Schedules of Controlled Substances: Placement of Methylone Into Schedule I, 63766-63771 [2012-25509]
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Federal Register / Vol. 77, No. 201 / Wednesday, October 17, 2012 / Proposed Rules
Federal Deposit Insurance Corporation.
Robert E. Feldman,
Executive Secretary.
[FR Doc. 2012–25495 Filed 10–16–12; 8:45 am]
BILLING CODE 6714–01–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA–357]
Schedules of Controlled Substances:
Placement of Methylone Into
Schedule I
Drug Enforcement
Administration, Department of Justice.
ACTION: Notice of proposed rulemaking.
AGENCY:
The Drug Enforcement
Administration (DEA) proposes placing
3,4-methylenedioxy-N-methylcathinone
(methylone) including its salts, isomers,
and salts of isomers whenever the
existence of such salts, isomers, and
salts of isomers is possible, into
Schedule I of the Controlled Substances
Act (CSA). This proposed action is
pursuant to the CSA which requires that
such actions be made on the record after
opportunity for a hearing through
formal rulemaking.
DATES: DEA will permit interested
persons to file written comments on this
proposal pursuant to 21 CFR 1308.43(g).
Electronic comments must be submitted
and written comments must be
postmarked on or before December 17,
2012. Commenters should be aware that
the electronic Federal Docket
Management System will not accept
comments after midnight Eastern Time
on the last day of the comment period.
Interested persons, defined at 21 CFR
1300.01 as those ‘‘adversely affected or
aggrieved by any rule or proposed rule
issuable pursuant to section 201 of the
Act (21 U.S.C. 811),’’ may file a request
for hearing pursuant to 21 CFR 1308.44
and in accordance with 21 CFR 1316.45
and 1316.47. Requests for hearing,
notices of appearance, and waivers of
participation must be received on or
before November 16, 2012.
ADDRESSES: To ensure proper handling
of comments, please reference ‘‘Docket
No. DEA–357’’ on all electronic and
written correspondence. DEA
encourages all comments be submitted
electronically through https://
www.regulations.gov using the
electronic comment form provided on
that site. An electronic copy of this
document and supplemental
information to this proposed rule are
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SUMMARY:
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also available at the https://
www.regulations.gov Web site for easy
reference. Paper comments that
duplicate the electronic submission are
not necessary as all comments
submitted to www.regulations.gov will
be posted for public review and are part
of the official docket record. Should
you, however, wish to submit written
comments via regular or express mail,
they should be sent to the Drug
Enforcement Administration, Attention:
DEA Federal Register Representative/
OD, 8701 Morrissette Drive, Springfield,
VA 22152. All requests for hearing must
be sent to Drug Enforcement
Administration, Attention: Hearing
Clerk/LJ, 8701 Morrissette Drive,
Springfield, VA 22152.
FOR FURTHER INFORMATION CONTACT:
Alan G. Santos, Associate Deputy
Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration; Mailing Address: 8701
Morrissette Drive, Springfield, Virginia
22152; Telephone: (202) 307–7165.
SUPPLEMENTARY INFORMATION:
Posting of Public Comments: Please
note that all comments received are
considered part of the public record and
made available for public inspection
online at https://www.regulations.gov
and in the DEA’s public docket. Such
information includes personal
identifying information (such as your
name, address, etc.) voluntarily
submitted by the commenter.
If you want to submit personal
identifying information (such as your
name, address, etc.) as part of your
comment, but do not want it to be
posted online or made available in the
public docket, you must include the
phrase ‘‘PERSONAL IDENTIFYING
INFORMATION’’ in the first paragraph
of your comment. You must also place
all of the personal identifying
information you do not want posted
online or made available in the public
docket in the first paragraph of your
comment and identify what information
you want redacted.
If you want to submit confidential
business information as part of your
comment, but do not want it to be
posted online or made available in the
public docket, you must include the
phrase ‘‘CONFIDENTIAL BUSINESS
INFORMATION’’ in the first paragraph
of your comment. You must also
prominently identify confidential
business information to be redacted
within the comment. If a comment has
so much confidential business
information that it cannot be effectively
redacted, all or part of that comment
may not be posted online or made
available in the public docket.
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Personal identifying information and
confidential business information
identified and located as set forth above
will be redacted, and the comment, in
redacted form, will be posted online and
placed in the DEA’s public docket file.
Please note that the Freedom of
Information Act applies to all comments
received. If you wish to inspect the
agency’s public docket file in person by
appointment, please see the FOR
FURTHER INFORMATION paragraph.
Request for Hearing, Notice of
Appearance at or Waiver of
Participation in Hearing
In accordance with the CSA, this
action is a formal rulemaking ‘‘on the
record after opportunity for a hearing.’’
21 U.S.C. 811(a). Such proceedings are
conducted pursuant to the provisions of
the Administrative Procedure Act (5
U.S.C. 556 and 557) and 21 CFR
1308.41. Pursuant to 21 CFR 1308.44(a)–
(c), requests for hearing, notices of
appearance, and waivers of
participation may be submitted only by
interested persons, defined at 21 CFR
1300.01 as those ‘‘adversely affected or
aggrieved by any rule or proposed rule
issuable pursuant to section 201 of the
Act (21 U.S.C. 811).’’ Such requests or
notices must conform to the
requirements of 21 CFR 1308.44(a) or (b)
and 1316.47 or 1316.48, as applicable. A
request or notice should state, with
particularity, the interest of the person
in the proceeding and the objections or
issues, if any, concerning which the
person desires to be heard. Any waiver
must conform to the requirements of 21
CFR 1308.44(c) and 1316.49, including
a written statement regarding the
interested person’s position on the
matters of fact and law involved in any
hearing.
Please note that pursuant to 21 U.S.C.
811(a), the purpose and subject matter
of the hearing is restricted to ‘‘(A)
find[ing] that such drug or other
substance has a potential for abuse, and
(B) mak[ing] with respect to such drug
or other substance the findings
prescribed by subsection (b) of section
812 of this title for the schedule in
which such drug is to be placed * * *’’
Requests for hearing, notices of
appearance at the hearing, and waivers
of participation in the hearing should be
submitted to DEA using the address
information provided above.
Legal Authority
The DEA implements and enforces
Titles II and III of the Comprehensive
Drug Abuse Prevention and Control Act
of 1970, often referred to as the
Controlled Substances Act and the
Controlled Substances Import and
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Export Act (21 U.S.C. 801–971), as
amended (hereinafter, ‘‘CSA’’). The
implementing regulations for these
statutes are found in Title 21 of the
Code of Federal Regulations (CFR), parts
1300 to 1321. Under the CSA, controlled
substances are classified in 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 by statute are found at 21
U.S.C. 812(c) and the current list of
scheduled substances are published at
21 CFR Part 1308.
The CSA permits these schedules to
be modified by providing that
scheduling of any drug or other
substance may be initiated by the
Attorney General (1) on his own motion;
(2) at the request of the Secretary of
HHS, or (3) on the petition of any
interested party. 21 U.S.C. 811(a). The
Attorney General may, by rule, ‘‘add to
such a schedule or transfer between
such schedules any drug or other
substance if he (A) finds that such drug
or other substance has a potential for
abuse, and (B) makes with respect to
such drug or other substance the
findings prescribed by subsection (b) of
section 812 of this title for the schedule
in which such drug is to be placed
* * *’’ 21 U.S.C. 811(a). The findings
required for the placement of a
controlled substance in Schedule I are:
‘‘(A) The drug or other substance has a
high potential for abuse. (B) The drug or
substance has no currently accepted
medical use in treatment in the United
States. (C) There is a lack of accepted
safety for use of the drug or other
substance under medical supervision.’’
21 U.S.C. 812(b).
Background
On September 8, 2011, the
Administrator of the DEA published a
Notice of Intent to temporarily place
3,4-methylenedioxy-N-methylcathinone
(methylone) along with two other
synthetic cathinones (4-methyl-Nmethylcathinone (mephedrone) and 3,4methylenedioxypyrovalerone (MDPV))
into Schedule I pursuant to the
temporary scheduling provisions of the
CSA (76 FR 55616). Following this, on
October 21, 2011, the Administrator
published a Final Order in the Federal
Register (76 FR 65371) amending 21
CFR 1308.11(g) to temporarily place
these three synthetic cathinones into
Schedule I of the CSA pursuant to the
temporary scheduling provisions of 21
U.S.C. 811(h). This Final Order, which
became effective on the date of
publication, was based on findings by
the Administrator of the DEA that the
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temporary scheduling of these three
synthetic cathinones was necessary to
avoid an imminent hazard to the public
safety pursuant to 21 U.S.C. 811(h)(1).
At the time the Final Order took effect,
Section 201(h)(2) of the CSA (21 U.S.C.
811(h)(2) (2011)) required that the
temporary scheduling of a substance
expire at the end of one year from the
date of issuance of the scheduling order,
and it provided that, during the
pendency of proceedings under 21
U.S.C. 811(a)(1) with respect to the
substance, temporary scheduling of that
substance could be extended for up to
six months.1 Under this provision, the
temporary scheduling of methylone
expires on October 20, 2012, unless
extended pursuant to 21 U.S.C.
811(h)(2). An extension until April 20,
2013, is being ordered by the
Administrator in a separate action.
As described in the October 21, 2011,
Final Order, methylone is a designer
drug of the phenethylamine class and is
structurally and pharmacologically
similar to amphetamine, 3,4methylenedioxymethamphetamine
(MDMA), cathinone and other related
substances. The addition of a beta-keto
(b-ketone) substituent to the
phenethylamine core structure produces
a group of substances that have b-ketophenethylamine as the core structure.
Methylone has a b-keto-phenethylamine
core structure. Methylone has been used
as research chemical. Based on the
review of the scientific literature, there
are no known medical uses for
methylone. The Assistant Secretary of
Health for the U.S. Department of
Health and Human Services (HHS) has
advised that there are no exemptions or
approvals in effect for methylone under
section 505 (21 U.S.C. 355) of the
Federal Food, Drug and Cosmetic Act.
Proposed Determination To Schedule
Methylone
This NPRM proposes the permanent
scheduling of methylone pursuant to 21
U.S.C. 811(a)(1). On March 30, 2012,
DEA requested a scientific and medical
evaluation and scheduling
recommendation from the Assistant
Secretary of Health for HHS for
methylone, mephedrone and MDPV
pursuant to 21 U.S.C. 811(b). Upon
1 On July 9, 2012, President Obama signed the
Food and Drug Administration Safety and
Innovation Act (Pub. L. 112–144) (FDASIA), which
amended several provisions of the CSA. Subtitle D
of FDASIA is titled the ‘‘Synthetic Drug Abuse
Prevention Act of 2012.’’ In particular, FDASIA
amended Schedule I of section 202(c) of the CSA
to include mephedrone and MDPV but not
methylone, and amended section 201(h)(2) to
increase the maximum timeframes for temporary
scheduling. Public Law 112–144, Sections 1152(b)
and 1153.
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receipt and evaluation of the scientific
and medical evaluation and scheduling
recommendation from the Assistant
Secretary,2 DEA concluded its analysis
of all other relevant data for the
proposal to place methylone into
Schedule I of the CSA.
Included below is a brief summary of
each factor as analyzed by HHS and
DEA, and as considered by DEA in the
scheduling decision. Please note that
both the DEA and HHS analyses are
available under ‘‘Supporting and
Related Material’’ of the public docket
for this proposed rule at
www.regulations.gov under docket
number DEA–357.
1. The Drug’s Actual or Relative
Potential for Abuse: The abuse potential
of methylone is associated with its
ability to evoke pharmacological effects
similar to those evoked by the Schedule
I and II substances such as cathinone
(Schedule I), methcathinone (Schedule
I), 3,4-MDMA (Schedule I),
amphetamine (Schedule II),
methamphetamine (Schedule II), and
cocaine (Schedule II). These Schedule I
and II substances have a high potential
for abuse.
The legislative history of the CSA
suggests the following four prongs to
consider in determining whether a
particular drug or substance has
potential for abuse: 3
i. There is evidence that individuals
are taking the drug or other substance in
amounts sufficient to create a hazard to
their health or to the safety of other
individuals or to the community; or
ii. There is significant diversion of the
drug or substance from legitimate drug
channels; or
iii. Individuals are taking the
substance on their own initiative rather
than on the basis of medical advice from
a practitioner licensed by law to
administer such drugs; or
iv. The drug is a new drug so related
in its action to a drug or other substance
already listed as having a potential for
abuse to make it likely that the drug or
other substance will have the same
potential for abuse as such drugs, thus
making it reasonable to assume that
there may be significant diversion from
legitimate channels, significant use
contrary to or without medical advice,
or that it has a substantial capability of
creating hazards to the health of the user
or to the safety of the community.
2 DEA received from HHS Evaluation and
Recommendation documents with respect to
methylone, but not for mephedrone and MDPV.
However, mephedrone and MDPV are listed as
Schedule I substances under FDASIA.
3 Comprehensive Drug Abuse Prevention and
Control Act of 1970, H.R. Rep. No. 91–1444, 91st
Cong., Sess. 1 (1970); 1970 U.S.C.C.A.N. 4566, 4601.
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With respect to the first prong, a
number of case reports and case series
have shown that individuals are taking
methylone and products containing
methylone in amounts sufficient to
induce adverse health effects similar to
those induced by amphetamine,
methamphetamine, and MDMA,
Schedule I and II substances. These
effects included elevated body
temperature, increases in heart rate and
respiratory exchange, changes in blood
pressure, seizures, erratic behavior, and
coma. Even death has been reported
following the abuse of methylone or
products containing methylone. Further,
law enforcement encounters indicate
the occurrence of a fatal automotive
accident that was caused by a driver
under the influence of a product
containing methylone.
In considering evidence of significant
diversion of the drug or substance from
legitimate drug channels under the
second prong, it must be noted that as
of October 21, 2011, methylone has been
temporarily controlled as a Schedule I
substance and thus has not been legally
available unless for research purposes.
However, the National Forensic
Laboratory Information System (NFLIS),
which details over 2,500 reports from
state and local forensic laboratories,
identified methylone in drug related
exhibits for a period from January 2009
to June 2012 from 42 states. The System
to Retrieve Information from Drug
Evidence (STRIDE), which details
reports from federal forensic
laboratories, identified methylone in
220 drug related exhibits from a period
from January 2009 to June 2012.
For the third prong, HHS states that
there is no currently accepted medical
use for methylone and no medical
practitioner is currently licensed by law
to administer methylone. Indeed, the
FDA has not approved a new drug
application (NDA) for methylone for any
therapeutic indication, and no
investigational new drug (IND)
application for methylone is currently
active. Thus, with no accepted medical
use or administering practitioners,
individuals currently using products
containing methylone are doing so on
their own initiative without medical
advice from a practitioner licensed to
administer methylone.
With regard to the fourth prong, HHS
states that methylone produces
pharmacological effects similar to those
produced by the Schedule I and II
central nervous system (CNS)
substances such as amphetamine,
methamphetamine, cocaine, and MDMA
which have a high potential for abuse.
Methylone, like these Schedule I and II
substances, affects the concentrations of
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the neurotransmitters dopamine,
serotonin and norepinephrine in the
CNS. In drug discrimination assays,
methylone substitutes for MDMA,
amphetamine, methamphetamine, and
cocaine, which suggests that methylone
will likely produce subjective effects in
humans similar to these substances and
have a similar pattern of abuse.
Methylone, like methamphetamine,
amphetamine, and cocaine, is a CNS
stimulant and produces locomotor
stimulant activity in animals.
Methylone has no known medical use
in the United States but evidence
demonstrates that methylone is being
abused by individuals for its
psychoactive effects. Methylone has
been encountered by law enforcement
throughout the United States as reported
in NFLIS and in STRIDE databases
suggesting that individuals are abusing
methylone. Methylone has also been
identified during the toxicological
screening of individual human urine
samples which also demonstrates that
individuals are abusing this substance.
In addition, information from poison
centers indicates the abuse of synthetic
cathinones which likely include
methylone. The American Association
of Poison Control Centers (AAPCC) 4
reported in a press release that poison
centers took 304 calls in 2010 regarding
synthetic cathinone exposures and
6,138 calls in 2011. As of September 12,
2012, poison centers have received
2,251 calls relating to these products
this year. These calls were received in
poison centers representing at least 47
states and the District of Columbia.
Although methylone may not be
specifically identified during exposure
calls or identified by toxicology testing
by AAPCC, it is likely that some of these
retail products described by the callers
contained methylone, based on the
identification of methylone in
approximately 26% of all synthetic
cathinones related exhibits reported to
NFLIS from January 2009 to June 2012.
State public health and poison centers
have warned of the dangers associated
with the use of synthetic cathinones and
their associated products being found
on the designer drug market. In
response to the abuse of methylone and
other synthetic cathinones, as of
September 2012, at least 42 states have
emergency scheduled or enacted
legislation placing regulatory controls
on some or many of the synthetic
cathinones including mephedrone,
methylone, MDPV and/or a defined
general class of cathinones. At least 27
4 AAPCC is a non-profit, national organization
that represents the poison centers of the United
States.
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states specifically control methylone.
Numerous local jurisdictions have also
placed controls on methylone and other
synthetic cathinones. All five branches
of the U.S. military prohibit military
personnel from possessing or using
synthetic cathinones including
methylone.
Methylone has been reported to cause
a number of adverse effects that are
characteristic of stimulants like
methamphetamine, amphetamine, and
cocaine. Adverse effects associated with
the consumption of methylone include
those typical of a sympathomimetic
agent such as palpitations,
hyperthermia, seizures, hyponatremia,
bruxism, sweating, hypertension,
tachycardia, headache, palpitations,
thirst, mydriasis, tremor, fever,
sweating, and hypertension. Other
effects that have been reported from the
use of methylone include psychological
effects such as confusion, psychosis,
paranoia, hallucinations,
combativeness, and agitation. Finally,
reports of death for individuals abusing
methylone indicate that methylone is a
serious public health threat.
2. Scientific Evidence of the Drug’s
Pharmacological Effects, If Known: In
the recommendation from HHS for the
placement of methylone in Schedule I of
the CSA, HHS states that based on the
results of preclinical studies and the
toxicological profile observed in
emergency room cases and medical
examiner cases it is probable that
methylone produces pharmacological
effects in humans that are similar to
those produced by the Schedule I and
II substances amphetamine,
methamphetamine, cocaine, and
MDMA. These findings are based on
published data on the release of
monoamines, inhibition of reuptake of
monoamines, and in vivo studies
(microdialysis, locomotor activity, body
temperature, drug discrimination) and
are also based on data from studies
(locomotor, drug discrimination, in vitro
receptor binding, and functional assays)
conducted by National Institute on Drug
Abuse (NIDA) contract researchers. The
preclinical data showed that methylone
can substitute for MDMA or
amphetamine in rats trained to
discriminate amphetamine or MDMA,
respectively. Methylone, like
methamphetamine, amphetamine, and
cocaine, is a CNS stimulant and
produces locomotor stimulant effects in
animals. Methylone, like
methamphetamine, has a rewarding
effect as evidenced by conditioned place
preference tests. Methylone is an
inhibitor of dopamine, serotonin and
norepinephrine uptake and also causes
the release of these neurotransmitters in
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the CNS. Furthermore, studies show
that methylone, like MDMA, can be
cytotoxic to liver cells. HHS further
states that the toxicological profile
observed in emergency room and
medical examiner cases involving
methylone demonstrate that the
pharmacological profile observed in
humans is in accordance with
preclinical data.
3. The State of Current Scientific
Knowledge Regarding the Drug or Other
Substance: Methylone is a bketophenethylamine (i.e., synthetic
cathinone) that is structurally and
pharmacologically similar to
amphetamine, methamphetamine,
MDMA, cathinone and other related
substances. Methylone can be prepared
from its corresponding ketone by a twostep synthesis. Studies indicate that
humans metabolize methylone and
metabolites of methylone have been
found in the urine samples of humans
and animals given methylone. Research
in anti-depressant and anti-parkinson
agents resulted in the synthesis and
patenting of methylone. According to
HHS, methylone has no approved
medical use in the United States, does
not have an approved NDA, and is not
currently marketed in the United States
in an FDA-approved drug product. A
drug has a ‘‘currently accepted medical
use’’ if all of the following five elements
have been satisfied: the drug’s chemistry
is known and reproducible; and there
are adequate safety studies; and there
are adequate and well-controlled studies
proving efficacy; and the drug is
accepted by qualified experts; and the
scientific evidence is widely available.
57 Fed. Reg. 10499 (March 26, 1992).
According to HHS, there are no
published clinical studies involving
methylone. DEA has also not found any
references to clinical studies involving
methylone’s efficacy and safety in the
scientific and medical literature.
Although the chemistry of methylone is
known and has been reproduced, as
mentioned above there are no clinical
studies involving methylone. Thus,
methylone has no currently accepted
medical use in treatment in the United
States and there is a lack of accepted
safety for use of methylone under
medical supervision.
4. Its History and Current Pattern of
Abuse: Methylone is a synthetic
cathinone that emerged on the United
States’ illicit drug market in 2009 and
prior to its temporary control was
perceived as being a ‘legal’ alternative to
cocaine, methamphetamine, and
MDMA. Methylone is falsely marketed
as ‘‘research chemicals,’’ ‘‘plant food,’’
or ‘‘bath salts’’ and has been sold at
smoke shops, head shops, convenience
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stores, adult book stores, and gas
stations and can also be purchased on
the Internet under a variety of product
names (White Dove, Explosion,
Tranquility etc.). It is commonly
encountered in the form of powders,
capsules, and tablets. The packages of
these commercial products usually
contain the warning ‘‘not for human
consumption.’’ Poison centers reported
a large number of toxic exposures to
these products as indicated by the
number of exposure calls related to
synthetic cathinones. A large majority of
these exposures were by intentional
abuse, misuse, or suspected suicide.
Most of these exposures were described
as acute. AAPCC data also identified the
most common route of administration
for the synthetic cathinones as
inhalation/nasal. Information from
published scientific studies indicate
that the most common routes of
administration for methylone is
ingestion by swallowing capsules or
tablets or nasal insufflation by snorting
the powder. Evidence from poison
centers, published case reports, and law
enforcement encounters suggest that the
main users of methylone are young
adults. These substances are popular
among youths and young adults with
males appearing to abuse methylone
more than females. There is evidence
that methylone may be co-ingested with
other substances including other
synthetic cathinones, pharmaceutical
agents, or other recreational substances.
5. The Scope, Duration, and
Significance of Abuse: Evidence that
methylone is being abused is confirmed
by drug courts,5 calls to poison centers,
and encounters by law enforcement.
Methylone has been identified in
specimens from individuals submitted
for testing by drug court participants.
Drug courts submitted to DEA 18 reports
that detail the analysis of biological
specimens that contained synthetic
cathinones. Methylone was mentioned
in 5 of these reports. Evidence from
poison centers also indicates that the
abuse of synthetic cathinones like
methylone is widespread. The AAPCC
reported in a press release that poison
centers took 304 calls in 2010 regarding
synthetic cathinone exposures and
6,138 calls in 2011. As of September 12,
2012, poison centers have received
5 Drug courts were developed to achieve a
reduction in recidivism and substance abuse among
nonviolent, substance abusing offenders by
increasing their likelihood for successful
rehabilitation through early, continuous, and
intense judicially supervised treatment, mandatory
periodic drug testing, and the use of appropriate
sanctions and other rehabilitation services. Drug
courts analyze specimens from participants for new
and existing drugs of abuse.
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2,251 calls relating to these products
this year. These calls were received in
poison centers representing at least 47
states and the District of Columbia.
Methylone may not have been
specifically mentioned during the
exposure calls but it is likely that some
of these retail products described by the
callers contained methylone based on
the identification of methylone in
approximately 26% of all synthetic
cathinones related exhibits reported to
NFLIS from January 2009 to June 2012.
Evidence of the increased abuse of
methylone is supported by law
enforcement encounters of methylone.
Forensic laboratories have analyzed
drug exhibits received from state, local,
or federal law enforcement agencies that
were found to contain methylone. The
National Forensic Laboratory
Information System (NFLIS) is a
program sponsored by DEA’s Office of
Diversion Control. NFLIS compiles
information on exhibits analyzed in
state and local law enforcement
laboratories. The System to Retrieve
Information from Drug Evidence
(STRIDE) is a DEA database which
compiles information on exhibits
analyzed in DEA laboratories. NFLIS
and STRIDE together capture data for all
substances reported by forensic
laboratory analyses. Methylone has been
encountered by law enforcement as
reported in NFLIS.6 NFLIS details 2,797
reports from state and local forensic
laboratories identifying methylone in
drug related exhibits for a period from
January 2009 to June 2012 from 42
States. NFLIS registered 4 reports from
3 states containing methylone in 2009.
However, there were 71 reports from 18
states related to these substances
registered in NFLIS in 2010 and there
were 1,655 reports from 41 states in
2011. From January to June 2012 there
were 1,067 reports from 36 states.
STRIDE also details 220 reports from
federal forensic laboratories identifying
methylone in drug related exhibits for a
period from January 2009 to June 2012.
STRIDE (which reports data from 6 DEA
laboratories) registered 1 exhibit
pertaining to methylone in 2009. There
were 7 exhibits pertaining to the
trafficking, distribution and abuse of
methylone registered in STRIDE in 2010
and 107 drug exhibits in 2011. In 2012,
105 drug exhibits pertaining to the
trafficking, distribution and abuse of
methylone were recorded in the STRIDE
database.
6 State and local forensic drug reports from
January 2009 to June 2012, analyzed on September
12, 2012. The 2012 drug reports are likely to be
incomplete as of September 12, 2012, due to
laboratory reporting lag time.
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63770
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At selected United States ports of
entry, the U.S. Customs and Border
Protection (CBP) has encountered
shipments of products containing
methylone. The most commonly
identified synthetic cathinone was
methylone. As of July 2012, methylone
was identified in 127 of 330 shipments
encountered by CBP from June 2008 to
July 2012. These shipments of
methylone were in powdered form
ranging from gram to multi-kilogram
quantities. Most of the shipments of
these synthetic cathinones that
contained methylone originated in
China and were destined for delivery
throughout the United States to places
like Alaska, Arizona, Arkansas,
California, Colorado, Florida, Hawaii,
Illinois, Kansas, Louisiana, Oklahoma,
Oregon, Missouri, Nevada, New Mexico,
Tennessee, Texas, Washington, and
West Virginia.
Concerns over the abuse of methylone
and other synthetic cathinones have
prompted many states to control these
substances. As of September 2012, at
least 42 states have emergency
scheduled or enacted legislation placing
regulatory controls on some or many of
the synthetic cathinones including
methylone. In addition, the U.S. Armed
Forces prohibited the use of synthetic
cathinones including mephedrone,
methylone and MDPV.
6. What, if any, Risk There is to the
Public Health: Law enforcement,
military, and public health officials
have reported exposure incidents that
demonstrate the dangers associated with
methylone to both the individual
abusers and other affected individuals.
Numerous individuals have presented at
emergency departments following
exposure to methylone or products
containing methylone. Case reports
describe presentations to emergency
departments of individuals exposed to
methylone with symptoms that include
tachycardia, headache, palpitations,
agitation, anxiety, mydriasis, tremor,
fever, sweating, and hypertension. Some
individuals under the influence of
methylone have acted violently and
unpredictably causing harm, or even
death, to themselves or others. In
addition, individuals suspected of
driving under the influence of
intoxicating substances have been found
to have positive test results for
methylone and some of these incidents
involving methylone intoxications have
resulted in the deaths of individuals.
There are at least three reported deaths
in which methylone was ruled as the
cause of death by the medical examiner
or after an autopsy and there are many
reports in which methylone was
implicated (i.e., the primary cause of
VerDate Mar<15>2010
15:02 Oct 16, 2012
Jkt 229001
death is not methylone toxicity) in
deaths. Additionally, products
containing methylone and other
synthetic cathinones often do not bear
labeling information regarding their
ingredients, and if they do it may not
contain the expected active ingredients
or identify the health risks and potential
hazards associated with these products.
7. Its Psychic or Physiological
Dependence Liability: According to
HHS, there are no studies or case reports
that document the psychic or
physiological dependence potential of
methylone. However, HHS states that
because methylone shares
pharmacological properties with those
of the Schedule I and II substances
amphetamine, methamphetamine,
cocaine, and MDMA, it is probable that
methylone has a dependence profile
similar to that of these substances which
are known to cause substance
dependence.
8. Whether the Substance is an
Immediate Precursor of a Substance
Already Controlled Under the CSA:
Methylone is not considered an
immediate precursor of any controlled
substance of the CSA as defined by 21
U.S.C 802(23).
Conclusion: Based on consideration of
the scientific and medical evaluation
and accompanying recommendation of
HHS, and based on DEA’s consideration
of its own eight-factor analysis, DEA
finds that these facts and all relevant
data constitute substantial evidence of
potential for abuse of methylone. As
such, DEA hereby proposes to schedule
methylone as a controlled substance
under the CSA.
Proposed Determination of Appropriate
Schedule
The CSA establishes five schedules of
controlled substances known as
Schedules I, II, III, IV, and V. The statute
outlines the findings required to place a
drug or other substance in any
particular schedule. 21 U.S.C. 812(b).
After consideration of the analysis and
recommendations of the Assistant
Secretary for Health of HHS and review
of all available data, the Administrator
of DEA, pursuant to 21 U.S.C. 812(b)(1),
finds that:
(1) 3,4-methylenedioxy-Nmethylcathinone (methylone) has a high
potential for abuse;
(2) 3,4-methylenedioxy-Nmethylcathinone (methylone) has no
currently accepted medical use in
treatment in the United States; and
(3) There is a lack of accepted safety
for use of 3,4-methylenedioxy-Nmethylcathinone (methylone) under
medical supervision.
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Frm 00008
Fmt 4702
Sfmt 4702
Based on these findings, the
Administrator of DEA concludes that
3,4-methylenedioxy-N-methylcathinone
(methylone) including its salts, isomers
and salts of isomers, whenever the
existence of such salts, isomers, and
salts of isomers is possible, warrants
control in Schedule I of the CSA (21
U.S.C. 812(b)(1)).
Requirements for Handling Methylone
Methylone is currently scheduled on
a temporary basis in Schedule I and is
subject to the CSA regulatory controls
and administrative, civil, and criminal
sanctions applicable to the manufacture,
distribution, possession, dispensing,
importing, and exporting of a Schedule
I controlled substance, including those
listed below. These controls on
methylone will continue on a
permanent basis if this rule is finalized
as proposed:
Registration. Any person who
manufactures, distributes, dispenses,
imports, exports, engages in research or
conducts instructional activities with
methylone or who desires to
manufacture, distribute, dispense,
import, export, engage in research or
conduct instructional activities with
methylone would need to be registered
to conduct such activities pursuant to
21 U.S.C. 822 and 958 and in
accordance with 21 CFR Part 1301.
Security. Methylone would be subject
to Schedule I security requirements and
would need to be manufactured and
distributed pursuant to 21 U.S.C. 823
and in accordance with 21 CFR 1301.71,
1301.72(a), (c) and (d), 1301.73, 1301.74,
1301.75(a) and (c), 1301.76.
Labeling and Packaging. All labels
and labeling for commercial containers
of methylone which is distributed on or
after the effective date of the finalization
of this rule would need to be in
accordance with 21 CFR 1302.03–
1302.07, pursuant to 21 U.S.C. 825.
Quotas. Quotas for methylone will be
established based on registrations
granted and quota applications received
pursuant to part 1303 of Title 21 of the
Code of Federal Regulations.
Inventory. Every registrant required to
keep records and who possesses any
quantity of methylone would be
required to keep an inventory of all
stocks of methylone on hand pursuant
to 21 U.S.C. 827 and in accordance with
21 CFR 1304.03, 1304.04, and 1304.11.
Every registrant who desires registration
in Schedule I for methylone would be
required to conduct an inventory of all
stocks of the substance on hand at the
time of registration.
Records. All registrants would be
required to keep records pursuant to 21
U.S.C. 827 and in accordance with 21
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Federal Register / Vol. 77, No. 201 / Wednesday, October 17, 2012 / Proposed Rules
CFR 1304.03, 1304.04, 1304.21, 1304.22,
and 1304.23.
Reports. All registrants required to
submit reports pursuant to 21 U.S.C.
827 and in accordance with 21 CFR
1304.33 would be required to do so
regarding methylone.
Order Forms. All registrants involved
in the distribution of methylone would
be required to comply with the order
form requirements pursuant to 21 U.S.C.
828 and 21 CFR 1305.
Importation and Exportation. All
importation and exportation of
methylone would need to be done in
accordance with 21 CFR Part 1312,
pursuant to 21 U.S.C. 952, 953, 957, and
958.
Criminal Liability. Any activity with
methylone not authorized by, or in
violation of, Subchapter I Part D and
Subchapter II of the CSA occurring on
or after effective date of the finalization
of this proposed rule would be
unlawful.
Regulatory Analyses
Executive Order 12988
This proposed regulation meets the
applicable standards set forth in
Sections 3(a) and 3(b)(2) of Executive
Order 12988 Civil Justice Reform to
eliminate ambiguity, minimize
litigation, establish clear legal
standards, and reduce burden.
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PART 1308—SCHEDULES OF
CONTROLLED SUBSTANCES
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.
2. Section 1308.11 is amended by
adding a new paragraph (d)(36) to read
as follows:
*
*
*
*
(d) * * *
(36) 3,4-Methylenedioxy-Nmethylcathinone (Methylone)—7540
*
*
*
*
*
Dated: October 10, 2012.
Michele M. Leonhart,
Administrator.
[FR Doc. 2012–25509 Filed 10–16–12; 8:45 am]
BILLING CODE 4410–09–P
39 CFR Part 111
ACTION:
Postal ServiceTM.
Proposed rule.
The Postal Service is
proposing to revise Mailing Standards
of the United States Postal Service,
Domestic Mail Manual (DMM®)
throughout various sections to modify
eligibility requirements for mailers to
obtain automation prices for First-Class
Mail®, Standard Mail®, Periodicals®,
and Bound Printed Matter® when
mailing postcards, letters, and flats.
Effective January 2014, use of ‘‘fullservice’’ Intelligent Mail® would be
required to obtain automation prices.
Additionally, the 10/24 transitional
barcoded tray label format would be
eliminated and mailers would be
required to use the 24-digit Intelligent
Mail barcode (IMbTM) format on tray,
tub, and sack labels.
SUMMARY:
PO 00000
Frm 00009
Fmt 4702
We must receive your comments
on or before November 16, 2012.
ADDRESSES: Mail or deliver written
comments to the Manager, Product
Classification, U.S. Postal Service, 475
L’Enfant Plaza SW., Room 4446,
Washington, DC 20260–5015. You may
inspect and photocopy all written
comments at USPS® Headquarters
Library, 475 L’Enfant Plaza SW., 11th
Floor N., Washington, DC by
appointment only between the hours of
9 a.m. and 4 p.m., Monday through
Friday by calling 1–202–268–2906 in
advance. Comments and questions can
also be emailed to
mailingstandards@usps.gov using the
subject line ‘‘full-service January 2014.’’
FOR FURTHER INFORMATION CONTACT:
Ana Cikowski, email:
ana.cikowski@usps.gov, phone: 202–
268–8079.
Himesh Patel, email:
himesh.a.patel@usps.gov, phone:
703–280–7498.
William Chatfield, email:
william.a.chatfield@usps.gov, phone:
202–268–7278.
SUPPLEMENTARY INFORMATION: On April
20, 2012, the Postal Service published
an advance notice of proposed
rulemaking in the Federal Register (77
FR 23643–23647) to require use of fullservice Intelligent Mail to obtain
automation prices for First-Class Mail
(FCM), Standard Mail, Periodicals, and
Bound Printed Matter (BPM) when
mailing postcards, letters, and flats.
DATES:
Background
POSTAL SERVICE
AGENCY:
Executive Order 13175
This proposed rule will not have
tribal implications and will not impose
substantial direct compliance costs on
Indian tribal governments.
Jkt 229001
Schedule I.
*
Implementation of Full-Service
Intelligent Mail Requirements for
Automation Prices
Executive Order 13132
This proposed rulemaking does not
preempt or modify any provision of
State law; nor does it impose
enforcement responsibilities on any
State; nor does it diminish the power of
any State to enforce its own laws.
Accordingly, this rulemaking does not
have federalism implications warranting
the application of Executive Order
13132.
15:02 Oct 16, 2012
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 proposed to be amended to
read as follows:
§ 1308.11
Executive Orders 12866 and 13563
In accordance with 21 U.S.C. 811(a),
this proposed scheduling action is
subject to formal rulemaking procedures
done ‘‘on the record after opportunity
for a hearing,’’ which are conducted
pursuant to the provisions of 5 U.S.C.
556 and 557. The CSA sets forth the
criteria for scheduling a drug or other
substance. Such actions are exempt
from review by the Office of
Management and Budget pursuant to
Section 3(d)(1) of Executive Order
12866 and the principles reaffirmed in
Executive Order 13563.
VerDate Mar<15>2010
Paperwork Reduction Act of 1995
This action does not impose a new
collection of information under the
Paperwork Reduction Act of 1995, 44
U.S.C. 3501–3521.
63771
Sfmt 4702
In January 2009, the Postal Service
offered the mailing industry two
Intelligent Mail options for automation
discounts: basic-service and full-service.
Currently, a large number of mailers are
using these options and reaping
significant benefits and value.
When using the full-service option,
mailers are required to: Apply unique
Intelligent Mail barcodes (IMb) to
identify each letter, postcard, and flat
mailpiece; individually meet the
eligibility requirements for automation
prices according to class and shape;
apply unique Intelligent Mail tray
barcodes (IMtb) on trays, tubs, and
sacks; apply unique Intelligent Mail
container barcodes (IMcb) on placards
for containers, such as pallets; schedule
appointments through Facility Access
and Shipment Tracking (FAST®) if their
mail is accepted at an origin facility and
entered at a downstream USPSTM
processing facility; and use an approved
electronic method to transmit to the
Postal Service mailing documentation
and postage statements. If the mailing is
being prepared or presented on behalf of
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Agencies
[Federal Register Volume 77, Number 201 (Wednesday, October 17, 2012)]
[Proposed Rules]
[Pages 63766-63771]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-25509]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-357]
Schedules of Controlled Substances: Placement of Methylone Into
Schedule I
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Notice of proposed rulemaking.
-----------------------------------------------------------------------
SUMMARY: The Drug Enforcement Administration (DEA) proposes placing
3,4-methylenedioxy-N-methylcathinone (methylone) including its salts,
isomers, and salts of isomers whenever the existence of such salts,
isomers, and salts of isomers is possible, into Schedule I of the
Controlled Substances Act (CSA). This proposed action is pursuant to
the CSA which requires that such actions be made on the record after
opportunity for a hearing through formal rulemaking.
DATES: DEA will permit interested persons to file written comments on
this proposal pursuant to 21 CFR 1308.43(g). Electronic comments must
be submitted and written comments must be postmarked on or before
December 17, 2012. Commenters should be aware that the electronic
Federal Docket Management System will not accept comments after
midnight Eastern Time on the last day of the comment period.
Interested persons, defined at 21 CFR 1300.01 as those ``adversely
affected or aggrieved by any rule or proposed rule issuable pursuant to
section 201 of the Act (21 U.S.C. 811),'' may file a request for
hearing pursuant to 21 CFR 1308.44 and in accordance with 21 CFR
1316.45 and 1316.47. Requests for hearing, notices of appearance, and
waivers of participation must be received on or before November 16,
2012.
ADDRESSES: To ensure proper handling of comments, please reference
``Docket No. DEA-357'' on all electronic and written correspondence.
DEA encourages all comments be submitted electronically through https://www.regulations.gov using the electronic comment form provided on that
site. An electronic copy of this document and supplemental information
to this proposed rule are also available at the https://www.regulations.gov Web site for easy reference. Paper comments that
duplicate the electronic submission are not necessary as all comments
submitted to www.regulations.gov will be posted for public review and
are part of the official docket record. Should you, however, wish to
submit written comments via regular or express mail, they should be
sent to the Drug Enforcement Administration, Attention: DEA Federal
Register Representative/OD, 8701 Morrissette Drive, Springfield, VA
22152. All requests for hearing must be sent to Drug Enforcement
Administration, Attention: Hearing Clerk/LJ, 8701 Morrissette Drive,
Springfield, VA 22152.
FOR FURTHER INFORMATION CONTACT: Alan G. Santos, Associate Deputy
Assistant Administrator, Office of Diversion Control, Drug Enforcement
Administration; Mailing Address: 8701 Morrissette Drive, Springfield,
Virginia 22152; Telephone: (202) 307-7165.
SUPPLEMENTARY INFORMATION:
Posting of Public Comments: Please note that all comments received
are considered part of the public record and made available for public
inspection online at https://www.regulations.gov and in the DEA's public
docket. Such information includes personal identifying information
(such as your name, address, etc.) voluntarily submitted by the
commenter.
If you want to submit personal identifying information (such as
your name, address, etc.) as part of your comment, but do not want it
to be posted online or made available in the public docket, you must
include the phrase ``PERSONAL IDENTIFYING INFORMATION'' in the first
paragraph of your comment. You must also place all of the personal
identifying information you do not want posted online or made available
in the public docket in the first paragraph of your comment and
identify what information you want redacted.
If you want to submit confidential business information as part of
your comment, but do not want it to be posted online or made available
in the public docket, you must include the phrase ``CONFIDENTIAL
BUSINESS INFORMATION'' in the first paragraph of your comment. You must
also prominently identify confidential business information to be
redacted within the comment. If a comment has so much confidential
business information that it cannot be effectively redacted, all or
part of that comment may not be posted online or made available in the
public docket.
Personal identifying information and confidential business
information identified and located as set forth above will be redacted,
and the comment, in redacted form, will be posted online and placed in
the DEA's public docket file. Please note that the Freedom of
Information Act applies to all comments received. If you wish to
inspect the agency's public docket file in person by appointment,
please see the For Further Information paragraph.
Request for Hearing, Notice of Appearance at or Waiver of Participation
in Hearing
In accordance with the CSA, this action is a formal rulemaking ``on
the record after opportunity for a hearing.'' 21 U.S.C. 811(a). Such
proceedings are conducted pursuant to the provisions of the
Administrative Procedure Act (5 U.S.C. 556 and 557) and 21 CFR 1308.41.
Pursuant to 21 CFR 1308.44(a)-(c), requests for hearing, notices of
appearance, and waivers of participation may be submitted only by
interested persons, defined at 21 CFR 1300.01 as those ``adversely
affected or aggrieved by any rule or proposed rule issuable pursuant to
section 201 of the Act (21 U.S.C. 811).'' Such requests or notices must
conform to the requirements of 21 CFR 1308.44(a) or (b) and 1316.47 or
1316.48, as applicable. A request or notice should state, with
particularity, the interest of the person in the proceeding and the
objections or issues, if any, concerning which the person desires to be
heard. Any waiver must conform to the requirements of 21 CFR 1308.44(c)
and 1316.49, including a written statement regarding the interested
person's position on the matters of fact and law involved in any
hearing.
Please note that pursuant to 21 U.S.C. 811(a), the purpose and
subject matter of the hearing is restricted to ``(A) find[ing] that
such drug or other substance has a potential for abuse, and (B)
mak[ing] with respect to such drug or other substance the findings
prescribed by subsection (b) of section 812 of this title for the
schedule in which such drug is to be placed * * *'' Requests for
hearing, notices of appearance at the hearing, and waivers of
participation in the hearing should be submitted to DEA using the
address information provided above.
Legal Authority
The DEA implements and enforces Titles II and III of the
Comprehensive Drug Abuse Prevention and Control Act of 1970, often
referred to as the Controlled Substances Act and the Controlled
Substances Import and
[[Page 63767]]
Export Act (21 U.S.C. 801-971), as amended (hereinafter, ``CSA''). The
implementing regulations for these statutes are found in Title 21 of
the Code of Federal Regulations (CFR), parts 1300 to 1321. Under the
CSA, controlled substances are classified in 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 by statute are
found at 21 U.S.C. 812(c) and the current list of scheduled substances
are published at 21 CFR Part 1308.
The CSA permits these schedules to be modified by providing that
scheduling of any drug or other substance may be initiated by the
Attorney General (1) on his own motion; (2) at the request of the
Secretary of HHS, or (3) on the petition of any interested party. 21
U.S.C. 811(a). The Attorney General may, by rule, ``add to such a
schedule or transfer between such schedules any drug or other substance
if he (A) finds that such drug or other substance has a potential for
abuse, and (B) makes with respect to such drug or other substance the
findings prescribed by subsection (b) of section 812 of this title for
the schedule in which such drug is to be placed * * *'' 21 U.S.C.
811(a). The findings required for the placement of a controlled
substance in Schedule I are: ``(A) The drug or other substance has a
high potential for abuse. (B) The drug or substance has no currently
accepted medical use in treatment in the United States. (C) There is a
lack of accepted safety for use of the drug or other substance under
medical supervision.'' 21 U.S.C. 812(b).
Background
On September 8, 2011, the Administrator of the DEA published a
Notice of Intent to temporarily place 3,4-methylenedioxy-N-
methylcathinone (methylone) along with two other synthetic cathinones
(4-methyl-N-methylcathinone (mephedrone) and 3,4-
methylenedioxypyrovalerone (MDPV)) into Schedule I pursuant to the
temporary scheduling provisions of the CSA (76 FR 55616). Following
this, on October 21, 2011, the Administrator published a Final Order in
the Federal Register (76 FR 65371) amending 21 CFR 1308.11(g) to
temporarily place these three synthetic cathinones into Schedule I of
the CSA pursuant to the temporary scheduling provisions of 21 U.S.C.
811(h). This Final Order, which became effective on the date of
publication, was based on findings by the Administrator of the DEA that
the temporary scheduling of these three synthetic cathinones was
necessary to avoid an imminent hazard to the public safety pursuant to
21 U.S.C. 811(h)(1). At the time the Final Order took effect, Section
201(h)(2) of the CSA (21 U.S.C. 811(h)(2) (2011)) required that the
temporary scheduling of a substance expire at the end of one year from
the date of issuance of the scheduling order, and it provided that,
during the pendency of proceedings under 21 U.S.C. 811(a)(1) with
respect to the substance, temporary scheduling of that substance could
be extended for up to six months.\1\ Under this provision, the
temporary scheduling of methylone expires on October 20, 2012, unless
extended pursuant to 21 U.S.C. 811(h)(2). An extension until April 20,
2013, is being ordered by the Administrator in a separate action.
---------------------------------------------------------------------------
\1\ On July 9, 2012, President Obama signed the Food and Drug
Administration Safety and Innovation Act (Pub. L. 112-144) (FDASIA),
which amended several provisions of the CSA. Subtitle D of FDASIA is
titled the ``Synthetic Drug Abuse Prevention Act of 2012.'' In
particular, FDASIA amended Schedule I of section 202(c) of the CSA
to include mephedrone and MDPV but not methylone, and amended
section 201(h)(2) to increase the maximum timeframes for temporary
scheduling. Public Law 112-144, Sections 1152(b) and 1153.
---------------------------------------------------------------------------
As described in the October 21, 2011, Final Order, methylone is a
designer drug of the phenethylamine class and is structurally and
pharmacologically similar to amphetamine, 3,4-
methylenedioxymethamphetamine (MDMA), cathinone and other related
substances. The addition of a beta-keto ([beta]-ketone) substituent to
the phenethylamine core structure produces a group of substances that
have [beta]-keto-phenethylamine as the core structure. Methylone has a
[beta]-keto-phenethylamine core structure. Methylone has been used as
research chemical. Based on the review of the scientific literature,
there are no known medical uses for methylone. The Assistant Secretary
of Health for the U.S. Department of Health and Human Services (HHS)
has advised that there are no exemptions or approvals in effect for
methylone under section 505 (21 U.S.C. 355) of the Federal Food, Drug
and Cosmetic Act.
Proposed Determination To Schedule Methylone
This NPRM proposes the permanent scheduling of methylone pursuant
to 21 U.S.C. 811(a)(1). On March 30, 2012, DEA requested a scientific
and medical evaluation and scheduling recommendation from the Assistant
Secretary of Health for HHS for methylone, mephedrone and MDPV pursuant
to 21 U.S.C. 811(b). Upon receipt and evaluation of the scientific and
medical evaluation and scheduling recommendation from the Assistant
Secretary,\2\ DEA concluded its analysis of all other relevant data for
the proposal to place methylone into Schedule I of the CSA.
---------------------------------------------------------------------------
\2\ DEA received from HHS Evaluation and Recommendation
documents with respect to methylone, but not for mephedrone and
MDPV. However, mephedrone and MDPV are listed as Schedule I
substances under FDASIA.
---------------------------------------------------------------------------
Included below is a brief summary of each factor as analyzed by HHS
and DEA, and as considered by DEA in the scheduling decision. Please
note that both the DEA and HHS analyses are available under
``Supporting and Related Material'' of the public docket for this
proposed rule at www.regulations.gov under docket number DEA-357.
1. The Drug's Actual or Relative Potential for Abuse: The abuse
potential of methylone is associated with its ability to evoke
pharmacological effects similar to those evoked by the Schedule I and
II substances such as cathinone (Schedule I), methcathinone (Schedule
I), 3,4-MDMA (Schedule I), amphetamine (Schedule II), methamphetamine
(Schedule II), and cocaine (Schedule II). These Schedule I and II
substances have a high potential for abuse.
The legislative history of the CSA suggests the following four
prongs to consider in determining whether a particular drug or
substance has potential for abuse: \3\
---------------------------------------------------------------------------
\3\ Comprehensive Drug Abuse Prevention and Control Act of 1970,
H.R. Rep. No. 91-1444, 91st Cong., Sess. 1 (1970); 1970 U.S.C.C.A.N.
4566, 4601.
---------------------------------------------------------------------------
i. There is evidence that individuals are taking the drug or other
substance in amounts sufficient to create a hazard to their health or
to the safety of other individuals or to the community; or
ii. There is significant diversion of the drug or substance from
legitimate drug channels; or
iii. Individuals are taking the substance on their own initiative
rather than on the basis of medical advice from a practitioner licensed
by law to administer such drugs; or
iv. The drug is a new drug so related in its action to a drug or
other substance already listed as having a potential for abuse to make
it likely that the drug or other substance will have the same potential
for abuse as such drugs, thus making it reasonable to assume that there
may be significant diversion from legitimate channels, significant use
contrary to or without medical advice, or that it has a substantial
capability of creating hazards to the health of the user or to the
safety of the community.
[[Page 63768]]
With respect to the first prong, a number of case reports and case
series have shown that individuals are taking methylone and products
containing methylone in amounts sufficient to induce adverse health
effects similar to those induced by amphetamine, methamphetamine, and
MDMA, Schedule I and II substances. These effects included elevated
body temperature, increases in heart rate and respiratory exchange,
changes in blood pressure, seizures, erratic behavior, and coma. Even
death has been reported following the abuse of methylone or products
containing methylone. Further, law enforcement encounters indicate the
occurrence of a fatal automotive accident that was caused by a driver
under the influence of a product containing methylone.
In considering evidence of significant diversion of the drug or
substance from legitimate drug channels under the second prong, it must
be noted that as of October 21, 2011, methylone has been temporarily
controlled as a Schedule I substance and thus has not been legally
available unless for research purposes. However, the National Forensic
Laboratory Information System (NFLIS), which details over 2,500 reports
from state and local forensic laboratories, identified methylone in
drug related exhibits for a period from January 2009 to June 2012 from
42 states. The System to Retrieve Information from Drug Evidence
(STRIDE), which details reports from federal forensic laboratories,
identified methylone in 220 drug related exhibits from a period from
January 2009 to June 2012.
For the third prong, HHS states that there is no currently accepted
medical use for methylone and no medical practitioner is currently
licensed by law to administer methylone. Indeed, the FDA has not
approved a new drug application (NDA) for methylone for any therapeutic
indication, and no investigational new drug (IND) application for
methylone is currently active. Thus, with no accepted medical use or
administering practitioners, individuals currently using products
containing methylone are doing so on their own initiative without
medical advice from a practitioner licensed to administer methylone.
With regard to the fourth prong, HHS states that methylone produces
pharmacological effects similar to those produced by the Schedule I and
II central nervous system (CNS) substances such as amphetamine,
methamphetamine, cocaine, and MDMA which have a high potential for
abuse. Methylone, like these Schedule I and II substances, affects the
concentrations of the neurotransmitters dopamine, serotonin and
norepinephrine in the CNS. In drug discrimination assays, methylone
substitutes for MDMA, amphetamine, methamphetamine, and cocaine, which
suggests that methylone will likely produce subjective effects in
humans similar to these substances and have a similar pattern of abuse.
Methylone, like methamphetamine, amphetamine, and cocaine, is a CNS
stimulant and produces locomotor stimulant activity in animals.
Methylone has no known medical use in the United States but
evidence demonstrates that methylone is being abused by individuals for
its psychoactive effects. Methylone has been encountered by law
enforcement throughout the United States as reported in NFLIS and in
STRIDE databases suggesting that individuals are abusing methylone.
Methylone has also been identified during the toxicological screening
of individual human urine samples which also demonstrates that
individuals are abusing this substance. In addition, information from
poison centers indicates the abuse of synthetic cathinones which likely
include methylone. The American Association of Poison Control Centers
(AAPCC) \4\ reported in a press release that poison centers took 304
calls in 2010 regarding synthetic cathinone exposures and 6,138 calls
in 2011. As of September 12, 2012, poison centers have received 2,251
calls relating to these products this year. These calls were received
in poison centers representing at least 47 states and the District of
Columbia. Although methylone may not be specifically identified during
exposure calls or identified by toxicology testing by AAPCC, it is
likely that some of these retail products described by the callers
contained methylone, based on the identification of methylone in
approximately 26% of all synthetic cathinones related exhibits reported
to NFLIS from January 2009 to June 2012.
---------------------------------------------------------------------------
\4\ AAPCC is a non-profit, national organization that represents
the poison centers of the United States.
---------------------------------------------------------------------------
State public health and poison centers have warned of the dangers
associated with the use of synthetic cathinones and their associated
products being found on the designer drug market. In response to the
abuse of methylone and other synthetic cathinones, as of September
2012, at least 42 states have emergency scheduled or enacted
legislation placing regulatory controls on some or many of the
synthetic cathinones including mephedrone, methylone, MDPV and/or a
defined general class of cathinones. At least 27 states specifically
control methylone. Numerous local jurisdictions have also placed
controls on methylone and other synthetic cathinones. All five branches
of the U.S. military prohibit military personnel from possessing or
using synthetic cathinones including methylone.
Methylone has been reported to cause a number of adverse effects
that are characteristic of stimulants like methamphetamine,
amphetamine, and cocaine. Adverse effects associated with the
consumption of methylone include those typical of a sympathomimetic
agent such as palpitations, hyperthermia, seizures, hyponatremia,
bruxism, sweating, hypertension, tachycardia, headache, palpitations,
thirst, mydriasis, tremor, fever, sweating, and hypertension. Other
effects that have been reported from the use of methylone include
psychological effects such as confusion, psychosis, paranoia,
hallucinations, combativeness, and agitation. Finally, reports of death
for individuals abusing methylone indicate that methylone is a serious
public health threat.
2. Scientific Evidence of the Drug's Pharmacological Effects, If
Known: In the recommendation from HHS for the placement of methylone in
Schedule I of the CSA, HHS states that based on the results of
preclinical studies and the toxicological profile observed in emergency
room cases and medical examiner cases it is probable that methylone
produces pharmacological effects in humans that are similar to those
produced by the Schedule I and II substances amphetamine,
methamphetamine, cocaine, and MDMA. These findings are based on
published data on the release of monoamines, inhibition of reuptake of
monoamines, and in vivo studies (microdialysis, locomotor activity,
body temperature, drug discrimination) and are also based on data from
studies (locomotor, drug discrimination, in vitro receptor binding, and
functional assays) conducted by National Institute on Drug Abuse (NIDA)
contract researchers. The preclinical data showed that methylone can
substitute for MDMA or amphetamine in rats trained to discriminate
amphetamine or MDMA, respectively. Methylone, like methamphetamine,
amphetamine, and cocaine, is a CNS stimulant and produces locomotor
stimulant effects in animals. Methylone, like methamphetamine, has a
rewarding effect as evidenced by conditioned place preference tests.
Methylone is an inhibitor of dopamine, serotonin and norepinephrine
uptake and also causes the release of these neurotransmitters in
[[Page 63769]]
the CNS. Furthermore, studies show that methylone, like MDMA, can be
cytotoxic to liver cells. HHS further states that the toxicological
profile observed in emergency room and medical examiner cases involving
methylone demonstrate that the pharmacological profile observed in
humans is in accordance with preclinical data.
3. The State of Current Scientific Knowledge Regarding the Drug or
Other Substance: Methylone is a [beta]-ketophenethylamine (i.e.,
synthetic cathinone) that is structurally and pharmacologically similar
to amphetamine, methamphetamine, MDMA, cathinone and other related
substances. Methylone can be prepared from its corresponding ketone by
a two-step synthesis. Studies indicate that humans metabolize methylone
and metabolites of methylone have been found in the urine samples of
humans and animals given methylone. Research in anti-depressant and
anti-parkinson agents resulted in the synthesis and patenting of
methylone. According to HHS, methylone has no approved medical use in
the United States, does not have an approved NDA, and is not currently
marketed in the United States in an FDA-approved drug product. A drug
has a ``currently accepted medical use'' if all of the following five
elements have been satisfied: the drug's chemistry is known and
reproducible; and there are adequate safety studies; and there are
adequate and well-controlled studies proving efficacy; and the drug is
accepted by qualified experts; and the scientific evidence is widely
available. 57 Fed. Reg. 10499 (March 26, 1992). According to HHS, there
are no published clinical studies involving methylone. DEA has also not
found any references to clinical studies involving methylone's efficacy
and safety in the scientific and medical literature. Although the
chemistry of methylone is known and has been reproduced, as mentioned
above there are no clinical studies involving methylone. Thus,
methylone has no currently accepted medical use in treatment in the
United States and there is a lack of accepted safety for use of
methylone under medical supervision.
4. Its History and Current Pattern of Abuse: Methylone is a
synthetic cathinone that emerged on the United States' illicit drug
market in 2009 and prior to its temporary control was perceived as
being a `legal' alternative to cocaine, methamphetamine, and MDMA.
Methylone is falsely marketed as ``research chemicals,'' ``plant
food,'' or ``bath salts'' and has been 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 (White Dove,
Explosion, Tranquility etc.). It is commonly encountered in the form of
powders, capsules, and tablets. The packages of these commercial
products usually contain the warning ``not for human consumption.''
Poison centers reported a large number of toxic exposures to these
products as indicated by the number of exposure calls related to
synthetic cathinones. A large majority of these exposures were by
intentional abuse, misuse, or suspected suicide. Most of these
exposures were described as acute. AAPCC data also identified the most
common route of administration for the synthetic cathinones as
inhalation/nasal. Information from published scientific studies
indicate that the most common routes of administration for methylone is
ingestion by swallowing capsules or tablets or nasal insufflation by
snorting the powder. Evidence from poison centers, published case
reports, and law enforcement encounters suggest that the main users of
methylone are young adults. These substances are popular among youths
and young adults with males appearing to abuse methylone more than
females. There is evidence that methylone may be co-ingested with other
substances including other synthetic cathinones, pharmaceutical agents,
or other recreational substances.
5. The Scope, Duration, and Significance of Abuse: Evidence that
methylone is being abused is confirmed by drug courts,\5\ calls to
poison centers, and encounters by law enforcement. Methylone has been
identified in specimens from individuals submitted for testing by drug
court participants. Drug courts submitted to DEA 18 reports that detail
the analysis of biological specimens that contained synthetic
cathinones. Methylone was mentioned in 5 of these reports. Evidence
from poison centers also indicates that the abuse of synthetic
cathinones like methylone is widespread. The AAPCC reported in a press
release that poison centers took 304 calls in 2010 regarding synthetic
cathinone exposures and 6,138 calls in 2011. As of September 12, 2012,
poison centers have received 2,251 calls relating to these products
this year. These calls were received in poison centers representing at
least 47 states and the District of Columbia. Methylone may not have
been specifically mentioned during the exposure calls but it is likely
that some of these retail products described by the callers contained
methylone based on the identification of methylone in approximately 26%
of all synthetic cathinones related exhibits reported to NFLIS from
January 2009 to June 2012. Evidence of the increased abuse of methylone
is supported by law enforcement encounters of methylone. Forensic
laboratories have analyzed drug exhibits received from state, local, or
federal law enforcement agencies that were found to contain methylone.
The National Forensic Laboratory Information System (NFLIS) is a
program sponsored by DEA's Office of Diversion Control. NFLIS compiles
information on exhibits analyzed in state and local law enforcement
laboratories. The System to Retrieve Information from Drug Evidence
(STRIDE) is a DEA database which compiles information on exhibits
analyzed in DEA laboratories. NFLIS and STRIDE together capture data
for all substances reported by forensic laboratory analyses. Methylone
has been encountered by law enforcement as reported in NFLIS.\6\ NFLIS
details 2,797 reports from state and local forensic laboratories
identifying methylone in drug related exhibits for a period from
January 2009 to June 2012 from 42 States. NFLIS registered 4 reports
from 3 states containing methylone in 2009. However, there were 71
reports from 18 states related to these substances registered in NFLIS
in 2010 and there were 1,655 reports from 41 states in 2011. From
January to June 2012 there were 1,067 reports from 36 states. STRIDE
also details 220 reports from federal forensic laboratories identifying
methylone in drug related exhibits for a period from January 2009 to
June 2012. STRIDE (which reports data from 6 DEA laboratories)
registered 1 exhibit pertaining to methylone in 2009. There were 7
exhibits pertaining to the trafficking, distribution and abuse of
methylone registered in STRIDE in 2010 and 107 drug exhibits in 2011.
In 2012, 105 drug exhibits pertaining to the trafficking, distribution
and abuse of methylone were recorded in the STRIDE database.
---------------------------------------------------------------------------
\5\ Drug courts were developed to achieve a reduction in
recidivism and substance abuse among nonviolent, substance abusing
offenders by increasing their likelihood for successful
rehabilitation through early, continuous, and intense judicially
supervised treatment, mandatory periodic drug testing, and the use
of appropriate sanctions and other rehabilitation services. Drug
courts analyze specimens from participants for new and existing
drugs of abuse.
\6\ State and local forensic drug reports from January 2009 to
June 2012, analyzed on September 12, 2012. The 2012 drug reports are
likely to be incomplete as of September 12, 2012, due to laboratory
reporting lag time.
---------------------------------------------------------------------------
[[Page 63770]]
At selected United States ports of entry, the U.S. Customs and
Border Protection (CBP) has encountered shipments of products
containing methylone. The most commonly identified synthetic cathinone
was methylone. As of July 2012, methylone was identified in 127 of 330
shipments encountered by CBP from June 2008 to July 2012. These
shipments of methylone were in powdered form ranging from gram to
multi-kilogram quantities. Most of the shipments of these synthetic
cathinones that contained methylone originated in China and were
destined for delivery throughout the United States to places like
Alaska, Arizona, Arkansas, California, Colorado, Florida, Hawaii,
Illinois, Kansas, Louisiana, Oklahoma, Oregon, Missouri, Nevada, New
Mexico, Tennessee, Texas, Washington, and West Virginia.
Concerns over the abuse of methylone and other synthetic cathinones
have prompted many states to control these substances. As of September
2012, at least 42 states have emergency scheduled or enacted
legislation placing regulatory controls on some or many of the
synthetic cathinones including methylone. In addition, the U.S. Armed
Forces prohibited the use of synthetic cathinones including mephedrone,
methylone and MDPV.
6. What, if any, Risk There is to the Public Health: Law
enforcement, military, and public health officials have reported
exposure incidents that demonstrate the dangers associated with
methylone to both the individual abusers and other affected
individuals. Numerous individuals have presented at emergency
departments following exposure to methylone or products containing
methylone. Case reports describe presentations to emergency departments
of individuals exposed to methylone with symptoms that include
tachycardia, headache, palpitations, agitation, anxiety, mydriasis,
tremor, fever, sweating, and hypertension. Some individuals under the
influence of methylone have acted violently and unpredictably causing
harm, or even death, to themselves or others. In addition, individuals
suspected of driving under the influence of intoxicating substances
have been found to have positive test results for methylone and some of
these incidents involving methylone intoxications have resulted in the
deaths of individuals. There are at least three reported deaths in
which methylone was ruled as the cause of death by the medical examiner
or after an autopsy and there are many reports in which methylone was
implicated (i.e., the primary cause of death is not methylone toxicity)
in deaths. Additionally, products containing methylone and other
synthetic cathinones often do not bear labeling information regarding
their ingredients, and if they do it may not contain the expected
active ingredients or identify the health risks and potential hazards
associated with these products.
7. Its Psychic or Physiological Dependence Liability: According to
HHS, there are no studies or case reports that document the psychic or
physiological dependence potential of methylone. However, HHS states
that because methylone shares pharmacological properties with those of
the Schedule I and II substances amphetamine, methamphetamine, cocaine,
and MDMA, it is probable that methylone has a dependence profile
similar to that of these substances which are known to cause substance
dependence.
8. Whether the Substance is an Immediate Precursor of a Substance
Already Controlled Under the CSA: Methylone is not considered an
immediate precursor of any controlled substance of the CSA as defined
by 21 U.S.C 802(23).
Conclusion: Based on consideration of the scientific and medical
evaluation and accompanying recommendation of HHS, and based on DEA's
consideration of its own eight-factor analysis, DEA finds that these
facts and all relevant data constitute substantial evidence of
potential for abuse of methylone. As such, DEA hereby proposes to
schedule methylone as a controlled substance under the CSA.
Proposed Determination of Appropriate Schedule
The CSA establishes five schedules of controlled substances known
as Schedules I, II, III, IV, and V. The statute outlines the findings
required to place a drug or other substance in any particular schedule.
21 U.S.C. 812(b). After consideration of the analysis and
recommendations of the Assistant Secretary for Health of HHS and review
of all available data, the Administrator of DEA, pursuant to 21 U.S.C.
812(b)(1), finds that:
(1) 3,4-methylenedioxy-N-methylcathinone (methylone) has a high
potential for abuse;
(2) 3,4-methylenedioxy-N-methylcathinone (methylone) has no
currently accepted medical use in treatment in the United States; and
(3) There is a lack of accepted safety for use of 3,4-
methylenedioxy-N-methylcathinone (methylone) under medical supervision.
Based on these findings, the Administrator of DEA concludes that
3,4-methylenedioxy-N-methylcathinone (methylone) including its salts,
isomers and salts of isomers, whenever the existence of such salts,
isomers, and salts of isomers is possible, warrants control in Schedule
I of the CSA (21 U.S.C. 812(b)(1)).
Requirements for Handling Methylone
Methylone is currently scheduled on a temporary basis in Schedule I
and is subject to the CSA regulatory controls and administrative,
civil, and criminal sanctions applicable to the manufacture,
distribution, possession, dispensing, importing, and exporting of a
Schedule I controlled substance, including those listed below. These
controls on methylone will continue on a permanent basis if this rule
is finalized as proposed:
Registration. Any person who manufactures, distributes, dispenses,
imports, exports, engages in research or conducts instructional
activities with methylone or who desires to manufacture, distribute,
dispense, import, export, engage in research or conduct instructional
activities with methylone would need to be registered to conduct such
activities pursuant to 21 U.S.C. 822 and 958 and in accordance with 21
CFR Part 1301.
Security. Methylone would be subject to Schedule I security
requirements and would need to be manufactured and distributed pursuant
to 21 U.S.C. 823 and in accordance with 21 CFR 1301.71, 1301.72(a), (c)
and (d), 1301.73, 1301.74, 1301.75(a) and (c), 1301.76.
Labeling and Packaging. All labels and labeling for commercial
containers of methylone which is distributed on or after the effective
date of the finalization of this rule would need to be in accordance
with 21 CFR 1302.03-1302.07, pursuant to 21 U.S.C. 825.
Quotas. Quotas for methylone will be established based on
registrations granted and quota applications received pursuant to part
1303 of Title 21 of the Code of Federal Regulations.
Inventory. Every registrant required to keep records and who
possesses any quantity of methylone would be required to keep an
inventory of all stocks of methylone on hand pursuant to 21 U.S.C. 827
and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11. Every
registrant who desires registration in Schedule I for methylone would
be required to conduct an inventory of all stocks of the substance on
hand at the time of registration.
Records. All registrants would be required to keep records pursuant
to 21 U.S.C. 827 and in accordance with 21
[[Page 63771]]
CFR 1304.03, 1304.04, 1304.21, 1304.22, and 1304.23.
Reports. All registrants required to submit reports pursuant to 21
U.S.C. 827 and in accordance with 21 CFR 1304.33 would be required to
do so regarding methylone.
Order Forms. All registrants involved in the distribution of
methylone would be required to comply with the order form requirements
pursuant to 21 U.S.C. 828 and 21 CFR 1305.
Importation and Exportation. All importation and exportation of
methylone would need to be done in accordance with 21 CFR Part 1312,
pursuant to 21 U.S.C. 952, 953, 957, and 958.
Criminal Liability. Any activity with methylone not authorized by,
or in violation of, Subchapter I Part D and Subchapter II of the CSA
occurring on or after effective date of the finalization of this
proposed rule would be unlawful.
Regulatory Analyses
Executive Orders 12866 and 13563
In accordance with 21 U.S.C. 811(a), this proposed scheduling
action is subject to formal rulemaking procedures done ``on the record
after opportunity for a hearing,'' which are conducted pursuant to the
provisions of 5 U.S.C. 556 and 557. The CSA sets forth the criteria for
scheduling a drug or other substance. Such actions are exempt from
review by the Office of Management and Budget pursuant to Section
3(d)(1) of Executive Order 12866 and the principles reaffirmed in
Executive Order 13563.
Executive Order 12988
This proposed regulation meets the applicable standards set forth
in Sections 3(a) and 3(b)(2) of Executive Order 12988 Civil Justice
Reform to eliminate ambiguity, minimize litigation, establish clear
legal standards, and reduce burden.
Executive Order 13132
This proposed rulemaking does not preempt or modify any provision
of State law; nor does it impose enforcement responsibilities on any
State; nor does it diminish the power of any State to enforce its own
laws. Accordingly, this rulemaking does not have federalism
implications warranting the application of Executive Order 13132.
Executive Order 13175
This proposed rule will not have tribal implications and will not
impose substantial direct compliance costs on Indian tribal
governments.
Paperwork Reduction Act of 1995
This action does not impose a new collection of information under
the Paperwork Reduction Act of 1995, 44 U.S.C. 3501-3521.
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 proposed to be
amended to read as follows:
PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES
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.
2. Section 1308.11 is amended by adding a new paragraph (d)(36) to
read as follows:
Sec. 1308.11 Schedule I.
* * * * *
(d) * * *
(36) 3,4-Methylenedioxy-N-methylcathinone (Methylone)--7540
* * * * *
Dated: October 10, 2012.
Michele M. Leonhart,
Administrator.
[FR Doc. 2012-25509 Filed 10-16-12; 8:45 am]
BILLING CODE 4410-09-P