Current through Register Vol. XLI, No. 50, December 13, 2024
Section 15-17-7 - Dispensing Responsibilities7.1. The determination of the drug product to be substituted as authorized by West Virginia Code of State Rules §15-17 et seq. is the professional responsibility of the pharmacist, and the pharmacist may not dispense any product that does not meet the requirements of the West Virginia Code of State Rules §15-17 et seq.7.2. Pharmacists shall use as a basis for the determination of interchangeability as defined in West Virginia Code of State Rules §15-17 et seq., most recent edition or supplement of the United States Food and Drug Administration's references (e.g. the Purple Book).7.3. Pharmacists shall use Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations (Purple Book) and current supplements published by the Federal Food and Drug Administration, within the limitations stipulated in that publication, to determine biosimilarity to or interchangeability with a reference biological product.