Developing an assessment workflow for 505(b)(2) products within the outpatient setting withina large academic medical center

Key Points

• The aim is to create an effective assessment workflow for managing 505(b)(2) products in academic outpatient settings.
• Developed structured tools, including a crosswalk comparison tool and a prioritization matrix.
• Implemented an interdisciplinary approach to identify and monitor 505(b)(2) medications.
• Adapted the model to accommodate the complexities of the regulatory environment.
• The developed tools provided a systematic way to track and manage 505(b)(2) products.
• The approach indicated potential adaptability for different care settings.
• Ongoing refinement of the model is recommended as regulatory policies continue to change.

Abstract