USP General Chapter <797> Pharmaceutical Compounding—Sterile Preparations

Learn about pharmaceutical compounding regulations

The purpose of USP General Chapter <797> Pharmaceutical Compounding—Sterile Preparations is to protect the health of patients by reducing the potential for microbial contamination caused by an unclean environment and endotoxins. The chapter was developed for use in healthcare institutions, pharmacies and physician practice facilities. It also applies to other facilities and areas that prepare, store and dispense compounded sterile preparations (CSPs), such as pharmacy intravenous rooms, chemotherapy clinics, satellite pharmacies and other areas where CSPs are prepared within a sterile environment.

It is critical to understand the environment and potential sources of contamination and put appropriate controls in place. Complying with General Chapter <797> requires the design and use of cleanroom facilities as well as the development of policies and procedures for cleaning, sterility testing, training and validation of personnel, and environmental monitoring.

USP General Chapter <797> documents

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