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Prohibition of the Extra Label Use of Cepahlosporin Antibiotics

Dan Grooms and Ron Erskine
Dept. of Large Animal Clinical Sciences

On April 6, 2012 the U.S. Food and Drug Administration (FDA) Order of Prohibition of Cephalosporins became effective. In the order, FDA prohibits certain “extra-label” or unapproved uses of cephalosporins in cattle, swine, chickens and turkeys. Common injectable cephalosporins approved for and used in cattle include Naxcel®, Excenel®, and Excede®. Intramammary cephalosporins include Today/Tomorrow, CefaLak/CefaDri and Spectramast®LC/DC.

This order is a result of increasing bacterial resistance to cephalosporin antibiotics used in humans.  The fear is that extensive usage in livestock may be adding to this resistance, thus steps to control and reduce usage are being taken.

It is important to note that these new regulations resulted after FDA initially proposed to completely eliminate any extra-label usage of cephalosporin antibiotics. The livestock industry worked diligently to prevent these very restrictive regulations from being adopted. The new regulations that have now been adopted allow for some flexibility in the usage of cephalosporins, thus helping to ensure the health and welfare of livestock. It is important that livestock producers follow these new regulations to reduce the risk of more restrictive actions being taken.

 Specifically, the prohibition includes:

  • Using cephalosporin drugs at unapproved dose levels, frequencies, durations, or routes of administration.
    • You are only allowed to use cephalosporin antibiotics according to the label directions – these directions dictate the dose (mg/lb of body weight), frequency of dosing, duration of use, and route of administration (IM, SQ, IV, oral). The new order prohibits deviation from the label.  As an example, it is illegal to give Excede® in any location except in the ear. As another example, it would be illegal to give Excenel® at a dose of 4 ml/100 lb of body weight (the label is 2 ml per 100 lb).

 

  • Using a cephalosporin antibiotic in cattle, swine, chickens or turkeys that are not approved for use in that species (e.g., cephalosporin drugs intended for humans or companion animals).
    • You are only allowed to use cephalosporin antibiotics that have been specifically approved by FDA for use in cattle, swine, chickens or turkeys. As an example, it is illegal to use CephaTabs, which is labeled for dogs, to treat neonatal calves.
  • Using cephalosporin drugs for disease prevention.
    • Cephalosporin drugs cannot be used for disease prevention. As an example, it is illegal to give heifers Excenel® prior to movement to a different farm for the prevention of respiratory disease.

 

The following exceptions to the prohibition apply:

  • Extra-label use of approved cephapirin products in food-producing animals. Cephapirin is currently only approved for use in food-producing animals as an intramammary infusion formulation for dairy cattle and there are currently no cephapirin drug products approved for use in humans. These include Today/Tomorrow and CefaLak/CefaDri.
    • It is OK to use cephapirin extra-label.  As an example, you can use ToDay or CefaLak for extended therapy for mastitis,

 

  • Use to treat or control an extra-label disease indication, as long as this use adheres to a labeled dose regimen (i.e., dose, route, frequency, and duration of administration) approved for that particular species and production class;
    • It is legal to use cephalosporin antibiotics for the treatment of diseases not on the label. So it is OK to treat a cow for a disease such as severe coliform mastitis or nephritis (kidney infection) with Excenel® as long as you use it according the label with respect to dose, frequency, duration and route of administration
  • Extra-label use in food-producing minor species such as ducks or rabbits.

 

Note: All extra-label drug use must follow the guidelines outlined by the Animal Medicinal Drug Use Act (AMDUCA) which limits extra-label drug usage to veterinarians or under their direction.

You are encouraged to work with your veterinarian to ensure that your treatment protocols adhere to the prohibitions outlined in this order. 

To view the Prohibition Order in the Federal Register, go to http://www.gpo.gov/fdsys/pkg/FR-2012-01-06/pdf/2012-35.pdf

More information on the order can be found at the FDA web site http://www.fda.gov
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