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USP 800 and the Effect on Oncology Practices


To protect patients and healthcare workers from potential harm, US Pharmacopeia (USP) Convention’s General Chapter <800> Hazardous Drugs – Handling in Healthcare Settings was developed to help ensure the safe handling of hazardous drugs throughout the healthcare system. These new regulations could mean significant capital expenditures and practice process changes for those who administer chemotherapy drugs.

What is a hazardous drug?

According to the National Institute for Occupational Safety and Health (NIOSH), hazardous drugs are those which exhibit one or more of the following characteristics:

  • Carcinogenicity
  • Teratogenicity or development toxicity
  • Reproductive toxicity
  • Organ toxicity at low doses
  • Genotoxicity
  • Structure and toxicity profiles of new drugs that mimic existing drugs determined hazardous by the above criteria

While NIOSH identifies hazardous drugs, USP developed standards for handling these drugs to minimize the risk to public health. The goals of these standards are to help increase awareness, provide uniform guidance to reduce the risk of managing hazardous drugs and help reduce the risk posed to patients and healthcare workers.

How does USP <800> affect an oncology practice?

USP General Chapter <800> is anticipated to become official on Dec. 1, 2019. If your practice is just getting started or is well on its way to compliance, here are a few key areas on which you should focus:

  • Designate a USP <800> Champion. This person will identify the hazardous drugs used in the practice and be responsible for implementing procedures and adhering to the standard.
  • Document everything related to USP <800>. To comply your practice must develop processes and procedures specific to hazardous drug risk assessment, document all hazardous drug training for staff, develop a Hazard Communications Plan and more.
  • Understand how hazardous drugs travel through your practice. From delivery to disposal, are compliance issues lurking?
  • Learn the requirements for the chemotherapy mixing room and negative vs. positive pressure areas.

Our business optimization team is ready to help your practice comply with USP <800>. For more information, email us at