902 KAR 55:040. Excluded over-the-counter products

      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.)

Notation

      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.