Food And Drug Administration Antibiotic Ruling 2013

By Dr. Lew Strickland, Extension Veterinarian, University of Tennessee

In December 2013 the Food and Drug Administration (FDA) proposed two documents, Guidance for Industry (GFI-209 & GFI 213), to phase out the use of "human medically important" antimicrobials in food animals when used to enhance growth or improve feed efficiency. This ruling will take effect December 2016 - January 2017.

What Does This Mean for Producers?

FDA is taking action to promote the judicious use of antimicrobial drugs in food animals. The goal of the strategy is:

• To phase out the use of medically important antibiotics in food animals for production purposes (e.g., to enhance growth or improve feed efficiency)
• Bring the therapeutic uses of such drugs (to treat, control, or prevent specific diseases) under the oversight of licensed veterinarians.

What Types of Drugs Will be Targeted?

This action focuses on feed additive antibiotics that are considered "medically important" human drugs such as:

• Penicillin, Tetracycline, Erythromycin, Cephalosporin, and Florfenicol.
• These products are used with the intent of enhancing growth or improving feed efficiency.
• OTC medications that are used in feed or drinking water of food-producing animals.
• Examples of an OTC feed additive that a producer can purchase are:

1. Aureomycin, Aureo S 700 (CTC, Chlortetracycline) (Also mixed in minerals)
2. Terramycin (Oxytetracycline)
3. Tylan (Tylosin)
4. Neomycin (Neomycin Sulfate)

How will producers be able to purchase feed additive antibiotics?

The producer will have to establish a valid client patient relationship (VCPR) with a veterinarian. There are a few steps required to establish a VCPR in Ohio. These are:

• The licensed veterinarian has assumed clinical responsibility for the animals and the owner of the animals has agreed to follow the veterinarian's instructions.
• The veterinarian has sufficient direct knowledge of the animal's condition to make a preliminary diagnosis and has examined the producer's animals recently, and also shall be acquainted personally with the keeping and care of the patient either by examining the patient or by making medically appropriate and timely visits to the premises where the patient is kept.
• The veterinarian is available for follow-up evaluation, or has arranged for emergency coverage in the event of adverse reactions or the failure of the treatment.
• A VCPR cannot be established nor maintained solely by telephone or other electronic means.

Under the Veterinary Feed Directive (VFD), veterinarians will still be able to prescribe feed grade antibiotics, ONLY if deemed necessary to treat, or control a current disease outbreak. After the prescribed time period has elapsed, the antibiotic will have to be removed from the feed. Using a feed grade medication for any other purpose than is on the label is extra label use and is illegal.

What about OTC Injectables?

As of right now OTC injectables will not be involved in this ruling, but they are next in line to become script items. A time frame has not been established as to when this will occur.

What Won't Change?

Producers will still be able to obtain and use medications that are considered non- "medically important" feed grade products. These include:

• Ionophores such as Rumensin, Bovatec,
• Bacitracin
• Coccidiosis medications. These medications are rarely used in human medicine, so their use will not be changed.

Source:osu.edu