(a) Substitution notification. Before delivery of a prescription for a generically equivalent drug or interchangeable biological product as authorized by Chapter 562, Subchapter A of the Act, a pharmacist must:
  (1) personally, or through his or her agent or employee inform the patient or the patient's agent that a less expensive generically equivalent drug or interchangeable biological product is available for the brand prescribed; and ask the patient or the patient's agent to choose between the generically equivalent drug or interchangeable biological product and the brand prescribed.
  (2) A pharmacist shall offer the patient or the patient's agent the option of paying for a prescription drug at a lower price instead of paying the amount of the copayment under the patient's prescription drug insurance plan if the price of the prescribed drug is lower than the amount of the patient's copayment.
(b) Exceptions. A pharmacy is not required to comply with the provisions of subsection (a) of this section:
  (1) in the case of the refill of a prescription for which the pharmacy previously complied with subsection (a) of this section with regard to the same patient or patient's agent; or
  (2) if the patient's physician or physician's agent advises the pharmacy that:
    (A) the physician has informed the patient or the patient's agent that a less expensive generically equivalent drug or interchangeable biological product is available for the brand prescribed; and
    (B) the patient or the patient's agent has chosen either the brand prescribed or the less expensive generically equivalent drug or interchangeable biological product.
(c) Notification by pharmacies delivering prescriptions by mail.
  (1) A pharmacy that supplies a prescription by mail is considered to have complied with the provision of subsection (a) of this section if the pharmacy includes on the prescription order form completed by the patient or the patient's agent language that clearly and conspicuously:
    (A) states that if a less expensive generically equivalent drug or interchangeable biological product is available for the brand prescribed, the patient or the patient's agent may choose between the generically equivalent drug or interchangeable biological product and the brand prescribed; and
    (B) allows the patient or the patient's agent to indicate the choice of the generically equivalent drug or interchangeable biological product or the brand prescribed.
  (2) If the patient or patient's agent fails to indicate otherwise to a pharmacy on the prescription order form under paragraph (1) of this subsection, the pharmacy may dispense a generically equivalent drug or interchangeable biological product.
(d) 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; amended to be effective December 4, 2005, 30 TexReg 7875; amended to be effective December 7, 2010, 35 TexReg 10693; amended to be effective December 6, 2015, 40 TexReg 8790