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What does NABP consider a hazardous drug?

For purposes of NABP’s inspection and accreditation programs, we follow the definition(s) provided by the U.S. Centers for Disease Control and Prevention (CDC) National Institute for Occupational Safety and Health (NIOSH) for hazardous drugs. 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. Regulatory Commission, and Either:

1. Is accompanied by prescribing information in the ‘package insert’ that includes manufacturer’s special handling information (MSHI) to protect workers handling the drug, or
2. Is identified as a carcinogenic hazard, developmental 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.” 

The current version of hazardous drugs can be found in the 2024 version of the NIOSH list.