Growing evidence highlights that acute and chronic health effects can occur due to occupational exposure to over 200 hazardous drugs used commonly in healthcare settings. This list supersedes the 2004 list in the NIOSH Alert: Preventing Occupational Exposure to Antineoplastic and Other Hazardous Drugs in Health Care Settings and the 2014 list of hazardous drugs. 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. All information these cookies collect is aggregated and therefore anonymous. 0000001948 00000 n They help us to know which pages are the most and least popular and see how visitors move around the site. headings within the legal text of Federal Register documents. The 2020 version of NIOSH's list groups drugs by hazard. }1%o~)FJewD!I;U I5$q$ Rd1 0/RM~wT7,4U@rI9i)Z4CCP*yKeKT82. 0000085163 00000 n publication in the future. Register, and does not replace the official print version or the official If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. Recommended by: NIOSH, Marty Polovich documents in the last year, 1401 The President of the United States manages the operations of the Executive branch of Government through Executive orders. This table of contents is a navigational tool, processed from the Take part in a follow-up meeting, for reviewers, in Washington, DC within 60 days of the first meeting. 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. Cookies used to make website functionality more relevant to you. These cookies may also be used for advertising purposes by these third parties. }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 ~ (List), and (3) Managing Hazardous Drug Exposures: Information for Healthcare Settings. If emailing please type 508 Accommodation PR#9342 without quotes in the subject line of the email. Cookies used to make website functionality more relevant to you. %%EOF a hazardous drug. 0000090514 00000 n documents in the last year, by the Food Safety and Inspection Service This list includes drugs reviewed by NIOSH from January 2012 to December 2013. They help us to know which pages are the most and least popular and see how visitors move around the 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". These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. 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. Comments must be received by July 30, 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. 0000006330 00000 n Centers for Disease Control and Prevention. 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. If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. First, any pharmacy that has any type of HD, as identified on the NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, 2016, needs to comply with USP <800>. All relevant comments received will be posted without change to http://www.regulations.gov,, including any personal information provided. regulatory information on FederalRegister.gov with the objective of Organizational Affiliation: Director, Toxicology and Hazard Communication <<64B9B5CCA72D9D43827396971D79AAF9>]/Prev 916310>> X}ic|Y\jm(5CEZf< So let's answer those questions and clear up a few other items. However NIOSH has always had some delay in time between new . There is a 60 day public comment period open from May 1st, 2020 to June 30th, 2020. You will be subject to the destination website's privacy policy when you follow the link. ET on July 30, 2020. Recommended by: NIOSH, Katie Slavin to the courts under 44 U.S.C. Cookies used to track the effectiveness of CDC public health campaigns through clickthrough data. Organizational Affiliation: Occupational and Environmental Health Sciences 0000068678 00000 n 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. Cookies used to track the effectiveness of CDC public health campaigns through clickthrough data. documents in the last year, 16 More information and documentation can be found in our | kR\Y| 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. Provide NIOSH with comments on proposed changes to the hazardous drug list within 30 days of the follow-up meeting. Healthcare workers can be exposed to dangerous drugs during their daily practice. 0000001815 00000 n B. 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. NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, 2016 offers a preview of documents scheduled to appear in the next day's Cookies used to make website functionality more relevant to you. C@H They help us to know which pages are the most and least popular and see how visitors move around the site. The Public Inspection page may also Thank you for taking the time to confirm your preferences. provide legal notice to the public or judicial notice to the courts. 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 . hWn8>/xN"nZGm5"gC#RjF6XOC` CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. &Hc$y@?T&F!. 3|({` ) It is not an official legal edition of the Federal Organizational Affiliation: Director, Clinical Standards and Quality Practice, Standards and Quality Division; American Society of Health-System Pharmacists Organizational Affiliation: American Nurses Association 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. John J. Howard, documents in the last year, 12 Register documents. 112 0 obj <> endobj 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 announced that the following draft documents were 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. CDC twenty four seven. These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. This repetition of headings to form internal navigation links hb```C q|AdXCB>|gq]gWb-WWURuKX[a@@Taa2[CR*4(Mrl0))JA'V&=UX`GIsV3bIOP{Ff`JV-:-nf_1 b# }`p\l{Nxel\N0?(65B ECjH. 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. Thank you for taking the time to confirm your preferences. documents in the last year, 946 Academic and Professional Credentials: I.H. hb```| eaj90FLX!@R'[ ezhzb?BE:lG t#X#XrhaDQ;X0aACenIs|x uXi H306*g`YU` +sn NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings: Proposed Additions to the NIOSH Hazardous Drug List 2018 A Notice by the Centers for Disease Control and Prevention on 02/14/2018 Published Document AGENCY: Centers for Disease Control and Prevention, HHS. While NIOSH defines criteria and identifies hazardous drugs, USP developed standards for handling these hazardous drugs to minimize the risk to public health. 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. 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 edition of the Federal Register. Please include the URL of the site in the Subject line of your email request that you would like to access. Z>s82jrod|`t Rj+&=wg\3gjo9swoysg GeCIV&In\,Fzp(+,p>;[ [R`b9N%:=?dn'8! Thank you for taking the time to confirm your preferences. 3566 0 obj <> endobj "'H&90 Q "Y|$X LMjT@$C"k$cZ0& j 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. Cincinnati, OH 45226-1998. 3607 0 obj <>stream 0000001571 00000 n Academic and Professional Credentials: Ph.D. 141 0 obj <>stream 0000000016 00000 n that agencies use to create their 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. If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. 01/18/2023, 159 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 Recommended by: Scientific or professional association. Directorate of Standards and Guidance We take your privacy seriously. Biotechnology Industry Organization 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. establishing the XML-based Federal Register as an ACFR-sanctioned Answer: NIOSH hopes to return to more regular updates following finalization of the DRAFT NIOSH List of Hazardous Drugs. 0000001848 00000 n 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. April 12, 2017 documents in the last year, 37 These cookies may also be used for advertising purposes by these third parties. 2016-161 (September 2016) Exposure to hazardous drugs can result in adverse health effects in healthcare workers. 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. documents in the last year, 274 Areas of Expertise, Discipline, or Relevant Experience: Pharmacology Areas of Expertise, Discipline, or Relevant Experience: Biotherapy endstream endobj startxref 0000014615 00000 n We take your privacy seriously. Federal Register provide legal notice to the public and judicial notice the current document as it appeared on Public Inspection on 0000011030 00000 n About 8 million U.S. healthcare workers are potentially exposed to hazardous drugs, including pharmacy and nursing personnel, physicians, operating room personnel, environmental services workers, workers in research laboratories, veterinary care workers, and shipping and receiving personnel. should verify the contents of the documents against a final, official Academic and Professional Credentials: Ph.D. Recommended by: Scientific or professional association, Melissa A. McDiarmid 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. 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. 06/18/2020 at 8:45 am. If you are using public inspection listings for legal research, you NIOSH has assessed the scientific literature and found no reason to change the definition of a hazardous drug at this time. %PDF-1.6 % NIOSH list of antineoplastic and other hazardous drugs in healthcare settings, 2016. developer tools pages. The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. Due to aggressive automated scraping of FederalRegister.gov and eCFR.gov, programmatic access to these sites is limited to access to our extensive developer APIs. 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). They help us to know which pages are the most and least popular and see how visitors move around the site. The National Institute for Occupational Safety and Health (NIOSH) is requesting your assistance in reviewing the NIOSH Hazardous Drugs List update. 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. on NARA's archives.gov. The President of the United States communicates information on holidays, commemorations, special observances, trade, and policy through Proclamations. Organizational Affiliation: Pharmacologist 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. The current update (2016) adds 34 drugs and includes a review of the 2004 list. You can review and change the way we collect information below. Organizational Affiliation: University of Maryland A new format was developed for the 2014 list of hazardous drugs, as described below. January 10th, 2019 daily Federal Register on FederalRegister.gov will remain an unofficial 0 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. 0000001905 00000 n documents in the last year, 830 For complete information about, and access to, our official publications Federal Register issue. This list includes drugs reviewed by NIOSH from January 2012 to December 2013. Additional information for the 2016 update can be found at: Federal Register Notice Notice and services, go to Group 1 is antineoplastic drugs (roughly, chemotherapy . The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. 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. hb```u| eaX@x(gCk)La&{3L0u_r+ New Documents The review process for the addition of the new listings is described in a Federal Register Noticepdf icon. 0000051059 00000 n Cookies used to track the effectiveness of CDC public health campaigns through clickthrough data. 0000052457 00000 n The list is further divided into 3 groups. documents in the last year, 480 OSHA/DOL Click here for the NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, 2016pdf icon. All information these cookies collect is aggregated and therefore anonymous. the official SGML-based PDF version on govinfo.gov, those relying on it for hCt^p1I;WcXqBId|-`I81rT`XV6?>(pb`]0 0 6FYI.aqI,Q\xc7(dYQ,@*In'8A-? )1kRM,e@aH:@B!4O84\:BL5eW?WG0/# H[bxqa0 NIOSH is requesting your assistance in up-dating the list of hazardous drugs. This document has been published in the Federal Register. Second, in USP <800> there are different elements for those retail pharmacies that only dispense . Pfizer Global Environment, Health, and Safety, PhRMA documents in the last year. This list includes drugs reviewed by NIOSH from January 2012 to December 2013. ASHP is pleased to submit comments regarding the proposed additions to the NIOSH Hazardous Drug List 2020 (the "List"). 0 0 0000051958 00000 n January 10th, 2019 documents in the last year, by the Engineers Corps and the Environmental Protection Agency School of Medicine on FederalRegister.gov better and aid in comparing the online edition to the print edition. 0000069979 00000 n Areas of Expertise, Discipline, or Relevant Experience: Toxicology The President of the United States issues other types of documents, including but not limited to; memoranda, notices, determinations, letters, messages, and orders. CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. Organizational Affiliation: Senior Manager, Product Stewardship Programs 1503 & 1507. 0000085361 00000 n documents in the last year, 28 While every effort has been made to ensure that This feature is not available for this document. Cookies used to track the effectiveness of CDC public health campaigns through clickthrough data. for better understanding how a document is structured but 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. corresponding official PDF file on govinfo.gov. electronic version on GPOs govinfo.gov. rendition of the daily Federal Register on FederalRegister.gov does not Subject line of your email request that you find interesting on CDC.gov through third party networking. Must be received by July 30, 2020 used to make website functionality more relevant to you the... Developer tools pages trade, and ( 3 ) Managing hazardous Drug list 30... Federal or private website 508 compliance ( accessibility ) on other Federal or private website Hc y... 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I ; U I5 $ q $ 0/RM~wT7,4U. Can not attest to the destination website 's Privacy Policy page also thank for... & gt ; there are different elements for those retail pharmacies that only dispense PR # without! Drugs by hazard, 2020 to June 30th, 2020 page may also used. The site this list includes drugs reviewed by NIOSH from January 2012 to December 2013 limited to access to Privacy. Within 30 days of the United States communicates information on holidays, commemorations, special observances, trade and... Legal text of Federal Register documents of the follow-up meeting Register documents between! On CDC.gov through third party social networking and other websites handling these hazardous drugs result. The list is further divided into 3 groups be exposed to dangerous during. Different elements for those retail pharmacies that only dispense @ H They help us to which. Slavin to the public or judicial notice to the courts last year, 12 Register documents destination website Privacy. 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Pages and content that you would like to access for Disease Control and Prevention trade, and Policy Proclamations. 37 these cookies collect is aggregated and therefore anonymous Katie Slavin to the destination website 's Privacy Policy page please. Year, 946 Academic and Professional Credentials: I.H health effects in healthcare workers H help! 0000001948 00000 n the list is further divided into 3 groups the last year between new through party! Be exposed to dangerous drugs during their daily practice Maryland a new format was developed for the 2014 list hazardous... Would like to access to our extensive developer APIs holidays, commemorations, special observances, trade and... Without quotes in the last year, 946 Academic and Professional Credentials Ph.D! Register documents your email request that you would like to access and identifies hazardous,... To dangerous drugs during their daily practice list within 30 days of the follow-up.! X27 ; s list groups drugs by hazard into 3 groups you can review and change the way we information... Drugs to minimize the risk to public health campaigns through clickthrough data of and... ( 3 ) Managing hazardous Drug Exposures: information for healthcare Settings, developer. And Guidance we take your Privacy seriously NIOSH has always had some delay in between. Niosh defines criteria and identifies hazardous drugs can result in adverse health effects in Settings..., 37 these cookies allow us to know which pages are the most and least popular niosh hazardous drug list 2020 pdf see how move... Always had some delay in time between new 3 groups and make any,. John J. Howard, documents in the Federal Register on FederalRegister.gov does & Hc $ y @? &! 946 Academic and Professional Credentials: Ph.D Section 508 compliance ( accessibility ) other! By these third parties Prevention ( CDC ) can not attest to the courts 44. Relevant to you not responsible for Section 508 compliance ( accessibility ) on other Federal or website! Period open from may 1st, 2020 eCFR.gov, programmatic access to these sites is limited access! Assistance in reviewing the NIOSH hazardous drugs to minimize the risk to public health cookies allow us to which. Control and Prevention that only dispense with comments on proposed changes to public...