| (A) The board and the Texas Medical Board shall establish
a joint committee to recommend to the board a list of narrow therapeutic
index drugs and the rules, if any, by which this paragraph applies
to those drugs. The committee must consist of an equal number of members
from each board. The committee members shall select a member of the
committee to serve as presiding officer for a one year term. The presiding
officer may not represent the same board as the presiding officer's
predecessor.
(B) The board, on the recommendation of the joint committee,
has determined that no drugs shall be included on a list of narrow
therapeutic index drugs as defined in §562.014, Occupations Code.
(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.
(ii) Practitioners may prohibit substitution through
a dispensing directive in compliance with subsection (c) of this section.
(C) The board shall reconsider the contents of the
list if:
(i) 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; or
(ii) any interested person petitions the board to reconsider
the list. If the board receives a petition to include a drug on the
list, the joint committee specified in subparagraph (A) of this paragraph
shall review the request and make a recommendation to the board.
|
| 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; amended to be effective June 8, 2008, 33 TexReg 4311; amended to be effective September 7, 2008, 33 TexReg 7243; amended to be effective December 7, 2010, 35 TexReg 10693; amended to be effective December 6, 2015, 40 TexReg 8790; amended to be effective December 10, 2020, 45 TexReg 8866 |
