Rule2026-08104
Schedules of Controlled Substances: Placement of MDMB-4en-PINACA 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
April 24, 2026
Effective
April 27, 2026
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
With the issuance of this final rule, the Drug Enforcement Administration places methyl 3,3-dimethyl-2-(1-(pent-4-en-1-yl)-1H- indazole-3-carboxamido)butanoate (other name: MDMB-4en-PINACA), including its 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 is being taken, in part, to enable the United States to meet its obligations under the 1971 Convention on Psychotropic Substances. 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 MDMB-4en-PINACA.
Full Text
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<title>Federal Register, Volume 91 Issue 79 (Friday, April 24, 2026)</title>
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[Federal Register Volume 91, Number 79 (Friday, April 24, 2026)]
[Rules and Regulations]
[Pages 21958-21963]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-08104]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-1356]
Schedules of Controlled Substances: Placement of MDMB-4en-PINACA
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 3,3-dimethyl-2-(1-(pent-4-en-1-yl)-1H-
indazole-3-carboxamido)butanoate (other name: MDMB-4en-PINACA),
including its 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 is being
taken, in part, to enable the United States to meet its obligations
under the 1971 Convention on Psychotropic Substances. 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 MDMB-4en-PINACA.
DATES: Effective April 27, 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 MDMB-4en-PINACA and its salts,
isomers, and salts of isomers, whenever the existence of such salts,
isomers, and salts of isomers is possible within the specific chemical
designation, in schedule I of the Controlled Substances Act (CSA).
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 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
[[Page 21959]]
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 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
The neurochemical effects of MDMB-4en-PINACA occur primarily
through cannabinoid receptor systems in the brain. MDMB-4en-PINACA
binds to cannabinoid subtype 1 (CB1) receptors, functions as a full
agonist, and has 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. On June 10, 2021, the
Secretary-General of the United Nations advised the Secretary of State
of the United States that the Commission on Narcotic Drugs (CND) voted
to place MDMB-4en-PINACA in Schedule II of the 1971 Convention during
its 64th Session held on April 14, 2021.
As a signatory to this international treaty, the United States is
required, by scheduling under the CSA, to place appropriate controls on
MDMB-4en-PINACA 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, discussed in the above legal authority
section, were not followed for MDMB-4en-PINACA, DEA is utilizing the
procedures for permanent scheduling set forth in 21 U.S.C. 811(a) and
(b) to control MDMB-4en-PINACA. Such scheduling would satisfy the
United States' international obligations.
To meet the minimum requirements of this treaty and to confront
this emerging substance, DEA published an order in the Federal Register
on December 12, 2023, temporarily placing MDMB-4en-PINACA in schedule I
of the CSA based upon a finding that this substance poses an imminent
hazard to the public safety under 21 U.S.C. 811(h)(1).\3\ That
temporary order was effective upon the date of publication. On December
11, 2025, DEA published a temporary scheduling order to extend the
temporary schedule I status of MDMB-4en-PINACA for one year, or until
the permanent scheduling action for this substance is completed,
whichever occurs first.\4\
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\3\ 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).
\4\ Schedules of Controlled Substances: Extension of Temporary
Placement of MDMB-4en-PINACA in Schedule I of the Controlled
Substances Act, 90 FR 57356 (Dec. 11, 2025).
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DEA and HHS Eight-Factor Analyses
In a letter dated September 29, 2023, in accordance with 21 U.S.C.
811(b), and in response to DEA's November 19, 2021 request, the
Department of Health and Human Services (HHS) provided to DEA a
scientific and medical evaluation and scheduling recommendation for
MDMB-4en-PINACA. 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 MDMB-4en-
PINACA warrants control in schedule I. Both the 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-1356.
Notice of Proposed Rulemaking To Schedule MDMB-4en-PINACA
On October 2, 2025, DEA published a notice of proposed rulemaking
(NPRM) to permanently control MDMB-4en-PINACA in schedule I.\5\
Specifically, DEA proposed to add MDMB-4en-PINACA 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 November 3, 2025. DEA did
not receive any requests for a hearing. The NPRM also provided an
opportunity for interested persons to submit comments on or before
November 3, 2025.
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\5\ Schedules of Controlled Substances: Placement of MDMB-4en-
PINACA in Schedule I, 90 FR 47663 (Oct. 2, 2025).
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Comments Received
DEA received 50 comments in response to the NPRM for the placement
of MDMB-4en-PINACA into schedule I of the CSA. As described in detail
below, comments were organized into the following general categories:
(1) Support of the rule; (2) Opposition to the rule; (3) Mixed support
and opposition to the rule; (4) Request for additional information; (5)
Procedural deficiencies; and (6) Responses that were not related to
this rulemaking.
Comments in support of the rulemaking: Thirty-seven comments were
in support of the rulemaking. Supporting responses commonly noted the
severe adverse effects following the ingestion of MDMB-4en-PINACA, the
link to toxicity and deaths reported following its use, the concern
about the drugs availability in the community, the access to the drug
by children, its high potential for abuse, and the lack of accepted
medical use.
DEA Response: DEA appreciates the comments in support of this
rulemaking.
Comments in opposition to the rulemaking: Three comments were in
opposition to the rulemaking. Two commenters felt that placing MDMB-
4en-PINACA in schedule I would inhibit research on this substance. The
third commenter only noted their opposition to the rule with no
additional detail.
DEA Response: DEA appreciates these comments and would like to
provide further clarification regarding the control of MDMB-4en-PINACA.
MDMB-4en-PINACA has been placed under international control. To comply
with treaty obligations, DEA must place MDMB-4en-PINACA under the most
appropriate schedule, taking into consideration all appropriate
scientific data. Additionally, as set forth in the NPRM, MDMB-4en-
PINACA has no currently accepted medical use in treatment in the United
States, nor were there any approved New Drug Applications. Therefore,
MDMB-4en-PINACA 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 bona fide research on these substances.\6\ DEA registrants
wishing to conduct research on schedule I substances may apply for
permission to do so through the schedule I researcher registration
program.<SUP>7 8</SUP>
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\6\ 21 U.S.C. 823(g)(2)(A).
\7\ <a href="https://apps.deadiversion.usdoj.gov/webforms2/spring/login?execution=e1s1">https://apps.deadiversion.usdoj.gov/webforms2/spring/login?execution=e1s1</a>.
\8\ 21 U.S.C. 822(h); 21 U.S.C. 823(g); 21 U.S.C. 823(n).
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Comments showing mixed support and opposition to the rulemaking:
Six comments showed mixed support and opposition to the rulemaking.
Five of the comments were similar in nature,
[[Page 21960]]
wherein support was noted due to the serious harmful effects of MDMB-
4en-PINACA. In opposition, these five comments noted their concern
regarding placement of MDMB-4en-PINACA in schedule I could hinder
further research. The sixth comment noted that there ``was minimum
research on MDMB-4en-PINACA to confirm the potential negative effects
of its consumption.''
DEA Response: As discussed previously, DEA appreciates the comments
regarding the serious adverse effects that were described in both the
HHS and DEA Eight-Factor Analyses on MDMB-4en-PINACA. DEA noted in the
second response above that the placement of MDMB-4en-PINACA in schedule
I of the CSA does not preclude bona fide research on this substance. As
noted above, a schedule I researcher registration program exists for
researchers to continue to conduct research on MDMB-4en-PINACA in
compliance with the CSA.\9\ The CSA as well as the corresponding
regulations provide opportunities for scientific and medical research
for all controlled substances while simultaneously mitigating the risk
of diversion and potential for public harm.\10\ In reference to the
sixth comment, DEA notes that research has demonstrated the binding and
functional activity of MDMB-4en-PINACA, as well as results from drug
discrimination studies. Multiple case reports, including fatal
intoxications following the ingestion of MDMB-4en-PINACA, have
demonstrated the dangerous effects of this substance, which supports
its placement in schedule I of the CSA.
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\9\ <a href="https://apps.deadiversion.usdoj.gov/webforms2/spring/login?execution=e1s1">https://apps.deadiversion.usdoj.gov/webforms2/spring/login?execution=e1s1</a>.
\10\ 21 U.S.C. 822(h); 21 U.S.C. 823(g); 21 U.S.C. 823(n).
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Comment requesting additional information: One commenter requested
additional information on why this rulemaking was proposed.
DEA Response: As described within DEA's Eight-Factor Analysis, on
June 10, 2021, the Secretary-General of the United Nations advised the
Secretary of State of the United States that, during its 64th Session
on April 14, 2021, the CND voted to place MDMB-4en-PINACA in Schedule
II of the 1971 Convention. As a signatory to this international treaty,
the United States is required, by scheduling under the CSA, to place
appropriate controls on MDMB-4en-PINACA to meet the minimum
requirements of the treaty. In addition, this substance has shown to be
a threat to public health and safety due to the serious adverse effects
and fatalities described within the supporting material. For these
reasons, MDMB-4en-PINACA was placed in schedule I of the CSA.
Comment raising procedural requests: One comment was received from
a public advocacy group with an accompanying attachment, which raised
four primary issues and made several requests. First, the commenter
claimed that DEA ``did not identify or estimate the number of small
entities directly regulated, describe the compliance requirements for
those entities, or explain why the impacts are not significant,'' and
requested that DEA either (1) withdraw its Regulatory Flexibility Act
(RFA) certification and publish an Initial Regulatory Flexibility
Analysis, or (2) ``reopen the record for 30 days'' to receive small-
entity impact data and consider reasonable accommodations. Second, the
commenter claims that any invocation of good cause under 5 U.S.C.
553(d)(3) ``to waive the 30-day delayed effective date'' is
``inadequate'' because ``[t]he timing of permanent scheduling is
foreseeable'' and ``avoiding a gap after a temporary order expires is
not good cause where the agency had ample time to plan.'' Third, the
commenter stated, in reference to the Paperwork Reduction Act and
Executive Order (E.O.) 12866, that ``DEA should confirm in the record
that this rule does not create any new information collection
requirements and identify the relevant Office of Management and Budget
(OMB) control numbers that will cover compliance activities related to
MDMB-4en-PINACA.'' Lastly, the commenter requested that ``DEA should
clarify in the docket its E.O. 12866 significance determination and
whether OIRA reviewed the action.'' \11\
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\11\ The attachment to the comment that DEA received included
the acronym ``OIRA'' with no further explanation or discussion. DEA
assumes that the commenter meant to reference the Office of
Information and Regulatory Affairs, which is within OMB.
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DEA Response: Regarding the first issue, DEA certified in the NPRM
that the proposed rule would not have a significant economic impact on
a substantial number of small entities and provided the factual basis
for that certification. To begin, DEA identified the types of entities
that would be affected by the proposed rule and determined the North
American Industry Classification System industries that best represent
those business activities. To determine whether a substantial number of
small entities are affected in any of the industries, DEA also relied
on data from the Statistics of U.S. Businesses to determine the number
of firms and small firms for each of the affected industries, and it
then compared the number of affected small entities to the number of
small entities for each industry. Further, based on the American
Chemical Society's SciFinder database, DEA identified one entity
supplying MDMB-4en-PINACA across the relevant industries, and that
entity was already registered with DEA to handle controlled substances.
Finally, because MDMB-4en-PINACA is not approved for medical use and
has a substantial capability to be a hazard to the health of the user
and to the safety of the community, DEA expected that the number of
researchers working with MDMB-4en-PINACA would be small, and that the
researchers working with MDMB-4en-PINACA may also work with other
controlled substances; therefore, researchers are likely already
registered with DEA and are qualified to handle controlled
substances.\12\
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\12\ See Schedules of Controlled Substances: Placement of MDMB-
4en-PINACA in Schedule I, 90 FR 47663, 47668-47669 (Oct. 2, 2025).
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Regarding the second issue, DEA finds that there is good cause
under 5 U.S.C. 553(d)(3) 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. The reasons in support
of DEA's good-cause finding are set forth below.
Regarding the third issue, DEA stated in the NPRM that the
``proposed rule would not impose a new collection or modify an existing
collection of information under the Paperwork Reduction Act of 1995,''
and that the ``proposed rule would not impose new or modify existing
recordkeeping or reporting requirements on state or local governments,
individuals, businesses, or organizations.'' \13\ Because any
collection of information requirements have been in place since the DEA
temporarily scheduled MDMB-4en-PINACA, and the permanent scheduling of
MDMB-4en-PINACA does not create any additional collection requirements,
DEA asserts that its statement regarding information collection in the
NPRM is supported. DEA also stated in the NPRM that the 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.\14\
Like the NPRM, this final rule provides that same below.
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\13\ Id. at 47669.
\14\ Id.
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[[Page 21961]]
Finally, regarding the fourth issue, section 3(d) of E.O. 12866
provides the definition of a ``regulation'' or ``rule'' subject to E.O.
12866. As DEA stated in the NPRM, such actions are exempt from E.O.
12866 pursuant to section 3(d)(1) of E.O. 12866 because a proposed
scheduling action under 21 U.S.C. 811(a) 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.
Comments that were not related to this rulemaking: DEA received two
comments that were neither explicitly for nor against the proposed
rule. These two comments were not related to the current scheduling
action. The first comment discussed oxycodone, while the second comment
discussed marijuana.
DEA Response: These comments were outside the scope of the current
scheduling action; therefore, these comments were 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 MDMB-4en-PINACA. As such, DEA is permanently scheduling MDMB-
4en-PINACA as a controlled substance under schedule I of the CSA. The
permanent scheduling of MDMB-4en-PINACA 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, 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) MDMB-4en-PINACA has a high potential for abuse that is
comparable to other scheduled synthetic cannabinoids, such as JWH-018,
XLR11, and ABKB-48. In vitro studies demonstrate that MDMB-4en-PINACA
binds to CB1 receptors and functions as a full agonist. In drug
discrimination studies conducted in animals to evaluate its
discriminative stimulus effects, MDMB-4en-PINACA was shown to fully
substitute for the discriminative stimulus effects produced by delta 9-
THC. In addition to the large numbers of law enforcement seizures of
MDMB-4en-PINACA in various forms including as a powder, on plant
material or in vaping devices, the ingestion of MDMB-4en-PINACA has
been documented to result in serious adverse effects including
agitation, psychosis including hallucinations and delusions, behavioral
changes, seizures, brain injury, and death.
(2) MDMB-4en-PINACA has no currently accepted medical use in
treatment in the United States. In HHS's 2023 recommendation to control
MDMB-4en-PINACA, it was noted there are no approved New Drug
Applications for MDMB-4en-PINACA and no known therapeutic applications
for MDMB-4en-PINACA in the United States. DEA is not aware of any other
evidence suggesting that MDMB-4en-PINACA has a currently accepted
medical use in treatment in the United States.\15\
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\15\ 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 MDMB-4en-
PINACA, or that the use of MDMB-4en-PINACA 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 MDMB-4en-PINACA
under medical supervision. Because MDMB-4en-PINACA 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
MDMB-4en-PINACA, 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 MDMB-4en-PINACA
MDMB-4en-PINACA 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 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, MDMB-4en-PINACA 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. 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 MDMB-4en-PINACA 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. MDMB-4en-PINACA
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. MDMB-4en-PINACA 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. Non-practitioners
handling MDMB-4en-PINACA 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
[[Page 21962]]
containers of MDMB-4en-PINACA 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 MDMB-4en-PINACA 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
MDMB-4en-PINACA must take an inventory of MDMB-4en-PINACA 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 MDMB-4en-PINACA) 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 MDMB-4en-PINACA) 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 MDMB-4en-PINACA, or products containing MDMB-
4en-PINACA, 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 MDMB-4en-
PINACA 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 MDMB-4en-
PINACA 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
MDMB-4en-PINACA 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 MDMB-4en-PINACA 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 OMB pursuant to section 3(d)(1) of 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.\16\ 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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\16\ 44 U.S.C. 3501-3521.
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Regulatory Flexibility Act
The Administrator of DEA, in accordance with the RFA, 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 MDMB-4en-PINACA (chemical name: methyl
3,3-dimethyl-2-(1-(pent-4-en-1-yl)-1H-indazole-3-
carboxamido)butanoate), 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 MDMB-4en-PINACA.
Based on the review of HHS's scientific and medical evaluation and
all other relevant data, DEA determined that MDMB-4en-PINACA 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 MDMB-4en-
PINACA 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
MDMB-4en-PINACA from legitimate suppliers. Therefore, this final rule
will 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
[[Page 21963]]
Government Agency Plan nor any other action is required under UMRA of
1995.
Congressional Review Act
The Office of Information and Regulatory Affairs has determined
that 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.
5 U.S.C. 553(d). 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. 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 MDMB-4en-PINACA is currently listed in schedule I
of the CSA under 21 U.S.C. 811(h).\17\ Second, as discussed in the
temporary scheduling order and NPRM, MDMB-4en-PINACA poses imminent
hazard 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.\18\
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\17\ 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 MDMB-4en-PINACA in Schedule I of the Controlled
Substances Act, 90 FR 57356 (Dec. 11, 2025).
\18\ 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 recordkeeping requirements.
For the reasons set out above, DEA amends 21 CFR part 1308 as
follows:
PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES
0
1. The authority citation for part 1308 continues to read as follows:
Authority: 21 U.S.C. 811, 812, 871(b), 956(b), unless otherwise
noted.
0
2. In Sec. 1308.11:
0
a. Addparagraph (d)(110); and
0
b. Remove and reserve paragraph (h)(62).
The addition reads as follows:
Sec. 1308.11 Schedule I.
* * * * *
(d) * * *
------------------------------------------------------------------------
------------------------------------------------------------------------
* * * * * * *
(110) methyl 3,3-dimethyl-2-(1-(pent-4-en-1-yl)-1H-indazole-3- 7090
carboxamido)butanoate (other name: MDMB-4en-PINACA)...........
* * * * * * *
------------------------------------------------------------------------
* * * * *
Signing Authority
This document of the Drug Enforcement Administration was signed on
April 20, 2026, by Assistant Administrator Cheri Oz. 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. 2026-08104 Filed 4-23-26; 8:45 am]
BILLING CODE 4410-09-P
</pre></body>
</html>Indexed from Federal Register on April 24, 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.