NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings: Proposed Additions to the NIOSH Hazardous Drug List 2016

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 for public comment entitled “NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings: Proposed Additions to the NIOSH Hazardous Drug List 2016.”

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, 2012, and 2014pdf icon and covered all new approved drugs and drugs with new warnings up to December 2011. Between January 2012 and December 2013, 60 new drugs received FDA approval and 270 drugs received special warnings (including black box warnings) based on reported adverse effects in patients. From this list of 330 drugs, 44 drugs were identified by NIOSH as potential hazardous drugs. In addition to these 44 drugs, the panel members were asked to comment on the addition of one drug requested by several stakeholders. Three drugs had safe handling recommendations from the manufacturer and NIOSH is following these recommendations. Therefore, these 3 drugs will be listed as hazardous without requiring further review. A panel consisting of peer reviewers and stakeholders was asked to review and comment on the 45 potentially hazardous drugs. Reviewers were not asked to provide a consensus opinion and NIOSH made the final determination regarding proposed additions to the 2016 hazardous drug List. NIOSH has determined that the remaining 34 drugs have one or more characteristics of a hazardous drug. Five of the 34 drugs have safe handling recommendations from the manufacturers.

NIOSH requested public comment on the proposed additions 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.govexternal icon and enter CDC-2015-0034 in the search field and click “Search.”

To view related dockets, see Docket 233, 233-B, 233-C.