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Accession Number PB2013-104350
Title Summary Report on Antimicrobials Sold or Distributed for Use in Food-Producing Animals, 2011.
Publication Date 2012
Media Count 4p
Personal Author N/A
Abstract Section 105 of the Animal Drug User Fee Amendments of 2008 (ADUFA) (110 P.L. 316; 122 Stat. 3509) amended section 512 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360b) to require that sponsors of applications for new animal drugs containing an antimicrobial active ingredient submit an annual report to the Food and Drug Administration on the amount of each such ingredient in the drug that is sold or distributed for use in food-producing animals, including information on any distributor-labeled product. This legislation was enacted to assist FDA in its continuing analysis of the interactions (including drug resistance), efficacy, and safety of antibiotics approved for use in both humans and food- producing animals (H. Rpt. 110-804). Each report submitted to the FDA must specify: (1) the amount of each antimicrobial active ingredient by container size, strength, and dosage form; (2) quantities distributed domestically and quantities exported; and (3) a listing of the target animals, indications, and production classes that are specified on the approved label of the product. Sponsors of antimicrobial drug products that are approved and labeled for more than one food-producing animal species are not required to report sales and distribution information for each individual animal species. Only total product sales information is required. Each years report provides monthly sales and distribution data for the preceding calendar year
Keywords Antimicrobials
Food-producting animals
New drugs
Sales information
Targeting animals

Source Agency Center for Veterinary Medicine
NTIS Subject Category 57E - Clinical Medicine
57K - Microbiology
57U - Public Health & Industrial Medicine
68G - Environmental Health & Safety
44 - Health Care
70F - Public Administration & Government
Corporate Author Food and Drug Administration, Rockville, MD. Center for Veterinary Medicine.
Document Type Technical report
Title Note N/A
NTIS Issue Number 1311
Contract Number N/A

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