A bill for an act relating to the inspection of compounding pharmacies, and making penalties applicable.

2025-2026 Regular Session Introduced by Doug Campbell

SF 240 mandates stricter inspections and penalties for compounding pharmacies, ensuring compliance with safety standards to protect public health and medication efficacy.

Subcommittee recommends passage.

#drugs #fines #health-relatedprofessions #inspections #pharmacy #prescriptiondrugs

Summary of SF 240: Inspection of Compounding Pharmacies

Bill Information:
- Bill Number: SF 240
- Title: A bill for an act relating to the inspection of compounding pharmacies, and making penalties applicable.
- Status: Subcommittee recommends passage.
- Introduced: February 10, 2025
- Classification: Bill
- Subject Areas: Drugs, Fines, Health-related Professions, Inspections, Pharmacy, Prescription Drugs

Purpose and Intent

The primary purpose of SF 240 is to enhance the regulatory framework governing compounding pharmacies, specifically those engaged in the compounding of nonsterile preparations. The bill aims to ensure compliance with established safety standards and to impose penalties for non-compliance, thereby protecting public health and safety.

Key Provisions

Amendment to Existing Code:

The bill amends Section 22.7 of the Code 2025 to include a new subsection (76) that mandates the maintenance of records related to investigations and remediation of infractions at compounding facilities.

New Section on Inspections and Penalties:

A new section (155A.15A) is introduced, detailing the inspection process for compounding facilities:
- Initial Inspection: If an inspector finds a facility out of compliance with the United States Pharmacopeia General Chapter 795, the pharmacist in charge must be notified to correct the infraction.
- Follow-Up Inspections:
- If the infraction is not corrected within 30 to 90 days of the initial inspection, the inspector will provide comprehensive instructions for correction.
- If the infraction remains uncorrected after another follow-up inspection, mandatory education will be prescribed for the pharmacist in charge.
Penalties: If a facility fails to correct an infraction, the board may impose a fine not exceeding $500, which will be adjusted for inflation.

Impact

Affected Entities: This bill primarily affects compounding pharmacies that prepare nonsterile medications. It places a greater responsibility on pharmacists to ensure compliance with safety standards and mandates educational requirements for those who fail to meet these standards.

Public Health: By enforcing stricter compliance measures and penalties, the bill aims to enhance the safety and efficacy of compounded medications, thereby protecting patients who rely on these products.

Procedural Aspects

The bill was introduced on February 10, 2025, and has already been recommended for passage by a subcommittee on February 12, 2025. The subcommittee meeting took place on February 11, 2025.

This summary provides an overview of SF 240, highlighting its purpose, key provisions, and potential impact on compounding pharmacies and public health.