By Christina Murdock, DVM
The FDA policy known as the Veterinary Feed Directive came into effect on January 1, 2017. It was passed to promote the judicious use of antimicrobials that affect both human and animal health, but I understand there will be frustration among the agricultural community. I just want everyone to understand why it came about and what this new policy entails.
Back in 2015 the White House issued its National Action Plan For Combating Antibiotic-Resistant Bacteria. It may seem like common sense, but what the public health officials want people to understand is that Antimicrobial Resistance is a scary concept: “The Right Antibiotic at the Right Time at the Right Dose for the Right Duration.” The FDA is responsible for regulating animal drugs, feeds, devices, and most animal health products. They want veterinarians to oversee the use of medicines that may have an effect on the human population who consume animals that may have undergone treatment. Under the Federal Food Drug and Cosmetic Act (FD and C), the FDA has the broad mandate to assure safety and effectiveness of drugs, devices, and the safety of the food supply.
A Veterinary Feed Directive is a nonverbal statement issued by a licensed veterinarian in the course of the veterinarian’s professional practice that authorizes the use of a VFD drug or combination VFD drug in or on an animal feed. The written statement authorizes the client to obtain and use animal feed containing a VFD drug to treat the client’s animals only in accordance with the conditions for use approved, conditionally approved, or indexed by the Food and Drug Administration. The licensed veterinarian issuing the VFD is responsible for ensuring it is filled out accurately and completely. The Veterinarian, the Producer or Client, and the Feed Distributor must keep a copy of the VFD for at least 2 years. The veterinarian can electronically transcribe the original copy to the client or feed distributor.
Drugs in veterinary medicine, including the antimicrobials, fall into 3 marketing categories, based on how they are available to producers or animal owners:
Over The Counter (OTC): Drugs that clients can purchase and use without supervision or permission from a veterinarian because adequate instructions for use can be written on the label and are likely to be followed by the public.
Veterinary Feed Directive (VFD): VFD drugs and feed containing VFD drugs require a written authorization via a VFD order from a licensed veterinarian before a client may obtain or use a VFD medicated feed. The FDA approves a drug as a VFD drug. VFD’s are federally Regulated.
Prescription (Rx): Prescription drugs require a written permission from a licensed veterinarian before a client may purchase. Medically important antimicrobials used in water for food producing animals require a prescription as of January 1, 2017. Prescription writing and dispensing is regulated by the States. Medically important antimicrobials delivered in water do not require a VFD.
In the past, the FDA Center for Veterinary Medicine approved antimicrobial drugs to be used for the following purposes: Disease Treatment, Disease Control, Disease Prevention, Improved Feed Efficiency, and Improved Rate of Gain. Now, the FDA, American Veterinary Medical Association, and the World Organization for Animal Health only recognize Treatment, Control, and Prevention to be the only therapeutic uses of antimicrobials, while they view Improved Feed Efficiency and Improved Rate of Gain to be Production Uses. A VFD cannot be written for Production Uses. The FDA now plans to promote judicious use of antimicrobials in food producing animals by removing Production Uses in food producing animals of antimicrobials that are medically important to treat human illness and also to establish veterinary oversight of all medically important antimicrobials administered to food producing animals in or on feed (VFD) and in water (prescription).
For a veterinarian to write a lawful VFD, a Veterinary-Client-Patient-Relationship must exist. Although typically defined by the State, the VCPR may follow the Federal or State definition. The State defined VCPR must at least address 3 concepts: the veterinarian engages with the client to assess responsibility for making clinical judgments about patient health, the veterinarian has sufficient knowledge of the patient by virtue of patient examination and/or visits to the facility where the patient is managed, and lastly, the veterinarian provides any necessary follow up, evaluation, or care. The veterinarian must be licensed in the state the animals reside in.
A VFD does not apply to injectable, boluses, or other dosage forms not administered to animals in or on feed. Antimicrobials remaining Over The Counter are not considered medically important in human medicine. Examples include De-Wormers used in cattle or horses, or coccidiostatic supplements such as Ionophores in Calf Milk Supplements.
The last big thing that relates to VFD’s is that Extra Label Drug Use is prohibited. If a medicine label says its for use in cattle but you want to use it in sheep or goats, that would be an example of Extra Label Drug Use since sheep or goat dosages are not listed on the medicine label. The only way a veterinarian could write up a VFD for a species not listed on the medicine label is if there are no other approved treatment options, if the health of that individual patient is threatened, or if failure to treat that individual patient will lead to suffering or death.
There is a lot involved with the Veterinary Feed Directive, but to sum everything up, here are the key points to understanding VFD’s. The VFD regulations give veterinarians more oversight to practice judicious use of medically important antimicrobials administered in animal feed. A veterinarian must be licensed in the State where the animals are located to issue a VFD. A VFD is only lawful if a valid VCPR exists. A VFD must be written but can be transmitted electronically. Extra Label Use of medicated feed directed by a VFD is illegal. Copies of the VFD must be kept by the veterinarian, producer, and feed distributor at least 2 years. A maximum 6 month expiration date is likely to apply to many VFD orders but is first subject to the drug’s approved label and veterinary discretion. For more information or questions on the VFD policy, you can contact the FDA at AskCVM@fda.hhs.gov
Christina Murdock, DVM
LAVender Veterinary Services