USP 800 Label Requirements: What Pharmacies Should Know
By Apothecary Products | Published: 2026-10-28
Category: Tips & Care
Learn the key labeling requirements under USP 800 for hazardous drugs, including what information must appear and how auxiliary labels help compliance.
Quick answer
USP 800 requires clear labeling of hazardous drugs to prevent mishandling, and using auxiliary labels like the USP 800 Label helps reinforce warnings and handling instructions.
Why labeling matters for hazardous drugs
Labeling is a critical part of USP 800 compliance because it directly affects how staff handle and store hazardous drugs. Clear labels reduce the risk of accidental exposure and ensure that anyone who comes into contact with the container knows the necessary precautions.
The standard emphasizes that all hazardous drugs must be labeled to indicate their hazardous nature. This includes both the immediate container and any secondary packaging, so the warning travels with the drug through every step of handling.
What to include on a USP 800 label
A compliant label should clearly identify the drug as hazardous, include the drug name and concentration, and state any special handling or storage instructions. The label must be legible and durable enough to withstand typical pharmacy conditions.
Auxiliary labels can supplement the primary label by adding specific warnings or instructions that might not fit on the main label. For example, a label that says "Hazardous Drug" or "Do not crush" can be added to the container to reinforce the message.
Common USP 800 labeling questions
- What does USP 800 require for labeling hazardous drugs?
- USP 800 requires that hazardous drugs be labeled to indicate their hazardous nature. The label should include the drug name, concentration, and any special handling or storage instructions. Auxiliary labels can be used to add warnings like 'Hazardous Drug' or 'Do not crush'.
- Can I use auxiliary labels to meet USP 800 requirements?
- Yes, auxiliary labels are a practical way to add specific warnings or handling instructions to hazardous drug containers. They supplement the primary label and help ensure that important information is not overlooked. Check that auxiliary labels are legible and adhere well to the container surface.
- How should hazardous drug labels be applied?
- Labels should be applied firmly to the container, ensuring they are not obscured by other labels or tape. The label should remain legible throughout the drug's shelf life and withstand handling and storage conditions. Inspect labels regularly for wear or damage and replace them if they become unreadable.
Product facts
- "USP 800 Label": The USP 800 Label is an auxiliary label designed to emphasize medication information through advisory labeling. Adding this label to hazardous drug containers helps ensure staff and patients see important warnings, supporting USP 800 compliance.
"USP 800 Label"
