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Basics of compounding: considerations for implementing United States pharmacopeia chapter 797 pharmaceutical compounding-sterile preparations, part 8: stability and beyond-use dating



Basics of compounding: considerations for implementing United States pharmacopeia chapter 797 pharmaceutical compounding-sterile preparations, part 8: stability and beyond-use dating



International Journal of Pharmaceutical Compounding 12(4): 344-353



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. Beyond-use dates are established on the basis of chemical and physical aspects of a compounded preparation. If a sterility testing program is in place, then each compounded preparation is considered "sterile" and the areas of concern are chemical and physical stability. In manufacturing, not every dosage unit is tested, only a sample. Similarly, only a sample of compounded preparations is tested. A sterility testing program must be in place to demonstrate that compounding proceures are under control. 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.

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Accession: 051761095

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PMID: 23969772


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