21818 Federal Register / Vol. 78, No. 71 / Friday, April 12, 2013 / Rules and Regulations 

northeast of the restricted areas (Note: In 

the NPRM, V–286 was incorrectly 

identified as V–386). 

The time of designation for R–6601A 

is increased by three hours daily from 

the current ‘‘0700 to 2300 local time 

daily,’’ to ‘‘0700 to 0200 local time 

daily.’’ The advance NOTAM 

requirement for activation of R–6601A 

at other times remains at 48 hours rather 

than being reduced to 24 hours as 

proposed in the NPRM. The time of 

designation for both R–6601B and R– 

6601C is ‘‘Intermittent by NOTAM at 

least 48 hours in advance.’’ 

The FAA has determined that this 

regulation only involves an established 

body of technical regulations for which 

frequent and routine amendments are 

necessary to keep them operationally 

current. Therefore, this regulation: (1) Is 

not a ‘‘significant regulatory action’’ 

under Executive Order 12866; (2) is not 

a ‘‘significant rule’’ under Department of 

Transportation (DOT) Regulatory 

Policies and Procedures (44 FR 11034; 

February 26, 1979); and (3) does not 

warrant preparation of a regulatory 

evaluation as the anticipated impact is 

so minimal. Since this is a routine 

matter that will only affect air traffic 

procedures and air navigation, it is 

certified that this rule, will not have a 

significant economic impact on a 

substantial number of small entities 

under the criteria of the Regulatory 

Flexibility Act. 

The FAA’s authority to issue rules 

regarding aviation safety is found in 

Title 49 of the United States Code. 

Subtitle I, Section 106 describes the 

authority of the FAA Administrator. 

Subtitle VII, Aviation Programs, 

describes in more detail the scope of the 

agency’s authority. This rulemaking is 

promulgated under the authority 

described in Subtitle VII, Part A, 

Subpart I, Section 40103. Under that 

section, the FAA is charged with 

prescribing regulations to assign the use 

of the airspace necessary to ensure the 

safety of aircraft and the efficient use of 

airspace. This regulation is within the 

scope of that authority as it modifies 

restricted area airspace to support 

military requirements at Fort A.P. Hill, 

VA. 

Environmental Review 

In accordance with FAA Order 

1050.1E, paragraphs 402 and 404d, the 

FAA has conducted an independent 

evaluation of the United States Army’s 

Environmental Assessment for Airspace 

Modification at Army Garrison Fort A.P. 

Hill, Bowling Green, Virginia, dated 

June 2012 (hereinafter the EA) regarding 

the modification of airspace at Fort A.P. 

Hill. The FAA adopted the EA and 

prepared a Finding of No Significant 

Impact/Record of Decision dated 

February 2013. The FAA has 

determined that no significant impacts 

would occur as a result of the Federal 

Action and therefore that preparation of 

an Environmental Impact Statement is 

not warranted and a Finding of No 

Significant Impact in accordance with 

40 CFR Part 1501.4(e) is appropriate. 

List of Subjects in 14 CFR Part 73 

Airspace, Prohibited areas, Restricted 

areas. 

The Amendment 

In consideration of the foregoing, the 

Federal Aviation Administration 

amends 14 CFR part 73 as follows: 

PART 73—SPECIAL USE AIRSPACE 

■ 1. The authority citation for part 73 

continues to read as follows: 

Authority: 49 U.S.C. 106(g), 40103, 40113, 

40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959– 

1963 Comp., p. 389. 

§ 73.66 [Amended] 

■ 2. Section 73.66 is amended as 

follows: 

* * * * * 

1. R–6601 Fort A.P. Hill, VA [Removed] 

2. R–6601A Fort A.P. Hill, VA [New] 

Boundaries. Beginning at lat. 

38°04′37′′ N., long. 77°18′44′′ W.; then 

along U.S. Highway 301; to lat. 

38°09′45′′ N., long. 77°11′59′′ W.; then 

along U.S. Highway 17; to lat. 38°07′50′′ 

long. 77°08′29′′ W.; to lat. 38°05′30′′ N., 

long. 77°09′05′′ W.; to lat. 38°04′40′′ N., 

long. 77°10′19′′ W.; to lat. 38°03′12′′ N., 

long. 77°09′34′′ W.; to lat. 38°02′22′′ N., 

long. 77°11′39′′ W.; to lat. 38°02′30′′ N., 

long. 77°14′39′′ W.; to lat. 38°01′50′′ N., 

long. 77°16′07′′ W.; to lat. 38°02′15′′ N., 

long. 77°18′03′′ W.; to lat. 38°02′40′′ N., 

long. 77°18′59′′ W.; then to the point of 

beginning. 

Designated altitudes. Surface to but 

not including 4,500 feet MSL. 

Time of Designation. 0700 to 0200 

local time daily. Other times by 

NOTAM at least 48 hours in advance. 

Controlling agency. FAA, Potomac 

TRACON. 

Using agency. U.S. Army, 

Commander, Fort A.P. Hill, VA. 

3. R–6601B Fort A.P. Hill, VA [New] 

Boundaries. Beginning at lat. 

38°04′37′′ N., long. Long. 77°18′44′′ W.; 

then along U.S. Highway 301 to lat. 

38°09′38′′ N., long. 77°12′07′′ W.; to lat. 

38°07′09′′ N., long. 77°08′40′′ W.; to lat. 

38°05′30′′ N., long. 77°09′05′′ W.; to lat. 

38°04′40′′ N., long. 77°10′19′′ W.; to lat. 

38°03′12′′ N., long. 77°09′34′′ W.; to lat. 

38°02′22′′ N., long. 77°11′39′′ W.; to lat. 

38°02′30′′ N., long. 77°14′39′′ W.; to lat. 

38°01′50′′ N., long. 77°16′07′′ W.; to lat. 

38°02′15′′ N., long. 77°18′03′′ W.; to lat. 

38°02′40′′ N., long. 77°18′59′′ W.; then to 

the point of beginning. 

Designated altitudes. 4,500 feet MSL 

to but not including 7,500 feet MSL. 

Time of designation. Intermittent by 

NOTAM at least 48 hours in advance. 

Controlling agency. FAA, Potomac 

TRACON. 

Using agency. U.S. Army, 

Commander, Fort A.P. Hill, VA. 

4. R–6601C Fort A.P. Hill, VA [New] 

Boundaries. Beginning at lat. 

38°04′37′′ N., long. Long. 77°18′44′′ W.; 

then along U.S. Highway 301 to lat. 

38°09′38′′ N., long. 77°12′07′′ W.; to lat. 

38°07′09′′ N., long. 77°08′40′′ W.; to lat. 

38°05′30′′ N., long. 77°09′05′′ W.; to lat. 

38°04′40′′ N., long. 77°10′19′′ W.; to lat. 

38°03′12′′ N., long. 77°09′34′′ W.; to lat. 

38°02′22′′ N., long. 77°11′39′′ W.; to lat. 

38°02′30′′ N., long. 77°14′39′′ W.; to lat. 

38°01′50′′ N., long. 77°16′07′′ W.; to lat. 

38°02′15′′ N., long. 77°18′03′′ W.; to lat. 

38°02′40′′ N., long. 77°18′59′′ W.; then to 

the point of beginning. 

Designated altitudes. 7,500 feet MSL 

to 9,000 feet MSL. 

Time of designation. Intermittent by 

NOTAM at least 48 hours in advance. 

Controlling agency. FAA, Potomac 

TRACON. 

Using agency. U.S. Army, 

Commander, Fort A.P. Hill, VA. 

* * * * * 

Issued in Washington, DC, on April 4, 

2013. 

Gary A. Norek, 

Manager, Airspace Policy and ATC 

Procedures Group. 

[FR Doc. 2013–08582 Filed 4–11–13; 8:45 am] 

BILLING CODE 4910–13–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 

AGENCY: Drug Enforcement 

Administration, Department of Justice. 

ACTION: Final rule. 

SUMMARY: With the issuance of this final 

rule, the Administrator of the Drug 

Enforcement Administration (DEA) 

places the substance 3,4- 

methylenedioxy-N-methylcathinone 

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Federal Register / Vol. 78, No. 71 / Friday, April 12, 2013 / Rules and Regulations 21819 

1As 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.’’ 

2On 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. 

(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. 

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-methylenedioxyN-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. 

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 

(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 

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 

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21820 Federal Register / Vol. 78, No. 71 / Friday, April 12, 2013 / Rules and Regulations 

3HHS 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). 

4Comprehensive 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. 

5NFLIS 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. 

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. 

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

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

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 

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Federal Register / Vol. 78, No. 71 / Friday, April 12, 2013 / Rules and Regulations 21821 

6AAPCC is a non-profit, national organization 

that represents the poison centers of the United 

States. 

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. 

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 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. 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 

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21822 Federal Register / Vol. 78, No. 71 / Friday, April 12, 2013 / Rules and Regulations 

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. 

8State 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. 

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. 

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 

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Federal Register / Vol. 78, No. 71 / Friday, April 12, 2013 / Rules and Regulations 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 posttraumatic 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, 

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21824 Federal Register / Vol. 78, No. 71 / Friday, April 12, 2013 / Rules and Regulations 

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-Nmethylcathinone (methylone) has a high 

potential for abuse; 

(2) 3,4-methylenedioxy-Nmethylcathinone (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-Nmethylcathinone (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 

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Federal Register / Vol. 78, No. 71 / Friday, April 12, 2013 / Rules and Regulations 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 § 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 

■ 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)(47) to read 

as follows: 

§ 1308.11 Schedule I. 

* * * * * 

(d) * * * 

(47) 3,4-Methylenedioxy-Nmethylcathinone (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 

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