Pharmacy OneSource Blog

What is Proposed USP 800 and Why It Should Matter to You

According to the Centers for Disease Control (CDC), about eight million healthcare workers are possibly exposed to hazardous drugs (HDs) each year. The impact of this exposure on long-term health is a matter of both concern and controversy. On the one hand, no incontrovertible links have been found between HD exposure and serious health risks (e.g. cancer, reproductive disease, and chromosomal abnormalities). On the other hand, hundreds of studies have been published that discuss HD exposure, and two 2010 studies published in the Journal of Occupational and Environmental Medicine1 raised the concern level among agencies that oversee healthcare practices.

In March 2014, the U.S. Pharmacopeia (USP) posted its proposed new chapter, USP 800, that specifically addresses the handling of compounded HDs in healthcare settings.   The HDs are referenced in the NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, which provides more clarity on what determines a drug to be “hazardous” in light of evidence-based science. USP 800’s intent is “to protect personnel and the environment when handling HDs. This includes but is not limited to receipt, storage, mixing, preparing, compounding, dispensing, administering, disposing, and otherwise altering, counting, crushing, or pouring HDs, and includes both sterile and nonsterile products and preparations.”

Even though a section of the 2014 USP Chapter 797 does address hazardous drugs sterile compounding, the level of detail is suboptimal, which was the catalyst to draft a new enforceable chapter. Furthermore, USP 797 only addresses the preparation of compounded medications, not the administration of these medications to patients. USP 800 is comprehensive in its level of detail regarding the storage, preparation, and administration of hazardous drugs.

USP 800 will apply to all personnel who compound HDs and all places where they are prepared, including pharmacies, hospitals and other healthcare institutions, physicians’ practice facilities, patient clinics, veterinarians’ offices and other locations/facilities where HDs are stored, transported and administered.

The final Chapter was published on February 1, 2016. Don’t delay – become familiar with USP Chapter 800 standards so you and your organization are better prepared regarding these safety concerns when handling hazardous drugs.

References:

1.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.

 

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