USP 800: What Community Pharmacies Need to Know

Most community pharmacies don’t compound with hazardous drugs, but that doesn’t mean you’re off the hook when it comes to USP 800 compliance. This standard, USP General Chapter <800> Hazardous Drugs: Handling in Healthcare Settings, applies to anyone who receives, stores, or dispenses hazardous drugs (HDs). And yes, that includes community pharmacies.

What Makes a Drug Hazardous?

NIOSH defines a drug as hazardous if it’s linked to cancer, reproductive harm, organ damage, or genetic effects. There are over 250 medications that need to be handled safely to reduce potential harm to employees including medications commonly stocked in community pharmacies such as: azathioprine, carbamazepine, colchicine, finasteride, methotrexate, phenytoin, topiramate, warfarin, as well as hormone products including oral contraceptives.

Key Steps for Compliance

  1. Create and maintain a Hazardous Drug List and review it annually
  2. Develop written Policies and Procedures that outline your work practices for handling hazardous drugs
  3. Perform and document Risk Assessments for each hazardous drug/dosage form
  4. Purchase or create a Spill Kit to handle spills safely
  5. Wear Personal Protective Equipment (PPE) as determined by your policies and risk assessment
  6. Train your staff on safe handling practices, PPE, and spills (complete prior to handling hazardous drugs and then annually)

Why It Matters

A trace of powder left on a counting tray may seem harmless, but repeated exposure can cause long-term health risks. USP 800 isn’t just red tape, it’s about protecting your pharmacy team while they are handling hazardous drugs.

By taking small but consistent steps – hazardous drug list, risk assessments, PPE, training, and spill planning – community pharmacies can stay compliant and create a safer workplace for everyone.

PAAS Tips:

  • Pharmacies interested in a turnkey USP 800 Compliance Program should review program details on the PAAS National® website or call (608) 873-1342 for additional information.
    • The PAAS program is not intended for pharmacies that are compounding with hazardous drugs.
  • For pharmacies that already utilize PAAS’ USP 800 program, ensure that you have reviewed the hazardous drug list based on NIOSH changes implemented in December 2024 as discussed in our May 2025 article, USP 800 Compliance Program Updates: NIOSH 2024 List
Eric Hartkopf, PharmD
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