This bill amends Iowa law to enhance the inspection and compliance process 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 and not subject to public examination. Additionally, a new section, 155A.15A, outlines a structured process 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 if the infraction remains unaddressed, and prescribing mandatory education if the issue persists after subsequent inspections.

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 specifies that this fine is the only penalty that can be imposed for violations of this section, while still allowing for other forms of damages in tort or contract claims.

Statutes affected:
Introduced: 22.7