South Carolina Multistate Pharmacy Jurisprudence Examination (MPJE) Practice Exam

Which entity is responsible for defining hazardous drugs in relation to USP 800?

1. FDA

2. NIOSH

3. CDC

4. DEA

The correct answer is: NIOSH

The correct answer is NIOSH, as it is the National Institute for Occupational Safety and Health, which has the specific role of identifying and listing hazardous drugs. NIOSH publishes a list of antineoplastic and other hazardous drugs for healthcare settings, which is relevant for compliance with USP Chapter 800. USP 800 outlines the standards for handling hazardous drugs in healthcare settings, ensuring safety for workers and patients. The guideline specifies that hazardous drug definitions must be based on criteria established by NIOSH, as this agency assesses the risk associated with exposure to certain drugs due to their potential to cause harm. The other entities mentioned, while involved in aspects of drug regulation and safety, do not have the same specific role in defining hazardous drugs as NIOSH does. The FDA focuses on drug approval and regulation, the CDC provides guidelines on public health practices, and the DEA regulates controlled substances primarily related to their scheduling and distribution, not specifically identifying hazardous drugs.