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Thursday, January 5, 2017

Drug companies are meeting new standards imposed by the U.S. Food and Drug Administration

U.S. drug companies are meeting new standards imposed by the U.S. Food and Drug Administration (FDA) regarding labels on medically important antibiotics used in food animals, the agency announced in a news release.The FDA said all affected companies have voluntarily complied with Guidance for Industry #213 that called for changing the marketing of antibiotics administered through animal feed and water requiring veterinary oversight. The guidance ­–which also removed “growth promotion” claims making it illegal to give antibiotics to healthy animals to promote weight gain – took effect Jan. 1.Of the 292 new animal drug applications initially affected by the guidance, 84 were completely withdrawn, 93 oral dosage products were converted to prescription-only status and 115 affected feed were converted to veterinary-directive status, the FDA reported. Another 22 applications tying growth promotion to the drugs were altered to remove the production promise, the agency added.The announcement won praise from the Pew Charitable Trusts, which noted that the FDA action “will help advance the global effort to slow the emergence of drug-resistant bacteria and preserve the effectiveness of these lifesaving drugs,” the organization said in a news release.