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June 2021 Appendix 11: Approved Animal Drugs for Aqua

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June 2021 Appendix 11: Approved Animal Drugs for Aqua APPENDIX 11: APPROVED ANIMAL DRUGS FOR AQUACULTURE USE This guidance represents the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the telephone number listed on the title page of this guidance. APPROVED ANIMAL DRUGS FOR AQUACULTURE Species/Class: Freshwater-reared salmonids, walleye, and freshwater-reared warmwater Animal Drugs for aquacultured food fish must meet finfish human food safety standards assessed during the approval process. When a fish producer (farmer) Indication for Use (21 CFR 529.382): or hatchery manager uses an approved drug for food fish as directed on the label, the treated fish • For the control of mortality in freshwater- are safe to eat. reared salmonids due to bacterial gill disease associated with Flavobacterium spp. The FDA-approved animal drugs for use in • For the control of mortality in walleye due aquaculture, with information on their approved to external columnaris disease associated sponsor/supplier, species for which the approval with Flavobacterium columnare. has been granted, required withdrawal periods, • For the control of mortality in freshwater- and other conditions are listed below. Additional reared warmwater finfish due to external details on provisions of use (e.g., administration columnaris disease associated with route, dosage level) can be obtained from Flavobacterium columnare. the Code of Federal Regulations (CFR) as cited below; the labeling for the drug; and the FDA Conditions of use: CVM Website, (the Animal Drugs @ FDA database: Marketing Status: This drug is approved as https://animaldrugsatfda.fda.gov/). an Over-the-Counter (OTC) product, and a FDA’s determination that these veterinary products prescription is not required for uses consistent are approved aquaculture drugs does not exempt with the product label instructions. facilities from complying with other federal, Extra-label use: A prescription from a licensed state, tribal, territorial, and local environmental veterinarian is required to prescribe an extra- requirements. For example, in the United States, label use of Halamid® Aqua to treat diseases facilities using these substances would still be or species not listed on the product label required to comply with the National Pollutant (21 CFR 529.382). Discharge Elimination System requirements. • Route of Administration: Immersion Mandatory withdrawal time before harvest: Not established Chloramine-T powder o Tolerance Level: The tolerance for para- Proprietary Name: HALAMID® AQUA (NADA toluenesulfonamide (marker residue) is 141-423) 0.90 ppm (900 ppb) in fish muscle/skin (21CFR556.118). Active Ingredient: Chloramine-T trihydrate Supplier: Axcentive SARL, France Appendix 11: Approved Animal Drugs for Aquaculture Use A11 - 1 (June 2021) o Formalin o Hydrogen peroxide ® Proprietary Name: Supplier: Proprietary Name: 35% PEROX-AID (NADA 141-255) Formalin-F (NADA 137-687) Natchez Animal Supply Co., USA Active Ingredient: Hydrogen peroxide Formacide-B (ANADA 200- B.L. Mitchell, Inc., USA 414) Supplier: Syndel USA, USA ® Parasite-S (NADA 140-989) Syndel USA, USA Species/Class: Freshwater-reared adult finfish, fingerlings and eggs Active Ingredient: Formalin: approximately 37% by weight of formaldehyde gas Indication for Use (21 CFR 529.1150): Species/Class: All finfish and penaeid shrimp- • For the control of mortality in freshwater- as a parasiticide, and the eggs of all finfish and reared salmonids due to bacterial gill freshwater-reared finfish as a fungicide. disease associated with Flavobacteriurn branchiophilum, Indication for Use (21 CFR 529.1030): • for the control of mortality in freshwater- Added to the environmental water as follows: reared warmwater and coolwater finfish and channel catfish due to external colurnnaris • All finfish-for the control of external protozoa disease (Flexibacler columnaris) associated (Chilodonella spp., Costia spp., Epistylis with Flavobacterium columnare. spp., Ichthyophthirius spp. Scyphidia spp. • For the control of mortality in freshwater- and Trichodina spp.) and the monogenetic reared finfish eggs due to saprolegniasis trematode parasites (Cleidodiscus spp., associated with fungi in the family Dactylogyrus spp., and Gyrodactylus spp.); Saprolegniaceae, • All finfish eggs- for the control of fungi of • For the control of mortality in freshwater- the family Saprolegniaceae; reared warmwater and coldwater fingerling • Penaeid shrimp- for the control of protozoan and adult finfish due to saprolegniasis parasites (Bodo spp., Epistylis spp., and associated with fungi in the family Zoothamnium spp.); and Saprolegniaceae, and • Freshwater-reared finfish-for control of • For the treatment and control of mortality mortality due to saprolegniasis associated in freshwater-reared salmonids associated with fungi in the family Saprolegniaceae. with Gyrodactylus spp. Conditions of use: Conditions of use: Marketing Status: This drug is approved as Marketing Status: This drug is approved as an Over-the-Counter (OTC) product, and a an Over-the-Counter (OTC) product, and a prescription is not required for uses consistent prescription is not required for uses consistent with the product label instructions. with the product label instructions. Extra-label use: A prescription from a licensed Extra-label use: A prescription from a licensed veterinarian is required to prescribe an extra- veterinarian is required to prescribe an extra- label use of Formalin-F and Parasite-S® to label use of 35% PEROX AID® to treat diseases treat diseases or species not listed on the or species not listed on the product label product label (21 CFR 529.1030). (21 CFR 529.1150). Mandatory withdrawal time before harvest: Mandatory withdrawal time before harvest: Not established Not established Tolerance Level: Not established (formalin Tolerance Level: Not established does not bioaccumulate in animal tissue) Appendix 11: Approved Animal Drugs for Aquaculture Use A11 - 2 (June 2021) o Oxytetracycline hydrochloride Esocidae, and Percidae. In other fish, the drug should be limited to hatchery or laboratory use Proprietary Name: Supplier: (21 CFR 529.2503). ® Tetroxy 343 Bimeda Animal Health Indication for Use (21 CFR 529.2503): (ANADA200-247) Limited, Ireland Tetroxy® Aquatic Bimeda Animal Health • For the temporary immobilization of fish, (ANADA200-460) Limited, Ireland amphibians, and other aquatic, cold-blooded animals. Tricaine methanesulfonate is used Pennox 343® Pharmgate Inc., USA as an aid in the handling of these animals (ANADA200-026) during manual spawning (fish stripping), TERRAMYCIN-343®, Zoetis Inc., USA weighing, measuring, marking, surgical TERRAMYCIN®, operations, and transport. TERRAMYCIN® Soluble Powder Concentrate (NADA Conditions of use: 008-622) Marketing Status: This drug is approved as OXYMarine™, Oxytet® Huvepharma EOOD, an Over-the-Counter (OTC) product, and a Soluble (ANADA 130-435) Bulgaria prescription is not required. Active Ingredient: Oxytetracycline hydro- Mandatory withdrawal time before harvest: chloride 21 days of harvesting fish for food. Species/Class: Finfish/fry and fingerling Tolerance Level: Not established Indication for Use (21 CFR 529.1660): • Route of Administration: Injectable • To provide a new indication for the marking of skeletal tissues in finfish fry o Chorionic gonadotropin and fingerlings as an aid in identification. Proprietary Name: Chorulon® (NADA 140- 927) Conditions of use: Active Ingredient: Chorionic gonadotropin Marketing Status: Federal law restricts this drug to use by or on the order of a licensed Supplier: Intervet Inc., USA veterinarian (21 CFR 529.1660) Species/Class: Finfish Mandatory withdrawal time before harvest: None. Indication for Use (21 CFR 522.1081): Tolerance Level: The tolerance level of 2 For the use as an aid in improving spawning ppm has been established for the sum of function in male and female brood finfish. eTh tetracycline residues (including oxytetracycline, drug may be administered by intramuscular chlortetracycline, and tetracycline) in finfish injection. The total dose should not exceed muscle tissue and lobster (21 CFR 556.500). 25,000 I.U. chorionic gonadotropin in fish intended for human consumption. o Tricaine methanesulfonate (MS-222) Conditions of use: Proprietary Name: Tricaine-S (ANADA 200- 226) Marketing Status: This drug is a prescription (Rx) product and the Federal (USA) law restricts Active Ingredient: Tricaine methanesulfonate this drug to use by or on the order of a licensed veterinarian (21 CFR 522.1081). Supplier: Syndel USA, USA Mandatory withdrawal time before harvest: Species/Class: For fish intended for human Not established. consumption, the use of drug is restricted to the following families: Ictaluridae, Salmonidae, Appendix 11: Approved Animal Drugs for Aquaculture Use A11 - 3 (June 2021) Tolerance Level: Not established (21 CFR Mandatory withdrawal time before harvest: 556.304). Feeds containing florfenicol must be withdrawn 15 days prior to slaughter (21 CFR 558.261). • Route of Administration: Medicated Articles/ Feeds Tolerance Level: The tolerance for florfenicol amine (the marker residue) in the target tissue o Florfenicol (muscle
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