[Federal Register Volume 84, Number 138 (Thursday, July 18, 2019)]
[Rules and Regulations]
[Pages 34291-34297]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-15184]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-495]
Schedules of Controlled Substances: Temporary Placement of N-
Ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-Chloro-[alpha]-
PVP in Schedule I
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Temporary amendment; temporary scheduling order.
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SUMMARY: The Acting Administrator of the Drug Enforcement
Administration (DEA) is issuing this temporary scheduling order to
schedule the synthetic cathinones, N-ethylhexedrone (2-(ethylamino)-1-
phenylhexan-1-one); alpha-pyrrolidinohexanophenone (1-phenyl-2-
(pyrrolidin-1-yl)hexan-1-one; alpha-pyrrolidinohexiophenone; trivial
name: [alpha]-PHP); 4-methyl-alpha-ethylaminopentiophenone (2-
(ethylamino)-1-(4-methylphenyl)pentan-1-one; trivial name: 4-MEAP); 4'-
methyl-alpha-pyrrolidinohexiophenone (1-(4-methylphenyl)-2-(pyrrolidin-
1-yl)hexan-1-one; 4'-methyl-alpha-pyrrolidinohexanophenone; trivial
name: MPHP); alpha-pyrrolidinoheptaphenone (1-phenyl-2-(pyrrolidin-1-
yl)heptan-1-one; trivial name: PV8); and 4'-chloro-alpha-
pyrrolidinovalerophenone (1-(4-chlorophenyl)-2-(pyrrolidin-1-yl)pentan-
1-one; 4'-chloro-alpha-pyrrolidinopentiophenone; trivial name: 4-
chloro-[alpha]-PVP), and their optical, positional, and geometric
isomers, salts, and salts of isomers in schedule I. This action is
based on a finding by the Acting Administrator that the placement of
these synthetic cathinones in schedule I of the Controlled Substances
Act is necessary to avoid an 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 will be imposed on persons who handle (manufacture,
distribute, reverse distribute, possess, import, export, research, or
conduct instructional activities or chemical analysis), or propose to
handle, N-ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-
[alpha]-PVP.
DATES: This temporary scheduling order is effective July 18, 2019,
until July 18, 2021. If this order is extended or made permanent, the
DEA will publish a document in the Federal Register.
[[Page 34292]]
FOR FURTHER INFORMATION CONTACT: Scott A. Brinks, Regulatory Drafting
and Policy Support Section (DPW), Diversion Control Division, Drug
Enforcement Administration; Mailing Address: 8701 Morrissette Drive,
Springfield, Virginia 22152; Telephone: (202) 598-6812.
SUPPLEMENTARY INFORMATION:
Legal Authority
Section 201 of the Controlled Substances Act (CSA), 21 U.S.C. 811,
provides the Attorney General 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. 21 U.S.C.
811(h)(1). In addition, if proceedings to control a substance
permanently are initiated under 21 U.S.C. 811(a)(1) while the substance
is temporarily controlled under section 811(h), the Attorney General
may extend the temporary scheduling \1\ for up to one year. 21 U.S.C.
811(h)(2).
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\1\ Though DEA has used the term ``final order'' with respect to
temporary scheduling orders in the past, this document adheres to
the statutory language of 21 U.S.C. 811(h), which refers to a
``temporary scheduling order.'' No substantive change is intended.
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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
section 202 of the CSA, 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 (FDCA), 21 U.S.C. 355. 21 U.S.C.
811(h)(1); 21 CFR part 1308. The Attorney General has delegated
scheduling authority under 21 U.S.C. 811 to the Administrator of the
DEA. 28 CFR 0.100.
Background
Section 201(h)(4) of the CSA, 21 U.S.C. 811(h)(4), requires the
Administrator to notify the Secretary of the Department of Health and
Human Services (HHS) of his intention to temporarily place a substance
in schedule I of the CSA.\2\ The Acting Administrator transmitted
notice of his intent to place N-ethylhexedrone; alpha-
pyrrolidinohexanophenone ([alpha]-PHP); 4-methyl-alpha-
ethylaminopentiophenone (4-MEAP); 4'-methyl-alpha-
pyrrolidinohexiophenone (MPHP); alpha-pyrrolidinoheptaphenone (PV8);
and 4-chloro-alpha-pyrrolidinovalerophenone (4-chloro-[alpha]-PVP) in
schedule I on a temporary basis to the Assistant Secretary for Health
of HHS by letter dated March 9, 2018. The Assistant Secretary responded
to this notice of intent by letter dated March 27, 2018, and advised
that based on a review by the Food and Drug Administration (FDA), there
were currently no approved new drug applications or active
investigational new drug applications for N-ethylhexedrone, [alpha]-
PHP, 4-MEAP, MPHP, PV8, and 4-chloro-[alpha]-PVP. The Assistant
Secretary also stated that the HHS had no objection to the temporary
placement of N-ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-
chloro-[alpha]-PVP in schedule I of the CSA.
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\2\ As discussed in a memorandum of understanding entered into
by the Food and Drug Administration (FDA) and the National Institute
on Drug Abuse (NIDA), the FDA acts as the lead agency within the HHS
in carrying out the Secretary's scheduling responsibilities under
the CSA, with the concurrence of NIDA. 50 FR 9518, Mar. 8, 1985. The
Secretary of the HHS has delegated to the Assistant Secretary for
Health of the HHS the authority to make domestic drug scheduling
recommendations. 58 FR 35460, July 1, 1993.
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The DEA has taken into consideration the Assistant Secretary's
comments as required by 21 U.S.C. 811(h)(4). N-Ethylhexedrone, [alpha]-
PHP, 4-MEAP, MPHP, PV8, and 4-chloro-[alpha]-PVP are not currently
listed in any schedule under the CSA, and no exemptions or approvals
are in effect for N-ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, and
4-chloro-[alpha]-PVP under section 505 of the FDCA, 21 U.S.C. 355. The
DEA has found that the control of N-ethylhexedrone (2-(ethylamino)-1-
phenylhexan-1-one); alpha-pyrrolidinohexanophenone (1-phenyl-2-
(pyrrolidin-1-yl)hexan-1-one; alpha-pyrrolidinohexiophenone; trivial
name: [alpha]-PHP); 4-methyl-alpha-ethylaminopentiophenone (2-
(ethylamino)-1-(4-methylphenyl)pentan-1-one; trivial name: 4-MEAP); 4'-
methyl-alpha-pyrrolidinohexiophenone (1-(4-methylphenyl)-2-(pyrrolidin-
1-yl)hexan-1-one; 4'-methyl-alpha-pyrrolidinohexanophenone; trivial
name: MPHP); alpha-pyrrolidinoheptaphenone (1-phenyl-2-(pyrrolidin-1-
yl)heptan-1-one; trivial name: PV8); and 4'-chloro-alpha-
pyrrolidinovalerophenone (1-(4-chlorophenyl)-2-(pyrrolidin-1-yl)pentan-
1-one; 4'-chloro-alpha-pyrrolidinopentiophenone; trivial name: 4-
chloro-[alpha]-PVP) in schedule I on a temporary basis is necessary to
avoid an imminent hazard to the public safety.
As required by 21 U.S.C. 811(h)(1)(A), DEA published a notice of
intent to temporarily schedule N-ethylhexedrone, [alpha]-PHP, 4-MEAP,
MPHP, PV8, and 4-chloro-[alpha]-PVP in the Federal Register on May 1,
2019 (84 FR 18423). That notice of intent identified the six substances
using the common names; however, in the three-factor analysis, which
DEA made available on www.regulations.gov contemporaneously with the
publication of the notice of intent, these same substances were
identified using the International Union of Pure and Applied Chemistry
(IUPAC) nomenclature. This temporary scheduling order provides the
common names, as well as the IUPAC names, for all six substances.
To find that placing a substance temporarily in schedule I of the
CSA is necessary to avoid an imminent hazard to the public safety, the
Administrator is required to 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. 21 U.S.C. 811(h)(3).
Consideration of these factors includes actual abuse, diversion from
legitimate channels, and clandestine importation, manufacture, or
distribution. 21 U.S.C. 811(h)(3).
A substance meeting the statutory requirements for temporary
scheduling may only be placed in schedule I. 21 U.S.C. 811(h)(1).
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. 21 U.S.C. 812(b)(1).
Available data and information for N-ethylhexedrone, [alpha]-PHP,
4-MEAP, MPHP, PV8, and 4-chloro-[alpha]-PVP, summarized below, indicate
that these synthetic cathinones 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. The DEA's
three-factor analysis and the Assistant Secretary's March 27, 2018
letter are available in their entirety under the tab ``Supporting
Documents'' of the public docket of this action at www.regulations.gov.
Synthetic Cathinones
Novel synthetic cathinones that mimic the biological effects of
substances with stimulant-like effects continue to emerge in the
illicit drug market. These novel cathinones, also known as designer
drugs, are structurally similar to several drugs of abuse such as
schedule I synthetic cathinones (e.g., methcathinone, mephedrone,
methylone, pentylone, and 3,4-methylenedioxypyrovalerone (MDPV)). The
illicit use of synthetic cathinones has continued throughout the United
States, resulting in severe adverse effects, overdoses, and deaths.
Indeed, hospital reports, scientific
[[Page 34293]]
publications, and/or law enforcement reports demonstrate that these
types of substances are being abused for their psychoactive properties
and they cause harm (see DEA 3-Factor Analysis). Recreational effects
reported by abusers of synthetic cathinones include: Euphoria, sense of
well-being, increased sociability, energy, empathy, increased
alertness, improved concentration and focus. Adverse effects such as
tachycardia, hypertension, rhabdomyolysis, hyponatremia, seizures, and
altered mental status (paranoia, hallucinations, and delusions) have
also been reported from the abuse of synthetic cathinones.
Consequently, there are documented reports of emergency room admissions
and deaths associated with the abuse of synthetic cathinone substances.
With several generations of synthetic cathinones having been
encountered since 2009, the abuse of N-ethylhexedrone, [alpha]-PHP, 4-
MEAP, MPHP, PV8, and 4-chloro-[alpha]-PVP is impacting or will
negatively impact communities.
Law enforcement data indicate that N-ethylhexedrone, [alpha]-PHP,
4-MEAP, MPHP, PV8, and 4-chloro-[alpha]-PVP have appeared in the United
States' illicit drug market (see DEA 3-Factor Analysis). Law
enforcement encounters include those reported to the National Forensic
Laboratory Information System (NFLIS), a DEA sponsored program that
systematically collects drug identification results and associated
information from drug cases analyzed by Federal, State, and local
forensic laboratories. From January 2012 to September 24, 2018, NFLIS
registered 1,131 drug exhibits pertaining to the trafficking,
distribution and abuse of N-ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP,
PV8, and 4-chloro-[alpha]-PVP. These exhibits had a net weight of
approximately 18.7 kilograms \3\ and were encountered in powder,
crystal, rock, resin, capsule and tablet forms.
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\3\ Not all exhibits had weights recorded in the NFLIS database.
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As observed by the DEA and by the United States Customs and Border
Protection (CBP), synthetic cathinones originate from foreign sources,
such as China. Bulk powder substances 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. There have been encounters of N-ethylhexedrone, [alpha]-PHP,
4-MEAP, MPHP, PV8, and 4-chloro-[alpha]-PVP by the CBP (see DEA 3-
Factor Analysis).
N-Ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-
[alpha]-PVP have no accepted medical use in the United States. N-
Ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-[alpha]-
PVP have been seized by law enforcement in the United States. The
misuse of [alpha]-PHP, 4-MEAP, MPHP, and PV8 has been reported to
result in adverse effects in humans in the United States. Although no
overdose information is currently available for N-ethylhexedrone and 4-
chloro-[alpha]-PVP, law enforcement seizures of these two substances
and their pharmacological similarity to currently controlled schedule I
synthetic cathinones (e.g., methcathinone, mephedrone, methylone,
pentylone, MDPV) suggest that these two synthetic cathinones are likely
to produce adverse effects similar to those produced by other synthetic
cathinones.
N-Ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-
[alpha]-PVP are synthetic cathinones that have pharmacological effects
similar to schedule I synthetic cathinone substances such as
methcathinone, mephedrone, methylone, pentylone, and MDPV and schedule
II stimulants such as methamphetamine and cocaine. The misuse of
[alpha]-PHP, 4-MEAP, MPHP, and PV8 has been associated with one or more
overdoses with some requiring emergency medical intervention in the
United States. With no approved medical use and limited safety or
toxicological information, N-ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP,
PV8, and 4-chloro-[alpha]-PVP have emerged on the designer drug market,
and the abuse or trafficking of these substances for their psychoactive
properties is concerning.
Factor 4. History and Current Pattern of Abuse
N-Ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-
[alpha]-PVP are synthetic cathinones that have been identified in the
United States' illicit drug market. Evidence indicates that these
substances are being substituted for schedule I synthetic cathinones.
Products containing synthetic cathinones have been falsely marketed as
``research chemicals,'' ``jewelry cleaner,'' ``stain remover,'' ``plant
food or fertilizer,'' ``insect repellants,'' or ``bath salts.'' They
have been sold at smoke shops, head shops, convenience stores, adult
bookstores, and gas stations. They can also be purchased on the
internet. These substances are commonly encountered in the form of
powders, crystals, tablets, and capsules. Other encountered forms
include resin, rock, liquid, and deposits on plant matter. Law
enforcement has encountered N-ethylhexedrone, [alpha]-PHP, 4-MEAP,
MPHP, PV8, and 4-chloro-[alpha]-PVP in powder, crystal, resin, rock,
capsule, or tablet forms. The packages of these commercial products
usually contain the warning ``not for human consumption,'' most likely
in an effort to circumvent statutory restrictions for these substances.
N-Ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-
[alpha]-PVP are likely to be abused in the same manner as schedule I
synthetic cathinones such as methcathinone, mephedrone, methylone,
pentylone, and MDPV. Information from published scientific studies
indicate that the most common routes of administration for synthetic
cathinones are nasal insufflation by snorting the powder and ingestion
by swallowing capsules or tablets. The powder can also be injected or
swallowed. Other methods of intake include rectal administration,
ingestion by ``bombing'' (wrapping a dose of powder in a paper wrap and
swallowing) and intramuscular injection.
Based upon the information collected from case reports, medical
journals, and scientific publications including survey data, the main
users of synthetic cathinones are youths and young adults. Given that
N-ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-[alpha]-
PVP are newly emerging synthetic cathinones, it is likely that these
substances will be used by the same population. This is consistent with
data collected from the use of schedule I synthetic cathinones (e.g.,
mephedrone, methylone, pentylone, MDPV). According to Monitoring the
Future (MTF) survey data,\4\ the 2017 annual prevalence rate of
synthetic cathinone use was 0.6% for high school seniors and 0.3% for
young adults (19--30 years). However, there was an 18 percentage point
increase in the perceived risk of trying ``bath salts'' in young adults
(aged 19--26 years).
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\4\ Monitoring the Future (MTF) is a research program conducted
at the University of Michigan's Institute for Social Research under
grants from NIDA. MTF tracks drug use trends among United States
adolescents in the 8th, 10th, and 12th grades and high school
graduates into adulthood by conducting national surveys.
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N-Ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-
[alpha]-PVP are likely to have duration of effects similar to those of
schedule I synthetic cathinones because of their structural and
pharmacological similarities. Users report (drug surveys, scientific
and medical literature, etc.) that the effects of synthetic cathinones
occur a few
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minutes to 15 minutes after administration, depending on the synthetic
cathinone and the route of administration (oral, insufflation,
intravenous, etc.), and can last up to three hours.
Evidence indicated that N-ethylhexedrone, [alpha]-PHP, 4-MEAP,
MPHP, PV8, and 4-chloro-[alpha]-PVP are ingested with other substances.
This is likely to either heighten the effects or ameliorate the come-
down effects of the synthetic cathinones. Co-ingestions can be from the
ingestion of multiple products separately or a single product that is
composed of multiple substances (e.g., one tablet containing N-
ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, 4-chloro-[alpha]-PVP,
and other illicit substances). Indeed, law enforcement routinely
encounters synthetic cathinone mixtures. Substances found in
combination with N-ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, or
4-chloro-[alpha]-PVP are: Other synthetic cathinones (e.g., MDPV, 4-
chloromethcathinone, N-ethylpentylone, [alpha]-PVP), common cutting
agents (e.g., caffeine), or other substances of abuse (e.g.,
methamphetamine, fentanyl, fentanyl analogues, carfentanil,
benzodiazepines (e.g., alprazolam), heroin, cocaine, synthetic
cannabinoids, fluoroamphetamine, MDMA). Multiple drug use and potential
co-ingestions are confirmed by forensic analysis of seized and
purchased synthetic cathinone products.
Factor 5. Scope, Duration and Significance of Abuse
Since 2009, the popularity of synthetic cathinones and their
associated products has continued, as evidenced by law enforcement
seizures, public health information, and media reports. As one
synthetic cathinone is controlled, another unscheduled synthetic
cathinone appears in the recreational drug market. N-Ethylhexedrone,
[alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-[alpha]-PVP are synthetic
cathinones that have been identified in the United States' illicit drug
market (see DEA 3-Factor Analysis for a full discussion).
Law enforcement data indicate that N-ethylhexedrone, [alpha]-PHP,
4-MEAP, MPHP, PV8, and 4-chloro-[alpha]-PVP are being abused in the
United States as recreational drugs. While law enforcement data are not
direct evidence of abuse, the data can infer that a drug has been
diverted and abused.\5\ Forensic laboratories have confirmed the
presence of these substances in drug exhibits received from state,
local, and federal law enforcement agencies. From January 2012 to
September 24, 2018, there were 1,131 exhibits reported to NFLIS
databases (Federal, State and local forensic laboratories) pertaining
to the trafficking, distribution and abuse of N-ethylhexedrone,
[alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-[alpha]-PVP. These
exhibits had a net weight of approximately 18.7 kilograms.\6\ These
data also indicated that the abuse of N-ethylhexedrone, [alpha]-PHP, 4-
MEAP, MPHP, PV8, and 4-chloro-[alpha]-PVP is widespread and has been
encountered in many states since 2012 in the United States.
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\5\ See 76 FR 77330, 77332, Dec. 12, 2011.
\6\ Not all exhibits had weights recorded in the NFLIS database.
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The following information details data obtained from the NFLIS
database (queried on September 24, 2018), including dates of first
encounter, exhibits/reports, and locations.
N-Ethylhexedrone: NFLIS--233 reports, first encountered in August
2016, locations include: Arizona, Florida, Georgia, Illinois, Indiana,
Kansas, Kentucky, Louisiana, Michigan, Minnesota, Mississippi,
Missouri, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, South
Carolina, Tennessee, Texas, Virginia, and Wyoming.
[alpha]-PHP: NFLIS--395 reports, first encountered in May 2014,
locations include: Arkansas, California, Colorado, Florida, Georgia,
Idaho, Illinois, Indiana, Iowa, Kentucky, Maine, Massachusetts,
Michigan, Minnesota, Missouri, New Hampshire, New Jersey, New York,
Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee,
Texas, Utah, Virginia, Wisconsin, and Wyoming.
4-MEAP: NFLIS--105 reports, first encountered in August 2013,
locations include: Alabama, Arkansas, California, Colorado,
Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana,
Maryland, Minnesota, New Hampshire, New York, Ohio, Oklahoma, Oregon,
Pennsylvania, Tennessee, and Texas.
MPHP: NFLIS--71 reports, first encountered in June 2012, locations
include: California, Connecticut, Florida, Georgia, Indiana, Kansas,
Kentucky, Maine, Minnesota, Missouri, Nebraska, Nevada, New Jersey,
Ohio, Pennsylvania, and Texas.
PV8: NFLIS--166 reports, first encountered in December 2013,
locations include: Arizona, Connecticut, District of Columbia, Florida,
Georgia, Idaho, Indiana, Iowa, Kentucky, Louisiana, Maine,
Massachusetts, Minnesota, Missouri, Nebraska, Nevada, New Hampshire,
New Jersey, New York, North Dakota, Ohio, Oklahoma, Oregon,
Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, and
Wisconsin.
4-Chloro-[alpha]-PVP: NFLIS--160 reports, first encountered in
December 2015, locations include: California, District of Columbia,
Louisiana, Maryland, Arizona, Connecticut, Florida, Georgia, Idaho,
Illinois, Indiana, Iowa, Kansas, Kentucky, Maine, Massachusetts,
Minnesota, Missouri, New Jersey, New York, Ohio, Oklahoma, Oregon,
Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah,
Virginia, and Washington.
Additionally, encounters/seizures of these substances have occurred
by the CBP at United States ports of entry. As observed by the DEA and
CBP, synthetic cathinones originate from foreign sources, such as
China. Bulk powder substances 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. From
2014 to 2017, CBP encountered 73 shipments of products containing N-
ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, or 4-chloro-[alpha]-
PVP. Additional evidence indicates that some of these synthetic
cathinones have been seized abroad. N-Ethylhexedrone and 4-chloro-
[alpha]-PVP have been identified in seized materials in China and
Poland, respectively. These data demonstrate that these substances are
being trafficked and abused in the United States and abroad.
Concerns over the abuse of synthetic cathinone substances have led
to the control of many synthetic cathinones. DEA controlled 13
synthetic cathinones: methylone, mephedrone, MDPV, 4-methyl-N-
ethylcathinone (4-MEC), 4-methyl-alpha-pyrrolidinopropiophenone (4-
MePPP), alpha-pyrrolidinopentiophenone ([alpha]-PVP), butylone (1-(1,3-
benzodioxol-5-yl)-2-(methylamino)butan-1-one), pentedrone (2-
(methylamino)-1-phenylpentan-1-one), pentylone, 4-fluoro-N-
methylcathinone (4-FMC), 3-fluoro-N-methylcathinone (3-FMC), naphyrone
(1-(naphthalen-2-yl)-2-(pyrrolidin-1-yl)pentan-1-one), and alpha-
pyrrolidinobutiophenone ([alpha]-PBP) from 2011 to 2014 (October 21,
2011; 76 FR 65371 and March 7, 2014; 79 FR 12938). Recently, DEA
controlled another synthetic cathinone, N-ethylpentylone (August, 31,
2018; 83 FR 44474), as a schedule I substance.
[[Page 34295]]
Factor 6. What, if Any, Risk There Is to the Public Health
Available evidence on the overall public health risks associated
with the use of synthetic cathinones suggests that N-ethylhexedrone,
[alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-[alpha]-PVP can cause
acute health problems leading to emergency department (ED) admissions,
violent behaviors causing harm to self or others, or death. Acute
adverse effects of synthetic cathinone substances are those typical of
sympathomimetic agents (e.g., cocaine, methamphetamine, amphetamine)
and include among other effects tachycardia, headache, palpitations,
agitation, anxiety, mydriasis, tremor, fever or sweating, and
hypertension. Other effects, with possible public health risk
implications, that have been reported from the use of synthetic
cathinone substances include psychological effects such as psychosis,
paranoia, hallucinations, and agitation.
[alpha]-PHP, 4-MEAP, MPHP, and PV8 have been associated with the
overdoses or deaths of individuals. There have been documented reports
of ED admissions or deaths associated with the abuse of [alpha]-PHP, 4-
MEAP, MPHP, and PV8. Individuals under the influence of 4-MEAP and MPHP
have acted violently or unpredictably causing harm, or even death, to
themselves or others. Adverse effects associated with [alpha]-PHP, 4-
MEAP, MPHP, and PV8 abuse included vomiting, agitation, paranoia,
hypertension, unconsciousness, tachycardia, seizures, cardiac arrest,
rhabdomyolysis, or death. No overdose information is currently
available for N-ethylhexedrone and 4-chloro-[alpha]-PVP, but the
pharmacological similarity of these substances to other currently
controlled schedule I synthetic cathinones (e.g., methcathinone,
mephedrone, methylone, pentylone, MDPV) suggests that these substances
can also pose an imminent hazard to public safety.
It remains highly likely that additional cases of adverse health
effects involving [alpha]-PHP, 4-MEAP, MPHP, and PV8 in the United
States may have occurred and will continue to be under-reported as
these substances, as well as N-ethylhexedrone and 4-chloro-[alpha]-PVP,
are not part of standard panels for biological specimens. The
pharmacological data for N-ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP,
PV8, and 4-chloro-[alpha]-PVP alone or combined with documented case
reports, if any, demonstrate that the potential for fatal and non-fatal
overdoses exists for N-ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8,
and 4-chloro-[alpha]-PVP; thus, these substances pose an imminent
hazard to the public health and safety.
As found with other synthetic cathinone substances, products
containing synthetic cathinones often do not bear labeling information
regarding the ingredients or the health risks and potential hazards
associated with these products. The limited knowledge about product
content and its purity, as well as lack of information about its
effects, pose additional risks for significant adverse health effects
to the users.
Based on pharmacological data or documented case reports of
overdose fatalities, the misuse and abuse of N-ethylhexedrone, [alpha]-
PHP, 4-MEAP, MPHP, PV8, and 4-chloro-[alpha]-PVP leads to the same
qualitative public health risks as schedule I and II substances such as
cathinone, methcathinone, mephedrone, methylone, pentylone, MDPV,
methamphetamine, cocaine, and MDMA. [alpha]-PHP, MPHP, and PV8 have
been associated with fatalities. As the data demonstrates, the
potential for fatal and non-fatal overdoses exists for N-
ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-[alpha]-
PVP; thus, N-ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-
chloro-[alpha]-PVP pose an imminent hazard to the public safety.
N-Ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-
[alpha]-PVP are being encountered on the illicit drug market in the
United States 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 continued uncontrolled
manufacture, distribution, reverse distribution, importation,
exportation, conduct of research and chemical analysis, possession,
and/or abuse of N-ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, and
4-chloro-[alpha]-PVP, resulting from the lack of control of these
substances, pose an imminent hazard to the public safety. The DEA is
not aware of any currently accepted medical uses for N-ethylhexedrone,
[alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-[alpha]-PVP in the United
States. A substance meeting the statutory requirements for temporary
scheduling, 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 N-ethylhexedrone,
[alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-[alpha]-PVP indicate that
these synthetic cathinones 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 section 201(h)(4) of the CSA, 21 U.S.C. 811(h)(4), the Acting
Administrator, through a letter dated March 9, 2018, notified the
Assistant Secretary of the DEA's intention to temporarily place N-
ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-[alpha]-
PVP in schedule I. DEA published a notice of intent in the Federal
Register on May 1, 2019. 84 FR 18423.
Conclusion
In accordance with the provisions of section 201(h) of the CSA, 21
U.S.C. 811(h), the Acting Administrator considered available data and
information, and herein sets forth the grounds for his determination to
temporarily schedule N-ethylhexedrone (2-(ethylamino)-1-phenylhexan-1-
one); alpha-pyrrolidinohexanophenone (1-phenyl-2-(pyrrolidin-1-
yl)hexan-1-one; alpha-pyrrolidinohexiophenone; trivial name: [alpha]-
PHP); 4-methyl-alpha-ethylaminopentiophenone (trivial name: 4-MEAP);
4'-methyl-alpha-pyrrolidinohexiophenone (1-(4-methylphenyl)-2-
(pyrrolidin-1-yl)hexan-1-one; 4'-methyl-alpha-pyrrolidinohexanophenone;
trivial name: MPHP); alpha-pyrrolidinoheptaphenone (1-phenyl-2-
(pyrrolidin-1-yl)heptan-1-one; trivial name: PV8); and 4'-chloro-alpha-
pyrrolidinovalerophenone (1-(4-chlorophenyl)-2-(pyrrolidin-1-yl)pentan-
1-one; 4'-chloro-alpha-pyrrolidinopentiophenone; trivial name: 4-
chloro-[alpha]-PVP) in schedule I of the CSA, and finds that placement
of N-ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-
[alpha]-PVP in schedule I of the CSA is necessary to avoid an imminent
hazard to the public safety.
Because the Acting Administrator hereby finds that it is necessary
to temporarily place N-ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8,
and 4-chloro-[alpha]-PVP in schedule I to avoid an imminent hazard to
the public safety, this temporary order scheduling these substances is
effective on the date of publication in the Federal Register, and is in
effect for a period of two years, with a possible extension of one
additional year, pending completion of
[[Page 34296]]
the regular (permanent) scheduling process. 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. 21 U.S.C. 811. 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 permanent scheduling process of formal rulemaking are
subject to judicial review. 21 U.S.C. 877. Temporary scheduling orders
are not subject to judicial review. 21 U.S.C. 811(h)(6).
Requirements for Handling
Upon the effective date of this temporary order, N-ethylhexedrone,
[alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-[alpha]-PVP 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 (manufactures, distributes,
reverse distributes, imports, exports, engages in research, or conducts
instructional activities or chemical analysis with, or possesses), or
who desires to handle, N-ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP,
PV8, and 4-chloro-[alpha]-PVP 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 July 18, 2019.
Any person who currently handles N-ethylhexedrone, [alpha]-PHP, 4-MEAP,
MPHP, PV8, and 4-chloro-[alpha]-PVP, and is not registered with the
DEA, must submit an application for registration and may not continue
to handle N-ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-
chloro-[alpha]-PVP as of July 18, 2019, 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 July 18, 2019 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 N-ethylhexedrone,
[alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-[alpha]-PVP must surrender
all currently held quantities of N-ethylhexedrone, [alpha]-PHP, 4-MEAP,
MPHP, PV8, and 4-chloro-[alpha]-PVP.
3. Security. N-Ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, and
4-chloro-[alpha]-PVP are subject to schedule I security requirements
and must be handled and stored in accordance with 21 CFR 1301.71-
1301.93, as of July 18, 2019.
4. Labeling and Packaging. All labels, labeling, and packaging for
commercial containers of N-ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP,
PV8, and 4-chloro-[alpha]-PVP must comply with 21 U.S.C. 825 and 958(e)
and be in accordance with 21 CFR part 1302. Current DEA registrants
shall have 30 calendar days from July 18, 2019, to comply with all
labeling and packaging requirements.
5. Inventory. Every DEA registrant who possesses any quantity of N-
ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-[alpha]-
PVP 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 shall 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 N-ethylhexedrone, [alpha]-PHP, 4-
MEAP, MPHP, PV8, and 4-chloro-[alpha]-PVP) 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 N-ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-
[alpha]-PVP pursuant to 21 U.S.C. 827 and 958(e), and in accordance
with 21 CFR parts 1304, 1312, 1317 and Sec. 1307.11. Current DEA
registrants authorized to handle N-ethylhexedrone, [alpha]-PHP, 4-MEAP,
MPHP, PV8, and 4-chloro-[alpha]-PVP 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 who manufacture or distribute N-
ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-[alpha]-
PVP must submit reports pursuant to 21 U.S.C. 827 and in accordance
with 21 CFR 1304 and 1312 as of July 18, 2019.
8. Order Forms. All DEA registrants who distribute N-
ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-[alpha]-
PVP must comply with order form requirements pursuant to 21 U.S.C. 828
and in accordance with 21 CFR part 1305 as of July 18, 2019.
9. Importation and Exportation. All importation and exportation of
N-ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-[alpha]-
PVP must be in compliance with 21 U.S.C. 952, 953, 957, 958, and in
accordance with 21 CFR part 1312 as of July 18, 2019.
10. Quota. Only DEA registered manufacturers may manufacture N-
ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-[alpha]-
PVP in accordance with a quota assigned pursuant to 21 U.S.C. 826 and
in accordance with 21 CFR part 1303 as of July 18, 2019.
11. Liability. Any activity involving N-ethylhexedrone, [alpha]-
PHP, 4-MEAP, MPHP, PV8, or 4-chloro-[alpha]-PVP not authorized by, or
in violation of the CSA, occurring as of July 18, 2019, is unlawful,
and may subject the person to administrative, civil, and/or criminal
sanctions.
Regulatory Matters
Section 201(h) of the CSA, 21 U.S.C. 811(h), provides for a
temporary scheduling action where such action is necessary to avoid an
imminent hazard to the public safety. As provided in this subsection,
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 intention 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 of HHS. 21 U.S.C. 811(h)(1).
Inasmuch as section 201(h) of the CSA 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, the
DEA believes that 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 scheduling order. The
specific language chosen by Congress indicates an intention for the DEA
to proceed through the issuance of an order instead of proceeding by
rulemaking. Given that Congress specifically requires the Attorney
[[Page 34297]]
General to follow rulemaking procedures for other kinds of scheduling
actions, see section 201(a) of the CSA, 21 U.S.C. 811(a), it is
noteworthy that, in section 201(h), Congress authorized the issuance of
temporary scheduling actions by order rather than by rule.
In the alternative, even assuming that this action might be subject
to section 553 of the APA, the Acting 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.
Further, the 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 (RFA).
The requirements for the preparation of an initial regulatory
flexibility analysis in 5 U.S.C. 603(a) are not applicable where, as
here, the DEA is not required by section 553 of the APA or any other
law to publish a general notice of proposed rulemaking.
Additionally, this action is not a significant regulatory action as
defined by Executive Order 12866 (Regulatory Planning and Review),
section 3(f), and, accordingly, this action has not been reviewed by
the Office of Management and Budget.
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 Executive Order
13132 (Federalism), it is determined that this action does not have
sufficient federalism implications to warrant the preparation of a
Federalism Assessment.
As noted above, this action is an order, not a rule. Accordingly,
the Congressional Review Act (CRA) is inapplicable, as it applies only
to rules. However, if this were a rule, pursuant to the CRA, ``any rule
for which an agency for good cause finds that notice and public
procedure thereon are impracticable, unnecessary, or contrary to the
public interest, shall take effect at such time as the federal agency
promulgating the rule determines.'' 5 U.S.C. 808(2). It is in the
public interest to schedule these substances immediately to avoid an
imminent hazard to the public safety. This temporary scheduling action
is taken pursuant to 21 U.S.C. 811(h), which is specifically designed
to enable the DEA to act in an expeditious manner to avoid an imminent
hazard to the public safety. 21 U.S.C. 811(h) exempts the temporary
scheduling order from standard notice and comment rulemaking procedures
to ensure that the process moves swiftly. For the same reasons that
underlie 21 U.S.C. 811(h), that is, the DEA's need to move quickly to
place these substances in schedule I because they pose an imminent
hazard to the public safety, it would be contrary to the public
interest to delay implementation of the temporary scheduling order.
Therefore, this order shall take effect immediately upon its
publication. The DEA has submitted a copy of this temporary order to
both Houses of Congress and to the Comptroller General, although such
filing is not required under the Small Business Regulatory Enforcement
Fairness Act of 1996 (Congressional Review Act), 5 U.S.C. 801-808
because, as noted above, this action is an order, not a rule.
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)(42) through (47) to read as
follows:
Sec. 1308.11 Schedule I.
* * * * *
(h) * * *
(42) N-Ethylhexedrone, its optical, positional, and geometric 7246
isomers, salts and salts of isomers (Other name: 2-
(ethylamino)-1-phenylhexan-1-one).............................
(43) alpha-Pyrrolidinohexanophenone, its optical, positional, 7544
and geometric isomers, salts and salts of isomers (Other
names: [alpha]-PHP; alpha-pyrrolidinohexiophenone; 1-phenyl-2-
(pyrrolidin-1-yl)hexan-1-one).................................
(44) 4-Methyl-alpha-ethylaminopentiophenone, its optical, 7245
positional, and geometric isomers, salts and salts of isomers
(Other names: 4-MEAP; 2-(ethylamino)-1-(4-methylphenyl)pentan-
1-one)........................................................
(45) 4'-Methyl-alpha-pyrrolidinohexiophenone, its optical, 7446
positional, and geometric isomers, salts and salts of isomers
(Other names: MPHP; 4'-methyl-alpha-pyrrolidinohexanophenone;
1-(4-methylphenyl)-2-(pyrrolidin-1-yl)hexan-1-one)............
(46) alpha-Pyrrolidinoheptaphenone, its optical, positional, 7548
and geometric isomers, salts and salts of isomers (Other
names: PV8; 1-phenyl-2-(pyrrolidin-1-yl)heptan-1-one).........
(47) 4'-Chloro-alpha-pyrrolidinovalerophenone, its optical, 7443
positional, and geometric isomers, salts and salts of isomers
(Other names: 4-chloro-[alpha]-PVP; 4'-chloro-alpha-
pyrrolidinopentiophenone; 1-(4-chlorophenyl)-2-(pyrrolidin-1-
yl)pentan-1-one)..............................................
Dated: July 10, 2019.
Uttam Dhillon,
Acting Administrator.
[FR Doc. 2019-15184 Filed 7-17-19; 8:45 am]
BILLING CODE 4410-09-P