Are You Complying with USP General Chapter <800>?

Designed to protect staff and patient safety, United States Pharmacopeia’s (USP’s) latest chapter on handling hazardous drugs in the healthcare setting is USP General Chapter <800>.1 While the USP is a private, non-profit organization, their standards are enforced through various regulatory agencies, such as the Joint Commission and individual states’ Boards of Pharmacy.

While much of the standard focuses on health and safety during compounding and preparation, USP <800> also provides comprehensive guidelines regarding the entire life cycle of hazardous drugs at a facility. From initial receipt and assessment of risk to final pharmaceutical waste segregation and drug disposal, various healthcare departments beyond the Pharmacy are affected, including Nursing, Environmental Services, Environmental Health and Safety, Employee Health, Infection Control, Engineering, and more. This has left many healthcare organizations scrambling—not only to comply, but to understand with what exactly they have to comply.

Prioritize These Areas for a Comprehensive USP <800> Program

To build a robust management program around USP <800> compliance and to ultimately enhance patient and staff safety, organizations must take a holistic, multidisciplinary approach. This includes focusing on high-priority items, such as:

  • Developing a hazardous drug inventory, by reviewing the National Institute for Occupational Safety and Health’s (NIOSH’s) hazardous drug list and performing assessments of risk for certain formulations
  • Updating policies and procedures related to onsite receipt and storage of hazardous drugs
  • Ensuring the proper personal protective equipment (PPE) is used by various personnel in their different roles
  • Training affected staff to the specific hazards of hazardous drugs, including new documentation requirements
  • Dispensing and administering medications to patients
  • Revising spill policies to ensure total deactivation, decontamination, cleaning, and disinfection
  • Ensuring proper waste segregation and drug disposal
  • Maintaining medical surveillance policies
  • and much more

Expert Advice on USP <800> Compliance

Triumvirate Environmental is a leader in both healthcare and hazardous material safety. Our skilled professionals can assist your organization in any number of ways, from providing a top-down assessment of your facility’s current state of USP compliance, to frontline work on policy revisions and staff training. For more information on DEA drug disposal and pharmaceutical waste management services, contact our experts.

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1 USP <800> is intended to align with USP General Chapters <797> and <795>, which are standards relating to sterile and nonsterile pharmaceutical compounding. USP <797> and <795> are currently postponed and pending appeal.