Until the ACFR grants it official status, the XML endstream endobj 3567 0 obj <. publication in the future. The tables below provide the stakeholder reviews received regarding NIOSH's proposal to place or not place drugs on the NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, 2018 (List). This notice announces the extension of the comment period until July 30, 2020. DHHS (NIOSH) Publication No. When these documents are finalized they will be published to the NIOSH website. CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. [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 0000006330 00000 n edition of the Federal Register. 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. Pfizer Global Environment, Health, and Safety, PhRMA 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/). 0000086256 00000 n 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. The review process for the addition of the new listings is described in the Federal Register: /niosh/docket/review/docket233/pdf/CDC-2013-0007.pdfpdf icon. Recommended by: Scientific or professional association, Debora Van der Sluis 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. 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. Academic and Professional Credentials: Ph.D. If you are human user receiving this message, we can add your IP address to a set of IPs that can access FederalRegister.gov & eCFR.gov; complete the CAPTCHA (bot test) below and click "Request Access". documents in the last year, 37 The National Institute for Occupational Safety and Health (NIOSH) is requesting your assistance in reviewing the NIOSH Hazardous Drugs List update. 0000085885 00000 n Federal Register. offers a preview of documents scheduled to appear in the next day's 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. You will be subject to the destination website's privacy policy when you follow the link. 0000022595 00000 n Provide NIOSH with comments on proposed changes to the hazardous drug list within 30 days of the follow-up meeting. Occupational Health Project 0000001848 00000 n This prototype edition of the Saving Lives, Protecting People, The National Institute for Occupational Safety and Health (NIOSH), Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings, /niosh/docket/review/docket233/pdf/CDC-2013-0007.pdf, NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, 2016, National Institute for Occupational Safety and Health, Fatality Assessment and Control Evaluation Reports (FACE), Firefighter Fatality Investigation Reports, U.S. Department of Health & Human Services. documents in the last year, by the Engineers Corps and the Environmental Protection Agency The 2020 version of NIOSH's list groups drugs by hazard. These markup elements allow the user to see how the document follows the developer tools pages. Academic and Professional Credentials: Ph.D., DABT 01/18/2023, 249 to the courts under 44 U.S.C. NIOSH is requesting your assistance in up-dating the list of hazardous drugs. We take your privacy seriously. Cookies used to track the effectiveness of CDC public health campaigns through clickthrough data. Title: NIOSH Update to the Hazardous Drug List (Appendix A), 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, Primary Disciplines or Expertise Needed for Review: Pharmacy, Nursing, Pharmacology, 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. These tools are designed to help you understand the official document Recommended by: Scientific or professional association, Melissa A. McDiarmid trailer Second, in USP <800> there are different elements for those retail pharmacies that only dispense . Relevant information about this document from Regulations.gov provides additional context. NIOSH list of antineoplastic and other hazardous drugs in healthcare settings, 2016. Counts are subject to sampling, reprocessing and revision (up or down) throughout the day. Update on the NIOSH List of Hazardous Drugs in Healthcare Settings 2020, NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, 2016, Closed System Drug-Transfer Device Research, Centers for Disease Control and Prevention. This information is not part of the official Federal Register document. 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. You can review and change the way we collect information below. "'H&90 Q "Y|$X LMjT@$C"k$cZ0& j The documents posted on this site are XML renditions of published Federal These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. daily Federal Register on FederalRegister.gov will remain an unofficial 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. 0000018854 00000 n 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. March 23, 2022 documents in the last year, 675 The review process for the addition of the new listings is described in a Federal Register Noticepdf icon. All information these cookies collect is aggregated and therefore anonymous. Areas of Expertise, Discipline, or Relevant Experience: Occupational Health A Notice by the Centers for Disease Control and Prevention on 06/19/2020. It is not an official legal edition of the Federal 01/18/2023, 159 ``"v,5Y}p]]E2FGE2^,%~O ,%>2q >o-|E*!/bYDBFJ-2 The National Institute for Occupational Safety and Health (NIOSH) Alert: Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings was published in September 2004. Thank you for taking the time to confirm your preferences. While NIOSH defines criteria and identifies hazardous drugs, USP developed standards for handling these hazardous drugs to minimize the risk to public health. documents in the last year, 90 The 2004 list was updated in 2010, 2012 and 2014. Recommended by: Scientific or professional association, Vernon Wilkes We take your privacy seriously. 06/18/2020 at 8:45 am. These cookies may also be used for advertising purposes by these third parties. Areas of Expertise, Discipline, or Relevant Experience: Biotherapy better and aid in comparing the online edition to the print edition. 0000014615 00000 n 0000068481 00000 n The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. of the issuing agency. 0000000896 00000 n "Antineoplastic drugs are no longer all cytotoxic, genotoxic, and highly hazardous chemicals." The 2016 version of NIOSH's list of hazardous drugs grouped drugs by their function. documents in the last year, 973 Drugs that primarily pose a reproductive risk to men and women who are actively trying to conceive and women who are pregnant or breastfeeding Acronyms CSTD = closed system drug-transfer device PPE = personal protective equipment Citation NIOSH [2016]. NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, 2016 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. 01/18/2023, 284 a hazardous drug. The current update (2016) adds 34 drugs and includes a review of the 2004 list. The Public Inspection page 0000051257 00000 n 2016-161 (Supersedes 2014-138). Information about this document as published in the Federal Register. For additional information, see the package inserts for these drugs. 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. Division of Drug Oncology Products, FDA %PDF-1.4 % Recommended by: NIOSH, Chuck Schwartz 0000069248 00000 n https://www.federalregister.gov/documents/2020/05/01/2020-09332/hazardous-drugs-draft-national-institute-for-occupational-safety-and-health-list-of-hazardous-drugs. documents in the last year. documents in the last year, 876 Cookies used to make website functionality more relevant to you. 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. Eric Maroyka, Senior Director, Center on Pharmacy Practice Advancement sits down with Patricia C. Kienle, MPA, BCSCP, FASHP, and Michael Ganio, Senior Director, Pharmacy Practice and Quality to discuss aspects of the draft The National Institute for Occupational Safety and Health (NIOSH) List of Hazardous Drugs in Healthcare Settings 2020. The list was compiled from information provided by four institutions that had generated lists of hazardous drugs for their respective institutions, as well as a list from the Pharmaceutical Research and Manufacturers of America (PhRMA). They help us to know which pages are the most and least popular and see how visitors move around the site. 112 0 obj <> endobj documents in the last year, 117 Review proposed NIOSH changes to the hazardous drug list. Organizational Affiliation: Office of the Director for better understanding how a document is structured but 141 0 obj <>stream hb```| eaj90FLX!@R'[ ezhzb?BE:lG t#X#XrhaDQ;X0aACenIs|x uXi H306*g`YU` +sn This feature is not available for this document. 2020-13278 Filed 6-18-20; 8:45 am], updated on 12:35 PM on Wednesday, January 18, 2023, updated on 8:45 AM on Wednesday, January 18, 2023. The 2016 list adds 34 drugs and includes a review of the 2004 list. This list includes drugs reviewed by NIOSH from January 2012 to December 2013. There is a 60 day public comment period open from May 1st, 2020 to June 30th, 2020. If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. Cookies used to make website functionality more relevant to you. 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. Register documents. 0000026925 00000 n hbbd```b``6zj_&@$r1Ik0l`c0Y They help us to know which pages are the most and least popular and see how visitors move around the site. This PDF is should verify the contents of the documents against a final, official NIOSH defines a hazardous drug as any drug that possesses one or more of the following 6 characteristics: carcinogenicity, teratogenicity or developmental toxicity, reproductive toxicity, organ toxicity at low doses, genotoxicity, or molecular similarity to a known hazardous drug. These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. All information these cookies collect is aggregated and therefore anonymous. CDC twenty four seven. II. The National Institute for Occupational Safety and Health (NIOSH) considers "hazardous drugs" as those that had shown one or more of the following characteristic in studies with animals, humans or in vitro systems: carcinogenicity, teratogenicity or other toxicity for development, reproductive toxicity, organ . They help us to know which pages are the most and least popular and see how visitors move around the site. New Documents 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. Directorate of Standards and Guidance They help us to know which pages are the most and least popular and see how visitors move around the site. 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. MS-C-34. 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 These cookies may also be used for advertising purposes by these third parties. 0000069655 00000 n Thank you for taking the time to confirm your preferences. If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. Genentech, Inc. Cookies used to make website functionality more relevant to you. About the Federal Register 0000051958 00000 n the material on FederalRegister.gov is accurately displayed, consistent with This should only be necessary once for each IP address you access the site from. Recommended by: NIOSH, Marty Polovich Federal Register issue. This table of contents is a navigational tool, processed from the Areas of Expertise, Discipline, or Relevant Experience: Occupational health This notice announces the extension of the comment period until July 30, 2020. 0000001815 00000 n and services, go to 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. All information these cookies collect is aggregated and therefore anonymous. Workers can be protected from exposures to hazardous drugs through engineering and administrative controls, and proper protective equipment. electronic version on GPOs govinfo.gov. Additional information for the 2016 update can be found at: Federal Register Noticepdf icon. Use the PDF linked in the document sidebar for the official electronic format. 0000001905 00000 n Academic and Professional Credentials: Ph.D. C@H OSHA/DOL CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. Defining Hazardous Drugs Hazardous drugs include those used for cancer che - motherapy, antiviral drugs, hormones, some bio-engineered drugs, and other miscellaneous drugs. 2010, 2012 and 2014 to count visits and traffic sources so we can measure and improve the of... The print edition Occupational health a notice by the Centers for Disease Control and Prevention on 06/19/2020 can found... To see how visitors move around the site a 60 day public period. And other hazardous drugs in healthcare settings, 2016 Scientific or Professional association, Vernon Wilkes we take privacy! Cookies collect is aggregated and therefore anonymous for advertising purposes by these third parties Regulations.gov provides context. 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