Is your drug use legal?

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If outside forces had their way, antibiotic usage on farm would stop today. So, if we want to continue to have medications available to treat sick animals and to relieve pain and suffering, due diligence is required by all of us. Which leads me to ask: “Are you using your medications in a legal manner?” Perhaps a refresher course is in order.

The rules

The Food and Drug Administration has classified all animal medications into three categories.

  • Over-the-counter (OTC). Approved for sale to anyone by a licensed dealer. Must be used only as the label indicates.
  • Prescription. The label contains the wording “Federal law prohibits this drug to use by or on the order of a licensed veterinarian.” A veterinarian must have a valid veterinary-client-patient relationship (VCPR) to prescribe.
  • Extra-label-use drug. These drugs can be used other than as labeled on the order of a veterinarian under a VCPR, as long as strict criteria are met. 

A drug’s label is often limited due to the expense of the drug-approval process. Companies seek label approval for major species and common diseases or conditions and then go to market. This leaves minor species, such as sheep and goats, or subspecies like lactating cattle, off of the manufacturer’s label. So, for dairy, a major disease like pneumonia is listed on the label while a minor one like metritis is not. This leaves producers without a labeled treatment option for metritis.

Legally, what does this mean? Simply put, only your veterinarian can order an OTC or prescription drug’s use in an extra-label manner, such as to treat metritis. And in order to do that, your veterinarian must follow these FDA criteria.  

  • Only FDA-approved drugs are used.
  • There is a valid VCPR.
  • It is used for a therapeutic purpose (animal health is suffering or threatened).
  • No labeled drug for the condition exists.
  • An approved drug is ineffective or must be given in a dose or manner not on the label to be effective.
  • There is scientific evidence to support its use.
  • There is an established withdrawal time for its use in an extra-label manner.

An extra-label-use drug cannot be used as feed additives or for production reasons. It cannot appear on the list of drugs prohibited for extra-label use shown below.

Fluoroquinolones

One drug that needs special explanation is the fluoroquinolone class of antibiotics. This group includes the FDA-approved drug Baytril for dogs, cats and beef cattle. Baytril is approved for the treatment of bovine respiratory disease in beef cattle only; it cannot be used in cattle intended for dairy production (heifer calves) or in calves to be processed for veal.

The FDA is on the lookout for any illegal use of this drug class since some in the scientific community believe that the low-residue levels found in food products may be a contributing factor of antibiotic resistance in humans. The human product, Ciprofloxin, is used to treat severe bacterial infections such as salmonella and E. coli.  If any abuse of fluoroquinolone is found in livestock, we will lose its use in all livestock.

The use of any drug in an extra-label manner outside the order and prescription of your veterinarian is illegal. Violation of these laws is a felony. The punishment can be a $250,000 fine and six months in prison for each violation.

Each one of us should ensure that medications are used in a legal and responsible manner.

Jim Brett is a practicing veterinarian in Montezuma, Ga.


These Drugs cannot be used in food animals

(Current as of 6/1/06)

  • Chloramphenicol.
  • Clenbuterol.
  • Diethylstilbesterol.
  • Dimetridazole.
  • Ipronidazole.
  • Other nitroimidazoles.
  • Furazolidone, nitrofurazone, other nitrofurans.
  • Sulfonamide drugs in lactating cows (except for sufadimethoxine,
    sulfabromomethazine, and sulfaethoxypridazine).
  • Fluoroquinolones.
  • Glycopeptides.
  • Phenylbutazone in dairy heifers 20 months of
    age and older.
  • Adamantane and neuraminidase inhibitor classes are prohibited
    in poultry.


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