Animal & Veterinary
Aquaculture
Aquaculture is becoming an increasingly important source of fish 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 the 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
- April 28, 2009 Notice of the Availability of Effectiveness Data to Support a New Animal Drug Application for Fish
- April 20, 2009 FDA Issues a Notice of the Availability of Effectiveness Data to Support a New Animal Drug Application for Fish
- July 10, 2008 FDA Approves Antimicrobial for Two New Aquaculture Indications
- November 06, 2007 FDA Approves New Antimicrobial for Salmonids for Treatment of Furunculosis
- May 02, 2007 FDA Removes Hydrogen Peroxide from the List of Low Regulatory Priority Aquaculture Drugs
- April 18, 2007 First FDA Conditionally Approved New Animal Drug for Columnaris Disease in Catfish
- March 22, 2007 FDA Approval of New Antimicrobial for Salmonids
- February 21, 2007 Environmental Considerations and Limitations for Use of Hydrogen Peroxide in Aquaculture
- February 05, 2007 FDA Approves New Drug for Freshwater-Reared Finfish
- June 23, 2006 Reminder To Aquaculture Producers About The Use Of Formaldehyde
- October 25, 2005 FDA Approves New Antimicrobial for Catfish
Guidances
- CVM GFI #150 Concerns Related to the use of Clove Oil as an Anesthetic for Fish (PDF - 40KB)
- VICH GL9 - Good Clinical Practices (PDF - 64KB)
- CVM GFI #61 FDA Approval of New Animal Drugs for MUMS (PDF - 685KB)
- 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 - 241KB)
CVM Policy & Procedures Manual
- 1240.4200 Drug Use in Aquaculture Enforcement Priorities (PDF - 88KB)
- 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