| (a) General requirements. In accordance with Chapter
562 of the Act, a pharmacist may dispense a generically equivalent
drug or interchangeable biological product if:
(1) the generic drug or interchangeable biological
product costs the patient less than the prescribed drug product;
(2) the patient does not refuse the substitution; and
(3) 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.
(b) Prescription format for written prescription drug
orders.
(1) A written prescription drug order issued in Texas
may:
(A) be on a form containing a single signature line
for the practitioner; and
(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) 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
or interchangeable biological product unless the practitioner has
prohibited substitution through a dispensing directive in compliance
with subsection (c)(1) of this section.
(3) The prescription format specified in paragraph
(1) of this subsection does not apply to the following types of prescription
drug orders:
(A) prescription drug orders issued by a practitioner
in a state other than Texas;
(B) prescriptions for dangerous drugs issued by a practitioner
in the United Mexican States or the Dominion of Canada; or
(C) prescription drug orders issued by practitioners
practicing in a federal facility provided they are acting in the scope
of their employment.
(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.
(c) Dispensing directive.
(1) General requirements. The following is applicable
to the dispensing directive outlined in this subsection.
(A) When a prescription is issued for a brand name
product that has no generic equivalent product, the pharmacist must
dispense the brand name product. If a generic equivalent or interchangeable
biological product becomes available, a pharmacist may substitute
the generically equivalent or interchangeable biological product unless
the practitioner has specified on the initial prescription that the
brand name product is medically necessary.
(B) If the practitioner has prohibited substitution
through a dispensing directive in compliance with this subsection,
a pharmacist shall not substitute a generically equivalent drug or
interchangeable biological product unless the pharmacist obtains verbal
or written authorization from the practitioner, notes such authorization
on the original prescription drug order, and notifies the patient
in accordance with §309.4 of this title (relating to Patient
Notification).
(2) Written prescriptions.
(A) A practitioner may prohibit the substitution of
a generically equivalent drug or interchangeable biological 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."
(B) The dispensing directive shall:
(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
(ii) comply with federal and state law, including rules,
with regard to formatting and security requirements.
(C) The dispensing directive specified in this paragraph
may not be preprinted, rubber stamped, or otherwise reproduced on
the prescription form.
(D) 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.
(3) Oral Prescriptions.
(A) If a prescription drug order is transmitted orally,
and the practitioner or practitioner's agent prohibited substitution
by specifying "brand necessary" or "brand medically necessary," a
notation of any substitution instructions by the practitioner or practitioner's
agent shall be made 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.
(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 or interchangeable
biological product.
(C) To prohibit substitution on an oral prescription
reimbursed through the medical assistance program specified in 42
C.F.R., §447.331:
(i) the practitioner or the practitioner's agent shall
orally indicate that the brand is medically necessary; and
(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.
(4) Electronic prescription drug orders.
(A) To prohibit substitution, the practitioner or practitioner's
agent shall clearly indicate substitution instructions in the electronic
prescription drug order.
(B) If the practitioner or practitioner's agent does
not indicate or does not clearly indicate in the electronic prescription
drug order that the brand is necessary, the pharmacist may substitute
a generically equivalent drug or interchangeable biological product.
(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 comply with state
and federal laws.
(5) Prescriptions issued by out-of-state, Mexican,
Canadian, or federal facility practitioners.
(A) The dispensing directive specified in this subsection
does not apply to the following types of prescription drug orders:
(i) prescription drug orders issued by a practitioner
in a state other than Texas;
(ii) prescriptions for dangerous drugs issued by a
practitioner in the United Mexican States or the Dominion of Canada;
or
(iii) prescription drug orders issued by practitioners
practicing in a federal facility provided they are acting in the scope
of their employment.
(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:
(i) the pharmacist obtains verbal or written authorization
from the practitioner (such authorization shall be noted on the original
prescription drug order); or
(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.
(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.
(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.
(III) Such documentation shall be updated yearly.
(d) Refills.
(1) Original substitution instructions. All refills
shall follow the original substitution instructions unless otherwise
indicated by the practitioner or practitioner's agent.
(2) Narrow therapeutic index drugs.
Cont'd... |
