Rule2026-10253
Schedules of Controlled Substances: Temporary Placement of 2-Fluorodeschloroketamine in Schedule I
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
May 22, 2026
Effective
May 22, 2026
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
The Drug Enforcement Administration (DEA) issues this temporary order to schedule 2-(2-fluorophenyl)-2- (methylamino)cyclohexan-1-one (commonly known as 2- fluorodeschloroketamine or 2-FDCK), including 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, in schedule I of the Controlled Substances Act. DEA bases this action on a finding that placing 2-fluorodeschloroketamine in schedule I is necessary to avoid an imminent hazard to public safety. This order 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 analysis, or possess), or propose to handle this substance.
Full Text
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<title>Federal Register, Volume 91 Issue 99 (Friday, May 22, 2026)</title>
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[Federal Register Volume 91, Number 99 (Friday, May 22, 2026)]
[Rules and Regulations]
[Pages 30204-30209]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-10253]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-1442]
Schedules of Controlled Substances: Temporary Placement of 2-
Fluorodeschloroketamine in Schedule I
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Temporary amendment; temporary scheduling order.
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SUMMARY: The Drug Enforcement Administration (DEA) issues this
temporary order to schedule 2-(2-fluorophenyl)-2-
(methylamino)cyclohexan-1-one (commonly known as 2-
fluorodeschloroketamine or 2-FDCK), including 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,
in schedule I of the Controlled Substances Act. DEA bases this action
on a finding that placing 2-fluorodeschloroketamine in schedule I is
necessary to avoid an imminent hazard to public safety. This order
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
analysis, or possess), or propose to handle this substance.
DATES: This temporary order is effective May 22, 2026, until May 22,
2028. If this order is extended or made permanent, DEA will publish a
document in the Federal Register.
ADDRESSES: 8701 Morrissette Drive, Springfield, Virginia 22152.
FOR FURTHER INFORMATION CONTACT: Dr. Terrence L. Boos, Drug and
Chemical Evaluation Section, Diversion Control Division, Drug
Enforcement Administration; Mailing Address: 8701 Morrissette Drive,
Springfield, Virginia 22152; Telephone: (571) 362-3249.
SUPPLEMENTARY INFORMATION: The Drug Enforcement Administration (DEA)
issues a temporary scheduling order \1\ (in the form of a temporary
amendment) to add 2-(2-fluorophenyl)-2-
[[Page 30205]]
(methylamino)cyclohexan-1-one (commonly known as 2-
fluorodeschloroketamine or 2-FDCK), including its salts, isomers, and
salts of isomers whenever the existence of such salts, isomers, and
salts of isomers is possible, to schedule I under the Controlled
Substances Act (CSA).
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\1\ Though DEA has used the term ``final order'' with respect to
temporary scheduling orders in the past, this action adheres to the
statutory language of 21 U.S.C. 811(h), which refers to a
``temporary scheduling order.'' No substantive change is intended.
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Legal Authority
The CSA provides the Attorney General with the authority to
temporarily place a substance in schedule I of the CSA for two years
without regard to the evaluation requirements of 21 U.S.C. 811(b), if
he finds that such action is necessary to avoid an imminent hazard to
the public safety.\2\ In addition, if proceedings to control a
substance are initiated under 21 U.S.C. 811(a)(1) while the substance
is temporarily controlled under section 811(h), the Attorney General
may extend the temporary scheduling for up to one year.\3\
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\2\ 21 U.S.C. 811(h)(1).
\3\ 21 U.S.C. 811(h)(2).
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Where the necessary findings are made, a substance may be
temporarily scheduled if it is not listed in any other schedule under
21 U.S.C. 812, or if there is no exemption or approval in effect for
the substance under section 505 of the Federal Food, Drug, and Cosmetic
Act (FD&C Act), 21 U.S.C. 355.\4\
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\4\ 21 U.S.C. 811(h)(1); 21 CFR part 1308.
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In addition, the United States is a party to the 1971 United
Nations Convention on Psychotropic Substances (1971 Convention), Feb.
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 set
forth in 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 indicating that a drug or other substance has been added to
a schedule specified in the notification, the Secretary of the
Department of Health and Human Services (HHS), after consultation with
the Attorney General, shall first determine whether existing legal
controls under subchapter I of the CSA and the FD&C Act meet the
requirements of the schedule specified in the notification with respect
to the specific drug or substance. In the event that the Secretary did
not consult with the Attorney General, and the Attorney General did not
issue a temporary order, as provided under 21 U.S.C. 811(d)(4), the
procedures for permanent scheduling set forth in 21 U.S.C. 811(a) and
(b) control. The Attorney General has delegated scheduling authority
under 21 U.S.C. 811 to the Administrator of DEA (Administrator).\5\
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\5\ 28 CFR 0.100.
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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), during its 67th session on March 19, 2024, voted to place
2-fluorodeschloroketamine in Schedule II of the Convention on
Psychotropic Substances of 1971 (CND Decision 67/4). As a signatory to
this international treaty, the United States is required to place
appropriate controls within the CSA on 2-fluorodeschloroketamine to
meet the requirements of the treaty. To meet the minimum requirements
of this treaty and to confront these emerging substances, DEA is
temporarily placing 2-fluorodeschloroketamine in schedule I of the CSA.
The CSA requires the Administrator to notify the Secretary of HHS
of an intent to temporarily place a substance in schedule I of the CSA
(i.e., to issue a temporary scheduling order).\6\ By letter dated
November 1, 2024 (the November 1 DEA letter), the previous
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 (Assistant Secretary).\7\ By
letter dated November 8, 2024 (the November 8 HHS letter), the previous
Assistant Secretary responded to this notice and advised DEA 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 previous
Assistant Secretary also stated that HHS had no objection to the
temporary placement of this substance in schedule I of the CSA.
However, DEA requested an updated response from HHS by letter dated May
28, 2025 (the May 28 DEA letter), due to the change in HHS's leadership
after the November 8 HHS letter. By letter dated June 11, 2025 (the
June 11 HHS letter), the then-Acting Assistant Secretary of HHS
responded that, based on an updated review by FDA, there were currently
no NDAs or INDs for 2-fluorodeschloroketamine. Therefore, HHS had no
objections to the temporary placement of 2-fluorodeschloroketamine in
schedule I. 2-Fluorodeschloroketamine is not currently listed in any
schedule under the CSA, and no exemptions or approvals under 21 U.S.C.
355, are in effect for this substance.
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\6\ 21 U.S.C. 811(h)(4).
\7\ The Secretary of HHS 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).
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DEA has taken into consideration the then-Acting Assistant
Secretary's comments as required by 21 U.S.C. 811(h)(4). DEA has found
the control of 2-fluorodeschloroketamine in schedule I on a temporary
basis is necessary to avoid an imminent hazard to public safety.
As required by 21 U.S.C. 811(h)(1)(A), DEA published a notice of
intent (NOI) to temporarily schedule 2-fluorodeschloroketamine in the
Federal Register on January 20, 2026.\8\ That NOI discussed findings
from DEA's three-factor analysis dated January 2026, which DEA made
available on <a href="http://www.regulations.gov">www.regulations.gov</a>.
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\8\ Schedules of Controlled Substances: Temporary Placement of
2-Fluorodeschloroketamine in Schedule I, 91 FR 2323 (Jan. 20, 2026).
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To find that temporarily placing a substance in schedule I of the
CSA is necessary to avoid an imminent hazard to public safety, the
Administrator must consider three of the eight factors set forth in 21
U.S.C. 811(c): the substance's history and current pattern of abuse;
the scope, duration, and significance of abuse; and what, if any, risk
there is to public health.\9\ Consideration of these factors includes
any information indicating actual abuse, diversion from legitimate
channels, and clandestine importation, manufacture, or distribution of
this substance.\10\
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\9\ 21 U.S.C. 811(c)(4)-(6), (h)(3).
\10\ Id.
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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, and a lack of accepted safety for use
under medical supervision.\12\
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\11\ 21 U.S.C. 811(h)(1).
\12\ 21 U.S.C. 812(b)(1).
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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
[[Page 30206]]
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 61 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. 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.\13\ DEA's three-factor analysis is available in its
entirety under ``Supporting and Related Material'' of the public docket
for this action at <a href="http://www.regulations.gov">www.regulations.gov</a> under Docket Number DEA-1442.
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\13\ 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 for marketing in interstate commerce.
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. See 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. In a recent published letter in a different context,
HHS applied an additional two-part test to determine currently
accepted medical use for substances that do not satisfy the five-
part test: (1) whether there exists widespread, current experience
with medical use of the substance by licensed health care providers
operating in accordance with implemented jurisdiction-authorized
programs, where medical use is recognized by entities that regulate
the practice of medicine, and, if so, (2) whether there exists some
credible scientific support for at least one of the medical
conditions for which part (1) is satisfied. On April 11, 2024, the
Department of Justice's Office of Legal Counsel (OLC) issued an
opinion, which, among other things, concluded that HHS's two-part
test would be sufficient to establish that a drug has a currently
accepted medical use. Office of Legal Counsel, Memorandum for
Merrick B. Garland Attorney General Re: Questions Related to the
Potential Rescheduling of Marijuana at 3 (April 11, 2024). For
purposes of this temporary order, there is no evidence that health
care providers have widespread experience with medical use of 2-
fluorodeschloroketamine or that the use of 2-fluorodeschloroketamine
is recognized 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 NDAs
or INDs for 2-fluorodeschloroketamine. Additionally, HHS
communicated no objections to the temporary placement of 2-
fluorodeschloroketamine into schedule I of the CSA. In the June 11
HHS letter, HHS reaffirmed its position and advised DEA that there
were currently no approved NDAs or INDs for 2-
fluorodeschloroketamine. Additionally, HHS reaffirmed that it had no
objections to the temporary placement of 2-fluorodeschloroketamine
in schedule I of the CSA.
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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. In the June 11 HHS letter to DEA, the then-
Acting Assistant Secretary reaffirmed that there were no FDA-approved
NDAs or INDs for 2-fluorodeschloroketamine.
2-Fluorodeschloroketamine emerged on the illicit drug market
similarly to other dissociative anesthetics that are trafficked for
their psychoactive effects; this is evidenced by the identification of
this substance in forensic drug exhibits and toxicology samples. Based
on available data from user reports and law enforcement seizures,
individuals typically purchase 2-fluorodeschloroketamine as powder or
crystals, which are then crushed and placed into capsules or
solubilized. Common routes of administration include oral consumption
or insufflation, while less commonly mentioned routes include
intramuscular injection, sublingual administration, and rectal
insertion. In addition, scientific literature and toxicological reports
indicate that 2-fluorodeschloroketamine is likely co-ingested with
other substances, whether as separate products or a single product
containing multiple licit and illicit substances. In toxicological
reports, substances co-identified with 2-fluorodeschloroketamine
included, but were not limited to, 2-fluoromethamphetamine (schedule
I); 3,4-methylenedioxyamphetamine (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 61 reports, across 12 states, pertaining to the
trafficking,
[[Page 30207]]
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.
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\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. 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 May 5, 2026. NFLIS-Drug
reports are still pending for 2025 and 2026 due to normal lag time.
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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 polysubstance 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. Consequently, additional emergency room
admissions and fatalities involving 2-fluorodeschloroketamine have
potentially occurred without report.
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\16\ DEA TOX is a surveillance program that aims to detect novel
psychoactive substances (NPS) in fatal and nonfatal overdose cases
within the United States. From these cases, biological samples, as
well as drug paraphernalia (on limited occasions), are submitted for
analysis by hospitals, medical examiners, poison centers, and law
enforcement nationwide. DEA TOX data include confirmed detections of
NPS through the data query date, May 5, 2026.
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Lastly, U.S. law enforcement data indicate that 2-
fluorodeschloroketamine has been encountered since 2018 and that this
substance is easily and affordably obtainable online and on the illicit
market. Due to the unknown purity and composition of drugs purchased
online or on the illicit market, individuals may be unknowingly exposed
to this substance despite their intentions to consume other drugs, such
as bucinnazine, ketamine, or methoxphenidine. Analytical testing of
seized 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. 2-
Fluorodeschloroketamine has not been approved by FDA and has not been
lawfully marketed in the United States. DEA is not aware of any
currently accepted medical uses for 2-fluorodeschloroketamine in the
United States. A substance meeting the statutory requirements for
temporary scheduling, found in 21 U.S.C. 811(h)(1), may only be placed
in schedule I. Substances in schedule I must have 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. Available data and information for 2-
fluorodeschloroketamine indicate that this substance meets the three
statutory criteria.
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 then-Acting
Assistant Secretary reaffirmed that HHS had no objection to the
temporary placement of 2-fluorodeschloroketamine in schedule I. DEA
subsequently published this NOI in the Federal Register on January 20,
2026.\17\
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\17\ Schedules of Controlled Substances: Temporary Placement of
2-Fluorodeschloroketamine in Schedule I, 91 FR 2323 (Jan. 20, 2026).
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Conclusion
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 is necessary 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 on the date the order is published in the
Federal Register and will remain in effect for two years, with a
possible extension of one year, pending completion of the regular
(permanent) scheduling process.\18\
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\18\ 21 U.S.C. 811(h)(1) and (2).
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The CSA sets forth specific criteria for scheduling drugs or other
substances. Permanent 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.\19\ The permanent 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 permanent scheduling
process of formal rulemaking are subject to judicial review.\20\
Temporary scheduling orders are not subject to judicial review.\21\
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\19\ 21 U.S.C. 811.
\20\ 21 U.S.C. 877.
\21\ 21 U.S.C. 811(h)(6).
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Requirements for Handling
Upon the effective date of this temporary order, 2-
fluorodeschloroketamine will be subject to the regulatory controls and
administrative, civil, and criminal sanctions applicable to the
manufacture, distribution, reverse distribution, importation,
exportation, possession of, and engagement in research and conduct of
instructional activities or chemical analysis with, schedule I
controlled substances, including but not limited to the following:
1. Registration. Any person who handles (possesses, manufactures,
distributes, reverse distributes, imports,
[[Page 30208]]
exports, engages in research, or conducts instructional activities or
chemical analysis with) or desires to handle, 2-fluorodeschloroketamine
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, as of May 22, 2026. Any person who currently handles 2-
fluorodeschloroketamine and is not registered with DEA to conduct
research with a schedule I controlled substance must submit an
application for registration and may not continue to handle 2-
fluorodeschloroketamine as of May 22, 2026, unless DEA has approved
that application for registration pursuant to 21 U.S.C. 822, 823, 957,
and 958, and in accordance with 21 CFR parts 1301 and 1312.
Notwithstanding the foregoing, pursuant to 21 U.S.C. 822(h), if, on
May 22, 2026, a person is conducting research on 2-
fluorodeschloroketamine and is already registered to conduct research
with another controlled substance in schedule I, the person may
continue to conduct research on 2-fluorodeschloroketamine if they
submit a completed application for registration or modification of
existing registration, as applicable, to conduct research with 2-
fluorodeschloroketamine not later than 90 calendar days after May 22,
2026. The person may continue to conduct such research until the person
withdraws the application or the Administrator serves on the person an
order to show cause proposing denial of the application pursuant to 21
U.S.C. 824(c) and in accordance with 21 CFR 1301.37. If the
Administrator serves an order to show cause proposing denial of the
application or modification, the person may not continue to conduct
research with 2-fluorodeschloroketamine and may not receive or
otherwise obtain additional 2-fluorodeschloroketamine. If an order to
show cause is served and the person requests a hearing in accordance
with 21 CFR 1301.37(d), the hearing shall be held in accordance with 21
CFR 1301.41-1301.46 on an expedited basis and not later than 45
calendar days after the request is made, except that the hearing may be
held at a later time if so requested by the person. If the person sends
a copy of the application to a manufacturer or distributor of 2-
fluorodeschloroketamine, receipt of the copy by the manufacturer or
distributor constitutes sufficient evidence that the person is
authorized to receive 2-fluorodeschloroketamine pursuant to 21 U.S.C.
822(h)(4). Continuation of research under 21 U.S.C. 822(h) does not
authorize any other handling (e.g., distribution) of 2-
fluorodeschloroketamine.
Retail sales of schedule I controlled substances to the general
public are not allowed under the CSA. Possession of any quantity of 2-
fluorodeschloroketamine in a manner not authorized by the CSA on or
after May 22, 2026 is unlawful, and those in possession of any quantity
of 2-fluorodeschloroketamine may be subject to prosecution pursuant to
the CSA.
2. Disposal of Stocks. Any person who does not desire or is unable
to obtain a schedule I registration to handle 2-fluorodeschloroketamine
must surrender all currently held quantities of this substance.
3. Security. 2-Fluorodeschloroketamine is subject to schedule I
security requirements and must be handled in accordance with 21 CFR
1301.71-1301.93, as of May 22, 2026.
4. Labeling and Packaging. All labels, labeling, and packaging for
commercial containers of 2-fluorodeschloroketamine must comply with 21
U.S.C. 825 and 958(e) and 21 CFR part 1302. Current DEA registrants
will have 30 calendar days from May 22, 2026 to comply with all
labeling and packaging requirements.
5. Inventory. Every DEA registrant who possesses any quantity of 2-
fluorodeschloroketamine on the effective date of this order must take
an inventory of all stocks of this substance on hand pursuant to 21
U.S.C. 827 and 958, and in accordance with 21 CFR 1304.03, 1304.04, and
1304.11. Current DEA registrants will have 30 calendar days from the
effective date of this order to comply with all inventory requirements.
After the initial inventory, every DEA registrant must take an
inventory of all controlled substances (including 2-
fluorodeschloroketamine) on hand on a biennial basis pursuant to 21
U.S.C. 827 and 958 and in accordance with 21 CFR 1304.03, 1304.04, and
1304.11.
6. Records. All DEA registrants must maintain records with respect
to 2-fluorodeschloroketamine pursuant to 21 U.S.C. 827 and 958(e) and
in accordance with 21 CFR parts 1304, 1312, and 1317, and section
1307.11. Current DEA registrants authorized to handle 2-
fluorodeschloroketamine shall have 30 calendar days from the effective
date of this order to comply with all recordkeeping requirements.
7. Reports. All DEA registrants must submit reports with respect to
2-fluorodeschloroketamine pursuant to 21 U.S.C. 827 and in accordance
with 21 CFR parts 1304, 1312, and 1317, and sections 1301.74(c) and
1301.76(b), as of May 22, 2026. Manufacturers and distributors must
also submit reports regarding 2-fluorodeschloroketamine 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. All DEA registrants who distribute 2-
fluorodeschloroketamine must comply with order form requirements
pursuant to 21 U.S.C. 828 and in accordance with 21 CFR part 1305 as of
May 22, 2026.
9. Importation and Exportation. All importation and exportation of
2-fluorodeschloroketamine must be in compliance with 21 U.S.C. 952,
953, 957, and 958, and in accordance with 21 CFR part 1312 as of May
22, 2026.
10. Quota. Only DEA-registered manufacturers may manufacture 2-
fluorodeschloroketamine in accordance with a quota assigned pursuant to
21 U.S.C. 826 and in accordance with 21 CFR part 1303, as of May 22,
2026.
11. Liability. Any activity involving 2-fluorodeschloroketamine not
authorized by or in violation of the CSA, occurring as of May 22, 2026,
is unlawful, and may subject the person to administrative, civil, and/
or criminal sanctions.
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 place 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, as delegated by the Secretary
of HHS.\22\
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\22\ 21 U.S.C. 811(h)(1).
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Inasmuch as section 811(h) directs that temporary scheduling
actions be issued by order (as distinct from a rule) and sets forth the
procedures by which such orders are to be issued, DEA believes the
notice-and-comment requirements of the Administrative Procedure Act
(APA) at 5 U.S.C. 553, which are applicable to rulemaking, do not apply
to this temporary scheduling order. The APA expressly differentiates
between orders and rules, as it defines an ``order'' to mean a ``final
disposition, whether affirmative, negative, injunctive, or declaratory
in form, of an agency in a matter other than rule
[[Page 30209]]
making.'' \23\ This contrasts with permanent scheduling actions, which
are subject to formal rulemaking procedures done ``on the record after
opportunity for a hearing,'' and final decisions that conclude the
scheduling process and are subject to judicial review.\24\ The specific
language chosen by Congress indicates its intent that DEA issue orders
instead of proceeding by rulemaking when temporarily scheduling
substances. Given that Congress specifically requires the Administrator
(as delegated by the Attorney General) to follow rulemaking procedures
for other kinds of scheduling actions,\25\ it is noteworthy that, in
section 811(h)(1), Congress authorized the issuance of temporary
scheduling actions by order rather than by rule.
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\23\ 5 U.S.C. 551(6) (emphasis added).
\24\ 21 U.S.C. 811(a) and 877.
\25\ See 21 U.S.C. 811(a).
---------------------------------------------------------------------------
Even assuming that this action is subject to the notice-and-comment
requirements of the APA, the Administrator finds that there is good
cause to forgo these 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 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 then-Acting Assistant
Secretary in response to the notices that DEA transmitted to the then-
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. Therefore, in this instance,
since DEA believes this temporary scheduling action is not a ``rule,''
it is not subject to the requirements of the RFA when issuing this
temporary action.
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. 13563 is supplemental to and
reaffirms the principles, structures, and definitions governing
regulatory review as established in E.O. 12866. E.O. 12866, Section
3(f), provides the definition of a ``significant regulatory action,''
requiring review by the Office of Management and Budget. Because this
is not a rulemaking action, this is not a significant regulatory action
as defined in Section 3(f) of E.O. 12866. In addition, DEA scheduling
actions are not subject to either E.O. 14192, Unleashing Prosperity
Through Deregulation, or E.O. 14294, Fighting Overcriminalization in
Federal Regulations.
This action will 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. Therefore, in accordance with E.O. 13132, it is
determined that this action does not have sufficient federalism
implications to warrant the preparation of a Federalism Assessment.
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. In Sec. 1308.11, add paragraph (h)(87) to read as follows:
Sec. 1308.11 Schedule I.
* * * * *
(h) * * *
------------------------------------------------------------------------
------------------------------------------------------------------------
* * * * * * *
(87) 2-Fluorodeschloroketamine, its salts, isomers, and salts 7284
of isomers (other name: 2-(2-fluorophenyl)-2-
(methylamino)cyclohexan-1-one; also known as 2-FDCK)........
------------------------------------------------------------------------
Signing Authority
This document of the Drug Enforcement Administration was signed on
May 14, 2026, by DEA 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. 2026-10253 Filed 5-21-26; 8:45 am]
BILLING CODE 4410-09-P
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</html>Indexed from Federal Register on May 22, 2026.
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.