Rule2023-27292
Specific Listing for Three Currently Controlled Schedule I Substances
Primary source
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Published
December 13, 2023
Effective
December 13, 2023
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
The Drug Enforcement Administration (DEA) is establishing a specific listing and DEA Controlled Substances Code Number (drug code) for three substances: N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-butyl- 1H-indazole-3-carboxamide (also known as ADB-BUTINACA); 4-methyl-1- phenyl-2-(pyrrolidin-1-yl)pentan-1-one (also known as [alpha]-PiHP or alpha-PiHP); and 2-(methylamino)-1-(3-methylphenyl)propan-1-one (also known as 3-MMC or 3-methylmethcathinone) in schedule I of the Controlled Substances Act (CSA). Although ADB-BUTINACA, [alpha]-PiHP, and 3-MMC are not specifically listed in schedule I of the CSA with their own unique drug codes, they are schedule I controlled substances in the United States because they are positional isomers of AB-PINACA (controlled January 30, 2015), [alpha]-PHP (controlled July 18, 2019), and mephedrone (controlled as a hallucinogen July 9, 2012), respectively, each of which are schedule I hallucinogens. Therefore, DEA is simply amending the schedule I hallucinogenic substances list in its regulations to separately include ADB-BUTINACA, [alpha]-PiHP, and 3-MMC.
Full Text
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<title>Federal Register, Volume 88 Issue 238 (Wednesday, December 13, 2023)</title>
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[Federal Register Volume 88, Number 238 (Wednesday, December 13, 2023)]
[Rules and Regulations]
[Pages 86266-86268]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-27292]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-1222]
Specific Listing for Three Currently Controlled Schedule I
Substances
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Final rule.
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SUMMARY: The Drug Enforcement Administration (DEA) is establishing a
specific listing and DEA Controlled Substances Code Number (drug code)
for three substances: N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-butyl-
1H-indazole-3-carboxamide (also known as ADB-BUTINACA); 4-methyl-1-
phenyl-2-(pyrrolidin-1-yl)pentan-1-one (also known as [alpha]-PiHP or
alpha-PiHP); and 2-(methylamino)-1-(3-methylphenyl)propan-1-one (also
known as 3-MMC or 3-methylmethcathinone) in schedule I of the
Controlled Substances Act (CSA). Although ADB-BUTINACA, [alpha]-PiHP,
and 3-MMC are not specifically listed in schedule I of the CSA with
their own unique drug codes, they are schedule I controlled substances
in the United States because they are positional isomers of AB-PINACA
(controlled January 30, 2015), [alpha]-PHP (controlled July 18, 2019),
and mephedrone (controlled as a hallucinogen July 9, 2012),
respectively, each of which are schedule I hallucinogens. Therefore,
DEA is simply amending the schedule I hallucinogenic substances list in
its regulations to separately include ADB-BUTINACA, [alpha]-PiHP, and
3-MMC.
DATES: Effective December 13, 2023.
FOR FURTHER INFORMATION CONTACT: Dr. Terrence L. Boos, Drug and
Chemical Evaluation, Diversion Control Division, Drug Enforcement
Administration; Telephone: (571) 362-3249.
SUPPLEMENTARY INFORMATION:
ADB-BUTINACA Control
ADB-BUTINACA (also known as N-(1-amino-3,3-dimethyl-1-oxobutan-2-
yl)-1-butyl-1H-indazole-3-carboxamide) is a chemical substance that is
structurally related to AB-PINACA (also known as N-(1-amino-3-methyl-1-
oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide). AB-PINACA is listed
as a hallucinogenic substance in schedule I at 21 CFR 1308.11(d)(70).
The introductory text to paragraph (d) provides: (1) A listed substance
includes ``any of its salts, isomers, and salts of isomers whenever the
existence of such salts, isomers, and salts of isomers is possible
within the specific chemical designation,'' and (2) the term ``isomer''
includes the ``optical, position[al], and geometric isomers.''
When compared to the chemical structure of AB-PINACA, ADB-BUTINACA
meets the definition of a positional isomer in 21 CFR 1300.01(b), which
cross-references the term ``positional isomer'' in 21 CFR 1308.11(d).
Both AB-PINACA and ADB-BUTINACA possess the same molecular formula and
core structure, and they have the same functional groups. They only
differ from one another by a rearrangement of an alkyl moiety between
functional groups that does not create new chemical functionalities or
destroy existing chemical functionalities. Accordingly, under 21 CFR
1308.11(d), ADB-BUTINACA, as a positional isomer of AB-PINACA, has been
and continues to be a schedule I controlled substance.\1\
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\1\ AB-PINACA (and its isomers) has been subject to temporary
schedule I controls since January 30, 2015, first pursuant to a
final order (January 30, 2015, 80 FR 5042) and the subsequent one-
year extension of that order (January 27, 2017, 82 FR 8590), and
then permanently pursuant to a final rule, which continued the
imposition of those controls (October 16, 2017, 82 FR 47971).
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[alpha]-PiHP Control
[alpha]-PiHP (also known as 4-methyl-1-phenyl-2-(pyrrolidin-1-
yl)pentan-1-one or alpha-PiHP) is a chemical substance that is
structurally related to [alpha]-PHP (also known as 1-phenyl-2-
(pyrrolidin-1-yl)hexan-1-one). [alpha]-PHP is listed as a
hallucinogenic substance in schedule I at 21 CFR 1308.11(d)(95). When
compared to the chemical structure of [alpha]-PHP, [alpha]-PiHP meets
the definition of a positional isomer in 21 CFR 1300.01(b), which
cross-references the term ``positional isomer'' in 21 CFR 1308.11(d).
Both [alpha]-PHP and [alpha]-PiHP possess the same molecular formula
and core structure, and they have the same functional groups. They only
differ from one another by a rearrangement of an alkyl moiety that does
not create new chemical functionalities or destroy existing chemical
functionalities. Accordingly, under 21 CFR 1308.11(d), [alpha]-PiHP, as
a positional isomer of [alpha]-PHP, has been and continues to be a
schedule I controlled substance.\2\
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\2\ [alpha]-PHP (and its isomers) has been subject to temporary
schedule I controls since July 18, 2019, first pursuant to a
temporary scheduling order (July 18, 2019, 84 FR 34291) and the
subsequent one-year extension of that order (July 16, 2021, 86 FR
37672), and then permanently pursuant to a final rule which
continued the imposition of those controls (June 1, 2022, 87 FR
32996).
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3-MMC Control
3-MMC (also known 2-(methylamino)-1-(3-methylphenyl)propan-1-one or
3-methylmethcathinone) is a chemical substance that is structurally
related to mephedrone (also known as 4-methylmethcathinone). Mephedrone
is listed as a hallucinogenic substance in schedule I at 21 CFR
1308.11(d)(36). When compared to the chemical structure of mephedrone,
3-MMC meets the definition of a positional isomer in 21 CFR 1300.01(b),
which cross-references the term ``positional isomer'' in 21 CFR
1308.11(d). Both mephedrone and 3-MMC possess the same molecular
formula and core structure, and they have the same functional groups.
They only differ from one another by a repositioning of an alkyl
moiety. Accordingly, under 21 CFR 1308.11(d), 3-MMC, as a positional
isomer of mephedrone, has been and continues to be a schedule I
controlled substance.\3\
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\3\ Positional isomers of mephedrone have been subject to
permanent schedule I controls since July 9, 2012 (Synthetic Drug
Abuse Prevention Act of 2012 or SDAPA, Public Law 112-144, Title XI,
Subtitle D).
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The Drug Enforcement Administration's (DEA) Authority To Control ADB-
BUTINACA, [alpha]-PiHP, and 3-MMC
This rule is prompted by a letter dated May 17, 2023, in which the
United States government was informed by the Secretariat of the United
Nations that ADB-BUTINACA, [alpha]-PiHP, and 3-MMC have been added to
Schedule II of the Convention on Psychotropic Substances of 1971 (1971
Convention). This letter was prompted by decisions at the 66th Session
of the Commission on Narcotic Drugs (CND) in March 2023 to schedule
ADB-BUTINACA, [alpha]-PiHP, and 3-MMC under Schedule II of the 1971
[[Page 86267]]
Convention (CND Decisions 66/5, 66/6, and 66/7). Preceding these
decisions, the Food and Drug Administration (FDA), on behalf of the
Secretary of Health and Human Services and pursuant to 21 U.S.C.
811(d)(2), published two notices in the Federal Register with an
opportunity to submit domestic information and opportunity to comment
on this action (August 3, 2022, 87 FR 47428 and February 17, 2023, 88
FR 10344). In each instance, FDA noted that ADB-BUTINACA, [alpha]-PiHP,
and 3-MMC were already controlled in schedule I of the Controlled
Substances Act (CSA) as positional isomers of AB-PINACA, [alpha]-PHP,
and mephedrone, respectively, and the February 2023 notice stated that
no additional permanent controls for ADB-BUTINACA, [alpha]-PiHP, and 3-
MMC under the CSA would be necessary to fulfill United States'
obligations as a party to the 1971 Convention.
As discussed above in this final rule, ADB-BUTINACA--by virtue of
being a positional isomer of AB-PINACA--has been controlled in schedule
I of the CSA temporarily since January 30, 2015 (80 FR 5042), and
permanently since October 16, 2017 (82 FR 47971). [alpha]-PiHP, a
positional isomer of [alpha]-PHP, has been controlled in schedule I of
the CSA temporarily since July 18, 2019 (84 FR 34291), and permanently
since June 1, 2022 (87 FR 32996). 3-MMC, a positional isomer of
mephedrone, has been controlled in schedule I of the CSA permanently
since July 9, 2012 (Pub. L. 112-144, Title XI, Subtitle D). Therefore,
all regulations and criminal sanctions applicable to schedule I
substances have been and remain applicable to ADB-BUTINACA, [alpha]-
PiHP, and 3-MMC. Drugs controlled in schedule I of the CSA satisfy and
exceed the required domestic controls of Schedule II under Article 2 of
the 1971 Convention.
Effect of Action
As discussed above, this rule does not affect the continuing status
of ADB-BUTINACA, [alpha]-PiHP, and 3-MMC as schedule I controlled
substances in any way. This action, as an administrative matter, merely
establishes a separate, specific listing for ADB-BUTINACA, [alpha]-
PiHP, and 3-MMC in schedule I of the CSA and assigns a DEA controlled
substances code number (drug code) for these substances. This action
will allow DEA to establish an aggregate production quota and grant
individual manufacturing and procurement quotas to DEA-registered
manufacturers of ADB-BUTINACA, [alpha]-PiHP, or 3-MMC, who had
previously been granted individual quotas for such purposes under the
drug codes for AB-PINACA, [alpha]-PHP, or mephedrone.
Regulatory Analyses
Administrative Procedure Act
An agency may find good cause to exempt a rule from certain
provisions of the Administrative Procedure Act (APA) including notice
of proposed rulemaking and the opportunity for public comment, if it is
determined to be unnecessary, impracticable, or contrary to the public
interest (5 U.S.C. 553). ADB-BUTINACA, [alpha]-PiHP, and 3-MMC are
currently controlled in schedule I as positional isomers of AB-PINACA,
[alpha]-PHP, and mephedrone, respectively.
Pursuant to 5 U.S.C. 553(b) (B), DEA finds that notice and comment
rulemaking is unnecessary and that good cause exists to dispense with
these procedures. The addition of a separate listing for ADB-BUTINACA,
[alpha]-PiHP, and 3-MMC and their DEA controlled substances code
numbers in the list of schedule I substances in 21 CFR 1308.11(d) makes
no substantive difference in the status of these drugs as schedule I
controlled substances, but instead is ``a minor or merely technical
amendment in which the public is not particularly interested.''
National Nutritional Foods Ass'n v. Kennedy, 572 F.2d 377, 385 (2d Cir.
1978) (quoting S. Rep. No. 79-752, at 200 (1945)). See also Utility
Solid Waste Activities Group v. E.P.A., 236 F.3d 749, 755 (D.C. Cir.
2001) (the ``unnecessary'' prong ``is confined to those situations in
which the administrative rule is a routine determination, insignificant
in nature and impact, and inconsequential to the industry and public'')
(internal quotations and citation omitted). This rule is a ``technical
amendment'' to 21 CFR 1308.11(d) as it is ``insignificant in nature and
impact, and inconsequential to the industry and public.'' Therefore,
publishing a notice of proposed rulemaking and soliciting public
comment are unnecessary.
In addition, because ADB-BUTINACA, [alpha]-PiHP, and 3-MMC are
already subject to domestic control under schedule I as positional
isomers and no additional requirements are being imposed through this
action, DEA finds good cause exists to make this rule effective
immediately upon publication in accordance with 5 U.S.C. 553(d)(3). DEA
is concerned that delaying the effective date of this rule potentially
could cause confusion regarding the regulatory status of ADB-BUTINACA,
[alpha]-PiHP, and 3-MMC. ADB-BUTINACA, [alpha]-PiHP, and 3-MMC are
currently controlled as schedule I controlled substances, and this
level of control does not change with this rulemaking.
Executive Orders 12866 (Regulatory Planning and Review), 13563
(Improving Regulation and Regulatory Review), and 14094 (Modernizing
Regulatory Review)
This regulation has been drafted and reviewed in accordance with
the principles of Executive Orders (E.O.) 12866, 13563, and 14094. This
rule is not a significant regulatory action under section 3(f) of E.O.
12866. ADB-BUTINACA, [alpha]-PiHP, and 3-MMC are already controlled
substances in the United States under schedule I, as they are
positional isomers of schedule I hallucinogens AB-PINACA, [alpha]-PHP,
and mephedrone, respectively. In this final rule, DEA is merely making
an administrative change by amending its regulations to separately list
ADB-BUTINACA, [alpha]-PiHP, and 3-MMC in schedule I and to assign DEA
controlled substances code numbers to these substances. A separate
listing for ADB-BUTINACA, [alpha]-PiHP, and 3-MMC and their DEA
controlled substances code numbers will not alter the status of these
substances as a schedule I controlled substances. Accordingly, this
rule has not been reviewed by the Office of Management and Budget
(OMB).
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, 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.
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.
[[Page 86268]]
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 or other laws. As noted in the above section regarding the
applicability of the APA, DEA determined that there was good cause to
exempt this final rule from notice and comment. Consequently, the RFA
does not apply.
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.
Unfunded Mandates Reform Act of 1995
In accordance with the Unfunded Mandates Reform Act (UMRA) of 1995,
2 U.S.C. 1532, 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 rule to both Houses of Congress and to the
Comptroller General.
Signing Authority
This document of the Drug Enforcement Administration was signed on
December 7, 2023, 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.
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, DEA amends 21 CFR part 1308 as
follows:
PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES
0
1. The authority citation for 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 adding new paragraphs (d)(102) to (104) to
read as follows:
Sec. 1308.11 Schedule I.
* * * * *
(d) * * *
* * * * * * *
(102) N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-butyl-1H- 7027
indazole-3-carboxamide (other name: ADB-BUTINACA)...............
(103) 4-methyl-1-phenyl-2-(pyrrolidin-1-yl)pentan-1-one (other 7551
names: [alpha]-PiHP; alpha-PiHP)................................
(104) 2-(methylamino)-1-(3-methylphenyl)propan-1-one (other 1259
names: 3-MMC; 3-methylmethcathinone)............................
* * * * * * *
* * * * *
[FR Doc. 2023-27292 Filed 12-12-23; 8:45 am]
BILLING CODE 4410-09-P
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