WSR 19-06-068
PERMANENT RULES
DEPARTMENT OF HEALTH
(Pharmacy Quality Assurance Commission)
[Filed March 5, 2019, 11:36 a.m., effective April 5, 2019]
Effective Date of Rule: Thirty-one days after filing.
Purpose: Chapter 246-887 WAC, Regulations implementing the Uniform Controlled Substance Act, the pharmacy quality assurance commission (commission) approved amendments to chapter 246-887 WAC to update citations to federal rules and laws adopted by the commission. Additionally, the commission approved to change the format of the schedules. The rule removes substances already established in chapter
69.50 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 the 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 were approved to clarify the language in rule and make the requirements more understandable. The commission approved the repeal of 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 appropriate schedules. This rule addresses a petition received by the commission from the attorney general's office, office of consumer protection, to add substances to Schedule I, and a petition from Greenwich BioSciences to add Epidiolex to Schedule V.
Citation of Rules Affected by this Order: Repealing 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; and amending WAC 246-887-020, 246-887-080, 246-887-090, 246-887-100, 246-887-140, 246-887-150, 246-887-160, 246-887-170, 246-887-180, and 246-887-200.
Statutory Authority for Adoption: RCW
69.50.201.
Adopted under notice filed as WSR 18-22-115 on November 6, 2018.
Number of Sections Adopted in Order to Comply with Federal Statute: New 0, Amended 0, Repealed 0; Federal Rules or Standards: New 0, Amended 0, Repealed 0; or Recently Enacted State Statutes: New 0, Amended 0, Repealed 0.
Number of Sections Adopted at the Request of a Nongovernmental Entity: New 0, Amended 0, Repealed 0.
Number of Sections Adopted on the Agency's own Initiative: New 0, Amended 6, Repealed 8.
Number of Sections Adopted in Order to Clarify, Streamline, or Reform Agency Procedures: New 0, Amended 4, Repealed 0.
Number of Sections Adopted using Negotiated Rule Making: New 0, Amended 0, Repealed 0; Pilot Rule Making: New 0, Amended 0, Repealed 0; or Other Alternative Rule Making: New 0, Amended 10, Repealed 8.
Date Adopted: December 13, 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 registrants—Requirements.
(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. |