SECTION 291.22. Petition to Establish an Additional Class of Pharmacy

(a) Purpose. The purpose of this section is to specify the procedures to be followed in petitioning the board to establish an additional class of pharmacy as authorized by §560.053 of the Texas Pharmacy Act (Chapters 551 - 566 and 568 - 569, Texas Occupations Code). In reviewing petitions, the board will only consider petitions that provide pharmaceutical care services which contribute to positive patient outcomes. The board will not consider any petition intended only to provide a competitive advantage.

(b) Procedures for petitioning the board to establish an additional class of pharmacy. A person who wishes the board to consider establishing an additional class of pharmacy shall submit to the board a petition that contains at least the following information:

(1) name, address, telephone number, and pharmacist's license number of the pharmacist responsible for submitting the petition;

(2) a detailed summary of the additional class of pharmacy which includes:

(A) a description of the type of pharmacy and the pharmaceutical care services provided to the public;

(B) if a pharmacy of this type currently exists, the name, address, and license number of the pharmacy;

(C) a full explanation of the reasons:

(i) the existing classifications of pharmacy licenses are not appropriate for this practice setting; and

(ii) that establishment of a new classification of pharmacy license is necessary to protect the public health, safety, and welfare.

(c) Review and approval or denial of the petition.

(1) On receipt of a petition to establish an additional class of pharmacy, board staff shall initially review the petition for completeness and appropriateness. If the petition is incomplete or inappropriate for board consideration for any reason, board staff shall return the petition with a letter of explanation. Such review shall be completed within 30 working days of receipt of the petition.

(2) Once board staff has determined that the petition is complete and appropriate, a task force composed of board staff, at least one board member and, if deemed necessary, resource personnel appointed by the board president, shall review the petition and make a written recommendation to the board regarding approval. Such recommendation shall be presented to the board at the next regularly scheduled meeting of the board that occurs at least three weeks after completion of the review and written recommendation.

(3) A copy of the recommendation shall be provided to the petitioner and the board at least two weeks prior to the board meeting.

(4) Both the petitioner and a representative of the task force shall be given equal time for presentations to the board.

(5) Upon hearing the presentations, the board shall approve or deny the petition. If the board approves the petition, the board shall direct staff to develop rules for the new class of pharmacy or appoint a task force to work with the staff to assist in developing rules for the new class of pharmacy. The board shall approve or deny any petition to establish an additional class of pharmacy not later than the board meeting following the meeting at which the petition is heard.

Source Note: The provisions of this §291.22 adopted to be effective March 4, 2004, 29 TexReg 1950; amended to be effective September 18, 2007, 32 TexReg 6318