Title 201 | Chapter 002 | Regulation 116REG
PROPOSED
This document is not yet current.
PREVIOUS VERSION
The previous document that this document is based upon is available.
BOARDS AND COMMISSIONS
Board of Pharmacy
(Amended at ARRS Committee)
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(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, 46th(b)
"Database(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 throughFILED WITH LRC: March 9, 2026
CONTACT PERSON: Christopher Harlow, Executive Director, Kentucky Board of Pharmacy, 125 Holmes Street, Suite 300, State Office Building Annex, Frankfort, Kentucky 40601, phone (502) 564-7910, fax (502) 696-3806, email Christopher.harlow@ky.gov.
BOARDS AND COMMISSIONS
Board of Pharmacy
(Amended at ARRS Committee)
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, 46th 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.FILED WITH LRC: March 9, 2026
CONTACT PERSON: Christopher Harlow, Executive Director, Kentucky Board of Pharmacy, 125 Holmes Street, Suite 300, State Office Building Annex, Frankfort, Kentucky 40601, phone (502) 564-7910, fax (502) 696-3806, email Christopher.harlow@ky.gov.