(a) Substitution notification. A pharmacist who selects a generically equivalent drug product as authorized by Subchapter A, Chapter 562 of the Act shall:
- (1) personally, or through his or her agent or employee and prior to delivery of a generically equivalent drug product, inform the patient or the patient's agent that a less expensive generically equivalent drug product has been substituted for the brand prescribed and the patient's or the patient's agent's right to refuse such substitution; or
- (2) cause to be displayed, in a prominent place that is in clear public view where prescription drugs are dispensed, a sign in block letters not less than one inch in height that reads, in both English and Spanish: TEXAS LAW ALLOWS A LESS EXPENSIVE GENERICALLY EQUIVALENT DRUG TO BE SUBSTITUTED FOR CERTAIN BRAND NAME DRUGS UNLESS YOUR PHYSICIAN DIRECTS OTHERWISE. YOU HAVE A RIGHT TO REFUSE SUCH SUBSTITUTION. CONSULT YOUR PHYSICIAN OR PHARMACIST CONCERNING THE AVAILABILITY OF A SAFE, LESS EXPENSIVE DRUG FOR YOUR USE. LAS LEYES DE TEXAS PERMITEN QUE SE SUSTITUYA UNA MEDICINA GENERICAMENTE EQUIVALENTE Y MENOS CARA POR CIERTAS MEDICINAS DE MARCA RECONOCIDA A MENOS QUE SU MEDICO INSTRUYA DE OTRA MANERA. UD. TIENE EL DERECHO DE REHUSAR DICHA SUSTITUCION. CONSULTE A SU MEDICO O FARMACEUTICO CON REFERENCIA A LA DISPONIBILIDAD DE UNA MEDICINA SEGURA Y MENOS CARA PARA SU USO. By the display of a sign as set out in this paragraph, a pharmacy shall be deemed in compliance with this subsection. Only one sign is required to be displayed in a pharmacy in order to be in compliance with this subsection.
- (3) A pharmacist complies with the requirements of this subsection if an employee or agent of the pharmacist notifies a purchaser as required by paragraph (1) of this subsection. The patient or patient's agent shall have the right to refuse substitution.
- (b) Inpatient notification exemption. Institutional pharmacies shall be exempt from the labeling provisions and patient notification requirements of §562.006 and §562.009 of the Act, as respects drugs distributed pursuant to medication orders.
Source Note:The provisions of this §309.4 adopted to be effective June 1, 2002, 27 TexReg 1782.