(Board of Pharmacy)
M. Kleinberg
Board Chair
OTS-3341.1
AMENDATORY SECTION(Amending WSR 97-21-054, filed 10/13/97,
effective 11/13/97)
WAC 246-887-140
Schedule II.
The board 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, places each of the following substances 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) Coca leaves and any salt, compound, derivative, or preparation of coca leaves, 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.
(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) 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) 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) ((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]pyran-i-ol, or
(-)-delta-9-(trans)-tetrahydrocannabinol.)
(2))) 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.)
[97-21-054, § 246-887-140, filed 10/13/97, effective 11/13/97. Statutory Authority: RCW 18.65.005 and 18.64.005. 94-07-105, § 246-887-140, filed 3/18/94, effective 3/18/94. Statutory Authority: RCW 18.64.005. 92-04-029 (Order 239B), § 246-887-140, 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 § 246-887-140, filed 8/30/91, effective 9/30/91. Statutory Authority: RCW 69.50.201. 89-17-023 (Order 226), § 360-36-420, filed 8/8/89, effective 9/8/89; 86-16-057 (Order 200), § 360-36-420, filed 8/1/86. 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), § 360-36-420, 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.
AMENDATORY SECTION(Amending WSR 96-01-032, filed 12/12/95,
effective 1/12/96)
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 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
(( |
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.
(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 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.