902 KAR 55:040.
Excluded over-the-counter products.
RELATES TO: KRS
218A.020-218A.130
STATUTORY
AUTHORITY: KRS 194.050, 211.090, 218A.020, 218A.250, EO-96-862
NECESSITY,
FUNCTION, AND CONFORMITY: Executive Order 96-862, effective July 2, 1996,
reorganizes the Cabinet for Human Resources, establishes and creates the
Cabinet for Health Services, changes the name of the Department for Health
Services to Department for Public Health, and places the Department for Public
Health and its programs under the Cabinet for Health Services. KRS 218A.020(4)
requires the Cabinet for Health Services to exclude products that may be
lawfully sold over the counter (without prescription) from the provisions of
KRS Chapter 218A. The purpose of this administrative regulation is to exclude
certain over-the-counter products from the provisions of KRS Chapter 218A.
Section 1.
Excluded Over-the-counter Products. The Cabinet for Health Services excludes
the following products from the provisions of KRS Chapter 218A:
(1) Asthma-Ese®,
tablet, NDC code 00349-2018: phenobarbital 8.10 mg.;
(2) Azma-Aids®,
tablet, NDC code 00367-3153: phenobarbital 8 mg;
(3)
Bronkolixir®, elixir, NDC code 00057-1004: phenobarbital 0.8 mg/ml;
(4) Bronkotabs®,
tablet, NDC code 00057-1005: phenobarbital 8 mg.;
(5) Choate's Leg
Freeze®, liquid: chloral hydrate 246.67 mg/ml.;
(6) Guiaphed®
Elixir, elixir, NDC code 00182-1377: phenobarbital 4 mg/ml;
(7) Primatene
(P-tablets)®, tablet, NDC code 0573-2940: phenobarbital 8 mg.;
(8) Tedral®,
tablet, NDC code 00071-1230: phenobarbital 8 mg.;
(9) Tedral
Elixir®, elixir, NDC code 00071-0242: phenobarbital 40 mg./ml.;
(10) Tedral
S.A.®, tablet, NDC code 00071-1231: phenobarbital 8 mg.;
(11) Tedral
Suspension®, suspension, NDC code 00071-0237: phenobarbital 80 mg./ml.;
(12) Tedrigen®,
tablet, NDC code 00182-0134: phenobarbital 8 mg.;
(13) Theophed®,
tablet, NDC code 00719-1945: phenobarbital 8 mg; and
(14) Vicks
Inhaler®, inhaler, NDC code 23900-0010: l-Desoxyephedrine 113 mg. (Recodified
from 901 KAR 1:040, 4-14-82; Am. 11 Ky.R. 1679; eff. 6-4-85; 18 Ky.R. 1471;
eff. 2-7-92; 19 Ky.R. 1665; 2251; eff. 3-17-93; 20 Ky.R. 863; eff. 12-6-93; 21
Ky.R. 1393; eff. 1-9-95; 23 Ky.R. 3985; 24 Ky.R. 126; eff. 7-16-97.)