Proposed Rule2026-19400
Schedules of Controlled Substances: Placement of 4-Hydroxy-N,N-Diisopropyltryptamine (4-OH-DiPT), 5-Methoxy-alpha-Methyltryptamine (5-MeO-AMT), 5-Methoxy-N-Methyl-N-Isopropyltryptamine (5-MeO-MiPT), 5-Methoxy-N,N-Diethyltryptamine (5-MeO-DET), and N,N-Diisopropyltryptamine (DiPT) Into 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
September 23, 2026
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
The Drug Enforcement Administration proposes placing five tryptamine hallucinogens, 4-hydroxy-N,N-diisopropyltryptamine (other names: 4-OH-DiPT; 3-(2-(diisopropylamino)ethyl)-1H-indol-4- ol), 5-methoxy-alpha-methyltryptamine (other names: 5-MeO-AMT; 1-(5- methoxy-1H-indol-3-yl)propan-2-amine), 5-methoxy-N-methyl-N- isopropyltryptamine (other names: 5-MeO-MiPT; N-(2-(5-methoxy-1H-indol- 3-yl)ethyl)-N-methylpropan-2-amine), 5-methoxy-N,N-diethyltryptamine (other names: 5-MeO-DET; N,N-diethyl-2-(5-methoxy-1H-indol-3- yl)ethanamine), and N,N-diisopropyltryptamine (other names: DiPT; N-(2- (1H-indol-3-yl)ethyl)-N-isopropylpropan-2-amine), including their salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible, in schedule I of the Controlled Substances Act. If finalized, this action would impose 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 these five specific tryptamine hallucinogens.
Full Text
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<title>Federal Register, Volume 91 Issue 183 (Wednesday, September 23, 2026)</title>
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[Federal Register Volume 91, Number 183 (Wednesday, September 23, 2026)]
[Proposed Rules]
[Pages 60338-60347]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-19400]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA1715]
Schedules of Controlled Substances: Placement of 4-Hydroxy-N,N-
Diisopropyltryptamine (4-OH-DiPT), 5-Methoxy-alpha-Methyltryptamine (5-
MeO-AMT), 5-Methoxy-N-Methyl-N-Isopropyltryptamine (5-MeO-MiPT), 5-
Methoxy-N,N-Diethyltryptamine (5-MeO-DET), and N,N-
Diisopropyltryptamine (DiPT) Into 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 five
tryptamine hallucinogens, 4-hydroxy-N,N-diisopropyltryptamine (other
names: 4-OH-DiPT; 3-(2-(diisopropylamino)ethyl)-1H-indol-4-
[[Page 60339]]
ol), 5-methoxy-alpha-methyltryptamine (other names: 5-MeO-AMT; 1-(5-
methoxy-1H-indol-3-yl)propan-2-amine), 5-methoxy-N-methyl-N-
isopropyltryptamine (other names: 5-MeO-MiPT; N-(2-(5-methoxy-1H-indol-
3-yl)ethyl)-N-methylpropan-2-amine), 5-methoxy-N,N-diethyltryptamine
(other names: 5-MeO-DET; N,N-diethyl-2-(5-methoxy-1H-indol-3-
yl)ethanamine), and N,N-diisopropyltryptamine (other names: DiPT; N-(2-
(1H-indol-3-yl)ethyl)-N-isopropylpropan-2-amine), including their
salts, isomers, and salts of isomers whenever the existence of such
salts, isomers, and salts of isomers is possible, in schedule I of the
Controlled Substances Act. If finalized, this action would impose 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 these five specific tryptamine
hallucinogens.
DATES: Comments must be submitted electronically or postmarked on or
before October 23, 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 involved in the hearing, must be received on or before October
23, 2026.
ADDRESSES: Interested persons may file written comments on this
rulemaking in accordance with 21 CFR 1308.43(g). To ensure proper
handling of comments, please reference ``Docket No. DEA1715'' on all
correspondence, including any attachments.
<bullet> Electronic comments: The Drug Enforcement Administration
(DEA) encourages commenters to submit all 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="https://www.regulations.gov">https://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 for your comment. Submitted comments
are not instantaneously available for public view on <a href="http://Regulations.gov">Regulations.gov</a>.
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 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 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 schedule the following five substances in schedule I of the
Controlled Substances Act (CSA), including their salts, isomers, and
salts of isomers whenever the existence of such salts, isomers, and
salts of isomers is possible within the specific chemical designation:
<bullet> 4-Hydroxy-N,N-diisopropyltryptamine (other names: 4-OH-
DiPT;3-(2-(diisopropylamino)ethyl)-1H-indol-4-ol),
<bullet> 5-Methoxy-alpha-methyltryptamine (other names: 5-MeO-
AMT;1-(5-methoxy-1H-indol-3-yl)propan-2-amine),
<bullet> N-Isopropyl-5-methoxy-N-methyltryptamine (other names: 5-
MeO-MiPT; N-(2-(5-methoxy-1H-indol-3-yl)ethyl)-N-methylpropan-2-amine),
<bullet> N,N-Diethyl-5-methoxytryptamine (other names: 5-MeO-DET;
N,N-diethyl-2-(5-methoxy-1H-indol-3-yl)ethanamine), and
<bullet> N,N-Diisopropyltryptamine (other names: DiPT; N-(2-(1H-
indol-3-yl)ethyl)-N-isopropylpropan-2-amine).
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>, unless reasonable
cause is given. Such information includes personal or business
identifiers (such as name, address, state or 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="https://www.regulations.gov">https://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 rule are available at <a href="https://www.regulations.gov">https://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
[[Page 60340]]
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 4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-
DET, or DiPT 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 his 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 Assistant Secretary for Health of the
Department of HHS (Assistant Secretary) and an evaluation of all other
relevant data by DEA. If finalized, this action would impose the
regulatory controls and administrative, civil, and criminal sanctions
applicable to schedule I controlled substances on persons who handle or
propose to handle 4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and
DiPT.
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\4\ 21 U.S.C. 811(a).
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Pursuant to 21 U.S.C. 811(a)(1), the Attorney General (as delegated
to the Administrator of DEA) may, by rule, add to such a schedule or
transfer between such schedules any drug or other substance, if he
finds that such drug or other substance has a potential for abuse, and
makes with respect to such drug or other substance the findings
prescribed by 21 U.S.C. 812(b) for the schedule in which such drug or
other substance is to be placed.
Background
4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and DiPT are
tryptamine hallucinogens. These five tryptamines have no known medical
use in the United States and are not marketed internationally as
approved drug products. They have all been reported as drugs of abuse
in the United States by law enforcement authorities and have been
identified in seizures.
Proposed Determination to Schedule 4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-
MeO-DET, and DiPT
In response to reports of abuse and trafficking, pursuant to 21
U.S.C. 811(b), DEA gathered and reviewed the available information
regarding the pharmacology, chemistry, trafficking, actual abuse,
pattern of abuse, and the relative potential for abuse and dependence
of 4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and DiPT. On December
19, 2008, DEA sent this data review document to the then-Assistant
Secretary for Health of the Department of HHS \5\ with a request to
provide scientific and medical evaluations and scheduling
recommendations for these five tryptamine hallucinogens. On March 29,
2012, May 17, 2012, and August 14, 2012, HHS provided to DEA five
separate scientific and medical evaluations and scheduling
recommendations for these substances.\6\ Following consideration of the
eight factors and findings related to each of the substances' abuse
potential, lack of legitimate medical use, and lack of accepted safety
for use under medical supervision, HHS recommended that 4-OH-DiPT, 5-
MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and DiPT and their respective salts be
controlled in schedule I of the CSA under 21 U.S.C. 812(b).
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\5\ As discussed in a memorandum of understanding entered into
by the U.S. Food and Drug Administration (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. Memorandum of
Understanding with the National Institute on Drug Abuse, 50 FR 9518
(Mar. 8, 1985). The Secretary of HHS has delegated to the Assistant
Secretary for Health of HHS the authority to make domestic drug
scheduling recommendations. Comprehensive Drug Abuse Prevention and
Control Act of 1970, Public Law 91-513, As Amended; Delegation of
Authority, 58 FR 35460 (July 1, 1993).
\6\ The scientific and medical evaluations were titled: (1)
``Basis for the Recommendation to Control 4-Hydroxy-N,N-
diisopropyltryptamine (4-OH-DIPT) and its Salts in Schedule I of the
Controlled Substances Act (CSA);'' (2) ``Basis for the
Recommendation to Control 5-Methoxy-alphamethyltryptamine (5-MeO-
AMT) and its Salts in Schedule I of the Controlled Substances Act
(CSA);'' (3) ``Basis for the Recommendation to Control N-Isopropyl-
5-Methoxy-N-Methyltryptamine (5-MeO-MIPT) and its Salts in Schedule
I of the Controlled Substances Act (CSA);'' (4) ``Basis for the
Recommendation to Control N,N-Diethyl-5-methoxytryptamine (5-MeO-
DET) and its Salts in Schedule I of the Controlled Substances Act
(CSA);'' and (5) ``Basis for the Recommendation to Control N,N-
Diisopropyltryptamine (DIPT) and its Salts in Schedule I of the
Controlled Substances Act (CSA).''
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Based on the scientific and medical evaluations and recommendations
that HHS provided to DEA, and all other relevant data, DEA published a
Notice of Proposed Rulemaking in the Federal Register on January 14,
2022, which proposed to place the five tryptamines in schedule I of the
CSA and invited interested persons to submit comments and requests for
a hearing.\7\ On July 6, 2022, DEA published an announcement of hearing
on the five tryptamines.\8\ Upon further consideration, DEA determined
that it was appropriate to submit a new request to HHS for an updated
scientific and medical evaluation and scheduling recommendations for
these substances.
[[Page 60341]]
Accordingly, DEA withdrew the proposed rule and notice of hearing.\9\
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\7\ Schedules of Controlled Substances: Placement of 4-hydroxy-
N,N-diisopropyltryptamine (4-OH-DiPT), 5-methoxy-alpha-
methyltryptamine (5-MeO-AMT), 5-methoxy-N-methyl-N-
isopropyltryptamine (5-MeO-MiPT), 5-methoxy-N,N-diethyltryptamine
(5-MeO-DET), and N,N-diisopropyltryptamine (DiPT) in Schedule I, 87
FR 2376 (Jan. 14, 2022).
\8\ Schedules of Controlled Substances: Placement of 4-hydroxy-
N,N-diisopropyltryptamine (4-OH-DiPT), 5-methoxy-alpha-
methyltryptamine (5-MeO-AMT), 5-methoxy-N-methyl-N-
isopropyltryptamine (5-MeO-MiPT), 5-methoxy-N,N-diethyltryptamine
(5-MeO-DET), and N,N-diisopropyltryptamine (DiPT) in Schedule I;
Announcement of Hearing, 87 FR 40167 (July 6, 2022).
\9\ Schedules of Controlled Substances: Placement of 4-hydroxy-
N,N-diisopropyltryptamine (4-OH-DiPT), 5-methoxy-alpha-
methyltryptamine (5-MeO-AMT), 5-methoxy-N-methyl-N-
isopropyltryptamine (5-MeO-MiPT), 5-methoxy-N,N-diethyltryptamine
(5-MeO-DET), and N,N-diisopropyltryptamine (DiPT) in Schedule I;
Withdrawal of Proposed Rule and Notice of Hearing, 87 FR 45076 (July
27, 2022).
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On November 16, 2023, DEA requested the updated scientific and
medical evaluation and scheduling recommendation for the five
tryptamines. On April 2, 2026, HHS provided to DEA the scientific and
medical evaluation titled ``Basis for the Recommendation to Control
N,N-Diisopropyltryptamine (DiPT), 4-Hydroxy-N,N-Diisopropyltryptamine
(4-OH-DiPT), 5-Methoxy-Alpha-Methyltryptamine (5-MeO-AMT), 5 Methoxy-N-
Methyl-N-Isopropyltryptamine (5-MeO-MiPT), and 5-Methoxy-N,N-
Diethyltryptamine (5-MeO-DET) and Their Salts in Schedule I of the
Controlled Substances Act.'' As communicated in the April 2, 2026
letter to DEA, following consideration of the eight factors
determinative of control under 21 U.S.C. 811(c), HHS recommended that
DiPT, 4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, and 5-MeO-DET and their
respective salts be controlled in schedule I of the CSA under 21 U.S.C.
812(b).
In response to the HHS communications in 2012 and 2026, DEA
reviewed the scientific and medical evaluation and scheduling
recommendations provided by HHS, and all other relevant data, and
completed its own eight-factor analysis in August 2021 and updated in
May 2026 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 for this proposed rule at <a href="https://www.regulations.gov">https://www.regulations.gov</a>
under docket number ``DEA1715.''
1. Their Actual or Relative Potential for Abuse
In addition to considering the information HHS provided in its
scientific and medical evaluation documents for 4-OH-DiPT, 5-MeO-AMT,
5-MeO-MiPT, 5-MeO-DET, and DiPT, DEA also considered all other relevant
data regarding actual or relative potential for abuse of 4-OH-DiPT, 5-
MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and DiPT. The term ``abuse'' is not
defined in the CSA; however, the legislative history of the CSA
suggests the consideration of the following four criteria in
determining whether a particular drug or substance has a potential for
abuse:\10\
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\10\ Comprehensive Drug Abuse Prevention and Control Act of
1970, H.R. Rep. No. 91-1444, 91st Cong., 2nd Sess. (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 significant diversion of the drug or other 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.
As stated previously, DEA reviewed the scientific and medical
evaluation provided by HHS and all other data relevant to the abuse
potential of 4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and DiPT.
These data as presented below demonstrate that these five tryptamine
hallucinogens have a high potential for abuse.
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 to the community.
Data show that 4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and
DiPT have been encountered by law enforcement in the United States (see
Factor 5 below, discussing evidence of abuse in the United States),
indicating 4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and DiPT are
available for abuse. Further, HHS noted that some of the five
tryptamines have been found in America's Poison Centers, National
Poison Data System (NPDS). In aggregate, there have been 65 exposures
to at least one of the five tryptamines between 2000-2021, and the
majority of exposures were single-substance cases. Some of the adverse
effects reported were tachycardia, hallucinations, agitation, and
hypertension. Thus, HHS determined that there is evidence of abuse with
``deleterious clinical effects'' and further stated that based on
available data, these substances have the potential to be consumed in
amounts sufficient to create a hazard to the health of individuals who
consume them.
b. There is significant diversion of the drug or substance from
legitimate drug channels.
4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and DiPT are not U.S.
Food and Drug Administration (FDA)-approved drugs in the United States,
and they are not legally marketed in any country. Therefore, legitimate
drug channels are limited to research conducted with the drugs,
manufacturing facilities, and to the supply chain that produces the
drug for legitimate research. However, HHS noted that FDA is not aware
of any diversion from research or legitimate manufacturing activities
for 4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and DiPT. Therefore,
this characteristic of abuse is not applicable.
c. Individuals are taking the substance on their own initiative
rather than on the basis of medical advice from a practitioner licensed
by law to administer such substance.
4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and DiPT are not
approved for medical use, are not formulated or available for clinical
use, and practitioners may not legally prescribe these substances.
Therefore, individuals are taking 4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-
MeO-DET, and DiPT on their own initiative, rather than based on medical
advice from a practitioner licensed by law to administer drugs. This is
consistent with the data from law enforcement seizures, the NPDS
database, and case reports indicating that individuals are taking 4-OH-
DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and DiPT on their own
initiative rather than on the medical advice of a licensed
practitioner. Therefore, it is assumed that individuals are taking
these five substances on their own initiative, rather than based on
medical advice from a practitioner licensed by law to administer drugs.
[[Page 60342]]
d. The drug or substance is so related in its action to a drug or
other substance already listed as having a potential for abuse to make
it likely that the drug or substance will have the same potential for
abuse as such drugs, thus making it reasonable to assume that there may
be significant diversion 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.
4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and DiPT are
structurally related to schedule I hallucinogens of the tryptamine
class and produce similar pharmacological effects to other natural and
synthetic schedule I hallucinogens. According to HHS, these five
tryptamine hallucinogens elicit pharmacological responses similar to
the schedule I substances both in in vitro and in vivo studies as well
as anecdotal reports, to include stimulation of the 2A subtype of
serotonin (5-HT) receptors (5-HT<INF>2A</INF>) and substitution in the
drug discrimination assay, as well as reports in the NPDS database.
Given the similarities to certain schedule I hallucinogens, the
five tryptamine hallucinogens are expected to have clinical effects and
risks to the public health similar to that of tryptamines currently
controlled in schedule I (e.g., 4-hydroxy-N,N-dimethyltryptamine [4-OH-
DMT, also known as psilocyn, the active metabolite of psilocybin]; N,N-
dimethyltryptamine [DMT]; alpha-methyltryptamine [AMT]; 5- methoxy-N,N-
diisopropyltryptamine [5-MeO-DiPT]; N,N-diethyltryptamine [DET]) as
well as a phenethylamine hallucinogen (4-methyl-2,5-dimethoxy-
amphetamine [DOM]) and an ergotamine hallucinogen (lysergic acid
diethylamide [LSD]). The indicators of abuse potential for the five
tryptamine hallucinogens suggest that they have a relative potential
for abuse that is comparable to other hallucinogenic substances already
controlled in schedule I of the CSA.
2. Scientific Evidence of Their Pharmacological Effects, If Known
The five tryptamine hallucinogens are structurally related to and
share pharmacological properties with schedule I tryptamine
hallucinogens. Based on non-clinical in vitro studies, the
neurochemical effects of 4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET,
and DiPT mainly involve the serotonergic system in the central nervous
system (CNS). Tryptamine hallucinogens are believed to produce their
characteristic effects primarily through stimulation of the 5-
HT<INF>2A</INF> receptor. Similar to schedule I hallucinogens that are
also mediated by serotonin receptors, such as DMT, DET, DOM, and LSD,
the five tryptamine hallucinogens have binding affinity for and act as
agonists at the 5-HT<INF>2A</INF> receptor. There have been reports of
partial involvement by activation of the serotonin 1A-subtype (5-
HT<INF>1A</INF>). 4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and DiPT
also bind to and functioned as agonists at 5-HT<INF>1A</INF> receptors.
Other potential targets include the 5-HT<INF>2C</INF> receptor
subtype and monoamine transporters (serotonin transporter [SERT],
norepinephrine [NE] transporter [NET] and dopamine [DA] transporter
[DAT]). At the 5-HT<INF>2C</INF> receptor, 5-MeO-AMT displayed the
highest affinity and displayed full agonist activity. All others bound
to the 5-HT<INF>2C</INF> receptor with varying affinities and fully
activated the receptor. 5-MeO-AMT, 5-MeO-MiPT, and 5-MeO-DET had weak
or no significant affinity for SERT, NET, and DAT and did not induce
the release of NE, 5-HT, or DA. However, 4-OH-DiPT and DiPT had greater
affinity for SERT, but did not have significant affinity for DAT or
NET.
As concluded by HHS and DEA, the complex pharmacology of 4-OH-DiPT,
5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and DiPT involve multiple serotonin
sites, one of which (5-HT<INF>2A</INF> receptor) is likely to mediate
their hallucinogenic effects. All five tryptamine hallucinogens bind to
the 5-HT<INF>2A</INF> receptor and behave as full or partial agonists
like DMT and psilocyn. Based on in vitro data the five tryptamine
hallucinogens are expected to have hallucinogenic properties and
potential toxicities, though they may differ by potency.
Non-clinical in vivo studies indicate 4-OH-DiPT, 5-MeO-AMT, 5-MeO-
MiPT, 5-MeO-DET, and DiPT produce similar pharmacological profiles to
that of serotonin-mediated hallucinogens controlled in schedule I of
the CSA as assessed via drug discrimination, locomotor activity, and
head twitch assays.
Clinical studies to evaluate the effects of 4-OH-DiPT, 5-MeO-DET,
and DiPT using formal clinical protocols under institutional settings
have not been reported in the published scientific literature. However,
subjective effects in humans for these three tryptamines have been
reported through individual case reports or summaries of anecdotal
reports usually on internet forums. There are limited published
clinical studies for 5-MeO-AMT and 5-MeO-DiPT. In humans, the five
tryptamines produced changes in mood, cognition, and perceptions. These
substances are orally active and may differ in regard to potency, onset
of action, duration of effects, and psychoactive and physiological
effects. Hence, based on available pharmacology information the five
tryptamines are expected to have significant overlap in effects with
schedule I hallucinogenic substances such as DMT, psilocybin, and
others.
3. The State of Current Scientific Knowledge Regarding the Drugs or
Other Substances
4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and DiPT are part of
the tryptamine family of hallucinogens and share the core tryptamine
structure with substitutions at various positions. All five substances
contain an indole ring with a substituted ethylamino sidechain. 4-OH-
DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and DiPT share structural
similarities with schedule I tryptamine hallucinogens such as DMT, DET,
AMT, and psilocyn.
Limited metabolism studies have been conducted for 5-MeO-MiPT and
other tryptamine hallucinogens. Data indicate that tryptamine
hallucinogens undergo metabolism through oxidative deamination, N-
demethylation, O-demethylation, and N-oxidation with N-oxides as major
metabolites. Additionally, various cytochrome P450 and monoamine
oxidase enzymes have been reported to play a role in the metabolism. It
is expected that these five tryptamine hallucinogens would undergo
similar metabolism.
There are no well-controlled clinical studies showing safety or
efficacy for these substances. In addition, there is no evidence by
qualified experts that 4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and
DiPT are accepted as having therapeutic uses. Thus, DEA concludes that
4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and DiPT have no currently
accepted medical use in treatment in the United States.
4. Their History and Current Pattern of Abuse
In the United States, law enforcement entities initially
encountered 5-MeO-AMT and DiPT in 2003, 5-MeO-MiPT in 2004, 5-MeO-DET
in 2006, and 4-OH-DiPT in 2009, according to the National Forensic
Laboratory Information System-Drug (NFLIS-Drug).\11\ Each of
[[Page 60343]]
these tryptamines is encountered in various forms (e.g., powder,
tablets, capsules, liquid, or on blotter paper). The abuser population
of these substances is commonly comprised of young adults. These
substances are generally purchased from internet-based companies in
addition to being purchased from dealers.
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\11\ NFLIS-Drug represents an important resource in monitoring
illicit drug trafficking, including the diversion of legally
manufactured pharmaceuticals into illegal markets. NFLIS-Drug is a
comprehensive information system that includes data from forensic
laboratories that handle more than 96 percent of an estimated 1
million distinct annual federal, state, and local drug analysis
cases. NFLIS-Drug includes drug chemistry results from completed
analyses only. While NFLIS-Drug data are not direct evidence of
abuse, these can lead to an inference that a drug has been diverted
and abused. See Schedules of Controlled Substances: Placement of
Carisoprodol Into Schedule IV,76 FR 77330, 77332 (Dec. 12, 2011).
NFLIS-Drug data were queried on April 7, 2026.
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4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and DiPT do not have a
currently accepted medical use in treatment in the United States.
Anecdotal reports from users of these substances indicate that these
substances produce classical hallucinogenic properties, such as
perceptual distortions and pleasurable physical effects. Users report
oral administration as the most common route of administration. Other
routes of administration such as insufflation, smoking, and rectal
administration have been reported. 5-MeO-MiPT has been mentioned to
cause a wide range of effects including: euphoria, mood lift,
intensification of tactile sensations and smell, sexual interest,
emotional opening, relaxation, powerful ``rushing'' sensation (smoked),
immersive experiences (smoked), feelings of body and muscle energy,
buzzing, visual distortions, color intensification, disorientation, and
sometimes dissociation, tremor, emotional lability, possible stomach
discomfort, gas and vomiting, anxious stimulation muscle tension/
discomfort, and difficulty sleeping for 4 to 8 hours after peak effects
in some people.
5. The Scope, Duration, and Significance of Abuse
According to NFLIS-Drug, in the United States, there has been
availability, trafficking, and abuse of a number of tryptamines
including 4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and DiPT. This
is evidenced by a cumulative total of 518 encounters of these
tryptamines by United States law enforcement in several states and the
District of Columbia. Additionally, there have been international
encounters of 5-MeO-AMT, 5-MeO-MiPT and 5-MeO-DET between 2006-2017, as
well as detection of 4-OH-DiPT in hair samples in China and urine
samples in Italy.\12\
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\12\ G[ouml]l E, [Ccedil]ok I. (2019). New psychoactive
substances in Turkey: Narcotics cases assessed by the Council of
Forensic Medicine between 2016 and 2017 in Ankara, Turkey. Forensic
Sci Int 294:113-123; Shi Y, Wang R, Yuan S, Qiang H, Shen M, Shen B,
Drummer OH, Yu Z, Zhao Y, Xiang P (2020). UHPLC-MS/MS method for
simultaneously detecting 16 tryptamines and their metabolites in
human hair and applications to real forensics cases. J Chromatogr B
Analyt Technol Biomed Life Sci 1159:122392; Pichini S, Pujadas M,
Marchei E, Pellegrini M, Fiz J, Pacifici R, Zuccaro P, Farr[eacute]
M, de la Torre R (2008). Liquid chromatography-atmospheric pressure
ionization electrospray mass spectrometry determination of
``hallucinogenic designer drugs'' in urine of consumers. J Pharm
Biomed Anal 47(2):335-42.
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According to HHS' 2026 review, based on data from the America's
Poison Centers' NPDS database, there were 65 exposure cases from
January 1, 2003, to December 31, 2021, involving one or more of the
five tryptamines. Over 61 percent of cases were single-substance cases,
84 percent were classified as ``abuse,'' and healthcare facilities
reported over 89 percent of exposure cases. The substances most
identified were 5-MeO-AMT (25), 5-MeO-DET (23), and 5-MeO-MiPT (14).
Two single-substance cases of intentional abuse were reported for DiPT,
whereas there was only one multi-substance case involving 4-OH-DiPT.
While most cases resulted in minor to moderate related medical effects,
moderate effects were the most frequently reported within single-
substance cases. Further, four cases were reported as major medical
effect (three of which were caused by 5-MeO-AMT). No single-substance
exposure cases involving the five tryptamines resulted in death. As
stated by HHS, NPDS only captures a small fraction of exposures
resulting in death because drug exposures that result in unattended, or
out-of-hospital death are unlikely to be reported to a United States
Poison Control Center. See HHS review for further information on the
NPDS analysis and potential caveats and limitations related to
reporting.
6. What, if Any, Risk There is to the Public Health
Available evidence indicates that 4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT,
5-MeO-DET, and DiPT pose a risk to public health due to their
hallucinogenic properties that usually occur quickly after drug
administration and may cause impairing effects on the user's judgment
and lead to dangerous behavior. The risks could be to the individual
user or to the community, especially when the user is operating a motor
vehicle. Several adverse effects were reported in animal studies and in
humans from internet forums for all five tryptamine hallucinogens.
Published and anecdotal reports have described various adverse effects
associated with these five hallucinogens including agitation,
confusion, psychological distress, and one death in the case of 5-MeO-
AMT in 2004. The toxicology report also reported alcohol and the
presence of an antidepressant, bupropion. Some users of 4-OH-DiPT
reported that the hallucinations were intense and the psychological and
physiological effects were frightening or disturbing. An adolescent
non-lethal poisoning was reported in 2005 after ingesting an alleged
combination of 5-MeO-MiPT and harmaline, a CNS stimulant.
7. Their Psychic or Physiological Dependence Liability
Assessing psychological dependence potential of 4-OH-DiPT, 5-MeO-
AMT, 5-MeO-MiPT, 5-MeO-DET, and DiPT was limited due to lack of
available data. From NPDS data, there is evidence individuals are using
these substances. The majority of the cases were classified as
``abuse'' cases.
Serotonin-mediated hallucinogens are not usually associated with
physical dependence and the physiological dependence liability in
animals or humans has not been reported in scientific and medical
literature for these five substances. At this time, it is not possible
to determine whether 4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and
DiPT produce physiological dependence following either acute or chronic
administration.
8. Whether the Substances Are an Immediate Precursor of Substances
Already Controlled Under the CSA
4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and DiPT are not
immediate precursors of any controlled substance of the CSA, as defined
by 21 U.S.C. 802(23).
Conclusion
Based on consideration of the scientific and medical evaluation and
accompanying recommendation of HHS, and on DEA's own eight-factor
analysis, DEA finds that the facts and all relevant data constitute
substantial evidence of potential for abuse of 4-OH-DiPT, 5-MeO-AMT, 5-
MeO-MiPT, 5-MeO-DET, and DiPT. As such, DEA hereby proposes to schedule
4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and DiPT as schedule I
controlled substances under the CSA.
[[Page 60344]]
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.\13\ After consideration of the analysis and recommendation of
the Assistant Secretary for Health of HHS and review of all other
available data, the Administrator of DEA, pursuant to 21 U.S.C. 811(a)
and 21 U.S.C. 812(b)(1), finds that:
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\13\ 21 U.S.C. 812(b).
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1. The Drugs Have a High Potential for Abuse
4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and DiPT elicit
pharmacological effects qualitatively similar to those of schedule I
hallucinogens, discussed below. These effects are marked by
hallucinations and CNS stimulation. Law enforcement reported a number
of encounters with these substances. Law enforcement first encountered
5-MeO-AMT and DiPT in 2003, 5-MeO-MiPT in 2004, 5-MeO-DET in 2006, and
4-OH-DiPT in 2009. NPDS data from 2003 to 2021 show sporadic cases of
the five tryptamines, mostly classified as abuse with minor to moderate
outcomes.
The available data indicate that 4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT,
5-MeO-DET, and DiPT have high potential for abuse that is similar to
that of schedule I tryptamine hallucinogens DET (5-MeO-AMT) and DMT (5-
MeO-DET, 5-MeO-MiPT, and DiPT), the phenethylamine hallucinogen DOM (4-
OH-DiPT, 5-MeO-DET, 5-MeO-MiPT, and DiPT), and the ergotamine
hallucinogen LSD (5-MeO-AMT, 4-OH-DiPT, 5-MeO-DET, 5-MeO-MiPT).
2. The Drugs Have No Currently Accepted Medical Use in Treatment in the
United States
According to HHS, 4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and
DiPT lack FDA-approval for any therapeutic indication. In addition,
there are no adequate and well-controlled clinical studies or well-
defined dosage forms for any of the five tryptamine hallucinogens. DEA
notes that there are no therapeutic applications for these five
tryptamine hallucinogens accepted by qualified experts, nor are there
adequate and well-controlled studies proving safety or efficacy for any
medical use. Thus, there is no evidence that 4-OH-DiPT, 5-MeO-AMT, 5-
MeO-MiPT, 5-MeO-DET, and DiPT have currently accepted medical uses in
treatment in the United States.\14\
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\14\ Pursuant to 21 U.S.C. 812(b)(1)(B), when placing a drug or
other substance in schedule I, DEA must consider whether the
substance has a currently accepted medical use in treatment in the
United States. First, DEA looks to whether the drug or substance has
FDA approval. When no FDA approval exists, DEA has traditionally
applied a five-part test to determine whether a drug or substance
has a currently accepted medical use: (1) the drug's chemistry must
be known and reproducible; (2) there must be adequate safety
studies; (3) there must be adequate and well-controlled studies
proving efficacy; (4) the drug must be accepted by qualified
experts; and (5) the scientific evidence must be widely available.
See Marijuana Scheduling Petition; Denial of Petition; Remand, 57 FR
10499 (Mar. 26, 1992), pet. for rev. denied, Alliance for Cannabis
Therapeutics v. Drug Enforcement Admin., 15 F.3d 1131, 1135 (D.C.
Cir. 1994). DEA and HHS applied the traditional five-part test for
currently accepted medical use in this matter and concluded the test
was not satisfied. In a published letter in a different context, HHS
applied a two-part test to determine currently accepted medical use
for substances that do not satisfy the five-part test: (1) whether
there exists widespread, current experience with medical use of the
substance by licensed health care practitioners operating in
accordance with implemented jurisdiction-authorized programs, where
medical use is recognized by entities that regulate the practice of
medicine, and, if so, (2) whether there exists some credible
scientific support for at least one of the medical conditions for
which part (1) is satisfied. On April 11, 2024, the Department of
Justice's Office of Legal Counsel (OLC) issued an opinion, which,
among other things, concluded that HHS' two-part test would be
sufficient to establish that a drug has a currently accepted medical
use. Office of Legal Counsel, Memorandum for Merrick B. Garland,
Attorney General, Re: Questions Related to the Potential
Rescheduling of Marijuana at 3 (April 11, 2024). For purposes of
this proposed rule, there is no evidence that health care providers
have widespread experience with medical use of 4-OH-DiPT, 5-MeO-AMT,
5-MeO-MiPT, 5-MeO-DET, or DiPT, or that the use of 4-OH-DiPT, 5-MeO-
AMT, 5-MeO-MiPT, 5-MeO-DET, or DiPT are 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 the Drugs Under
Medical Supervision
Because 4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and DiPT have
no approved medical use and have not been thoroughly investigated as
new drugs, their safety for use under medical supervision is not
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 4-OH-
DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and DiPT warrant control in
schedule I of the CSA. More precisely, because of their hallucinogenic
effects, DEA proposes to place 4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-
DET, and DiPT, including their salts, isomers, and salts of isomers
whenever the existence of such salts, isomers, and salts of isomers is
possible within the specific chemical description, in 21 CFR 1308.11(d)
(the hallucinogens category of schedule I).
Requirements for Handling 4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET,
and DiPT
If this rule is finalized as proposed, 4-OH-DiPT, 5-MeO-AMT, 5-MeO-
MiPT, 5-MeO-DET, or DiPT would be subject 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,
reverse distributes, dispenses, imports, exports, engages in research,
or conducts instructional activities or chemical analysis with, or
possesses), or who desires to handle 4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT,
5-MeO-DET, or DiPT would need to 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.
Any person who currently handles 4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT,
5-MeO-DET, or DiPT and is not registered with DEA to conduct research
with a schedule I controlled substance must submit an application for
registration and may not continue to handle 4-OH-DiPT, 5-MeO-AMT, 5-
MeO-MiPT, 5-MeO-DET, or DiPT, unless DEA has approved that application
for registration pursuant to 21 U.S.C. 822, 823, 957, 958, and in
accordance with 21 CFR parts 1301 and 1312.
Notwithstanding the foregoing, pursuant to 21 U.S.C. 822(h), if, on
the date the final rule is effectuated, a person is conducting research
on 4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, or DiPT and is already
registered to conduct research with another controlled substance in
schedule I, the person may continue to conduct research on 4-OH-DiPT,
5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, or DiPT if they submit a completed
application for registration or modification of existing registration,
as applicable, to conduct research with 4-OH-DiPT, 5-MeO-AMT, 5-MeO-
MiPT, 5-MeO-DET, or DiPT not later than 90 calendar days after the date
of effectuation of the final rule. The person may continue to conduct
such research until the person withdraws the application or the
Administrator serves on the person an order to show cause proposing
denial of the application pursuant to 21 U.S.C. 824(c) and in
[[Page 60345]]
accordance with 21 CFR 1301.37. If the Administrator serves an order to
show cause proposing denial of the application or modification, the
person may not continue to conduct research with 4-OH-DiPT, 5-MeO-AMT,
5-MeO-MiPT, 5-MeO-DET, or DiPT and may not receive or otherwise obtain
additional 4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, or DiPT. If an
order to show cause is served and the person requests a hearing in
accordance with 21 CFR 1301.37(d), the hearing shall be held in
accordance with 21 CFR 1301.41-1301.46 on an expedited basis and not
later than 45 calendar days after the request is made, except that the
hearing may be held at a later time if so requested by the person. If
the person sends a copy of the application to a manufacturer or
distributor of 4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, or DiPT,
receipt of the copy by the manufacturer or distributor constitutes
sufficient evidence that the person is authorized to receive 4-OH-DiPT,
5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, or DiPT pursuant to 21 U.S.C.
822(h)(4). Continuation of research under 21 U.S.C. 822(h) does not
authorize any other handling (e.g., distribution) of 4-OH-DiPT, 5-MeO-
AMT, 5-MeO-MiPT, 5-MeO-DET, or DiPT.
Retail sales of schedule I controlled substances to the general
public are not allowed under the CSA. Possession of any quantity of a
schedule I controlled substance in a manner not authorized by the CSA
is unlawful and those in possession of any quantity may be subject to
prosecution pursuant to the CSA.
2. Disposal of Stocks. Any person unwilling or unable to obtain a
schedule I registration must surrender or transfer all quantities of
currently held 4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, or DiPT to
a person registered with DEA before the effective date of the final
scheduling action in accordance with all applicable Federal, State,
local, and Tribal laws. 4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, or
DiPT must be disposed of in accordance with 21 CFR part 1317, in
addition to all other applicable Federal, State, local, and Tribal
laws.
3. Security. 4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, or DiPT
would be subject to schedule I security requirements and must be
handled and stored pursuant to 21 U.S.C. 821 and 823, and in accordance
with 21 CFR 1301.71-1301.76. Non-practitioners handling this substance
also would need to comply with the screening requirements of 21 CFR
1301.90-1301.93.
4. Labeling and Packaging. All labels, labeling, and packaging for
commercial containers of 4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET,
or DiPT would need to comply with 21 U.S.C. 825 and 958(e) and be in
accordance with 21 CFR part 1302.
5. Quota. Generally, only registered manufacturers would be
permitted to manufacture 4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET,
or DiPT 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 would handle 4-OH-DiPT, 5-
MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, or DiPT must have an initial inventory
of all stocks of controlled substances including 4-OH-DiPT, 5-MeO-AMT,
5-MeO-MiPT, 5-MeO-DET, or DiPT on hand on the date the registrant first
engages in the handling of controlled substances pursuant to 21 U.S.C.
827 and 958, and in accordance with 21 CFR 1304.03, 1304.04, and
1304.11.
After the initial inventory, every DEA registrant would need to
take an inventory of all controlled substances (including 4-OH-DiPT, 5-
MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, or DiPT) 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.
7. Records and Reports. Every DEA registrant would need to maintain
records and submit reports with respect to 4-OH-DiPT, 5-MeO-AMT, 5-MeO-
MiPT, 5-MeO-DET, or DiPT, pursuant to 21 U.S.C. 827, 832(a), and
958(e), and in accordance with 21 CFR 1301.74 and 1301.76, and parts
1304, 1312, and 1317. Manufacturers and distributors would need to
submit reports regarding 4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET,
or DiPT to the Automated Reports and Consolidated Ordering System
pursuant to 21 U.S.C. 827, and in accordance with 21 CFR parts 1304 and
1312.
8. Order Forms. Every DEA registrant who distributes 4-OH-DiPT, 5-
MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, or DiPT would need to comply with the
order form requirements, pursuant to 21 U.S.C. 828 and 21 CFR part
1305.
9. Importation and Exportation. All importation and exportation of
4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, or DiPT would need to
comply with 21 U.S.C. 952, 953, 957, and 958, and in accordance with 21
CFR part 1312.
10. Liability. Any activity involving 4-OH-DiPT, 5-MeO-AMT, 5-MeO-
MiPT, 5-MeO-DET, or DiPT 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 performed ``on the
record after opportunity for a hearing,'' which are conducted pursuant
to the provisions of 5 U.S.C. 556 and 557. The CSA sets forth the
procedures and criteria for scheduling a drug or other substance. Such
actions are exempt from review by the Office of Management and Budget
(OMB) pursuant to section 3(d)(1) of Executive Order (E.O.) 12866 and
the principles reaffirmed in E.O. 13563. DEA scheduling actions
promulgated by formal rulemaking are not regulatory actions under E.O.
14192, Unleashing Prosperity Through Deregulation, and are not subject
to 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 on 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.
Paperwork Reduction Act
This proposed rule would require compliance with the following
existing OMB collections: 1117-0003, 1117-
[[Page 60346]]
0004, 1117-0006, 1117-0008, 1117-0009, 1117-0010, 1117-0012, 1117-0014,
1117-0021, 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.
Regulatory Flexibility Act
The Administrator, in accordance with the Regulatory Flexibility
Act, 5 U.S.C. 601-612, 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.
DEA proposes placing the substances 4-OH-DiPT, 5-MeO-AMT, 5-MeO-
MiPT, 5-MeO-DET, and DiPT, including their salts, isomers, and salts of
isomers whenever the existence of such salts, isomers, and salts of
isomers is possible within the specific chemical designation, in
schedule I of the CSA. If finalized, this action would impose the
regulatory controls and administrative, civil, and criminal sanctions
applicable to schedule I controlled substances on persons who handle or
propose to handle 4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, or DiPT.
The entities affected by this rule include the manufacturers,
distributors, importers, exporters, and researchers of 4-OH-DiPT, 5-
MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, or DiPT. DEA determined the North
American Industry Classification System (NAICS) industries that best
represent these business activities. Table 1 lists the business
activities and corresponding NAICS industries.\15\
---------------------------------------------------------------------------
\15\ 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 2/5/2026).
Table 1--Business Activity and Corresponding NAICS Industries
------------------------------------------------------------------------
NAICS industry
Business activity NAICS code description
------------------------------------------------------------------------
Manufacturer..................... 325412 Pharmaceutical
Preparation
Manufacturing.
Distributor, Importer, Exporter.. 424210 Drugs and Druggists'
424690 Sundries Merchant
Wholesalers.
Other Chemical and
Allied Products
Merchant Wholesalers.
Researcher....................... 541715 Research and Development
611310 in the Physical,
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.
---------------------------------------------------------------------------
\16\ Statistics of U.S. Businesses, 2022 SUSB Annual Data Tables
by Establishment Industry, <a href="https://www.census.gov/data/tables/2022/econ/susb/2022-susb-annual.html">https://www.census.gov/data/tables/2022/econ/susb/2022-susb-annual.html</a> (Accessed 2/5/2026).
\17\ U.S. Small Business Administration, Table of size
standards, Version March 2023, Effective: March 17, 2023, <a href="https://www.sba.gov/document/support-table-size-standards">https://www.sba.gov/document/support-table-size-standards</a>. (Accessed 2/5/
2026) Size standards are based on the number of employees or annual
receipts depending on industry.
\18\ Based on the estimated number of firms below the SBA size
standard for each industry.
Table 2--Percent Small Entities by Industry
----------------------------------------------------------------------------------------------------------------
Percent
Small firms small
NAICS industry Firms\16\ SBA size standard \17\ \18\ entities
(%)
----------------------------------------------------------------------------------------------------------------
325412-Pharmaceutical Preparation 1,179 1,300 employees.................. 1,099 93.2
Manufacturing.
424210-Drugs and Druggists' Sundries 7,012 250 employees.................... 6,703 95.6
Merchant Wholesalers.
424690-Other Chemical and Allied 5,487 175 employees.................... 5,197 94.7
Products Merchant Wholesalers.
541715-Research and Development in the 10,042 1,000 employees.................. 9,599 95.6
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,\19\
DEA identified 25 domestic entities supplying 4-OH-DiPT, 5-MeO-AMT, 5-
MeO-MiPT, 5-MeO-DET, or DiPT across these industries. Suppliers include
NAICS code 325412, 424210, and 424690 industries. Even if all affected
suppliers were small entities, they would account for only 0.18 percent
of the small entities in those industries, not a substantial
number.\20\ Additionally, DEA expects the number of researchers working
with 4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, or DiPT is small
because 4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and DiPT lack
current marketing approval under a new drug application or an
abbreviated new drug application, and is not subject to an
investigational new drug application as noted in the HHS review. Also,
DEA believes the researchers working with 4-OH-DiPT, 5-MeO-AMT, 5-MeO-
MiPT, 5-MeO-DET, or DiPT may also work with other controlled
substances; hence, they have probably 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 NAICS code 541715 and
611310 industries.
---------------------------------------------------------------------------
\19\ SciFinder; Chemical Abstracts Service: Columbus, OH;
<a href="https://scifinder.cas.org">https://scifinder.cas.org</a> (accessed 5/15/2026).
\20\ 25 / (1,179 + 7,012 + 5,487) = 0.02%.
---------------------------------------------------------------------------
In summary, an insubstantial number of small entities will be
affected by this proposed rule. As such, the proposed rule, if
finalized, is not expected to result in a significant economic impact
on a substantial number of small entities.
[[Page 60347]]
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 proposed
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.
List of Subjects in 21 CFR Part 1308
Administrative practice and procedure, Drug traffic control,
Reporting and recordkeeping requirements.
For the reasons set out above, 21 CFR part 1308 is proposed to be
amended as follows:
PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES
0
1. The authority citation for 21 CFR 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)(118) to (122) to read as follows:
Sec. 1308.11 Schedule I.
* * * * *
(d) * * *
------------------------------------------------------------------------
------------------------------------------------------------------------
* * * * * * *
(118) 4-hydroxy-N,N-diisopropyltryptamine (Other names: 4-OH- 7516
DiPT; 3-(2-(diisopropylamino)ethyl)-1H-indol-4-ol).............
(119) 5-methoxy-alpha-methyltryptamine (Other names: 5-MeO-AMT; 7506
1-(5-methoxy-1H-indol-3-yl)propan-2-amine).....................
(120) 5-methoxy-N-methyl-N-isopropyltryptamine (Other names: 5- 7512
MeO-MiPT; N-(2-(5-methoxy-1H-indol-3-yl)ethyl)-N-methylpropan-2-
amine).........................................................
(121) 5-methoxy-N,N-diethyltryptamine (Other names: 5-MeO-DET; 7525
N,N-diethyl-2-(5-methoxy-1H-indol-3-yl)ethanamine).............
(122) N,N-diisopropyltryptamine (Other names: DiPT; N-(2-(1H- 7522
indol-3-yl)ethyl)-N-isopropylpropan-2-amine)...................
* * * * * * *
------------------------------------------------------------------------
* * * * *
Signing Authority
This document of the Drug Enforcement Administration was signed on
September 11, 2026, by DEA Administrator Terrance C. Cole. That
document with the original signature and date is maintained by DEA. For
administrative purposes only, and in compliance with requirements of
the Office of the Federal Register, the undersigned DEA Federal
Register Liaison Officer has been authorized to sign and submit the
document in electronic format for publication, as an official document
of DEA. This administrative process in no way alters the legal effect
of this document upon publication in the Federal Register.
Heather Achbach,
Federal Register Liaison Officer, Drug Enforcement Administration.
[FR Doc. 2026-19400 Filed 9-22-26; 8:45 am]
BILLING CODE 4410-09-P
</pre></body>
</html>Indexed from Federal Register on September 23, 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.