FDA-Approved Drugs for Aquaculture Use in the US (2019)
FDA-Approved Drugs for Aquaculture Use in the US (2019)
Drug | Species | Indications | Dosage Regimen | Comments |
|---|---|---|---|---|
Immersion | ||||
Formalin | All finfish | Control external protozoa (Chilodonella, Ichthyobodo, Epistylis, Ichthyophthirius, Ambiphyra, Trichodina spp), Tetrahymena spp and monogeneans (Cleidodiscus, Dactylogyrus, Gyrodactylus spp) | Tanks and raceways: salmon and trout: >10°C (50°F): up to 170 μL/L for up to 1 hour; < 10°C (50°F): up to 250 μL/L for up to 1 hour. All other finfish: up to 250 μL/L for up to 1 hour Earthen ponds: 15–25 μL/L indefinitely | Drug must not be subjected to temperature < 4.44°C (40°F). Do not apply to ponds when water is >26.67°C (80°F), there is a heavy phytoplankton bloom, or dissolved oxygen concentration is < 5 mg/L. Ponds may be re-treated in 5–10 days if needed. Do not treat ponds containing striped bass. Test on a small number from each lot to check for any unusual sensitivity to formalin before proceeding. |
All finfish eggs | Control water molds of the family Saprolegniaceae | All finfish eggs: 1,000–2,000 mcL/mL for 15 minutes Acipenseriformes: up to 1,500 mcL/mL for 15 minutes | Preliminary bioassay should be conducted to determine species sensitivity. | |
Penaeid shrimp | Control protozoan parasites (Bodo, Epistylis, and Zoothamnium spp) | Tanks and raceways: 50–100 mcL/L for up to 4 hours daily Earthen ponds: 25 mcL/L as single treatment | Drug must not be subjected to temperature < 4.44°C (40°F). Do not apply to ponds when water is >26.67°C (80°F), when there is a heavy phytoplankton bloom, or when dissolved oxygen concentration is < 5 mg/L. Ponds may be re-treated in 5–10 days if needed. | |
Hydrogen peroxide | Freshwater-reared finfish eggs | Control mortality due to saprolegniasis | Coldwater and coolwater: 500–1,000 mg/L for 15 minutes in a continuous flow system daily on consecutive or alternate days until hatch Warmwater: 750–1,000 mg/L for 15 minutes in a continuous flow system daily on consecutive or alternative days until hatch | Initial bioassay on a small number is recommended before treating entire group. |
Freshwater-reared salmonids | Control mortality due to bacterial gill disease (Flavobacterium branchiophilum) | 100 mg/L (30 minutes) or 50–100 mg/L (60 minutes) daily on alternate days for 3 treatments | Initial bioassay on a small number is recommended before treating entire group. | |
Freshwater-reared coolwater finfish and channel catfish | Control mortality due to external columnaris disease (Flavobacterium columnare) | Fingerling and adults (except northern pike and paddlefish): 50–75 mg/L (60 minutes) daily on alternate days for 3 treatments Fry (except northern pike, pallid sturgeon, and paddlefish): 50 mg/L (60 minutes) daily on alternate days for 3 treatments | Use with caution on walleye. Initial bioassay on a small number is recommended before treating entire group. | |
Oxytetracycline hydrochloride | Finfish fry and fingerlings | Mark skeletal tissues, most often otoliths, of finfish fry and fingerlings for identification purposes | 200–700 mg/L (buffered) for 2–6 hours | |
Tricaine methanesulfonate | Fish, amphibians, and other aquatic poikilotherms | Temporary immobilization | 15–330 mg/L (fish) 1:1,000 to 1:20,000 (other poikilotherms) | Powder is added to water; concentration depends on desired degree of anesthesia, species, size, water temperature and softness, stage of development. Preliminary tests of solution should be made with a few fish; 21-day withdrawal time (fish); laboratory or hatchery use only in other poikilotherms; water temperature >50°F (10°C) |
Chloramine-T | Freshwater-reared salmonids | Bacterial gill disease caused by Flavobacterium spp. | 12 to 20 mg/L in a continuous flow water supply or as a static bath once per day for 60 minutes on consecutive or alternative days for three treatments. | |
Walleye | External columnaris disease caused by Flavobacterium columnare | 10 to 20 mg/L in a continuous flow water supply or as a static bath once per day for 60 minutes on consecutive or alternative days for three treatments. | ||
Freshwater-reared warmwater finfish | External columnaris caused by Flavobacterium columnare | 20 mg/L in a continuous flow water supply or as a static bath once per day for 60 minutes on consecutive or alternative days for three treatments. | ||
Injectable | ||||
Chorionic gonadotropin | Male and female brood finfish | Help improve spawning function | Males: 110–1122 U/kg Females: 147.4–3995.2 U/kg | IM injection up to 3 doses; total dose not to exceed 25,000 U in fish intended for human consumption; restricted to use by or on the order of a licensed veterinarian |
Medicated Article/Feed | ||||
Florfenicol | Freshwater-reared finfish | Control of mortality due to enteric septicemia of catfish associated with Edwardsiella ictaluri, streptococcal septicemia in freshwater-reared warmwater finfish, columnaris disease in freshwater-reared finfish | 10 mg/kg/day for 10 consecutive days | Veterinary Feed Directive drug; 12-day withdrawal time |
Oxytetracycline dihydrate | Pacific salmon | Mark skeletal tissue, most often otoliths, of finfish fry and fingerlings for identification purposes | 250 mg/kg/day for 4 days | Veterinary Feed Directive drug; salmon < 30 g; in feed as sole ration; 7-day withdrawal time |
Freshwater-reared salmonids | Bacterial coldwater disease (Flavobacterium psychrophilum) | 2.5–3.75 g/100 lb/day for 10 days | Veterinary Feed Directive drug; in mixed ration; water temperature not < 9°C (48.2°F); 21-day withdrawal time | |
Cool freshwater-reared finfish | Control bacterial hemorrhagic septicemia (Aeromonas liquefaciens, furunculosis (Aeromonas salmonicida), and pseudomonas disease (Pseudomonas) | 2.5–3.75 g/100 lb/day for 10 days | Veterinary Feed Directive drug; in mixed ration; water temperature not < 16.7°C (62°F); 21-day withdrawal time | |
Lobster | Control gaffkemia (Aeroccocus viridans) | 1 g/lb medicated feed for 5 days | Veterinary Feed Directive drug; in feed as sole ration; 30-day withdrawal time | |
All freshwater-reared Pacific salmon | Control of columnaris disease | Veterinary Feed Directive drug, only allowed in feed; 21-day withdrawal time. | ||
Sulfadimethoxine-ormetoprim | Salmonids | Control furunculosis (Aeromonas salmonicida) | 50 mg/kg/day for 5 days | Veterinary Feed Directive drug; in feed; 42-day withdrawal time |
Catfish | Control enteric septicemia (Edwardsiella ictaluri) | 50 mg/kg/day for 5 days | Veterinary Feed Directive drug; only allowed in feed; 3-day withdrawal time | |
Note: This is an abbreviated summary. For more information visit the FDA website (https://www.fda.gov/animal-veterinary/aquaculture/approved-aquaculture-drugs). For complete labeling, see the package insert. Approval applies only to the specific drug that is the subject of a new animal drug application (NADA); active ingredients from other sources (eg, a bulk drug from a chemical company or similar compounds made by companies other than those specified in the NADA) are not approved new animal drugs. Approval applies only to use of the drug for the indications and manner specified on the label. The Aquatic Animal Drug Approval Partnership (AADAP) has several helpful publications on FDA-approved drugs. | ||||