Schedules of Controlled Substances: Temporary Placement of Four Synthetic Cannabinoids Into Schedule I, 7577-7582 [2014-02848]

Agencies

• Drug Enforcement Administration
• Department of Justice

[Federal Register Volume 79, Number 27 (Monday, February 10, 2014)]
[Rules and Regulations]
[Pages 7577-7582]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-02848]


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

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-385]


Schedules of Controlled Substances: Temporary Placement of Four 
Synthetic Cannabinoids Into Schedule I

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Final order.

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

SUMMARY: The Deputy Administrator of the Drug Enforcement 
Administration (DEA) is issuing this final order to temporarily 
schedule four synthetic cannabinoids into schedule I pursuant to the 
temporary scheduling provisions of the Controlled Substances Act (CSA). 
The substances are: Quinolin-8-yl 1-pentyl-1H-indole-3-carboxylate (PB-
22; QUPIC); quinolin-8-yl 1-(5-fluoropentyl)-1H-indole-3-carboxylate 
(5-fluoro-PB-22; 5F-PB-22); N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(4-
fluorobenzyl)-1H-indazole-3-carboxamide (AB-FUBINACA); and N-(1-amino-
3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide (ADB-
PINACA). This action is based on a finding by the Deputy Administrator 
that the placement of these synthetic cannabinoids and their optical, 
positional, and geometric isomers, salts 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 regulatory controls and 
administrative, civil, and criminal sanctions applicable to schedule I 
controlled substances will be imposed on persons who handle 
(manufacture, distribute, import, export,

[[Page 7578]]

engage in research, conduct instructional activities, and possess), or 
propose to handle these synthetic cannabinoids.

DATES: This final order is effective February 10, 2014.

FOR FURTHER INFORMATION CONTACT: Ruth A. Carter, Office of Diversion 
Control, Drug Enforcement Administration; Mailing Address: 8701 
Morrissette Drive, Springfield, Virginia 22152, Telephone (202) 598-
6812.

SUPPLEMENTARY INFORMATION: 

Legal Authority

    The DEA implements and enforces titles II and III of the 
Comprehensive Drug Abuse Prevention and Control Act of 1970, as 
amended. 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 purpose of this 
action. 21 U.S.C. 801-971. The DEA publishes the implementing 
regulations for these statutes in title 21 of the Code of Federal 
Regulations (CFR), parts 1300 to 1321. 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 providing 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, controlled substances are classified into one of 
five schedules based upon their potential for abuse, their currently 
accepted medical use, and the degree of dependence the substance may 
cause. 21 U.S.C. 812. The initial schedules of controlled substances 
established by Congress are found at 21 U.S.C. 812(c), and the current 
list of all scheduled substances is published at 21 CFR part 1308.
    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 
an 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 for 
up to one year. 21 U.S.C. 811(h)(2).
    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 for the substance under section 505 of the Federal 
Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 355. 21 U.S.C. 
811(h)(1); 21 CFR part 1308. The Attorney General has delegated his 
authority under 21 U.S.C. 811 to the Administrator of the DEA, who in 
turn has delegated her authority to the Deputy Administrator of the 
DEA. 28 CFR 0.100, Appendix to Subpart R of Part 0, Sec. 12.

Background

    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 
transmitted notice of his intent to place PB-22, 5F-PB-22, AB-FUBINACA, 
and ADB-PINACA into schedule I on a temporary basis to the Assistant 
Secretary by letter dated November 7, 2013. The Assistant Secretary 
responded to this notice by letter dated January 27, 2014, and advised 
that based on review by the FDA, there are currently no investigational 
new drug applications or approved new drug applications for PB-22, 5F-
PB-22, AB-FUBINACA, or ADB-PINACA. The Assistant Secretary also stated 
that the HHS has no objection to the temporary placement of PB-22, 5F-
PB-22, AB-FUBINACA, and ADB-PINACA into schedule I of the CSA.
---------------------------------------------------------------------------

    \1\ Because the Secretary of the HHS has delegated to the 
Assistant Secretary for Health of the HHS 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 the HHS, the Food and Drug 
Administration (FDA), and the National Institute on Drug Abuse 
(NIDA), FDA acts as the lead agency within the HHS in carrying out 
the Assistant Secretary's scheduling responsibilities under the CSA, 
with the concurrence of NIDA. 50 FR 9518, Mar. 8, 1985.
---------------------------------------------------------------------------

    The DEA has taken into consideration the Assistant Secretary's 
comments as required by 21 U.S.C. 811(h)(4). As PB-22, 5F-PB-22, AB-
FUBINACA, and ADB-PINACA are not currently listed in any schedule under 
the CSA, and as no exemptions or approvals are in effect for PB-22, 5F-
PB-22, AB-FUBINACA, and ADB-PINACA under section 505 of the FDCA, 21 
U.S.C. 355, the conditions of 21 U.S.C. 811(h)(1) have been satisfied. 
As required by 21 U.S.C. 811(h)(1)(A), a notice of intent to 
temporarily schedule these four synthetic cannabinoids was published in 
the Federal Register on January 10, 2014. 79 FR 1776.
    To find 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(c): 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(h)(3). 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 may only be placed in schedule I. 21 U.S.C. 811(h)(1). 
Substances in schedule I are those that have a high potential for 
abuse, no currently accepted medical use in treatment in the United 
States, and a lack of accepted safety for use under medical 
supervision. 21 U.S.C. 812(b)(1). Available data and information for 
PB-22, 5F-PB-22, AB-FUBINACA, and ADB-PINACA indicate that these four 
synthetic cannabinoids have a high potential for abuse, no currently 
accepted medical use in treatment in the United States, and a lack of 
accepted safety for use under medical supervision.

Synthetic Cannabinoids

    Synthetic cannabinoids are a large family of compounds that are 
functionally (biologically) similar to delta9-tetrahydrocannabinol 
(THC), the main active ingredient in marijuana. Synthetic cannabinoids, 
however, are not organic but are chemicals created in a laboratory. Two 
of the synthetic cannabinoids currently controlled (CP-47,497 and 
cannabicyclohexanol) were first synthesized in the early 1980s for 
research purposes in the investigation of the cannabinoid system. JWH-
018, JWH-073, and JWH-200 (temporarily scheduled on March 1, 2011, at 
76 FR 11075 and permanently scheduled on July 9, 2012, by Section 1152 
of the Food and Drug Administration Safety and Innovation Act (FDASIA), 
Pub. L. 112-144) were synthesized in the mid-1990s and studied to 
further advance the understanding of drug-receptor interactions 
regarding the cannabinoid system. Synthesized as research tools, no 
other known legitimate uses have been identified for these five 
synthetic cannabinoids.
    According to forensic laboratory reports, the initial appearance of 
synthetic cannabinoids in herbal

[[Page 7579]]

incense products in the United States occurred in November 2008 when 
U.S. Customs and Border Protection (CBP) first encountered products 
using brand names such as ``Spice.'' Prior to appearing on the U.S. 
market, synthetic cannabinoids were marketed in herbal incense products 
in several European countries. After experiencing numerous health-
related incidents, some European countries banned these products/
chemicals. According to CBP, a number of the synthetic cannabinoids 
appeared to originate from foreign sources.
    Detailed chemical analyses by DEA and other agencies have found 
synthetic cannabinoids applied on plant material in herbal incense 
products marketed to the general public. Product analyses have found 
variations in both the type of synthetic cannabinoid and the amount of 
the substance found on the plant material.
    The vast majority of cannabinoids are manufactured in Asia by 
individuals who are not bound by any manufacturing requirements or 
quality control standards. The bulk products are smuggled into the 
United States typically as misbranded imports. These chemicals are 
generally found in powder form or are dissolved in solvents, such as 
acetone, before being applied to the plant material comprising the 
``herbal incense'' products. After local distributors apply the drug to 
the leafy material, they package it for retail distribution, ignoring 
any control mechanisms to prevent contamination or to ensure a 
consistent, uniform concentration of drug in each package. According to 
Internet discussion boards and law enforcement encounters, spraying or 
mixing the synthetic cannabinoids on plant material provides a vehicle 
for the most common route of administration--smoking (using a pipe, a 
water pipe, or rolling the drug-spiked plant material in cigarette 
papers). They are sold under hundreds of different brand names, 
including ``Spice,'' ``K2,'' ``Blaze,'' ``Red X Dawn,'' ``Paradise,'' 
``Demon,'' ``Black Magic,'' ``Spike,'' ``Mr. Nice Guy,'' ``Ninja,'' 
``Zohai,'' ``Dream,'' ``Genie,'' ``Sence,'' ``Smoke,'' ``Skunk,'' 
``Serenity,'' ``Yucatan,'' ``Fire,'' and ``Crazy Clown.''
    Law enforcement personnel have encountered dosage form and 
packaging operations in residential neighborhoods, garages, and 
warehouses. Throughout this process, there is no concern for preventing 
contamination of the product, consistent dosage, or the adverse health 
consequences that may occur from ingesting the drug. As proposed in the 
scientific literature, the risk of adverse health effects is further 
increased by the fact that similarly labeled products vary in the 
composition and concentration of synthetic cannabinoids applied on the 
plant material.
    There is an incorrect assumption that these products are safe. 
Numerous states, local jurisdictions, and the international community 
have controlled many synthetic cannabinoids. These substances have no 
accepted medical use in the United States and have been reported to 
produce adverse health effects in those who abuse them.
    PB-22, 5F-PB-22, AB-FUBINACA and ADB-PINACA are synthetic 
cannabinoids that have pharmacological effects similar to the schedule 
I hallucinogen delta-9-tetrahydrocannabinol (THC). PB-22 and 5F-PB-22 
were not reported in the scientific literature prior to their 
appearance on the illicit drug market. First appearing in a 2009 patent 
filed by the pharmaceutical manufacturer Pfizer, AB-FUBINACA was most 
recently reported in the scientific literature as a component of so-
called ``herbal products'' purchased via the Internet in July 2012. 
ADB-PINACA was first encountered by law enforcement following reports 
of serious adverse events in Georgia and Colorado in August and 
September 2013, respectively.
    From January through December 2013, according to the System to 
Retrieve Information from Drug Evidence (STRIDE) \2\ there were 211 
reports involving PB-22, 168 reports involving 5F-PB-22, and 74 reports 
involving AB-FUBINACA (Queried on January 22, 2014). From January 
through December 2013, the National Forensic Laboratory Information 
System (NFLIS) \3\ registered 1,318 reports containing PB-22 in 29 
states, 1,294 reports containing 5F-PB-22 in 29 states, 822 reports 
containing AB-FUBINACA in 21 states and 40 reports containing ADB-
PINACA in three states (Queried on January 22, 2014). No reports in 
NFLIS or STRIDE were identified for PB-22 or 5F-PB-22 prior to January 
2013. No reports in NFLIS or STRIDE were identified for AB-FUBINACA 
prior to June 2013 or for ADB-PINACA prior to August 2013.
---------------------------------------------------------------------------

    \2\ STRIDE is a database of drug exhibits sent to DEA 
laboratories for analysis. Exhibits from the database are from the 
DEA, other federal agencies, and local law enforcement agencies.
    \3\ NFLIS is a national drug forensic laboratory reporting 
system that systematically collects results from drug chemistry 
analyses conducted by state and local forensic laboratories across 
the country.
---------------------------------------------------------------------------

Factor 4. History and Current Pattern of Abuse

    Synthetic cannabinoids have been developed over the last 30 years 
as tools for investigating the cannabinoid system. Synthetic 
cannabinoids intended for illicit use were first reported in the United 
States in a November 2008 encounter, where a shipment of ``Spice'' was 
seized and analyzed by CBP in Dayton, Ohio. Additionally around the 
same time, in December 2008, JWH-018 and cannabicyclohexanol (CP-47,497 
C8 homologue) were identified by German forensic laboratories. Since 
the initial identification of JWH-018, many additional synthetic 
cannabinoids have been found applied on plant material and encountered 
as designer drug products. The majority of the substances encountered 
on the illicit market have not been tested beyond preliminary pre-
clinical laboratory screens before clandestine operators apply them on 
plant material.
    JWH-018 was the first synthetic cannabinoid to be identified as a 
product adulterant in Germany in 2008. This substance was initially 
synthesized as a research tool to investigate the cannabinoid system. 
Since then, numerous other synthetic cannabinoids have been identified 
as product adulterants and law enforcement has seized bulk amounts of 
these substances. The first synthetic cannabinoids identified as being 
abused included JWH-018, JWH-200, JWH-073, CP-47,497 and CP-47,497 C8 
homologue, followed shortly thereafter by new generations of synthetic 
cannabinoids that included AM2201 and others, and eventually UR-144, 
XLR11 and AKB48. JWH-018, JWH-073, JWH-200, CP-47,497, and CP-47,497 C8 
were temporarily scheduled on March 1, 2011 (76 FR 11075), and later 
permanently placed in schedule I by Section 1152 of FDASIA on July 9, 
2012. Section 1152 of FDASIA amended the CSA by placing cannabimimetic 
agents and 26 specific substances (including 15 synthetic cannabinoids, 
2 synthetic cathinones, and 9 synthetic phenethylamines of the 2C-
series) in schedule I. UR-144, XLR11 and AKB48 were temporarily 
scheduled on May 16, 2013 (78 FR 28735). The most recent synthetic 
cannabinoids emerging as drugs of abuse include PB-22, 5F-PB-22, AB-
FUBINACA, and ADB-PINACA. These four synthetic cannabinoids, along with 
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.

[[Page 7580]]

    Synthetic cannabinoid products are marketed directly to adolescents 
and youth who appear to be the primary abusers of synthetic 
cannabinoids and synthetic cannabinoid-containing products. This is 
supported by law enforcement encounters and reports from emergency 
rooms; however, all age groups have been reported by media as abusing 
these substances and related products.
    According to recent testimony given by the Deputy Director of the 
Office of National Drug Control Policy (ONDCP) to the United States 
Senate Caucus on International Narcotics Control (September 25, 2013), 
current drug testing misses significant populations of synthetic 
cannabinoid users. This testimony describes a study showing that in a 
sample of men 30 years old or younger within the District of Columbia 
parole and probation system, 39 percent of those who cleanly passed a 
traditional drug screen tested positive for synthetic cannabinoids. The 
study continued that between one-quarter and one-third of young men who 
were tested in the Washington, DC criminal justice system had positive 
test results for synthetic cannabinoids, regardless of whether they had 
failed or passed a traditional drug screen.

Factor 5. Scope, Duration and Significance of Abuse

    Recently, increased exposure incidents have been documented by 
poison control centers in the United States as the abuse of synthetic 
cannabinoids has been associated with both acute and long-term public 
health and safety concerns. From January through December 2013, 
according to STRIDE there were 211 reports involving PB-22; 168 reports 
involving 5F-PB-22; and 74 reports involving AB-FUBINACA (Queried on 
January 22, 2014). From January through December 2013, NFLIS registered 
1,318 reports containing PB-22 in 29 states (Arkansas, Arizona, 
Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Kansas, 
Kentucky, Louisiana, Maryland, Minnesota, Missouri, North Dakota, 
Nebraska, New Hampshire, New Jersey, New Mexico, Ohio, Oklahoma, 
Oregon, Pennsylvania, South Carolina, Texas, Utah, Virginia, Wisconsin 
and Wyoming); 1,294 reports containing 5F-PB-22 in 29 states (Arkansas, 
Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, 
Indiana, Kansas, Kentucky, Louisiana, Minnesota, Missouri, North 
Dakota, New Hampshire, New Jersey, New Mexico, Nevada, Ohio, Oregon, 
Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, 
Wisconsin and Wyoming); 822 reports containing AB-FUBINACA in 21 states 
(Arizona, Colorado, Connecticut, Florida, Georgia, Iowa, Indiana, 
Kansas, Louisiana, Minnesota, Missouri, North Dakota, New Hampshire, 
New Jersey, Nevada, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas 
and Wisconsin); and 40 reports containing ADB-PINACA in three states 
(Colorado, Georgia and Wisconsin) (Queried on January 22, 2014). No 
reports in NFLIS or STRIDE were identified for PB-22 or 5F-PB-22 prior 
to January 2013. No reports in NFLIS or STRIDE were identified for AB-
FUBINACA prior to June 2013 or for ADB-PINACA prior to August 2013.
    ADB-PINACA was first encountered in the United States following 
reports of serious adverse events in Georgia on August 23, 2013. 
Reports of ADB-PINACA were not found in the scientific literature prior 
to its emergence on the designer drug market. The Georgia Bureau of 
Investigation (GBI) reported on September 12, 2013, that ADB-PINACA was 
detected in ``herbal incense'' products sold under the brand name 
``Crazy Clown.'' It was later confirmed by the Centers for Disease 
Control and Prevention (CDC) as the substance responsible for severe 
adverse events in at least 22 persons who consumed the product. In 
addition, on August 30, 2013, the Colorado Department of Public Health 
and Environment (CDPHE) was notified by several hospitals of an 
increase in the number of patients visiting their emergency departments 
(EDs) with altered mental status after using ``synthetic marijuana.'' 
CDC 2013. On September 8, 2013, CDPHE, with the assistance of CDC, 
began an epidemiologic investigation whereby 221 cases of severe 
illness due to ingestion of a synthetic cannabinoid were identified. 
Those that presented at emergency rooms in the Denver, Colorado area 
around September 1, 2013, had symptoms similar to those found in the 
August 2013 Georgia incident. Laboratory analysis of samples from the 
Colorado incident confirmed that the substance abused in the ``herbal 
incense'' products was ADB-PINACA.
    The American Association of Poison Control Centers (AAPCC) reported 
receiving over 2,639 calls from January to December 2013, regarding 
exposures to products purportedly containing synthetic cannabinoids, 
although the data provided does not generally include biological sample 
testing that would confirm to which cannabinoids the user was exposed. 
A majority of these exposure incidents resulted in individuals seeking 
medical attention at health care facilities.

Factor 6. What, If any, Risk There Is to the Public Health

    The earliest reported encounter of PB-22 was by Finnish Customs 
(Tulli) in Helsinki who intercepted a consignment of 54 kilograms en 
route from China to Russia on October 27, 2012. From January through 
November 2013, CBP shared information related to synthetic cannabinoid 
shipments encountered at United States Ports of Entry and intended for 
destinations within the United States: PB-22--25 encounters involving 
69.6 kg; 5F-PB-22--23 encounters involving 32.9 kg; and AB-FUBINACA--9 
encounters involving 16.1 kg. The DEA has reported multiple encounters 
of large quantities of PB-22, 5F-PB-22 and/or AB-FUBINACA that have 
been confirmed by forensic laboratories (STRIDE).
    In late August 2013, local law enforcement in Brunswick, Georgia 
reported that 22 persons ranging in age from 16 to 57 presented to 
emergency departments with severe adverse reactions after consuming a 
synthetic product called ``Crazy Clown.'' Adverse effects included the 
inability to stand, foaming at the mouth, violence towards police and 
paramedics and memory lapse. The substance responsible for these 
effects was later identified by the GBI as ADB-PINACA. In early 
September 2013, 221 patients presented to emergency departments in 
Colorado after having adverse reactions to a synthetic product labeled 
as ``Black Mamba.'' Adverse effects included having no gag reflex, 
inability to breathe on their own, hallucinations and psychotic 
episodes as described by nurses and attending physicians. The substance 
in the product consumed was identified as ADB-PINACA. In addition to 
the incidents in Georgia and Colorado, ADB-PINACA was also identified 
in exhibits of plant material labeled ``10X'' and ``20X'' submitted to 
a laboratory in Illinois on October 7, 2013.
    Health warnings have been issued by numerous state public health 
departments and poison control centers describing adverse health 
effects associated with smoking (inhaling) synthetic cannabinoid 
products including agitation, vomiting, tachycardia, elevated blood 
pressure, seizures, hallucinations, and non-responsiveness.
    Medical examiner and postmortem toxicology reports demonstrate the 
involvement of 5F-PB-22 in the death of at least five individuals. 
These reports demonstrated that 5F-PB-22 was qualitatively identified 
in the blood and/or urine of all five of the deceased

[[Page 7581]]

individuals. In addition, 5F-PB-22 intoxication was the sole cause of 
death in one case, while a second case stated that the cause of death 
was a fatal cardiac arrhythmia and/or fatal seizure in association with 
the use of 5F-PB-22.
    Since abusers obtain these drugs through unknown sources, the 
identity, purity, and quantity of these substances is uncertain and 
inconsistent, thus posing significant adverse health risks to users. 
There are no recognized therapeutic uses of these substances in the 
United States.

Finding of Necessity of Schedule I Placement To Avoid Imminent Hazard 
to Public Safety

    Based on the above summarized data and information, the continued 
uncontrolled manufacture, distribution, importation, exportation, and 
abuse of PB-22, 5F-PB-22, AB-FUBINACA and ADB-PINACA pose an imminent 
hazard to the public safety. The DEA is not aware of any currently 
accepted medical uses for these synthetic cannabinoids in the United 
States. A substance meeting the statutory requirements for temporary 
scheduling, 21 U.S.C. 811(h)(1), may only be placed into schedule I. 
Substances in schedule I are those that have a high potential for 
abuse, no currently accepted medical use in treatment in the United 
States, and a lack of accepted safety for use under medical 
supervision. Available data and information for PB-22, 5F-PB-22, AB-
FUBINACA, and ADB-PINACA indicate that these four synthetic 
cannabinoids have a high potential for abuse, no currently accepted 
medical use in treatment in the United States, and a lack of accepted 
safety for use under medical supervision. As required by section 
201(h)(4) of the CSA, 21 U.S.C. 811(h)(4), the Deputy Administrator, 
through a letter dated November 7, 2013, notified the Assistant 
Secretary of the intention to temporarily place these four synthetic 
cannabinoids in schedule I.

Conclusion

    In accordance with the provisions of section 201(h) of the CSA, 21 
U.S.C. 811(h), the Deputy Administrator considered available data and 
information, herein set forth the grounds for his determination that it 
is necessary to temporarily place four synthetic cannabinoids, PB-22, 
5F-PB-22, AB-FUBINACA, and ADB-PINACA into 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 two years, with a possible extension of one additional year, 
pending completion of the regular (permanent) scheduling process. 21 
U.S.C. 811(h)(1) and (2).
    The CSA sets forth specific criteria for scheduling a drug or other 
substance. 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. 21 U.S.C. 811. 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 determination. Final decisions that conclude the 
regular scheduling process of formal rulemaking are subject to judicial 
review. 21 U.S.C. 877. Temporary scheduling orders are not subject to 
judicial review. 21 U.S.C. 811(h)(6).

Requirements for Handling

    Upon the effective date of this final order, PB-22, 5F-PB-22, AB-
FUBINACA, and ADB-PINACA become subject to the regulatory controls and 
administrative, civil and criminal sanctions applicable to the 
manufacture, distribution, importing, exporting, research, conduct of 
instructional activities, and possession of schedule I controlled 
substances including the following:
    1. Registration. Any person who handles (manufactures, distributes, 
imports, exports, engages in research, conducts instructional 
activities with, or possesses), or desires to handle, PB-22, 5F-PB-22, 
AB-FUBINACA, or ADB-PINACA, 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 as of February 10, 2014. Any 
person who currently handles PB-22, 5F-PB-22, AB-FUBINACA, or ADB-
PINACA, and is not registered with the DEA, must submit an application 
for registration and may not continue to handle PB-22, 5F-PB-22, AB-
FUBINACA, or ADB-PINACA as of February 10, 2014 unless the DEA has 
approved that application for registration, pursuant to 21 U.S.C. 822, 
823, 957, 958, and in accordance with 21 CFR parts 1301 and 1312. 
Retail sales of schedule I controlled substances to the general public 
are not allowed under the CSA.
    2. Security. PB-22, 5F-PB-22, AB-FUBINACA, and ADB-PINACA are 
subject to schedule I security requirements and must be handled and 
stored pursuant to 21 U.S.C. 821, 823, 871(b), and in accordance with 
21 CFR 1301.71-1301.93, as of February 10, 2014.
    3. Labeling and Packaging. All labels and labeling for commercial 
containers of PB-22, 5F-PB-22, AB-FUBINACA, and ADB-PINACA must be in 
compliance with 21 U.S.C. 825, 958(e), and be in accordance with 21 CFR 
part 1302 as of February 10, 2014. Current DEA registrants shall have 
30 calendar days from February 10, 2014 to comply with all labeling and 
packaging requirements.
    4. Inventory. Every DEA registrant who possesses any quantity of 
PB-22, 5F-PB-22, AB-FUBINACA, or ADB-PINACA on the effective date of 
this order, must take an inventory of all stocks of these substances on 
hand as of February 10, 2014, pursuant to 21 U.S.C. 827, 958, and in 
accordance with 21 CFR 1304.03, 1304.04, and 1304.11(a) and (d). 
Current DEA registrants shall have 30 calendar days from the effective 
date of this order to be in compliance with all inventory requirements.
    After the initial inventory, every DEA registrant must take an 
inventory of all controlled substances (including PB-22, 5F-PB-22, AB-
FUBINACA, and ADB-PINACA) on hand on a biennial basis, pursuant to 21 
U.S.C. 827, 958, and in accordance with 21 CFR 1304.03, 1304.04, and 
1304.11.
    5. Records. All DEA registrants must maintain records with respect 
to PB-22, 5F-PB-22, AB-FUBINACA, or ADB-PINACA pursuant to 21 U.S.C. 
827, 958, and in accordance with 21 CFR parts 1304, 1307, and 1312 as 
of February 10, 2014. Current DEA registrants authorized to handle PB-
22, 5F-PB-22, AB-FUBINACA, or ADB-PINACA shall have 30 calendar days 
from the effective date of this order to be in compliance with all 
recordkeeping requirements.
    6. Reports. All DEA registrants who manufacture or distribute PB-
22, 5F-PB-22, AB-FUBINACA, or ADB-PINACA must submit reports pursuant 
to 21 U.S.C. 827 and in accordance with 21 CFR 1304.33 as of February 
10, 2014.
    7. Order Forms. All registrants who distribute PB-22, 5F-PB-22, AB-
FUBINACA, or ADB-PINACA must comply with order form requirements 
pursuant to 21 U.S.C. 828 and in accordance with 21 CFR part 1305 as of 
February 10, 2014.

[[Page 7582]]

    8. Importation and Exportation. All importation and exportation of 
PB-22, 5F-PB-22, AB-FUBINACA, or ADB-PINACA must be in compliance with 
21 U.S.C. 952, 953, 957, 958, and in accordance with 21 CFR part 1312 
as of February 10, 2014.
    9. Quota. Only registered manufacturers may manufacture PB-22, 5F-
PB-22, AB-FUBINACA, or ADB-PINACA in accordance with a quota assigned 
pursuant to 21 U.S.C. 826 and in accordance with 21 CFR part 1303.
    10. Criminal Liability. Any activity involving PB-22, 5F-PB-22, AB-
FUBINACA, or ADB-PINACA not authorized by, or in violation of the CSA, 
occurring as of February 10, 2014 is unlawful, and may subject the 
person to administrative, civil, and/or criminal sanctions.

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 Assistant 
Secretary of HHS. 21 U.S.C. 811(h)(1).
    Inasmuch 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, the 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 temporary scheduling 
action. In the alternative, even assuming that this action might 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 to avoid an imminent 
hazard to the public safety. Further, the DEA believes that this 
temporary scheduling action final order is not a ``rule'' as defined by 
5 U.S.C. 601(2), and, accordingly, is not subject to the requirements 
of the Regulatory Flexibility Act (RFA). 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 DEA 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 (OMB).
    This action will not have substantial direct effects on the States, 
on the relationship between the national government and the States, or 
on the 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 section 808(2) of the Congressional Review Act (CRA), 
``any rule for which an agency for good cause finds. . .that notice and 
public procedure thereon are impracticable, unnecessary, or contrary to 
the public interest, shall take effect at such time as the Federal 
agency promulgating the rule determines.'' 5 U.S.C. 808(2). It is in 
the public interest to schedule these substances immediately because 
they pose a public health risk. This temporary scheduling action is 
taken pursuant to 21 U.S.C. 811(h), which is specifically designed to 
enable the DEA to act in an expeditious manner to avoid an imminent 
hazard to the public safety from new or designer drugs or abuse of 
those drugs. 21 U.S.C. 811(h) exempts the temporary scheduling order 
from standard notice and comment rulemaking procedures to ensure that 
the process moves swiftly. For the same reasons that underlie 21 U.S.C. 
811(h), that is, the DEA's need to move quickly to place these 
substances into schedule I because they pose a threat to public health, 
it would be contrary to the public interest to delay implementation of 
the temporary scheduling order. Therefore, in accordance with section 
808(2) of the CRA, this order shall take effect immediately upon its 
publication.

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 21 CFR 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 adding paragraphs (h)(15) through (h)(18) to 
read as follows:


Sec.  1308.11  Schedule I.

* * * * *
    (h) * * *
    (15) Quinolin-8-yl 1-pentyl-1H-indole-3-carboxylate, its optical, 
positional, and geometric isomers, salts and salts of isomers--7222 
(Other names: PB-22; QUPIC)
    (16) Quinolin-8-yl 1-(5-fluoropentyl)-1H-indole-3-carboxylate, its 
optical, positional, and geometric isomers, salts and salts of 
isomers--7225 (Other names: 5-fluoro-PB-22; 5F-PB-22)
    (17) N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-
indazole-3-carboxamide, its optical, positional, and geometric isomers, 
salts and salts of isomers--7012 (Other names: AB-FUBINACA)
    (18) N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-
3-carboxamide, its optical, positional, and geometric isomers, salts 
and salts of isomers--7035 (Other names: ADB-PINACA)

    Dated: February 5, 2014.
Thomas M. Harrigan,
Deputy Administrator.
[FR Doc. 2014-02848 Filed 2-7-14; 8:45 am]
BILLING CODE 4410-09-P