FDA Finalizes Policy Meant to Limit Use of Antibiotics in Farm Animals

Regulatory NewsRegulatory News
| 02 June 2015 | By Alexander Gaffney, RAC

The US Food and Drug Administration (FDA) has released a long-anticipated final rule meant to limit the use of antibiotics in food-producing animals in order to limit the spread of antibiotic-resistant bacteria.

The rule, known as the Veterinary Feed Directive (VFD), has been amended to require veterinary antibiotics to be prescribed by a veterinarian "within the context of a veterinarian-client-patient relationship (VCPR)," FDA explained in an accompanying press statement. Previously, such drugs were available over-the-counter (OTC).

Among the requirements of the VFD is that prescribing may only be done if the veterinarian engages with the animal's caretaker/producer, has "sufficient knowledge of the animal by conducting examinations or visits," and conducts follow-up care or evaluations, FDA explained.

The rule is FDA's most ambitious step to date in the agency's broader effort to ensure the "judicious use" of animal antibiotics. Its previous efforts took the shape of guidance documents which, while influential, are non-binding.

In comparison, the VFD establishes concrete rules with which veterinarians and companies will need to comply.

For example, drug distributors will need to certify that they will not ship any antibiotics covered under the VFD to an animal production facility not covered by a Veterinary Feed Directive.

(The Veterinary Feed Directive is both the name of FDA's rule and the authorization form used to distribute animal drugs covered by the rule, known as VFD drugs.)

Animal production facilities will only be permitted to feed antibiotics to their animals if they have the approval of a licensed veterinarian.

In addition, the "use and labeling of a VFD drug or a combination VFD drug in feed is limited to the approved, conditionally approved or indexed conditions of use," FDA's rule states. In other words, no off-label use is permitted.

A copy of the authorization to use a drug must be retained for two years, the VFD states. The authorization must contain an extensive amount of information, including contact information, the date the VFD was issued, information about the animals covered by the VFD, the extent of use of the drug, and more.



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