Title 201 | Chapter 002 | Regulation 116
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); 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.HISTORY: (16 Ky.R. 1720; 2154; eff. 5-13-1990; 17 Ky.R. 2212; 2725; eff. 4-5-1991; 45 Ky.R. 3453, 46 Ky.R. 412; eff. 8-19-2019.)
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); 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.HISTORY: (16 Ky.R. 1720; 2154; eff. 5-13-1990; 17 Ky.R. 2212; 2725; eff. 4-5-1991; 45 Ky.R. 3453, 46 Ky.R. 412; eff. 8-19-2019.)