documents in the last year, 887 Docket 233-C: List of Hazardous Drugs in Healthcare Settings, 2020 The OFR/GPO partnership is committed to presenting accurate and reliable What additional information would improve its usefulness and why? 05/01/2023, 244 NIOSH response: After scientific review and consideration of input from peer reviewers and public commenters, NIOSH is proposing a reorganization of the List. Comment: In the draft Policy and Procedures footnote 45, NIOSH lists criteria used to evaluate information from animal studies. These hazardous medications are capable of causing serious effects including cancer, organ toxicity, fertility problems, genetic damage, and birth defects. Comments were invited on any topic related to the drugs reviewed by NIOSH for possible placement on the planned 2018 version of the List. Fluconazole meets the NIOSH criteria for a hazardous drug while the other two, ketoconazol and itraconazole, do not. [FR Doc. the material on FederalRegister.gov is accurately displayed, consistent with Register, and does not replace the official print version or the official PDF NIOSH Procedures for Hazardous Drugs draft - CDC on Sargent EV and Kirk GD [1988], Establishing Airborne Exposure Control Limits in the Pharmaceutical Industry, Am Ind Hyg Assoc J 49(6):309-13; Naumann BD and Sargent EV [1997], Setting Occupational Exposure Limits for Pharmaceuticals, Occup Med 12(1):67-80; Sargent EV, Naumann BD, Dolan DG, Faria EC, Schulman L [2002], The Importance of Human Data in the Establishment of Occupational Exposure Limits, Hum Ecol Risk Assess 8(4):805-822. Comment: Peer reviews should be conducted before the close of the public comment period to allow public commenters time to review them. b. documents in the last year, 669 The Procedures for Developing the NIOSH List of Hazardous Drugs in Healthcare Settings ( Procedures) establish the NIOSH definition of a hazardous drug and a methodology for evaluating chemical properties, pre-clinical information, and available clinical information about each drug. NIOSH response: NIOSH concurs with commenters that the evidence of carcinogenicity for darbepoetin alfa in patients who did not already have cancer was insufficient to support a NIOSH finding of carcinogenicity. This convention was prepared to implement USP General Chapter <800> on December 1, 2019, which would have been an enforceable standard for managing sterile and non-sterile hazardous . . In that case, NIOSH may consider it to be appropriately grouped with carcinogenic drugs, although it would not necessarily meet the criteria for an occupational carcinogen according to the NIOSH Chemical Carcinogen Policy. More information and documentation can be found in our Peer Review Summaries and NIOSH Responses, Identifying, Screening, Evaluating, and Reviewing a Drug for Placement on the, Reconsideration (Reevaluation) of NIOSH Decisions to Place and Remove Drugs, B.
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