[Federal Register Volume 78, Number 3 (Friday, January 4, 2013)]
[Rules and Regulations]
[Pages 664-666]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-31698]
[[Page 664]]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-368]
Establishment of Drug Codes for 26 Substances
AGENCY: Drug Enforcement Administration (DEA), Department of Justice.
ACTION: Final rule.
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SUMMARY: On July 9, 2012, the President signed into law the Synthetic
Drug Abuse Prevention Act of 2012 (SDAPA). SDAPA amends the Controlled
Substances Act by placing 26 substances in Schedule I. DEA is
publishing this rule to establish drug codes for these 26 substances,
and to make technical and conforming amendments in accordance with
SDAPA.
DATES: Effective Date: January 4, 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
DEA administers, 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, the lack of accepted safety for use
under medical supervision, and the degree of dependence the substance
may cause. 21 U.S.C. 812. The list of legislatively scheduled
controlled substances is found at 21 U.S.C. 812(c) and the current list
of scheduled substances is published at 21 CFR part 1308. These initial
schedules may be modified either by legislation or by rulemaking.
Purpose of This Rulemaking
On July 9, 2012, the SDAPA of 2012, Public Law 112-144, Title XI,
Subtitle D, became effective. SDAPA amended the CSA by legislatively
placing ``cannabimimetic agents'' \1\ and 26 substances in Schedule I.
Public Law 112-144, Title XI, Subtitle D, Section 1152. DEA is
publishing this rule to establish drug codes for these 26 substances.
These 26 substances include 15 cannabimimetic agents, 9
phenethylamines, and 2 cathinones and are listed in the regulatory text
section, below.
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\1\ SDAPA also included a definition of ``cannabimimetic
agents.'' Although this rule is only addressing the 26 specific
substances, DEA intends to issue a separate rulemaking that will
address the broader definition of cannabimimetic agents. Even in the
absence of such a rulemaking as of July 9, 2012, cannabimimetic
agents, as defined in SDAPA are controlled under Schedule I.
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Related Procedural Matters
At the time SDAPA became effective on July 9, 2012, a total of 8
substances were covered by temporary scheduling final orders: 5
synthetic cannabinoids (JWH-018, JWH-073, JWH-200, CP-47,497, and CP-
47,497 C8 homologue) \2\ and 3 synthetic cathinones (mephedrone, MDPV,
and methylone).\3\ DEA also issued a Notice of Proposed Rulemaking
(NPRM) in March 2012, to place the 5 synthetic cannabinoids (JWH-018,
JWH-073, JWH-200, CP-47,497, and CP-47,497 C8 homologue) permanently in
Schedule I.\4\ With the sole exception of methylone,\5\ these
substances were specifically placed in Schedule I by SDAPA. Therefore,
it is no longer necessary to finalize the NPRM regarding the 5
synthetic cannabinoids (JWH-018, JWH-073, JWH-200, CP-47,497, and CP-
47,497 C8 homologue), or to take further action with respect to 2 of
the 3 synthetic cathinones (mephedrone and MDPV). However, DEA has
posted a copy of the Secretary of Health and Human Services (HHS)
Scientific and Medical Evaluation and Scheduling Recommendations
regarding the 5 synthetic cannabinoids on www.regulations.gov so that
the public can benefit from the scientific review that was undertaken
with respect to these substances.\6\ These HHS documents can be found
on www.regulations.gov under Docket ID ``DEA-2012-0001.''
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\2\ See DEA Notice of Intent entitled ``Schedules of Controlled
Substances: Temporary Placement of Five Synthetic Cannabinoids Into
Schedule I,'' published in the Federal Register on November 24,
2010, at 75 FR 71635, DEA Notice of Intent; correction entitled
``Schedules of Controlled Substances: Temporary Placement of Five
Synthetic Cannabinoids Into Schedule I; Correction,'' published in
the Federal Register on January 13, 2011, at 76 FR 2287, DEA Final
Order entitled ``Schedules of Controlled Substances: Temporary
Placement of Five Synthetic Cannabinoids into Schedule I,''
published in the Federal Register on March 1, 2011, at 76 FR 11075,
and DEA Final Order entitled ``Schedules of Controlled Substances:
Extension of Temporary Placement of Five Synthetic Cannabinoids Into
Schedule I of the Controlled Substances Act,'' published in the
Federal Register on February 29, 2012, at 77 FR 12201.
\3\ See DEA Notice of Intent entitled ``Schedules of Controlled
Substances: Temporary Placement of Three Synthetic Cathinones Into
Schedule I,'' published in the Federal Register on September 8,
2011, at 76 FR 55616 and DEA Final Order entitled ``Schedules of
Controlled Substances: Temporary Placement of Three Synthetic
Cathinones Into Schedule I,'' published in the Federal Register on
October 21, 2011, at 76 FR 65371.
\4\ See Schedules of Controlled Substances: Placement of Five
Synthetic Cannabinoids Into Schedule I, 77 FR 12508, Mar. 1, 2012.
\5\ DEA extended the temporary scheduling of methylone in a
Final Order published in the Federal Register on October 18, 2012 at
77 FR 64032.
\6\ HHS did not provide a Scientific and Medical Evaluation and
Scheduling Recommendation regarding mephedrone and MDPV.
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In addition to establishing drug codes for these 26 substances,\7\
this rulemaking makes several technical and conforming amendments to 21
CFR 1308.11 in accordance with SDAPA. This rulemaking adds a new
subsection (g) to 21 CFR 1308.11 and gives it the title
``cannabimimetic agents,'' redesignates the old subsection (g) as (h)
and retains its title as ``[t]emporary listing of substances subject to
emergency scheduling,'' and transfers 7 of the 8 substances currently
listed in 21 CFR 1308.11(g) under the title of ``[t]emporary listing of
substances subject to emergency scheduling,'' to either the new
subsection (g) entitled ``cannabimimetic agents'' or to the previously
existing subsection (d) entitled ``[h]allucinogenic substances.'' In
summary, as a result of SDAPA, a new subsection entitled
``cannabimimetic agents'' will be created and will initially contain 15
substances, the existing subsection entitled ``[h]allucinogenic
substances'' will increase by 11 substances, and the existing
subsection entitled ``temporary listing of substances subject to
emergency scheduling'' will be redesignated from (g) to (h) and will
decrease from 8 substances to 1 substance (methylone).
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\7\ Some of these substances (for example, JWH-018) had already
received drug codes by virtue of the prior temporary scheduling
actions discussed above. Such substances will retain their
previously established drug codes but are included in this rule for
purposes of completeness and to ensure that each of these 26
substances are properly classified in the Code of Federal
Regulations. Substances for which a drug code has not previously
been established (for example, 2-(2,5-Dimethoxy-4-
ethylphenyl)ethanamine (2C-E)) will have a drug code assigned to
them by this rule.
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[[Page 665]]
Regulatory Analyses
Administrative Procedure Act
An agency may find good cause to exempt a rule from certain
provisions of the Administrative Procedure Act (APA) (5 U.S.C. 553),
including notice of proposed rulemaking and the opportunity for public
comment, if it is determined to be unnecessary, impracticable, or
contrary to the public interest. This rule merely establishes drug
codes for the 26 substances placed in Schedule I by SDAPA, and makes
several technical and conforming amendments in accordance with SDAPA.
Because DEA has no discretion with respect to these changes, publishing
a notice of proposed rulemaking and soliciting public comment are
unnecessary. In addition, because the placement of these 26 substances
in Schedule I has already been in effect since July 9, 2012, DEA finds
good cause exists to make this rule effective immediately upon
publication.
Executive Orders 12866 and 13563
This rule, establishing drug codes for the 26 substances placed in
Schedule I by SDAPA, and making technical and conforming amendments in
accordance with SDAPA has been developed in accordance with the
principles of Executive Orders 12866 and 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 ambiguity, minimize litigation, establish clear legal
standards, and reduce burden.
Executive Order 13132
This rulemaking does not preempt or modify any provision of State
law, impose enforcement responsibilities on any State, or diminish the
power of any State to enforce its own laws. Accordingly, this
rulemaking does not have federalism implications warranting the
application of Executive Order 13132.
Executive Order 13175
This rule is required by statute, will not have tribal
implications, and will not impose substantial direct compliance costs
on Indian tribal governments.
Regulatory Flexibility Act
The Deputy Administrator hereby certifies that this rulemaking has
been drafted in accordance with the Regulatory Flexibility Act (5
U.S.C. 601-612), has reviewed this regulation, and by approving it
certifies that this regulation will not have a significant economic
impact on a substantial number of small entities.
Paperwork Reduction Act of 1995
This rule does not involve a collection of information within the
meaning of the Paperwork Reduction Act of 1995, 44 U.S.C. 3501-3521.
Unfunded Mandates Reform Act of 1995
This rule will not result in the expenditure by State, local, and
tribal governments, in the aggregate, or by the private sector, of
$136,000,000 or more (adjusted for inflation) in any one year, and will
not significantly or uniquely affect small governments. Therefore, no
actions were deemed necessary under the provisions of the Unfunded
Mandates Reform Act of 1995. 2 U.S.C. 1532.
Congressional Review Act
This rule is not a major rule as defined by the Congressional
Review Act (5 U.S.C. 804). This rule will not result in an annual
effect on the economy of $100,000,000 or more, a major increase in cost
or prices, or have significant adverse effects on competition,
employment, investment, productivity, innovation, or the ability of
United States-based companies to compete with foreign based companies
in domestic and export markets. However, DEA has submitted a copy of
this 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 as
follows:
PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES
0
1. The authority citation for part 1308 continues to read as follows:
Authority: 21 U.S.C. 811, 812, 871(b), unless otherwise noted.
0
2. Amend Sec. 1308.11 by:
0
a. Adding new paragraphs (d)(36) through (d)(46);
0
b. Redesignating paragraph (g) as paragraph (h) and revising newly
redesignated paragraph (h)(1); and
0
c. Adding a new paragraph (g).
The additions and revisions read as follows:
Sec. 1308.11 Schedule I.
* * * * *
(d) * * *
(36) 4-methylmethcathinone (Mephedrone)........................ 1248
(37) 3,4-methylenedioxypyrovalerone (MDPV)..................... 7535
(38) 2-(2,5-Dimethoxy-4-ethylphenyl)ethanamine (2C-E).......... 7509
(39) 2-(2,5-Dimethoxy-4-methylphenyl)ethanamine (2C-D)......... 7508
(40) 2-(4-Chloro-2,5-dimethoxyphenyl)ethanamine (2C-C)......... 7519
(41) 2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine (2C-I)........... 7518
(42) 2-[4-(Ethylthio)-2,5-dimethoxyphenyl]ethanamine (2C-T-2).. 7385
(43) 2-[4-(Isopropylthio)-2,5-dimethoxyphenyl]ethanamine (2C-T- 7532
4)............................................................
(44) 2-(2,5-Dimethoxyphenyl)ethanamine (2C-H).................. 7517
(45) 2-(2,5-Dimethoxy-4-nitro-phenyl)ethanamine (2C-N)......... 7521
(46) 2-(2,5-Dimethoxy-4-(n)-propylphenyl)ethanamine (2C-P)..... 7524
* * * * *
(g) Cannabimimetic agents. Unless specifically exempted or unless
listed in another schedule, any material, compound, mixture, or
preparation which contains any quantity of the following substances, or
which contains their salts, isomers, and salts of isomers whenever the
existence of such salts, isomers, and salts of isomers is possible
within the specific chemical designation:
(1) 5-(1,1-dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]- 7297
phenol (CP-47,497)........................................
(2) 5-(1,1-dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]- 7298
phenol (cannabicyclohexanol or CP-47,497 C8-homolog)......
(3) 1-pentyl-3-(1-naphthoyl)indole (JWH-018 and AM678)..... 7118
(4) 1-butyl-3-(1-naphthoyl)indole (JWH-073)................ 7173
(5) 1-hexyl-3-(1-naphthoyl)indole (JWH-019)................ 7019
(6) 1-[2-(4-morpholinyl)ethyl]-3-(1-naphthoyl)indole (JWH- 7200
200)......................................................
(7) 1-pentyl-3-(2-methoxyphenylacetyl)indole (JWH-250)..... 6250
(8) 1-pentyl-3-[1-(4-methoxynaphthoyl)]indole (JWH-081).... 7081
(9) 1-pentyl-3-(4-methyl-1-naphthoyl)indole (JWH-122)...... 7122
(10) 1-pentyl-3-(4-chloro-1-naphthoyl)indole (JWH-398)..... 7398
(11) 1-(5-fluoropentyl)-3-(1-naphthoyl)indole (AM2201)..... 7201
(12) 1-(5-fluoropentyl)-3-(2-iodobenzoyl)indole (AM694).... 7694
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(13) 1-pentyl-3-[(4-methoxy)-benzoyl]indole (SR-19 and RCS- 7104
4)........................................................
(14) 1-cyclohexylethyl-3-(2-methoxyphenylacetyl)indole 7008 7008
(SR-18 and RCS-8).........................................
(15) 1-pentyl-3-(2-chlorophenylacetyl)indole (JWH-203)..... 7203
(h) * * *
(1) 3,4-methylenedioxy-N-methylcathinone (Other names: 7540
methylone)................................................
* * * * *
Dated: December 21, 2012.
Michele M. Leonhart,
Administrator.
[FR Doc. 2012-31698 Filed 1-3-13; 8:45 am]
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