AMDUCA and drug issues in sheep and goats (Proceedings)
Since 2005, the American Veterinary Medical Association and several species specialty groups have published their policy statements regarding judicious use of antimicrobials online at http://www.avma.org/issues/policy/jtua.asp. The policy statement for the American Association of Small Ruminant Practitioners concerning prudent drug use guidelines is available at http://www.aasrp.org/. Veterinarians and producers are reminded that FDA revises its policies frequently and the information in this paper is based on data available in August 2009.
All sheep and goats are food animals
Both USDA and FDA classify all sheep and goats as food animals regardless of the reason that the producer chooses to maintain them. The cute pet pygmy and the horse companion are only one owner away from the slaughterhouse, and veterinarians should remember this when choosing drugs for treating any sheep or goat. FDA currently maintains a list of approved animal drugs searchable by species or product at http://www.accessdata.fda.gov/scripts/AnimalDrugsAtFDA/. While this website indicates that 154 drugs are licensed and labeled for use in sheep and 35 are legally available for use in goats, most of these are actually different formulations of a small number of drugs. For example, the 35 drugs licensed for use in goats include only the 7 products ceftiofur, decoquinate, fenbendazole, morantel tartrate, neomycin, rumensin, and thiabendazole. Very few of the drugs that veterinarians use or prescribe for goats on a daily basis are on this list.Animal medicinal drug use clarification act - AMDUCA
After much debate and comment, the Food and Drug Administration published the final rule for the Animal Medicinal Drug Use Clarification Act of 1994, effective December 9, 1996. AMDUCA allows veterinarians to use approved animal drugs for indications and species that are not on the drug label when labeled products are not available. In order for the AMDUCA regulations to apply, a drug must have a new animal drug application on file; not all drugs that are commonly used have NADA's. An example of a commonly used drug that does not have an NADA is aspirin which is marketed and labeled for use in cattle but cannot legally be used in sheep or goats. The AMDUCA regulations have differing impact for food and non-food animal veterinarians. Extra-label use of drugs for non-food animals is now acceptable in most situations if it will not pose a threat to animal health. These rules allow equine and companion animal veterinarians access to most human drugs as well as all approved animal drugs. Companion animals are rarely consumed for food in this country, so the rules recognize that there is little concern for drug residues. Because the problem of drug residues is of great concern in those species consumed for food, AMDUCA regulations for food animals are restrictive and specific.
Extra label drug use - ELDU
AMDUCA outlines what classes of drugs can be used in a manner different than what appears on the label and under what circumstances they can be used. Small ruminant practitioners are frequently asked to prescribe drugs to manipulate reproduction in goats, yet AMDUCA allows extra-label use only when licensed drugs are not available and then only to save the life of an animal. ELDU refers to extra-label drug use or the privilege granted to veterinarians to prescribe the use of a legal drug in a manner than is different from what appears on its label. ELDU might mean a different dosage, duration of therapy, method of administration or specie. An important concept is that producers cannot legally use drugs in an extra-label manner, but a veterinarian can prescribe drugs for producers to use in an extra-label manner.