Dictionary termProposed
Beyond-Use Date (BUD)
A beyond-use date (BUD) is the date, or date and hour, established by a compounding pharmacist after which a compounded preparation must not be used, stored, or transported. It is set at the time of compounding and is distinct from a manufacturer's expiration date, which applies only to the original, unopened, commercially manufactured product. Under USP General Chapter 797 (sterile preparations, current since November 1, 2023), the BUD is determined primarily by the CSP Category the preparation was compounded under (Category 1, 2, or 3, reflecting the degree of verified environmental control), together with the storage condition (controlled room temperature, refrigerated, or frozen), the dosage form, and any supporting sterility or stability testing or applicable stability data. Under USP General Chapter 795 (nonsterile preparations, also current since November 1, 2023), the BUD is determined primarily by whether the formulation is aqueous or nonaqueous, the dosage form and packaging, the storage condition, and whether supporting stability data exists — the chapter provides conservative default periods to use when no such data is available. In both chapters, the current chapter text and the USP Compounding Compendium contain the exact, category-specific and formulation-specific tables a compounder should use to assign a BUD to a given preparation; a value copied from a pre-2023 reference will not reflect the current framework.
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