| (a) When the pharmacist dispenses a generically equivalent
drug or interchangeable biological product pursuant to the Subchapter
A, Chapter 562 of the Act, the following information shall be noted
on the original prescription or in the pharmacy's data processing
system:
(1) any substitution instructions communicated orally
to the pharmacist by the practitioner or practitioner's agent or a
notation that no substitution instructions were given; and
(2) the name and strength of the actual drug product
dispensed shall be noted on the original or hard-copy prescription
drug order. The name shall be either:
(A) the brand name and strength; or
(B) the generic name or the name of the interchangeable
biological product, strength, and name of the manufacturer or distributor
of such generic drug or interchangeable biological product. (The name
of the manufacturer or distributor may be reduced to an abbreviation
or initials, provided the abbreviation or initials are sufficient
to identify the manufacturer or distributor. For combination drug
products having no brand name, the principal active ingredients shall
be indicated on the prescription.)
(b) If a pharmacist refills a prescription drug order
with a generically equivalent product or interchangeable biological
product from a different manufacturer or distributor than previously
dispensed, the pharmacist shall record on the prescription drug order
the information required in subsection (a) of this section for the
product dispensed on the refill.
(c) If a pharmacy utilizes patient medication records
for recording prescription information, the information required in
subsections (a) and (b) of this section shall be recorded on the patient
medication records.
(d) The National Drug Code (NDC) of a drug or any other
code may be indicated on the prescription drug order at the discretion
of the pharmacist, but such code shall not be used in place of the
requirements of subsections (a) and (b) of this section.
|
| Source Note: The provisions of this §309.6 adopted to be effective June 1, 2002, 27 TexReg 1782; amended to be effective December 6, 2015, 40 TexReg 8790; amended to be effective January 4, 2018, 42 TexReg 7710 |
