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FDA Reminds Professionals Not All Drugs Approved

19 October 2012

US - The US Food and Drug Administration (FDA) has sent a letter, reminding aquaculture professionals, that not all drugs currently marketed for food fish are approved.

The FDA warns that even if a marketed product has the same established name (active ingredient) as an FDA-approved drug, that doesn’t mean it’s also FDA-approved.

If a product currently marketed for food fish isn't listed by the FDA, it's not FDA-approved, and therefore, hasn’t been shown to be safe and effective in food fish. For example, only the four listed formalin products are approved by FDA for fish. Any other formalin-containing products marketed are not FDA-approved.

FDA rigorously evaluates an animal drug before approving it. As part of the approval process, the drug company must prove to FDA that:

  • The drug is safe and effective for a specific use in a specific animal species. For food fish intended for human consumption, the drug company must also prove that food made from fish treated with the drug is safe for people to eat;
  • The manufacturing process is adequate to preserve the drug’s identity, strength, quality, and purity; and
  • The drug’s labeling is truthful and complete.

FDA’s role doesn’t stop after the agency approves an animal drug. As long as the drug company markets the animal drug, the agency continues to monitor the drug’s:

  • Safety and effectiveness to determine if concerns arise that were unknown at the time of approval;
  • Manufacturing process to ensure quality and consistency are maintained; and
  • Labeling to make sure the information remains truthful and complete.

Further Reading

You can view the list of FDA approved drugs by clicking here.

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