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Antimicrobial Animal Drug Sales and Distribution Reporting (US Food and Drug Administration Regulation) (FDA) (2018 Edition) The Law Library

Antimicrobial Animal Drug Sales and Distribution Reporting (US Food and Drug Administration Regulation) (FDA) (2018 Edition) The Law Library presents the complete text of the Antimicrobial Animal Drug Sales and Distribution Reporting (US Food and Drug Administration Regulation) (FDA) (2018 Edition). Updated as of May 29, 2018 The Food and Drug Administration (FDA or we) is issuing a final rule to require that the sponsor of each approved or conditionally approved new animal drug product that contains an antimicrobial active ingredient submit an annual report to us on the amount of each such ingredient in the drug product that is sold or distributed for use in food-producing animals, including information on any distributor-labeled product. This final rule codifies the reporting requirements established in section 105 of the Animal Drug User Fee Amendments of 2008 (ADUFA). The final rule also includes an additional reporting provision intended to enhance our 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. This book contains: - The complete text of the Antimicrobial Animal Drug Sales and Distribution Reporting (US Food and Drug Administration Regulation) (FDA) (2018 Edition) - A table of contents with the page number of each section