Title of Rule: WAC 246-887-160 Uniform Controlled Substances Act, Schedule III.

     Purpose: This rule lists the drugs that have been designated as Schedule III controlled substances.

     Statutory Authority for Adoption: RCW 18.64.005, 69.50.201.

     Statute Being Implemented: RCW 69.50.201.

     Summary: The proposed rule amendment will add the drug Buprenorphine to Schedule III of the Uniform Controlled Substances Act.

     Reasons Supporting Proposal: Amending this rule to add Buprenorphine to Schedule III will make state law consistent with federal rules. In October 2002, the federal government published a final rule moving Buprenorphine from Schedule V to Schedule III.

     Name of Agency Personnel Responsible for Drafting, Implementation and Enforcement: Donald H. Williams, 310 Israel Road, Tumwater, WA 98501, 236-4825.

     Name of Proponent: Department of Health, Washington State Board of Pharmacy, governmental.

     Rule is necessary because of federal law, Federal Register, October 7, 2002, Volume 67, Number 194, 21 C.F.R. part 1308.

     Explanation of Rule, its Purpose, and Anticipated Effects: The proposed rule will place Buprenorphine in Schedule III of the Uniform Controlled Substances Act. In October 2002, the federal government moved Buprenorphine from Schedule V to Schedule III. This action was taken after the drug's abuse potential and dependence profile was reevaluated. By moving Buprenorphine to Schedule III, there will be stricter controls placed on the drug. The tighter controls are intended to deter abuse of the drug.

     Proposal Changes the Following Existing Rules: Adds Buprenorphine to the substances listed in Schedule III of the Uniform Controlled Substances Act.

January 2, 2004

D. H. Williams

Executive Director

OTS-6608.1

AMENDATORY SECTION(Amending WSR 03-02-021, filed 12/23/02, effective 1/23/03)

WAC 246-887-160   Schedule III.   The board finds that the following substances have a potential for abuse less than the substances listed in Schedules I and II, 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, places each of the following substances 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 CFR 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) 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) 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) 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.

     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) The following anabolic steroid products 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.)

[Statutory Authority: RCW 69.50.201 and 18.64.005(7). 03-02-021, § 246-887-160, filed 12/23/02, effective 1/23/03; 00-10-113, § 246-887-160, filed 5/3/00. 00-01-075, § 246-887-160, filed 12/13/99. Statutory Authority: RCW 18.64.005. 96-01-032, § 246-887-160, filed 12/12/95, effective 1/12/96; 94-08-098, § 246-887-160, filed 4/6/94, effective 5/7/94. Statutory Authority: RCW 18.64.005. 93-14-038 (Order 376B), § 246-887-160, filed 6/29/93, effective 7/30/93; 93-06-093 (Order 343B), § 246-887-160, filed 3/3/93, effective 4/3/93; 92-04-029 (Order 239B), § 246-887-160, filed 1/28/92, effective 2/29/92. Statutory Authority: RCW 18.64.005 and chapter 18.64A RCW. 91-18-057 (Order 191B), recodified as § 246-887-160, filed 8/30/91, effective 9/30/91. Statutory Authority: RCW 69.50.201. 89-17-023 (Order 226), § 360-36-430, filed 8/8/89, effective 9/8/89. Statutory Authority: RCW 69.50.201, 69.50.203, 69.50.205, 69.50.207, 69.50.209 and 69.50.211. 84-22-062 (Order 190), § 360-36-430, filed 11/7/84.]

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

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