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

To describe the development of a proactive workflow to identify medications approved through the 505(b)(2) pathway and anticipate potential challenges they may pose to the medication-use process within a large multisite health system.

The baseline workflow was based on the health system's response to a potential mix-up with bendamustine products, which resulted in the formation of a 505(b)(2) task force. An Excel tool was created to visualize and track changes to Centers for Medicare and Medicaid Services (CMS) ASP NDC-HCPCS crosswalk files. A 505(b)(2) directory was created to store the changes identified from the Excel tool. A list of 505(b)(2) medications was assessed with a prioritization matrix and gap analysis. The baseline workflow and gap analysis informed the creation of a new proactive workflow. The top-priority medication identified from the prioritization matrix was selected to trial the new workflow.

A proactive, interdisciplinary approach is essential to effectively manage the evolving challenges associated with 505(b)(2) medications. Implementing structured tools, including a crosswalk comparison tool, directory, and prioritization matrix, provided a systematic method to identify and monitor these products within a complex regulatory environment. Continued refinement will be necessary as CMS and Food and Drug Administration policies evolve, but this model offers a framework that may be adapted to different care settings.