Which statement reflects how BUDs relate to compounded prescriptions?

• A. Compounded prescriptions do not have BUDs
• B. Compounded prescriptions have BUDs determined by the compounding process
• C. BUDs are always exactly 6 months
• D. BUDs are the same as commercial products

Answer: (B)

Beyond-use dating is about how long a compounded preparation is expected to remain safe and effective after it’s made. For compounded medicines, the date isn’t fixed; it’s set by the pharmacist using stability data, the formulation type (nonaqueous, aqueous, sterile vs non-sterile), storage conditions, and the risk level of the compounding. When solid stability data exist, a longer BUD may be approved within those limits; if data are limited or absent, USP guidelines provide default BUDs based on the formulation. This means compounded prescriptions have BUDs determined by the compounding process, not a universal six months or the expiration date of commercial products, and not that they don’t have BUDs.