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DEA 21 CFR Part 1308 Synthetic Cannabinoids

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DEA 21 CFR Part 1308 Synthetic Cannabinoids 11075 Rules and Regulations Federal Register Vol. 76, No. 40 Tuesday, March 1, 2011 This section of the FEDERAL REGISTER of Diversion Control, Drug Enforcement finding that temporarily placing a contains regulatory documents having general Administration, 8701 Morrissette Drive, substance into Schedule I of the CSA is applicability and legal effect, most of which Springfield, VA 22152, telephone (202) necessary to avoid an imminent hazard are keyed to and codified in the Code of 307–7183, fax (202) 353–1263, or e-mail to the public safety, the Administrator Federal Regulations, which is published under [email protected]. must consider three of the eight factors 50 titles pursuant to 44 U.S.C. 1510. DATES: Effective Date: March 1, 2011. (factors 4, 5, and 6) set forth in section The Code of Federal Regulations is sold by SUPPLEMENTARY INFORMATION: 201(c) of the CSA (21 U.S.C. 811(c)). the Superintendent of Documents. Prices of These factors are the history and current new books are listed in the first FEDERAL Background pattern of abuse, the scope, duration, REGISTER issue of each week. The Comprehensive Crime Control and significance of abuse, and what, if Act of 1984 (Pub. L. 98–473), which was any, risk there is to the public health, signed into law on October 12, 1984, including actual abuse, diversion from DEPARTMENT OF JUSTICE amended section 201 of the CSA (21 legitimate channels, and clandestine importation, manufacture, or Drug Enforcement Administration U.S.C. 811) to give the Attorney General the authority to temporarily place a distribution. 21 U.S.C. 811(h)(3). The temporary placement of these five 21 CFR Part 1308 substance into Schedule I of the CSA for one year without regard to the synthetic cannabinoids into Schedule I [Docket No. DEA–345F] requirements of 21 U.S.C. 811(b) if he of the CSA is necessary in order to avoid finds that such action is necessary to an imminent hazard to the public safety. Schedules of Controlled Substances: avoid imminent hazard to the public First, these substances are not intended Temporary Placement of Five safety. The Attorney General may for human consumption, but there has Synthetic Cannabinoids Into extend the temporary scheduling up to been a rapid and significant increase in Schedule I six months during pendency of abuse of these substances in the United AGENCY: Drug Enforcement proceedings under 21 U.S.C. 811(a)(1). States. As a result of this abuse, Administration (DEA), U.S. Department A substance may be temporarily synthetic cannabinoids are banned in at of Justice. scheduled under the emergency least 18 states in the United States and ACTION: Final order. provisions of the CSA if it is not listed several countries, and all five branches in any other schedule under section 202 of the U.S. military prohibit military SUMMARY: The Administrator of the Drug of the CSA (21 U.S.C. 812) or if there is personnel from possessing or using Enforcement Administration (DEA) is no exemption or approval in effect synthetic cannabinoids. Second, law issuing this final order to temporarily under 21 U.S.C. 355 for the substance. enforcement has seized synthetic place five synthetic cannabinoids into The Attorney General has delegated his cannabinoids in conjunction with the Controlled Substances Act (CSA) authority under 21 U.S.C. 811 to the controlled substances and based on self- pursuant to the temporary scheduling DEA Administrator (28 CFR 0.100). reports to law enforcement and health provisions. The substances are 1-pentyl- As per section 201(h)(4) of the CSA care professionals, synthetic 3-(1-naphthoyl)indole (JWH–018), 1- (21 U.S.C. 811(h)(4)), the Deputy cannabinoids are abused for their butyl-3-(1-naphthoyl)indole (JWH–073), Administrator, now Administrator, psychoactive properties. Third, 1-[2-(4-morpholinyl)ethyl]-3-(1- transmitted notice of her intention to numerous state and local public health naphthoyl)indole (JWH–200), 5-(1,1- temporarily place JWH–018, JWH–073, departments and poison control centers dimethylheptyl)-2-[(1R,3S)-3- JWH–200, CP–47,497, and have issued health warnings describing hydroxycyclohexyl]-phenol (CP– cannabicyclohexanol into Schedule I of the adverse health effects associated 47,497), and 5-(1,1-dimethyloctyl)-2- the CSA to the Assistant Secretary for with synthetic cannabinoids. Based on [(1R,3S)-3-hydroxycyclohexyl]-phenol Health of the Department of Health and scientific data currently available, these (cannabicyclohexanol; CP–47,497 C8 Human Services (HHS) in a letter dated five substances have the potential to be homologue). This action is based on a October 6, 2010. In response to this extremely harmful and, therefore, pose finding by the Administrator that the notification, the Assistant Secretary of an imminent hazard to the public safety. placement of these synthetic Health, HHS communicated in a letter History and Current Pattern of Abuse cannabinoids into Schedule I of the CSA dated November 22, 2010, to the then- is necessary to avoid an imminent DEA Acting Administrator that there are A ‘‘cannabinoid’’ is a class of chemical hazard to the public safety. As a result no exemptions or approvals in effect for compounds in the marijuana plant that of this order, the full effect of the CSA JWH–018, JWH–073, JWH–200, CP– are structurally related. The and its implementing regulations 47,497, and cannabicyclohexanol under cannabinoid D9-tetrahydrocannabinol including criminal, civil and Section 505 of the Federal Food, Drug (THC) is the primary psychoactive administrative penalties, sanctions and and Cosmetic Act (21 U.S.C. 355). The constituent of marijuana. ‘‘Synthetic regulatory controls of Schedule I substances are not listed in any other cannabinoids’’ are a large family of substances will be imposed on the schedule in 21 U.S.C. 812. chemically unrelated structures manufacture, distribution, possession, A notice of intent to temporarily place functionally (biologically) similar to importation, and exportation of these JWH–018, JWH–073, JWH–200, CP– THC, the active principle of marijuana. synthetic cannabinoids. 47,497, and cannabicyclohexanol into Two of the five synthetic FOR FURTHER INFORMATION CONTACT: Schedule I of the CSA was published in cannabinoids (CP–47,497 and Christine A. Sannerud, PhD, Chief, Drug the Federal Register on November 24, cannabicyclohexanol) were synthesized and Chemical Evaluation Section, Office 2010 (75 FR 71635). Before making a in the early 1980s for research purposes VerDate Mar<15>2010 18:07 Feb 28, 2011 Jkt 223001 PO 00000 Frm 00001 Fmt 4700 Sfmt 4700 E:\FR\FM\01MRR1.SGM 01MRR1 mstockstill on DSKH9S0YB1PROD with RULES 11076 Federal Register / Vol. 76, No. 40 / Tuesday, March 1, 2011 / Rules and Regulations in the investigation of the cannabinoid propose that the packaging is Pennsylvania, South Carolina, system. JWH–018, JWH–073, and JWH– professional and conspicuous, targeting Tennessee, and Virginia. 200 were prepared in the mid-1990s and young people, possibly eager to use Even though there is no evidence of evaluated to further advance cannabis, but who are afraid of the legitimate non-research related use for understanding of drug-receptor judicial consequences and/or these synthetic cannabinoids, multiple interactions regarding the cannabinoid association with illicit drugs. shipments of JWH–018 and JWH–073 system. Developed and evaluated as According to Internet discussion have been encountered by U.S. Customs research tools, no other known boards and law enforcement encounters and Border Protection in 2010. One legitimate uses have been identified for reported directly to DEA, these five enforcement operation encountered five these five synthetic cannabinoids. synthetic cannabinoids are being both shipments of JWH–018 totaling over 50 Furthermore, these five synthetic abused alone and/or being sprayed on kilograms (110.2 pounds) of powder. In cannabinoids are not intended for plant material (which is then smoked). addition, bulk loads of JWH–018 and human consumption. The most common route of JWH–200 have been encountered by law The emergence of these five synthetic administration of these synthetic enforcement in 2010. For example, in cannabinoids represents a recent cannabinoids is by smoking (using a Casper, Wyoming, DEA agents phenomenon in the U.S. designer drug pipe, a water pipe, or rolling the drug- encountered large quantities of herbal market. Since the initial identification spiked plant material in cigarette incense products laced with the of JWH–018 by U.S. forensic papers). synthetic cannabinoid JWH–018 in laboratories, many additional synthetic These five synthetic cannabinoids conjunction with methamphetamine cannabinoids including JWH–073, alone or spiked on plant material have and other illegal drugs in execution of JWH–200, CP–47,497, and the potential to be extremely harmful search and arrest warrants. On March 24, 2010, the American cannabicyclohexanol have been due to their method of manufacture and Association of Poison Control Centers identified in related herbal incense high pharmacological potency. There is reported receiving 112 calls from 15 products and plant food. These little information regarding the states related to synthetic cannabinoids synthetic cannabinoids have purported pharmacology, toxicology, and safety of to U.S. poison centers since 2009. Just psychotropic effects when smoked or these substances in humans given the nine months later, the number of calls ingested. These substances are typically minimal amount of pre-clinical found in powder form or are
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