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FDA, Stakeholders Implementing New Policy on Use of Antibiotics

Policy ensures farmers and veterinarians have medicines to fight animal disease while safeguarding public health

FDA Policy

As antibiotic resistance has become a growing public health concern, farmers, veterinarians and the companies that make medicines for animals have collaborated with the FDA to implement guidelines that maximize animal health and well-being while providing consumers with the safest food possible.

The FDA’s new policy on judicious use in food animals is contained in FDA Guidances 209 and 213. These new policies are really instructions to the animal health and veterinary communities on how to implement FDA policy, but here’s what they mean:

1. Growth promotion has been eliminated.

2. Medically important antibiotics used in animal feed and water can be used only under the supervision and order or prescription of a veterinarian.

When the FDA Judicious Use policy is fully implemented in January 2017, medically important antibiotics will be used in food animals only to fight disease under the supervision of a veterinarian.

On January 3, 2017 FDA announced full implementation of the Judicious Use policy. As a result, medically important antibiotics are used in food animals only to fight disease under the supervision of a veterinarian.

FDA Guidance 209: This document set forth the FDA policy that growth promotion use of “medically important” antibiotics is not a judicious use and that medically important antibiotics should only be used under the supervision of a veterinarian. “Medically important” compounds include antibiotics such as penicillins, tetracyclines, macrolides and streptogramins. This policy covers only in-feed and water uses of medically important compounds. Compounds like ionophores, which are not used in human medicine, and bacitracin, which is used for minor human uses, are not covered by Guidance 209.

FDA Guidance 213: This outlines the process whereby companies can withdraw growth claims from the label of products containing medically-important antibiotics and restrict the product to use by or on the order of a licensed veterinarian. This guidance was published in December 2013, and it directed that companies had until January 2017 to change product labels. It also describes how a company can apply for a prevention claim or therapeutic claim on those same compounds. Application for a prevention claim in this case generally follows the process of a supplemental new animal drug application, and it requires the sponsor to submit data demonstrating the drug is safe and e ective at a specified dose against a targeted pathogen or a targeted disease.