[Federal Register Volume 76, Number 204 (Friday, October 21, 2011)]
[Rules and Regulations]
[Pages 65371-65375]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-27282]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-357]
Schedules of Controlled Substances: Temporary Placement of Three
Synthetic Cathinones Into Schedule I
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Final Order.
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SUMMARY: The Administrator of the Drug Enforcement Administration (DEA)
is issuing this final order to temporarily schedule three synthetic
cathinones under the Controlled Substances Act (CSA) pursuant to the
temporary scheduling provisions of 21 U.S.C. 811(h). The substances are
4-methyl-N-methylcathinone (mephedrone), 3,4-methylenedioxy-N-
methylcathinone (methylone), and 3,4-methylenedioxypyrovalerone (MDPV).
This action is based on a finding by the Administrator that the
placement of these synthetic cathinones and their salts, isomers, 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
full effect of the CSA and its implementing regulations including
criminal, civil and administrative penalties, sanctions and regulatory
controls of Schedule I substances will be imposed on the manufacture,
distribution, possession, importation, and exportation of these
synthetic cathinones.
DATES: Effective Date: This Final Order is effective on October 21,
2011.
FOR FURTHER INFORMATION CONTACT: Imelda L. Paredes, Office of Diversion
Control, Drug Enforcement Administration, 8701 Morrissette Drive,
Springfield, Virginia 22152; Telephone (202) 307-7165.
SUPPLEMENTARY INFORMATION:
Background
The Comprehensive Crime Control Act of 1984 (Pub. L. 98-473), which
was signed into law on October 12, 1984, amended section 201 of the CSA
(21 U.S.C. 811) to give the Attorney General the authority to
temporarily place a substance into Schedule I of the CSA for one year
without regard to the requirements of 21 U.S.C. 811(b) if he finds that
such action is necessary to avoid imminent hazard to the public safety.
21 U.S.C. 811(h); 21 CFR 1308.49. If proceedings to control a substance
are initiated under 21 U.S.C. 811(a)(1), the Attorney General may
extend the temporary scheduling up to an additional six months. 21
U.S.C. 811(h)(2). Where the necessary findings are made, a substance
may be temporarily scheduled in Schedule I 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 under section 505 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355) for the substance. 21
U.S.C. 811(h)(1). The Attorney General has delegated his authority
under 21 U.S.C. 811 to the Administrator of DEA. 28 CFR 0.100.
Section 201(h)(4) of the CSA (21 U.S.C. 811(h)(4)) requires the
Administrator to notify the Secretary of Health and Human Services of
her intention to temporarily place a substance into Schedule I of the
CSA.\1\
[[Page 65372]]
The Administrator transmitted notice of her intent to place mephedrone,
methylone and MDPV in Schedule I on a temporary basis to the Assistant
Secretary in a letter dated June 15, 2011. The Assistant Secretary
responded to this notice by letter dated July 25, 2011, and advised
that based on review by the Food and Drug Administration (FDA) there
are currently no investigational new drug applications (INDs) or
approved new drug applications (NDAs) for MDPV, mephedrone, or
methylone. The Assistant Secretary also stated that the Department of
Health and Human Services has no objection to the temporary placement
of MDPV, mephedrone, and methylone into Schedule I of the CSA. DEA has
taken into consideration the Assistant Secretary's comments. As MDPV,
mephedrone, and methylone are not currently listed in any schedule
under the CSA, as no exemptions or approvals are in effect for MDPV,
mephedrone, and methylone under section 505 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355), and as this temporary scheduling is
necessary to avoid an imminent hazard to the public safety, DEA
believes that the conditions of 21 U.S.C. 811(h)(1) have been
satisfied.
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\1\ Because the Secretary of Health and Human Services has
delegated to the Assistant Secretary for Health of the Department of
Health and Human Services 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.''
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A notice of intent to temporarily place mephedrone, methylone, and
MDPV into Schedule I of the CSA was published in the Federal Register
on September 8, 2011 (76 FR 55616). The data in support of the notice
of intent and additional data continue to support the necessary
findings to place mephedrone, methylone, and MDPV temporarily into
Schedule I of the CSA as necessary to avoid an imminent hazard to the
public safety.\2\ In making this finding, the 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)). These factors are as follows: 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(c)(4)-(6). Consideration of these factors
includes actual abuse, diversion from legitimate channels, and
clandestine importation, manufacture, or distribution. 21 U.S.C.
811(h)(3).
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\2\ See ``Background, Data and Analysis of Synthetic Cathinones:
Mephedrone (4-MMC), Methylone (MDMC) and 3,4-
Methylenedioxypyrovalerone (MDPV)'' found at http://www.regulations.gov.
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Mephedrone, methylone, and MDPV are not currently listed in any
schedule under the CSA. The temporary placement of these three
synthetic cathinones into Schedule I of the CSA is necessary in order
to avoid an imminent hazard to the public safety. First, there has been
a rapid and significant increase in abuse of these substances in the
United States. As a result of this abuse, synthetic cathinones are
banned in at least 37 states in the United States and several
countries, and all five branches of the U.S. military prohibit military
personnel from possessing or using synthetic cathinones. Second, law
enforcement has seized synthetic cathinones and, based on self-reports
to law enforcement and health care professionals, synthetic cathinones
are abused for their psychoactive properties. Third, federal, state and
local public health departments and poison control centers have issued
reports describing public health consequences such as emergency
department visits and deaths from the use of these synthetic
cathinones. Based on scientific data currently available, these three
substances have the potential to be extremely harmful and, therefore,
pose an imminent hazard to the public safety.
Factor 4: History and Current Pattern of Abuse
Synthetic cathinones are designer drugs of the phenethylamine class
which are structurally and pharmacologically similar to amphetamine,
3,4-methylenedioxymethamphetamine (MDMA), cathinone and other related
substances. The addition of a beta-keto ([beta]-keto) substituent to
the phenethylamine core structure produces a group of substances that
now have cathinone as the core structure. Synthetic cathinones, like
amphetamine, cathinone, methcathinone, and methamphetamine, are central
nervous system (CNS) stimulants.
The synthetic cathinones mephedrone, methylone, and MDPV have
recently emerged on the United States' illicit drug market and are
being perceived as being `legal' alternatives to cocaine,
methamphetamine, and MDMA. Although synthetic cathinones are new to the
United States' illicit drug market, they have been popular drugs of
abuse in Europe since 2007. MDPV is a derivative of pyrovalerone, which
is a psychoactive drug that was used to treat chronic lethargy and
fatigue. Research in anti-depressant and anti-parkinson agents resulted
in the development and patenting of methylone. Methylone, however, has
not been approved for these purposes. There are no currently accepted
medical uses in treatment in the United States for mephedrone,
methylone, or MDPV.
Mephedrone, methylone, and MDPV are falsely marketed as ``research
chemicals,'' ``plant food,'' or ``bath salts.'' They are sold at smoke
shops, head shops, convenience stores, adult book stores, and gas
stations. They can also be purchased on the Internet and mailed using
the U.S. Postal Service or international mail services. The packages of
products containing these synthetic cathinones usually have the warning
``not for human consumption,'' most likely in an effort to circumvent
statutory restrictions for these substances. Despite disclaimers that
the products are not intended for human consumption, retailers promote
that routine urinalysis drug tests will not typically detect the
presence of these synthetic cathinones. However, analytical methods for
the detection of mephedrone, methylone, MDPV, and other synthetic
cathinones have recently been developed for these substances.
Evidence indicates that mephedrone, methylone, and MDPV are being
abused for their psychoactive properties. Drug surveys found that these
and other synthetic cathinones are being used as recreational drugs and
are used as alternatives to illicit stimulants like MDMA and cocaine.
Accordingly, mephedrone, methylone, and MDPV have been identified in
human urine samples that were obtained for routine drug screenings,
they have been detected in samples from drivers suspected of driving
under the influence, and they have been detected by drug courts during
mandatory periodic drug screens. They have also been identified in
biological specimens from individuals (some exhibiting symptoms of
``extreme agitation'' or ``excited delirium'') who have been arrested
for possession of a controlled substance, child endangerment, or
homicide. They have been detected in samples from decedents whose
causes of death were reported as drug-induced toxicity, multiple drug
toxicity, or other causes (e.g., blunt force trauma from a vehicular
collision or suicide).
Based on studies in the scientific literature, the marketing of
products that contain mephedrone, methylone, and MDPV is geared towards
teens and young adults. Accordingly, reports indicate that the main
users of synthetic cathinones are young male adults. These substances
are also used by mid-to-late adolescents and older adults. Many of
these abusers of synthetic cathinones have a previous history of drug
abuse.
[[Page 65373]]
According to drug surveys, the reported average amount of synthetic
cathinones used per dose ranged from approximately 25 to 250 milligrams
and the average amount used per session (i.e., repeated administration
and binging) ranged from approximately 25 milligrams to 5 grams
depending on the substance consumed, duration of intake, and route of
administration. The most common routes of administration of these
substances are nasal insufflation by snorting the powder and oral
ingestion by swallowing capsules or tablets. Other reported methods of
administration include injection, rectal administration, and
``bombing'' (wrapping a dose of powder in a paper wrap and swallowing).
Synthetic cathinones have also been reported to be used in binges.
Reasons cited for binging include to prolong the duration of effects,
to satisfy a ``craving,'' or to satisfy a strong urge to re-dose.
According to information found in drug surveys, clinical case
reports, and law enforcement reports, users have reported using
products containing mephedrone, methylone, and MDPV with other
synthetic cathinones (e.g., butylone, fluoromethcathinone, 4-MEC,
etc.), pharmaceutical agents (e.g., lidocaine, caffeine, benzocaine,
etc.), or other recreational substances (e.g., amphetamine, MDMA,
cocaine, gamma-butyrolactone (GBL), kratom, N,N-benzylpiperazine (BZP),
and 1-(3-trifluoromethylphenyl)-piperazine (TFMPP)). Chemical analyses
of seized and purchased synthetic cathinone products indicate that some
products contain multiple substances. Furthermore, investigative
toxicology reports of drug screens in which more than one substance was
detected indicate that users have ingested products composed of drug
combinations (e.g., a tablet composed of MDPV and BZP) or multiple drug
products (e.g., a MDPV powder product and a MDMA tablet).
Factor 5: Scope, Duration and Significance of Abuse
The popularity of synthetic cathinones as recreational drugs has
increased since they first appeared on the United States' illicit drug
market. According to forensic laboratory reports, the first appearance
of these synthetic cathinones in the United States occurred in 2009. In
2009, NFLIS registered 15 exhibits from 8 states containing these three
synthetic cathinones. In 2010, there were 574 reports from 29 states
related to these substances registered in NFLIS, and in 2011 (January
to August) there were 995.\3\
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\3\ Analyzed on September 15, 2011.
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Based on reports to DEA from law enforcement and public health
officials, synthetic cathinones are becoming increasingly prevalent and
abused throughout the United States. At one United States point of
entry, the U.S. Customs and Border Protection (CBP) has encountered at
least 127 shipments containing primarily mephedrone, methylone, and
MDPV, as well as other synthetic cathinones like 4-MEC, butylone,
fluoromethcathinone, and dimethylcathinone. Most of these shipments
originated in China or India and were being shipped to destinations
throughout the United States such as Arizona, Alaska, Hawaii, Kansas,
Louisiana, Oklahoma, Oregon, Pennsylvania, Missouri, Virginia,
Washington, and West Virginia. The American Association of Poison
Control Centers (AAPCC), a non-profit, national organization that
represents the poison control centers of the United States, reported
that in 2010, poison control centers took 303 calls about synthetic
cathinones. However, in just the first eight months of 2011, poison
control centers have already received 4,720 calls relating to these
products. These calls were received in poison control centers
representing at least 47 states and the District of Columbia.
Individual state poison control centers have also reported an increase
in the number of calls regarding ``bath salts'' from 2009 to 2011.
Concerns over the abuse of these and other synthetic cathinones
have prompted many states to control these substances. As of September
15, 2011, at least 37 states have emergency scheduled or enacted
legislation placing regulatory controls on some or many of the
synthetic cathinones. These states include Alabama, Arkansas,
Connecticut, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa,
Kansas, Kentucky, Louisiana, Maine, Maryland, Michigan, Minnesota,
Mississippi, Missouri, New Jersey, New Mexico, New York, North
Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Texas,
Tennessee, Utah, Vermont, Virginia, Washington, West Virginia,
Wisconsin and Wyoming. Several countries including all members of the
European Union have also placed controls on the possession and/or sale
of one or more of these substances. Moreover, the use of synthetic
cathinones by members of the U.S. Armed Forces is prohibited.
Factor 6: What, if Any, Risk There Is to the Public Health
The risks to the public health associated with the abuse of
mephedrone, methylone, and MDPV relate to acute and long term public
health and safety problems. These synthetic cathinones have become a
serious drug abuse threat as there have been reports of emergency room
admissions and deaths associated with the abuse of these substances.
Clinical case reports indicate that these synthetic cathinones
produce a number of stimulant-like adverse effects such as palpitation,
seizure, vomiting, sweating, headache, discoloration of the skin,
hypertension, and hyper-reflexia. Adverse effects associated with
consumption of these drugs as reported by abusers include nose-bleeds,
bruxism (teeth grinding), paranoia, hot flashes, dilated pupils,
blurred vision, dry mouth/thirst, palpitations, muscular tension in the
jaw and limbs, headache, agitation, anxiety, tremor, and fever or
sweating. Consequently, numerous individuals have presented at
emergency departments in response to exposure incidents and several
cases of acute toxicity have been reported due to the ingestion of
mephedrone, methylone, or MDPV. In addition, case reports have shown
that the abuse of synthetic cathinones can lead to psychological
dependence like that reported for other stimulant drugs.
According to clinical case reports, investigative toxicological
reports, and autopsy reports, mephedrone, methylone, and MDPV have been
implicated in drug induced overdose deaths. In at least three reported
deaths, one of these synthetic cathinones was ruled as the cause of
death. Other deaths involved individuals under the influence of these
synthetic cathinones who acted violently and unpredictably in causing
harm to themselves or others. There have also been reports in the
scientific literature of deaths caused by individuals who were driving
under the influence of these synthetic cathinones.
A number of synthetic cathinones and their products, as identified
by CBP and reported in the scientific literature, appear to originate
from foreign sources. The manufacturers and retailers who make and sell
these products do not fully disclose the product ingredients including
the active ingredients or the health risks and potential hazards
associated with these products. This poses significant risk to abusers
who may not know what they are purchasing or the risk associated with
the use of those products.
[[Page 65374]]
Based on the above data, the continued uncontrolled manufacture,
distribution, importation, exportation, and abuse of mephedrone,
methylone, and MDPV pose an imminent hazard to the public safety. DEA
is not aware of any recognized therapeutic uses of these synthetic
cathinones in the United States.
DEA has considered the three criteria for placing a substance into
Schedule I of the CSA (21 U.S.C. 812), and finds that the data
available and reviewed for mephedrone, methylone, and MDPV indicate
that these synthetic cathinones each have a high potential for abuse,
no currently accepted medical use in treatment in the United States,
and lack accepted safety for use under medical supervision.
In accordance with the provisions of section 201(h) of the CSA (21
U.S.C. 811(h)) and 28 CFR 0.100, the Administrator has considered the
available data and the three factors required to support a
determination to temporarily schedule three synthetic cathinones (4-
methyl-N-methylcathinone, 3,4-methylenedioxy-N-methylcathinone, and
3,4-methylenedioxypyrovalerone) in Schedule I of the CSA and finds that
placement of these synthetic cathinones and their salts, isomers, and
salts of isomers into Schedule I of the CSA is necessary to avoid an
imminent hazard to the public safety.
Regulatory Requirements
With the issuance of this final order, mephedrone, methylone, and
MDPV become subject to the regulatory controls and administrative,
civil and criminal sanctions applicable to the manufacture,
distribution, possession, importation and exportation of a Schedule I
controlled substance under the CSA.
1. Registration. Any person who manufactures, distributes,
dispenses, imports, exports, or possesses mephedrone, methylone, or
MDPV or who engages in research or conducts instructional activities
with respect to mephedrone, methylone, or MDPV, or who proposes to
engage in such activities, must be registered to conduct such
activities in accordance with 21 U.S.C. 823 and 958. Any person who is
currently engaged in any of the above activities and is not registered
with DEA must submit an application for registration and may not
continue their activities until DEA has approved that application.
Retail sales of Schedule I controlled substances to the general public
are not allowed under the Controlled Substances Act.
2. Security. Mephedrone, methylone, and MDPV are subject to
Schedule I security requirements. Accordingly, appropriately registered
DEA registrants must manufacture, distribute and store these substances
in accordance with 1301.71; 1301.72(a), (c), and (d); 1301.73; 1301.74;
1301.75(a) and (c); and 1301.76 of Title 21 of the Code of Federal
Regulations as of October 21, 2011.
3. Labeling and packaging. All labeling and packaging requirements
for controlled substances set forth in Part 1302 of Title 21 of the
Code of Federal Regulations shall apply to commercial containers of
mephedrone, methylone, and MDPV. Current DEA registrants shall have
thirty (30) calendar days from the effective date of this Final Order
to be in compliance with all labeling and packaging requirements.
4. Quotas. Quotas for mephedrone, methylone, and MDPV will be
established based on registrations granted and quota applications
received pursuant to Part 1303 of Title 21 of the Code of Federal
Regulations.
5. Inventory. Every DEA registrant who possesses any quantity of
mephedrone, methylone, or MDPV is required to keep inventory of all
stocks of these substances on hand pursuant to 1304.03, 1304.04, and
1304.11 of Title 21 of the Code of Federal Regulations. Every current
DEA registrant who desires registration in Schedule I for mephedrone,
methylone, or MDPV shall conduct an inventory of all stocks of these
substances. Current DEA registrants shall have thirty (30) calendar
days from the effective date of this Final Order to be in compliance
with all inventory requirements.
6. Records. All registrants who handle mephedrone, methylone, or
MDPV are required to keep records pursuant to 1304.03, 1304.04,
1304.21, 1304.22, and 1304.23 of Title 21 of the Code of Federal
Regulations. Current DEA registrants shall have thirty (30) calendar
days from the effective date of this Final Order to be in compliance
with all recordkeeping requirements.
7. Reports. All registrants are required to submit reports in
accordance with 1304.33 of Title 21 of the Code of Federal Regulations.
Registrants who manufacture or distribute mephedrone, methylone, or
MDPV are required to comply with these reporting requirements and shall
do so as of October 21, 2011.
8. Order Forms. All registrants involved in the distribution of
mephedrone, methylone, or MDPV must comply with order form requirements
of Part 1305 of Title 21 of the Code of Federal Regulations as of
October 21, 2011.
9. Importation and Exportation. All importation and exportation of
mephedrone, methylone, or MDPV must be conducted by appropriately
registered DEA registrants in compliance with Part 1312 of Title 21 of
the Code of Federal Regulations on or after October 21, 2011.
10. Criminal Liability. The manufacture, distribution,
dispensation, or possession with the intent to conduct these
activities: Possession, importation, or exportation of mephedrone,
methylone, or MDPV not authorized by, or in violation of the CSA or the
Controlled Substances Import and Export Act occurring as of October 21,
2011 is unlawful.
Pursuant to the Small Business Regulatory Enforcement Fairness Act
of 1996 (Congressional Review Act) (5 U.S.C. 801-808), DEA has
submitted a copy of this Final Order to both Houses of Congress and to
the Comptroller General.
List of Subjects in 21 CFR Part 1308
Administrative practice and procedure, Drug traffic control,
Reporting and recordkeeping requirements.
Under the authority vested in the Attorney General by section
201(h) of the CSA (21 U.S.C. 811(h)), and delegated to the
Administrator of the DEA by Department of Justice regulations (28 CFR
0.100), the Administrator hereby orders that 21 CFR Part 1308 be
amended 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), unless otherwise noted.
0
2. Section 1308.11 is amended by adding new paragraphs (g)(6), (7) and
(8) to read as follows:
Sec. 1308.11 Schedule I.
* * * * *
(g) * * *
(6) 4-methyl-N-methylcathinone--1248
(Other names: mephedrone)
(7) 3,4-methylenedioxy-N-methylcathinone--7540
(Other names: methylone)
(8) 3,4-methylenedioxypyrovalerone--7535
(Other names: MDPV)
* * * * *
[[Page 65375]]
Dated: October 14, 2011.
Michele M. Leonhart,
Administrator.
[FR Doc. 2011-27282 Filed 10-20-11; 8:45 am]
BILLING CODE 4410-09-P