What is the BUD for single-dose vials outside of ISO 5 conditions after puncture?

The appropriate beyond-use date (BUD) for single-dose vials that have been punctured and are maintained outside of ISO 5 conditions is indeed six hours. This timeframe is established based on guidelines intended to ensure the safety and efficacy of compounded sterile preparations.

When a single-dose vial is punctured, it becomes exposed to potential contaminants from the environment, and the integrity of its contents may be compromised. The BUD is designed to minimize the risk of microbial growth and assure that the preparation can be safely used.

The decision to assign a BUD of six hours for single-dose vials outside of ISO 5 conditions is based on the understanding that after this time, the risk of contamination increases significantly. This guideline helps pharmacists and healthcare providers manage and mitigate risks associated with sterile compounding in less-than-ideal conditions. Therefore, adhering to this BUD is crucial for patient safety and pharmaceutical practice standards.