HealthJuly 12, 2017

Introducing a better USP 800 compliance strategy

It's time for best practices to become common practice in today's hospitals and health systems for compounding hazardous drugs.

That's why the Wolters Kluwer expert team remains resolute in our efforts to create solutions that help you solve high-level industry challenges and drive better performance with patient safety, clinical outcomes and the bottom line.

Simplifi 797® helps pharmacies comply with USP Chapter <800> (USP 800) with a turn-key offering addresses important employee education and safety needs to ensure safe compounding of hazardous drugs.

Introduced in 2016, USP 800 aims to address alarming statistics related to hazardous drug exposure - equating to approximately 8 million healthcare workers annually, according to the Centers for Disease Control and Prevention[i]. Pharmacy directors recognize the urgency, yet many lack the resources needed to ensure ongoing, sustainable compliance by the upcoming deadline.

The scope of USP 800 is wider than that of USP Chapter <797> (USP 797), focusing on the following key elements:

  • Facility design. Hazardous drugs must be stored in negative or normal/neutral pressure, and compounding must be completed in certified biological safety cabinets or compounding aseptic containment isolators in a separate room with negative pressure.
  • Garb. Details for personal protective equipment are based on the function being performed.
  • Cleaning and disinfection. Deactivation and disinfection must be done with an oxidizer, cleaning with a germicidal detergent and disinfection with sterile alcohol.
  • Administration. Closed-system drug-transfer devices should be used when compounding and shall be used when administering hazardous drugs.

USP 797 and USP 800 work in tandem to ensure the highest level of safety with sterile compounding practices, and the stakes are increasingly high for aligning with these best practice standards. Both enforceable guidelines, healthcare organizations that fall short are more vulnerable to adverse patient incidents as well as notable financial and reputational consequences. Pharmacy directors recognize the need for elevating sterile compounding practices. Many just need a line of sight into the most effective strategies and solutions to elevate practice.

The good news is that Simplifi 797 now helps pharmacies confidently address the full scope of USP 797 and USP 800 compliance, elevate staff competencies and promote the highest level of safety.

Facilities can rely on a single quality management solution to maximize pharmacy operational efficiencies and guide proper handling and storage of sterile compounded preparations.

Additional features addressing USP 800 enable staff to:

  • Implement expanded Hazardous Drug Policies & Procedures that meet new USP 800 requirements
  • Perform competency assessments with updated documents, including HD Decontamination, Cleaning and Disinfecting, HD Donning and Doffing, and HD Spill Management
  • Manage a facility-specific list of formulary of drugs classified as hazardous by NIOSH
  • Collect Employee Hazardous Drug Risk Acknowledgement sign-offs and forms
Content is a key differentiator for Simplifi 797. Written by trusted industry experts Eric S. Kastango, MBA, BSPharm, FASHP and ClinicalIQ, expanded USP 800 custom content includes:
  • Policy and procedure templates
  • Supporting form templates
  • Competency templates
  • Ability to add additional policy and procedures as well as competencies
  • Competency specific dashboard tab status totals; assignment status and competency history reporting; and email notifications to employees and administrators.

"Simplifi 797 equips pharmacies with all of the tools and resources needed to comply with the complexities of USP 797 and USP 800. It is the most comprehensive quality management solution available for enacting proper policies and procedures, elevating staff competencies, streamlining cleanroom operations and most importantly, protecting patients and staff from the risks of sterile and hazardous drug compounding," said Eric S. Kastango, MBA, BSPharm, FASHP.


Power, Luci A., MS, RPh, Kastango, Eric S., MBA, RPh, et al. Understanding the New Proposed USP Chapter <800>. Pharmacy Purchasing & Products. June 2014, Vol. 11 No. 6. Page 6.

Simplifi 797®

Take the guesswork out of USP medication compounding compliance with a customizable, mobile, evidence-based solution.

Simplifi 797 provides the latest evidence-based guidance and helps navigate the complex USP Chapters 795, 797 and 800 processes to ensure inspection confidence and keep patients and staff safe.