Pharmacy OneSource Blog

Performing an Assessment of Risk Requirement in USP 800

Posted on 04/21/16


Patricia C. Kienle, RPh, MPA, FASHP is a member of the USP Compounding Expert Committee, however, the information in this blog is not endorsed by or affiliated with USP.

USP 800 Hazardous Drugs – Handling in Healthcare Settings was published on February 1, 2016, and will become official (and federally enforceable) on July 1, 2018.

The hazardous drugs of concern to USP 800 are medications that are hazardous to people; this differs from EPA hazardous materials that are hazardous to the environment. Some drugs are on both lists, but the list to reference for USP 800 is the NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings (the 2014 current list is available here). An updated 2016 list is expected later this year. The NIOSH list sorts drugs into three categories:

  • Antineoplastics
  • Non-antineoplastics
  • Reproductive hazards only

Once you have identified the drugs and the dosage forms that you handle, you need to assess how you will protect personnel from exposure to these agents. USP 800 allows two approaches:

  • Handle all dosage forms of all agents on the list with all the containment precautions and work practices listed in 800, or
  • Perform an assessment of risk for drugs that are not Active Pharmaceutical Ingredient (API) or are not antineoplastics that need to be manipulated and determine alternative containment strategies and/or work practices that protect personnel

Some drugs must be handled with all the containment strategies and work practices listed in 800:

  • API of any three categories of hazardous drugs
  • Antineoplastics that need to be manipulated

Other agents may be considered for your assessment of risk. These agents include:

  • Antineoplastics that only need to be counted or packaged
  • Non-antineoplastics
  • Reproductive hazards only

Start this process by reviewing the NIOSH list and identifying those drugs you handle, and which dosage forms of those drugs you handle. Determine if you will handle all of those with all the requirements in 800, or if you will perform an assessment of risk for some of the dosage forms.

Most organizations will take the assessment of risk approach. The dosage form and packaging that you handle will drive a lot of the decision points you need to make.

Topics: Sterile Compounding

About the Author

Patricia C. Kienle, RPh, MPA, FASHP is the Director of Accreditation and Medication Safety for Cardinal Health Innovative Delivery Solutions. Her experience includes serving on the ASHP Board of Directors and as an ASHP Fellow. She is a current member of the USP Expert Committee on Compounding, and chair of the Subcommittee and Expert Panel on Hazardous Drugs. She was named Pharmacist of the Year by the Pennsylvania Society of Health-System Pharmacists and received the Distinguished Achievement Award in Hospital and Institutional Practice from the American Pharmaceutical Association Academy of Pharmacy Practice and Management. She has also served on the on the Board of Governors of the National Patient Safety Foundation. In addition to authoring multiple guides and videos dealing with sterile compounding, Patti is a frequent presenter to professional groups, with special interests in promoting medication safety, compounding sterile preparations, accreditation and regulatory issues.