Division, Drug
Enforcement Administration; Telephone: (571) 362-3249.
SUPPLEMENTARY INFORMATION: This final rule refers to the single entity,
serdexmethylphenidate. The chloride salt of serdexmethylphenidate is
chemically known as 3-[[[(1S)-1-carboxy-2-hydroxyethyl]-
amino]carbonyl]-1-[[[[(2R)-2-[(1R)-2-methoxy-2-oxo-1-phenylethyl]-1-
piperidinyl]carbonyl]oxy]methyl]pyridinium chloride. This rule
maintains the placement of serdexmethylphenidate, including its salts,
isomers, and salts of isomers, in schedule IV of the Controlled
Substances Act (CSA), thereby facilitating the commercial distribution
of AZSTARYS as a controlled substance.
Background and Legal Authority
Under the 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 March 2, 2021, DEA received notification that the United States
Food and Drug Administration approved, on that same date, a new drug
application for AZSTARYS capsules for oral use, a combination drug
product containing serdexmethylphenidate chloride (3-[[[(1S)-1-carboxy-
2-hydroxyethyl]-amino]carbonyl]-1-[[[[(2R)-2-[(1R)-2-methoxy-2-oxo-1-
phenylethyl]-1-piperidinyl]carbonyl]oxy]methyl]pyridinium chloride) and
dexmethylphenidate hydrochloride, for the treatment of Attention
Deficit Hyperactivity Disorder in patients six years of age or older.
In addition, on that same date, HHS recommended that DEA place
serdexmethylphenidate in schedule IV of the CSA. On May 7, 2021, DEA,
pursuant to 21 U.S.C. 811(j), published an IFR to place
serdexmethylphenidate (including its salts, isomers, and salts of
isomers) in schedule IV. 86 FR 24487. The IFR provided an opportunity
for interested persons to submit comments, as well as file a request
for hearing or waiver of hearing, on or before June 7, 2021. DEA did
not receive any requests for hearing or waiver of hearing.
Comments Received
In response to the IFR, DEA received seven comments. The
submissions were from individuals or anonymous commenters. Four of the
seven commenters were in support of the IFR to place
serdexmethylphenidate in schedule IV of the CSA and one commenter was
opposed to the placement of serdexmethylphenidate in schedule IV of the
CSA. Of the two remaining comments, one had no relevant content and the
other was against the scheduling of drugs in general and did not
specifically comment on serdexmethylphenidate. This latter commenter
associated the scheduling of substances with the ``war on drugs,''
which according to the commenter ``has failed.'' No response is
necessary for the former comment and the latter comment is outside the
scope of this current scheduling action and, therefore, these comments
will not be addressed.
Support of the Interim Final Rule
Four commenters supported controlling serdexmethylphenidate as a
schedule IV controlled substance. These commenters indicated support
for scheduling serdexmethylphenidate under the CSA due to its
similarity to phentermine, a schedule IV substance. Three of the
commenters also recommended monitoring serdexmethylphenidate for
increased public health risk or undertaking more clinical research to
determine its long-term effects, but did not specify who should perform
this monitoring or research. One of these commenters expressed concern
about the misuse, including overprescribing, and abuse of stimulant
medications in general, and believes that additional prevention
measures are needed besides just placing the drug in schedule IV.
DEA Response. DEA appreciates the support for this rulemaking. The
requests for additional research or prevention measures suggested by
the commenters are outside of DEA's purview. Therefore, DEA has no
response to these requests.
Opposition to the Interim Final Rule
One commenter opposed the IFR to control serdexmethylphenidate as a
schedule IV drug. The commenter's primary issue with the scheduling of
serdexmethylphenidate was that, as a new drug, there was no documented
evidence of abuse potential. While the commenter did not completely
disagree with the placement of serdexmethylphenidate in schedule IV,
the commenter suggested that DEA should ``let scientists experiment
with it first to determine if it has any beneficial use'' or if
serdexmethylphenidate is more effective for controlling Attention
Deficit Hyperactivity Disorder compared to current drug treatments.
Thus, the commenter thought DEA should only schedule
serdexmethylphenidate if problems occur. The commenter also referred to
ongoing clinical studies for
[[Page 37734]]
use of this substance in the treatment of Stimulant Use Disorder and
the potential for future expansion of its use.
DEA Response: Scheduling a drug does not preclude its use as a
therapeutic medication. Substances are scheduled to protect the public
health and safety. In addition, substances that are scheduled are
subject to regulatory controls and administrative, civil, and criminal
sanctions of the schedule that it is placed to allow an adequate supply
of controlled substances while preventing those substances from being
diverted for illicit purposes. Thus, pursuant to 21 U.S.C. 811(a), the
CSA authorizes the Administrator of DEA, under authority delegated by
the Attorney General, to control any drug or other substance if it is
found that the drug or other substance has a potential for abuse, and
makes with respect to such drug or other substance the findings
prescribed by 21 U.S.C. 812(b). As discussed in the IFR, after
considering the eight factors in 21 U.S.C. 811(c), including
consideration of the substance's abuse potential based upon the
available information and all relevant data, DEA concluded that
serdexmethylphenidate warranted control in schedule IV of the CSA.
The commenter's reference to ongoing clinical studies investigating
the usefulness of serdexmethylphenidate in stimulant use disorder and
its future therapeutic potential is not relevant. DEA continues to
support through this final rule its scheduling determination, and
adopts the IFR, without change.
Requirements for Handling Serdexmethylphenidate
As indicated above, serdexmethylphenidate has been a schedule IV
controlled substance by virtue of an IFR issued by DEA in May 2021.
Thus, this final rule does not alter the regulatory requirements
applicable to handlers of serdexmethylphenidate that have been in place
since that time. Nonetheless, for informational purposes, we restate
here those requirements. Serdexmethylphenidate is subject to the CSA's
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 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, serdexmethylphenidate, 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 serdexmethylphenidate, and is
not registered with DEA, must submit an application for registration
and may not handle serdexmethylphenidate unless DEA approves that
application for registration, 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 serdexmethylphenidate pursuant to a lawful
prescription.
2. Disposal of stocks. Any person who obtains a schedule IV
registration to handle serdexmethylphenidate but who subsequently does
not desire or is not able to maintain such registration must surrender
all quantities of serdexmethylphenidate or may transfer all quantities
of serdexmethylphenidate to a person registered with DEA in accordance
with 21 CFR part 1317, in additional to all other applicable Federal,
State, local, and tribal laws.
3. Security. Serdexmethylphenidate 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 serdexmethylphenidate 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
serdexmethylphenidate pursuant to a lawful prescription.
4. Labeling and Packaging. All labels, labeling, and packaging for
commercial containers of serdexmethylphenidate 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
serdexmethylphenidate was required to keep an inventory of
serdexmethylphenidate on hand, as of May 7, 2021, pursuant to 21 U.S.C.
827 and 958, 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 serdexmethylphenidate pursuant to a lawful
prescription.
6. Records and Reports. DEA registrants must maintain records and
submit reports for serdexmethylphenidate, pursuant to 21 U.S.C. 827 and
832(a), and in accordance with 21 CFR 1301.74(b) and (c) and parts
1304, 1312, and 1317.
7. Prescriptions. All prescriptions for serdexmethylphenidate, or
products containing serdexmethylphenidate, 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
serdexmethylphenidate may only be for the legitimate purposes
consistent with the drug's labeling, or for research activities
authorized by the Federal Food and Drug Cosmetic Act and the CSA.
9. Importation and Exportation. All importation and exportation of
serdexmethylphenidate 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 serdexmethylphenidate 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 (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) 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 May 7, 2021, 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 comments submitted by the public
and issuing the final rule, in accordance with 21 U.S.C. 811(j).
[[Page 37735]]
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 final 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 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. This action would not impose recordkeeping or reporting
requirements on State or local governments, individuals, businesses, or
organizations. An agency may not conduct or sponsor, and a person is
not required to respond to, a collection of information unless it
displays a currently valid OMB control number.
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 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.
Signing Authority
This document of the Drug Enforcement Administration was signed on
June 21, 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.
0
Accordingly, the interim final rule amending 21 CFR part 1308, which
published on May 7, 2021 (86 FR 24487), is adopted as a final rule
without change.
Scott Brinks,
Federal Register Liaison Officer, Drug Enforcement Administration.
[FR Doc. 2022-13538 Filed 6-23-22; 8:45 am]
BILLING CODE 4410-09-P
</pre></body>
</html>Indexed from Federal Register on June 24, 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.