1. (a) General requirements.

   1. (1) In accordance with Chapter 562 of the Act, a pharmacist may dispense a generically equivalent drug product if:

      1. (A) the generic product costs the patient less than the prescribed drug product;
      2. (B) the patient does not refuse the substitution; and
      3. (C) the practitioner does not certify on the prescription form that a specific prescribed brand is medically necessary as specified in a dispensing directive described in subsection (c) of this section.
   2. (2) If the practitioner has prohibited substitution through a dispensing directive in compliance with subsection (c) of this section, a pharmacist shall not substitute a generically equivalent drug product unless the pharmacist obtains verbal or written authorization from the practitioner and notes such authorization on the original prescription drug order.

2. (b) Prescription format for written prescription drug orders.

   1. (1) A written prescription drug order issued in Texas may:

      1. (A) be on a form containing a single signature line for the practitioner; and
      2. (B) contain the following reminder statement on the face of the prescription: "A generically equivalent drug product may be dispensed unless the practitioner hand writes the words 'Brand Necessary' or 'Brand Medically Necessary' on the face of the prescription."
   2. (2) A pharmacist may dispense a prescription that is not issued on the form specified in paragraph (1) of this subsection, however, the pharmacist may dispense a generically equivalent drug product unless the practitioner has prohibited substitution through a dispensing directive in compliance with subsection (c)(1) of this section.

   3. (3) The prescription format specified in paragraph (1) of this subsection does not apply to the following types of prescription drug orders:

      1. (A) prescription drug orders issued by a practitioner in a state other than Texas;
      2. (B) prescriptions for dangerous drugs issued by a practitioner in the United Mexican States or the Dominion of Canada; or
      3. (C) prescription drug orders issued by practitioners practicing in a federal facility provided they are acting in the scope of their employment.
   4. (4) In the event of multiple prescription orders appearing on one prescription form, the practitioner shall clearly identify to which prescription(s) the dispensing directive(s) apply. If the practitioner does not clearly indicate to which prescription(s) the dispensing directive(s) apply, the pharmacist may substitute on all prescriptions on the form.

3. (c) Dispensing directive.

   1. (1) Written prescriptions.

      1. (A) A practitioner may prohibit the substitution of a generically equivalent drug product for a brand name drug product by writing across the face of the written prescription, in the practitioner's own handwriting, the phrase "brand necessary" or "brand medically necessary."

      2. (B) The dispensing directive shall:

         1. (i) be in a format that protects confidentiality as required by the Health Insurance Portability and Accountability Act of 1996 (29 U.S.C. Section 1181 et seq.) and its subsequent amendments; and
         2. (ii) comply with federal and state law, including rules, with regard to formatting and security requirements.
      3. (C) The dispensing directive specified in this paragraph may not be preprinted, rubber stamped, or otherwise reproduced on the prescription form.
      4. (D) After, June 1, 2002, a practitioner may prohibit substitution on a written prescription only by following the dispensing directive specified in this paragraph. Two-line prescription forms, check boxes, or other notations on an original prescription drug order which indicate "substitution instructions" are not valid methods to prohibit substitution, and a pharmacist may substitute on these types of written prescriptions.
      5. (E) A written prescription drug order issued prior to June 1, 2002, but presented for dispensing on or after June 1, 2002, shall follow the substitution instructions on the prescription.

   2. (2) Verbal Prescriptions.

      1. (A) If a prescription drug order is transmitted to a pharmacist orally, the practitioner or practitioner's agent shall prohibit substitution by specifying "brand necessary" or "brand medically necessary." The pharmacists 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 one-line format indicated in subsection (b)(1) of this section, or any other format that clearly indicates the substitution instructions.
      2. (B) If the practitioner's or practitioner's agent does not clearly indicate that the brand name is medically necessary, the pharmacist may substitute a generically equivalent drug product.

      3. (C) To prohibit substitution on a verbal prescription reimbursed through the medical assistance program specified in 42 C.F.R., §447.331:

         1. (i) the practitioner or the practitioner's agent shall verbally indicate that the brand is medically necessary; and
         2. (ii) the practitioner shall mail or fax a written prescription to the pharmacy which complies with the dispensing directive for written prescriptions specified in paragraph (1) of this subsection within 30 days.

   3. (3) Electronic prescription drug orders.

      1. (A) To prohibit substitution, the practitioner or practitioner's agent shall note "brand necessary" or "brand medically necessary" in the electronic prescription drug order.
      2. (B) If the practitioner or practitioner's agent does not clearly indicate in the electronic prescription drug order that the brand is medically necessary, the pharmacist may substitute a generically equivalent drug product.
      3. (C) To prohibit substitution on an electronic prescription drug order reimbursed through the medical assistance program specified in 42 C.F.R., §447.331, the practitioner shall fax a copy of the original prescription drug order which complies with the requirements of a written prescription drug order specified in paragraph (1) of this subsection within 30 days.

   4. (4) Prescriptions issued by out-of-state, Mexican, Canadian, or federal facility practitioners.

      1. (A) The dispensing directive specified in this subsection 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.

      2. (B) A pharmacist may not substitute on prescription drug orders identified in subparagraph (A) of this paragraph unless the practitioner has authorized substitution on the prescription drug order. 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.

            1. (I) 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.
            2. (II) The pharmacist shall note on the original prescription drug order the fact that documentation from such other state board of pharmacy is on file.
            3. (III) Such documentation shall be updated yearly.

4. (d) Substitution of dosage form.

   1. (1) As specified in §562.012 of the Act, a pharmacist may dispense a dosage form of a drug product different from that prescribed, such as tablets instead of capsules or liquid instead of tablets, provided:

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

      3. (C) the dosage form so dispensed:

         1. (i) contains the identical amount of the active ingredients as the dosage prescribed for the patient;
         2. (ii) is not an enteric-coated or time release product; and
         3. (iii) does not alter desired clinical outcomes;
   2. (2) 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.

5. (e) Refills.

   1. (1) Original substitution instructions.

      1. (A) All refills, shall follow the original substitution instructions, unless otherwise indicated by the practitioner or practitioner's agent
      2. (B) Prescriptions issued prior to June 1, 2002, on the two-line form shall follow the substitution instructions on the form.

   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.

         1. (i) The board has specified in §309.7 of this title (relating to dispensing responsibilities) that for drugs listed in the publication, 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. For drugs listed in the publications, 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 through a dispensing directive in compliance with subsection (c) of this section.
      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 June 1, 2002, 27 TexReg 1782; amended to be effective June 12, 2005, 30 TexReg 3210.