Proposed Rule2022-00713
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
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
January 14, 2022
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
The Drug Enforcement Administration proposes placing five tryptamine hallucinogens, as identified in this proposed rule, 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 controlled substances.
Full Text
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<title>Federal Register, Volume 87 Issue 10 (Friday, January 14, 2022)</title>
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[Federal Register Volume 87, Number 10 (Friday, January 14, 2022)]
[Proposed Rules]
[Pages 2376-2383]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-00713]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-623]
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
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, as identified in this proposed rule, 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 controlled substances.
[[Page 2377]]
DATES: Comments must be submitted electronically or postmarked on or
before February 14, 2022.
Requests for hearing and waivers of an opportunity for a hearing or
to participate in a hearing must be received on or before February 14,
2022.
ADDRESSES: Interested persons may file written comments on this
proposal in accordance with 21 CFR 1308.43(g). 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. To ensure proper
handling of comments, please reference ``Docket No. DEA-623'' on all
electronic and written correspondence, including any attachments.
<bullet> Electronic comments: 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 on-line
instructions at that site for submitting comments. Upon completion of
your submission, you will receive a Comment Tracking Number. 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, you
have submitted your comment successfully 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 FR 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 sent to: Drug
Enforcement Administration, Attn: Administrator, 8701 Morrissette
Drive, Springfield, Virginia 22152. All 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 FR Representative/DPW, 8701 Morrissette Drive, Springfield,
Virginia 22152.
FOR FURTHER INFORMATION CONTACT: Terrence L. Boos, Drug & Chemical
Evaluation Section, Diversion Control Division, Drug Enforcement
Administration; Telephone: (571) 362-3249.
SUPPLEMENTARY INFORMATION: In this proposed rule, the Drug Enforcement
Administration (DEA) proposes to schedule the following five controlled
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 (4-OH-DiPT),
<bullet> 5-Methoxy-alphamethyltryptamine (5-MeO-AMT),
<bullet> N-Isopropyl-5-Methoxy-N-Methyltryptamine (5-MeO-MiPT),
<bullet> N,N-Diethyl-5-methoxytryptamine (5-MeO-DET), and
<bullet> N,N-Diisopropyltryptamine (DiPT).
Posting of Public Comments
All comments received in response to this docket are considered
part of the public record. DEA will make comments available, unless
reasonable cause is given, for public inspection online at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Such information includes personal identifying
information (such as your name, address, etc.) voluntarily submitted by
the commenter. The Freedom of Information Act applies to all comments
received. If you want to submit personal identifying information (such
as your name, address, etc.) as part of your comment, but do not want
DEA to make it publicly available, you must include the phrase
``PERSONAL IDENTIFYING INFORMATION'' in the first paragraph of your
comment. You must also place all of the personal identifying
information you do not want made publicly available in the first
paragraph of your comment and identify what information you want
redacted.
If you want to submit confidential business information as part of
your comment, but do not want DEA to make it publicly available, you
must include the phrase ``CONFIDENTIAL BUSINESS INFORMATION'' in the
first paragraph of your comment. You must also prominently identify the
confidential business information to be redacted within the comment.
DEA will generally make available in publicly redacted from
comments containing personal identifying information and confidential
business information identified, as directed above. If a comment has so
much confidential business information that DEA cannot effectively
redact it, DEA may not make available publicly all or part of that
comment. Comments posted to <a href="https://www.regulations.gov">https://www.regulations.gov</a> may include any
personal identifying information (such as name, address, and phone
number) included in the text of your electronic submission that is not
identified as confidential as directed above.
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> for
easy reference.
Request for Hearing or Appearance; Waiver
Pursuant to 21 U.S.C. 811(a), this action is a formal rulemaking
``on the record after opportunity for a hearing.'' Such proceedings are
conducted pursuant to the provisions of the Administrative Procedure
Act, 5 U.S.C. 551-59. 21 CFR 1308.41 through 1308.45; 21 CFR part 1316,
subpart D. Interested persons may file requests for a hearing or
notices of intent to participate in a hearing in conformity with the
requirements of 21 CFR 1308.44(a) or (b), and such requests must
include a statement of interest in the proceeding and the objections or
issues, if any, concerning which the person desires to be heard. 21 CFR
1316.47(a). Any interested person may file a waiver of an opportunity
for a hearing or to participate in a hearing together with a written
statement regarding the interested person's position on the matters of
fact and law involved in any hearing as set forth in 21 CFR 1308.44(c).
All requests for 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.
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 on his own motion. 21 U.S.C. 811(a).
This proposed action was initiated on the Attorney General's own
motion, as delegated to the Administrator of DEA (Administrator), and
is supported by, inter alia, a recommendation from the former Assistant
Secretary for Health of the Department of Health and Human Services
(former Assistant Secretary of
[[Page 2378]]
HHS or former Assistant Secretary) \1\ and an evaluation of all
relevant data by DEA. If finalized, this action would impose the
regulatory controls and administrative, civil, and criminal sanctions
applicable to controlled substances, including those specific 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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\1\ The Secretary of HHS has delegated to the Assistant
Secretary for Health the authority to make domestic drug scheduling
recommendations.
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Background
4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and DiPT are
tryptamine hallucinogens. They share structural and pharmacological
similarities with several schedule I tryptamine hallucinogens, such as
alpha-methyltryptamine (AMT), N,N-dimethyltryptamine (DMT), 5-methoxy-
N,N-diisopropyltryptamine (5-MeO-DiPT), and psilocyn. They have no
approved medical use in the United States.
Proposed Determination To Schedule 4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-
MeO-DET, and DiPT
Pursuant to 21 U.S.C. 811(b), DEA gathered the necessary data on 4-
OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and DiPT, and on December
19, 2008, submitted it to the former Assistant Secretary with a request
for a scientific and medical evaluation of available information and a
scheduling recommendation for 4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-
DET, and DiPT.
On March 29, 2012, May 17, 2012, and August 14, 2012, HHS provided
to DEA scientific and medical evaluations for the above mentioned five
tryptamines and a scheduling recommendation for each. The evaluations
were entitled: (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).''
Following consideration of the eight factors and findings related to
each of the substances' abuse potential, legitimate medical use, and
dependence liability, 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).
In response, DEA reviewed the scientific and medical evaluation and
scheduling recommendation provided by HHS and all other relevant data,
and completed its own eight-factor review pursuant to 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 DEA
and HHS analyses are available in their entirety under ``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 ``DEA-623.''
1. The Drugs' 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 each
substance. The term ``abuse'' is not defined in the CSA, however the
legislative history of the CSA suggests the following four prongs in
determining whether a particular drug or substance has a potential for
abuse: \2\
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\2\ 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. Individuals are taking the drug or other substance in amounts
sufficient to create a hazard to their health or to the safety of other
individuals or to the community; or
b. There is a significant diversion of the drug or other substance
from legitimate drug channels; or
c. Individuals are taking the drug or other substance on their own
initiative rather than on the basis of medical advice from a
practitioner licensed by law to administer such drugs; or
d. The drug 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 it will have the same potential for abuse as such
substance, 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.
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 4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and DiPT
have a high potential for abuse.
a. There is evidence that individuals are taking the drug or other
substance in amounts sufficient to create a hazard to their health or
to the safety of other individuals or to the community.
According to HHS 2012 review, and more current DEA findings, data
show that 4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and DiPT have
been encountered by law enforcement (Factor 5). Based on published case
reports in the medical literature and anecdotal reports (Factor 2), HHS
states that these substances are being abused for their hallucinogenic
properties. HHS has determined that consumption of these five
tryptamines due to their hallucinogenic properties poses a safety
hazard to the public health. There were hospital emergency room
admissions related to the abuse of 5-MeO-AMT and 5-MeO-MiPT. One
confirmed death was reported in 2004 from the abuse of 5-MeO-AMT, taken
in combination with alcohol and the antidepressant bupropion; however,
it is unclear what role 5-MeO-AMT played in the death.
b. There is significant diversion of the drug or substance from
legitimate drug channels.
HHS, in its 2012 review, stated that 4-OH-DiPT, 5-MeO-AMT, 5-MeO-
MiPT, 5-MeO-DET, and DiPT are not Food and Drug Administration (FDA)-
approved drug products for treatment in the United States and that it
is unaware of any country in which their use is legal. DEA has
confirmed with HHS that their 2012 statements are still applicable. In
addition, HHS' 2012 review stated that there appear to be no legitimate
sources for 4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and DiPT as
marketed drugs. DEA notes that these substances are available for
purchase from legitimate suppliers for scientific research. However,
there is no evidence of significant diversion of 4-OH-DiPT, 5-MeO-AMT,
5-MeO-MiPT, 5-MeO-DET, and DiPT from legitimate suppliers.
[[Page 2379]]
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 and are not formulated or available for
clinical use. 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 and case reports suggesting that individuals are taking these
substances for similar hallucinogenic effects produced by lysergic acid
diethylamide (LSD) and N,N-diethyltryptamine (DET), while possibly
simultaneously attempting to circumvent criminal prosecution since
these are explicitly scheduled substances (see Factor 5 for more
detailed information).
d. The drug is a new drug 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 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.
After scientific evaluation, HHS states that 4-OH-DiPT, 5-MeO-AMT,
5-MeO-MiPT, 5-MeO-DET, and DiPT are structural analogs of schedule I
hallucinogens (4-OH-DiPT of 5-MeO-DiPT, 5-MeO-AMT of AMT, 5-MeO-MiPT of
DMT, 5-MeO-DET of 5-MeO-DMT and DMT, and DiPT of 5-MeO-DiPT) and
produce similar pharmacological effects to natural and synthetic
schedule I hallucinogens.
4-OH-DiPT
4-OH-DiPT elicits pharmacological responses similar to the schedule
I substances 4-methyl-2,5-dimethoxy-amphetamine (DOM) and LSD, which
have no accepted medical use and have high abuse potential. In animal
drug discrimination studies, 4-OH-DiPT fully generalizes for the
discriminative stimulus effects of DOM and LSD in rats. Additionally,
4-OH-DiPT produces classic hallucinogenic effects such as perceptual
distortions and pleasurable physical effects. Risks and effects of 4-
OH-DiPT include: Hallucinations, euphoria, fatigue, headache,
gastrointestinal distress, insomnia, and anxiety. HHS states that these
effects are like those of schedule I hallucinogens and concludes that
based on the psychological and cognitive disturbances associated with
effects of 4-OH-DiPT, it is reasonable to assume that this substance
has a substantial capability to cause a hazard to public health, both
to the user and to the community.
5-MeO-AMT
According to HHS, 5-MeO-AMT elicits pharmacological responses
similar to the schedule I substances LSD and DET which have no accepted
medical use and have high abuse potential. Drug discrimination data
demonstrate that 5-MeO-AMT produces partial generalization for the
discriminative stimulus effects of LSD in rats. In humans, 5-MeO-AMT
produces hallucinogenic effects similar to those produced by LSD and
DET, including euphoria and visual and auditory hallucinations. Adverse
effects caused by 5-MeO-AMT are similar to those of schedule I
hallucinogens including: Fatigue, headache, gastrointestinal distress,
insomnia, and anxiety. Based on the hallucinogenic and other effects
caused by 5-MeO-AMT, HHS states that it is reasonable to assume that
this substance has substantial capability to cause a hazard to public
health, both to the user and to the community.
5-MeO-MiPT
According to HHS, 5-MeO-MiPT elicits pharmacological responses
similar to the schedule I substances LSD and DMT, which have no
accepted medical use and have high abuse potential. Drug discrimination
studies showed that 5-MeO-MiPT fully generalizes to the discriminative
stimulus effects of DOM in rats, and partially generalizes to the
discrimination stimulus effects of LSD, DMT, and 3,4-methylenedioxy-
methamphetamine (MDMA, schedule I). In humans it has been reported that
5-MeO-MiPT is 15-fold more potent than DMT when comparing doses that
produce hallucinogenic effects. Thus, HHS concluded that it is
reasonable to assume that 5-MeO-MiPT has substantial capability to
cause a hazard to public health, both to the user and to the community.
5-MeO-DET
According to HHS, 5-MeO-DET elicits pharmacological responses
similar to the schedule I substances DMT and DOM, which have no
accepted medical use and have high abuse potential. In animal drug
discrimination studies, 5-MeO-DET fully generalizes for the
discriminative stimulus effect of DMT in rats. 5-MeO-DET partially
generalizes to the discriminative stimulus cues of DOM and MDMA. The
reports from users describe the effects of 5-MeO-DET as being similar
to those produced by DMT and LSD. Adverse health risks associated with
5-MeO-DET use include: Bizarre behavior, hallucinations, and
sympathomimetic effects, such as increased heart rate. These adverse
effects are similar to those of schedule I hallucinogens. Based on
available information, it is reasonable to assume that 5-MeO-DET has
substantial capability to cause a hazard to public health, both to the
user and to the community.
DiPT
According to HHS, DiPT elicits pharmacological responses similar to
the schedule I substances DOM and DMT, which have no accepted medical
use and have high abuse potential. Drug discrimination studies showed
that DiPT fully substitutes for the discriminative stimulus effects of
DOM and DMT in rats. The reports from users describe the effects of
DiPT as being similar to those produced by 4-bromo-2,5-
dimethoxyphenethylamine (2C-B), 2-(2,5-dimethoxy-4-
methylphenyl)ethanamine (2C-D), and 2,5-dimethoxy-4-ethylamphetamine
(DOET), all of which are classified as schedule I substances. Risks
associated with DiPT use are based on the perceptual changes in the
auditory experience. Like schedule I hallucinogens, DiPT produces
adverse effects such as: Auditory and other sensory distortions,
lethargy, nausea, hyperreflexia, and mydriasis. Based on the adverse
effects associated with DiPT, it is reasonable to assume that this
substance has substantial capability to cause a hazard to public
health, both to the user and to the community.
2. Scientific Evidence of the Drugs' Pharmacological Effects, If Known
As stated by HHS (HHS reviews, 2012a-e), the neurochemical effects
of 4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and DiPT mainly involve
serotonergic system in the central nervous system (CNS). Tryptamine
hallucinogens are believed to produce their characteristic effects
primarily through stimulation of the 2A subtype of serotonin (5-HT)
receptors (5-HT<INF>2A</INF>). DEA further notes that the 5-
HT<INF>2A</INF> receptor has also been shown to mediate the in vivo
behavioral effects and discriminative stimulus effects of the three
classes of classic hallucinogens, ergotamines (e.g., LSD),
[[Page 2380]]
phenethylamines (e.g., DOM), and tryptamines (e.g., DMT).
Animal testing data in rats show that stimulus properties of 4-OH-
DiPT are similar to DOM and LSD, and partially similar to DMT; 5-MeO-
AMT substantially overlaps with LSD; 5-MeO-MiPT substantially overlaps
with DOM, LSD, and MDMA; 5-MeO-DMT are similar to DMT, DOM, and MDMA;
and DiPT are similar to DOM and DMT, and are partially similar to LSD.
Thus, 4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and DiPT produce
psychopharmacologic effects similar to those produced by serotonin-
mediated hallucinogens in an animal model, which are predictive of its
abuse in humans.
In humans, users of 4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET,
and DiPT report hallucinogenic effects similar to LSD and DET
including: Euphoria, hallucinations involving various senses,
perceptual distortions and pleasant intensification of sensory
experiences. Physiological and psychological effects have been reported
to be frightening or disturbing and can include: Dizziness, fatigue,
headache, trembling, anxiety, insomnia, restlessness, cold sweats, and
gastrointestinal disturbances (i.e., nausea, vomiting, and diarrhea),
among others. One death was reported in 2004 with the use of 5-MeO-AMT,
however alcohol and bupropion (an antidepressant) were also detected in
post mortem toxicology analyses.
3. The State of Current Scientific Knowledge Regarding the Drugs or
Other Substances
Chemistry
4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and DiPT are part of
the tryptamine family and share the core tryptamine structure with
substitutions at the [alpha]-position, 4-position, 5-position, and on
the nitrogen (N) atom. All of these 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.
Pharmacokinetics
Metabolism studies have not been conducted for 4-OH-DiPT, 5-MeO-
AMT, 5-MeO-DET, and DiPT. However, metabolism has been reported for 5-
MeO-MiPT. Similar to other structurally related tryptamines, 5-MeO-MiPT
has been reported to undergo metabolism through oxidative deamination,
N-demethylation, O-demethylation, and N-oxidation with N-oxides as the
major metabolites. Thus, it is highly likely that 4-OH-DiPT, 5-MeO-AMT,
5-MeO-DET, and DiPT will be metabolized in a similar manner.
4. Its History and Current Pattern of Abuse
In the U.S., law enforcement entities have 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 (NFLIS).\3\ Each of these tryptamines has been
encountered in one or more of the following forms: Powder, tablets,
capsules, liquid, or on blotter paper. These substances are generally
purchased from internet-based companies in addition to being purchased
from dealers. These tryptamines are often misrepresented as LSD to
users due to their similarities in producing hallucinogenic effects.
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\3\ NFLIS is a national drug forensic laboratory reporting
system that systematically collects results from drug chemistry
analyses conducted by state and local forensic laboratories across
the country. The NFLIS participation rate, defined as the percentage
of the national drug caseload represented by laboratories that have
joined NFLIS, is over 97 percent. NFLIS includes drug chemistry
results from completed analyses only.
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4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and DiPT do not have
an approved medical indication in the U.S. and therefore have no
legitimate medical use in the U.S. 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. The Scope, Duration, and Significance of Abuse
Tryptamine hallucinogens, both natural and synthetic, have been
popular among the attendees of rave parties, music concerts, and other
large or social venues, as well as in intimate and smaller settings
since the 1990s in the U.S. and Europe. Often these substances are
promoted as substitutes for LSD. Synthetic hallucinogens and stimulants
are known as ``club drugs.'' In addition to sales in raves and
nightclubs, internet sales have become one of the main outlets for the
sale and distribution of tryptamine hallucinogens.
In the U.S., there has been significant 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 large numbers of
encounters of one or more of these tryptamines by U.S. law enforcement
in 47 states and the District of Columbia.
According to NFLIS, there have been 5 reports of 4-OH-DiPT (first
reported in 2009), 92 reports of 5-MeO-AMT (first reported in 2003),
348 reports of 5-MeO-MiPT (first reported in 2004), 17 reports of 5-
MeO-DET (first reported in 2006), and 25 reports of DiPT (first
reported in 2003).\4\
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\4\ NFLIS data were queried August 17, 2021, by date of
submission.
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6. What, if Any, Risk There Is to the Public Health
HHS 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 (often between 5-15 minutes,
dependent on the route of administration) after ingestion 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 tryptamines (see Factor 2). HHS also
cited published and anecdotal reports that described the adverse
effects of these five hallucinogens including agitation, confusion,
psychological distress for all five substances, and death in the case
of 5-MeO-AMT. It is unclear what role 5-MeO-AMT played in the death.
The toxicology report also reported alcohol and the presence of an
antidepressant, bupropion. Users of 4-OH-DiPT reported that the
hallucinations were intense and the psychological and physiological
effects were frightening or disturbing. A non-lethal poisoning was
reported in an adolescent after ingesting an alleged combination of 5-
MeO-MiPT and harmaline, a CNS stimulant.
7. Its Psychic or Physiological Dependence Liability
According to HHS, 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. Thus, it is not possible at this
time to determine whether 4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET,
and DiPT produce physiological dependence
[[Page 2381]]
following acute or chronic administration. However, hallucinogen
abusers may develop psychological dependence to these substances as
evidenced by the continued use of these substances despite knowledge of
the potential toxic and adverse effects.
The data on the drug discrimination studies conducted by the
National Institute on Drug Abuse, cited in HHS reviews and later
published, show that 4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and
DiPT share discriminative stimulus effects with other schedule I
hallucinogens: 4-OH-DiPT fully substitutes for DOM and LSD; 5-MeO-AMT
partially substitutes for LSD and DMT; 5-MeO-MiPT fully substitutes for
DOM; 5-MeO-DET fully substitutes for DMT; and DiPT fully substitutes
for DOM and DMT. DEA adds that LSD, DOM, and MDMA fully substitute for
DiPT-trained discriminative stimulus effects, confirming that DiPT has
hallucinogenic effects similar to other schedule I hallucinogens.
8. Whether the Substance Is an Immediate Precursor of a Substance
Already Controlled Under the CSA
4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and DiPT are not
immediate precursors of a substance already controlled under the CSA as
defined by 21 U.S.C. 802(23).
Conclusion
Based on consideration of the scientific and medical evaluation and
accompanying recommendations of HHS, and on DEA's consideration of its
own eight-factor analysis, DEA finds that these 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 controlled substances under the CSA.
Proposed Determination of Appropriate Schedule
The CSA establishes five schedules of controlled substances known
as schedules I, II, III, IV, and V. The CSA also outlines the findings
required to place a drug or other substance in any particular schedule.
21 U.S.C. 812(b). After consideration of the analysis and
recommendation of the former Assistant Secretary and review of all
other available data, the Administrator, pursuant to 21 U.S.C.
812(b)(1), finds that:
(1) 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 (e.g., DOM, LSD, DMT, DET). These effects are marked by
hallucinations and CNS stimulation. Law enforcement reported a number
of encounters of 5-MeO-AMT and DiPT beginning in 2003, 5-MeO-MiPT
beginning in 2004, 5-MeO-DET beginning in 2006, and 4-OH-DiPT beginning
in 2009.
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 other 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) 4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and DiPT are not
legally marketed in the U.S. They lack current marketing approval under
new drug applications, abbreviated new drug applications, or
investigational use under an active investigational new drug
application. There is no evidence that 4-OH-DiPT, 5-MeO-AMT, 5-MeO-
MiPT, 5-MeO-DET, and DiPT have a currently accepted medical use in
treatment in the U.S.\5\
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\5\ Although there is no evidence suggesting that 4-OH-DiPT, 5-
MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and DiPT have a currently accepted
medical use in treatment in the United States, it bears noting that
a drug cannot be found to have such medical use unless DEA concludes
that it satisfies a five-part test. Specifically, with respect to a
drug that has not been approved by FDA, to have a currently accepted
medical use in treatment in the United States, all of the following
must be demonstrated: i. the drug's chemistry must be known and
reproducible; ii. there must be adequate safety studies; iii. there
must be adequate and well-controlled studies proving efficacy; iv.
the drug must be accepted by qualified experts; and v. the
scientific evidence must be widely available. 57 FR 10499 (1992),
pet. for rev. denied, Alliance for Cannabis Therapeutics v. DEA, 15
F.3d 1131, 1135 (D.C. Cir. 1994).
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(3) 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, and because they may produce hallucinogenic-like tolerance and
dependence in humans, 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 hallucinogenic substances 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, and 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,
import, export, research, conduct of instructional activities or
chemical analysis with, and possession of schedule I controlled
substances, including the following:
1. Registration. Any person who handles (manufactures, distributes,
reverse distributes, imports, exports, engages in research, or conducts
instructional activities or chemical analysis with, or possesses), or
who desires to handle, 4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, or
DiPT would be required 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, as of the effective date of
a final scheduling action. 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, would need to 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
as of the effective date of a final scheduling action, 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.
2. Disposal of stocks. Any person unwilling or unable to obtain a
schedule I registration would be required to surrender or transfer all
quantities of currently held 4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-
DET, and DiPT to a person registered with DEA before the effective date
of a final scheduling action, in accordance with all applicable
Federal, State, local, and tribal laws. As of the effective date of a
final scheduling action, 4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET,
and DiPT would be required to be disposed of in accordance with 21 CFR
part 1317, in
[[Page 2382]]
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, and DiPT
would be subject to schedule I security requirements for DEA
registrants and would need to be handled and stored pursuant to 21
U.S.C. 823 and in accordance with 21 CFR 1301.71 through 1301.76 as of
the effective date of a final scheduling action. Non-practitioners
handling 4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and DiPT would
also need to comply with the employee screening requirements of 21 CFR
1301.90 through 1301.93.
4. Labeling and Packaging. All labels and labeling for commercial
containers of 4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, or DiPT
would need to be in compliance with 21 U.S.C. 825, and be in accordance
with 21 CFR part 1302, as of the effective date of a final scheduling
action.
5. Quota. Only registered manufacturers would be permitted to
manufacture 4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and DiPT in
accordance with a quota assigned pursuant to 21 U.S.C. 826 and in
accordance with 21 CFR part 1303, as of the effective date of a final
scheduling action.
6. Inventory. Every DEA registrant who possesses any quantity of 4-
OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and DiPT on the effective
date of the final rule would need to take an inventory of 4-OH-DiPT, 5-
MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and/or DiPT on hand at that time,
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 on or after the effective date of
the final scheduling action would be required to take an initial
inventory of all stocks of controlled substances (including 4-OH-DiPT,
5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and/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 in accordance with 21 CFR 1304.03,
1304.04, and 1304.11(a) and (b).
After the initial inventory, every DEA registrant would be required
to take a new inventory of controlled substances (including 4-OH-DiPT,
5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and/or DiPT) 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 would be required to
maintain records and submit reports with respect to 4-OH-DiPT, 5-MeO-
AMT, 5-MeO-MiPT, 5-MeO-DET, DiPT, or products containing 4-OH-DiPT, 5-
MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and/or DiPT pursuant to 21 U.S.C. 827
and in accordance with 21 CFR 1301.74(b) and (c) and parts 1304, 1312,
and 1317, as of the effective date of a final scheduling action.
Manufacturers and distributors would need to submit reports regarding
these substances 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, as of the effective date of a final scheduling action.
8. Order Forms. Every DEA registrant who distributes 4-OH-DiPT, 5-
MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, or DiPT would be required to comply
with the order form requirements, pursuant to 21 U.S.C. 828, and 21 CFR
part 1305, as of the effective date of a final scheduling action.
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 be
in compliance with 21 U.S.C. 952, 953, 957, and 958, and in accordance
with 21 CFR part 1312, as of the effective date of a final scheduling
action.
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 could subject
the person to administrative, civil, and/or criminal sanctions.
Regulatory Analyses
Executive Orders 12866 and 13563 (Regulatory Planning and Review;
Improving Regulation and Regulatory Review)
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
procedures and criteria for scheduling a drug or other substance. Such
actions are exempt from review by the Office of Management and Budget
pursuant to section 3(d)(1) of Executive Order (E.O.) 12866 and the
principles reaffirmed in E.O. 13563.
Executive Order 12988, Civil Justice Reform
This proposed regulation meets the applicable standards set forth
in sections 3(a) and 3(b)(2) of E.O. 12988, to eliminate drafting
errors and ambiguity, minimize litigation, provide a clear legal
standard for affected conduct, and promote simplification and burden
reduction.
Executive Order 13132, Federalism
This proposed rulemaking does not have federalism implications
warranting the application of E.O. 13132. The proposed rule does not
have substantial direct effects on the States, on the relationship
between the National Government and the States, or the distribution of
power and responsibilities among the various levels of government.
Executive Order 13175, Consultation and Coordination With Indian Tribal
Governments
This proposed rule does not have tribal implications warranting the
application of E.O. 13175. It does not have substantial direct effects
on one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.
Paperwork Reduction Act of 1995
This proposed action does not impose a new collection of
information requirement under the Paperwork Reduction Act of 1995 (44
U.S.C. 3501-3521).
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-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), 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
regulatory controls and administrative, civil, and/or criminal
sanctions applicable to schedule I controlled substances on persons who
handle (manufacture, distribute, reverse distribute, import, export,
engage in research, conduct instructional activities, or chemical
analysis with, or possess), or propose to handle 4-OH-DiPT, 5-MeO-AMT,
5-MeO-MiPT, 5-MeO-DET, or DiPT.
[[Page 2383]]
There appear to be no legitimate sources for 4-OH-DiPT, 5-MeO-AMT,
5-MeO-MiPT, 5-MeO-DET, and DiPT as marketed drugs and no accepted
medical use in the United States, but DEA notes that these substances
are available for purchase from legitimate suppliers for scientific
research. There is no evidence of significant diversion of 4-OH-DiPT,
5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and DiPT from legitimate suppliers.
DEA has identified 31 domestic suppliers of one or more of the
following substances: 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). Thirty (30) of the 31
domestic suppliers are not registered with DEA to handle controlled
substances. The one registered supplier is already registered with DEA
and has all security and other handling processes in place, resulting
in minimal impact to this supplier. Therefore, the remaining 30 non-
registered domestic suppliers are affected. Since the vast majority of
DEA registrants are small entities or are employed by small entities,
all 30 affected suppliers are assumed to be small entities. It is
impossible to know how much 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) are
distributed by these suppliers. It is common for suppliers to have
items on their catalog while not actually having any material level of
sales. Based on the discussion above, DEA believes any quantity of
sales from these distributors for legitimate purposes is minimal.
Therefore, these suppliers are expected to remove the product from
their catalog rather than incur the cost of obtaining a DEA
registration and physical security for products with minimal sales.
Therefore, DEA estimates the cost of this rule, in form of lost sales,
if any, on the affected small entities is minimal. DEA welcomes any
public comment regarding this estimate.
Because of these facts, this proposed rule will not, if
promulgated, result in a significant economic impact on a substantial
number of small entities.
Unfunded Mandates Reform Act of 1995
On the basis of information contained in the ``Regulatory
Flexibility Act'' section above, DEA has determined pursuant to the
Unfunded Mandates Reform Act (UMRA) of 1995 (2 U.S.C. 1501 et seq.)
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, DEA proposes to amend 21 CFR part
1308 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, as proposed to be amended at 86 FR 16553 (March
30, 2021), 86 FR 37719 (July 16, 2021), and 86 FR 69187 (December 7,
2021), add paragraphs (d)(101) through (105) to read as follows:
Sec. 1308.11 Schedule I.
* * * * *
(d) * * *
(101) 4-hydroxy-N,N-diisopropyltryptamine (other names: 4-OH-DiPT;
3-(2-(diisopropylamino)ethyl)-1H-indol-4-ol) 7516.
(102) 5-methoxy-alpha-methyltryptamine (Other names: 5-MeO-AMT; 1-
(5-methoxy-1H-indol-3-yl)propan-2-amine) 7506.
(103) 5-methoxy-N-methyl-N-isopropyltryptamine (Other names: 5-MeO-
MiPT; N-(2-(5-methoxy-1H-indol-3-yl)ethyl)-N-methylpropan-2-amine)
7512.
(104) 5-methoxy-N,N-diethyltryptamine (Other names: 5-MeO-DET; N,N-
diethyl-2-(5-methoxy-1H-indol-3-yl)ethanamine) 7525.
(105) N,N-diisopropyltryptamine (Other names: DiPT; N-(2-(1H-indol-
3-yl)ethyl)-N-isopropylpropan-2-amine) 7522.
* * * * *
Anne Milgram,
Administrator.
[FR Doc. 2022-00713 Filed 1-13-22; 8:45 am]
BILLING CODE 4410-09-P
</pre></body>
</html>Indexed from Federal Register on January 14, 2022.
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.