PART 529—CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS Authority: 21 U.S.C. 360b. Source: 40 FR 13881, Mar. 27, 1975, unless otherwise noted. § 529.56 Amikacin. (a) Specifications. (b) Sponsors. (c) Conditions of use in horses Amount. (2) Indications for use. Escherichia coli, Pseudomonas Klebsiella (3) Limitations. [76 FR 17339, Mar. 29, 2011, as amended at 78 FR 17597, Mar. 22, 2013; 79 FR 10973, Feb. 27, 2014; 86 FR 14821, Mar. 19, 2021] § 529.382 Chloramine-T. (a) Specifications. (b) Sponsor. (c) Related tolerances. (d) Conditions of use Freshwater-reared salmonids Amount. (ii) Indications for use. Flavobacterium (2) Walleye Amount. (ii) Indications for use. Flavobacterium columnare. (3) Freshwater-reared warmwater finfish Amount. (ii) Indications for use. F. columnare. [79 FR 37621, July 2, 2014] § 529.400 Chlorhexidine tablets and suspension. (a) Specification. (b) Sponsor. (c) Related tolerances. (d) Conditions of use Amount. (2) Indications for use. (3) Limitations. [43 FR 10705, Feb. 23, 1979, as amended at 79 FR 10973, Feb. 27, 2014; 81 FR 67152, Sept. 30, 2016; 84 FR 32993, July 11, 2019] § 529.443 Ciclesonide. (a) Specifications. (b) Sponsor. (c) Conditions of use Amount. (2) Indications for use. (3) Limitations. [86 FR 13188, Mar. 8, 2021] § 529.536 Detomidine. (a) Specifications. (b) Sponsor. (c) Conditions of use in horses Amount. (2) Indications for use. (3) Limitations. [75 FR 21163, Apr. 23, 2010, as amended at 76 FR 16533, Mar. 24, 2011] § 529.539 Dexmedetomidine. (a) Specifications. (b) Sponsor. (c) Conditions of use Amount. (2) Indications for use. (3) Limitations. [81 FR 17608, Mar. 30, 2016] § 529.778 Doxycycline. (a) Specifications. (b) Sponsor. (c) Conditions of use in dogs Amount. (2) Indications for use. (3) Limitations. [79 FR 10973, Feb. 27, 2014] § 529.1004 Formalin. (a) Specifications. (b) Sponsors. (1) No. 050378 for use as in paragraph (d) of this section. (2) Nos. 049968 and 067188 for use as in paragraphs (d)(1)(i), (ii), and (iii), (d)(2)(i), (ii), and (iii), and (d)(3) of this section. (c) [Reserved] (d) Conditions of use. (1) Indications for use Penaeid shrimp. Bodo Epistylis Zoothamnium (ii) All finfish. Ichthyophthirius Chilodonella Ichthyobodo Ambiphrya Epistylis Trichodina Cleidodiscus Gyrodactylus Dactylogyrus (iii) All finfish eggs: For control of fungi of the family Saprolegniaceae. (iv) Freshwater-reared finfish. (2) Amount. (i) For control of external protozoan parasites on shrimp: Shrimp Concentration of formalin (microliters per liter) Tanks and raceways (up to 4 hours daily) Earthen ponds (single treatment) Penaeid Shrimp 50 to 100 1 25 2 1 2 (ii) For control of external parasites on finfish: Aquatic species Administer in tanks and raceways for up to 1 hour (microliter/liter or part per million (µL/L or ppm)) Administer in earthen ponds single treatment (µL/L or ppm) Salmon and trout: Above 50 °F Up to 170 15 to 25 1 2 Below 50 °F Up to 250 15 to 25 1 2 All other finfish Up to 250 15 to 25 1 2 1 2 (iii) For control of fungi of the family Saprolegniaceae on finfish eggs: Eggs of all finfish except Acipenseriformes, 1,000 to 2,000 µL/L (ppm) for 15 minutes; eggs of Acipenseriformes, up to 1,500 µL/L (ppm) for 15 minutes. A preliminary bioassay should be conducted on a small subsample of fish eggs to determine sensitivity before treating an entire group. This is necessary for all species because egg sensitivity can vary with species or strain and the unique conditions at each facility. (iv) For the control of mortality in freshwater-reared finfish due to saprolegniasis associated with fungi in the family Saprolegniaceae: In tanks and raceways, administer 150 µL/L (ppm) for 60 minutes per day on alternate days for three treatments. (3) Limitations. Ichthyophthirius [51 FR 11441, Apr. 3, 1986, as amended at 58 FR 59169, Nov. 8, 1993; 59 FR 60076, Nov. 22, 1994; 63 FR 38304, July 16, 1998; 68 FR 5563; Feb. 4, 2003; 72 FR 45158, Aug. 13, 2007; 76 FR 17339, Mar. 29, 2011; 79 FR 2786, Jan. 16, 2014; 82 FR 58556, Dec. 13, 2017; 84 FR 53311, Oct. 7, 2019. Redesignated at 87 FR 10970, Feb. 28, 2022; 89 FR 85428, Oct. 28, 2024] § 529.1044 Gentamicin in certain other dosage forms. § 529.1044a Gentamicin solution for infusion. (a) Specifications. (b) Sponsors. (c) Conditions of use in horses Amount. (2) Indications for use. (3) Limitations. [71 FR 51727, Aug. 31, 2006, as amended at 78 FR 17597, Mar. 22, 2013; 78 FR 21060, Apr. 9, 2013; 79 FR 10973, Feb. 27, 2014; 83 FR 48947, Sept. 28, 2018; 84 FR 8974, Mar. 13, 2019; 86 FR 14821, Mar. 19, 2021; 88 FR 55567, Aug. 16, 2023] § 529.1044b Gentamicin solution for dipping eggs. (a) Specifications. (b) Sponsors. (c) Conditions of use in turkeys Amount. (2) Indications for use. Arizona hinshawii paracolon Salmonella Mycoplasma meleagridis. (3) Limitations. [40 FR 13881, Mar. 27, 1975, as amended at 52 FR 7833, Mar. 13, 1987; 62 FR 22889, Apr. 28, 1997; 71 FR 13543, Mar. 16, 2006; 79 FR 10973, Feb. 27, 2014; 88 FR 16549, Mar. 20, 2023; 88 FR 55567, Aug. 16, 2023] § 529.1115 Halothane. (a) Specifications. (b) Sponsor. (c) Conditions of use Amount. (2) Indications for use. (3) Limitations. [46 FR 27915, May 22, 1981, as amended at 62 FR 29014, May 29, 1997; 79 FR 10973, Feb. 27, 2014; 85 FR 4208, Jan. 24, 2020] § 529.1150 Hydrogen peroxide. (a) Specifications. (b) Sponsor. (c) Conditions of use Indications and amount. (A) For all coldwater and coolwater species of freshwater-reared finfish eggs: 500 to 1,000 mg per liter (/L) of culture water for 15 minutes in a continuous flow system once per day on consecutive or alternate days until hatch, or (B) For all freshwater-reared warmwater finfish eggs: 750 to 1,000 mg/L for 15 minutes in a continuous flow system once per day on consecutive or alternate days until hatch. (ii) Freshwater-reared finfish for the control of mortality due to saprolegniasis associated with the fungi in the family Saprolegniaceae: For freshwater-reared coldwater finfish including salmonids (all life stages), freshwater-reared coolwater finfish fingerlings and adults, and freshwater-reared warmwater finfish fingerlings and adults: 75 mg/L for 60 minutes in continuous flow water supply or as a static bath once per day on alternate days for three treatments. (iii) Freshwater-reared salmonids for the control of mortality due to bacterial gill disease associated with Flavobacterium branchiophilum: (iv) Freshwater-reared salmonids for the treatment and control of Gyrodactylus (v) Freshwater-reared coolwater and warmwater finfish fingerlings and adults for the control of mortality due to external columnaris disease associated with Flavobacterium columnare: (vi) Freshwater-reared coolwater finfish fry and warmwater finfish fry for the control of mortality due to external columnaris disease associated with Flavobacterium columnare: (2) Limitations. (ii) Eggs: Some strains of rainbow trout eggs are sensitive to hydrogen peroxide treatment at a time during incubation concurrent with blastopore formation through closure, about 70 to 140 Daily Temperature Units, °C. Consider withholding treatment or using an alternate therapeutant during that sensitive time to reduce egg mortalities due to drug toxicity. (iii) Finfish: Because finfish sensitivity to 35% PEROX-AID® increases with increasing water temperature, consider administering initial treatments at the lower end of the treatment regimen or reducing water temperature before treatment. Do not use this product to treat northern pike ( Esox lucius Polyodon spathula Sander vitreus (iv) Preharvest withdrawal time: Zero days. [72 FR 5330, Feb. 6, 2007, as amended at 78 FR 73698, Dec. 9, 2013; 85 FR 4208, Jan. 24, 2020; 89 FR 85428, Oct. 28, 2024] § 529.1186 Isoflurane. (a) Specifications. (b) Sponsors. (c) Conditions of use. (1) Amount Horses: (ii) Dogs: (2) Indications for use. (3) Limitations. [51 FR 594, Jan. 7, 1986, as amended at 54 FR 23472, June 1, 1989; 58 FR 17346, Apr. 2, 1993; 59 FR 44315, Aug. 29, 1994; 60 FR 40456, Aug. 9, 1995; 63 FR 8122, Feb. 18, 1998; 63 FR 24106, May 1, 1998; 66 FR 17510, Apr. 2, 2001; 71 FR 43967, Aug. 3, 2006; 74 FR 68530, Dec. 28, 2009; 76 FR 16533, Mar. 24, 2011; 78 FR 14669, Mar. 7, 2013; 78 FR 17868, Mar. 25, 2013; 80 FR 18776, Apr. 8, 2015; 87 FR 58963, Sept. 29, 2022; 89 FR 14411, Feb. 27, 2024; 89 FR 42360, May 15, 2024; 91 FR 41561, July 7, 2026] § 529.1350 Meloxicam. (a) Specifications. (b) Sponsor. (c) Conditions of use in dogs Amount. (2) Indications for use. (3) Limitations. [77 FR 76863, Dec. 31, 2012, as amended at 80 FR 18776, Apr. 8, 2015] § 529.1660 Oxytetracycline. (a) Specifications. (2) Each gram of powder contains 753 mg oxytetracycline hydrochloride. (b) Sponsors. (1) Nos. 054771 and 061133 for use of product in paragraph (a)(1) of this section. (2) Nos. 054771, 061133, and 069254 for use of product described in paragraph (a)(2) of this section. (c) Related tolerances. See (d) Conditions of use in finfish Amount. (2) Indications for use. (3) Limitations. [69 FR 6557, Feb. 11, 2004, as amended at 69 FR 61999, Oct. 22, 2004; 70 FR 41140, July 18, 2005; 72 FR 26289, May 9, 2007; 76 FR 17026, Mar. 28, 2011; 79 FR 10973, Feb. 27, 2014; 81 FR 22524, Apr. 18, 2016; 81 FR 94991, Dec. 27, 2016; 84 FR 8974, Mar. 13, 2019] § 529.1940 Progesterone intravaginal inserts. (a) Specifications. (1) 1.38 grams (g) progesterone in molded silicone over a nylon spine. (2) 0.3 g progesterone in molded silicone over a flexible nylon spine. (b) Sponsor. (c) Related tolerances. (d) Special considerations. (e) Conditions of use Cows Amount. (ii) Indications for use. (B) For synchronization of estrus in lactating dairy cows. (C) For synchronization of the return to estrus in lactating dairy cows inseminated at the immediately preceding estrus. (D) For induction of estrous cycles in anestrous lactating dairy cows. (iii) Limitations. (2) Ewes Amount. (ii) Indications for use. (iii) Limitations. [74 FR 59074, Nov. 17, 2009, as amended at 75 FR 63085, Oct. 14, 2010; 79 FR 10965, 10974, Feb. 27, 2014; 79 FR 44278, July 31, 2014; 87 FR 10970, Feb. 28, 2022; 87 FR 17947, Mar. 29, 2022] § 529.2110 Sevoflurane. (a) Specifications. (b) Sponsors. (c) Conditions of use Amount. (2) Indications for use. (3) Limitations. [64 FR 71640, Dec. 22, 1999, as amended at 73 FR 25508, May 7, 2008; 74 FR 10484, Mar. 11, 2009, 75 FR 1021, Jan. 8, 2010; 76 FR 16533, Mar. 24, 2011; 78 FR 17868, Mar. 25, 2013; 80 FR 18776, Apr. 8, 2015. Redesignated at 86 FR 13188, Mar. 8, 2021, as amended at 87 FR 58963, Sept. 29, 2022; 89 FR 42360, May 15, 2024; 91 FR 41561, July 7, 2026] § 529.2464 Ticarcillin. (a) Specifications. (b) Sponsor. (c) Conditions of use in horses Amount. (2) Indications for use. (3) Limitations. [79 FR 10974, Feb. 27, 2014] § 529.2503 Tricaine methanesulfonate. (a) Specifications. m (b) Sponsor. (c) Conditions of use Amount. (i) Fish. (ii) Amphibians and other aquatic coldblooded animals. (2) Indications for use. (3) Limitations. [79 FR 10974, Feb. 27, 2014] § 529.2620 Triptorelin. (a) Specifications. (b) Sponsor. (c) Conditions of use in swine Amount. (2) Indications for use. (3) Limitations. [77 FR 64717, Oct. 23, 2012, as amended at 90 FR 6801, Jan. 21, 2025]