Source: https://www.federalregister.gov/documents/2014/02/10/2014-02848/schedules-of-controlled-substances-temporary-placement-of-four-synthetic-cannabinoids-into-schedule
Timestamp: 2019-10-16 03:14:09
Document Index: 109935160

Matched Legal Cases: ['arts 1301', 'arts 1301', 'art 1302', 'arts 1304', 'art 1305', 'art 1312', 'art 1303', '§\u20091308']

A Rule by the Drug Enforcement Administration on 02/10/2014
This final order is effective February 10, 2014.
7577-7582 (6 pages)
DEA-2014-0003
Final Order Three Factor Analysis Four Synthetic Cannabinoids
https://www.federalregister.gov/d/2014-02848 https://www.federalregister.gov/d/2014-02848
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-1 H-indole-3-carboxylate (PB-22; QUPIC); quinolin-8-yl 1-(5-fluoropentyl)-1 H-indole-3-carboxylate (5-fluoro-PB-22; 5F-PB-22); N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1 H-indazole-3-carboxamide (AB-FUBINACA); and N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1 H-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, Start Printed Page 7578engage in research, conduct instructional activities, and possess), or propose to handle these synthetic cannabinoids.
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.
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).
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 Start Printed Page 7579incense 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.
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.”
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.
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.Start Printed Page 7580
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.
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 Start Printed Page 7581individuals. 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.
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.
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).
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.Start Printed 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.
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.
2. Amend § 1308.11 by adding paragraphs (h)(15) through (h)(18) to read as follows:
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.
[FR Doc. 2014-02848 Filed 2-7-14; 8:45 am]