FDA Announces Full Compliance with Antibiotics Strategy

On July 3, 2014, in Antibiotics, FDA, by Kourtney Determan

The U.S. Food and Drug Administration (FDA) this week released the first progress report regarding Guidance for Industry #213, dealing with antibiotics use for growth promotion in livestock and increased veterinarian oversight.

According to the FDA, all 26 drug manufacturers impacted by Guidance #213 have agreed to phase out medically important drugs and phase in veterinarian oversight for the remaining drugs.  Guidance #213 sets a three year goal for the manufacturers to complete the goal, though many of the sponsors have already started to implement the changes.

As of June 30th, there have been two published label changes and one pending label change. The final drug manufacturer, Pharmaq AS , has signed on to the  strategy and there have currently been thirty-one drug approval withdrawals for affected products.

The FDA has posted a list of affected products on a web page where it will update label changes.

To read the complete first progress report, click here.  The FDA will be releasing progress reports every six months to update the public on Guidance #213.