Specific Listing for 1-boc-4-piperidone, a Currently Controlled List I Chemical

<RULE> DEPARTMENT OF JUSTICE <SUBAGY>Drug Enforcement Administration</SUBAGY> <CFR>21 CFR Part 1310</CFR> <DEPDOC>[Docket No. DEA-1394]</DEPDOC> <SUBJECT>Specific Listing for 1-boc-4-piperidone, a Currently Controlled List I Chemical</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Drug Enforcement Administration, Department of Justice. <HD SOURCE="HED">ACTION:</HD> Final rule. <SUM> <HD SOURCE="HED">SUMMARY:</HD> The Drug Enforcement Administration (DEA) is establishing a specific listing and DEA Chemical Code Number for <E T="03">tert</E> -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. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> Effective date October 2, 2025. </EFFDATE> <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> 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 <E T="03">www.regulations.gov.</E> </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <E T="03">tert</E> -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. <SU>1</SU> <FTREF/> <FTNT> <SU>1</SU>   <E T="03">See</E> 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.”). </FTNT> <HD SOURCE="HD1">Legal Authority</HD> The Controlled Substances Act (CSA) gives the Attorney General the authority to specify, by regulation, chemicals as list I chemicals. <SU>2</SU> <FTREF/> 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.”  <SU>3</SU> <FTREF/> 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). <FTNT> <SU>2</SU>  21 U.S.C. 802(34).; 21 U.S.C. 871(b).; 21 CFR 1310.02(c). </FTNT> <FTNT> <SU>3</SU>   <E T="03">Id.; see also</E> 21 CFR 1300.02(b). </FTNT> 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. <HD SOURCE="HD1">Background</HD> 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. <SU>4</SU> <FTREF/> 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. <FTNT> <SU>4</SU>   <E T="03">See</E> Designation of 4-Piperidone as a List I Chemical, 88 FR 21902 (Apr. 12, 2023) (effective date of designation was May 12, 2023). </FTNT> <HD SOURCE="HD1">Effect of Action</HD> 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. <HD SOURCE="HD1">Chemical Mixtures of 1-boc-4-piperidone</HD> Pursuant to the final rule published on April 12, 2023, <SU>5</SU> <FTREF/> 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. <FTNT> <SU>5</SU>   <E T="03">Id.</E> </FTNT> 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. <HD SOURCE="HD1">Application Process for Exemption of Chemical Mixtures</HD> DEA has implemented an application process to exempt certain chemical mixtures from the requirements of the CSA and its implementing regulations. <SU>6</SU> <FTREF/> 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 <E T="04">Federal Register</E> <E T="03">,</E> 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. <FTNT> <SU>6</SU>  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. <E T="03">See also</E> 21 CFR 1300.02 (defining the term “chemical mixture”). </FTNT> <HD SOURCE="HD1">Requirements for Handling List I Chemicals</HD> 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. <E T="03">Registration.</E> 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. <SU>7</SU> <FTREF/> 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. <SU>8</SU> <FTREF/> <FTNT> <SU>7</SU>  21 CFR 1309.21. </FTNT> <FTNT> <SU>8</SU>  21 CFR 1309.23(a); <E T="03">see also</E> 21 U.S.C. 822(e)(1) (separate registration requirements pertaining to manufacturing or distributing a list I chemical). </FTNT> DEA notes that under the CSA, “warehousemen” ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 24k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━