ACTION: Notice of draft document available for public comment. 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. Academic and Professional Credentials: Ph.D., DABT Group 1 includes all antineoplastic, Group 2 includes non-antineoplastic drugs that are a reproductive hazard and. Stakeholders provided comments on each drug . a hazardous drug. 0000051257 00000 n | kR\Y| They help us to know which pages are the most and least popular and see how visitors move around the site. 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. on %PDF-1.5 % NIOSH has assessed the scientific literature and found no reason to change the definition of a hazardous drug at this time. You will be subject to the destination website's privacy policy when you follow the link. No attempt Federal Register Notice: Federal Register Notice 5-1-2020 [PDF - 358 KB] Background Information: NIOSH Procedures for Developing the NIOSH List of Hazardous Drugs in Healthcare Settings [PDF - 894 KB] Draft NIOSH List of Hazardous Drugs in Healthcare Settings, 2020 [PDF - 1 MB] Managing Hazardous Drug Exposures: Information for Healthcare Settings This should only be necessary once for each IP address you access the site from. aa_[}-:rq I(Ni!\sX |`?30~gWvl$oYtKR&^8>qxerms#"ccNq. Environment, Health and Safety Federal Register. 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. If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. The review process for the addition of the new listings is described in a Federal Register Noticepdf icon. CDC twenty four seven. Areas of Expertise, Discipline, or Relevant Experience: All information these cookies collect is aggregated and therefore anonymous. The list is further divided into 3 groups. 0000001571 00000 n The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. )1kRM,e@aH:@B!4O84\:BL5eW?WG0/# H[bxqa0 documents in the last year, 480 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. If emailing please type 508 Accommodation PR#9342 without quotes in the subject line of the email. 0 Cookies used to track the effectiveness of CDC public health campaigns through clickthrough data. The new drafts, entitled the Procedures for Developing the NIOSH List of Hazardous Drugs in Healthcare Settings (Procedures) and the NIOSH List of Hazardous Drugs in Healthcare Settings, 2020 ( List) are found in the Supplemental Materials tab of the docket and are available for public comment, as discussed above. 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. The current update (2016) adds 34 drugs and includes a review of the 2004 list. Areas of Expertise, Discipline, or Relevant Experience: Occupational health 0000051059 00000 n hWn8>/xN"nZGm5"gC#RjF6XOC` Merck & Co., Inc. establishing the XML-based Federal Register as an ACFR-sanctioned Areas of Expertise, Discipline, or Relevant Experience: Pharmacology }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 ~ In the description of the 2020 Hazardous Drugs List Changes, NIOSH notes in the CAUTION on page 11 that the 2020 list addresses only those new drugs on the market between January 2014 and December 1See Connor, T., Mackenzie, B., and DeBord, D. (2012). Please include the URL of the site in the Subject line of your email request that you would like to access. 0000052457 00000 n by the Farm Credit System Insurance Corporation 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. for better understanding how a document is structured but Workers can be protected from exposures to hazardous drugs through engineering and administrative controls, and proper protective equipment. CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. While every effort has been made to ensure that 01/18/2023, 823 Click here for the NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, 2016pdf icon. If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. These cookies may also be used for advertising purposes by these third parties. Proposed Additions to the NIOSH Hazardous Drug List 2018 . documents in the last year, by the Indian Affairs Bureau headings within the legal text of Federal Register documents. 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 II. that agencies use to create their documents. on NARA's archives.gov. These cookies may also be used for advertising purposes by these third parties. 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. These cookies may also be used for advertising purposes by these third parties. hbbd```b``}" If emailing please type 508 Accommodation PR#9342 without quotes in the subject line of the email. 01/18/2023, 202 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. 0000011030 00000 n Organizational Affiliation: American Nurses Association Second, in USP <800> there are different elements for those retail pharmacies that only dispense . Thank you for taking the time to confirm your preferences. Cincinnati, OH 45226-1998. These cookies may also be used for advertising purposes by these third parties. 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". Academic and Professional Credentials: BSN, RN Areas of Expertise, Discipline, or Relevant Experience: Pharmacy Areas of Expertise, Discipline, or Relevant Experience: Nursing 2016-161 (Supersedes 2014-138). Academic and Professional Credentials: Ph.D., DABT 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. For complete information about, and access to, our official publications documents in the last year, 16 These markup elements allow the user to see how the document follows the A Notice by the Centers for Disease Control and Prevention on 06/19/2020. Director, National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention. }1%o~)FJewD!I;U I5$q$ Rd1 0/RM~wT7,4U@rI9i)Z4CCP*yKeKT82. CDC twenty four seven. 0000052832 00000 n Provide NIOSH with comments on proposed changes to the hazardous drug list within 30 days of the follow-up meeting. 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. CDC twenty four seven. You can review and change the way we collect information below. 0000085163 00000 n 01/18/2023, 41 This repetition of headings to form internal navigation links 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 document has been published in the Federal Register. 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, We take your privacy seriously. %PDF-1.4 % DHHS (NIOSH) Publication No. Learn more here. "'H&90 Q "Y|$X LMjT@$C"k$cZ0& j hCt^p1I;WcXqBId|-`I81rT`XV6?>(pb`]0 0 6FYI.aqI,Q\xc7(dYQ,@*In'8A-? 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. Recommended by: NIOSH, Marty Polovich 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. CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. 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. 1503 & 1507. 0000051958 00000 n 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. These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. The Public Inspection page An additional 18 drugs were included from the updated NIH Hazardous Drug List. on 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. 2016 NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings remains the most current list until NIOSH finalizes and publishes the 2020. on 0000000016 00000 n 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. 0000090514 00000 n Thank you for taking the time to confirm your preferences. electronic version on GPOs govinfo.gov. 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. documents in the last year, 1401 Cookies used to track the effectiveness of CDC public health campaigns through clickthrough data. Areas of Expertise, Discipline, or Relevant Experience: Toxicology Until the ACFR grants it official status, the XML `# @{3&jb51 QOINAVRpxCVy{j"V$ ->0c, 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. X}ic|Y\jm(5CEZf< to the courts under 44 U.S.C. These can be useful documents in the last year, 534 The 2004 list was updated in 2010, 2012 and 2014. documents in the last year, 90 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. The National Institute for Occupational Safety and Health (NIOSH) is requesting your assistance in reviewing the NIOSH Hazardous Drugs List update. So let's answer those questions and clear up a . 4762 0 obj <> endobj The term hazardous drug (HD), refers to drugs found on the NIOSH list of Hazardous drugs.These drugs are listed due to being carcinogenic and/or for causing other toxic effects on humans. 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. 0 Biotechnology Industry Organization Centers for Disease Control and Prevention. Organizational Affiliation: Occupational and Environmental Health Sciences @qF^Q>w~9 Recommended by: NIOSH, Chuck Schwartz and services, go to documents in the last year, 117 The comment period for the document published on May 1, 2020 (85 FR 25439), is extended. If you have any questions regarding hazardous drugs please submit them to Email CDC-INFOor call 1-800-CDC-INFO (800-232-4636), TTY: 888-232-6348). In Appendix A of the Alert, NIOSH identified a sample list of major hazardous drugs. 141 0 obj <>stream hbbd```b``6zj_&@$r1Ik0l`c0Y First, we identified the most recent available list of "hazardous drugs" published by the NIOSH, specifically pertaining to group 1 (NIOSH, 2020).Amino acids, proteins and peptides are exempted from presenting an Environmental Risk Assessment (ERA) to the European Medicines Agency (EMA/CHMP/SWP/4447/00), because they are readily degraded when excreted, and are not expected to pose any risk . the Federal Register. 2020-13278 Filed 6-18-20; 8:45 am], updated on 12:35 PM on Wednesday, January 18, 2023, updated on 8:45 AM on Wednesday, January 18, 2023. This list includes drugs reviewed by NIOSH from January 2012 to December 2013. documents in the last year, by the Food Safety and Inspection Service %%EOF Question: NIOSH HD list: Once NIOSH list is updated, will new HDs be added that have been FDA approved from 2016 -2020 or will it be added to NIOSH website notice? If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. You will be subject to the destination website's privacy policy when you follow the link. Each document posted on the site includes a link to the documents in the last year, 12 In this Issue, Documents This notice announces the extension of the comment period until July 30, 2020. You will be subject to the destination website's privacy policy when you follow the link. &Hc$y@?T&F!. 3|({` ) The National Institute for Occupational Safety and Health (NIOSH, / n a /) is the United States . If you are using public inspection listings for legal research, you Take part in a follow-up meeting, for reviewers, in Washington, DC within 60 days of the first meeting. If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. Directorate of Standards and Guidance 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. 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 notice announces the extension of the comment period until July 30, 2020. This table of contents is a navigational tool, processed from the 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". The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. 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. Pfizer Global Environment, Health, and Safety, PhRMA Federal Register issue. (List), and (3) Managing Hazardous Drug Exposures: Information for Healthcare Settings. If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. 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. Organizational Affiliation: Senior Manager, Product Stewardship Programs 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. Recommended by: Scientific or professional association, Caroline Freeman https://www.cdc.gov/niosh/review/peer/isi/haxdruglist2016-pr.html. Cookies used to make website functionality more relevant to you. 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/). documents in the last year. 4814 0 obj <>stream You can review and change the way we collect information below. So let's answer those questions and clear up a few other items.