In the May 11, 2016, Federal Register, FDA issued a final rule requiring the sponsor of each approved or conditionally approved new animal drug product containing an antimicrobial active ingredient to submit an annual report on the amount of each such ingredient in drug products sold or distributed for use in food-producing animals, including information on any distributor-labeled product. The final rule codifies the reporting requirements established in section 105 of the Animal Drug User Fee Amendments of 2008 and includes an additional reporting provision intended to enhance FDA's understanding of antimicrobial new animal drug sales intended for use in specific food-producing animal species and the relationship between such sales and antimicrobial resistance. The rule is effective July 11, 2016.
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