Activity Description : Stability studies are essential for assigning Category 3 BUDs under USP , yet the process remains a black box for many sterile compounders. This session walks pharmacists and technicians through how to design a stability-indicating study for compounded sterile preparations, covering method validation, forced degradation testing, and the AET and container-closure integrity requirements specific to sterile compounding. Equal emphasis is placed on critically assessing stability studies found in the literature, so attendees can determine whether published data actually support relying on a given BUD for their own formulations. The session is designed for pharmacists and technicians across experience levels, from those new to compounding to those refining existing stability programs.

Handouts/Tools: 1. Stability Study Design & Documentation Checklist: a one-page decision tool covering when Category 3 testing is required, which tests apply (assay, AET, sterility, endotoxin, container-closure integrity, particulate matter), storage/interval requirements, and documentation needed for a defensible study. 2. Literature Assessment Worksheet: a structured form for evaluating a published stability study before relying on it, checking formulation match, container-closure system, method validation, storage conditions/intervals, and source quality. 3. Quick Reference Card: Validation Criteria & Terminology: condensed acceptance criteria for specificity, linearity, accuracy, precision, and robustness, plus a glossary of key terms (bracketing, forced degradation, container-closure integrity) for fast lookup during study design. 4. Resource & Citation List: references to the USP Stimuli article, relevant USP general chapters ( , , , , / , , , , , ), FDA ICH Q1A(R2) and 503B guidance, and the drug-flavoring interaction studies discussed, so attendees can locate the original sources independently.