Proposed Rule2025-22963
Schedules of Controlled Substances: Placement of 4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, and MMB-FUBICA in Schedule I
Primary source
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Published
December 16, 2025
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
The Drug Enforcement Administration proposes placing methyl 2- [[1-(4-fluorobutyl)indole-3-carbonyl]amino]-3,3-dimethylbutanoate (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 (including optical, positional, and geometric isomers), and salts of isomers, in schedule I of the Controlled Substances Act. 4F- MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, and MMB-FUBICA were temporarily scheduled in an order dated December 12, 2023. If finalized, this action would make permanent the existing 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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[Federal Register Volume 90, Number 239 (Tuesday, December 16, 2025)]
[Proposed Rules]
[Pages 58174-58181]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-22963]
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Proposed Rules
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
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Federal Register / Vol. 90, No. 239 / Tuesday, December 16, 2025 /
Proposed Rules
[[Page 58174]]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA1604]
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: Notice of proposed rulemaking.
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SUMMARY: The Drug Enforcement Administration proposes placing methyl 2-
[[1-(4-fluorobutyl)indole-3-carbonyl]amino]-3,3-dimethylbutanoate
(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 (including optical, positional, and geometric isomers), and
salts of isomers, in schedule I of the Controlled Substances Act. 4F-
MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, and MMB-FUBICA were
temporarily scheduled in an order dated December 12, 2023. If
finalized, this action would make permanent the existing 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: Comments must be submitted electronically or postmarked on or
before January 15, 2026. The electronic Federal Docket Management
System will not accept comments after 11:59 p.m. Eastern Time on the
last day of the comment period.
Interested persons may file a request for a hearing or waiver of
hearing pursuant to 21 CFR 1308.44 and in accordance with 21 CFR
1316.47 and/or 1316.49, as applicable. Requests for a hearing and
waivers of an opportunity for a hearing or to participate in a hearing,
together with a written statement of position on the matters of fact
and law asserted in the hearing, must be received or postmarked on or
before January 15, 2026.
ADDRESSES: Interested persons may file written comments on this
proposal in accordance with 21 CFR 1308.43(g). To ensure proper
handling of comments, please reference ``Docket No. DEA1064'' on all
electronic and written correspondence, including any attachments.
<bullet> Electronic comments: The Drug Enforcement Administration
(DEA) encourages commenters to submit comments electronically through
the Federal eRulemaking Portal, which provides the ability to type
short comments directly into the comment field on the web page or
attach a file for lengthier comments. Please go to <a href="http://www.regulations.gov">http://www.regulations.gov</a> and follow the online instructions at that site for
submitting comments. Upon completion of your submission, you will
receive a Comment Tracking Number. If you have received a Comment
Tracking Number, your comment has been successfully submitted and there
is no need to resubmit the same comment. Commenters should be aware
that the electronic Federal Docket Management System will not accept
comments after 11:59 p.m. Eastern Time on the last day of the comment
period.
<bullet> Paper comments: Paper comments that duplicate the
electronic submissions are not necessary and are discouraged. Should
you wish to mail a paper comment in lieu of an electronic comment, it
should be sent via regular or express mail to: Drug Enforcement
Administration, Attn: DEA Federal Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia 22152.
<bullet> Hearing requests: All requests for a hearing and waivers
of participation, together with a written statement of position on the
matters of fact and law asserted in the hearing, must be filed with the
DEA Administrator, who will make the determination of whether a hearing
will be needed to address such matters of fact and law in the
rulemaking. Such requests must be sent to: Drug Enforcement
Administration, Attn: Administrator, 8701 Morrissette Drive,
Springfield, Virginia 22152. For informational purposes, a courtesy
copy of requests for hearing and waivers of participation should also
be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/
OALJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug
Enforcement Administration, Attn: DEA Federal Register Representative/
DPW, 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; Telephone: (571) 362-3249.
As required by 5 U.S.C. 553(b)(4), a summary of this proposed rule
may be found in the docket for this rulemaking at <a href="http://www.regulations.gov">www.regulations.gov</a>.
SUPPLEMENTARY INFORMATION: The Drug Enforcement Administration (DEA)
proposes to permanently schedule the following four controlled
substances in schedule I of the Controlled Substances Act (CSA),
including their salts, isomers (including optical, positional, and
geometric 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-
dimethylbutanoate (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).
Posting of Public Comments
All comments received in response to this docket are considered
part of the public record. DEA will make comments available for public
inspection online at
[[Page 58175]]
<a href="http://www.regulations.gov">http://www.regulations.gov</a>, unless reasonable cause is given. Such
information includes personal or business identifiers (such as name,
address, state of federal identifiers, etc.) voluntarily submitted by
the commenter.
Commenters submitting comments which include personal identifying
information (PII), confidential, or proprietary business information
that the commenter does not want to be made publicly available should
submit two copies of the comment. One copy must be marked ``CONTAINS
CONFIDENTIAL INFORMATION'' and should clearly identify all PII or
business information the commenter does not want to be made publicly
available, including any supplemental materials. DEA will review this
copy, including the claimed PII and confidential business information,
in its consideration of comments. The second copy should be marked ``TO
BE PUBLICLY POSTED'' and must have all claimed confidential PII and
business information already redacted. DEA will post only the redacted
comment on <a href="http://www.regulations.gov">http://www.regulations.gov</a> for public inspection. DEA
generally will not redact additional information contained in the
comment marked ``TO BE PUBLICLY POSTED.'' The Freedom of Information
Act applies to all comments received.
For easy reference, an electronic copy of this document and
supplemental information to this proposed scheduling action are
available at <a href="http://www.regulations.gov">http://www.regulations.gov</a>.
Request for Hearing or Appearance; Waiver
Pursuant to 21 U.S.C. 811(a), this action is a formal rulemaking
``on the record after opportunity for a hearing.'' Such proceedings are
conducted pursuant to the provisions of the Administrative Procedure
Act (APA).\1\ Interested persons, as defined in 21 CFR 1300.01(b), may
file requests for a hearing in conformity with the requirements of 21
CFR 1308.44(a) and 1316.47(a), and such requests must:
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\1\ 5 U.S.C. 551-559; 21 CFR 1308.41-1308.45; 21 CFR part 1316,
subpart D.
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(1) state with particularity the interest of the person in the
proceeding;
(2) state with particularity the objections or issues concerning
which the person desires to be heard; and
(3) state briefly the position of the person regarding the
objections or issues.
Any interested person may file a waiver of an opportunity for a
hearing or to participate in a hearing in conformity with the
requirements of 21 CFR 1308.44(c), together with a written statement of
position on the matters of fact and law involved in any hearing.\2\
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\2\ 21 CFR 1316.49.
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All requests for a hearing and waivers of participation, together
with a written statement of position on the matters of fact and law
involved in such hearing, must be sent to DEA using the address
information provided above. The decision whether a hearing will be
needed to address such matters of fact and law in the rulemaking will
be made by the Administrator. If a hearing is needed, DEA will publish
a notice of hearing on the proposed rulemaking in the Federal
Register.\3\ Further, once the Administrator determines a hearing is
needed to address such matters of fact and law in rulemaking, he will
then designate an Administrative Law Judge (ALJ) to preside over the
hearing. The ALJ's functions shall commence upon designation, as
provided in 21 CFR 1316.52.
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\3\ 21 CFR 1308.44(b), 1316.53.
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In accordance with 21 U.S.C. 811 and 812, the purpose of a hearing
would be to determine whether 4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-
PICA, or MMB-FUBICA meet the statutory criteria for placement in
schedule I, as proposed in this rulemaking.
Legal Authority
The CSA provides that proceedings for the issuance, amendment, or
repeal of the scheduling of any drug or other substance may be
initiated by the Attorney General (delegated to the Administrator of
DEA pursuant to 28 CFR 0.100) on her own motion, at the request of the
Secretary of Health and Human Services (HHS), or on the petition of an
interested party.\4\ This proposed action is initiated on the
Administrator's own motion and supported by, inter alia, a
recommendation from the then-Assistant Secretary for Health of the HHS
(Assistant Secretary) and an evaluation of all other relevant data by
DEA. If finalized, this action would make permanent the existing
temporary regulatory controls and administrative, civil, and criminal
sanctions of schedule I controlled substances on any person who handles
or proposes to handle 4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, and
MMB-FUBICA.
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\4\ 21 U.S.C. 811(a).
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Background
On December 12, 2023, pursuant to 21 U.S.C. 811(h)(1), the previous
Administrator published an order in the Federal Register temporarily
placing six synthetic cannabinoids (SCs) in schedule I of the CSA based
on the finding that these substances pose an imminent threat to public
safety.\5\ The six SCs temporarily controlled under the CSA included
the four SCs that are the subject of this proposed rulemaking, as well
as methyl 3,3-dimethyl-2-(1-(pent-4-en-1-yl)-1H-indazole-3-
carboxamido)butanoate (other name: MDMB-4en-PINACA), and 5-pentyl-2-(2-
phenylpropan-2-yl)pyrido[4,3-b]indol-1-one (other names: CUMYL-
PEGACLONE; SGT-151). These six SCs have not been investigated for
medical use. Nor are they intended for human use. This proposed
rulemaking focuses on 4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, and
MMB-FUBICA only.
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\5\ 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).
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Pursuant to 21 U.S.C. 811(b), DEA gathered the necessary data on
4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, and MMB-FUBICA and, on
April 15, 2025, submitted it to the then-Assistant Secretary for Health
of HHS with a request for a scientific and medical evaluation of
available information and a scheduling recommendation for 4F-MDMB-
BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, and MMB-FUBICA.
On December 3, 2025, HHS provided DEA a scientific and medical
evaluation entitled, ``Basis for the Recommendation to Place 4F-MDMB-
BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, and MMB-FUBICA and their salts in
Schedule I of the Controlled Substances Act,'' and a scheduling
recommendation. Pursuant to 21 U.S.C. 811(b), following consideration
of the eight factors and findings related to the substance's abuse
potential, legitimate medical use, and dependence liability, HHS
recommended that 4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, and MMB-
FUBICA be controlled in schedule I of the CSA under 21 U.S.C. 812(b).
HHS noted that 4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, and MMB-
FUBICA are full agonists at the cannabinoid type 1 (CB1) receptor, have
no known medical use in the United States, have no approved new drug
applications, and are not known to be marketed anywhere in the world as
an approved drug product. HHS also noted that health care practitioners
and medical examiners have reported cases of severe clinical adverse
events and even death when 4F-MDMB-BUTICA and 5F-EDMB-PICA was
ingested.
[[Page 58176]]
Proposed Determination To Permanently Schedule 4F-MDMB-BUTICA, ADB-4en-
PINACA, 5F-EDMB-PICA, and MMB-FUBICA
As discussed above in the background section, the Administrator is
initiating proceedings, pursuant to 21 U.S.C. 811(a), to permanently
add 4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, and MMB-FUBICA to
schedule I. DEA reviewed the scientific and medical evaluation and
scheduling recommendation provided by HHS, all other relevant data, and
conducted its own eight-factor analysis in accordance with 21 U.S.C.
811(c). Included below is a brief summary of each factor as analyzed by
HHS and DEA in their respective eight-factor analyses, and as
considered by DEA in this proposed scheduling determination. Please
note that both the DEA and HHS analyses, including the evaluation of
the eight factors determinative of control along with their supporting
data and citations, are available in their entirety under the tab
``Supporting Documents'' of the public docket of this proposed rule at
<a href="https://www.regulations.gov">https://www.regulations.gov</a>, under docket number ``DEA1064.''
1. The Drug's Actual or Relative Potential for Abuse
In addition to considering the information HHS provided in its
scientific and medical evaluation document for 4F-MDMB-BUTICA, ADB-4en-
PINACA, 5F-EDMB-PICA, and MMB-FUBICA, DEA also considered all other
relevant data regarding actual or relative potential for abuse of 4F-
MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, and MMB-FUBICA. The term
``abuse'' is not defined in the CSA; however, the legislative history
of the CSA suggests the following four prongs in determining whether a
particular drug or substances has a potential for abuse: \6\
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\6\ Comprehensive Drug Abuse Prevention and Control Act of 1970,
H.R. Rep. No. 91-1444, 91st Cong., Sess. 1 (1970); reprinted in 1970
U.S.C.C.A.N. 4566, 4603.
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a. There is evidence that individuals are taking the drug or drugs
containing such a substance in amounts sufficient to create a hazard to
their health or to the safety of other individuals or of the community;
or
b. There is a significant diversion of the drug or substance from
legitimate drug channels; or
c. Individuals are taking the drug or drugs containing such a
substance on their own initiative rather than on the basis of medical
advice from a practitioner licensed by law to administer such drugs in
the course of his professional practice; or
d. The drug or drugs containing such a substance are new drugs so
related in their action to a drug or drugs already listed as having a
potential for abuse to make it likely that the drug will have the same
potentiality for abuse as such drugs, thus making it reasonable to
assume that there may be significant diversions from legitimate
channels, significant use contrary to or without medical advice, or
that it has a substantial capability of creating hazards to the health
of the user or to the safety of the community.
Both DEA and HHS eight-factor analyses found that the abuse of 4F-
MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, and MMB-FUBICA is creating a
hazard to the health and safety of both the individual users and others
within the community. These four SCs produce pharmacological effects,
including adverse effects, that are similar to those produced by other
schedule I SCs, such as JWH-018, FUB-AMB, and ADB-PINACA. In its letter
dated March 7, 2022, HHS stated that there are no Food and Drug
Administration (FDA)-approved drug products containing 4F-MDMB-BUTICA,
ADB-4en-PINACA, 5F-EDMB-PICA, and MMB-FUBICA in the United States, and
there appear to be no legitimate sources for these substances as
marketed drugs.
Overall, data demonstrate that 4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-
EDMB-PICA, and MMB-FUBICA have a high potential for abuse. Thus, based
on these data, it is reasonable to conclude that 4F-MDMB-BUTICA, ADB-
4en-PINACA, 5F-EDMB-PICA, and MMB-FUBICA, having no medical use, and
thus no therapeutic value, present a hazard to the health and safety of
individuals and the community.
2. Scientific Evidence of the Drug's Pharmacological Effects, if Known
As explained in HHS's and DEA's respective eight-factor analyses,
the available data indicate that 4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-
EDMB-PICA, and MMB-FUBICA produce pharmacological effects that are
similar to those produced by schedule I SCs, such as JWH-018, FUB-AMB,
and ADB-PINACA. Scientific studies demonstrate that, similar to other
schedule I SCs, 4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, and MMB-
FUBICA bind to cannabinoid subtype 1 (CB1) receptors and act as
agonists at CB1 receptors. Data also demonstrates that 4F-MDMB-BUTICA,
ADB-4en-PINACA, 5F-EDMB-PICA, and MMB-FUBICA produce discriminative
stimulus effects that are similar to SCs that have been encountered
within the United States. SCs are substances synthesized in
laboratories that mimic the biological effects of the schedule I
hallucinogen delta-9-tetrahydrocannabinol (THC), the main psychoactive
component in marijuana (schedule I). SCs were introduced to the
designer drug market in several European countries as ``herbal
incense'' before the initial encounter in the United States by U.S.
Customs and Border Protection in November 2008. From 2009 to the
present, misuse of SCs has increased in the United States. Law
enforcement has encountered SCs applied onto plant material and in
other designer drug products intended for human consumption.
4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, and MMB-FUBICA have
not been investigated for medical use, and they are not intended for
human use. With no known legitimate use and safety information,
manufacturers are surreptitiously adulterating plant material with 4F-
MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, and/or MMB-FUBICA, and
distributors are selling the associated products which pose potentially
dangerous consequences to the consumer. The adulterated products, such
as ``Spice,'' ``K2,'' and many others, are marketed under the guise of
``herbal incense'' or ``potpourri'' products and as ``legal
alternatives to marijuana'' or ``legal high.'' Data from law
enforcement, health care practitioners, and scientific and medical
literature indicate that SC products are being abused for their
psychoactive properties in the absence of information regarding their
safety. There have been reports of adverse effects following abuse of
4F-MDMB-BUTICA and 5F-EDMB-PICA, similar to schedule I SCs (e.g., JWH-
018, FUB-AMB, and ADB-PINACA). These pharmacological characteristics of
4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, and MMB-FUBICA are
predictive of substances that have a high potential for abuse. Overall,
these data indicate that 4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA,
and MMB-FUBICA produces pharmacological effects and that are similar to
those of the JWH-018, FUB-AMB, and ADB-PINACA.
3. The State of Current Scientific Knowledge Regarding the Drug or
Other Substance
4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, and MMB-FUBICA are
structurally unrelated to THC, the principle psychoactive chemical in
marijuana. Rather, 4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-
[[Page 58177]]
EDMB-PICA, and MMB-FUBICA are potent SCs that are reported to be smoked
for recreational purposes. 4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-
PICA, and MMB-FUBICA are CB1 receptor agonists that are
pharmacologically similar to THC. Neither DEA nor HHS is aware of any
currently accepted medical use for 4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-
EDMB-PICA, or MMB-FUBICA. There are no well-controlled clinical studies
showing safety or efficacy for these substances. In addition, there is
no evidence by qualified experts that 4F-MDMB-BUTICA, ADB-4en-PINACA,
5F-EDMB-PICA, or MMB-FUBICA are accepted as having therapeutic uses.
4. History and Current Pattern of Abuse
SCs were developed by researchers over the last 30 years as tools
for investigating the endocannabinoid system. Since this first
encounter, law enforcement seizures, public health and published case
reports, and media reporting have demonstrated an increase in the use
and abuse of SCs. Law enforcement and public health officials in the
United States continue to encounter synthetic cannabinoids, including
4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, and MMB-FUBICA. According
to the National Forensic Laboratory Information System (NFLIS) data,
4F-MDMB-BUTICA was first identified in July 2020 within drug seizure
evidence, which was followed by 5F-EDMB-PICA (in December 2020), 4F-
MDMB-BUTICA (in February 2021), and ADB-4en-PINACA (in March 2021).\7\
The drug seizures reported by DEA, state and local laboratories, and
other federal agencies demonstrate that the four SCs are available for
illicit use. In its review, HHS concluded that law enforcement data are
suggestive of the illicit availability of the four SCs, which
demonstrates that there is a history and current pattern of abuse of
these drugs.
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\7\ NFLIS represents an important resource in monitoring illicit
drug trafficking, including the diversion of legally manufactured
pharmaceuticals into illegal markets. NFLIS is a comprehensive
information system that includes data from forensic laboratories
that handle more than 96% of an estimated 1.0 million distinct
annual State and local drug analysis cases. NFLIS includes drug
chemistry results from completed analyses only. While NFLIS data is
not direct evidence of abuse, it 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).
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5. Scope, Duration and Significance of Abuse
Evidence shows that 4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA,
and MMB-FUBICA are recreational drugs of abuse. HHS noted in its
recommendation that SCs continue to be encountered on the illicit
market despite scheduling actions that attempt to safeguard the public
from the adverse effects and safety issues associated with these
substances. Novel substances continue to be encountered that differ
only by small chemical structural modifications intended to avoid
prosecution, while maintaining the pharmacological effects. Law
enforcement and health care professionals continue to report the abuse
of these substances and their associated products. According to NFLIS,
there have been 568 encounters with 4F-MDMB-BUTICA, 403 encounters with
ADB-4en-PINACA, 130 encounters with 5F-EDMB-PICA, and 417 encounters
with MMB-FUBICA.\8\ Despite attempts to control SCs, illicit
manufacturers continue to make small chemical modifications to
substances that retain pharmacological activity at the CB1 receptor;
thus, they continue to be encountered on the illicit drug market. These
encounters of 4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, and MMB-
FUBICA by law enforcement indicate that these substances are being
trafficked and abused in the United States.
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\8\ NFLIS data were quired on October 22, 2025.
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6. What, if Any, Risk There Is to the Public Health
Available evidence on the overall public health risks associated
with the use of SCs demonstrate that their use can cause acute health
problems leading to emergency department admissions and death. Case
reports detailing serious adverse effects have been reported in the
literature (see additional details at <a href="https://www.regulations.gov">https://www.regulations.gov</a>
contained within DEA's eight-factor analysis at docket DEA-1604).
According to HHS, 4F-MDMB-BICA is reported to produce symptoms that are
similar to other SCs. In case reports of abusers that were tested and
found positive for SCs, 4F-MDMB-BICA was identified as contributing to
the reported SC-like adverse symptoms. Adverse health symptoms reported
from incidents involving 4F-MDMB-BICA include chest pain, respiratory
problems, tremor, and seizures. Multiple deaths have also been reported
following the ingestion of products containing 4F-MDMB-BICA or 5F-EDMB-
PICA. While no case reports have been identified regarding ADB-4en-
PINACA or MMB-FUBICA, due to their similar pharmacology to other
schedule I SCs, it is likely that they would share a similar adverse
effect profile.
7. Its Psychic or Physiological Dependence Liability
In its evaluation and recommendation, HHS noted that there are no
clinical studies evaluating dependence liabilities specific for 4F-
MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, and MMB-FUBICA. However,
scientific data indicate that 4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-
PICA, and MMB-FUBICA have a pharmacological profile that is similar to
other schedule I SCs. 4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, and
MMB-FUBICA bind to the CB1 receptor, function as agonists at the CB1
receptor, and have been shown to produce discriminative stimulus
effects that are similar to other schedule I SCs. Thus, it is
reasonable to conclude that the cannabinoid-like properties of 4F-MDMB-
BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, and MMB-FUBICA may produce a
psychic and/or physiological dependence liability that is similar to
other SCs already controlled in schedule I under the CSA, such as JWH-
018, FUB-AMB, and ADB-PINACA.
8. Whether the Substance is an Immediate Precursor of a Substance
Already Controlled Under the CSA
4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, and MMB-FUBICA are
not immediate precursors of any substance controlled under the CSA, as
defined in 21 U.S.C. 802(23).
Conclusion
After considering the scientific and medical evaluation conducted
by HHS, HHS's accompanying scheduling recommendation, and DEA's own
eight-factor analysis, DEA finds that these facts and all relevant data
constitute substantial evidence of the potential for abuse of 4F-MDMB-
BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, and MMB-FUBICA. As such, DEA
proposes to permanently schedule 4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-
EDMB-PICA, and MMB-FUBICA as schedule I controlled substances under the
CSA.
Proposed Determination of Appropriate Schedule
The CSA establishes five schedules of controlled substances known
as schedules I, II, III, IV, and V. The CSA also outlines the findings
required to place a drug or other substance in any particular
schedule.\9\ After consideration of the analysis and recommendation of
the Assistant Secretary for Health of HHS and review of all other
available data, the
[[Page 58178]]
Administrator of DEA, pursuant to 21 U.S.C. 811(a) and 812(b)(1), finds
that:
---------------------------------------------------------------------------
\9\ 21 U.S.C. 812(b).
---------------------------------------------------------------------------
(1) 4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, and MMB-FUBICA
have a high potential for abuse, evidenced in part by data from in
vitro binding affinity and functional activity studies, as well as by
data from in vivo drug discrimination tests in animals. In these
studies, 4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, and MMB-FUBICA
were demonstrated to be agonists at CB1 receptors, which is a mechanism
of action shared with other SCs substances with a high potential for
abuse and controlled in schedule I under the CSA. In summary, 4F-MDMB-
BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, and MMB-FUBICA have similar
patterns of drug abuse, as well as similar adverse outcomes as other
SCs currently controlled in schedule I of the CSA.
(2) 4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, and MMB-FUBICA
are not legally marketed in the United States, and FDA has not approved
a marketing application for a drug product containing 4F-MDMB-BUTICA,
ADB-4en-PINACA, 5F-EDMB-PICA, or MMB-FUBICA for any indication. There
are no known medically approved uses worldwide at this time for these
substances. Moreover, there are no adequate and well-controlled
clinical studies or petitioners, that claim an accepted medical use for
these substances in the United States. Thus, there is no evidence that
4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, or MMB-FUBICA has a
currently accepted medical use in treatment in the United States.\10\
---------------------------------------------------------------------------
\10\ Pursuant to 21 U.S.C. 812(b)(1)(B), when placing a drug or
substance in schedule I of the CSA, 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 a drug or substance to determine whether
a drug or substance has a currently 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'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 proposal, 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 these substances is recognized by entities that regulate the
practice of medicine, so the two-part test also is not satisfied.
---------------------------------------------------------------------------
(3) Because 4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, and MMB-
FUBICA have no approved medical use and have not been thoroughly
investigated as new drugs, their safety for use under medical
supervision has not been determined. Thus, there is a lack of accepted
safety for use of these substances under medical supervision.
Based on these findings, the Administrator concludes that 4F-MDMB-
BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, and MMB-FUBICA, including their
salts, isomers (including optical, positional, and geometric isomers),
and salts of isomers, warrant control in schedule I of the CSA.
Requirements for Handling 4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA,
and MMB-FUBICA
As discussed above, 4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA,
and MMB-FUBICA are currently subject to a temporary scheduling order,
which added them to schedule I. If this rule is finalized as proposed,
4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, and MMB-FUBICA would be
subject, on a permanent basis, to the CSA's schedule I regulatory
controls and administrative, civil, and criminal sanctions applicable
to the manufacture, distribution, reverse distribution, dispensing,
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,
dispenses, imports, exports, engages in research, or conducts
instructional activities or chemical analysis with, or possesses) 4F-
MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, or MMB-FUBICA 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.
2. 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. 821, 823, and in accordance
with 21 CFR 1301.71-1301.76. Non-practitioners handling these three
substances also must comply with the screening requirements of 21 CFR
1301.90-1301.93.
3. Labeling and Packaging. All labels and labeling 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 958(e), and be in accordance
with 21 CFR part 1302.
4. Quota. Only registered manufacturers would be permitted to
manufacture 4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, and MMB-
FUBICA in accordance with a quota assigned, pursuant to 21 U.S.C. 826,
and in accordance with 21 CFR part 1303.
5. Inventory. Any person registered with DEA to handle 4F-MDMB-
BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, and MMB-FUBICA must have an
initial inventory of all stocks of controlled substances (including
these substances) on hand on the date the registrant first engages in
the handling of controlled substances pursuant to 21 U.S.C. 827 and
958(e), and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11.
After the initial inventory, every DEA registrant must take a new
inventory of all stocks of 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 958(e), and in accordance with 21
CFR 1304.03, 1304.04, and 1304.11.
6. Records and Reports. Every DEA registrant must maintain records
and submit reports with respect to 4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-
EDMB-PICA, and MMB-FUBICA, pursuant to 21 U.S.C. 827, 832(a), and
958(e), and in accordance with 21 CFR 1301.74(b) and (c) and
1301.76(b), and parts 1304, 1312, and 1317. Manufacturers and
distributors would be required to 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 21 U.S.C. 827, and in
accordance with 21 CFR parts 1304 and 1312.
7. Order Forms. Every DEA registrant who distributes 4F-MDMB-
BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, and MMB-FUBICA must comply with
the order form requirements, pursuant to 21 U.S.C. 828 and 21 CFR part
1305.
[[Page 58179]]
8. Importation and Exportation. All importation and exportation of
4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, and MMB-FUBICA must be in
compliance with 21 U.S.C. 952, 953, 957, and 958, and in accordance
with 21 CFR part 1312.
9. Liability. Any activity involving 4F-MDMB-BUTICA, ADB-4en-
PINACA, 5F-EDMB-PICA, and MMB-FUBICA not authorized by, or in violation
of, the CSA or its implementing regulations would be 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 proposed scheduling
action is subject to formal rulemaking procedures done ``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 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,
Fighting Overcriminalization in Federal Regulations.
Executive Order 12988, Civil Justice Reform
This proposed 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 proposed rulemaking does not have federalism implications
warranting the application of E.O. 13132. The proposed rule does not
have substantial direct effects on the States, on the relationship
between the National Government and the States, or the distribution of
power and responsibilities among the various levels of government.
Executive Order 13175, Consultation and Coordination With Indian Tribal
Governments
This proposed 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, in accordance with the Regulatory Flexibility
Act, 5 U.S.C. 601-602, has reviewed this proposed rule and, by
approving it, certifies that it will not have a significant economic
impact on a substantial number of small entities.
On December 12, 2023, DEA published an order to temporarily place
4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, and MMB-FUBICA, including
their salts, isomers (including optical, positional, and geometric
isomers), and salts of isomers, in schedule I of the CSA pursuant to
the temporary scheduling provisions of 21 U.S.C. 811(h). DEA estimates
that all entities handling or planning to handle 4F-MDMB-BUTICA, ADB-
4en-PINACA, 5F-EDMB-PICA, and MMB-FUBICA have already established and
implemented systems and processes required to handle these substances.
If finalized, this action would make permanent the existing regulatory
controls and administrative, civil, and criminal sanctions applicable
to schedule I controlled substances on persons who handle (manufacture,
distribute, reverse distribute, dispense, 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, and MMB-FUBICA.
According to HHS, 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 lacks 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 drug in the United States, but DEA notes
that these substances are 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, DEA has concluded that
this proposed rule, if finalized, will not have a significant economic
impact on a substantial number of small entities.
---------------------------------------------------------------------------
\11\ Executive Office of the President Office of Management and
Budget, North American Industry Classification System, United
States, 2022, <a href="https://www.census.gov/naics/reference_files_tools/2022_NAICS_Manual.pdf">https://www.census.gov/naics/reference_files_tools/2022_NAICS_Manual.pdf</a>. (Accessed 9/25/2025).
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The entities affected by this proposed rule include the
manufacturers, distributors, importers, exporters, and researchers of
4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, and MMB-FUBICA. DEA
determines the North American Industry Classification System (NAICS)
industries that best represent these business activities. Table 1 lists
the business activities and corresponding NAICS industries.\11\
[[Page 58180]]
Table 1--Business Activity and Corresponding NAICS Industries
----------------------------------------------------------------------------------------------------------------
Business activity NAICS code NAICS industry description
----------------------------------------------------------------------------------------------------------------
Manufacturer.................................. 325412 Pharmaceutical Preparation Manufacturing.
Distributor, Importer, Exporter............... 424210 Drugs and Druggists' Sundries Merchant
424690 Wholesalers. Other Chemical and Allied Products
Merchant Wholesalers.
Researcher.................................... 541715 Research and Development in Physical,
611310 Engineering, and Life Sciences (except
Nanotechnology and Biotechnology) Colleges,
Universities and Professional Schools.
----------------------------------------------------------------------------------------------------------------
From Statistics of U.S. Businesses (SUSB) data, DEA determined the
number of firms and small firms for each of the affected industries,
and by comparing the number of affected small entities to the number of
small entities for each industry, DEA determined whether a substantial
number of small entities are affected in any of the industries. Table 2
lists the number of firms, small firms, and percent small firms in each
affected industry.
Table 2--Percent Affected Small Entities by Industry
----------------------------------------------------------------------------------------------------------------
Percent of
Small firms small
NAICS industry Firms \12\ SBA size standard \13\ \14\ entities
(%)
----------------------------------------------------------------------------------------------------------------
325412--Pharmaceutical Preparation 1,179 1,300 employees.................. 1,099 93.2
Manufacturing.
424210--Drugs and Druggists' Sundries 7,012 250 employees.................... 6,760 96.4
Merchant Wholesalers.
424690--Other Chemical and Allied 5,487 175 employees.................... 5,197 94.7
Products Merchant Wholesalers.
541715--Research and Development in 10,042 1,000 employees.................. 9,599 95.6
the Physical, Engineering, and Life
Sciences (except Nanotechnology and
Biotechnology).
611310--Colleges, Universities and 2,494 $34.5 million.................... 1,515 60.8
Professional Schools.
----------------------------------------------------------------------------------------------------------------
Based on the American Chemical Society's SciFinder database,\15\
DEA identified 11 entities supplying 4F-MDMB-BUTICA, ADB-4en-PINACA,
5F-EDMB-PICA, or MMB-FUBICA across the industries 325412, 424210, and
424690. However, one entity has already registered with DEA to handle
controlled substances. Hence, DEA expects only 10 of the entities in
the 325412, 424210, and 424690 industries will be affected by this
rule. Assuming that all affected suppliers were small entities and
concentrated in the smallest NAICS industry, 325412--Pharmaceutical
Preparation Manufacturing, they would account for insubstantial number
of small entities in that industry, 0.91 percent.\16\
---------------------------------------------------------------------------
\12\ Statistics of U.S. Businesses, 2022 SUSB Annual Data Tables
by Establishment Industry, <a href="https://www.census.gov/data/tables/2021/econ/susb/2021-susb-annual.html">https://www.census.gov/data/tables/2021/econ/susb/2021-susb-annual.html</a> (Accessed 9/25/2025).
\13\ U.S. Small Business Administration, Table of size
standards, Version March 2023, Effective: March 17, 2023, <a href="https://www.sba.gov/sites/default/files/2023-06/Table%20of%20Size%20Standards_Effective%20March%2017%2C%202023%20%282%29.pdf">https://www.sba.gov/sites/default/files/2023-06/Table%20of%20Size%20Standards_Effective%20March%2017%2C%202023%20%282%29.pdf</a> (Accessed 9/25/2025).
\14\ Based on the estimated number of firms below the SBA size
standard for each industry.
\15\ SciFinder; Chemical Abstracts Service: Columbus, OH; CAS
2504100-70-1; <a href="https://scifinder.cas.org">https://scifinder.cas.org</a> (accessed September 24,
2025).
\16\ 10/1,099 = 0.91%.
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Additionally, DEA expects that the number of researchers working
with 4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, and/or MMB-FUBICA is
small, because 4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, and MMB-
FUBICA are not approved for medical use and have a substantial
capability to be a hazard to the health of the user and to the safety
of the community. Also, DEA believes that the researchers working with
4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, and/or MMB-FUBICA may
also work with other controlled substances; hence, these researchers
are likely already registered with DEA and are qualified to handle
controlled substances. For these reasons, DEA believes the number of
affected researchers that are small entities is not a substantial
number of small entities in 541715 and 611310 industries.
In summary, the small entities affected by this proposed rule are
those in 325412--Pharmaceutical Preparation Manufacturing, 424210--
Drugs and Druggists' Sundries Merchant Wholesalers, and 424690--Other
Chemical and Allied Products Merchant Wholesalers. The affected small
entities account for less than 0.91 percent of small businesses and are
not likely to manufacture or carry inventory of 4F-MDMB-BUTICA, ADB-
4en-PINACA, 5F-EDMB-PICA, or MMB-FUBICA. As such, the proposed rule, if
finalized, is not expected to result in 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 and certifies 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.
Paperwork Reduction Act of 1995
This proposed rule would not impose a new collection or modify an
existing collection of information under the Paperwork Reduction Act of
1995.\17\ Also, this proposed rule would not impose new or modify
existing recordkeeping or reporting requirements on State or local
governments, individuals, businesses, or organizations. However, this
proposed 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.
---------------------------------------------------------------------------
\17\ 44 U.S.C. 3501-3521.
---------------------------------------------------------------------------
List of Subjects in 21 CFR Part 1308
Administrative practice and procedure, Drug traffic control,
[[Page 58181]]
Reporting and recordkeeping requirements.
For the reasons set out above, DEA proposes to amend 21 CFR part
1308 as follows:
PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES
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 new paragraphs (d)(106-109) to read as follows:
0
b. Remove and reserve paragraphs (h)(63), (64), (66) and (67):
Sec. 1308.11 Schedule I.
* * * * *
(d) * * *
------------------------------------------------------------------------
------------------------------------------------------------------------
* * * * * * *
(106) Methyl 2-[[1-(4-fluorobutyl)indole-3-carbonyl]amino]-3,3- 7091
dimethyl-butanoate (other names: 4F-MDMB-BUTICA; 4F-MDMB-BICA)
(107) 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)...
(108) Ethyl 2-[[1-(5-fluoropentyl)indole-3-carbonyl]amino]-3,3- 7094
dimethyl-butanoate) (other names: 5F-EDMB-PICA; 5F-EDMB-2201).
(109) 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
December 10, 2025, 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. 2025-22963 Filed 12-15-25; 8:45 am]
BILLING CODE 4410-09-P
</pre></body>
</html>Indexed from Federal Register on December 16, 2025.
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.