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:
- Include a set of expert-based policies and procedures.
- Provide a reference library that provides up-to-date information on techniques, policies and other key compliance facts.
- Have the capability to maintain and standardize documents electronically to eliminate paper records for organizations.
- Be customizable to the facility for the provision of surveillance activities, benchmarking, and quality systems review.
- Provide continuously updated information to remain compliant with any and all changes in USP 797 guidelines, procedures and policies.
- Include access to ACPE-approved online continuing education that includes videos and interactive experiences.
- Track all training, schedules and tasks, including notification of overdue items, exceptions and out-of-range measurements.
- Provide staff competency tests based on best-practice analysis and note annual test due dates for each employee.
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."