[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]]

=======================================================================
-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

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.''
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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).
---------------------------------------------------------------------------

    \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.

---------------------------------------------------------------------------

[[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

[[Page 666]]

 
(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]
BILLING CODE 4410-09-P