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Two antibiotics partially taken out of US market

The US Food and Drug Administration has written a letter to stakeholders in agriculture to remind them of withdrawal of neomycin and oxytetracyline from the market.

Daniel G. McChesney, FDA Director, Office of Surveillance and Compliance at the Center for Veterinary Medicine in a letter reminds stakeholders that “Type A medicated articles containing neomycin and oxytetracydine […] should be removed from the market by April 2, 2010, and that Type B and Type C medicated feeds should be removed by October 2, 2010.”
 
The type of drugs are described in21 CFR 558.15 (§ 558.15).
 
The two sponsors of fixed-ratio Type A medicated articles containing neomycin and oxytetracydine, Phibro Animal Health and Pennfield Oil Co., have each submitted revised labelling that removed unsupported intended uses.
 
The conditions of use approved in these supplemental applications were codified in 21 CFR 558.455 (§ 558.455), in 2006 for Phibro Animal Health and in 2009 for Pennfield Oil Co.
 
These amendments to the animal drug regulations completed each application's transition from interim marketing status and rendered inaccurate and obsolete the conditions of use codified in § 558.15.
 
McChesney furthermore reminds stakeholders that as a result of the regulations in § 558.455:
  • only Type A medicated articles containing neomycin and oxytetracydine in a 1:1 ratio may be used for the uses reflected in § 558.455;
  • neomycin sulfate is the only chemical form of neomycin approved for feed use in combination with oxytetracydine;
  • combination medicated feeds containing neomycin and oxytetracydine are not approved for use in chickens or turkeys producing eggs for human consumption; and
  • combination medicated feeds containing neomycin and oxytetracydine are not approved for use in baby pigs, (e.g., in swine milk replacers).
On March 31, 2010, FDA published a final rule in the Federal Register that removed the obsolete regulations in § 558.15.
 
 

Dick Ziggers

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