VFD Rule and Implementation – What we know to-date

VFD Rule and Implementation – What we know to-date

Written by DATCP staff Liz Meils, State Apiarist, and Heather Bartley, Feed Program Specialist

As of January 1, 2017 the Veterinary Feed Directive (VFD) Rule is now in effect.  This means that in order to purchase and apply medically important antibiotics to your beehive, you need either a VFD Order or a Prescription from a licensed veterinarian—depending on the treatment you require.

Before a vet will issue one of the above, you will need to establish a Veterinarian Client Patient Relationship (VCPR).  A "veterinarian-client-patient relationship" is defined in Title 21, the Food, Drug & Cosmetic Act, Section 530.3(i), and means a relationship between a veterinarian, a client and the patient in which all of the following apply:

  1. A veterinarian has assumed the responsibility for making medical judgments regarding the health of (an) animal(s) and the need for medical treatment, and the client (the owner of the animal or animals or other caretaker) has agreed to follow the instructions of the veterinarian;
  2. There is sufficient knowledge of the animal(s) by the veterinarian to initiate at least a general or preliminary diagnosis of the medical condition of the animal(s); and
  3. The practicing veterinarian is readily available for follow-up in case of adverse reactions or failure of the regimen of therapy. Such a relationship can exist only when the veterinarian has recently seen and is personally acquainted with the keeping and care of the animal(s) by virtue of examination of the animal(s), and/or by medically appropriate and timely visits to the premises where the animal(s) are kept.

The VCPR is the prerequisite that establishes an important professional supervision over the beekeeper by the veterinarian. Start by asking your current vet for other animals in your care if he/she will work with your bees, otherwise check out http://www.honeybeeveterinaryconsortium.org/ or http://beevets.com/ to see if there are any vets in your area willing to work with bees.  Another option includes local bee clubs; several around Wisconsin have identified vets in their club’s area willing to work with all the member beekeepers.

Under the VCPR, and based upon historical experience and knowledge, the beekeeper and veterinarian work together to determine when a VFD order is necessary. VFD Orders are written for medicated feed such as Tetra-B mix, Terramycin, OXTC and OTC 50 (NADA N138-938, N008-804, N095-143[1]).  While a VFD is not required to purchase a Type A medicated article (like Terramycin concentrate), in order for a beekeeper to apply the terramycin/powdered sugar mix to a hive, that beekeeper is still required to acquire a VFD Order issued by a vet prior to manufacturing a medicated feed using the Type A medicated article. VFD orders can be filled by manufacturers/distributors of VFD medicated feeds.  Lists of approved mills and distributors by state can be found on FDA.gov, keyword search: “VFD distributor list by state”.

A distributor can manufacture/distribute/sell a “reasonable” amount of medicated feed to fulfill the VFD order. That means, if the VFD calls for 0.8 lbs. they can sell the whole 2 lb. package. That being said, a beekeeper will need to be aware that they cannot use the remaining 1.2 lbs. without a second VFD. A VFD is for a ONE-TIME treatment, and typically does not require a diagnosis. That, again, is the purpose of the professional supervision established by the VCPR.

Work with your veterinarian to make sure the VFD is filled out completely and identifies the number of hives and the duration/intervals of treatments.  Currently there are no approved VFD drugs that allow refills or reorders.  VFDs have an expiration date, to be determined by the veterinarian, not to exceed 6 months.  If the VFD order will expire before completing the duration of use on the order, the beekeeper will need to contact the vet to request a new VFD order.

Prescriptions are written for oral dosage medications with active ingredients Tylosin tartrate or Lincomycin hydrochloride such as Tylan or Lincomix.  Prescriptions will typically be filled by the veterinarian.  Another option would be to identify a pharmacy that is an authorized compounding pharmacy.

In Wisconsin, it will be the Federal Food & Drug Administration, DATCP Feed Program and the Department of Safety and Professional Services (DSPS) who will inspect for compliance with this rule.  As some details are not yet worked out, it would be in the beekeepers best interest to keep thorough records for all medication applications including written prescriptions or VFD orders, date, dosage, number of colonies, locations of apiaries at the time of administration, etc.  Beekeepers, Veterinarians, Pharmacies and Distributors must retain all records for at least two years after the issue date of the VFD order or prescription.

**Note: Fumagilin is not classified as a medically important antimicrobial drug for humans and therefore does not fall under the VFD Rule.

 

[1] NADA stands for New Animal Drug Application. A NADA is the packet of information submitted by a drug sponsor (manufacturer) to the Federal Food & Drug Administration for approval of a drug and its use(s). The NADA, once approved, contains the information about how and when a drug may be used, in what species, and any other specific information about the administration of the drug to the animal.