| (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 |
