AQUACULTURE DRUGS: WHAT ARE THEY AND WHY DOES FDA REVIEW MATTER?

What's an animal drug? A product's intended use determines whether it's a drug or not.

For example, when formalin is used to fix a biopsy sample from a fish, it isn't a drug because the intended use is to preserve the tissue for future study. But when formalin is used to kill external parasites on finfish, it's a drug because the intended use is to treat a disease (parasitism), which makes it a drug under federal law.

Why does FDA review animal drugs? FDA review process ensures that animal drugs meet the following standards defined by law:

• The animal drug is safe and effective for its intended use;
• Food products from treated animals are safe for people to eat (if the drug is for a food-producing species);  
• The drug is properly manufactured;
• The drug is properly labeled.

FDA's review also considers:

• The drug's impact on the environment; and
• The safety of the people who will give the drug to the animal or who may come in contact with the drug.
  

This rigorous review process ensures that the approved animal drug is safe for animals, people, and the environment; effective; high quality; and has complete and truthful labeling.

FDA continues to monitor the drug's safety and effectiveness after it reaches the market. FDA also continues to monitor the drug's labeling, the drug's manufacturing process, and the company's marketing communications related to the drug.

Why should you care? As a fish producer or animal health professional, if you use an aquaculture drug with legal marketing status, you're assured that the drug is safe, effective, manufactured to a high quality standard, and that the label includes all information necessary for you to use the drug safely and effectively, including the risks associated with the drug.

Currently, few legally marketed drugs are available for fish compared to other animals like cats, dogs, cattle, and chickens. Drug companies are often hesitant to spend a lot of resources to develop aquaculture drugs when there is little return on their investment due to the small size of the U.S. aquaculture market. However, you can help change this. You can collaborate with government agencies and other private and public aquaculture professionals and use your facilities and expertise to help get more aquaculture drugs to legal marketing status in the U.S.