A VFD drug is a medication that is intended for use in or on animal feed and is limited to use only under the professional supervision of a licensed veterinarian. Until recently, only a few antimicrobials(e.g., Tilmicosin and Florfenicol) have been designated as VFD drugs. Prompted by increasing concerns surrounding antimicrobial resistance in humans and animals, the Food and Drug Administration (FDA) has revised the VFD regulations.
In these revised regulations, published June 3, 2015, the FDA defines a group of antimicrobials that are "medically important" based on their use in human health applications. Medicated feeds containing these antimicrobials will no longer be available over the counter (OTC) and will now require a VFD for therapeutic uses (i.e., to treat or control disease). Using medically important antimicrobials in medicated feed for sub-therapeutic uses (i.e., growth promotion or feed efficiency) will be prohibited after the full implementation of the regulations on January 1, 2017. Examples of medically important antimicrobials that will transition from OTC to VFD are provided below. Those drugs that are not considered important for human health (e.g., ionophores, coccidiostats, etc.) will not be affected by these regulatory changes.
In addition to the information provided on this website, I have prepared a one-page handout as a quick reference guide. Also available are the slides from a recent presentation that I gave on this topic.
How Can You Prepare for the Regulatory Changes?
- Develop a relationship or strengthen an existing relationship with a veterinarian to ensure you are prepared for the January 1, 2017 transition;
- Contact your feed supplier to ensure they are informed about the VFD rule changes and that they will be a VFD feed distributor;
- Review your operation’s current health protocols and feeds to identify products/procedures that will be affected by the new regulations; and
- Review your overall health program to determine if there are changes that can be made to reduce the need for antibiotics.
What Products Will Be Affected?
Medically important antimicrobials that will be no longer be over-the counter include, but are not limited to:
- Chlortetracycline (e.g., Aureo S 700, Aureomycin)
- Neomycin (e.g., Neo-Oxy 50/50)
- Oxytetracycline (e.g., Terramycin)
- Sulfamethazine (e.g., Aureo S 700)
- Tylosin (e.g., Tylan 10)
The full list of drugs transitioning from over-the-counter to VFD distribution can be accessed here.
Water-soluble drugs containing medically important antimicrobials will transition from OTC to prescription (Rx). The full list of water-soluble drugs transitioning from over-the-counter to prescription distribution can be found here.
Products used exclusively on animals (non-medically important) will not be affected by the regulations. These products included, but are not limited to:
- Ionophores (e.g., Rumensin, Bovatec)
- Beta Agonists (e.g., Optaflexx, Actogain 45)
- Coccidiostats (e.g., Corid)
- Bambermycins (e.g., Gainpro)
As a Producer, What Are You Required to do?
- Only feed a medicated animal feed containing a VFD drug to animals based on a VFD issued by a licensed veterinarian;
- Do not feed a medicated animal feed containing a VFD drug after the expiration date of the VFD;
- Maintain a copy of the VFD order for a minimum of two years;
- Provide VFD orders for inspection to the FDA upon request; and
- Avoid extra-label use of VFD feed, which is strictly prohibited.
Food and Drug Administration Guidance for Industry
Veterinary Feed Directive Final Rule The final rule amends 21 CFR 514 and 21 CFR 558. Published June 3, 2015
GFI #209 Medically Important Antimicrobials -- Judicious Use This document discusses the FDA's concerns regarding antimicrobial resistance in humans and animals and recommends principles for assuring the appropriate and judicious use of antimicrobial drugs in food-producing animals. Published April 13, 2012.
GFI #213 Medically Important Antimicrobials -- Recommendations for Drug Sponsors This document outlines the timeline for drug sponsors to modify the use conditions (i.e., labels) of their medically important antibiotics administered in feed or water. Published December 13, 2013.