[Federal Register Volume 78, Number 95 (Thursday, May 16, 2013)]
[Rules and Regulations]
[Pages 28735-28739]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-11593]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-373]
Schedules of Controlled Substances: Temporary Placement of Three
Synthetic Cannabinoids Into Schedule I
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Final order.
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SUMMARY: The Deputy Administrator of the Drug Enforcement
Administration (DEA) is issuing this final order to temporarily
schedule three synthetic cannabinoids under the Controlled Substances
Act (CSA) pursuant to the temporary scheduling provisions of 21 U.S.C.
811(h). The substances are (1-pentyl-1H-indol-3-yl)(2,2,3,3-
tetramethylcyclopropyl)methanone (UR-144), [1-(5-fluoro-pentyl)-1H-
indol-3-yl](2,2,3,3-tetramethylcyclopropyl)methanone (5-fluoro-UR-144,
XLR11) and N-(1-adamantyl)-1-pentyl-1H-indazole-3-carboxamide (APINACA,
AKB48). This action is based on a finding by the Deputy Administrator
that the placement of these synthetic cannabinoids and their salts,
isomers and salts of isomers into Schedule I of the CSA is necessary to
avoid an imminent hazard to the public safety. As a result of this
order, the full effect of the CSA and the Controlled Substances Import
and Export Act (CSIEA) and their implementing regulations including
criminal, civil and administrative penalties, sanctions and regulatory
controls of Schedule I substances will be imposed on the manufacture,
distribution, possession, importation, and exportation of these
synthetic cannabinoids.
DATES: Effective Date: This Final Order is effective on May 16, 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:
Background
Section 201 of the CSA (21 U.S.C. 811) provides the Attorney
General with the authority to temporarily place a substance into
Schedule I of the CSA for two years without regard to the requirements
of 21 U.S.C. 811(b) if he finds that such action is necessary to avoid
imminent hazard to the public safety. 21 U.S.C. 811(h). In addition, if
proceedings to control a substance are initiated under 21 U.S.C.
811(a)(1), the Attorney General may extend the temporary scheduling up
to one year.
Where the necessary findings are made, a substance may be
temporarily scheduled if it is not listed in any other schedule under
section 202 of the CSA (21 U.S.C. 812) or if there is no exemption or
approval in effect under section 505 of the Federal Food, Drug and
Cosmetic Act (FD&C Act) (21 U.S.C. 355) for the substance (21 U.S.C.
811 (h)(1)). The Attorney General has delegated his authority under 21
U.S.C. 811 to the Administrator of DEA, who in turn has delegated her
authority to the Deputy Administrator of DEA. 28 CFR 0.100, Appendix to
Subpart R.
Section 201(h)(4) of the CSA (21 U.S.C. 811(h)(4)) requires the
Deputy Administrator to notify the Secretary of the Department of
Health and Human Services (HHS) of his intention to temporarily place a
substance into Schedule I of the CSA.\1\ The Deputy Administrator has
transmitted notice of his intent to place UR-144, XLR11 and AKB48 in
Schedule I on a temporary basis to the Assistant Secretary by letter
dated February 14, 2013. The Assistant Secretary responded to this
notice by letter dated March 14, 2013 (received by DEA on March 21,
2013), and advised that based on review by the Food and Drug
Administration (FDA), there are currently no investigational new drug
applications or approved new drug applications for UR-144, XLR11 or
AKB48. The Assistant Secretary also stated that HHS has no objection to
the temporary placement of UR-144, XLR11 or AKB48 into Schedule I of
the CSA. DEA has taken into consideration the Assistant Secretary's
comments (21 U.S.C. 811(h)(4)). As UR-144, XLR11 and AKB48 are not
currently listed in any schedule under the CSA, and as no exemptions or
approvals are in effect for UR-144, XLR11 and AKB48 under Section 505
of the FD&C Act (21 U.S.C. 355), DEA believes that the conditions of 21
U.S.C. 811(h)(1) have been satisfied. On April 12, 2013, a Notice of
Intent to temporarily schedule these three synthetic cannabinoids was
published in the Federal Register (78 FR 21858).
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\1\ Because the Secretary of the Department of Health and Human
Services (HHS) 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 Final
Order, all subsequent references to ``Secretary'' have been replaced
with ``Assistant Secretary.'' As set forth in a memorandum of
understanding entered into by HHS, the Food and Drug Administration
(FDA), and the National Institute on Drug Abuse (NIDA), FDA acts as
the lead agency within HHS in carrying out the Secretary's
scheduling responsibilities under the Controlled Substance Act
(CSA), with the concurrence of NIDA. 50 FR 9518.
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To make a finding that placing a substance temporarily into
Schedule I of the CSA is necessary to avoid an imminent hazard to the
public safety, the Deputy Administrator is required to consider three
of the eight factors set forth in section 201(c) of the CSA (21 U.S.C.
811(h)(3)). These factors are as follows: the substance's history and
current pattern of abuse; the scope, duration and significance of
abuse, and what, if any, risk there is to the public health. 21 U.S.C.
811(c)(4)-(6). Consideration of these factors includes actual abuse,
diversion from legitimate channels and clandestine importation,
manufacture or distribution. 21 U.S.C. 811(h)(3).
A substance meeting the statutory requirements for temporary
scheduling (21 U.S.C. 811(h)) may only be placed in Schedule I.
Substances in Schedule I are those that have a high potential for
[[Page 28736]]
abuse, no currently accepted medical use in treatment in the United
States (U.S.), and a lack of accepted safety for use under medical
supervision. 21 U.S.C. 812(b)(1). Available data and information for
UR-144, XLR11 and AKB48 indicate that these three synthetic
cannabinoids have a high potential for abuse, no currently accepted
medical use in treatment in the U.S., and a lack of accepted safety for
use under medical supervision.
Synthetic Cannabinoids
While synthetic cannabinoids have been developed over the last 30
years for research purposes to investigate the cannabinoid system, no
scientific literature referring to UR-144, XLR11 or AKB48 was available
prior to these drugs' identification in the illicit market. In
addition, no legitimate non-research uses have been identified for
these synthetic cannabinoids nor have they been approved by FDA for
human consumption. Synthetic cannabinoids, of which (1-pentyl-1H-indol-
3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone (UR-144), [1-(5-fluoro-
pentyl)-1H-indol-3-yl](2,2,3,3-tetramethylcyclopropyl)methanone (5-
fluoro-UR-144, XLR11), and N-(1-adamantyl)-1-pentyl-1H-indazole-3-
carboxamide (APINACA, AKB48) are representative, are so-termed for
their [Delta]9-tetrahydrocannabinol (THC)-like pharmacological
properties. Numerous herbal products have been analyzed, and UR-144,
XLR11 and AKB48 have been identified, in varying mixture profiles and
amounts, spiked on plant material.
As of April 3, 2013, according to the System to Retrieve
Information from Drug Evidence (STRIDE) data, there are 1,510 reports
involving 179 total cases for UR-144, 1,194 reports involving 186 total
cases for XLR11 and 112 reports involving 40 total cases for AKB48.
From January 2010 to March 2013, the National Forensic Laboratory
Information System (NFLIS) registered 14,831 reports containing these
synthetic cannabinoids (UR-144--5,465 reports; XLR11--8,837 reports;
AKB48--529 reports) from at least 32 states. No instances regarding UR-
144, XLR11 or AKB48 were reported in NFLIS prior to March of 2010. For
the period January 2010 through March 2013, NFLIS and STRIDE reports
\2\ for the three synthetic cannabinoids UR-144, XLR11 and AKB48
(16,014 total reports) exceeded the number of reports for the five
synthetic cannabinoids JWH-018, JWH-073, JWH-200, CP-47,497 and CP-
47,497 C8 (7,555 total reports). JWH-018, JWH-200, JWH-073, CP-47,497
and CP-47,497 C8 homologue were temporarily scheduled on March 1, 2011,
and later placed in Schedule I by Section 1152 of Food and Drug
Administration Safety and Innovation Act (FDASIA), Pub. L. 112-144, on
July 9, 2012. Section 1152 of the FDASIA \3\ amended the CSA by placing
cannabimimetic agents and 26 specific substances (including 15
synthetic cannabinoids, 2 synthetic cathinones, and 9 phenethylamines
of the 2C-series) in Schedule I. UR-144, XLR11 and AKB48 were not
included among the 15 specific named synthetic cannabinoids, and do not
fall under the definition of cannabimimetic agents, under FDASIA.
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\2\ National Forensic Laboratory Information System (NFLIS) is a
program sponsored by the Drug Enforcement Administration's (DEA),
Office of Diversion Control which compiles information on exhibits
analyzed in State and local law enforcement forensic laboratories.
System to Retrieve Information from Drug Evidence (STRIDE) is a DEA
database which compiles information on exhibits analyzed in DEA
laboratories.
\3\ Subtitle D of Title XI of the Food and Drug Administration
Safety and Innovation Act (FDASIA), which includes Sections 1151-
1153 of Pub. L. 112-144, is also known as the ``Synthetic Drug Abuse
Prevention Act of 2012,'' or ``SDAPA.''
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Factor 4. History and Current Pattern of Abuse
Synthetic cannabinoids (JWH-018) laced on plant material were first
reported in the U.S. in December 2008, when a shipment of ``Spice'' was
seized and analyzed by U.S. Customs and Border Patrol in Dayton, Ohio.
Also in December 2008, JWH-018 and cannabicyclohexanol were identified
by German forensic laboratories.
Since the initial identification of JWH-018 (December 2008), many
additional synthetic cannabinoids with purported psychotropic effects
have been found laced on plant material or related products. The
popularity of these synthetic cannabinoids and their associated
products appears to have increased since January 2010 in the U.S. based
on seizure exhibits and media reports. This trend appears to mirror
that experienced in Europe since 2008. Synthetic cannabinoids are being
encountered in several regions of the U.S. with the substances
primarily found as adulterants on plant material products as self-
reported on internet discussion boards. Since then, numerous other
synthetic cannabinoids including UR-144, XLR11 and AKB48 have been
identified as product adulterants.
Data gathered from published studies, supplemented by discussions
on Internet Web sites and personal communications with toxicological
testing laboratories, demonstrate that products laced with UR-144,
XLR11 and/or AKB48 are being abused mainly by smoking for their
psychoactive properties. The adulterated products are marketed as
`legal' alternatives to marijuana. This characterization, along with
their reputation as potent herbal intoxicants, has increased their
popularity. Several synthetic cannabinoids, including UR-144, XLR11 and
AKB48, have been shown to display higher potency in scientific studies
when compared to THC. Smoking mixtures of these substances for the
purpose of achieving intoxication has been identified as a reason for
numerous emergency room visits and calls to poison control centers.
Abuse of these synthetic cannabinoids and their products has been
characterized with both acute and long term public health and safety
issues. In addition, numerous states, local jurisdictions, and the
international community have controlled these substances.
Factor 5. Scope, Duration and Significance of Abuse
According to forensic laboratory reports, the first appearance of
synthetic cannabinoids in the U.S. occurred in December 2008, when U.S.
Customs and Border Protection analyzed ``Spice'' products. NFLIS has
reported 14,831 exhibits (January 2010 to March 2013) related to UR-
144, XLR11 and AKB48 from various states including Alaska, Alabama,
Arkansas, California, Colorado, Florida, Georgia, Iowa, Indiana,
Illinois, Kansas, Kentucky, Louisiana, Maryland, Minnesota, Missouri,
New Hampshire, New Jersey, New Mexico, North Dakota, Nebraska, Nevada,
Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Utah,
Virginia, Wisconsin and Wyoming. STRIDE has reported 2,816 records
involving UR-144, XLR11 and/or AKB48 from January 2010 through April 3,
2013. From January 1 through December 31, 2012, the American
Association of Poison Control Centers \4\ has reported receiving in
excess of 5,200 calls relating to products purportedly laced with
synthetic cannabinoids. Although the center does not identify specific
cannabinoid substances, the data does indicate the magnitude of adverse
exposure to synthetic cannabinoids.
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\4\ American Association of Poison Control Centers (AAPCC) is a
non-profit, national organization that represents the poison centers
of the United States.
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Factor 6. What, If Any, Risk There Is to the Public Health
UR-144, XLR11 and AKB48 are pharmacologically similar to Schedule I
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substances THC and JWH-018, as well as other synthetic cannabinoids. By
sharing pharmacological similarities with the Schedule I substances
(THC and JWH-018), synthetic cannabinoids pose a risk to the abuser. In
addition, the chronic abuse of products laced with synthetic
cannabinoids has also been linked to addiction and withdrawal. Law
enforcement, military and public health officials have reported
exposure incidents that demonstrate the dangers associated with abuse
of synthetic cannabinoids to both the individual abusers and other
affected individuals since these substances were never intended for
human use. Warnings regarding the dangers associated with abuse of
synthetic cannabinoids and their products have been issued by numerous
state public health departments, poison control centers and private
organizations. In a 2012 report, the Substance Abuse and Mental Health
Services Administration (SAMHSA) reported 11,406 emergency department
visits involving a synthetic cannabinoid product during 2010. In a 2013
report, SAMHSA reported the number of emergency department visits in
2011 involving a synthetic cannabinoid product had increased 2.5 times
to 28,531.
Detailed product analyses have detected variations in the amount
and type of synthetic cannabinoid laced on plant material even within
samplings of the same product. Since abusers obtain these drugs through
unknown sources, purity of these drugs is uncertain, thus posing
significant adverse health risk to these users. Submissions to DEA
laboratories from January 2012 through February 11, 2013, have
documented over 142 distinct packaging examples containing a mixture of
UR-144, XLR11 and/or AKB48. These unknown factors present a significant
risk of danger to the abuser. Some of the adverse health effects
reported in response to the abuse of synthetic cannabinoids include
vomiting, anxiety, agitation, irritability, seizures, hallucinations,
tachycardia, elevated blood pressure, and loss of consciousness. As
mentioned above, there are reported instances of emergency department
admissions in association with the abuse of these THC-like substances.
There are no recognized therapeutic uses of these substances in the
U.S.
In February 2013, the Centers for Disease Control and Prevention
published a report by Murphy et al. describing unexplained cases of
acute kidney injury in 16 patients, all of whom had reported recent
smoking of synthetic cannabinoids. Upon further investigation, it was
determined that of the 16 patients, 7 of the subjects had smoked
substances that were positive for XLR11 or its metabolite. Cases were
reported from Wyoming (4 cases), Rhode Island (1 case), New York (2
cases), Oregon (6 cases), Kansas (1 case) and Oklahoma (2 cases).
Finding of Necessity of Schedule I Scheduling To Avoid Imminent Hazard
to Public Safety
Based on the available data and information, the continued
uncontrolled manufacture, distribution, importation, exportation and
abuse of UR-144, XLR11 and AKB48 pose an imminent hazard to the public
safety. DEA is not aware of any currently accepted medical uses for
these synthetic cannabinoids in the U.S. A substance meeting the
statutory requirements for temporary scheduling (21 U.S.C. 811(h)) may
only be placed in Schedule I. Substances in Schedule I are those that
have a high potential for abuse, no currently accepted medical use in
treatment in the U.S., and a lack of accepted safety for use under
medical supervision. Available data and information for UR-144, XLR11
and AKB48 indicate that these three synthetic cannabinoids have a high
potential for abuse, no currently accepted medical use in treatment in
the U.S., and a lack of accepted safety for use under medical
supervision.
Conclusion
In accordance with the provisions of section 201(h) of the CSA (21
U.S.C. 811(h)), the Deputy Administrator has considered available data
and information and has set forth herein the grounds for his
determination that it is necessary to temporarily schedule three
synthetic cannabinoids, (1-pentyl-1H-indol-3-yl)(2,2,3,3-
tetramethylcyclopropyl)methanone (UR-144), [1-(5-fluoro-pentyl)-1H-
indol-3-yl](2,2,3,3-tetramethylcyclopropyl)methanone (5-fluoro-UR-144,
XLR11) and N-(1-adamantyl)-1-pentyl-1H-indazole-3-carboxamide (APINACA,
AKB48) in Schedule I of the CSA and finds that placement of these
synthetic cannabinoids into Schedule I of the CSA is warranted in order
to avoid an imminent hazard to the public safety.
Because the Deputy Administrator hereby finds that it is necessary
to temporarily place these synthetic cannabinoids into Schedule I to
avoid an imminent hazard to the public safety, the final order
temporarily scheduling these substances will be effective on the date
of publication in the Federal Register, and will be in effect for a
period of up to three years pending completion of the permanent or
regular scheduling process.
Regular scheduling actions in accordance with 21 U.S.C. 811(a) are
subject to formal rulemaking procedures done ``on the record after
opportunity for a hearing'' conducted pursuant to the provisions of 5
U.S.C. 556 and 557. The CSA sets forth specific criteria for scheduling
a drug or other substance. While temporary scheduling orders are not
subject to judicial review (21 U.S.C. 811(h)(6)), the regular
scheduling process of formal rulemaking affords interested parties with
appropriate process and the government with any additional relevant
information needed to make a permanent scheduling determination. Final
decisions which conclude the regular scheduling process of formal
rulemaking are subject to judicial review. 21 U.S.C. 877.
Regulatory Requirements
With the issuance of this final order, UR-144, XLR11 and AKB48
become subject to the regulatory controls and administrative, civil and
criminal sanctions applicable to the manufacture, distribution,
possession, importation and exportation of a Schedule I controlled
substance under the CSA and the CSIEA.
1. Registration. Any person who manufactures, distributes, imports,
exports, or possesses UR-144, XLR11 or AKB48, or who engages in
research or conducts instructional activities with respect to UR-144,
XLR11 or AKB48, or who proposes to engage in such activities, must be
registered to conduct such activities in accordance with 21 U.S.C. 822
and 957. Any person who is currently engaged in any of the above
activities and is not registered with DEA must submit an application
for registration and may not continue their activities until DEA has
approved that application. Retail sales of Schedule I controlled
substances to the general public are not allowed under the CSA.
Possession of any of these substances in a manner not authorized by the
CSA on or after May 16, 2013 is unlawful and may subject those in
possession of any of these substances to prosecution pursuant to the
Controlled Substances Act.
2. Security. UR-144, XLR11 and AKB48 are subject to Schedule I
security requirements. Accordingly, appropriately registered DEA
registrants must manufacture, distribute and store these substances in
accordance with 1301.71; 1301.72(a), (c) and (d); 1301.73; 1301.74;
1301.75(a) and (c); and 1301.76 of Title 21 of the Code of Federal
Regulations as of May 16, 2013.
[[Page 28738]]
3. Labeling and packaging. All labeling and packaging requirements
for controlled substances set forth in Part 1302 of Title 21 of the
Code of Federal Regulations shall apply to commercial containers of UR-
144, XLR11 and AKB48. Current DEA registrants authorized to handle UR-
144, XLR11 and AKB48 shall comply with Part 1302 of Title 21 of the
Code of Federal Regulations within thirty (30) calendar days of May 16,
2013.
4. Quotas. Every manufacturer authorized to manufacture UR-144,
XLR11 and AKB48 must apply for and be granted a quota to manufacture
such substance(s) pursuant to Part 1303 of Title 21 of the Code of
Federal Regulations. No authorized manufacturer may manufacture UR-144,
XLR11 or AKB48 in excess of a quota assigned to him as of May 16, 2013.
5. Inventory. Every DEA registrant authorized to possess any
quantity of UR-144, XLR11 or AKB48 is required to keep inventory of all
stocks of these substances on hand pursuant to 1304.03, 1304.04 and
1304.11 of Title 21 of the Code of Federal Regulations. Every
authorized DEA registrant shall comply with all inventory requirements
within thirty (30) calendar days of May 16, 2013.
6. Records. All registrants who are authorized to handle UR-144,
XLR11 or AKB48 are required to keep records pursuant to 1304.03,
1304.04, 1304.21, 1304.22 and 1304.23 of Title 21 of the Code of
Federal Regulations. Current DEA registrants authorized to handle UR-
144, XLR11 or AKB48 shall comply with all recordkeeping requirements
within thirty (30) calendar days of May 16, 2013.
7. Reports. All registrants are required to submit reports in
accordance with 1304.33 of Title 21 of the Code of Federal Regulations.
Registrants who manufacture or distribute UR-144, XLR11 or AKB48 are
required to comply with these reporting requirements and shall do so as
of May 16, 2013.
8. Order Forms. All registrants involved in the distribution of UR-
144, XLR11 or AKB48 must comply with order form requirements of Part
1305 of Title 21 of the Code of Federal Regulations as of May 16, 2013.
9. Importation and Exportation. All importation and exportation of
UR-144, XLR11 or AKB48 must be conducted by appropriately registered
DEA registrants in compliance with Part 1312 of Title 21 of the Code of
Federal Regulations on or after May 16, 2013.
10. Criminal Liability. The manufacture, distribution or possession
with the intent to conduct these activities; as well as possession,
importation or exportation of UR-144, XLR11 or AKB48 not authorized by,
or in violation of the CSA or the Controlled Substances Import and
Export Act occurring as of May 16, 2013 is unlawful.
Regulatory Matters
Section 201(h) of the CSA (21 U.S.C. 811(h)) provides for an
expedited temporary scheduling action where such action is necessary to
avoid an imminent hazard to the public safety. As provided in this
subsection, the Attorney General may, by order, schedule a substance in
Schedule I on a temporary basis. Such an order may not be issued before
the expiration of 30 days from (1) the publication of a notice in the
Federal Register of the intention to issue such order and the grounds
upon which such order is to be issued, and (2) the date that notice of
a proposed temporary scheduling order is transmitted to the Secretary
of HHS. 21 U.S.C. 811(h)(1).
In as much as section 201(h) of the CSA directs that temporary
scheduling actions be issued by order and sets forth the procedures by
which such orders are to be issued, DEA believes that the notice and
comment requirements of section 553 of the Administrative Procedure Act
(APA) (5 U.S.C. 553) do not apply to this final order. In the
alternative, even assuming that this final order might be deemed to be
subject to section 553 of the APA, the Deputy Administrator finds that
there is good cause to forgo the notice and comment requirements of
section 553, as any further delays in the process for issuance of
temporary scheduling orders would be impracticable and contrary to the
public interest in view of the manifest urgency of the temporary
scheduling action to avoid an imminent hazard to the public safety.
Further, DEA believes that this temporary scheduling action Final
Order is not a ``rule'' as defined by 5 U.S.C. 601(2), and,
accordingly, not subject to the requirements of the Regulatory
Flexibility Act. The requirements for the preparation of an initial
regulatory flexibility analysis in 5 U.S.C. 603(a) are not applicable
where (as here) the agency is not required by section 553 of the APA or
any other law to publish a general notice of proposed rulemaking.
Additionally, this action is not a significant regulatory action as
defined by Executive Order 12866 ``Regulatory Planning and Review,''
section 3(f), and, accordingly, this action has not been reviewed by
the Office of Management and Budget.
This action will not have substantial direct effects on the states,
on the relationship between the national government and the states, or
on distribution of power and responsibilities among the various levels
of government. Therefore, in accordance with Executive Order 13132
``Federalism'' it is determined that this action does not have
sufficient federalism implications to warrant the preparation of a
Federalism Assessment.
Pursuant to the Small Business Regulatory Enforcement Fairness Act
of 1996 (Congressional Review Act) (5 U.S.C. 801-808), DEA has
submitted a copy of this Final Order 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.
Under the authority vested in the Attorney General by section
201(h) of the CSA (21 U.S.C. 811(h)), and delegated to the Deputy
Administrator of the DEA by Department of Justice regulations (28 CFR
0.100, Appendix to Subpart R), the Deputy Administrator hereby orders
that 21 CFR part 1308 be 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. Section 1308.11 is amended by adding new paragraphs (h)(9), (10),
and (11) to read as follows:
Sec. 1308.11 Schedule I.
* * * * *
(h) * * *
(9) (1-pentyl-1H-indol-3-yl)(2,2,3,3-
tetramethylcyclopropyl)methanone, its optical, positional, and
geometric isomers, salts and salts of isomers--7144 (Other names: UR-
144, 1-pentyl-3-(2,2,3,3-tetramethylcyclopropoyl)indole)
(10) [1-(5-fluoro-pentyl)-1H-indol-3-yl](2,2,3,3-
tetramethylcyclopropyl)methanone, its optical, positional, and
geometric isomers, salts and salts of isomers--7011 (Other names: 5-
fluoro-UR-144, 5- F-UR-144, XLR11, 1-(5-fluoro-pentyl)-3-(2,2,3,3-
tetramethylcyclopropoyl)indole)
(11) N-(1-adamantyl)-1-pentyl-1H-indazole-3-carboxamide, its
optical, positional, and geometric isomers, salts and salts of
isomers--7048 (Other names: APINACA, AKB48)
[[Page 28739]]
Dated: May 10, 2013.
Thomas M. Harrigan,
Deputy Administrator.
[FR Doc. 2013-11593 Filed 5-15-13; 8:45 am]
BILLING CODE 4410-09-P