WSR 11-16-040

PROPOSED RULES

DEPARTMENT OF HEALTH


(Board of Pharmacy)

[ Filed July 27, 2011, 2:52 p.m. ]

Original Notice.

Preproposal statement of inquiry was filed as WSR 11-12-005.

Title of Rule and Other Identifying Information: WAC 246-887-100, adding synthetic cannabinoids (marijuana) and substituted cathinones to the Schedule I controlled substance list.

Hearing Location(s): Washington State Department of Health, Creekside Three at Centerpoint, Room 1, 20435 72nd Avenue South, Suite 200, Kent, WA 98032, on September 8, 2011, at 3:30 p.m.

Date of Intended Adoption: September 6, 2011.

Submit Written Comments to: Kitty Slater-Einert, P.O. Box 47863, Olympia, WA 98504-7863, web site http://www3.doh.wa.gov/policyreview/, fax (360) 236-2901, by September 1, 2011.

Assistance for Persons with Disabilities: Contact Kitty Slater-Einert by September 1, 2011, TTY (800) 833-6388 or 711.

Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: The proposed rule adds synthetic cannabinoids and substituted cathinones to Schedule I of the Controlled Substances Act. Synthetic cannabinoids are sold as incense and are most commonly known as Spice. Substituted cathinones are sold as bath salts and are known by names like Ivory Wave and Zoom. The rule will give law enforcement clear authority to prosecute for the sale, possession, manufacture and delivery of these substances.

Reasons Supporting Proposal: The board of pharmacy has identified these substances as having a high potential for abuse with no medical use. Adding these substances to Schedule I will make them illegal and protect the public from potential health risks and harm that can be caused by their use.

Statutory Authority for Adoption: RCW 18.64.005.

Statute Being Implemented: RCW 69.50.201 and 69.50.203.

Rule is not necessitated by federal law, federal or state court decision.

Name of Proponent: Washington state board of pharmacy, governmental.

Name of Agency Personnel Responsible for Drafting: Kitty A. Slater, 310 Israel Road S.E., Tumwater, WA 98501, (360) 236-4861; Implementation and Enforcement: Susan T. Boyer, 310 Israel Road S.E., Tumwater, WA 98501, (360) 236-4835.

A small business economic impact statement has been prepared under chapter 19.85 RCW.

Small Business Economic Impact Statement

Scope of the Proposed Rule Package: The proposed rule will permanently add synthetic cannabinoids (marijuana) and substituted cathinones (including their salts, isomers, and salts of isomers, unless specifically excepted, whenever the existence of these salts, isomers, and salts of isomers is possible within the specific chemical designation) to Schedule I of the Uniform Controlled Substances Act (UCSA). The proposed rule will make it illegal to sell, possess, manufacture or deliver these substances and will give law enforcement clear authority to prosecute these crimes.

Background and History: The board of pharmacy (board) filed an emergency rule on April 15, 2011, to immediately make synthetic cannabinoids (marijuana) and substituted cathinones (including their salts, isomers, and salts of isomers, unless specifically excepted, whenever the existence of these salts, isomers, and salts of isomers is possible within the specific chemical designation) illegal by placing them into Schedule I. The emergency rule followed a previous emergency rule that had made only synthetic cannabinoids illegal. The board is proposing to permanently add both synthetic cannabinoids (marijuana) and substituted cathinones (including their salts, isomers, and salts of isomers, unless specifically excepted, whenever the existence of these salts, isomers, and salts of isomers is possible within the specific chemical designation) into the Schedule I list because it has determined these substances have been found to be unsafe and have a high potential for abuse, have no current accepted medical use for treatment in the United States, and potentially serious health and safety risks have been linked to their use.

Synthetic Cannabinoids: Synthetic cannabinoids are psychoactive substances which, when consumed, mimic the affects of tetrahydrocannibinol (THC), the active ingredient in marijuana. Products containing cannabinoids present a clear and imminent danger to the public. These products also known as Spice, K2 and other names, produce a "marijuana-like" high making them appealing to teens and young adults. Products containing these substances have been marketed as safe, as legal herbal products and are sold as incense to hide their intended purpose. They are available through retail outlets, tobacco/smoke shops, paraphernalia/head shops and over the internet. The federal Drug Administration (DEA) does not approve these substances for human consumption and does not oversee their manufacturing.

Since 2009, the DEA has received an increasing number of reports from poison centers, hospitals and law enforcement regarding these substances. Locally, the Washington State Poison Center (WSPC) reported eight cases of Spice ingestion in the last half of 2009 and sixty-eight cases of Spice ingestion reported in 2010.

On March 1, 2011, the DEA temporarily banned five types of synthetic cannabinoids, placing these into Schedule I of the federal Controlled Substances Act, under the temporary scheduling provision of Title 21 of the United States Code. In addition, several countries, as well as fifteen states, have already taken action to make one or more of these substances illegal.

Substituted Cathinones: Products containing substituted cathinones also present a clear and imminent danger to the public. Marketed as "bath salts" and "pond cleaner" and known by a variety of names, such as Ivory, Purple Wave, Red Dove, Blue Silk, and Zoom, these products are sold legally as synthetic powder both over the internet and in drug paraphernalia stores. Doctors and clinicians at United States poison centers have indicated that ingesting or snorting "bath salts" cause chest pains, increased blood pressure, increased heart rate, agitation, hallucinations, extreme paranoia, and delusions. These effects are similar to the effects of methamphetamine, ecstasy, and cocaine. There have also been reports of self-mutilations, suicides, and homicides linked to the drug.1

Cathinone and methcathinone have been Schedule I controlled substances since the early 1990's. The substituted cathinones listed in the proposed rule are analogs of cathinone and methcathinone, with minor structural derivative that may only be different by a single element. The Federal Analog Act does not apply to these analogs because they are marketed as "incense" and "bath salts" that are labeled as "not for human consumption."

Data from both national poison centers and the WSPC show increasing ingestion exposures related to "bath salts." Data from 2010 through March 2011 shows that national poison centers are reporting a three-fold increase in cases reported.2

Conclusion: Synthetic cannabinoids are psychoactive substances which, when consumed, mimic the affects of THC, the active ingredient in marijuana. Products containing cannabinoids present a clear and imminent danger to the public.

Substituted cathinones also present a clear and imminent danger to the public. Products that contain substituted cathinones, when consumed, can cause chest pains, increased blood pressure, increased heart rate, agitation, hallucinations, extreme paranoia, and delusions. These effects are similar to the effects of methamphetamine, ecstasy, and cocaine. There have also been reports of self-mutilations, suicides, and homicides linked to the drug.

All of these substances have high potential for abuse; have no currently accepted medical use in treatment in the United States; and they lack accepted safety for use in treatment under medical supervision. These substances and products containing these substances are labeled as "not for human consumption" and are unsafe.

The proposed rule may affect businesses that sell, possess, manufacture or deliver these substances. This may include retail outlets, tobacco/smoke shops, and paraphernalia/head shops. Adam Eidinger, owner of Capitol Hemp, a store in Washington D.C., said that "in the 18 months he has been stocking Spice, the demand has doubled every month and it is now making up a third of his revenue."3 However, it is important to note that these substances have high potential for abuse, lack accepted safety for use, and are clearly dangerous to the public.

The board has discussed the proposed rules, and the uses and effects of the substances at open public meetings, in which the public, including small business owners were given the opportunity to provide input. By making it illegal to sell, possess, manufacture or deliver these substances some businesses may lose revenue from future sale of these substances or products containing these substances. Considering the severity of the health hazards of these substances such as self-mutilations, suicides, and homicides, the department and the board have determined that:


Estimating the revenue losses for sellers/suppliers does not serve any positive social purpose.
There are no viable methods to reduce the cost or loss of revenue without impacting the health and safety of the people in Washington state.
Estimating the number of jobs that will be lost as the result of compliance with the proposed rule does not serve any positive social purpose.

The loss of future revenue to businesses from selling socially hazardous products are clearly offset with the benefit of reducing injury, hospitalizations and death associated with the use of these substances. Thus, the total probable benefits of the proposed rule outweigh the total probable costs or loss of revenue.


1 Anon. Methylendeiozypyrovalerone. Drug Enforcment [Enforcement] Adminstration [Administration]. December 2010.

2 National Institute for Drug Abuse - http://www.drugabuse.gov/about/welcome/MessageBathSalts211.html.

3 http://blogcritics.org/politics/article/synthetic-marijuana-sales-soar-as-demand1/#ixzz1QbiiFAVs.

A copy of the statement may be obtained by contacting Kitty Slater, 310 Israel Road S.E., Tumwater, WA 98501, phone (360) 236-4861, fax (360) 236-4901, e-mail kitty.slater@doh.wa.gov.

A cost-benefit analysis is required under RCW 34.05.328. A preliminary cost-benefit analysis may be obtained by contacting Kitty Slater, 310 Israel Road S.E., Olympia, WA 98501, phone (360) 236-4861, fax (360) 236-4901, e-mail kitty.slater@doh.wa.gov.

July 27, 2011

Susan Teil Boyer

Executive Director

Board of Pharmacy

OTS-3833.3


AMENDATORY SECTION(Amending WSR 01-03-108, filed 1/22/01, effective 1/22/01)

WAC 246-887-100   Schedule I.   The board finds that the following substances have high potential for abuse and have no accepted medical use in treatment in the United States or that they lack accepted safety for use in treatment under medical supervision. The board, therefore, places each of the following substances in Schedule I.

(a) The controlled substances listed in this section, by whatever official name, common or usual name, chemical name, or brand name, are included in Schedule I.

(b) Opiates. Unless specifically excepted or unless listed in another schedule, any of the following opiates, including their isomers, esters, ethers, salts, and salts of isomers, esters, and ethers, whenever the existence of these isomers, esters, ethers, and salts is possible within the specific chemical designation:


(1) Acetyl-alpha-methylfentanyl (N-[1-(1-methyl-2-phenethyl)-4-piperidinyl]-N-phenylacetamide);

(2) Acetylmethadol;

(3) Allylprodine;

(4) Alphacetylmethadol; (([(except for levo-alphacetylmethadol - also known as levo-alpha-acetylmethadol, levomethadyl acetate or LAAM);])) (except for levo-alphacetylmethadol - Also known as levo-alpha-acetylmethadol, levomethadyl acetate or LAAM);

(5) Alphameprodine;

(6) Alphamethadol;

(7) Alpha-methylfentanyl (N-[1-alpha-methyl-beta-phenyl) ethyl-4-piperidyl] propionanilide; 1-(1-methyl-2-phenylethyl)-4-(N-propanilido) piperidine);

(8) Benzethidine;

(9) Betacetylmethadol;

(10) Betameprodine;

(11) Betamethadol;

(12) Betaprodine;

(13) Clonitazene;

(14) Dextromoramide;

(15) Diampromide;

(16) Diethylthiambutene;

(17) Difenoxin;

(18) Dimenoxadol;

(19) Dimepheptanol;

(20) Dimethylthiambutene;

(21) Dioxaphetyl butyrate;

(22) Dipipanone;

(23) Ethylmethylthiambutene;

(24) Etonitazene;

(25) Etoxeridine;

(26) Furethidine;

(27) Gamma-hydroxybutyric Acid (other names include: GHB);

(28) Hydroxypethidine;

(29) Ketobemidone;

(30) Levomoramide;

(31) Levophenacylmorphan;

(32) 3-Methylfentanyl (N-[3-Methyl-1-(2-phenylethyl)-4-piperidyl)]-N-phenylpropanamide);

(33) Morpheridine;

(34) MPPP (1-Methyl-4-phenyl-4-propionoxypiperidine);

(35) Noracymethadol;

(36) Norlevorphanol;

(37) Normethadone;

(38) Norpipanone;

(39) PEPAP (1-(-2-phenethyl)-4-phenyl-4-acetoxypiperidine);

(40) Phenadoxone;

(41) Phenampromide;

(42) Phenomorphan;

(43) Phenoperidine;

(44) Piritramide;

(45) Proheptazine;

(46) Properidine;

(47) Propiram;

(48) Racemoramide;

(49) Tilidine;

(50) Trimeperidine.


(c) Opium derivatives. Unless specifically excepted or unless listed in another schedule, any of the following opium derivatives, their salts, isomers, and salts of isomers, whenever the existence of these salts, isomers, and salts of isomers is possible within the specific chemical designation:


(1) Acetorphine;

(2) Acetyldihydrocodeine;

(3) Benzylmorphine;

(4) Codeine methylbromide;

(5) Codeine-N-Oxide;

(6) Cyprenorphine;

(7) Desomorphine;

(8) Dihydromorphine;

(9) Drotebanol;

(10) Etorphine (except hydrochloride salt);

(11) Heroin;

(12) Hydromorphinol;

(13) Methyldesorphine;

(14) Methyldihydromorphine;

(15) Morphine methylbromide;

(16) Morphine methylsulfonate;

(17) Morphine-N-Oxide;

(18) Myrophine;

(19) Nicocodeine;

(20) Nicomorphine;

(21) Normorphine;

(22) Pholcodine;

(23) Thebacon.


(d) Hallucinogenic substances. Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of the following hallucinogenic substances, or which contains any of its salts, isomers, and salts of isomers, whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation (for purposes of paragraph (d) of this section, only, the term "isomer" includes the optical, position, and geometric isomers):

(1) 4-bromo-2,5-dimethoxy-amphetamine: Some trade or other names: 4-bromo-2,5-dimethoxy-a-methylphenethylamine; 4-bromo-2,5-DMA;

(2) 2,5-dimethoxyamphetamine: Some trade or other names: 2,5-dimethoxy-a-methylphenethylamine; 2,5-DMA;

(3) 2,5-dimethoxy-4-ethylamphetamine (DOET)

(4) 4-methoxyamphetamine: Some trade or other names: 4-methoxy-a-methylphenethylamine; paramethoxyamphetamine, PMA;

(5) 5-methoxy-3,4-methylenedioxy-amphetamine;

(6) 4-methyl-2,5-dimethoxy-amphetamine: Some trade and other names: 4-methyl-2,5-dimethoxy-a-methylphenethylamine; "DOM"; and "STP";

(7) 3,4-methylenedioxy amphetamine;

(8) 3,4-methylenedioxymethamphetamine (MDMA);

(9) 3,4,5-trimethoxy amphetamine;

(10) Bufotenine: Some trade or other names: 3-(beta-Dimethylaminoethyl)-5-hydroxindole; 3-(2-dimethylaminoethyl)-5-indolol; N, N-dimethylserotonin; 5-hydroxy-N,N-dimethyltryptamine; mappine;

(11) Diethyltryptamine: Some trade or other names: N,N-Diethyltryptamine; DET;

(12) Dimethyltryptamine: Some trade or other names: DMT;

(13) Ibogaine: Some trade or other names: 7-Ethyl-6,6 beta,7,8,9,10,12,13,-octahydro-2-methoxy-6,9methano-5H-pyndo (1',2':1,2) azepino (5,4-b) indole; Tabernanthe iboga;

(14) Lysergic acid diethylamide;

(15) Marihuana;

(16) Mescaline;

(17) Parahexyl-7374; some trade or other names: 3-Hexyl-1-hydroxy-7, 8, 9, 10-tetrahydro-6, 6, 9-trimethyl-6H-dibenzo[b,d]pyran; synhexyl;

(18) Peyote, meaning all parts of the plant presently classified botanically as Lophophora Williamsii Lemaire, whether growing or not, the seeds thereof, any extract from any part of such plant, and every compound, manufacture, salts, derivative, mixture, or preparation of such plant, its seeds, or extracts; (interprets 21 USC 812 (c), Schedule I (c)(12))

(19) N-ethyl-3-piperidyl benzilate;

(20) N-methyl-3-piperidyl benzilate;

(21) Psilocybin;

(22) Psilocyn;

(23) Any of the following synthetic cannabimimetics, their salts, isomers, and salts of isomers, unless specifically excepted, whenever the existence of these salts, isomers, and salts of isomers is possible within the specific chemical designation:

(i) Naphthoylindoles: Any compound containing a 3-(1-naphthoyl) indole structure with substitution at the nitrogen atom of the indole ring by an alkyl, haloalkyl, alkenyl, cycloalkylmethyl, cycloalkylethyl, 1-(N-methyl-2-piperidinyl) methyl, or 2-(4-morpholinyl) ethyl group, whether or not further substituted in the indole ring to any extent and whether or not substituted in the naphthyl ring to any extent including, but not limited to, JWH-015, JWH-018, JWH-019, JWH-073, JWH-081, JWH-122, JWH-200, JWH-210, and AM-2201;

(ii) Naphthylmethylindoles: Any compound containing a1H-indol-3-yl-(1-naphthyl) methane structure with substitution at the nitrogen atom of the indole ring by an alkyl, haloalkyl, alkenyl, cycloalkylmethyl, cycloalkylethyl, 1-(N-methyl-2-piperidinyl) methyl, or 2-(4-morpholinyl) ethyl group, whether or not further substituted in the indole ring to any extent and whether or not substituted in the naphthyl ring to any extent including, but not limited to, JWH-175, JWH-184, and JWH-199;

(iii) Naphthoylpyrroles: Any compound containing a 3-(1-naphthoyl) pyrrole structure with substitution at the nitrogen atom of the pyrrole ring by an alkyl, haloalkyl, alkenyl, cycloalkylmethyl, cycloalkylethyl, 1-(N-methyl-2-piperidinyl) methyl, or 2-(4-morpholinyl) ethyl group, whether or not further substituted in the pyrrole ring to any extent and whether or not substituted in the naphthyl ring to any extent including, but not limited to, JWH-307;

(iv) Naphthylmethylindenes: Any compound containing a naphthylideneindene structure with substitution at the 3-position of the indene ring by an alkyl, haloalkyl, alkenyl, cycloalkylmethyl, cycloalkylethyl, 1-(N-methyl-2-piperidinyl) methyl, or 2-(4-morpholinyl) ethyl group, whether or not further substituted in the indene ring to any extent and whether or not substituted in the naphthyl ring to any extent including, but not limited to, JWH-176;

(v) Phenylacetylindoles: Any compound containing a 3-phenylacetylindole structure with substitution at the nitrogen atom of the indole ring by an alkyl, haloalkyl, alkenyl, cycloalkylmethyl, cycloalkylethyl, 1-(N-methyl-2-piperidinyl) methyl, or 2-(4-morpholinyl) ethyl group, whether or not further substituted in the indole ring to any extent and whether or not substituted in the phenyl ring to any extent including, but not limited to, JWH-203, JWH-250, JWH-251, and RCS-8;

(vi) Cyclohexylphenols: Any compound containing a 2-(3-hydroxycyclohexyl) phenol structure with substitution at the 5-position of the phenolic ring by an alkyl, haloalkyl, alkenyl, cycloalkylmethyl, cycloalkylethyl, 1-(N-methyl-2-piperidinyl) methyl, or 2-(4-morpholinyl) ethyl group, whether or not substituted in the cyclohexyl ring to any extent including, but not limited to, Cannabicyclohexanol, and CP 47,497;

(vii) Benzoylindoles: Any compound containing a 3-(benzoyl) indole structure with substitution at the nitrogen atom of the indole ring by an alkyl, haloalkyl, alkenyl, cycloalkylmethyl, cycloalkylethyl, 1-(N-methyl-2-piperidinyl) methyl, or 2-(4-morpholinyl) ethyl group, whether or not further substituted in the indole ring to any extent and whether or not substituted in the phenyl ring to any extent including, but not limited to, AM-694, Pravadoline (WIN 48,098), RCS-4, and AM-1241;

(viii) 2,3-Dihydro-5-methyl-3-(4-morpholinylmethyl) pyrrolo [1,2,3-de]-1,4-benzoxazin-6-yl]-1-napthalenylmethanone: Some trade or other names: WIN 55,212-2.

(24) Tetrahydrocannabinols, synthetic equivalents of the substances contained in the plant, or in the resinous extractives of Cannabis, sp., and/or synthetic substances, derivatives, and their isomers with similar chemical structure and pharmacological activity such as the following:

(i) Delta 1 - cis - or transtetrahydrocannabinol, and their optical isomers, excluding tetrahydrocannabinol in sesame oil and encapsulated in a soft gelatin capsule in a drug product approved by the United States Food and Drug Administration;

(ii) Delta 6 - cis - or transtetrahydrocannabinol, and their optical isomers;

(iii) Delta 3,4 - cis - or transtetrahydrocannabinol, and its optical isomers;

(iv) (6aR,10aR)-9-(hydroxymethyl)-6, 6-dimethyl-3-(2-methyloctan-2-yl)-6a,7,10, 10a-tetrahydrobenzo[c]chromen-1-ol: Some trade or other names: HU-210.

(Since nomenclature of these substances is not internationally standardized, compounds of these structures, regardless of numerical designation of atomic positions covered.)

(((24))) (25) Ethylamine analog of phencyclidine: Some trade or other names: N-ethyl-1-phenylcyclohexylamine, (1-phenylcyclohexyl) ethylamine, N-(1-phenylcyclohexyl)ethylamine, cyclohexamine, PCE;

(((25))) (26) Pyrrolidine analog of phencyclidine: Some trade or other names: 1-(1-phencyclohexyl)pyrrolidine; PCPy; PHP;

(((26))) (27) Thiophene analog of phencyclidine: Some trade or other names: 1-(1-[2-thenyl]-cyclohexly)-pipendine; 2-thienylanalog of phencyclidine; TPCP; TCP;

(e) Depressants. Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of the following substances having a depressant effect on the central nervous system, including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation:

(i) Mecloqualone;

(ii) Methaqualone.

(f) Stimulants. Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of the following substances having a stimulant effect on the central nervous system, including its salts, isomers, and salts of isomers:

(((i))) (1) Cathinone (also known as 2-amino-1-phenyl-1-propanone, alpha-aminopropiophenone, 2-aminopropiophenone and norephedrone);

(((ii))) (2) 4-Fluoromethcathinone (Flephedrone);

(3) Beta-keto-N-Methylbenzodioxolylpropylamine (bk-MBDB, Butylone);

(4) 3,4-Methylenedioxymethcathinone (Methylone);

(5) 3,4-Methylenedioxypyrovalerone (MDPV);

(6) 4-Methylmethcathinone (Mephedrone);

(7) Fenethylline;

(((iii))) (8) N-ethylamphetamine;

(((iv))) (9) 4-methylaminorex;

(((v))) (10) N,N-dimethylamphetamine.

[01-03-108, 246-887-100, filed 1/22/01, effective 1/22/01. Statutory Authority: RCW 18.64.005. 94-08-098, 246-887-100, filed 4/6/94, effective 5/7/94. Statutory Authority: RCW 18.65.005 and 18.64.005. 94-07-105, 246-887-100, filed 3/18/94, effective 3/18/94. Statutory Authority: RCW 18.64.005. 92-04-029 (Order 239B), 246-887-100, filed 1/28/92, effective 2/29/92. Statutory Authority: RCW 18.64.005 and chapter 18.64A RCW. 91-18-057 (Order 191B), recodified as 246-887-100, filed 8/30/91, effective 9/30/91. Statutory Authority: RCW 69.50.201. 89-17-023 (Order 226), 360-36-410, filed 8/8/89, effective 9/8/89; 86-16-057 (Order 200), 360-36-410, filed 8/1/86. Statutory Authority: RCW 69.50.201, 69.50.203, 69.50.205, 69.50.207, 69.50.209 and 69.50.211. 84-22-062 (Order 190), 360-36-410, filed 11/7/84.]

Reviser's note: The brackets and enclosed material in the text of the above section occurred in the copy filed by the agency and appear in the Register pursuant to the requirements of RCW 34.08.040.

Reviser's note: The typographical error in the above section occurred in the copy filed by the agency and appears in the Register pursuant to the requirements of RCW 34.08.040.

Washington State Code Reviser's Office