Managing the risks inherent in nonsterile compounding requires a comprehensive pharmacy compliance program that incorporates established USP 795 standards into daily practice.

A closed-loop solution that supports efforts to comply with USP Chapter 795 is essential for ensuring patient safety and the overall quality of medications compounded.

What is USP 795?

USP Chapter 795 compounding non-sterile preparations pertains to extemporaneous compounding of pharmaceuticals, which is an integral pharmacy operation, especially in community pharmacies and pediatric hospitals.

Errors and health and safety risks are inherent in nonsterile compounding. USP guidelines for 795 were developed to address specific areas of pharmacy responsibility, including: 

  • Staff competency
  • Ingredient quality
  • Equipment maintenance and use
  • Process standardization
  • Safe and appropriate environment
  • Inspection and documentation
  • Accurate Beyond-Use dating (BUD)

How Simplifi 797 streamlines USP 795 compliance in your pharmacy

Simplifi® 797 is a closed-loop, expert-developed web-based solution that supports compliance with USP 795 in the pharmacy. The solution includes:

  • A customizable interface eliminates the paper and binder clutter of the documentation process, reducing time and effort for your team. Turnkey inspection reporting makes compiling the data you need for a successful inspection effortless. 
  • 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. Our solution supports your quality assurance program and provides real-time access to best practices from industry experts to help you stay up to date.
Learn More about Simplifi 797

Everything your pharmacy needs to be USP 795 compliant

Simplifi 797 provides your pharmacy with expert-led policies, procedures, and resources that support USP 795 compliance, including:

  • Designated Person for CNSP
  • Training and Competency Requirements
  • Hand hygiene and garbing for non-hazardous, nonsterile compounding
  • Cleaning of compounding space and equipment
  • Facility and design specifications – nonsterile area
  • Equipment selection and maintenance
  • Inventory selection and control
  • Spill management
  • Master formulation records
  • CNSP Release inspections and labeling
  • CNSP packaging and transport
  • CNSP stability and assignment of BUD
  • Quality assurance and quality control
  • Complaints and adverse events
Simplifi 797 offers pharmacy compounding continuing education for USP <795>
Developed by the Simplifi 797 team to ensure alignment to core skills for USP Chapter 795 including tasks, policies and procedures, and competencies. Re-accredited annually and aligned with needs and compliance requirements.

Collaborate with our Pharmacy Compounding 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 Chapter 795 Expert Insight Articles
Yes, I'd Like to Know More About USP 795 and Simplifi 797!
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