902 KAR 55:035. Schedule V substances.
RELATES TO: KRS 218A.010-218A.030, 218A.120, 218A.130, 21 C.F.R. 1308.15, 21 U.S.C. 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 to add, delete, or reschedule substances enumerated in KRS Chapter 218A. KRS 218.020(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 V controlled substances.
Section 1. Schedule V Controlled Substances. The Cabinet for Health and Family Services hereby designates as Schedule V controlled substances, in addition to those specified by KRS 218A.130, the following:
(1) Narcotic drugs containing nonnarcotic active medicinal ingredients. A 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 set forth below, which shall include one (1) or more nonnarcotic active medicinal ingredients in sufficient proportion to confer upon the compound, mixture, or preparation valuable medicinal qualities other than those possessed by narcotic drugs alone:
(a) Not more than 100 milligrams of dihydrocodeine per 100 milliliters or per 100 grams;
(b) Not more than 100 milligrams of ethylmorphine per 100 milliliters or per 100 grams;
(c) Not more than two and five-tenths (2.5) milligrams of diphenoxylate hydrochloride and not less than twenty-five (25) micrograms of atropine sulfate per dosage unit;
(d) Not more than 100 milligrams of opium per 100 milliliters or per 100 grams; and
(e) Not more than five-tenths (0.5) milligram of difenoxin and not less than twenty-five (25) micrograms of atropine sulfate per dosage unit.
(2) Stimulants. A material, compound, mixture, or preparation which contains any quantity of the following substance having a stimulant effect on the central nervous system, including its salts, isomers, and salts of isomers: Pyrovalerone.
(3) Depressants. A material, compound, mixture, or preparation which contains any quantity of the following substance having a depressant effect on the central nervous system, including its salts: Pregabalin.
Section 2. Dispensing Without Prescription. A controlled substance listed in Schedule V which is not a prescription drug under the Federal Food, Drug, and Cosmetic Act, may be dispensed by a pharmacist without a prescription to a purchaser at retail, if:
(1) The medicinal preparation contains in addition to the controlled substances, some drug or drugs conferring upon it medicinal qualities other than those possessed by the controlled substances alone;
(2) Not more than 240cc (eight (8) ounces) nor more than forty-eight (48) dosage units of any such controlled substance containing opium, is dispensed at retail to the same purchaser in any given forty-eight (48) hour period;
(3) The labeling and packaging is in accordance with the requirements of the federal and state Food, Drug, and Cosmetic Act and the United States Pharmacopeia;
(4) The preparation is dispensed or sold in good faith as a medicine, and not for the purpose of evading the provisions of KRS Chapter 218A;
(5) The preparation is not displayed in areas open to the public;
(6) The dispensing is made only by a pharmacist, and not by a nonpharmacist employee even if under the supervision of a pharmacist. Although, after the pharmacist has fulfilled his professional and legal responsibilities set forth in this section, the actual cash, credit transaction, or delivery, may be completed by a nonpharmacist;
(7) The purchaser is at least eighteen (18) years of age;
(8) The pharmacist requires every purchaser of a controlled substance under this section, not known to him, to furnish suitable identification, including proof of age if appropriate; and
(9) The dispensing of exempt controlled substances under this administrative regulation is recorded in a bound book, maintained by the pharmacist, which shall contain the name and address of the purchaser, the name and quantity of controlled substance purchased, the date of each purchase, and the name or initials of the pharmacist who dispensed the substance to the purchaser. The book shall be maintained in accordance with the recordkeeping requirements of KRS 218A.200. (Recodified from 901 KAR 1:032, 4-14-82; Am. 11 Ky.R. 1679; eff. 6-4-85; 15 Ky.R. 868; eff. 11-4-88; 20 Ky.R. 660; eff. 10-21-93; 29 Ky.R. 1407; eff. 1-15-2003; 33 Ky.R. 1438; 1821; eff. 2-2-07.)