Schedules of Controlled Substances: Placement of Mesocarb in Schedule I, 71247-71250 [2022-25219]

Agencies

• Drug Enforcement Administration
• Department of Justice

[Federal Register Volume 87, Number 224 (Tuesday, November 22, 2022)]
[Rules and Regulations]
[Pages 71247-71250]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-25219]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-397]


Schedules of Controlled Substances: Placement of Mesocarb in 
Schedule I

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: With the issuance of this final rule, the Drug Enforcement 
Administration places mesocarb (chemical name: N-phenyl-N' -(3-(1-
phenylpropan-2-yl)-1,2,3-oxadiazol-3-ium-5-yl)carbamimidate), including 
its salts, isomers, and salts of isomers, in schedule I of the 
Controlled Substances Act. This action is being taken to enable the 
United States to meet its obligations under the 1971 Convention on 
Psychotropic Substances. This action imposes the regulatory controls 
and administrative, civil, and criminal sanctions applicable to 
schedule I controlled substances on persons who handle (manufacture, 
distribute, import, export, engage in research, conduct instructional 
activities or chemical analysis with, or possess), or propose to handle 
mesocarb.

DATES: Effective date: December 22, 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: 

Legal Authority

    The United States is a party to the 1971 United Nations Convention 
on Psychotropic Substances (1971 Convention), February 21, 1971, 32 
U.S.T. 543, 1019 U.N.T.S. 175, as amended. Procedures respecting 
changes in drug schedules under the 1971 Convention are governed 
domestically by 21 U.S.C. 811(d)(2)--(4). When the United States 
receives notification of a scheduling decision pursuant to Article 2 of 
the 1971 Convention adding a drug or other substance to a specific 
schedule, the Secretary of the Department of Health and Human Services 
(HHS),\1\ after consultation with the Attorney General, shall first 
determine whether existing legal controls under subchapter I of the 
Controlled Substances Act (CSA) and the Federal Food, Drug, and 
Cosmetic Act meet the requirements of the schedule specified in the 
notification with respect to the specific drug or substance.\2\ Based 
on those determinations, as appropriate, the Secretary of HHS 
(Secretary) shall recommend to the Attorney General that he initiate 
proceedings for scheduling the drug or substance pursuant to 21 U.S.C. 
811(a) and (b).\3\ The CSA also

[[Page 71248]]

stipulates that in certain circumstances where the permanent section 
811(a) scheduling will not be completed in time as required by the 1971 
Convention, the Attorney General shall, after satisfying other 
specified conditions, issue a temporary order controlling the drug or 
substance under schedule IV or V, whichever is most appropriate to 
carry out the minimum United States obligations under the 1971 
Convention.\4\
---------------------------------------------------------------------------

    \1\ As discussed in a memorandum of understanding entered into 
by the Food and Drug Administration (FDA) and the National Institute 
on Drug Abuse (NIDA), FDA acts as the lead agency within HHS in 
carrying out the Secretary's scheduling responsibilities under the 
CSA, with the concurrence of NIDA. 50 FR 9518 (March 8, 1985). The 
Secretary of HHS has delegated to the Assistant Secretary for Health 
of HHS the authority to make domestic drug scheduling 
recommendations. 58 FR 35460 (July 1, 1993).
    \2\ 21 U.S.C. 811(d)(3).
    \3\ Id.
    \4\ 21 U.S.C. 811(d)(4)(A).
---------------------------------------------------------------------------

    In the event that the Secretary did not so consult with the 
Attorney General to make a determination about the existing legal 
controls, and the Attorney General did not issue a temporary order, the 
procedures for permanent scheduling are set forth in 21 U.S.C. 811(a) 
and (b). Pursuant to 21 U.S.C. 811(a)(1), the Attorney General may, by 
rule, add to such a schedule or transfer between such schedules any 
drug or other substance, if he finds that such 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) for the schedule 
in which such drug or other substance is to be placed. The Attorney 
General has delegated this scheduling authority to the Administrator of 
the Drug Enforcement Administration (Administrator).\5\
---------------------------------------------------------------------------

    \5\ 28 CFR 0.100.
---------------------------------------------------------------------------

Background

    Mesocarb (chemical name: N-phenyl-N' -(3-(1-phenylpropan-2-yl)-
1,2,3-oxadiazol-3-ium-5-yl)carbamimidate) is a central nervous system 
(CNS) stimulant.
    At its 38th session (March 1995), the United Nations Commission on 
Narcotic Drugs added mesocarb to Schedule IV of the 1971 Convention, 
thus notifying all parties to the 1971 Convention.

DEA and HHS Eight Factor Analyses

    On April 3, 2012, in accordance with 21 U.S.C. 811(b), and in 
response to the Drug Enforcement Administration's (DEA) August 12, 2008 
request, HHS provided to DEA a scientific and medical evaluation and a 
scheduling recommendation for mesocarb. DEA subsequently reviewed HHS' 
evaluation and recommendation for schedule I placement and all other 
relevant data and conducted its own analysis under the eight factors 
stipulated in 21 U.S.C. 811(c). DEA found, under 21 U.S.C. 812(b)(1), 
that this substance warrants control in schedule I. Both DEA and HHS 
analyses are available in their entirety under ``Supporting and Related 
Material'' of the public docket for this rule at https://www.regulations.gov under docket number DEA-397.

Notice of Proposed Rulemaking To Schedule Mesocarb

    On August 11, 2021, DEA published a notice of proposed rulemaking 
(NPRM) entitled ``Schedules of Controlled Substances: Placement of 
mesocarb in schedule I.'' \6\ The NPRM provided an opportunity for 
interested persons to file a request for a hearing in accordance with 
DEA regulations on or before September 10, 2021. No requests for such a 
hearing were received by DEA. The NPRM also provided an opportunity for 
interested persons to submit comments on the proposed rule on or before 
October 12, 2021.
---------------------------------------------------------------------------

    \6\ 86 FR 43978.
---------------------------------------------------------------------------

Comments Received

    DEA received two comments on the proposed rule to control mesocarb 
in schedule I of the CSA.
    Support for rulemaking: One commenter supported the placement of 
mesocarb in schedule I due to the continued abuse of controlled 
substances.
    DEA Response: DEA appreciates the comment in support of this 
rulemaking.
    Opposition to rulemaking: One commenter opposed the placement of 
mesocarb in schedule I by suggesting it be placed in schedule II due to 
the infrequent use in the United States and its availability and use in 
other countries.
    DEA Response: DEA does not agree. DEA is not aware of any 
availability or source of mesocarb in the United States, and the 
commenter did not provide any evidence of its use in the United States. 
As discussed in HHS's eight-factor analysis, mesocarb is not approved 
by the United States Food and Drug Administration (FDA) for use in the 
United States. As explained in the NPRM, the medical and scientific 
evaluation and scheduling recommendation issued by the Assistant 
Secretary for Health of HHS (Assistant Secretary) concludes that 
mesocarb has no currently accepted medical use in treatment in the 
United States and lacks accepted safety for use under medical 
supervision.
    In addition, DEA conducted an eight-factor analysis pursuant to 21 
U.S.C. 811(c), and based its scheduling determination on a 
comprehensive evaluation of all available data. As stated in the NPRM, 
after careful review of all data, DEA concurred with HHS' assessment 
that mesocarb has a high potential for abuse with no currently accepted 
medical use in treatment in the United States and lacks accepted safety 
for use under medical supervision. Congress established only one 
schedule, schedule I, for drugs of abuse with ``no currently accepted 
medical use in treatment in the United States'' and ``lack of accepted 
safety for use under medical supervision.'' \7\ The other four 
schedules require the drug or other substance to have a currently 
accepted medical use in treatment in the United States or a currently 
accepted medical use with severe restrictions (schedule II) or a 
currently accepted medical use in treatment in the United States 
(schedules III through V).\8\ DEA is therefore promulgating this final 
rule placing mesocarb in schedule I under the CSA.
---------------------------------------------------------------------------

    \7\ 21 U.S.C. 812(b).
    \8\ Id.
---------------------------------------------------------------------------

Scheduling Conclusion

    After consideration of the public comments, the scientific and 
medical evaluation and accompanying recommendation of HHS, and 
conducting an independent eight-factor analysis, DEA finds substantial 
evidence of potential for abuse of mesocarb. As such, DEA is 
permanently scheduling mesocarb as a controlled substance under the 
CSA.

Determination of Appropriate Schedule

    The CSA establishes five schedules of controlled substances known 
as schedules I, II, III, IV, and V.\9\ The CSA also outlines the 
findings required to place a drug or other substance in any particular 
schedule.\10\ After consideration of the analysis and recommendation of 
the Assistant Secretary and review of all other available data, the 
Administrator, pursuant to 21 U.S.C. 811(a) and 812(b)(1), finds that:
---------------------------------------------------------------------------

    \9\ 21 U.S.C. 812(a).
    \10\ 21 U.S.C. 812(b).
---------------------------------------------------------------------------

    (1) Mesocarb has a high potential for abuse. This potential is 
comparable to certain schedule II substances (e.g., methamphetamine or 
amphetamine);
    (2) Mesocarb has no currently accepted medical use in treatment in 
the United States; \11\ and
---------------------------------------------------------------------------

    \11\ Although there is no evidence suggesting that mesocarb has 
a currently accepted medical use in treatment in the United States, 
it bears noting that a drug cannot be found to have such medical use 
unless DEA concludes that it satisfies a five-part test. 
Specifically, with respect to a drug that has not been approved by 
FDA, to have a currently accepted medical use in treatment in the 
United States, all of the following must be demonstrated: i. the 
drug's chemistry must be known and reproducible; ii. there must be 
adequate safety studies; iii. there must be adequate and well-
controlled studies proving efficacy; iv. the drug must be accepted 
by qualified experts; and v. the scientific evidence must be widely 
available. 57 FR 10499 (1992), pet. for rev. denied, Alliance for 
Cannabis Therapeutics v. DEA, 15 F.3d 1131, 1135 (D.C. Cir. 1994).

---------------------------------------------------------------------------

[[Page 71249]]

    (3) There is a lack of accepted safety for use of mesocarb under 
medical supervision.
    Based on these findings, the Administrator concludes that mesocarb, 
including its salts, isomers, and salts of isomers, warrants control in 
schedule I of the CSA.\12\
---------------------------------------------------------------------------

    \12\ 21 U.S.C. 812(b)(1).
---------------------------------------------------------------------------

Requirements for Handling Mesocarb

    Effective as of December 22, 2022, mesocarb will be subject to the 
CSA's schedule I regulatory controls and administrative, civil, and 
criminal sanctions applicable to the manufacture, distribution, 
dispensing, importing, exporting, research, and conduct of 
instructional activities, including the following:
    1. Registration. Any person who handles (manufactures, distributes, 
imports, exports, engages in research, or conducts instructional 
activities or chemical analysis with, or possesses) mesocarb, or who 
desires to handle mesocarb, 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 handles 
mesocarb and is not registered with DEA must submit an application for 
registration and may not continue to handle mesocarb after the 
effective date of this rule, 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.
    2. Disposal of stocks. Any person unwilling or unable to obtain a 
schedule I registration must surrender all quantities of mesocarb as of 
the effective date of this rule, or may transfer all such quantities of 
mesocarb to a person registered with DEA. Mesocarb is required to be 
disposed of in accordance with 21 CFR part 1317, in addition to all 
other applicable Federal, State, local, and tribal laws.
    3. Security. Mesocarb is subject to schedule I security 
requirements and must be handled and stored pursuant to 21 U.S.C. 821 
and 823 and in accordance with 21 CFR parts 1301.71-1301.76. Non-
practitioners handling mesocarb must also comply with the employee 
screening requirements of 21 CFR parts 1301.90-1301.93.
    4. Labeling and Packaging. All labels, labeling, and packaging for 
commercial containers of mesocarb must comply with 21 U.S.C. 825 and be 
in accordance with 21 CFR part 1302.
    5. Quota. Only registered manufacturers are permitted to 
manufacture mesocarb in accordance with a quota assigned pursuant to 21 
U.S.C. 826 and in accordance with 21 CFR part 1303.
    6. Inventory. Every DEA registrant who possesses any quantity of 
mesocarb must take an inventory of mesocarb on hand pursuant to 21 
U.S.C. 827, and in accordance with 21 CFR parts 1304.03, 1304.04, and 
1304.11(a) and (d).
    Any person who registers with DEA must take an initial inventory of 
all stocks of controlled substances (including mesocarb) on hand on the 
date the registrant first engages in the handling of controlled 
substances, pursuant to 21 U.S.C. 827, 958, and in accordance with 21 
CFR parts 1304.03, 1304.04, and 1304.11(a) and (b).
    After the initial inventory, every DEA registrant must take an 
inventory of all controlled substances (including mesocarb) on hand 
every two years, pursuant to 21 U.S.C. 827, and in accordance with 21 
CFR parts 1304.03, 1304.04, and 1304.11.
    7. Records and Reports. Every DEA registrant must maintain records 
and submit reports with respect to mesocarb, pursuant to 21 U.S.C. 827, 
and in accordance with 21 CFR 1301.74(b) and (c) and 1301.76(b), and 
parts 1304, 1312, and 1317. Manufacturers and distributors must submit 
reports regarding mesocarb to the Automation of Reports and 
Consolidated Order System pursuant to 21 U.S.C. 827 and in accordance 
with 21 CFR parts 1304 and 1312.
    8. Order Forms. Every DEA registrant who distributes or orders 
mesocarb must comply with the order form requirements, pursuant to 21 
U.S.C. 828 and in accordance with 21 CFR part 1305.
    9. Importation and Exportation. All importation and exportation of 
mesocarb must comply with 21 U.S.C. 952, 953, 957, and 958, and in 
accordance with 21 CFR part 1312.
    10. Liability. Any activity involving mesocarb 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

Executive Orders 12866 (Regulatory Planning and Review) and 13563 
(Improving Regulation and Regulatory Review)

    In accordance with 21 U.S.C. 811(a), this final 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 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 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. 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 Administrator, in accordance with the Regulatory Flexibility 
Act, 5 U.S.C. 601-612, has reviewed this final rule and by approving it 
certifies that it will not have a significant economic impact on a 
substantial number of small entities.
    DEA is placing the substance mesocarb, including its salts, 
isomers, and salts of isomers, in schedule I of the CSA. This action is 
being taken to enable the United States to meet its obligations under 
the 1971 Convention. This action imposes the regulatory controls and 
administrative, civil, and criminal sanctions applicable to schedule I 
controlled substances on persons who handle (manufacture, distribute, 
reverse distribute, import, export, engage in research, conduct 
instructional activities or chemical

[[Page 71250]]

analysis with, or possess) mesocarb, or propose to handle mesocarb.
    Based on the review of HHS' scientific and medical evaluation and 
all other relevant data, DEA determined that mesocarb has a high 
potential for abuse, has no currently accepted medical use in treatment 
in the United States, and lacks accepted safety for use under medical 
supervision. DEA's research confirms that there is no legitimate 
commercial market for mesocarb in the United States. Therefore, DEA 
estimates that no United States entity currently handles mesocarb and 
does not expect any United States entity to handle mesocarb in the 
foreseeable future. DEA concludes that no legitimate United States 
entity would be affected by this rule. As such, this rule will not have 
a significant effect on a substantial number of small entities.

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 and certifies 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.

Signing Authority

    This document of the Drug Enforcement Administration was signed on 
November 14, 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.

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 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.


0
2. Amend Sec.  1308.11 by redesignating paragraphs (f)(7) through (10) 
as paragraphs (f)(8) through (11) and adding a new paragraph (f)(7) to 
read as follows:


Sec.  1308.11  Schedule I.

* * * * *
    (f) * * *

(7) Mesocarb (N-phenyl-N '-(3-(1-phenylpropan-2-yl)-                1227
 1,2,3-oxadiazol-3-ium-5-yl)carbamimidate)..............
 

* * * * *

Scott Brinks,
Federal Register Liaison Officer, Drug Enforcement Administration.
[FR Doc. 2022-25219 Filed 11-21-22; 8:45 am]
BILLING CODE 4410-09-P