documents in the last year, 1401 January 10th, 2019 The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. Pfizer Global Environment, Health, and Safety, PhRMA Defining Hazardous Drugs Hazardous drugs include those used for cancer che - motherapy, antiviral drugs, hormones, some bio-engineered drugs, and other miscellaneous drugs. endstream endobj startxref Biotechnology Industry Organization 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. 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. A new format was developed for the 2014 list of hazardous drugs, as described below. endstream endobj startxref 0000068481 00000 n documents in the last year, by the Engineers Corps and the Environmental Protection Agency 4814 0 obj <>stream If emailing please type 508 Accommodation PR#9342 without quotes in the subject line of the email. This list is not all-inclusive and represents an assessment of some, but not all, marketed drugs at a fixed point in time. %PDF-1.6 % Cookies used to track the effectiveness of CDC public health campaigns through clickthrough data. on The President of the United States manages the operations of the Executive branch of Government through Executive orders. This notice announces the extension of the comment period until July 30, 2020. This list includes drugs reviewed by NIOSH from January 2012 to December 2013. %%EOF II. They have looked into hazardous drugs that healthcare workers may be exposed to and categorized these compounds into three groups. Learn more here. [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 These cookies may also be used for advertising purposes by these third parties. More information and documentation can be found in our Thank you for taking the time to confirm your preferences. 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". Areas of Expertise, Discipline, or Relevant Experience: 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 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. You can review and change the way we collect information below. Qh+Q0' PUNGF)AEx8I$d,TDI "s}Rp$u}!ZIV;I@ A$! 141 0 obj <>stream Academic and Professional Credentials: I.H. documents in the last year, by the International Trade Commission 01/18/2023, 249 0000051958 00000 n Centers for Disease Control and Prevention. 0000001815 00000 n %%EOF We take your privacy seriously. A Notice by the Centers for Disease Control and Prevention on 06/19/2020. Register (ACFR) issues a regulation granting it official legal status. 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. Areas of Expertise, Discipline, or Relevant Experience: Toxicology This PDF is that agencies use to create their documents. documents in the last year, 274 edition of the Federal Register. startxref CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. hbbd```b``}" 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? are not part of the published document itself. Areas of Expertise, Discipline, or Relevant Experience: Pharmacy 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. Recommended by: Scientific or professional association, Vernon Wilkes 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. CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. The OFR/GPO partnership is committed to presenting accurate and reliable establishing the XML-based Federal Register as an ACFR-sanctioned NIOSH has assessed the scientific literature and found no reason to change the definition of a hazardous drug at this time. Genentech, Inc. documents in the last year, 946 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>. 06/18/2020 at 8:45 am. 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. Use the PDF linked in the document sidebar for the official electronic format. Register, and does not replace the official print version or the official 0000051257 00000 n 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. All information these cookies collect is aggregated and therefore anonymous. If emailing please type 508 Accommodation PR#9342 without quotes in the subject line of the email. 112 30 hb```| eaj90FLX!@R'[ ezhzb?BE:lG t#X#XrhaDQ;X0aACenIs|x uXi H306*g`YU` +sn Recommended by: Scientific or professional association, Bruce Naumann and services, go to Cookies used to track the effectiveness of CDC public health campaigns through clickthrough data. Register documents. headings within the legal text of Federal Register documents. [FR Doc. 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. 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. 0000001848 00000 n The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. 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 Division of Drug Oncology Products, FDA NIOSH is not seeking a consensus opinion from the reviewers as a group. Organizational Affiliation: Office of the Director C@H They help us to know which pages are the most and least popular and see how visitors move around the site. 0 Recommended by: Scientific or professional association, S. Leigh Verbois hCt^p1I;WcXqBId|-`I81rT`XV6?>(pb`]0 0 6FYI.aqI,Q\xc7(dYQ,@*In'8A-? Submitted comments may not be available to be read until the agency has approved them. 4762 0 obj <> endobj }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 ~ 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. 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, If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. trailer 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. 0000052457 00000 n 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. documents in the last year. Directorate of Standards and Guidance 01/18/2023, 284 0 These markup elements allow the user to see how the document follows the `# @{3&jb51 QOINAVRpxCVy{j"V$ ->0c, 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 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 . on NARA's archives.gov. provide legal notice to the public or judicial notice to the courts. We take your privacy seriously. These cookies may also be used for advertising purposes by these third parties. All information these cookies collect is aggregated and therefore anonymous. on 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. a hazardous drug. 2016 NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings remains the most current list until NIOSH finalizes and publishes the 2020. 0000000896 00000 n 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. 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]. CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. 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. In Appendix A of the Alert, NIOSH identified a sample list of major hazardous drugs. Merck & Co., Inc. 01/18/2023, 823 School of Medicine If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. 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 . If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. Areas of Expertise, Discipline, or Relevant Experience: Pharmacology About the Federal Register 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). Proposed Additions to the NIOSH Hazardous Drug List 2018 . i8U So let's answer those questions and clear up a . These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. offers a preview of documents scheduled to appear in the next day's Organizational Affiliation: University of Maryland hbbd```b``6zj_&@$r1Ik0l`c0Y 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. Agencies review all submissions and may choose to redact, or withhold, certain submissions (or portions thereof). Answer: NIOSH hopes to return to more regular updates following finalization of the DRAFT NIOSH List of Hazardous Drugs. Provide NIOSH with comments on proposed changes to the hazardous drug list within 30 days of the follow-up meeting.