Press Releases

Simplifi 797 from Wolters Kluwer Now Includes Content to Ensure Compliance with USP 797 and USP 800

December 2, 2016 – Numerous incidents resulting in preventable adverse events continue to occur at sterile compounding facilities. Accrediting and governing agencies such as The Joint Commission, Centers for Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA) and State Boards of Pharmacy regularly inspect compounding pharmacies, paying particular attention to quality control, training and documentation, which are guided by USP Chapter 797 and USP Chapter 800. The failure to adhere to these standards increases preventable incidents that result in infections or death, as well as increases the risk to employees from exposure to hazardous drugs.

Simplifi 797®, a quality management system for USP 797, offers everything needed to establish the training, risk management and quality assurance practices necessary for a safe and efficient sterile compounding environment where the potential for errors is minimized. It now also includes content designed to help facilities meet the requirements of compounding hazardous drugs. With added policies and procedures, assessments and other tools to address the specific requirements of USP 800, Simplifi 797 enables compounding facilities to manage the hazardous drug compounding that is essential to patient safety and risk mitigation.

The additional USP 800 content enables staff to:

  • Implement expanded Hazardous Drug Policies & Procedures that meet new USP 800 requirements
  • Perform competency assessments with updated documents
  • Manage a facility-specific list of formulary of drugs classified as hazardous by NIOSH
  • Collect Employee Hazardous Drug Risk Acknowledgement sign-offs and forms

“Simplifi 797 provides the tools and resources needed to ensure compliance with USP Chapter <797> and <800> standards,” said Eric S. Kastango, MBA, BSPharm, FASHP. “Using Simplifi 797 with the included proper policies and procedures, competencies and staff training program will streamline your cleanroom operation and protect patients from the risks of sterile and hazardous drug compounding.”

For more information on Simplifi 797, visit

About Wolters Kluwer

Wolters Kluwer N.V. (AEX: WKL) is a global leader in information services and solutions for professionals in the health, tax and accounting, risk and compliance, finance and legal sectors. We help our customers make critical decisions every day by providing expert solutions that combine deep domain knowledge with specialized technology and services.

Wolters Kluwer reported 2015 annual revenues of €4.2 billion. The company, headquartered in Alphen aan den Rijn, the Netherlands, serves customers in over 180 countries, maintains operations in over 40 countries and employs 19,000 people worldwide.

Wolters Kluwer shares are listed on Euronext Amsterdam (WKL) and are included in the AEX and Euronext 100 indices. Wolters Kluwer has a sponsored Level 1 American Depositary Receipt program. The ADRs are traded on the over-the-counter market in the U.S. (WTKWY).

Wolters Kluwer Health is a leading global provider of information and point of care solutions for the healthcare industry. For more information about our products and organization, visit, follow @WKHealth or @Wolters_Kluwer on Twitter, like us on Facebook, follow us on LinkedIn, or follow WoltersKluwerComms on YouTube.


Deb Oroszlan
Marketing Communications Manager
Wolters Kluwer Health | Pharmacy OneSource
800-654-8395 x 199

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by clinicians.