Hazardous Drug Alert

April 2009
NIOSH Docket Number 105-A

Summary: The National Institute for Occupational Safety and Health of the Centers for Disease Control and Prevention (CDC) requested comments on proposed additions and deletions to the list of hazardous drugs (Appendix A). The NIOSH Alert was published in September 2004 (/niosh/docs/2004-165/). Following the publication of the Alert, NIOSH reviewed 70 new FDA-approved drugs and approximately 60 that had received special warnings. NIOSH developed a list of approximately 60 drugs that appeared to fit the NIOSH definition for a hazardous drug. Following a public meeting [72 FR 33507], NIOSH posted the proposed list in the Federal Register in July 2007. NIOSH then convened a panel of 10 external reviewers to review the NIOSH list and the public comments. NIOSH reviewed the comments from the external reviewers and revised the proposed list to 24 additions and one deletion.

Docket Number 105 is a collection of documents related to the development and progress of this Hazardous Drug Alert.

Related Docket

Final Document Information

Notice; 75 FR 57044; Final Document announcement; 9/17/10pdf icon [PDF – 2,812 KB]

Final document “NIOSH List of Antineoplastic and other Hazardous Drugs in Healthcare Settings, 2010;” 9/1/10pdf icon [PDF – 13,255 KB]

Material under Evaluation

74 FR 19570; Updating the List of Hazardous Drugs for the NIOSH Alert: Additions and Deletions to the NIOSH Hazardous Drug List; 4/29/09pdf icon [PDF – 1.70 MB]

Draft Proposed Additions and Deletions to Appendix A of NIOSH Alert on Hazardous Drugs (April 6, 2009); 4/6/09pdf icon [PDF – 696 KB]

NIOSH Response to Peer Review Comments (April 6, 2009); 4/6/09pdf icon [PDF – 2.95 MB]

Summary of comments received through NIOSH Docket with NIOSH responses; 4/6/09pdf icon [PDF – 2.95 MB]

Submissions in order of Receipt

Submission to NIOSH Docket from Thomas Rogers (MD Anderson Cancer Center, Orlando, FL); 5/5/09pdf icon [PDF – 375 KB]

Submission to NIOSH Docket from Katie Slavin and Nancy Hughes (American Nurses Association); 5/8/09pdf icon [PDF – 781 KB]

Submission to NIOSH Docket from Kay Howard (Upstate Medical University, NY); 5/14/09pdf icon [PDF – 406 KB]

Submission to NIOSH Docket from Mark Crosby (Intermountain Home Care); 5/14/09pdf icon [PDF – 193 KB]

Submission to NIOSH Docket from Linda McElhiney (Clarian); 5/15/09pdf icon [PDF – 274 KB]

Submission to NIOSH Docket from Holly McKillop (Huron Regional); 5/25/09pdf icon [PDF – 312 KB]

Submission to NIOSH Docket from Noreen Kishimoto (Kaiser Permanente of Colorado); 6/10/09pdf icon [PDF – 280 KB]

Submission to NIOSH Docket from Marie Dimicco (Westchester Medical Center); 6/16/09pdf icon [PDF – 402 KB]

Submission to NIOSH Docket from Bruce Chaffee and James Stevenson (University of Michigan Health System); 6/23/09pdf icon [PDF – 3.06 MB]

Submission to NIOSH Docket from Justine Coffey (American Society of Health- System Pharmacists); 6/24/09pdf icon [PDF – 1.58 MB]

Submission to NIOSH Docket from Elizabeth Treanor (BioPharma EHS Forum); 6/29/09pdf icon [PDF – 1.16 MB]

Submission to NIOSH Docket from Michael Cuozzo (Centocor Ortho Biotech Services, LLC); 6/30/09pdf icon [PDF – 1.55 MB]

Submission to NIOSH Docket from Gene Murano (Genentech); 6/30/09pdf icon [PDF – 1.85 MB]

Submission to NIOSH Docket from Sara Radcliffe (Biotechnology Industry Organization); 6/30/09pdf icon [PDF – 2.66 MB]

Submission to NIOSH Docket from Ellen Faria (Johnson & Johnson); 8/7/09pdf icon [PDF – 4,171 KB]

Submission to NIOSH Docket from Mariska Kooijmans-Coutinho (Biogen Idec) w/references; 1/13/10pdf icon [PDF – 4,819 KB]

Reference #1 – Avonex US Full Prescribing Information, 2008pdf icon [PDF – 657 KB]

Reference #2 – Bos JD and Meinardi (2000). The 500 kilodalton rule for the skin penetration of chemical compounds and drugs. Exp Dermatol 9:165-169.pdf icon [PDF – 59 KB]

Reference #3 – Patton JS and Byron PR (2007). Inhaling medicines: delivering drugs to the body through the lungs. Nat Rev Drug Discov 6:67-74.pdf icon [PDF – 57 KB]

Reference #4 – Avonex 23rd periodic safety update report, May 17 to November 16, 2009.pdf icon [PDF – 4 KB]

Reference #5 – March of Dimes (Accessed at http://www.marchofdimes.com)pdf icon [PDF – 215 KB]

Reference #6 – American College of Obstetrics and Gynaecology (Accessed at http://www.americanpregnancy.org/)pdf icon [PDF – 147 KB]

Reference #7 – Frogoso YD, et al. Arquivos de Neuro-Psiquiatria pregnancy and Multiple Sclerosis: The initial results from a Brazilian database. 67(3A):657-660.pdf icon [PDF – 46 KB]

Reference #8 – Weber-Schoendorfer C, and Schaefer C (2009). Multiple Sclerosis, immunomodulators and pregnancy outcome: a prospective observational study. Multiple Sclerosis 15:1037-1042.pdf icon [PDF – 53 KB]

Page last reviewed: July 6, 2010