Best Practices in Ensuring the Quality of Compounded Sterile IV Preparations: Updates on Legislation, Standards, and Beyond
A Sunday Symposium conducted at the 51st ASHP Midyear Clinical Meeting and Exhibition
Mandalay Bay North Convention Center, Lower Level
Las Vegas, Nevada
Activity Overview
This activity will begin by examining the use of technology in the clean room to meet new patient safety best practice goals. Following this, faculty will review the current legislative landscape with respect to IV sterile compounding, including highlights and implications of FDA draft guidances on the compounding of human drugs. An update on standards, specifically USP Chapter <797>, will provide pharmacists with information they can use to maintain compliance. Resources and answers for questions that pharmacists continue to pose on various aspects of compounding IV sterile preparations that meet the requirements of the Drug Quality and Security Act (DQSA) will also be addressed.
Learning Objectives
After the conclusion of this application-based educational activity, participants should be able to
- Apply the core elements of technology to best practices in patient safety.
- Review key components of recently released FDA draft guidances related to the compounding of human drugs.
- Develop a readiness plan for compliance with the changes to USP Chapter <797> and FDA guidances on pharmacy operations.
- Explain strategies pharmacy directors can use to obtain sufficient staff and resources to meet the requirements of the Drug Quality and Security Act (DQSA).
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Target Audience
This activity was planned to meet the needs of pharmacists in a variety of practice settings, including acute and ambulatory care, managed care organizations, and pharmacy administrators who are responsible for compliance and the quality of compounded drug preparations. The activity is particularly beneficial for pharmacy directors, IV pharmacy supervisors, and pharmacists working in an IV environment.
