"On July 3, 2008, the U.S. Food and Drug Administration [FDA] published a final rule that prohibits the extra-label use of cephalosporin antimicrobial drugs in food-producing animals.…This rule will help further protect consumers against antimicrobial-resistant strains of zoonotic foodborne bacterial pathogens.”
This quote, from a recent e-mail alert, is easy to dismiss as just one more example of forces that do not have our industry's best interests in mind. Yet without access to such tools, food safety and animal welfare will suffer.
Antibiotics come with directions specifying the diseases they are intended to be used for, dosages, treatment lengths, routes of administration and animal types. Many times, these directions are quite restrictive if followed to the letter.
So FDA recognizes it is sometimes necessary to use drugs in an extra-label fashion. In fact, there is a specific set of guidelines for extra-label use.
If we expect
the FDA and consumers to take our industry seriously, we need to follow these extra-label guidelines judiciously. They require that your veterinarian has determined there is no other labeled product available or that the drug approved for the condition being treated is not effective.
In addition, they require that there be a prescription that describes the specific extra-label use as well as appropriate withdrawal times. Records must be kept that clearly document this activity.
Periodically reviewing treatment and diagnosis protocols with your veterinarian is a good first step toward meeting regulatory requirements.
- November 2008