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.)