The risks inherent to sterile compounding are critical and can have a considerable and lasting impact on your practice
Mitigating those risks requires a comprehensive pharmacy compliance program that incorporates established standards into daily practice. A closed-loop solution that supports USP compliance is essential for patient safety, efficient pharmacy operations, and overall quality of medications compounded.
What is USP 797?
USP Chapter 797—Pharmaceutical Compounding—Sterile Preparations ensures the quality and safety of compounded sterile drug preparations. These are medications that are administered intravenously. USP Chapter 797 standards apply to all pharmacies that produce compounded sterile preparations (CSPs), including those in hospitals, retail, and standalone settings.
USP 797 provides the standards under which regulatory agencies, particularly the state-level department of public health and board of pharmacy, can pursue pharmacies for unsafe compounding practices. The chapter was developed to prevent:
- Patient harm and fatality from microbial contamination
- Excessive bacterial endotoxins
- Large content errors in the strength of the correct ingredients
- The inclusion of incorrect ingredients in CSPs
The Joint Commission actively surveys for USP 797 compliance as required by the Centers for Medicare & Medicaid Services (CMS).
How Simplifi 797 streamlines USP 797 compliance in your pharmacy
Simplifi 797 is a closed-loop, expert-developed compliance solution that supports compliance with USP 797 in the pharmacy and includes: