Extralabel drug use (ELDU) is defined as the use of an FDA-approved medication in a manner that differs from what is provided on the label of the medication.1 Administration of the medication to a different species or at a different dose, volume, route, duration, indication, or frequency than indicated on the label is considered ELDU. Extralabel drug use also requires an extended withdrawal period to avoid violative residues, and practitioners can get advice on withdrawal intervals (WDIs) following ELDU from the Food Animal Residue Avoidance and Depletion Program (FARAD). Penicillin is one of the most commonly used
From a food safety point of view, any animal that has the potential to be consumed by humans is considered a food-producing animal; therefore, the regulations pertaining to ELDU in food-producing animals should be followed. This applies to wildlife species that may be free ranging or captive raised and consumed by humans, such as cervids, game birds, and marine mammals as well as species treated in wildlife rescue and rehabilitation centers, because those animals have the potential to be anesthetized, treated for injuries or illnesses, and released back into their native habitats following anesthesia or drug administration.
In the present FARAD Digest, common medications used to treat small ruminants in the United States and FARAD-recommended WDIs following ELDU in small ruminants will be reviewed. For this digest, we use the term small ruminants to refer only to sheep and goats. In the United States, sheep and goats are considered minor species by the FDA and are therefore exempt from many of the rules used to regulate drug use in the major species (horses, cats, dogs, cattle, swine, turkeys, and chickens). From 2007 to 2012, the overall number of sheep and goats in production in the United States
Inadvertent or intentional administration of pesticides to food animals such as egg-laying hens (layers) and broilers often leads veterinarians to contact FARAD to inquire about withdrawal intervals. Unfortunately, US law permitting ELDU does not include products registered by the EPA; thus, ELDU use of pesticides puts FARAD in a precarious situation. Fipronil, a broad-spectrum phenylpyrazole pesticide, is used to prevent insects such as fleas and ticks from plaguing cats and dogs as well as repelling a variety of insects from crops and homes. Fipronil is not approved for use in any food animal species in the United States or any
Calfhood diseases have major negative economic consequences on beef and dairy operations owing to costs associated with treatment, long-term effects on growth and performance, and death of affected calves.1–3 The number of drugs approved for the treatment of diseased calves by the FDA is limited; however, veterinarians have the authority to administer drugs in an extralabel manner to that class of animals under provisions established by AMDUCA.4 Nevertheless, drug labels that state, “a withdrawal period has not been established for this product in preruminating calves” can cause confusion about whether those drugs can or cannot be
The FARAD manages the Food Animal Residue Avoidance Databank and has been serving the veterinary profession for 35 years. It is funded and sponsored by the USDA National Institute of Food and Agriculture and is overseen and operated by faculty and staff within the colleges of veterinary medicine at the University of California-Davis, University of Florida, Kansas State University, and North Carolina State University.
The overarching goal of FARAD is to provide veterinary practitioners the most current and accurate information to facilitate the production of safe foods of animal origin through the prevention and mitigation of violative chemical (eg,
Flunixin meglumine is an NSAID that is approved by the FDA for the treatment of inflammatory conditions in cattle, horses, and swine and alleviation of pain associated with musculoskeletal disorders and colic in horses; it is not labeled for alleviation of pain in food-producing animals. Currently, there are no FDA-approved drugs for the treatment of pyrexia, inflammatory conditions, or pain in minor food-producing species such as sheep and goats. Owing to the lack of alternatives, veterinarians often administer food-producing animals products containing flunixin in an extralabel manner for the treatment of signs of pain. In the United States, NSAIDs are
In recent years, backyard poultry flocks have become increasingly popular in urban areas throughout the United States. Results of a 2010 USDA study1 of 4 US cities (Denver, Los Angeles, Miami, and New York) indicated that 1% of households surveyed owned chickens and another 4% of households surveyed were planning on owning chickens within the next 5 years. The increase in the number of small poultry flocks in urban areas has led to an increase in the demand for veterinary services for those flocks, and veterinarians whose clientele is usually limited to companion animals now find themselves treating
Analytical precision and accuracy in residue chemistry are constantly improving toward the goal of a safe food supply. On July 6, 2012, the USDA FSIS announced a restructuring of the US NRP with respect to sampling of compounds in meat, poultry, and egg products and the scheduling of animal production classes.1 The FSIS has also implemented several new MRMs for analyzing tissue samples from harvested animals for violative residues. These MRMs allow for several compounds to be tested simultaneously. As a result, compounds that have not been previously tested in certain animal production classes are now included in
Extralabel drug use encompasses the use of a drug in an animal in a manner that is not in accordance with the FDA-approved label. This includes use in a species or for a disease or condition not listed on the label; use at dosages, frequencies, or routes of administration that differ from those stated on the label; or deviation from the labeled withdrawal time. Extralabel drug use in veterinary species was made legal by the passage of AMDUCA in 1994.1 However, there are restrictions to AMDUCA, particularly with reference to ELDU in food-producing animals.