The Food Animal Residue Avoidance Databank (FARAD) recently provided guidance to small ruminant producers and their veterinarians in an article titled “Extralabel drug use (ELDU) in small ruminants” in JAVMA, Vol 253, No. 8, Oct. 15, 2018, pp 1001-1009.
“FARAD is a university-based national program that serves as the primary source for scientifically-based recommendations regarding safe withdrawal intervals of drugs and chemicals in food-producing animals. As such, FARAD is a key resource for protection of our nation’s food supply, including meat, milk and eggs, against accidental contamination of animal-derived foods with violative residues of drugs, pesticides or other agents that could compromise food safety.”
FARAD regularly provides guidance to the food animal producing industry and veterinarians regarding “the use of therapeutic drugs, pesticides and other agents that improve overall animal health and promote safe, efficient and humane production practices.”
The purpose of its latest digest, as stated, “was to provide US veterinarians guidance regarding ELDU in small ruminants. The lack of FDA-approved drugs for sheep and goats frequently necessitates ELDU in those species. When the FDA approves a drug for use in a particular species, it establishes a tolerance or that drug in the various tissues or products (eg, milk or eggs) of that species that might be consumed by people. When a drug not labeled for use in a small ruminant is administered in an extralabel manner, there is a zero tolerance for residues of the parent drug or its metabolites in the edible tissues or products of treated animals, and detection of the parent drug or metabolites in any product marketed for human consumption is considered a violation and subject to regulatory action. Given the lack of tolerance and pharmacokinetic and tissue depletion data for many drugs administered in an extralabel manner to small ruminants, extended meat and milk WDIs are generally required to ensure that drug residues are undetectable. Veterinarians need to be cognizant of the requirements for legal ELDU in food-animal species to safeguard the human food supply while continuing to promote the health and welfare of small ruminants.”
As a former owner of a veterinary large animal practice in which 50% of my patients were small ruminants (goats, sheep, alpaca and llama), it was imperative to be able to prescribe or administer drugs in an extralabel manner to provide humane care and prevent animal suffering.
Extralabel use means actual use or intended use of a drug in an animal in a manner that is not in accordance with the approved labeling. This includes, but is not limited to, use in species not listed in the labeling, use for indications (disease or other conditions) not listed in the labeling, use at dosage levels, frequencies, or routes of administration other than those stated in the labeling, and deviation from the labeled withdrawal time based on these different uses. 21 CFR 530.3.
Some of these uses have included medications added to commercial feeds, that are now governed under the Veterinary Feed Directive that FDA enforces for use in major, but not minor species.
According to guidance from FDA, “many commercial medical feeds that require a VFD are not approved for use in minor species,” defined by FDA as all species other than cattle, horses, swine, chickens, turkeys, dogs, and cats. Compliance Policy Guide Sec. 615.115 Extralabel Use of Medicated Feeds for Minor Species. A veterinarian may consider ELDU of medicated feed in minor species if:
There are no approved treatment options available;
The health of the animals is threatened; and
Failure to treat the animals would result in suffering or death.
The veterinarian must provide a written recommendation that includes the medical rationale for ELDU of medicated feed.
Before a veterinarian can provide such professional guidance, a valid veterinarian-client-patient relationship (VCPR) must exist. While state laws govern the practice of veterinary medicine, including such relationships, FDA has inserted itself in the equation by identifying which states do not require the elements of a VCPR that FDA considers sufficient for the purposes of enforcing its Veterinary Feed Directive and other federal laws.
These multilayered state and federal laws can be difficult for veterinarians and small ruminant producers to decipher—hence the necessity of FARAD and other agencies to provide more specific guidance.