Friday 31 October 2014

FDAAntibotics

FDA: Some Livestock Antibiotics Will Be Limited

From the Associated Press:

The Food and Drug Administration has moved to limit the use of an antibiotic that is injected into livestock before slaughter, saying it could increase antibiotic resistance in humans.

While the action is limited to only one of several drugs used on industrial feedlots, it is encouraging news for public health advocates who have long pushed the government to force livestock producers to use fewer antibiotics, saying they are overused and could endanger human lives by building up resistance to the drugs. One main concern is the use of antibiotics in healthy animals to spur growth or to keep them well in unsanitary feedlot conditions.

The FDA said Wednesday it will restrict the use of cephalosporin antibiotics, which are given to some cattle, swine, chickens and turkeys before slaughter. The drugs are used to treat pneumonia, skin infections and meningitis, among other diseases, in humans.

Cephalosporins, which are directly injected into eggs or animals, are not as widely used as many other antibiotics that are mixed with feed in massive quantities. But they are significant because the class of drugs is so important to humans.

The Impact

In its order, the FDA is prohibiting what are called “extralabel” or unapproved uses of cephalosporins in cattle, swine, chickens and turkeys, the so-called major species of food-producing animals. Specifically, the prohibited uses include:

  • using cephalosporin drugs at unapproved dose levels, frequencies, durations, or routes of administration;
  • using cephalosporin drugs 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);
  • using cephalosporin drugs for disease prevention.

The following exceptions to the prohibition apply:

  • Extralabel use of approved cephapirin products in food-producing animals;
  • Use to treat or control an extralabel disease indication, as long as this use adheres to a labeled dosage regimen (i.e., dose, route, frequency, and duration of administration) approved for that particular species and production class; and
  • Extralabel use in food-producing minor species, such as ducks or rabbits.

The FDA also announced that it will prohibit using drugs not originally intended for use in livestock. Some limited extra-label use will still be permitted, including prescription drugs in less-commonly eaten (minor species) animals such as rabbits and ducks.

The FDA’s new rules are scheduled to take effect April 5.  It has published a Q & A about antibioticson its website.

Once the rules take effect any use of the antibiotic will be considered adulterated under the FD&C. This can result in a recall, injunction or seizure of affected products. It also important to remember the FDA can now exercise mandatory recall authority under the Food Safety Modernization Act. Producers need to begin to take steps to be ready for the April 5th deadline.

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