Non-compliance with USP <800> can lead to which consequences?

• A. All of the above
• B. Increased worker exposure risk
• C. Regulatory penalties, legal liability, and potential inability to operate
• D. Safety hazards

Answer: (D)

Non-compliance with USP <800> opens up multiple, intertwined risks. The standard is in place to protect workers and the environment from exposure to hazardous drugs, so when it isn’t followed, safety hazards can arise from spills, leaks, improper containment, or inadequate engineering and administrative controls. This directly increases worker exposure risk, which is a core safety concern. At the same time, not meeting regulatory requirements can lead to penalties from authorities, legal liability, and even interruptions to operations until corrective actions are implemented. Because all of these consequences can occur, the option that encompasses them all best reflects the real impact of not adhering to USP <800>.