Current through Register Vol. 50, No. 9, March 1, 2024
RELATES TO:
KRS
217.819
NECESSITY, FUNCTION, AND CONFORMITY:
KRS
217.819(1) requires the
Kentucky Board of Pharmacy to prepare by administrative regulation a drug
product formulary of drugs which should not be interchanged by pharmacists.
This administrative regulation references drug products with active ingredients
or dosage forms that are interchangeable. All other products not referenced as
interchangeable are non-interchangeable.
Section
1. The following have been determined by the board to be
interchangeable:
(1) Drugs, drug products, or
dosage formulations considered by the United States Food and Drug
Administration to be therapeutically equivalent as published in the Approved
Drug Products with Therapeutic Equivalence Evaluations (Orange Book);
and
(2) Biologics drugs, biologics
drug products, or biologics dosage formulations considered by the United States
Food and Drug Administration to be therapeutically equivalent as published in
the Lists of Licensed Biological Products with Reference Product Exclusivity
and Biosimilarity or Interchangeability Evaluations (Purple Book).
Section 2. Incorporation by
Reference.
(1) The following material is
incorporated by reference:
(a) "Approved Drug
Products with Therapeutic Equivalence Evaluations," (Orange Book), U.S. Food
and Drug Administration, 39th Edition, 2019; and
(b) "Lists of Licensed Biological Products
with Reference Product Exclusivity and Biosimilarity or Interchangeability
Evaluations" (Purple Book), United States Food and Drug Administration, June
2019.
(2) This material
may be inspected, copied, or obtained, subject to applicable copyright law, at
the Kentucky Board of Pharmacy, 125 Holmes Street, Suite 300, Frankfort,
Kentucky 40601-8204, Monday throught Friday, 8 a.m. to 4:30 p.m. and is
available online at
http://www.fda.gov.
STATUTORY AUTHORITY:
KRS
217.814(5), (6), (7), (8),
217.819(1)
