The Chapter 795 Answer Book 2nd Ed

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