by Dr. Michelle Arnold
On June 11th, 2021, The Food and Drug Administration (FDA) finalized a Guidance for Industry (GFI) #263, which outlines the process for animal drug manufacturers to change all remaining antibiotic formulations used in animal health care from over-the-counter (OTC) to prescription status. Products commonly used by producers such as injectable penicillin and oxytetracycline (for example, LA-300) will no longer be available without a prescription from a veterinarian as of June 2023. Specifically, all dosage forms of medically important antimicrobials approved for use in food animals will only be available from, or under the supervision of, a licensed veterinarian, and only when necessary for the treatment, control or prevention of specific diseases. Producers will need to consult a veterinarian to obtain all antibiotics in any form (injectable, bolus, topical, intramammary) or to request a prescription to purchase them from a distributor.
FDA’s goal through GFI #263 is to curb the development of antibiotic-resistant bacteria and, in turn, reduce the risk of human infections that are difficult to treat due to ineffective antibiotics. To accomplish the goal, FDA is promoting the implementation of “responsible antibiotic stewardship practices in veterinary medicine” which are defined as “actions that preserve the effectiveness of antibiotics while maintaining animal health”. Examples of responsible practices include 1) only using antibiotics when necessary to treat a sick animal; 2) establishing vaccination protocols and other disease prevention plans to reduce the need for antibiotics; and 3) livestock owners and veterinarians working together to make decisions to improve the overall animal health and welfare of the herd or flock over the long term.
Small ruminants are classified as “minor food animal species” according to the FDA. Although on some farms a small ruminant may be considered a “companion animal” or pet, in the eyes of the law any sheep or goat is still a food animal. Simply stated, if a drug is illegal for food animal use, then it is illegal for use in sheep and goats. Therefore, before a veterinarian takes the first step towards selecting an antibiotic for a sheep or goat, he or she must know what is currently approved and labeled for those species by the FDA. Only if there is no labeled drug available that is considered clinically effective, then an approved food animal drug may be used in an extra-label manner. Note that factors such as convenience and cost are not valid reasons to select an extralabel drug. The Animal Medicinal Drug Use Clarification Act (AMDUCA) states that only a licensed veterinarian with a valid Veterinary-Client-Patient-Relationship (VCPR) can use and prescribe a drug in an extra- label fashion, it must be an FDA approved drug and used only for therapeutic purposes or where suffering or death may result from failure to treat. Similarly, when using an antibiotic in a small ruminant, whether the animal’s role is production or companion, a veterinarian must legally provide a meat and milk withdrawal time to the owner and document this in the medical record. For more information, see http://www.usfarad.org/extralabel-drug-use-in-minor-species.html
Given that this change is less than 6 months away, what can a small ruminant producer do now to prepare for it? For a veterinarian to legally sell or prescribe prescription products, FDA states, “A licensed veterinarian may legally use or dispense a prescription animal drug only within the course of her/his professional practice where a valid veterinarian-client-patient relationship exists. Veterinarians employed by drug manufacturers or distributors may not legally dispense prescription drugs to laypersons unless they meet the above criteria. Similarly, practicing veterinarians or their employees may not legally sell prescription animal drugs to walk-in customers unless the same criteria are met.” Therefore, the first step to do now is establish a valid veterinary-client-patient relationship (VCPR). Kentucky has its own definition of a VCPR (see Box 1). Although the rules are straightforward, how to actually build a VCPR first requires communication with a veterinarian and asking the question “What do I need to do to establish and maintain a VCPR with you?” The law requires the veterinarian to be familiar with the client, the animals, and the management on the farm through “medically appropriate and timely visits” to the place the animals are kept. Scheduling routine veterinary visits to the farm at intervals established by the veterinarian is a perfect way to meet this requirement. At a minimum, the veterinarian needs to know the small ruminant business you are in (dairy or meat production, show animals/breeding stock, pet/companion), what vaccines are routinely given and when, what diseases are recurring problems at the farm and how you typically treat or prevent them (for example, pinkeye, foot rot, bronchopneumonia, abortion, etc.) and any health concerns that may be on the horizon. Some veterinarians will execute a written VCPR agreement although it is not required.
KRS Sec 321.185 Veterinarian-client-patient relationship (VCPR)
(1) In order for a veterinarian to practice veterinary medicine, a relationship among the veterinarian, the client, and the patient shall be established and maintained.
"Veterinarian-client-patient relationship" means that:
(a) The veterinarian has assumed the responsibility for making judgments regarding the health of the animal and the need for veterinary treatment, and the client, whether owner or other caretaker, has agreed to follow the instructions of the veterinarian;
(b) There is sufficient knowledge of the animal by the veterinarian to initiate at least a general or preliminary diagnosis of the medical condition of the animal. This means that the veterinarian has recently seen and is personally acquainted with the keeping and care of the animal by virtue of an examination of the animal or by medically appropriate and timely visits to the premises where the animal is kept; and
(c) The practicing veterinarian is readily available or shall provide medical service for follow-up in case of adverse reactions or failure of the regimen of therapy. A new regimen of therapy shall be contingent only upon cooperation of the client and availability of the subject animal.
(2) The veterinarian shall maintain records which document patient visits, diagnosis, treatment, and other relevant information
Once the VCPR is established and recognized by both the client and the veterinarian, then the discussions can begin regarding how to obtain prescription antibiotics after June 2023.
Extra-label Drug Use (ELDU) is the use of an FDA approved drug in an animal in a manner that differs in any way from the drug's approved labeling. ELDU includes using a drug in one or more of the following ways:
Working with the veterinarian to establish when antibiotics are necessary before illness occurs is crucial to having the drugs on hand when needed. Setting up treatment protocols in advance with the veterinarian for commonly occurring, easily recognized conditions on your farm, including a written plan of when to treat an animal (also known as a “case definition”), what drug to use (dose, route of administration, how often to give it), what treatment records should be kept, and how withdrawal times will be recorded and observed will reduce the need for emergency veterinary visits and expedite treatment. An important piece of the protocol is to establish when an antibiotic treatment should be considered a failure and what the next step should be when failure is recognized. The treatment protocol needs to be discussed with every person on the farm who may be involved in identifying and treating a sick animal in the herd or flock.
Although producers express frustration if a veterinarian does not honor a request for a prescription medication or veterinary feed directive (VFD), it is important to understand that any violative antibiotic residue detected in meat, milk, hair, blood or tissue sample will result in an investigation of the veterinarian who prescribed the drug, even if the drug was administered improperly by the producer and/or instructions were not followed. In addition, if an extralabel drug was used, it should not be assumed that withdrawal recommendations established for cattle are the same for sheep and goats. Often the meat withdrawal time must be extended for the residue concentrations to reach undetectable levels. Veterinarians can contact the Food Animal Residue Avoidance Databank (FARAD) for guidance in establishing the required withdrawal time.
Bottom Line: Talk to your veterinarian, sooner rather than later!
Dr. Michelle Arnold, is a native of Louisville, KY and received her DVM from the University of TN in 1990. After graduation, she began her veterinary career in Sweetwater, TN in a mixed animal rural practice where she was responsible for the food animal calls. She launched a solo large animal exclusive practice in 1991 consisting of 95% dairy and beef and 5% equine/smallruminant. In 1997 she became part owner in a 100-head Holstein dairy that was converted in 2003 to a feeder calf weaning/preconditioning facility. There she managed approximately 400 calves per year on a variety of intensively grazed forages and managed a small beef cow/calf operation on an adjacent farm. In 2010, Michelle joined the University of Kentucky as Ruminant Extension Veterinarian. Her areas of expertise are beef herd health programs, biosecurity, diagnostic testing and bovine respiratory disease in feeder calves. Michelle currently lives in Lexington. She has two sons: Briscoe (25) who graduated from UK and is a mechanical engineer for Toyota and Brody (23) is pre-med and an avid golfer.