Beyond-Use Date

The beyond-use date (BUD) is the date after which a compounded preparation or an opened multi-dose product should no longer be administered, distinct from the manufacturer expiration date assigned to unopened, commercially packaged products. For peptides, the BUD is determined by stability testing data specific to the formulated product under its intended storage conditions and accounts for factors including chemical degradation, microbial contamination risk after first puncture, and physical stability of the solution. USP chapter 797 provides default BUD guidelines for compounded sterile preparations based on their risk category and storage temperature. For reconstituted lyophilised peptides stored under refrigeration, BUDs typically range from 14 to 30 days depending on the peptide and formulation. ORYN pre-mixed peptide pens are assigned beyond-use dates based on proprietary accelerated and real-time stability studies, and their sealed cartridge system minimises microbial exposure compared to traditional multi-use vials that require repeated needle punctures, contributing to extended product integrity throughout the dosing protocol.