“They’re cutting our BUDs!” I heard this from an exasperated compounding pharmacist looking for any way to make the most out of his product’s shelf life. BUDs, or the Beyond-Use Dates assigned to compounded products, determine when a product must be destroyed if it has not yet been used.  Wasted products are not good for business or patients.  

The draft chapter for USP <797> “Pharmaceutical Compounding – Sterile Preparations” has been available for almost a year. The massive overhaul of the parameters used to assign Beyond-Use Dates should no longer be a surprise. In most cases, compounded products will have shorter shelf lives. This heavily impacts batch planning and availability to patients.  

There are some ways to extend the BUDs that are outlined in the new revision. Most notably, performing a sterility test on each lot can often double the BUD window. But waiting for a sterility test takes at least two weeks, which significantly cuts into that window. Read more >