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.”(1)
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 to store 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 with whom a producer has a legitimate professional relationship, 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. As stated by the U.S. Food and Drug Administration, “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.”(2)
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-client-patient 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.(3)
11. ELDU does not cover feed additives or medicated feeds. No one has the authority to use feed additives or medicated feeds other than exactly as directed on the product label. The FDA regulates the medicated feed industry.
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 withholding 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 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:
1. Date
2. Producer’s name and contact information
3. Veterinarian’s name and contact information
4. Medication’s name
5. Directions from the veterinarian (dosage amount, route, and duration)
6. Warnings or cautions
7. Withdrawal period for meat, milk, eggs, or other animal-derived food products
8. Animal’s species and name or number.
Despite the lack of many approved medications for sheep and goats, producers can both stay within the law and treat their animals if they abide by extra-label drug use procedures and work closely with a licensed veterinarian within a valid veterinarian-client-patient relationship. Proper animal identification and record-keeping practices also go a long way toward avoiding illegal medication residues in marketed products.
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.
Resources
http://www.fda.gov/opacom/laws/fdcact/fdctoc.htm
http://www.avma.org/reference/amduca/amduca1.asp
http://www.fda.gov/ora/compliance_ref/cpg/cpgvet/cpg615-200.html
http://www.avma.org/issues/drugs/mums/brochure.pdf
http://www.colostate.edu/programs/SSQA/chapter_3.htm
http://www2.luresext.edu/goats/library/field/DawsonA05.pdf
References
1. JAVMA News, Sept. 1, 2004.
2. 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.
3. Extralabel Drug Use (ELDU): An Informational Outline of the Animal Medicinal Drug Use Clarification Act (AMDUCA), American Veterinary Medical Association, 2006.