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Approved Drugs for Use in Aquaculture


Approved Drugs for Use in Aquaculture

    • Chorulon® - NADA 140-927

    • Terramycin® - NADA 038-439

    • Romet-30® - NADA 125-933

    • Finquel® - NADA 042-427

    • Tricaine-S - ANADA 200-226

    • Formalin-F® - NADA 137-687

    • Paracide-F® - NADA 140-831

    • Parasite-S® - NADA 140-989

    • Sulfamerazine - NADA 033-950

Drugs Approved for Use in Aquaculture (Poikilothermic Food Species)

Drug

Species

Indication

Dosage regimen

Limitations/Comments

 

 

 

 

 

Chorionic Gonadotropin, (Chorulon® by et, Inc.)

Male and female brood finfish

Aid in improving spawning function

50 to 510 IU/lb males
67 to 1816 IU/lb females

Up to three doses. Total dose not to exceed 25,000 IU in fish intended for human consumption

Oxytetracycline monoalkyl trimethyl ammonium (Terramycin® by Pfizer, Inc.)

Pacific salmon

Mark skeletal tissue

250 mg/kg/day for 4 days

--Salmon < 30 g
In feed as sole ration
-- 7 day withdrawal time
Also hydrochloride form

 

Salmonids

Control ulcer disease
furunculosis, bacterial hemorrhagic septicemia, and pseudomonas disease,(Hemophilus piscium, Aeromonas salmonicida, A. . liquefaciens, Pseudomonas)

2.5 to 3.75 g/100 lb/day for 10 days

--In mixed ration
-- Water temperature not below 48.2° F
--21 day withdrawal time

 

Catfish

Control bacterial hemorrhagic septicemia and pseudomonas disease (A. liquefaciens, Pseudomonas)

2.5 to 3.75 g/100 lb/day for 10 days

--In mixed ration
-- Water temperature not below 62° F
--21 day withdrawal time

 

Lobster

Control gaffkemia
(Aerococcus viridans)

1 g/lb medicated feed for 5 days

--In feed as sole ration
--30 day withdrawal time

Sulfadimethoxine, ormetoprim (Romet-30®by Roche Vitamins, Inc.)

Salmonids

Control furunculosis
(Aeromonas salmonicida)

50 mg/kg/days for 5 days

--In feed
--42 day withdrawal time

 

Catfish

Control enteric septicemia (Edwardsiella ictaluri)

50 mg/kg/days for 5 days

--In feed
--3 day withdrawal time

Tricaine methanesulfonate

Fish
(Ictaluridae, Salmonidae, Esocidae, Percidae)


Other aquatic poikilotherms

Sedation/anesthesia

15 to 330 mg/L (fish)



1:1,000 to 1:20,000
(other poikilotherms)

--Powder is added to water
--Concentration depends upon , 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 over 50° F

 

Drugs Approved for Use in Aquaculture (Poikilothermic Food Species)

Drug

Species

Indication

Dosage regimen

Limitations/Comments

 

 

 

 

 

Formalin (Formalin-F® by Natchez Animal Supply Co. & Paracide-F® by Argent Laboratories)

Select finfish: salmon, trout, catfish, bluegill, largemouth bass

Control protozoa (Chilodonella, Costia, Epistylis, Ichthyophthirius, Scyphidia, Trichodina spp.) and monogenetic trematodes (Cleidodiscus, Dactylogyrus, Gyrodactylus spp.)

Tanks and raceways: Salmon & trout
Above 50°F: up to 170 µl/L; up to 1 hr
Below 50°F: up to 250 µl/L; up to 1 hr
Catfish, bluegill, largemouth bass up to 250 µl/L; up to 1 hr
Earthern ponds: 15 to 25 µl/L; indefinitely

--Drug must not be subjected to temperature below 40° F --Do not apply to ponds when water is warmer than 80° F, 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 --Do not treat ponds containing striped bass.

 

Select finfish eggs: salmon, trout, esocid

Control fungi of the family Saprolegniaceae

Select finfish eggs: 1000-2000 ppm for

Preliminary bioassay should be conducted to determine

Formalin (Parasite-S® by Western Chemical,

All finfish

Control protozoa (Chilodonella, Costia, Epistylis, Ichthyophthirius, Scyphidia, Trichodina spp.) and monogenetic trematodes (Cleidodiscus, Dactylogyrus, Gyrodactylus spp.)

Tanks and raceways: Salmon & trout
Above 50°F: up to 170 µl/L; up to 1 hr
Below 50°F: up to 250 µl/L; up to 1 hr
All other finfish up to --250 µl/L; up to 1 hr
Earthern ponds: 15 to 25 µl/L; indefinitely

--Drug must not be subjected to temperature below 40° F
--Do not apply to ponds when water is warmer than 80° F, 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
--Do not treat ponds containing striped bass

 

All finfish eggs

Control fungi of the family Saprolegniaceae

All finfish eggs:
1000-2000 ppm for 15 min.; Acipenseriformes up to 1500 ppm for 15 min.

Preliminary bioassay should be conducted to determine species sensitivity

 

Penaeid shrimp

Control protozoan parasites (Bodo, Epistylis and Zoothamnium spp.)

 

Tanks and raceways:
50 to 100 µl/L, up to and 4 hours daily;
Earthern ponds:
25 µl/L; single treatment

--Drug must not be subjected to
temperature below 40° F
--Do not apply to ponds when water is warmer than 80° F,
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 (by Roche Vitamins, Inc.)

Rainbow, brook, and brown trout

Control furunculosis

--10 g/100 lb/day for up to 14 days

--In feed
--21 day withdrawal 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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