Extra-label drug use: Too much of a good thing?

Extra-label drug use (ELDU) is any use of a Food and Drug Administration (FDA) approved drug that differs from instructions on the product label. Prior to the FDA’s Animal Medicinal Drug Use Clarification Act (AMDUCA) in 1994, federal law prohibited off-label drug use in animals. In order to provide care for animals whose health is threatened or who may suffer and die without treatment, the FDA established legal methods for ELDU, but only under the order of a licensed veterinarian in the framework of a valid veterinary-client-patient-relationship (VCPR).

Libby Bigler

Colorado BQA Coordinator / Colorado State University

Email Libby Bigler

Using animal health products judiciously is our responsibility, and here are a few reasons why we need to be vigilant about ELDU.

Antibiotics affect cattle health, the food supply and even human safety

Preventative health strategies are producers’ first line of defense against disease, but antibiotics are vital secondary tools to maintain healthy, productive cattle. As long as cattle producers commit to utilizing these tools responsibly, we can be confident in the safety of both the food supply and our consumers. Unfortunately, even the slightest misinterpretation of a product label can lead to antibiotic residues, a tainted food supply and even the potential for antibiotic resistance. That’s why it is vital to establish a VCPR, abide by product labels and only use products in an extra-label manner under the order of a vet, who has established a proper withdrawal period for the extra-label use.

Deciding whether ELDU is necessary can be confusing

You can’t double the dose because a calf is showing more signs of illness than his contemporaries are, just as you can’t treat a calf that has unusual symptoms with a drug specifically labeled for pneumonia. Even though it seems like these solutions might work to clear up the illness, ELDU regulations suggest otherwise. It is always best to contact your vet to ensure your treatment is appropriate and isn’t considered an unlawful ELDU. Under the AMDUCA, there are very specific circumstances that must be in place to validate ELDU. Your vet can verify that one of the requirements for ELDU has been met prior to prescribing a treatment.

ELDU can be inadvertently mistaken for proper antibiotic management

Incorrect dosage and disease indication are not the only things considered ELDU. Any use of a product other than what is on the FDA-approved label is considered ELDU. Examples include giving two doses of a product labeled for once-a-day treatment in a single day, treating an animal with the wrong dosage based on an inaccurate weight estimate and even something as simple as giving a product intramuscularly when it is labeled for subcutaneous administration.

Keep in mind that any of the following deviations from the label are examples of how a product can be used extra-label and would ultimately require authorization from your veterinarian. These include administration:

To a different species or Animal Use Class
Of a different dose
Of a different volume per injection site
Via a different route
At a different interval (frequency)
For a different duration
For a different indication or purpose

(This list is from the Food Animal Residue Avoidance Databank.)

Consumers want safe, nutritious beef – without antibiotics

“Antibiotic-free” is one of the newest consumer buzzwords. Some want to know their food was raised without antibiotics, but a majority just want to be assured that their meat products don’t actually contain antibiotics. Although there are several safeguards in place to ensure antibiotic residues will not enter the food supply, it is producers’ responsibility to stand behind this guarantee. That’s why maintaining a VCPR is crucial, and sound record keeping is key. All cattle health records, especially those that have received veterinarian-prescribed extra-label treatment, need to be kept for two years after the animal is sold or transferred, and should include:

Date
Individual or group identification
Individual or group average weight
Product administered
Product lot/serial number
Earliest date animal could clear withdrawal
Dose
Route of administration
Location of injection
Name of person who administered treatment

Often the right thing to do isn’t always the easiest. It’s easy to disregard label instructions and increase the dosage or use the wrong product because it has worked in the past, but the consequences of inappropriate antibiotic usage can blemish the industry. Committing to responsible antibiotic use is one way each and every cattle producer can help protect the beef industry’s reputation and guarantee a safe, nutritious product.