[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

[[Page 34294]]

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