| English term or phrase: extra -label use | There are some very limited circumstances, under supervision of a licensed veterinarian, where Terramycin® for Fish or Romet-30® medicated feed can be used for other aquatic animals not listed on the label. This is considered extra-label use, meaning use of a drug in any way that is not in accordance with approved product labeling. In 1994, Congress passed legislation, Animal Drug Use Clarification Act (AMDUCA), which allows veterinarians to prescribe FDA approved drugs in an extra-label manner under specific conditions. The regulations that implement AMDUCA can be found in Title 21 Code of Federal Regulations (CFR) Part 530. These extra-label uses have limited utility in most commercial aquaculture but might be feasible for valuable brood stock or ornamental fishes.
A veterinarian can prescribe the extra-label use of medicated feed when the health of animals is threatened and suffering or death would result from failure to treat affected animals. To use a medicated feed in an extra-label manner, the following conditions must be met: |
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The translation workplace 
peer agreement (net): +7