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. Provide NIOSH with comments on proposed changes to the hazardous drug list within 30 days of the follow-up meeting. The current update (2016) adds 34 drugs and includes a review of the 2004 list. Submitted comments may not be available to be read until the agency has approved them. 0 We take your privacy seriously. Organizational Affiliation: University of Maryland Comments were to be received by June 30, 2020. 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. to the courts under 44 U.S.C. "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. All information these cookies collect is aggregated and therefore anonymous. 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. You will be subject to the destination website's privacy policy when you follow the link. documents in the last year, 534 on NARA's archives.gov. 4762 0 obj <> endobj 0000001905 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. 3607 0 obj <>stream If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. 0000085885 00000 n 0000014615 00000 n Agencies review all submissions and may choose to redact, or withhold, certain submissions (or portions thereof). 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. `# @{3&jb51 QOINAVRpxCVy{j"V$ ->0c, %%EOF However NIOSH has always had some delay in time between new . 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. 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. 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. Academic and Professional Credentials: BSN, RN 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 . 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. 06/18/2020 at 8:45 am. Recommended by: Scientific or professional association, Debora Van der Sluis Biotechnology Industry Organization 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. Areas of Expertise, Discipline, or Relevant Experience: Biotherapy Cookies used to make website functionality more relevant to you. (List), and (3) Managing Hazardous Drug Exposures: Information for Healthcare Settings. Areas of Expertise, Discipline, or Relevant Experience: Pharmacy Pfizer Global Environment, Health, and Safety, PhRMA for better understanding how a document is structured but Directorate of Standards and Guidance 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. Clarification about hazardous drugs. documents in the last year, 946 documents in the last year, 1487 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". edition of the Federal Register. Director, National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention. 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. 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. on 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. &Hc$y@?T&F!. 3|({` ) trailer There is a 60 day public comment period open from May 1st, 2020 to June 30th, 2020. The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), in the Department of Health and Human Services announces that the following draft documents are available for public comment: (1) NIOSH Procedures for Developing the NIOSH List of Hazardous Drugs in Healthcare Settings (Procedures); (2) NIOSH List of Hazardous Drugs in Healthcare Settings, 2020 (List), including those drugs proposed for placement on the 2020 List, and (3) Managing Hazardous Drug Exposures: Information for Healthcare Settings. the material on FederalRegister.gov is accurately displayed, consistent with HS>;z^ eJ_ER%!gPm5IWba4IEVl>tp?ms&/bYHLIJ:Y~KkA0&j%5* documents in the last year, 973 All information these cookies collect is aggregated and therefore anonymous. 01/18/2023, 202 Centers for Disease Control and Prevention. }1%o~)FJewD!I;U I5$q$ Rd1 0/RM~wT7,4U@rI9i)Z4CCP*yKeKT82. 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/). These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. If you do not allow these cookies we will not know when you have visited our site, and will not be able to monitor its performance. Organizational Affiliation: Pharmacologist 112 0 obj <> endobj Merck & Co., Inc. You will be subject to the destination website's privacy policy when you follow the link. You can review and change the way we collect information below. Areas of Expertise, Discipline, or Relevant Experience: Pharmacology Recommended by: Scientific or professional association, Caroline Freeman Cookies used to make website functionality more relevant to you. Organizational Affiliation: American Nurses Association 0 endstream endobj startxref The documents posted on this site are XML renditions of published Federal documents in the last year, by the Energy Department documents in the last year, by the Food Safety and Inspection Service 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. Areas of Expertise, Discipline, or Relevant Experience: Occupational health hbbd```b``6zj_&@$r1Ik0l`c0Y The 2016 list adds 34 drugs and includes a review of the 2004 list. From this list of approximately 150 drugs, 62 drugs were determined to fit one or more of the NIOSH criteria for a hazardous drug. 0000085361 00000 n 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. Recommended by: NIOSH, Marty Polovich Recommended by: Scientific or professional association, S. Leigh Verbois Areas of Expertise, Discipline, or Relevant Experience: 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. @qF^Q>w~9 i8U You will be subject to the destination website's privacy policy when you follow the link. 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 ACTION: Notice of draft document available for public comment. 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. | kR\Y| Cincinnati, OH 45226-1998. You can review and change the way we collect information below. 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. This table of contents is a navigational tool, processed from the Group 1 is antineoplastic drugs (roughly, chemotherapy . Academic and Professional Credentials: Ph.D. If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. [PDF 32 KB] Required Elements for Initial Public Posting Title: NIOSH Update to the Hazardous Drug List (Appendix A) Subject: NIOSH Hazardous Drug List 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 You can review and change the way we collect information below. Document page views are updated periodically throughout the day and are cumulative counts for this document. 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. Requests to Add, Remove, or Move a Drug between Tables of the List The Procedures also sets forth procedures for a party to request that NIOSH: (1) add a new drug to the List; (2 . Learn more here. documents in the last year, 274 Academic and Professional Credentials: R.Ph. daily Federal Register on FederalRegister.gov will remain an unofficial This site displays a prototype of a Web 2.0 version of the daily documents in the last year, 84 If emailing please type 508 Accommodation PR#9342 without quotes in the subject line of the email. Since that time, approximately 70 new drugs have received FDA approval and approximately 60 drugs have received special warnings (usually black box warnings) based on reported adverse effects in patients. CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. 0000069248 00000 n 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]. These can be useful 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. They help us to know which pages are the most and least popular and see how visitors move around the site. We take your privacy seriously. documents in the last year, 1401 The comment period for the document published on May 1, 2020 (85 FR 25439), is extended. 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. 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. NIOSH list of antineoplastic and other hazardous drugs in healthcare settings, 2016. Organizational Affiliation: Office of the Director If emailing please type 508 Accommodation PR#9342 without quotes in the subject line of the email. 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. Centers for Disease Control and Prevention. by the Farm Credit System Insurance Corporation X}ic|Y\jm(5CEZf< Cookies used to make website functionality more relevant to you. Academic and Professional Credentials: MPH 0000011030 00000 n CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. on Organizational Affiliation: Duke University 0000069655 00000 n Proposed Additions to the NIOSH Hazardous Drug List 2018 . 0000001948 00000 n on 3590 0 obj <>/Filter/FlateDecode/ID[<473407BB4B871C4FABB102F468EAE769>]/Index[3566 42]/Info 3565 0 R/Length 115/Prev 645075/Root 3567 0 R/Size 3608/Type/XRef/W[1 3 1]>>stream 01/18/2023, 41 hb```| eaj90FLX!@R'[ ezhzb?BE:lG t#X#XrhaDQ;X0aACenIs|x uXi H306*g`YU` +sn If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. 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 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, by the Indian Affairs Bureau 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. As a result, drugs that required different protective measures were grouped together. 1503 & 1507. Using these criteria, the NIOSH list further stratifies . These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. Additional information for the 2016 update can be found at: Federal Register Notice 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. So let's answer those questions and clear up a few other items. 112 30 documents in the last year, by the Engineers Corps and the Environmental Protection Agency Cookies used to track the effectiveness of CDC public health campaigns through clickthrough data. When these documents are finalized they will be published to the NIOSH website. Areas of Expertise, Discipline, or Relevant Experience: Occupational Health 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, 0000001571 00000 n 0000068678 00000 n These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. a hazardous drug. All information these cookies collect is aggregated and therefore anonymous. aa_[}-:rq I(Ni!\sX |`?30~gWvl$oYtKR&^8>qxerms#"ccNq. documents in the last year, 37 Federal Register provide legal notice to the public and judicial notice 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. 0000001505 00000 n has no substantive legal effect. 0000000896 00000 n Relevant information about this document from Regulations.gov provides additional context. Centers for Disease Control and Prevention. regulatory information on FederalRegister.gov with the objective of Review public comments on proposed NIOSH changes to the hazardous drug list. CDC twenty four seven. 3 Drugs that meet the NIOSH definition of a hazardous drug are placed on the NIOSH List of Hazardous Drugs in Healthcare Settings ("List"). They help us to know which pages are the most and least popular and see how visitors move around the site. Recommended by: Scientific or professional association. 0000051958 00000 n These cookies may also be used for advertising purposes by these third parties. Academic and Professional Credentials: Ph.D., DABT documents in the last year, 480 %PDF-1.5 % Thank you for taking the time to confirm your preferences. 0000001848 00000 n NIOSH has assessed the scientific literature and found no reason to change the definition of a hazardous drug at this time. %%EOF You will be subject to the destination website's privacy policy when you follow the link. 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. 01/18/2023, 249 Recommended by: NIOSH, Chuck Schwartz 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 Genentech, Inc. hbbd```b``}" Until the ACFR grants it official status, the XML 01/18/2023, 284 0 An additional 18 drugs were included from the updated NIH Hazardous Drug List. ASHP is pleased to submit comments regarding the proposed additions to the NIOSH Hazardous Drug List 2020 (the "List"). Centers for Disease Control and Prevention, HHS. 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). Therefore, NIOSH considers these drugs to be included in Table 1 of the NIOSH list of hazardous drugs. March 23, 2022 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 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>. Academic and Professional Credentials: MN, RN, AOCN hCt^p1I;WcXqBId|-`I81rT`XV6?>(pb`]0 0 6FYI.aqI,Q\xc7(dYQ,@*In'8A-? NIOSH is not seeking a consensus opinion from the reviewers as a group. 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. xref ``"v,5Y}p]]E2FGE2^,%~O ,%>2q >o-|E*!/bYDBFJ-2 2016-161 (September 2016) For complete information about, and access to, our official publications 0000000016 00000 n This notice announces the extension of the comment period until July 30, 2020. %PDF-1.4 % documents in the last year, by the International Trade Commission The National Institute for Occupational Safety and Health (NIOSH) is the federal agency that oversees research, data, and analysis on workplace hazards. On May 1, 2020, the National Institute for Occupational Safety and Health (NIOSH), within the Center for Disease Control and Prevention (CDC), opened a docket to obtain public input on the following draft documents: (1) NIOSH Procedures for Developing the NIOSH List of Hazardous Drugs in Healthcare Settings (Procedures); (2) NIOSH List of Hazardous Drugs in Healthcare Settings, 2020 These cookies perform functions like remembering presentation options or choices and, in some cases, delivery of web content that based on self-identified area of interests. Cookies used to track the effectiveness of CDC public health campaigns through clickthrough data. 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 We take your privacy seriously. 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]. developer tools pages. <<64B9B5CCA72D9D43827396971D79AAF9>]/Prev 916310>> the official SGML-based PDF version on govinfo.gov, those relying on it for 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? Review proposed NIOSH changes to the hazardous drug list. The 2004 list was updated in 2010, 2012 and 2014. While every effort has been made to ensure that 0000068481 00000 n Register documents. 0000018854 00000 n The reviewers will be requested to take part in the following process: The reviewers will be required to sign a conflict of interest form and to provide their individual reviews to NIOSH. All relevant comments received will be posted without change to http://www.regulations.gov,, including any personal information provided. They help us to know which pages are the most and least popular and see how visitors move around the site. This PDF is This document has been published in the Federal Register. documents in the last year, 28 This list includes drugs reviewed by NIOSH from January 2012 to December 2013. Federal Register. The President of the United States manages the operations of the Executive branch of Government through Executive orders. Academic and Professional Credentials: I.H. documents in the last year, 675 Answer: NIOSH hopes to return to more regular updates following finalization of the DRAFT NIOSH List of Hazardous Drugs. 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. 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. CDC twenty four seven. hWn8>/xN"nZGm5"gC#RjF6XOC` Cookies used to track the effectiveness of CDC public health campaigns through clickthrough data. establishing the XML-based Federal Register as an ACFR-sanctioned [FR Doc. January 10th, 2019 1090 Tusculum Avenue. 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. The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. offers a preview of documents scheduled to appear in the next day's Environment, Health and Safety 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". "'H&90 Q "Y|$X LMjT@$C"k$cZ0& j
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