SECTION 291.23. Pilot or Demonstration Research Projects for Innovative Applications in the Practice of Pharmacy

(a) Purpose. The purpose of this section is to specify the procedures to be followed in applying for approval of a pilot or demonstration research project for innovative applications in the practice of pharmacy as authorized by §554.011 of the Texas Pharmacy Act (Chapters 551- 566 and 568 - 569, Texas Occupations Code). In reviewing projects, the board will only consider projects that expand pharmaceutical care services which contribute to positive patient outcomes. The board will not consider any project intended only to provide a competitive advantage.

(b) Scope of pilot or demonstration research projects and the board's approval of such projects.

(1) Pilot or demonstration research projects may not:

(A) expand the definition of the practice of pharmacy as provided in the Act; or

(B) include therapeutic substitution or substitution of medical devices used in patient care.

(2) The board's approval of pilot or demonstration research projects may include the granting of an exception to the rules adopted under the Texas Pharmacy Act, but may not include an exception from any law relating to the practice of pharmacy. Such exception to the rules shall be for a specified period of time and such period may not exceed 18 months.

(3) The board may extend the time an exception to a rule is granted as necessary for the board to adopt an amendment or modification of the rule.

(c) Procedures for applying for approval of pilot or demonstration research projects. A person who wishes the board to consider approval of a pilot or demonstration research project shall submit to the board a petition for approval which contains at least the following information:

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

(2) specific location and, if a pharmacy, the pharmacy license number where the proposed pilot or demonstration project will be conducted;

(3) a detailed summary of the proposed pilot or demonstration project which includes:

(A) the goals, hypothesis, and/or objectives of the proposed project;

(B) a full explanation of the project and how it will be conducted;

(C) the time frame for the project including the proposed start date and length of study. Such time frame may not exceed 18 months;

(D) background information and/or literature review to support the proposal;

(E) the rule(s) that will have to be waived in order to complete the project and a request to waive the rule(s);

(F) procedures to be used during the project to ensure that the public's health and safety are not compromised as a result of the rule waiver.

(d) Review and approval or denial of the proposed projects.

(1) On receipt of a petition for approval of a pilot or demonstration research project, board staff shall initially review the petition for completeness and appropriateness. If the petition is incomplete or inappropriate for board consideration for any reason, 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 either approve or deny the petition. If the board approves the petition, the approval:

(A) shall be specific for that project and for a specific time period; and

(B) may include conditions or qualifications, if deemed appropriate by the board.

(6) The board or its representatives shall be allowed to inspect and review the project documentation and site at any time during the review process and after the project is approved.

(e) Presentation of results to the board.

(1) The pharmacist responsible for overseeing the project shall forward to the board a summary of the results of the project and conclusions drawn from the results within three months after completion of the project.

(2) 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 results and make written recommendations to the board regarding the results of the project.

(3) The board will receive the report of the task force at the next regularly scheduled meeting of the board that occurs at least three weeks after the task force has completed its review and issued written recommendations.

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

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

Source Note: The provisions of this §291.23 adopted to be effective October 11, 1996, 21 TexReg 9441; amended to be effective December 27, 2000, 25 TexReg 12690; amended to be effective September 18, 2007, 32 TexReg 6318