Is sterility testing required to establish BUD (beyond use dating, aka ‘expiration dates’) for compounded sterile preparations?
No. USP <797> has default maximum BUD times depending on the risk level and storage conditions of the compounded preparation. <797> only requires that there is ‘justification’ from ‘appropriate literature sources’ or direct testing for the BUD decisions that fall outside the maximum default times. Otherwise, BUDs can be assigned as described in the Chapter. Sterility and stability testing are required if the BUD exceeds the maximum default periods.
