Updating the List of Hazardous Drugs for the NIOSH Alert: Additions and Deletions to the NIOSH Hazardous Drug List

AGENCY:

National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).

ACTION:

Notice of draft document available for public comment.

SUMMARY:

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 “Updating the List of Hazardous Drugs for the NIOSH Alert: Additions and Deletions to the NIOSH Hazardous Drug List.” The document and instructions for submitting comments can be found at http://www.cdc.gov/niosh/review/public/105a/ .

DATES:

Comments must be postmarked by June 30, 2009.

ADDRESSES:

You may submit comments to nioshdocket@cdc.gov or to the NIOSH Docket Office, Robert A. Taft Laboratories, MS-C34, 4676 Columbia Parkway, Cincinnati, OH 45226 or by facsimile (513) 533-8285. Comments should be in Microsoft Word format and should reference NIOSH docket number 105-A. NIOSH includes all comments received without change in the docket, including any personal information provided. After the comment period has closed, comments will be able to be accessed electronically at http://www.cdc.gov/NIOSH under the link to the NIOSH docket. As appropriate, NIOSH will post comments with the commenters' names, affiliations and other information, on the Internet.

Background: The “NIOSH Alert: Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings” was published in September 2004 ( http://www.cdc.gov/niosh/docs/2004-165/ ). Since that time, approximately 60 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. An additional 18 drugs were included from the updated National Institutes of Health (NIH) Hazardous Drug List. From this list of approximately 150 drugs, 62 drugs were determined to have one or more characteristic of a hazardous drug and published for comment in NIOSH docket number 105.

After review by experts, public review and comment, input from stakeholders and review of the scientific literature, NIOSH has proposed a second draft list of hazardous drugs. A number of drugs were removed from the initial proposed list based on comments from the various groups and organizations. The second draft list identifies 24 drugs that fit the NIOSH definition of hazardous drugs. Based on comments received by NIOSH, Bacillus Calmette-Guerin (BCG) will be removed from Appendix A in the 2004 NIOSH Alert on Hazardous Drugs ( http://www.cdc.gov/niosh/docs/2004-165/ ) due to potential adverse effects in some patients from cross-contamination.

This guidance document does not have the force and effect of law.

FOR FURTHER INFORMATION CONTACT:

Barbara MacKenzie, NIOSH, Robert A. Taft Laboratories, MS-C26, 4676 Columbia Parkway, Cincinnati, OH 45226, telephone (513) 533-8132, E-mail: hazardousdrugs@cdc.gov.

Reference: http://www.cdc.gov/niosh/docs/2004-102/. Web address for this document: http://www.cdc.gov/niosh/review/public/105a/. All information received in response to this notice will be available for public examination and copying at the NIOSH Docket Office, 4676 Columbia Parkway, Room 111, Cincinnati, Ohio, 45226, telephone (513) 533-8303.