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eBook details

• Title: Antimicrobial Animal Drug Sales and Distribution Reporting (US Food and Drug Administration Regulation) (FDA) (2018 Edition)
• Author : The Law Library
• Release Date : January 06, 2018
• Genre: Law,Books,Professional & Technical,
• Pages : * pages
• Size : 170 KB

Description

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 ebook contains:
- The complete text of the Antimicrobial Animal Drug Sales and Distribution Reporting (US Food and Drug Administration Regulation) (FDA) (2018 Edition)
- A dynamic table of content linking to each section
- A table of contents in introduction presenting a general overview of the structure

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