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        Development & Approval Process

Aquaculture

                        
                Approved Aquaculture Drugs Home
          Animal & Veterinary
          Development & Approval Process
          AquacultureDevelopment & Approval Process Aquaculture
  	
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    PrintAquaculture 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.

News

Center for Veterinary Medicine Aquaculture Strategic Plan Fiscal Years 2022 – 2026Guidances

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 Draft #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) NoticesMore Guidances

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

                                                                                  Content current as of:
      02/02/2023Aquaculture                
                          

                        Approved Aquaculture Drugs
 
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