Proposed Rule2023-06893
Schedules of Controlled Substances: Temporary Placement of MDMB-4en-PINACA, 4F-MDMB-BUTICA, ADB-4en-PINACA, CUMYL-PEGACLONE, 5F-EDMB-PICA, and MMB-FUBICA in Schedule I
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
April 4, 2023
Effective
April 4, 2023
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
The Administrator of the Drug Enforcement Administration is issuing this notice of intent to publish a temporary order to schedule six synthetic cannabinoids and their optical and geometric isomers, salts, and salts of isomers, whenever the existence of such isomers and salts is possible, in schedule I under the Controlled Substances Act. When it is issued, the temporary scheduling order will impose the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on persons who handle (manufacture, distribute, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis with, or possess) or propose to handle these six specified controlled substances.
Full Text
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<title>Federal Register, Volume 88 Issue 64 (Tuesday, April 4, 2023)</title>
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[Federal Register Volume 88, Number 64 (Tuesday, April 4, 2023)]
[Proposed Rules]
[Pages 19896-19901]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-06893]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-1006]
Schedules of Controlled Substances: Temporary Placement of MDMB-
4en-PINACA, 4F-MDMB-BUTICA, ADB-4en-PINACA, CUMYL-PEGACLONE, 5F-EDMB-
PICA, and MMB-FUBICA in Schedule I
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Proposed amendment; notice of intent.
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SUMMARY: The Administrator of the Drug Enforcement Administration is
issuing this notice of intent to publish a temporary order to schedule
six synthetic cannabinoids and their optical and geometric isomers,
salts, and salts of isomers, whenever the existence of such isomers and
salts is possible, in schedule I under the Controlled Substances Act.
When it is issued, the temporary scheduling order will impose the
regulatory controls and administrative, civil, and criminal sanctions
applicable to schedule I controlled substances on persons who handle
(manufacture, distribute, reverse distribute, import, export, engage in
research, conduct instructional activities or chemical analysis with,
or possess) or propose to handle these six specified controlled
substances.
DATES: This notice of intent is effective April 4, 2023.
FOR FURTHER INFORMATION CONTACT: Terrence L. Boos, Drug & Chemical
Evaluation Section, Diversion Control Division, Drug Enforcement
Administration; Telephone: (571) 362-3249.
SUPPLEMENTARY INFORMATION: The notice of intent contained in this
document is issued pursuant to the temporary scheduling provisions of
21 U.S.C. 811(h). The Drug Enforcement Administration (DEA) intends to
issue a temporary scheduling order (in the form of a temporary
amendment) to add the following six substances, including their
optical, positional, and geometric isomers, salts, and salts of isomers
whenever the existence of such isomers and salts is possible, to
schedule I under the Controlled Substances Act (CSA): \1\
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\1\ Though DEA has used the term ``final order'' with respect to
temporary scheduling orders in the past, this notice of intent
adheres to the statutory language of 21 U.S.C. 811(h), which refers
to a ``temporary scheduling order.'' No substantive change is
intended.
[[Page 19897]]
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<bullet> Methyl 3,3-dimethyl-2-(1-(pent-4-en-1-yl)-1H-indazole-3-
carboxamido)butanoate (Other name: MDMB-4en-PINACA),
<bullet> Methyl 2-[[1-(4-fluorobutyl)indole-3-carbonyl]amino]-3,3-
dimethyl-butanoate (Other names: 4F-MDMB-BUTICA; 4F-MDMB-BICA),
<bullet> N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(pent-4-en-1-yl)-
1H-indazole-3-carboxamide (Other name: ADB-4en-PINACA),
<bullet> 5-Pentyl-2-(2-phenylpropan-2-yl)pyrido[4,3-b]indol-1-one
(Other name: CUMYL-PEGACLONE; SGT-151),
<bullet> Ethyl 2-[[1-(5-fluoropentyl)indole-3-carbonyl]amino]-3,3-
dimethyl-butanoate (Other names: 5F-EDMB-PICA; 5F-EDMB-2201),
<bullet> Methyl 2-(1-(4-fluorobenzyl)-1H-indole-3-carboxamido)-3-methyl
butanoate (Other name: MMB-FUBICA)
The temporary scheduling order will be published in the Federal
Register on or after May 4, 2023.
Legal Authority
The CSA provides the Attorney General (as delegated to the
Administrator of DEA (Administrator) pursuant to 28 CFR 0.100) with the
authority to temporarily place a substance in schedule I of the CSA for
two years without regard to the requirements of 21 U.S.C. 811(b), if he
finds that such action is necessary to avoid an imminent hazard to the
public safety.\2\ In addition, if proceedings to control a substance
are initiated under 21 U.S.C. 811(a)(1) while the substance is
temporarily controlled under section 811(h), the Administrator may
extend the temporary scheduling for up to one year.\3\
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\2\ 21 U.S.C. 811(h)(1).
\3\ 21 U.S.C. 811(h)(2).
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Where the necessary findings are made, a substance may be
temporarily scheduled if it is not listed in any other schedule under
21 U.S.C. 812, or if there is no exemption or approval in effect for
the substance under section 505 of the Federal Food, Drug, and Cosmetic
Act, 21 U.S.C. 355. 21 U.S.C. 811(h)(1); 21 CFR part 1308.
Background
The CSA requires the Administrator to notify the Secretary of the
Department of Health and Human Services (HHS) of an intent to place a
substance in schedule I of the CSA temporarily (i.e., to issue a
temporary scheduling order).\4\ The Administrator transmitted the
required notice to the Assistant Secretary for Health of HHS (Assistant
Secretary) \5\ by letter dated January 24, 2022 regarding MDMB-4en-
PINACA, 4F-MDMB-BUTICA, ADB-4en-PINACA, CUMYL-PEGACLONE, 5F-EDMB-PICA,
and MMB-FUBICA. The Assistant Secretary responded to this notice by
letter dated March 7, 2022, and advised that based on a review by the
Food and Drug Administration, there are currently no approved new drug
applications or investigational new drug applications for MDMB-4en-
PINACA, 4F-MDMB-BUTICA, ADB-4en-PINACA, CUMYL-PEGACLONE, 5F-EDMB-PICA,
or MMB-FUBICA. The Assistant Secretary also stated that HHS has no
objection to the temporary placement of these substances in schedule I
of the CSA. MDMB-4en-PINACA, 4F-MDMB-BUTICA, ADB-4en-PINACA, CUMYL-
PEGACLONE, 5F-EDMB-PICA, or MMB-FUBICA currently are not listed in any
schedule under the CSA, and no exemptions or approvals under 21 U.S.C.
355 are in effect for these six substances.
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\4\ 21 U.S.C. 811(h)(4).
\5\ The Secretary of HHS has delegated to the Assistant
Secretary for Health of HHS the authority to make domestic drug
scheduling recommendations. 58 FR 35460, July 1, 1993.
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Under 21 U.S.C. 811(h)(3), to find that temporarily placing a
substance in schedule I of the CSA is necessary to avoid an imminent
hazard to the public safety, the Administrator must consider three of
the eight factors set forth in 21 U.S.C. 811(c): The substance's
history and current pattern of abuse; the scope, duration and
significance of abuse; and what, if any, risk there is to the public
health. This consideration includes any information indicating actual
abuse; diversion from legitimate channels; and clandestine importation,
manufacture, or distribution of these substances.
A substance meeting the statutory requirements for temporary
scheduling may only be placed in schedule I.\6\ Substances in schedule
I have a high potential for abuse, no currently accepted medical use
for treatment in the United States, and no accepted safety for use
under medical supervision.\7\
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\6\ 21 U.S.C. 811(h)(1).
\7\ 21 U.S.C. 812(b)(1).
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Synthetic Cannabinoids
Synthetic cannabinoids (SCs) are substances synthesized in
laboratories that mimic the biological effects of delta-9-
tetrahydrocannabinol (THC, schedule I), the main psychoactive
ingredient in marijuana (schedule I). SCs were introduced to the
designer drug market in several European countries as ``herbal
incense'' before the initial encounter in the United States by the
United States Customs and Border Protection (CBP) in November 2008.
From 2009, abuse of SCs has escalated in the United States as evidenced
by large numbers of law enforcement encounters of SCs applied onto
plant material and in other designer drug products intended for human
consumption.\8\ Recent hospital reports, scientific publications and/or
law enforcement reports demonstrate that MDMB-4en-PINACA, 4F-MDMB-
BUTICA, ADB-4en-PINACA, CUMYL-PEGACLONE, 5F-EDMB-PICA, and MMB-FUBICA,
and their associated designer drug products, are being abused for their
psychoactive properties (see Factors 5 and 6). As with many generations
of SCs encountered since 2009, the abuse of MDMB-4en-PINACA, 4F-MDMB-
BUTICA, ADB-4en-PINACA, CUMYL-PEGACLONE, 5F-EDMB-PICA, and MMB-FUBICA
is negatively impacting communities in the United States.
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\8\ While law enforcement data are not direct evidence of abuse,
they can lead to an inference that drugs have been diverted and
abused. See 76 FR 77330, 77332, Dec. 12, 2011.
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As noted by DEA and CBP, SCs originate from foreign sources, such
as China. Substances in bulk powder form are smuggled via common
carrier into the United States and find their way to clandestine
designer drug product manufacturing operations located in residential
neighborhoods, garages, warehouses, and other similar destinations
throughout the country. According to online discussion boards and law
enforcement encounters, spraying or mixing the SCs with plant material
provides a vehicle for the most common route of administration--smoking
(using a pipe, a water pipe, or rolling the drug-laced plant material
in cigarette papers).
MDMB-4en-PINACA, 4F-MDMB-BUTICA, ADB-4en-PINACA, CUMYL-PEGACLONE,
5F-EDMB-PICA, and MMB-FUBICA have no accepted medical use in treatment
in the United States.\9\ Emergency department
[[Page 19898]]
presentations involving MDMB-4en-PINACA or CUMYL-PEGACLONE have
included seizures, sudden collapse, involuntary muscle spasms, jerking
movements, catatonia, and increased violence. Multiple deaths have been
reported involving MDMB-4en-PINACA, 4F-MDMB-BUTICA and CUMYL-PEGACLONE.
In addition, all six SCs have been seized by law enforcement in the
United States. Use of other schedule I SCs (e.g., JWH-018, AB-FUBINACA)
has resulted in signs of addiction and withdrawal. Based on the
pharmacological similarities between MDMB-4en-PINACA, 4F-MDMB-BUTICA,
ADB-4en-PINACA, CUMYL-PEGACLONE, 5F-EDMB-PICA, and MMB-FUBICA and other
schedule I SCs (e.g., JWH-018, AB-FUBINACA), these six SCs are likely
to produce signs of addiction and withdrawal similar to those produced
by other schedule I SCs (e.g., JWH-018, AB-FUBINACA).
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\9\ Although there is no evidence suggesting that MDMB-4en-
PINACA, 4F-MDMB-BUTICA, ADB-4en-PINACA, CUMYL-PEGACLONE, 5F-EDMB-
PICA, and MMB-FUBICA have a currently accepted medical use in
treatment in the United States, it bears noting that a drug cannot
be found to have such medical use unless DEA concludes that it
satisfies a five-part test. Specifically, with respect to a drug
that has not been approved by FDA, to have a currently accepted
medical use in treatment in the United States, all of the following
must be demonstrated: i. The drug's chemistry must be known and
reproducible; ii. there must be adequate safety studies; iii. there
must be adequate and well-controlled studies proving efficacy; iv.
the drug must be accepted by qualified experts; and v. the
scientific evidence must be widely available. 57 FR 10499, Mar. 26,
1992, pet. for rev. denied, Alliance for Cannabis Therapeutics v.
DEA, 15 F.3d 1131, 1135 (D.C. Cir. 1994).
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MDMB-4en-PINACA, 4F-MDMB-BUTICA, ADB-4en-PINACA, CUMYL-PEGACLONE,
5F-EDMB-PICA, and MMB-FUBICA are SCs that have pharmacological effects
similar to the schedule I hallucinogen THC and other temporarily and
permanently controlled schedule I SCs. With no approved medical use and
limited safety or toxicological information, MDMB-4en-PINACA, 4F-MDMB-
BUTICA, ADB-4en-PINACA, CUMYL-PEGACLONE, 5F-EDMB-PICA, and MMB-FUBICA
have emerged in the designer drug market, and the abuse of these
substances for their psychoactive properties is concerning.
Factor 4. History and Current Pattern of Abuse
SCs have been developed by researchers over the last 30 years as
tools for investigating the endocannabinoid system (e.g., determining
CB1 and CB2 receptor activity). The first encounter of SCs intended for
illicit use within the United States occurred in November 2008 by CBP.
Since then, the popularity of SCs as product adulterants and objects of
abuse has increased as evidenced by law enforcement seizures, public
health information, and media reports.
Research and clinical reports have demonstrated that SCs are
applied onto plant material so that the material may be smoked as users
attempt to obtain a euphoric and psychoactive ``high,'' believed to be
similar to marijuana. The adulterated products are marketed as
``legal'' alternatives to marijuana.
The designer drug products laced with SCs, including MDMB-4en-
PINACA, 4F-MDMB-BUTICA, ADB-4en-PINACA, CUMYL-PEGACLONE, 5F-EDMB-PICA,
and MMB-FUBICA, are often sold under the guise of ``herbal incense'' or
``potpourri,'' using various product names, and are routinely labeled
``not for human consumption.'' Additionally, these products are
marketed as a ``legal high'' or ``legal alternative to marijuana'' and
are readily available over the internet, in head shops, or sold in
convenience stores. There are incorrect assumptions that these products
are safe, that these are synthetic forms of marijuana, and that
labeling these products as ``not for human consumption'' is a legal
defense to criminal prosecution under the Controlled Substances
Analogue Enforcement Act.
The powder form of SCs is typically dissolved in solvents (e.g.,
acetone) before being applied to plant material, or dissolved in a
propellant intended for use in electronic cigarette devices. Law
enforcement personnel have encountered various application methods
including buckets or cement mixers in which plant material and one or
more SCs are mixed together, or in large areas where the plant material
is spread out so that a dissolved SC mixture can be applied directly.
Once mixed, the SC plant material is then allowed to dry before
manufacturers package the product for distribution, ignoring any
quality control mechanisms to prevent contamination or to ensure a
uniform concentration of the substance in each package. Adverse health
consequences may also occur from directly ingesting the drug during the
manufacturing process. The failure to adhere to any manufacturing
standards with regard to amounts, the substance(s) included, purity, or
contamination may further increase the risk of adverse events. However,
it is important to note that adherence to manufacturing standards would
not eliminate their potential to produce adverse effects because the
toxicity and safety profiles of these SCs have not been studied. MDMB-
4en-PINACA, 4F-MDMB-BUTICA, ADB-4en-PINACA, CUMYL-PEGACLONE, 5F-EDMB-
PICA, and MMB-FUBICA, similar to other schedule I SCs (e.g., JWH-018,
AB-FUBINACA), have been found in powder form or mixed with dried leaves
or herbal blends that were marketed for human use.
Following their manufacture in China, SCs are often encountered in
countries including New Zealand, Australia, and Russia before appearing
throughout Europe and eventually in the United States. Law enforcement
in the United States has encountered MDMB-4en-PINACA, 4F-MDMB-BUTICA,
ADB-4en-PINACA, CUMYL-PEGACLONE, 5F-EDMB-PICA, and MMB-FUBICA and has
documented the abuse of these substances. SCs and their associated
products are available over the internet and sold in gas stations,
convenience stores, and tobacco and head shops. MDMB-4en-PINACA, 4F-
MDMB-BUTICA, ADB-4en-PINACA, CUMYL-PEGACLONE, 5F-EDMB-PICA, and MMB-
FUBICA, similar to the previously scheduled SCs, have been seized alone
and/or laced on products that are marketed under the guise of ``herbal
incense'' and promoted as a ``legal'' alternative to marijuana.
CUMYL-PEGACLONE was detailed in a patent published in 2014, was
first reported as an adulterated plant material in Germany in December
2016, and appeared in the United States in September 2018. These data
further support the trend that SCs often appear in the illicit drug
markets of other countries including those in Europe before being
reported in the United States. Law enforcement has seized CUMYL-
PEGACLONE and its abuse has been associated with overdoses requiring
emergency medical intervention. Adverse effects reported following the
abuse of CUMYL-PEGACLONE have included seizures followed by collapse
and deaths. CUMYL-PEGACLONE has also been encountered laced onto paper
in attempts to be smuggled inside of prison facilities.
Users abuse SCs by smoking for the purpose of achieving
intoxication, which has resulted in numerous emergency department
visits and calls to poison centers. As reported by the American
Association of Poison Control Centers (AAPCC), severe, life-threatening
health effects including severe agitation and anxiety, nausea,
vomiting, seizures, and hallucinations can occur following ingestion of
SCs. The AAPCC has specifically noted that SCs are made specifically to
be abused.\10\ Emergency department presentations involving MDMB-4en-
PINACA or CUMYL-PEGACLONE have included seizures, sudden collapse,
involuntary muscle spasms, jerking movements, catatonia, or increased
violence. Multiple deaths have been reported involving MDMB-4en-PINACA,
4F-MDMB-BUTICA, and CUMYL-PEGACLONE (See DEA Factor 6 in Three Factor
Analysis).
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\10\ <a href="https://aapcc.org/track/synthetic-cannabinoids">https://aapcc.org/track/synthetic-cannabinoids</a>.
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[[Page 19899]]
Factor 5. Scope, Duration, and Significance of Abuse
Novel SCs substances, differing only by small chemical structural
modifications intended to avoid prosecution while maintaining the
pharmacological effects, continue to be sold on the illicit drug market
as evidenced by law enforcement encounters of these substances. Law
enforcement and health care professionals continue to report the abuse
of these substances and their associated products. The threat of
serious injury to the individual and the imminent threat to public
safety following the ingestion of MDMB-4en-PINACA, 4F-MDMB-BUTICA, ADB-
4en-PINACA, CUMYL-PEGACLONE, 5F-EDMB-PICA, MMB-FUBICA, and other SCs
persist.
Additional information obtained through the National Forensic
Laboratory Information System (NFLIS) \11\ along with additional data
may be found in DEA's Three Factor Analysis. According to NFLIS
data,\12\ state and local forensic laboratories have detected the
following information about the SCs in question:
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\11\ NFLIS 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.
\12\ At the time of query (March 16, 2022), 2021 and 2022 data
were still reporting.
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<bullet> MDMB-4en-PINACA was identified in 9,566 NFLIS reports
since 2019. In addition, MDMB-4en-PINACA was identified in five
exhibits mixed with heroin and/or fentanyl and packaged for sale as
suspected heroin.
<bullet> 4F-MDMB-BUTICA was identified in 385 NFLIS reports since
2020. 4F-MDMB-BUTICA was also identified in one exhibit in a pill form,
mixed with methamphetamine and a synthetic cathinone known as eutylone.
<bullet> CUMYL-PEGACLONE was identified in two CBP drug seizures in
2018 and 2021, respectively.
<bullet> 5F-EDMB-PICA was identified in 106 NFLIS reports since
2020.
<bullet> MMB-FUBICA was identified in 397 NFLIS reports since 2016.
Factor 6. What, if Any, Risk There is to the Public Health
Since first being identified in the United States in 2008, the
ingestion of SCs continues to result in serious adverse effects.
Details of these events involving MDMB-4en-PINACA and CUMYL-PEGACLONE
are summarized below. (For additional information and citations, see
DEA Factors 5 and 6 in Three Factor Analysis.)
1. In October 2017 in France, two 16-year old juveniles were given
a cigarette laced with white powder by an unknown individual. Upon
arrest of the dealer, he stated the powder was SGT-151. Both juveniles
developed seizures followed by collapse. Toxicological analysis of both
victim's blood and blood collected from the arrested dealer (who
claimed to be a user of the same powder) confirmed the presence of
CUMYL-PEGACLONE (SGT-151) and its metabolite, N-dealkyl CUMYL-PEGACLONE
(SGT-151).
2. Between January and December 2017 in Germany, CUMYL-PEGACLONE
was detected in 34 forensic serum/blood samples from fatal and non-
fatal cases. Of these cases, six deaths were reported by the Institute
of Forensic Medicine in Munich and the Institute of Forensic Medicine
in Mainz, respectively. Details of the deaths demonstrated multiple
factors in addition to SCs as possible causes of death.
3. Between July 1, 2018 and December 31, 2020 in Northern
Australia, CUMYL-PEGACLONE was detected in five deaths. Concurrent
alcohol use and underlying cardiovascular disease were considered
relevant factors in most cases. Toxicological Significance Scoring
(TSS) was carefully considered in all five cases, and in four cases,
the presence of CUMYL-PEGACLONE was considered to be highly significant
(TSS = 3).
4. In September 2019, the Center for Forensic Science Research and
Education released a report detailing the identification of MDMB-4en-
PINACA in biological fluids per their toxicology department.
5. In February 2020, local law enforcement in Holyoke, MA, reported
serious adverse effects following the abuse of the contents in glassine
bags with suspected heroin. Analysis of contents in the bags confirmed
the presence of MDMB-4en-PINACA. Per law enforcement witnesses to the
overdoses, individuals were experiencing involuntary body/muscle spasms
and movements that appeared similar to a seizure, although more
violent. Victims were alert and conscious and they appeared to be under
the influence of some unknown narcotics at the time, with officers
noting that what was observed was nothing like a typical heroin
overdose. Victims described it like being under the influence of PCP
(schedule II substance) or something similar. In some cases, people
were violent and emergency personnel were having a difficult time
providing medical attention to these individuals. Emergency personnel
also described very high heart rates and blood pressure. Some
individuals were acting erratic and running in and out of traffic.
6. In March 2021, a forensic toxicology report from the Defense
Health Agency reported the presence of ADB-BUTINACA, ADB-BUTINACA N-
butanoic acid (a metabolite of ADB-BUTINACA), and MDMB-4en-PINACA 3,3-
dimethylbutanoic acid (a metabolite of MDMB-4en-PINCA) in a submitted
urine specimen.
7. MDMB-4en-PINACA and/or its metabolite were detected in 25
forensic investigation cases between August 2019 and March 2020. The
first positive sample was collected in May 2019. The majority of cases
(n = 16, 64%) were submitted from postmortem investigations, followed
by eight cases from suspected clinical toxicology investigations, and
one case from an impaired driving investigation.
Because they share pharmacological similarities with schedule I
substances ([Delta]\9\-THC, JWH-018, and other temporarily and
permanently controlled schedule I SCs), MDMB-4en-PINACA, 4F-MDMB-
BUTICA, ADB-4en-PINACA, CUMYL-PEGACLONE, 5F-EDMB-PICA, and MMB-FUBICA
pose serious risks to an abuser. Tolerance to SCs may develop fairly
rapidly with larger doses being required to achieve the desired effect.
Acute and chronic abuse of SCs in general have been linked to adverse
health effects including signs of addiction and withdrawal, numerous
reports of emergency department admissions, and overall toxicity and
deaths. Psychiatric case reports have been reported in the scientific
literature detailing the SC abuse and associated psychoses (See DEA
Factor 6 in Three Factor Analysis). As abusers obtain these drugs
through unknown sources, the identity and purity of these substances is
uncertain and inconsistent, thus posing significant adverse health
risks to users.
MDMB-4en-PINACA, 4F-MDMB-BUTICA, ADB-4en-PINACA, CUMYL-PEGACLONE,
5F-EDMB-PICA, and MMB-FUBICA are being encountered on the illicit drug
market and have no accepted medical use in the United States.
Regardless, these products continue to be easily available and abused
by diverse populations.
Finding of Necessity of Schedule I Placement To Avoid Imminent Hazard
to Public Safety
In accordance with 21 U.S.C. 811(h)(3), based on the available data
and information summarized above, the uncontrolled manufacture,
distribution, reverse distribution, importation, exportation, conduct
of research and chemical analysis with, possession, and
[[Page 19900]]
abuse of MDMB-4en-PINACA, 4F-MDMB-BUTICA, ADB-4en-PINACA, CUMYL-
PEGACLONE, 5F-EDMB-PICA, or MMB-FUBICA, resulting from the lack of
control of these substances, pose an imminent hazard to the public
safety. DEA is not aware of any currently accepted medical uses for
these substances in the United States. A substance meeting the
statutory requirements for temporary scheduling, found in 21 U.S.C.
811(h)(1), may only be placed in schedule I. Substances in schedule I
are those that have a high potential for abuse, no currently accepted
medical use in treatment in the United States, and a lack of accepted
safety for use under medical supervision. Available data and
information for MDMB-4en-PINACA, 4F-MDMB-BUTICA, ADB-4en-PINACA, CUMYL-
PEGACLONE, 5F-EDMB-PICA, and MMB-FUBICA indicate that these substances
have a high potential for abuse, no currently accepted medical use in
treatment in the United States, and a lack of accepted safety for use
under medical supervision. As required by 21 U.S.C. 811(h)(4), the
Administrator, through a letter dated January 24, 2022, notified the
Assistant Secretary of DEA's intention to temporarily place MDMB-4en-
PINACA, 4F-MDMB-BUTICA, ADB-4en-PINACA, CUMYL-PEGACLONE, 5F-EDMB-PICA,
and MMB-FUBICA in schedule I.
Conclusion
This notice of intent provides the 30-day notice pursuant to 21
U.S.C. 811(h)(1) of DEA's intent to issue a temporary scheduling order.
In accordance with 21 U.S.C. 811(h)(1) and (3), the Administrator
considered available data and information, herein set forth the grounds
for her determination that it is necessary to temporarily schedule
MDMB-4en-PINACA, 4F-MDMB-BUTICA, ADB-4en-PINACA, CUMYL-PEGACLONE, 5F-
EDMB-PICA, and MMB-FUBICA in schedule I of the CSA, and finds that
placement of these substances in schedule I of the CSA is necessary in
order to avoid an imminent hazard to the public's safety.
The temporary placement of MDMB-4en-PINACA, 4F-MDMB-BUTICA, ADB-
4en-PINACA, CUMYL-PEGACLONE, 5F-EDMB-PICA, and MMB-FUBICA in schedule I
of the CSA will take effect pursuant to a temporary scheduling order,
which will not be issued before May 4, 2023. Because the Administrator
hereby finds that it is necessary to temporarily place MDMB-4en-PINACA,
4F-MDMB-BUTICA, ADB-4en-PINACA, CUMYL-PEGACLONE, 5F-EDMB-PICA, and MMB-
FUBICA in schedule I to avoid an imminent hazard to the public safety,
the temporary order scheduling these substances will be effective on
the date the order is published in the Federal Register, and will be in
effect for a period of two years, with a possible extension of one
additional year, pending completion of the regular (permanent)
scheduling process.\13\ It is the intention of the Administrator to
issue a temporary scheduling order as soon as possible after the
expiration of 30 days from the date of publication of this document.
Upon publication of the temporary order, MDMB-4en-PINACA, 4F-MDMB-
BUTICA, ADB-4en-PINACA, CUMYL-PEGACLONE, 5F-EDMB-PICA, and MMB-FUBICA
will then be subject to the CSA's schedule I regulatory controls and
administrative, civil, and criminal sanctions applicable to the
manufacture, distribution, reverse distribution, importation,
exportation, research, conduct of instructional activities and chemical
analysis with, and possession. The CSA sets forth specific criteria for
scheduling a drug or other substance. Regular scheduling actions in
accordance with 21 U.S.C. 811(a) are subject to formal rulemaking
procedures done ``on the record after opportunity for a hearing''
conducted pursuant to the provisions of 5 U.S.C. 556 and 557. The
regular scheduling process of formal rulemaking affords interested
parties with appropriate process and the government with any additional
relevant information needed to make a determination. Final decisions
that conclude the regular scheduling process of formal rulemaking are
subject to judicial review. Temporary scheduling orders are not subject
to judicial review.\14\
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\13\ 21 U.S.C. 811(h)(1) and (2).
\14\ 21 U.S.C. 811(h)(6). This contrasts with permanent
scheduling actions which are subject to formal rulemaking procedures
done ``on the record after opportunity for a hearing,'' and final
decisions that conclude the scheduling process are subject to
judicial review. See 21 U.S.C. 811(a) and 877.
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Regulatory Analyses
The CSA provides for expedited temporary scheduling action where
such action is necessary to avoid an imminent hazard to the public
safety.\15\ As provided in 21 U.S.C. 811(h)(1), the Administrator (as
delegated by the Attorney General) may, by order, schedule a substance
in schedule I on a temporary basis. Such an order may not be issued
before the expiration of 30 days from: (1) The publication of a notice
in the Federal Register of the intent to issue such order and the
grounds upon which such order is to be issued, and (2) the date that
notice of the proposed temporary scheduling order is transmitted to the
Assistant Secretary for Health of HHS, as delegated by the Secretary of
HHS.
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\15\ 21 U.S.C. 811(h)(1).
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Inasmuch as this section directs that temporary scheduling actions
be issued by order and sets forth the procedures by which such orders
are to be issued, including the requirement of a publication in the
Federal Register of a notice of intent, the notice-and-comment
requirements of section 553 of the Administrative Procedure Act (APA),
5 U.S.C. 553, do not apply to this notice of intent. The APA expressly
differentiates between an order and a rule, as it defines an ``order''
to mean a ``final disposition, whether affirmative, negative,
injunctive, or declaratory in form, of an agency in a matter other than
rule making.'' \16\ The specific language chosen by Congress indicates
an intention for DEA to proceed through the issuance of an order
instead of proceeding by rulemaking when temporarily scheduling
substances. Given that Congress specifically requires the Administrator
to follow rulemaking procedures for other kinds of scheduling actions,
see 21 U.S.C. 811(a), it is noteworthy that, in 21 U.S.C. 811(h)(1),
Congress authorized the issuance of temporary scheduling actions by
order rather than by rule.
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\16\ 5 U.S.C. 551(6) (emphasis added).
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In the alternative, even assuming that this notice of intent might
be subject to section 553 of the APA, the Administrator finds that
there is good cause to forgo the notice-and-comment requirements of
section 553, as any further delays in the process for issuance of
temporary scheduling orders would be impracticable and contrary to the
public interest in view of the manifest urgency to avoid an imminent
hazard to the public safety.
Although DEA believes this notice of intent to issue a temporary
scheduling order is not subject to the notice-and-comment requirements
of section 553 of the APA, DEA notes that in accordance with 21 U.S.C.
811(h)(4), the Administrator took into consideration comments submitted
by the Assistant Secretary in response to the notice that DEA
transmitted to the Assistant Secretary pursuant to such subsection.
Further, DEA believes that this notice of intent is not a ``rule''
as defined by 5 U.S.C. 601(2), and, accordingly, is not subject to the
requirements of the Regulatory Flexibility Act. The requirements for
the preparation of an initial regulatory flexibility analysis in 5
U.S.C. 603(a) only apply when DEA is required, under 5 U.S.C. 553, to
issue a
[[Page 19901]]
notice of proposed rulemaking. As discussed above, DEA is issuing this
notice of intent pursuant to DEA's authority to issue a temporary
scheduling order. See 21 U.S.C. 811(h)(1). Therefore, because DEA
believes this temporary scheduling action is not a ``rule,'' DEA is not
subject to the requirements of the Regulatory Flexibility Act when
issuing this temporary action.
In accordance with the principles of Executive Orders (E.O.) 12866
and 13563, this notice of intent is not a significant regulatory
action. E.O. 12866 directs agencies to assess all costs and benefits of
available regulatory alternatives and, if regulation is necessary, to
select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health, and safety effects;
distributive impacts; and equity). E.O. 13563 is supplemental to and
reaffirms the principles, structures, and definitions governing
regulatory review as established in E.O. 12866. E.O. 12866 classifies a
``significant regulatory action,'' requiring review by the Office of
Management and Budget, as any regulatory action that is likely to
result in a rule that may: (1) Have an annual effect on the economy of
$100 million or more or adversely affect in a material way the economy;
a sector of the economy; productivity; competition; jobs; the
environment; public health or safety; or State, local, or tribal
governments or communities; (2) create a serious inconsistency or
otherwise interfere with an action taken or planned by another agency;
(3) materially alter the budgetary impact of entitlements, grants, user
fees, or loan programs, or the rights and obligations of recipients
thereof; or (4) raise novel legal or policy issues arising out of legal
mandates, the President's priorities, or the principles set forth in
the E.O. Because this is not a rulemaking action, this is not a
significant regulatory action as defined in Section 3(f) of E.O. 12866.
This action will 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. Therefore, in accordance with E.O. 13132, it is
determined that this action does not have sufficient federalism
implications to warrant the preparation of a federalism Assessment.
Signing Authority
This document of the Drug Enforcement Administration was signed on
March 29, 2023, by Administrator Anne Milgram. 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.
List of Subjects in 21 CFR Part 1308
Administrative practice and procedure, Drug Traffic control,
Reporting and Recordkeeping requirements.
For the reasons set out above, DEA proposes to amend 21 CFR part
1308 as follows:
PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES
0
1. The authority citation for 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 paragraphs (h)(57) through (62) to read as
follows:
Sec. 1308.11 Schedule I.
* * * * *
(h) * * *
(57) Methyl 3,3-dimethyl-2-(1-(pent-4-en-1-yl)-1H-indazole-3- 7090
carboxamido)butanoate, its optical and geometric isomers,
salts and salts of isomers (Other name: MDMB-4en-PINACA)......
(58) Methyl 2-[[1-(4-fluorobutyl)indole-3-carbonyl]amino]-3,3- 7091
dimethyl-butanoate, its optical and geometric isomers, salts
and salts of isomers (Other names: 4F-MDMB-BUTICA; 4F-MDMB-
BICA).........................................................
(59) N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(pent-4-en-1- 7092
yl)-1H-indazole-3-carboxamide, its optical and geometric
isomers, salts and salts of isomers (Other name: ADB-4en-
PINACA).......................................................
(60) 5-Pentyl-2-(2-phenylpropan-2-yl)pyrido[4,3-b]indol-1-one, 7093
its optical and geometric isomers, salts and salts of isomers
(Other names: CUMYL-PEGACLONE; SGT-151).......................
(61) Ethyl 2-[[1-(5-fluoropentyl)indole-3-carbonyl]amino]-3,3- 7094
dimethyl-butanoate, its optical and geometric isomers, salts
and salts of isomers (Other names: 5F-EDMB-PICA; 5F-EDMB-2201)
(62) Methyl 2-(1-(4-fluorobenzyl)-1H-indole-3-carboxamido)-3- 7095
methyl butanoate, its optical and geometric isomers, salts and
salts of isomers (Other name: MMB-FUBICA).....................
* * * * *
Heather Achbach,
Federal Register Liaison Officer, Drug Enforcement Administration.
[FR Doc. 2023-06893 Filed 4-3-23; 8:45 am]
BILLING CODE 4410-09-P
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</html>Indexed from Federal Register on April 4, 2023.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.