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Sterile compounding also requires cleaner facilities; specific training and testing of personnel in principles and practices of aseptic manipulations; air quality evaluation and maintenance; and sound knowledge of sterilization and solution stability principles and practices.
Greater care is required for aqueous injections that are compounded sterile preparations (CSPs)the most common CSPs used in therapy.
BUDs are defined by as the date after which a compounded preparation should not be used; determined from the date the preparation is compounded.
BUDs are best assigned on the basis of direct testing or extrapolation from reliable literature sources and other documentation (see Stability Criteria and Beyond-Use Dating under Pharmaceutical Compounding-Nonsterile Preparations ) or, if not available using the default dates provided in the chapters.
The chapter is divided into the following main sections: Compounding personnel are responsible for ensuring that CSPs are accurately identified, measured, diluted, and mixed; and are correctly purified, sterilized, packaged, sealed, labeled, stored, dispensed, and distributed.