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  1. Development & Approval Process

Aquaculture is an increasingly important source of food available for human consumption. The FDA's Center for Veterinary Medicine (CVM) Office of New Animal Drug Evaluation (ONADE) and the Office of Minor Use and Minor Species Animal Drug Development (OMUMS) are working with various government agencies and aquaculture associations to increase the number of safe and effective drugs that can be used by the aquaculture industry. The Minor Use and Minor Species Animal Health Act of 2004 plays a critical role in making more drugs legally available to veterinarians and animal owners to treat minor animal species such as fish. CVM’s Office of Surveillance and Compliance (OSC), Division of Animal Feeds (DAF) is also working with stakeholders to ensure that any substance intentionally added to an animal food, whether intended to be fed to aquaculture species or an aquaculture by-product intended to be fed to other animals, is used in accordance with a food additive approval or is generally recognized as safe (GRAS) among qualified experts for its intended use. Additionally, CVM’s Office of Research (OR) has an aquaculture research program that supports innovations to inform the safety and efficacy evaluations of aquaculture drugs and to support compliant drug use.

These pages list Guidance documents, sections of the Policy and Procedures Manual, research projects, and other information that are used in support of CVM's aquaculture program, as well as drugs approved for use in aquaculture.



More Guidances

CVM Policy & Procedures Manual

Additional Resources


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