Changes to Antibiotics Regulations Coming December 2016

By Dr. Mike Apley

The discussion of antibiotic use in food animals continues to get a lot of attention as new regulations are scheduled to take effect.

Per the last update from Dr. Mike Apley, professor of veterinary clinical sciences at Kansas State University, two guidance documents, #209 and #213 have been released by the Food and Drug Administration (FDA) Center for Veterinary Medicine. The first document stated two principles for which the FDA Center for Veterinary Medicine sought voluntary compliance from the pharmaceutical industry. These two principles are:

1. The use of medically important antimicrobial drugs in food-producing animals should be limited to those uses that are considered necessary for assuring animal health.
2. The use of medically important antimicrobial drugs in food producing animals should be limited to those uses that include veterinary oversight or consultation.

Guidance #213 defined how the goals of guidance #209 could be met by the sponsors. Pharmaceutical companies had 90 days from the release of #213 to voluntarily commit to the new regulations. After this, companies had three years to fully withdraw growth promotion claims from their labels.

Since the guidance was put into effect in December of 2013, all 26 companies representing the 283 affected labels came forward voluntarily to cooperate. The status of the affected labels can be viewed on the FDA Center for Veterinary Medicine website at

According to Apley, there are two big challenges that the industry will face due to these new regulations.

1. How do we get it all done?
2. Should we get it all done?

The biggest takeaway for producers in this discussion, Apley said, is to have a veterinarian that knows your operation.

“As of December 2016, a veterinarian will have to authorize any antibiotic use in the feed except for the ionophores (Rumensin, Bovatec, Catalyst), the bambermycins (Gainpro), bacitracin (BMD, Baciferm), and tiamulin (Denegard, used in swine). All other antibiotics used in the feed are classified as “medically important” (based off of importance in human medicine) and will require a veterinary feed directive (VFD), which requires knowledge of the client’s operation.”

This means that a VFD will be required for any type of medicated feed containing a medically important antibiotic, including medicated milk replacer and even small quantities of feed for home-raised animals, such as show cattle. The details of what constitutes a “free choice feed” in a range situation are still being worked out, but it is clear that range mineral and range cubes will be included in the requirements. To buy any of the feed types (Type A, Type B, Type C), a producer will need a VFD to purchase the product. Type A feeds are the most concentrated forms of the drug and are designed to be incorporated in a premix before inclusion in a final ration. Type B feeds are premixes, which include the drug in a form ready to be incorporated into the final ration. Type C feeds are the final ration ready for feeding.

In addition, all water antibiotics will require a prescription as of December 2016. Unless your local farm store wants to go through the process of becoming authorized to dispense drugs on the basis of a prescription, then these water soluble antibiotics will most likely disappear from their shelves. The same is true for medicated milk replacer and medicated feeds if they contain a medically important antibiotic.

These requirements for veterinary authorization of medically important antibiotics in feed and water have led to questions of how veterinarians will get all of the authorizations done.

“But, another big change is not just who is responsible for authorizing the use of medically important antibiotics in feed and water, but also who is accountable,” Apley said. “Currently, a veterinarian may function in an advisory status concerning antibiotics in feed, but often a nutritionist is leading decisions concerning tylosin, oxytetracycline, or chlortetracycline in feed. Now, a veterinarian must authorize these uses, and is therefore accountable for what happens. The veterinarian is now in the position of determining when an in-feed antibiotic use is appropriate, such as indications and timing of a tetracycline product, and whether or not the use is clinically justified.”

The final VFD rule is expected out this spring, and then veterinary groups such as the Academy of Veterinary Consultants and the American Association of Bovine Practitioners, producer organizations, regulatory officials, and even state legislators will need to put their heads together to refine the details of how all of this will get done. The details of the veterinary oversight are left up to the states.

You should expect a lot of updates and information coming out on this subject, especially in 2016 as the time for change draws near. There is no reason to change at the current time, as the drug labels must change, which will most likely be phased in over a short period near the end of 2016.

VFD Modules