USP 797 safeguards sterile compounding for consumer protection, but concerns about the well-being of healthcare manufacturing personnel led to the creation of USP 800.
While USP 797 prioritizes patient safety, USP 800 focuses on protecting healthcare workers handling hazardous drugs.
NIOSH defines a hazardous drug as displaying characteristics such as carcinogenicity, teratogenicity, reproductive toxicity, organ toxicity at low doses, genotoxicity, or resembling existing hazardous drugs in humans or animals.