What are beyond-use dates (BUDs) in sterile compounding?

Beyond-use dates (BUDs) in sterile compounding are critical for ensuring the stability and safety of compounded sterile preparations. The BUD is determined based on the conditions under which the preparation was compounded, the nature of the ingredients used, and the storage conditions that are expected post-compounding. It signifies the last date on which the preparation can be safely used, after which it may not be guaranteed to retain its potency or sterility.

Establishing BUDs is essential to prevent patient harm due to using compounded products that may have degraded or become contaminated over time. The determination of BUD is guided by established guidelines laid out in standards like USP 797, which considers factors such as risk level of the compounding process and storage conditions (ambient, refrigerated, etc.).

The other options address broader topics related to pharmacy practice, but they do not accurately reflect the specific role and importance of BUDs in sterile compounding.