The ASHP Discussion Guide for Compounding Sterile Preparations has been written by Eric S. Kastango. It provides an important overview of the complexities and regulatory requirements for sterile compounding. The guide focuses on USP Chapter 797, Pharmaceutical Compounding: Sterile Preparations.
Here is the executive summary:
“Over the past three decades, several pharmacy practice documents have been published in hopes of establishing a standard of practice for compounding sterile preparations that could be universally adopted. None of these documents was successful in achieving this goal. However, on January 1, 2004, USP Chapter 797, Pharmaceutical Compounding: Sterile Preparations, which is published in USP 27/NF 22, came into effect. USP Chapter 797 details the procedures and requirements for compounding sterile preparations and sets standards that are applicable to all practice settings in which sterile preparations are compounded. These standards may be adopted and enforced by state boards of pharmacy and surveyable by accreditation organizations. This discussion guide will provide important information about Chapter <797> and its procedures and requirements. As pharmacists, we have been given the right to compound, but as professionals, we have the obligation to compound right.”
Posted by Tim Sandle