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FDA Issues Guidance on Antibiotic Use

FDA Issues Guidance on Antibiotic Use

Three documents will impact uses of antibiotics in animal agriculture. Deliberations going on since 2010.

The U.S. Food & Drug Administration has released three documents impacting certain uses of medically important antibiotics in animal agriculture. Implementation of the policy means all medically important antibiotics used in animal agriculture will be used only for therapeutic purposes -- such as disease treatment, control and prevention – and under the supervision of a licensed veterinarian.

The first of the documents, entitled “The judicious use of medically important antimicrobial drugs in food-producing animals (GFI #209), is a guidance for the industry on FDA’s current thinking on the use of antimicrobial drugs in animal agriculture.

A CHANGE IN THE WIND: FDA move could change antibiotic use nationwide.

The second is a draft guidance for the industry that provides information to drug sponsors of certain new animal drug products interested in developing revised conditions of use in order to make their products compliant to GFI #209.

The final document is a draft text for proposed regulation intended to improve the efficiency of FDA’s Veterinary Feed Directive (VFD) program. FDA said it is making this draft text available because of the complex scientific and regulatory issues involved and because of the potential impact that changes to the VFD regulations may have on stakeholders.

The animal health industry’s immediate responded to the announcement was to say it supports the process and sees it as being designed to protect the health of animals and ultimately public health, while preserving animal care tools for veterinarians and producers.

“The veterinarian is critically important in animal care decisions and, ultimately, in protecting food safety and human health. We strongly support responsible use of antibiotic medicines and the involvement of a veterinarian whenever antibiotics are administered to food producing animals,” said the Animal Health Institute in its statement. AHI added, however, that there remain details that must be addressed to make this approach practical and workable.

The guidance and policy by FDA fulfills the requests by a number of public health advocacy groups in a July 2009 letter to the Senior Economic Policy Advisor at the White House.

The three documents will be published in the April 13 Federal Register.

Source: Feedstuffs

TAGS: Regulatory
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