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(v) For control of fungi of the family Saprolegniaceae on all 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.
(3) Limitations. Fish tanks and raceways may be treated daily until parasite control is achieved. Pond treatment may be repeated in 5 to 10 days if needed. However, pond treatments for Ichthyophthirius should be made at 2-day intervals until control is achieved. Egg tanks may be treated as often as necessary to prevent growth of fungi. Do not use formalin which has been subjected to temperatures below 40 °F, or allowed to freeze. Do not treat ponds containing striped bass. Treatments in tanks should never exceed 1 hour even if fish show no signs of stress. Do not apply formalin to ponds with water warmer than 27 °C (80 °F), when a heavy bloom of phytoplankton is present, or when the concentration of dissolved oxygen is less than 5 milligrams per liter.
[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]
§ 529.1044 Gentamicin sulfate in certain other dosage forms.
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§ 529.1044a Gentamicin sulfate intrauterine solution.
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(a) Specifications. Each milliliter of the drug contains 50 or 100 milligrams of gentamicin (as the sulfate) in sterile aqueous solution.
(b) Sponsor. See Nos. 000010, 000061, 000856, 057561, 059130, and 061623 in §510.600(c) of this chapter.
(c) Conditions of use. (1) The drug is indicated for use for control of bacterial infections of the uterus in horses (metritis) and as an aid in improving conception in mares with uterine infections caused by bacteria sensitive to gentamicin.
(2) It is administered at a dosage level of 2 to 2.5 grams per day for 3 to 5 days during estrus, each dose being diluted with 200 to 500 milliliters of sterile physiological saline before aseptic infusion into the uterus.
(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(4) Not for use in horses intended for food.
[40 FR 13881, Mar. 27, 1975, as amended at 40 FR 48676, Oct. 17, 1975; 48 FR 31386, July 8, 1983; 52 FR 7833, Mar. 13, 1987; 58 FR 14314, Mar. 17, 1993; 59 FR 31140, June 17, 1994; 60 FR 45042, Aug. 30, 1995; 60 FR 48894, Sept. 21, 1995; 61 FR 17830, Apr. 23, 1996; 62 FR 611, Jan. 6, 1997; 62 FR 35077, June 30, 1997; 63 FR 6644, Feb. 10, 1998; 68 FR 59881, Oct. 20, 2003]
§ 529.1044b Gentamicin sulfate solution.
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(a) Specifications. Each milliliter of solution contains gentamicin sulfate equivalent to 50 milligrams of gentamicin base.
(b) Sponsors. See Nos. 000061 and 054925 in §510.600(c) of this chapter.
(c) Conditions of use. (1) The drug is recommended as an aid in the reduction or elimination of the following microorganisms from turkey-hatching eggs: Arizona hinshawii (paracolon), Salmonella st. paul, and Mycoplasma meleagridis.
(2) The drug is added to clean water to provide a dip solution with a gentamicin concentration of 250 to 1,000 parts per million. A concentration of 500 parts per million is recommended. Clean eggs should be held submerged in the gentamicin solution under a vacuum of about 27.5 to 38 centimeters of mercury for 5 minutes followed by additional soaking in gentamicin solution for approximately 10 minutes at atmospheric pressure. Eggs can also be treated by warming them for 3 to 6 hours at approximately 100 °F. then immediately submerging them in gentamicin solution maintained at about 40 °F., keeping the eggs submerged for 10 to 15 minutes.
(3) For use in the dipping treatment of turkey-hatching eggs only. Eggs which have been dipped in the drug shall not be used for food.
[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]
§ 529.1115 Halothane.
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(a) Specifications. The drug is a colorless, odorless, nonflammable, nonexplosive, heavy liquid containing 0.01 percent thymol as a preservative.
(b) Sponsor. See 000856 and 012164 in §510.600(c) of this chapter.
(c) Conditions of use—(1) Amount. Two to 5 percent of inhaled atmosphere for induction of anesthesia; 0.5 to 2 percent for maintenance of anesthesia.1
1 These conditions have been reviewed by FDA and found effective. NADA's for similar products for these conditions of use need not include effectiveness data as specified by §514.111 of this chapter, but may require bioequivalency and safety information.
(2) Indications for use. For nonfood animals for the induction and maintenance of anesthesia.1
(3) Limitations. Administered by inhalation. May be administered with either oxygen or a mixture of oxygen and nitrous oxide. Place drug vaporizer between the gas supply and breathing bag to prevent overdosage. Not recommended for obstetrical anesthesia except when uterine relaxation is required. Do not use in pregnant animals; information on possible adverse effects on fetal development is not available. Operating rooms should have adequate ventilation to prevent accumulation of anesthetic gases. Not for use in animals intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian.1
[46 FR 27915, May 22, 1981, as amended at 62 FR 29014, May 29, 1997]
§ 529.1186 Isoflurane.
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(a) Specifications. The drug is a clear, colorless, stable liquid.
(b) Sponsors. See Nos. 000074, 000209, 010019, 012164, 060307, and 066112 in §510.600(c) of this chapter.
(c) Conditions of use. Administer by inhalation:
(1) Amount—(i) Horses: For induction of surgical anesthesia: 3 to 5 percent isoflurane (with oxygen) for 5 to 10 minutes. For maintenance of surgical anesthesia: 1.5 to 1.8 percent isoflurane (with oxygen).
(ii) Dogs: For induction of surgical anesthesia: 2 to 2.5 percent isoflurane (with oxygen) for 5 to 10 minutes. For maintenance of surgical anesthesia: 1.5 to 1.8 percent isoflurane (with oxygen).
(2) Indications for use. For induction and maintenance of general anesthesia in horses and dogs.
(3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[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]
§ 529.1660 Oxytetracycline.
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(a) Specifications—(1) Each gram of powder contains 366 milligrams (mg) oxytetracycline hydrochloride.
(2) Each gram of powder contains 753 mg oxytetracycline hydrochloride.
(b) Sponsors. See sponsors in §510.600(c) of this chapter for use of products described in paragraph (a) of this section as in paragraph (d) of this section.
(1) No. 046573 for use of product described in paragraph (a)(1) of this section.
(2) Nos. 000069 and 059130 for use of product described in paragraph (a)(2) of this section.
(c) Related tolerances. See §556.500 of this chapter.
(d) Conditions of use in finfish—(1) Amount. Immerse fish in a solution containing 200 to 700 mg oxytetracycline hydrochloride (buffered) per liter of water for 2 to 6 hours.
(2) Indications for use. For skeletal marking of finfish fry and fingerlings.
[69 FR 6557, Feb. 11, 2004, as amended at 69 FR 61999, Oct. 22, 2004; 70 FR 41140, July 18, 2005]
§ 529.1940 Progesterone intravaginal inserts.
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(a) Specifications. Each insert contains 1.38 grams of progesterone in molded silicone over a nylon spine.
(b) Sponsor. See No. 000009 in §510.600(c) of this chapter.
(c) Related tolerances. See §556.540(a) of this chapter.
(d) Special considerations. (1) Product labeling shall bear the following warnings: “Avoid contact with skin by wearing latex gloves when handling inserts. Store removed inserts in a plastic bag or other sealable container until they can be disposed of in accordance with applicable local, State, and Federal regulations.”
(2) This product is approved with the concurrent use of dinoprost solution on day 6 of the 7-day administration period when used for indications listed in paragraph (e)(2)(i) of this section. See §522.690(c) of this chapter.
(e) Conditions of use—(1) Amount. Administer one intravaginal insert per animal for 7 days. When used for indications listed in paragraph (e)(2)(i) of this section, administer 25 milligrams (mg) dinoprost (5 milliliters (mL) of 5 mg/mL solution as in §522.690(a) of this chapter) as a single intramuscular injection one day prior to insert removal.
(2) Indications for use—(i) For synchronization of estrus in suckled beef cows and replacement beef and dairy heifers, for advancement of first postpartum estrus in suckled beef cows, and for advancement of first pubertal estrus in replacement beef heifers.
(ii) For synchronization of the return to estrus in lactating dairy cows inseminated at the immediately preceding estrus.
(3) Limitations. Do not use in animals with abnormal, immature, or infected genital tracts; or in beef cows that are fewer than 20 days postpartum; or in beef or dairy heifers of insufficient size or age for breeding. Do not use an insert more than once. To prevent the potential transmission of venereal and bloodborne diseases, the inserts should be disposed after a single use. Administration of vaginal inserts for periods greater than 7 days may result in reduced fertility. Dinoprost solution as provided by No. 000009 in §510.600(c) of this chapter.
[67 FR 41824, June 20, 2002, as amended at 67 FR 51080, Aug. 7, 2002; 68 FR 57613, Oct. 6, 2003]
§ 529.2150 Sevoflurane.
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(a) Specifications. The drug is a clear, colorless, stable liquid containing no additives or chemical stabilizers.
(b) Sponsor. See No. 000074 in §510.600(c) of this chapter.
(c) Conditions of use—(1) Amount. For induction of surgical anesthesia: 5 to 7 percent sevoflurane with oxygen. For maintenance of surgical anesthesia: 3.7 to 4 percent sevoflurane with oxygen in the absence of premedication and 3.3 to 3.6 percent in the presence of premedication.
(2) Indications for use. For induction and maintenance of general anesthesia in dogs.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[64 FR 71640, Dec. 22, 1999]
§ 529.2464 Ticarcillin powder.
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(a) Specifications. Each vial contains ticarcillin disodium equivalent to 6 grams of ticarcillin to be reconstituted with 25 milliliters of sterile water for injection or sterile physiological saline.
(b) Sponsor. See No. 000069 in §510.600(c) of this chapter.
(c) Conditions of use—(1) Amount. 6 grams per day, intrauterine, for 3 consecutive days during estrus.
(2) Indications for use. Horses. Intrauterine treatment of endometritis caused by beta-hemolytic streptococci.
(3) Limitations. For intrauterine use in horses only. Infuse aseptically. Not for use in horses raised for food production. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[57 FR 37336, Aug. 18, 1992, as amended at 60 FR 55660, Nov. 2, 1995]
§ 529.2503 Tricaine methanesulfonate.
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(a) Chemical name. Ethyl-m-amino-benzoate methanesulfonate.
(b) Sponsor. See Nos. 050378 and 051212 in §510.600(c) of this chapter.
(c) Conditions of use. (1) It is used for the temporary immobilization of fish, amphibians, and other aquatic coldblooded animals (poikilotherms) as an aid in handling during manual spawning (fish stripping), weighing, measuring, marking, surgical operations, transport, photography, and research.
(2) It is used as follows:
(i) For fish the drug is added to ambient water at a concentration of from 15 to 330 milligrams per liter depending upon the degree of anesthetization or sedation desired, the species and size of the fish, and the temperature and softness of the water. Preliminary tests of solutions must be made with small numbers of fish to determine the desired rates of sedation or anesthesia and the appropriate exposure times for the specific lots of fish under prevailing conditions.
(ii) For amphibians and other aquatic coldblooded animals, the drug is added to ambient water in concentrations of from 1:1000 to 1:20,000 depending upon species and stage of development.
(iii) Do not use within 21 days of harvesting fish for food. Use in fish intended for food should be restricted to Ictaluridae, Salmonidae, Esocidae, and Percidae, and water temperature should exceed 10 °C. (50 °F.). In other fish and in cold-blooded animals, the drug should be limited to hatchery or laboratory use.
[40 FR 13881, Mar. 27, 1975, as amended at 49 FR 5748, Feb. 15, 1984; 51 FR 11439, Apr. 3, 1986; 63 FR 7702, Feb. 17, 1998]
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