344 Part 529—Certain Other Dos- Age Form New Animal
§ 529.50 21 CFR Ch. I (4-1-96 Edition)
(3) Limitations. Milk taken from ani- caused by susceptible organisms in- mals during treatment and for 36 hours cluding E. coli, Pseudomonas spp., and (three milkings) following the last Klebsiella ssp. treatment must not be used for food. (3) Limitations. For intrauterine infu- Treated animals must not be slaugh- sion in the horse only. Not for use in tered for food use for 28 days following horses intended for food. Federal law the last treatment. Cows with systemic restricts this drug to use by or on the clinical signs caused by mastitis should order of a licensed veterinarian. receive other appropriate therapy [48 FR 9640, Mar. 8, 1983, as amended at 53 FR under the direction of a licensed veteri- 27852, July 25, 1988] narian. Federal law restricts this drug to use by or on the order of a licensed § 529.360 Cephalothin discs. veterinarian. (a) Specifications. Cephalothin discs, [58 FR 58486, Nov. 2, 1993] comply with the requirements of § 460.1 of this chapter. PART 529—CERTAIN OTHER DOS- (b) Sponsor. See No. 000986 in AGE FORM NEW ANIMAL DRUGS § 510.600(c) of this chapter. (c) Conditions of use. (1) The discs are Sec. used for determining the in vitro sus- 529.50 Amikacin sulfate intrauterine solu- ceptibility of bacteria to cephaloridine tion. and cephalonium. 529.360 Cephalothin discs. (2) For veterinary laboratory diag- 529.365 Cephapirin sodium for nosis only. intramammary infusion. 529.400 Chlorhexidine tablets and suspen- § 529.365 Cephapirin sodium for sion. intramammary infusion. 529.810 Enflurane. 529.1003 Flurogestone acetate-impregnated (a) Specifications. Each 10-milliliter vaginal sponge. dose contains 200 milligrams of 529.1030 Formalin solution. cephapirin sodium activity in a peanut- 529.1044 Gentamicin sulfate in certain other oil gel. dosage forms. (b) Sponsor. See No. 000856 in 529.1044a Gentamicin sulfate intrauterine § 510.600(c) of this chapter. solution. (c) Related tolerances. See § 556.115 of 529.1044b Gentamicin sulfate solution. this chapter. 529.1115 Halothane. 529.1186 Isoflurane. (d) Conditions of use. (1) The drug is 529.1526 Nifurpirinol capsules. used for the treatment of lactating 529.2090 Salicylic acid. cows having bovine mastitis caused by 529.2464 Ticarcillin powder. susceptible strains of Streptococcus 529.2503 Tricaine methanesulfonate. agalactiae and Staphylococcus aureus. AUTHORITY: Sec. 512 of the Federal Food, (2) Administer one dose into each in- Drug, and Cosmetic Act (21 U.S.C. 360b). fected quarter immediately after the quarter has been completely milked SOURCE: 40 FR 13881, Mar. 27, 1975, unless otherwise noted. out. Do not milk out for 12 hours. Re- peat once only in 12 hours. If improve- § 529.50 Amikacin sulfate intrauterine ment is not noted within 48 hours after solution. treatment, consult your veterinarian. (a) Specifications. Each milliliter of (3) Milk that has been taken from sterile aqueous solution contains 250 animals during treatment and for 96 milligrams of amikacin (as the sul- hours (8 milkings) after the last treat- fate). ment must not be used for food. Treat- (b) Sponsor. See No. 000856 in ed animals must not be slaughtered for § 510.600(c) of this chapter. food until 4 days after the last treat- (c) Conditions of use—(1) Amount. Two ment. grams (8 milliliters) diluted with 200 [40 FR 57455, Dec. 10, 1975, as amended at 53 milliliters of sterile physiological sa- FR 27852, July 25, 1988] line per day for 3 consecutive days. (2) Indications for use. For treating genital tract infections (endometritis, metritis, and pyometra) in mares when
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§ 529.400 Chlorhexidine tablets and muscle relaxants with enflurane; not suspension. for use in horses intended for food; ob- (a) Specification. Each tablet and each serve all customary precautions for use 28-milliliter syringe of suspension con- of vascoconstrictor substances; Federal tain 1 gram of chlorhexidine law restricts this drug to use by or on dihydrochloride.1 the order of a licensed veterinarian. (b) Sponsor. See No. 000856 in [46 FR 18965, Mar. 27, 1981, as amended at 49 § 510.600(c) of this chapter. FR 13494, Apr. 5, 1984] (c) Conditions of use—(1) Amount. Place 1 or 2 tablets deep in each uter- § 529.1003 Flurogestone acetate-im- ine horn; or infuse a solution of 1 tab- pregnated vaginal sponge. let disolved in an appropriate amount (a) Specifications. Each vaginal sponge of clean boiled water; or infuse one sy- contains 20 milligrams of flurogestone ringe of suspension into the uterus.1 acetate. (2) Indications for use. For prevention (b) Sponsor. See No. 000014 in or treatment of metritis and vaginitis § 510.600(c) of this chapter. in cows and mares when caused by (c) Conditions of use—(1) Indications pathogens sensitive to chlorhexidine for use. For synchronizing estrus/ovula- dihydrochloride.1 tion in cycling adult ewes during their (3) Limitations. Prior to administra- normal breeding season. tion, remove any unattached placental (2) Limitations. Using applicator pro- membranes, any excess uterine fluid or vided, insert sponge into ewe’s vagina debris, and carefully clean external 13 days before desired start of breeding. genitalia. Use a clean, sterile insemi- For intravaginal use in sheep only. Do nating pipette for administrating solu- not use in young ewes that have not tions and suspensions. Treatment may had lambs. Use plastic or rubber gloves 1 be repeated in 48 to 72 hours. when handling large numbers of [43 FR 10705, Feb. 23, 1979] sponges to minimize exposure to drug. Do not leave sponge in the vagina for § 529.810 Enflurane. more than 21 days. Ewes must not be (a) Specifications. The drug is a clear, slaughtered for food within 30 days of colorless, nonflammable, nonexplosive sponge removal. liquid. [49 FR 45420, Nov. 16, 1984] (b) Sponsor. See 010019 in § 510.600(c) of this chapter. § 529.1030 Formalin solution. (c) Conditions for use—(1) Amount. For induction of surgical anesthesia: 4 to 5 (a) Specifications. Formalin solution percent enflurane (with oxygen) for 10 is an aqueous solution containing ap- to 15 minutes. For maintenance of sur- proximately 37 percent by weight of gical anesthesia: 2.2 to 3.5 percent formaldehyde gas, U.S.P. enflurane (with oxygen). (b) Sponsor. Approval to firms identi- (2) Indications for use. For induction fied in § 510.600(c) of this chapter for use and maintenance of general anesthesia as indicated: in horses. (1) No. 050378 for use as in paragraph (3) Limitations. Administer by inhala- (c) of this section. tion; not for use in horses sensitive to (2) Nos. 049968 and 051212 for use as in halogenated anesthetics; increasing paragraphs (c)(1)(i), (c)(1)(ii), (c)(2)(i), depth of anesthesia may produce mus- (c)(2)(ii), and (c)(3) of this section. cle twitching, particularly about face, (c) Conditions of use—(1) Indications neck, and forelimb; not for use in preg- for use. The drug is added to the envi- nant mares, foals or weanlings; use less ronmental water as follows: than usual amounts of nondepolarizing (i) For control of the protozoa: Ichthyophthirius spp., Chilodonella spp., Costia spp., Scyphidia spp., Epistylis 1 These conditions are NAS/NRC reviewed spp., and Trichodina spp.; and the and deemed effective. Applications for these uses need not include effectiveness data as monogenetic trematodes: Cleidodiscus specified by § 514.111 of this chapter, but may spp., Gyrodactylus spp., and require bioequivalency and safety informa- Dactylogyrus spp. on salmon, trout, cat- tion. fish, largemouth bass, and bluegill.
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(ii) For control of fungi of the family heavy bloom of phytoplankton is Saprolegniaceae on salmon, trout, and present, or when the concentration of esocid eggs. dissolved oxygen is less than 5 milli- (iii) For control of external proto- grams per liter. zoan parasites Bodo spp., Epistylis spp., and Zoothamnium spp. on penaeid [51 FR 11441, Apr. 3, 1986, as amended at 58 FR 59169, Nov. 8, 1993; 59 FR 60076, Nov. 22, shrimp. 1994] (2) Amount. The drug concentrations required are as follows: § 529.1044 Gentamicin sulfate in cer- (i) For control of external parasites tain other dosage forms. on fish: § 529.1044a Gentamicin sulfate intra- Concentration of formalin uterine solution. (microliters per liter) (a) Specifications. Each milliliter of Fish Tanks and Earthen raceways (for ponds (in- the drug contains 50 or 100 milligrams up to 1 hour) definitely) of gentamicin (as the sulfate) in sterile Salmon and trout: aqueous solution. Above 50 ° F ...... Up to 170 ...... 15±25 (b) Sponsor. See Nos. 000061, 000856, Below 50 ° F ...... Up to 250 ...... 15±25 054273, 057561, and 058711 in § 510.600(c) of Catfish, largemouth Up to 250 ...... 1 15±25 bass, and bluegill. this chapter. (c) Conditions of use. (1) The drug is 1 Use the lower concentrations when pond is heavily loaded with fish or phytoplankton. indicated for use for control of bac- terial infections of the uterus in horses (ii) For control of fungi of the (metritis) and as an aid in improving Saprolegniaceae on salmon, trout, and conception in mares with uterine infec- esocid eggs: Apply in constant flow tions caused by bacteria sensitive to water supply of incubating facilities gentamicin. for 15 minutes. Concentration of for- (2) It is administered at a dosage malin used is 1,000 to 2,000 microliters level of 2 to 2.5 grams per day for 3 to per liter. 5 days during estrus, each dose being (iii) For control of external proto- diluted with 200 to 500 milliliters of zoan parasites on shrimp: sterile physiological saline before asep- Concentration of formalin (microliters tic infusion into the uterus. per liter) (3) Federal law restricts this drug to Shrimp use by or on the order of a licensed vet- Tanks and race- Earthen ponds ways (up to 4 erinarian. hours daily) (single treatment) (4) Not for use in horses intended for Penaeid Shrimp .... 50 to 1001 ...... 252 food. 1Treat for up to 4 hours daily. Treatment may be repeated daily until parasite control is achieved. Use the lower con- [40 FR 13881, Mar. 27, 1975, as amended at 40 centration when the tanks and raceways are heavily loaded. FR 48676, Oct. 17, 1975; 48 FR 31386, July 8, 2Single treatment. Treatment may be repeated in 5 to 10 1983; 52 FR 7833, Mar. 13, 1987; 58 FR 14314, days if needed. Mar. 17, 1993; 59 FR 31140, June 17, 1994; 60 FR (3) Limitations. Fish tanks and race- 45042, Aug. 30, 1995; 60 FR 48894, Sept. 21, 1995] ways may be treated daily until para- site control is achieved. Pond treat- § 529.1044b Gentamicin sulfate solu- ment may be repeated in 5 to 10 days if tion. needed. However, pond treatments for (a) Specifications. Each milliliter of Ichthyophthirius should be made at 2- solution contains gentamicin sulfate day intervals until control is achieved. equivalent to 50 milligrams of Egg tanks may be treated as often as gentamicin base. necessary to prevent growth of fungi. (b) Sponsor. See No. 000061 in Do not use formalin which has been § 510.600(c) of this chapter. subjected to temperatures below 40 ° F, (c) Conditions of use. (1) The drug is or allowed to freeze. Do not treat ponds recommended as an aid in the reduc- containing striped bass. Treatments in tion or elimination of the following tanks should never exceed 1 hour even microorganisms from turkey-hatching if fish show no signs of stress. Do not eggs: Arizona hinshawii (paracolon), apply formalin to ponds with water Salmonella st. paul, and Mycoplasma warmer than 27 ° C (80 ° F), when a meleagridis.
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(2) The drug is added to clean water anesthetic gases. Not for use in ani- to provide a dip solution with a mals intended for food. Federal law re- gentamicin concentration of 250 to stricts this drug to use by or on the 1,000 parts per million. A concentration order of a licensed veterinarian.1 of 500 parts per million is rec- [46 FR 27915, May 22, 1981] ommended. Clean eggs should be held submerged in the gentamicin solution § 529.1186 Isoflurane. under a vacuum of about 27.5 to 38 cen- (a) Specifications. The drug is a clear, timeters of mercury for 5 minutes fol- colorless, stable liquid containing no lowed by additional soaking in additives or chemical stabilizers. It is gentamicin solution for approximately nonflammable and nonexplosive. 10 minutes at atmospheric pressure. (b) Sponsor. See Nos. 000074, 010019, Eggs can also be treated by warming and 012164 in § 510.600(c) of this chapter. them for 3 to 6 hours at approximately (c) Conditions of use—(1) Amount—(i) ° 100 F. then immediately submerging Horses: For induction of surgical anes- them in gentamicin solution main- thesia: 3 to 5 percent isoflurane (with ° tained at about 40 F., keeping the eggs oxygen) for 5 to 10 minutes. For main- submerged for 10 to 15 minutes. tenance of surgical anesthesia: 1.5 to (3) For use in the dipping treatment 1.8 percent isoflurane (with oxygen). of turkey-hatching eggs only. Eggs (ii) Dogs: For induction of surgical which have been dipped in the drug anesthesia: 2 to 2.5 percent isoflurane shall not be used for food. (with oxygen) for 5 to 10 minutes. For [40 FR 13881, Mar. 27, 1975, as amended at 52 maintenance of surgical anesthesia: 1.5 FR 7833, Mar. 13, 1987] to 1.8 percent isoflurane (with oxygen). (2) Indications for use. For induction § 529.1115 Halothane. and maintenance of general anesthesia (a) Specifications. The drug is a color- in horses and dogs. less, odorless, nonflammable, nonexplo- (3) Limitations. Administer by inhala- sive, heavy liquid containing 0.01 per- tion; not for use in horses or dogs sen- cent thymol as a preservative. sitive to halogenated agents; increas- (b) Sponsor. See 000856 in § 510.600(c) of ing depth of anesthesia may increase this chapter. hypotension and respiratory depres- (c) Conditions of use—(1) Amount. Two sion; use less than usual amounts of to 5 percent of inhaled atmosphere for nondepolarizing relaxants; use with va- induction of anesthesia; 0.5 to 2 percent porizers producing predictable percent- for maintenance of anesthesia.1 age concentrations; not for use in (2) Indications for use. For nonfood horses intended for food; Federal law animals for the induction and mainte- restricts this drug to use by or on the nance of anesthesia.1 order of a licensed veterinarian. (3) Limitations. Administered by inha- [51 FR 594, Jan. 7, 1986, as amended at 54 FR lation. May be administered with ei- 23472, June 1, 1989; 58 FR 17346, Apr. 2, 1993; 59 ther oxygen or a mixture of oxygen and FR 44315, Aug. 29, 1994; 60 FR 40456, Aug. 9, nitrous oxide. Place drug vaporizer be- 1995] tween the gas supply and breathing bag § 529.1526 Nifurpirinol capsules. to prevent overdosage. Not rec- ommended for obstetrical anesthesia (a) Specifications. Each capsule con- except when uterine relaxation is re- tains 3.8 or 7.6 milligrams of quired. Do not use in pregnant animals; nifurpirinol. information on possible adverse effects (b) Sponsor. See No. 000074 in on fetal development is not available. § 510.600(c) of this chapter. Operating rooms should have adequate (c) Conditions of use. (1) The drug is ventilation to prevent accumulation of used in treating aquarium fish for the control of columnaris disease caused by Chondrococcus columnaris susceptible to 1 These conditions have been reviewed by FDA and found effective. NADA’s for similar nifurpirinol. products for these conditions of use need not (2) Use one 3.8 milligram nifurpirinol include effectiveness data as specified by capsule for each 10 gallons of aquarium § 514.111 of this chapter, but may require bio- water. Empty the contents of the cap- equivalency and safety information. sule directly into the water and stir
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briefly. Treat for at least 1 hour. If ac- (b) Sponsor. See No. 000069 in tivated charcoal or carbon filtration is § 510.600(c) of this chapter. being used, disconnect during treat- (c) Conditions of use—(1) Amount. 6 ment, but maintain adequate aeration. grams per day, intrauterine, for 3 con- Resume water filtration after 1 hour secutive days during estrus. treatment. Usually a single treatment (2) Indications for use. Horses. Intra- is sufficient. For aquariums with char- uterine treatment of endometritis coal filters, nifurpirinol can be used caused by beta-hemolytic streptococci. once each 24 hours up to 3 consecutive (3) Limitations. For intrauterine use days, discontinuing filtration during in horses only. Infuse aseptically. Not treatment. If aquarium does not have charcoal filter, do not retreat within 5 for use in horses raised for food produc- days. tion. Federal law restricts this drug to (3) Do not use in salt water aquar- use by or on the order of a licensed vet- iums. erinarian. (4) Do not use while egg bearers or [57 FR 37336, Aug. 18, 1992, as amended at 60 live bearers are reproducing. FR 55660, Nov. 2, 1995] [40 FR 60052, Dec. 31, 1975, as amended at 47 FR 20758, May 14, 1982; 56 FR 43699, Sept. 4, § 529.2503 Tricaine methanesulfonate. 1991] (a) Chemical name. Ethyl-m-amino- benzoate methanesulfonate. § 529.2090 Salicylic acid. (b) Sponsor. See No. 051212 in (a) Specifications. (1) Each dose con- § 510.600(c) of this chapter. tains 0.55 gram of salicylic acid in a (c) Conditions of use. (1) It is used for gum arabic and dextrin vehicle. the temporary immobilization of fish, (2) Each dose is incorporated upon a amphibians, and other aquatic cold- device (teat dilator) suitable for inser- blooded animals (poikilotherms) as an tion into and subsequent removal from aid in handling during manual spawn- the teat canal. ing (fish stripping), weighing, measur- (b) Sponsor. See No. 045087 in ing, marking, surgical operations, § 510.600(c) of this chapter. transport, photography, and research. (c) Conditions of use. (1) The drug is (2) It is used as follows: used for the removal of scar tissue in the teat canal of milk-producing cows. (i) For fish the drug is added to ambi- (2) The labeling bears directions to ent water at a concentration of from 15 the user to: to 330 milligrams per liter depending (i) Treat lactating cows initially by upon the degree of anesthetization or inserting dosage and removal of the de- sedation desired, the species and size of vice; the fish, and the temperature and soft- (ii) Insert second dose and permit de- ness of the water. Preliminary tests of vice to remain in canal until the next solutions must be made with small milking; and numbers of fish to determine the de- (iii) Insert one dose following each sired rates of sedation or anesthesia milking for not more than 2 days. and the appropriate exposure times for (3) Milk that has been drawn from the specific lots of fish under prevail- animals within 48 hours of such treat- ing conditions. ment may not be used for food. (ii) For amphibians and other aquatic coldblooded animals, the drug is added [41 FR 10984, Mar. 15, 1976, as amended at 43 FR 29290, July 7, 1978; 55 FR 29842, July 23, to ambient water in concentrations of 1990; 55 FR 31481, Aug. 2, 1990] from 1:1000 to 1:20,000 depending upon species and stage of development. § 529.2464 Ticarcillin powder. (iii) Do not use within 21 days of har- (a) Specifications. Each vial contains vesting fish for food. Use in fish in- ticarcillin disodium equivalent to 6 tended for food should be restricted to grams of ticarcillin to be reconstituted Ictaluridae, Salmonidae, Esocidae, and with 25 milliliters of sterile water for Percidae, and water temperature injection or sterile physiological sa- should exceed 10° C. (50° F.). In other line. fish and in cold-blooded animals, the
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drug should be limited to hatchery or 556.425 Morantel tartrate. laboratory use. 556.428 Narasin. 556.430 Neomycin. [40 FR 13881, Mar. 27, 1975, as amended at 49 556.440 Nequinate. FR 5748, Feb. 15, 1984; 51 FR 11439, Apr. 3, 556.445 Nicarbazin. 1986] 556.460 Novobiocin. 556.470 Nystatin. PART 556—TOLERANCES FOR RESI- 556.480 Oleandomycin. DUES OF NEW ANIMAL DRUGS IN 556.490 Ormetoprim. 556.495 Oxfendazole. FOOD 556.500 Oxytetracycline. 556.510 Penicillin. Subpart A—General Provisions 556.515 Pirlimycin. Sec. 556.520 Prednisolone. 556.1 General considerations; tolerances for 556.530 Prednisone. residues of new animal drugs in food. 556.540 Progesterone. 556.550 Propylparaben. Subpart B—Specific Tolerances for 556.560 Pyrantel tartrate. Residues of New Animal Drugs 556.580 Robenidine hydrochloride. 556.590 Salicylic acid. 556.20 2-Acetylamino-5-nitrothiazole. 556.594 Sarafloxacin. 556.30 Aklomide. 556.600 Spectinomycin. 556.34 Albendazole. 556.610 Streptomycin. 556.38 Amoxicillin. 556.620 Sulfabromomethazine sodium. 556.40 Ampicillin. 556.625 Sodium sulfachloropyrazine 556.50 Amprolium. monohydrate. 556.52 Apramycin. 556.630 Sulfachlorpyridazine. 556.60 Arsenic. 556.640 Sulfadimethoxine. 556.70 Bacitracin. 556.650 Sulfaethoxypyridazine. 556.90 Buquinolate. 556.660 Sulfamerazine. 556.100 Carbadox. 556.110 Carbomycin. 556.670 Sulfamethazine. 556.113 Ceftiofur. 556.680 Sulfanitran. 556.115 Cephapirin. 556.690 Sulfathiazole. 556.120 Chlorhexidine. 556.700 Sulfomyxin. 556.140 Chlorobutanol. 556.710 Testosterone propionate. 556.150 Chlortetracycline. 556.720 Tetracycline. 556.160 Clopidol. 556.730 Thiabendazole. 556.163 Clorsulon. 556.735 Tilmicosin. 556.165 Cloxacillin. 556.738 Tiamulin. 556.170 Decoquinate. 556.739 Trenbolone. 556.180 Dichlorvos. 556.740 Tylosin. 556.200 Dihydrostreptomycin. 556.750 Virginiamycin. 556.220 3,5-Dinitrobenzamide. 556.760 Zeranol. 556.230 Erythromycin. 556.770 Zoalene. 556.240 Estradiol and related esters. 556.260 Ethopabate. AUTHORITY: Secs. 402, 512, 701 of the Federal 556.270 Ethylenediamine. Food, Drug, and Cosmetic Act (21 U.S.C. 342, 556.275 Fenbendazole. 360b, 371). 556.277 Fenprostalene. SOURCE: 40 FR 13942, Mar. 27, 1975, unless 556.290 Furazolidone. otherwise noted. 556.300 Gentamicin sulfate. 556.308 Halofuginone hydrobromide. 556.310 Haloxon. Subpart A—General Provisions 556.320 Hydrocortisone. 556.330 Hygromycin B. § 556.1 General considerations; toler- 556.344 Ivermectin. ances for residues of new animal 556.347 Lasalocid. drugs in food. 556.350 Levamisole hydrochloride. (a) Tolerances established in this 556.360 Lincomycin. part are based upon residues of drugs in 556.375 Maduramicin ammonium. edible products of food-producing ani- 556.380 Melengestrol acetate. 556.390 Methylparaben. mals treated with such drugs. Consid- 556.400 Methylprednisolone. eration of an appropriate tolerance for 556.410 Metoserpate hydrochloride. a drug shall result in a conclusion ei- 556.420 Monensin. ther that:
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