Safety First Blog

USP <800> Compliance: Budgetary Challenges & Opportunities

Posted by Laura Paxton on Jul 5, 2023 8:58:03 AM
Laura Paxton
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More than 12 billion doses of hazardous drugs are handled per year, according to NIOSH. Each handling instance represents multiple opportunities for exposure - from the initial receiving of the drug to clinical administration and finally to safe disposal. 

USP <800> aims to protect healthcare workers who could be in harm's way if exposed during their daily work tasks. The healthcare industry’s ongoing efforts to comply with USP <800> and protect healthcare workers from hazardous drug exposure require significant investment - both in resources and budget. 

In the annual survey conducted by Pharmacy Products & Purchasing (PP&P) in 2022, 75% of the 201 pharmacy leaders who responded said they are leveraging USP requirements to secure funds for their compliance efforts. 

Since the introduction of USP <797> and <800>, healthcare facilities have been planning for the required cleanroom construction, staff training, and ongoing personnel and environmental testing. As Pharmacy Products & Purchasing noted, when planning for USP <800> compliance, facilities must consider what upgrades or changes are necessary for any location where hazardous drugs are handled, including patient rooms, ADC stations, med refrigerators, surgical suites, infusion chairs, hospital clinics, MRI suites, CT suites, anesthesia tooms and of course pharmacies. 

According to a presentation by Ryan A. Forrey, Pharm.D., M.S., FASHP in 2017, the cost of USP <800> compliance could be between $800K and $800M, depending on the extent of the necessary upgrades. His estimate for a 550 sq. ft clean room space and similar sized office total $700,678, which includes required equipment, i.e. the heating, ventilation, and air conditioning (HVAC) system. 

While this budget included the facility and equipment upgrades in hospital-based pharmacies, it did not account for in-depth assessments of each hazardous drug that facilities handle, significant workflow and work practice changes, and thorough staff training, most of which are ongoing expenses.

When we surveyed attendees at an event, 80% said they did not have a current budget in place dedicated to USP <800> compliance efforts. In other surveys, participants estimated the necessary budget for the hazardous drugs communication portion of the chapter requirements to be between $100K and $500K. 

PP&P warned healthcare facilities to “expect thorough and detailed inspections as inspectors have a deep understanding of the chapter… with a particular focus on documentation, especially for training, SOPs, and the capture of lot numbers and expiration dates.” 

Some of the “musts” that will fall under the procedural, documentation and training upgrades and improvements include: 

  • Improved safety data sheets 
  • Document method of drug transport, including closed system transfer devices?
  • Communication of exposure data and/or control methods
  • Communication of proper disposal methods
  • Determine residual drug clean-up method for engineering controls
  • Proper spill clean-up procedures for this drug
  • Determine appropriate respirator
  • Recommended exposure limit
  • SOPs for PPE based on the risk of exposure and activities performed
  • Creation and maintenance of a list of the hazardous drugs (HDs) that they handle and review it every 12 months 
  • Confirm that all personnel who handle (HDs) must understand the hazards, practices and precautions
  • Signs posted designating handling areas, access to these areas must be restricted
  • Labels on the exterior of drug packages 

This short blog just touches on the potential purchases healthcare facilities must consider when working toward USP <800> compliance. Between upgraded and new equipment and procedures, technology and workflows, what is your facility using your compliance-based budget for? Let us know at 

We are steadily working to create high-value community resources and industry knowledge. Our Safety First blog consists of many articles with USP <800> guidance covering PPE, what to expect in an inspection and much more

Topics: Rhazdrugs, Policy, USP <800>, Formweb

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