In order for producers, veterinarians and feed distributors to prepare with possible participation in the new FDA Veterinary Feed Directive (VFD) pilot project, there is required information that you should have ready.

The first stop in an inspection for an investigator is the distributor, where they will examine three randomly selected VFD forms for the necessary parts. From these, they will pick one form to follow back to the veterinarian and forward to the producer. The following elements are included in the inspection tool for the investigators to use to ensure that the required items appear on the VFD form.

  1. Veterinarian’s name, address and telephone number
  2. Client’s name, business or home address and telephone number
  3. Premises where the animals specified in the VFD order are located
  4. Date the VFD order was issued
  5. Expiration date of the VFD order
  6. Is the name of the VFD drug or drugs identified on the form?
  7. Species and production class of animals to be fed the VFD feed
  8. Approximate number of animals to be fed the VFD feed by the expiration date of the VFD order
  9. Reason the VFD order was issued (the indication)
  10. Level of VFD drug in the feed and duration of use
  11. Withdrawal time, special instructions and cautionary statements necessary to use the drug according to its approved labeling.
  12. The number of reorders (refills) authorized if permitted by the drug’s approval, conditional approval or index listing
  13. This required statement: “Use of feed containing this veterinary feed directive (VFD) drug in a manner other than as directed on the labeling (extra-label use) is not permitted”
  14. Affirmation of intent for combination VFD drugs (see instructions)
  15. Veterinarian’s electronic or written signature

Some elements are specific to distributors, veterinarians or producers.

Questions specific to distributors:

  1. Did the distributor notify FDA of the intent to distribute VFD feeds? (Verify VFD distributor notification listing on www.fda.gov)
  2. Does the distributor keep copies of VFD orders for at least two years if distributing VFD feed to the end user?
  3. If the operation being inspected distributes VFD feed to other distributors and not to the end user, does this operation keep copies of acknowledgement letters for at least two years from the date of last shipment under the acknowledgement letter?

Questions specific to distributors who manufacture VFD feed:

  1. Does the feed label contain the VFD caution statement?
  2. Do the drug inventory or production records show the correct amount of drug added?
  3. Do the labels and formulas match the VFD orders?

Questions specific to veterinarians:

  1. Does the veterinarian have a valid license in those states where VFD feed is being fed?
    1. If no, can the veterinarian provide any evidence that he or she is complying with applicable state veterinary licensing and practice requirements in the states in which the veterinarian does not have a license?
  2. Does the veterinarian know that either the state or federal requirements for veterinary client patient relationship (VCPR) apply in each state?
    1. Can the veterinarian show any medical record(s) for the client’s animals named on the VFD?
  3. Does the veterinarian keep copies of VFD orders for at least two years?

Questions specific to producers (clients):

  1. Does the client keep copies of VFD orders for at least two years?
  2. Did the client feed the VFD feed to the authorized number of animals on the VFD order?
  3. Did the client feed the VFD feed for the identified duration on the VFD order?
  4. Did the client stop feeding the VFD feed prior to the expiration date on the VFD order?
  5. Did the client follow the withdrawal period for the VFD feed, if any?
  6. Did the client follow any special instructions or caution statements on the VFD order, if any?
  7. If a combination VFD feed was fed, was its use consistent with the affirmation statement on the VFD order?
  8. Does the client have labels for VFD feeds? If yes,
    1. Does the feed label contain the VFD caution statement?
    2. Did the drug level on the label match the drug level on the VFD form?
    3. Is the drug level and indication on the VFD form consistent with the approval?