[Federal Register Volume 79, Number 45 (Friday, March 7, 2014)]
[Rules and Regulations]
[Pages 12938-12943]
From the Federal Register Online via the Government Publishing 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
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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,
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[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
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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