Sterilization Methods
In the upcoming version of USP <797> Pharmaceutical Compounding – Sterile Preparations, the method of sterilization has a significant impact on the maximum allowable Beyond-Use date (BUD) a compounded preparation may be assigned. The two approaches to sterilization in the chapter are aseptic processing and terminal sterilization. Terminal sterilization provides the longest BUDs possible but may not be compatible with the compounded preparation due to the conditions required to sterilize. Ultimately, the appropriate sterilization method for a particular formulation depends on the product, with the allowable BUD a consequence.