Pharmacy OneSource Blog

USP 800: Don’t Let Your Guard Down

Posted on 10/10/17

Three reasons pharmacies still need to act now

Pharmacies across the U.S. now have more time to implement their plans following the recent postponement of the USP General Chapter <800> (USP 800) enactment date. The announcement of the new December 1, 2019 deadline was made by the United States Pharmacopeia Convention last month to support better harmonization with the coming revisions to USP General Chapter <797> (USP 797).

While it’s a good strategy that promotes a unified approach to quality compounding, today’s pharmacies should not let their guard down and remain resolute in their efforts to prepare for the new standards covering the safe handling of hazardous drugs. It’s true that an additional 18-month compliance buffer now exists, but forward-looking hospitals and health systems recognize the need to prioritize safer compounding practices in all areas.

Consider these three reasons why USP <800> compliance matters now.

1. It’s the right thing to do 

A growing body of evidence—including a recent meta-analysis—points to the prevalence of genetic damage in healthcare workers who are exposed to hazardous compounded drugs (HCDs). In tandem with these findings, alarming statistics from the Centers for Disease Control and Prevention suggest that approximately 8 million U.S. healthcare workers are potentially exposed to HCDs each year. Healthcare organizations have a responsibility to protect both their employees and patients from harm—in fact, safety should be the primary mantra of any pharmacy operation. Those that fall short of industry-accepted compounding best practices may be more vulnerable to adverse patient incidents as well as organizational consequences.

2. Better positioning for coming USP 797 revisions

USP delayed the implementation of USP 800 to allow the Compounding Expert Committee time to finish the revisions to USP 797. This way, both chapters will become official at the same time. While this approach is effective for aligning efforts on the national level, hospitals and health systems don’t want to find themselves facing the burden of preparing for USP 797 revisions and USP 800 implementation at the same time. The reality is that USP 800 compliance often requires construction or remodels to the physical layout of a pharmacy. All of this must be budgeted and completed before the deadline, and most pharmacies simply do not have the resources available to address these projects simultaneously.

3. Evolving regulatory oversight

Increased regulatory scrutiny over compounding practices has been underway for some time, and the evolution of new requirements is expected to continue. Recent high-profile events involving sub-par processes have moved USP 797 and USP 800 compliance front and center, and many experts believe that it’s only a matter of time before Centers for Medicare and Medicaid Services (CMS) and accreditation organizations follow current state boards of pharmacy efforts to enforce compliance to greater extent. As such, readiness is increasingly important to future positioning to protect both patients and employees.

In truth, USP compliance is a complex undertaking for any pharmacy, and manual workflows exacerbate the challenge. Strategies to comply with USP are often characterized by paper-based, disparate logs spread throughout a pharmacy and time-consuming efforts to track and monitor performance of required tasks. In addition, the responsibility for staff training falls on the shoulders of pharmacy management, who must create programs from scratch and manually track completion for each employee.

The good news is that Simplifi 797 dramatically improves the outlook as a comprehensive quality management system that addresses both USP 800 and USP 797 compliance. Developed by Eric S. Kastango, MBA, BSPharm, FASHP, the leading expert in the field of sterile compounding, the solution provides the comprehensive framework needed to address all USP compliance concerns and help pharmacy directors navigate regulatory inspections with greater confidence. The platform includes:

  • Customized expert guidance: a facility-specific quality assurance plan developed that includes a full set of policies and procedures written by by Eric S. Kastango and his team at Clinical IQ and updated with changing regulations.
  • Unparalleled education content written by industry-leading subject matter experts from CriticalPoint: staff members receive online ACPE-approved sterile compounding training with 33 hours of CE credit.
  • Ongoing identification and mitigation of risks: enables staff to respond quickly to day-to-day deviations from quality assurance plans with real-time alerts on facility and system-level compliance risks.
  • Compliance tracking functionality: easily access reports on compliance trends and issues for hassle-free inspections. Generate reports on trends and analysis by activity, compounding area or facility.

“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.”

- Eric S. Kastango, MBA, BSPharm, FASHP

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