NIOSH Docket Number 233, CDC-2013-0007
NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings: Additions and Deletions to the NIOSH Hazardous Drug List
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the availability of the following draft document available for public comment entitled "NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings: Additions and Deletions to the NIOSH Hazardous Drug List."
The NIOSH Alert: Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings was published in September 2004. This Alert contained Appendix A which was a list of drugs that were deemed to be hazardous and may require special handling. This list of hazardous drugs was updated in 2010 and 2012 and covered all new approved drugs and drugs with new warnings up to December 2009. Between January 2010 and December 2011, 48 new drugs received FDA approval and 276 drugs received special warnings (usually black box warnings) based on reported adverse effects in patients. From this list of 324 drugs, 42 drugs were identified by NIOSH as candidate hazardous drugs. Four of these drugs had safe handling recommendations from the manufacturer and NIOSH is following the recommendations of the manufacturers. Therefore, these four drugs will be listed as hazardous without requiring further review. NIOSH has determined that the remaining 38 drugs have one or more characteristics of a hazardous drug. In addition, NIOSH is recommending the addition of one drug requested by several stakeholders and the removal of one drug from the 2012 Hazardous Drug List.
NIOSH is requesting public comment on the proposed additions and deletions to the list of antineoplastic and other hazardous drugs as to the appropriateness of listing these drugs. To view the notice and related materials, visit http://www.regulations.gov and enter CDC-2013-0007 in the search field and click "Search."
Federal Register Notice:
Notice of draft publication available for public comment; 6/3/13
Public Comment Period
Comments will be accepted until 5:00 p.m. EST on August 2, 2013.
Written comments, identified by CDC-2013-0007 and docket number NIOSH-233, may be submitted by any of the following methods:
Federal rulemaking portal: Follow the instructions for submitting comments.
Instructions: All submissions received must include the agency name and docket number. All relevant comments, including any personal information provided, will be posted without change to http://www.regulations.gov
- Mail: NIOSH Docket Office
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Cincinnati, OH 45226
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