WSR 18-22-115
PROPOSED RULES
DEPARTMENT OF HEALTH
(Pharmacy Quality Assurance Commission)
[Filed November 6, 2018, 11:12 a.m.]
Original Notice.
Proposal is exempt under RCW 34.05.310(4) or 34.05.330(1).
Title of Rule and Other Identifying Information: Chapter 246-887 WAC, Regulations implementing the Uniform Controlled Substances Act, the pharmacy quality assurance commission (commission) is amending this chapter to update federal citations, make grammatical corrections, clarify language, and update all schedules to reflect the changes made by the Drug Enforcement Administration (DEA) to 21 C.F.R. 1308 made from 2010 to April 1, 2018.
Hearing Location(s): On December 13, 2018, at 9:05 a.m., at Highline Community College, 2400 South 240 Street, Mt. Constance Room, Des Moines, WA 98198.
Date of Intended Adoption: December 13, 2018.
Submit Written Comments to: Tracy West, P.O. Box 48750, Olympia, WA 98504-8750, email https://fortress.wa.gov/doh/policyreview, fax 360-236-2260, by December 10, 2018.
Assistance for Persons with Disabilities: Contact Doreen Beebe, phone 360-236-4946, TTY 360-833-6388 or 711, email WSPQAC@doh.wa.gov, by December 10, 2018.
Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: The commission is proposing amendments to chapter 246-887 WAC to update citations to federal rules and laws adopted by the commission. Additionally, the commission is proposing to change the format of the schedules to be a staging ground for anticipated changes needed to the Revised Code of Washington (RCW). The rules will now only include substances not scheduled in RCW. The two separate lists eliminate redundancy and the chance for misspelling of substances. Also, by having the rule formatted to only schedule substances missing from RCW it will provide efficiency when the commission requests future updates to chapter 69.50 RCW, or if the legislature asks for assistance in updating the schedules. Other changes are proposed to clarify the language in rule and make the requirements more understandable. The commission is proposing to repeal WAC 246-887-110, 246-887-120, 246-887-130, 246-887-131, 246-887-132, 246-887-133, 246-887-165, and 246-887-190, to consolidate previously added substances into their appropriate schedules.
Reasons Supporting Proposal: RCW 69.50.201(d) requires the commission to update controlled substance schedules annually. The commission has not updated this chapter or schedules in over three years. In addition, the proposed rules incorporate amendments to WAC 246-887-100 Schedule I, requested in a rule petition from the Washington state attorney general's office to add certain synthetic cannabinoids, synthetic cathinones, fentanyl, and synthetic opioid drugs to Schedule I consistent with DEA classification of these substances. The petition resulted in the commission filing four emergency rules, recently refiled as WSR 18-16-098 on July 31, 2018, adding these substances to Schedule I. This proposal would make those emergency rule amendments to Schedule I permanent.
Statutory Authority for Adoption: RCW 69.50.201.
Statute Being Implemented: RCW 69.50.101 through 69.50.315, 69.50.401 through 69.50.525, and 69.50.601 through 69.50.608.
Rule is necessary because of federal law, 21 C.F.R. 1306, 21 C.F.R. 1308.
Name of Proponent: Pharmacy quality assurance commission and Washington state attorney general's office, consumer protection division, governmental.
Name of Agency Personnel Responsible for Drafting: Tracy West, Deputy Director, 111 Israel Road S.E., Tumwater, WA 98501, 360-236-4988; Implementation and Enforcement: Steve Saxe, Executive Director, 111 Israel Road S.E., Tumwater, WA 98501, 360-236-4853.
A school district fiscal impact statement is not required under RCW 28A.305.135.
A cost-benefit analysis is not required under RCW 34.05.328. The agency did not complete a cost-benefit analysis under RCW 34.05.328. RCW 34.05.328 (5)(b)(iii) exempts rules that adopt or incorporate by reference without material change federal statutes or regulations, Washington state law, the rules of other Washington state agencies, or national consensus codes that generally establish industry standards; and RCW 34.05.328 (5)(b)(iv) exempts rules that only correct typographical errors, make address or name changes or clarify the language of a rule without changing its effect.
This rule proposal, or portions of the proposal, is exempt from requirements of the Regulatory Fairness Act because the proposal:
Is exempt under RCW 19.85.061 because this rule making is being adopted solely to conform and/or comply with federal statute or regulations. Citation of the specific federal statute or regulation and description of the consequences to the state if the rule is not adopted: See explanations below.
Is exempt under RCW 19.85.025(3) as the rules are adopting or incorporating by reference without material change federal statutes or regulations, Washington state statutes, rules of other Washington state agencies, shoreline master programs other than those programs governing shorelines of statewide significance, or, as referenced by Washington state law, national consensus codes that generally establish industry standards, if the material adopted or incorporated regulates the same subject matter and conduct as the adopting or incorporating rule; and rules only correct typographical errors, make address or name changes, or clarify language of a rule without changing its effect.
Explanation of exemptions: WAC 246-887-020, exempt under RCW 34.05.010 (4)(c), (d) and 19.85.061. In this section there are updates to incorporated references, typographical and grammatical corrections, and changes on emergency oral prescriptions to conform to timelines in 21 C.F.R. 1306.11.
WAC 246-887-080 and 246-887-090, exempt under RCW 34.05.010 (4)(d) by correcting references to the pharmacy quality assurance commission rather than board.
WAC 246-887-100, exempt under RCW 34.05.010 (4)(d) and 19.85.061. In this section updates are based on clarifying and correcting language, and changes made to the federal schedules of controlled substances in 21 C.F.R. 1308.11.
WAC 246-887-140, exempt under RCW 34.05.010 (4)(d) and 19.85.061. In this section updates are based on clarifying and correcting language, and changes made to the federal schedules of controlled substances in 21 C.F.R. 1308.12.
WAC 246-887-150 and 246-887-200, exempt under RCW 34.05.010 (4)(d) by correcting references to the pharmacy quality assurance commission rather than board, and clarifying other language.
WAC 246-887-160, exempt under RCW 34.05.010 (4)(d) and 19.85.061. In this section updates are based on clarifying and correcting language, and changes made to the federal schedules of controlled substances in 21 C.F.R. 1308.13.
WAC 246-887-170, exempt under RCW 34.05.010 (4)(d) and 19.85.061. In this section updates are based on clarifying and correcting language, and changes made to the federal schedules of controlled substances in 21 C.F.R. 1308.14.
WAC 246-887-180, exempt under RCW 34.05.010 (4)(d) and 19.85.061. In this section updates are based on clarifying and correcting language, and changes made to the federal schedules of controlled substances in 21 C.F.R. 1308.15.
November 6, 2018
Tim Lynch, PharmD, MS, Chair
Pharmacy Quality Assurance Commission
AMENDATORY SECTION(Amending WSR 15-13-086, filed 6/15/15, effective 7/16/15)
WAC 246-887-020Uniform Controlled Substances Act.
(1) ((Consistent with the concept of uniformity where possible with the federal regulations for controlled substances (21 C.F.R.), the federal regulations are specifically made applicable to registrants in this state by virtue of RCW 69.50.306. Although those regulations are automatically applicable to registrants in this state,))The pharmacy quality assurance commission (commission) ((is nevertheless adopting as its own regulations the existing regulations of the federal government published in))adopts Title 21 of the Code of Federal Regulations ((revised as of April 1, 1991, and all references made therein to the director or the secretary shall have reference to the commission, and)). The following sections ((are not applicable))do not apply: Section ((1301.11-.13, section 1301.31, section 1301.43-.57))1301.13, section 1301.33, section 1301.35-.46, section 1303, section ((1308.41-.48))1308.41-.45, and section 1316.31-.67. ((The following specific rules shall take precedence over the federal rules adopted herein by reference, and therefore any inconsistencies shall be resolved in favor of the following specific rules.))Any inconsistencies between Title 21 of the Code of Federal Regulations sections 1300 through 1321 and chapter 246-887 WAC should be resolved in favor of chapter 246-887 WAC. Further, nothing in these rules applies to the production, processing, distribution, or possession of marijuana as authorized and regulated by the Washington state liquor and cannabis board.
(2) Registration. A separate registration is required for each place of business,((())as defined in ((section 1301.23)))21 C.F.R. 1301.12 where controlled substances are manufactured, distributed or dispensed. Application for registration must be made on forms supplied by the commission, and all requested information ((called for thereon)) must be supplied unless the information is not applicable, ((in)) which ((case it)) must be indicated by the applicant. An applicant for registration must hold the appropriate wholesaler, manufacturer or pharmacy license provided for in chapter 18.64 RCW.
(3) Every registrant shall be required to keep inventory records required by ((section))21 C.F.R. 1304.04 (((of the federal rules which have been adopted by reference by Rule 1))) and must maintain said inventory records for a period of two years from the date of inventory. Such registrants are further required to keep a record of receipt and distribution of controlled substances. Such record shall include:
(a) Invoices, orders, receipts, etc. showing the date, supplier and quantity of drug received, and the name of the drug;
(b) Distribution records; i.e., invoices, etc. from wholesalers and manufacturers and prescriptions records for dispensers;
(c) In the event of a significant loss ((by))or theft ((or destruction)), two copies of DEA 106 (report of theft or loss of controlled substances) must be transmitted to the federal authorities and a copy must be sent to the commission;
(d) For transfers of controlled substances from one dispenser to another, a record of the transfer must be made at the time of transfer indicating the drug, quantity, date of transfer, who it was transferred to and from whom. Said record must be retained by both the transferee and the transferor. These transfers can only be made in emergencies pursuant to ((section))21 C.F.R. 1307.11 (((federal rules))).
(4) The records must be maintained separately for Schedule II drugs. The records for Schedule III, IV and V drugs may be maintained either separately or in a form that is readily retrievable from the business records of the registrant. ((Prescription records will be deemed readily retrievable if the prescription has been stamped in red ink in the lower right hand corner with the letter "C" no less than one inch high, and said prescriptions are filed in a consecutively numbered prescription file which includes prescription and noncontrolled substances.))
(5) A federal order form is required for each distribution of a Schedule I or II controlled substance, and said forms along with other records required to be kept must be made readily available to authorized employees of the commission.
(6) Schedule II drugs require that a dispenser have a signed prescription in his possession prior to dispensing said drugs. An exception is permitted in an "emergency." An emergency exists when the immediate administration of the drug is necessary for proper treatment and no alternative treatment is available, and further, it is not possible for the physician to provide a written or electronic prescription for the drug at that time. If a Schedule II drug is dispensed in an emergency, the practitioner must deliver a signed prescription to the dispenser within ((72 hours))seven days after authorizing an emergency oral prescription or if delivered by mail it must be postmarked within the seven-day period, and further ((he))the pharmacist must note on the prescription that it was filled on an emergency basis.
(7) A prescription for a substance included in Schedule II may not be refilled.
(8) A prescription for a substance included in Schedule II may not be filled more than six months after the date the prescription was issued.
(9) Except when dispensed directly by a practitioner authorized to prescribe or administer a controlled substance, other than a pharmacy, to an ultimate user, a substance included in Schedule III, IV, or V, which is a prescription drug as determined under RCW 69.04.560, may not be dispensed without a written, oral, or electronically communicated prescription of a practitioner. Any oral prescription must be promptly reduced to writing. The prescription for a substance included in Schedule III, IV, or V may not be filled or refilled more than six months after the date issued by the practitioner or be refilled more than five times, unless the practitioner issues a new prescription.
AMENDATORY SECTION(Amending WSR 91-18-057, filed 8/30/91, effective 9/30/91)
WAC 246-887-080Sodium pentobarbital registration disciplinary action.
In addition to any criminal or civil liabilities that may occur, the ((board))pharmacy quality assurance commission (commission) may deny, suspend, or revoke registration upon determination that:
(1) The registration was procured through fraud or misrepresentation((,));
(2) The registrant or any agent or employee of the registrant has violated any of the federal or state laws related to drugs, or has violated any of the rules or regulations of the ((board of pharmacy))commission.
AMENDATORY SECTION(Amending WSR 91-18-057, filed 8/30/91, effective 9/30/91)
WAC 246-887-090Authority to control.
Pursuant to the authority granted to the ((board of)) pharmacy quality assurance commission (commission) in RCW 69.50.201, the ((board))commission has considered the following factors with regards to each of the substances listed in this chapter and in chapter 69.50 RCW:
(1) The actual or relative potential for abuse;
(2) The scientific evidence of its pharmacological effect, if known;
(3) The state of current scientific knowledge regarding the substance;
(4) The history and current pattern of abuse;
(5) The scope, duration, and significance of abuse;
(6) The risk to the public health;
(7) The potential of the substance to produce psychic or psychological dependence liability; and
(8) Whether the substance is an immediate precursor of a substance already controlled under the Uniform Controlled Substances Act (chapter 69.50 RCW).
AMENDATORY SECTION(Amending WSR 11-22-086, filed 11/1/11, effective 12/2/11)
WAC 246-887-100Schedule I.
The ((board))pharmacy quality assurance commission (commission) 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,))In addition to the substances scheduled in RCW 69.50.204 the commission places each of the following controlled substances by whatever official name, common or usual name, chemical name, or brand name 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)))(1) 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);
(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)))(a) (N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide); some other names: Acetyl fentanyl;
(b) 3,4-Dichloro-N-[2-(dimethylamino)cyclohexyl]-N-methylbenzamide, its isomers, esters, ethers, salts and salts of isomers, esters and ethers; some other names: U-47700;
(c) 3,4-dichloro-N-[(1-dimethylamino) cyclohexylmethyl]benzamide; some other names: AH-7921;
(d) Dextrorphan;
(e) N-(1-phenethylpiperidin-4-yl)-N-phenylacrylamide, its isomers, esters, ethers, salts and salts of isomers, esters and ethers; some other names: Acryl fentanyl and acryloylfentanyl;
(f) N-(1-phenethylpiperidin-4-yl)-N-phenylbutyramide, its isomers, esters, ethers, salts and salts of isomers, esters and ethers; some other names: Butyryl fentanyl;
(g) N-(1-phenethylpiperidin-4-yl)-N-phenylfuran-2-carboxamide, its isomers, esters, ethers, salts and salts of isomers, esters and ethers; some other names: Furanyl fentanyl;
(h) N-(4-fluorophenyl)-N-(1-phenethylpiperidin-4-yl)isobutyramide, its isomers, esters, ethers, salts and salts of isomers, esters and ethers; some other names: 4-fluoroisobutyryl fentanyl and para-fluoroisobutyryl fentanyl;
(i) N-[1-[2-hydroxy-2-(thiophen-2-yl)ethyl]piperidin-4-yl]-N-phenylpropionamide, its isomers, esters, ethers, salts and salts of isomers, esters and ethers; some other names: Beta-hydroxythiofentanyl;
(j) Propheptazine.
(2) Opium derivatives. Unless specifically excepted or unless listed in another schedule, any of the following opium derivatives, ((their))its 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)))Methylhydromorphine.
(3) 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,))this subsection 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 U.S.C. § 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 trans tetrahydrocannabinol, 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.)
(25) Ethylamine analog of phencyclidine: Some trade or other names: N-ethyl-1-phenylcyclohexylamine, (1-phenylcyclohexyl) ethylamine, N-(1-phenylcyclohexyl)ethylamine, cyclohexamine, PCE;
(26) Pyrrolidine analog of phencyclidine: Some trade or other names: 1-(1-phencyclohexyl)pyrrolidine; PCPy; PHP;
(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))):
(a) 1-(1,3-benzodioxol-5-yl)-2-(methylamino)butan-1-one; some other names: butylone and bk-MBDB;
(b) 1-(1,3-benzodioxol-5-yl)-2-(methylamino)pentan-1-one; some other names: pentylone and bk-MBDP;
(c) 2-(2,5-Dimethoxy-4-(n)-propylphenyl)ethanamine; some other names: 2C-P;
(d) 2-(2,5-Dimethoxy-4-ethylphenyl)ethanamine; some other names: 2C-E;
(e) 2-(2,5-Dimethoxy-4-methylphenyl)ethanamine; some other names: 2C-D;
(f) 2-(2,5-Dimethoxy-4-nitrophenyl)ethanamine; some other names: 2C-N;
(g) 2-(2,5-Dimethoxyphenyl)ethanamine; some other names: 2C-H;
(h) 2-(4-bromo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine; some other names: 25B-NBOMe and 2C-B-NBOMe;
(i) 2-(4-Chloro-2,5-dimethoxyphenyl)ethanamine; some other names: 2C-C;
(j) 2-(4-chloro-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine; some other names: 25C-NBOMe and 2C-C-NBOMe;
(k) 2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine; some other names: 2C-I;
(l) 2-(4-Iodo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine; some other names: 25I-NBOMe and 2C-I-NBOMe;
(m) 2,5-dimethoxyamphetamine; some other names: 2,5-dimethoxy-alpha-methylphenethylamine and 2,5-DMA;
(n) 2-[4-(Ethylthio)-2,5-dimethoxyphenyl]ethanamine; some other names: 2C-T-2;
(o) 2-[4-(Isopropylthio)-2,5-dimethoxyphenyl]ethanamine; some other names: 2C-T-4;
(p) 3,4-Methylenedioxymethcathinone; some other names: Methylone;
(q) 3,4-methylenedioxy-N-ethylamphetamine; some other names: N-ethyl-alpha-methyl-3,4(methylenedioxy)-phenethylamine, N-ethyl MDA, MDE, and MDEA;
(r) 3,4-Methylenedioxypyrovalerone; some other names: MDPV;
(s) 4-bromo-2,5-dimethoxy-amphetamine: Some trade or other names: 4-bromo-2,5-dimethoxy-alpha-methylphenethylamine; some other names: 4-bromo-2,5-DMA;
(t) 4-methoxyamphetamine; some other names: 4-methoxy-alpha-methylphenethylamine; paramethoxyamphetamine, PMA;
(u) 4-methyl-2,5-diamethoxyamphetamine;
(v) 4-methyl-2,5-dimethoxy-amphetamine; some other names: 4-methyl-2,5-dimethoxy-alpha-methylphenethylamine; "DOM;" and "STP";
(w) 4-Methylmethcathinone; some other names: Mephedrone;
(x) 5-methoxy-N,N-dimethyltryptamine; some other names: 5-methoxy-3-[2-(dimethylamino)ethyl]indole and 5-MeO-DMT;
(y) Alpha-ethyltryptamine; some other names: Etryptamine; monase; a-ethyl-1H-indole-3-ethanamine; 3-(2-aminobutyl) indole; a-ET; and AET;
(z) Beta-keto-N-Methylbenzodioxolylpropylamine; some other names: bk-MBDB and Butylone;
(aa) Ethylamine analog of phencyclidine; some other names: N-ethyl-1phenylcyclohexalymine, (1-phenylcyclohexyl) ethylamine; N-(1-phenylcyclohexyl)ethylamine; cyclohexamine; and PCE;
(bb) Ibogaine; some other names: 7-Ethyl-6,6 beta,7,8,9,10,12,13-octahydro-2-methoxy-6,9-methano-5H-pyrido [1',2':1,2] azepino [5,4-b] indole; and Tabernanthe iboga;
(cc) Marijuana Extract—Meaning an extract containing one or more cannabinoids that has been derived from any plant of the genus Cannabis, other than the separated resin (whether crude or purified) obtained from the plant;
(dd) N-hydroxy-3,4-methylenedioxyamphetamine; some other names: N-hydroxy-alpha-methyl-3,4(methylenedioxy)-phenethylamine; and N-hydroxy MDA;
(ee) Pyrrolidine analog of phencyclidine; some other names: 1-(1-phenylcyclohexyl)pyrrolidine; PCPy; and PHP;
(ff) Thiophene analog of phencyclidine; some other names: 1-[1-(2-thienyl)-cyclohexyl]-pipendine; 2-thienylanalog of phencyclidine; TPCP; TCP.
(4) 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:
(((1)))(a) Cathinone ((()); also known as 2-amino-1-phenyl-1-propanone, alpha-aminopropiophenone((,)); 2-aminopropiophenone; and norephedrone(()));
(((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;
(8) N-ethylamphetamine;
(9) 4-methylaminorex;
(10)))(b)N,N-dimethylamphetamine; some other names: N,N-alpha-trimethyl-benzeneethanamine; and N,N-alpha-trimethylphenethylene.
(5) Cannabimimetic agents and synthetic cannabinoids. Any of the following synthetic cannabimimetics and cannabinoids, commonly known as spice, their salts, isomers, and salts of isomers, unless specifically exempted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quality of the following substances, or which contains their salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation:
(a) (1-pentyl-1H-indol-3-yl) (2,2,3,3-tetramethylcyclopropyl)methanone; some other names: UR-144;
(b) [1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1-yl)methanone, its optical, positional, and geometric isomers, salts, and salts of isomers; some other names: THJ-2201;
(c) [1-(5-fluoro-pentyl)-1H-indol-3-yl](2,2,3,3-tetramethylcyclopropyl)methanone; some other names: 5-fluoro-UR-144 and XLR11;
(d) 1-(5-fluoropentyl)-3-(1-naphthoyl)indole; some other names: AM2201;
(e) 1-(5-fluoropentyl)-3-(2-iodobenzoyl)indole; some other names: AM694;
(f) 1-[2-(4-morpholinyl)ethyl]-3-(1-naphthoyl)indole; some other names: JWH-200;
(g) 1-butyl-3-(1-naphthoyl)indole; some other names: JWH-073;
(h) 1-cyclohexylethyl-3-(2-methoxyphenylacetyl)indole; some other names: SR-18 and RCS-8;
(i) 1-hexyl-3-(1-naphthoyl)indole; some other names: JWH-019;
(j) 1-pentyl-3-(1-naphthoyl)indole; some other names: JWH-018 and AM678;
(k) 1-pentyl-3-(2-chlorophenylacetyl)indole; some other names: JWH-203;
(l) 1-pentyl-3-(2-methoxyphenylacetyl)indole; some other names: JWH-250;
(m) 1-pentyl-3-(4-chloro-1-naphthoyl)indole; some other names: JWH-398;
(n) 1-pentyl-3-(4-methyl-1-naphthoyl)indole; some other names: JWH-122;
(o) 1-pentyl-3-[(4-methoxy)-benzoyl]indole; some other names: SR-19 and RCS-4;
(p) 1-pentyl-3-[1-(4-methoxynaphthoyl)]indole; some other names: JWH-081;
(q) 5-(1,1-dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol; some other names: CP-47,497;
(r) 5-(1,1-dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol; some other names: cannabicyclohexanol or CP-47,497 C8-homolog;
(s) Methyl 2-(1-(4-fluorobenzyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate, its optical, positional, and geometric isomers, salts and salts of isomers; some other names: MDMB-FUBINACA;
(t) Methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate, its optical, positional, and geometric isomers, salts and salts of isomers; some other names: 5F-ADB; and 5F-MDMB-PINACA;
(u) Methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3-methylbutanoate, its optical, positional, and geometric isomers, salts and salts of isomers; some other names: 5F-AMB;
(v) Methyl 2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3,3-dimethylbutanoate, its optical, positional, and geometric isomers, salts and salts of isomers; some other names: MDMB-CHMICA; and MMB-CHMINACA;
(w) N-(1-adamantyl)-1-pentyl-1H-indazole-3-carboxamide; some other names: APINACA and AKB48;
(x) N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide, its optical, positional, and geometric isomers, salts and salts of isomers; some other names: ADB-FUBINACA;
(y) N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-carboxamide, its optical, positional, and geometric isomers, salts and salts of isomers; some other names: MAB-CHMINACA; and ADB-CHMINACA;
(z) N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide; some other names: ADB-PINACA;
(aa) N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide; some other names: AB-FUBINACA;
(bb) N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-carboxamide, its optical, positional, and geometric isomers, salts, and salts of isomers; some other names: AB-CHMINACA;
(cc) N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide, its optical, positional, and geometric isomers, salts, and salts of isomers; some other names: AB-PINACA;
(dd) N-(adamantan-1-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide, its optical, positional, and geometric isomers, salts and salts of isomers; some other names: 5F-APINACA; and 5F-AKB48;
(ee) Quinolin-8-yl 1-(5-fluoropentyl)-1H-indole-3-carboxylate; some other names: 5-fluoro-PB-22; and 5F-PB-22;
(ff) Quinolin-8-yl 1-pentyl-1H-indole-3-carboxylate; some other names: PB-22; and QUPIC.
(6) Synthetic cathinones, commonly known as bath salts, and its derivatives. Unless specifically exempted or listed in another schedule, any of the following synthetic cathinone and derivatives, their salts, isomers, and salts of isomers, whenever the existence of these salts, isomers, and salts of isomers is possible within the specific designation:
(a) 1-(naphthalen-2-yl)-2-(pyrrolidin-1-yl)pentan-1-one; some other names: Naphyrone;
(b) 2-(methylamino)-1-phenylpentan-1-one; some other names: Pentedrone;
(c) 3-fluoro-N-methylcathinone; some other names: 3-FMC;
(d) 4-fluoro-N-methylcathinone; some other names: 4-FMC and flephedrone;
(e) 4-methyl-alpha-pyrrolidinopropiophenone; some other names: 4-MePPP;
(f) 4-methyl-N-ethylcathinone; some other names: 4-MEC;
(g) Alpha-pyrrolidinobutiophenone; some other names: Alpha-PBP;
(h) Alpha-pyrrolidinopentiophenone; some other names: Alpha-PVP;
(i) N-Ethylpentylone, its optical, positional, and geometric isomers, salts and salts of isomers; some other names: 1-(1,3-benzodioxol-5-yl)-2-(ethylamino)-pentan-1-one).
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.
AMENDATORY SECTION(Amending WSR 00-01-075, filed 12/13/99)
WAC 246-887-140Schedule II.
The ((board))pharmacy quality assurance commission (commission) finds that the following substances have a high potential for abuse and have currently accepted medical use in treatment in the United States, or currently accepted medical use with severe restrictions and that the abuse of the following substances may lead to severe psychic or psychological dependence. ((The board, therefore,))In addition to the substances listed in RCW 69.50.206, the commission places each of the following drugs and other substances by whatever official name, common or usual name, chemical name, or brand name in Schedule II.
(((a) The drugs and other substances listed in this section, by whatever official name, common or usual name, chemical name, or brand name designated, are included in Schedule II.
(b) Substances. (Vegetable origin or chemical synthesis.) Unless specifically excepted, any of the following substances, except those listed in other schedules, whether produced directly or indirectly by extraction from substances of vegetable origin, or independently by means of chemical synthesis, or by combination of extraction and chemical synthesis:
(1) Opium and opiate, and any salt, compound, derivative, or preparation of opium or opiate, excluding apomorphine, dextrorphan, nalbuphine, naloxone, and naltrexone, and their respective salts, but including the following:
(i) Raw opium;
(ii) Opium extracts;
(iii) Opium fluid;
(iv) Powdered opium;
(v) Granulated opium;
(vi) Tincture of opium;
(vii) Codeine;
(viii) Ethylmorphine;
(ix) Etorphine hydrochloride;
(x) Hydrocodone;
(xi) Hydromorphone;
(xii) Metopon;
(xiii) Morphine;
(xiv) Oxycodone;
(xv) Oxymorphone; and
(xvi) Thebaine.
(2) Any salt, compound, isomer, derivative, or preparation thereof which is chemically equivalent or identical with any of the substances referred to in paragraph (b)(1) of this section, but not including the isoquinoline alkaloids of opium.
(3) Opium poppy and poppy straw.
(4)))(1) Coca leaves and any salt, compound, derivative, or preparation of coca leaves (including cocaine and ecgonine and their salts, isomers, derivatives and salts of isomers and derivatives), and any salt, compound, derivative, or preparation thereof which is chemically equivalent or identical with any of these substances, but not including decocainized coca leaves or extractions which do not contain cocaine or ecgonine; or [123I]ioflupane.
(((5) Methylbenzoylecgonine (cocaine—its salts, optical isomers, and salts of optical isomers).
(6) Concentrate of poppy straw (the crude extract of poppy straw in either liquid, solid, or powder form which contains the phenanthrine alkaloids of the opium poppy).
(c)))(2) Opiates. Unless specifically excepted or unless in another schedule any of the following opiates, including its isomers, esters, ethers, salts((,)) and salts of isomers, esters((,)) and ethers whenever the existence of such isomers, esters, ethers, and salts is possible within the specific chemical designation, dextrorphan and levopropoxyphene excepted:
(((1) Alfentanil;
(2) Alphaprodine;
(3) Anileridine;
(4) Bezitramide;
(5) Bulk dextropropoxyphene (nondosage forms);
(6) Carfentanil;
(7) Dihydrocodeine;
(8) Diphenoxylate;
(9) Fentanyl;
(10) Isomethadone;
(11) Levo-alphacetylmethadol - also known as levo-alpha-acetylmethadol, levomethadyl acetate or LAAM;
(12) Levomethorphan;
(13) Levorphanol;
(14) Metazocine;
(15) Methadone;
(16) Methadone—Intermediate, 4-cyano-2-dimethylamino-4,4-diphenyl butane;
(17) Moramide—Intermediate, 2-methyl-3-morpholino-1,1-diphenylpropane-carboxylic acid;
(18) Pethidine (meperidine);
(19) Pethidine—Intermediate—A,4-cyano-1-methyl-4-phenylpiperidine;
(20) Pethidine—Intermediate—B,ethyl-4-phenylpiperidine-4-carboxylate;
(21) Pethidine—Intermediate—C,1-methyl-4-phenylpiperidine-4-carboxylic acid;
(22) Phenazocine;
(23) Piminodine;
(24) Racemethorphan;
(25) Remifentanil;
(26) Racemorphan;
(27) Sufentanil.
(d) 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:
(1) Amphetamine, its salts, optical isomers, and salts of its optical isomers;
(2) Methamphetamine, its salts, optical isomers, and salts of optical isomers;
(3) Phenmetrazine and its salts;
(4) Methylphenidate.
(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:
(1) Amobarbital;
(2) Glutethimide;
(3) Pentobarbital;
(4) Phencyclidine;
(5) Secobarbital.
(f)))Thiafentanil.
(3) Hallucinogenic substances.
(a) Dronabinol[(-)-delta-9-trans tetrahydrocannabinol] in an oral solution in a drug product approved for marketing by the U.S. Food and Drug Administration;
(b) Nabilone; some other names: (±)-trans-3-(1,1-dimethlheptyl)-6,6a,7,8,10,10a-hexahydro-1-hydroxy-6,6-dimethyl-9H-dibenzol[b,d]pyran-9-one.
(4) Immediate precursors. Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of the following substances: (((1) Immediate precursor to amphetamine and methamphetamine:
(2) Phenylacetone: Some trade or other names phenyl-2-propanone, P2P, benzyl methyl ketone, methyl benzyl ketone.
(3) Immediate precursors to phencyclidine (PCP):
(i) 1-phenylcyclohexylamine;
(ii) 1-piperidinocyclohexanecarbonitrile (PCC).
(g) Hallucinogenic substances.
(1) Nabilone. (Another name for nabilone: (±)-trans-3-(1,1-dimethylheptyl)-6,6a,7,8,10,10a-hexahydro-1-hydroxy-6,6-dimethyl-9H-dibenzo[b,d]pyran-9-one.)))Immediate precursor to fentanyl: 4-anilino-N-phenethyl-4-piperidine (ANPP).
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.
AMENDATORY SECTION(Amending WSR 94-07-105, filed 3/18/94, effective 3/18/94)
WAC 246-887-150Schedule II immediate precursors.
(((1))) The ((board))pharmacy quality assurance commission (commission) finds and designates the following substances as being the principal compound used or produced primarily for use and which are an immediate chemical intermediary used or likely to be used, in the manufacture of a Schedule II controlled substance, the control of which is necessary to prevent, curtail or limit manufacture.
(((2)))(1) Unless specifically excepted or listed in another schedule, any material, compound, mixture or preparation which contains any quantity of the following substances or their salts or isomers having potential for abuse associated with the preparation of controlled substances shall be a Schedule II controlled substance.
(a) Anthranilic acid.
(b) Ephedrine.
(c) Hydriodic acid.
(d) Methylamine.
(e) Phenylacetic acid.
(f) Pseudoephedrine.
(g) Methephedrine.
(h) Lead acetate.
(i) Methyl formamide.
((Provided: That))(2) Any drug or compound containing Ephedrine, or any of its salts or isomers, or Pseudoephedrine, or any of its salts or isomers that are prepared for dispensing or over-the-counter distribution and are in compliance with the Federal Food, Drug and Cosmetic Act and applicable regulations are not controlled substances for the purpose of this section((: And Provided Further, That)).
(3) Any cosmetic containing lead acetate that is distributed in compliance with the Federal Food, Drug and Cosmetic Act and applicable regulations are not controlled substances.
AMENDATORY SECTION(Amending WSR 04-13-162, filed 6/23/04, effective 7/24/04)
WAC 246-887-160Schedule III.
The ((board))pharmacy quality assurance commission (commission) finds that the following substances have a potential for abuse less than the substances listed in Schedule((s)) I under RCW 69.50.204 and WAC 246-887-100 and Schedule II under RCW 69.50.206 and WAC 246-887-140, and have currently accepted medical use in treatment in the United States and that the abuse of the substances may lead to moderate or low physical dependency or high psychological dependency. ((The board, therefore,))In addition to substances listed in RCW 69.50.208, the commission places each of the following drugs and other substances by whatever official name, common or usual name, chemical name, or brand name in Schedule III.
(((a) The drugs and other substances listed in this section, by whatever official name, common or usual name, chemical name, or brand name designated, are included in Schedule III.
(b) 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 (whether optical, position, or geometric), and salts of such isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation:
(1) Those compounds, mixtures, or preparations in dosage unit form containing any stimulant substances listed in Schedule II which compounds, mixtures, or preparations are referred to as excepted compounds in Schedule III as published in 21 C.F.R. 1308.13 (b)(1) as of April 1, 1984, and any other drug of the quantitative composition shown in that list for those drugs or which is the same except that it contains a lesser quantity of controlled substances;
(2) Benzphetamine;
(3) Chlorphentermine;
(4) Clortermine;
(5) Phendimetrazine.
(c)))(1) 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: (((1) Any compound, mixture, or preparation containing:
(i) Amobarbital;
(ii) Secobarbital;
(iii) Pentobarbital;
or any salt thereof and one or more other active medicinal ingredients which are not listed in any schedule;
(2) Any suppository dosage form containing:
(i) Amobarbital;
(ii) Secobarbital;
(iii) Pentobarbital;
or any salt of any of these drugs and approved by the Food and Drug Administration for marketing only as a suppository;
(3) Any substance which contains any quantity of a derivative of barbituric acid, or any salt of a derivative of barbituric acid;
(4) Chlorhexadol;
(5) Ketamine, its salts, isomers, and salts of isomers—some other names for ketamine: (<plus-minus˃)-2-(2- chlorophenyl)-2-(methylamino)-cyclohexanone;
(6) Lysergic acid;
(7) Lysergic acid amide;
(8) Methyprylon;
(9) Sulfondiethylmethane;
(10) Sulfonethylmethane;
(11) Sulfonmethane;
(12) Tiletamine and zolazepam or any salt thereof—some trade or other names for a tiletamine-zolazepam combination product: Telazol some trade or other names for tiletamine: 2-(ethylamino)-2-(2-thienyl) cyclohexanone—some trade or other names for zolazepam: 4-(2-fluorophenyl)-6,8-dihydro-1,3,8-trimethylpyrazolo-[3,4-e] [1,4]diazepin 7 (1H)-one flupyrazapon.
(d) Nalorphine.
(e)))Perampanel, and its salts, isomers, and salt of isomers.
(2) Anabolic steroids. The term "anabolic steroid" means any drug or hormonal substance, chemically and pharmacologically related to testosterone,((())other than estrogens, progestins, and corticosteroids(())), that promotes muscle growth, and includes:
(((1) Boldenone;
(2) Chlorotestosterone;
(3) Clostebol;
(4) Dehydrochlormethyltestosterone;
(5) Dihydrotestosterone;
(6) Drostanolone;
(7) Ethylestrenol;
(8) Fluoxymesterone;
(9) Formebulone (Formebolone);
(10) Mesterolone;
(11) Methandienone;
(12) Methandranone;
(13) Methandriol;
(14) Methandrostenolone;
(15) Methenolone;
(16) Methyltestosterone;
(17) Mibolerone;
(18) Nandrolone;
(19) Norethandrolone;
(20) Oxandrolone;
(21) Oxymesterone;
(22) Oxymetholone;
(23) Stanolone;
(24) Stanozolol;
(25) Testolactone;
(26) Testosterone;
(27) Trenbolone; and
(28)))(a) 17alpha-methyl-3alpha,17beta-dihydroxy-5alpha-androstane;
(b) 17alpha-methyl-3beta,17beta-dihydroxy-5alpha-androstane;
(c) 17alpha-methyl-delta1-dihydrotestosterone (17beta-hydroxy-17alpha-methyl-5alpha-androst-1-en-3-one) some other names: '17-alpha-methyl-1-testosterone';
(d) 19-nor-4,9(10)-androstadienedione (estra-4,9(10)-dine-3,17-dione);
(e) Norandrostenediol:
(i) 19-nor-4-androstenediol (3alpha, 17beta-dihydroxyestr-4-ene);
(ii) 19-nor-4-androstenediol (3beta, 17beta-dihydroxyestr-4-ene);
(iii) 19-nor-5-androstenediol (3beta, 17beta-dihydroxyestr-5-ene);
(iv) 19-nor-5-androstenediol (3alpha, 17beta-dihydroxyestr-5-ene).
(f) Norandrostenedione:
(i) 19-nor-4-androstenedione (estr-4-en-3,17-dione);
(ii) 9-nor-5-androstenedione (estr-5-en-3,17-dione).
(g) Androstanediol:
(i) 3alpha,17beta-dihydroxy-5alpha-androstane;
(ii) 3beta,17beta-dihydroxy-5alpha-androstane.
(h) Boldione (androsta-1,4-dine-3,17-dione);
(i) Desoxymethyltestosterone (17alpha-methyl-5alpha-androst-2-en-17beta-ol); some other names: 'madol'.
(j) Mestanolone (17alpha-methyl-17beta-hydroxy-5alpha-androstan-3-one);
(k) Methasterone (2alpha,17alpha-dimethyl-5alpha-androstan-17beta-ol-3-one);
(l) Prostanozol (17beta-hydroxy-5alpha-androstano[3,2-c]pyrazole).
(m) Any salt, ester, or isomer of a drug or substance described or listed in this paragraph, if that salt, ester, or isomer promotes muscle growth. Except such term does not include an anabolic steroid which is expressly intended for administration through implants to cattle or other nonhuman species and which has been approved by the secretary of health and human services for such administration. If any person prescribes, dispenses, or distributes such steroid for human use such person shall be considered to have prescribed, dispensed, or distributed an anabolic steroid within the meaning of this ((paragraph))subsection.
((The following are implants or pellets which are exempt:
Ingredients
Trade Name
Company
Testosterone Propionate, Oestradiol Benzoate
F-TO
Animal Health Div. Upjohn International Kalamazoo, MI
Trenbolone Acetate
Finaplix-H
Hoechst-Roussel Agri-Vet Co.,
Somerville, NJ
Trenbolone Acetate
Finaplix-S
Hoechst-Roussel Agri-Vet Co.,
Somerville, NJ
Testosterone Propionate,
Estradiol Benzoate
Heifer-oid
Anchor Division Boehringer Ingelheim St. Joseph, MO
Testosterone Propionate,
Estradiol Benzoate
Heifer-oid
Bio-Ceutic Division Boehringer Ingelheim
St. Joseph, MO
Testosterone Propionate,
Estradiol Benzoate
Heifer-oid
Ivy Laboratories, Inc.
Overland Park, KS
Testosterone Propionate,
Estradiol Benzoate
Implus
The Upjohn Co.
Kalamazoo, MI
Trenbolone Acetate,
Estradiol
Revalor-s
Hoechst-Roussel Agri-Vet Co.,
Somerville, NJ
Testosterone Propionate,
Estradiol Benzoate
Synovex H
Syntex Laboratories
Palo Alto, CA
(f)))(3) Exempt anabolic steroid products. The following anabolic steroid products in Table A of this subsection containing compounds, mixtures, or preparations are exempt from the recordkeeping, refill restrictions, and other Controlled Substances Act requirements:
((Ingredients
Trade Name
Company
Testosterone enanthate
90 mg/ml
Estradiol valerate
4 mg/ml
Androgyn L.A.
Forest Pharmaceuticals
St. Louis, MO
Testosterone enanthate
90 mg/ml
Estradiol valerate
4 mg/ml
Andro-Estro 90-4
Rugby Laboratories
Rockville Centre, NY
Testosterone cypionate
50 mg/ml
Estradiol cypionate
2 mg/ml
depANDROGYN
Forest Pharmaceuticals
St. Louis, MO
Testosterone cypionate
50 mg/ml
Estradiol cypionate
2 mg/ml
DEPO-T.E.
Quality Research Laboratories
Carmel, IN
Testosterone cypionate
50 mg/ml
Estradiol cypionate
2 mg/ml
depTESTROGEN
Martica Pharmaceuticals
Phoenix, AZ
Testosterone enanthate
90 mg/ml
Estradiol valerate
4 mg/ml
Duomone
Wintec Pharmaceutical
Pacific, MO
Testosterone cypionate
50 mg/ml
Estradiol cypionate
2 mg/ml
DURATESTRIN
W.E. Hauck
Alpharetta, GA
Testosterone cypionate
50 mg/ml
Esterified cypionate
2 mg/ml
DUO-SPAN II
Primedics Laboratories
Gardena, CA
Esterified estrogens
1.25 mg.
Methyltestosterone
2.5 mg.
Estratest
Solvay Pharmaceuticals
Marietta, GA
Esterified estrogens
0.525 mg.
Methyltestosterone
1.25 mg.
Estratest HS
Solvay Pharmaceuticals
Marietta, GA
Testosterone cypionate
50 mg/ml
Estradiol cypionate
2 mg/ml
PAN ESTRA TEST
Pan American Labs
Covington, LA
Conjugated estrogens
1.25 mg.
Methyltestosterone
10 mg.
Premarin with Methyltestosterone
Ayerst Labs, Inc.
New York, NY
Conjugated estrogens
0.625 mg.
Methyltestosterone
5 mg.
Premarin with Methyltestosterone
Ayerst Labs, Inc.
New York, NY
Testosterone propionate
25 mg
Estradiol benzoate
2.5 mg
Synovex H Pellets
in process
Syntex Animal Health
Palo Alto, CA
Testosterone propionate
10 parts
Estradiol benzoate
1 part
Synovex H Pellets
in process,
granulation
Syntex Animal Health
Palo Alto, CA
Testosterone cypionate
50 mg/ml
Estradiol cypionate
2 mg/ml
Testagen
Clint Pharmaceutical
Nashville, TN
Testosterone cypionate
50 mg/ml
Estradiol cypionate
2 mg/ml
TEST-ESTRO Cypionates
Rugby Laboratories
Rockville Centre, NY
Testosterone cypionate
50 mg/ml
Estradiol cypionate
2 mg/ml
Testosterone Cyp 50 Estradiol Cyp 2
I.D.E.-Interstate
Amityville, NY
Testosterone cypionate
50 mg/ml
Estradiol cypionate
2 mg/ml
Testosterone Cypionate-Estradiol Cypionate Injection
Best Generics
No. Miami Beach,
FL
Testosterone cypionate
50 mg/ml
Estradiol cypionate
2 mg/ml
Testosterone Cypionate-Estradiol Cypionate Injection
Goldline Labs
Ft. Lauderdale FL
Testosterone cypionate
50 mg/ml
Estradiol cypionate
2 mg/ml
Testosterone Cypionate-Estradiol Cypionate Injection
Schein Pharmaceuticals
Port Washington, NY
Testosterone cypionate
50 mg/ml
Estradiol cypionate
2 mg/ml
Testosterone Cypionate-Estradiol Cypionate Injection
Steris Labs, Inc.
Phoenix, AZ
Testosterone enanthate
90 mg/ml
Estradiol valerate
4 mg/ml
Testosterone Enanth-ate-Estradiol Valer-ate Injection
Goldline Labs
Ft. Lauderdale FL
Testosterone enanthate
90 mg/ml
Estradiol valerate
4 mg/ml
Testosterone Enanthate-Estradiol Valerate Injection
Schein Pharmaceuticals
Port Washington, NY
Testosterone enanthate
90 mg/ml
Estradiol valerate
4 mg/ml
Testosterone Enanthate-Estradiol Valerate Injection
Steris Labs, Inc.
Phoenix, AZ
(g) Narcotic drugs. Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation containing limited quantities of any of the following narcotic drugs, or any salts thereof calculated as the free anhydrous base or alkaloid, in limited quantities as set forth in paragraph (e) of this section:
(1) Not more than 1.8 grams of codeine per 100 milliliters or not more than 90 milligrams per dosage unit, with an equal or greater quantity of an isoquinoline alkaloid of opium;
(2) Not more than 1.8 grams of codeine per 100 milliliters or not more than 90 milligrams per dosage unit, with one or more active, nonnarcotic ingredients in recognized therapeutic amounts;
(3) Not more than 300 milligrams of dihydrocodeinone per 100 milliliters or not more than 15 milligrams per dosage unit, with a fourfold or greater quantity of an isoquinoline alkaloid of opium;
(4) Not more than 300 milligrams of dihydrocodeinone per 100 milliliters or not more than 15 milligrams per dosage unit, with one or more active, nonnarcotic ingredients in recognized therapeutic amounts;
(5) Not more than 1.8 grams of dihydrocodeine per 100 milliliters or not more than 90 milligrams per dosage unit, with one or more active, nonnarcotic ingredients in recognized therapeutic amounts;
(6) Not more than 300 milligrams of ethylmorphine per 100 milliliters or not more than 15 milligrams per dosage unit, with one or more active, nonnarcotic ingredients in recognized therapeutic amounts;
(7) Not more than 500 milligrams of opium per 100 milliliters or per 100 grams, or not more than 25 milligrams per dosage unit, with one or more active, nonnarcotic ingredients in recognized therapeutic amounts;
(8) Not more than 50 milligrams of morphine per 100 milliliters or per 100 grams with one or more active, nonnarcotic ingredients in recognized therapeutic amounts.
(h) Any material, compound, mixture, or preparation containing any of the following narcotic drugs or their salts, as set forth below;
(1) Buprenorphine.
(i) Hallucinogenic substances.
(1) Dronabinol (synthetic) in sesame oil and encapsulated in a soft gelatin capsule in a United States Food and Drug Administration approved product. (Some other names for dronabinol [6aR-trans]-6a,7,8,10a-tetrahydro-6,6,9-trimethyl-3-pentyl-6H-dibenzo[b,d]pyran-i-ol, or (-)-delta-9-(trans)-tetrahydrocannabinol.)))
Table A
Trade Name
Company
Form
Ingredients
Quantity
Andro-Estro 90-4
Rugby Laboratories,
Rockville Centre, NY
Vial
Testosterone enanthate; Estradiol valerate
90 mg/mL;
4 mg/mL
Androgyn L.A.
Forest Pharmaceuticals,
St. Louis, MO
Vial
Testosterone enanthate; Estradiol valerate
90 mg/mL;
4 mg/mL
Component E-H in process granulation
Ivy Laboratories, Inc.,
Overland Park, KS
Pail or drum
Testosterone propionate; Estradiol benzoate
10 parts;
1 part
Component E-H in process pellets
Ivy Laboratories, Inc.,
Overland Park, KS
Pail
Testosterone propionate; Estradiol benzoate
25 mg/2.5 mg/pellet
Component TE-S in process granulation
Ivy Laboratories, Inc.,
Overland Park, KS
Pail or drum
Trenbolone acetate; Estradiol USP
5 parts;
1 part
Component TE-S in process pellets
Ivy Laboratories, Inc.,
Overland Park, KS
Pail
Trenbolone acetate; Estradiol USP
120 mg/24 mg/pellet
depANDROGYN
Forest Pharmaceuticals,
St. Louis, MO
Vial
Testosterone cypionate; Estradiol cypionate
50 mg/mL;
2 mg/mL
Depo-Testadiol
The Upjohn Company,
Kalamazoo, MI
Vial
Testosterone cypionate; Estradiol cypionate
50 mg/mL;
2 mg/mL
depTESTROGEN
Martica Pharmaceuticals,
Phoenix, AZ
Vial
Testosterone cypionate; Estradiol cypionate
50 mg/mL;
2 mg/mL
DEPTO-T.E.
Quality Research Pharm.,
Carmel, IN
Vial
Testosterone cypionate; Estradiol cypionate
50 mg/mL;
2 mg/mL
Duomone
Wintec Pharmaceutical,
Pacific, MO
Vial
Testosterone enanthate; Estradiol valerate
90 mg/mL;
4 mg/mL
DUO-SPAN II
Primedics Laboratories,
Gardena, CA
Vial
Testosterone cypionate; Estradiol cypionate
50 mg/mL;
2 mg/mL
DURATESTRIN
W. E. Hauck,
Alpharetta, GA
Vial
Testosterone cypionate; Estradiol cypionate
50 mg/mL;
2 mg/mL
Essian
Pharmaceutics International Inc.,
Hunt Valley, MD
TB
Esterified estrogens; Methyltestosterone
1.25 mg;
2.5 mg
Essian H.S.
Pharmaceutics International Inc.,
Hunt Valley, MD
TB
Esterified estrogens; Methyltestosterone
0.625 mg;
1.25 mg
Esterified Estrogens and Methyltestosterone, USP (0.625 mg/1.25 mg)
Interpharm, Inc.,
TB
Esterified estrogens; Methyltestosterone
0.625 mg;
1.25 mg
Esterified Estrogens and Methyltestosterone, USP (1.25 mg/2.5 mg)
Interpharm, Inc.
TB
Esterified estrogens; Methyltestosterone
1.25 mg;
2.5 mg
Esterified Estrogens/ Methyltestosterone, (0.625 mg/1.25 mg) Tablet
ANDAPharm, LLC
TB
Esterified estrogens; Methyltestosterone
0.625 mg;
1.25 mg
Esterified Estrogens/ Methyltestosterone, (1.25 mg/2.5 mg) Tablet
ANDAPharm, LLC
TB
Esterified estrogens; Methyltestosterone
1.25 mg;
2.5 mg
Estratest
Solvay Pharmaceuticals,
Marietta, GA
TB
Esterified estrogens; Methyltestosterone
1.25 mg;
2.5 mg
Estratest H.S.
Solvay Pharmaceuticals,
Marietta, GA
TB
Esterified estrogens; Methyltestosterone
0.625 mg;
1.25 mg
Masculinizing Feed for Fish (Investigational)
Rangen, Inc.,
Buhl, ID
Plastic Bags
Methyltestosterone
60 mg/kg fish feed
Menogen
Sage Pharmaceuticals,
Shreveport, LA
TB
Esterified estrogens; Methyltestosterone
1.25 mg;
2.5 mg
Menogen HS
Sage Pharmaceuticals,
Shreveport, LA
TB
Esterified estrogens; Methyltestosterone
0.625 mg;
1.25 mg
Methyltestosterone and Esterified Estrogens (2.5 mg/1.25 mg)
Lannett Company, Inc.
TB
Esterified estrogens; Methyltestosterone
1.25 mg;
2.5 mg
Methyltestosterone and Esterified Estrogens (Half Strength) (1.25 mg/0.625 mg)
Lannett Company, Inc.
TB
Esterified estrogens; Methyltestosterone
0.625 mg;
1.25 mg
PAN ESTRA TEST
Pan American Labs;
Covington, LA
Vial
Testosterone cypionate; Estradiol cypionate
50 mg/mL;
2 mg/mL
Premarin with Methyltestosterone
Ayerst Labs Inc.,
New York, NY
TB
Conjugated estrogens; Methyltestosterone
0.625 mg;
5.0 mg
Premarin with Methyltestosterone
Ayerst Labs Inc.,
New York, NY
TB
Conjugated estrogens; Methyltestosterone
1.25 mg;
10.0 mg
Synovex H in-process bulk pellets
Syntex Animal Health,
Palo Alto, CA
Drum
Testosterone propionate; Estradiol benzoate
25 mg;
2.5 mg/pellet
Synovex H in-process granulation
Syntex Animal Health,
Palo Alto, CA
Drum
Testosterone propionate; Estradiol benzoate
10 part;
1 part
Synovex Plus in-process bulk pellets
Fort Dodge Animal Health,
Fort Dodge, IA
Drum
Trenbolone acetate; Estradiol benzoate
25 mg;
3.5 mg/pellet
Synovex Plus in-process granulation
Fort Dodge Animal Health,
Fort Dodge, IA
Drum
Trenbolone acetate; Estradiol benzoate
25 parts;
3.5 parts
Syntest D.S.
Syntho Pharmaceuticals, Inc.
TB
Esterified estrogens; Methyltestosterone
1.25 mg;
2.5 mg
Syntest H.S.
Syntho Pharmaceuticals, Inc.
TB
Esterified estrogens; Methyltestosterone
0.625 mg;
1.25 mg
TEST-ESTRO Cypionates
Rugby Laboratories,
Rockville Centre, NY
Vial
Testosterone cypionate; Estradiol cypionate
50 mg/mL;
2 mg/mL
Testoderm 4 mg/d
Alza Corp.,
Palo Alto, CA
Patch
Testosterone
10 mg
Testoderm 6 mg/d
Alza Corp.,
Palo Alto, CA
Patch
Testosterone
15 mg
Testoderm in-process film
Alza Corp.,
Palo Alto, CA
Sheet
Testosterone
0.25 mg/cm2
Testoderm with Adhesive 4 mg/d
Alza Corp.,
Palo Alto, CA
Patch
Testosterone
10 mg
Testoderm with Adhesive 6 mg/d
Alza Corp.,
Palo Alto, CA
Patch
Testosterone
15 mg
Testoderm with Adhesive in-process film
Alza Corp.,
Palo Alto, CA
Sheet
Testosterone
0.25 mg/cm2
Testosterone Cyp 50 Estradiol Cyp 2
I.D.E.-Interstate,
Amityville, NY
Vial
Testosterone cypionate; Estradiol cypionate
50 mg/mL;
2 mg/mL
Testosterone Cypionate/Estradiol Cypionate Injection
Best Generics,
North Miami Beach, FL
Vial
Testosterone cypionate; Estradiol cypionate
50 mg/mL;
2 mg/mL
Testosterone Cypionate/Estradiol Cypionate Injection
Goldline Labs,
Ft. Lauderdale, FL
Vial
Testosterone cypionate; Estradiol cypionate
50 mg/mL;
2 mg/mL
Testosterone Cypionate/Estradiol Cypionate Injection
Schein Pharmaceuticals,
Port Washington, NY
Vial
Testosterone cypionate; Estradiol cypionate
50 mg/mL;
2 mg/mL
Testosterone Cypionate/Estradiol Cypionate Injection
Steris Labs Inc.,
Phoenix, AZ
Vial
Testosterone cypionate; Estradiol cypionate
50 mg/mL;
2 mg/mL
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.
AMENDATORY SECTION(Amending WSR 10-02-080, filed 1/5/10, effective 2/5/10)
WAC 246-887-170Schedule IV.
The ((board))pharmacy quality assurance commission (commission) finds that the following substances have a low potential for abuse relative to substances in Schedule III under RCW 69.50.208 and WAC 246-887-160, and have currently accepted medical use in treatment in the United States and that the abuse of the substances may lead to limited physical dependence or psychological dependence relative to the substances in Schedule III. ((The board, therefore,))In addition to substances listed in RCW 69.50.210, the commission places each of the following drugs and substances by whatever official name, common or usual name, chemical name, or brand name in Schedule IV.
(((a) The drugs and other substances listed in this section, by whatever official name, common or usual name, chemical name, or brand name designated, are included in Schedule IV.
(b)))(1) Narcotic drugs. Unless specifically ((excepted))exempted or unless listed in another schedule, any material, compound, mixture, or preparation containing any of the following narcotic drugs, or their salts calculated as the free anhydrous base or alkaloid, in limited quantities as set ((forth below:
(1) Not more than 1 milligram of difenoxin and not less than 25 micrograms of atropine sulfate per dosage unit.
(2) Dextropropoxyphene (alpha-(+)-e-dimethylamino-1,2-diphenyl-3-methyl-2 propionoxybutane).
(c)))in this subsection: 2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol, its salts, optical and geometric isomers and salts of these isomers (including tramadol).
(2) Depressants. Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of the following substances, 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:
(((1) Alprazolam;
(2) Barbital;
(3) Bromazepam;
(4) Camazepam;
(5) Carisoprodol;
(6) Chloral betaine;
(7) Chloral hydrate;
(8) Chlordiazepoxide;
(9) Clobazam;
(10) Clonazepam;
(11) Clorazepate;
(12) Clotiazepam;
(13) Cloxazolam;
(14) Delorazepam;
(15) Diazepam;
(16) Estazolam;
(17) Ethchlorvynol;
(18) Ethinamate;
(19) Ethyl loflazepate;
(20) Fludiazepam;
(21) Flunitrazepam;
(22) Flurazepam;
(23) Halazepam;
(24) Haloxazolam;
(25) Ketazolam;
(26) Loprazolam;
(27) Lorazepam;
(28) Lormetazepam;
(29) Mebutamate;
(30) Medazepam;
(31) Meprobamate;
(32) Methohexital;
(33) Methylphenobarbital (mephobarbital);
(34) Midazolam;
(35) Nimetazepam;
(36) Nitrazepam;
(37) Nordiazepam;
(38) Oxazepam;
(39) Oxazolam;
(40) Paraldehyde;
(41) Petrichloral;
(42) Phenobarbital;
(43) Pinazepam;
(44) Prazepam;
(45) Quazepam;
(46) Temazepam;
(47) Tetrazepam;
(48) Triazolam;
(49) Zolpidem.
(d) Fenfluramine. Any material, compound, mixture, or preparation which contains any quantity of the following substances, including its salts, isomers (whether optical, position or geometric), and salts of such isomers, whenever the existence of such salts, isomers and salts of isomers is possible.
(e)))(a) Alfaxalone;
(b) Fospropofol;
(c) Suvorexant.
(3) Any material, compound, mixture, or preparation which contains any quantity of Lorcaserin, including its salts, isomers, and salts of such isomers, wherever the existence of such salts, isomers, and salts of isomers is possible.
(4) 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 (whether optical, position, or geometric), and salts of such isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation:
(((1)))(a) Cathine ((+) - norpseudoephedrine);
(((2) Diethylpropion;
(3) Fencamfamin;
(4) Fenproporex;
(5) Mazindol;
(6) Mefenorex;
(7) Pemoline (including organometallic complexes and chelates thereof);
(8) Phentermine;
(9) Pipradrol;
(10)))(b) SPA ((-)-1-dimethylamino-1,((2-dephenylethane))2-diphenylethane).
(((f)))(5) Other substances. Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of the following substances, including its salts:
(((1) Pentazocine;
(2) Butorphanol.))Eluxadoline (5-[[[(2S)-2-amino-3-[4-aminocarbonyl)-2,6-dimethylphenyl]-1-oxopropyl][(1S)-1-(4-phenyl-1H-imidazol-2-yl)ethyl]amino]methyl]-2-methoxybenzoic acid) (including its optical isomers) and its salts, isomers, and salts of isomers.
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.
AMENDATORY SECTION(Amending WSR 91-18-057, filed 8/30/91, effective 9/30/91)
WAC 246-887-180Schedule V.
The ((board))pharmacy quality assurance commission (commission) finds that the following substances have low potential for abuse relative to substances in Schedule IV under RCW 69.50.210 and WAC 246-887-170 and have currently accepted medical use in treatment in the United States and that the substances have limited physical dependence or psychological dependence liability relative to the substance in Schedule IV. ((The board, therefore,))In addition to the substances listed in RCW 69.50.212, the commission places each of the following drugs and substances by whatever official name, common or usual name, chemical name, or brand name in Schedule V.
(((a) The drugs and other substances listed in this section, by whatever official name, common or usual name, chemical name, or brand name designated, are included in Schedule V.
(b) Narcotic drugs containing nonnarcotic active medicinal ingredients. Any compound, mixture, or preparation containing any of the following narcotic drugs, or their salts calculated as the free anhydrous base or alkaloid, in limited quantities as set forth in this section, which shall include one or more nonnarcotic active medicinal ingredients in sufficient proportion to confer upon the compound, mixture, or preparation, valuable medicinal qualities other than those possessed by the narcotic drug alone:
(1) Not more than 200 milligrams of codeine per 100 milliliters or per 100 grams;
(2) Not more than 100 milligrams of dihydrocodeine per 100 milliliters or per 100 grams;
(3) Not more than 100 milligrams of ethylmorphine per 100 milliliters or per 100 grams;
(4) Not more than 2.5 milligrams of diphenoxylate and not less than 25 micrograms of atropine sulfate per dosage unit;
(5) Not more than 100 milligrams of opium per 100 milliliters or per 100 grams;
(6) Not more than 0.5 milligrams of difenoxin and not less than 25 micrograms of atropine sulfate per dosage unit.))Depressants. Unless specifically exempted or excluded 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:
(1) Brivaracetam ((2S)-2-[(4R)-2-oxo-4-propylpyrrolidin-1-yl] butanamide); also referred to as BRV; UCB-34714; Briviact;
(2) Ezogabine [N-[2-amino-4-(4-fluorobenzylamino)-phenyl]-carbamic acid ethyl ester].
(3) Approved cannabidiol drugs. A drug product in finished dosage formulation that has been approved by the U.S. Food and Drug Administration that contains cannabidiol (2-[1R-3-methyl-6R-(1-methylethenyl)-2-cyclohexen-1-yl]-5-pentyl-1,3-benzenediol) derived from cannabis and no more than 0.1 percent (w/w) residual tetrahydrocannabinols, also known as Epidiolex.
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.
AMENDATORY SECTION(Amending WSR 92-12-035, filed 5/28/92, effective 6/28/92)
WAC 246-887-200Other controlled substance registrantsRequirements.
(1) All persons and firms, except persons exempt from registration, ((shall))must register with the ((board))pharmacy quality assurance commission (commission) in order to legally ((to)) possess or use controlled substances.
(2) Persons or firms which are not classified as pharmacies, wholesalers, manufacturers, or researchers ((shall))will be classified as other controlled substance registrants. Examples of persons or firms in this classification include analytical laboratories, dog handlers/trainers who use dogs for drug detection purposes, school laboratories and other agencies which have a legitimate need to use precursor chemicals as defined in WAC 246-887-150.
(3) The applicant for a controlled substance registration ((shall))must complete and return an application form supplied by the ((board))commission. Either on the form or on an addendum, the applicant ((shall))must list the controlled substances to be used, the purpose for such use, and the names of the persons authorized to access the controlled substances.
(4) All controlled substances ((shall))must be stored in a substantially constructed locked cabinet. The registrant shall maintain records in sufficient detail in order to account for the receipt, use, and disposition of all controlled substances. ((An))The registrant shall inventory ((of)) all controlled substances in the possession of the registrant ((shall be completed)) every two years on the anniversary of the issuances of the registration and shall ((be maintained))maintain the inventory list for two years. The registrant shall return unwanted, outdated, or unusable controlled substances ((shall be returned)) to the source from which it was obtained or surrendered to the Federal Drug Enforcement Administration.
REPEALER
The following sections of the Washington Administrative Code are repealed:
WAC 246-887-110
Adding MPPP to Schedule I.
WAC 246-887-120
Adding PEPAP to Schedule I.
WAC 246-887-130
Adding MDMA to Schedule I.
WAC 246-887-131
Adding Methcathinone to Schedule I.
WAC 246-887-132
Adding Aminorex to Schedule I.
WAC 246-887-133
Adding Alpha-ethyltryptamine to Schedule I.
WAC 246-887-165
Adding Xyrem to Schedule III.
WAC 246-887-190
Adding buprenorphine to Schedule V.