Resources for Selecting Aquaculture Medications

Resources for Selecting Aquaculture Medications

The fields of aquaculture and fisheries science require safe and effective medications for treating fish diseases and managing fisheries—as well as information to help guide the professionals who administer these medications.   The Food and Drug Administration has sole regulatory authority to approve new animal drugs. This page is intended to assist aquaculture professionals find information and determine what treatments are best suited to meet their needs. 

• Aquatic Animal Drugs Keep Fish Healthy
• How an Aquatic Animal Drug is Approved in the U.S.

Aquatic Animal Drug Approval Program Quick Desk Reference Guide to Approved Drugs for Use in Aquaculture   

Need an easy-to-use resource to help you know what aquaculture drugs are approved by FDA and what they can be used for? Download the Quick Desk Reference Guide to Approved Drugs for Use in Aquaculture (updated July 2020).   Due to the COVID-19 pandemic, hard copies will be available for shipment intermittently upon request. If you would like a hard copy, please email Pam Sponholtz with your shipping address, phone number, and the number of copies you would like and we will ship them at our earliest convenience.  

Download the Quick Desk Reference Guide to Approved Drugs for Use in Aquaculture

Contact PAM SPONHOLTZ

American Fisheries Society Guide to Using Drugs, Biologics, and Other Chemicals in Aquaculture  

Link to external site: American Fisheries Society Guide to Using Drugs, Biologics, and Other Chemicals in Aquaculture   

The Guide to Using Drugs, Biologics, and Other Chemicals in Aquaculture is a comprehensive introduction to the legal and judicious use of regulated products in aquaculture and is a great resource for fish culturists and fish health biologists involved in fish culture. The Guide is intended for informational and educational purposes only.   

Investigational New Animal Drugs (INADs)   

Investigational New Animal Drugs (INADs) are drugs that are in the approval pipeline but are not yet approved by FDA for use in the United States. Participation in the AADAP National INAD Program requires enrolling in the program which allows access to one or all of the drugs listed below.   

Investigational New Animal Drugs University

Antibiotic Use in Finfish Fact Sheet  

In the United States, antibiotics may be used in fish culture for control of bacterial infections, if necessary and under the direction of a U.S. licensed veterinarian. The Antibiotic Use in Finfish Fact Sheet provides helpful information for those considering the use of approved finfish antibiotics.  

Link to external site: Antibiotic Use in Finfish Fact Sheet   

Uses of Fishes in Research  

The Guidelines for Use of Fishes in Research was developed to provide a structure structure
Something temporarily or permanently constructed, built, or placed; and constructed of natural or manufactured parts including, but not limited to, a building, shed, cabin, porch, bridge, walkway, stair steps, sign, landing, platform, dock, rack, fence, telecommunication device, antennae, fish cleaning table, satellite dish/mount, or well head.

Learn more about structure that advances appropriate attention toward valid experimental designs and procedures with aquatic animals while ensuring humane treatment of the experimental subjects.

 Link to external site: Guidelines from AFS

Food and Drug Administration Resources   

FDA Phish-Pharm 

The Phish-Pharm database was built because information about pharmacokinetic parameters and drug residues in aquatic species (fish, shellfish, crustaceans, etc.) is relatively sparse. Phish-Pharm currently consists of over 700 articles that include data from 191 aquatic species (fish, shellfish, and more). Phish-Pharm enables users to quickly evaluate what information is available on drugs and chemicals studied in fish and to identify research gaps to guide future research.

• Phish-Pharm  - A Searchable Database of Pharmacokinetics and Drug Residue Literature in Fish

FDA Approved Fish Drugs   

FDA Approved drugs can only be used for specific purposes unless extra-label use is prescribed by a veterinarian. The FDA approves a product, not the active ingredient. For more detailed information, refer to the following resources.   

• FDA's Center for Veterinary Medicines list of approved aquaculture drugs   

• FDA Letter to Aquaculture Professionals   

FDA Low Regulatory Priority Drugs   

Low Regulatory Priority drugs are innocuous compounds that have historically been used in aquaculture but will likely never be approved by FDA. The FDA Center for Veterinary Medicine has determined these compounds to be of “low regulatory priority.”   

• FDA Center for Veterinary Medicine Frequently Asked Questions: What about products I hear referred to as “low regulatory priority”?   

• For more information and a list of Low Regulatory Priority compounds, refer to the FDA Center for Veterinary Medicine – Program Policy and Procedures Manual (1240.4200    Drug Use in Aquaculture Enforcement Priorities)   

FDA Aquaculture Guidance - Additional Resources    

• CPG Sec 615.115 Extra-label 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)   

 Minor Use / Minor Species (MUMS)

Designations, indexing, and other provisions.   

Extra-label Drug Use and Veterinary Feed Directive Information   

• FDA Manual of Compliance Policy Guides – CPG Sec. 615.115 Extralabel Use of Medicated Feeds for Minor Species   

• The Ins and Outs of Extra-Label Drug Use in Animals: A Resource for Veterinarians -   

• FACT SHEET: Veterinary Feed Directive Final Rule and Next Steps   

• Veterinary Feed Directive for Veterinarians (video)   

• Veterinary Feed Directive Requirements for Veterinarians - For Veterinary Students   

Return to the Aquatic Animal Drug Approval Partnership Program