FDA says antimicrobial phase-out has full compliance
Story Date: 7/3/2014

 

Source: MEATINGPLACE, 7/2/14

The U.S. Food and Drug Administration said all 26 drug makers affected by its initiative to phase out use of medically important antimicrobials in food animals have agreed to follow the agency’s recommendations.


The drug manufacturers have agreed in writing to phase out use of antimicrobials in food-producing animals and phase in the oversight of a veterinarian for the remaining therapeutic uses of such drugs.


While drug makers have until December 2016 to complete the recommended changes to their antimicrobial products, some companies have already begun to implement them, FDA said in a progress report on the strategy. The changes include 31 drug approval withdrawals, meaning those products can no longer be sold in the United States.


In addition, two changes to product labeling have been made, one to withdraw a production claim and one to change a drug’s marketing status from over-the-counter to available by prescription only. One additional drug label change, from over-the-counter marketing status to prescription status, is pending.


FDA said it would provide updates on its antimicrobial initiative every six months.

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