201 KAR 2:116.
Drug products with therapeutic problems.
RELATES TO: KRS
AUTHORITY: KRS 217.814(5), (6), (7), (8), 217.819(1)
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
"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.