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April 2009
NIOSH Docket Number 105-A

Hazardous Drug Alert

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 (http://www.cdc.gov/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; 9/17/10 [PDF - 2,812 KB]

Final document "NIOSH List of Antineoplastic and other Hazardous Drugs in Healthcare Settings, 2010;" 9/1/10 [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; 4/29/09 [PDF - 1.70 MB]

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

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

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

Submissions in order of Receipt

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Submission to NIOSH Docket from Carolyn Jones (Biogen Idec); 1/13/10 [PDF - 4,819 KB]

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

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

Reference #1 – Avonex US Full Prescribing Information, 2008 [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 - 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 - 57 KB]

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

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

Reference #6 – American College of Obstetrics and Gynaecology (Accessed at http://www.americanpregnancy.org/) [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 - 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 - 53 KB]

 
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