Why USP General Chapter 800?

July 15, 2019

At Pharma Logistics, we understand how frustrating it can be to keep up with all the changing rules and regulations. That’s why we continue to provide helpful information to guide you through the turbulence and keep you and your staff safe and compliant. Here’s some information you need to know about the new ruling on USP General Chapter <800>.

What is the purpose of USP General Chapter <800>?

Considering the potential impact on health and safety, the purpose of USP <800> is to define standards for handling hazardous drugs (HDs) and to help promote patient, worker and environmental protection.

The chapter outlines the proper requirements for:

  • All personnel handling or coming in contact with HDs
  • Facility and engineering controls
  • Deactivating, decontaminating and cleaning
  • Spill control
  • Medical surveillance

When is the deadline for compliance with USP <800>?

The USP Compounding Expert Committee created the chapter with assistance from the FDA, CDC, and NIOSH. USP <800> was published on February 1, 2016, with an initial compliance deadline of July 1, 2017. But this was postponed until December 1, 2019, to align with the latest revision to USP <797>.

How is USP <800> Different than USP <797>?
While centered around preventing harm to patients from microbial or other contamination, USP <797> only provided proper guidelines for the sterile compounding of both hazardous and nonhazardous drugs. It did not include standards for the handling of HDs.

For more information on how to remain compliant, check out our series of blogs on the USP General Chapter <800> on our website. You can also download our free handbook.