Aquaculture
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 Applied Science (OAS) 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.
News
Guidances
- CVM GFI #150 Concerns Related to the use of Clove Oil as an Anesthetic for Fish
- CVM GFI #85 (VICH GL9) Good Clinical Practice
- CVM GFI #53 Evaluation of the Utility of Food Additives in Diet Fed to Aquatic Animals
- CVM GFI #185 (VICH GL43) Target Animal Safety for Veterinary Pharmaceutical Products
- CVM GFI #257 (VICH GL57) Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Species: Marker Residue Depletion Studies to Establish Product Withdrawal Periods in Aquatic Species
- CVM GFI #61 Special Considerations, Incentives, and Programs to Support the Approval of New Animal Drugs for Minor Uses and for Minor Species
- CVM GFI #262 Pre-Submission Consultation Process for Animal Food Additive Petitions or Generally Recognized as Safe (GRAS) Notices
CVM Policy & Procedures Manual
- CPG Sec 615.115 Extralabel Use of Medicated Feeds for Minor Species
- 1240.4200 Drug Use in Aquaculture Enforcement Priorities (PDF - 506KB)
- 1240.4210 Extra-label Use of Approved Drugs in Aquaculture (PDF - 62KB)
- 1240.4230 Regulation of Fish Identification Products (PDF - 56KB)
- 1240.4260 Classification of Aquaculture Species/Population as Food/ Non-food (PDF - 93KB)
- 1240.4270 Use of Drugs in Outdoor Aquatic Research Facilities (PDF - 75KB)
Additional Resources
- ADE Reporting for Fish Drugs
- Aquaculture Research
- Aquaculture and Aquaculture Drugs Basics
- AquAdvantage Salmon
- FDA Answers Your Questions about Fish Drugs
- Letter to Aquaculture Professionals
- Public Master Files (PMFs) Supporting Applications for Minor Use and Minor Species Drugs
- Minor Use/Minor Species
- Drug Designation
- Drug Indexing
- Resources and First Steps for Aquaculture New Animal Drug Sponsors