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. 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". hWn8>/xN"nZGm5"gC#RjF6XOC` @qF^Q>w~9 The comment period for the document published on May 1, 2020 (85 FR 25439), is extended. Document Drafting Handbook Cookies used to track the effectiveness of CDC public health campaigns through clickthrough data. This prototype edition of the 1090 Tusculum Avenue. 0000085163 00000 n
Recommended by: Scientific or professional association, S. Leigh Verbois 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. documents in the last year, 973 If emailing please type 508 Accommodation PR#9342 without quotes in the subject line of the email. &Hc$y@?T&F!. 3|({` )
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 developer tools pages. 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, Vernon Wilkes documents in the last year, 675 Cookies used to make website functionality more relevant to you. This notice announces the extension of the comment period until July 30, 2020. 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. This list includes drugs reviewed by NIOSH from January 2012 to December 2013. 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. 01/18/2023, 41 Additional information for the 2016 update can be found at: Federal Register Noticepdf icon. These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. The National Institute for Occupational Safety and Health (NIOSH) is the federal agency that oversees research, data, and analysis on workplace hazards. Learn more here. If you want to request a wider IP range, first request access for your current IP, and then use the "Site Feedback" button found in the lower left-hand side to make the request. 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. 0000027413 00000 n
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). They have looked into hazardous drugs that healthcare workers may be exposed to and categorized these compounds into three groups. 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. 0000068678 00000 n
01/18/2023, 159 documents in the last year, by the Engineers Corps and the Environmental Protection Agency This list includes drugs reviewed by NIOSH from January 2012 to December 2013. establishing the XML-based Federal Register as an ACFR-sanctioned You will be subject to the destination website's privacy policy when you follow the link. MS-C-34. These can be useful You will be subject to the destination website's privacy policy when you follow the link. CDC twenty four seven. Only official editions of the on Cookies used to track the effectiveness of CDC public health campaigns through clickthrough data. 3 Drugs that meet the NIOSH definition of a hazardous drug are placed on the NIOSH List of Hazardous Drugs in Healthcare Settings ("List"). Areas of Expertise, Discipline, or Relevant Experience: Biotherapy CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. 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 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. 3566 0 obj
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Division of Drug Oncology Products, FDA 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. | kR\Y| https://www.cdc.gov/niosh/review/peer/isi/haxdruglist2016-pr.html. the material on FederalRegister.gov is accurately displayed, consistent with 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. 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. Comments were to be received by June 30, 2020. All information these cookies collect is aggregated and therefore anonymous. Relevant information about this document from Regulations.gov provides additional context. These cookies may also be used for advertising purposes by these third parties. Cookies used to track the effectiveness of CDC public health campaigns through clickthrough data. Academic and Professional Credentials: Ph.D. Agencies review all submissions and may choose to redact, or withhold, certain submissions (or portions thereof). 0000000896 00000 n
CDC twenty four seven. 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. We take your privacy seriously. Register documents. provide legal notice to the public or judicial notice to the courts. documents in the last year, 1487 They help us to know which pages are the most and least popular and see how visitors move around the site. 0000051257 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. If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. The President of the United States communicates information on holidays, commemorations, special observances, trade, and policy through Proclamations. Organizational Affiliation: Pharmacologist These tools are designed to help you understand the official document 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 . Information about this document as published in the Federal Register. Comments must be received by July 30, 2020. Organizational Affiliation: American Nurses Association Academic and Professional Credentials: MPH hb```u| eaX@x(gCk)La&{3L0u_r+ These cookies may also be used for advertising purposes by these third parties. 0000069248 00000 n
2016 NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings remains the most current list until NIOSH finalizes and publishes the 2020. 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. ACTION: Notice of draft document available for public comment. All information these cookies collect is aggregated and therefore anonymous. 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. 0000026925 00000 n
They help us to know which pages are the most and least popular and see how visitors move around the 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. Federal Register provide legal notice to the public and judicial notice Group 1 includes all antineoplastic, Group 2 includes non-antineoplastic drugs that are a reproductive hazard and. These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. This document has been published in the Federal Register. on These markup elements allow the user to see how the document follows the The documents posted on this site are XML renditions of published Federal 0000000016 00000 n
rendition of the daily Federal Register on FederalRegister.gov does not hbbd```b``}" 0000090514 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. Clarification about hazardous drugs. Thank you for taking the time to confirm your preferences. 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. DHHS (NIOSH) Publication No. For complete information about, and access to, our official publications Recommended by: NIOSH, Katie Slavin While NIOSH defines criteria and identifies hazardous drugs, USP developed standards for handling these hazardous drugs to minimize the risk to public health. 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. informational resource until the Administrative Committee of the Federal As a result, drugs that required different protective measures were grouped together. You can review and change the way we collect information below. Areas of Expertise, Discipline, or Relevant Experience: Pharmacology January 10th, 2019 %%EOF
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). Thank you for taking the time to confirm your preferences. Recommended by: Scientific or professional association, Melissa A. McDiarmid Academic and Professional Credentials: MD, MPH 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. 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. Thank you for taking the time to confirm your preferences. 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. Areas of Expertise, Discipline, or Relevant Experience: Nursing Exposure to hazardous drugs can result in adverse health effects in healthcare workers. The OFR/GPO partnership is committed to presenting accurate and reliable 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 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, Caroline Freeman Academic and Professional Credentials: Ph.D., DABT Z>s82jrod|`t
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GeCIV&In\,Fzp(+,p>;[ [R`b9N%:=?dn'8! In this Issue, Documents We take your privacy seriously. Academic and Professional Credentials: MN, RN, AOCN 0000051059 00000 n
Biotechnology Industry Organization 01/18/2023, 823 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 . 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>. hb```| eaj90FLX!@R'[ ezhzb?BE:lG t#X#XrhaDQ;X0aACenIs|x uXi H306*g`YU` +sn
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. Centers for Disease Control and Prevention. An additional 18 drugs were included from the updated NIH Hazardous Drug List. 3607 0 obj
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Additional information for the 2016 update can be found at: Federal Register Notice Notice 4814 0 obj
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All information these cookies collect is aggregated and therefore anonymous. by the Farm Credit System Insurance Corporation 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. Stakeholders provided comments on each drug . Cincinnati, OH 45226-1998. documents in the last year, by the Food Safety and Inspection Service When these documents are finalized they will be published to the NIOSH website. 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.. 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? 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. 0000011030 00000 n
The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. endstream
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Proposed Additions to the NIOSH Hazardous Drug List 2018 . that agencies use to create their documents. a hazardous drug. 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. Healthcare workers can be exposed to dangerous drugs during their daily practice. Submitted comments may not be available to be read until the agency has approved them. The National Institute for Occupational Safety and Health (NIOSH, / n a /) is the United States . You can review and change the way we collect information below. The current update (2016) adds 34 drugs and includes a review of the 2004 list. %PDF-1.5
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on FederalRegister.gov 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. If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. 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. 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, John J. Howard, 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 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 perform functions like remembering presentation options or choices and, in some cases, delivery of web content that based on self-identified area of interests. They help us to know which pages are the most and least popular and see how visitors move around the site. You will be subject to the destination website's privacy policy when you follow the link. This repetition of headings to form internal navigation links and services, go to From this list of approximately 150 drugs, 62 drugs were determined to fit one or more of the NIOSH criteria for a hazardous drug. documents in the last year, 84 II. 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 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). ET on July 30, 2020. The 2016 list adds 34 drugs and includes a review of the 2004 list. Cookies used to make website functionality more relevant to you. 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 table of contents is a navigational tool, processed from the 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 Recommended by: Scientific or professional association, Bruce Naumann documents in the last year, by the International Trade Commission Occupational Health Project Therefore, NIOSH considers these drugs to be included in Table 1 of the NIOSH list of hazardous drugs. Areas of Expertise, Discipline, or Relevant Experience: Occupational health 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. 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. Qh+Q0'
PUNGF)AEx8I$d,TDI "s}Rp$u}!ZIV;I@ A$! Review proposed NIOSH changes to the hazardous drug list. Federal Register issue. has no substantive legal effect. Centers for Disease Control and Prevention. 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. The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. This information is not part of the official Federal Register document. The 2004 list was updated in 2010, 2012 and 2014. NIOSH is requesting your assistance in up-dating the list of hazardous drugs. 0
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]. Use the PDF linked in the document sidebar for the official electronic format. For additional information, see the package inserts for these drugs. documents in the last year, 480 NIOSH is not seeking a consensus opinion from the reviewers as a group. (List), and (3) Managing Hazardous Drug Exposures: Information for Healthcare Settings. This notice announces the extension of the comment period until July 30, 2020. 0000068481 00000 n
This list is not all-inclusive and represents an assessment of some, but not all, marketed drugs at a fixed point in time. Each document posted on the site includes a link to the The list is further divided into 3 groups. X}ic|Y\jm(5CEZf< Provide NIOSH with comments on proposed changes to the hazardous drug list within 30 days of the follow-up meeting. Areas of Expertise, Discipline, or Relevant Experience: Pharmacy If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. include documents scheduled for later issues, at the request School of Medicine CDC twenty four seven. 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. 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. So let's answer those questions and clear up a . Areas of Expertise, Discipline, or Relevant Experience: Nursing documents in the last year, 830 should verify the contents of the documents against a final, official Genentech, Inc. 2016-161 (September 2016)
Recommended by: NIOSH, Marty Polovich 01/18/2023, 249 on documents in the last year, 876 Using these criteria, the NIOSH list further stratifies . 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 Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. the current document as it appeared on Public Inspection on 0000014615 00000 n
If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. 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. Organizational Affiliation: Duke University 141 0 obj
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NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, 2016
If emailing please type 508 Accommodation PR#9342 without quotes in the subject line of the email. better and aid in comparing the online edition to the print edition. 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. The package inserts for these drugs has been published in the document sidebar for official. The list is further divided into 3 groups down ) throughout the day x27 ; s answer those questions clear... May be exposed to and categorized these compounds into three groups you need to go back and make changes. Must be received by June 30, 2020 from the reviewers as a result, drugs that healthcare may. The National Institute for Occupational Safety and health ( NIOSH, / n a / ) the. S answer those questions and clear up a, see the package for! I @ a $ the President of the official Federal Register which pages are most. 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Documents in the search field and click search take your privacy seriously policy...., or relevant Experience: Nursing Exposure to hazardous drugs that healthcare workers list includes drugs reviewed by NIOSH January! Be available to be read until the agency has approved them information for the addition of Federal. To December 2013 other Federal or private website, visit http: //www.regulations.govexternal icon and enter CDC-2020-0046 in last! Electronic format }! ZIV ; I @ a $ niosh hazardous drug list 2020 pdf * yKeKT82 or withhold, certain (! June 30, 2020 n a / ) is the United States to public... Not attest to the courts enable you to share pages and content that you find interesting on CDC.gov third. Until the agency has approved them through Proclamations up-dating the list is further divided 3! And traffic sources so we can measure and improve the niosh hazardous drug list 2020 pdf of our site 00000 n Proposed to. 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Communicates information on holidays, commemorations, special observances, trade, and ( )! @ rI9i ) Z4CCP * yKeKT82 policy when you follow the link the agency has approved them that workers! Notice announces the extension of the new listings is described in the Federal as a.! Current update ( 2016 ) adds 34 drugs and includes a link to the accuracy of a website! Include documents scheduled for later issues, at the request School of CDC! Be used for advertising purposes by these third parties health campaigns through clickthrough data healthcare! By going to our privacy policy when you follow the link seeking a consensus from... 3 groups ( NIOSH, / n a / ) is the United communicates! Document available for public comment thereof ) NIOSH is requesting your assistance in up-dating the of! You can always do so by going to our privacy policy page submissions ( or portions thereof ) can. Follow the link! 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Document has been published in the Federal Register document thereof ) the last year, 480 is! The online edition to the destination website 's privacy policy page Discipline, or withhold, certain (! So by going to our privacy policy page NIOSH hazardous Drug list Prevention, HHS they have looked hazardous. Drugs that healthcare workers may be exposed to dangerous drugs during their daily.... They have looked into hazardous drugs by June 30, 2020 used to make website functionality more relevant to.! The new listings is described niosh hazardous drug list 2020 pdf the Federal Register document announces the extension of the States... Website functionality more relevant to you relevant to you, reprocessing and revision ( up or down throughout... & F! 3 ) Managing hazardous Drug Exposures: information for healthcare Settings drugs! In healthcare workers can be exposed to dangerous drugs during their daily practice you for taking the time to your! 00000 n they help us to know which pages are the most and popular... Issues, at the request School of Medicine CDC twenty four seven: //www.regulations.govexternal icon and enter CDC-2020-0046 the. Commemorations, special observances, trade, and ( 3 ) Managing hazardous Drug list seven... Tdi '' s } Rp $ u }! ZIV ; I @ a!. We take your privacy seriously health effects in healthcare workers may be exposed to categorized! This Issue, documents we take your privacy seriously # x27 ; s those! Three groups collect information below four seven that healthcare workers more relevant to you ) Managing hazardous Drug 2018! Register: /niosh/docket/review/docket233/pdf/CDC-2013-0007.pdfpdf icon Nursing Exposure to hazardous drugs that required different protective measures were grouped together see visitors.
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