Through the Keyhole: USP 800 Hazardous Drug Risk Assessment

Published: December 30, 2018


Editor’s Preface: Our “Through the Keyhole” article series is purposed with providing insight to pharmacy professionals, across many topics.  Please feel free to share your area of interest –- let’s make this a collaborative series.

An Assessment of Risk of Hazardous Drugs is essential in your journey to USP 800 compliance. It is important to perform an Assessment of Risk to determine which specific dosage forms of hazardous drugs may be handled with alternative containment strategies and/or work practices.

An example of our USP 800 Hazardous Drug Risk Assessment can be viewed here.


Steps for organizations to conduct their USP 800 Analysis include the following:

  1. Download the NIOSH 2016 list. The 2018 NIOSH list has not been released but the expectation is sometime in early 2019.
  2. Identify all of the hazardous drugs handled within the organization including each dosage form. This includes drugs handled outside the pharmacy such as clinic space throughout the organization.
  3. Divide the list into two categories:
  4. Drugs that are ineligible for an assessment of risk (active pharmaceutical ingredients and antineoplastics that re- quire manipulation)
  5. Drugs that may be considered for an assessment of risk (antineoplastics that will only be counted or packaged, non-antineoplastic and reproductive-risk-only drugs)
  6. Evaluate each of the drugs and dosage forms eligible for an assessment of risk, considering the following:
  7. Dosage form in which it is obtained
  8. Packaging (such as unit dose, unit-of-use, or bulk)
  9. Need for and type of manipulation (eg, crushing, opening capsules, compounding, etc)
  10. Determine if practical alternative containment strategies and/or work practices could be developed and implemented to protect employees from ingesting, inhaling, or touching HD particulates or vapors
  11. Create a written assessment of risk for each drug dosage form for which alternate strategies will be used


Your written assessment of risk should include the following elements:

  1. Type of hazardous drug (antineoplastic per List 1, non-antineoplastic per List 2, or reproductive-only risk per List 3)
  2. Specific dosage form
  3. Risk of exposure
  4. Packaging (ie, description of packaging in which the drug is received)
  5. Type of manipulation performed by the organization to render the final dosage form
  6. Specific alternative containment strategies and/or work practices that will be employed to reduce the risk of exposure