To view the draft document, visit https://www.federalregister.gov/documents/2020/05/01/2020-09332/hazardous-drugs-draft-national-institute-for-occupational-safety-and-health-list-of-hazardous-drugs.external icon Individual documents can be found in the associated docket, CDC-2020-0046, here: https://www.regulations.gov/docket?D=CDC-2020-0046external icon. Areas of Expertise, Discipline, or Relevant Experience: Pharmacology "'H&90 Q "Y|$X LMjT@$C"k$cZ0& j Academic and Professional Credentials: MD, MPH Academic and Professional Credentials: Ph.D., DABT You can review and change the way we collect information below. hbbd```b``6zj_&@$r1Ik0l`c0Y The President of the United States manages the operations of the Executive branch of Government through Executive orders. Qh+Q0' PUNGF)AEx8I$d,TDI "s}Rp$u}!ZIV;I@ A$! documents in the last year, 117 ``"v,5Y}p]]E2FGE2^,%~O ,%>2q >o-|E*!/bYDBFJ-2 This feature is not available for this document. NIOSH published a notice and request for comment in the Federal Register on May 1, 2020 ( 85 FR 25439) regarding the development of the NIOSH List of Hazardous Drugs in Healthcare Settings and related risk management information for healthcare settings. The NIOSH definition of hazardous drugs used in the Alert is based on a definition originally devel-oped in 1990 by the American Society of Hospital Organizational Affiliation: American Nurses Association NIOSH has determined it is unlikely that paliperidone (Invega) poses a carcinogenic, reproductive or developmental hazard to workers in a healthcare setting and is no longer considered a hazardous drug by NIOSH. On May 1, 2020, the National Institute for Occupational Safety and Health (NIOSH), within the Center for Disease Control and Prevention (CDC), opened a docket to obtain public input on the following draft documents: (1) NIOSH Procedures for Developing the NIOSH List of Hazardous Drugs in Healthcare Settings (Procedures); (2) NIOSH List of Hazardous Drugs in Healthcare Settings, 2020 documents in the last year, 274 documents in the last year, by the Food Safety and Inspection Service All information these cookies collect is aggregated and therefore anonymous. II. @qF^Q>w~9 Stakeholder Comments . For complete information about, and access to, our official publications New Documents They help us to know which pages are the most and least popular and see how visitors move around the site. Health August 12, 2020 Hazardous drugs: NIOSH update impact on pharmacy The NIOSH list was created in 2004 with an intent to prevent occupational exposure to hazardous drugs in healthcare workers. These cookies perform functions like remembering presentation options or choices and, in some cases, delivery of web content that based on self-identified area of interests. If you do not allow these cookies we will not know when you have visited our site, and will not be able to monitor its performance. trailer edition of the Federal Register. 0000001905 00000 n This list includes drugs reviewed by NIOSH from January 2012 to December 2013. the Federal Register. Areas of Expertise, Discipline, or Relevant Experience: Biotherapy These cookies may also be used for advertising purposes by these third parties. endstream endobj 4763 0 obj <>/Metadata 93 0 R/Outlines 97 0 R/Pages 4760 0 R/StructTreeRoot 106 0 R/Type/Catalog/ViewerPreferences<>>> endobj 4764 0 obj <>/MediaBox[0 0 792 612]/Parent 4760 0 R/Resources<>/Font<>/ProcSet[/PDF/Text]>>/Rotate 0/StructParents 0/Tabs/S/Type/Page>> endobj 4765 0 obj <>stream If emailing please type 508 Accommodation PR#9342 without quotes in the subject line of the email. Merck & Co., Inc. Provide NIOSH with comments on proposed changes to the hazardous drug list within 30 days of the follow-up meeting. 0000069979 00000 n RE: Docket CDC-2020-0046, Docket Number NIOSH-233-C for "NIOSH List of Hazardous Drugs in Healthcare Settings, 2020; Procedures; and Risk Management Information". Recommended by: Scientific or professional association. NIOSH has determined it is unlikely that risperidone (Risperidal) poses a carcinogenic, reproductive, or developmental hazard to workers in a healthcare setting and is no longer considered a hazardous drug by NIOSH. 01/18/2023, 823 0000069655 00000 n Each document posted on the site includes a link to the Academic and Professional Credentials: MPH documents in the last year, by the Energy Department The current update (2016) adds 34 drugs and includes a review of the 2004 list. CDC twenty four seven. )1kRM,e@aH:@B!4O84\:BL5eW?WG0/# H[bxqa0 If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. documents in the last year, 28 Saving Lives, Protecting People, The National Institute for Occupational Safety and Health (NIOSH), NIOSH Procedures for Developing the NIOSH List of Hazardous Drugs in Healthcare Settings, Draft NIOSH List of Hazardous Drugs in Healthcare Settings, 2020, Managing Hazardous Drug Exposures: Information for Healthcare Settings, National Institute for Occupational Safety and Health, U.S. Department of Health & Human Services. Academic and Professional Credentials: Ph.D. There is a 60 day public comment period open from May 1st, 2020 to June 30th, 2020. Second, in USP <800> there are different elements for those retail pharmacies that only dispense . Barbara MacKenzie, NIOSH, Robert A. Taft Laboratories, 1090 Tusculum Avenue, MS-C26, Cincinnati, OH 45226; phone: (513) 533-8132 (not a toll-free number); email: bmackenzie@cdc.gov. NIOSH is not seeking a consensus opinion from the reviewers as a group. Areas of Expertise, Discipline, or Relevant Experience: Nursing If emailing please type 508 Accommodation PR#9342 without quotes in the subject line of the email. The NIOSH Alert: Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings was published in September 2004 (/niosh/docs/2004-165/). The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) published this list of hazardous drugs in 2016. The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) has updated its list of hazardous drugs for 2016. Thank you for taking the time to confirm your preferences. The review process for the addition of the new listings is described in a Federal Register Noticepdf icon. Recommended by: NIOSH, Katie Slavin daily Federal Register on FederalRegister.gov will remain an unofficial January 10th, 2019 Federal Register issue. CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. If you do not allow these cookies we will not know when you have visited our site, and will not be able to monitor its performance. The health risk depends on how much exposure a worker has to these drugs and how toxic they are. These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. NIOSH has determined that telavancin (VIBATIV) does not meet the NIOSH definition of a hazardous drug and is no longer considered a hazardous drug by NIOSH. The Public Inspection page endstream endobj startxref If you are using public inspection listings for legal research, you Comments must be received by July 30, 2020. The manufacturers of trabectedin (Yondelis), inotuzumab ozogamicin (Besponsa), polatuzumab vedotin (Polivy), enfortumab vedotin (Padcev), trastuzumab deruxtecan (Enhertu), sacituzumab govitecan (Trodelvy), loncastuximab tesirine (Zynlonta), melphalan flufenamide (Pepaxto), belantamab mafodotin (Blenrep), and tisotumab vedotin-tftv (Tivdak) recommend that they be handled as hazardous drugs. No attempt You may submit written comments, identified by docket numbers CDC-2020-0046 and NIOSH-233-C, by either of the following two methods: Instructions: All information received in response to this notice must include the agency name and docket number [CDC-2020-0046; NIOSH-233-C]. on If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. Thank you for taking the time to confirm your preferences. Areas of Expertise, Discipline, or Relevant Experience: Pharmacology 3607 0 obj <>stream rendition of the daily Federal Register on FederalRegister.gov does not 06/18/2020 at 8:45 am. | kR\Y| a hazardous drug. headings within the legal text of Federal Register documents. All information these cookies collect is aggregated and therefore anonymous. Toxicology, Occupational Health, Industrial Hygiene, Reviewers Selected by: NIOSH, ASHP, ONS, ANA, VA, OSHA, FDA, PhRMA, and BIO, Public Nominations Requested for Reviewers: No, Opportunities for the Public to Comment: Yes, Peer Reviewers Provided with Public Comments Before Their Review: Yes, Cynthia Reilly Biotechnology Industry Organization Pfizer Global Environment, Health, and Safety, PhRMA 0000052457 00000 n Cookies used to make website functionality more relevant to you. 0000090514 00000 n to the courts under 44 U.S.C. Recommended by: NIOSH, Chuck Schwartz Counts are subject to sampling, reprocessing and revision (up or down) throughout the day. Cookies used to enable you to share pages and content that you find interesting on CDC.gov through third party social networking and other websites. 0000027413 00000 n An official website of the United States government. John J. Howard, First, we identified the most recent available list of "hazardous drugs" published by the NIOSH, specifically pertaining to group 1 (NIOSH, 2020).Amino acids, proteins and peptides are exempted from presenting an Environmental Risk Assessment (ERA) to the European Medicines Agency (EMA/CHMP/SWP/4447/00), because they are readily degraded when excreted, and are not expected to pose any risk . To view the notice and related materials, visit http://www.regulations.govexternal icon and enter CDC-2020-0046 in the search field and click Search.. [PDF 32 KB] Required Elements for Initial Public Posting Title: NIOSH Update to the Hazardous Drug List (Appendix A) Subject: NIOSH Hazardous Drug List Purpose: To provide an update of the list of hazardous drugs in the Alert: Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings Submitted comments may not be available to be read until the agency has approved them. Please include the URL of the site in the Subject line of your email request that you would like to access. Agencies review all submissions and may choose to redact, or withhold, certain submissions (or portions thereof). Since its inception, it has been revised to keep up to date with drug development and evolution, and it is undergoing its most recent update. You will be subject to the destination website's privacy policy when you follow the link. The 2004 list was updated in 2010, 2012 and 2014. `# @{3&jb51 QOINAVRpxCVy{j"V$ ->0c, An additional 18 drugs were included from the updated NIH Hazardous Drug List. The list is further divided into 3 groups. This list includes drugs reviewed by NIOSH from January 2012 to December 2013. We take your privacy seriously. We take your privacy seriously. 3590 0 obj <>/Filter/FlateDecode/ID[<473407BB4B871C4FABB102F468EAE769>]/Index[3566 42]/Info 3565 0 R/Length 115/Prev 645075/Root 3567 0 R/Size 3608/Type/XRef/W[1 3 1]>>stream Areas of Expertise, Discipline, or Relevant Experience: Occupational health documents in the last year, 84 hCt^p1I;WcXqBId|-`I81rT`XV6?>(pb`]0 0 6FYI.aqI,Q\xc7(dYQ,@*In'8A-? ACTION: Notice of draft document available for public comment. Areas of Expertise, Discipline, or Relevant Experience: Nursing Healthcare workers can be exposed to dangerous drugs during their daily practice. All relevant comments received will be posted without change to http://www.regulations.gov,, including any personal information provided. }l>smnqrC[{{mM ,Hb /h@ r-v{@(N%yH&H#(\,::Db)u,p>\.b1V"E/@,Q`\ cRd2@n#@!$0"fw l#@`GB@ u83.w!Xcb)p$"GL#7:*8d(|? kXcI6?}d(Nu8y4R: Da ~ has no substantive legal effect. The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. Cookies used to make website functionality more relevant to you. Areas of Expertise, Discipline, or Relevant Experience: Occupational Health that agencies use to create their documents. 0 Recommended by: Scientific or professional association, Melissa A. McDiarmid https://www.cdc.gov/niosh/review/peer/isi/haxdruglist2016-pr.html. Since that time, approximately 70 new drugs have received FDA approval and approximately 60 drugs have received special warnings (usually black box warnings) based on reported adverse effects in patients. on Document Drafting Handbook Thank you for taking the time to confirm your preferences. NIOSH is extending the comment period to close on July 30, 2020, to allow stakeholders and other interested parties additional time to respond. If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. All information these cookies collect is aggregated and therefore anonymous. Document page views are updated periodically throughout the day and are cumulative counts for this document. }1%o~)FJewD!I;U I5$q$ Rd1 0/RM~wT7,4U@rI9i)Z4CCP*yKeKT82. January 10th, 2019 The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. 3566 0 obj <> endobj corresponding official PDF file on govinfo.gov. %PDF-1.4 % Proposed Additions to the NIOSH Hazardous Drug List 2018 . Occupational Health Project %%EOF documents in the last year, by the Engineers Corps and the Environmental Protection Agency the current document as it appeared on Public Inspection on documents in the last year, 876 Academic and Professional Credentials: BSN, RN Saving Lives, Protecting People, The National Institute for Occupational Safety and Health (NIOSH), NIOSH Procedures for Developing the NIOSH List of Hazardous Drugs in Healthcare Settings, Draft NIOSH List of Hazardous Drugs in Healthcare Settings, 2020, Managing Hazardous Drug Exposures: Information for Healthcare Settings, National Institute for Occupational Safety and Health, U.S. Department of Health & Human Services. Linking to a non-federal website does not constitute an endorsement by CDC or any of its employees of the sponsors or the information and products presented on the website. 0000022595 00000 n In Appendix A of the Alert, NIOSH identified a sample list of major hazardous drugs. Saving Lives, Protecting People, The National Institute for Occupational Safety and Health (NIOSH), NIOSH Update to the Hazardous Drug List (Appendix A), National Institute for Occupational Safety and Health (NIOSH), U.S. Department of Health & Human Services. 2016-161 (September 2016) MS-C-34. Genentech, Inc. A Notice by the Centers for Disease Control and Prevention on 06/19/2020. Cookies used to enable you to share pages and content that you find interesting on CDC.gov through third party social networking and other websites. 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