201 KAR 2:116.

Drug products with therapeutic problems.

 

      RELATES TO: KRS

217.819

      STATUTORY

AUTHORITY: KRS 217.814(5), (6), (7), (8), 217.819(1)

      NECESSITY,

FUNCTION, AND CONFORMITY: KRS 217.819 directs the Kentucky Board of Pharmacy to

prepare a drug product formulary of drugs which should not be interchanged by

pharmacists. This administrative regulation lists drug products with active

ingredients or dosage forms with potential bioequivalence problems, drugs characteristically

possessing a narrow therapeutic index, or categories of agents for which there

is either documented evidence of inequivalent therapeutic effect or a potential

for it based on differences in bioavailability.

 

      Section 1. The

following have been determined by the board to be noninterchangeable: drugs,

drug products, or dosage formulations considered by the United States Food and

Drug Administration not to be therapeutically equivalent as published in the

"Approved Drug Products with Therapeutic Equivalence Evaluations."

 

      Section 2. The

following have been determined by the board to be noninterchangeable unless the

United States Food and Drug Administration considers them therapeutically

equivalent as published in the "Approved Drug Products with Therapeutic

Equivalence Evaluations":

      (1) Digitalis

glycosides;

      (2)

Antiepileptic drugs;

      (3)

Antiarrhythmic agents;

      (4) Conjugated

estrogens;

      (5) Esterified

estrogens;

      (6) Warfarin

anticoagulants;

      (7) Theophylline

products; and

      (8) Thyroid

preparations.

 

      Section 3.

"Approved Drug Products with Therapeutic Equivalence Evaluations,"

11th Edition, 1991, U.S. Food and Drug Administration is incorporated by

reference. (16 Ky.R. 1720; Am. 2154; eff. 5-13-90; 17 Ky.R. 2212; 2725; eff.

4-5-91.)