Schedules of Controlled Substances: Temporary Placement of N
| Citation | 84 FR 18423 |
| Record Number | 2019-08704 |
| Published date | 01 May 2019 |
| Section | Proposed rules |
| Court | Drug Enforcement Administration |
Federal Register, Volume 84 Issue 84 (Wednesday, May 1, 2019)
[Federal Register Volume 84, Number 84 (Wednesday, May 1, 2019)]
[Proposed Rules]
[Pages 18423-18428]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-08704]
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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: Proposed amendment; notice of intent.
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SUMMARY: The Acting Administrator of the Drug Enforcement
Administration is issuing this notice of intent to publish a temporary
order to schedule the synthetic cathinones, N-ethylhexedrone; alpha-
pyrrolidinohexanophenone (trivial name: [alpha]-PHP); 4-methyl-alpha-
ethylaminopentiophenone (trivial name: 4-MEAP); 4'-methyl-alpha-
pyrrolidinohexiophenone (trivial name: MPHP); alpha-
pyrrolidinoheptaphenone (trivial name: PV8); and 4-chloro-alpha-
pyrrolidinovalerophenone (trivial name: 4-chloro-[alpha]-PVP), in
schedule I. When it is issued, the temporary scheduling order will
impose regulatory requirements under the Controlled Substances Act
(CSA) on the manufacture, distribution, reverse distribution,
possession, importation, exportation, research, conduct of
instructional activities, and chemical analysis of these synthetic
cathinones, as well as administrative, civil, and criminal remedies
with respect to persons who fail to comply with such requirements or
otherwise violate the CSA with respect to these substances.
DATES: May 1, 2019.
FOR FURTHER INFORMATION CONTACT: Lynnette M. Wingert, 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: This 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) placing N-ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8,
and 4-chloro-[alpha]-PVP in schedule I of the Controlled Substances Act
(CSA).\1\ The temporary scheduling order will be published in the
Federal Register on or after May 31, 2019.
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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.
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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 for up to one year. 21 U.S.C.
811(h)(2).
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]-PHP, 4-MEAP,
MPHP, PV8, and 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 Acting 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 Acting 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. 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.
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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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In order 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,
[[Page 18424]]
and a lack of accepted safety for use under medical supervision. 21
U.S.C. 812(b)(1).
Synthetic Cathinones
Recently, novel synthetic cathinones that mimic the biological
effects of substances with stimulant-like effects have emerged on 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 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 many
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 and were encountered in powder, crystal,
rock, resin, capsule, and tablet forms.
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. Encounters of N-ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP,
PV8, and 4-chloro-[alpha]-PVP have occurred 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,\3\ the 2017 annual
[[Page 18425]]
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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\3\ 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 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 recreational substances (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.\4\ 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. 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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\4\ See 76 FR 77330, 77332, Dec. 12, 2011.
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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. The 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-
[[Page 18426]]
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, the DEA controlled another
synthetic cathinone, N-ethylpentylone (August, 31, 2018; 83 FR 44474),
as a schedule I substance.
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
Acting 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.
Conclusion
This notice of intent provides the 30-day notice pursuant to
section 201(h) of the CSA, 21 U.S.C. 811(h), of the DEA's intent to
issue a temporary scheduling order. 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, herein set
forth the grounds for his determination to temporarily schedule N-
ethylhexedrone; alpha-pyrrolidinohexanophenone (trivial name: [alpha]-
PHP); 4-methyl-alpha-ethylaminopentiophenone (trivial name: 4-MEAP);
4'-methyl-alpha-pyrrolidinohexiophenone (trivial name: MPHP); alpha-
pyrrolidinoheptaphenone (trivial name: PV8); and 4-chloro-alpha-
pyrrolidinovalerophenone (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 on a temporary basis is necessary to avoid an imminent
hazard to the public safety.
The temporary placement of N-ethylhexedrone, [alpha]-PHP, 4-MEAP,
MPHP, PV8, and 4-chloro-[alpha]-PVP in schedule I of the CSA will take
effect pursuant to a temporary scheduling order, which will not be
issued before May 31, 2019. Because the Acting Administrator hereby
finds that it is necessary to temporarily place N-
[[Page 18427]]
ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-[alpha]-
PVP in schedule I to avoid an imminent hazard to the public safety, the
temporary order scheduling these substances will be effective on the
date that 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. 21 U.S.C. 811(h)(1) and (2). It is the intention of
the Acting Administrator to issue a temporary scheduling order as soon
as possible after the expiration of 30 days from the date of
publication of this notice. Upon publication of the 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, research,
conduct of instructional activities and chemical analysis, and
possession of a schedule I controlled substance.
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. 21 U.S.C. 811. 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. 21 U.S.C. 877. Temporary scheduling orders are not subject to
judicial review. 21 U.S.C. 811(h)(6).
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 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.'' 5 U.S.C. 551(6) (emphasis added). 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
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 notice of intent 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.
Although the 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, the DEA notes that in
accordance with 21 U.S.C. 811(h)(4), the Acting Administrator took into
consideration comments submitted by the Assistant Secretary in response
to the notice that DEA transmitted to the Assistant Secretary pursuant
to section 811(h)(4).
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.
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 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)(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...........................
(43) alpha-Pyrrolidinohexanophenone, its optical, positional, (7544)
and geometric isomers, salts and salts of isomers (Other
names: [alpha]-PHP)...........................................
(44) 4-Methyl-alpha-ethylaminopentiophenone, its optical, (7245)
positional, and geometric isomers, salts and salts of isomers
(Other names: 4-MEAP).........................................
(45) 4'-Methyl-alpha-pyrrolidinohexiophenone, its optical, (7446)
positional, and geometric isomers, salts and salts of isomers
(Other names: MPHP)...........................................
(46) alpha-Pyrrolidinoheptaphenone, its optical, positional, (7548)
and geometric isomers, salts and salts of isomers (Other
names: PV8)...................................................
(47) 4-Chloro-alpha-pyrrolidinovalerophenone, its optical, (7443)
positional, and geometric isomers, salts and salts of isomers
(Other names: 4-chloro-[alpha]-PVP)...........................
[[Page 18428]]
Dated: April 22, 2019.
Uttam Dhillon,
Acting Administrator.
[FR Doc. 2019-08704 Filed 4-30-19; 8:45 am]
BILLING CODE 4410-09-P
