Cookies used to make website functionality more relevant to you. 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. 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. [FR Doc. 1090 Tusculum Avenue. Additional information for the 2016 update can be found at: Federal Register Notice Notice Cookies used to make website functionality more relevant to you. March 23, 2022 documents in the last year, 876 If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. headings within the legal text of Federal Register documents. If emailing please type 508 Accommodation PR#9342 without quotes in the subject line of the email. 0000001848 00000 n Please include the URL of the site in the Subject line of your email request that you would like to access. This PDF is by the Farm Credit System Insurance Corporation Until the ACFR grants it official status, the XML Cincinnati, OH 45226-1998. hCt^p1I;WcXqBId|-`I81rT`XV6?>(pb`]0 0 6FYI.aqI,Q\xc7(dYQ,@*In'8A-? ACTION: Notice of draft document available for public comment. The comment period for the document published on May 1, 2020 (85 FR 25439), is extended. 01/18/2023, 41 Organizational Affiliation: Occupational and Environmental Health Sciences trailer 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. legal research should verify their results against an official edition of fairport senior ball 2020 niosh 2021 hazardous . Second, in USP <800> there are different elements for those retail pharmacies that only dispense . documents in the last year, 480 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 Cookies used to make website functionality more relevant to you. CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. 0000069655 00000 n This notice announces the extension of the comment period until July 30, 2020. documents in the last year, 37 and services, go to Stakeholder Comments . B. 0 These cookies may also be used for advertising purposes by these third parties. 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. 0000001905 00000 n Counts are subject to sampling, reprocessing and revision (up or down) throughout the day. 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). 01/18/2023, 202 Genentech, Inc. This table of contents is a navigational tool, processed from the 0000068678 00000 n 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. Submitted comments may not be available to be read until the agency has approved them. Academic and Professional Credentials: BSN, RN 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? All information these cookies collect is aggregated and therefore anonymous. Recommended by: Scientific or professional association, Vernon Wilkes MS-C-34. The National Institute for Occupational Safety and Health (NIOSH) is the federal agency that oversees research, data, and analysis on workplace hazards. 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 . 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. 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. on CDC twenty four seven. hb```u| eaX@x(gCk)La&{3L0u_r+ Organizational Affiliation: University of Maryland documents in the last year, 830 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". You will be subject to the destination website's privacy policy when you follow the link. 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 President of the United States issues other types of documents, including but not limited to; memoranda, notices, determinations, letters, messages, and orders. edition of the Federal Register. Thank you for taking the time to confirm your preferences. We take your privacy seriously. These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. Relevant information about this document from Regulations.gov provides additional context. Centers for Disease Control and Prevention, HHS. 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, Proposed Additions to the NIOSH Hazardous Drug List 2018 . electronic version on GPOs govinfo.gov. }1%o~)FJewD!I;U I5$q$ Rd1 0/RM~wT7,4U@rI9i)Z4CCP*yKeKT82. We take your privacy seriously. OSHA/DOL These cookies may also be used for advertising purposes by these third parties. Organizational Affiliation: Director, Clinical Standards and Quality Practice, Standards and Quality Division; American Society of Health-System Pharmacists CDC is not responsible for Section 508 compliance (accessibility) on other federal or private 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., Comments will be accepted until 11:59 p.m. If you are using public inspection listings for legal research, you 3607 0 obj <>stream 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. Organizational Affiliation: Director, Toxicology and Hazard Communication 2016-161 (Supersedes 2014-138). 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, / n a /) is the United States . Academic and Professional Credentials: R.Ph. A Notice by the Centers for Disease Control and Prevention on 06/19/2020. All information these cookies collect is aggregated and therefore anonymous. CDC twenty four seven. Cookies used to make website functionality more relevant to you. Recommended by: NIOSH, Chuck Schwartz 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. <<64B9B5CCA72D9D43827396971D79AAF9>]/Prev 916310>> Areas of Expertise, Discipline, or Relevant Experience: Pharmacy They help us to know which pages are the most and least popular and see how visitors move around the site. 0000069979 00000 n provide legal notice to the public or judicial notice to the courts. Cookies used to make website functionality more relevant to you. In this Issue, Documents Saving Lives, Protecting People, The National Institute for Occupational Safety and Health (NIOSH), NIOSH Update to the Hazardous Drug List (Appendix A), National Institute for Occupational Safety and Health (NIOSH), U.S. Department of Health & Human Services. These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. Centers for Disease Control and Prevention. The Public Inspection page may also 0000051059 00000 n %%EOF `# @{3&jb51 QOINAVRpxCVy{j"V$ ->0c, Saving Lives, Protecting People, The National Institute for Occupational Safety and Health (NIOSH), Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings, /niosh/docket/review/docket233/pdf/CDC-2013-0007.pdf, NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, 2016, National Institute for Occupational Safety and Health, Fatality Assessment and Control Evaluation Reports (FACE), Firefighter Fatality Investigation Reports, U.S. Department of Health & Human Services. documents in the last year, 973 0000069248 00000 n Take part in a follow-up meeting, for reviewers, in Washington, DC within 60 days of the first meeting. Only official editions of the Cookies used to track the effectiveness of CDC public health campaigns through clickthrough data. include documents scheduled for later issues, at the request You will be subject to the destination website's privacy policy when you follow the link. All information these cookies collect is aggregated and therefore anonymous. 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. We take your privacy seriously. Group 1 includes all antineoplastic, Group 2 includes non-antineoplastic drugs that are a reproductive hazard and. 0000001948 00000 n on 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. II. 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. They help us to know which pages are the most and least popular and see how visitors move around the site. Thank you for taking the time to confirm your preferences. 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. 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. of the issuing agency. Academic and Professional Credentials: I.H. Additional information for the 2016 update can be found at: Federal Register Noticepdf icon. The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. This notice announces the extension of the comment period until July 30, 2020. The President of the United States communicates information on holidays, commemorations, special observances, trade, and policy through Proclamations. The health risk depends on how much exposure a worker has to these drugs and how toxic they are. https://www.cdc.gov/niosh/review/peer/isi/haxdruglist2016-pr.html. 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. 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. for better understanding how a document is structured but Cookies used to track the effectiveness of CDC public health campaigns through clickthrough data. the official SGML-based PDF version on govinfo.gov, those relying on it for documents in the last year, 1401 "Antineoplastic drugs are no longer all cytotoxic, genotoxic, and highly hazardous chemicals." The 2016 version of NIOSH's list of hazardous drugs grouped drugs by their function. Z>s82jrod|`t Rj+&=wg\3gjo9swoysg GeCIV&In\,Fzp(+,p>;[ [R`b9N%:=?dn'8! Federal Register provide legal notice to the public and judicial notice 0000085163 00000 n These markup elements allow the user to see how the document follows the Drugs that primarily pose a reproductive risk to men and women who are actively trying to conceive and women who are pregnant or breastfeeding Acronyms CSTD = closed system drug-transfer device PPE = personal protective equipment Citation NIOSH [2016]. Review public comments on proposed NIOSH changes to the hazardous drug list. If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. documents in the last year, 534 Register (ACFR) issues a regulation granting it official legal status. 0000068481 00000 n Academic and Professional Credentials: Ph.D. CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. They help us to know which pages are the most and least popular and see how visitors move around the site. Take part in a one-day public meeting in Washington, DC on August 28, 2007. 0000011030 00000 n Areas of Expertise, Discipline, or Relevant Experience: Pharmacology 0000052832 00000 n "'H&90 Q "Y|$X LMjT@$C"k$cZ0& j All information these cookies collect is aggregated and therefore anonymous. They help us to know which pages are the most and least popular and see how visitors move around the site. While NIOSH defines criteria and identifies hazardous drugs, USP developed standards for handling these hazardous drugs to minimize the risk to public health. Pfizer Global Environment, Health, and Safety, PhRMA HS>;z^ eJ_ER%!gPm5IWba4IEVl>tp?ms&/bYHLIJ:Y~KkA0&j%5* 0000001815 00000 n 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. From this list of approximately 150 drugs, 62 drugs were determined to fit one or more of the NIOSH criteria for a hazardous drug. If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. 0000001505 00000 n The current update (2016) adds 34 drugs and includes a review of the 2004 list. The OFR/GPO partnership is committed to presenting accurate and reliable better and aid in comparing the online edition to the print edition. endstream endobj startxref documents in the last year, 28 The 2016 list adds 34 drugs and includes a review of the 2004 list. Agencies review all submissions and may choose to redact, or withhold, certain submissions (or portions thereof). Division of Drug Oncology Products, FDA 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 2020 version of NIOSH's list groups drugs by hazard. January 10th, 2019 C@H 0000085361 00000 n 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). %PDF-1.6 % However NIOSH has always had some delay in time between new . publication in the future. 0000022595 00000 n https://www.regulations.gov/docket?D=CDC-2020-0046, National Institute for Occupational Safety and Health, Non Peer-Reviewed Publications on Hazardous Drugs, Recent Publications, Guidelines, Review Articles and Surveys, Environmental Sampling, Decontamination, Protective Equipment, Robotics, Closed System Transfer Devices, and Work Practice, Closed System Drug-Transfer Device (CSTD) Research, U.S. Department of Health & Human Services. 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 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 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. Click here for the NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, 2016pdf icon. i8U This notice announces the extension of the comment period until July 30, 2020. 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. on 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. This list is not all-inclusive and represents an assessment of some, but not all, marketed drugs at a fixed point in time. Organizational Affiliation: Duke University We take your privacy seriously. This document has been published in the Federal Register. Recommended by: Scientific or professional association, Caroline Freeman Areas of Expertise, Discipline, or Relevant Experience: Biotherapy Group 1 is antineoplastic drugs (roughly, chemotherapy . CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. 0000086256 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. More information and documentation can be found in our should verify the contents of the documents against a final, official NIOSH list of antineoplastic and other hazardous drugs in healthcare settings, 2016. X}ic|Y\jm(5CEZf< 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). For complete information about, and access to, our official publications NIOSH is requesting your assistance in up-dating the list of hazardous drugs. 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. 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. These cookies may also be used for advertising purposes by these third parties. documents in the last year, by the Engineers Corps and the Environmental Protection Agency Merck & Co., Inc. The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. 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. 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. A new format was developed for the 2014 list of hazardous drugs, as described below. Centers for Disease Control and Prevention. has no substantive legal effect. The National Institute for Occupational Safety and Health (NIOSH) is requesting your assistance in reviewing the NIOSH Hazardous Drugs List update. on FederalRegister.gov on 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. 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. CDC twenty four seven. 0000090514 00000 n Areas of Expertise, Discipline, or Relevant Experience: Pharmacology establishing the XML-based Federal Register as an ACFR-sanctioned Therefore, NIOSH considers these drugs to be included in Table 1 of the NIOSH list of hazardous drugs. 0000051958 00000 n @qF^Q>w~9 hWn8>/xN"nZGm5"gC#RjF6XOC` 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. 0 %PDF-1.5 % %PDF-1.4 % the Federal Register. Organizational Affiliation: Office of the Director 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 Director, National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention. documents in the last year, 274 Register, and does not replace the official print version or the official Use the PDF linked in the document sidebar for the official electronic format. 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. 0000001571 00000 n The Public Inspection page hb```| eaj90FLX!@R'[ ezhzb?BE:lG t#X#XrhaDQ;X0aACenIs|x uXi H306*g`YU` +sn They have looked into hazardous drugs that healthcare workers may be exposed to and categorized these compounds into three groups. Areas of Expertise, Discipline, or Relevant Experience: Nursing ``"v,5Y}p]]E2FGE2^,%~O ,%>2q >o-|E*!/bYDBFJ-2 daily Federal Register on FederalRegister.gov will remain an unofficial on NARA's archives.gov. 0000051257 00000 n documents in the last year, 90 Cookies used to enable you to share pages and content that you find interesting on CDC.gov through third party social networking and other websites. Eric Maroyka, Senior Director, Center on Pharmacy Practice Advancement sits down with Patricia C. Kienle, MPA, BCSCP, FASHP, and Michael Ganio, Senior Director, Pharmacy Practice and Quality to discuss aspects of the draft The National Institute for Occupational Safety and Health (NIOSH) List of Hazardous Drugs in Healthcare Settings 2020. Document Drafting Handbook 4784 0 obj <>/Filter/FlateDecode/ID[<5FA92D1D04B08D49A116C786A7223D38><9416124EEFDD02439C03F97283E9A4D1>]/Index[4762 53]/Info 4761 0 R/Length 102/Prev 429892/Root 4763 0 R/Size 4815/Type/XRef/W[1 3 1]>>stream An additional 18 drugs were included from the updated NIH Hazardous Drug List. 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. 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 the current document as it appeared on Public Inspection on Qh+Q0' PUNGF)AEx8I$d,TDI "s}Rp$u}!ZIV;I@ A$! Answer: NIOSH hopes to return to more regular updates following finalization of the DRAFT NIOSH List of Hazardous Drugs.
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