Animal & Veterinary
Aquaculture is becoming an increasingly important source of food available for human consumption. As the number of aquaculture facilities grows, so does the need to develop safe and effective drugs for treating fish diseases. The FDA's Center for Veterinary Medicine (CVM) Office of New Animal Drug Evaluation (ONADE) is 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 is playing a critical role in making more medications legally available to veterinarians and animal owners to treat minor animal species such as fish. Additionally, CVM’s Office of Research (OR) has greatly expanded its commitment to aquaculture research.
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.
CVM Updates/FDA Press Releases
CVM GFI #150 Concerns Related to the use of Clove Oil as an Anesthetic for Fish(PDF - 41KB) VICH GL9 - Good Clinical Practice(PDF - 260KB) CVM GFI #53 Evaluation of the Utility of Food Additives in Diet Fed to Aquatic Animals VICH GL43 - Target Animal Safety for Veterinary Pharmaceutical Products(PDF - 261KB)
CVM Policy & Procedures Manual
1240.4200 Drug Use in Aquaculture Enforcement Priorities(PDF - 90KB) 1240.4210 Extra-label Use of Approved Drugs in Aquaculture(PDF - 22KB) 1240.4220 Drug-Pesticide Issues(PDF - 22KB) 1240.4230 Regulation of Fish Identification Products(PDF - 26KB) 1240.4260 Classification of Aquaculture Species/Population as Food/ Non-food(PDF - 41KB) 1240.4270 Use of Drugs in Outdoor Aquatic Research Facilities(PDF - 43KB) CPG Sec 615.115 Extra-Label Use of Medicated Feeds for Minor Species
Veterinary Adverse Event Voluntary Reporting Veterinary Adverse Event Reporting for Manufacturers ADE Reporting for Fish Drugs
- CVM Aquaculture Research
Aquaculture and Aquaculture Drugs Basics Public Master Files (PMFs) Supporting Applications for Minor Use and Minor Species Drugs Minor Use/Minor Species Drug Indexing FDA Answers Your Questions about Fish Drugs