Approved Drugs for Use in Aquaculture

 Approved Drugs for Use in Aquaculture  New Animal Drugs of Low Regulatory Priority (LRP) used in Aquaculture  Unapproved Drugs for Use in Aquaculture Approved Drugs for Use in Aquaculture  Drugs Approved for Use in Aquaculture (revised January 2000) o Chorulon® - NADA 140-927 o Terramycin® - NADA 038-439 o Romet-30® - NADA 125-933 o Finquel® - NADA 042-427 o Tricaine-S - ANADA 200-226 o Formalin-F® - NADA 137-687 o Paracide-F® - NADA 140-831 o Parasite-S® - NADA 140-989 o Sulfamerazine - NADA 033-950 Drugs Approved for Use in Aquaculture (Poikilothermic Food Species)

Drug Species Indication Dosage Limitations/Comments regimen

Chorionic Male and Aid in improving 50 to 510 Up to three doses. Gonadotropin, female brood spawning function IU/lb males Total dose not to (Chorulon® by et, finfish 67 to 1816 exceed 25,000 IU in Inc.) IU/lb females fish intended for human consumption

Oxytetracycline Pacific Mark skeletal tissue 250 --Salmon < 30 g monoalkyl salmon mg/kg/day for In feed as sole ration trimethyl 4 days -- 7 day withdrawal ammonium time (Terramycin® by Also hydrochloride Pfizer, Inc.) form

Salmonids Control ulcer disease 2.5 to 3.75 --In mixed ration furunculosis, g/100 lb/day -- Water temperature bacterial for 10 days not below 48.2° F hemorrhagic --21 day withdrawal septicemia, and time pseudomonas disease,(Hemophilus piscium, Aeromonas salmonicida, A. . liquefaciens, Pseudomonas) Catfish Control bacterial 2.5 to 3.75 --In mixed ration hemorrhagic g/100 lb/day -- Water temperature septicemia and for 10 days not below 62° F pseudomonas --21 day withdrawal disease (A. time liquefaciens, Pseudomonas)

Lobster Control gaffkemia 1 g/lb --In feed as sole ration (Aerococcus medicated --30 day withdrawal viridans) feed for 5 time days

Sulfadimethoxine, Salmonids Control furunculosis 50 --In feed ormetoprim (Aeromonas mg/kg/days --42 day withdrawal (Romet-30®by salmonicida) for 5 days time Roche Vitamins, Inc.)

Catfish Control enteric 50 --In feed septicemia mg/kg/days --3 day withdrawal time (Edwardsiella ictaluri) for 5 days

Tricaine Fish Sedation/anesthesia 15 to 330 --Powder is added to methanesulfonate (Ictaluridae, mg/L (fish) water Salmonidae, --Concentration Esocidae, depends upon , desired Percidae) degree of anesthesia, 1:1,000 to species, size, water 1:20,000 temperature and Other aquatic (other softness, stage of poikilotherms poikilotherms) 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 over 50° F

Drugs Approved for Use in Aquaculture (Poikilothermic Food Species)

Drug Species Indication Dosage regimen Limitations/Comments

Formalin Select finfish: Control protozoa Tanks and --Drug must not be (Formalin-F® salmon, trout, (Chilodonella, raceways: subjected to by Natchez catfish, Costia, Epistylis, Salmon & trout temperature below 40° Animal Supply bluegill, Ichthyophthirius, Above 50°F: up F --Do not apply to Co. & largemouth Scyphidia, to 170 µl/L; up to ponds when water is Paracide-F® bass Trichodina spp.) 1 hr warmer than 80° F, by Argent and monogenetic Below 50°F: up to there is a heavy Laboratories) trematodes 250 µl/L; up to 1 phytoplankton bloom or (Cleidodiscus, hr dissolved oxygen is Dactylogyrus, Catfish, bluegill, less than 5 mg/L Gyrodactylus largemouth bass --Ponds may be spp.) up to 250 µl/L; up retreated in 5 to 10 to 1 hr days if needed --Do not Earthern ponds: treat ponds containing 15 to 25 µl/L; striped bass. indefinitely

Select finfish Control fungi of Select finfish Preliminary bioassay eggs: salmon, the family eggs: 1000-2000 should be conducted to trout, esocid Saprolegniaceae ppm for determine

Formalin All finfish Control protozoa Tanks and --Drug must not be (Parasite-S® (Chilodonella, raceways: subjected to by Western Costia, Epistylis, Salmon & trout temperature below 40° Chemical, Ichthyophthirius, Above 50°F: up F Scyphidia, to 170 µl/L; up to --Do not apply to ponds Trichodina spp.) 1 hr when water is warmer and monogenetic Below 50°F: up to than 80° F, there is a trematodes 250 µl/L; up to 1 heavy phytoplankton (Cleidodiscus, hr bloom, Dactylogyrus, All other finfish up or dissolved oxygen is Gyrodactylus to --250 µl/L; up less than 5 mg/L spp.) to 1 hr --Ponds may be Earthern ponds: retreated in 5 to 10 15 to 25 µl/L; days if needed indefinitely --Do not treat ponds containing striped bass

All finfish eggs Control fungi of All finfish eggs: Preliminary bioassay the family 1000-2000 ppm should be conducted to Saprolegniaceae for 15 min.; determine species Acipenseriformes sensitivity up to 1500 ppm for 15 min.

Penaeid Control Tanks and --Drug must not be shrimp protozoan raceways: subjected to parasites (Bodo, 50 to 100 µl/L, up temperature below 40° Epistylis and to and 4 hours F Zoothamnium daily; --Do not apply to ponds spp.) Earthern ponds: when water is warmer 25 µl/L; single than 80° F, treatment there is a heavy phytoplankton bloom, or dissolved oxygen is less than 5 mg/L --Ponds may be retreated in 5 to 10 days if needed

Sulfamerazine Rainbow, Control --10 g/100 lb/day --In feed (by Roche brook, and furunculosis for up to 14 days --21 day withdrawal Vitamins, Inc.) brown trout time --Not currently available

Approval applies only to the specific drug which is the subject of a new animal drug application (NADA); active ingredients from other sources (e.g. 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.

An INAD exemption is not the same as approval; it merely temporarily permits research (under specific conditions) on an unapproved compound.

This is an abbreviated summary. For complete labeling see the package insert. New Animal Drugs of Low Regulatory Priority (LRP) used in Aquaculture (FDA low regulatory priority aquaculture drugs) FDA's Center for Veterinary Medicine has identified a number of "low regulatory priority aquaculture drugs." The following list identifies these compounds and provides their indicated use and usage levels. These compounds have undergone review by the Food and Drug Administration and have been determined to be new animal drugs of low regulatory priority. Additional information on this subject can be obtained from: the FDA Center for Veterinary Medicine; or "Guide to Drug, Vaccine, and Pesticide Use in Aquaculture," Texas Agricultural Extension Service, Publication B-5085.  Acetic Acid Used in a 1000 to 2000 ppm dip for 1 to 10 minutes as a parasitide for fish.  Calcium Chloride Used to increase water calcium concentration to insure proper egg hardening. Dosages used would be those necessary to raise calcium concentration to 1-20 ppm CaCO3. Used up to 150 ppm indefinitely to increase the hardness of water for holding and transporting fish in order to enable fish to maintain osmotic balance.  Calcium Oxide Used as an external protozoacide for fingerlings to adult fish at a concentration of 2000 mg/L for 5 seconds.  Carbon Dioxide Gas Used for anesthetic purposes in cold, cool, and warm water fish.

 Fuller's Earth Used to reduce the adhesiveness of fish eggs to improve hatchability.  Garlic (whole form) Used for control of helminth and sea lice infestations of marine salmonids at all life stages.  Hydrogen Peroxide Used at 250-500 mg/L to control fungi on all species and life states of fish, including eggs.  Ice Used to reduce metabolic rate of fish during transport.  Magnesium Sulfate Used to treat external monogenic trematode infestations and external crustacean infestations in fish at all life stages. Used in all freshwater species. Fish are immersed in a 30,000 mg MgSO4/L and 7000 mg NaCl/L solutions for 5 to 10 minutes.

 Onion (whole form) Used to treat external crustacean parasites, and to deter sea lice from infesting external surface of salmonids at all life stages.  Papain Used in a 0.2% solution to remove the gelatinous matrix of fish egg masses in order to improve hatchability and decrease the incidence of disease.  Potassium Chloride Used as an aid in osmoregulation; relieves stress and prevents shock. Dosages used would be those necessary to increase chloride ion concentration to 10-2000 mg/L.  Povidone Iodine Used in a 100 ppm solution for 10 minutes as an egg surface disinfectant during and after water hardening.  Sodium Bicarbonate Used at 142 to 642 ppm for 5 minutes as a means of introducing carbon dioxide into the water to anesthetize fish.

 Sodium Chloride Used in a 0.5% to 1.0% solution for an indefinite period as an osmoregulatory aid for the relief of stress and prevention of shock; and 3% solution for 10 to 30 minutes as a parasitide.  Sodium Sulfite Used in a 15% solution for 5 to 8 minutes to treat eggs in order to improve their hatchability.  Urea & Tannic Acid Used to denature the adhesive component of fish eggs at concentrations of 15g urea and 20g NaCl/5 liters of water for approximately 6 minutes, followed by a separate solution of 0.75 g tannic acid/5 liters of water for an additional 6 minutes. These amounts will treat approximately 400,000 eggs. Unapproved Drugs for Use in Aquaculture

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