[Federal Register Volume 82, Number 39 (Wednesday, March 1, 2017)]
[Rules and Regulations]
[Pages 12171-12177]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-03974]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-436]
Schedules of Controlled Substances: Placement of 10 Synthetic
Cathinones 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 Drug Enforcement
Administration places 10 synthetic
[[Page 12172]]
cathinones: 4-methyl-N-ethylcathinone (4-MEC); 4-methyl-alpha-
pyrrolidinopropiophenone (4-MePPP); alpha-pyrrolidinopentiophenone
([alpha]-PVP); 1-(1,3-benzodioxol-5-yl)-2-(methylamino)butan-1-one
(butylone, bk-MBDB e); 2-(methylamino)-1-phenylpentan-1-one
(pentedrone); 1-(1,3-benzodioxol-5-yl)-2-(methylamino)pentan-1-one
(pentylone, bk-MBDP); 4-fluoro-N-methylcathinone (4-FMC, flephedrone);
3-fluoro-N-methylcathinone (3-FMC); 1-(naphthalen-2-yl)-2-(pyrrolidin-
1-yl)pentan-1-one (naphyrone); alpha-pyrrolidinobutiophenone ([alpha]-
PBP) and their optical, positional, and geometric isomers, salts 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. This scheduling action is pursuant to the Controlled
Substances Act which requires that such actions be made on the record
after opportunity for a hearing through formal rulemaking. This rule
continues the imposition of the regulatory controls and administrative,
civil, and criminal sanctions applicable to schedule I controlled
substances on persons who handle (manufacture, distribute, reverse
distribute, import, export, engage in research, conduct instructional
activities or chemical analysis, or possess), or propose to handle 4-
MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-
FMC, naphyrone, or [alpha]-PBP.
DATES: Effective date: March 1, 2017.
FOR FURTHER INFORMATION CONTACT: Michael J. Lewis, Diversion Control
Division, Drug Enforcement Administration; Mailing Address: 8701
Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 598-
6812.
SUPPLEMENTARY INFORMATION:
Legal Authority
The Drug Enforcement Administration (DEA) implements and enforces
titles II and III of the Comprehensive Drug Abuse Prevention and
Control Act of 1970, as amended. 21 U.S.C. 801-971. Titles II and III
are referred to as the ``Controlled Substances Act'' and the
``Controlled Substances Import and Export Act,'' respectively, and are
collectively referred to as the ``Controlled Substances Act'' or the
``CSA'' for the purposes of this action. The DEA publishes the
implementing regulations for these statutes in title 21 of the Code of
Federal Regulations (CFR), chapter II.
The CSA and its implementing regulations are designed to prevent,
detect, and eliminate the diversion of controlled substances and listed
chemicals into the illicit market while ensuring an adequate supply is
available for the legitimate medical, scientific, research, and
industrial needs of the United States. Controlled substances have the
potential for abuse and dependence and are controlled to protect the
public health and safety.
Under the CSA, each controlled substance is classified into one of
five schedules based upon its potential for abuse, its currently
accepted medical use in treatment in the United States, and the degree
of dependence the substance may cause. 21 U.S.C. 812. The initial
schedules of controlled substances established by Congress are found at
21 U.S.C. 812(c), and the current list of scheduled substances is
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 * * * finds that such drug or other substance has
a potential for abuse, and * * * 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 Attorney General has delegated scheduling authority under 21
U.S.C. 811 to the Administrator of the DEA. 28 CFR 0.100.
The CSA provides that proceedings for the issuance, amendment, or
repeal of the scheduling of any drug or other substance may be
initiated by the Attorney General (1) on his own motion; (2) at the
request of the Secretary of the Department of Health and Human Services
(HHS); \1\ or (3) on the petition of any interested party. 21 U.S.C.
811(a). This action was initiated on the Attorney General's own motion,
as delegated to the Administrator of the DEA, and is supported by,
inter alia, a recommendation from the Assistant Secretary for Health of
the HHS and an evaluation of all relevant data by the DEA. This action
continues the imposition of the regulatory controls and administrative,
civil, and criminal sanctions of schedule I controlled substances on
any person who handles or proposes to handle 4-MEC, 4-MePPP, [alpha]-
PVP, butylone, pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, or
[alpha]-PBP.
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\1\ As set forth in a memorandum of understanding entered into
by the Food and Drug Administration (FDA) and the National Institute
on Drug Abuse (NIDA), the FDA acts as the lead agency within the
Department of Health and Human Services (HHS) in carrying out the
Secretary's scheduling responsibilities under the CSA, with the
concurrence of NIDA. 50 FR 9518, Mar. 8, 1985. The Secretary of the
HHS has delegated to the Assistant Secretary for Health of the HHS
the authority to make domestic drug scheduling recommendations. 58
FR 35460, July 1, 1993.
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Background
On January 28, 2014, the DEA published a notice of intent to
temporarily place 4-methyl-N-ethylcathinone (4-MEC); 4-methyl-alpha-
pyrrolidinopropiophenone (4-MePPP); alpha-pyrrolidinopentiophenone
([alpha]-PVP); 1-(1,3-benzodioxol-5-yl)-2-(methylamino)butan-1-one
(butylone); 2-(methylamino)-1-phenylpentan-1-one (pentedrone); 1-(1,3-
benzodioxol-5-yl)-2-(methylamino)pentan-1-one (pentylone); 4-fluoro-N-
methylcathinone (4-FMC); 3-fluoro-N-methylcathinone (3-FMC); 1-
(naphthalen-2-yl)-2-(pyrrolidin-1-yl)pentan-1-one (naphyrone); and
alpha-pyrrolidinobutiophenone ([alpha]-PBP) into schedule I pursuant to
the temporary scheduling provisions of the CSA. 79 FR 4429. On March 7,
2014, the DEA published a final order amending 21 CFR 1308.11(h) to
temporarily place these 10 synthetic cathinones into schedule I of the
CSA. 79 FR 12938. That final order, effective on the date of
publication, was based on findings by the DEA that the temporary
scheduling of these 10 synthetic cathinones was necessary to avoid an
imminent hazard to the public safety pursuant to 21 U.S.C. 811(h)(1).
Section 201(h)(2) of the CSA requires that the temporary control of
these substances expires two years from the issuance date of the
scheduling order, or on or before March 6, 2016. 21 U.S.C. 811(h)(2).
However, the CSA also provides that the temporary scheduling may be
extended for up to one year during the pendency of proceedings under 21
U.S.C. 811(a)(1). Id. Accordingly, on March 4, 2016, the DEA extended
the temporary scheduling of 4-MEC, 4-MePPP, [alpha]-PVP, butylone,
pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, and [alpha]-PBP by one
year, until March 3, 2017. 81 FR 11429. Also, on March 4, 2016, the DEA
published a notice of proposed rulemaking (NPRM) to permanently control
4-MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-
FMC, naphyrone, and [alpha]-PBP in schedule I of the CSA. 81 FR 11479.
Specifically, the DEA proposed to add these 10 synthetic cathinones to
21 CFR 1308.11(d), hallucinogenic substances.
DEA and HHS Eight Factor Analyses
By letter dated March 2, 2016, the HHS provided the DEA with a
scientific and medical evaluation document prepared by the FDA entitled
``Basis for the Recommendation to Control 4-
[[Page 12173]]
methyl-N-ethylcathinone (4-MEC), 4-methyl-pyrrolidinopropiophenone (4-
MePPP), alpha-pyrrolidinopentiophenone ([alpha]-PVP), 1-(1,3-
benzodioxol-5-yl)-2-(methylamino)butan-1-one (butylone), 2-
(methylamino)-1-phenylpentan-1-one (pentedrone), 1-(1,3-benzodioxol-5-
yl)-2-(methylamino)pentan-1-one (pentylone), 4-fluoro-N-methylcathinone
(4-FMC), 3-fluoro-N-methylcathinone (3-FMC), 1-(naphthalen-2-yl)-2-
(pyrrolidin-1-yl)pentan-1-one (naphyrone), alpha-
pyrrolidinobutiophenone ([alpha]-PBP) and their Salts in Schedule I of
the Controlled Substances Act (CSA).'' After considering the eight
factors in 21 U.S.C. 811(c), including consideration of each
substance's abuse potential, legitimate medical use, and dependence
liability, the Assistant Secretary of the HHS recommended that 4-MEC,
4-MePPP, [alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-FMC,
naphyrone, [alpha]-PBP, and their salts be controlled in schedule I of
the CSA. In response, the DEA conducted its own eightfactor analysis of
4-MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-
FMC, naphyrone, and [alpha]-PBP. Both the DEA and HHS analyses are
available in their entirety, under the tab ``Supporting Documents'' of
the public docket of this action at http://www.regulations.gov, under
FDMS Docket ID: DEA-2016-0004 (Docket No. DEA-436).\2\
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\2\ Although the published notice of proposed rulemaking stated
that the DEA 8-factor analysis had been placed into the docket on
http://www.regulations.gov, DEA discovered in preparing this final
rule that it had in fact not been posted. However, this document was
available for review at the DEA. The DEA posted the cited analysis
to http://www.regulations.gov upon discovery of the omission.
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Determination To Schedule 4-MEC, 4-MePPP, [alpha]-PVP, Butylone,
Pentedrone, Pentylone, 4-FMC, 3-FMC, Naphyrone, and [alpha]-PBP
After a review of the available data, including the scientific and
medical evaluations and the scheduling recommendations from the HHS,
the DEA published an NPRM entitled ``Schedules of Controlled
Substances: Placement of 10 Synthetic Cathinones into Schedule I,''
proposing to control 4-MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone,
pentylone, 4-FMC, 3-FMC, naphyrone, [alpha]-PBP, and their optical,
positional and geometric isomers, salts and salts of isomers in
schedule I of the CSA. 81 FR 11479, Mar. 4, 2016. The proposed rule
provided an opportunity for interested persons to file a request for
hearing in accordance with the DEA regulations on or before April 4,
2016. No requests for such a hearing were received by the DEA. The NPRM
also provided an opportunity for interested persons to submit written
comments on the proposal on or before April 4, 2016.
Comments Received
The DEA received two comments on the proposed rule to control 4-
MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-
FMC, naphyrone, and [alpha]-PBP in schedule I of the CSA. Both
commenters were in opposition to the proposed scheduling of 4-MEC, 4-
MePPP, [alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-FMC,
naphyrone, and [alpha]-PBP in schedule I of the CSA, but the reasons
for the opposition were different. The first commenter associated the
scheduling of these substances with the ``War on Drugs,'' which
according to the commenter ``has proven to be ineffective in past years
in reducing the number of drug abuse victims in the United States.''
The second commenter questioned the findings considered by the DEA to
control 4-MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone, pentylone,
4-FMC, 3-FMC, naphyrone, and [alpha]-PBP. Both commenters offered
alternative methods to address problems related to drug abuse instead
of scheduling the 10 synthetic cathinones in schedule I of the CSA.
Opposition from First Commenter. The first commenter stated that he
understood the DEA's reasons for proposing to schedule 4-MEC, 4-MePPP,
[alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone,
and [alpha]-PBP in schedule I of the CSA, but still opposed the control
of these substances because, according to the commenter, it would
neither reduce the number of drug users nor stop the production of
illegal drugs. The commenter suggested that the DEA consider harm
reduction solutions such as establishing drug clinics, finding jobs for
prior offenders, and offering treatment and health care for drug users
to address problems related to drug abuse.
DEA Response: Substances are controlled to protect the public
health and safety. Pursuant to 21 U.S.C. 811(a), the CSA authorizes the
DEA, under authority delegated by the Attorney General, to control any
drug or other substance if it is found that the drug or other substance
has a potential for abuse, and makes with respect to such drug or other
substance the findings prescribed by 21 U.S.C. 812(b). After
considering the eight factors in 21 U.S.C. 811(c), including
consideration of each substance's abuse potential, legitimate medical
use, safety and dependence liability, the Assistant Secretary of the
HHS recommended that 4-MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone,
pentylone, 4-FMC, 3-FMC, naphyrone, [alpha]-PBP and their salts be
controlled in schedule I of the CSA. The recommendations of the HHS to
the DEA are binding on the DEA as to the scientific and medical
matters. The DEA reviewed HHS's scientific and medical evaluations and
all other relevant data on these substances and concurs with the HHS
evaluations and findings. The current scientific, medical and other
evidence on 4-MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone,
pentylone, 4-FMC, 3-FMC, naphyrone, and [alpha]-PBP warrant control of
these substances and their optical, positional, and geometric isomers,
salts and salts of isomers in schedule I of the CSA.
While the DEA appreciates the commenter's suggestions regarding the
problems related to drug abuse, some of the suggested alternative
solutions are outside the scope of the current scheduling action which
pursuant to 21 U.S.C. 811 and 812 is to add drugs into one of the five
schedules, remove drugs from the schedules, or transfer drugs within
the schedules based on the drug's potential for abuse, medicinal value,
harmfulness, and psychological or physical dependence. However, please
note that in addition to law enforcement operations to reduce the
supply of illicit controlled drugs, the DEA also recommends and
supports non-enforcement programs such as the DEA 360 and the DEA
Demand Reduction Section programs. The DEA 360 strategy involves
community outreach activities such as the dissemination of drug
information to increase the public's awareness about the dangers
associated with drug use. The DEA's Community Outreach and Prevention
Support Section supports initiatives to reduce the demand for drugs and
gives assistance to community coalitions and drug prevention
initiatives.
Some of the alternative methods suggested by the commenter to
address the problems related to drug abuse that are outside of the
scope of the DEA are, in fact, part of the initiatives of other federal
institutions. For example, the Office of National Drug Control Policy
(ONDCP), a component of the Executive Office of the President of the
United States that coordinates drug-control activities and related
funding across the Federal government including the DEA, incorporates
community-based prevention programs, policies and systems to divert
non-violent drug offenders into treatment instead of jail,
[[Page 12174]]
outreach programs as well as other drug control policies in its long
term plans to reduce drug use and its consequences.
Opposition from Second Commenter. The second commenter also opposed
the control of 4-MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone,
pentylone, 4-FMC, 3-FMC, naphyrone, and [alpha]-PBP in schedule I of
the CSA, but for different reasons than the first commenter. The second
commenter maintained that the three arguments the DEA relied on in its
proposed rule for the scheduling of the 10 synthetic cathinones: (1)
``no medical or scientific use for these drugs;'' (2) ``there is a
distinct public safety concern allowing these drugs to be sold;'' and
(3) ``the use of this drug poses health concerns to those who use it,''
were illogical and based on faulty premises or speculative data. The
commenter also stated that the number of reported cases (or law
enforcement drug reports) involving these substances, especially if
considered over the defined five year period (i.e., January 2010
through December 2015), along with the population of the United States,
is ``miniscule'' which indicates that these substances do not pose a
large public safety concern. For example, the commenter provided
information that estimated the U.S. population for 2015 to be 320
million, and considered this with the 20,090 total reported cases for
all ten substances, as well as the 84 reported cases for naphyrone
alone, over the defined five year period. Extrapolating this data
further, the commenter estimated 4,018 reported cases annually for all
ten substances (i.e., 20,090 divided by 5 = 4,018), potentially
impacting 0.000013 percent of the U.S. population (4,018 divided by 320
million = 0.000013 percent), and 17 reported cases annually for
naphyrone alone (84 divided by 5 = 17). Furthermore, the commenter
stated that there is no toxicology, efficacy, or safety data on these
10 synthetic cathinones in human beings indicating that these
substances actually cause harm. The commenter also expressed concern
that the proposed scheduling of the 10 synthetic cathinones would
prohibit or significantly restrict the use of these substances in
scientific and medical research, and that schedule I placement would
put barriers in place for clinicians or researchers who might be
interested in investigating the potential benefits of these substances
in patients. In addition, this commenter believed that the proposed
rule was unduly burdensome, leading to increased regulation and costs
with ``little, if no impact'' on deterring abuse of these 10 synthetic
cathinones. As an alternative to controlling these 10 synthetic
cathinones, this commenter suggested ``placing restrictions on who can
sell products with these compounds in them, and a restriction of the
quantity that can be sold to any individual,'' and allowing States to
regulate these substances.
DEA Response: Pursuant to 21 U.S.C. 811, the DEA considered the
eight factors enumerated in 21 U.S.C. 811(c), the scientific and
medical evaluations and scheduling recommendations from the HHS, and
all other available data before making the required findings under 21
U.S.C. 812 to place these drugs into schedule I of the CSA. The DEA
does not consider these finding to be illogical and based on faulty
premises or speculative data. The summary of each factor as analyzed by
the HHS and the DEA, and as considered by the DEA in this scheduling
action, was provided in the proposed rule. The information in these
factors is from legitimate sources such as peer reviewed publications,
national statistics (e.g., seizure numbers, surveys), law enforcement
communications, medical examiner reports, etc.
As of March 7, 2014, the date the final order to temporarily place
the 10 synthetic cathinones into schedule I of the CSA was published
and became effective, all persons handling the 10 synthetic cathinones
were subject to the regulatory controls and administrative, civil, and
criminal sanctions applicable to schedule I controlled substances.
Based on a review of the DEA's records, each of the 43 registrations
that have been identified to handle any of the 10 synthetic cathinones
also handle other schedule I controlled substances. They have already
established and implemented the systems and processes required to
handle any of the 10 synthetic cathinones. Any additional cost to
handle the one or more of the 10 synthetic cathinones is estimated to
be minimal. Both the DEA and the HHS analyses have been made available
in their entirety under ``Supporting Documents'' section of the public
docket for this rule at http://www.regulations.gov, under FDMS Docket
ID: DEA-2016-0004 (Docket No. DEA-436).\3\
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\3\ Although the published notice of proposed rulemaking stated
that the DEA 8-factor analysis had been placed into the docket on
http://www.regulations.gov, DEA discovered in preparing this final
rule that it had in fact not been posted. However, this document was
available for review at the DEA. The DEA posted the cited analysis
to http://www.regulations.gov upon discovery of the omission.
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As detailed in the HHS and DEA analyses and the HHS recommendation,
studies indicate that the abuse potential and pharmacological effects
of the 10 synthetic cathinones are similar to those of certain schedule
I and II substances. Preclinical studies indicated that the 10
synthetic cathinones, like cocaine (schedule II), methamphetamine
(schedule II), methcathinone (schedule I), and MDMA (schedule I) have
pharmacological effects at monoamine transporters. Furthermore,
behavioral effects of the 10 synthetic cathinones in animals were found
to be similar to those of schedule I and II substances which have a
high potential for abuse. In humans, the 10 synthetic cathinones are
expected to produce subjective responses similar to methamphetamine and
cocaine based on drug discrimination studies in rodents. Accordingly,
published case reports demonstrate that some of the 10 synthetic
cathinones produce pharmacological effects including adverse effects
that are characteristic of substances like MDMA, methamphetamine, and
cocaine that have a stimulant effect. However, there is no currently
accepted medical use in treatment in the United States for any of the
10 synthetic cathinones. There are reports of emergency room admissions
and deaths associated with the abuse of synthetic cathinones in
general. Regarding the 10 synthetic cathinones, butylone, [alpha]-PVP,
pentedrone, and pentylone have been implicated in the deaths of
individuals. Consequently, the abuse of the 10 synthetic cathinones
presents the possibility of death and potential safety hazards to the
health of individuals.
Law enforcement data indicate that the 10 synthetic cathinones are
being abused. Since 2010, law enforcement encounters of the 10
synthetic cathinones have increased and have been encountered in nearly
every State (47 States as of December 2015). Regardless of the number
of encounters of these 10 synthetic cathinones, evidence indicates that
the abuse of the 10 synthetic cathinones is widespread. Thus, taking
into consideration the harm that these substances can cause as
demonstrated in case reports and other related information, the DEA
believes that there is potential for widespread harm to the public
health.
The DEA also considered all other relevant data including public
comments regarding the proposed scheduling before controlling these
drugs. After careful consideration of preclinical studies, case
reports, law enforcement data and all other relevant data and in
accordance with 21 U.S.C. 811(a) and (b) and considering the factors
enumerated in 21 U.S.C. 811(c),
[[Page 12175]]
the DEA finds that the 10 synthetic cathinones have a high potential
for abuse, have no currently accepted medical use in treatment in the
United States, and lack accepted safety for use under medical
supervision, thus supporting their placement in schedule I of the CSA.
The DEA does not agree that placement of these substances in
schedule I of the CSA precludes scientific research from being
conducted using these substances. Persons interested in using any of
the 10 synthetic cathinones for research purposes can do so provided
that they have a DEA schedule I researcher registration and meet all
other statutory and regulatory criteria. This registration can be
obtained by submitting an application for schedule I registration in
accordance with 21 CFR 1301.11, 1301.13, 1301.18 and 1301.32.
As for the commenter's suggestion to allow States to regulate these
substances, the DEA has no statutory authority under the CSA to require
states to regulate these substances. With regard to the suggestion by
the commenter to place ``restrictions on who can sell products with
these compounds in them, and a restriction on the quantity that can be
sold to any individual,'' the CSA and its implementing regulations do
provide regulatory controls and administrative sanctions applicable to
schedule I substances such as controls on persons who handle
(manufacture, distribute, reverse distribute, import, export, engage in
research, conduct instructional activities or chemical analysis, or
possess) schedule I substances.
Scheduling Conclusion
After consideration of the relevant matter presented as a result of
public comment, the scientific and medical evaluations and accompanying
recommendations of the HHS, and the DEA's consideration of its own
eight-factor analysis, the DEA finds that these facts and all other
relevant data constitute substantial evidence of potential for abuse of
4-MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-
FMC, naphyrone, and [alpha]-PBP. As such, the DEA is permanently
scheduling 4-MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone,
pentylone, 4-FMC, 3-FMC, naphyrone, and [alpha]-PBP as controlled
substances 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 CSA also 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
recommendation of the Assistant Secretary for the HHS and review of all
other available data, the Administrator of the DEA, pursuant to 21
U.S.C. 811(a) and 21 U.S.C. 812(b)(1), finds that:
(1) 4-MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone,
pentylone, 4-FMC, 3-FMC, naphyrone, and [alpha]-PBP each have a high
potential for abuse that is comparable to other schedule I and
schedule II substances such as mephedrone, methylone, MDPV,
methcathinone, MDMA, methamphetamine, and cocaine;
(2) 4-MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone,
pentylone, 4-FMC, 3-FMC, naphyrone, and [alpha]-PBP have no
currently accepted medical use in treatment in the United States;
and
(3) There is a lack of accepted safety for use of 4-MEC, 4-
MePPP, [alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-FMC,
naphyrone, and [alpha]-PBP under medical supervision.
Based on these findings, the Administrator of the DEA concludes
that 4-methyl-N-ethylcathinone (4-MEC); 4-methyl-alpha-
pyrrolidinopropiophenone (4-MePPP); alpha-pyrrolidinopentiophenone
([alpha]-PVP); 1-(1,3-benzodioxol-5-yl)-2-(methylamino)butan-1-one
(butylone); 2-(methylamino)-1-phenylpentan-1-one (pentedrone); 1-(1,3-
benzodioxol-5-yl)-2-(methylamino)pentan-1-one (pentylone); 4-fluoro-N-
methylcathinone (4-FMC); 3-fluoro-N-methylcathinone (3-FMC); 1-
(naphthalen-2-yl)-2-(pyrrolidin-1-yl)pentan-1-one (naphyrone); alpha-
pyrrolidinobutiophenone ([alpha]-PBP) and their optical, positional,
and geometric isomers, salts and salts of isomers, whenever the
existence of salts, isomers, and salts of isomers is possible, warrant
control in schedule I of the CSA. 21 U.S.C. 812(b)(1).
Requirements for Handling 4-MEC, 4-MePPP, [alpha]-PVP, butylone,
pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, and [alpha]-PBP
4-MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone, pentylone, 4-
FMC, 3-FMC, naphyrone, and [alpha]-PBP are currently scheduled on a
temporary basis in schedule I \4\ and are therefore currently subject
to the regulatory controls and administrative, civil, and criminal
sanctions applicable to the manufacture, distribution, reverse
distribution, importation, exportation, engaging in research,
conducting instructional activities or chemical analysis, or possession
of schedule I controlled substances, including those listed below.
These controls will continue on a permanent basis:
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\4\ 4-MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone,
pentylone, 4-FMC, 3-FMC, naphyrone, and [alpha]-PBP are currently
subject to schedule I controls on a temporary basis, pursuant to 21
U.S.C. 811(h). 79 FR 12938, Mar. 7, 2014.
1. Registration. Any person who handles (manufactures,
distributes, reverse distributes, imports, exports, engages in
research, conducts instructional activities or chemical analysis
with, or possesses) 4-MEC, 4-MePPP, [alpha]-PVP, butylone,
pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, or [alpha]-PBP, or
who desires to handle 4-MEC, 4-MePPP, [alpha]-PVP, butylone,
pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, or [alpha]-PBP must
be registered with the DEA to conduct such activities pursuant to 21
U.S.C. 822, 823, 957, and 958, and in accordance with 21 CFR parts
1301 and 1312.
2. Security. 4-MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone,
pentylone, 4-FMC, 3-FMC, naphyrone, and [alpha]-PBP are subject to
schedule I security requirements and must be handled and stored
pursuant to 21 U.S.C. 821 and 823, and in accordance with 21 CFR
1301.71-1301.93.
3. Labeling and Packaging. All labels, labeling, and packaging
for commercial containers of 4-MEC, 4-MePPP, [alpha]-PVP, butylone,
pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, or [alpha]-PBP must
be in compliance with 21 U.S.C. 825 and 958(e), and be in accordance
with 21 CFR part 1302.
4. Quota. Only registered manufacturers are permitted to
manufacture 4-MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone,
pentylone, 4-FMC, 3-FMC, naphyrone, or [alpha]-PBP in accordance
with a quota assigned pursuant to 21 U.S.C. 826, and in accordance
with 21 CFR part 1303.
5. Inventory. Every DEA registrant required to keep records and
who possesses any quantity of 4-MEC, 4-MePPP, [alpha]-PVP, butylone,
pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, and/or [alpha]-PBP
is required to maintain inventory of all stocks of 4-MEC, 4-MePPP,
[alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-FMC,
naphyrone, and [alpha]-PBP on hand, pursuant to 21 U.S.C. 827 and
958, and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11.
6. Records and Reports. Every DEA registrant must maintain
records and submit reports pursuant to 21 U.S.C. 827 and 958, and in
accordance with 21 CFR parts 1304 and 1317. Manufacturers and
distributors must submit reports regarding 4-MEC, 4-MePPP, [alpha]-
PVP, butylone, pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, and/
or [alpha]-PBP to the Automation of Reports and Consolidated Orders
System (ARCOS) pursuant to 21 U.S.C. 827 and in accordance with 21
CFR 1304.33.
8. Order Forms. Every DEA registrant who distributes 4-MEC, 4-
MePPP, [alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-FMC,
naphyrone, or [alpha]-PBP must continue to comply with the order
form requirements, pursuant to 21 U.S.C. 828, and 21 CFR part 1305.
9. Importation and Exportation. All importation and exportation
of 4-MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone, pentylone, 4-
FMC, 3-FMC, naphyrone, and [alpha]-
[[Page 12176]]
PBP must continue to be in compliance with 21 U.S.C. 952, 953, 957,
and 958, and in accordance with 21 CFR part 1312.
10. Liability. Any activity involving 4-MEC, 4-MePPP, [alpha]-
PVP, butylone, pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, or
[alpha]-PBP not authorized by, or in violation of, the CSA or its
implementing regulations is unlawful, and may subject the person to
administrative, civil, and/or criminal sanctions.
Regulatory Analyses
Executive Orders 12866 and 13563, Regulatory Planning and Review, and
Improving Regulation and Regulatory Review
In accordance with 21 U.S.C. 811(a), this final 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 (OMB) pursuant to section
3(d)(1) of Executive Order 12866 and the principles reaffirmed in
Executive Order 13563.
Executive Order 12988, Civil Justice Reform
This regulation meets the applicable standards set forth in
sections 3(a) and 3(b)(2) of Executive Order 12988 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, Federalism
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, Consultation and Coordination With Indian Tribal
Governments
This rule does not have tribal implications warranting the
application of Executive Order 13175. It 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 (RFA), 5 U.S.C. 601-602, 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. On March 7, 2014, the
DEA published a final order amending 21 CFR 1308.11(h) to temporarily
place these ten synthetic cathinones into schedule I of the CSA
pursuant to the temporary scheduling provisions of 21 U.S.C. 811(h). 79
FR 12938. On March 4, 2016, the DEA published a final order extending
the temporary placement of these substances in schedule I of the CSA
for up to one year pursuant to 21 U.S.C. 811(h)(2). 81 FR 11429. The
DEA estimates that all entities handling or planning to handle 4-MEC,
4-MePPP, [alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-FMC,
naphyrone, or [alpha]-PBP are currently registered to handle these
substances. There are currently 43 registrants authorized to handle 4-
MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-
FMC, naphyrone, or [alpha]-PBP, as well as a number of registered
analytical labs that are authorized to handle schedule I controlled
substances generally.\5\ These 43 registrants represent 31 entities, of
which 11 are small entities based on RFA definition of ``small entity''
and Small Business Administration size standards. Therefore, the DEA
estimates that 11 small entities are affected by this rule.
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\5\ While analytical labs are required to obtain a registration
for schedule I controlled substances, in order to handle any of the
10 synthetic cathinones, analytical labs are not required to
identify the substances on their registration. Therefore, while
every analytical lab that is authorized to handle schedule I
controlled substances may handle any of the 10 synthetic cathinones,
the DEA does not have a basis by which to estimate the number of
analytical labs that actually handle the 10 synthetic cathinones.
Since an analytical lab registered to handle schedule I controlled
substances may manufacture or obtain any of the 10 synthetic
cathinones without any modification to the analytical lab's
registration, the DEA believes analytical labs' inventories of these
substances are not significant and will have minimal impact on
existing schedule I controlled substance storage space. Therefore,
for the purposes of this analysis, the DEA assumes that no
analytical lab is affected by this rule.
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A review of the 43 registrants indicates that all entities that
currently handle 4-MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone,
pentylone, 4-FMC, 3-FMC, naphyrone, or [alpha]-PBP also handle other
schedule I controlled substances, and have established and implemented
(or currently maintain) the systems and processes required to handle 4-
MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-
FMC, naphyrone, or [alpha]-PBP. Therefore, the DEA anticipates that
this rule will impose minimal or no economic impact on any affected
entities; and thus, will not have a significant economic impact on any
of the 11 affected small entities. Accordingly, the DEA has concluded
that this rule will not have a significant economic impact on a
substantial number of small entities.
Unfunded Mandates Reform Act of 1995
In accordance with the Unfunded Mandates Reform Act (UMRA) of 1995,
2 U.S.C. 1501 et seq., the DEA has determined and certifies that this
action would not result in any 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, neither a Small
Government Agency Plan nor any other action is required under UMRA of
1995.
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. This action
would not impose recordkeeping or reporting requirements on State or
local governments, individuals, businesses, or organizations. An agency
may not conduct or sponsor, and a person is not required to respond to,
a collection of information unless it displays a currently valid OMB
control number.
Congressional Review Act
This rule is not a major rule as defined by section 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, the 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,
[[Page 12177]]
Reporting and recordkeeping requirements.
For the reasons set out above, 21 CFR part 1308 is amended as
follows:
PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES
0
1. The authority citation for 21 CFR part 1308 continues to read as
follows:
Authority: 21 U.S.C. 811, 812, 871(b), unless otherwise noted.
0
2. In Sec. 1308.11:
0
a. Add paragraphs (d)(59) through (68);
0
b. Remove paragraphs (h)(1) through (10);
0
c. Redesignate paragraphs (h)(11) through (19) as (h)(1) through (9);
and
0
d. Remove reserved paragraphs (h)(20) through (22).
The additions read as follows:
Sec. 1308.11 Schedule I.
* * * * *
(d) * * *
(59) 4-methyl-N-ethylcathinone (4-MEC).................. (1249)
(60) 4-methyl-alpha-pyrrolidinopropiophenone (4-MePPP).. (7498)
(61) alpha-pyrrolidinopentiophenone ([alpha]-PVP)....... (7545)
(62) 1-(1,3-benzodioxol-5-yl)-2-(methylamino)butan-1-one (7541)
(butylone, bk-MBDB)....................................
(63) 2-(methylamino)-1-phenylpentan-1-one (pentedrone).. (1246)
(64) 1-(1,3-benzodioxol-5-yl)-2-(methylamino)pentan-1- (7542)
one (pentylone, bk-MBDP)...............................
(65) 4-fluoro-N-methylcathinone (4-FMC; flephedrone).... (1238)
(66) 3-fluoro-N-methylcathinone (3-FMC)................. (1233)
(67) 1-(naphthalen-2-yl)-2-(pyrrolidin-1-yl)pentan-1-one (1258)
(naphyrone)............................................
(68) alpha-pyrrolidinobutiophenone ([alpha]-PBP)........ (7546)
* * * * *
Dated: February 22, 2017.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2017-03974 Filed 2-28-17; 8:45 am]
BILLING CODE 4410-09-P