Schedules of Controlled Substances: Placement of 3-Methoxyphencyclidine (1-[1-(3-methoxyphenyl)cyclohexyl]piperidine) in Schedule I, 24370-24378 [2025-10503]
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Federal Register / Vol. 90, No. 110 / Tuesday, June 10, 2025 / Proposed Rules
For the reasons set out above, DEA
proposes to amend 21 CFR part 1308 as
follows:
PART 1308—SCHEDULES OF
CONTROLLED SUBSTANCES
1. The authority citation for 21 CFR
part 1308 continues to read as follows:
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d. Add new paragraphs (b)(83),
(b)(85), and (b)(91);
The additions to read as follows:
■
2. In § 1308.11:
a. Redesignate paragraphs (b)(89)
through (110) as (b)(92) through (113);
■ b. Redesignate paragraphs (b)(84)
through (b)(88) as (b)(86) through (90);
■ c. Redesignate paragraphs (b)(83) as
(b)(84); and
■
■
§ 1308.11
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Schedule I.
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(83) para-bromofentanyl (N-(4-bromophenyl)-N-(1-phenethylpiperidin-4-yl)propionamide) ...................................................................
9872
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(85) para-fluoroacetyl fentanyl (N-(4-fluorophenyl)-N-(1-phenethylpiperidin-4-yl)acetamide) ................................................................
9874
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(91) para-methyl acetyl fentanyl (N-(4-methylphenyl)-N-(1-phenethylpiperidin-4-yl)acetamide) ...........................................................
9875
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Signing Authority
This document of the Drug
Enforcement Administration was signed
on June 2, 2025, by Acting
Administrator Robert J. Murphy. That
document with the original signature
and date is maintained by DEA. For
administrative purposes only, and in
compliance with requirements of the
Office of the Federal Register, the
undersigned DEA Federal Register
Liaison Officer has been authorized to
sign and submit the document in
electronic format for publication, as an
official document of DEA. This
administrative process in no way alters
the legal effect of this document upon
publication in the Federal Register.
Heather Achbach,
Federal Register Liaison Officer, Drug
Enforcement Administration.
[FR Doc. 2025–10372 Filed 6–9–25; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA1146]
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Authority: 21 U.S.C. 811, 812, 871(b),
956(b), unless otherwise noted.
Schedules of Controlled Substances:
Placement of 3-Methoxyphencyclidine
(1-[1-(3-methoxyphenyl)
cyclohexyl]piperidine) in Schedule I
Drug Enforcement
Administration, Department of Justice.
ACTION: Notice of proposed rulemaking.
AGENCY:
The Drug Enforcement
Administration proposes placing 3methoxyphencyclidine, including its
SUMMARY:
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salts, isomers, and salts of isomers, an
arylcyclohexylamine hallucinogen, in
schedule I of the Controlled Substances
Act. This action is proposed to enable
the United States to meet its obligations
under the 1971 Convention on
Psychotropic Substances. 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 3-methoxyphencyclidine.
DATES: Comments must be submitted
electronically or postmarked on or
before July 10, 2025. 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.
Requests for a hearing and waivers of
an opportunity for a hearing or to
participate in a hearing, together with a
written statement of position on the
matters of fact and law involved in the
hearing, must be received on or before
July 10, 2025.
ADDRESSES: Interested persons may file
written comments on this rulemaking in
accordance with 21 CFR 1308.43(g). To
ensure proper handling of comments,
please reference ‘‘Docket No. DEA1146’’
on all correspondence, including any
attachments.
• Electronic comments: The Drug
Enforcement Administration (DEA)
encourages commenters to submit all
comments electronically through the
Federal eRulemaking Portal, which
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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 online instructions at that site for
submitting comments. Upon completion
of your submission you will receive a
Comment Tracking Number for your
comment. Submitted comments are not
instantaneously available for public
view on Regulations.gov. If you have
received a Comment Tracking Number,
your comment has been successfully
submitted and there is no need to
resubmit the same comment.
• Paper comments: Paper comments
that duplicate electronic submissions
are not necessary. Should you wish to
mail a paper comment in lieu of an
electronic comment, it should be sent
via regular or express mail to: Drug
Enforcement Administration, Attn: DEA
Federal Register Representative/DPW,
8701 Morrissette Drive, Springfield,
Virginia 22152.
• Hearing requests: All requests for a
hearing and waivers of participation,
together with a written statement of
position on the matters of fact and law
asserted in the hearing, must be filed
with the DEA Administrator, who will
make the determination of whether a
hearing will be needed to address such
matters of fact and law in the
rulemaking. Such requests must be sent
to: Drug Enforcement Administration,
Attn: Administrator, 8701 Morrissette
Drive, Springfield, Virginia 22152. For
informational purposes, a courtesy copy
of requests for hearing and waivers of
participation should also be sent to: (1)
Drug Enforcement Administration, Attn:
Hearing Clerk/OALJ, 8701 Morrissette
Drive, Springfield, Virginia 22152; and
(2) Drug Enforcement Administration,
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Federal Register / Vol. 90, No. 110 / Tuesday, June 10, 2025 / Proposed Rules
Attn: DEA Federal Register
Representative/DPW, 8701 Morrissette
Drive, Springfield, Virginia 22152.
FOR FURTHER INFORMATION CONTACT:
Terrence L. Boos, Drug and Chemical
Evaluation Section, Diversion Control
Division, Drug Enforcement
Administration; Telephone: (571) 362–
3249. As required by 5 U.S.C. 553(b)(4),
a summary of this rule may be found in
the docket for this rulemaking at
www.regulations.gov.
In this
proposed rule, the Drug Enforcement
Administration (DEA) proposes to
schedule 3-methoxyphencyclidine (1-[1(3-methoxyphenyl)cyclohexyl]
piperidine; 3-MeO-PCP) in schedule I of
the Controlled Substances Act (CSA),
including its salts, isomers, and salts of
isomers whenever the existence of such
salts, isomers, and salts of isomers is
possible within the specific chemical
designation.
SUPPLEMENTARY INFORMATION:
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Posting of Public Comments
Please note that all comments
received in response to this docket are
considered part of the public record.
DEA will make comments available for
public inspection online at https://
www.regulations.gov. Such information
includes personal identifying
information (such as your name,
address, State or Federal identifiers,
etc.) voluntarily submitted by the
commenter. In general, all information
voluntarily submitted by the
commenter, unless clearly marked as
Confidential Information in the method
described below, will be publicly
posted. Comments may be submitted
anonymously. The Freedom of
Information Act applies to all comments
received.
Commenters submitting comments
which include personal identifying
information (PII), confidential, or
proprietary business information that
the commenter does not want made
publicly available should submit two
copies of the comment. One copy must
be marked ‘‘CONTAINS
CONFIDENTIAL INFORMATION’’ and
should clearly identify all PII or
business information the commenter
does not want to be made publicly
available, including any supplemental
materials. DEA will review this copy,
including the claimed PII and
confidential business information, in its
consideration of comments. The second
copy should be marked ‘‘TO BE
PUBLICLY POSTED’’ and must have all
claimed confidential PII and business
information already redacted. DEA will
post only the redacted comment on
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https://www.regulations.gov for public
inspection.
For easy reference, an electronic copy
of this document and supplemental
information to this proposed rule are
available at https://
www.regulations.gov.
Request for Hearing or Appearance;
Waiver
Pursuant to 21 U.S.C. 811(a), this
action is a formal rulemaking ‘‘on the
record after opportunity for a hearing.’’
Such proceedings are conducted
pursuant to the provisions of the
Administrative Procedure Act (APA).1
Interested persons, as defined in 21 CFR
1300.01(b), may file requests for a
hearing in conformity with the
requirements of 21 CFR 1308.44(a) and
1316.47(a), and such requests must:
(1) state with particularity the interest
of the person in the proceeding;
(2) state with particularity the
objections or issues concerning which
the person desires to be heard; and
(3) state briefly the position of the
person with regard to the objections or
issues.
Any interested person may file a
waiver of an opportunity for a hearing
or to participate in a hearing in
conformity with the requirements of 21
CFR 1308.44(c), together with a written
statement of position on the matters of
fact and law involved in any hearing.2
All requests for a hearing and waivers
of participation, together with a written
statement of position on the matters of
fact and law involved in such hearing,
must be sent to DEA using the address
information provided above. The
decision whether a hearing will be
needed to address such matters of fact
and law in the rulemaking will be made
by the Administrator. If a hearing is
needed, DEA will publish a notice of
hearing on the proposed rulemaking in
the Federal Register.3 Further, once the
Administrator determines a hearing is
needed to address such matters of fact
and law in rulemaking, he will then
designate an Administrative Law Judge
(ALJ) to preside over the hearing. The
ALJ’s functions shall commence upon
designation, as provided in 21 CFR
1316.52.
In accordance with 21 U.S.C. 811 and
812, the purpose of a hearing would be
to determine whether 3-MeO-PCP meets
the statutory criteria for placement in
schedule I.
1 5 U.S.C. 551–559. 21 CFR 1308.41–1308.45; 21
CFR part 1316, subpart D.
2 21 CFR 1316.49.
3 21 CFR 1308.44(b), 1316.53.
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Legal Authority
The CSA provides that proceedings
for the issuance, amendment, or repeal
of the scheduling of any drug or other
substance may be initiated by the
Attorney General (delegated to the
Administrator of DEA pursuant to 28
CFR 0.100) on his own motion. 21
U.S.C. 811(a). This proposed action is
supported by a recommendation from
the then Assistant Secretary for Health
of the Department of Health and Human
Services (HHS).
In addition, the United States is a
party to the 1971 United Nations
Convention on Psychotropic Substances
(1971 Convention), February 21, 1971,
32 U.S.T. 543, 1019 U.N.T.S. 175, as
amended. Procedures respecting
changes in drug schedules under the
1971 Convention are governed
domestically by 21 U.S.C. 811(d)(2)–(4).
When the United States receives
notification of a scheduling decision
pursuant to Article 2 of the 1971
Convention indicating that a drug or
other substance has been added to a
schedule specified in the notification,
the Secretary of HHS (Secretary),4 after
consultation with the Attorney General,
shall first determine whether existing
legal controls under subchapter I of the
Controlled Substances Act (CSA) and
the Federal Food, Drug, and Cosmetic
Act meet the requirements of the
schedule specified in the notification
with respect to the specific drug or
substance.5 In the event that the
Secretary did not so consult with the
Attorney General, and the Attorney
General did not issue a temporary order,
as provided under 21 U.S.C. 811(d)(4),
the procedures for permanent
scheduling set forth in 21 U.S.C. 811(a)
and (b) control. Pursuant to 21 U.S.C.
811(a)(1), the Attorney General (as
delegated to the Administrator of DEA)
may, by rule, add to such a schedule or
transfer between such schedules any
drug or other substance, if he finds that
such drug or other substance has a
potential for abuse, and makes with
respect to such drug or other substance
the findings prescribed by 21 U.S.C.
812(b) for the schedule in which such
drug or other substance is to be placed.
4 As discussed in a memorandum of
understanding entered into by the Food and Drug
Administration (FDA) and the National Institute on
Drug Abuse (NIDA), FDA acts as the lead agency
within HHS in carrying out the Secretary’s
scheduling responsibilities under the CSA, with the
concurrence of NIDA. 50 FR 9518 (March 8, 1985).
The Secretary has delegated to the Assistant
Secretary for Health of HHS the authority to make
domestic drug scheduling recommendations. 58 FR
35460 (July 1, 1993).
5 21 U.S.C. 811(d)(3).
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Federal Register / Vol. 90, No. 110 / Tuesday, June 10, 2025 / Proposed Rules
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Background
3-Methoxyphencyclidine (1-[1-(3methoxyphenyl)cyclohexyl]piperidine;
3-MeO-PCP) is an arylcyclohexylamine
that has been identified in the United
States’ illicit drug market. It is a 3methoxy derivative of phencyclidine
(PCP; schedule II substance) and
produces similar hallucinogenic effects
as PCP. 3-MeO-PCP has no approved
medical use in the United States.
On June 10, 2021, the SecretaryGeneral of the United Nations advised
the Secretary of State of the United
States that the Commission on Narcotic
Drugs (CND), during its 64th Session in
April 2021, voted to place 3-MeO-PCP
in Schedule II of the 1971 Convention
(CND Decision 64/4). As a signatory to
this international treaty, the United
States is required, by scheduling under
the CSA, to place appropriate controls
on 3-MeO-PCP to meet the minimum
requirements of the treaty. The relevant
treaty provisions and domestic statutes
executing those provisions are below.
To begin, Article 2, paragraph 7(b), of
the 1971 Convention sets forth the
minimum requirements that the United
States must meet when a substance has
been added to Schedule II of the 1971
Convention. Pursuant to the 1971
Convention, the United States must
require licenses for the manufacture,
export and import, and distribution of 3MeO-PCP. The CSA’s registration
requirement as set forth in 21 U.S.C.
822, 823, 957, and 958, as well as
implementing regulations in 21 CFR
parts 1301 and 1312, set forth this
licensing requirement.
In addition, the United States must
adhere to specific export and import
provisions that are provided in the 1971
Convention. The CSA’s export and
import provisions established in 21
U.S.C. 952, 953, 957, and 958, and
implemented in 21 CFR part 1312,
execute these requirements.
Likewise, under Article 13,
paragraphs 1 and 2, of the 1971
Convention, a party to the 1971
Convention may notify another party,
through the UN Secretary-General, that
it prohibits the importation of a
substance in Schedule II, III, or IV of the
1971 Convention. If such notice is
presented to the United States, the
United States shall take measures to
ensure that the named substance is not
exported to the country of the notifying
party. The CSA’s above-mentioned
export provisions set forth these
procedures.
Further, under Article 16, paragraph
4, of the 1971 Convention, the United
States is required to provide annual
statistical reports to the International
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Narcotics Control Board (INCB). Using
INCB Form P, the United States shall
provide the following information: (1) In
regard to each substance in Schedule I
and II of the 1971 Convention,
quantities manufactured, exported to
and imported from each country or
region as well as stocks held by
manufacturers; (2) in regard to each
substance in Schedule III and IV of the
1971 Convention, quantities
manufactured, as well as quantities
exported and imported; (3) in regard to
each substance in Schedule II and III of
the 1971 Convention, quantities used in
the manufacture of exempt preparations;
and (4) in regard to each substance in
Schedule II–IV of the 1971 Convention,
quantities used for the manufacture of
non-psychotropic substances or
products.
Lastly, under Article 2, paragraph
7(b)(vi) of the 1971 Convention, the
United States must adopt measures in
accordance with Article 22 to address
violations of any statutes or regulations
that are adopted pursuant to its
obligations under the 1971 Convention.
The United States complies with this
provision, as persons acting outside the
legal framework established by the CSA
are subject to administrative, civil, and/
or criminal action.
DEA notes that there are differences
between the schedules of substances in
the 1971 Convention and the CSA. The
CSA has five schedules (schedules I–V)
with specific criteria set forth for each
schedule. Schedule I is the only
possible schedule in which a drug or
other substance may be placed if it has
high potential for abuse and no
currently accepted medical use in
treatment in the United States. See 21
U.S.C. 812(b). In contrast, the 1971
Convention has four schedules
(Schedules I–IV) but does not have
specific criteria for each schedule. The
1971 Convention simply defines its four
schedules, in Article 1, to mean the
correspondingly numbered lists of
psychotropic substances annexed to the
Convention, and altered in accordance
with Article 2.
Proposed Determination to Schedule 3MeO-PCP
Pursuant to 21 U.S.C. 811(b), DEA
gathered the necessary data on 3-MeOPCP and on October 25, 2021, submitted
it to the then Assistant Secretary for
Health of HHS with a request for a
scientific and medical evaluation of
available information and a scheduling
recommendation for 3-MeO-PCP. On
November 15, 2022, HHS provided to
DEA a scientific and medical evaluation
entitled ‘‘Basis for the Recommendation
to Control 1-[1-(3-
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Methoxyphenyl)cyclohexyl]piperidine
and its Salts in Schedule I of the
Controlled Substances Act’’ and a
scheduling recommendation. Following
consideration of the eight factors and
findings related to these substances’
abuse potential, legitimate medical use,
and dependence liability, HHS
recommended that 3-MeO-PCP and its
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 the DEA and HHS analyses,
including the evaluation of the eight
factors determinative of control along
with their supporting data and citations,
are available in their entirety under
‘‘Supporting Documents’’ of the public
docket for this proposed rule at https://
www.regulations.gov under docket
number ‘‘DEA–1146.’’
1. The Drug’s Actual or Relative
Potential for Abuse
In addition to considering the
information HHS provided in its
scientific and medical evaluation
document for 3-MeO-PCP, DEA also
considered all other relevant data
regarding actual or relative potential for
abuse of 3-MeO-PCP. The term ‘‘abuse’’
is not defined in the CSA; however, the
legislative history of the CSA suggests
the consideration of the following four
criteria in determining whether a
particular drug or substance has a
potential for abuse: 6
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 substance; or
d. The drug or substance is so related
in its action to a drug or other substance
already listed as having a potential for
abuse to make it likely that it will have
6 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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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 3-MeO-PCP. These data as
presented below demonstrate that 3MeO-PCP has 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.
Data show that 3-MeO-PCP has been
encountered by law enforcement in the
United States (see Factor 5 below,
discussing evidence of abuse in the
United States), indicating 3-MeO-PCP is
available for abuse. Non-fatal and fatal
intoxications have been reported in the
United States and Europe. The 2020
European Monitoring Centre for Drugs
and Drug Addiction (EMCDDA) 7 report
on 3-MeO-PCP mentioned 19 cases of
severe intoxication that resulted in
hospitalization and 21 confirmed deaths
(by analysis of postmortem biological
samples). 3-MeO-PCP was determined
to be the cause of death in at least seven
of those cases (WHO, 2020). According
to HHS, individuals are using 3-MeOPCP for its hallucinogenic effects and
taking it in amounts sufficient to create
a hazard to their health.
b. There is significant diversion of the
drug or substance from legitimate drug
channels.
HHS states that 3-MeO-PCP is not a
Food and Drug Administration (FDA)approved drug for treatment in the
United States and is unaware of any
country in which its use is legal. 3-MeOPCP is available for purchase from
legitimate chemical synthesis
companies because it is used in
scientific research.
EMCDDA reported drug seizures of 3MeO-PCP from 12 countries, including
several European countries (Lithuania,
Romania, Italy, Spain, Latvia, Austria,
Slovenia, and France) and noted that 24
countries had the capability to detect 3MeO-PCP in drug samples (WHO, 2020).
NFLIS-Drug 8 data reflects that 3MeO-PCP is present in the U.S. drug
7 The European Monitoring Centre for Drugs and
Drug Addiction (EMCDDA) is an agency of the
European Union tasked with gathering and
analyzing data of drug trends.
8 NFLIS-Drug represents an important resource in
monitoring illicit drug trafficking, including the
diversion of legally manufactured pharmaceuticals
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market. DEA interprets this to mean that
3-MeO-PCP is being abused
domestically as a recreational drug.
From January 2011 to August 2024,
NFLIS-Drug registered 399 reports from
several states pertaining to the
trafficking, distribution, and abuse of 3MeO-PCP. These encounters of 3-MeOPCP by law enforcement indicate that
this substance is being trafficked in the
United States.
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.
3-MeO-PCP is not an FDA-approved
drug product and practitioners may
neither legally prescribe nor dispense
these substances. Therefore, it is
inferred that individuals are taking 3MeO-PCP on their own initiative, rather
than based on medical advice from
practitioners licensed by law to
administer drugs. This is consistent
with the data from law enforcement
seizures and case reports, discussed in
greater detail in Factor 5.
d. The drug or substance is so related
in its action to a drug or other substance
already listed as having a potential for
abuse to make it likely that the drug or
substance will have the same potential
for abuse as such drugs, thus making it
reasonable to assume that there may be
significant diversion from legitimate
channels, significant use contrary to or
without medical advice, or that it has a
substantial capability of creating
hazards to the health of the user or to
the safety of the community.
3-MeO-PCP is a synthetic
arylcyclohexylamine and is a 3-methoxy
analogue of the abused drug
phencyclidine (PCP; schedule II) and
has pharmacological properties similar
to other arylcyclohexylamines such as
PCP and ketamine (schedule III). Both
the DEA and the HHS analyses
concluded that 3-MeO-PCP is being
abused for its hallucinogenic effects.
PCP is a hallucinogen with a long
history of abuse with clinical effects that
include dissociation and euphoria. 3MeO-PCP has a similar pharmacological
profile to PCP, where the primary
mechanism of action is thought to be on
glutamatergic neurotransmission.
Glutamate is the major excitatory
into illegal markets. NFLIS is a comprehensive
information system that includes data from forensic
laboratories that handle more than 96% of an
estimated 1 million distinct annual state and local
drug analysis cases. NFLIS includes drug chemistry
results only from completed analyses. Although
NFLIS-Drug data are not direct evidence of abuse,
they can lead to an inference that a drug has been
diverted and abused. See 76 FR 77330, 77332 (Dec.
12, 2011). NFLIS-Drug data was queried on
September 6, 2024.
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neurotransmitter system in the brain. In
vitro binding studies show that 3-MeOPCP binds to the glutamatergic Nmethyl-D-aspartate (NMDA) receptor
and acts as an antagonist with higher
potency compared to PCP (schedule II)
and ketamine (schedule III). As a result,
3-MeO-PCP is expected to have a high
abuse potential and pose a high risk to
public health (HHS, 2022).
Due to the psychological and
cognitive disturbances associated with
3-MeO-PCP, as with other similar
schedule II and III hallucinogens noted
above, it is reasonable to conclude that
3-MeO-PCP has substantial capability to
be a hazard to the health of the user and
to the safety of the community.
2. Scientific Evidence of the Drug’s
Pharmacological Effects, If Known
3-MeO-PCP is a novel psychoactive
substance with a mechanism of action
similar to PCP that produces
psychopharmacological effects similar
to other dissociative amnestic drugs
such as PCP and ketamine. Based on
non-clinical in vitro studies, 3-MeO-PCP
has higher affinity for the NMDA
receptor and acts as an antagonist,
suggesting it may have greater potency
than PCP or ketamine. 3-MeO-PCP also
interacts with monoamine transmission
through binding at the serotonin
transporter and increasing serotonin
transmission. Non-clinical in vivo
studies show 3-MeO-PCP acts as a
NMDA receptor antagonist through the
Maximal Electroshock Seizure (MES)
test and substitutes for PCP in drug
discrimination. Although no clinical
studies have been performed for 3-MeOPCP, case reports show that the effects
of 3-MeO-PCP are similar to abuse of or
intoxication with PCP.
3. The State of Current Scientific
Knowledge Regarding the Drug or Other
Substance
3-MeO-PCP is a centrally-acting
hallucinogen that is part of the
arylcyclohexylamine hallucinogen
family and shares structural similarities
with schedule II and III phenethylamine
hallucinogens such as PCP and
ketamine. 3-MeO-PCP (Chemical
Abstracts Service Registry Number
72242–03–6) has a molecular formula of
C18H27NO and a molecular weight of
273.41 g/mol. The half-life of 3-MeOPCP is estimated to be 10–11 hours. 3MeO-PCP undergoes extensive
metabolism, such that at least 30 phase
I and II metabolites can be generated.
Globally, there have been at least 19
cases of severe intoxication that
required hospitalization and 21 deaths,
where 3-MeO-PCP was identified in the
blood of the decedent. In at least seven
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of those deaths, 3-MeO-PCP was listed
as the cause of death. HHS notes that in
many of the cases reported by the WHO,
other drugs of abuse were also identified
clouding the direct toxicity of 3-MeOPCP, and there is not sufficient
information otherwise available to
provide specific toxicity information
regarding 3-MeO-PCP since its usage
was primarily with other substances or
lacking poly substance use information.
4. Its History and Current Pattern of
Abuse
3-MeO-PCP is a relatively new drug in
the drug abuse and drug trafficking
setting, and thus, there is relatively little
information related to its history and
pattern of abuse. The World Health
Organization (WHO) reports that 3MeO-PCP has been available in Europe
since 2010. Distribution and trafficking
of 3-MeO-PCP began increasing in 2011
(WHO, 2020). The history and current
pattern of abuse of 3-MeO-PCP is
described in law enforcement reports
and anecdotal reports by drug abusers.
In the United States, law enforcement
entities initially encountered 3-MeOPCP in 2011, according to the National
Forensic Laboratory Information System
(NFLIS)-Drug 9 database. See Factor 5
for additional information.
ddrumheller on DSK120RN23PROD with PROPOSALS1
HHS noted that since 3-MeO-PCP is
an analogue of PCP with similar
mechanisms of action, the extensive
history and pattern of PCP abuse may be
appropriate to inform on the potential
pattern of abuse of 3-MeO-PCP. The
2011 Substance Abuse and Mental
Health Services Administration reported
75,538 emergency department visits
related to PCP use. The 2011 National
Survey on Drug Use and Health data
showed that 6.1 million Americans, 12
years or older, reported using PCP in
their lifetime. A case series study
conducted at a tertiary care center
reported patients with PCP intoxication
tended to be young males who
presented with signs and symptoms of
retrograde amnesia, nystagmus,
hypertension, and agitation.
Coadministration with other substances
9 NFLIS-Drug is a national forensic laboratory
reporting system that systematically collects results
from drug chemistry analyses conducted by state
and local forensic laboratories in the United States.
NFLIS-Drug data were queried on September 6,
2024.
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was common (e.g., benzodiazepines,
alcohol, marijuana, cocaine).
5. The Scope, Duration, and
Significance of Abuse
3-MeO-PCP has pharmacological
effects similar to the schedule II
hallucinogen PCP (with higher potency)
and has no currently accepted medical
use in the United States or anywhere in
the world. HHS states (2022) it is not
associated with an investigational new
drug application or an approved new
drug application.
In the United States, evidence of
abuse of 3-MeO-PCP initially appeared
in 2011, one year later than was
reported by the EMCDDA. Since then,
reports of worldwide abuse have
increased substantially. According to
the WHO Critical Review Report
published in 2020, 15 countries
reported that 3-MeO-PCP was being
used by individuals for its psychoactive
properties. The WHO document also
reported a total of 314 drug seizures
from 2018–2020. Within the United
States, from January 2011 to August
2024, there were 399 exhibits reported
to the NFLIS-Drug database, which
show evidence of trafficking,
distribution, and abuse of 3-MeO-PCP in
33 states.
Case reports and case series of abuse
and deaths associated with 3-MeO-PCP
have been published globally. 3-MeOPCP is typically abused orally and by
insufflation (sniffing or snorting), but
has also been reported to be smoked,
inhaled, or vaporized. It is often used
with other substances (e.g.,
benzodiazepines, cannabinoids).
Clinical effects from 3-MeO-PCP are
similar to other abused
arylcyclohexylamines hallucinogens
(e.g., PCP) and include confusion,
dissociation, hallucinations, sedation
through agitation, disinhibition,
euphoria, cognitive changes, sensory
changes, motor changes, and
cardiovascular effects (e.g.,
hypertension and tachycardia).
Abuse of 3-MeO-PCP has been
characterized as causing acute public
health and safety issues worldwide. The
WHO reported that 3-MeO-PCP has been
available in Europe since 2010. Based
on available abuse data, public health
risk, and drug trafficking data, the WHO
recommended to the United Nations
(UN) that 3-MeO-PCP be controlled
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internationally. In April 2021, the UN
Commission on Narcotic Drugs voted to
place 3-MeO-PCP into Schedule II of the
1971 Convention.
6. What, if Any, Risk There Is to the
Public Health
3-MeO-PCP shares similar
mechanisms of action with and
produces similar physiological and
subjective effects (see Factor 2 for more
information) as other schedule II and III
hallucinogens, such as PCP and
ketamine. Thus, 3-MeO-PCP poses the
same risks to public health as similar
hallucinogens. Predominantly, the risks
to public health are borne by users (i.e.,
hallucinogenic effects, sensory
distortion, impaired judgement, strange
or dangerous behaviors), but they can
affect the general public, as with driving
under the influence. There have been
reports of distressing responses and
death associated with 3-MeO-PCP in
medical literature, many of which, but
not all, report poly-substance use.
Adverse events associated with 3-MeOPCP have been reported and include,
but not limited to, hypertension,
confusion, dissociation, hallucinations,
tachycardia, nystagmus, respiratory
acidosis, hypothermia, coma, and death.
The 2020 review published by the WHO
noted at least 19 cases of severe
intoxications occurred after use of 3MeO-PCP that required hospitalization
and 21 deaths were reported where 3MeO-PCP was confirmed in blood
samples. At least seven of those deaths
were attributed to 3-MeO-PCP as the
cause of death. Thus, based on the
review of both HHS and DEA, serious
adverse events that may include death
represent a risk to the individual drug
users and to public health.
7. Its Psychic or Physiological
Dependence Liability
HHS noted that a study with 4-MeOPCP (a structural isomer) does produce
rewarding (conditioned place
preference) and reinforcing effects (selfadministration) through activation of
the mesolimbic dopamine reward
pathway in rats. Therefore, HHS
concluded that it is likely that 3-MeOPCP produces similar effects in rats. The
only literature available on human
exposure to 3-MeO-PCP is based on case
study reports, two of which indicate
long-term use of 3-MeO-PCP.
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HHS noted that no studies have
evaluated the dependence potential of
3-MeO-PCP. However, 3-MeO-PCP has
similar pharmacological properties of
PCP (schedule II) and ketamine
(schedule III), which do have welldemonstrated dependence potential.
Thus, the HHS and DEA reviews both
concluded that it is probable that 3MeO-PCP has a dependence profile
similar to these known substances.
8. Whether the Substance Is an
Immediate Precursor of a Substance
Already Controlled Under the CSA
3-MeO-PCP is not an immediate
precursor of any controlled substance of
the CSA as defined by 21 U.S.C.
802(23).
ddrumheller on DSK120RN23PROD with PROPOSALS1
Conclusion
Based on consideration of the
scientific and medical evaluation and
accompanying recommendation of HHS,
and on DEA’s own eight-factor analysis,
DEA finds that these facts and all
relevant data constitute substantial
evidence of potential for abuse of 3MeO-PCP. As such, DEA proposes to
schedule 3-MeO-PCP as a controlled
substance 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, per 21 U.S.C.
812(b). After consideration of the
analysis and recommendation of the
Assistant Secretary for Health of HHS
and review of all other available data,
the Acting Administrator of DEA,
pursuant to 21 U.S.C. 812(b)(1), finds
that:
(1) 3-MeO-PCP has a high potential
for abuse.
3-MeO-PCP is a synthetic
arylcyclohexylamine, chemically related
and pharmacologically similar to the
ethylamine analog of phencyclidine
(PCE; schedule I), the thiophene analog
of phencyclidine (TCP; schedule I),
phencyclidine (PCP, schedule II), and
ketamine (schedule III). 3-MeO-PCP,
similar to PCP and ketamine, produces
dissociative anesthetic and
hallucinogenic effects.
3-MeO-PCP has a pharmacological
profile similar to other
arylcyclohexylamines, such as PCP
(schedule II) and ketamine (schedule
III). Binding studies demonstrate a
similar mechanism of action (i.e.,
NMDA receptor antagonism) and case
reports indicate that 3-MeO-PCP
clinically resembles PCP intoxication
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(i.e., hallucinogenic effects). Little
evidence exists regarding 3-MeO-PCP
direct psychic or physiologic
dependence liability; 3-MeO-PCP fully
substituted for PCP in drug
discrimination studies. However, it can
be assumed from the above evidence
(Factor 7) that 3-MeO-PCP has a
physical dependence liability similar to
these controlled substances, with
evidence of dependence potential.
(2) 3-MeO-PCP has no currently
accepted medical use in treatment in
the United States.
3-MeO-PCP is not legally marketed in
the United States, as the FDA has not
approved a marketing application for a
drug product containing 3-MeO-PCP for
any indication. As noted in the HHS
review, 3-MeO-PCP lacks current
marketing approval under a new drug
application or an abbreviated new drug
application, and is not subject to an
investigational new drug application.
There is no evidence that 3-MeO-PCP
has a currently accepted medical use in
treatment in the United States.10
10 To place a drug or other substance in schedule
I under the CSA, DEA must consider whether the
substance has a currently accepted medical use in
treatment in the United States. 21 U.S.C.
812(b)(1)(B). There is no evidence suggesting that 3MeO-PCP has a currently accepted medical use in
treatment in the United States. To determine
whether a drug or other substance has a currently
accepted medical use, DEA has traditionally
applied a five-part test to a drug that has not been
approved by FDA: i. The drug’s chemistry must be
known and reproducible; ii. there must be adequate
safety studies; iii. there must be adequate and wellcontrolled studies proving efficacy; iv. the drug
must be accepted by qualified experts; and v. the
scientific evidence must be widely available.
Marijuana Scheduling Petition; Denial of Petition;
Remand, 57 FR 10499 (Mar. 26, 1992), pet. for rev.
denied, Alliance for Cannabis Therapeutics v. Drug
Enforcement Admin., 15 F.3d 1131, 1135 (D.C. Cir.
1994). DEA and HHS applied the traditional fivepart test for currently accepted medical use in this
matter. In a recent published letter in a different
context, HHS applied an additional two-part test to
determine currently accepted medical use for
substances that do not satisfy the five-part test: (1)
whether there exists widespread, current
experience with medical use of the substance by
licensed health care practitioners operating in
accordance with implemented jurisdictionauthorized programs, where medical use is
recognized by entities that regulate the practice of
medicine, and, if so, (2) whether there exists some
credible scientific support for at least one of the
medical conditions for which the part 1 is satisfied.
On April 11, 2024, the Department of Justice’s
Office of Legal Counsel (OLC) issued an opinion,
which, among other things, concluded that HHS’s
two-part test would be sufficient to establish that a
drug has a currently accepted medical use. Office
of Legal Counsel, Memorandum for Merrick B.
Garland Attorney General Re: Questions Related to
the Potential Rescheduling of Marijuana at 3 (April
11, 2024). For purposes of this proposed rule, there
is no evidence that health care providers have
widespread experience with medical use of 3-MeOPCP, or that the use of 3-MeO-PCP is recognized by
entities that regulate the practice of medicine under
either the traditional five-part test or the two-part
test.
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(3) There is a lack of accepted safety
for use of 3-MeO-PCP under medical
supervision.
Because 3-MeO-PCP has no approved
medical use and has not been
thoroughly investigated as a new drug,
its safety for use under medical
supervision is not determined. Thus,
there is a lack of accepted safety for use
of this substance under medical
supervision.
Based on these findings, the Acting
Administrator of DEA concludes that 3MeO-PCP warrants control in schedule
I of the CSA. More precisely, because of
its hallucinogenic effects, and because it
may produce hallucinogenic-like
dependence in humans, DEA proposes
to place 3-MeO-PCP, including its 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 3-MeO-PCP
If this rule is finalized as proposed, 3MeO-PCP would be subject to the CSA’s
schedule I regulatory controls and
administrative, civil, and criminal
sanctions applicable to the manufacture,
distribution, dispensing, importing,
exporting, research, and conduct of
instructional activities, including the
following:
1. Registration. Any person who
handles (manufactures, distributes,
dispenses, imports, exports, engages in
research, or conducts instructional
activities or chemical analysis with, or
possesses) 3-MeO-PCP would need to be
registered with DEA to conduct such
activities pursuant to 21 U.S.C. 822,
823, 957, and 958, and in accordance
with 21 CFR parts 1301 and 1312.
2. Security. 3-MeO-PCP would be
subject to schedule I security
requirements, and handled and stored
pursuant to 21 U.S.C. 821, 823, and in
accordance with 21 CFR 1301.71–
1301.76. Non-practitioners handling this
substance also would need to comply
with the screening requirements of 21
CFR 1301.90–1301.93.
3. Labeling and Packaging. All labels
and packaging for commercial
containers of 3-MeO-PCP would need to
comply with 21 U.S.C. 825, and be in
accordance with 21 CFR part 1302.
4. Quota. Only registered
manufacturers would be permitted to
manufacture 3-MeO-PCP in accordance
with a quota assigned pursuant to 21
U.S.C. 826 and in accordance with 21
CFR part 1303.
5. Inventory. Any person registered
with DEA to handle 3-MeO-PCP would
need to have an initial inventory of all
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stocks of controlled substances
(including this substance) on hand on
the effective date of a final scheduling
action pursuant to 21 U.S.C. 827, and in
accordance with 21 CFR 1304.03,
1304.04, and 1304.11.
After the initial inventory, every DEA
registrant would need to take a new
inventory of all stocks of controlled
substances (including 3-MeO-PCP) 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.
6. Records and Reports. Every DEA
registrant would need to maintain
records and submit reports with respect
to 3-MeO-PCP, pursuant to 21 U.S.C.
827 and 832(a), and in accordance with
21 CFR 1301.74 and 1301.76, and parts
1304, 1312, and 1317.
7. Order Forms. Every DEA registrant
who distributes 3-MeO-PCP would need
to comply with the order form
requirements, pursuant to 21 U.S.C. 828
and 21 CFR part 1305.
8. Importation and Exportation. All
importation and exportation of 3-MeOPCP would need to be in compliance
with 21 U.S.C. 952, 953, 957, and 958,
and in accordance with 21 CFR part
1312.
9. Liability. Any activity involving 3MeO-PCP not authorized by, or in
violation of, the CSA or its
implementing regulations would be
unlawful, and may subject the person to
administrative, civil, and/or criminal
sanctions.
Regulatory Analyses
Executive Orders 12866 and 13563, and
14192 (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 the 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. DEA
scheduling actions are not subject to
E.O. 14192, Unleashing Prosperity
Through Deregulation.
Executive Order 12988, Civil Justice
Reform
This proposed regulation meets the
applicable standards set forth in
sections 3(a) and 3(b)(2) of E.O. 12988
to eliminate drafting errors and
ambiguity, minimize litigation, provide
a clear legal standard for affected
conduct, and promote simplification
and burden reduction.
Executive Order 13132, Federalism
This proposed rulemaking does not
have federalism implications warranting
the application of E.O. 13132. The
proposed rule does not have substantial
direct effects on the States, on the
relationship between the national
government and the States, or on the
distribution of power and
responsibilities among the various
levels of government.
Executive Order 13175, Consultation
and Coordination With Indian Tribal
Governments
This proposed rule does not have
tribal implications warranting the
application of E.O. 13175. It does not
have substantial direct effects on one or
more Indian tribes, on the relationship
between the Federal government and
Indian tribes, or on the distribution of
power and responsibilities between the
Federal government and Indian tribes.
Paperwork Reduction Act
This proposed rule would not impose
a new collection or modify an existing
collection of information under the
Paperwork Reduction Act of 1995. Also,
this proposed rule would not impose
new or modify existing recordkeeping or
reporting requirements on state or local
governments, individuals, businesses, or
organizations. However, this proposed
rule would require compliance with the
following existing OMB collections:
1117–0003, 1117–0004, 1117–0006,
1117–0008, 1117–0009, 1117–0010,
1117–0012, 1117–0014, 1117–0021,
1117–0023, 1117–0029, and 1117–0056.
An agency may not conduct or sponsor,
and a person is not required to respond
to, a collection of information unless it
displays a currently valid OMB control
number.
Regulatory Flexibility Act
The Acting 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 substance
3-MeO-PCP (chemical name: 1-[1-(3methoxyphenyl)cyclohexyl]piperidine),
including its salts, isomers, and salts of
isomers whenever the existence of such
salts, isomers, and salts of isomers is
possible within the specific chemical
designation, in schedule I of the CSA.
This action is being taken, in part, to
enable the United States to meet its
obligations under the 1971 Convention.
If finalized, this action would impose
the regulatory controls and
administrative, civil, and criminal
sanctions applicable to schedule I
controlled substances on persons who
handle or propose to handle 3-MeOPCP.
The entities affected by this rule
include the manufacturers, distributors,
importers, exporters, and researchers of
3-MeO-PCP. DEA determined the North
American Industry Classification
System (NAICS) industries that best
represent these business activities.
Table 1 lists the business activities and
corresponding NAICS industries.11
TABLE 1—BUSINESS ACTIVITY AND CORRESPONDING NAICS INDUSTRIES
Business activity
NAICS code
ddrumheller on DSK120RN23PROD with PROPOSALS1
Manufacturer .............................................
Distributor, Importer, Exporter ..................
325412
424210
424690
541715
611310
Researcher ...............................................
NAICS industry description
Pharmaceutical Preparation Manufacturing.
Drugs and Druggists’ Sundries Merchant Wholesalers.
Other Chemical and Allied Products Merchant Wholesalers.
Research and Development in the Physical, Engineering, and Life Sciences (except
Nanotechnology and Biotechnology).
Colleges, Universities and Professional Schools.
From Statistics of U.S. Businesses
(SUSB) data, DEA determined the
number of firms and small firms for
each of the affected industries, and by
comparing the number of affected small
entities to the number of small entities
11 Executive Office of the President Office of
Management and Budget, North American Industry
Classification System, United States, 2022, https://
www.census.gov/naics/reference_files_tools/2022_
NAICS_Manual.pdf. (Accessed 4/2/2024).
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for each industry, DEA determined
whether a substantial number of small
entities are affected in any of the
industries. Table 2 lists the number of
firms, small firms, and percent small
firms in each affected industry.
TABLE 2—PERCENT SMALL ENTITIES BY INDUSTRY
325412—Pharmaceutical Preparation Manufacturing .....................................
424210—Drugs and Druggists’ Sundries Merchant Wholesalers ...................
424690—Other Chemical and Allied Products Merchant Wholesalers ...........
541715—Research and Development in the Physical, Engineering, and Life
Sciences (except Nanotechnology and Biotechnology) ...............................
611310—Colleges, Universities and Professional Schools .............................
Based on the American Chemical
Society’s SciFinder database, DEA
identified 13 entities supplying 3-MeOPCP across these industries. Suppliers
include 325412, 424210, and 424690
industries. Even if all affected suppliers
were small entities, they would account
for only 0.10 percent of the small
entities in those industries, not a
substantial number.15 Additionally,
DEA expects the number of researchers
working with 3-MeO-PCP is small
because 3-MeO-PCP lacks current
marketing approval under a new drug
application or an abbreviated new drug
application, and is not subject to an
investigational new drug application as
noted in the HHS review. Also, DEA
believes the researchers working with 3MeO-PCP may also work with other
controlled substances; hence, they have
probably already registered with DEA
and are qualified to handle controlled
substances. For these reasons DEA
believes the number of affected
researchers that are small entities is not
a substantial number of small entities in
541715 and 622310 industries.
The primary costs associated with this
proposed rule would be the annual
registration fee for Schedule I controlled
substances ($3,699 for manufacturers,
$1,850 for distributors, and $296 for
researchers). As mentioned above, DEA
has identified 13 domestic suppliers of
3-MeO-PCP from the SciFinder database
SBA size
standard 13
Firms 12
NAICS industry
Small
firms 14
Percent small
entities
(%)
1,007
6,958
6,069
1,300
250
175
931
6,663
5,781
92.4
95.8
95.3
8,019
2,433
1,000
$34.5
7,571
1,515
94.4
62.3
and none of these suppliers has
registered with DEA to handle Schedule
I controlled substances. However, it is
common for suppliers to have items in
their catalog while not actually having
any material level of sales because FDA
has not approved a marketing
application for a drug product
containing 3-MeO-PCP. Therefore, some
suppliers may simply remove 3-MeOPCP from their catalog without any
impact. Additionally, as discussed
above, the researchers who work with 3MeO-PCP are likely to work with other
controlled substances and hence, must
already register with DEA.
In summary, the small entities
impacted by this rule are those in
325412-Pharmaceutical Preparation
Manufacturing, 424210-Drugs and
Druggists’ Sundries Merchant
Wholesalers, and 424690-Other
Chemical and Allied Products Merchant
Wholesalers. The affected small entities
account for only 0.1 percent of the small
businesses and are not likely to
manufacture or carry 3-MeO-PCP
inventory. As such, the proposed rule
will not, if promulgated, result in a
significant effect 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, 21 CFR
part 1308 is proposed to be amended to
read as follows:
PART 1308—SCHEDULES OF
CONTROLLED SUBSTANCES
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.
2. In § 1308.11, add paragraph (d)(105)
to read as follows:
■
§ 1308.11
*
Schedule I.
*
*
(d) * * *
*
*
*
*
*
*
*
*
*
(105) 3-methoxyphencyclidine (Other names: 1-[1-(3-methoxyphenyl)cyclohexyl] piperidine; 3-MeO-PCP) .........................................
ddrumheller on DSK120RN23PROD with PROPOSALS1
*
*
*
*
*
*
*
*
12 Statistics of U.S. Businesses, 2021 SUSB
Annual Data Tables by Establishment Industry,
https://www.census.gov/data/tables/2021/econ/
susb/2021-susb-annual.html (Accessed 4/2/2024).
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*
*
*
7457
*
Signing Authority
This document of the Drug
Enforcement Administration was signed
on June 3, 2025, by Acting
Administrator Robert J. Murphy. That
document with the original signature
and date is maintained by DEA. For
administrative purposes only, and in
13 U.S. Small Business Administration, Table of
size standards, Version March 2023, Effective:
March 17, 2023, https://www.sba.gov/sites/sbagov/
files/2023-06/Table%20of%20Size%20Standards_
Effective%20March%2017%2C%202023_.xlsx.
(Accessed 4/2/2024).
14 Note 12.
15 13/(931 + 6,664 + 5,781) = 0.10%.
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24378
Federal Register / Vol. 90, No. 110 / Tuesday, June 10, 2025 / Proposed Rules
compliance with requirements of the
Office of the Federal Register, the
undersigned DEA Federal Register
Liaison Officer has been authorized to
sign and submit the document in
electronic format for publication, as an
official document of DEA. This
administrative process in no way alters
the legal effect of this document upon
publication in the Federal Register.
Heather Achbach,
Federal Register Liaison Officer, Drug
Enforcement Administration.
DEPARTMENT OF THE INTERIOR
Fish and Wildlife Service
50 CFR Part 17
[FXES1111090FEDR–256–FF09E21000]
Endangered and Threatened Wildlife
and Plants; Two Species Not
Warranted for Listing as Endangered
or Threatened Species
Fish and Wildlife Service,
Interior.
ACTION: Notification of findings.
AGENCY:
[FR Doc. 2025–10503 Filed 6–9–25; 8:45 am]
We, the U.S. Fish and
Wildlife Service (Service), announce
findings that two species are not
warranted for listing as endangered or
threatened species under the
Endangered Species Act of 1973, as
SUMMARY:
BILLING CODE 4410–09–P
amended (Act). After a thorough review
of the best available scientific and
commercial information, we find that it
is not warranted at this time to list the
cannulate cave isopod
(Pseudobaicalasellus cannula) and Dry
Fork Valley cave beetle
(Pseudanophthalmus montanus).
However, we ask the public to submit to
us at any time any new information
relevant to the status of any of the
species mentioned above or their
habitats.
The findings in this document
were made on June 10, 2025.
DATES:
Detailed descriptions of the
bases for these findings are available on
the internet at https://
www.regulations.gov under the
following docket numbers:
ADDRESSES:
Species
Docket No.
Cannulate cave isopod ..........................................................................................................................................
Dry Fork Valley cave beetle ..................................................................................................................................
ddrumheller on DSK120RN23PROD with PROPOSALS1
Those descriptions are also available
by contacting the appropriate person, as
specified under FOR FURTHER
INFORMATION CONTACT. Please submit any
new information, materials, comments,
or questions concerning these findings
to the appropriate person, as specified
under FOR FURTHER INFORMATION
CONTACT.
FOR FURTHER INFORMATION CONTACT:
Jennifer Norris, Field Supervisor, West
Virginia Field Office, 304–866–3858,
Jennifer_L_Norris@fws.gov. Individuals
in the United States who are deaf,
deafblind, hard of hearing, or have a
speech disability may dial 711 (TTY,
TDD, or TeleBraille) to access
telecommunications relay services.
Individuals outside the United States
should use the relay services offered
within their country to make
international calls to the point-ofcontact in the United States.
SUPPLEMENTARY INFORMATION:
Background
Under section 4(b)(3)(B) of the Act (16
U.S.C. 1533(b)(3)(B)), we are required to
make a finding on whether or not a
petitioned action is warranted within 12
months after receiving any petition that
we have determined contains
substantial scientific or commercial
information indicating that the
petitioned action may be warranted
(‘‘12-month finding’’). We must make a
finding that the petitioned action is: (1)
not warranted; (2) warranted; or (3)
warranted, but precluded by other
listing activity. We must publish a
VerDate Sep<11>2014
17:04 Jun 09, 2025
Jkt 265001
notification of these 12-month findings
in the Federal Register.
Summary of Information Pertaining to
the Five Factors
Section 4 of the Act (16 U.S.C. 1533)
and the implementing regulations at
part 424 of title 50 of the Code of
Federal Regulations (50 CFR part 424)
set forth procedures for adding species
to, removing species from, or
reclassifying species on the Lists of
Endangered and Threatened Wildlife
and Plants (Lists). The Act defines
‘‘species’’ as including any subspecies
of fish or wildlife or plants, and any
distinct population segment of any
species of vertebrate fish or wildlife
which interbreeds when mature. The
Act defines an ‘‘endangered species’’ as
a species that is in danger of extinction
throughout all or a significant portion of
its range (16 U.S.C. 1532(6)) and a
‘‘threatened species’’ as a species that is
likely to become an endangered species
within the foreseeable future throughout
all or a significant portion of its range
(16 U.S.C. 1532(20)). Under section
4(a)(1) of the Act, the Secretary of the
Interior (Secretary) may determine
whether any species is an endangered
species or a threatened species because
of any of the following five factors:
(A) The present or threatened
destruction, modification, or
curtailment of its habitat or range;
(B) Overutilization for commercial,
recreational, scientific, or educational
purposes;
(C) Disease or predation;
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FWS–R5–ES–2025–0035.
FWS–R5–ES–2025–0036.
(D) The inadequacy of existing
regulatory mechanisms; or
(E) Other natural or manmade factors
affecting its continued existence.
These factors represent broad
categories of natural or human-caused
actions or conditions that could have an
effect on a species’ continued existence.
In evaluating these actions and
conditions, we look for those that may
have a negative effect on individuals of
the species, as well as other actions or
conditions that may ameliorate any
negative effects or may have positive
effects.
We use the term ‘‘threat’’ to refer in
general to actions or conditions that are
known to or are reasonably likely to
negatively affect individuals of a
species. The term ‘‘threat’’ includes
actions or conditions that have a direct
impact on individuals (direct impacts),
as well as those that affect individuals
through alteration of their habitat or
required resources (stressors). The term
‘‘threat’’ may encompass—either
together or separately—the source of the
action or condition or the action or
condition itself. However, the mere
identification of any threat(s) does not
necessarily mean that the species meets
the statutory definition of an
‘‘endangered species’’ or a ‘‘threatened
species.’’ In determining whether a
species meets either definition, we must
evaluate all identified threats by
considering the species’ expected
response and the effects of the threats—
in light of those actions and conditions
that will ameliorate the threats—on an
E:\FR\FM\10JNP1.SGM
10JNP1
Agencies
[Federal Register Volume 90, Number 110 (Tuesday, June 10, 2025)]
[Proposed Rules]
[Pages 24370-24378]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-10503]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA1146]
Schedules of Controlled Substances: Placement of 3-
Methoxyphencyclidine (1-[1-(3-methoxyphenyl) cyclohexyl]piperidine) in
Schedule I
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Notice of proposed rulemaking.
-----------------------------------------------------------------------
SUMMARY: The Drug Enforcement Administration proposes placing 3-
methoxyphencyclidine, including its salts, isomers, and salts of
isomers, an arylcyclohexylamine hallucinogen, in schedule I of the
Controlled Substances Act. This action is proposed to enable the United
States to meet its obligations under the 1971 Convention on
Psychotropic Substances. 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 3-methoxyphencyclidine.
DATES: Comments must be submitted electronically or postmarked on or
before July 10, 2025. 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.
Requests for a hearing and waivers of an opportunity for a hearing
or to participate in a hearing, together with a written statement of
position on the matters of fact and law involved in the hearing, must
be received on or before July 10, 2025.
ADDRESSES: Interested persons may file written comments on this
rulemaking in accordance with 21 CFR 1308.43(g). To ensure proper
handling of comments, please reference ``Docket No. DEA1146'' on all
correspondence, including any attachments.
Electronic comments: The Drug Enforcement Administration
(DEA) encourages commenters to submit all comments electronically
through the Federal eRulemaking Portal, which provides the ability to
type short comments directly into the comment field on the web page or
attach a file for lengthier comments. Please go to https://www.regulations.gov and follow the online instructions at that site for
submitting comments. Upon completion of your submission you will
receive a Comment Tracking Number for your comment. Submitted comments
are not instantaneously available for public view on Regulations.gov.
If you have received a Comment Tracking Number, your comment has been
successfully submitted and there is no need to resubmit the same
comment.
Paper comments: Paper comments that duplicate electronic
submissions are not necessary. Should you wish to mail a paper comment
in lieu of an electronic comment, it should be sent via regular or
express mail to: Drug Enforcement Administration, Attn: DEA Federal
Register Representative/DPW, 8701 Morrissette Drive, Springfield,
Virginia 22152.
Hearing requests: All requests for a hearing and waivers
of participation, together with a written statement of position on the
matters of fact and law asserted in the hearing, must be filed with the
DEA Administrator, who will make the determination of whether a hearing
will be needed to address such matters of fact and law in the
rulemaking. Such requests must be sent to: Drug Enforcement
Administration, Attn: Administrator, 8701 Morrissette Drive,
Springfield, Virginia 22152. For informational purposes, a courtesy
copy of requests for hearing and waivers of participation should also
be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/
OALJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug
Enforcement Administration,
[[Page 24371]]
Attn: DEA Federal Register Representative/DPW, 8701 Morrissette Drive,
Springfield, Virginia 22152.
FOR FURTHER INFORMATION CONTACT: Terrence L. Boos, Drug and Chemical
Evaluation Section, Diversion Control Division, Drug Enforcement
Administration; Telephone: (571) 362-3249. As required by 5 U.S.C.
553(b)(4), a summary of this rule may be found in the docket for this
rulemaking at www.regulations.gov.
SUPPLEMENTARY INFORMATION: In this proposed rule, the Drug Enforcement
Administration (DEA) proposes to schedule 3-methoxyphencyclidine (1-[1-
(3-methoxyphenyl)cyclohexyl] piperidine; 3-MeO-PCP) in schedule I of
the Controlled Substances Act (CSA), including its salts, isomers, and
salts of isomers whenever the existence of such salts, isomers, and
salts of isomers is possible within the specific chemical designation.
Posting of Public Comments
Please note that all comments received in response to this docket
are considered part of the public record. DEA will make comments
available for public inspection online at https://www.regulations.gov.
Such information includes personal identifying information (such as
your name, address, State or Federal identifiers, etc.) voluntarily
submitted by the commenter. In general, all information voluntarily
submitted by the commenter, unless clearly marked as Confidential
Information in the method described below, will be publicly posted.
Comments may be submitted anonymously. The Freedom of Information Act
applies to all comments received.
Commenters submitting comments which include personal identifying
information (PII), confidential, or proprietary business information
that the commenter does not want made publicly available should submit
two copies of the comment. One copy must be marked ``CONTAINS
CONFIDENTIAL INFORMATION'' and should clearly identify all PII or
business information the commenter does not want to be made publicly
available, including any supplemental materials. DEA will review this
copy, including the claimed PII and confidential business information,
in its consideration of comments. The second copy should be marked ``TO
BE PUBLICLY POSTED'' and must have all claimed confidential PII and
business information already redacted. DEA will post only the redacted
comment on https://www.regulations.gov for public inspection.
For easy reference, an electronic copy of this document and
supplemental information to this proposed rule are available at https://www.regulations.gov.
Request for Hearing or Appearance; Waiver
Pursuant to 21 U.S.C. 811(a), this action is a formal rulemaking
``on the record after opportunity for a hearing.'' Such proceedings are
conducted pursuant to the provisions of the Administrative Procedure
Act (APA).\1\ Interested persons, as defined in 21 CFR 1300.01(b), may
file requests for a hearing in conformity with the requirements of 21
CFR 1308.44(a) and 1316.47(a), and such requests must:
---------------------------------------------------------------------------
\1\ 5 U.S.C. 551-559. 21 CFR 1308.41-1308.45; 21 CFR part 1316,
subpart D.
---------------------------------------------------------------------------
(1) state with particularity the interest of the person in the
proceeding;
(2) state with particularity the objections or issues concerning
which the person desires to be heard; and
(3) state briefly the position of the person with regard to the
objections or issues.
Any interested person may file a waiver of an opportunity for a
hearing or to participate in a hearing in conformity with the
requirements of 21 CFR 1308.44(c), together with a written statement of
position on the matters of fact and law involved in any hearing.\2\
---------------------------------------------------------------------------
\2\ 21 CFR 1316.49.
---------------------------------------------------------------------------
All requests for a hearing and waivers of participation, together
with a written statement of position on the matters of fact and law
involved in such hearing, must be sent to DEA using the address
information provided above. The decision whether a hearing will be
needed to address such matters of fact and law in the rulemaking will
be made by the Administrator. If a hearing is needed, DEA will publish
a notice of hearing on the proposed rulemaking in the Federal
Register.\3\ Further, once the Administrator determines a hearing is
needed to address such matters of fact and law in rulemaking, he will
then designate an Administrative Law Judge (ALJ) to preside over the
hearing. The ALJ's functions shall commence upon designation, as
provided in 21 CFR 1316.52.
---------------------------------------------------------------------------
\3\ 21 CFR 1308.44(b), 1316.53.
---------------------------------------------------------------------------
In accordance with 21 U.S.C. 811 and 812, the purpose of a hearing
would be to determine whether 3-MeO-PCP meets the statutory criteria
for placement in schedule I.
Legal Authority
The CSA provides that proceedings for the issuance, amendment, or
repeal of the scheduling of any drug or other substance may be
initiated by the Attorney General (delegated to the Administrator of
DEA pursuant to 28 CFR 0.100) on his own motion. 21 U.S.C. 811(a). This
proposed action is supported by a recommendation from the then
Assistant Secretary for Health of the Department of Health and Human
Services (HHS).
In addition, the United States is a party to the 1971 United
Nations Convention on Psychotropic Substances (1971 Convention),
February 21, 1971, 32 U.S.T. 543, 1019 U.N.T.S. 175, as amended.
Procedures respecting changes in drug schedules under the 1971
Convention are governed domestically by 21 U.S.C. 811(d)(2)-(4). When
the United States receives notification of a scheduling decision
pursuant to Article 2 of the 1971 Convention indicating that a drug or
other substance has been added to a schedule specified in the
notification, the Secretary of HHS (Secretary),\4\ after consultation
with the Attorney General, shall first determine whether existing legal
controls under subchapter I of the Controlled Substances Act (CSA) and
the Federal Food, Drug, and Cosmetic Act meet the requirements of the
schedule specified in the notification with respect to the specific
drug or substance.\5\ In the event that the Secretary did not so
consult with the Attorney General, and the Attorney General did not
issue a temporary order, as provided under 21 U.S.C. 811(d)(4), the
procedures for permanent scheduling set forth in 21 U.S.C. 811(a) and
(b) control. Pursuant to 21 U.S.C. 811(a)(1), the Attorney General (as
delegated to the Administrator of DEA) may, by rule, add to such a
schedule or transfer between such schedules any drug or other
substance, if he finds that such drug or other substance has a
potential for abuse, and makes with respect to such drug or other
substance the findings prescribed by 21 U.S.C. 812(b) for the schedule
in which such drug or other substance is to be placed.
---------------------------------------------------------------------------
\4\ As discussed in a memorandum of understanding entered into
by the Food and Drug Administration (FDA) and the National Institute
on Drug Abuse (NIDA), FDA acts as the lead agency within HHS in
carrying out the Secretary's scheduling responsibilities under the
CSA, with the concurrence of NIDA. 50 FR 9518 (March 8, 1985). The
Secretary has delegated to the Assistant Secretary for Health of HHS
the authority to make domestic drug scheduling recommendations. 58
FR 35460 (July 1, 1993).
\5\ 21 U.S.C. 811(d)(3).
---------------------------------------------------------------------------
[[Page 24372]]
Background
3-Methoxyphencyclidine (1-[1-(3-
methoxyphenyl)cyclohexyl]piperidine; 3-MeO-PCP) is an
arylcyclohexylamine that has been identified in the United States'
illicit drug market. It is a 3-methoxy derivative of phencyclidine
(PCP; schedule II substance) and produces similar hallucinogenic
effects as PCP. 3-MeO-PCP has no approved medical use in the United
States.
On June 10, 2021, the Secretary-General of the United Nations
advised the Secretary of State of the United States that the Commission
on Narcotic Drugs (CND), during its 64th Session in April 2021, voted
to place 3-MeO-PCP in Schedule II of the 1971 Convention (CND Decision
64/4). As a signatory to this international treaty, the United States
is required, by scheduling under the CSA, to place appropriate controls
on 3-MeO-PCP to meet the minimum requirements of the treaty. The
relevant treaty provisions and domestic statutes executing those
provisions are below.
To begin, Article 2, paragraph 7(b), of the 1971 Convention sets
forth the minimum requirements that the United States must meet when a
substance has been added to Schedule II of the 1971 Convention.
Pursuant to the 1971 Convention, the United States must require
licenses for the manufacture, export and import, and distribution of 3-
MeO-PCP. The CSA's registration requirement as set forth in 21 U.S.C.
822, 823, 957, and 958, as well as implementing regulations in 21 CFR
parts 1301 and 1312, set forth this licensing requirement.
In addition, the United States must adhere to specific export and
import provisions that are provided in the 1971 Convention. The CSA's
export and import provisions established in 21 U.S.C. 952, 953, 957,
and 958, and implemented in 21 CFR part 1312, execute these
requirements.
Likewise, under Article 13, paragraphs 1 and 2, of the 1971
Convention, a party to the 1971 Convention may notify another party,
through the UN Secretary-General, that it prohibits the importation of
a substance in Schedule II, III, or IV of the 1971 Convention. If such
notice is presented to the United States, the United States shall take
measures to ensure that the named substance is not exported to the
country of the notifying party. The CSA's above-mentioned export
provisions set forth these procedures.
Further, under Article 16, paragraph 4, of the 1971 Convention, the
United States is required to provide annual statistical reports to the
International Narcotics Control Board (INCB). Using INCB Form P, the
United States shall provide the following information: (1) In regard to
each substance in Schedule I and II of the 1971 Convention, quantities
manufactured, exported to and imported from each country or region as
well as stocks held by manufacturers; (2) in regard to each substance
in Schedule III and IV of the 1971 Convention, quantities manufactured,
as well as quantities exported and imported; (3) in regard to each
substance in Schedule II and III of the 1971 Convention, quantities
used in the manufacture of exempt preparations; and (4) in regard to
each substance in Schedule II-IV of the 1971 Convention, quantities
used for the manufacture of non-psychotropic substances or products.
Lastly, under Article 2, paragraph 7(b)(vi) of the 1971 Convention,
the United States must adopt measures in accordance with Article 22 to
address violations of any statutes or regulations that are adopted
pursuant to its obligations under the 1971 Convention. The United
States complies with this provision, as persons acting outside the
legal framework established by the CSA are subject to administrative,
civil, and/or criminal action.
DEA notes that there are differences between the schedules of
substances in the 1971 Convention and the CSA. The CSA has five
schedules (schedules I-V) with specific criteria set forth for each
schedule. Schedule I is the only possible schedule in which a drug or
other substance may be placed if it has high potential for abuse and no
currently accepted medical use in treatment in the United States. See
21 U.S.C. 812(b). In contrast, the 1971 Convention has four schedules
(Schedules I-IV) but does not have specific criteria for each schedule.
The 1971 Convention simply defines its four schedules, in Article 1, to
mean the correspondingly numbered lists of psychotropic substances
annexed to the Convention, and altered in accordance with Article 2.
Proposed Determination to Schedule 3-MeO-PCP
Pursuant to 21 U.S.C. 811(b), DEA gathered the necessary data on 3-
MeO-PCP and on October 25, 2021, submitted it to the then Assistant
Secretary for Health of HHS with a request for a scientific and medical
evaluation of available information and a scheduling recommendation for
3-MeO-PCP. On November 15, 2022, HHS provided to DEA a scientific and
medical evaluation entitled ``Basis for the Recommendation to Control
1-[1-(3-Methoxyphenyl)cyclohexyl]piperidine and its Salts in Schedule I
of the Controlled Substances Act'' and a scheduling recommendation.
Following consideration of the eight factors and findings related to
these substances' abuse potential, legitimate medical use, and
dependence liability, HHS recommended that 3-MeO-PCP and its 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 the
DEA and HHS analyses, including the evaluation of the eight factors
determinative of control along with their supporting data and
citations, are available in their entirety under ``Supporting
Documents'' of the public docket for this proposed rule at https://www.regulations.gov under docket number ``DEA-1146.''
1. The Drug's Actual or Relative Potential for Abuse
In addition to considering the information HHS provided in its
scientific and medical evaluation document for 3-MeO-PCP, DEA also
considered all other relevant data regarding actual or relative
potential for abuse of 3-MeO-PCP. The term ``abuse'' is not defined in
the CSA; however, the legislative history of the CSA suggests the
consideration of the following four criteria in determining whether a
particular drug or substance has a potential for abuse: \6\
---------------------------------------------------------------------------
\6\ 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.
---------------------------------------------------------------------------
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 substance; or
d. The drug or substance is so related in its action to a drug or
other substance already listed as having a potential for abuse to make
it likely that it will have
[[Page 24373]]
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 3-MeO-PCP. These
data as presented below demonstrate that 3-MeO-PCP has 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.
Data show that 3-MeO-PCP has been encountered by law enforcement in
the United States (see Factor 5 below, discussing evidence of abuse in
the United States), indicating 3-MeO-PCP is available for abuse. Non-
fatal and fatal intoxications have been reported in the United States
and Europe. The 2020 European Monitoring Centre for Drugs and Drug
Addiction (EMCDDA) \7\ report on 3-MeO-PCP mentioned 19 cases of severe
intoxication that resulted in hospitalization and 21 confirmed deaths
(by analysis of postmortem biological samples). 3-MeO-PCP was
determined to be the cause of death in at least seven of those cases
(WHO, 2020). According to HHS, individuals are using 3-MeO-PCP for its
hallucinogenic effects and taking it in amounts sufficient to create a
hazard to their health.
---------------------------------------------------------------------------
\7\ The European Monitoring Centre for Drugs and Drug Addiction
(EMCDDA) is an agency of the European Union tasked with gathering
and analyzing data of drug trends.
---------------------------------------------------------------------------
b. There is significant diversion of the drug or substance from
legitimate drug channels.
HHS states that 3-MeO-PCP is not a Food and Drug Administration
(FDA)-approved drug for treatment in the United States and is unaware
of any country in which its use is legal. 3-MeO-PCP is available for
purchase from legitimate chemical synthesis companies because it is
used in scientific research.
EMCDDA reported drug seizures of 3-MeO-PCP from 12 countries,
including several European countries (Lithuania, Romania, Italy, Spain,
Latvia, Austria, Slovenia, and France) and noted that 24 countries had
the capability to detect 3-MeO-PCP in drug samples (WHO, 2020).
NFLIS-Drug \8\ data reflects that 3-MeO-PCP is present in the U.S.
drug market. DEA interprets this to mean that 3-MeO-PCP is being abused
domestically as a recreational drug. From January 2011 to August 2024,
NFLIS-Drug registered 399 reports from several states pertaining to the
trafficking, distribution, and abuse of 3-MeO-PCP. These encounters of
3-MeO-PCP by law enforcement indicate that this substance is being
trafficked in the United States.
---------------------------------------------------------------------------
\8\ NFLIS-Drug represents an important resource in monitoring
illicit drug trafficking, including the diversion of legally
manufactured pharmaceuticals into illegal markets. NFLIS is a
comprehensive information system that includes data from forensic
laboratories that handle more than 96% of an estimated 1 million
distinct annual state and local drug analysis cases. NFLIS includes
drug chemistry results only from completed analyses. Although NFLIS-
Drug data are not direct evidence of abuse, they can lead to an
inference that a drug has been diverted and abused. See 76 FR 77330,
77332 (Dec. 12, 2011). NFLIS-Drug data was queried on September 6,
2024.
---------------------------------------------------------------------------
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.
3-MeO-PCP is not an FDA-approved drug product and practitioners may
neither legally prescribe nor dispense these substances. Therefore, it
is inferred that individuals are taking 3-MeO-PCP on their own
initiative, rather than based on medical advice from practitioners
licensed by law to administer drugs. This is consistent with the data
from law enforcement seizures and case reports, discussed in greater
detail in Factor 5.
d. The drug or substance is so related in its action to a drug or
other substance already listed as having a potential for abuse to make
it likely that the drug or substance will have the same potential for
abuse as such drugs, thus making it reasonable to assume that there may
be significant diversion from legitimate channels, significant use
contrary to or without medical advice, or that it has a substantial
capability of creating hazards to the health of the user or to the
safety of the community.
3-MeO-PCP is a synthetic arylcyclohexylamine and is a 3-methoxy
analogue of the abused drug phencyclidine (PCP; schedule II) and has
pharmacological properties similar to other arylcyclohexylamines such
as PCP and ketamine (schedule III). Both the DEA and the HHS analyses
concluded that 3-MeO-PCP is being abused for its hallucinogenic
effects.
PCP is a hallucinogen with a long history of abuse with clinical
effects that include dissociation and euphoria. 3-MeO-PCP has a similar
pharmacological profile to PCP, where the primary mechanism of action
is thought to be on glutamatergic neurotransmission. Glutamate is the
major excitatory neurotransmitter system in the brain. In vitro binding
studies show that 3-MeO-PCP binds to the glutamatergic N-methyl-D-
aspartate (NMDA) receptor and acts as an antagonist with higher potency
compared to PCP (schedule II) and ketamine (schedule III). As a result,
3-MeO-PCP is expected to have a high abuse potential and pose a high
risk to public health (HHS, 2022).
Due to the psychological and cognitive disturbances associated with
3-MeO-PCP, as with other similar schedule II and III hallucinogens
noted above, it is reasonable to conclude that 3-MeO-PCP has
substantial capability to be a hazard to the health of the user and to
the safety of the community.
2. Scientific Evidence of the Drug's Pharmacological Effects, If Known
3-MeO-PCP is a novel psychoactive substance with a mechanism of
action similar to PCP that produces psychopharmacological effects
similar to other dissociative amnestic drugs such as PCP and ketamine.
Based on non-clinical in vitro studies, 3-MeO-PCP has higher affinity
for the NMDA receptor and acts as an antagonist, suggesting it may have
greater potency than PCP or ketamine. 3-MeO-PCP also interacts with
monoamine transmission through binding at the serotonin transporter and
increasing serotonin transmission. Non-clinical in vivo studies show 3-
MeO-PCP acts as a NMDA receptor antagonist through the Maximal
Electroshock Seizure (MES) test and substitutes for PCP in drug
discrimination. Although no clinical studies have been performed for 3-
MeO-PCP, case reports show that the effects of 3-MeO-PCP are similar to
abuse of or intoxication with PCP.
3. The State of Current Scientific Knowledge Regarding the Drug or
Other Substance
3-MeO-PCP is a centrally-acting hallucinogen that is part of the
arylcyclohexylamine hallucinogen family and shares structural
similarities with schedule II and III phenethylamine hallucinogens such
as PCP and ketamine. 3-MeO-PCP (Chemical Abstracts Service Registry
Number 72242-03-6) has a molecular formula of
C18H27NO and a molecular weight of 273.41 g/mol.
The half-life of 3-MeO-PCP is estimated to be 10-11 hours. 3-MeO-PCP
undergoes extensive metabolism, such that at least 30 phase I and II
metabolites can be generated. Globally, there have been at least 19
cases of severe intoxication that required hospitalization and 21
deaths, where 3-MeO-PCP was identified in the blood of the decedent. In
at least seven
[[Page 24374]]
of those deaths, 3-MeO-PCP was listed as the cause of death. HHS notes
that in many of the cases reported by the WHO, other drugs of abuse
were also identified clouding the direct toxicity of 3-MeO-PCP, and
there is not sufficient information otherwise available to provide
specific toxicity information regarding 3-MeO-PCP since its usage was
primarily with other substances or lacking poly substance use
information.
4. Its History and Current Pattern of Abuse
3-MeO-PCP is a relatively new drug in the drug abuse and drug
trafficking setting, and thus, there is relatively little information
related to its history and pattern of abuse. The World Health
Organization (WHO) reports that 3-MeO-PCP has been available in Europe
since 2010. Distribution and trafficking of 3-MeO-PCP began increasing
in 2011 (WHO, 2020). The history and current pattern of abuse of 3-MeO-
PCP is described in law enforcement reports and anecdotal reports by
drug abusers. In the United States, law enforcement entities initially
encountered 3-MeO-PCP in 2011, according to the National Forensic
Laboratory Information System (NFLIS)-Drug \9\ database. See Factor 5
for additional information.
---------------------------------------------------------------------------
\9\ NFLIS-Drug is a national forensic laboratory reporting
system that systematically collects results from drug chemistry
analyses conducted by state and local forensic laboratories in the
United States. NFLIS-Drug data were queried on September 6, 2024.
---------------------------------------------------------------------------
HHS noted that since 3-MeO-PCP is an analogue of PCP with similar
mechanisms of action, the extensive history and pattern of PCP abuse
may be appropriate to inform on the potential pattern of abuse of 3-
MeO-PCP. The 2011 Substance Abuse and Mental Health Services
Administration reported 75,538 emergency department visits related to
PCP use. The 2011 National Survey on Drug Use and Health data showed
that 6.1 million Americans, 12 years or older, reported using PCP in
their lifetime. A case series study conducted at a tertiary care center
reported patients with PCP intoxication tended to be young males who
presented with signs and symptoms of retrograde amnesia, nystagmus,
hypertension, and agitation. Coadministration with other substances was
common (e.g., benzodiazepines, alcohol, marijuana, cocaine).
5. The Scope, Duration, and Significance of Abuse
3-MeO-PCP has pharmacological effects similar to the schedule II
hallucinogen PCP (with higher potency) and has no currently accepted
medical use in the United States or anywhere in the world. HHS states
(2022) it is not associated with an investigational new drug
application or an approved new drug application.
In the United States, evidence of abuse of 3-MeO-PCP initially
appeared in 2011, one year later than was reported by the EMCDDA. Since
then, reports of worldwide abuse have increased substantially.
According to the WHO Critical Review Report published in 2020, 15
countries reported that 3-MeO-PCP was being used by individuals for its
psychoactive properties. The WHO document also reported a total of 314
drug seizures from 2018-2020. Within the United States, from January
2011 to August 2024, there were 399 exhibits reported to the NFLIS-Drug
database, which show evidence of trafficking, distribution, and abuse
of 3-MeO-PCP in 33 states.
Case reports and case series of abuse and deaths associated with 3-
MeO-PCP have been published globally. 3-MeO-PCP is typically abused
orally and by insufflation (sniffing or snorting), but has also been
reported to be smoked, inhaled, or vaporized. It is often used with
other substances (e.g., benzodiazepines, cannabinoids). Clinical
effects from 3-MeO-PCP are similar to other abused arylcyclohexylamines
hallucinogens (e.g., PCP) and include confusion, dissociation,
hallucinations, sedation through agitation, disinhibition, euphoria,
cognitive changes, sensory changes, motor changes, and cardiovascular
effects (e.g., hypertension and tachycardia).
Abuse of 3-MeO-PCP has been characterized as causing acute public
health and safety issues worldwide. The WHO reported that 3-MeO-PCP has
been available in Europe since 2010. Based on available abuse data,
public health risk, and drug trafficking data, the WHO recommended to
the United Nations (UN) that 3-MeO-PCP be controlled internationally.
In April 2021, the UN Commission on Narcotic Drugs voted to place 3-
MeO-PCP into Schedule II of the 1971 Convention.
6. What, if Any, Risk There Is to the Public Health
3-MeO-PCP shares similar mechanisms of action with and produces
similar physiological and subjective effects (see Factor 2 for more
information) as other schedule II and III hallucinogens, such as PCP
and ketamine. Thus, 3-MeO-PCP poses the same risks to public health as
similar hallucinogens. Predominantly, the risks to public health are
borne by users (i.e., hallucinogenic effects, sensory distortion,
impaired judgement, strange or dangerous behaviors), but they can
affect the general public, as with driving under the influence. There
have been reports of distressing responses and death associated with 3-
MeO-PCP in medical literature, many of which, but not all, report poly-
substance use. Adverse events associated with 3-MeO-PCP have been
reported and include, but not limited to, hypertension, confusion,
dissociation, hallucinations, tachycardia, nystagmus, respiratory
acidosis, hypothermia, coma, and death. The 2020 review published by
the WHO noted at least 19 cases of severe intoxications occurred after
use of 3-MeO-PCP that required hospitalization and 21 deaths were
reported where 3-MeO-PCP was confirmed in blood samples. At least seven
of those deaths were attributed to 3-MeO-PCP as the cause of death.
Thus, based on the review of both HHS and DEA, serious adverse events
that may include death represent a risk to the individual drug users
and to public health.
7. Its Psychic or Physiological Dependence Liability
HHS noted that a study with 4-MeO-PCP (a structural isomer) does
produce rewarding (conditioned place preference) and reinforcing
effects (self-administration) through activation of the mesolimbic
dopamine reward pathway in rats. Therefore, HHS concluded that it is
likely that 3-MeO-PCP produces similar effects in rats. The only
literature available on human exposure to 3-MeO-PCP is based on case
study reports, two of which indicate long-term use of 3-MeO-PCP.
[[Page 24375]]
HHS noted that no studies have evaluated the dependence potential
of 3-MeO-PCP. However, 3-MeO-PCP has similar pharmacological properties
of PCP (schedule II) and ketamine (schedule III), which do have well-
demonstrated dependence potential. Thus, the HHS and DEA reviews both
concluded that it is probable that 3-MeO-PCP has a dependence profile
similar to these known substances.
8. Whether the Substance Is an Immediate Precursor of a Substance
Already Controlled Under the CSA
3-MeO-PCP is not an immediate precursor of any controlled substance
of the CSA as defined by 21 U.S.C. 802(23).
Conclusion
Based on consideration of the scientific and medical evaluation and
accompanying recommendation of HHS, and on DEA's own eight-factor
analysis, DEA finds that these facts and all relevant data constitute
substantial evidence of potential for abuse of 3-MeO-PCP. As such, DEA
proposes to schedule 3-MeO-PCP as a controlled substance 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,
per 21 U.S.C. 812(b). After consideration of the analysis and
recommendation of the Assistant Secretary for Health of HHS and review
of all other available data, the Acting Administrator of DEA, pursuant
to 21 U.S.C. 812(b)(1), finds that:
(1) 3-MeO-PCP has a high potential for abuse.
3-MeO-PCP is a synthetic arylcyclohexylamine, chemically related
and pharmacologically similar to the ethylamine analog of phencyclidine
(PCE; schedule I), the thiophene analog of phencyclidine (TCP; schedule
I), phencyclidine (PCP, schedule II), and ketamine (schedule III). 3-
MeO-PCP, similar to PCP and ketamine, produces dissociative anesthetic
and hallucinogenic effects.
3-MeO-PCP has a pharmacological profile similar to other
arylcyclohexylamines, such as PCP (schedule II) and ketamine (schedule
III). Binding studies demonstrate a similar mechanism of action (i.e.,
NMDA receptor antagonism) and case reports indicate that 3-MeO-PCP
clinically resembles PCP intoxication (i.e., hallucinogenic effects).
Little evidence exists regarding 3-MeO-PCP direct psychic or
physiologic dependence liability; 3-MeO-PCP fully substituted for PCP
in drug discrimination studies. However, it can be assumed from the
above evidence (Factor 7) that 3-MeO-PCP has a physical dependence
liability similar to these controlled substances, with evidence of
dependence potential.
(2) 3-MeO-PCP has no currently accepted medical use in treatment in
the United States.
3-MeO-PCP is not legally marketed in the United States, as the FDA
has not approved a marketing application for a drug product containing
3-MeO-PCP for any indication. As noted in the HHS review, 3-MeO-PCP
lacks current marketing approval under a new drug application or an
abbreviated new drug application, and is not subject to an
investigational new drug application. There is no evidence that 3-MeO-
PCP has a currently accepted medical use in treatment in the United
States.\10\
---------------------------------------------------------------------------
\10\ To place a drug or other substance in schedule I under the
CSA, DEA must consider whether the substance has a currently
accepted medical use in treatment in the United States. 21 U.S.C.
812(b)(1)(B). There is no evidence suggesting that 3-MeO-PCP has a
currently accepted medical use in treatment in the United States. To
determine whether a drug or other substance has a currently accepted
medical use, DEA has traditionally applied a five-part test to a
drug that has not been approved by FDA: 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.
Marijuana Scheduling Petition; Denial of Petition; Remand, 57 FR
10499 (Mar. 26, 1992), pet. for rev. denied, Alliance for Cannabis
Therapeutics v. Drug Enforcement Admin., 15 F.3d 1131, 1135 (D.C.
Cir. 1994). DEA and HHS applied the traditional five-part test for
currently accepted medical use in this matter. In a recent published
letter in a different context, HHS applied an additional two-part
test to determine currently accepted medical use for substances that
do not satisfy the five-part test: (1) whether there exists
widespread, current experience with medical use of the substance by
licensed health care practitioners operating in accordance with
implemented jurisdiction-authorized programs, where medical use is
recognized by entities that regulate the practice of medicine, and,
if so, (2) whether there exists some credible scientific support for
at least one of the medical conditions for which the part 1 is
satisfied. On April 11, 2024, the Department of Justice's Office of
Legal Counsel (OLC) issued an opinion, which, among other things,
concluded that HHS's two-part test would be sufficient to establish
that a drug has a currently accepted medical use. Office of Legal
Counsel, Memorandum for Merrick B. Garland Attorney General Re:
Questions Related to the Potential Rescheduling of Marijuana at 3
(April 11, 2024). For purposes of this proposed rule, there is no
evidence that health care providers have widespread experience with
medical use of 3-MeO-PCP, or that the use of 3-MeO-PCP is recognized
by entities that regulate the practice of medicine under either the
traditional five-part test or the two-part test.
---------------------------------------------------------------------------
(3) There is a lack of accepted safety for use of 3-MeO-PCP under
medical supervision.
Because 3-MeO-PCP has no approved medical use and has not been
thoroughly investigated as a new drug, its safety for use under medical
supervision is not determined. Thus, there is a lack of accepted safety
for use of this substance under medical supervision.
Based on these findings, the Acting Administrator of DEA concludes
that 3-MeO-PCP warrants control in schedule I of the CSA. More
precisely, because of its hallucinogenic effects, and because it may
produce hallucinogenic-like dependence in humans, DEA proposes to place
3-MeO-PCP, including its 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 3-MeO-PCP
If this rule is finalized as proposed, 3-MeO-PCP would be subject
to the CSA's schedule I regulatory controls and administrative, civil,
and criminal sanctions applicable to the manufacture, distribution,
dispensing, importing, exporting, research, and conduct of
instructional activities, including the following:
1. Registration. Any person who handles (manufactures, distributes,
dispenses, imports, exports, engages in research, or conducts
instructional activities or chemical analysis with, or possesses) 3-
MeO-PCP would need to be registered with DEA to conduct such activities
pursuant to 21 U.S.C. 822, 823, 957, and 958, and in accordance with 21
CFR parts 1301 and 1312.
2. Security. 3-MeO-PCP would be subject to schedule I security
requirements, and handled and stored pursuant to 21 U.S.C. 821, 823,
and in accordance with 21 CFR 1301.71-1301.76. Non-practitioners
handling this substance also would need to comply with the screening
requirements of 21 CFR 1301.90-1301.93.
3. Labeling and Packaging. All labels and packaging for commercial
containers of 3-MeO-PCP would need to comply with 21 U.S.C. 825, and be
in accordance with 21 CFR part 1302.
4. Quota. Only registered manufacturers would be permitted to
manufacture 3-MeO-PCP in accordance with a quota assigned pursuant to
21 U.S.C. 826 and in accordance with 21 CFR part 1303.
5. Inventory. Any person registered with DEA to handle 3-MeO-PCP
would need to have an initial inventory of all
[[Page 24376]]
stocks of controlled substances (including this substance) on hand on
the effective date of a final scheduling action pursuant to 21 U.S.C.
827, and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11.
After the initial inventory, every DEA registrant would need to
take a new inventory of all stocks of controlled substances (including
3-MeO-PCP) 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.
6. Records and Reports. Every DEA registrant would need to maintain
records and submit reports with respect to 3-MeO-PCP, pursuant to 21
U.S.C. 827 and 832(a), and in accordance with 21 CFR 1301.74 and
1301.76, and parts 1304, 1312, and 1317.
7. Order Forms. Every DEA registrant who distributes 3-MeO-PCP
would need to comply with the order form requirements, pursuant to 21
U.S.C. 828 and 21 CFR part 1305.
8. Importation and Exportation. All importation and exportation of
3-MeO-PCP would need to be in compliance with 21 U.S.C. 952, 953, 957,
and 958, and in accordance with 21 CFR part 1312.
9. Liability. Any activity involving 3-MeO-PCP not authorized by,
or in violation of, the CSA or its implementing regulations would be
unlawful, and may subject the person to administrative, civil, and/or
criminal sanctions.
Regulatory Analyses
Executive Orders 12866 and 13563, and 14192 (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 the
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. DEA scheduling actions are not
subject to E.O. 14192, Unleashing Prosperity Through Deregulation.
Executive Order 12988, Civil Justice Reform
This proposed regulation meets the applicable standards set forth
in sections 3(a) and 3(b)(2) of E.O. 12988 to eliminate drafting errors
and ambiguity, minimize litigation, provide a clear legal standard for
affected conduct, and promote simplification and burden reduction.
Executive Order 13132, Federalism
This proposed rulemaking does not have federalism implications
warranting the application of E.O. 13132. The proposed rule does not
have substantial direct effects on the States, on the relationship
between the national government and the States, or on the distribution
of power and responsibilities among the various levels of government.
Executive Order 13175, Consultation and Coordination With Indian Tribal
Governments
This proposed rule does not have tribal implications warranting the
application of E.O. 13175. It does not have substantial direct effects
on one or more Indian tribes, on the relationship between the Federal
government and Indian tribes, or on the distribution of power and
responsibilities between the Federal government and Indian tribes.
Paperwork Reduction Act
This proposed rule would not impose a new collection or modify an
existing collection of information under the Paperwork Reduction Act of
1995. Also, this proposed rule would not impose new or modify existing
recordkeeping or reporting requirements on state or local governments,
individuals, businesses, or organizations. However, this proposed rule
would require compliance with the following existing OMB collections:
1117-0003, 1117-0004, 1117-0006, 1117-0008, 1117-0009, 1117-0010, 1117-
0012, 1117-0014, 1117-0021, 1117-0023, 1117-0029, and 1117-0056. An
agency may not conduct or sponsor, and a person is not required to
respond to, a collection of information unless it displays a currently
valid OMB control number.
Regulatory Flexibility Act
The Acting 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 substance 3-MeO-PCP (chemical name: 1-[1-
(3-methoxyphenyl)cyclohexyl]piperidine), including its salts, isomers,
and salts of isomers whenever the existence of such salts, isomers, and
salts of isomers is possible within the specific chemical designation,
in schedule I of the CSA. This action is being taken, in part, to
enable the United States to meet its obligations under the 1971
Convention. If finalized, this action would impose the regulatory
controls and administrative, civil, and criminal sanctions applicable
to schedule I controlled substances on persons who handle or propose to
handle 3-MeO-PCP.
The entities affected by this rule include the manufacturers,
distributors, importers, exporters, and researchers of 3-MeO-PCP. DEA
determined the North American Industry Classification System (NAICS)
industries that best represent these business activities. Table 1 lists
the business activities and corresponding NAICS industries.\11\
---------------------------------------------------------------------------
\11\ Executive Office of the President Office of Management and
Budget, North American Industry Classification System, United
States, 2022, https://www.census.gov/naics/reference_files_tools/2022_NAICS_Manual.pdf. (Accessed 4/2/2024).
Table 1--Business Activity and Corresponding NAICS Industries
------------------------------------------------------------------------
NAICS industry
Business activity NAICS code description
------------------------------------------------------------------------
Manufacturer................... 325412 Pharmaceutical
Preparation
Manufacturing.
Distributor, Importer, Exporter 424210 Drugs and Druggists'
424690 Sundries Merchant
Wholesalers.
Other Chemical and
Allied Products
Merchant Wholesalers.
Researcher..................... 541715 Research and
611310 Development in the
Physical, Engineering,
and Life Sciences
(except Nanotechnology
and Biotechnology).
Colleges, Universities
and Professional
Schools.
------------------------------------------------------------------------
From Statistics of U.S. Businesses (SUSB) data, DEA determined the
number of firms and small firms for each of the affected industries,
and by comparing the number of affected small entities to the number of
small entities
[[Page 24377]]
for each industry, DEA determined whether a substantial number of small
entities are affected in any of the industries. Table 2 lists the
number of firms, small firms, and percent small firms in each affected
industry.
Table 2--Percent Small Entities by Industry
----------------------------------------------------------------------------------------------------------------
SBA size Small firms Percent small
NAICS industry Firms \12\ standard \13\ \14\ entities (%)
----------------------------------------------------------------------------------------------------------------
325412--Pharmaceutical Preparation Manufacturing 1,007 1,300 931 92.4
424210--Drugs and Druggists' Sundries Merchant 6,958 250 6,663 95.8
Wholesalers....................................
424690--Other Chemical and Allied Products 6,069 175 5,781 95.3
Merchant Wholesalers...........................
541715--Research and Development in the 8,019 1,000 7,571 94.4
Physical, Engineering, and Life Sciences
(except Nanotechnology and Biotechnology)......
611310--Colleges, Universities and Professional 2,433 $34.5 1,515 62.3
Schools........................................
----------------------------------------------------------------------------------------------------------------
Based on the American Chemical Society's SciFinder database, DEA
identified 13 entities supplying 3-MeO-PCP across these industries.
Suppliers include 325412, 424210, and 424690 industries. Even if all
affected suppliers were small entities, they would account for only
0.10 percent of the small entities in those industries, not a
substantial number.\15\ Additionally, DEA expects the number of
researchers working with 3-MeO-PCP is small because 3-MeO-PCP lacks
current marketing approval under a new drug application or an
abbreviated new drug application, and is not subject to an
investigational new drug application as noted in the HHS review. Also,
DEA believes the researchers working with 3-MeO-PCP may also work with
other controlled substances; hence, they have probably already
registered with DEA and are qualified to handle controlled substances.
For these reasons DEA believes the number of affected researchers that
are small entities is not a substantial number of small entities in
541715 and 622310 industries.
---------------------------------------------------------------------------
\12\ Statistics of U.S. Businesses, 2021 SUSB Annual Data Tables
by Establishment Industry, https://www.census.gov/data/tables/2021/econ/susb/2021-susb-annual.html (Accessed 4/2/2024).
\13\ U.S. Small Business Administration, Table of size
standards, Version March 2023, Effective: March 17, 2023, https://www.sba.gov/sites/sbagov/files/2023-06/Table%20of%20Size%20Standards_Effective%20March%2017%2C%202023_.xlsx.
(Accessed 4/2/2024).
\14\ Note 12.
\15\ 13/(931 + 6,664 + 5,781) = 0.10%.
---------------------------------------------------------------------------
The primary costs associated with this proposed rule would be the
annual registration fee for Schedule I controlled substances ($3,699
for manufacturers, $1,850 for distributors, and $296 for researchers).
As mentioned above, DEA has identified 13 domestic suppliers of 3-MeO-
PCP from the SciFinder database and none of these suppliers has
registered with DEA to handle Schedule I controlled substances.
However, it is common for suppliers to have items in their catalog
while not actually having any material level of sales because FDA has
not approved a marketing application for a drug product containing 3-
MeO-PCP. Therefore, some suppliers may simply remove 3-MeO-PCP from
their catalog without any impact. Additionally, as discussed above, the
researchers who work with 3-MeO-PCP are likely to work with other
controlled substances and hence, must already register with DEA.
In summary, the small entities impacted by this rule are those in
325412-Pharmaceutical Preparation Manufacturing, 424210-Drugs and
Druggists' Sundries Merchant Wholesalers, and 424690-Other Chemical and
Allied Products Merchant Wholesalers. The affected small entities
account for only 0.1 percent of the small businesses and are not likely
to manufacture or carry 3-MeO-PCP inventory. As such, the proposed rule
will not, if promulgated, result in a significant effect 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, 21 CFR part 1308 is proposed to be
amended to read 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, add paragraph (d)(105) to read as follows:
Sec. 1308.11 Schedule I.
* * * * *
(d) * * *
------------------------------------------------------------------------
------------------------------------------------------------------------
* * * * * * *
(105) 3-methoxyphencyclidine (Other names: 1-[1-(3- 7457
methoxyphenyl)cyclohexyl] piperidine; 3-MeO-PCP)..............
* * * * * * *
------------------------------------------------------------------------
* * * * *
Signing Authority
This document of the Drug Enforcement Administration was signed on
June 3, 2025, by Acting Administrator Robert J. Murphy. That document
with the original signature and date is maintained by DEA. For
administrative purposes only, and in
[[Page 24378]]
compliance with requirements of the Office of the Federal Register, the
undersigned DEA Federal Register Liaison Officer has been authorized to
sign and submit the document in electronic format for publication, as
an official document of DEA. This administrative process in no way
alters the legal effect of this document upon publication in the
Federal Register.
Heather Achbach,
Federal Register Liaison Officer, Drug Enforcement Administration.
[FR Doc. 2025-10503 Filed 6-9-25; 8:45 am]
BILLING CODE 4410-09-P