Safe Handling of Hazardous Drugs
Introduction As stated in the Procedures for Developing the NIOSH List of Hazardous Drugs in Healthcare Settings (Procedures) , NIOSH defines a hazardous drug as a drug that is Approved for use in humans by FDA CDER, Not otherwise regulated by the U.S. Nuclear Regulatory Commission, and Either Is accompanied by prescribing information in the "package insert" that includes manufacturer's special handling information (MSHI) to protect workers handling the drug, or Is identified as a carcinogenic hazard, development hazard, reproductive hazard, genotoxic hazard, or other health hazard by exhibiting one or more of the following toxicity criteria in humans, animal models or in vitro systems. Carcinogenicity Developmental toxicity (including teratogenicity) Reproductive toxicity Genotoxicity Organ toxicity at low doses, or a Structure and toxicity profile that mimics existing drugs determined hazardous by exhibiting any one of the previous five toxicity types. However, if a ...