[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 [www.gpo.gov]
[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.
     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 https://www.regulations.gov 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 
regulations.gov. 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.
     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.
     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:
     4-Hydroxy-N,N-diisopropyltryptamine (4-OH-DiPT),
     5-Methoxy-alphamethyltryptamine (5-MeO-AMT),
     N-Isopropyl-5-Methoxy-N-Methyltryptamine (5-MeO-MiPT),
     N,N-Diethyl-5-methoxytryptamine (5-MeO-DET), and
     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 https://www.regulations.gov. 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 https://www.regulations.gov 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 https://www.regulations.gov 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 https://www.regulations.gov 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-HT2A). DEA further notes that the 5-
HT2A 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\
---------------------------------------------------------------------------

    \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).
---------------------------------------------------------------------------

    (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