The Animal Drug Availability Act of 1996 (ADAA) established a new category of drugs, veterinary feed directive (VFD) drugs. The revised Veterinary Feed Directive rule that goes into effect October 1, 2015 addresses the use of drugs in feeds for livestock. Current focus is on antimicrobials that are considered medically-important (human medicine applications).
What does the VFD rule and associated guidance do?
The VFD rule and associated FDA Guidance documents –
- ends the use of medically-important antimicrobials to enhance livestock performance,
- transitions many of the feed medications that are currently available “over-the-counter” into the VFD drug category,
- places the use of VFD animal drugs in or on animal feed under the professional supervision of a licensed veterinarian,
- requires producers to obtain written VFD orders from a licensed veterinarian to purchase and utilize the VFD antimicrobials on or in feed.
When does the VFD rule become effective?
This rule becomes effective October 1, 2015. All changes associated with medically important antimicrobials that are now available over-the-counter must be implemented by January 1, 2017.
What are VFD Drugs?
VFD drugs are FDA-approved for use in animal feeds under veterinarian supervision and under written VFD orders. Current focus is on antimicrobials delivered in feeds that are deemed to be medically-important. This does not preclude a broadened approach in the future. The label for the additive, or the label for the medicated feed item containing the additives, must state whether the additive is a VFD drug or not.
As of September 2015 there are three VFD drugs – florfenical (Nuflor – swine; Aquaflor – aquaculture), avilamycin (Kavault; swine), and tilmicosin (Pulmotil; swine, beef, dairy).
By January 1, 2017, all medically-important antimicrobials intended for use in feed that are currently available “over-the-counter” will become VFD drugs. Additives such as lasalocid (Bovatec-cattle, Avatec-poultry), monensin (Rumensin-cattle, Coban-poultry), bacitracin, bambermycins (Flavomycin – swine, Gainpro – cattle), and amprolium are not “medically-important” and will not fall under the VFD unless they are used in combination with a VFD drug.
Producers need written authorization from a licensed veterinarian
Use of VFD drugs now falls under the supervision of licensed veterinarians. Producers must receive signed and written (not verbal) authorization from a licensed veterinarian to purchase and utilize VFD antimicrobials on and in feed. This authorization is referred to as a VFD Order.
An established Veterinarian-Client-Patient Relationship (VCPR) is required
To write the VFD order, the licensed veterinarian must have an established veterinarian-client-patient relationship (VCPR) with the producer. Based on the Texas Veterinary Licensing Act, a valid VCPR is present if:
- The veterinarian assumes responsibility for medical judgments regarding the health of the livestock, and the client (the owner or caretaker of the livestock), agrees to follow the veterinarian’s instructions.
- The veterinarian possesses sufficient knowledge of the livestock to initiate a general or preliminary diagnosis of the medical condition of the livestock. Sufficient knowledge exists if the veterinarian has recently seen, or is personally acquainted with, the keeping and care of the livestock as a result of (a) examining the animal, or (b) making medically appropriate and timely visits to the premises where the livestock are kept. A veterinarian-client-patient relationship may not be established solely by telephone or electronic means.
- The veterinarian is readily available to provide follow-up medical care in the event of an adverse reaction, or failure of the regimen of therapy.
Steps to obtain a VFD Order
- Contact your veterinarian with whom you have a valid VCPR. If a producer does not have a valid VCPR with an appropriate veterinarian, then the preliminary step is to establish a VCPR.
- The veterinarian determines whether conditions warrant use of a VFD drug or feed.
- If warranted, the veterinarian issues a written and signed VFD order containing information specified by regulations. Verbal orders are not allowed but electronic orders are acceptable. Incomplete and unsigned orders are invalid and cannot be filled.
- The veterinarian retains a copy of the VFD order and gives the completed, signed original and a copy to the client.
- The client keeps the copy and gives the original signed VFD to the feed mill/feed distributor supplying the VFD feed. The VFD order allows the feed to be released to the client.
- Depending on the specific VFD drug, and the conditions outlined by the veterinarian, separate VFD orders may be required for different groups of livestock and, new VFD orders may be required to extend the treatment duration (depends on “refill” specifications).
Information required on a lawful VFD order
- Veterinarian’s name, address, and telephone number
- Client’s name, business or home address, and telephone number
- Premises where the livestock specified in the VFD are located
- Date the VFD was issued
- Expiration date of the VFD (this is the date the VFD is no longer valid and use of the VFD feed is illegal)
- Name of the VFD drug(s) in the order
- Species and production class of livestock to receive the VFD feed
- Approximate number of livestock to receive the VFD feed by the expiration date
- Health indication for which the VFD was issued
- Concentration of VFD drug in the feed
- Duration of use (length of time the livestock will receive the treatment)
- Withdrawal time, special instructions, and cautionary statements necessary for use of the drug to conform with the approval
- Number of reorders (refills) authorized, if permitted
- Statement: “Use of feed containing this veterinary feed directive (VFD) drug in a manner other than as directed on the labeling (extralabel use), is not permitted”;
- Veterinarian’s electronic or written signature
Optional information on the VFD order
- More specific description of the location (i.e. pen, barn, pasture or other)
- Approximate age range of the animals
- Approximate weight range of the animals Any other information the veterinarian deems appropriate to identify the animals involved
Basic Producer Responsibilities
- Establish a VCPR with an appropriate veterinarian.
- Contact your veterinarian for consultation and guidance.
- Follow your veterinarian’s recommendations. Administer the VFD medicated feed according to the directions on the VFD order.
- Keep copies of your VFD orders for at least two years.
- Provide your VFD order copies for FDA inspectors to copy and review, if requested.