Posted on October 29, 2014
One of the most important factors for compliance with USP 797 is a reliable system to track the many facets of USP 797. These standards include employee training programs with ongoing competency evaluations, environmental testing logs, quality assurance programs, and documentation of activities related to compound sterile preparations (CSPs).
Chapters of the USP numbered between <1> and <999> are considered to be requirements and official standards of the USP. Pharmacies are subject to inspection against these standards by the FDA, state pharmacy boards, as well as independent accrediting organizations such as The Joint Commission. Given recent publicity surrounding compounding pharmacies, there is increased scrutiny on CSP quality outcomes and greater oversight of compounding processes. Such oversight encourages pharmacies and other compounding locations to diligently follow all of the relevant USP 797 guidelines.
One of the best solutions for ensuring USP 797 compliance is to use web-based computer software that streamlines compliance management tasks , documentation requirements and staff competency assessments. This type of software allows pharmacies and other CSP preparation sites to attain and maintain a state of control. Software features should:
How has implementation of a software-based USP 797 compliance program helped your organization?
1. Kastango, Eric S. MBA, RPh, FASHP. The American Society of Health-System Pharmacists. “The ASHP Discussion Guide for Compounding Sterile Preparations.”