The Chapter <795> Answer Book will provide a balance of both formal requirements of the USP chapter as well as practical advice and consideration in complying with the chapter. The reader will be able to follow a nonsterile product from receipt to preparation in a healthcare facility, addressing core elements of the USP chapter. The standards outlined in this chapter include:
Facility design specification
Personnel training and core competencies
Suggested approaches for documenting competency
Work practices to meet requirements and best practices
Guidelines, procedures, and compliance requirements for compounding nonsterile preparations
Compounding quality nonsterile preparations
Beyond use dating guidance and training
And much more...
Author Patricia Kienle is a known authority on sterile compounding. She currently serves as a member of the USP Compounding Expert Committee and was Chair of the subcommittee and Expert Panel that developed USP <800> as a guide for practical advice and explanation to help ensure compliance