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Federal regulatory practice issues: Drugs

Prohibiting extralabel use of adamantane and neuraminidase inhibitor anti-influenza drugs in poultry
Formal title:
Docket No. 2006N-0106; New Animal Drugs; Adamantane and Neuraminidase Inhibitor Anti-influenza Drugs; Extralabel Animal Drug Use; Order of Prohibition

View Federal Register document (PDF, 853 Kb)

Summary

On March 22, 2006 the FDA published a final rule prohibiting the extralabel use of adamantane and neuraminidase inhibitor classes of antiviral drugs in chickens, turkeys, and ducks. The FDA approved the drugs for treating or preventing influenza A in humans.

The FDA published the rule in spite of indicating that it is unaware of ongoing extralabel use of these human antiviral drugs by U.S. poultry producers.

Though the AVMA is supportive of preserving drugs of public health importance, including the specified antiviral drugs, the AVMA believes that the FDA final rule is unnecessary because the drug use that is prohibited has no anticipated application in U.S. commercial poultry production.

Response
View AVMA's response to FDA (PDF) (April 4, 2006)
Status
AVMA responded on April 4, 2006. The final rule becomes effective June 20, 2006.