PERMANENT RULES
(Board of Pharmacy)
Date of Adoption: December 19, 2002.
Purpose: Removes dehydroepiandrosterone (DHEA) from the listing of Schedule III of the Uniform Controlled Substances Act. DHEA was erroneously placed in Schedule III in 1996.
Citation of Existing Rules Affected by this Order: Amending WAC 246-887-160.
Statutory Authority for Adoption: RCW 69.50.201.
Other Authority: RCW 18.64.005(7).
Adopted under notice filed as WSR 02-13-060 on June 14, 2002.
Number of Sections Adopted in Order to Comply with Federal Statute: New 0, Amended 1, Repealed 0; Federal Rules or Standards: New 0, Amended 0, Repealed 0; or Recently Enacted State Statutes: New 0, Amended 0, Repealed 0.
Number of Sections Adopted at Request of a Nongovernmental Entity: New 0, Amended 0, Repealed 0.
Number of Sections Adopted on the Agency's Own Initiative: New 0, Amended 1, Repealed 0.
Number of Sections Adopted in Order to Clarify, Streamline, or Reform Agency Procedures: New 0, Amended 0, Repealed 0.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Repealed 0;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Repealed 0;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Repealed 0.
Effective Date of Rule:
Thirty-one days after filing.
December 19, 2002
Donna Dockter
Chair
OTS-5548.1
AMENDATORY SECTION(Amending WSR 00-10-113, filed 5/3/00)
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) ((Dehydroepiandrosterone;
(6))) Dihydrotestosterone;
(((7))) (6) Drostanolone;
(((8))) (7) Ethylestrenol;
(((9))) (8) Fluoxymesterone;
(((10))) (9) Formebulone (Formebolone);
(((11))) (10) Mesterolone;
(((12))) (11) Methandienone;
(((13))) (12) Methandranone;
(((14))) (13) Methandriol;
(((15))) (14) Methandrostenolone;
(((16))) (15) Methenolone;
(((17))) (16) Methyltestosterone;
(((18))) (17) Mibolerone;
(((19))) (18) Nandrolone;
(((20))) (19) Norethandrolone;
(((21))) (20) Oxandrolone;
(((22))) (21) Oxymesterone;
(((23))) (22) Oxymetholone;
(((24))) (23) Stanolone;
(((25))) (24) Stanozolol;
(((26))) (25) Testolactone;
(((27))) (26) Testosterone;
(((28))) (27) Trenbolone; and
(((29))) (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 |
(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.
(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.)
[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.