Beyond-Use Dating for Compounded Preparations

Sterile Compounding BUD

Beyond-use dating (BUD) determines how long a compounded preparation can be used. For sterile compounding under USP 797, BUD depends on the risk level and storage conditions. Low-risk CSPs have a BUD of 48 hours at room temperature or 14 days refrigerated. Medium-risk CSPs have 30 hours at room temperature or 9 days refrigerated.

If sterility testing is performed, extended BUDs may apply. High-risk CSPs have shorter default BUDs of 24 hours at room temperature or 3 days refrigerated without sterility testing.

Nonsterile Compounding BUD

Under USP 795, nonsterile compounded preparations have default BUDs based on the formulation type. Water-containing oral preparations have a BUD of 14 days refrigerated. Non-aqueous preparations may have up to 180 days. Solid dosage forms may have up to 180 days as well.

If published stability data supports a longer BUD, the compounder may assign one up to the earliest expiration date of any ingredient used.

Study BUD Rules

BUD questions require memorization of specific timeframes. Drill them with PTCB flashcards and test recall with mini exams.