Rule2026-00633
Schedules of Controlled Substances: Placement of 4-Fluoroamphetamine 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
January 15, 2026
Effective
February 17, 2026
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
With the issuance of this final rule, the Drug Enforcement Administration places 4-fluoroamphetamine (4-FA; 1-(4- fluorophenyl)propan-2-amine; para-fluoroamphetamine), including its salts, isomers, and salts of isomers, in schedule I of the Controlled Substances Act. This action is being taken, in part, to enable the United States to meet its obligations under the 1971 Convention on Psychotropic Substances. This action 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 with, or possess) or propose to handle 4-fluoroamphetamine.
Full Text
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<title>Federal Register, Volume 91 Issue 10 (Thursday, January 15, 2026)</title>
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[Federal Register Volume 91, Number 10 (Thursday, January 15, 2026)]
[Rules and Regulations]
[Pages 1692-1695]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-00633]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-1180]
Schedules of Controlled Substances: Placement of 4-
Fluoroamphetamine in Schedule I
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Final rule.
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SUMMARY: With the issuance of this final rule, the Drug Enforcement
Administration places 4-fluoroamphetamine (4-FA; 1-(4-
fluorophenyl)propan-2-amine; para-fluoroamphetamine), including its
salts, isomers, and salts of isomers, in schedule I of the Controlled
Substances Act. This action is being taken, in part, to enable the
United States to meet its obligations under the 1971 Convention on
Psychotropic Substances. This action 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 with, or possess)
or propose to handle 4-fluoroamphetamine.
DATES: Effective February 17, 2026.
FOR FURTHER INFORMATION CONTACT: Dr. Terrence L. Boos, Drug and
Chemical Evaluation Section, Diversion Control Division, Drug
Enforcement Administration; Telephone: (571) 362-3249.
SUPPLEMENTARY INFORMATION:
Legal Authority
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 governed domestically by
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 Health and Human
Services (Secretary),\1\ after consultation with the Attorney General,
shall first determine whether existing legal controls under subchapter
I of the Controlled Substances Act (CSA) and the Federal Food, Drug,
and Cosmetic Act meet the requirements of the schedule specified in the
notification with respect to the specific drug or substance.\2\ In the
event that the Secretary did not so 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.
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\1\ As discussed in a memorandum of understanding entered into
by the 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. 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. 58 FR 35460 (July 1, 1993).
\2\ 21 U.S.C. 811(d)(3).
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Pursuant to 21 U.S.C. 811(a)(1) and (2), the Attorney General (as
delegated to the Administrator of the Drug Enforcement Administration
(DEA) pursuant to 28 CFR 0.100) may, by rule, and upon the
recommendation of the Secretary, add to such a schedule or transfer
between such schedules any drug or other substance, if she finds that
such drug or other substance has a potential for abuse, and makes with
respect to such drug or other substance the findings prescribed by 21
U.S.C. 812(b) for the schedule in which such drug or other substance is
to be placed.
Background
4-Fluoroamphetamine (also known as 4-FA and para-fluoroamphetamine)
is a central nervous system stimulant and shares structural and
pharmacological similarities with schedule II stimulants, such as
amphetamine and methamphetamine, and the schedule I substance 3,4-
methylenedioxymethamphetamine. (MDMA). On May 15, 2018, the Secretary-
General of the United Nations advised the Secretary of State of the
United States that the Commission on Narcotic Drugs (CND), during its
61st session held in March 2018, voted to place 4-FA in Schedule II of
the 1971 Convention (CND Dec/61/12).
As a signatory to the 1971 Convention, the United States is
required, by scheduling under the CSA, to place appropriate controls on
4-FA to meet the minimum requirements of the treaty. Because the
procedures in 21 U.S.C. 811(d)(3) and (4) for consultation and issuance
of a temporary order for 4-FA, discussed in the above legal authority
section, were not followed, DEA is utilizing the procedures for
permanent scheduling set forth in 21 U.S.C. 811(a) and (b) to control
4-FA. Such scheduling would satisfy the United States' international
obligations.
DEA and HHS Eight Factor Analyses
In a letter dated March 2, 2021, in accordance with 21 U.S.C.
811(b), and in response to DEA's September 6, 2019, request, the
Department of Health and Human Services (HHS) provided to DEA a
scientific and medical evaluation and scheduling recommendation for 4-
FA. DEA reviewed the scientific and medical evaluation and scheduling
recommendation for schedule I placement provided by HHS, and all other
relevant data, pursuant to 21 U.S.C. 811(b) and (c), and conducted its
own analysis under the eight factors stipulated in 21 U.S.C. 811(c).
DEA found, under 21 U.S.C. 812(b)(1), that this substance warrants
control in schedule I. Both DEA's and HHS' Eight-Factor analyses are
available in their entirety under the tab Supporting Documents of the
public docket for this action at <a href="https://www.regulations.gov">https://www.regulations.gov</a> under
docket number DEA-1180.
Notice of Proposed Rulemaking to Schedule 4-FA
On June 3, 2025, DEA published a notice of proposed rulemaking
(NPRM) to permanently control 4-FA in schedule I.\3\ Specifically, DEA
proposed to add 4-FA to the list of stimulant substances under 21 CFR
1308.11(f). The NPRM provided an opportunity for interested persons to
file a request for hearing in accordance with DEA regulations on or
before July 3, 2025. DEA did not receive any requests for such a
hearing. The NPRM also provided an opportunity for interested persons
to submit comments on or before July 3, 2025.
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\3\ Schedules of Controlled Substances: Placement of 4-
Fluoroamphetamine in Schedule I, 90 FR 23477 (June. 3, 2025).
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Comments Received
DEA received nine comments in response to the NPRM for the
placement of 4-FA into schedule I of the CSA. The submissions were from
individuals or anonymous commenters. Two commenters supported the
placement of 4-FA in schedule I of the CSA, five commenters were
against the placement of 4-FA in schedule I of the CSA, and two
commenters expressed statements that were neither for nor against the
[[Page 1693]]
proposed rule (one of which noted 4-FA has helped them feel calmer).
Support of Rulemaking: DEA received two comments in support of the
placement of 4-FA in schedule I.
DEA Response: DEA appreciates these comments in support of this
rulemaking.
Opposition to Rulemaking: DEA received five comments against the
placement of 4-FA in schedule I of the CSA. Of these comments, one
asserted that 4-FA is already controlled under schedule II of the CSA
under the Controlled Substances Analogue Act, and that criminal illicit
use is already illegal. Three of these comments noted that placing 4-FA
in schedule I would negatively impact the ability to do research. One
commenter asserted 4-FA could be an effective treatment for PTSD and
depression and should not be controlled until additional studies have
been conducted. The following is DEA's response to the comments against
the proposed rulemaking.
DEA Response: DEA appreciates these comments and would like to
emphasize that 4-FA is not currently scheduled under the CSA and to
provide further clarification regarding the control of 4-FA. 4-FA has
been placed under international control. In order to comply with treaty
obligations, DEA must place 4-FA under the most appropriate schedule,
taking into consideration all appropriate scientific data.
Additionally, as set forth in the NPRM, 4-FA has no currently accepted
medical use in treatment in the United States, nor were there any New
Drug Applications. Therefore, 4-FA must be placed in schedule I of the
CSA along with other substances which have no currently accepted
medical use, lack accepted safety for use under medical supervision,
and possess a high potential for abuse. With respect to research for
potential medical use, the placement of substances in schedule I of the
CSA does not preclude academic research on these substances.\4\ Those
wishing to conduct research on 4-FA must seek permission to do so with
the DEA.\5\
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\4\ 21 U.S.C. 822(h); 21 U.S.C. 823(g)(2)(A); 21 U.S.C. 823(n).
\5\ <a href="https://apps.deadiversion.usdoj.gov/webforms2/spring/login?execution=e1s1">https://apps.deadiversion.usdoj.gov/webforms2/spring/login?execution=e1s1</a>.
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Scheduling Conclusion
After consideration of the public comments, scientific and medical
evaluation and accompanying scheduling recommendation from HHS, and
after its own eight-factor evaluation, DEA finds that these facts and
all relevant data constitute substantial evidence of potential for
abuse of 4-FA. As such, DEA is permanently scheduling 4-FA as a
controlled substance under schedule I of the CSA. The permanent
scheduling of 4-FA fulfills the United States' obligations as a party
to the 1971 Convention.
Determination of Appropriate Schedule
The CSA establishes five schedules of controlled substances known
as schedules I, II, III, IV, and V. The CSA also specifies the findings
required to place a drug or other substance in any particular schedule,
21 U.S.C. 812(b). After consideration of the analysis and
recommendation of the then Assistant Secretary for Health of HHS and
review of all other available data, the Administrator of DEA, pursuant
to 21 U.S.C. 812(b)(1), finds that:
(1) 4-FA has a high potential for abuse that is comparable to other
scheduled I and II substances, such as amphetamine, methamphetamine,
and MDMA.
(2) 4-FA has no currently accepted medical use in treatment in the
United States. In HHS' 2021 recommendation to control 4-FA, it was
noted there are no approved New Drug Applications for 4-FA and no known
therapeutic applications for 4-FA in the United States. DEA is not
aware of any other evidence suggesting that 4-FA has a currently
accepted medical use in treatment in the United States.\6\
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\6\ Pursuant to 21 U.S.C. 812(b)(1)(B), when placing a substance
in schedule I, DEA must consider whether the substance 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 substance 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
and HHS applied the traditional five-part test for currently
accepted medical use in this matter 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 practitioners 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' 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 final rule, there is no evidence that health care
providers have widespread experience with medical use of 4-FA or
that the use of 4-FA is recognized by entities that regulate the
practice of medicine, so the two-part test also is not satisfied.
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(3) There is a lack of accepted safety for use of 4-FA under
medical supervision. Because 4-FA has no approved medical use and has
not been investigated as a new drug, its safety for use under medical
supervision has not been determined.
Based on these findings, the Administrator of DEA concludes that 4-
FA, as well as its salts, isomers, and salts of isomers whenever the
existence of such salts, isomers, and salts of isomers is possible,
warrants control in schedule I of the CSA.
Requirements for Handling 4-FA
4-FA is subject to the CSA's schedule I regulatory controls and
administrative, civil, and criminal sanctions applicable to the
manufacture, distribution, reverse distribution, import, export,
engagement in research, conduct of instructional activities or chemical
analysis with, and possession of, schedule I controlled substances,
including the following:
1. Registration. Any person who handles (manufactures, distributes,
reverse distributes, imports, exports, engages in research, or conducts
instructional activities or chemical analysis with, or possesses), or
who desires to handle, 4-FA must register 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. Any person who currently
handles 4-FA and is not registered with DEA must submit an application
for registration and may not continue to handle 4-FA, unless DEA has
approved that application for registration pursuant to 21 U.S.C. 822,
823, 957, 958, and in accordance with 21 CFR parts 1301 and 1312.
Retail sales of schedule I controlled substances to the general public
are not allowed under the CSA. Possession of any quantity in a manner
not authorized by the CSA is unlawful and those in possession of any
quantity may be subject to prosecution pursuant to the CSA.
2. Disposal of Stocks. Any person unwilling or unable to obtain a
schedule I registration must surrender or transfer all quantities of
currently held 4-FA to a person registered with DEA before the
effective date of the final scheduling action in accordance with all
applicable Federal, State, local, and Tribal laws. 4-
[[Page 1694]]
FA must be disposed of in accordance with 21 CFR part 1317, in addition
to all other applicable Federal, State, local, and Tribal laws
3. Security. 4-FA is subject to schedule I security requirements
and must be handled and stored pursuant to 21 U.S.C. 823, and in
accordance with 21 CFR 1301.71-1301.76, as of the effective date of
this final scheduling action. Non-practitioners handling 4-FA must
comply with the employee screening requirements of 21 CFR 1301.90
through 1301.93.
4. Labeling and Packaging. All labels, labeling, and packaging for
commercial containers of 4-FA must comply with 21 U.S.C. 825 and be in
accordance with 21 CFR part 1302.
5. Quota. Generally, only registered manufacturers are permitted to
manufacture 4-FA in accordance with a quota assigned pursuant to 21
U.S.C. 826, and in accordance with 21 CFR part 1303.
6. Inventory. Every DEA registrant who possesses any quantity of 4-
FA must take an inventory of 4-FA on hand, pursuant to 21 U.S.C. 827
and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11(a) and (d).
Any person who registers with DEA must take an initial inventory of
all stocks of controlled substances (including 4-FA) on hand on the
date the registrant first engages in the handling of controlled
substances, pursuant to 21 U.S.C. 827 and in accordance with 21 CFR
1304.03, 1304.04, and 1304.11(a) and (b).
After the initial inventory, every DEA registrant must take an
inventory of all controlled substances (including 4-FA) on hand every
two years, pursuant to 21 U.S.C. 827 and in accordance with 21 CFR
1304.03, 1304.04, and 1304.11.
7. Records and Reports. Every DEA registrant must maintain records
and submit reports for 4-FA, or products containing 4-FA, pursuant to
21 U.S.C. 827 and in accordance with 21 CFR 1301.74(b) and (c),
1301.76(b), and parts 1304, 1312 and 1317. Manufacturers and
distributors must submit reports regarding 4-FA to the Automated
Reports and Consolidated Ordering System pursuant to 21 U.S.C. 827 and
in accordance with 21 CFR parts 1304 and 1312.
8. Order Forms. Every DEA registrant who distributes 4-FA must
comply with the order form requirements, pursuant to 21 U.S.C. 828 and
21 CFR part 1305.
9. Importation and Exportation. All importation and exportation of
4-FA must comply with 21 U.S.C. 952, 953, 957, and 958, and in
accordance with 21 CFR parts 1304 and 1312.
10. Liability. Any activity involving 4-FA not authorized by, or in
violation of, the CSA or its implementing regulations, is unlawful, and
may subject the person to administrative, civil, and/or criminal
sanctions.
Regulatory Analyses
Executive Orders 12866, 13563, 14192, and 14294
In accordance with 21 U.S.C. 811(a), this final scheduling action
is subject to formal rulemaking procedures performed ``on the record
after opportunity for a hearing,'' which are conducted pursuant to the
provisions of 5 U.S.C. 556 and 557. The CSA sets forth the procedures
and criteria for scheduling a drug or other substance. Such actions are
exempt from review by the Office of Management and Budget (OMB)
pursuant to section 3(d)(1) of Executive Order (E.O.) 12866 and the
principles reaffirmed in E.O. 13563. DEA scheduling actions are not
subject to either E.O. 14192, Unleashing Prosperity Through
Deregulation, or E.O. 14294, Overcriminalization of Federal
Regulations.
Executive Order 12988, Civil Justice Reform
This regulation meets the applicable standards set forth in
sections 3(a) and 3(b)(2) of E.O. 12988 to eliminate drafting errors
and ambiguity, provide a clear legal standard for affected conduct, and
promote simplification and burden reduction.
Executive Order 13132, Federalism
This rulemaking does not have federalism implications warranting
the application of E.O. 13132. The rule does not have substantial
direct effects on the states, on the relationship between the National
Government and the States, or on the distribution of power and
responsibilities among the various levels of government.
Executive Order 13175, Consultation and Coordination With Indian Tribal
Governments
This rule does not have Tribal implications warranting the
application of E.O. 13175. It does not have substantial direct effects
on one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.
Regulatory Flexibility Act
The Administrator of DEA, in accordance with the Regulatory
Flexibility Act, 5 U.S.C. 601-612, has reviewed this final rule, and by
approving it, certifies that it will not have a significant economic
impact on a substantial number of small entities.
DEA is placing the substance 4-FA (chemical name: 1-(4-
fluorophenyl)propan-2-amine), including its salts, isomers, and salts
of isomers, in schedule I of the CSA to enable the United States to
meet its obligations under the 1971 Convention. This action 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 with,
or possess) or propose to handle 4-FA.
Based on the review of HHS' scientific and medical evaluation and
all other relevant data, DEA determined that 4-FA has high potential
for abuse, has no currently accepted medical use in treatment in the
United States, and lacks accepted safety for use under medical
supervision. There appear to be no legitimate sources for 4-FA as a
marketed drug in the United States, but DEA notes that this substance
is available for purchase from legitimate suppliers for scientific
research. There is no evidence of significant diversion of 4-FA from
legitimate suppliers. Therefore, this final rule will not have a
significant economic impact on a substantial number of small entities.
Paperwork Reduction Act of 1995
This action does not impose a new collection of information
requirement under the Paperwork Reduction Act of 1995.\7\ This action
would not impose recordkeeping or reporting requirements on State or
local governments, individuals, businesses, or organizations. However,
this rule requires compliance with the following existing OMB
collections: 1117-0003, 1117-0004, 1117-0006, 1117-0008, 1117-0009,
1117-0010, 1117-0012, 1117-0014, 1117-0021, 1117-0023, 1117-0029, and
1117-0056. 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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\7\ 44 U.S.C. 3501 through 3521.
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Unfunded Mandates Reform Act of 1995
In accordance with the Unfunded Mandates Reform Act (UMRA) of 1995,
2 U.S.C. 1532, DEA has determined that this action would not result in
any Federal mandate that may result ``in the expenditure by State,
local, and Tribal
[[Page 1695]]
governments, in the aggregate, or by the private sector, of
$100,000,000 or more (adjusted annually for inflation) in any 1 year .
. . .'' Therefore, neither a Small Government Agency Plan nor any other
action is required under UMRA of 1995.
Congressional Review Act
This rule is not a major rule as defined by the Congressional
Review Act (CRA), 5 U.S.C. 804. However, pursuant to the CRA, DEA is
submitting a copy of this rule to both Houses of Congress and to the
Comptroller General.
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, 21 CFR part 1308 is amended as
follows:
PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES
0
1. The authority citation for part 1308 continues to read as follows:
Authority: 21 U.S.C. 811, 812, 871(b), 956(b), unless otherwise
noted.
0
2. Amend Sec. 1308.11 by:
0
a. Redesignating paragraphs (f)(8) through (f)(13) as (f)(9) through
(f)(14); and
0
b. Adding a new paragraph (f)(8).
The addition reads as follows:
Sec. 1308.11 Schedule I.
* * * * *
(f) * * *
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(8) 4-Fluoroamphetamine (4-FA, 1-(4-fluorophenyl)propan-2- 1476
amine, para-fluoroamphetamine)...........................
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* * * * *
Signing Authority
This document of the Drug Enforcement Administration was signed on
January 8, 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. 2026-00633 Filed 1-14-26; 8:45 am]
BILLING CODE 4410-09-P
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</html>Indexed from Federal Register on January 15, 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.