PUBLIC SUBMISSION | As of: February 16, 2009 Tracking No. 80733984 Comments Due: November 03, 2008 |
Docket: FDA-2008-N-0326
New Animal Drugs; Cephalosporin Drugs; Extralabel Animal Drug Use; Order of Prohibition
Comment On: FDA-2008-N-0326-0049
New Animal Drugs; Cephalosporin Drugs; Extralabel Animal Drug Use; Order of Prohibition; Extension of Comment Period; Delay of Effective Date of Final Rule
Document: FDA-2008-N-0326-0080
New Pittsburg Large Animal Clinic - Comment
October 2, 2008
Re: FDA 2008-N-0326 Proposed EDLU Cephalosporin Ban
Dear Sirs/Madame
As a dairy veterinarian, I believe the proposed ban on ELDU of cephalosporins is
being painted with too broad of a brush. I grant that Salmonella resistance may
be real, but enforcing EDLU cephalosporins on non-enteric target organisms
involving mastitis, metritis and footrot in cattle is at best as ticky-tacky. Example
1: Exenel is labeled for footrot in cattle whereas a different formulation of the same
ceftiofur compound, Naxel is not. Example 2: Exenel is labeled for metritis in
cattle whereas Excede is not. These examples illustrate a difficult sell for me to
my dairy clients which will undermine your credibility.
If you wish to impact Salmonella resistance via food producing animals then
provide a regulation that is clearly defined, believable and enforceable. I suggest
limiting ELDU cephalosporins to non-enteric health issues.
Sincerely,
Richard E. Wiley DVM
Richard E. Wiley DVM
New Pittsburg Large Animal Clinic
1436 West Old Lincoln Way
Wooster, OH 44691
| FDA-2008-N-0326-0080.1 | New Pittsburg Large Animal Clinic - Comment |