SECTION 309.6. Records

(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