Peer reviews on the draft Policy and Procedures, as well as NIOSH's responses, are discussed below. Often the mechanism of action for the drug being assessed is known and can be compared to other drugs of a similar structure/activity. . 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). The requestor need only provide some new information that is relevant to the issue of whether the drug does or does not meet the NIOSH definition of a hazardous drug or the decision to place a drug on a particular table in the List. 3. the current document as it appeared on Public Inspection on Please provide information about your professional experience, if any, of implementing control strategies for exposures to hazardous drugs in healthcare or similar settings. USP <800> requires an assessment of risk, which is a consideration of the type of HD, dosage form, risk of exposure, packaging, and manipulation. NIOSH defines HDs as the following: NIOSH response: Compilation of the List is a hazard identification and hazard characterization process, as described in the draft Procedures. the material on FederalRegister.gov is accurately displayed, consistent with NIOSH proposed an updated list in 2020, Ms. Kienle noted, which is not yet official. In mice, doses near the maximum recommended human dose lead to increased neonatal death. USP 800 only states Table 1. Carcinogenicity: Cited studies demonstrated an increased incidence of various oncologic presentations (hepatocellular adenoma/carcinoma, interstitial cell hyperplasia, and uterine endometrial adenocarcinoma), in multiple animal species (rat and mice) at exposure lower than human doses (0.7-1.4 fold in rats and 0.3-0.7 fold in mice compared to a human dosing). 'When available, published, peer-reviewed scientific literature about the hazard potential of a particular drug, including any studies cited in the package insert that are relevant to workers in a health care setting.' All relevant comments received will be posted without change to www.regulations.gov,, including any personal information provided. I wonder whether the current regulatory climate permits NIOSH any level of control over the handling of drugs in this category.. Note: General Chapter <800> is informational and not compendially applicable. Although rare, NIOSH notes any labeling changes that could affect the status of a drug that has been previously classified as hazardous.
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