The Veterinary Feed Directive- What is it?

 By John C. Wenzel, NMSU Extension Veterinarian


“The FDA acknowledges the important role medically important antimicrobials play in treating, controlling, and preventing disease in food-producing animals. However, the agency has been actively engaging veterinary organizations, animal producer organizations and other stakeholders to express our position that medically important antibiotics labeled for continuous or undefined durations of use is not consistent with judicious use principles, as outlined in previously-released guidance documents.” The labeled indications for using antimicrobials included disease treatment, control and prevention, along with growth promotion and feed efficiency. As of Jan 2016, the label indications of growth promotion and feed efficiency were prohibited and had to be removed from the label.
Before 1996, there were only two options for dispensing new animal drugs: (1) over-the-counter (OTC), and (2) prescription. In 1996 Congress enacted the Animal Drug Availability Act (ADAA) to facilitate the approval and marketing of new animal drugs and medicated feeds. As part of the ADAA, Congress recognized that certain new animal drugs intended for use in animal feed should only be administered under a veterinarian's order and professional supervision. For example, veterinarians are needed to control the use of certain antimicrobials. Control is critical to reducing unnecessary use of such drugs in animals and to slowing or preventing any potential for the development of bacterial resistance to antimicrobial drugs. Therefore, the ADAA created a new category of products called veterinary feed directive drugs (or VFD drugs). So when a new animal drug application is submitted to FDA’s Center for Veterinary Medicine (CVM) for approval, CVM evaluates the drug for safety and effectiveness, and as part of the review process, determines whether the drug will be an over-the-counter (OTC) drug, a prescription (Rx) drug, or a VFD drug (limited to drugs used in or on animal feed).
According to federal regulations enacted through the Animal Medicinal Drug Use Clarification Act (AMDUCA), extralabel drug use (ELDU) means "actual use or intended use of a drug in an animal in a manner that is not in accordance with the approved labeling. This includes, but is not limited to, use in species not listed in the labeling, use for indications (disease or other conditions) not listed in the labeling, use at dosage levels, frequencies, or routes of administration other than those stated in the labeling, and deviation from the labeled withdrawal time based on these different uses." According to AMDUCA, veterinarians who treat food animals with drugs in an extralabel manner must use evidence "...derived from food safety data or other scientific information..." in order to determine an appropriate withdrawal interval (WDI) that allows for a
New Mexico State University
Extension Animal Sciences & Natural Resources Department Volume 83 November 2016
conservative estimate of drug residue level in edible animal tissues. Under the VFD provisions, EXTRALABEL DRUG USE IN FEED IS ILLEGAL. Extralabel drug use in feed, even by a veterinarian where a valid VCPR exists, is NOT permitted and is considered illegal.
In New Mexico, a valid VCPR is defined by Statute and Rule as follows:
A. NMSA 61.14.2.J. "valid veterinarian-client-patient relationship" means:
(1) The veterinarian has assumed responsibility for making medical judgments regarding the health of an animal being treated and the need for and the course of the animal's medical treatment;
(2) The client has agreed to follow the instructions of the veterinarian;
(3) The veterinarian is sufficiently acquainted with an animal being treated, whether through examination of the animal or timely visits to the animal's habitat for purposes of assessing the condition in which the animal is kept, to be capable of making a preliminary or general diagnosis of the medical condition of the animal being treated; and
(4) The veterinarian is reasonably available for follow-up treatment;
B. NMSA 16.25.9.8.3.C. 1- For the purposes of a VFD order, the veterinarian must be licensed in NM and must have been present on the premise for which the VFD order is made, within 6 months prior to each VFD order being issued.
NMSA 16.25.9.8.3.C.2-The veterinarian writing a veterinary food directive (VFD) order for premises in New Mexico must be a New Mexico-licensed veterinarian and present on the premises within the six (6) months preceding the issuance of the order. All elements of the federal rules to issue a VFD order must be met and the issuing veterinarian must provide supporting documentation of the visit to the premises including medical records within fourteen (14) days of a request from the board to provide such documentation
Definitions of language used in the VFD Directive:
A “veterinary feed directive” is a written (nonverbal) statement issued by a licensed veterinarian in the course of the veterinarian’s professional practice that orders the use of a VFD drug or combination VFD drug in or on an animal feed. This written statement authorizes the client (the owner of the animal or animals or other caretaker) to obtain and use animal feed bearing or containing a VFD drug or combination VFD drug to treat the client’s animals only in accordance with the conditions for use approved, conditionally approved, or indexed by the FDA (21 CFR 558.3(b)(7)). A VFD may also be referred to as a VFD order.
A “veterinary feed directive (VFD) drug” is a drug intended for use in or on animal feed which is limited by an approved new animal drug application filed pursuant to section 512(b) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), a conditionally approved application filed pursuant to section 571 of the FD&C Act, or an index listing pursuant to section 572 of the FD&C Act to use under the professional supervision of a licensed veterinarian (21 CFR 558.3(b)(6)). Use of animal feed bearing or containing a VFD drug (VFD feed) must be authorized by a lawful VFD (21 CFR 558.6(a)(1)).
A "combination veterinary feed directive (VFD) drug” is a combination new animal drug (as defined in § 514.4(c)(1)(i) intended for use in or on animal feed which is limited by an approved application filed pursuant to section 512(b) of the FD&C Act, a conditionally approved application filed pursuant to section 571 of the FD&C Act, or an index listing pursuant to section 572 of the FD&C Act to use under the professional supervision of a licensed veterinarian, and at least one of the new animal drugs in the combination is a VFD drug. Use of animal feed bearing or containing
a combination VFD drug must be authorized by a lawful veterinary feed directive (21 CFR 558.3(b)(12)). If any component drug in an approved, conditionally approved, or indexed combination drug is a VFD drug, the combination drug is a combination VFD drug and its use must comply with the VFD requirements.
The expiration date on the VFD specifies the last day the VFD feed can be fed. In other words, a VFD feed or combination VFD feed must not be fed to animals after the expiration date on the VFD (21 CFR 558.6(a) (2)).
The “duration of use” and how does it relate to the "expiration date"?
The VFD expiration date defines the period of time for which the authorization to feed an animal feed containing a VFD drug is lawful. This period of time may be specified in the approved labeling of a given VFD drug or, if not specified in the labeling, the veterinarian must specify an expiration date for the VFD that does not exceed 6 months (21 CFR 558.6(b)(3)(v)). The duration of use is a separate concept from the expiration date, and determines the length of time, established as part of the approval, conditional approval, or index listing process, that the animal feed containing the VFD drug is allowed to be fed to the animals. This period of time is specified in the labeling of the VFD drug. For example, the currently approved VFD drug tilmicosin has an expiration date of 45 days and a duration of use of 21 days. This means that when the VFD is issued, the client has 45 days to obtain the VFD feed and complete the 21 day course of therapy. It is unlawful to feed the VFD feed to animals after the VFD expiration date or duration of use period (21 CFR 558.6(a)(2)).
Client responsibilities:
Only feed animal feed bearing or containing a VFD drug or a combination VFD drug (a VFD feed or combination VFD feed) to animals based on a VFD issued by a licensed veterinarian (21 CFR 558.6(a)(1)); feed a VFD feed or combination VFD feed to animals by no later than the expiration date on the VFD (21 CFR 558.6(a)(2))and for only the specified duration of use listed on the VFD; provide a copy of the VFD order to the distributor if the issuing veterinarian sends the distributor’s copy of the VFD through you, the client (21CFR 558.6(b)(8); maintain a copy of the VFD order for a minimum of 2 years (21 CFR 558.6(a)(4)); and provide VFD orders for inspection and copying by FDA upon request (21 CFR 558.6(a)(5)).
Frequently Asked Questions:
• Can a client feed a VFD feed past the VFD expiration date? No. A VFD feed or combination VFD feed must not be fed to animals after the expiration date on the VFD (21 CFR 558.6(a)(2)).
• I have a VFD order that I would like to use to feed a VFD feed, but the order will expire before I can complete the duration of use on the order, what should I do? The client should contact his/her veterinarian to request a new VFD order. A VFD feed or combination VFD feed must not be fed to animals after the expiration date on the VFD (21 CFR 558.6(a)(2)).
Cattle drugs currently requiring a VFD: Tilmicosin, florfenicol
Cattle drugs which change from over-the-counter sales to use only by veterinary feed directive in 2017: Neomycin, Tylosin, Virginiamycin, Chlortetracycline, Oxytetracycline, Penicillin, Sulfadimethoxine:Ormetoprim, Sulfamerazine, Sulfamethazine
This would include virtually all feed drugs except dewormers, carbadox, bambermycins, ionophores, bacitracin and a few others.
Summary- If Animal Livestock Production does not show judicious and accountable use of antimicrobials now, then antimicrobials labeled for prevention and control may be targeted and no longer be permitted for use in livestock production.