Bill
Bill > SF240
IA SF240
IA SF240A bill for an act relating to the inspection of compounding pharmacies, and making penalties applicable.
summary
Introduced
02/10/2025
02/10/2025
In Committee
02/10/2025
02/10/2025
Crossed Over
Passed
Dead
Introduced Session
91st General Assembly
Bill Summary
This bill relates to the investigation and remediation of infractions at compounding facilities (facility) engaging in the compounding of nonsterile preparations. The bill requires an inspector employed by the board of pharmacy (board) who discovers during the course of an inspection that a facility engaging in the compounding of nonsterile preparations is out of compliance with the United States pharmacopeia general chapter 795 to notify the pharmacist in charge of the infraction. If an inspector discovers at a subsequent inspection that the infraction has not been corrected, the bill requires the inspector to provide comprehensive instruction regarding the infraction and the correction of the infraction to the pharmacist in charge. If an inspector discovers at a third inspection that an infraction has not been corrected, the bill requires the inspector to prescribe mandatory education for the correction of the infraction to the pharmacist in charge. The bill allows the board to impose a single fee of not more than $500, adjusted for inflation, on a facility that fails to correct an infraction as provided in the bill. The bill makes records relating to the investigation and remediation of infractions pursuant to the bill confidential records that are not subject to examination by the public.
AI Summary
This bill establishes a multi-step process for addressing compliance issues in compounding pharmacies that prepare nonsterile medications. Specifically, if a board of pharmacy inspector discovers during an inspection that a compounding facility is not following the United States Pharmacopeia (USP) general chapter 795 guidelines, the inspector must first notify the pharmacist in charge of the infraction. If the same infraction is not corrected within 30-90 days during a subsequent inspection, the inspector must provide comprehensive instructions about the violation. If the infraction remains uncorrected during a third inspection within 30-90 days, the inspector must require mandatory education for the pharmacist in charge. The bill also allows the pharmacy board to impose a single fine of up to $500 (adjusted for inflation every two years) for facilities that fail to correct identified infractions. Additionally, the bill makes records related to these investigations confidential and not subject to public examination, protecting the privacy of the facilities during the compliance process. The goal of these provisions is to ensure proper pharmaceutical compounding practices and provide a structured approach to addressing and remedying regulatory violations.
Committee Categories
Health and Social Services, Justice
Sponsors (1)
Last Action
Subcommittee recommends passage. (on 02/12/2025)
Official Document
bill text
bill summary
Loading...
bill summary
Loading...
bill summary
| Document Type | Source Location |
|---|---|
| State Bill Page | https://www.legis.iowa.gov/legislation/BillBook?ga=91&ba=SF240 |
| BillText | https://www.legis.iowa.gov/docs/publications/LGI/91/attachments/SF240.html |
Loading...