Small Ruminant Medications: How to Stay Within the Law

Dr. Susan Kerr, WSU-Klickitat County
Publish Date: 
Fall 2007
VolNo: 
Vol. II No.3

How would you feel if you received this notice from the U.S. Food and Drug Administration about a tissue residue violation in a food animal product you marketed?

A goat sold for food on or about Sept. 30, 2007,
is adulterated within the meaning of Section
402(a)(2)(C)(ii) of the Food, Drug and Cosmetic
Act. Analysis of tissues disclosed the presence
of fenbendazole at 2.4 ppm in the liver. The
tolerance level for this drug in goat liver is 0.8
ppm. Our investigation revealed that you are
responsible for this violation.1

Ruminant

Unfortunately, very few medications are approved for use in goats and sheep. Indeed, “a critical shortage of approved animal drugs for minor uses and minor species exists because of limited sales opportunity, low profit margins, and the high capital investment necessary for bringing a drug to market.” 2

What, then, are small ruminant producers to do when their animals need treatment? Without proper treatment, animals will experience pain and suffering and some may die; producers will experience increased expenses, decreased revenues and other economic hardships. Yet use of animal medications in unapproved species and in unapproved ways can lead to dangerous medication residues in food animal tissues that enter the food supply.

On Label and Extra-label Drug Use (ELDU)

All medication labels contain information about conditions for which the medication is indicated, how much to give an animal, how long to give the medication, how to administer it, how long to withhold animal products from the food supply and so on. Using an over-the-counter or prescription medication exactly as indicated on the label is called “on label drug use.” Any deviation from the medication’s label directions, whether giving a higher dosage of the medication, dosing for a longer duration, using the medication in a different species, using it for an unlisted illness, administering using a different route, etc., is called “extra-label drug use” (ELDU).

Without the involvement of a licensed veterinarian, ELDU by producers is illegal and a violation of the federal Food, Drug and Cosmetics Act. Many producers unwittingly violate this important act, which was enacted to help protect consumers. “Extra-label use of drugs by non-veterinarians in food-producing animals is a significant public health concern and a contributing factor in illegal residues in edible animal tissue.” 3

The item presented in this image is copyrighted material of the Sheep Learning Laboratory Kit from The Ohio State University Curriculum Materials Service. Used with permission.

Requirements for Legal ELDU

Congress passed the Animal Medicinal Drug Use Clarification Act (AMDUCA) in 1994. This act amended the Food, Drug and Cosmetics Act and made ELDU legal given certain conditions:
1. ELDU is legal only under the supervision of a licensed veterinarian
2. A valid veterinarian-clientpatient relationship exists
3. The veterinarian has diagnosed the animal’s problem
4. No labeled medication exists that will treat the problem OR labeled medications will not be effective if used according to label directions
5. Treated animals are identified and all treatment-related information is recorded
6. The veterinarian has made a determination of the market withholding period for all animal products from the treated animal
7. Only FDA-approved animal or human medications can be used
8. ELDU is for disease treatment purposes only, not for production or reproduction purposes. ELDU rules also apply to medications delivered in water but not in feed. Cost is another factor that does not warrant ELDU.
9. ELDU is not permitted if it will cause a drug residue in food and pose a public health risk
10. Specific medications are completely banned for use in food animals. These include Chloramphenicol, Clenbuterol, Diethylstilbestrol (DES), Dimetridazole, Ipronidazole, other nitroimidazoles, Furazolidone, nitrofurazone, other nitrofurans, Sulfonamide drugs in lactating dairy cattle (except approved use of sulfadimethoxine, sulfabromomethazine, and sulfaethoxypyridazine), Fluoroquinolones, Glycopeptides (example: vancomycin), Phenybutazone in female dairy cattle 20 months of age or older. 4

A Valid Veterinarian-Client-Patient Relationship is Essential

Several key factors must be present for a valid veterinarian-client-patient relationship to exist:
1. A veterinarian has taken responsibility for making judgments about an animal’s health and treatment and the client has agreed to follow the veterinarian’s instructions.
2. Through examinations or farm visits, that veterinarian is personally acquainted with the animal’s care and environment.
3. That veterinarian has enough knowledge about the animal(s) to at least make a preliminary diagnosis of the animal’s problem.
4. That veterinarian is available or has made provisions for emergency service in case of unforeseen reactions or treatment failure.

Avoiding Illegal Medication Residues

No matter what type of medication is administered to a food animal, producers must make and keep accurate records. These records should be kept for two years or the animal’s lifetime, whichever is longer. The FDA may ask to review such records in the event of an illegal tissue residue situation. The information below must be recorded for every treatment on every animal:

  • Date(s) of treatment
  • Name of product and its active ingredient
  • Product manufacturer
  • Product’s lot and serial number
  • Dosage given
  • Route and location of administration
  • Withdrawal period (days or hours)
  • Name of person who administered the product
  • Animal identification
  • Species treated
  • Condition treated (pneumonia, foot rot, etc.)
  • Length of treatment (for example, “5 days”)
  • If ELDU, record of veterinarian’s name and contact information 

A medication’s withdrawal or with-holding period
is the amount of time after the last treatment
with the medication that all food products from
the treated animal (meat, milk, eggs or other
products) must be held from market until residues
of the medication have fallen to acceptable levels
in all tissues. Withdrawal periods are established
by medication manufacturers through tissue
residue studies using the label directions. ELDU
of any medication can cause tissue residues with
unpredictable medication clearance rates.

ELDU Label Requirements

If a veterinarian recommends ELDU, the following information must be included on a label attached to the medication. Such a label must also be attached to any prescription medication used on-label or extra-label:

  • Date
  • Producer’s name and contact information
  • Veterinarian’s name and contact information
  • Medication’s name
  • Directions from the veterinarian (dosage amount, route and duration)
  • Warnings or cautions
  • Withdrawal period for meat, milk, eggs or other animal-derived food products
  • Animal’s species and name or number 
Key Steps to Prevent Illegal Medication Residues
• Identify and track treated animals
• Properly store, label and administer all medications and medicated feed
• Make and keep excellent records

More Quality Assurance Issues

To decrease the possible transmission of disease-causing prions between ruminants, many mammal origin protein sources are prohibited from use in ruminant diets. Prions are believed to be the disease agent that causes transmissible spongiform encephalopathies such as Scrapie (sheep and goats), Bovine Spongiform Encephalopathy (BSE or “mad cow” disease in cattle) and Chronic Wasting Disease (deer and elk). The only mammalian by-products allowed to be included in ruminant feed are blood and its by-products, milk products, pure porcine or equine protein products and gelatin. Keep feed tags for five years. Do not let sheep or goats consume cat or dog food because these feeds contain protein sources outlawed for ruminants.
Injections should be given in the neck whenever possible. Always inject subcutaneously instead of intramuscularly when both administration routes are allowed according to label instructions. Always check for withholding information about the substance being injected—some vaccinations have a required withholding period.

Conclusion

Despite the lack of many approved medications for sheep and goats, producers can both stay within the law and treat their animals if they remember to abide by extra-label drug use procedures and work closely with a licensed veterinarian within a valid veterinarianclient-patient relationship. Proper animal identification and record keeping practices also go a long way toward avoiding illegal medication residues in marketed products. The Minor Use and Minor Species Animal Health Act (MUMS) passed by Congress in 2004 encourages pharmaceutical companies to create medications to prevent and treat rare diseases in major species (cattle, horses, dogs, cats, swine and poultry) and common diseases in minor species (all other species). Let’s hope reaction to MUMS will translate into more approved and effective medications for small ruminants in the years to come.

Resources and References

1. Adapted from wording in U.S Food and Drug Administration Compliance Policy Guide, Compliance Policy Guidance for FDA Staff, CHAPTER 6, SUBCHAPTER, 615 Sec. 615.115 Extra-label Use of Medicated Feeds for Minor Species, April 4, 2001.
2. JAVMA News, Sept. 1, 2004.
3. U.S. Food and Drug Administration/Office of Regulatory Affairs Compliance Policy Guides, Sec. 615.200, “Proper Drug Use and Residue Avoidance by Non-Veterinarians” (CPG 7125.37), 1993.
4. Extralabel Drug Use (ELDU): An Informational Outline of the Animal Medicinal Drug Use Clarification Act (AMDUCA), American Veterinary Medical Association, 2006.

Delicious Goat Recipe

(Submitted by Sam Angima)
2 pounds of stew meat (small one-inch cubes)
Pressure cooker
¼ salt
1 teaspoon curry powder
1 large onion
2 medium tomatoes
1 medium red or green bell pepper
½ cup chopped cilantro
1 cup water
2 teaspoon olive oil
Add olive oil to the pressure cooker pan (you can use a pan if you have no pressure cooker) on a hot stove and add the onions. Stir and let cook for 2 minutes. Now, add red or green bell peppers and let cook for one to two minutes, add cilantro and chopped tomatoes and curry powder, stir and let cook for 2-3 minutes. Now add the chopped goat meat and ¼ teaspoon of salt and stir intermittently for about 3 minutes. Cover and let cook for another 2 minutes. Add 1 cup water, stir well and pressure cook for 10-12 minutes; remove from heat source and cool pan to release presure. (If you do not have a pressure cooker, use a covered pan and cook on medium heat for 30-40 minutes). Check to make sure meat is fully cooked. Add more salt to your liking and serve with rice or pasta or potatoes.