Beyond-Use Dates (BUD) for Tc-99m Policy Statement

The term Expiration Date, often called Shelf Life, is typically defined as the latest date that a manufactured drug product can be used as determined by the manufacturer. The term Beyond-Use Date is typically defined as the latest date or time that a compounded drug preparation (as described in General Chapters <795> and <797> of the United States Pharmacopeia [USP]) can be administered as assigned by the compounding pharmacist or physician. Confusion may occur, however, because many practitioners use the term Expiration Date in a broad sense when they actually mean Beyond-Use Date. With this in mind, the Committee on Pharmacopeia created the document to recommend BUD for Tc-99m Radiopharmaceuticals.