Completed Assessments of Risk

NIOSH has officially finalized its updates to the NIOSH List of Hazardous Drugs in Healthcare Settings, 2024, and the changes are significant—drugs have shifted between Tables 1 and 2, and Table 3 has been removed entirely. If your pharmacy dispenses hazardous drugs, your Assessment of Risk (AoR) may now be outdated.

To help you stay compliant, we’ve relaunched our Assessment of Risk Solution, fully aligned with the new NIOSH list and built specifically for independent retail pharmacies like yours.

Why Do I need Completed Assessments of Risk?

The Long Answer: Completing and maintaining AoRs is essential for pharmacies to manage hazardous drugs safely and in compliance with regulatory standards.  Under USP <800>, pharmacies that handle hazardous drugs (HDs) must either implement all specified containment strategies or perform a documented Assessment of Risk (AoR) for each HD. (OSHA- Controlling Occupational Exposure to Hazardous Drugs) Without a completed AoR, all HDs must be stored and handled in full compliance with USP <800> containment requirements, which include:​

  • Storing HDs in a negative pressure room with at least 12 air changes per hour
  • Utilizing appropriate ventilated compounding equipment
  • Implementing engineering controls to protect personnel and prevent contamination

These measures are designed to minimize occupational exposure to hazardous drugs and ensure the safety of healthcare workers. ​Performing and documenting an AoR allows pharmacies to identify alternative containment strategies and work practices for specific HDs, potentially reducing the need for some of the more stringent containment measures.  However, if an AoR is not conducted, the pharmacy is required to adhere to all containment strategies outlined in USP <800> for every HD handled.

The Short Answer: Because USP <800> requires it—and inspectors are looking for it.  If your pharmacy dispenses any medications listed on the NIOSH Hazardous Drug List, you must complete an Assessment of Risk (AoR) for each one or follow the full USP <800> handling standards (which are far more stringent and time-consuming).  Without completed and signed AoRs on file, your pharmacy is not compliant, even if you use gloves and safety precautions.  It’s the documentation that proves your processes meet USP <800> standards and protects you during an inspection.

What Does a Completed Assessments of Risk Need to Include?

Each AoR must:

  • Identify the drug and its form (tablet, capsule, etc.)
  • Evaluate the risk to your staff
  • Outline safety precautions
  • Be signed and reviewed annually

     

What’s included in the R.J. Hedges Completed AoR?

  • Over 265 pre-built AoRs covering common HDs
  • Hosted in your Compliance Portal for 24/7 access
  • Designed for 5 years of annual review & signature
  • Updated automatically as NIOSH or USP <800> changes
  • Just $300/year (or $500 for a printed binder + digital access)

How do I order the Completed Assessments of Risk?

Current clients will get immediate access, billed with your next invoice.

New clients can get started with a quick call and payment setup.