Rule2023-27243
Schedules of Controlled Substances: Temporary Placement of MDMB-4en-PINACA, 4F-MDMB-BUTICA, ADB-4en-PINACA, CUMYL-PEGACLONE, 5F-EDMB-PICA, and MMB-FUBICA into Schedule I
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
December 12, 2023
Effective
December 12, 2023
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
The Administrator of the Drug Enforcement Administration is issuing this 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. This action is based on a finding by the Administrator that the placement of these six substances in schedule I is necessary to avoid imminent hazard to the public safety. As a result of this order, 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
<html>
<head>
<title>Federal Register, Volume 88 Issue 237 (Tuesday, December 12, 2023)</title>
</head>
<body><pre>
[Federal Register Volume 88, Number 237 (Tuesday, December 12, 2023)]
[Rules and Regulations]
[Pages 86040-86046]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-27243]
=======================================================================
-----------------------------------------------------------------------
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 into Schedule I
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Temporary amendment; temporary scheduling order.
-----------------------------------------------------------------------
SUMMARY: The Administrator of the Drug Enforcement Administration is
issuing this 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. This action is based on
a finding by the Administrator that the placement of these six
substances in schedule I is necessary to avoid imminent hazard to the
public safety. As a result of this order, 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 temporary scheduling order is effective December 12, 2023,
until December 12, 2025. If this order is extended or made permanent,
the DEA will publish a document in the Federal Register.
FOR FURTHER INFORMATION CONTACT: Terrence L. Boos, Ph.D., Drug and
Chemical Evaluation Section, Diversion Control Division, Drug
Enforcement Administration; Mailing Address: 8701 Morrissette Drive,
Springfield, Virginia 22152; Telephone: (571) 362-3249.
SUPPLEMENTARY INFORMATION: The Drug Enforcement Administration (DEA)
issues a temporary scheduling order \1\ (in the form of a temporary
amendment) to add the following six substances, including their optical
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\ Though DEA has used the term ``final order'' with respect to
temporary scheduling orders in the past, this order adheres to the
statutory language of 21 U.S.C. 811(h), which refers to a
``temporary scheduling order.'' No substantive change is intended.
---------------------------------------------------------------------------
<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), and
<bullet> Methyl 2-(1-(4-fluorobenzyl)-1H-indole-3-carboxamido)-3-
methyl butanoate (Other name: MMB-FUBICA).
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
the Administrator 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\
---------------------------------------------------------------------------
\2\ 21 U.S.C. 811(h)(1).
\3\ 21 U.S.C. 811(h)(2).
---------------------------------------------------------------------------
[[Page 86041]]
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.\4\
---------------------------------------------------------------------------
\4\ 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).\5\ The Administrator transmitted the
required notice to the Assistant Secretary for Health of HHS (Assistant
Secretary),\6\ 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 (FDA), 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, and 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.
---------------------------------------------------------------------------
\5\ 21 U.S.C. 811(h)(4).
\6\ 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.
---------------------------------------------------------------------------
DEA has taken into consideration the Assistant Secretary's comments
as required by subsection 811(h)(4). DEA has found that the control of
these six synthetic cannabinoids (SCs) in schedule I on a temporary
basis is necessary to avoid an imminent hazard to the public safety.
MDMB-4en-PINACA, 4F-MDMB-BUTICA, ADB-4en-PINACA, CUMYL-PEGACLONE, 5F-
EDMB-PICA, and 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.
As required by 21 U.S.C. 811(h)(1)(A), DEA published a notice of
intent (NOI) to temporarily schedule MDMB-4en-PINACA, 4F-MDMB-BUTICA,
ADB-4en-PINACA, CUMYL-PEGACLONE, 5F-EDMB-PICA, and MMB-FUBICA on April
4, 2023.\7\ That NOI discussed findings from DEA's three-factor
analysis dated April 2023, which DEA made available on
<a href="http://www.regulations.gov">www.regulations.gov</a>.
---------------------------------------------------------------------------
\7\ 88 FR 19896.
---------------------------------------------------------------------------
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. Consideration of these factors includes
any information indicating actual abuse, diversion from legitimate
channels, and clandestine importation, manufacture, or distribution of
these substances.\8\
---------------------------------------------------------------------------
\8\ 21 U.S.C. 811(h)(3).
---------------------------------------------------------------------------
Substances meeting the statutory requirements for temporary
scheduling may only be placed in schedule I.\9\ Substances in schedule
I have high potential for abuse, no currently accepted medical use in
treatment in the United States, and no accepted safety for use under
medical supervision.\10\
---------------------------------------------------------------------------
\9\ 21 U.S.C. 811(h)(1).
\10\ 21 U.S.C. 812(b)(1).
---------------------------------------------------------------------------
The DEA's three-factor analysis and the Assistant Secretary's March
7, 2022, letter are available in their entirety under the tab
``Supporting Documents'' of the public docket of this action at
<a href="http://www.regulations.gov">www.regulations.gov</a>.
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 U.S.
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.\11\ 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 in DEA's three-factor
analysis). 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.
---------------------------------------------------------------------------
\11\ 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.
---------------------------------------------------------------------------
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.\12\ Emergency department 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
[[Page 86042]]
those produced by other schedule I SCs (e.g., JWH-018, AB-FUBINACA).
---------------------------------------------------------------------------
\12\ 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).
---------------------------------------------------------------------------
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 the substance's 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.\13\ 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 Factor 6 in DEA's three-factor
analysis).
---------------------------------------------------------------------------
\13\ <a href="https://aapcc.org/track/synthetic-cannabinoids">https://aapcc.org/track/synthetic-cannabinoids</a>.
---------------------------------------------------------------------------
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 evidence 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
[[Page 86043]]
(NFLIS),\14\ along with additional data, may be found in DEA's three-
factor analysis. According to NFLIS data,\15\ state and local forensic
laboratories have detected the following information about the SCs in
question:
---------------------------------------------------------------------------
\14\ 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.
\15\ At the time of query (March 16, 2022), 2021 and 2022 data
were still reporting.
---------------------------------------------------------------------------
<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
Factors 5 and 6 in DEA's 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.
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.
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,
Massachusetts, 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 phencyclidine (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 Factor
6 in DEA's 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/or abuse of
MDMB-4en-PINACA, 4F-MDMB-BUTICA, ADB-4en-PINACA, CUMYL-PEGACLONE, 5F-
EDMB-PICA, and MMB-FUBICA 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.
[[Page 86044]]
As required by 21 U.S.C. 811(h)(4), the Administrator transmitted
to the Assistant Secretary for Health, via a letter dated January 24,
2022, notice of her intent to place MDMB-4en-PINACA, 4F-MDMB-BUTICA,
ADB-4en-PINACA, CUMYL-PEGACLONE, 5F-EDMB-PICA, and MMB-FUBICA in
schedule I on a temporary basis. HHS had no objection to the temporary
placement of these substances in schedule I.
DEA subsequently published a NOI in the Federal Register on April
4, 2023.\16\
---------------------------------------------------------------------------
\16\ 88 FR 19896.
---------------------------------------------------------------------------
Conclusion
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 place 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 safety.
This temporary order scheduling these substances will be effective
on the date the order is published in the Federal Register and remain
in effect for two years, with a possible extension of one year, pending
completion of the regular (permanent) scheduling process.\17\
---------------------------------------------------------------------------
\17\ 21 U.S.C. 811(h)(1) and (2).
---------------------------------------------------------------------------
The CSA sets forth specific criteria for scheduling a drug or other
substance. Permanent 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.\18\ The permanent 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.\19\
Temporary scheduling orders are not subject to judicial review.\20\
---------------------------------------------------------------------------
\18\ 21 U.S.C. 811.
\19\ 21 U.S.C. 877.
\20\ 21 U.S.C. 811(h)(6).
---------------------------------------------------------------------------
Requirements for Handling
Upon the effective date of this temporary order, MDMB-4en-PINACA,
4F-MDMB-BUTICA, ADB-4en-PINACA, CUMYL-PEGACLONE, 5F-EDMB-PICA, and MMB-
FUBICA will be subject to the regulatory controls and administrative,
civil, and criminal sanctions applicable to the manufacture,
distribution, reverse distribution, importation, exportation,
engagement in research, and conduct of instructional activities or
chemical analysis with, and possession of schedule I controlled
substances, including the following:
1. Registration. Any person who handles (possesses, manufactures,
distributes, reverse distributes, imports, exports, engages in
research, or conducts instructional activities or chemical analysis
with), or desires to handle, MDMB-4en-PINACA, 4F-MDMB-BUTICA, ADB-4en-
PINACA, CUMYL-PEGACLONE, 5F-EDMB-PICA, or MMB-FUBICA must be registered
with the DEA to conduct such activities pursuant to 21 U.S.C. 822, 823,
957, and 958, and in accordance with 21 CFR parts 1301 and 1312, as of
December 12, 2023. Any person who currently handles MDMB-4en-PINACA,
4F-MDMB-BUTICA, ADB-4en-PINACA, CUMYL-PEGACLONE, 5F-EDMB-PICA, or MMB-
FUBICA, and is not registered with the DEA, must submit an application
for registration and may not continue to handle MDMB-4en-PINACA, 4F-
MDMB-BUTICA, ADB-4en-PINACA, CUMYL-PEGACLONE, 5F-EDMB-PICA, and MMB-
FUBICA as of December 12, 2023, unless the DEA has approved that
application for registration pursuant to 21 U.S.C. 822, 823, 957, and
958, and in accordance with 21 CFR parts 1301 and 1312. Retail sales of
schedule I controlled substances to the general public are not allowed
under the CSA. Possession of any quantity of these substances in a
manner not authorized by the CSA on or after December 12, 2023 is
unlawful and those in possession of any quantity of these substances
may be subject to prosecution pursuant to the CSA.
2. Disposal of stocks. Any person who does not desire or is not
able to obtain a schedule I registration to handle MDMB-4en-PINACA, 4F-
MDMB-BUTICA, ADB-4en-PINACA, CUMYL-PEGACLONE, 5F-EDMB-PICA, or MMB-
FUBICA must surrender all currently held quantities of these six
substances.
3. Security. MDMB-4en-PINACA, 4F-MDMB-BUTICA, ADB-4en-PINACA,
CUMYL-PEGACLONE, 5F-EDMB-PICA, and MMB-FUBICA are subject to schedule I
security requirements and must be handled in accordance with 21 CFR
1301.71-1301.93, as of December 12, 2023.
4. Labeling and Packaging. All labels, labeling, and packaging for
commercial containers of MDMB-4en-PINACA, 4F-MDMB-BUTICA, ADB-4en-
PINACA, CUMYL-PEGACLONE, 5F-EDMB-PICA, and MMB-FUBICA must comply with
21 U.S.C. 825 and 958(e), and 21 CFR part 1302. Current DEA registrants
shall have 30 calendar days from December 12, 2023 to comply with all
labeling and packaging requirements.
5. Inventory. Every DEA registrant who possesses any quantity of
MDMB-4en-PINACA, 4F-MDMB-BUTICA, ADB-4en-PINACA, CUMYL-PEGACLONE, 5F-
EDMB-PICA, and MMB-FUBICA on the effective date of this order must take
an inventory of all stocks of these substances on hand pursuant to 21
U.S.C. 827 and 958, and in accordance with 21 CFR 1304.03, 1304.04, and
1304.11. Current DEA registrants will have 30 calendar days from the
effective date of this order to be in compliance with all inventory
requirements. After the initial inventory, every DEA registrant must
take an inventory of all controlled substances (including MDMB-4en-
PINACA, 4F-MDMB-BUTICA, ADB-4en-PINACA, CUMYL-PEGACLONE, 5F-EDMB-PICA,
and MMB-FUBICA) on hand on a biennial basis pursuant to 21 U.S.C. 827
and 958, and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11.
6. Records. All DEA registrants must maintain records with respect
to MDMB-4en-PINACA, 4F-MDMB-BUTICA, ADB-4en-PINACA, CUMYL-PEGACLONE,
5F-EDMB-PICA, and MMB-FUBICA pursuant to 21 U.S.C. 827 and 958(e), and
in accordance with 21 CFR parts 1304, 1312, 1317 and section 1307.11.
Current DEA registrants authorized to handle these six substances shall
have 30 calendar days from the effective date of this order to be in
compliance with all recordkeeping requirements.
7. Reports. All DEA registrants must submit reports with respect to
MDMB-4en-PINACA, 4F-MDMB-BUTICA, ADB-4en-PINACA, CUMYL-PEGACLONE, 5F-
EDMB-PICA, and MMB-FUBICA pursuant to 21 U.S.C. 827, and in accordance
with 21 CFR 1304, 1312, and 1317, and sections 1301.74(c) and
1301.76(b), as of December 12, 2023. Manufacturers and distributors
must also submit reports regarding these six substances to the
Automation of Reports and Consolidated Order System pursuant to 21
U.S.C. 827 and in accordance with 21 CFR parts 1304 and 1312.
8. Order Forms. All DEA registrants who distribute MDMB-4en-PINACA,
4F-MDMB-BUTICA, ADB-4en-PINACA, CUMYL-PEGACLONE, 5F-EDMB-PICA, and MMB-
FUBICA must
[[Page 86045]]
comply with order form requirements pursuant to 21 U.S.C. 828 and in
accordance with 21 CFR part 1305 as of December 12, 2023.
9. Importation and Exportation. All importation and exportation of
MDMB-4en-PINACA, 4F-MDMB-BUTICA, ADB-4en-PINACA, CUMYL-PEGACLONE, 5F-
EDMB-PICA, and MMB-FUBICA must be in compliance with 21 U.S.C. 952,
953, 957, and 958, and in accordance with 21 CFR part 1312 as of
December 12, 2023.
10. Quota. Only DEA registered manufacturers may manufacture MDMB-
4en-PINACA, 4F-MDMB-BUTICA, ADB-4en-PINACA, CUMYL-PEGACLONE, 5F-EDMB-
PICA, and MMB-FUBICA in accordance with a quota assigned pursuant to 21
U.S.C. 826, and in accordance with 21 CFR part 1303, as of December 12,
2023.
11. Liability. Any activity involving MDMB-4en-PINACA, 4F-MDMB-
BUTICA, ADB-4en-PINACA, CUMYL-PEGACLONE, 5F-EDMB-PICA, and MMB-FUBICA
not authorized by, or in violation of the CSA, occurring as of December
12, 2023, is unlawful and may subject the person to administrative,
civil, and/or criminal sanctions.
Regulatory Matters
The CSA provides for expedited temporary scheduling actions where
necessary to avoid imminent hazards to the public safety. Under 21
U.S.C. 811(h), the Administrator, as delegated by the Attorney General,
may, by order, temporarily schedule substances in schedule I. Such
orders 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.\21\
---------------------------------------------------------------------------
\21\ 21 U.S.C. 811(h)(1).
---------------------------------------------------------------------------
Inasmuch as section 811(h) directs that temporary scheduling
actions be issued by order (as distinct from a rule) and sets forth the
procedures by which such orders are to be issued, including the
requirement to publish in the Federal Register a notice of intent, the
notice-and-comment requirements of section 553 of the Administrative
Procedure Act (APA), 5 U.S.C. 553, which are applicable to rulemaking,
do not apply to this temporary scheduling order. The APA expressly
differentiates between orders and rules, 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.'' \22\ The specific language chosen by Congress indicates its
intent that DEA issue orders instead of proceeding by rulemaking when
temporarily scheduling substances. Given that Congress specifically
requires the Administrator (as delegated by the Attorney General) to
follow rulemaking procedures for other kinds of scheduling actions, see
21 U.S.C. 811(a), it is noteworthy that, in section 811(h), Congress
authorized the issuance of temporary scheduling actions by order rather
than by rule.
---------------------------------------------------------------------------
\22\ 5 U.S.C. 551(6) (emphasis added).
---------------------------------------------------------------------------
Alternatively, even if this action was subject to section 553 of
the APA, the Administrator finds that there is good cause to forgo its
notice-and-comment requirements, as any further delays in the process
for issuing temporary scheduling orders would be impracticable and
contrary to the public interest given the manifest urgency to avoid
imminent hazards to public safety.
Although DEA believes this 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 notices that DEA transmitted to
the Assistant Secretary pursuant to such subsection.
Further, DEA believes that this temporary scheduling action 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) are not applicable where, as here, DEA is
not required by section 553 of the APA or any other law to publish a
general notice of proposed rulemaking.
In accordance with the principles of Executive Orders (E.O.) 12866,
13563, and 14094, this action 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, sec. 3(f),
as amended by E.O. 14094, sec. 1(b), provides the definition of a
``significant regulatory action,'' requiring review by the Office of
Management and Budget. 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
(Federalism), 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
December 7, 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.
Scott Brinks,
Federal Register Liaison Officer, Drug Enforcement Administration.
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, the DEA amends 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)(62) to (h)(67) to read as
follows:
Sec. 1308.11 Schedule I
* * * * *
(h) * * *
[[Page 86046]]
* * * * * * *
(62) 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)......
(63) 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).........................................................
(64) 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).......................................................
(65) 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).......................
(66) 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)
(67) 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).....................
[FR Doc. 2023-27243 Filed 12-11-23; 8:45 am]
BILLING CODE 4410-09-P
</pre></body>
</html>Indexed from Federal Register on December 12, 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.