The FDA announced its plan to help phase out the use of medically important antimicrobials in food animals for food production, such as to enhance growth or to improve feed efficiency.
The plan also includes phasing in veterinary oversight of the remaining appropriate therapeutic uses of such antimicrobials.
Some antimicrobials have been used in the feed and water of cattle, poultry, hogs, and other food animals for food production purposes, including using less food to gain weight.
But concerns have been raised about the increase in possible antimicrobial resistance, as some of these drugs are used to treat human infection.
The plan focuses on antimicrobials that are considered medically important and which are approved for use in feed and water of food animals.
The FDA detailed out plans for animal pharmaceutical companies to voluntarily revise the approved used conditions on the product labels to remove product indications. Also, the FDA plans to change the current over-the-counter (OTC) status to bring the remaining appropriate therapeutic uses under veterinary oversight.
Once these changes are implemented by the manufacturer, the medically important antimicrobials can no longer be used for production purposes, and will require veterinary oversight regarding their use for treatment, control, and prevention of disease in animals.
These companies will have a three-year transition process after notifying the FDA of their intent to proceed with this strategy.
The FDA has also proposed to update the existing regulations relating to Veterinary Feed Directive (VFD) drugs. The proposed rule is intended to update existing VFD process and facilitate expanded veterinary oversight by clarifying and increasing the flexibility of the requirements for distribution and use of VFD drugs.
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