Identifying candidates for USP Compounded Preparation Monograph studies from ASHP and University of Utah Drug...

Compounded preparations are essential for meeting unique patient needs, especially during drug shortages. The United States Pharmacopeia (USP) identifies candidates for developing compounded preparation monographs (CPMs) using the American Society of Health-System Pharmacists (ASHP) Drug Shortages List, created by ASHP and the University of Utah Drug Information Service (UUDIS).

The ASHP Drug Shortages List, covering January 1, 2021, to December 31, 2023, was analyzed to target drugs in chronic shortage (540 days or more). Exclusion criteria were applied to filter out capsule/tablet forms, diagnostic agents, β-lactams, hazardous drugs, and those deemed unfeasible for compounding per US Food and Drug Administration (FDA) guidance. Drugs without a USP Reference Standard for the active ingredient were also excluded. After initial exclusions, a focused review by the USP Compounding Expert Committee (CMP EC) further refined the list by removing drugs with readily available alternatives and those unsuitable for compounding. From the initial list of 3,361 drugs, 883 were identified as chronically in shortage; of these, 135 were actively in shortage. Following exclusions, 42 drugs were recommended as candidates for CPM development to assist in managing shortages and ensuring patient access to essential medications.

This structured, collaborative approach demonstrates how USP can effectively utilize the ASHP Drug Shortages List to prioritize CPM candidates, addressing drug shortages and supporting continuity of care across the US healthcare system.