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 overall quality of medications compounded. 

What is USP 795?

USP Chapter 795 Pharmaceutical Compounding—Nonsterile Preparations pertains to extemporaneous compounding of pharmaceuticals, which is an integral pharmacy operation, especially in community pharmacies and pediatric hospitals.

USP 795

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. 
  • Exclusive partnership with CriticalPoint to integrate USP training into our solution. This means the training your staff undergoes will be directly related to the competencies and tasks relevant to your facility. 
  • 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.
Simplifi-797
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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
USP 795 process
Simplifi 797 is also an exclusive provider of CriticalPoint USP training. It includes up to 11 CEs related to USP Chapter 795
These training courses align with the competencies and tasks we’ll build for you upon implementation, ensuring nothing falls through the cracks in your nonsterile compounding operation.
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Collaborate with our USP Compliance Expert
Annie Lambert
Annie Lambert, PharmD, BCSCP
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.
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USP Chapter 795 expert pharmacy support content from Simplifi 797
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