[Federal Register Volume 78, Number 71 (Friday, April 12, 2013)]
[Rules and Regulations]
[Pages 21818-21825]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-08673]



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: Final rule.

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SUMMARY: With the issuance of this final rule, the Administrator of the 
Drug Enforcement Administration (DEA) places the substance 3,4-
methylenedioxy-N-methylcathinone

[[Page 21819]]

(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 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: Effective date: April 12, 2013.

FOR FURTHER INFORMATION CONTACT: John W. Partridge, Executive 
Assistant, Office of Diversion Control, Drug Enforcement 
Administration; Mailing Address: 8701 Morrissette Drive, Springfield, 
Virginia 22152; Telephone: (202) 307-7165.

SUPPLEMENTARY INFORMATION:

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 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.
    Pursuant to 21 U.S.C. 811(a)(1), 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 * 
* *'' 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 (U.S.) (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). Pursuant to 28 CFR 
0.100(b), the Attorney General has delegated this scheduling authority 
to the Administrator of DEA.
    The CSA provides 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 for Health of the Department of Health and 
Human Services (HHS), or (3) on the petition of any interested party. 
21 U.S.C. 811(a). This action is based on a recommendation from the 
Assistant Secretary for Health (Assistant Secretary) \1\ of HHS and on 
an evaluation of all other relevant data by DEA. In light of 
methylone's current status as a temporarily scheduled, Schedule I 
controlled substance (see Section titled ``Background,'' below), this 
action permanently imposes the regulatory controls and criminal 
sanctions of Schedule I on the manufacture, distribution, dispensing, 
importation, and exportation of methylone and products containing 
methylone.
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    \1\ As set forth in a memorandum of understanding entered into 
by HHS, the Food and Drug Administration (FDA), and the National 
Institute on Drug Abuse (NIDA), FDA acts as the lead agency within 
HHS in carrying out the Secretary's scheduling responsibilities 
under the CSA, with the concurrence of NIDA. 50 FR 9518. In 
addition, because the Secretary of the Department 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 
document, all subsequent references to ``Secretary'' have been 
replaced with ``Assistant Secretary.''
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    Pursuant to 21 CFR 1308.44(e), the Administrator of DEA may issue 
her final order ``[I]f all interested persons waive or are deemed to 
waive their opportunity for the hearing or to participate in the 
hearing.'' As no requests for a hearing were filed on this proposed 
scheduling action, all interested persons are deemed to have waived 
their opportunity for a hearing pursuant to 21 CFR 1308.44(d), and the 
Administrator may issue her final order without a hearing.

Background

    On September 8, 2011, 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, DEA published a Final Order 
in the Federal Register 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). 76 FR 65371. 
This Final Order, which became effective on the date of publication, 
was based on findings by the DEA Administrator 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, 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 also provided that, during the pendency of 
proceedings under 21 U.S.C. 811(a)(1) with respect to the substance, 
the temporary scheduling of that substance could be extended for up to 
six months.\2\ Under this provision, the temporary scheduling of 
methylone expired on October 20, 2012. Pursuant to 21 U.S.C. 811(h)(2), 
an extension until April 20, 2013, was ordered by the DEA 
Administrator. 77 FR 64032. In addition, on October 17, 2012, DEA 
published a Notice of Proposed Rulemaking (NPRM) which proposed the 
permanent placement of methylone in Schedule I of the CSA. 77 FR 63766. 
This action finalizes the scheduling action proposed in the October 17, 
2012, NPRM.
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    \2\ 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. Pub. L. 112-144, Sections 1152(b) and 1153.
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    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 
lawfully as a research chemical, but based on the review of the 
scientific literature, there are no known medical uses for methylone. 
Furthermore, the Assistant Secretary 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.

Determination To Schedule Methylone

    Pursuant to 21 U.S.C. 811 (a), proceedings to add a drug or 
substance

[[Page 21820]]

to those controlled under the CSA may be initiated by the Attorney 
General on his own motion. On March 30, 2012, DEA requested a 
scientific and medical evaluation and scheduling recommendation from 
the Assistant Secretary for methylone, mephedrone and MDPV pursuant to 
21 U.S.C. 811(b). On August 14, 2012, the Assistant Secretary provided 
DEA with a scientific and medical evaluation and scheduling 
recommendation document prepared by the Food and Drug Administration 
(FDA) titled ``Basis for the Recommendation to Place 3,4-
Methylenedioxymethcathinone (Methylone) and its Salts in Schedule I of 
the Controlled Substances Act (CSA).'' Pursuant to 21 U.S.C. 811(b), 
this document contained an eight-factor analysis of the abuse potential 
of methylone, along with HHS' recommendation to control methylone under 
Schedule I of the CSA. Upon receipt and evaluation of the scientific 
and medical evaluation and scheduling recommendation from the Assistant 
Secretary,\3\ and after conducting an eight-factor analysis of 
methylone's abuse potential pursuant to 21 U.S.C. 811(c), DEA published 
the NPRM titled ``Schedules of Controlled Substances: Placement of 
Methylone into Schedule I'' on October 17, 2012. 77 FR 63766. This NPRM 
proposed placement of methylone into Schedule I of the CSA, and 
provided an opportunity for all interested persons to request a hearing 
on or before November 16, 2012, or to submit comments on or before 
December 17, 2012.
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    \3\ HHS did not provide a scientific and medical evaluation and 
scheduling recommendation regarding mephedrone and MDPV. However, 
mephedrone and MDPV were listed as Schedule I substances under the 
FDASIA (see Footnote 2, above).
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    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 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), 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: \4\
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    \4\ 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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    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.
    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) details 4,727 reports from state 
and local forensic laboratories, identifying methylone in drug related 
exhibits for a period from January 2009 to December 2012 from 42 
states.\5\ The System to Retrieve Information from Drug Evidence 
(STRIDE) identified methylone in 404 drug related exhibits from a 
period from January 2009 to December 2012.\5\
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    \5\ NFLIS is a program sponsored by DEA's Office of Diversion 
Control which compiles information on exhibits analyzed in State and 
local law enforcement laboratories. STRIDE is a DEA database which 
compiles information on exhibits analyzed in DEA laboratories.
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    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 U.S. but evidence 
demonstrates that methylone is being abused by individuals for its 
psychoactive effects. Methylone has been encountered by law enforcement 
throughout the U.S. 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

[[Page 21821]]

cathinones which likely includes methylone. The American Association of 
Poison Control Centers (AAPCC) \6\ reported in a press release that 
poison centers took 304 calls in 2010 regarding synthetic cathinone 
exposures and 6,136 calls in 2011. As of December 31, 2012, poison 
centers have received 2,654 calls relating to these products. 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 27% of all synthetic 
cathinones related exhibits reported to NFLIS from January 2009 to 
December 2012.
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    \6\ AAPCC is a non-profit, national organization that represents 
the poison centers of the United States.
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    State public health and poison centers have warned of the dangers 
associated with the use of synthetic cathinones and their associated 
products that are being found on the designer drug market. In response 
to the abuse of methylone and other synthetic cathinones, as of March 
2013, 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 or a defined 
general class of cathinones. 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 hyperthermia, seizures, hyponatremia, bruxism, sweating, 
hypertension, tachycardia, headache, palpitations, thirst, and 
mydriasis. 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 from 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 highly likely 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 in vitro data such as 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 conducted by National Institute on Drug 
Abuse contract researchers (locomotor, drug discrimination, in vitro 
receptor binding, and functional assays). The preclinical data show 
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 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. However, according to HHS, methylone has no accepted medical 
use in the U.S., does not have an approved NDA, and is not currently 
marketed in the U.S. 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 FR 10499. HHS also states that 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 U.S. 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 U.S.' illicit drug market in 
2009 and prior to its temporary control was perceived as being a 
``legal'' alternative to cocaine, methamphetamine, and MDMA. Methylone 
has been 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

[[Page 21822]]

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,\7\ 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 6,136 calls in 2011. As of December 31, 2012, 
poison centers have received 2,654 calls relating to these products for 
calendar year 2012. 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 27% of all synthetic cathinones related exhibits reported 
to NFLIS from January 2009 to December 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.\8\ NFLIS details 4,727 reports from state and 
local forensic laboratories identifying methylone in drug related 
exhibits for a period from January 2009 to December 2012 from 42 
States. NFLIS registered 4 reports identifying methylone from 3 states 
in 2009. However, there were 71 reports from 18 states related to 
methylone registered in NFLIS in 2010 and there were 1,712 reports from 
41 states in 2011. From January to December 2012 there were 2,940 
reports from 40 states. STRIDE also details 404 reports from federal 
forensic laboratories identifying methylone in drug related exhibits 
for a period from January 2009 to December 2012. STRIDE (which reports 
data from 6 DEA laboratories) registered 2 exhibits pertaining to the 
trafficking, distribution, and abuse of methylone in 2009. There were 
13 exhibits pertaining to the trafficking, distribution and abuse of 
methylone registered in STRIDE in 2010 and 130 drug exhibits in 2011. 
In 2012, 259 drug exhibits pertaining to the trafficking, distribution 
and abuse of methylone were recorded in the STRIDE database.
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    \7\ 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.
    \8\ State and local forensic drug reports from January 2009 to 
December 2012 analyzed on February 6, 2013 and federal on February 
7, 2013. The 2012 drug reports are likely to be incomplete due to 
laboratory reporting lag time.
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    At selected U.S. 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 February 2013, methylone was identified in 145 of 352 
shipments encountered by CBP from June 2008 to December 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 U.S. to places like Alaska, 
Arizona, Arkansas, California, Colorado, Florida, Hawaii, Illinois, 
Indiana, 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 March 
2013, 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, either 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).

Requests for a Hearing and Comments

    DEA received no requests for a hearing on this scheduling action, 
but did receive 15 comments in response to the October 17, 2012, NPRM 
to schedule methylone. These comments expressed mixed support for the 
NPRM.
    Comments expressing support for the rule: Five commenters supported 
the proposal to schedule methylone as a Schedule I substance. One 
commenter stated that drug forum Web site accounts regarding methylone 
indicated elevated heart rates (similar to

[[Page 21823]]

amphetamines), but that (unlike amphetamines) there was little evidence 
to suggest any medical benefits from methylone. This commenter 
concluded that Schedule I placement was appropriate for methylone 
because of the lack of knowledge regarding the substance and its high 
potential for harm. Another commenter stated that methylone is a 
synthetic hallucinogenic amphetamine analogue (similar to MDMA) and 
that in vitro studies have revealed that methylone is as potent as MDMA 
in binding to monoamine transporters on the neuronal cell surface, 
which leads to increased serotonin and dopamine levels in the brain 
that could enhance the substance's addictive potential. In addition, 
the commenter stated that subjective comparisons among recreational 
users regarding methylone's effects suggest subtle differences to those 
of MDMA. The commenter concluded that due to structural similarities 
with MDMA, limited safety data, and no identified medical use, 
classification of methylone as a Schedule I controlled substance was 
appropriate. Another commenter stated that Schedule I placement for 
methylone was warranted. The commenter noted that methylone has similar 
effects to some Schedule I and II controlled substances (such as 
amphetamine, methamphetamine, cocaine, and MDMA), and that methylone 
has been used as an alternative to methamphetamine, cocaine, and other 
illegal drugs. This commenter also stated that actual abuse data 
indicates that individuals are abusing methylone and concluded that 
methylone should be treated like Schedule I drugs.
    A social worker emphasized the importance of outreach efforts aimed 
at educating and informing the public the meaning and consequences of 
placing methylone in Schedule I of the CSA, the method to identify 
methylone or substances containing methylone, and the side effects of 
methylone. The commenter also stated that methylone should be 
designated as a harmful drug for health care use so that medical costs 
of treating adverse effects resulting from the use of methylone would 
be covered by insurance. Finally, the commenter stressed the need for 
increased law enforcement and drug court funding appropriations in 
anticipation of the potential increase in drug charges related to 
methylone.
    DEA response: DEA appreciates the support of these commenters for 
this final rule, but notes that some of the suggestions regarding the 
consequences of scheduling methylone in Schedule I of the CSA are 
beyond the scope of the CSA.
    Comments expressing opposition to the rule: Nine of the comments 
were in opposition to the proposed scheduling of methylone in Schedule 
I of the CSA. Various reasons for the disapproval of the scheduling of 
methylone were provided. These comments can be grouped in the following 
general categories: (1) Concern over prohibition or restrictions on use 
in research, (2) concern regarding DEA's findings that methylone has 
high abuse potential and no currently accepted medical use, (3) concern 
regarding various procedural aspects of the CSA, and (4) concern about 
the long-term effects of scheduling methylone.
    Concern over prohibition or restriction of use in research: Several 
commenters claimed that Schedule I placement would put barriers in 
place for clinicians or researchers who might be interested in 
investigating the potential benefits of methylone in patients. 
According to these commenters, placing methylone in Schedule I would be 
disastrous for research in the use of serotonin releasing agents to 
treat anxiety disorders. In addition, the commenters claimed that 
although recent studies have shown methylone to have tremendous 
potential and ``effectiveness'' with regard to post-traumatic stress 
disorder (PTSD), Schedule I placement ``implicitly undermines'' and 
``severely impedes'' further research attempts to find medical uses. 
One of these commenters also claimed that ``while, like MDMA, methylone 
acts to release serotonin, and to a lesser extent dopamine and 
norepinephrine, it releases these chemicals in different ratios than 
MDMA.'' This commenter reasoned that Schedule I placement would somehow 
harm efforts to contrast the effects of methylone to MDMA by 
``essentially silenc[ing]'' such research and ``hinder[ing] the 
advancement'' of better treatments. Yet another commenter claimed that 
Schedule I placement would ``cripple efforts at learning,'' make it 
``difficult and tedious'' to be approved to do research, and ``create a 
stigma'' regarding methylone. This commenter reasoned that unknown 
substances like methylone should be left in a legal status which makes 
further research into such substances possible.
    DEA response: Placement of a substance in Schedule I of the CSA 
does not preclude scientific research from being conducted using 
methylone. Any person wishing to conduct research using methylone may 
do so provided that the person has obtained a Schedule I researcher 
registration with DEA, has the appropriate research protocols in place 
with FDA, and meets all other statutory and regulatory requirements. 
This registration can be obtained by submitting an application for 
schedule I registration in accordance with 21 CFR 1301.11, 1301.13, 
1301.32 and 1301.18.
    Concern regarding the pharmacological and abuse potential findings 
considered by DEA for the purpose of scheduling methylone: Several 
commenters argued that methylone did not satisfy the criteria for 
placement in Schedule I, because it either did not meet the ``high 
potential for abuse'' prong or the ``no currently accepted medical use 
in treatment in the U.S.'' prong that the CSA requires in order for a 
substance to be placed in Schedule I. 21 U.S.C. 812(b)(1)(A)-(B).
    With regard to methylone's high potential for abuse, one commenter 
stated that DEA incorrectly assumed that ``methylone'' is coextensive 
with reports of abuse of ``synthetic cathinones.'' Another commenter 
stated that scheduling decisions should not be made on the basis of 
``singular, albeit appalling'' ``hyperbolic news events.'' Yet another 
commenter stated that the scheduling of methylone was based on 
``conjecture and one fatality.'' Finally, one commenter cited to a 
published animal study (Baumann et al., 2012, Neuropsychopharmacology, 
37: 1192-1203) which the commenter claimed ``suggests that methylone 
might have reduced potential for adverse effects and abuse compared to 
MDMA and methamphetamine.''
    With regard to methylone's currently accepted medical use in 
treatment in the U.S., one commenter stated that too little is 
currently known about methylone to conclude that it has no therapeutic 
value or to justify placement in Schedule I. This commenter claimed 
that anecdotal reports have shown that methylone has beneficial effects 
and that it may be of value in treating PTSD or other disorders having 
an anxiety component. According to the commenter, these facts 
underscored the need for clinical tests. Another commenter noted that 
like methylone, Einsteinium, which DEA notes is an element like 
hydrogen, oxygen, and carbon, lacks a known medical purpose but yet is 
not a controlled substance.
    DEA response: DEA does not agree with these statements. As detailed 
in the HHS and DEA analyses and the HHS recommendation, studies 
indicate that the abuse potential and pharmacological effects of 
methylone are similar to those of Schedule I and II substances. 
Preclinical studies indicated that methylone, like amphetamine,

[[Page 21824]]

methamphetamine, cathinone and methcathinone, has pharmacological 
effects at monoamine transporters. Furthermore, behavioral effects of 
methylone in animals and humans were found to be similar to those of 
Schedule I and II substances which have a high potential for abuse. In 
humans, methylone is expected to produce subjective responses similar 
to MDMA, methamphetamine, and cocaine based on drug discriminations 
studies in rodents. Accordingly, published case reports demonstrate 
that methylone produces pharmacological effects including adverse 
effects that are characteristic of substances like MDMA, 
methamphetamine, amphetamine, and cocaine. In addition, the abuse of 
methylone presents a safety hazard to the health of individuals. There 
are reports of emergency room admissions and deaths associated with the 
abuse of methylone. In addition, there is no currently accepted medical 
use for methylone (for reasons that have already been provided (see 
Factor 3, ``The State of Current Scientific Knowledge Regarding the 
Drug or Other Substance,'' above)).
    Concern regarding various procedural aspects of the CSA: A few 
commenters raised concerns about the legitimacy of the CSA. One 
commenter stated that the ``CSA should have to prove its effectiveness 
before expanding its parameters.'' Other commenters stated that the CSA 
is ``pointless'' and that Schedule I is an unnecessary and harmful 
classification for any substance.
    DEA Response: DEA disagrees with these comments. DEA's mission is 
to enforce the controlled substance laws and regulations. Methylone 
satisfies the CSA's criteria for placement in Schedule I by virtue of 
its high potential for abuse, the fact that it has no currently 
accepted medical use in treatment in the U.S., and its lack of safety 
for use under medical supervision. 21 U.S.C. 812(b)(1).
    Long-term effects: One commenter argued that outlawing methylone 
would push the market for this dangerous substance further underground 
and would cause the production of a replacement product.
    DEA Response: Persons producing such noncontrolled replacement 
products may nevertheless subject themselves to criminal prosecution 
under the Controlled Substances Analogue Enforcement Act of 1986 (Pub. 
L. 99-570) to the extent such products are intended for human 
consumption and share sufficient chemical and pharmacological 
similarities to Schedule I or Schedule II controlled substances. 21 
U.S.C. 802(32)(a) and 813.
    Allocation of Statutory Responsibilities Between DEA and FDA: One 
commenter did not express an opinion either for or against the 
scheduling of methylone. The commenter stated that FDA should handle 
pharmacological matters. According to this commenter, DEA is biased 
which affects its science and taints its decision-making. Thus, FDA's 
decision would be more objective and science-based. This commenter is 
concerned that DEA is biased in matters regarding science and this bias 
taints the DEA's decision making.
    DEA Response: Congress has crafted the CSA to ensure a proper 
balance in scheduling actions by assigning different responsibilities 
to HHS and to DEA. The CSA requires the Secretary of HHS to consider 
the scientific evidence of a drug's pharmacological effect (if known) 
in making its scientific and medical evaluation and scheduling 
recommendation (21 U.S.C. 811(c)(2)), and provides that ``[t]he 
recommendations of the Secretary to the Attorney General shall be 
binding on the Attorney General as to such scientific and medical 
matters * * *'' 21 U.S.C. 811(b). DEA is directly responsible for 
review in areas of abuse and diversion.

Scheduling 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 will schedule methylone as a controlled 
substance under the CSA.

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 U.S.; 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 therefore currently 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:
    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 must 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 is subject to Schedule I security requirements 
and must 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 must be in accordance with 21 CFR 1302.03-
1302.07, pursuant to 21 U.S.C. 825.
    Quotas. Quotas for methylone have been 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 must 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 must conduct an inventory of 
all stocks of the substance on hand at the time of registration.
    Records. All registrants must keep records pursuant to 21 U.S.C. 
827 and

[[Page 21825]]

in accordance with 21 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 must do so regarding 
methylone.
    Order Forms. All registrants involved in the distribution of 
methylone must 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 must 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, the Controlled Substances Act or the Controlled 
Substances Import and Export Act is unlawful.

Regulatory Analyses

Executive Orders 12866 and 13563

    In accordance with 21 U.S.C. 811(a), this 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 regulation meets the applicable standards set forth in 
Sections 3(a) and 3(b)(2) of Executive Order 12988 Civil Justice Reform 
to eliminate drafting errors and ambiguity, minimize litigation, 
provide a clear legal standard for affected conduct, and promote 
simplification and burden reduction.

Executive Order 13132

    This rulemaking does not have federalism implications warranting 
the application of Executive Order 13132. The rule does not have 
substantial direct effects on the States, on the relationship between 
the national government and the States, or the distribution of power 
and responsibilities among the various levels of government.

Executive Order 13175

    This rule does not have tribal implications warranting the 
application of Executive Order 13175. The rule does not have 
substantial direct effects on one or more Indian tribes, on the 
relationship between the Federal Government and Indian tribes, or on 
the distribution of power and responsibilities between the Federal 
Government and Indian tribes.

Regulatory Flexibility Act

    The Administrator, in accordance with the Regulatory Flexibility 
Act (5 U.S.C. 601-612) (RFA), has reviewed this final rule and by 
approving it certifies that it will not have a significant economic 
impact on a substantial number of small entities. First, there is no 
commercial, industrial, or accepted medical use for methylone. At least 
42 states have already prohibited the manufacture, distribution, and 
use of methylone, and all U.S. military service members are prohibited 
from possessing and using it. There have been 30 entities registered 
with the DEA to handle methylone since it was temporarily scheduled on 
October 21, 2011. If the synthetic cannabinoid JWH-018 is used as a 
reference, as it also has no commercial, industrial, or accepted 
medical use, there are currently 40 entities registered to handle this 
substance since it was temporarily scheduled on March 1, 2011, and 
subsequently placed in Schedule I permanently on July 9, 2012, by the 
Synthetic Drug Abuse Prevention Act of 2012, Public Law 112-144, Title 
XI, Subtitle D, Sections 1151-1153. Based on this, and because there 
have been no references to clinical studies involving methylone in the 
scientific and medical literature, DEA assumes the number of entities 
registered to handle methylone will remain relatively small. Secondly, 
there are approximately 1.4 million controlled substances registrants 
who represent approximately 381,000 businesses affected by this rule. 
DEA estimates that 371,000 (97 percent) of the affected businesses are 
considered ``small entities'' in accordance with the RFA and Small 
Business Administration standards. 5 U.S.C. 601(6) and 15 U.S.C. 632. 
Even if all those registered to handle methylone (30 entities) are 
considered to be small entities, the number of small entities affected 
by this rule would not be substantial.

Unfunded Mandates Reform Act of 1995

    This rule does not include a Federal mandate that may result in the 
expenditure by State, local, and tribal governments, in the aggregate, 
or by the private sector, of $100,000,000 or more (adjusted for 
inflation) in any one year. Therefore, no actions were deemed necessary 
under provisions of the Unfunded Mandates Reform Act of 1995 (UMRA).

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.

Congressional Review Act

    This rule is not a major rule as defined by Sec.  804 of the Small 
Business Regulatory Enforcement Fairness Act of 1996 (Congressional 
Review Act (CRA)). This rule will not result in: an annual effect on 
the economy of $100,000,000 or more; a major increase in costs or 
prices for consumers, individual industries, Federal, State, or local 
government agencies, or geographic regions; or significant adverse 
effects on competition, employment, investment, productivity, 
innovation, or on the ability of U.S.-based companies to compete with 
foreign-based companies in domestic and export markets. However, 
pursuant to the CRA, DEA has submitted a copy of this Final Rule 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.

    For the reasons set out above, 21 CFR part 1308 is amended to read 
as follows:

PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES

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

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


0
2. Section 1308.11 is amended by adding a new paragraph (d)(47) to read 
as follows:


Sec.  1308.11  Schedule I.

* * * * *
    (d) * * *
    (47) 3,4-Methylenedioxy-N-methylcathinone (Methylone) * * * (7540)
* * * * *

    Dated: April 5, 2013.
Michele M. Leonhart,
Administrator.
[FR Doc. 2013-08673 Filed 4-11-13; 8:45 am]
BILLING CODE 4410-09-P