Use of aquatic animal therapeutic agents

Comment on this policy

There are few approved drugs for aquatic animals in the USA. The AVMA recognizes the need for sufficient approved therapeutics to facilitate safe and effective prevention and treatment of aquatic animal disease.

Approved aquatic drugs and therapeutics

Regarding approved aquatic drugs and therapeutics having legal marketing status, the AVMA:

  1. Supports implementation of the Minor Use and Minor Species Animal Health Act of 2004
  2. Cooperates with other organizations to obtain approval for new therapeutics for aquatic animals
  3. Promotes educational information for veterinarians, producers, and owners
  4. Works with government agencies to develop appropriate policies and guidelines regarding their safe and effective use
  5. Supports a veterinarian-client-patient-relationship and related state and federal requirements
  6. Supports the FDA Center for Veterinary Medicine’s (CVM) Compliance Policy Guide (CPG) on the “Extralabel Use of Medicated Feeds for Minor Species (CPG 615.115)

Investigational new animal drugs (INADs)

The AVMA supports safety and efficacy studies of unapproved drugs for potential approval in aquatic animals through the Investigational New Animal Drug (INAD) Program. AVMA encourages veterinary involvement in the INAD Program, particularly if the intended use will require veterinary oversight once the drug is approved. Favorable drug data generated through the INAD process will serve as incentives to sponsors and investigators to pursue studies addressing the remaining sections of the approval process.

Index of legally marketed unapproved new animal drugs

The AVMA supports the FDA review process of drug indexing for non-food-producing aquatic species and non-food early life stages of food-producing aquatic species to obtain legal marketing for eligible products.

Deferred regulatory status drugs

The AVMA supports FDA CVM’s decision to classify copper sulfate and potassium permanganate as deferred regulatory status drugs pending further evaluation.

Low regulatory priority drugs (LRP)

The AVMA supports FDA CVM’s decision to classify certain unapproved drugs and compounds used in aquaculture as LRP. These LRP are considered low-risk when used in food fish for human consumption. Further details on LRP can be found at:  Fish and Fishery Products Hazards and Controls – June 2022 Edition, Chapter 11: Aquaculture Drugs
Conditionally approved drugs

The AVMA supports marketing of drugs for minor species under the category of “conditional approval” that have satisfied FDA’s safety and manufacturing requirements and have demonstrated “substantial evidence of effectiveness”. A conditionally approved drug can be marketed for up to five years while the sponsor accumulates data to meet the required efficacy evidence. Further details on conditional approval of drugs can be found at:  CVM Guidance for Industry #61 – Special Considerations, Incentives, and Programs to Support the Approval of New Animal Drugs for Minor Uses and for Minor Species – December 2023

Illegally marketed drugs

The AVMA encourages enforcement action be taken by FDA CVM to remove drugs that are illegally marketed.

Veterinary biologics

The AVMA supports cooperation with the USDA for the development and use of biologics and disease diagnostic tests.

EPA-regulated pesticides and disinfectants

The AVMA supports the on-label use of pesticides and disinfectants that are licensed through the Environmental Protection Agency to control pests of aquatic animals (in the environment). Uses that are not specifically labeled are allowed by Section 2(ee) of the Federal Insecticide, Fungicide and Rodenticide Act. For example, there are no disinfectants registered for use against Lake Tilapia Lake Virus or Spring Viremia of Carp Virus. However, if the product is used on a site that is on the label, then it can be used for disinfection of these viruses unless the label specifies only specific pests. (Note: Some state regulations may not permit 2 (ee) uses.) Although the use of these products does not require a veterinary prescription, the AVMA encourages veterinarians and aquatic animal facility managers to work together to ensure their responsible use.

The AVMA supports an integrated pest management plan as a sustainable approach to minimize risks to health and the environment.

References for EPA regulations

Related policy