- The FDA and the state’s agency regulating “veterinary licensure” specifically defines this relationship in their regulations as a “veterinary-client-patient relationship” (VCPR). It requires the licensed veterinarian writing the VFD to:
- Be familiar with the care and management cattle receive by a client, including being able to make a preliminary diagnosis of the targeted concern
- Be willing to assume responsibility for making clinical judgments (and the client agrees to follow the veterinarian’s instructions)
- Be willing to provide treatment oversight and be readily available for follow-up evaluation and case management
- Maintain and evaluate case and treatment records
Cattle producers will find obtaining VFD antibiotics simpler and less frustrating if they will visit with their veterinarian ahead of the need for the feed antibiotic.
- Let your vet know about upcoming cattle management issues that may require a feed-use antibiotic. Examples might include weaning, anticipated cattle purchases or a seasonal endemic disease such as anaplasmosis.
- Visit with your vet about how a VFD medication will be obtained on a timely basis through your feed distributor.
- In your conversation, be sure to discuss other feed additives you typically use and ask about specific limitations that will have to be considered when a VFD medication is used.
Cattle producers considering a VFD medication might find it useful to visit with their feed distributor about the details to be considered when obtaining the VFD medication from their distributorship.
What information will the cattle owner or manager be required to provide on the VFD form?
The VFD form requires the veterinarian’s client’s name, address, phone, location of the cattle, the approximate weight of the cattle and the number of cattle that will be covered under the VFD.
What records will cattle owners and managers be required to keep?
- A copy of the signed VFD received from your veterinarian must be kept for two years.
- VFD medication-use records, which includes feed mixing records, must be kept and be made available to the FDA if requested.
- No FDA inspectors will come to the cattle operation using a VFD unless they are using the most concentrated VFD product available and the VFD requires a withdrawal time.
The most concentrated FDA-approved feed additive is known as a “Type A Article” drug and is classified as a “Category 2” drug if a withdrawal time is required.
Will a cattle owner or manager have to see a veterinarian to get a VFD?
Not necessarily. If the cattle owner or manager has a VCPR with a veterinarian, together they can develop outlines for situations when VFD medication use would be appropriate.
Using these outlines, VFD usage can be anticipated, and in many situations the VFD medication can be available as required to address the health and well-being of the cattle without the veterinarian personally evaluating the cattle.
For example, a veterinarian can develop guidelines and training for tentatively diagnosing a disease listed on the approved VFD medication, and documentation of the trained personnel will allow the use of the VFD medication without the cattle being personally evaluated by their veterinarian.
Will one VFD cover cattle owned by one person in different pastures?
Yes, a VFD can be written to cover the same health condition in cattle owned or managed by the same operation in multiple locations, including across county lines.
However, some VFD antibiotics will have labeling inclusions similar to: ‘‘Use only in cattle fed in confinement for slaughter” or “fed in a complete feed” or “included in the sole ration.” If these type of statements are included on the label, use in pasture situations would not be allowed by the FDA.
Will a VFD antibiotic be allowed to be used in breeding cattle?
It will depend on the approved label. Some VFD antibiotics will have not been studied in breeding cattle or replacement heifers/bulls and will not be labeled to feed breeding cattle.
There currently is a feed-grade antibiotic approved for controlling anaplasmosis. The current labeling allows its use in breeding beef cattle. If the company that controls this antibiotic applies for VFD approval, there is no reason to think restrictions on its use in breeding cattle would be added.
Will one VFD cover cattle owned by one person in different states?
No, a separate VFD will be required. Additionally, the veterinarian who writes the VFD is required to be licensed to practice in the state where the cattle are being kept when the VFD antibiotic is being used on those cattle.
What flexibility will cattle producers have in how they dose a VFD medication?
The simple answer is: none. Regulations governing feed medications have never allowed usage other than as labeled. Off-label use or extra-label has never been allowed, and this legal requirement will continue with the use of VFD medications.
For cattle producers who also have sheep or goats, the FDA will not allow a VFD written for cattle to be used for sheep or goats.
Will a VFD antibiotic be allowed for pinkeye or foot rot?
Pinkeye or foot rot prevention, treatment or control are not listed on the labels of any of the feed-grade antibiotics currently approved, and therefore use for these diseases is not allowed by the FDA.
Use for these diseases may or may not be allowed in the future depending on requests by companies applying for VFD approval for their feed-grade antibiotic and the FDA’s ruling on those requests.
What flexibility will be available for mixing a VFD medication?
The cattle operation will have the same flexibility in how the VFD is mixed in a complete feed as has been available previously for use of FDA-approved feed additives.
Restrictions on which FDA additives can be used together and how much of an additive can be added per ton of feed have long existed, and these restrictions will continue with VFD regulation implementation in Dec. 2016.
Will special procedures or mixers be required to use a VFD medication?
An issue often overlooked by producers who practice on-farm feed mixing is cross-contamination of feeds with FDA-approved feed additives. A procedure to “flush out” a feed mixer after using a VFD will need to be developed.
A veterinarian, nutritionist or extension educator can assist with developing a flush-out procedure. Typically, this involves running a small amount of a coarse feedstuff through the feed mixer after a VFD medication has been mixed. The feedstuff used to clean or “flush out” the feed mixer can be used in the ration for the cattle receiving the VFD on the following day.
Will VFD antibiotics have a marketing withdrawal time?
It will depend on the specific VFD antibiotic being considered. The VFD tilmicosin (Pulmotil) currently approved by the FDA has a 28-day withdrawal time.
There are a number of antibiotics the FDA currently approves for disease prevention, treatment or control that do not require a withdrawal time, and there is no reason to think the FDA will add withdrawal times to medications for which a withdrawal time is not currently required.
How long does a VFD remain in effect after it is written by my veterinarian?
VFD orders will have both an “effective date” and an “expiration date.” The effective date is not necessarily the date your veterinarian signs the VFD order.
On the VFD order, a veterinarian is required to indicate an effective date, and the VFD antibiotic for which the order is written will have an expiration date requirement. The VFD antibiotic cannot be fed after the end of the expiration date.
Will the length of time from the effective date to the expiration date be the same for all VFD antibiotics?
The FDA has indicated the expiration date could vary between the different VFD antibiotics approved. If the VFD antibiotic does not explicitly indicate the length of time for an order to expire, the VFD regulations require the veterinarian to limit the VFD order expiration date to 180 days or less.
Pulmotil, the only VFD the FDA has currently approved, expires 45 days after the date the veterinarian indicates as the effective date. The effective date will be the last day the use of a VFD antibiotic can be used.
For example, if a VFD antibiotic intended for use has a 45-day expiration time, and the course of therapy is 14 days, the last day a course of therapy can begin is day 31 of the 45-day window between the effective date and the expiration date.
When does this regulation take effect?
It went into effect June 3, 2015. Currently, feed manufacturers are revising medicated feed labels to remove all feeding performance statements. These labels will read for use to treat, control or prevent a disease.
The first of these revised labels will be available Jan. 1, 2016. Labeling transition will continue to Jan. 1, 2017, when all feed-grade antibiotics will require a valid VFD.
Next issue: Which products apply to the VFD.
- Veterinarian, Professor
- Great Plains Veterinary Education Center - University of Nebraska
- Email Dee Griffin