Schedules of Controlled Substances: Temporary Placement of 10 Synthetic Cathinones Into Schedule I, 12938-12943 [2014-04997]

Agencies

• Drug Enforcement Administration
• Department of Justice

[Federal Register Volume 79, Number 45 (Friday, March 7, 2014)]
[Rules and Regulations]
[Pages 12938-12943]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-04997]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-386]


Schedules of Controlled Substances: Temporary Placement of 10 
Synthetic Cathinones Into Schedule I

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Final order.

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SUMMARY: The Deputy Administrator of the Drug Enforcement 
Administration (DEA) is issuing this final order to temporarily 
schedule 10 synthetic cathinones into schedule I pursuant to the 
temporary scheduling provisions of the Controlled Substances Act (CSA). 
The 10 substances are: 4-methyl-N-ethylcathinone (``4-MEC''); 4-methyl-
alpha-pyrrolidinopropiophenone (``4-MePPP''); alpha-
pyrrolidinopentiophenone (``[alpha]-PVP''); 1-(1,3-benzodioxol-5-yl)-2-
(methylamino)butan-1-one (``butylone''); 2-(methylamino)-1-
phenylpentan-1-one (``pentedrone''); 1-(1,3-benzodioxol-5-yl)-2-
(methylamino)pentan-1-one (``pentylone''); 4-fluoro-N-methylcathinone 
(``4-FMC''); 3-fluoro-N-methylcathinone (``3-FMC''); 1-(naphthalen-2-
yl)-2-(pyrrolidin-1-yl)pentan-1-one (``naphyrone''); and alpha-
pyrrolidinobutiophenone (``[alpha]-PBP''). This action is based on a 
finding by the Deputy Administrator that the placement of these 
synthetic cathinones and their optical, positional, and geometric 
isomers, salts and salts of isomers into schedule I of the CSA 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, import, 
export, engage in research, conduct instructional activities, and 
possess), or propose to handle these synthetic cathinones.

DATES: This final order is effective March 7, 2014.

FOR FURTHER INFORMATION CONTACT: Ruth A. Carter, Office of Diversion 
Control, Drug Enforcement Administration; Mailing Address: 8701 
Morrissette Drive, Springfield, Virginia 22152, Telephone (202) 598-
6812.

SUPPLEMENTARY INFORMATION: 

Legal Authority

    The DEA implements and enforces titles II and III of the 
Comprehensive Drug Abuse Prevention and Control Act of 1970, as 
amended. Titles II and III are referred to as the ``Controlled 
Substances Act'' and the ``Controlled Substances Import and Export 
Act,'' respectively, and are collectively referred to as the 
``Controlled Substances Act'' or the ``CSA'' for the purpose of this 
action. 21 U.S.C. 801-971. The DEA publishes the implementing 
regulations for these statutes in title 21 of the Code of Federal 
Regulations (CFR), parts 1300 to 1321. The CSA and its implementing 
regulations are designed to prevent, detect, and eliminate the 
diversion of controlled substances and listed chemicals into the 
illicit market while providing for the legitimate medical, scientific, 
research, and industrial needs of the United States. Controlled 
substances have the potential for abuse and dependence and are 
controlled to protect the public health and safety.
    Under the CSA, controlled substances are classified into one of 
five schedules based upon their potential for abuse, their currently 
accepted medical use, and the degree of dependence the substance may 
cause. 21 U.S.C. 812. The initial schedules of controlled substances 
established by Congress are found at 21 U.S.C. 812(c), and the current 
list of all scheduled substances is published at 21 CFR part 1308.
    Section 201 of the CSA, 21 U.S.C. 811, provides the Attorney 
General with the authority to temporarily place a substance into 
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). In addition, 
if proceedings to control a substance are initiated under 21 U.S.C. 
811(a)(1), 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 his 
authority under 21 U.S.C. 811 to the Administrator of the DEA, who in 
turn has delegated her authority to the Deputy Administrator of the 
DEA. 28 CFR 0.100, Appendix to Subpart R of Part 0, Sec. 12.

Background

    Section 201(h)(4) of the CSA (21 U.S.C. 811(h)(4)) requires the 
Deputy Administrator to notify the Secretary of the Department of 
Health and Human Services (HHS) of his intention to temporarily place a 
substance into schedule I of the CSA.\1\ The Deputy Administrator 
transmitted notice of his intent to place 4-MEC, 4-MePPP, [alpha]-PVP, 
butylone, pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, and [alpha]-
PBP into schedule I on a temporary basis to

[[Page 12939]]

the Assistant Secretary by letter dated November 7, 2013. The Assistant 
Secretary responded to this notice by letter dated December 4, 2013, 
and advised that based on review by the FDA, there are currently no 
investigational new drug applications or approved new drug applications 
for 4-MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone, pentylone, 4-
FMC, 3-FMC, naphyrone, or [alpha]-PBP. The Assistant Secretary also 
stated that the HHS has no objection to the temporary placement of 4-
MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-
FMC, naphyrone, and [alpha]-PBP into schedule I of the CSA.
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    \1\ Because the Secretary of the HHS has delegated to the 
Assistant Secretary for Health of the HHS the authority to make 
domestic drug scheduling recommendations, for purposes of this Final 
Order, all subsequent references to ``Secretary'' have been replaced 
with ``Assistant Secretary.'' As set forth in a memorandum of 
understanding entered into by HHS, the Food and Drug Administration 
(FDA), and the National Institute on Drug Abuse (NIDA), FDA acts as 
the lead agency within HHS in carrying out the Assistant Secretary's 
scheduling responsibilities under the CSA, with the concurrence of 
NIDA. 50 FR 9518, Mar. 8, 1985.
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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). As 4-MEC, 4-MePPP, 
[alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, 
and [alpha]-PBP are not currently listed in any schedule under the CSA, 
and as no exemptions or approvals are in effect for 4-MEC, 4-MePPP, 
[alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, 
and [alpha]-PBP under section 505 of the FDCA, 21 U.S.C. 355, the 
conditions of 21 U.S.C. 811(h)(1) have been satisfied. As required by 
21 U.S.C. 811(h)(1)(A), a notice of intent to temporarily schedule 
these 10 synthetic cathinones was published in the Federal Register on 
January 28, 2014. 79 FR 4429.
    To find that placing a substance temporarily into schedule I of the 
CSA is necessary to avoid an imminent hazard to the public safety, the 
Deputy Administrator is required to consider three of the eight factors 
set forth in section 201(c) of the CSA, 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 4-
MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-
FMC, naphyrone, and [alpha]-PBP indicate that these 10 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.

Synthetic Cathinones

    Synthetic cathinones are [beta]-keto-phenethylamine derivatives of 
the larger phenethylamine structural class (amphetamines, cathinones, 
2C compounds, aminoindanes, etc.). Synthetic cathinones share a core 
phenethylamine structure with substitutions at the [beta]-position, 
[alpha]-position, phenyl ring, or nitrogen atom. The addition of a 
beta-keto ([beta]-keto) substituent (i.e., carbonyl (C=O)) to the 
phenethylamine core structure along with substitutions on the alpha 
([alpha]) carbon (C) atom or the nitrogen (N) atom produce a variety of 
substances called cathinones or synthetic cathinones. Many synthetic 
cathinones produce pharmacological effects substantially similar to the 
schedule I substances cathinone, methcathinone, and 3,4-
methylenedioxymethamphetamine (MDMA) and schedule II stimulants 
amphetamine, methamphetamine, and cocaine. 4-MEC, 4-MePPP, [alpha]-PVP, 
butylone, pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, and [alpha]-
PBP are synthetic cathinones and are structurally and pharmacologically 
similar to amphetamine, MDMA, cathinone, and other related substances. 
Accordingly, these synthetic cathinone substances share substantial 
similarities with schedule I and schedule II substances with respect to 
desired and adverse effects. In general, desired effects reported by 
abusers of synthetic cathinone substances include euphoria, sense of 
well-being, increased sociability, energy, empathy, increased 
alertness, and improved concentration and focus. Abusers also report 
experiencing unwanted effects such as tremor, vomiting, agitation, 
sweating, fever, and chest pain. Other adverse or toxic effects that 
have been reported with the abuse of synthetic cathinones include 
tachycardia, hypertension, hyperthermia, mydriasis, rhabdomyolysis, 
hyponatremia, seizures, altered mental status (paranoia, 
hallucinations, delusions), and even death. These synthetic cathinone 
substances have no known medical use in the United States but evidence 
demonstrates that these substances are being abused by individuals. 
There have been documented reports of emergency room admissions and 
deaths associated with the abuse of synthetic cathinone substances.
    Products that contain synthetic cathinones have been falsely 
marketed as ``research chemicals,'' ``jewelry cleaner,'' ``stain 
remover,'' ``plant food or fertilizer,'' ``insect repellants,'' or 
``bath salts.'' These products are sold at smoke shops, head shops, 
convenience stores, adult book stores, and gas stations and can also be 
purchased on the Internet. These substances are commonly encountered in 
the form of powders, crystals, resins, tablets, and capsules.
    From January 2010 through December 2013, according to the System to 
Retrieve Information from Drug Evidence \2\ (STRIDE) data, there are 
377 exhibits for 4-MEC; 125 exhibits for 4-MePPP; 689 exhibits for 
[alpha]-PVP; 75 exhibits for butylone; 304 exhibits for pentedrone; 121 
exhibits for pentylone; 37 exhibits for FMC \3\; 24 exhibits for 
naphyrone; and 37 exhibits for [alpha]-PBP. From January 2010 through 
December 2013, the National Forensic Laboratory Information System \4\ 
(NFLIS) registered 9,113 reports containing these synthetic cathinones 
(4-MEC--1,952 reports; 4-MePPP--289 reports; [alpha]-PVP--4,536 
reports; butylone--495 reports; pentedrone--1,167 reports; pentylone--
238 reports; FMC \5\--292 reports; naphyrone--44 reports; [alpha]-PBP--
100 reports) across 42 States.
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    \2\ STRIDE is a database of drug exhibits sent to the DEA 
laboratories for analysis. Exhibits from the database are from the 
DEA, other Federal agencies, and some local law enforcement 
agencies. STRIDE data was queried on 2/5/2014 by date submitted to 
Federal forensic laboratories.
    \3\ FMC refers to both 3-FMC and 4-FMC.
    \4\ NFLIS is a national drug forensic laboratory reporting 
system that systematically collects results from drug chemistry 
analyses conducted by State and local forensic laboratories across 
the country. NFLIS State and local forensic drug reports were 
queried on 2/6/2014.
    \5\ FMC refers to both 3-FMC and 4-FMC.
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Factor 4. History and Current Pattern of Abuse

    4-MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone, pentylone, 4-
FMC, 3-FMC, naphyrone, and [alpha]-PBP are synthetic cathinones that 
emerged on the United States' illicit drug market around the time of 
the temporary scheduling of mephedrone, MDPV, and methylone on October 
21, 2011. 76 FR 65371. Mephedrone and MDPV were permanently placed in 
schedule I on July 9, 2012, by the Food and Drug Administration Safety 
and Innovation Act (Pub. L. 112-144), and methylone was permanently 
placed in schedule I by the DEA on April 12, 2013 (78 FR 21818). These 
synthetic cathinone substances, like the schedule I synthetic 
cathinones (mephedrone, methylone, and MDPV), are promoted as being a 
``legal'' alternative to cocaine, methamphetamine, and MDMA. Products 
that contain 4-MEC, 4-MePPP,

[[Page 12940]]

[alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, 
and [alpha]-PBP are falsely marketed as ``research chemicals,'' 
``jewelry cleaner,'' ``stain remover,'' ``plant food or fertilizer,'' 
``insect repellants,'' or ``bath salts.'' They are sold at smoke shops, 
head shops, convenience stores, adult book stores, and gas stations, 
and can also be purchased on the Internet under a variety of product 
names (e.g., ``White Dove,'' ``Explosion,'' and ``Tranquility''). They 
are commonly encountered in the form of powders, crystals, resins, 
tablets, and capsules. The packages of these commercial products 
usually contain the warning ``not for human consumption.''
    Information from published scientific studies indicates that the 
most common routes of administration for synthetic cathinone substances 
is ingestion by swallowing capsules or tablets or nasal insufflation by 
snorting the powder. Other methods of intake include intravenous or 
intramuscular injection, rectal administration, and swallowing via 
ingestion by ``bombing'' (wrapping a dose of powder in paper).
    There is evidence that these synthetic cathinone substances are 
abused alone or ingested with other substances including other 
synthetic cathinones, pharmaceutical agents, or other recreational 
substances. Substances found in combination with 4-MEC, 4-MePPP, 
[alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, or naphyrone are: 
Other synthetic cathinones (e.g., methylone and MDPV), common cutting 
agents (e.g., lidocaine, caffeine, lignocaine, ephedrine, etc.), or 
other recreational substances (e.g., cocaine, methamphetamine, and 
amphetamine).
    Evidence from poison centers and published reports suggest that the 
primary users of synthetic cathinones are youths and young adults. 
Synthetic cathinone exposures reported to the Texas Poison Center 
Network during 2010 and 2011 involved mostly adolescents (12 to 19-
years-old) and young adults (mean age was 30-years-old). A survey of 
college students reported that the lifetime use (used at least once) of 
synthetic cathinones among college students (at a large Southeastern 
United States university) is 25 out of 2,349 students surveyed. A 
national survey on drug use by the Monitoring the Future (MTF) \6\ 
research program showed that 0.2% of full-time college students (one to 
four years past high school) used synthetic cathinone substances in 
2012. Similarly, the use of synthetic cathinone substances among 8th, 
10th, and 12th grade students, and young adults (non-college peers aged 
19 to 28-years-old) was 0.8%, 0.6%, 1.3%, and 0.8%, respectively.
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    \6\ MTF is a research program conducted by the University of 
Michigan's Institute for Social Research under grants from NIDA. MTF 
tracks drug use trends among American adolescents in the 8th, 10th, 
and 12th grades and high school graduates into adulthood by 
conducting nationwide surveys.
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Factor 5. Scope, Duration and Significance of Abuse

    4-MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone, pentylone, 4-
FMC, 3-FMC, naphyrone, and [alpha]-PBP, like the schedule I cathinones 
mephedrone, methylone, and MDPV, are popular recreational drugs. 
Evidence that these synthetic cathinone substances are being abused is 
indicated by law enforcement encounters of these substances. Forensic 
laboratories have analyzed drug exhibits received from State, local, 
and Federal law enforcement agencies and confirmed the presence of 4-
MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-
FMC, naphyrone, or [alpha]-PBP in these exhibits.
    STRIDE registered 1,789 drug exhibits pertaining to the 
trafficking, distribution and abuse of 4-MEC, 4-MePPP, [alpha]-PVP, 
butylone, pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, and [alpha]-
PBP from January 2010 to December 2013.\7\ Specifically, in 2010, 
STRIDE contains four reports related to 4-MEC and none for the other 
nine substances. However, in 2011, there were 216 reports related to 
these 10 substances, and in 2012, there were 1,314 reports. In 2013, 
there were 255 reports.
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    \7\ STRIDE data was queried on 2/5/2014 by date submitted to 
Federal forensic laboratories.
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    NFLIS registered over 9,000 reports from State and local forensic 
laboratories identifying these substances in drug-related exhibits for 
the period from January 2010 to December 2013, across 42 States. 
Specifically, in 2010, NFLIS registered 13 reports from 5 States 
containing many of these synthetic cathinone substances.\8\ In 2011, 
there were 800 reports from 32 States related to these substances 
registered in NFLIS, in 2012 there were 5,519 reports from 41 States, 
and in 2013 there were 2,781 reports from 42 States.
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    \8\ NFLIS State and local forensic drug reports were queried on 
2/6/2014.
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    Additionally, large seizures of these substances have occurred by 
the United States Customs and Border Protection (CBP). At selected 
United States ports of entry, CBP encountered several shipments of 
products from April 2010 to November 2013 containing these synthetic 
cathinone substances (4-MEC--78 encounters; 4-MePPP--8 encounters; 
[alpha]-PVP--40 encounters; butylone--21 encounters; pentedrone--18 
encounters; pentylone--10 encounters; FMC \9\--13 encounters; 
naphyrone--3 encounters; [alpha]-PBP--11 encounters), thus indicating 
the appeal of these substances. Most of the shipments of these 
synthetic cathinones originated overseas and were destined for delivery 
throughout the United States to States including Arizona, Arkansas, 
California, Colorado, Florida, Hawaii, Idaho, Illinois, Michigan, 
Missouri, Nebraska, Nevada, New Jersey, New Mexico, Oklahoma, Oregon, 
Texas, Virginia, Washington, and Wyoming.
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    \9\ FMC refers to both 3-FMC and 4-FMC.
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    Concerns over the abuse of these synthetic cathinone substances 
have prompted many States to regulate them. As of June 24, 2013, more 
than half of the States in the United States have emergency scheduled 
or enacted legislation placing regulatory controls on some or many of 
the 10 synthetic cathinones that are the subject of this final order. 
In addition, due to the use of synthetic cathinones by service members, 
the United States Armed Forces has prohibited the use of synthetic 
cathinones for intoxication purposes.

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 indicates that 4-MEC, 4-MePPP, 
[alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, 
and [alpha]-PBP can cause acute health problems leading to emergency 
department admissions, violent behaviors causing harm to self or 
others, or death. For example, individuals have presented at emergency 
departments following exposure to some of these synthetic cathinone 
substances or products containing them. In addition, products 
containing these synthetic cathinone substances often do not bear 
labeling information regarding their ingredients and, if they do, they 
may not list the active synthetic ingredients or identify the health 
risks and potential hazards associated with these products. Acute 
effects of these substances are those typical of sympathomimetic agents 
(e.g., cocaine, methamphetamine, and amphetamine) and include, among 
other effects, tachycardia, headache, bruxism (teeth grinding), 
palpitations, agitation, anxiety, insomnia, mydriasis, tremor, fever or 
sweating, and hypertension. Other effects, with public health risk 
implications, that have been reported from the use of synthetic

[[Page 12941]]

cathinone substances include vomiting, palpitations, chest pain, 
hyperthermia, rhabdomyolysis, hyponatremia, seizures, and altered 
mental status (paranoia, hallucinations, and delusions). Finally, the 
possibility of death for individuals abusing 4-MEC, 4-MePPP, [alpha]-
PVP, butylone, pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, and 
[alpha]-PBP indicates that these substances are serious public health 
threats. Some of these synthetic cathinone substances have been 
directly or indirectly implicated in the death of individuals. For 
example, a 24-year-old female died after ingesting two capsules of what 
she believed to be ``Ecstasy'' but was subsequently confirmed to be a 
mixture of methylone and butylone. The cause of death determined by the 
medical examiner was serotonin syndrome secondary to methylone and 
butylone ingestion. A 21-year-old male who ingested butylone for 
suicidal intentions died after he developed seizures and suffered a 
cardiac and respiratory arrest. The cause of death was reported as 
multi-organ failure resulting from malignant serotonin syndrome.

Finding of Necessity of Schedule I Placement To Avoid Imminent Hazard 
to Public Safety

    Based on the above summarized data and information, the continued 
uncontrolled manufacture, distribution, importation, exportation, and 
abuse of 4-MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone, pentylone, 
4-FMC, 3-FMC, naphyrone, and [alpha]-PBP pose an imminent hazard to the 
public safety. The DEA is not aware of any currently accepted medical 
uses for these synthetic cathinones 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. 21 U.S.C. 812(b). Based on 
available data and information for 4-MEC, 4-MePPP, [alpha]-PVP, 
butylone, pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, and [alpha]-
PBP, the Deputy Administrator has made the determination that these 10 
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 Deputy 
Administrator through a letter dated November 7, 2013, notified the 
Assistant Secretary of the DEA's intention to temporarily place these 
10 synthetic cathinones in schedule I.

Conclusion

    In accordance with the provisions of section 201(h) of the CSA, 21 
U.S.C. 811(h), the Deputy Administrator considered available data and 
information, herein set forth the grounds for his determination that it 
is necessary to temporarily place 10 synthetic cathinones, 4-MEC, 4-
MePPP, [alpha]-PVP, pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, and 
[alpha]-PBP into schedule I of the CSA, and finds that placement of 
these synthetic cathinones into schedule I of the CSA is warranted in 
order to avoid an imminent hazard to the public safety.
    Because the Deputy Administrator hereby finds that it is necessary 
to temporarily place these synthetic cathinones into schedule I to 
avoid an imminent hazard to the public safety, the final order 
temporarily scheduling these substances will be effective on the date 
of publication 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).
    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).

Requirements for Handling

    Upon the effective date of this final order, 4-MEC, 4-MePPP, 
[alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, 
and [alpha]-PBP become subject to the regulatory controls and 
administrative, civil, and criminal sanctions applicable to the 
manufacture, distribution, importing, exporting, research, conduct of 
instructional activities, and possession of schedule I controlled 
substances including the following:
    1. Registration. Any person who handles (manufactures, distributes, 
imports, exports, engages in research, conducts instructional 
activities with, or possesses), or desires to handle, 4-MEC, 4-MePPP, 
[alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, 
or [alpha]-PBP, 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 March 7, 2014. Any 
person who currently handles 4-MEC, 4-MePPP, [alpha]-PVP, butylone, 
pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, or [alpha]-PBP, and is 
not registered with the DEA, must submit an application for 
registration and may not continue to handle 4-MEC, 4-MePPP, [alpha]-
PVP, butylone, pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, or 
[alpha]-PBP as of March 7, 2014, unless the DEA has approved that 
application for registration, pursuant to 21 U.S.C. 822, 823, 957, 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.
    2. Security. 4-MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone, 
pentylone, 4-FMC, 3-FMC, naphyrone, and [alpha]-PBP are subject to 
schedule I security requirements and must be handled and stored 
pursuant to 21 U.S.C. 821, 823, 871(b), and in accordance with 21 CFR 
1301.71-1301.93, as of March 7, 2014.
    3. Labeling and Packaging. All labels and labeling for commercial 
containers of 4-MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone, 
pentylone, 4-FMC, 3-FMC, naphyrone, and [alpha]-PBP must be in 
compliance with 21 U.S.C. 825, 958(e), and be in accordance with 21 CFR 
part 1302 as of March 7, 2014. Current DEA registrants shall have 30 
calendar days from March 7, 2014, to comply with all labeling and 
packaging requirements.
    4. Inventory. Every DEA registrant who possesses any quantity of 4-
MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-
FMC, naphyrone, or [alpha]-PBP on the effective date of this order, 
must take an inventory of all stocks of these substances on hand as of 
March 7, 2014, pursuant to 21 U.S.C. 827, 958, and in accordance with 
21 CFR 1304.03, 1304.04, and 1304.11(a) and (d). 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 4-MEC, 4-MePPP, 
[alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, 
and [alpha]-PBP) on hand on a biennial basis, pursuant to 21 U.S.C. 
827, 958, and in

[[Page 12942]]

accordance with 21 CFR 1304.03, 1304.04, and 1304.11.
    5. Records. All DEA registrants must maintain records with respect 
to 4-MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 
3-FMC, naphyrone, or [alpha]-PBP pursuant to 21 U.S.C. 827, 958, and in 
accordance with 21 CFR parts 1304, 1307, and 1312 as of March 7, 2014. 
Current DEA registrants authorized to handle 4-MEC, 4-MePPP, [alpha]-
PVP, butylone, pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, or 
[alpha]-PBP shall have 30 calendar days from the effective date of this 
order to be in compliance with all recordkeeping requirements.
    6. Reports. All DEA registrants who manufacture or distribute 4-
MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-
FMC, naphyrone, or [alpha]-PBP must submit reports pursuant to 21 
U.S.C. 827 and in accordance with 21 CFR 1304.33 as of March 7, 2014.
    7. Order Forms. All registrants who distribute 4-MEC, 4-MePPP, 
[alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, 
or [alpha]-PBP must comply with order form requirements pursuant to 21 
U.S.C. 828 and in accordance with 21 CFR part 1305 as of March 7, 2014.
    8. Importation and Exportation. All importation and exportation of 
4-MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-
FMC, naphyrone, or [alpha]-PBP must be in compliance with 21 U.S.C. 
952, 953, 957, 958, and in accordance with 21 CFR part 1312 as of March 
7, 2014.
    9. Quota. Only registered manufacturers may manufacture 4-MEC, 4-
MePPP, [alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-FMC, 
naphyrone, or [alpha]-PBP in accordance with a quota assigned pursuant 
to 21 U.S.C. 826 and in accordance with 21 CFR part 1303.
    10. Criminal Liability. Any activity involving 4-MEC, 4-MePPP, 
[alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, 
or [alpha]-PBP not authorized by, or in violation of the CSA, occurring 
as of March 7, 2014, 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 an 
expedited 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. 21 U.S.C. 811(h)(1).
    Inasmuch as section 201(h) of the CSA directs that temporary 
scheduling actions be issued by order 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, do not apply to this temporary scheduling 
action. In the alternative, even assuming that this action might be 
subject to section 553 of the APA, the Deputy 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 final order 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 (OMB).
    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.
    Pursuant to section 808(2) of the Congressional Review Act (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 
because they pose a public health risk. 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 from new or designer drugs or 
abuse of those drugs. 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 into schedule I because they pose a threat to the public 
safety, it would be contrary to the public interest to delay 
implementation of the temporary scheduling order. Therefore, in 
accordance with section 808(2) of the CRA, this order shall take effect 
immediately upon its publication.

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, 21 CFR part 1308 is amended as 
follows:

PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES

0
1. The authority citation for 21 CFR Part 1308 continues to read as 
follows:

    Authority: 21 U.S.C. 811, 812, 871(b), unless otherwise noted.

0
2. Amend Sec.  1308.11 by adding new paragraphs (h)(19) through 
(h)(28), to read as follows:


Sec.  1308.11  Schedule I.

* * * * *
    (h) * * *
    (19) 4-methyl-N-ethylcathinone, its optical, positional, and 
geometric isomers, salts and salts of isomers--1249 (Other names: 4-
MEC; 2-(ethylamino)-1-(4-methylphenyl)propan-1-one)
    (20) 4-methyl-alpha-pyrrolidinopropiophenone, its optical, 
positional, and geometric isomers, salts and salts of isomers--7498 
(Other names: 4-MePPP; MePPP; 4-methyl-[alpha]-
pyrrolidinopropiophenone; 1-(4-methylphenyl)-2-(pyrrolidin-1-yl)-
propan-1-one)
    (21) alpha-pyrrolidinopentiophenone, its optical, positional, and 
geometric isomers, salts and salts of isomers--7545 (Other names: 
[alpha]-PVP; [alpha]-pyrrolidinovalerophenone; 1-phenyl-2-(pyrrolidin-
1-yl)pentan-1-one)
    (22) Butylone, its optical, positional, and geometric isomers, 
salts and salts of

[[Page 12943]]

isomers--7541 (Other names: bk-MBDB; 1-(1,3-benzodioxol-5-yl)-2-
(methylamino)butan-1-one)
    (23) Pentedrone, its optical, positional, and geometric isomers, 
salts and salts of isomers--1246 (Other names: [alpha]-
methylaminovalerophenone; 2-(methylamino)-1-phenylpentan-1-one)
    (24) Pentylone, its optical, positional, and geometric isomers, 
salts and salts of isomers--7542 (Other names: bk-MBDP; 1-(1,3-
benzodioxol-5-yl)-2-(methylamino)pentan-1-one)
    (25) 4-fluoro-N-methylcathinone, its optical, positional, and 
geometric isomers, salts and salts of isomers--1238 (Other names: 4-
FMC; flephedrone; 1-(4-fluorophenyl)-2-(methylamino)propan-1-one)
    (26) 3-fluoro-N-methylcathinone, its optical, positional, and 
geometric isomers, salts and salts of isomers--1233 (Other names: 3-
FMC; 1-(3-fluorophenyl)-2-(methylamino)propan-1-one)
    (27) Naphyrone, its optical, positional, and geometric isomers, 
salts and salts of isomers--1258 (Other names: naphthylpyrovalerone; 1-
(naphthalen-2-yl)-2-(pyrrolidin-1-yl)pentan-1-one)
    (28) alpha-pyrrolidinobutiophenone, its optical, positional, and 
geometric isomers, salts and salts of isomers--7546 (Other names: 
[alpha]-PBP; 1-phenyl-2-(pyrrolidin-1-yl)butan-1-one)

    Dated: February 28, 2014.
Thomas M. Harrigan,
Deputy Administrator.
[FR Doc. 2014-04997 Filed 3-6-14; 8:45 am]
BILLING CODE 4410-09-P