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August 2013
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) announced 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 requested 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."

Background Information

Federal Register Notice: Notice of draft publication available for public comment; 6/3/13 [PDF- 195 KB]

Draft List [PDF- 57 KB]

 
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