Rule2025-19349
Specific Listing for 1-boc-4-piperidone, a Currently Controlled List I Chemical
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
October 2, 2025
Effective
October 2, 2025
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
The Drug Enforcement Administration (DEA) is establishing a specific listing and DEA Chemical Code Number for tert-butyl 4- oxopiperidine-1-carboxylate (also known as 1-boc-4-piperidone; and CAS Number: 79099-07-3) and its salts as a list I chemical under the Controlled Substances Act (CSA). Although 1-boc-4-piperidone is not specifically listed as a list I chemical of the CSA with its own unique Chemical Code Number, it has been regulated as a list I chemical in the United States as a carbamate of 4-piperidone, a list I chemical, since May 12, 2023. Therefore, DEA is simply amending the list of list I chemicals in its regulations to separately include 1-boc-4-piperidone.
Full Text
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<title>Federal Register, Volume 90 Issue 189 (Thursday, October 2, 2025)</title>
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[Federal Register Volume 90, Number 189 (Thursday, October 2, 2025)]
[Rules and Regulations]
[Pages 47563-47566]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-19349]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1310
[Docket No. DEA-1394]
Specific Listing for 1-boc-4-piperidone, a Currently Controlled
List I Chemical
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 Chemical Code Number for tert-butyl 4-
oxopiperidine-1-carboxylate (also known as 1-boc-4-piperidone; and CAS
Number: 79099-07-3) and its salts as a list I chemical under the
Controlled Substances Act (CSA). Although 1-boc-4-piperidone is not
specifically listed as a list I chemical of the CSA with its own unique
Chemical Code Number, it has been regulated as a list I chemical in the
United States as a carbamate of 4-piperidone, a list I chemical, since
May 12, 2023. Therefore, DEA is simply amending the list of list I
chemicals in its regulations to separately include 1-boc-4-piperidone.
DATES: Effective date October 2, 2025.
FOR FURTHER INFORMATION CONTACT: Terrence L. Boos, Drug and Chemical
Evaluation Section, Diversion Control Division, Drug Enforcement
Administration; Telephone: (571) 362-3249.
A summary of this rule may be found in the docket for this
rulemaking at <a href="http://www.regulations.gov">www.regulations.gov</a>.
SUPPLEMENTARY INFORMATION: tert-Butyl 4-oxopiperidine-1-carboxylate
(also known as 1-boc-4-piperidone) is a chemical that is structurally
related to 4-piperidone (also known as piperidin-4-one). 4-Piperidone,
including its acetals, its amides, its carbamates, its salts, and salts
of its acetals, its amides, and its carbamates, and any combination
thereof, whenever the existence of such is possible, is a list I
chemical at 21 CFR 1310.02(a)(38). The chemical structure of 1-boc-4-
piperidone defines it as a carbamate of 4-piperidone. Accordingly,
under 21 CFR 1310.02(a), 1-boc-4-piperidone, as a carbamate of 4-
piperidone, is, and continues to be, a regulated list I chemical.\1\
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\1\ See Designation of 4-Piperidone as a List I Chemical, 88 FR
21902, 21904 (Apr. 12, 2023) (``As a carbamate of 4-piperidone, 1-
boc-4-piperidone is subject to this rulemaking.'').
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Legal Authority
The Controlled Substances Act (CSA) gives the Attorney General the
authority to specify, by regulation, chemicals as list I chemicals.\2\
A ``list I chemical'' is defined as ``a chemical that is used in
manufacturing a controlled substance in violation of [the CSA] and is
important to the manufacture of the controlled substances.'' \3\ The
current list of all list I chemicals is available in 21 CFR 1310.02(a).
Pursuant to 28 CFR 0.100(b), the Attorney General has delegated her
authority to designate list I chemicals to the Administrator of DEA
(Administrator).
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\2\ 21 U.S.C. 802(34).; 21 U.S.C. 871(b).; 21 CFR 1310.02(c).
\3\ Id.; see also 21 CFR 1300.02(b).
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In addition, the United States is a party to the 1988 United
Nations Convention Against Illicit Traffic in Narcotic Drugs and
Psychotropic Substances (1988 Convention), Dec. 20, 1988, 1582 U.N.T.S.
95. Under Article 12 of the 1988 Convention, when the United States
receives notification that a chemical has been added to Table I or
Table II of the 1988 Convention, the United States is required to take
measures it deems appropriate to monitor the manufacture and
distribution of that chemical within the United States and to prevent
its diversion, including measures related to international trade.
[[Page 47564]]
Background
In a letter dated June 6, 2024, in accordance with Article 12,
paragraph 6, of the 1988 Convention, the Secretariat of the United
Nations informed the Permanent Mission of the United States of America
to the United Nations (Vienna) that the Commission on Narcotic Drugs
(CND) added the chemical 1-boc-4-piperidone to Table I of the 1988
Convention during its 67th Session on March 19, 2024 (CND Dec/67/7). As
discussed above, the United States is a party to the 1988 Convention
and has certain obligations pursuant to Article 12. Because 1-boc-4-
piperidone is a carbamate of 4-piperidone, it has been regulated as a
list I chemical of the CSA since May 12, 2023.\4\ Therefore, all
regulations and criminal sanctions applicable to list I chemicals have
been, and remain, applicable to 1-boc-4-piperidone, and the United
States has fulfilled its obligations under the 1988 Convention.
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\4\ See Designation of 4-Piperidone as a List I Chemical, 88 FR
21902 (Apr. 12, 2023) (effective date of designation was May 12,
2023).
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Effect of Action
As discussed above, this rule does not affect the continuing status
of 1-boc-4-piperidone as a list I chemical in any way. This action, as
an administrative matter, establishes a separate, specific listing for
1-boc-4-piperidone in list I of the CSA and assigns a DEA chemical code
number for the substance. This action will allow DEA to effectively
monitor regulated transactions of 1-boc-4-piperidone, including the
manufacture, distribution, importation, or exportation of 1-boc-4-
piperidone, and to provide accurate reporting to the International
Narcotics Control Board.
Chemical Mixtures of 1-boc-4-piperidone
Pursuant to the final rule published on April 12, 2023,\5\ chemical
mixtures containing 1-boc-4-piperidone are not exempt from regulatory
requirements at any concentration, unless a manufacturer of 1-boc-4-
piperidone submits to DEA an application for exemption of a chemical
mixture, DEA accepts the application for filing, and DEA exempts the
chemical mixture in accordance with 21 CFR 1310.13.
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\5\ Id.
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Because even a small amount of 1-boc-4-piperidone can potentially
yield a significant amount of finished controlled substances, DEA
believes that the continued regulation of chemical mixtures containing
any concentration of 1-boc-4-piperidone as a list I chemical is
necessary to prevent its illicit extraction, isolation, and use. 1-Boc-
4-piperidone is already subject to domestic control under list I as a
carbamate of 4-piperidone, and DEA's current regulations provide that a
chemical mixture containing any concentration of 4-piperidone is a list
I chemical. As a technical conforming change in connection with the
separate listing of 1-boc-4-piperidone, this rule modifies the ``Table
of Concentration Limits'' in 21 CFR 1310.12(c) to reflect that a
chemical mixture containing any concentration of 1-boc-4-piperidone is
subject to CSA chemical control provisions, including 21 CFR parts
1309, 1310, 1313, and 1316. No additional requirements are being
imposed.
Application Process for Exemption of Chemical Mixtures
DEA has implemented an application process to exempt certain
chemical mixtures from the requirements of the CSA and its implementing
regulations.\6\ Manufacturers may apply for an automatic exemption for
those mixtures that do not meet the criteria set forth in 21 CFR
1310.12(d). Pursuant to 21 CFR 1310.13(a), DEA may grant an exemption
of a chemical mixture, by publishing a final rule in the Federal
Register, if DEA determines that: (1) the mixture is formulated in such
a way that it cannot be easily used in the illicit production of a
controlled substance, and (2) the listed chemical or chemicals cannot
be readily recovered.
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\6\ 21 CFR 1310.13 specifies that this chemical mixture is a
chemical mixture consisting of two or more chemical components, at
least one of which is a list I or list II chemical. See also 21 CFR
1300.02 (defining the term ``chemical mixture'').
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Requirements for Handling List I Chemicals
The listing of 1-boc-4-piperidone as a list I chemical continues to
subject handlers (manufacturers, distributors, importers, and
exporters) and proposed handlers to all the regulatory controls and
administrative, civil, and criminal actions applicable to the
manufacture, distribution, importation, and exportation of a list I
chemical. Since May 12, 2023, persons handling 1-boc-4-piperidone,
including regulated chemical mixtures containing 1-boc-4-piperidone,
have been required to comply with list I chemical regulations,
including the following:
1. Registration. Any person who handles (manufactures, distributes,
imports, or exports), or proposes to engage in such handling, of 1-boc-
4-piperidone or a chemical mixture containing 1-boc-4-piperidone, must
obtain a registration pursuant to 21 U.S.C. 822, 823, 957, and 958.
Regulations describing registration for list I chemical handlers are
set forth in 21 CFR part 1309. DEA regulations require separate
registrations for manufacturing, distributing, importing, and exporting
of 1-boc-4-piperidone.\7\ Further, a separate registration is required
for each principal place of business at one general physical location
where list I chemicals are manufactured, distributed, imported, or
exported by a person.\8\
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\7\ 21 CFR 1309.21.
\8\ 21 CFR 1309.23(a); see also 21 U.S.C. 822(e)(1) (separate
registration requirements pertaining to manufacturing or
distributing a list I chemical).
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DEA notes that under the CSA, ``warehousemen'' are not required to
register and may lawfully possess list I chemicals, if the possession
of those chemicals is in the usual course of business or employment.\9\
Under DEA implementing regulations, the warehouse in question must
receive the list I chemical from a DEA registrant, and shall only
distribute the list I chemical back to the DEA registrant at the
registered location from which it was received.\10\ A warehouse that
distributes list I chemicals to persons other than the registrant, at
the registered location from which they were obtained, is conducting
distribution activities and is required to register as such.
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\9\ 21 U.S.C. 822(c)(2); 21 U.S.C. 957(b)(1)(B).
\10\ See 21 CFR 1309.23(b)(1).
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2. Records and Reports. Every DEA registrant must maintain records
and submit reports to DEA with respect to 1-boc-4-piperidone pursuant
to 21 U.S.C. 830 and in accordance with 21 CFR 1310. Pursuant to 21 CFR
1310.04, a record must be made and maintained for two years after the
date of a transaction involving a listed chemical, provided the
transaction is a regulated transaction.
Each regulated bulk manufacturer of a listed chemical would be
required to submit manufacturing, inventory, and use data on an annual
basis.\11\ Existing standard industry reports containing the required
information would be acceptable, provided the information is separate
or readily retrievable from the report.
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\11\ 21 CFR 1310.05(d).
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The CSA and its implementing regulations require that each
regulated person report to DEA any regulated transaction involving an
extraordinary quantity of a listed chemical, an uncommon method of
payment or delivery, or any other circumstance that the regulated
person believes may indicate that the listed chemical will be used in
violation of subchapter I of the
[[Page 47565]]
CSA. In addition, regulated persons must report the following: any
proposed regulated transaction with a person whose description or other
identifying characteristics DEA has previously furnished to the
regulated person, any unusual or excessive loss or disappearance of a
listed chemical under the control of the regulated person, and any in-
transit loss in which the regulated person is the supplier.\12\
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\12\ 21 U.S.C. 830(b); 21 CFR 1310.05(a) and (b).
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3. Importation and Exportation. All importation and exportation of
1-boc-4-piperidone must comply with 21 U.S.C. 957, 958, and 971 and be
in accordance with 21 CFR part 1313.
4. Security. All applicants and registrants must provide effective
controls against theft and diversion of list I chemicals in accordance
with 21 CFR 1309.71-1309.73.
5. Administrative Inspection. Places, including factories,
warehouses, or other establishments and conveyances, where registrants
or other regulated persons may lawfully hold, manufacture, distribute,
or otherwise dispose of a list I chemical or where records relating to
those activities are maintained, are controlled premises as defined in
21 U.S.C. 880(a) and 21 CFR 1316.02(c). The CSA allows for
administrative inspections of these controlled premises as provided in
21 CFR part 1316, subpart A.\13\
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\13\ 21 U.S.C. 880.
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6. Liability. Any activity involving 1-boc-4-piperidone not
authorized by, or in violation of, the CSA is unlawful, and would
subject the person to administrative, civil, and/or criminal action.
Regulatory Analyses
Administrative Procedure Act
Pursuant to the Administrative Procedure Act at 5 U.S.C. 553(b)(B),
DEA finds that good cause exists here to dispense with notice-and-
comment rulemaking because it is unnecessary. 1-boc-4-piperidone is
currently regulated as a list I chemical as a carbamate of 4-
piperidone. The addition of a separate listing for 1-boc-4-piperidone
and its DEA chemical code number in the list of list I chemicals in 21
CFR 1310.02(a) makes no substantive difference in the status of this
chemical as a list I chemical, but instead is ``a minor or merely
technical amendment in which the public is not particularly
interested.'' \14\ Therefore, DEA finds that publishing a notice of
proposed rulemaking and soliciting public comment are unnecessary and
good cause exists to dispense with these procedures.
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\14\ 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 applicable in
``those situations in which the administrative rule is a routine
determination, insignificant in nature and impact, and
inconsequential to the industry and to the public'') (internal
quotations and citation omitted).
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In addition, DEA is concerned that delaying the effective date of
this rule potentially could cause confusion regarding the regulatory
status of 1-boc-4-piperidone. With 1-boc-4-piperidone currently
regulated as a list I chemical, and with no additional requirements
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).
Executive Orders 12866, 13563, 14912, and 14294 (Regulatory Review)
This rule was developed in accordance with the principles of
Executive Orders (E.O.) 12866, 13563, and 14912. This rule is not a
significant regulatory action under section 3(f) of E.O. 12866. 1-boc-
4-piperidone is already regulated as a list I chemical in the United
States, as a carbamate of the list I chemical 4-piperidone. In this
final rule, DEA is making an administrative change by amending its
regulations to separately list 1-boc-4-piperidone as a list I chemical
and to assign the DEA chemical code number 8331 to this chemical. A
separate listing for 1-boc-4-piperidone will not alter the status of 1-
boc-4-piperidone as a list I chemical. Accordingly, this rule has not
been reviewed by the Office of Management and Budget (OMB). DEA
scheduling actions are not subject to E.O. 14912, Unleashing Prosperity
Through Deregulation.
E.O. 14294, Overcriminalization of Federal Regulations, requires
agencies promulgating regulations with criminal regulatory offenses
potentially subject to criminal enforcement to explicitly describe the
conduct subject to criminal enforcement, the authorizing statutes, and
the mens rea standard applicable to each element of those offenses.
This final rule does not impose a criminal regulatory penalty and is
thus exempt from E.O. 14924 requirements.
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 Regulatory Flexibility Act (RFA) \15\ 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 is good cause to exempt this final rule
from notice and comment. Consequently, the RFA does not apply.
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\15\ 5 U.S.C. 601-612.
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Unfunded Mandates Reform Act of 1995
In accordance with the Unfunded Mandates Reform Act of 1995 (UMRA),
2 U.S.C. 1501 et seq., DEA has determined and certifies that this rule
will 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 the UMRA.
Paperwork Reduction Act of 1995
The action does not impose a new collection of information
requirement under the Paperwork Reduction Act of 1995.\16\ This action
will 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.
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\16\ 44 U.S.C. 3501-3521.
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[[Page 47566]]
Congressional Review Act
This final rule is not a major rule as defined by the Congressional
Review Act (CRA), 5 U.S.C. 804(2). 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 21 CFR Part 1310
Administrative practice and procedure, Drug traffic control,
Exports, Imports, Reporting and recordkeeping requirements.
Accordingly, for the reasons set forth in the preamble, DEA amends
21 CFR part 1310 as follows:
PART 1310--RECORDS AND REPORTS OF LISTED CHEMICALS AND CERTAIN
MACHINES; IMPORTATION AND EXPORTATION OF CERTAIN MACHINES
0
1. The authority citation for 21 CFR part 1310 continues to read as
follows:
Authority: 21 U.S.C. 802, 827(h), 830, 871(b), 890.
0
2. In Sec. 1310.02, add paragraph (a)(40) to read as follows:
Sec. 1310.02 Substances covered.
* * * * *
(a) * * *
------------------------------------------------------------------------
------------------------------------------------------------------------
* * * * * * *
(40) 1-boc-4-piperidone (tert-butyl 4-oxopiperidine-1- 8331
carboxylate) and its salts................................
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* * * * *
0
3. In Sec. 1310.04:
0
a. Redesignate paragraphs (g)(1)(iv) through (xix) as paragraphs
(g)(1)(v) through (xx), respectively; and
0
b. Add new paragraph (g)(1)(iv).
The addition reads as follows:
Sec. 1310.04 Maintenance of records.
* * * * *
(g) * * *
(1) * * *
* * * * *
(iv) 1-boc-4-piperidone (tert-butyl 4-oxopiperidine-1-carboxylate)
and its salts.
* * * * *
0
4. In Sec. 1310.12, amend the table in paragraph (c) by adding in
alphabetical order the entry for ``1-boc-4-piperidone (tert-butyl 4-
oxopiperidine-1-carboxylate) and its salts'' to read as follows:
Sec. 1310.12 Exempt chemical mixtures.
* * * * *
(c) * * *
Table of Concentration Limits
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DEA chemical
code No. Concentration Special conditions
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List I Chemicals
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* * * * * * *
1-boc-4-piperidone (tert-butyl 4- 8331 Not exempt at any Chemical mixtures
oxopiperidine-1-carboxylate) and its concentration. containing any amount of
salts. 1-boc-4-piperidone (tert-
butyl 4-oxopiperidine-1-
carboxylate) and its
salts are not exempt.
* * * * * * *
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* * * * *
Signing Authority
This document of the Drug Enforcement Administration was signed on
September 30, 2025, by Administrator Terrance Cole. 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.
Heather Achbach,
Federal Register Liaison Officer, Drug Enforcement Administration.
[FR Doc. 2025-19349 Filed 10-1-25; 8:45 am]
BILLING CODE 4410-09-P
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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.