Rule2026-08517
Schedules of Controlled Substances: Placement of 4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, and MMB-FUBICA 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 1, 2026
Effective
May 1, 2026
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
With the issuance of this final rule, the Drug Enforcement Administration places methyl 2-[[1-(4-fluorobutyl)indole-3- carbonyl]amino]-3,3-dimethyl-butanoate (other names: 4F-MDMB-BUTICA; 4F-MDMB-BICA), N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(pent-4-en-1- yl)-1H-indazole-3-carboxamide (other name: ADB-4en-PINACA), ethyl 2- [[1-(5-fluoropentyl)indole-3-carbonyl]amino]-3,3-dimethyl-butanoate (other names: 5F-EDMB-PICA; 5F-EDMB-2201), and methyl 2-(1-(4- fluorobenzyl)-1H-indole-3-carboxamido)-3-methyl butanoate (other name: MMB-FUBICA), including their salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible, in schedule I of the Controlled Substances Act. This action imposes 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 4F-MDMB-BUTICA, ADB- 4en-PINACA, 5F-EDMB-PICA, or MMB-FUBICA.
Full Text
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<title>Federal Register, Volume 91 Issue 84 (Friday, May 1, 2026)</title>
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[Federal Register Volume 91, Number 84 (Friday, May 1, 2026)]
[Rules and Regulations]
[Pages 23359-23363]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-08517]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-1604]
Schedules of Controlled Substances: Placement of 4F-MDMB-BUTICA,
ADB-4en-PINACA, 5F-EDMB-PICA, and MMB-FUBICA 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 methyl 2-[[1-(4-fluorobutyl)indole-3-
carbonyl]amino]-3,3-dimethyl-butanoate (other names: 4F-MDMB-BUTICA;
4F-MDMB-BICA), N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(pent-4-en-1-
yl)-1H-indazole-3-carboxamide (other name: ADB-4en-PINACA), ethyl 2-
[[1-(5-fluoropentyl)indole-3-carbonyl]amino]-3,3-dimethyl-butanoate
(other names: 5F-EDMB-PICA; 5F-EDMB-2201), and methyl 2-(1-(4-
fluorobenzyl)-1H-indole-3-carboxamido)-3-methyl butanoate (other name:
MMB-FUBICA), including their salts, isomers, and salts of isomers
whenever the existence of such salts, isomers, and salts of isomers is
possible, in schedule I of the Controlled Substances Act. This action
imposes 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 4F-MDMB-BUTICA, ADB-
4en-PINACA, 5F-EDMB-PICA, or MMB-FUBICA.
DATES: Effective date: May 1, 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: In this final rule, the Drug Enforcement
Administration (DEA) permanently places the following four substances
in schedule I of the Controlled Substances Act (CSA), including their
salts, isomers, and salts of isomers, whenever the existence of such
salts, isomers, and salts of isomers is possible within the specific
chemical designation:
<bullet> methyl 2-[[1-(4-fluorobutyl)indole-3-carbonyl]amino]-3,3-
dimethyl-butanoate (other names: 4F-MDMB-BUTICA; 4F-MDMB-BICA),
<bullet> N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(pent-4-en-1-
yl)-1H-indazole-3-carboxamide (other name: ADB-4en-PINACA),
<bullet> ethyl 2-[[1-(5-fluoropentyl)indole-3-carbonyl]amino]-3,3-
dimethyl-butanoate (other names: 5F-EDMB-PICA; 5F-EDMB-2201), and,
<bullet> methyl 2-(1-(4-fluorobenzyl)-1H-indole-3-carboxamido)-3-
methyl butanoate (other name: MMB-FUBICA).
Legal Authority
Pursuant to 21 U.S.C. 811(a)(1) and (2), the Attorney General (as
delegated to the Administrator of the DEA pursuant to 28 CFR 0.100)
may, by rule, and upon the recommendation of the Secretary of Health
and Human Services, 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.
[[Page 23360]]
812(b) for the schedule in which such drug or other substance is to be
placed.
Background
The neurochemical effects of 4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-
EDMB-PICA, and MMB-FUBICA occur primarily through cannabinoid receptor
systems in the brain. 4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, and
MMB-FUBICA bind to cannabinoid subtype 1 (CB1) receptors, function as
full agonists, and have a binding affinity and functional activity
profile that is similar to that of other schedule I cannabinoids,
including [Delta]9-THC, JWH-018, XLR11, and AKB-48.
DEA published an order in the Federal Register on December 12,
2023, temporarily placing 4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA,
and MMB-FUBICA in schedule I of the CSA based upon a finding that these
substances pose an imminent hazard to the public safety under 21 U.S.C.
811(h)(1).\1\ That temporary order was effective upon the date of
publication. On December 10, 2025, the DEA Administrator signed a
temporary scheduling order to extend the temporary schedule I status of
4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, and MMB-FUBICA for one
year, or until the permanent scheduling action for these substances are
completed, whichever occurs first.\2\
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\1\ Schedules of Controlled Substances: Temporary Placement of
MDMB-4en-PINACA, 4F-MDMB-BUTICA, ADB-4en-PINACA, CUMYL-PEGACLONE,
5F-EDMB-PICA, and MMB-FUBICA into Schedule I, 88 FR 86040 (Dec. 12,
2023).
\2\ Schedules of Controlled Substances: Extension of Temporary
Placement of 4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, and MMB-
FUBICA in Schedule I of the Controlled Substances Act, 90 FR 58149
(Dec. 16, 2025).
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DEA and HHS Eight-Factor Analyses
In a letter dated December 3, 2025, in accordance with 21 U.S.C.
811(b), and in response to DEA's April 15, 2025 request, the Department
of Health and Human Services (HHS) provided to DEA a scientific and
medical evaluation and scheduling recommendation for 4F-MDMB-BUTICA,
ADB-4en-PINACA, 5F-EDMB-PICA, and MMB-FUBICA. 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. 811(b)(1), that 4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-
EDMB-PICA, and MMB-FUBICA warrant control in schedule I. Both DEA and
HHS's 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-1604.
Notice of Proposed Rulemaking To Schedule 4F-MDMB-BUTICA, ADB-4en-
PINACA, 5F-EDMB-PICA, and MMB-FUBICA
On December 10, 2025, the DEA Administrator signed a notice of
proposed rulemaking (NPRM) to permanently control 4F-MDMB-BUTICA, ADB-
4en-PINACA, 5F-EDMB-PICA, and MMB-FUBICA in schedule I.\3\
Specifically, DEA proposed to add 4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-
EDMB-PICA, and MMB-FUBICA to the list of hallucinogenic substances
under 21 CFR 1308.11(d). The NPRM provided an opportunity for
interested persons to file a request for hearing in accordance with DEA
regulations on or before January 15, 2026. DEA did not receive any
requests for a hearing. The NPRM also provided an opportunity for
interested persons to submit comments on or before January 15, 2026.
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\3\ Schedules of Controlled Substances: Placement of 4F-MDMB-
BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, and MMB-FUBICA in Schedule I,
90 FR 58174 (Dec. 16, 2025).
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Comments Received
DEA received one comment in response to the NPRM that was not
related to the rulemaking for the placement of 4F-MDMB-BUTICA, ADB-4en-
PINACA, 5F-EDMB-PICA, and MMB-FUBICA into schedule I of the CSA.
Comment that was not related to this rulemaking: DEA received one
comment that was neither explicitly for nor against the proposed rule.
This comment discussed marijuana and was not related to the current
scheduling action.
DEA Response: This comment was outside the scope of the current
scheduling action; therefore, it was not considered.
Scheduling Conclusion
After consideration of the public comment, 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 4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, and MMB-FUBICA.
As such, DEA is permanently scheduling 4F-MDMB-BUTICA, ADB-4en-PINACA,
5F-EDMB-PICA, and MMB-FUBICA as controlled substances under schedule I
of the CSA.
Determination of Appropriate Schedule
The CSA establishes five schedules of controlled substances known
as schedules I, II, II, IV, and V. The CSA also specifies the findings
requires 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) 4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, and MMB-FUBICA
have a high potential for abuse that is comparable to other scheduled
synthetic cannabinoids, such as JWH-018, XLR11, and AKB-48. In vitro
studies demonstrate that 4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA,
and MMB-FUBICA bind to CB1 receptors and function as full agonists. In
drug discrimination studies conducted in animals to evaluate its
discriminative stimulus effects, 4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-
EDMB-PICA, and MMB-FUBICA were shown to fully substitute for the
discriminative stimulus effects produced by delta 9-THC. The ingestion
of 4F-MDMB-BUTICA, ADB-4en-PINACA, or 5F-EDMB-PICA has been documented
to result in serious adverse effects, including poisonings and deaths.
Based upon results from in vitro and in vivo studies, and its
similarity to other schedule I synthetic cannabinoids, MMB-FUBICA in
particular would be expected to cause similar serious adverse effects
following its ingestion.
(2) 4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, and MMB-FUBICA
have no currently accepted medical use in treatment in the United
States. In HHS's 2025 recommendation to control 4F-MDMB-BUTICA, ADB-
4en-PINACA, 5F-EDMB-PICA, and MMB-FUBICA, it was noted there are no
approved New Drug Applications and no known therapeutic applications
for these substances in the United States. DEA is not aware of any
other evidence suggesting that 4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-
PICA, or MMB-FUBICA have a currently accepted medical use in treatment
in the United States.\4\
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\4\ To place a drug or other substance in schedule I under the
CSA, DEA must consider whether the substance has a currently
accepted medical use in treatment in the United States. 21 U.S.C.
812(b)(1)(B). 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 a drug or substance that has not been
approved by the FDA: (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'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 final rule, there is no evidence that health care
providers have widespread experience with medical use of 4F-MDMB-
BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, or MMB-FUBICA, or that the use
of 4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, or MMB-FUBICA is
recognized by entities that regulate the practice of medicine, so
the two-part test also is not satisfied.
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[[Page 23361]]
(3) There is a lack of accepted safety for use of 4F-MDMB-BUTICA,
ADB-4en-PINACA, 5F-EDMB-PICA, and MMB-FUBICA under medical supervision.
Because 4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, and MMB-FUBICA
have no approved medical use and have not been investigated as new
drugs, their safety for use under medical supervision has not been
determined.
Based on these findings, the DEA Administrator concludes that 4F-
MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, and MMB-FUBICA, as well as
their salts, isomers, and salts of isomers whenever the existence of
such salts, isomers, and salts of isomers is possible, warrant control
in schedule I of the CSA.
Requirements for Handling 4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA,
and MMB-FUBICA
4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, and MMB-FUBICA are
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 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, 4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, or
MMB-FUBICA 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 4F-MDMB-BUTICA, ADB-4en-PINACA,
5F-EDMB-PICA, or MMB-FUBICA 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 4F-MDMB-
BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, or MMB-FUBICA as of May 1, 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 1, 2026, a person is conducting research on 4F-MDMB-BUTICA, ADB-
4en-PINACA, 5F-EDMB-PICA, or MMB-FUBICA and is already registered to
conduct research with another controlled substance in schedule I, the
person may continue to conduct research on 4F-MDMB-BUTICA, ADB-4en-
PINACA, 5F-EDMB-PICA, or MMB-FUBICA if they submit a completed
application for registration or modification of existing registration,
as applicable, to conduct research with 4F-MDMB-BUTICA, ADB-4en-PINACA,
5F-EDMB-PICA, or MMB-FUBICA not later than 90 calendar days after May
1, 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 4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, or MMB-
FUBICA and may not receive or otherwise obtain additional 4F-MDMB-
BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, or MMB-FUBICA. 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 4F-MDMB-
BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, or MMB-FUBICA, receipt of the
copy by the manufacturer or distributor constitutes sufficient evidence
that the person is authorized to receive 4F-MDMB-BUTICA, ADB-4en-
PINACA, 5F-EDMB-PICA, or MMB-FUBICA 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 4F-MDMB-BUTICA, ADB-4en-PINACA,
5F-EDMB-PICA, or MMB-FUBICA.
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 4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, or MMB-
FUBICA 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. 4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-
PICA, and MMB-FUBICA 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. 4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, and MMB-
FUBICA are 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. Non-practitioners handling 4F-MDMB-BUTICA, ADB-
4en-PINACA, 5F-EDMB-PICA, or MMB-FUBICA 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 4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA,
and MMB-FUBICA 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 4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, or MMB-FUBICA
in accordance with a quota assigned pursuant to 21 U.S.C. 826, and in
accordance with 21 CFR part 1303.
[[Page 23362]]
6. Inventory. Every DEA registrant who possesses any quantity of
4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, or MMB-FUBICA must take
an inventory of 4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, and MMB-
FUBICA 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 4F-MDMB-BUTICA, ADB-4en-
PINACA, 5F-EDMB-PICA, and MMB-FUBICA) 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 4F-MDMB-BUTICA, ADB-
4en-PINACA, 5F-EDMB-PICA, and MMB-FUBICA) 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 4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA,
and MMB-FUBICA, or products containing 4F-MDMB-BUTICA, ADB-4en-PINACA,
5F-EDMB-PICA, and MMB-FUBICA, 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 4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, and MMB-FUBICA
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. Every DEA registrant who distributes 4F-MDMB-
BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, or MMB-FUBICA 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
4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, or MMB-FUBICA 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 4F-MDMB-BUTICA, ADB-4en-
PINACA, 5F-EDMB-PICA, or MMB-FUBICA 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 in 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, minimize litigation, provide a clear legal standard for
affected conduct, and promote simplification and burden reduction.
Executive Order 13132, Federalism
This rulemaking does not have federalism implications warranting
the application of E.O. 13132. The rule does not have substantial
direct effects on the states, on the relationship between the National
Government and the States, or 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.
Paperwork Reduction Act of 1995
This action does not impose a new collection or modify an existing
collection of information under the Paperwork Reduction Act of 1995.\5\
Also, this rule does not impose new or modify existing recordkeeping or
reporting requirements on state or local governments, individuals,
businesses, or organizations. However, this rule would require
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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\5\ 44 U.S.C. 3501-3521.
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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 methyl 2-[[1-(4-fluorobutyl)indole-3-
carbonyl]amino]-3,3-dimethyl-butanoate (other names: 4F-MDMB-BUTICA;
4F-MDMB-BICA), N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(pent-4-en-1-
yl)-1H-indazole-3-carboxamide (other name: ADB-4en-PINACA), ethyl 2-
[[1-(5-fluoropentyl)indole-3-carbonyl]amino]-3,3-dimethyl-butanoate
(other names: 5F-EDMB-PICA; 5F-EDMB-2201), and methyl 2-(1-(4-
fluorobenzyl)-1H-indole-3-carboxamido)-3-methyl butanoate (other name:
MMB-FUBICA), including their salts, isomers, and salts of isomers, in
schedule I of the CSA. 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 4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, or MMB-
FUBICA.
Based on the review of HHS's scientific and medical evaluation and
all other relevant data, DEA determined that 4F-MDMB-BUTICA, ADB-4en-
PINACA, 5F-EDMB-PICA, and MMB-FUBICA have a high potential for abuse,
have no currently accepted medical use in treatment in the United
States, and lack accepted safety for use under medical supervision.
There appear to be no legitimate sources for 4F-MDMB-BUTICA, ADB-4en-
PINACA, 5F-EDMB-PICA, and MMB-FUBICA as marketed drugs 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 4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-
PICA, or MMB-FUBICA from legitimate suppliers. Therefore, this final
rule will
[[Page 23363]]
not have a significant economic impact on a substantial number of small
entities.
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 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.
Determination To Make Rule Effective Immediately
The Administrative Procedure Act (APA) generally requires that
rules enacted in accordance with the procedures of 5 U.S.C. 553 to be
effective not less than 30 days after publication of the proposed
rule.\6\ However, the APA provides three exceptions for when an agency
may make a rule effective sooner than 30 days after publication,
including if the agency finds for good cause why the rule should be
effective sooner and publishes those reasons with the rule.\7\
---------------------------------------------------------------------------
\6\ 5 U.S.C. 553(d).
\7\ 5 U.S.C. 553(d)(3).
---------------------------------------------------------------------------
DEA finds that there is good cause for this scheduling action to be
immediately effective upon publication because a delay in the effective
date is unnecessary and contrary to the public interest. First, it is
unnecessary because 4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, and
MMB-FUBICA are currently listed in schedule I of the CSA under 21
U.S.C. 811(h).\8\ Second, as discussed in the temporary scheduling
order and NPRM, 4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, and MMB-
FUBICA pose imminent hazards to public safety. Therefore, DEA believes
it is unnecessary and contrary to the public interest to delay the
effectiveness of this final rule by 30 days.\9\
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\8\ Schedules of Controlled Substances: Temporary Placement of
MDMB-4en-PINACA, 4F-MDMB-BUTICA, ADB-4en-PINACA, CUMYL-PEGACLONE,
5F-EDMB-PICA, and MMB-FUBICA into Schedule I, 88 FR 86040 (Dec. 12,
2023); Schedules of Controlled Substances: Extension of Temporary
Placement of 4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, and MMB-
FUBICA in Schedule I of the Controlled Substances Act, 90 FR 58149
(Dec. 16, 2025).
\9\ See, e.g., Schedules of Controlled Substances: Placement of
beta-Hydroxythiofentanyl in Schedule I, 84 FR 20023, 20027 (May 8,
2019); Schedules of Controlled Substances: Placement of UR-144,
XLR11, and AKB48 into Schedule I, 81 FR 29142, 29144 (May 11, 2016);
accord Schedules of Controlled Substances: Placement of Seven
Specific Fentanyl-Related Substances in Schedule I, 90 FR 44979
(Sept. 18, 2025); Schedules of Controlled Substances: Placement of
Nine Specific Fentanyl-Related Substances in Schedule I, 88 FR 85104
(Dec. 7, 2023).
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List of Subjects in 21 CFR Part 1308
Administrative practice and procedure, Drug traffic control,
Reporting and record keeping 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:
0
a. Add paragraphs (d)(111) through (114).
0
b. Remove and reserve paragraphs (h)(63), (64), (66), and (67).
The additions read as follows:
Sec. 1308.11 Schedule I.
* * * * *
(d) * * *
------------------------------------------------------------------------
------------------------------------------------------------------------
* * * * * * *
(111) Methyl 2-[[1-(4-fluorobutyl)indole-3-carbonyl]amino]-3,3- 7091
dimethyl-butanoate (other names: 4F-MDMB-BUTICA; 4F-MDMB-BICA)
(112) N-(1-Amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(pent-4-en-1- 7092
yl)-1H-indazole-3-carboxamide (other name: ADB-4en-PINACA)....
(113) Ethyl 2-[[1-(5-fluoropentyl)indole-3-carbonyl]amino]-3,3- 7094
dimethyl-butanoate (other names: 5F-EDMB-PICA; 5F-EDMB-2201)..
(114) Methyl 2-(1-(4-fluorobenzyl)-1H-indole-3-carboxamido)-3- 7095
methyl butanoate (other name: MMB-FUBICA).....................
------------------------------------------------------------------------
* * * * *
Signing Authority
This document of the Drug Enforcement Administration was signed on
March 23, 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. 2026-08517 Filed 4-30-26; 8:45 am]
BILLING CODE 4410-09-P
</pre></body>
</html>Indexed from Federal Register on May 1, 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.