After review, NIOSH now finds that the information in the package insert for this drug does not support a determination that it presents a hazard to healthcare workers and is no longer proposing to place it on the List. Federal Register provide legal notice to the public and judicial notice In very few cases, if any, would sufficient studies be available to conduct a formal meta-analysis relating to a specific drug. Peer review comment: NIOSH should clarify a sentence concerning NIOSH's preference for human genotoxicity data which states: If available, NIOSH gives preference to those studies. This drug poses no risk to healthcare workers; the evidence supporting its addition is not based on occupational exposure. If you have any questions regarding hazardous drugs please submit them to Email CDC-INFO or call 1-800-CDC-INFO (800-232-4636), TTY: 888-232-6348) When studies are available for review of a drug being considered for placement on the List or for the reevaluation of a drug already on the List, quality may be evaluated by NIOSH scientists and independent peer reviewers on a case-by-case basis. and III.B: bevacizumab, botulinum toxins, darbepoetin alfa, interferon beta-1b, osimertinib, trastuzumab, and triazolam. Register, and does not replace the official print version or the official Accordingly, darbepoetin alfa is no longer proposed for placement on the 2020 List. NIOSH response: NIOSH applies the same methodology for evaluating each drug approved by the FDA Center for Drug Evaluation and Research, regardless of class. USP General Chapter <800> AHazardous Drugs Handling in Healthcare Settings USP first published General Chapter <800> in February 2016, with the official date anticipated for December 2019. 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). Animal studies, where available, are also used in our evaluations. Each document posted on the site includes a link to the NIOSH response: NIOSH has determined that teratogenicity or other developmental toxicity after exposure to osimertinib were observed at doses higher than the maximum recommended human dose and reproductive effects at doses lower than the maximum recommended human doses were equivocal. include documents scheduled for later issues, at the request Three commenters offered opinions on the timeliness of the List, which NIOSH has attempted to publish every 2 years since 2010. the Federal Register. Accordingly, NIOSH proposes to place olaparib on the List. Is the information threshold scientifically sound? Comment: NIOSH indicated that 10 drugscetuximab, ibrutinib, ipilmumab, necitumumab, nintedanib, nivolumab, palbociclib, panitumumab, ramucirumab, and ruxolitinibdemonstrated available information that shows a toxic effect that does not meet the NIOSH definition of a hazardous drug. These standards apply to all healthcare personnel who receive, prepare, administer, transport or otherwise come in contact with hazardous drugs and all the environments in which they are handled. You will receive an e-mail containing your requested General Chapter downloads after submission.
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