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 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:

  • A customizable interface eliminates the paper and binder clutter of the documentation process, reducing time and effort for your team.
  • Expert content, task management and alerts to ensure you’re operating safely and compliantly—available on a mobile-friendly electronic platform. This way you have easy access wherever compounding occurs and greater visibility into completion and compliance in real time.
  • Now offering two Pharmacy Compounding CE collections to meet didactic training requirements. Each course teaches specific core skills or 2023 chapter requirements with interactive elements to support skills-based learning. Easily track course completions, attempts, and final scores.
  • Unlike other products that stop at inspection readiness, Simplifi 797 helps you continuously improve your practice with customizable analytics. Robust Quality Scorecards and data that can be parsed on a system level or in a specific unit can help you identify and mitigate trends and issues before they become major compliance problems. 
Learn More About Simplifi 797

Everything you need to be USP Chapter 797 compliant

Simplifi 797 provides your pharmacy with expert-led policies, procedures, and resources that support USP 797 compliance, including:

  • CSP stability and assignment of Beyond Use Dating
  • Preparing sterile solutions from non-sterile components
  • Adverse event
  • Controlled substance storage and handling
  • Management and oversight of outsourced services
  • Prescription labeling
  • Visual inspection of compounded medications
  • Temperature and humidity monitoring
  • Quality management in environmental and personnel sampling
  • Good pharmacy documentation practices overview
  • CSP handling storing, packaging, shipping and transporting
  • Corrective action prevention
  • Surface sampling
  • Gloved fingertip sampling
  • Use of ACDs
  • Supporting forms and job aides
Simplifi 797 offers pharmacy compounding continuing education for USP <797>
These training courses align with the competencies and tasks we’ll build for you upon implementation, ensuring nothing falls through the cracks when compounding sterile preparations.

Collaborate with our USP Compliance Experts

Annie Lambert
Clinical Program Manager for Compliance Solutions
Compliance Solution Clinical Program Manager Annie Lambert, PharmD, BCSCP is committed to providing up-to-date USP content and expert compliance guidance, and to work with you to optimize the use of our Simplifi+ pharmacy compliance solutions.

USP 797 Expert Insight Articles

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