WSR 99-16-116

DEPARTMENT OF HEALTH


(Board of Pharmacy)

[ Filed August 4, 1999, 11:28 a.m. ]

Reviser's note: The following material has not been adopted under the Administrative Procedure Act, RCW 34.05, but has been filed in the office of the code reviser and is published in the Register exactly as filed.



NOTICE OF INTENT TO ADOPT FEDERAL SCHEDULING

ORDER - RESCHEDULING OF DRONABINOL FROM

SCHEDULE II TO SCHEDULE III



NOTICE


The Washington State Board of Pharmacy intends to adopt the July 2, 1999, action of the Drug Enforcement Administration (DEA) to reschedule Dronabinol from Schedule II to Schedule III of the Uniform Controlled Substances Act.

THIS RULE IS BEING PROPOSED TO BE ADOPTED USING AN EXPEDITED RULE-MAKING PROCESS THAT WILL ELIMINATE THE NEED FOR THE AGENCY TO HOLD PUBLIC HEARINGS, PREPARE A SMALL BUSINESS ECONOMIC IMPACT STATEMENT, OR PROVIDE RESPONSES TO THE CRITERIA FOR A SIGNIFICANT LEGISLATIVE RULE. IF YOU OBJECT TO THIS RULE BEING ADOPTED USING THE EXPEDITED RULE-MAKING PROCESS, YOU MUST EXPRESS YOUR OBJECTIONS IN WRITING AND THEY MUST BE SENT TO Donald H. Williams, Executive Director, Washington State Board of Pharmacy, P.O. Box 47863, Olympia, WA 98504-7863, or fax (360) 586-4359.

RCW 69.50.201(e) allows the Board of Pharmacy to directly adopt DEA scheduling orders without the need for the issuance of a Notice of Proposed Rule under RCW 34.05. The board will use the expedited rule process allowed for under RCW 69.50.201 provided no objection is made to the board's adoption of the DEA scheduling order.

The proposed rule will be adopted by the Board of Pharmacy on October 2, 1999, provided no objection to the rule is received. The board will accept comments up to September 30, 1999.

Donald H. Williams

Executive Director



[AMENDATORY SECTION (Amending Order WSR 96-01-032, filed 12/12/95)]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) Lysergic acid;

(6) Lysergic acid amide;

(7) Methyprylon;

(8) Sulfondiethylmethane;

(9) Sulfonethylmethane;

(10) Sulfonmethane;

(11) 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) Dehydroepiandrosterone;

(6) Dihydrotestosterone;

(7) Drostanolone;

(8) Ethylestrenol;

(9) Fluoxymesterone;

(10) Formebulone (Formebolone);

(11) Mesterolone;

(12) Methandienone;

(13) Methandranone;

(14) Methandriol;

(15) Methandrostenolone;

(16) Methenolone;

(17) Methyltestosterone;

(18) Mibolerone;

(19) Nandrolone;

(20) Norethandrolone;

(21) Oxandrolone;

(22) Oxymesterone;

(23) Oxymetholone;

(24) Stanolone;

(25) Stanozolol;

(26) Testolactone;

(27) Testosterone;

(28) Trenbolone; and

(29) 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 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 Cypoinate 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) hallucinogenic substances

(i) Dronabinol (synthetic) in sesame oil and encapsulated in a soft gelatin capsule in a United States Food and Drug Administration approved drug product. (Some other names for dronabinol [6aR-trans]-6a,7,8,10a-tetrahydro-6,6,9-trimethyl-3-pentyl-6H-dibenzo[b,d]pyrani-ol, or (-)-delta-9-(trans)-tetrahydrocannabinol.)

[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 RCW 18.64A.  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, RCW 69.50.203, RCW 69.50.205, RCW 69.50.207, RCW 69.50.209 and RCW 69.50.211.  84-22-062 (Order 190), 360-36-430, filed 11/7/84.]

Reviser's note: The bracketed material preceding the section above was supplied by the code reviser's office.

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

Reviser's note: RCW 34.05.395 requires the use of underlining and deletion marks to indicate amendments to existing rules. The rule published above varies from its predecessor in certain respects not indicated by the use of these markings.