Earlier this year, NIOSH finalized the 2024 List of Hazardous Drugs in Healthcare Settings, introducing major changes that affect independent pharmacies nationwide.
25 new drugs were added
7 drugs were removed
Table 3 was eliminated entirely
Nearly 100 drugs were reclassified between Tables 1 and 2
If your pharmacy dispenses hazardous drugs (HDs), your Assessment of Risk (AoR) documents may now be outdated and that could spell T-R-O-U-B-L-E during an inspection.
The short answer: Because USP <800> requires it, and state board of pharmacy inspectors are looking for it.
If your pharmacy does not complete an AoR for each hazardous drug you dispense, you are required to follow every containment strategy outlined in USP <800>, including:
Storing all hazardous drugs in a negative pressure room with a minimum of 12 air changes per hour
Handling HDs only within ventilated containment devices (e.g., biological safety cabinets)
Implementing additional engineering controls to protect personnel
Without signed and current AoRs on file, even basic practices like wearing gloves and using closed containers will not be enough to satisfy Board of Pharmacy inspectors. Documentation is your protection. Without it, your pharmacy risks citations, fines, or mandatory costly upgrades.
An Assessment of Risk (AoR) is a formal evaluation of the hazardous drugs handled by your pharmacy. They allow pharmacies to implement alternative, less restrictive work practices without compromising staff safety. Instead of following the full USP <800> containment requirements (which are complex, costly, and primarily intended for compounding pharmacies), retail pharmacies can perform a documented AoR for each hazardous drug they dispense.
Each Assessment of Risk must:
Identify the hazardous drug and its dosage form (tablet, capsule, etc.)
Evaluate the level of risk to pharmacy staff
Outline safety precautions taken during storage, handling, and dispensing
Be signed and reviewed annually
Every valid AoR should:
List the hazardous drug by name and dosage form
Assess the potential exposure risks to staff
Describe alternative work practices and safety precautions
Be reviewed, signed, and dated by the pharmacy annually (for up to 5 years of tracking)
Incomplete or unsigned AoRs do not meet compliance requirements.
To help pharmacies stay ahead, R.J. Hedges & Associates has relaunched our Assessment of Risk Solution, fully aligned with the updated NIOSH list and designed specifically for independent retail pharmacies. We know independent pharmacies don't have time to research all the hazardous drugs, evaluate risks, and write forms from scratch. That’s why we’ve done it for you!
Our newly updated Assessment of Risk Solution includes:
Over 265 ready-to-use AoRs, based on the 2024 NIOSH list
24/7 access through your RJH Compliance Portal
5 years of annual reviews and signatures
Automatic updates as drugs are added, removed, or reclassified
Available for just $300/year (digital access) OR
$500 for a printed binder + digital access (first year)
Current RJH clients can receive immediate access, billed with their next invoice. New clients can get access within a few days after a quick questionnaire and simple payment setup.
USP <800> isn’t going away, more Boards of Pharmacy are adding these requirements to their inspections. Completing and maintaining your AoRs is the simplest, most cost-effective way to meet your obligations and protect your staff.
At R.J. Hedges & Associates, we make it easy for you to focus on patient care, not paperwork. If your ready to update your Assessments of Risk Call us at 724-357-8380 or email sales@rjhedges.com today.