201 KAR 2:116. Substitution of drugs, biologics, and biosimilar products

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); (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 Database of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations (Purple Book) available at https://purplebooksearch.fda.gov/; and (3) Animal drug products considered by the United States Food and Drug Administration to be therapeutically equivalent as published in the Approved Animal Drug Products (Green Book) updated monthly, and available at https://animaldrugsatfda.fda.gov/adafda/views/#/search. 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, 46 th Edition, 2026; (b) "Database of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations" (Purple Book), United States Food and Drug Administration, 2026; and (c) "Approved Animal Drug Products," (Green Book), U.S. Food and Drug Administration, 2026. (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 through Friday, 8 a.m. to 4:30 p.m. and is available online at http://www.fda.gov.