USP 800 Preparation Checklist

Is your facility ready for <USP> 800? 

Hazardous drugs are handled throughout a healthcare organization every day which poses risks to employees, patients and the environment. USP <800> outlines the practice and quality standards for the safe handling of these drugs through nearly every aspect of the medication process. This affects not only the pharmacy, but a variety of personnel, such as the nursing unit staff, environmental services, operating room staff and much more. Regulatory personnel are expecting to enforce the standards and hand out citations for non-compliance. Do you have your bases covered?

As the December 1, 2019 deadline draws closer, here are proactive steps that organizations can take to prepare and navigate the complexities of USP <800> compliance.

Hazardous Drug List

  • Maintain a complete list of all hazardous drugs used in your facility.
    • Hazardous drugs are defined by The National Institute for Occupational Safety and Health (NIOSH) as those exhibiting “one or more of the following characteristics in humans or animals: carcinogenicity, teratogenicity or developmental toxicity, reproductive toxicity, organ toxicity at low doses, genotoxicity, or structure and toxicity profiles of new drugs that mimic existing hazardous drugs.”1
  • Complete a risk assessment and determine necessary precautions for each drug and dosage form.
  • Develop a plan to review your hazardous drug list every 12 months in order to add new hazardous drugs that enter the market and will be used.
    • Hazardous drug list must be reviewed annually.
  • Complete a risk assessment including hazardous drug type, dosage form, exposure risk, packaging and manipulation


Policies & Procedures

  • Assess your facilities personal protective equipment (PPE) for compliance with the regulations.
  • Ensure all personnel who handles hazardous drugs are adhering to the standards for wearing personal protective equipment while mixing or administering the hazardous drugs.
  • Enforce hazardous drugs are handled in designated areas that include: receipt and unpacking, hazardous drug storage facilities, sterile and non-sterile compounding areas (if performed by entity).
  • Document all standard operating procedures related to hazardous drug handling.



  • Appoint 1 experienced person as the compliance leader.
    • Each organization is required to designate a trained individual to develop, implement procedures and standards, oversee compliance, training and monitoring of personnel handling hazardous drugs.
    • The compliance leader should have a solid understanding of USP <800> guidelines so that they can serve as a go-to person for accountability and dissemination of information.
  • Create a list of all staff members who may come into contact with hazardous drugs while performing their job duties.
  • Train all personnel who handles hazardous drugs based on their job function, before the employee independently handles any hazardous drugs; this includes, but is not limited to, the receiving, labeling, packaging, transport, disposal, administration, deactivation, decontamination, cleaning and disinfection of hazardous drugs and handling areas.


Cleaning, Decontamination and Spill Response

  • Establish written procedures for the decontamination, deactivation and cleaning of all areas where hazardous drugs are handled, as well as, all reusable equipment and devices which come in contact with hazardous drugs.
    • Healthcare personnel performing these activities must wear appropriate PPE resistant to the cleaning agents used, including two pairs of chemotherapy gloves and impermeable disposable gowns.
  • Personnel qualified for the cleaning of hazardous drug spills must always be available while hazardous drugs are being handled.
  • Spill kits containing all necessary materials for the cleaning of hazardous drug spills must be readily available in all areas where they are routinely handled.


Keeping your staff safe is Curtis Bay's #1 job when it comes to handling hazardous drugs. Our hazardous waste experts have helped champion these standards to ensure staff and patient safety while handling hazardous drugs across different departments within your facility. To learn more about <USP> 800 and hazardous waste regulations, please contact our experts at (855) 228-1715.