[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 [www.gpo.gov]
[FR Doc No: 2022-13538]


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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.

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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 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