For a USP chapter numbered below 1000 to become compendially required, it needs to either be referenced in General Notices, a monograph or another general chapter numbered below <1000>. Interested parties are invited to participate in this activity by submitting Start Printed Page 25440written views, opinions, recommendations, and/or data. This PDF is . In rats, exenatide administered during the period of organogenesis reduced fetal growth and produced skeletal ossification deficits at doses that approximate the maximum recommended human dose. USP <800> incorporates by reference the NIOSH List and imposes certain requirements on its users when handling certain drugs on the List. However, after consideration of input from the public and stakeholders, NIOSH has decided to review the toxicity and the hazards related to occupational exposure to botulinum toxins. NIOSH response: A systematic review is a significant undertaking requiring the prior publication or dissemination of multiple studies relating to a specific drug. Hazardous-Drugs-Lists-Where-to-Look - Pharmacy Practice News documents in the last year, by the Energy Department PDF USP General Chapter <800> Hazardous DrugsHandling in Healthcare Settings documents in the last year, 669 NIOSH response: In 2004, NIOSH used lists from several organizations as examples of hazardous drugs. NIOSH consulted four independent peer reviewers, who were asked to consider the following questions: Overall, the independent peer reviewers found the draft Policy and Procedures to be clearly written and supported by the available science and the reconsideration process (now referred to as reevaluation) to be adequate. NIOSH response: NIOSH has determined that dihydroergotamine has demonstrated reproductive toxicity in experimental animals. After evaluating public comments, NIOSH made the following determination: 13 drugs are proposed for placement on the List, 3 drugs are automatically added to the List because they have MSHI in the package insert (2 drugs identified in the 2018 FRN and another recently-approved by FDA), 7 drugs proposed for placement on the List in the 2018 FRN are no longer considered in this action. edition of the Federal Register. Of the 275 drugs identified during that timeframe, two had special handling information specified by the manufacturer (MSHI) and were automatically placed on the List. 05/01/2023, 39 NIOSH may consider molecular weight along with the other intrinsic molecular properties of a drug that affect the hazard a drug poses. . Counts are subject to sampling, reprocessing and revision (up or down) throughout the day. Comment: Ivabradine should not be placed on the List. The following seven drugs that were proposed for placement on the List in the February 2018 FRN are no longer proposed for placement on the List, for the reasons discussed above in Sections II.B. 2. [7] NIOSH response: NIOSH's rationale for proposing the placement of triazolam on the List was that it mimics the benzodiazepines which are included on the List because they are teratogenic or cause other developmental effects. A new peer review was not conducted. Peer review comment: NIOSH should offer an example of why a drug identified as a hazardous drug because it poses as carcinogenic hazard might not be a classified as a carcinogen pursuant to the NIOSH Chemical Carcinogen Policy. This drug is scheduled to be reviewed for the next, Because drugs sold over the counter are not contemplated in this activity, this drug has not been and will not be reviewed for placement on the, This drug was reviewed by NIOSH and presented in the 2018 FRN; the available information shows a toxic effect that does not meet the NIOSH definition of hazardous drug. offers a preview of documents scheduled to appear in the next day's The President of the United States manages the operations of the Executive branch of Government through Executive orders. Barbara MacKenzie, NIOSH, Robert A. Taft Laboratories, 1090 Tusculum Avenue, MS-C26, Cincinnati, OH 45226, telephone (513) 533-8132 (not a toll free number), email: bmackenzie@cdc.gov. Procedures for Developing the NIOSH List of Hazardous Drugs in Healthcare Settings is intended to formalize the methodology that NIOSH uses to add hazardous drugs to its list. Facility and engineering protocols. documents in the last year. NIOSH response: Only a few of the drugs on the List are known to have an appreciable vapor pressure; reliable information concerning the vapor pressure of most drugs can be difficult to identify. Peer review comment: Some paragraphs in the section entitled, Evidence of Health Effects in Workers from Handling Hazardous Drugs do not belong in the scientific approach section and should be moved to be part of section B Systematic and Sequential Methodology section. Peer reviews on the draft Policy and Procedures, as well as NIOSH's responses, are discussed below. NIOSH response: NIOSH uses the subset of Bradford Hill criteria which are most useful for evaluating human study results on hazardous drugs. Accordingly, darbepoetin alfa is no longer proposed for placement on the 2020 List. USP <800> requires an assessment of risk, which is a consideration of the type of HD, dosage form, risk of exposure, packaging, and manipulation. documents in the last year, 931 NIOSH response: Drugs still under investigation are not included on the List because no scientific information, including information normally provided in package inserts, is available for NIOSH review. All three draft documents are available in the docket for this activity. documents in the last year, 1471 hazardous drugs. better and aid in comparing the online edition to the print edition. NIOSH response: FDA-approved drugs generally have a reasonable body of toxicity information because the manufacturers are required by FDA to provide this information to ensure patient safety when seeking approval for their drugs. NIOSH response: As presented in the 2018 FRN, NIOSH reviewed cetuximab, ibrutinib, ipilimumab, necitumumab, nintedanib, nivolumab, palbociclib, panitumumab, ramucirumab, and ruxolitinib for placement on the List and, for each, the available information showed a toxic effect that does not meet the NIOSH definition of a hazardous drug. Teratogenicity: The package insert contains a warning of embryofetal toxicity when administered to pregnant women.
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