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. Workers can be protected from exposures to hazardous drugs through engineering and administrative controls, and proper protective equipment. <<64B9B5CCA72D9D43827396971D79AAF9>]/Prev 916310>> hCt^p1I;WcXqBId|-`I81rT`XV6?>(pb`]0 0 6FYI.aqI,Q\xc7(dYQ,@*In'8A-? Document Drafting Handbook CDC twenty four seven. For complete information about, and access to, our official publications The President of the United States manages the operations of the Executive branch of Government through Executive orders. 0000069655 00000 n Recommended by: NIOSH, Marty Polovich 2016-161 (Supersedes 2014-138). Federal Register provide legal notice to the public and judicial notice NIOSH is requesting your assistance in up-dating the list of hazardous drugs. 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). 0000001948 00000 n Z>s82jrod|`t Rj+&=wg\3gjo9swoysg GeCIV&In\,Fzp(+,p>;[ [R`b9N%:=?dn'8! 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. Cookies used to track the effectiveness of CDC public health campaigns through clickthrough data. However NIOSH has always had some delay in time between new . Clarification about hazardous drugs. 3566 0 obj <> endobj 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. 06/18/2020 at 8:45 am. Centers for Disease Control and Prevention. headings within the legal text of Federal Register documents. 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. 0000069979 00000 n Answer: NIOSH hopes to return to more regular updates following finalization of the DRAFT NIOSH List of Hazardous Drugs. These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. A new format was developed for the 2014 list of hazardous drugs, as described below. CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. These cookies may also be used for advertising purposes by these third parties. 3607 0 obj <>stream documents in the last year, 117 [FR Doc. Cookies used to track the effectiveness of CDC public health campaigns through clickthrough data. documents in the last year, 675 Exposure to hazardous drugs can result in adverse health effects in healthcare workers. 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. Cincinnati, OH 45226-1998. 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. 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. 0000086256 00000 n OSHA/DOL documents in the last year, by the Indian Affairs Bureau Centers for Disease Control and Prevention. startxref 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 01/18/2023, 41 These can be useful 4762 0 obj <> endobj 0000051257 00000 n corresponding official PDF file on govinfo.gov. 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. CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. Submitted comments may not be available to be read until the agency has approved them. The current update (2016) adds 34 drugs and includes a review of the 2004 list. 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 January 10th, 2019 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. For additional information, see the package inserts for these drugs. Learn more here. If emailing please type 508 Accommodation PR#9342 without quotes in the subject line of the email. In Appendix A of the Alert, NIOSH identified a sample list of major hazardous drugs. Academic and Professional Credentials: Ph.D. Academic and Professional Credentials: MD, MPH hb```| eaj90FLX!@R'[ ezhzb?BE:lG t#X#XrhaDQ;X0aACenIs|x uXi H306*g`YU` +sn Review proposed NIOSH changes to the hazardous drug list. 0000001571 00000 n NIOSH requests public comment on the updated draft of the NIOSH List of Hazardous Drugs in Healthcare Settings, 2020, as well as the draft NIOSH Procedures for Developing the NIOSH List of Hazardous Drugs in Healthcare Settings, and the draft Managing Hazardous Drugs Exposures: Information for Healthcare Settings. 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. The Public Inspection page may also Pfizer Global Environment, Health, and Safety, PhRMA Comments must be received by July 30, 2020. 0000001815 00000 n Areas of Expertise, Discipline, or Relevant Experience: Occupational health 0000026925 00000 n HS>;z^ eJ_ER%!gPm5IWba4IEVl>tp?ms&/bYHLIJ:Y~KkA0&j%5* The comment period for the document published on May 1, 2020 (85 FR 25439), is extended. | kR\Y| Health care workers who prepare or administer hazardous drugs (e.g., those used for cancer therapy, and some antiviral drugs, hormone agents, and bioengineered drugs) or who work in areas where these drugs are used may be exposed to these agents in the workplace. 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. The health risk depends on how much exposure a worker has to these drugs and how toxic they are. Comments were to be received by June 30, 2020. This count refers to the total comment/submissions received on this document as reported by Regulations.gov (last updated on 08/08/2020 at 11:30 pm). fairport senior ball 2020 niosh 2021 hazardous . 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. You can review and change the way we collect information below. ET on July 30, 2020. include documents scheduled for later issues, at the request The 2016 list adds 34 drugs and includes a review of the 2004 list. Proposed Additions to the NIOSH Hazardous Drug List 2018 . 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. We take your privacy seriously. 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. The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), in the Department of Health and Human Services announces that the following draft documents are available for public comment: (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 (List), including those drugs proposed for placement on the 2020 List, and (3) Managing Hazardous Drug Exposures: Information for Healthcare Settings. An official website of the United States government. documents in the last year, 16 Group 1 includes all antineoplastic, Group 2 includes non-antineoplastic drugs that are a reproductive hazard and. 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., Comments will be accepted until 11:59 p.m. CDC twenty four seven. 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. 01/18/2023, 284 establishing the XML-based Federal Register as an ACFR-sanctioned II. Cookies used to make website functionality more relevant to you. Use the PDF linked in the document sidebar for the official electronic format. Click here for the NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, 2016pdf icon. They help us to know which pages are the most and least popular and see how visitors move around the site. %PDF-1.4 % 2016 NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings remains the most current list until NIOSH finalizes and publishes the 2020. 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". 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. Cookies used to track the effectiveness of CDC public health campaigns through clickthrough data. Areas of Expertise, Discipline, or Relevant Experience: Nursing No attempt https://www.federalregister.gov/documents/2020/05/01/2020-09332/hazardous-drugs-draft-national-institute-for-occupational-safety-and-health-list-of-hazardous-drugs. If you are using public inspection listings for legal research, you Only official editions of the The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. This site displays a prototype of a Web 2.0 version of the daily The review process for the addition of the new listings is described in a Federal Register Noticepdf icon. 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. This list includes drugs reviewed by NIOSH from January 2012 to December 2013. 01/18/2023, 159 You will be subject to the destination website's privacy policy when you follow the link. CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. 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 . The format for the 2014 list was revised to include three groups of hazardous drugs: (1) Antineoplastic drugs; (2) Non-antineoplastic hazardous drugs; and (3) Drugs with reproductive effects. If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. i8U This information is not part of the official Federal Register document. 0000018854 00000 n The reviewers will be requested to take part in the following process: The reviewers will be required to sign a conflict of interest form and to provide their individual reviews to NIOSH. developer tools pages. All relevant comments received will be posted without change to http://www.regulations.gov,, including any personal information provided. 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. As a result, drugs that required different protective measures were grouped together. All information these cookies collect is aggregated and therefore anonymous. 0000068678 00000 n }1%o~)FJewD!I;U I5$q$ Rd1 0/RM~wT7,4U@rI9i)Z4CCP*yKeKT82. This list includes drugs reviewed by NIOSH from January 2012 to December 2013. documents in the last year, 973 The National Institute for Occupational Safety and Health (NIOSH, / n a /) is the United States . publication in the future. MS-C-34. NIOSH requests public comment on the updated draft of the NIOSH List of Hazardous Drugs in Healthcare Settings, 2020, as well as the draft NIOSH Procedures for Developing the NIOSH List of Hazardous Drugs in Healthcare Settings, and the draft Managing Hazardous Drugs Exposures: Information for Healthcare Settings. You will be subject to the destination website's privacy policy when you follow the link. Counts are subject to sampling, reprocessing and revision (up or down) throughout the day. %%EOF xref Areas of Expertise, Discipline, or Relevant Experience: Pharmacology ACTION: Notice of draft document available for public comment. The National Institute for Occupational Safety and Health (NIOSH) is the federal agency that oversees research, data, and analysis on workplace hazards. This notice announces the extension of the comment period until July 30, 2020. This PDF is 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. The list is further divided into 3 groups. Organizational Affiliation: Duke University 0 endstream endobj startxref In this Issue, Documents Academic and Professional Credentials: I.H. These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. 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". Thank you for taking the time to confirm your preferences. Additional information for the 2016 update can be found at: Federal Register Noticepdf icon. 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. 112 30 0 Stakeholders provided comments on each drug . %%EOF 01/18/2023, 202 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/). Written comments, identified by CDC-2020-0046 and docket number NIOSH-233-C, may be submitted by any of the following methods: Persons with disabilities experiencing problems accessing this page should contact CDC-INFO at CDC-INFO email form: http://www.cdc.gov/info/, 800-232-4636 or the TTY number at (888) 232-6348 and ask for a 508 Accommodation PR#9342. Areas of Expertise, Discipline, or Relevant Experience: Nursing NIOSH is not seeking a consensus opinion from the reviewers as a group. for better understanding how a document is structured but Recommended by: Scientific or professional association, Vernon Wilkes This list includes drugs reviewed by NIOSH from January 2012 to December 2013. 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 electronic version on GPOs govinfo.gov. ``"v,5Y}p]]E2FGE2^,%~O ,%>2q >o-|E*!/bYDBFJ-2 Persons with disabilities experiencing problems accessing this page should contact CDC-INFO at CDC-INFO email form: http://www.cdc.gov/info/, 800-232-4636 or the TTY number at (888) 232-6348 and ask for a 508 Accommodation PR#9342. Director, National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention. 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. Take part in a follow-up meeting, for reviewers, in Washington, DC within 60 days of the first meeting. Register documents. These cookies may also be used for advertising purposes by these third parties. All information these cookies collect is aggregated and therefore anonymous. Areas of Expertise, Discipline, or Relevant Experience: Toxicology 0000006330 00000 n offers a preview of documents scheduled to appear in the next day's They help us to know which pages are the most and least popular and see how visitors move around the site. You can review and change the way we collect information below. Recommended by: Scientific or professional association, Melissa A. McDiarmid Healthcare workers can be exposed to dangerous drugs during their daily practice. These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our 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. From this list of approximately 150 drugs, 62 drugs were determined to fit one or more of the NIOSH criteria for a hazardous drug. %PDF-1.5 % Defining Hazardous Drugs Hazardous drugs include those used for cancer che - motherapy, antiviral drugs, hormones, some bio-engineered drugs, and other miscellaneous drugs. Recommended by: NIOSH, Chuck Schwartz 0000069248 00000 n documents in the last year, 1401 on Thank you for taking the time to confirm your preferences. Until the ACFR grants it official status, the XML The President of the United States communicates information on holidays, commemorations, special observances, trade, and policy through Proclamations. 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 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. Recommended by: Scientific or professional association. the official SGML-based PDF version on govinfo.gov, those relying on it for better and aid in comparing the online edition to the print edition. Biotechnology Industry Organization Review public comments on proposed NIOSH changes to the hazardous drug list. informational resource until the Administrative Committee of the Federal "'H&90 Q "Y|$X LMjT@$C"k$cZ0& j LIST OF COMMON HAZARDOUS DRUGS (HDS) This Appendix is taken verbatim from the NIOSH List of and Other Hazardous Drugs in Healthcare Settings, 2016, DHHS (NIOSH) Publication No. 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. All information these cookies collect is aggregated and therefore anonymous. the Federal Register. They help us to know which pages are the most and least popular and see how visitors move around the site. by the Farm Credit System Insurance Corporation Organizational Affiliation: Veterans Health Administration Cookies used to track the effectiveness of CDC public health campaigns through clickthrough data. endstream endobj 3567 0 obj <. New Documents This table of contents is a navigational tool, processed from the documents in the last year, 830 Organizational Affiliation: Occupational and Environmental Health Sciences Recommended by: Scientific or professional association, S. Leigh Verbois This list is not all-inclusive and represents an assessment of some, but not all, marketed drugs at a fixed point in time. They help us to know which pages are the most and least popular and see how visitors move around the site. 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. 0000052457 00000 n X}ic|Y\jm(5CEZf< 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. 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. This feature is not available for this document. and services, go to Areas of Expertise, Discipline, or Relevant Experience: Pharmacy edition of the Federal Register. are not part of the published document itself. 112 0 obj <> endobj C@H Academic and Professional Credentials: MPH Open for Comment, Rules of Practice and Procedure; Adjusting Civil Money Penalties for Inflation, Economic Sanctions & Foreign Assets Control, Revised Definition of Waters of the United States, Certain Preserved Mushrooms From France Determination, Energy Conservation Program: Test Procedure for Dishwashers, Prior Label Approval System: Expansion of Generic Label Approval, Rate Adjustments for Indian Irrigation Projects, Establishing the President's Advisory Council on African Diaspora Engagement in the United States, Centers for Disease Control and Prevention, Read the 171 public comments on this document, https://www.federalregister.gov/d/2020-13278, MODS: Government Publishing Office metadata. In fact, published studies have shown that workplace exposures to hazardous drugs can cause both acute and chronic health effects such as skin rashes, adverse reproductive outcomes (including infertility, spontaneous abortions, and congenital malformations), and possibly leukemia and other cancers. https://www.cdc.gov/niosh/review/peer/isi/haxdruglist2016-pr.html. documents in the last year, 534

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