What is BUD?
Date and time after which a compounded preparation shall not be used. Determined by sterility testing, container type, storage conditions, and USP <797> guidelines.
For sterile preparations, USP <797> (2023) assigns maximum BUDs by category: Category 1 (up to 12 hours at room temperature or 24 hours refrigerated), Category 2 (from 1 to 90 days depending on sterilization method, sterility testing, and storage), and Category 3 (up to 180 days with sterility testing and enhanced requirements). For nonsterile preparations, USP <795> caps BUDs by water activity and preservation: 14 days for nonpreserved aqueous, 35 for preserved aqueous, 90 for nonaqueous oral liquids, and 180 for other nonaqueous forms.
A BUD can never exceed the shortest remaining expiration date of any component, and stability data may shorten — never lengthen — the default limits.
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