Regulation of Fish drug use
Fish, like other animals, can get sick. Bacteria, fungi, parasites, viruses, and poor water quality can cause various diseases in fish. Fish producers and fish hatchery managers worry about fish health because diseases can kill many fish quickly.
FDA works to ensure that safe and effective drugs are available to treat fish diseases. The agency also works to ensure that treated food fish are safe for people and other animals to eat. Along with other government agencies, aquaculture groups, and fish health professionals, FDA promotes the proper use of legal aquaculture drugs. Through educational outreach, the agency also encourages research to support the approval of safe and effective aquaculture drugs.
Aquaculture drug approval
The basic approval process for an aquaculture drug is the same as the approval process for any animal drug. A drug company collects information about the safety and effectiveness of a new animal drug. Public agencies, such as the U.S. Fish and Wildlife Service, U.S. Geological Survey, U.S. Department of Agriculture, and state fish and wildlife agencies, may help collect the required safety and effectiveness data to support the approval of an aquaculture drug. Commercial fish farms and public fish hatcheries may also be involved in this research.
Based on the collected information, the drug company decides if there’s enough proof that the drug is safe and effective for the intended use. If so, the company submits a New Animal Drug Application to FDA for review. The application includes all the information about the drug and the company’s proposed label. If the application proves that the drug is safe, effective, properly manufactured, and adequately labeled and packaged, the agency approves the drug.
When FDA approves a drug, the agency is approving the final drug product, not the active ingredient alone. The final drug product includes both active and inactive ingredients.
An active ingredient is the pharmacologically-active component responsible for achieving the drug’s intended effect—for example, to treat a fish disease or to change the structure or function of a fish’s body. A drug may have one or more active ingredients. Inactive ingredients are all other components of the final drug product, such as coloring and flavoring substances, preservatives, and binding agents.
For example, the approved aquaculture drug 35% PEROX-AID contains the active ingredient hydrogen peroxide at a specific concentration. As part of the approval process for 35% PEROX-AID, the company showed that the final drug product was consistently manufactured to ensure strength, quality, and purity. The company also showed that the final drug product was safe and effective to control mortality due to certain fungal and bacterial fish diseases. Another product containing hydrogen peroxide as the active ingredient, even at the same concentration, isn’t the same as 35% PEROX-AID. Unapproved hydrogen peroxide products may not be safe or effective to treat fish diseases, and the quality and consistency of the manufacturing process cannot be assured.
Legal approval aquaculture drugs used in fish
Besides approved aquaculture drugs, there are two other categories of legally marketed animal drugs that can be used in fish, depending on the situation. These two categories are: (1) conditionally approved animal drugs; and (2) indexed animal drugs.
Conditional Approval
A conditionally approved animal drug has gone through FDA's drug approval process except the drug has not yet met the effectiveness standard for full approval. FDA’s conditional approval means that when used according to the label, the drug is safe and has a “reasonable expectation of effectiveness.”
The conditional approval is valid for one year. The drug company can ask FDA to renew the conditional approval annually for up to four more years, for a total of five years of conditional approval. During the 5-year period, the drug company can legally sell the animal drug while collecting the remaining effectiveness data. This early marketing is good for two reasons: first, the drug is available sooner to be used in animals that may benefit from it; and second, the company can recoup some of the investment costs while completing the full approval.
After collecting the remaining effectiveness data, the company applies to FDA for full approval. The agency reviews the application and, if appropriate, fully approves the drug.
Indexing
An indexed animal drug is a drug on FDA’s Index of Legally Marketed Unapproved New Animal Drugs for Minor Species, referred to simply as “the Index.” As the name says, a drug listed on the Index is unapproved but has legal marketing status. It can be legally sold for a specific use in certain minor species. FDA classifies horses, dogs, cats, cattle, pigs, chickens, and turkeys as the seven major species. All other animals, including fish, are minor species.
Indexing is allowed for drugs for:
Non-food-producing minor species, such as ornamental fish. These fish are typically not eaten by people or by other animals that produce food for people to eat; and
An early non-food life stage of a food-producing minor species, such as oyster spat (immature oysters). Because people don’t generally eat oyster spat, a drug to treat a disease in spat can be indexed, but a drug to treat a disease in adult oysters, which people commonly eat, can’t be indexed.
Indexing a drug is quite different from the drug approval process. Indexing relies heavily on a panel of qualified experts outside FDA. The experts review the drug’s safety in the specific minor species and the drug's effectiveness for the intended use. All experts on the panel must agree that, when used according to the label, the drug’s benefits outweigh the risks to the treated animal. If FDA agrees with the panel, the agency adds the drug to the Index.
Approval of conditional and indexed aquaculture drugs
All approved, conditionally approved, and indexed aquaculture drugs should be used according to the label, which states:
The species of fish the drug is intended for;
The diseases or conditions the drug is to be used for; and
Specific directions for use.
Legal marketed aquaculture drugs.
Look at the drug’s label.
All FDA-approved animal drugs have a New Animal Drug Application (NADA) number, or for generic animal drugs, an Abbreviated New Animal Drug Application (ANADA) number. Many drug companies currently list the six-digit NADA or ANADA number and the statement, “Approved by FDA,” on the drug’s label. By the end of September 2023, all drug manufacturers will be required to list this information on the label of every approved animal drug.
Conditionally approved animal drugs also have a six-digit application number which appears on the drug’s label as part of the following required statement:
“Conditionally approved by FDA pending a full demonstration of effectiveness under application number XXX-XXX.”
Indexed animal drugs have a Minor species Index File (MIF) number. The six-digit MIF number appears on the drug’s label as part of the following required statements:
“LEGAL STATUS—In order to be legally marketed, a new animal drug intended for a minor species must be Approved, Conditionally Approved, or Indexed by the FDA. THIS PRODUCT IS INDEXED—MIF# XXX-XXX. Extra-label use is prohibited."
impact of aquaculture drugs on the environment
Under the National Environmental Policy Act, FDA must consider how the environment will be affected if the agency approves, conditionally approves, or indexes an animal drug. This requirement applies to all animal drugs, including aquaculture drugs.
In most cases for an aquaculture drug, the drug company prepares an environmental assessment to describe:
How much drug is expected to get into the environment; The drug’s potential toxicity to aquatic life, and Potential effects the drug’s use will have on the environment.
If FDA determines that the aquaculture drug will not significantly impact the environment based on the information in the drug company’s environmental assessment, the agency writes what’s called a “Finding of No Significant Impact.” If FDA determines that the aquaculture drug will significantly impact the environment, the agency writes an Environmental Impact Statement.
unapproved animal drugs
Unapproved animal drugs are animal drugs illegally marketed in the U.S. that haven’t been approved, conditionally approved, or indexed by FDA. The agency has serious concerns about unapproved animal drugs because they potentially put the health of animals and people at risk. These drugs are not reviewed by FDA and may not meet the agency’s strict standards for safety, effectiveness, and quality. Unapproved animal drugs also may be inadequately labeled and packaged.
Because unapproved animal drugs don’t go through FDA’s review process, veterinarians, fish biologists, and fish owners have no way to know if these drugs are safe and effective or if their manufacturing processes are adequate to maintain quality and consistency from batch to batch. Also, because drug companies aren't required to report adverse events for unapproved animal drugs to FDA, it may take more time for problems with these drugs to be identified.
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