Extra-Label Drug Use
There are few drugs for use in goats that have Food and Drug Administration (FDA) approval. Administering any drug not specifically labeled for use in goats or any product, either prescription or over the counter, that is not used as directed on the label is considered "Extra-label" or "off-label" drug use. Only veterinarians may prescribe or use products "off-label" or "Extra-label" provided they have a valid veterinarian - client - patient relationship (VCPR) with the producer.
The issue of "extra label" use also applies to feed medications not approved for use in goats. While extra-label use of medications in or on animal feed is prohibited, in 2001 the FDA provided guidance on extra-label use of medicated feeds in minor species such as goats. In brief, extra-label use of medicated feed in minor species is limited to treatment of animals whose health is suffering or is threatened or whose death may result from failure to treat. If medicated feed is to be used in a food producing minor species, the product used must be approved for use in a food producing major species. The FDA discourages use of medicated feed in an extra-label manner for improving rates of weight gain, feed efficiency, or other production purposes.
Most goat producers are unaware that they do NOT have "extra-label" drug use privileges. Only veterinarians who have established a VCPR with a particular client may prescribe or use drugs in an extra-label manner on that client's animals if the animal health is threatened and suffering or death may result from failure to treat. To establish a VCPR, the veterinarian should have visited the farm, and have a thorough knowledge of the management of these animals, or has recently seen the animal to be treated. Once a VCPR has been established, the veterinarian may use drugs in an extra-label manner provided that the client has agreed to follow his or her recommendations.
Three conditions of extra-label drug use
- The veterinarian has examined the animal(s) in question recently and has made a diagnosis and a determination that products with proper labeling will not work in this instance.
- The client has been instructed by the veterinarian in the proper use and administration of the product, a withdrawal period has been determined, and the client is willing to follow the instructions given by the veterinarian.
- The veterinarian is available to respond to any adverse reaction or follow up examination and treatment that may occur to the animal due to the administration of the drug or failure of the drug to work.
FDA criteria for using pharmaceuticals extra-label
The FDA has also established five criteria that must be met before any drug may be used in a food-producing animal in a manner different from that product's label.
- The veterinarian must first examine the animal and assumes responsibility for making clinical decisions regarding the health and treatment of the animal within the guidelines of a VCPR. Often a goat owner will not have the animal examined by a veterinarian, but will telephone a veterinarian, who may never have visited the farm, with a list of symptoms and ask for a recommended treatment.
- The second criterion requires that the veterinarian determine there is no marketed drug specifically labeled to treat the diagnosed condition, or that the recommended dosage on the label for that product is clinically ineffective. Since there are few drugs labeled for use in goats, it is not difficult to determine whether or not there is a legally licensed product available.
- The third criterion requires that the individual animals to be treated are clearly identified, and that accurate records be maintained regarding the treatment of those specific individuals. Many registered goats are either tattooed, ear-tagged, or notched for identification. If there is no permanent identification, the owner must make some effort to identify the treated animals with a visible temporary mark by using temporary tags or paint. If possible, these animals should be isolated. Records on animals and treatment must be kept for future reference to avoid any drug residues in the meat or milk.
- The fourth criterion requires that a significantly extended time period be assigned for drug withdrawal prior to marketing meat or milk from treated animals when pharmaceuticals are used in an extra-label manner. The owner must keep accurate records of the treatment, namely the person treating this animal, date, route of administration, product used and a proper withdrawal period. Proper withdrawal period can be obtained from your veterinarian. Most goat owners casually treat their animals and do not keep proper records of animals treated, drugs used or proper withdrawal period for that product. If no information is available to establish a withdrawal time, then the treated animal or animal products such as milk and meat are permanently barred from the human food chain.
- The last criterion details the information that must be listed on the drug dispensed for extra-label use. The label should include the name and address of the veterinarian, the established name of the drug(s), and the specific directions for use including: dosage, routes of administration, frequency of treatment, duration of therapy, cautionary statements, and the withdrawal time for any food that might be derived from the treated animal.