(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.
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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 |