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. These hazardous medications are capable of causing serious effects including cancer, organ toxicity, fertility problems, genetic damage, and birth defects. In the case of a drug being reevaluated, conclusions about study quality would be discussed in a notice published in the Federal Register. Carcinogenicity/teratogenicity: Cited studies demonstrated an increased incidence of hepatocellular adenomas in mice. 4th Edition, (Burlington, MA: Jones & Bartlett). It is unclear why animal studies were not included as a source of evaluating potentially hazardous drugs. are not part of the published document itself. For some of these drugs, no drug-specific data were available in the package inserts to support warnings in the inserts regarding developmental or reproductive effects; for other drugs, the toxic effects occurred at doses higher than human recommended doses. . Register, and does not replace the official print version or the official Federal Register provide legal notice to the public and judicial notice Therefore, when antineoplastic drugs are grouped as they were in earlier versions of Table 1 of the List, an appearance that these drugs pose the same hazard was inadvertently created (i.e., non-cytotoxic drugs with cytotoxic drugs). Usp 800 | Usp NIOSH may consider molecular weight along with the other intrinsic molecular properties of a drug that affect the hazard a drug poses. [1], Fifty-seven submissions were received in docket CDC-2018-0004 (NIOSH-233-B) from 55 commenters (one commenter sent three separate submissions to the docket). Therefore, when drugs are grouped by their function (i.e., antineoplastic), as they were in earlier versions of Table 1, drugs that required different protective measures were grouped together (non-cytotoxic drugs with cytotoxic drugs). NIOSH response: The List is updated any time NIOSH is aware that a drug manufacturer has added special handling information to the patient information for a specific drug.
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usp <800> hazardous drug list 2020