1. (a) Written prescription drug orders.

   1. (1) Required prescription format.

      1. (A) A pharmacist may not dispense a written prescription drug order issued in Texas unless it is ordered on a form containing two signature lines of equal prominence, side by side, at the bottom of the form. Under either signature line shall be printed clearly the words "product selection permitted," and under the other signature line shall be printed clearly the words "dispense as written."

      2. (B) The two signature line requirement does not apply to the following types of prescription drug orders:

         1. (i) prescription drug orders issued by a practitioner in a state other than Texas;
         2. (ii) prescriptions for dangerous drugs issued by a practitioner in the United Mexican States or the Dominion of Canada; or
         3. (iii) prescription drug orders issued by practitioners practicing in a federal facility provided they are acting in the scope of their employment.
      3. (C) Preprinted prescription forms. No prescription form furnished to a practitioner shall contain a preprinted order for a drug product by brand name, generic name, or manufacturer.

   2. (2) Authorization for substitution.

      1. (A) Generic substitution.

         1. (i) A pharmacist may dispense a generically equivalent drug product if:

            1. (I) the generic product cost the patient less than the prescribed drug product;
            2. (II) the patient does not refuse the substitution; and
            3. (III) the prescribing practitioner authorizes the substitution of a generically equivalent product; or
            4. (IV) the practitioner or practitioner's agent does not clearly indicate that the verbal or electronic prescription drug order shall be dispensed as ordered.
         2. (ii) Practitioners shall indicate their dispensing instructions by signing on either the "Dispense as Written" or "Product Selection Permitted" line on the prescription drug order. If the practitioner's signature does not clearly indicate the prescription drug order shall be dispensed as written, the pharmacist may substitute a generically equivalent drug product.
         3. (iii) A pharmacist may not substitute on prescription drug orders identified in paragraph (1)(B) of this subsection unless the practitioner has authorized substitution on the prescription drug order.

         4. (iv) If the practitioner has not authorized substitution on the written prescription drug order, a pharmacist shall not substitute a generically equivalent drug product unless:

            1. (I) the pharmacist obtains verbal or written authorization from the practitioner (such authorization shall be noted on the original prescription drug order); or

            2. (II) the pharmacist obtains written documentation regarding substitution requirements from the State Board of Pharmacy in the state, other than Texas, in which the prescription drug order was issued. The following is applicable concerning this documentation.

               (-a-) The documentation shall state that a pharmacist may substitute on a prescription drug order issued in such other state unless the practitioner prohibits substitution on the original prescription drug order.

               (-b-) The pharmacist shall note on the original prescription drug order the fact that documentation from such other state board of pharmacy is on file.

               (-c-) Such documentation shall be updated yearly.

      2. (B) Substitution of dosage form.

         1. (i) A pharmacist may dispense a dosage form of a drug product different from that prescribed, such as a tablet instead of a capsule or liquid instead of tablets, provided:

            1. (I) the patient consents to the dosage form substitution;
            2. (II) the pharmacist notifies the practitioner of the dosage form substitution; and

            3. (III) the dosage form so dispensed:

               (-a-) contains the identical amount of the active ingredients as the dosage prescribed for the patient;

               (-b-) is not an enteric-coated or time release product;

               (-c-) does not alter desired clinical outcomes;

         2. (ii) Substitution of dosage form may not include the substitution of a product that has been compounded by the pharmacist unless the pharmacist contacts the practitioner prior to dispensing and obtains permission to dispense the compounded product.

2. (b) Oral prescription drug orders.

   1. (1) If a prescription drug order is transmitted to a pharmacist orally, the pharmacist shall note any substitution instructions by the practitioner or practitioner's agent, on the file copy of the prescription drug order. Such file copy may follow the two-line format indicated in subsection (a)(1)(A) of this section, or any other format that clearly indicates the substitution instructions.
   2. (2) If the practitioner's or practitioner's agent does not clearly indicate that the prescription drug shall be dispensed as ordered, the pharmacist may substitute a generically equivalent drug product.

3. (c) Electronic prescription drug orders.

   1. (1) The practitioner or practitioner's agent shall note any substitution instructions on the electronic prescription drug order. Such electronic prescription drug order may follow the two-line format indicated in subsection (a)(1)(A) of this subsection, or any other format that clearly indicates the substitution instructions.
   2. (2) If the practitioner or practitioner's agent does not clearly indicate on the electronic prescription drug order that the prescription shall be dispensed as ordered, the pharmacist may substitute a generically equivalent drug product.

4. (d) Refills.

   1. (1) Original substitution instructions. Refills shall follow the original substitution instructions unless otherwise indicated by the practitioner or practitioner's agent.

   2. (2) Narrow therapeutic index drugs.

      1. (A) The board, in consultation with the Texas State Board of Medical Examiners, has determined that no drugs shall be included on a list of narrow therapeutic index drugs as defined in §562.013, Occupations Code. The board has specified in §309.7 of this title (relating to dispensing responsibilities) that pharmacist shall use as a basis for determining generic equivalency, Approved Drug Products with Therapeutic Equivalence Evaluations and current supplements published by the Federal Food and Drug Administration, within the limitations stipulated in that publication.

         1. (i) Pharmacists may only substitute products that are rated therapeutically equivalent in the Approved Drug Products with Therapeutic Equivalence Evaluations and current supplements.
         2. (ii) Practitioners may prohibit substitution either by signing on the "Dispense as Written" line of a written prescription drug order or by clearly indicating on an oral prescription drug order that the brand name product must be dispensed.
      2. (B) The board shall reconsider the contents of the list if the Federal Food and Drug Administration determines a new equivalence classification which indicates that certain drug products are equivalent but special notification to the patient and practitioner is required when substituting these products.

Source Note:The provisions of this §309.3 adopted to be effective April 23, 1982, 7 TexReg 1479; amended to be effective March 17, 1983, 8 TexReg 773; amended to be effective September 14, 1988, 13 TexReg 4327; amended to be effective March 18, 1991, 16 TexReg 1365; amended to be effective June 1, 1994, 19 TexReg 3929; amended to be effective March 21, 1996, 21 TexReg 2245; amended to be effective September 22, 1998, 23 TexReg 9547; amended to be effective December 9, 1998, 23 TexReg 12301; amended to be effective March 29, 2000, 25 TexReg 2619.