902 KAR 55:025. Schedule III substances.

 

      RELATES TO: KRS 218A.010-218A.030, 218A.080, 218A.090, 21 C.F.R. 1300.01, 21 C.F.R. 1308.01, 21 C.F.R. 1308.13, 21 C.F.R. 1308.34, 21 U.S.C. 801, 812

      STATUTORY AUTHORITY: KRS 218A.020

      NECESSITY, FUNCTION, AND CONFORMITY: KRS 218A.020(1) authorizes the Cabinet for Health and Family Services to promulgate administrative regulations in order to add, delete, or reschedule substances enumerated in KRS Chapter 218A. KRS 218A.020(3) authorizes the Cabinet for Health and Family Services to promulgate administrative regulations to control substances controlled under federal law. This administrative regulation designates Schedule III controlled substances. This administrative regulation differs from the federal regulation because it designates pentazocine, barbital, methylphenobarbital, and phenobarbital as a Schedule III controlled substance, and the federal regulation designates these substances as Schedule IV controlled substances. The Cabinet for Health and Family Services recognizes that pentazocine and derivatives of barbituric acid or its salts have significant abuse potential, and inclusion on Kentucky’s Schedule III list will help reduce the risk to public health.

 

      Section 1. Amphetamine and Methamphetamine Combination Products. The Cabinet for Health and Family Services designates the following amphetamine and methamphetamine combination products as Schedule III controlled substances:

      (1) A tablet or capsule containing:

      (a) Methamphetamine hydrochloride 1 mg.;

      (b) Conjugated estrogens-equine 0.25 mg.; and

      (c) Methyl testosterone 2.5 mg; and

      (2) A liquid containing, in each 15 cc:

      (a) Methamphetamine hydrochloride 1 mg.;

      (b) Conjugated estrogens-equine 0.25 mg.; and

      (c) Methyl testosterone 2.5 mg.

 

      Section 2. Stimulants. The Cabinet for Health and Family Services designates as Schedule III controlled substances a material, compound, mixture, or preparation which contains any quantity of the following substances having a stimulant effect on the central nervous system, including their salts, isomers (whether optical position or geometric), and salts of those isomers if the existence of the salts, isomers or salts of isomers is possible within the specific chemical designation:

      (1) Benzphetamine;

      (2) Chlorphentermine;

      (3) Clortermine; and

      (4) Phendimetrazine.

 

      Section 3. Depressants. The Cabinet for Health and Family Services designates as Schedule III controlled substances the following:

      (1) A material, compound, mixture, or preparation containing amobarbital, secobarbital, or pentobarbital, or any of their salts, and at least one (1) other active medicinal ingredient which is not a controlled substance;

      (2) A suppository dosage form containing amobarbital, secobarbital, or pentobarbital, or any of their salts, which has been approved by the United States 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 thereof;

      (4) Chlorhexadol;

      (5) Embutramide;

      (6) A drug product containing gamma-hydroxybutyric acid, including its salts, isomers, and salts of isomers, for which an application is approved under section 505 of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. Chapter 9. Gamma hydroxybutyric acid is also known as:

      (a) GHB;

      (b) Gamma-hydroxybutyrate;

      (c) 4-hydroxybutyrate;

      (d) 4-hydroxybutanoic acid;

      (e) Sodium oxybate; or

      (f) Sodium oxybutyrate;

      (7) Ketamine, its salts, isomers, and salts of isomers. Ketamine is also known as (±)-2-(2-chlorophenyl)-2-(methylamino)-cyclohexanone;

      (8) Lysergic acid;

      (9) Lysergic acid amide;

      (10) Methyprylon;

      (11) Perampanel and its salts, isomers, and salts of isomers;

      (12) Sulfondiethylmethane;

      (13) Sulfonethylmethane;

      (14) Sulfonmethane; and

      (15) Tiletamine and zolazepam or any of their salts.

      (a) Tiletamine is also known as 2-(ethylamino)-2-(2-thienyl)-cyclohexanone.

      (b) Zolazepam is also known as 4-(2-fluorophenyl)-6,8-dihydro-1,3,8-trimethylpyrazolo- -diazepin-7(1H)-one, flupyrazapon.

 

      Section 4. Pentazocine Drug Products. The Cabinet for Health and Family Services designates, in addition to the parenteral or injectable form of Pentazocine which is designated as a Schedule III controlled substance by KRS 218A.090(3), a material, compound, mixture, or preparation which contains a quantity of Pentazocine, including its salts.

 

      Section 5. Anabolic Steroids. (1) The Cabinet for Health and Family Services designates as Schedule III Controlled Substances, in addition to those listed in KRS 218.090(5), any material, compound, mixture, or preparation containing any quality of an anabolic steroid as defined by 21 C.F.R. 1300.01, including its salts, esters, and ethers.

      (2) As used in this section, the term anabolic steroid shall not include an anabolic steroid:

      (a) That is expressly intended for administration through implants to cattle or other nonhuman species; and

      (b) That has been approved by the Secretary of the United States Department of Health and Human Services for administration as described in paragraph (a) of this subsection.

      (3) If any person prescribes, dispenses, or distributes a product identified in subsection (2) of this section for human use, the person shall be considered to have prescribed, dispensed, or distributed a Schedule III anabolic steroid.

 

      Section 6. Hallucinogenic Substances. The Cabinet for Health and Family Services designates as Schedule III controlled substances, in addition to those listed in KRS 218A.090, a material, compound, mixture, or preparation which contains a quantity of dronabinol (synthetic) in sesame oil and encapsulated in a soft gelatin capsule in a U.S. Food and Drug Administration approved product. Dronabinol is also known as:

      (1) (6aR-trans)-6a,7,8,10a- tetrahydro-6,6,9-trimethyl-3-pentyl-6H-dibenzo pyran-1-ol; or

      (2) (-)-delta-9-(trans)-tetrahydrocannabinol.

 

      Section 7. Narcotics. (1) The Cabinet for Health and Family Services designates as Schedule III controlled substance any material, compound, mixture, or preparation containing any of the following narcotic drugs, or their salts calculated as the free anhydrous base or alkaloid, in limited quantities as established in this subsection:

      (a) Not more than one and four-fifths (1.8) grams of codeine per 100 milliliters or not more than ninety (90) milligrams per dosage unit with an equal or greater quantity of an isoquinoline alkaloid of opium;

      (b) Not more than one and four-fifths (1.8) grams of codeine per 100 milliliters or not more than ninety (90) milligrams per dosage unit with one (1) or more active, nonnarcotic ingredients in recognized therapeutic amounts;

      (c) Not more than one and four-fifths (1.8) grams of dihydrocodeine per 100 milliliters or not more than ninety (90) milligrams per dosage unit with one (1) or more active nonnarcotic ingredients in recognized therapeutic amounts;

      (d) Not more than 300 milligrams of ethylmorphine per 100 milliliters or not more than fifteen (15) milligrams per dosage unit with one (1) or more active, nonnarcotic ingredients in recognized therapeutic amounts;

      (e) Not more than 500 milligrams of opium per 100 milliliters or per 100 grams or not more than twenty-five (25) milligrams per dosage unit with one (1) or more active, nonnarcotic ingredients in recognized therapeutic amounts; and

      (f) Not more than fifty (50) milligrams of morphine per 100 milliliters or per 100 grams with one (1) or more active, nonnarcotic ingredients in recognized therapeutic amounts.

      (2) The Cabinet for Health and Family Services designates as Schedule III controlled substance a material, compound, mixture, or preparation which contains any quantity of buprenorphine, or its salts.

 

      Section 8. Nalorphine. The Cabinet for Health and Family Services designates as Schedule III controlled substance a material, compound, mixture, or preparation which contains any quantity of nalorphine or its salts. (Recodified from 901 KAR 1:025, 4-14-1982; Am. 11 Ky.R. 1676; eff. 6-4-1985; 13 Ky.R. 1946; eff. 6-9-1987; 15 Ky.R. 865; eff. 11-4-1988; 17 Ky.R. 3283; eff. 6-19-1991; 20 Ky.R. 861; eff. 12-6-1993; 26 Ky.R. 1238; 1562; eff. 2-1-2000; 29 Ky.R. 817; 1277; eff. 10-16-2002; 42 Ky.R. 1977; eff. 3-4-2016.)