- (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 utilize as a basis for the determination of generic equivalency as defined in the Subchapter A, Chapter 562 of the Act, Approved Drug Products With Therapeutic Equivalence Evaluations (Orange Book) and current supplements published by the Federal Food and Drug Administration, within the limitations stipulated in that publication.
- (c) Pharmacists may only substitute products that are rated therapeutically equivalent in the Orange Book and have an "A" rating. "A" rated drug products include but are not limited to, those designated AA, AB, AN, AO, AP, or AT in the Orange Book.
Source Note:The provisions of this §309.7 adopted to be effective June 1, 2002, 27 TexReg 1782.