This bill amends the Code of Iowa to enhance the inspection and compliance processes for compounding pharmacies that engage in the preparation of nonsterile medications. It introduces a new subsection to Section 22.7, which designates records related to the investigation and remediation of infractions at these facilities as confidential. Additionally, a new section, 155A.15A, outlines a structured approach for inspectors from the board of pharmacy to follow when they identify compliance issues with the United States Pharmacopeia General Chapter 795. The process includes notifying the pharmacist in charge of any infractions, providing comprehensive instructions for correction upon subsequent inspections, and mandating education if the infractions remain unaddressed.

Furthermore, the bill establishes a penalty framework for compounding facilities that fail to correct identified infractions. If a facility does not rectify an infraction after the prescribed inspections, the board may impose a single fine of up to $500, which will be adjusted for inflation every two years. Importantly, the bill clarifies that this penalty is the sole financial consequence for violations under this section, while also preserving the right to pursue damages through other legal avenues.

Statutes affected:
Introduced: 22.7