The revised USP Chapter <797> on sterile compounding introduces a new role in pharmacy operations: the “designated person” (DP). This individual is responsible for overseeing the performance and operations of the sterile compounding facility and personnel, ensuring compliance with standards related to the preparation of compounded sterile preparations (CSPs). USP <797> mandates that the DP be clearly identified in the pharmacy’s standard operating procedures (SOPs). The revision also requires sterile compounding organizations to create customized SOPs to ensure compliance across various areas, such as garbing procedures, which may differ based on facility layout, and environmental sampling, which depends on both facility layout and compounding category. This article examines the critical role of SOPs, provides practical tips for developing and implementing effective SOPs, and offers guidance on staff training for compliance. It also clarifies the distinctions between policies, procedures, and processes and outlines accreditation expectations for developing and updating SOPs, ensuring personnel competencies, and delivering training aligned with USP <797> standards. This activity is designed for pharmacists and pharmacy technicians.
- Provider:National Home Infusion Association (NHIA)
- Start Date: 2025-01-24 06:00:00
- End Date: 2025-01-24 06:00:00
- Credit Details: Dietetic CPEUs: 1.0 hours
Nursing: 1.0 hours
Pharmacy: 1.0 hours - Commercial Support: No
- Activity Type: Enduring Material
- CME Finder Type: Online Learning
- Measured Outcome: Learner/Team Competence
- Provider Ship: Directly Provided
- Registration: Open to all