FDA takes veterinary feed directive to next level
New guidelines issued in June by the FDA will effectively end over-the-counter antibiotic use in animal agriculture.
The agency’s guidance for industry (GFI) 263 puts more “medically important” animal health drugs under veterinary oversight. It’s a follow-up to 2017 FDA rules that took feed-through and water-soluble forms of these products to prescription status, requiring a veterinary feed directive for purchase and use. The intent was to eliminate the use of antimicrobials for production purposes, such as growth promotion, and only allow veterinarians to prescribe them when necessary for the treatment, control or prevention of specific diseases.
This latest document requests that animal health companies voluntarily start labeling, marketing and distributing the remaining forms of over-the-counter (OTC) antibiotics—injectable, topical and oral products—as prescription-only. Once the change is made, these medications can only be used in animals under the supervision of a licensed veterinarian.
According to the FDA, about 96% of medically important antimicrobials used in animals are now under veterinary oversight. The remaining 4% will be covered by the new guidance for industry. Dr. Tony Martin, MFA Incorporated manager of animal health, said current OTC products that will be affected include penicillin, tetracycline, erythromycin, sulfamethazine, sulfadimethoxine and tylosin, among others.
“This situation is not totally new information,” Martin said. “We knew shortly after the VFD regulation went into effect in 2017 that the remaining OTC versions of these same antibiotics would likely be the next group to be scrutinized and regulated. The new FDA guidance confirms that the change is now underway.”
Implementation of the new regulations will take place over a two-year timeframe. FDA plans to work with affected stakeholders and state partners to answer questions and provide assistance in the transition process.
“Producers need to be preparing to access the affected products either directly from their veterinarian or through use of a written prescription provided by a veterinarian for their acquisition and use when this process is completed in two years,” Martin said. “When it is all said and done, MFA and other retail locations will no longer be able to legally stock and sell the affected products.”
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