Schedules of Controlled Substances: Temporary Placement of 2-Fluorodeschloroketamine in Schedule I

delegated scheduling authority under 21 U.S.C. 811 to the Administrator of DEA (Administrator). 6

5 As discussed in a memorandum of understanding entered into by the U.S. 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. Memorandum of Understanding with the National Institute on Drug Abuse, 50 FR 9518 (Mar. 8, 1985). The Secretary has delegated to the Assistant Secretary for Health of HHS the authority to make domestic drug scheduling recommendations. Comprehensive Drug Abuse Prevention and Control Act of 1970, Public Law 91-513, As Amended; Delegation of Authority, 58 FR 35460 (July 1, 1993).

6 28 CFR 0.100.

Background

On June 6, 2024, the Secretariat of the United Nations advised the Secretary of State of the United States that the Commission on Narcotic Drugs (CND),

The CSA requires the Administrator to notify the Secretary of HHS of this intent to issue a temporary scheduling order. 7 By letter dated November 1, 2024 (the November 1 DEA letter), the then-Administrator transmitted the required notice to place 2-fluorodeschloroketamine in schedule I on a temporary basis to the then-Assistant Secretary for Health of HHS (then-Assistant Secretary). 8 By letter dated November 8, 2024 (the November 8 HHS letter), the then-Assistant Secretary responded to this notice and advised that based on a review by the Food and Drug Administration (FDA), there were currently no investigational new drug applications (IND) or approved new drug applications (NDA) for 2-fluorodeschloroketamine. The then-Assistant Secretary also stated that HHS had no objection to the temporary placement of this substance in schedule I of the CSA; however, due to the change in HHS's leadership after the November 8 HHS letter, DEA requested an updated response from HHS, by letter dated May 28, 2025 (the May 28 DEA letter)

distribution of this substance. 10

9 21 U.S.C. 811(h)(3).

10 Id.

Substances meeting the statutory requirements for temporary scheduling may only be placed in schedule I. 11 Substances in schedule I have high potential for abuse, no currently accepted medical use in treatment in the United States, 12 and a lack of accepted safety for use under medical supervision. 13

11 21 U.S.C. 811(h)(1).

12 When finding schedule I placement on a temporary basis is necessary to avoid imminent hazard to the public, 21 U.S.C. 811(h) does not require DEA to consider whether the substance has a currently accepted medical use in treatment in the United States. Nonetheless, there is no evidence suggesting that 2-fluorodeschloroketamine has a currently accepted medical use in treatment in the United States. First, DEA looks to whether the drug or substance has FDA approval. When no FDA approval exists, DEA has traditionally applied a five-part test to determine whether a drug or substances has a currently accepted medical use: (1) the drug's chemistry must be known and reproducible; (2) there must be adequate safety studies; (3) there must be adequate and well-controlled studies proving efficacy; (4) the drug must be accepted by qualified experts; and (5) the scientific evidence must be widely available. Marijuana Scheduling Petition; Denial of Petition; Remand, 57 FR 10499 (Mar. 26, 1992), pet. for rev. denied, Alliance for Cannabis Therapeutics v. Drug Enforcement Admin., 15 F.3d 1131, 1135 (D.C. Cir. 1994). DEA applied the traditional five-part test and concluded the test was not satisfied

by entities that regulate the practice of medicine, so the two-part test also is not satisfied. In the November 8 HHS letter, HHS advised DEA that there were currently no approved new drug applications or investigational new drug applications for 2-fluorodeschloroketamine. Additionally, HHS communicated no objections to the temporary placement of 2-fluorodeschloroketamine in schedule I of the CSA. In the July 11 HHS letter, HHS reaffirmed its position and advised DEA that there are currently no approved new drug applications or investigational new drug applications for 2-fluorodeschloroketamine. Additionally, HHS reaffirmed that it had no objections to the temporary placement of 2-fluorodeschloroketamine in schedule I of the CSA.

13 21 U.S.C. 812(b)(1).

2-Fluorodeschloroketamine

The availability of new psychoactive substances on the illicit drug market continues to pose an imminent hazard to public safety. Adverse health effects associated with the abuse of such substances and their increased popularity have become a serious concern in recent years. Such substances include 2-fluorodeschloroketamine, which has been identified on the illicit drug market in the United States and worldwide.

The positive identification of 2-fluorodeschloroketamine in law enforcement seizures and toxicology reports poses a serious concern to public safety. 2-Fluorodeschloroketamine has been detected in 52 drug seizures across 12 states since 2018, and this substance has been detected in biological samples from 3 overdose cases in the United States.

Data obtained from preclinical pharmacology studies show that 2-fluorodeschloroketamine has a pharmacological profile similar to that of other arylcyclohexylamines, such as phencyclidine (PCP) and ketamine, which are schedule II and III controlled substances, respectively. Due to these pharmacological similarities, the use of 2-fluorodeschloroketamine presents a high risk of abuse and may negatively affect users and their communities

cology studies show that 2-fluorodeschloroketamine has a pharmacological profile similar to that of other arylcyclohexylamines, such as phencyclidine (PCP) and ketamine, which are schedule II and III controlled substances, respectively. Due to these pharmacological similarities, the use of 2-fluorodeschloroketamine presents a high risk of abuse and may negatively affect users and their communities. These pharmacological similarities also lead to similar clinical presentations of intoxication that range from hallucinogenic-like adverse effects to death. Thus, 2-fluorodeschloroketamine poses an imminent hazard to public safety.

Available data and information for 2-fluorodeschloroketamine, summarized below, indicate that this substance has a high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use under medical supervision. DEA's three-factor analysis is available in its entirety under “Supporting and Related Material” of the public docket for this action at www.regulations.gov under Docket Number DEA-1442.

Factor 4. History and Current Pattern of Abuse

2-Fluorodeschloroketamine belongs to a chemical structural class of substances known as arylcyclohexylamines that includes dissociative anesthetics PCP (a schedule II substance) and ketamine (a schedule III substance). Details on 2-fluorodeschloroketamine synthesis have been available since 2014, long after its first reported synthesis without details in 1987. In 2015, online forum users began to discuss the psychoactive properties of 2-fluorodeschloroketamine and commonly compared 2-fluorodeschloroketamine to ketamine. Unlike ketamine, however, 2-fluorodeschloroketamine has no currently approved medical use. In the November 8 HHS letter to DEA, the then-Assistant Secretary stated that there were no FDA-approved NDAs or INDs for 2-fluorodeschloroketamine

dioxyamphetamine (MDA; schedule I); 3,4-methylenedioxymethamphetamine (MDMA; schedule I); 4-methoxy PCP; ADB-BUTINACA (schedule I); ketamine (schedule III); fentanyl (schedule II); mitragynine; morphine (schedule II); and various prescription drugs.

Factor 5. Scope, Duration, and Significance of Abuse

Users on online forums began to discuss 2-fluorodeschloroketamine and its consumption in 2015. In 2016, government authorities in Spain first documented the appearance of 2-fluorodeschloroketamine on the illicit drug market, and this substance has since been detected in numerous countries, such as Australia, Austria, Canada, China, Denmark, Finland, France, Italy, the Netherlands, the United Kingdom, and the United States. Some of these countries actively regulated 2-fluorodeschloroketamine under psychoactive drug control regulations prior to its international control in 2024.

Law enforcement data indicate that the presence of 2-fluorodeschloroketamine is widespread in the United States. Since 2018, DEA's National Forensic Laboratory Information System (NFLIS-Drug) 14 registered a total of 52 reports, across 12 states, pertaining to the trafficking, distribution, and abuse of 2-fluorodeschloroketamine. 15 These states include California, Connecticut, Florida, Illinois, Louisiana, Michigan, New Jersey, New York, Ohio, Pennsylvania, Virginia, and West Virginia.

14 NFLIS-Drug represents an important resource in monitoring illicit drug trafficking, including the diversion of legally manufactured pharmaceuticals into illegal markets. NFLIS-Drug is a comprehensive information system that includes data from forensic laboratories that handle more than 96 percent of an estimated 1 million distinct annual federal, state, and local drug analysis cases. NFLIS-Drug includes drug chemistry results from completed analyses only. While NFLIS-Drug data are not direct evidence of abuse, these can lead to an inference that a drug has been diverted and abused

omprehensive information system that includes data from forensic laboratories that handle more than 96 percent of an estimated 1 million distinct annual federal, state, and local drug analysis cases. NFLIS-Drug includes drug chemistry results from completed analyses only. While NFLIS-Drug data are not direct evidence of abuse, these can lead to an inference that a drug has been diverted and abused. See Schedules of Controlled Substances: Placement of Carisoprodol Into Schedule IV, 76 FR 77330, 77332 (Dec. 12, 2011).

15 NFLIS-Drug data were queried on December 11, 2025. NFLIS-Drug reports are still pending for 2025 due to normal lag time.

Factor 6. What, if Any, Risk There Is to Public Health

2-Fluorodeschloroketamine is a potent arylcyclohexylamine, and evidence suggests that users abuse this substance for its dissociative effects. Literature and case reports indicate that the clinical presentation of 2-fluorodeschloroketamine intoxication is similar to that from other arylcyclohexylamines, such as PCP (schedule II) and ketamine (schedule III), and ranges from hallucinogenic-like adverse effects to death. In nonfatal intoxications, adverse effects include acute neurological symptoms resulting in cognitive and behavioral abnormalities, as well as cardiovascular symptoms, such as hypertension and tachycardia. Literature also indicates that 2-fluorodeschloroketamine has been used as a “date rape” drug and was detected among 11 cases of drug-facilitated sexual assault internationally.

In addition, according to findings by the DEA Toxicology Testing Program (DEA TOX), 16 2-fluorodeschloroketamine has been positively identified in a total of three overdose cases, two of which were fatal, and included both male (n = 2, both age 31) and female (n = 1, age 36) users. While toxicological and forensic case reports are available in medical and scientific literature and provide evidence of 2-fluorodeschloroketamine abuse, commonly used drug screening methods may not yet be able to identify 2-fluorodeschloroketamine

eized samples indicates single and combinations of substances, suggesting that 2-fluorodeschloroketamine may be frequently used as an adulterant or ketamine substitute. The unpredictable levels of adulterant or drug purity across samples may pose significant harm to public health.

Finding of Necessity of Schedule I Placement To Avoid Imminent Hazard to Public Safety

In accordance with 21 U.S.C. 811(h)(3), based on the available data and information summarized above, the uncontrolled manufacture, distribution, reverse distribution, importation, exportation, conduct of research and chemical analysis, possession, and abuse of 2-fluorodeschloroketamine pose an imminent hazard to public safety. DEA is not aware of any currently accepted medical uses for 2-fluorodeschloroketamine in treatment in the United States. A substance meeting

As required by 21 U.S.C. 811(h)(4), in the November 1 DEA letter, the then-Administrator notified the then-Assistant Secretary of DEA's intention to temporarily place 2-fluorodeschloroketamine in schedule I. HHS had no objection to the temporary placement of this substance in schedule I. However, due to the change in HHS's leadership after the November 8 HHS letter, DEA requested an updated response from HHS in the May 28 DEA letter. In the June 11 HHS letter, the Acting Assistant Secretary reaffirmed that HHS had no objection to the temporary placement of 2-fluorodeschloroketamine in schedule I.

Conclusion

This notice of intent provides the 30-day notice pursuant to 21 U.S.C. 811(h)(1) of DEA's intent to issue a temporary scheduling order. In accordance with 21 U.S.C. 811(h)(1) and (3), the Administrator considered available data and information, herein set forth the grounds for his determination that it is necessary to temporarily schedule 2-fluorodeschloroketamine in schedule I of the CSA, and finds that placement of this substance in schedule I of the CSA is necessary in order to avoid an imminent hazard to the public's safety

r. In accordance with 21 U.S.C. 811(h)(1) and (3), the Administrator considered available data and information, herein set forth the grounds for his determination that it is necessary to temporarily schedule 2-fluorodeschloroketamine in schedule I of the CSA, and finds that placement of this substance in schedule I of the CSA is necessary in order to avoid an imminent hazard to the public's safety.

The temporary placement of 2-fluorodeschloroketamine in schedule I of the CSA will take effect pursuant to a temporary scheduling order, which will not be issued before February 19, 2026. Because the Administrator hereby finds that this temporary scheduling order is necessary to avoid an imminent hazard to public safety, it will take effect on the date the order is published in the Federal Register and remain in effect for two years, with a possible extension of an additional year, pending completion of the regular (permanent) scheduling process. 17 The Administrator intends to issue a temporary scheduling order as soon as possible after the expiration of 30 days from the date of publication of this document. Upon publication of the temporary order, 2-fluorodeschloroketamine will then be subject to the CSA's schedule I regulatory controls and administrative, civil, and criminal sanctions applicable to the manufacture, distribution, reverse distribution, importation, exportation, research, conduct of instructional activities and chemical analysis, and possession.

17 21 U.S.C.811(h)(1) and (2).

The CSA sets forth specific criteria for scheduling drugs or other substances. Regular scheduling actions in accordance with 21 U.S.C. 811(a) are subject to formal rulemaking procedures “on the record after opportunity for a hearing” conducted pursuant to the provisions of 5 U.S.C. 556 and 557. 18 The regular scheduling process of formal rulemaking affords interested parties appropriate process and the government any additional relevant information needed to make a determination

lar scheduling actions in accordance with 21 U.S.C. 811(a) are subject to formal rulemaking procedures “on the record after opportunity for a hearing” conducted pursuant to the provisions of 5 U.S.C. 556 and 557. 18 The regular scheduling process of formal rulemaking affords interested parties appropriate process and the government any additional relevant information needed to make a determination. Final decisions that conclude the regular scheduling process of formal rulemaking are subject to judicial review. 19 Temporary scheduling orders are not subject to judicial review. 20

18 21 U.S.C. 811.

19 21 U.S.C. 877.

20 21 U.S.C. 811(h)(6).

Regulatory Analyses

The CSA provides for expedited temporary scheduling actions where necessary to avoid an imminent hazard to public safety. Under 21 U.S.C. 811(h)(1), the Administrator (as delegated by the Attorney General) may, by order, temporarily schedule substances in schedule I. Such orders may not be issued before the expiration of 30 days from: (1) the publication of a notice in the Federal Register of the intent to issue such order and the grounds upon which such order is to be issued, and (2) the date that notice of the proposed temporary scheduling order is transmitted to the Assistant Secretary of HHS, as delegated by the Secretary of HHS. 21

21 21 U.S.C. 811(h)(1).

Inasmuch as section 811(h) directs that temporary scheduling actions be issued by order and sets forth the procedures by which such orders are to be issued, including the requirement of a publication in the Federal Register of a notice of intent, the notice-and-comment requirements of the Administrative Procedure Act (APA), 5 U.S.C. 553, do not apply to this notice of intent

notice of intent is subject to the notice-and-comment requirements of the APA, the Administrator finds that there is good cause to forgo the those requirements pursuant to 5 U.S.C. 553(b)(B), as any further delays in the process for issuing temporary scheduling orders would be impracticable and contrary to the public interest given the manifest urgency to avoid an imminent hazard to public safety.

Although DEA believes this notice of intent to issue a temporary scheduling order is not subject to the notice-and-comment requirements of the APA, DEA notes that in accordance with 21 U.S.C. 811(h)(4), the Administrator took into consideration comments submitted by the Acting Assistant Secretary in response to the notice that DEA transmitted to the Acting Assistant Secretary pursuant to such subsection.

Further, DEA believes that this temporary scheduling action is not a “rule” as defined by 5 U.S.C. 601(2), and, accordingly, is not subject to the requirements of the Regulatory Flexibility Act (RFA). The requirements for the preparation of an initial regulatory flexibility analysis in 5 U.S.C. 603(a) are not applicable where, as here, DEA is not required by the APA or any other law to publish a general notice of proposed rulemaking. As discussed above, DEA is issuing this notice of intent pursuant to DEA's authority to issue a temporary scheduling order. 25 Therefore, in this instance, since DEA believes this temporary scheduling

25 21 U.S.C. 811(h)(1).

In accordance with the principles of Executive Orders (E.O.) 12866 and 13563, this action is not a significant regulatory action. E.O. 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health, and safety effects; distributive impacts; and equity). E.O

g and recordkeeping requirements.

For the reasons set out above, DEA proposes to amend 21 CFR part 1308 as follows:

PART 1308—SCHEDULES OF CONTROLLED SUBSTANCES

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.

2. In § 1308.11: Add paragraph (h)(77) to read as follows:

§ 1308.11 Schedule I

(h) * * *

*         *         *         *         *         *         * (86) 2-Fluorodeschloroketamine, its salts, isomers, and salts of isomers (other name: 2-(2-fluorophenyl)-2-(methylamino)cyclohexan-1-one; also known as 2-FDCK) 7284 *         *         *         *         *         *         *

Signing Authority

This document of the Drug Enforcement Administration was signed on January 13, 2026, by Administrator Terrance C. 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. 2026-00954 Filed 1-16-26; 8:45 am] BILLING CODE 4410-09-P