(a) The determination of the drug product to be substituted as authorized by the Subchapter A, Chapter 562 of the Act, is the professional responsibility of the pharmacist, and the pharmacist may not dispense any product that does not meet the requirements of the Subchapter A, Chapter 562 of the Act.
(b) Pharmacists shall use as a basis for the determination of generic equivalency or interchangeability as defined in the Subchapter A, Chapter 562 of the Act, most recent edition or supplement of the United States Food and Drug Administration's references (e.g., the Orange Book or Purple Book).
(c) Pharmacists. For drugs not listed in the Orange Book, pharmacists shall use their professional judgment to determine generic equivalency.
(d) 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.

Source Note: The provisions of this §309.7 adopted to be effective June 1, 2002, 27 TexReg 1782; amended to be effective June 12, 2005, 30 TexReg 3210; amended to be effective December 6, 2015, 40 TexReg 8790