“It’s all about personal protective equipment, engineering controls, and work practices we need to change to protect the health care worker.”

Patricia C. Kienle, RPh, MPA, FASHP

USP <800> was published on February 1, 2016 with an implementation date of December 2019.

The purpose of the chapter is to describe practice and quality standards for handling hazardous drugs in health care settings and help promote patient safety, worker safety, and environmental protection. Chapter <800> was written to protect all workers, patients and the general public who may be accessing facilities where hazardous drugs (HDs) are prepared. This includes but is not limited to pharmacists, technicians, nurses, physicians, physician assistants, home healthcare workers, veterinarians, and veterinary technicians.

The chapter applies to all health care personnel who handle HD preparations and all entities that store, prepare, transport, or administer HDs, such as pharmacies, hospitals and other health care institutions, patient treatment clinics, physicians’ practice facilities, or veterinarians’ offices.

What is USP <800>?

Use this short video to:

  • Understand what USP <800> means to you.
  • Forward to a colleague to make them aware of the standard.

The chapter defines processes intended to minimize the exposure to hazardous drugs in health care settings. It was developed by the USP Compounding Expert Committee with the assistance of the USP Compounding with Hazardous Drugs Expert Panel and government liaisons from the U.S. Food and Drug Administration (FDA) and the U.S. Centers for Disease Control and Prevention (CDC), including NIOSH.

Expert Q and A:

Use this 60-minute video to:

  • Provide an hour of in-depth discussion in an open table forum from the experts.
  • Understand “why and how” the standard was developed.

The enforcement of USP standards depends on local, state, and federal regulatory agencies. Accrediting bodies like The Joint Commission survey for compliance with USP compounding standards. The CMS State Operations Manual, which is used by surveyors to ensure that all of the Conditions of Participation are being met, includes references to USP standards. Additionally, many state pharmacy practice acts have included references to USP compounding standards. Each professional licensing board also has the ability to enforce the regulations of that state, which may include USP compounding standards.

Get Ready for <800>

A useful approach to help conceptualize USP <800> is to think about the journey of an HD through your organization and the HD interaction points. Chapter <800> contains handling requirements from receipt through disposal. 

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