Iowa Admin. Code r. 481-552.28 - [Effective 7/16/2025] Pharmacy pilot or demonstration research projects

In accordance with Iowa Code section 155A.47, a pharmacy may submit a pilot or demonstration research project ("pilot project") to the board for approval.

(1) Petition. A petition for a pilot project, including for renewal of a previously approved project, will include:
a. The name, email address, and pharmacist license number of each pharmacist responsible for overseeing the project.
b. The name, address, and telephone number of each specific location, including the pharmacy license number if the location is a pharmacy where the project will be conducted.
c. A detailed summary of the pilot project that includes:
(1) The goals, hypothesis, and objective(s) of the pilot project.
(2) An explanation of the project, including background information or a literature review to support the project, and how it will be conducted.
(3) The time frame for the project, including the start date and study length.
(4) The rule(s) to be waived for the project and a petition for waiver of the rule(s).
(5) Procedures to be used during the project to ensure that public health and safety are not compromised.
(2) Board decision. Upon review of a petition for a pilot project, the board may approve or deny a petition. Project approval:
a. Will be specific for the project requested.
b. Will identify a time period for the project.
c. May include conditions to be satisfied.
(3) Final project report. A final project report will include a written summary of the result(s) of the project and the conclusion(s) drawn from the result(s), which will be submitted to the board within three months of the conclusion or termination of the project.

Notes

Iowa Admin. Code r. 481-552.28
Adopted by IAB June 11, 2025/Volume XLVII, Number 25, effective 7/16/2025

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