Beyond‐Use Dating

Abstract

Determining an effective beyond-use date (BUD) is a critical component of both sterile and nonsterile compounding as it indicates the date and time after which a compound must not be used. BUDs are calculated from the date/time that the compound was prepared. Both BUDs and expiration dates are determined based on when a medication will degrade to the point that it contains lower active drug levels or higher toxin levels than allowed in official compendia. However, BUDs are often determined based on significantly less robust data than that used for establishing expiration dates making them much shorter. This is appropriate when considered in the context that compounding is designed to be unique, patient-specific preparations made in accordance with a prescription, so the several-year shelf life seen with manufactured products is not necessary. This chapter will review the factors affecting BUDs, how to identify appropriate studies for extending BUDs, and considerations when evaluating the BUDs on compounded medications prepared by outside pharmacies.