WSR 04-13-162

PERMANENT RULES

DEPARTMENT OF HEALTH


(Board of Pharmacy)

[ Filed June 23, 2004, 9:49 a.m. , effective July 24, 2004 ]


Purpose: The proposed rule will move the drug buprenorphine from Schedule V to Schedule III of the Uniform Controlled Substances Act to be consistent with federal rules. Placing buprenorphine in Schedule III will impose additional controls on the drug to deter abuse of the drug.

Citation of Existing Rules Affected by this Order: Amending WAC 246-887-160.

Statutory Authority for Adoption: RCW 18.64.005.

Other Authority: RCW 69.50.201.

Adopted under notice filed as WSR 04-03-105 on January 21, 2004.

Number of Sections Adopted in Order to Comply with Federal Statute: New 0, Amended 0, Repealed 0; Federal Rules or Standards: New 0, Amended 1, Repealed 0; or Recently Enacted State Statutes: New 0, Amended 0, Repealed 0.

Number of Sections Adopted at Request of a Nongovernmental Entity: New 0, Amended 0, Repealed 0.

Number of Sections Adopted on the Agency's Own Initiative: New 0, Amended 1, Repealed 0.

Number of Sections Adopted in Order to Clarify, Streamline, or Reform Agency Procedures: New 0, Amended 0, Repealed 0.

Number of Sections Adopted Using Negotiated Rule Making: New 0, Amended 0, Repealed 0; Pilot Rule Making: New 0, Amended 0, Repealed 0; or Other Alternative Rule Making: New 0, Amended 1, Repealed 0.

Date Adopted: April 1, 2004.

May 27, 2004

George Roe

Board Chair

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.

Legislature Code Reviser 

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Washington State Code Reviser's Office