USP 800 defines standards for handling which of the following?

• A. Controlled substances
• B. Hazardous drugs
• C. Over-the-counter medications
• D. Vitamins

Answer: (B)

USP 800 sets safety standards for handling hazardous drugs to protect health-care workers and the environment from exposure during every step of handling—receiving, storage, compounding, dispensing, administration, and disposal, including spill management and waste. Hazardous drugs are those with properties that pose risks even at low doses, such as carcinogenicity, teratogenicity or reproductive toxicity, organ toxicity at low doses, genotoxicity, or other harmful effects demonstrated by new drugs with similar properties. The standard requires appropriate engineering controls (like negative-pressure rooms and containment hoods), administrative controls, and personal protective equipment (such as chemo gloves and gowns) to limit exposure. It’s not about over-the-counter medications or vitamins, and while controlled substances have their own regulations, USP 800 specifically targets hazardous drugs and the safe handling of those agents throughout their life cycle.