What is the maximum room temperature BUD for Immediate Use?

The maximum room temperature beyond-use date (BUD) for Immediate Use compounded sterile preparations is one hour. This regulation is designed to ensure patient safety by minimizing the risk of contamination and stability issues that can arise with compounded medications. Immediate use preparations are typically meant for emergency situations where the risk of infection is heightened by longer preparation times.

Following this guideline, any compounded preparation designated for immediate use must be administered within one hour of preparation. If not administered within this timeframe, the compounded sterile preparation must be discarded to prevent potential harm to the patient due to reduced effectiveness or bacterial growth. This strict rule underscores the importance of swift administration in urgent therapeutic settings.