International journal of pharmaceutical compounding
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Beyond-use-dates for sterile preparations are divided into two categories. If a program of sterility testing is not in place, then the short beyond-use dates specified in United States Pharmacopeia Chapter 797 for the different risk levels are to be used. If a program of sterility testing is in place, then the beyond-use dates described in United States Pharmacopeia Chpater 795 for stability of various types of preparations/formulations can be used, which are somewhat longer than those in Chapter 797. ⋯ If a longer beyond-use date is needed, then appropriate and specific stability studies of the compounded preparation must be undertaken. A very generalized difference between Chapter 795 and Chapter 797 is the requirement for sterility. The majority of Chapter 797 is involved with the requirements necessary to achieve and/or maintain sterility in compounded preparations and includes standards for the facility, equipment materials, personnel, and training.