The Chapter <795> Answer Book, 2nd Edition provides a comprehensive overview and explanation of the requirements and recommendations of USP Chapter <795>, as well as practical advice and consideration in complying with the chapter.
This book outlines quality of practice standards for nonsterile compounding by following a nonsterile product from receipt to preparation in a healthcare facility, addressing core elements of the revised USP Chapter <795>.
Key discussion areas of the book include:
- Overview of major changes between 2008 version of USP <795> and 2023 revision
- Facility design specification
- Personnel training and core competencies, including suggested approaches for documenting competency
- Work practices to meet requirements and ensure best practices
- Guidelines, procedures, and compliance requirements for compounding nonsterile preparations
- Compounding quality nonsterile preparations
- Beyond-use dating guidance and training