What Is a Beyond-Use Date (BUD)?
A beyond-use date (BUD) is the date or time after which a compounded preparation should not be stored or used. The compounder assigns it from the date and time of compounding. An expiration date is set by a manufacturer for an FDA-approved drug product after stability studies. Default BUDs in USP compounding chapters are shorter than most commercial expiration dates, and extending a BUD needs formulation-specific data from a stability-indicating method, usually HPLC.
