Pt. 520 21 CFR Ch. I (4–1–05 Edition)

PART 520—ORAL DOSAGE FORM 520.310 Caramiphen ethanedisulfonate and ammonium chloride tablets. NEW ANIMAL DRUGS 520.312 Carnidazole tablets. 520.314 Cefadroxil tablets. Sec. 520.315 Cefadroxil powder for oral suspen- 520.23 Acepromazine maleate tablets. sion. 520.44 Acetazolamide sodium soluble pow- 520.370 Cefpodoxime tablets. der. 520.390 Chloramphenicol oral dosage forms. 520.45 Albendazole oral dosage forms. 520.390a Chloramphenicol tablets. 520.45a Albendazole suspension. 520.390b Chloramphenicol capsules. 520.45b Albendazole paste. 520.390c Chloramphenicol palmitate oral 520.48 Altrenogest solution. suspension. 520.62 Aminopentamide hydrogen sulphate 520.420 Chlorothiazide tablets and boluses. tablets. 520.434 Chlorphenesin carbamate tablets. 520.82 Aminopropazine fumarate oral dosage 520.445 Chlortetracycline oral dosage forms. forms. 520.445a Chlortetracycline bisulfate/ 520.82a Aminopropazine fumarate tablets. sulfamethazine bisulfate soluble powder. 520.82b Aminopropazine fumarate, neomy- 520.445b Chlortetracycline powder (chlor- cin sulfate tablets. tetracycline hydrochloride or chlortetra- 520.88 Amoxicillin oral dosage forms. cycline bisulfate). 520.88a Amoxicillin trihydrate film-coated 520.445c Chlortetracycline tablets and tablets. boluses. 520.88b Amoxicillin trihydrate for oral sus- 520.446 Clindamycin capsules and tablets. pension. 520.447 Clindamycin liquid. 520.88c Amoxicillin trihydrate oral suspen- 520.452 Clenbuterol syrup. sion. 520.455 Clomipramine hydrochloride tab- 520.88d Amoxicillin trihydrate soluble pow- lets. der. 520.462 Clorsulon drench. 520.88e Amoxicillin trihydrate boluses. 520.522 Cyclosporine. 520.88f Amoxicillin trihydrate tablets. 520.530 Cythioate oral liquid. 520.88g Amoxicillin trihydrate and 520.531 Cythioate tablets. clavulanate potassium film-coated tab- 520.534 Decoquinate. lets. 520.538 Deracoxib. 520.540 Dexamethasone oral dosage forms. 520.88h Amoxicillin trihydrate and 520.540a Dexamethasone powder. clavulanate potassium for oral suspen- 520.540b Dexamethasone tablets and sion. boluses. 520.90 Ampicillin oral dosage forms. 520.540c Dexamethasone chewable tablets. 520.90a Ampicillin capsules. 520.550 Dextrose/glycine/electrolyte. 520.90b Ampicillin trihydrate tablets. 520.563 Diatrizoate meglumine and dia- 520.90c Ampicillin trihydrate capsules. trizoate sodium oral solution. 520.90d Ampicillin trihydrate for oral sus- 520.580 Dichlorophene and toluene capsules. pension. 520.581 Dichlorophene tablets. 520.90e Ampicillin trihydrate soluble pow- 520.600 Dichlorvos. der. 520.608 Dicloxacillin sodium monohydrate 520.90f Ampicillin trihydrate boluses. capsules. 520.100 Amprolium oral dosage forms. 520.620 Diethylcarbamazine oral dosage 520.100a Amprolium drinking water. forms. 520.100b Amprolium drench. 520.622 Diethylcarbamazine citrate oral dos- 520.100c Amprolium crumbles. age forms. 520.110 Apramycin sulfate soluble powder. 520.622a Diethylcarbamazine citrate tablets. 520.154 Bacitracin oral dosage forms. 520.622b Diethylcarbamazine citrate syrup. 520.154a Soluble bacitracin methylene disa- 520.622c Diethylcarbamazine citrate chew- licylate. able tablets. 520.154b Soluble bacitracin methylene disa- 520.622d Diethylcarbamazine citrate cap- licylate and streptomycin sulfate oral sules. powder. 520.623 Diethylcarbamazine citrate, 520.154c Bacitracin zinc soluble powder. oxibendazole chewable tablets. 520.182 Bicyclohexylammonium fumagillin. 520.645 Difloxacin. 520.222 Bunamidine hydrochloride. 520.763 Dithiazanine iodide oral dosage 520.246 Butorphanol tartrate tablets. forms. 520.260 n-Butyl chloride capsules. 520.763a Dithiazanine iodide tablets. 520.300 Cambendazole oral dosage forms. 520.763b Dithiazanine iodide powder. 520.300a Cambendazole suspension. 520.763c Dithiazanine iodide and piperazine 520.300b Cambendazole pellets. citrate suspension. 520.300c Cambendazole paste. 520.784 Doxylamine succinate tablets. 520.309 Carprofen. 520.804 Enalapril tablets.

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520.812 Enrofloxacin tablets. 520.1242c Levamisole hydrochloride and pi- 520.813 Enrofloxacin oral solution. perazine dihydrochloride. 520.816 Epsiprantel tablets. 520.1242d Levamisole resinate. 520.823 Erythromycin phosphate. 520.1242e Levamisole hydrochloride effer- 520.863 Ethylisobutrazine hydrochloride vescent tablets. tablets. 520.1242f Levamisole hydrochloride gel. 520.870 Etodolac. 520.1242g Levamisole resinate and famphur 520.903 Febantel oral dosage forms. paste. 520.903a Febantel paste. 520.1263 Lincomycin hydrochloride 520.903b Febantel suspension. monohydrate oral dosage forms. 520.903c [Reserved] 520.1263a Lincomycin hydrochloride 520.903d Febantel-praziquantel paste. monohydrate tablets and sirup. 520.903e Febantel tablets. 520.1263b [Reserved] 520.905 Fenbendazole oral dosage forms. 520.1263c Lincomycin hydrochloride soluble 520.905a Fenbendazole suspension. powder. 520.905b Fenbendazole granules. 520.1265 Lincomycin and spectinomycin 520.905c Fenbendazole paste. soluble powder. 520.905d Fenbendazole powder. 520.1284 Sodium liothyronine tablets. 520.905e Fenbendazole blocks. 520.1288 Lufenuron tablets. 520.928 Firocoxib. 520.1289 Lufenuron suspension. 520.955 Florfenicol. 520.1310 Marbofloxacin tablets. 520.960 Flumethasone tablets. 520.1320 Mebendazole oral. 520.970 Flunixin oral dosage forms. 520.1326 Mebendazole and trichlorfon oral 520.970a Flunixin meglumine granules. dosage forms. 520.970b Flunixin meglumine paste. 520.1326a Mebendazole and trichlorfon pow- 520.1010 Furosemide. der. 520.1044 Gentamicin sulfate oral dosage 520.1326b Mebendazole and trichlorfon paste. forms. 520.1330 Meclofenamic acid granules. 520.1044a Gentamicin sulfate oral solution. 520.1331 Meclofenamic acid tablets. 520.1044b Gentamicin sulfate pig pump oral 520.1341 Megestrol acetate tablets. solution. 520.1350 Meloxicam. 520.1044c Gentamicin sulfate soluble pow- 520.1380 Methocarbamol tablets. der. 520.1390 (S)-methoprene. 520.1100 Griseofulvin. 520.1408 Methylprednisolone tablets. 520.1120 Haloxon oral dosage forms. 520.1409 Methylprednisolone, aspirin tab- 520.1120a Haloxon drench. lets. 520.1120b Haloxon boluses. 520.1422 Metoserpate hydrochloride. 520.1130 Hetacillin oral dosage forms. 520.1430 Mibolerone. 520.1130a Hetacillin potassium capsules. 520.1445 Milbemycin oxime tablets. 520.1130b Hetacillin potassium oral suspen- 520.1446 Milbemcyin oxime and lufenuron sion. tablets. 520.1130c Hetacillin potassium tablets. 520.1448 Monensin oral dosage forms. 520.1157 Iodinated casein tablets. 520.1448a Monensin blocks. 520.1158 Iodochlorhydroxyquin boluses. 520.1450 Morantel tartrate oral dosage 520.1182 Iron dextran oral suspension. forms. 520.1192 Ivermectin paste. 520.1450a Morantel tartrate bolus. 520.1193 Ivermectin tablets and chewables. 520.1450b Morantel tartrate cartridge. 520.1194 Ivermectin meal. 520.1450c Morantel tartrate sustained-re- 520.1195 Ivermectin liquid. lease trilaminate cylinder/sheet. 520.1196 Ivermectin and pyrantel pamoate 520.1451 Moxidectin. chewable tablets. 520.1452 Moxidectin gel. 520.1197 Ivermectin sustained-release bolus. 520.1453 Moxidectin and praziquantel gel. 520.1198 Ivermectin and praziquantel paste. 520.1468 Naproxen granules. 520.1204 Kanamycin sulfate, 520.1484 Neomycin sulfate soluble powder. aminopentamide hydrogen sulfate, pec- 520.1485 Neomycin sulfate oral solution. tin, bismuth subcarbonate, activated 520.1498 Nitazoxanide paste. attapulgite suspension. 520.1510 Nitenpyram tablets. 520.1205 Kanamycin sulfate, pectin, bismuth 520.1615 Omeprazole. subcarbonate, activated attapulgite tab- 520.1616 Orbifloxacin tablets. lets. 520.1628 Oxfendazole powder and pellets. 520.1242 Levamisole hydrochloride oral dos- 520.1629 Oxfendazole paste. age forms. 520.1630 Oxfendazole suspension. 520.1242a Levamisole powder for oral solu- 520.1631 Oxfendazole and trichlorfon paste. tion. 520.1638 Oxibendazole paste. 520.1242b Levamisole hydrochloride tablet 520.1640 Oxibendazole suspension. or oblet (bolus). 520.1660 Oxytetracycline.

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520.1660a Oxytetracycline and carbomycin 520.2123 Spectinomycin dihydrochloride in combination. pentahydrate oral dosage forms. 520.1660b Oxytetracycline hydrochloride 520.2123a Spectinomycin dihydrochloride capsules. pentahydrate tablets. 520.1660c Oxytetracycline hydrochloride 520.2123b Spectinomycin dihydrochloride tablets/boluses. pentahydrate soluble powder. 520.1660d Oxytetracycline hydrochloride 520.2123c Spectinomycin dihydrochloride soluble powder. pentahydrate solution. 520.1696 Penicillin oral dosage forms. 520.2150 Stanozolol oral dosage forms. 520.1696a Buffered penicillin powder, peni- 520.2150a Stanozolol tablets. cillin powder with buffered aqueous dil- 520.2150b Stanozolol chewable tablets. uent. 520.2158 Streptomycin/dihydrostreptomycin 520.1696b Penicillin G potassium in drinking oral dosage forms. water. 520.2158a Streptomycin sulfate oral solu- 520.1696c Penicillin V potassium for oral so- tion. lution. 520.2158b Dihydrostreptomycin tablets. 520.1696d Penicillin V potassium tablets. 520.2158c Dihydrostreptomycin oral suspen- 520.1720 Phenylbutazone oral dosage forms. sion. 520.1720a Phenylbutazone tablets and 520.2160 Styrylpyridinium, boluses. diethylcarbamazine oral dosage forms. 520.1720b Phenylbutazone granules. 520.2170 Sulfabromomethazine sodium 520.1720c Phenylbutazone paste. boluses. 520.1720d Phenylbutazone gel. 520.2184 Sodium sulfachloropyrazine 520.1802 Piperazine-carbon disulfide complex monohydrate. oral dosage forms. 520.2200 Sulfachlorpyridazine oral dosage 520.1802a Piperazine-carbon disulfide com- forms. plex suspension. 520.2200a Sulfachlorpyridazine bolus. 520.1802b Piperazine-carbon disulfide com- 520.2200b Sulfachlorpyridazine medicated plex boluses. milk and drinking water. 520.1802c Piperazine-carbon disulfide com- 520.2200c Sulfachlorpyridazine tablets. plex with phenothiazine suspension. 520.2215 Sulfadiazine/pyrimethamine sus- 520.1803 Piperazine citrate capsules. pension. 520.1804 Piperazine phosphate capsules. 520.2220 Sulfadimethoxine oral dosage 520.1805 Piperazine phosphate with thenium forms. closylate tablets. 520.2220a Sulfadimethoxine oral solution 520.1806 Piperazine monohydrochloride liq- and soluble powder. uid. 520.2220b Sulfadimethoxine tablets and 520.1807 Piperazine. boluses. 520.1840 Poloxalene. 520.2220c Sulfadimethoxine oral suspension. 520.1846 Polyoxyethylene (23) lauryl ether 520.2220d Sulfadimethoxine-ormetoprim blocks. tablets. 520.1855 Ponazuril. 520.2240 Sulfaethoxypyridazine. 520.1870 Praziquantel tablets. 520.2240a Sulfaethoxypyridazine drinking 520.1871 Praziquantel/pyrantel pamoate tab- water. lets. 520.2240b Sulfaethoxypyridazine tablets. 520.1872 Praziquantel, pyrantel pamoate, 520.2260 Sulfamethazine oral dosage forms. and febantel tablets. 520.2260a Sulfamethazine oblet, tablet, and 520.1880 Prednisolone tablets. bolus. 520.1900 Primidone tablets. 520.2260b Sulfamethazine sustained-release 520.1920 Prochlorperazine, isopropamide sus- boluses. tained release capsules. 520.2260c Sulfamethazine sustained-release 520.1921 Prochlorperazine, isopropamide, tablets. with neomycin sustained-release cap- 520.2261 Sulfamethazine sodium oral dosage sules. forms. 520.1962 Promazine hydrochloride. 520.2261a Sulfamethazine sodium drinking 520.2002 Propiopromazine hydrochloride. water solution. 520.2041 Pyrantel pamoate chewable tablets. 520.2261b Sulfamethazine sodium soluble 520.2042 Pyrantel pamoate tablets. powder. 520.2043 Pyrantel pamoate suspension. 520.2280 Sulfamethizole and methenamine 520.2044 Pyrantel pamoate paste. mandelate tablets. 520.2045 Pyrantel tartrate powder; pyrantel 520.2320 Sulfanitran and aklomide in com- tartrate pellets. bination. 520.2087 Roxarsone soluble powder. 520.2325 Sulfaquinoxaline oral dosage forms. 520.2088 Roxarsone tablets. 520.2325a Sulfaquinoxaline drinking water. 520.2089 Roxarsone liquid. 520.2325b Sulfaquinoxaline drench. 520.2098 Selegiline hydrochloride tablets. 520.2330 Sulfisoxazole tablets. 520.2100 Selenium, vitamin E capsules. 520.2340 Tepoxalin.

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520.2345 Tetracycline oral dosage forms. (1) For No. 000856, use of 5-, 10-, or 25- 520.2345a Tetracycline hydrochloride cap- milligram tablets as in paragraph (b) of sules. this section. 520.2345b Tetracycline tablets. (2) For No. 000010, use of 10- or 25-mil- 520.2345c Tetracycline boluses. 520.2345d Tetracycline hydrochloride solu- ligram tablets as in paragraph (c) of ble powder. this section. 520.2345e Tetracycline oral liquid. (b) Conditions of use. It is used in dogs 520.2345f Tetracycline phosphate complex and cats as follows: and sodium novobiocin capsules. (1) Indications for use. It is used in 520.2345g Tetracycline hydrochloride and so- dogs and cats as a tranquilizer. dium novobiocin tablets. (2) Amount. Dogs: 0.25 to 1.0 milli- 520.2345h Tetracycline hydrochloride, so- dium novobiocin, and prednisolone tab- gram per pound of body weight; Cats: lets. 0.5 to 1.0 milligram per pound of body 520.2362 Thenium closylate tablets. weight. 520.2380 Thiabendazole oral dosage forms. (3) Limitations. The drug is adminis- 520.2380a Thiabendazole top dressing and tered orally. Dosage may be repeated mineral protein feed block. as required. Federal law restricts this 520.2380b Thiabendazole drench or oral drug to use by or on the order of a li- paste. censed veterinarian. 520.2380c Thiabendazole bolus. 520.2380d Thiabendazole, piperazine citrate (c) Conditions of use. It is used in dogs suspension. as follows: 520.2380e Thiabendazole with trichlorfon. (1) Indications for use. It is used in 520.2380f Thiabendazole, piperazine phos- dogs as an aid in tranquilization and as phate powder. a preanesthetic agent. 520.2455 Tiamulin soluble powder. (2) Amount. Dogs: 0.25 to 1.0 milli- 520.2456 Tiamulin liquid concentrate. 520.2473 Tioxidazole oral dosage forms. gram per pound of body weight. 520.2473a Tioxidazole granules. (3) Limitations. The drug is adminis- 520.2473b Tioxidazole paste. tered orally. Dosage may be repeated 520.2481 Triamcinolone acetonide tablets. as required. Federal law restricts this 520.2482 Triamcinolone acetonide oral pow- drug to use by or on the order of a li- der. censed veterinarian. 520.2520 Trichlorfon oral dosage forms. 520.2520b Trichlorfon and atropine. [46 FR 44443, Sept. 4, 1981, as amended at 49 520.2520e Trichlorofon boluses. FR 49091, Dec. 18, 1984; 52 FR 666, Jan. 8, 1987; 520.2520f Trichlorofon granules. 53 FR 40727, Oct. 18, 1988; 56 FR 37473, Aug. 7, 520.2520g Trichlorfon, phenothiazine, and pi- 1991; 62 FR 35075, June 30, 1997] perazine dihydrochloride powder. 520.2582 Triflupromazine hydrochloride tab- § 520.44 Acetazolamide sodium soluble lets. powder. 520.2604 Trimeprazine tartrate and prednis- (a) Specifications. The drug is in a olone tablets. 520.2605 Trimeprazine tartrate and prednis- powder form containing acetazolamide olone capsules. sodium, USP equivalent to 25 percent 520.2610 Trimethoprim and sulfadiazine tab- acetazolamide activity. lets. (b) Sponsor. See No. 053501 in 520.2611 Trimethoprim and sulfadiazine oral § 510.600(c) of this chapter. paste. (c) Conditions of use. (1) It is used in 520.2612 Trimethoprim and sulfadiazine oral dogs as an aid in the treatment of mild suspension. 520.2613 Trimethoprim and sulfadiazine congestive heart failure and for rapid 1 powder. reduction of intraocular pressure. 520.2640 Tylosin. (2) It is administered orally at a dos- age level of 5 to 15 milligrams per AUTHORITY: 21 U.S.C. 360b. pound of body weight daily.1 SOURCE: 40 FR 13838, Mar. 27, 1975, unless otherwise noted. 1 These conditions are NAS/NRC reviewed § 520.23 Acepromazine maleate tablets. and deemed effective. Applications for these uses need not include effectiveness data as (a) Sponsors. See drug labeler codes in specified by § 514.111 of this chapter, but may § 510.600(c) of this chapter for identi- require bioequivalency and safety informa- fication of sponsors as follows: tion.

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(3) For use only by or on the order of (4) Conditions of use in sheep—(i) a licensed veterinarian.1 Amount. 7.5 milligrams per kilogram of body weight (3.4 milligrams per pound). [40 FR 13838, Mar. 27, 1975, as amended at 67 (ii) Indications for use. For removal FR 78355, Dec. 24, 2002] and control of the following internal § 520.45 Albendazole oral dosage parasites of sheep: Adult liver flukes forms. (Fasciola hepatica, Fascioloides magna); heads and segments of common tape- § 520.45a Albendazole suspension. worms (Moniezia expansa) and fringed tapeworm (Thysanosoma actinioides); (a)(1) Specifications. The product con- adult and fourth stage larvae of stom- tains 11.36 percent albendazole. ach worms (brown stomach worm (2) Sponsor. See No. 000069 in § 510.600 (Ostertagia circumcinta and Marshallagia of this chapter. marshalli), barberpole worm (3) Related tolerances. See § 556.34 of (Haemonchus contortus), small stomach this chapter. worm (Trichostrongylus axei)); adult and (4) Conditions of use in cattle—(i) fourth stage larvae of intestinal worms Amount. 4.54 milligrams per pound of (thread-necked intestinal worm body weight (10 milligrams per kilo- (Nematodirus spathiger and N. filicollis), gram). Cooper’s worm (Cooperia oncophora), (ii) Indications for use. For removal bankrupt worm (Trichostrongylus and control of the following internal colubriformis), nodular worm parasites of cattle: Adult liver flukes (Oesophagostomum columbianum), and (Fasciola hepatica); heads and segments large-mouth bowel worm (Chabertia of tapeworms (Moniezia benedeni, M. ovina)); adult and larval stages of expansa); adult and 4th stage larvae of lungworms (Dictyocaulus filaria). stomach worms (brown stomach worms (iii) Limitations. Administer as a sin- including 4th stage inhibited larvae gle oral dose using dosing gun or dos- (Ostertagia ostertagi), barberpole worm ing syringe. Do not slaughter within 7 (Haemonchus contortus, H. placei), small days of last treatment. Do not admin- stomach worm (Trichostrongylus axei)); ister to ewes during first 30 days of adult and 4th stage larvae of intestinal pregnancy or for 30 days after removal worms (thread-necked intestinal worm of rams. Consult your veterinarian for (Nematodirus spathiger, N. helvetianus), assistance in the diagnosis, treatment, small intestinal worm (Cooperia and control of parasitism. punctata and C. oncophora)); adult stages of intestinal worms (hookworm [54 FR 25115, June 13, 1989, as amended at 56 FR 50653, Oct. 8, 1991; 59 FR 65711, Dec. 21, (Bunostomum phlebotomum), bankrupt 1994; 60 FR 55658, Nov. 2, 1995; 61 FR 4875, Feb. worm (Trichostrongylus colubriformis), 9, 1996; 64 FR 1504, Jan. 11, 1999] nodular worm (Oesophagostomum radiatum)); adult and 4th stage larvae § 520.45b Albendazole paste. of lungworms (Dictyocaulus viviparus). (a) Specifications. The product con- (iii) Limitations. Administer as a sin- tains 30 percent albendazole. gle oral dose using dosing gun or dos- (b) Sponsor. See No. 000069 in ing syringe. Do not slaughter within 27 § 510.600(c) of this chapter. days of last treatment. Do not use in (c) Related tolerances. See § 556.34 of female dairy cattle of breeding age: Do this chapter. not administer to female cattle during (d) Conditions of use in cattle—(1) first 45 days of pregnancy or for 45 days Amount. Equivalent to 4.54 milligrams after removal of bulls. Consult your per 1 pound of body weight (10 milli- veterinarian for assistance in the diag- grams per kilogram). nosis, treatment, and control of para- (2) Indications for use. For removal sitism. and control of the following internal (b)(1) Specifications. The product con- parasites of cattle: adult liver flukes tains 4.55 or 11.36 percent albendazole. (Fasciola hepatica); heads and segments (2) Sponsor. See No. 000069 in of tapeworms (Moniezia benedeni, M. § 510.600(c) of this chapter. expansa); adult and 4th stage larvae of (3) Related tolerances. See § 556.34 of stomach worms (brown stomach worms this chapter. including 4th stage inhibited larvae

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(Ostertagia ostertagi); barberpole worm (iii) Limitations. Do not use in gilts (Haemonchus contortus, H. placei); small having a previous or current history of stomach worm (Trichostrongylus axei)); uterine inflammation (i.e., acute, adult and 4th stages larvae of intes- subacute or chronic endometritis). tinal worms (thread-necked intestinal Gilts must not be slaughtered for worm (Nematodirus spathiger, N. human consumption for 21 days after helvetianus); small intestinal worm the last treatment. (Cooperia punctata and C. oncophora)); [66 FR 47960, Sept. 17, 2001, as amended at 68 adult stages of intestinal worms FR 62006, Oct. 31, 2003] (hookworm (Bunostomum phlebotmum); bankrupt worm (Trichostrongylus § 520.62 Aminopentamide hydrogen colubriformis), nodular worm sulphate tablets. (Oesophagostomum radiatum)); adult and (a) Chemical name. 4- 4th stage larvae of lungworms (Dimethylamino)-2,2- (Dictyocaulus viviparus). diphenylvaleramide hydrogen sulfate. (3) Administer as a single Limitations. (b) Specifications. Each tablet con- oral dose. Do not slaughter within 27 tains 0.2 milligram of the drug. days of last treatment. Do not use in (c) Sponsor. See No. 000856 in female dairy cattle of breeding age. Do § 510.600(c) of this chapter. not administer to female cattle during (d) Conditions of use. (1) It is intended first 45 days of pregnancy or for 45 days for use in dogs and cats only for the after removal of bulls. Consult your treatment of vomiting and/or diarrhea, veterinarian for assistance in the diag- nausea, acute abdominal visceral nosis, treatment, and control of para- spasm, pylorospasm, or hypertrophic sitism. gastritis. [54 FR 51385, Dec. 15, 1989, as amended at 56 FR 50653, Oct. 8, 1991; 60 FR 55658, Nov. 2, NOTE: Not for use in animals with glau- 1995] coma because of the occurrence of mydriasis. (2) Dosage is administered by oral § 520.48 Altrenogest solution. tablet every 8 to 12 hours, as follows: (a) Specifications. Each milliliter Dosage in (mL) of solution contains 2.2 milli- Weight of animal in pounds milligrams grams (mg) altrenogest. (b) Sponsor. See No. 057926 in Up to 10 ...... 0.1 11 to 20 ...... 0.2 § 510.600(c) of this chapter. 21 to 50 ...... 0.3 (c) Tolerances. See § 556.36 of this 51 to 100 ...... 0.4 chapter. Over 100 ...... 0.5 (d) Conditions of use—(1)Horses— (i)Amount. 1.0 mL per 110 pounds body Dosage may be gradually increased up weight (0.044 mg/kg) daily for 15 con- to a maximum of five times the sug- secutive days. gested dosage. Oral administration of (ii) Indications for use. For suppres- tablets may be preceded by subcuta- sion of estrus in mares. neous or intramuscular use of the (iii) Limitations. For oral use in injectable form of the drug. horses only; avoid contact with the (3) For use only by or on the order of skin. Do not administer to horses in- a licensed veterinarian. tended for use as food. Federal law re- [40 FR 13838, Mar. 27, 1975, as amended at 53 stricts this drug to use by or on the FR 27851, July 25, 1988] order of a licensed veterinarian. (2) Swine—(i) Amount. Administer 6.8 § 520.82 Aminopropazine fumarate oral mL (15 mg altrenogest) per gilt once dosage forms. daily for 14 consecutive days by top- dressing on a portion of each gilt’s § 520.82a Aminopropazine fumarate daily feed. tablets. (ii) Indications for use. For synchroni- (a) Specifications. The drug is in tab- zation of estrus in sexually mature let form. Each tablet contains gilts that have had at least one estrous aminopropazine fumarate equivalent to cycle. 25 milligrams of aminopropazine base.

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(b) Sponsor. See No. 000061 in (b) Sponsor. See No. 000069 in § 510.600(c) of this chapter. § 510.600(c) of this chapter. (c) Conditions of use. (1) The drug is (c) Conditions of use—(1) Dogs—(i) used in dogs and cats for reducing ex- Amount. 5 milligrams per pound of body cessive smooth muscle contractions, weight, twice a day. such as occur in urethral spasms asso- (ii) Indications for use. Treatment of 1 ciated with urolithiasis. infections of the respiratory tract (ton- (2) It is administered at a dosage sillitis, tracheobronchitis), genito- level of 1 to 2 milligrams per pound of urinary tract (cystitis), gastro- body weight. The dosage can be re- intestinal tract (bacterial peated every 12 hours, as indicated.1 gastroenteritis), and soft tissues (ab- (3) Not for use in animals intended scesses, lacerations, wounds), caused for food purposes. (4) For use only by or on the order of by susceptible strains of Staphylococcus a licensed veterinarian.1 aureus, Streptococcus spp., Escherichia coli, Proteus mirabilis, and bacterial der- [40 FR 13838, Mar. 27, 1975, as amended at 46 matitis caused by S. aureus, Strepto- FR 48642, Oct. 2, 1981; 61 FR 8873, Mar. 6, 1996; coccus spp., and P. mirabilis. 62 FR 61624, Nov. 19, 1997] (iii) Limitations. Administer for 5 to 7 § 520.82b Aminopropazine fumarate, days or 48 hours after all symptoms neomycin sulfate tablets. have subsided. If no improvement is (a) Specifications. The drug is in tab- seen in 5 days, review diagnosis and let form. Each tablet contains both change therapy. Federal law restricts aminopropazine fumarate equivalent to this drug to use by or on the order of a 25 milligrams of aminopropazine base licensed veterinarian. and neomycin sulfate equivalent to 50 (2) Cats—(i) Amount. 50 milligrams (5 milligrams of neomycin base. to 10 milligrams per pound of body (b) Sponsor. See No. 000061 in weight) once a day. § 510.600(c) of this chapter. (ii) Indications for use. Treatment of (c) Conditions of use. (1) The drug is infections caused by susceptible orga- used in dogs to control bacterial diar- nisms as follows: upper respiratory rhea caused by organisms susceptible tract due to S. aureus, Streptococcus to neomycin and to reduce smooth spp., and E. coli; genitourinary tract muscle contractions.1 (cystitis) due to S. aureus, Streptococcus (2) It is administered at a dosage spp., E. coli, and P. mirabilis; gastro- level of one to two tablets per 10 intestinal tract due to E. coli; and skin pounds of body weight twice daily for 3 and soft tissue (abscesses, lacerations, 1 days. and wounds) due to S. aureus, Strepto- (3) Federal law restricts this drug to coccus spp., E. coli, and Pasteurella use by or on the order of a licensed vet- multocida. erinarian.1 (iii) Limitations. Administer for 5 to 7 [40 FR 13838, Mar. 27, 1975, as amended at 46 days or 48 hours after all symptoms FR 48642, Oct. 2, 1981; 61 FR 8873, Mar. 6, 1996; have subsided. If no improvement is 62 FR 61624, Nov. 19, 1997] seen in 5 days, review diagnosis and § 520.88 Amoxicillin oral dosage forms. change therapy. Federal law restricts this drug to use by or on the order of a § 520.88a Amoxicillin trihydrate film- licensed veterinarian. coated tablets. [57 FR 37319, Aug. 18, 1992, as amended at 60 (a) Specifications. Each tablet con- FR 55658, Nov. 2, 1995] tains amoxicillin trihydrate equivalent to 50, 100, 150, 200, or 400 milligrams of § 520.88b Amoxicillin trihydrate for amoxicillin. oral suspension. (a) Specifications. When reconstituted, 1 These conditions are NAS/NRC reviewed each milliliter contains amoxicillin and deemed effective. Applications for these trihydrate equivalent to 50 milligrams uses need not include effectiveness data as specified by § 514.111 of this chapter, but may of amoxicillin. require bioequivalency and safety informa- (b) Sponsor. See No. 000069 in tion. § 510.600(c) of this chapter.

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(1) Conditions of use—(i) Dogs—(A) and E. coli, and soft tissue infections Amount. 5 milligrams per pound of body (abscesses, wounds, lacerations) due to weight twice daily. S. aureus, Streptococcus spp., E. coli, P. (B) Indications for use. Treatment of mirabilis and Staphylococcus spp. infections caused by susceptible strains (iii) Limitations. Use for 5 to 7 days. of organisms as follows: respiratory Continue for 48 hours after all symp- tract (tonsillitis, tracheobronchitis) toms have subsided. If no improvement caused by Staphylococcus aureus, Strep- is seen in 5 days, review diagnosis and tococcus spp., Escherichia coli, and Pro- change therapy. Federal law restricts teus mirabilis; genitourinary tract (cys- this drug to use by or on the order of a titis) caused by S. aureus, Streptococcus licensed veterinarian. spp., E. coli, and P. mirabilis; gastro- (2) [Reserved] intestinal tract (bacterial gastroenteritis) caused by S. aureus, [57 FR 37319, Aug. 18, 1992; 57 FR 42623, Sept. 15, 1992, as amended at 60 FR 55658, Nov. 2, Streptococcus spp., E. coli, and P. 1995; 62 FR 13302, Mar. 20, 1997; 67 FR 67521, mirabilis; bacterial dermatitis caused Nov. 6, 2002; 68 FR 54658, Sept. 18, 2003; 68 FR by S. aureus, Streptococcus spp., and P. 55824, Sept. 29, 2003] mirabilis; and soft tissues (abscesses, lacerations, and wounds) caused by S. § 520.88c Amoxicillin trihydrate oral aureus, Streptococcus spp., E. coli, and P. suspension. mirabilis. (a) Specifications. Each 0.8-milliliter (C) Limitations. Use for 5 to 7 days or dose contains amoxicillin trihydrate 48 hours after all symptoms have sub- equivalent to 40 milligrams of sided. Federal law restricts this drug to amoxicillin. use by or on the order of a licensed vet- (b) Sponsor. See No. 000069 in erinarian. § 510.600(c) of this chapter. (ii) Cats—(A) Amount. 50 milligrams (c) Related tolerances. See § 556.510 of (5 to 10 milligrams per pound) once this chapter. daily. (d) Conditions of use. Swine—(1) (B) Indications for use. Treatment of Amount. 40 milligrams orally, twice a infections caused by susceptible strains day using a dosing pump. of organisms as follows: upper res- (2) Indications for use. Treatment of piratory tract due to Staphylococcus baby pigs under 10 pounds for porcine spp., Streptococcus spp., Hemophilus colibacillosis caused by Escherichia coli spp., E. coli, Pasteurella spp., and P. susceptible to amoxicillin. genitourinary tract (cystitis) mirabilis; (3) Limitations. Treat animals for 48 due to S. aureus, Streptococcus spp., E. hours after all symptoms have subsided coli, P. mirabilis, and Corynebacterium but not beyond 5 days. Do not slaugh- spp.; gastrointestinal tract due to E. ter during treatment or for 15 days coli, Proteus spp., Staphylococcus spp., after latest treatment. Federal law re- and Streptococcus spp.; skin and soft tis- stricts this drug to use by or on the sue (abscesses, lacerations, and order of a licensed veterinarian. wounds) due to Staphylococcus spp., Streptococcus spp., E. coli, and [57 FR 37319, Aug. 18, 1992, as amended at 60 Pasteurella multocida. FR 55658, Nov. 2, 1995] (C) Limitations. Use for 5 to 7 days or 48 hours after all symptoms have sub- § 520.88d Amoxicillin trihydrate solu- sided. Federal law restricts this drug to ble powder. use by or on the order of a licensed vet- (a) Specifications. Each gram contains erinarian. amoxicillin trihydrate equivalent to (2) [Reserved] 115.4 milligrams of amoxicillin. (c) Sponsors. See Nos. 000856 and (b) Sponsor. See No. 000069 in 051311 in § 510.600(c) of this chapter. § 510.600(c) of this chapter. (1) Conditions of use. Dogs—(i) Amount. (c) Related tolerances. See § 556.38 of 5 milligrams per pound of body weight this chapter. twice daily. (d) Conditions of use. Preruminating (ii) Indications for use. Treatment of calves including veal calves—(1) Amount. bacterial dermatitis due to S. aureus, 400 milligrams per 100 pounds of body Streptococcus spp., Staphylococcus spp., weight twice daily.

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(2) Indications for use. Treatment of to 50, 100, 200, or 400 milligrams of bacterial enteritis when due to suscep- amoxicillin. tible Escherichia coli in preruminating (b) Sponsors. See Nos. 000856 and calves including veal calves. 051311 in § 510.600(c) of this chapter. (3) Limitations. Administer by drench (c) Conditions of use—(1) Dogs—(i) or by mixing in milk. Treatment Amount. 5 milligrams per pound of body should be continued for 48 hours after weight twice a day. all symptoms have subsided but not to (ii) Indications for use. Treatment of exceed 5 days. For use in bacterial dermatitis due to Staphy- preruminating calves including veal lococcus aureus, Streptococcus spp., calves only, not for use in other ani- Staphylococcus spp., and Escherichia mals which are raised for food produc- coli; and soft tissue infections (ab- tion. Do not slaughter animals during scesses, wounds, lacerations) due to S. treatment or for 20 days after the lat- aureus, Streptococcus spp., E. coli, Pro- est treatment. Federal law restricts teus mirabilis, and Staphylococcus spp. this drug to use by or on the order of a (iii) Limitations. Use for 5 to 7 days or licensed veterinarian. 48 hours after all symptoms have sub- sided. If no improvement is seen in 5 [57 FR 37319, Aug. 18, 1992; 57 FR 42623, Sept. days, review diagnosis and change ther- 15, 1992; 58 FR 18304, Apr. 8, 1993, as amended at 60 FR 55658, Nov. 2, 1995; 62 FR 5525, Feb. apy. Federal law restricts this drug to 6, 1997] use by or on the order of a licensed vet- erinarian. § 520.88e Amoxicillin trihydrate (2) [Reserved] boluses. [57 FR 37320, Aug. 18, 1992, as amended at 62 (a) Specifications. Each bolus contains FR 13302, Mar. 20, 1997; 67 FR 67521, Nov. 6, the equivalent of 400 milligrams of 2002; 68 FR 54658, Sept. 18, 2003; 68 FR 55824, amoxicillin. Sept. 29, 2003] (b) Sponsor. See No. 000069 in § 510.600(c) of this chapter. § 520.88g Amoxicillin trihydrate and clavulanate potassium film-coated (c) Related tolerances. See § 556.38 of tablets. this chapter. (a) Each tablet con- (d) Conditions of use. Preruminating Specifications. tains amoxicillin trihydrate and calves including veal calves—(1) Amount. 400 milligrams per 100 pounds of body clavulanate potassium, equivalent to weight twice daily. either 50 milligrams of amoxicillin and 12.5 milligrams clavulanic acid, or 100 (2) Indications for use. Treatment of milligrams of amoxicillin and 25 milli- bacterial enteritis when due to suscep- grams clavulanic acid, or 200 milli- tible Escherichia coli in preruminating grams amoxicillin and 50 milligrams calves including veal calves. clavulanic acid or 300 milligrams (3) Limitations. For oral use in amoxicillin and 75 milligrams preruminating calves including veal clavulanic acid. calves only, not for use in other ani- (b) Sponsor. See No. 000069 in mals which are raised for food produc- § 510.600(c) of this chapter. tion. Treatment should be continued (c) Conditions of use—(1) Dogs—(i) for 48 hours after all symptoms have Amount. 6.25 milligrams (equivalent to subsided but not to exceed 5 days. Do 5 milligrams amoxicillin and 1.25 milli- not slaughter animals during treat- grams clavulanic acid) per pound of ment or for 20 days after the latest body weight twice daily. treatment. Federal law restricts this (ii) Indications for use. Treatment of drug to use by or on the order of a li- skin and soft tissue infections such as censed veterinarian. wounds, abscesses, cellulitis, super- [57 FR 37320, Aug. 18, 1992, as amended at 60 ficial/juvenile and deep pyoderma due FR 55659, Nov. 2, 1995; 62 FR 5526, Feb. 6, 1997] to susceptible strains of beta- lactamase (penicillinase) Staphy- § 520.88f Amoxicillin trihydrate tab- lococcus aureus, nonbeta-lactamase S. lets. aureus, Staphylococcus spp., Strepto- (a) Specifications. Each tablet con- coccus spp., and Escherichia coli. Treat- tains amoxicillin trihydrate equivalent ment of periodontal infections due to

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susceptible strains of aerobic and an- (b) Sponsor. See No. 000069 in aerobic bacteria. § 510.600(c) of this chapter. (iii) Limitations. Wounds, abscesses, (c) Conditions of use—(1) Dogs—(i) cellulitis, and superficial/juvenile Amount. 6.25 milligrams (equivalent to pyoderma: Treat for 5 to 7 days or for 5 milligrams amoxicillin and 1.25 milli- 48 hours after all signs have subsided. grams clavulanic acid) per pound of If no improvement is seen after 5 days body weight twice daily. of treatment, discontinue therapy and (ii) Indications for use. Treatment of reevaluate diagnosis. Deep pyoderma skin and soft tissue infections such as may require treatment for 21 days; do wounds, abscesses, cellulitis, super- not treat for more than 30 days. Not for ficial/juvenile and deep pyoderma due use in dogs maintained for breeding. to susceptible strains of beta- Federal law restricts this drug to use lactamase (penicillinase) producing by or on the order of a licensed veteri- Staphylococcus aureus, nonbeta- narian. lactamase Staphylococcus aureus, Staph- (2) Cats—(i) Amount. 62.5 milligrams ylococcus spp., Streptococcus spp., and (1 milliliter) (50 milligrams amoxicillin Escherichia coli. Treatment of peri- and 12.5 milligrams clavulanic acid) odontal infections due to susceptible twice daily. strains of aerobic and anaerobic bac- (ii) Indications for use. Treatment of teria. skin and soft tissue infections, such as (iii) Limitations. Administer for 5 to 7 wounds, abscesses and cellulitis/derma- days or 48 hours after all symptoms titis due to susceptible strains of beta- subsided. Deep pyoderma may require lactamase (penicillinase) producing S. 21 days, not to exceed 30 days. If no im- aureus, nonbeta-lactamase producing S. provement is seen in 5 days, dis- aureus, Staphylococcus spp., Strepto- continue therapy and reevaluate the coccus spp., E. coli, and Pasteurella spp. case. Not for use in dogs maintained Also, treatment of urinary tract infec- for breeding. Federal law restricts this tions (cystitis) due to susceptible drug to use by or on the order of a li- strains of E. coli. censed veterinarian. (iii) Limitations. Skin and soft tissue (2) Cats—(i) Amount. 62.5 milligrams infections: abscesses, cellulitis/derma- (1 milliliter) (50 milligrams of titis should be treated for 5 to 7 days or amoxicillin and 12.5 milligrams for 48 hours after all signs have sub- clavulanic acid) twice daily. sided. If no response is seen after 3 days (ii) Indications for use. Treatment of of treatment, therapy should be discon- feline skin and soft tissue infections, tinued and diagnosis reevaluated. Uri- nary tract infections may require such as wounds, abscesses and treatment for 10 to 14 days or longer. cellulitis/dermatitis due to susceptible The maximum duration of treatment strains of beta-lactamase (penicil- should not exceed 30 days. Safety of use linase) producing S. aureus, nonbeta- in pregnant or breeding animals has lactamase S. aureus, Staphylococcus not been established. Federal law re- spp., Streptococcus spp., E. coli, stricts this drug to use by or on the Pasteurella multocida, and Pasteurella order of a licensed veterinarian. spp. (iii) Limitations. Administer 48 hours [57 FR 37320, Aug. 18, 1992, as amended at 60 after all symptoms have subsided. If no FR 55659, Nov. 2, 1995; 63 FR 13121, Mar. 18, improvement is seen after 3 days of 1998] treatment, discontinue therapy and re- § 520.88h Amoxicillin trihydrate and evaluate diagnosis. Maximum duration clavulanate potassium for oral sus- of treatment should not exceed 30 days. pension. Not for use in cats maintained for (a) Specifications. When reconstituted, breeding. Federal law restricts this each milliliter contains amoxicillin drug to use by or on the order of a li- trihydrate equivalent to 50 milligrams censed veterinarian. of amoxicillin with clavulanate potas- [57 FR 37320, Aug. 18, 1992, as amended at 60 sium equivalent to 12.5 milligrams of FR 55659, Nov. 2, 1995; 63 FR 13121, Mar. 18, clavulanic acid. 1998]

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§ 520.90 Ampicillin oral dosage forms. indicated in infections caused by peni- cillinase-producing organisms. Not for § 520.90a Ampicillin capsules. use in animals which are raised for (a) Specifications. Each capsule con- food production. Federal law restricts tains 125 milligrams or 250 milligrams this drug to use by or on the order of a of ampicillin. licensed veterinarian. (b) Sponsor. See No. 000008 in [57 FR 37321, Aug. 18, 1992] § 510.600(c) of this chapter. (c) Conditions of use—(1) Dogs—(i) § 520.90b Ampicillin trihydrate tablets. Amount. 5 to 10 milligrams per pound of body weight, e.g., one 125 mg capsule (a) Specifications. Each tablet con- per 14 to 25 pounds, given 2 to 4 times tains ampicillin trihydrate equivalent daily; for animals weighing 6 to 14 to 50 or 100 milligrams of ampicillin. pounds, one capsule twice daily. (b) Sponsor. See No. 000069 in (ii) Indications for use. Treatment of § 510.600(c) of this chapter. urinary tract infections (cystitis) due (c) Conditions of use. Dogs—(1) to Proteus spp., hemolytic and non- Amount. 5 milligrams per pound of body hemolytic streptococci, beta hemolytic weight, at 8-hour intervals, 1 to 2 hours streptococci, and Escherichia coli. In prior to feeding, to be continued 36 to upper respiratory tract infections 48 hours after all symptoms have sub- tracheobronchitis (kennel cough), ton- sided. If no improvement is seen within sillitis due to alpha and beta hemolytic 5 days, stop treatment, reevaluate di- streptococci, hemolytic positive agnosis, and change therapy. staphylococci, E. coli, and Proteus spp. (2) Indications for use. Oral treatment In infections associated with abscesses, of infections caused by susceptible or- lacerations, and wounds due to Staphy- ganisms as follows: Upper respiratory lococcus spp. and Streptococcus spp. infections, tonsillitis, and bronchitis (iii) Limitations. Bacteriologic studies due to Streptococcus spp., Staphylococcus to determine the causative organisms spp., Escherichia coli, Proteus mirabilis, and their susceptibility to ampicillin and Pasteurella spp., urinary tract in- should be performed. Use of the drug is fections (cystitis) due to Streptococcus contraindicated in animals with a his- spp., Staphylococcus spp., E., coli, P. tory of an allergic reaction to any of mirabilis, and Enterococcus spp.; gastro- the penicillins. Ampicillin is contra- intestinal infections due to Staphy- indicated in infections caused by peni- lococcus spp., Streptococcus spp., cillinase-producing organisms. Not for Enterococcus spp., and E. coli. ; infec- use in animals which are raised for tions associated with abscesses, lacera- food production. Federal law restricts tions, and wounds caused by Staphy- this drug to use by or on the order of a lococcus spp., and Streptococcus spp. licensed veterinarian. (3) Limitations. Not for use in animals (2) Cats—(i) Amount. 125 milligrams which have shown hypersensitivity to twice daily; in more acute conditions penicillin or for infections caused by three times daily. penicillinase-producing organisms. Not (ii) Indications for use. Treatment of for use in animals which are raised for respiratory tract infections (bacterial food production. Federal law restricts pneumonia) due to alpha and beta he- this drug to use by or on the order of a molytic streptococci, hemolytic posi- licensed veterinarian. tive staphylococci, E. coli, and Proteus spp. In infections associated with ab- [57 FR 37321, Aug. 18, 1992, as amended at 60 scesses, lacerations, and wounds due to FR 55659, Nov. 2, 1995] Staphylococcus spp. and Streptococcus spp. § 520.90c Ampicillin trihydrate cap- sules. (iii) Limitations. Bacteriologic studies to determine the causative organisms (a) Specifications. Each capsule con- and their susceptibility to ampicillin tains ampicillin trihydrate equivalent should be performed. Use of the drug is to 125, 250, or 500 milligrams of ampi- contraindicated in animals with a his- cillin. tory of an allergic reaction to any of (b) Sponsor. See No. 055529 in the penicillins. Ampicillin is contra- § 510.600(c) of this chapter.

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(c) Conditions of use—(1) Dogs—(i) § 520.90d Ampicillin trihydrate for oral Amount. 5 to 10 milligrams per pound of suspension. body weight two or three times daily. (a) Specifications. When reconstituted In severe or acute conditions, 10 milli- as directed, each milliliter contains grams per pound of body weight, three ampicillin trihydrate equivalent to 25 times daily. Administer 1 to 2 hours milligrams of ampicillin. prior to feeding. (ii) Indications for use. Treatment (b) Sponsor. See No. 055529 in against strains of gram-negative and § 510.600(c) of this chapter. gram-positive organisms sensitive to (c) Conditions of use—(1) Dogs—(i) ampicillin and associated with res- Amount. 5 to 10 milligrams per pound of piratory tract infections body weight orally, 2 or 3 times daily, (tracheobronchitis and tonsillitis); uri- 1 to 2 hours prior to feeding. In severe nary tract infections (cystitis); bac- or acute conditions, 10 milligrams per terial gastroenteritis; generalized in- pound of body weight 3 times daily. fections (septicemia) associated with (ii) Indications for use. Treatment of abscesses, lacerations, and wounds; and respiratory tract infections bacterial dermatitis. (tracheobronchitis and tonsillitis) due (iii) Limitations. The drug may be to Escherichia coli, Pseudomonas spp., given as an emergency measure; how- Proteus spp., Staphylococcus spp., and ever, in vitro sensitivity tests on sam- Streptococcus spp., urinary tract infec- ples collected prior to treatment tions (cystitis) due to E. coli, Staphy- should be made. Ampicillin is contra- lococcus spp., Streptococcus spp., and indicated for use in infections caused Proteus spp.; bacterial gastroenteritis by penicillinase-producing organisms due to E. coli; generalized infections and for use in animals known to be al- (septicemia) associated with abscesses, lergic to any of the penicillins. Not for lacerations, and wounds, due to Staphy- use in animals raised for food produc- lococcus spp. and Streptococcus spp.; bac- tion. Federal law restricts this drug to terial dermatitis due to Staphylococcus use by or on the order of a licensed vet- spp., Streptococcus spp., Proteus spp., erinarian. and Pseudomonas spp. (2) Cats—(i) Amount. 10 to 30 milli- (iii) Limitations. Duration of treat- grams per pound of body weight or ment is usually 3 to 5 days. Continue three times daily. Administer 1 to 2 treatment 48 hours after the animal’s hours prior to feeding. temperature has returned to normal (ii) Indications for use. Treatment and all other signs of infection have against strains of gram-negative and subsided. If no response is obtained gram-positive organisms sensitive to within 3 to 5 days, reevaluate diagnosis ampicillin and associated with res- and treatment. Appropriate laboratory piratory tract infections (bacterial tests should be conducted, including in pneumonia); urinary tract infections vitro culturing and susceptibility tests (cystitis); and generalized infections on samples collected prior to treat- (septicemia) associated with abscesses, ment. Federal law restricts this drug lacerations, and wounds. to use by or on the order of a licensed (iii) Limitations. The drug may be veterinarian. given as an emergency measure; how- (2) Cats—(i) Amount. 10 to 30 milli- ever, in vitro sensitivity tests on sam- grams per pound of body weight orally, ples collected prior to treatment 2 or 3 times daily, 1 to 2 hours prior to should be made. Ampicillin is contra- feeding. indicated for use in infections caused (ii) Indications for use. Treatment of by penicillinase-producing organisms respiratory tract infections (bacterial and for use in animals known to be al- pneumonia) due to Staphylococcus spp., lergic to any of the penicillins. Not for Streptococcus spp., E. coli, and Proteus use in animals raised for food produc- spp.; urinary tract infections (cystitis) tion. Federal law restricts this drug to due to E. coli, Staphylococcus spp., use by or on the order of a licensed vet- Streptococcus spp., Proteus spp., and erinarian. Corynebacterium spp.; generalized infec- [57 FR 37321, Aug. 18, 1992, as amended at 58 tions (septicemia) associated with ab- FR 61016, Nov. 19, 1993] scesses, lacerations, and wounds, due

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to Staphylococcus spp., Streptococcus paragraph (d)(1), 000069 for use as in spp., Bacillus spp., and Pasteurella spp. paragraph (d)(2). (iii) Limitations. Duration of treat- (c) Related tolerances. See § 556.40 of ment is usually 3 to 5 days. Continue this chapter. treatment 48 hours after the animal’s (d) Conditions of use. Nonruminating temperature has returned to normal calves—(1) Amount. 5 milligrams per and all other signs of infection have pound of body weight twice daily for up subsided. If no response is obtained to 5 days. within 3 to 5 days, reevaluate diagnosis (i) Indications for use. Oral treatment and treatment. Appropriate laboratory of colibacillosis caused by Escherichia tests should be conducted, including in coli, bacterial enteritis caused by Sal- vitro culturing and susceptibility tests monella spp., and bacterial pneumonia on samples collected prior to treat- caused by Pasteurella spp. ment. Federal law restricts this drug (ii) Limitations. Treated calves must to use by or on the order of a licensed not be slaughtered for food during veterinarian. treatment and for 15 days after the last treatment. Not for use in other ani- [57 FR 37321, Aug. 18, 1992, as amended at 58 FR 61016, Nov. 19, 1993] mals raised for food production. Fed- eral law restricts this drug to use by or § 520.90e Ampicillin trihydrate soluble on the order of a licensed veterinarian. powder. (2) Amount. 5 milligrams per pound of (a) Specifications. Each gram contains body weight twice daily not to exceed 4 ampicillin trihydrate equivalent to 88.2 days. milligrams of ampicillin. (i) Indications for use. Oral treatment of bacterial enteritis (colibacillosis) (b) Sponsor. See No. 055529 in caused by § 510.600(c) of this chapter. E. coli. (ii) Limitations. Treated calves must (c) Related tolerances. See § 556.40 of not be slaughtered for food during this chapter. treatment and for 7 days after the last (d) Conditions of use. Swine—(1) treatment. Not for use in other ani- Amount. 5 milligrams of ampicillin per mals raised for food production. Fed- pound of body weight twice daily, oral- eral law restricts this drug to use by or ly by gavage or in drinking water for on the order of a licensed veterinarian. up to 5 days. (2) Indications for use. Oral treatment [57 FR 37322, Aug. 18, 1992, as amended at 58 of porcine colibacillosis (Escherichia FR 61016, Nov. 19, 1993; 60 FR 55659, Nov. 2, coli) and salmonellosis (Salmonella spp.) 1995] infections in swine up to 75 pounds of § 520.100 Amprolium oral dosage body weight, and bacterial pneumonia forms. caused by Pasteurella multocida, Staphy- lococcus spp., Streptococcus spp., and § 520.100a Amprolium drinking water. Salmonella spp. (a) Chemical name. 1-(4-Amino-2-n- (3) Limitations. For use in swine only. propyl-5-pyrimidinylmethyl)-2- Not for use in other animals which are picolinium chloride hydrochloride. raised for food production. Treated (b) Sponsor. See No. 050604 in § 510.600 swine must not be slaughtered for food (c) of this chapter. during treatment and for 24 hours fol- (c) Related tolerances. See § 556.50 of lowing the last treatment. Federal law this chapter. restricts this drug to use by or on the (d) Conditions of use. It is used in order of a licensed veterinarian. drinking water as follows: [57 FR 37322, Aug. 18, 1992, as amended at 58 (1) Chickens and turkeys—(i) Amount. FR 61016, Nov. 19, 1993] 20 percent soluble powder. (ii) Indications for use. Treatment of § 520.90f Ampicillin trihydrate boluses. coccidiosis. (a) Specifications. Each bolus contains (iii) Limitations. Administer at the ampicillin trihydrate equivalent to 400 0.012 percent level in drinking water as milligrams of ampicillin. soon as coccidiosis is diagnosed and (b) Sponsor. See No. 055529 in continue for from 3 to 5 days (in severe § 510.600(c) of this chapter for use as in outbreaks, give amprolium at the 0.024

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percent level); continue with 0.006 per- (d) Conditions of use. It is used for cent amprolium-medicated water for calves as follows: an additional 1 to 2 weeks; no other (1) Amount. 9.6 percent solution or 20 source of drinking water should be percent soluble powder. available to the birds during this time; (i) Indications for use. As an aid in the as sole source of amprolium. treatment of coccidiosis caused by (2) Calves—(i) Amount. 9.6 percent so- Eimeria bovis and E. zurnii. lution or 20 percent soluble powder. (ii) Limitations. Add 3 fluid ounces of (a) Indications for use. As an aid in the 9.6 percent solution to 1 pint of the treatment of coccidiosis caused by water or 3 ounces of the 20 percent Eimeria bovis and E. zurnii. soluble powder to each quart of water (b) Limitations. Add 16 fluid ounces of and with a dose syringe administer 1 the 9.6 percent solution to each 100 gal- fluid ounce of this solution for each 100 lons of drinking water; or 4 ounces of pounds of body weight; this will pro- the soluble powder to each 50 gallons of vide a dose of approximately 10 milli- drinking water; at the usual rate of grams per kilogram (2.2 pounds) of water consumption, this will provide body weight; administer daily for 5 an intake of approximately 10 milli- days; for a satisfactory diagnosis, a mi- grams per kilogram (2.2 pounds) of croscopic examination of the feces body weight; offer this solution as the should be done by a veterinarian or di- only source of water for 5 days; for a agnostic laboratory before treatment; satisfactory diagnosis, a microscopic when treating outbreaks, the drug examination of the feces should be should be administered promptly after done by a veterinarian or diagnostic diagnosis is determined; withdraw 24 laboratory before treatment; when hours before slaughter. treating outbreaks, the drug should be (2) Amount. 9.6 percent solution or 20 administered promptly after diagnosis percent soluble powder. is determined; withdraw 24 hours be- (i) Indications for use. As an aid in the fore slaughter. prevention of coccidiosis caused by Eimeria bovis and E. zurnii. (ii) Amount. 9.6 percent solution or 20 (ii) Limitations. Add 11⁄2 fluid ounces percent soluble powder. of the 9.6 percent solution to 1 pint of (a) Indications for use. As an aid in water or 11⁄2 ounces of the 20 percent the prevention of coccidiosis caused by soluble powder to each quart of water Eimeria bovis and E. zurnii. and with a dose syringe administer 1 (b) Limitations. Add 8 fluid ounces of fluid ounce of this solution for each 100 the 9.6 percent solution or 4 ounces of pounds of body weight; this will pro- the 20 percent soluble powder to each vide a dose of approximately 5 milli- 100 gallons of drinking water; at the grams per kilogram (2.2 pounds) of usual rate of water consumption, this body weight; administer daily for 21 will provide an intake of approxi- days during periods of exposure or mately 5 milligrams per kilogram (2.2 when experience indicates that coccidi- pounds) of body weight; offer this solu- osis is likely to be a hazard; withdraw tion as the only source of water for 21 24 hours before slaughter. days during periods of exposure or when experience indicates that coccidi- [40 FR 13838, Mar. 27, 1975, as amended at 62 osis is likely to be a hazard; withdraw FR 63270, Nov. 28, 1997] 24 hours before slaughter. § 520.100c Amprolium crumbles. [40 FR 13838, Mar. 27, 1975, as amended at 62 (a) Specifications. Amprolium crum- FR 63270, Nov. 28, 1997] bles contain 1.25 percent amprolium. (b) Sponsor. See No. 050604 in § 520.100b Amprolium drench. § 510.600(c) of this chapter. (a) Chemical name. 1-(4-Amino-2-n- (c) Related tolerances. See § 556.50 of propyl - 5 - pyrimidinylmethyl) - 2 - this chapter. picolinium chloride hydrochloride. (d) Conditions of use. It is top-dressed (b) Sponsor. See No. 050604 in on or thoroughly mixed in the daily § 510.600(c) of this chapter. feed ration of calves as follows: (c) Related tolerances. See § 556.50 of (1) Amount. 1.6 ounces of crumbles per this chapter. 250 pounds of body weight per day (5

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milligrams per kilogram of body should be adjusted according to water weight). consumption which varies depending (i) Indications for use. As an aid in the on ambient temperature, humidity, prevention of coccidiosis caused by and other factors. Eimeria bovis and E. zurnii. (3) Prepare fresh medicated water (ii) Limitations. Administer for 21 con- daily. secutive days during periods of expo- (4) Do not slaughter treated swine for sure or when experience indicates that 28 days following treatment coccidiosis is likely to be a hazard. Withdraw 24 hours before slaughter. [47 FR 15771, Apr. 13, 1982, as amended at 49 Use as sole source of amprolium. FR 19642, May 9, 1984; 53 FR 37753, Sept. 28, (2) Amount. 3.2 ounces of crumbles per 1988] 250 pounds of body weight per day (10 § 520.154 Bacitracin oral dosage forms. milligrams per kilogram of body weight). § 520.154a Soluble bacitracin meth- (i) Indications for use. As an aid in the ylene disalicylate. treatment of coccidiosis caused by (a) Specifications. Each pound of solu- Eimeria bovis and E. zurnii. ble powder contains the equivalent of (ii) Limitations. Administer for 5 con- 50 grams of bacitracin activity for use secutive days. For satisfactory diag- as in paragraph (d)(1) or (d)(2) of this nosis, a microscopic fecal examination section, or the equivalent of 200 grams should be done by a veterinarian or di- of bacitracin activity for use as in agnostic laboratory before treatment. paragraph (d) of this section. When treating outbreaks, the drug should be administered promptly after (b) Sponsor. See No. 046573 in diagnosis is determined. Withdraw 24 § 510.600(c) of this chapter. hours before slaughter. Use as sole (c) Related tolerances. See § 556.70 of source of amprolium. this chapter. (d) Conditions of use—(1) Growing tur- [42 FR 41855, Aug. 19, 1977, as amended at 62 keys—(i) Amount. 400 milligrams per FR 63270, Nov. 28, 1997] gallon in drinking water. § 520.110 Apramycin sulfate soluble (ii) Indications for use. Aid in the con- powder. trol of transmissible enteritis com- plicated by organisms susceptible to (a) Specifications. A water soluble bacitracin methylene disalicylate. powder used to make a medicated (iii) Limitations. Prepare a fresh solu- drinking water containing apramycin tion daily. sulfate equivalent to 0.375 gram of apramycin activity per gallon of drink- (2) Broiler and replacement chickens— ing water. (i) Amount. 100 milligrams per gallon in (b) Sponsor. See No. 000986 in drinking water. § 510.600(c) of this chapter. (A) Indications for use. Aid in the pre- (c) Related tolerances. See § 556.52 of vention of necrotic enteritis caused by this chapter. Clostridium perfringens susceptible to (d) Conditions of use. (1) In swine for bacitracin methylene disalicylate. control of porcine colibacillosis (B) Limitations. Prepare a fresh solu- (weanling pig scours) caused by strains tion daily. of E. coli sensitive to apramycin. (ii) Amount. 200 to 400 milligrams per (2) It is administered for 7 days in gallon in drinking water. drinking water at the rate of 12.5 milli- (A) Indications for use. Aid in the con- grams of apramycin per kilogram (5.7 trol of necrotic enteritis caused by C. milligrams per pound) of body weight perfringens susceptible to bacitracin per day. Swine will normally consume methylene disalicylate. 1 gallon per day of medicated water (B) Limitations. Prepare a fresh solu- containing 375 milligrams of tion daily. apramycin for each 66 pounds of body (3) Swine—(i) Amount. 1 gram per gal- weight. Water consumption should be lon in drinking water. monitored to determine that the re- (ii) Indications for use. Treatment of quired amount of apramycin is being swine dysentery associated with consumed. The drug concentration Treponema hyodysenteriae. Administer

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continuously for 7 days or until signs (c) Related tolerances. See § 556.70 of of dysentery disappear. this chapter. (iii) Limitations. Prepare a fresh solu- (d) Conditions of use. (1) Broiler chick- tion daily. Treatment not to exceed 14 ens—(i) Amount. 100 milligrams per gal- days. If symptoms persist after 4 to 5 lon in drinking water. days consult a veterinarian. Not to be (A) Indications for use. Prevention of given to swine that weigh more than necrotic enteritis caused by Clostridium 250 pounds. perfringens susceptible to bacitracin (4) Growing quail—(i) Amount. 400 mil- zinc. ligrams per gallon in drinking water. (B) Limitations. Prepare a fresh solu- (ii) Indications for use. For prevention tion daily. of ulcerative enteritis due to Clos- (ii) Amount. 200 to 400 milligrams per tridium colinum susceptible to baci- gallon in drinking water. tracin methylene disalicylate. (A) Indications for use. Control of ne- (iii) Limitations. Prepare fresh solu- crotic enteritis caused by Clostridium tion daily. Use as sole source of drink- perfringens susceptible to bacitracin ing water. zinc. [57 FR 37322, Aug. 18, 1992; 57 FR 42623, Sept. (B) Limitations. Prepare a fresh solu- 15, 1992, as amended at 63 FR 38474, July 17, tion daily. 1998; 64 FR 13068, Mar. 17, 1999] (2) Growing quail—(i) Amount. 500 mil- § 520.154b Soluble bacitracin meth- ligrams per gallon in drinking water ylene disalicylate and streptomycin for 5 days followed by 165 milligrams sulfate oral powder. per gallon in drinking water for 10 days. (a) Specifications. Each gram contains 200 units of soluble bacitracin meth- (ii) Indications for use. Control of ul- ylene disalicylate, streptomycin sul- cerative enteritis caused by Clostridium fate equivalent to 20 milligrams of spp. susceptible to bacitracin zinc. streptomycin, and 850 milligrams of (iii) Limitations. Prepare a fresh solu- carob flour. tion daily. (b) Sponsor. See No. 062925 in [57 FR 37322, Aug. 18, 1992, as amended at 67 § 510.600(c) of this chapter. FR 78355, Dec. 24, 2002] (c) Conditions of use. Dogs—(1) Amount. 1 level teaspoonful per 10 § 520.182 Bicyclohexylammonium pounds of body weight three times fumagillin. daily, mixed in a small quantity of liq- (a) Specifications. The drug is a sol- uid or feed. uble powder containing (2) Indications for use. Treatment of bicyclohexylammonium fumagillin and bacterial enteritis caused by pathogens appropriate phosphate buffers. susceptible to bacitracin and strepto- (b) Sponsor. See No. 059620 in mycin such as Escherichia coli, Proteus § 510.600(c) of this chapter. spp., Staphylococcus spp., and Strepto- (c) Conditions of use. (1) The drug is coccus spp., and for the symptomatic used for the prevention of nosema in treatment of associated diarrhea. honey bees.1 (3) Limitations. If no improvement is (2) It is administered usually in a 2:1 noted in 2 to 3 days, diagnosis should sugar sirup containing a concentration be reevaluated. Federal law restricts of from 75 to 100 milligrams of this drug to use by or on the order of a fumagillin activity per gallon of sugar licensed veterinarian. sirup.1 [57 FR 37322, Aug. 18, 1992, as amended at 61 (3) Colonies used for package produc- FR 66581, Dec. 18, 1996] tion should be fed medicated sirup as a principal food supply for a month prior § 520.154c Bacitracin zinc soluble pow- der. 1 (a) Specifications. Each pound con- These conditions are NAS/NRC reviewed and deemed effective. Applications for these tains the equivalent of not less than 5 uses need not include effectiveness data as grams of bacitracin. specified by § 514.111 of this chapter, but may (b) Sponsor. See No. 053501 in require bioequivalency and safety informa- § 510.600(c) of this chapter. tion.

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to stocking nuclei or shaking packages (2) Indications for use. For the relief of for market.1 chronic nonproductive cough associ- (4) The medicated sirup should not be ated with tracheo-bronchitis, tra- fed immediately before or during the cheitis, tonsillitis, laryngitis, and honey flow. pharyngitis associated with inflam- matory conditions of the upper res- [40 FR 13838, Mar. 27, 1975, as amended at 42 FR 65151, Dec. 30, 1977; 56 FR 43699, Sept. 4, piratory tract. 1991; 58 FR 5608, Jan. 22, 1993] (3) Limitations. For oral use in dogs only. Repeat at intervals of 6 to 12 § 520.222 Bunamidine hydrochloride. hours as required. If necessary, in- (a) Chemical name. N,N-Dibutyl-4- crease dose to a maximum of 0.5 milli- (hexyloxy)-1-naphthamidine hydro- gram per pound of body weight. Treat- chloride. ment should not normally be required (b) Specifications. The drug is an oral for longer than 7 days. Federal law re- tablet containing 100, 200, or 400 milli- stricts this drug to use by or on the grams of bunamidine hydrochloride. order of a licensed veterinarian. (c) Sponsor. See No. 000061 in [47 FR l4702, Apr. 6, 1982, as amended at 53 FR § 510.600(c) of this chapter. 27851, July 25, 1988] (d) Conditions of use. (1) The drug is intended for oral administration to § 520.260 n-Butyl chloride capsules. dogs for the treatment of the tape- (a)(1) Specifications. n-Butyl chloride worms Dipylidium caninum, Taenia capsules, veterinary contain 272 milli- pisiformis, and Echinococcus granulosus, grams or 816 milligrams of n-butyl and to cats for the treatment of the chloride in each capsule. tapeworms Dipylidium caninum and (2) Sponsor. See No. 021091 in Taenia taeniaeformis. § 510.600(c) of this chapter. (2) It is administered to cats and dogs (3) Conditions of use. (i) It is used for at the rate of 25 to 50 milligrams per the removal of ascarids (Toxocara canis kilogram of body weight. The drug and Toxascaris leonina) and hookworms should be given on an empty stomach (Ancylostoma caninum, Ancylostoma and food should not be given for 3 braziliense, and Uncinaria stenocephala) hours following treatment. from dogs and of the ascarid (Toxocara (3) Tablets should not be crushed, cati) and hookworm (Ancylostoma mixed with food, or dissolved in liquid. tubaeforme) from cats. Repeat treatments should not be given (ii)(a) Animals should not be fed for within 14 days. The drug should not be 18 to 24 hours before being given the given to male dogs within 28 days prior drug. Puppies and kittens should be to their use for breeding. Do not ad- wormed at 6 weeks of age. However, if minister to dogs or cats having known heavily infested, they may be wormed heart conditions. at 4 or 5 weeks of age. Administration (4) For use only by or on the order of of the drug should be followed in 1⁄2 to a licensed veterinarian. 1 hour with a teaspoonful to a table- [40 FR 13838, Mar. 27, 1975, as amended at 42 spoonful of milk of magnesia or 1 or 2 FR 13018, Mar. 8, 1977; 46 FR 48642, Oct. 2, milk of magnesia tablets. Normal ra- 1981; 61 FR 8873, Mar. 6, 1996; 62 FR 61624, tions may be resumed 4 to 8 hours after Nov. 19, 1997] treatment. Puppies and kittens should be given a repeat treatment in a week § 520.246 Butorphanol tartrate tablets. or 10 days. After that they should be (a) Specifications. Each tablet con- treated every 2 months (or as symp- tains 1, 5, or 10 milligrams of toms reappear) until a year old. When butorphanol base activity as the puppy or kitten is a year old, one butorphanol tartrate. treatment every 3 to 6 months is suffi- (b) Sponsor. See No. 000856 in cient. § 510.600(c) of this chapter. (b) For dogs or cats that have been (c) Conditions of use. The drug is used wormed regularly, treatment every 3 to for the treatment of dogs as follows: 6 months will be sufficient. If a dog or (1) Amount. 0.25 milligram of cat has not been wormed previously butorphanol base activity per pound of and has the symptoms of large body weight. roundworms a dose should be given and

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repeated in 10 days. Removal of tered to dogs weighing under 5 pounds hookworms may require 3 or 4 doses at at a dosage level of 1 capsule per 11⁄4 10-day intervals. pound of body weight. Capsules con- (c) Puppies, dogs, cats, or kittens taining 442 milligrams of n-butyl chlo- weighing 1 to 3 pounds should be given ride are administered to dogs weighing 2 capsules per dose which contain 272 under 5 pounds at a dosage level of 1 milligrams of n-butyl chloride each. capsule per 21⁄2 pounds body weight. Such animals weighing 4 to 5 pounds Capsules containing 884 milligrams of should be given 3 such capsules. Ani- n-butyl chloride are administered to mals weighing 6 to 7 pounds should be dogs as follows: Weighing under 5 given 4 such capsules and animals pounds, 1 capsule; weighing 5 to 10 weighing 8 to 9 pounds should be given pounds, 2 capsules; weighing 10 to 20 5 such capsules. Animals weighing 10 to pounds, 3 capsules; weighing 20 to 40 20 pounds should be given 3 capsules pounds, 4 capsules; over 40 pounds, 5 which contain 816 milligrams of n- capsules. Capsules containing 1,768 mil- butyl chloride each, animals weighing ligrams of n-butyl chloride are admin- 20 to 40 pounds should be given 4 such istered at a dosage level of 1 capsule capsules and animals weighing over 40 pounds should be given 5 such capsules per dog weighing 5 to 10 pounds. Cap- with the maximum dosage being 5 cap- sules containing 4.42 grams of n-butyl sules, each of which contains 816 milli- chloride are administered at a dosage grams of n-butyl chloride. level of 1 capsule per dog weighing 40 (iii) A veterinarian should be con- pounds or over. 1 sulted before using in severely debili- (iii) A veterinarian should be con- tated dogs or cats and also prior to re- sulted before using in severely debili- peated use in cases which present signs tated dogs. 1 of persistent parasitism. (c)(1) Specifications. n-Butyl chloride (b)(1) Specifications. n-Butyl chloride capsules, veterinary contain 884 or 1,768 capsules contain 221, 442, 884, or 1,768 milligrams or 4.42 grams of n-butyl milligrams or 4.42 grams of n-butyl chloride in each capsule. chloride in each capsule. 1 (2) Sponsor. See No. 000115 in (2) Sponsors. See No. 023851 in § 510.600(c) of this chapter. § 510.600(c) of this chapter for 221, 442, (3) Conditions of use. (i) It is used for 884, or 1,768 milligram or 4.42 gram cap- the removal of ascarids (Toxocara canis sules; No. 000115 or 038782 for 884 or 1,768 and Toxascaris leonina) and hookworms milligram or 4.42 gram capsules; and (Ancyclostoma caninum, Ancyclostoma No. 000069 for 221 milligram capsules. braziliense, and Uncinaria stenocephala) (3) Conditions of use. (i) It is used for from dogs. the removal of ascarids (Toxocara canis (ii)(a) Dogs should not be fed for 18 to and Toxascaris leonina) and hookworms 24 hours before being given the drug. (Ancylostoma caninum, Ancylostoma Administration of the drug should be braziliense, and Uncinaria stenocephala) 1 from dogs. 1 followed in ⁄2 to 1 hour with a mild ca- (ii)(a) Dogs should not be fed for 18 to thartic. Normal rations may be re- 24 hours before being given the drug. sumed 4 to 8 hours after treatment. Administration of the drug should be (b) The drug is administered orally to followed in 1⁄2 to 1 hour with a mild ca- dogs. Capsules containing 884 milli- thartic. Normal feeding may be re- grams of n-butyl chloride are adminis- sumed 4 to 8 hours after treatment. tered to dogs as follows: weighing Animals subject to reinfection may be under 5 pounds, 1 capsule; weighing 5–10 retreated in 2 weeks. 1 pounds, 2 capsules; weighing 10–20 (b) The drug is administered orally to pounds, 3 capsules; weighing 20–40 dogs. Capsules containing 221 milli- pounds, 4 capsules; over 40 pounds, 5 grams of n-butyl chloride are adminis- capsules. Capsules containing 1,768 mil- ligrams of n-butyl chloride are admin- 1 These conditions are NAS/NRC reviewed istered at a dosage level of 1 capsule and deemed effective. Applications for these per dogs to dogs weighing 5–10 pounds uses need not include effectiveness data as and 2 capsules per dog to dogs weighing specified by § 514.111 of this chapter. 20–40 pounds. Capsules containing 4.42

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grams of n-butyl chloride are adminis- edentatus, S. equinus); small strongyles tered at dosage level of 1 capsule per (Trichonema, Poteriostomum, dog to dogs weighing 40 pounds or over. Cylicobrachytus, Craterostomum, (iii) A veterinarian should be con- Oesophagodontus); roundworms sulted before using in severely debili- (Parascaris); pinworms (Oxyuris); and tated dogs. threadworms (Strongyloides). [40 FR 13838, Mar. 27, 1975, as amended at 40 (2) Administer 20 milligrams FR 39858, Aug. 29, 1975; 44 FR 10059, Feb. 16, cambendazole per kilogram body 1979; 54 FR 38515, Sept. 19, 1989; 55 FR 24556, weight (6 ounces per 1,000 pounds) by June 18, 1990; 64 FR 15684, Apr. 1, 1999] mixing with normal grain ration given at one feeding. Doses for individual § 520.300 Cambendazole oral dosage horses should be mixed and fed sepa- forms. rately to assure that each horse will § 520.300a Cambendazole suspension. consume the correct amount. (3) For animals maintained on prem- (a) Specifications. Each fluid ounce ises where reinfection is likely to contains 0.9 gram of cambendazole. occur, re-treatments may be necessary. (b) Sponsor. No. 050604 in § 510.600(c) of this chapter. For most effective results, re-treat in 6 (c) Conditions of use. (1) It is used in to 8 weeks. horses for the control of large (4) Not for use in horses intended for strongyles (Strongylus vulgaris, S. food. edentatus, S. equinus); small strongyles (5) Caution: Do not administer to (Trichonema, Poteriostomum, pregnant mares during first 3 months Cylicobrachytus, Craterostomum, of pregnancy. Oesophagodontus); roundworms (6) Consult your veterinarian for as- (Parascaris); pinworms. (Oxyuris); and sistance in the diagnosis, treatment, threadworms (Strongyloides). and control of parasitism. (2) It is administered by stomach [41 FR 1276, Jan. 7, 1976, as amended at 42 FR tube or as a drench at a dose of 0.9 3838, Jan. 21, 1977; 62 FR 63270, Nov. 28, 1997] gram of cambendazole per 100 pounds of body weight (20 milligrams per kilo- § 520.300c Cambendazole paste. gram). (3) For animals maintained on prem- (a) Specifications. The drug is a paste ises where reinfection is likely to containing 45 percent cambendazole. occur, re-treatments may be necessary. (b) Sponsor. No. 050604 in § 510.600(c) of For most effective results, re-treat in 6 this chapter. to 8 weeks. (c) Conditions of use. (1) It is used in (4) Not for use in horses intended for horses for the control of large food. strongyles (Strongylus vulgaris, S. (5) Caution: Do not administer to edentatus, S. equinus); small strongyles pregnant mares during first 3 months (Trichonema, Poteriostomum, of pregnancy. Cylicobrachytus, Craterostomum, (6) Federal law restricts this drug to Oesophagodontus); roundworms use by or on the order of a licensed vet- (Parascaris); pinworms (Oxyuris); and erinarian. threadworms (Strongyloides). [40 FR 13838, Mar. 27, 1975. Redesignated at 41 (2) Administer 20 milligrams FR 1276, Jan. 7, 1976, and amended at 42 FR cambendazole per kilogram body 3838, Jan. 21, 1977; 62 FR 63270, Nov. 28, 1997] weight (5 grams per 550 pounds (250 kilograms)) by depositing the paste on § 520.300b Cambendazole pellets. the back of the tongue using a dosing (a) Specifications. The drug is in feed gun. pellets containing 5.3 percent (3) For animals maintained on prem- cambendazole. ises where reinfection is likely to (b) Sponsor. No. 050604 in § 510.600(c) of occur, re-treatments may be necessary. this chapter. For most effective results, re-treat in 6 (c) Conditions of use. (1) It is used in to 8 weeks. horses for the control of large (4) Not for use in horses intended for strongyles (Strongylus vulgaris, S. food.

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(5) Caution: Do not administer to § 520.312 Carnidazole tablets. pregnant mares during first 3 months (a) Specifications. Each tablet con- of pregnancy. tains 10 milligrams of carnidazole. (6) Consult your veterinarian for as- (b) Sponsor. See 053923 in § 510.600(c) of sistance in the diagnosis, treatment, this chapter. and control of parasitism. (c) Conditions of use—(1) Amount. [41 FR 1276, Jan. 7, 1976, as amended at 42 FR Adult pigeons: 1 tablet (10 milligrams); 3838, Jan. 21, 1977; 62 FR 63270, Nov. 28, 1997] newly weaned pigeons: 1⁄2 tablet (5 mil- ligrams). § 520.309 Carprofen. (2) Indications for use. For treating (a) Specifications. (1) Each caplet con- trichomoniasis (canker) in ornamental tains 25, 75, or 100 milligrams (mg) and homing pigeons. carprofen. (3) Limitations. Not for use in pigeons (2) Each chewable tablet contains 25, intended for human food. Consult your 75, or 100 mg carprofen. veterinarian for assistance in the diag- (b) Sponsor. See No. 000069 in nosis, treatment, and control of para- § 510.600(c) of this chapter. sitism or when severely ill birds do not (c) [Reserved] respond to treatment. (d) Conditions of use in dogs—(1) Amount. 2 mg per pound (/lb) of body [54 FR 32336, Aug. 7, 1989] weight once daily or 1 mg/lb twice daily. For the control of postoperative § 520.314 Cefadroxil tablets. pain, administer approximately 2 hours (a) Specifications. 50-, 100-, and 200- before the procedure. milligram tablets for dogs and cats; 1 (2) Indications for use. For the relief of gram tablet for dogs. pain and inflammation associated with (b) Sponsor. See No. 000856 in osteoarthritis, and for the control of § 510.600(c) of this chapter. postoperative pain associated with soft (c) Conditions of use. (1) For use in tissue and orthopedic surgery. dogs as follows: (3) Limitations. Federal Law restricts (i) Indications for use. For the treat- this drug to use by or on the order of a ment of skin and soft tissue infections licensed veterinarian. including cellulitis, pyoderma, derma- titis, wound infections, and abscesses [61 FR 66581, Dec. 18, 1996, as amended at 64 due to susceptible strains of Staphy- FR 32181, June 16, 1999; 66 FR 63165, Dec. 5, 2001; 67 FR 6866, Feb. 14, 2002; 67 FR 65038, lococcus aureus. For the treatment of Oct. 23, 2002; 67 FR 65697, Oct. 28, 2002] genitourinary tract infections (cys- titis) due to susceptible strains of Esch- § 520.310 Caramiphen erichia coli, Proteus mirabilis, and Staph- ethanedisulfonate and ammonium ylococcus aureus. chloride tablets. (ii) Amount. Ten milligrams per (a) Specifications. Each tablet con- pound of body weight twice daily. tains 10 milligrams of 5stcaramiphen (iii) Limitations. The drug is adminis- ethanedisulfonate and 80 milligrams of tered orally. For skin and soft tissue ammonium chloride.1 infections, treatment should be contin- (b) Sponsor. See No. 000856 in ued for a minimum of 3 days. For geni- § 510.600(c) of this chapter. tourinary tract infections, treatment (c) Conditions of use in dogs—(1) should be continued for a minimum of Amount. One tablet per 15 to 30 pounds 7 days. Continue treatment at least 48 of body weight every 4 to 6 hours.1 hours after the dog has become afebrile (2) Indications for use. For relief of or asymptomatic. If no response is seen cough.1 after 3 days of treatment, therapy [43 FR 55385, Nov. 28, 1978] should be discontinued and the case re- evaluated. Do not treat for more than 30 days. Safety for use in pregnant 1 These conditions are NAS/NRC reviewed bitches and stud dogs has not been de- and deemed effective. Applications for these uses need not include effectiveness data as termined. Federal law restricts this specified by § 514.111 of this chapter, but may drug to use by or on the order of a li- require bioequivalency and safety informa- censed veterinarian. tion. (2) For use in cats as follows:

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(i) Indications for use. For the treat- (3) Limitations. Discard unused por- ment of skin and soft tissue infections tion of reconstituted product after 14 including abscesses, wound infections, days. Treatment should continue for 48 cellulitis, and dermatitis caused by hours after animal is afebrile or susceptible strains of Pasteurella asymptomatic. If no response after 3 multocida, Staphylococcus aureus, Staph- days, discontinue treatment and re- ylococcus epidermidis, and Streptococcus evaluate therapy. Not for use in ani- spp. mals raised for food production. Safe (ii) Amount. Ten milligrams per use in pregnant or breeding animals pound of body weight once daily. has not been established. Federal law (iii) Limitations. The drug is adminis- restricts this drug to use by or on the tered orally. Continue treatment at order of a licensed veterinarian. least 48 hours after the cat has become afebrile or asymptomatic. If no re- [53 FR 27344, July 20, 1988] sponse is seen after 3 days of treat- § 520.370 Cefpodoxime tablets. ment, therapy should be discontinued and the case reevaluated. Do not treat (a) Specifications. Each tablet con- for more than 21 days. Safety for use in tains cefpodoxime proxetil equivalent pregnant cats and breeding male cats to 100 or 200 milligrams (mg) has not been determined. Federal law cefpodoxime. restricts this drug to use by or on the (b) Sponsors. See No. 000009 in order of a licensed veterinarian. § 510.600(c) of this chapter. [47 FR 41105, Sept. 17, 1982, as amended at 49 (c) Conditions of use in dogs—(1) FR 43052, Oct. 26, 1984; 51 FR 4165, Feb. 3, 1986; Amount. 5 to 10 mg per kilogram (2.3 to 52 FR 11989, Apr. 14, 1987; 53 FR 27851, July 25, 4.5 mg per pound) body weight daily for 1988] 5 to 7 days, or for 2 to 3 days beyond the cessation of clinical signs, up to a § 520.315 Cefadroxil powder for oral maximum of 28 days. suspension. (2) Indications for use. For the treat- (a) Specifications. Cefadroxil powder is ment of skin infections (wounds and reconstituted to form a 50 milligram- abscesses) caused by susceptible strains per-milliliter aqueous suspension. of Staphylococcus intermedius, S. aureus, (b) Sponsor. See No. 000856 in Streptococcus canis (group G, -hemo- § 510.600(c) of this chapter. lytic), Escherichia coli, Pasteurella (c) Conditions of use. (1) For use in multocida, and Proteus mirabilis. dogs as follows: (3) Limitations. Federal law restricts (i) Indications for use. For treating this drug to use by or on the order of a genitourinary tract infections (cys- licensed veterinarian. titis) caused by susceptible strains of Escherichia coli, Proteus mirabilis, and [69 FR 52815, Aug. 30, 2004] Staphylococcus aureus; and skin and soft tissue infections including § 520.390 Chloramphenicol oral dosage cellulitis, pyoderma, dermatitis, wound forms. infections, and abscesses caused by sus- § 520.390a Chloramphenicol tablets. ceptible strains of Staphylococcus aureus. (a)(1) Specifications. Each tablet con- (ii) Amount. 10 milligrams per pound tains 100, 250, or 500 milligrams, 1 or 2.5 of body weight, twice daily. grams of chloramphenicol. (2) For use in cats as follows: (2) Sponsor. In § 510.600(c) of this chap- (i) Indications for use. For treating ter: No. 000010 for 100-, 250-, and 500-mil- skin and soft tissue infections includ- ligram and 1-gram tablets; No. 000856 ing abscesses, wound infections, for 100-, 250-. and 500-milligram tablets; cellulitis, and dermatitis caused by No. 017030 for 100-milligram tablets; No. susceptible strains of Pasteurella 000010 for 100-, 250-, and 500-milligram multocida, Staphylococcus aureus, Staph- and 1- and 2.5-gram tablets; No. 000069 ylococcus epidermidis, and Streptococcus for 250-milligram tablets. spp. (3) Conditions of use. Dogs—(i) Amount. (ii) Amount. 10 milligrams per pound 25 milligrams per pound of body weight of body weight, once daily. every 6 hours.

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(ii) Indications for use. Oral treatment this drug to use by or on the order of a of bacterial pulmonary infections, bac- licensed veterinarian. terial infections of the urinary tract, [57 FR 37323, Aug. 18, 1992, as amended at 62 bacterial enteritis, and bacterial infec- FR 35076, June 30, 1997; 66 FR 14073, Mar. 9, tions associated with canine distemper 2001; 68 FR 4914, Jan. 31, 2003] caused by susceptible organisms. (iii) Limitations. Laboratory tests § 520.390b Chloramphenicol capsules. should be conducted, including in vitro (a) Specifications. Each capsule con- culturing and susceptibility tests on tains 50, 100, 250, or 500 milligrams of samples collected prior to treatment. If chloramphenicol. no response to chloramphenicol ther- (b) Sponsor. (1) For chloramphenicol apy is obtained in 3 to 5 days, dis- capsules containing 50, 100, 250, or 500 continue its use and review diagnosis. milligrams of chloramphenicol see Nos. Not for animals which are raised for 000069, 000185, and 027454 in § 510.600(c) of food production. Chloramphenicol this chapter. products must not be used in meat-, (2) For chloramphenicol capsules egg-, or milk-producing animals. The containing 100 or 250 milligrams of length of time that residues persist in chloramphenicol see No. 058034 in milk or tissues has not been deter- § 510.600(c) of this chapter. mined. Because of potential antag- (c) Conditions of use. Dogs—(1) onism, chloramphenicol should not be Amount. 25 milligrams per pound of administered simultaneously with pen- body weight every 6 hours. icillin or streptomycin. Federal law re- (2) Indications for use. Oral treatment stricts this drug to use by or on the of bacterial pulmonary infections, bac- order of a licensed veterinarian. terial infections of the urinary tract, bacterial enteritis, and bacterial infec- (b)(1) Specifications. Each tablet con- tions associated with canine distemper tains 50, 100, 250, or 500 milligrams, or caused by susceptible organisms. 1 gram of chloramphenicol. (3) Limitations. Laboratory tests (2) Sponsor. See No. 061623 in should be conducted including in vitro § 510.600(c) of this chapter. culturing and susceptibility tests on (3) Conditions of use. Dogs—(i) Amount. samples collected prior to treatment. 25 milligrams per pound of body weight This product must not be used in meat- every 6 hours. , egg-, or milk-producing animals. The (ii) Indications for use. Oral treatment length of time that residues persist in of bacterial gastroenteritis associated milk or tissues has not been deter- with bacterial diarrhea, bacterial pul- mined. Federal law restricts this drug monary infections, and bacterial infec- to use by or on the order of a licensed tions of the urinary tract caused by veterinarian. susceptible organisms. [57 FR 37323, Aug. 18, 1992, as amended at 63 (iii) Limitations. Laboratory tests FR 5255, Feb. 2, 1998] should be conducted, including in vitro culturing and susceptibility tests on § 520.390c Chloramphenicol palmitate samples collected prior to treatment. If oral suspension. no response is obtained in 3 to 5 days, (a) Specifications. Each milliliter con- discontinue use and reevaluate diag- tains chloramphenicol palmitate equiv- nosis. Not for animals that are raised alent to 30 milligrams of chloramphen- for food production. Chloramphenicol icol. products should not be administered in (b) Sponsor. See No. 000856 in conjunction with or 2 hours prior to § 510.600(c) of this chapter. the induction of general anesthesia (c) Conditions of use. Dogs—(1) with pentobarbital because of pro- Amount. 25 milligrams per pound of longed recovery. Chloramphenicol body weight every 6 hours. If no re- should not be administered to dogs sponse is obtained in 3 to 5 days, dis- maintained for breeding purposes. Be- continue use and reevaluate diagnosis. cause of potential antagonism, chlor- (2) Indications for use. Treatment of amphenicol should not be administered bacterial pulmonary infections, infec- simultaneously with penicillin or tions of the urinary tract, enteritis, streptomycin. Federal law restricts and infections associated with canine

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distemper that are caused by orga- this drug to use by or on the order of a nisms susceptible to chloramphenicol. licensed veterinarian. 1 (3) Limitations. Not for use in animals (b)(1) Specifications. Each bolus con- that are raised for food production. tains 2 grams of chlorothiazide. Must not be used in meat-, egg-, or (2) Sponsor. See No. 000006 in milk-producing animals. The length of § 510.600(c) of this chapter. time that residues persist in milk or (3) Conditions of use—(i) Amount. 2 tissues has not been determined. Fed- grams once or twice daily for 3 or 4 eral law restricts this drug to use by or days. 1 on the order of a licensed veterinarian. (ii) Indications for use. For use in cat- [57 FR 37323, Aug. 18, 1992; 57 FR 42623, Sept. tle as an aid in reduction of 15, 1992] postparturient udder edema. 1 (iii) Limitations. Animals should be § 520.420 Chlorothiazide tablets and boluses. regularly and carefully observed for early signs of fluid and electrolyte im- (a)(1) Specifications. Each tablet con- balance. Take appropriate counter- tains 0.25 gram of chlorothiazide. measures if this should occur. Milk (2) Sponsor. See No. 050604 in taken from dairy animals during treat- § 510.600(c) of this chapter. ment and for 72 hours (six milkings) (3) Conditions of use—(i) Amount. after latest treatment must not be Usual dosage is 5 to 10 milligrams per used for food. Federal law restricts this pound of body weight two or three drug to use by or on the order of a li- 1 times daily. censed veterinarian. 1 (ii) Indications for use. For use in dogs for treatment of congestive heart fail- [43 FR 39085, Sept. 1, 1978, as amended at 62 ure and renal edema. 1 FR 63270, Nov. 28, 1997] (iii) Limitations. (a) Dosage must be adjusted to meet the changing needs of § 520.434 Chlorphenesin carbamate the individual animal. In mild and re- tablets. sponsive cases, it is suggested that a (a) Specifications. Each tablet con- dose of 5 milligrams per pound of body tains 400 milligrams of chlorphenesin weight be administered two or three carbamate. times daily. In moderately edematous (b) Sponsor. See No. 000009 in and moderately responsive animals, a § 510.600(c) of this chapter. dose of 7.5 to 10 milligrams per pound (c) Conditions of use in dogs—(1) of body weight may be administered Amount. 50 milligrams per pound of three times daily. Severe conditions body weight on first day; 25 milligrams may require higher doses. Certain ani- per pound of body weight each fol- mals may respond adequately to inter- lowing day. Divide total daily dose into mittent therapy; in these cases, the 2 or 3 equal doses—administer at 12- or drug may be administered either every 8-hour intervals. other day or for 3 to 5 days each week. (2) Indications for use. For use as an (b) Animals should be regularly and adjunct to therapy of acute inflam- carefully observed for early signs of matory and traumatic conditions of fluid and electrolyte imbalance. Take skeletal muscles. The drug provides re- appropriate countermeasures if this lief of the signs of discomfort associ- should occur. In some dogs, ated with myositis, muscle sprains, hypochloremic alkalosis may occur traumatic injuries, stifle injuries—es- (that is, excretion of chloride in rela- pecially when administered before or tion to sodium is excessive; the plasma after surgery—and invertebral disc bicarbonate level increases and syndrome (can be used concurrently alkalosis results). Federal law restricts with adrenal corticosteroids). (3) Limitations. Not recommended for 1 These conditions are NAS/NRC reviewed pregnant animals or those with a and deemed effective. Applications for these uses need not include effectiveness data as known hepatic dysfunction. Periodic specified by § 514.111 of this chapter, but may liver function studies are recommended require bioequivalency and safety informa- for animals on prolonged treatment. If tion. no response is evident within 5 days of

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the beginning of treatment, the diag- section; No. 053501 for conditions of use nosis should be redetermined and ap- as in paragraph (d)(4) of this section; propriate therapy instituted. Not rec- No. 000010 for conditions of use as in ommended for use with general anes- paragraphs (d)(4)(i)(A) and (B) and thetics other than the barbiturates. (d)(4)(ii) through (iv) of this section; Federal law restricts this drug to use Nos. 017519 and 059130 for conditions of by or on the order of a licensed veteri- use as in paragraphs (d)(4)(i)(A) and (B) narian. and (d)(4)(ii) and (iii) of this section. (c) Related tolerances. See § 556.150 of [44 FR 16009, Mar. 16, 1979] this chapter. § 520.445 Chlortetracycline oral dosage (d) Conditions of use. (1) Use as chlor- forms. tetracycline hydrochloride in drinking water as follows: § 520.445a Chlortetracycline bisulfate/ (i) Swine—(A) Amount. Ten milli- sulfamethazine bisulfate soluble grams per pound of body weight daily powder. in divided doses. (a) Specifications. Each pound con- (1) Indications for use. Control and tains chlortetracycline bisulfate equiv- treatment of bacterial enteritis alent to 102.4 grams of chlortetra- (scours) caused by Escherichia coli and cycline hydrochloride with bacterial pneumonia associated with sulfamethazine bisulfate equivalent to Pasteurella spp., Actinobacillus 102.4 grams of sulfamethazine. pleuropneumoniae (Hemophilus spp.), and (b) Sponsor. See No. 053501 in Klebsiella spp. § 510.600(c) of this chapter. (2) Limitations. Prepare a fresh solu- (c) Related tolerances. See §§ 556.150 tion twice daily; as sole source of and 556.670 of this chapter. chlortetracycline; administer for not (d) Conditions of use. Swine—Used in more than 5 days. drinking water as follows: (B) [Reserved] (1) Amount. 250 milligrams of chlor- (ii) [Reserved] tetracycline with 250 milligrams of (2) Use as chlortetracycline hydro- sulfamethazine per gallon. chloride in a drench or drinking water (2) Indications for use. Prevention and as follows: treatment of bacterial enteritis; aid in (i) Calves—(A) Amount. Ten milli- the reduction of the incidence of cer- grams per pound of body weight daily vical abscesses; aid in the maintenance in divided doses. of weight gains in the presence of bac- (1) Control and treatment of bac- terial enteritis and atrophic rhinitis. terial enteritis (scours) caused by E. (3) Limitations. Not to be used for coli and bacterial pneumonia (shipping more than 28 consecutive days; with- fever) associated with Pasteurella spp., draw 15 days before slaughter; as sole A. pleuropneumoniae (Hemophilus spp.), source of chlortetracycline and sul- and Klebsiella spp. fonamide. (2) Limitations. Prepare fresh solution [57 FR 37323, Aug. 18, 1992, as amended at 67 daily; as sole source of chlortetra- FR 78355, Dec. 24, 2002] cycline; administer for not more than 5 days; do not slaughter animals for food § 520.445b Chlortetracycline powder within 24 hours of treatment; do not (chlortetracycline hydrochloride or administer this product with milk or chlortetracycline bisulfate). milk replacers; administer 1 hour be- (a) Specifications. Chlortetracycline fore or 2 hours after feeding milk or powder contains not less than 15 milli- milk replacers; a withdrawal period has grams per gram chlortetracycline hy- not been established in preruminating drochloride, or chlortetracycline bisul- calves; do not use in calves to be proc- fate equivalent to 25.6, 64 or 102.4 grams essed for veal. per pound (56.4, 141 or 225.6 milligrams (B) [Reserved] per gram) chlortetracycline hydro- (ii) [Reserved] chloride. (3) [Reserved] (b) Sponsors. See No. 048164 in (4) The following uses of chlortetra- § 510.600(c) of this chapter for condi- cycline hydrochloride or chlortetra- tions of use as in paragraph (d) of this cycline bisulfate in drinking water or

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drench were reviewed by the National (B) Indications for use. Control and Academy of Sciences/National Re- treatment of bacterial enteritis search Council (NAS/NRC) and found (scours) caused by E. coli and Sal- effective: monella spp. and bacterial pneumonia (i) Chickens—(A) Amount. 200 to 400 associated with Pasteurella spp., milligrams per gallon. Actinobacillus pleuropneumoniae (1) Indications for use. Control of in- (Hemophilus spp.), and Klebsiella spp. fectious synovitis caused by Myco- (C) Limitations. Prepare fresh solution plasma synoviae. daily; as sole source of chlortetra- (2) Limitations. Prepare fresh solution cycline; do not use for more than 5 daily; as sole source of chlortetra- days; for 000010 and 017519 do not cycline; do not use for more than 14 slaughter animals for food within 5 days; do not slaughter animals for food days of treatment; for 053501 do not within 24 hours of treatment; do not slaughter animals for food within 24 use in laying chickens. hours of treatment. (B) Amount. 400 to 800 milligrams per (iv) Calves, beef cattle, and nonlac- gallon. tating dairy cattle—(A) Amount. 10 milli- (1) Indications for use. Control of grams per pound daily in divided doses. chronic respiratory disease and air-sac (B) Indications for use. Control and infections caused by M. gallisepticum treatment of bacterial enteritis and E. coli. (scours) caused by E. coli and Sal- (2) Limitations. Prepare fresh solution monella spp. and bacterial pneumonia daily; as sole source of chlortetra- (shipping fever complex) associated cycline; do not use for more than 14 with Pasteurella spp., A. days; do not slaughter animals for food pleuropneumoniae (Hemophilus spp.), and within 24 hours of treatment; do not Klebsiella spp. use in laying chickens. (C) Limitations. Prepare fresh solution (C) Amount. One thousand milligrams daily; use as a drench; as sole source of per gallon. chlortetracycline; do not use for more (1) Indications for use. Control of mor- than 5 days; do not slaughter animals tality due to fowl cholera caused by for food within 24 hours of treatment; Pasteurella multocida susceptible to do not use in lactating cattle; do not chlortetracycline. administer this product with milk or (2) Limitations. See paragraph milk replacers; administer 1 hour be- (d)(4)(i)(A)(2) of this section. fore or 2 hours after feeding milk or (ii) Growing turkeys—(A) Amount. 400 milk replacers; a withdrawal period has milligrams per gallon. not been established in preruminating (1) Indications for use. Control of in- calves; do not use in calves to be proc- fectious synovitis caused by M. essed for veal. synoviae. (2) Limitations. Prepare fresh solution [57 FR 37324, Aug. 18, 1992; 57 FR 42623, Sept. daily; as sole source of chlortetra- 15, 1992; 58 FR 61015, Nov. 19, 1993; 59 FR 39439, Aug. 3, 1994; 60 FR 26827, May 19, 1995; 60 FR cycline; do not use for more than 14 47052, Sept. 11, 1995; 62 FR 27691, May 21, 1997; days; do not slaughter animals for food 62 FR 35076, June 30, 1997; 62 FR 60656, Nov. within 24 hours of treatment. 12, 1997; 64 FR 37673, July 13, 1999; 65 FR 10706, (B) Amount. 25 milligrams per pound Feb. 29, 2000; 66 FR 35898, July 10, 2001; 67 FR of body weight daily. 78355, Dec. 24, 2002; 69 FR 62406, Oct. 26, 2004] (1) Indications for use. Control of com- plicating bacterial organisms associ- § 520.445c Chlortetracycline tablets ated with bluecomb (transmissible en- and boluses. teritis, coronaviral enteritis). (a) Specifications. Each tablet/bolus (2) Limitations. Prepare fresh solution contains 25, 250, or 500 milligrams of daily; as sole source of chlortetra- chlortetracycline hydrochloride. cycline; do not use for more than 14 (b) Sponsors. See No. 000010 in days; do not slaughter animals for food § 510.600(c) of this chapter for the 250- within 24 hours of treatment. milligram chlortetracycline hydro- (iii) Swine—(A) Amount. 10 milligrams chloride bolus; see No. 053501 for the 25- per pound body weight daily in divided milligram tablet and the 500 milligram doses. bolus.

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(c) Related tolerances. See § 556.150 of water for drenching; if no improvement this chapter. is noted after 3 days of treatment, con- (d) National Academy of Sciences/Na- sult a veterinarian; do not use for more tional Research Council NAS/NRC) status. than 5 days; do not administer within The conditions of use specified in this 24 hours of slaughter. section were NAS/NRC reviewed and [57 FR 37325, Aug. 18, 1992, as amended at 67 found effective. Applications for these FR 78355, Dec. 24, 2002] uses need not include effectiveness data as specified in § 514.111 of this § 520.446 Clindamycin capsules and chapter but may require bioequiva- tablets. lency and safety information. (a) Specifications—(1) Each capsule (e) Conditions of use. Calves—(1) contains the equivalent of 25, 75, 150, or Amount. One 250 milligram bolus per 50 300 milligrams (mg) clindamycin as the pounds of body weight twice a day for hydrochloride salt. 3 to 5 days. (2) Each tablet contains the equiva- (i) Indications for use. Treatment of lent of 25, 75, or 150 mg clindamycin as bacterial enteritis (scours) caused by the hydrochloride salt. Escherichia coli and bacterial pneu- (b) Sponsors. See sponsors in monia associated with Pasteurella spp., § 510.600(c) of this chapter as follows: Klesbsiella spp., and Hemophilus spp. (1) Nos. 000009 and 059130 for use of (ii) Limitations. Administer bolus di- capsules described in paragraph (a)(1) rectly by mouth or crush and dissolve of this section as in paragraphs (d)(1)(i) in milk or water for drenching or buck- and (d)(2)(i) of this section. et feeding; if no improvement is noted (2) No. 051311 for use of tablets de- after 3 days of treatment, consult a scribed in paragraph (a)(2) of this sec- veterinarian; do not use for more than tion as in paragraphs (d)(1)(ii) and 5 days; do not administer within 24 (d)(2)(ii) of this section. hours of slaughter. (c) Special considerations. Federal law (2) Amount. One 25 milligram tablet restricts this drug to use by or on the for each 5 pounds of body weight every order of a licensed veterinarian. 12 hours daily for 3 to 5 days. (d) Conditions of use in dogs—(1) (i) Indications for use. Control and Amount—(i) Wounds, abscesses, and treatment of bacterial enteritis dental infections: 2.5 to 15 mg per (scours) caused by E. coli and Sal- pound (/lb) of body weight every 12 monella spp. and bacterial pneumonia hours for a maximum of 28 days. Osteo- associated with Pasteurella spp., myelitis: 5.0 to 15 mg/lb of body weight Hemophilus spp., and Klebsiella spp., sus- every 12 hours for a minimum of 28 ceptible to chlortetracycline. days. (ii) Limitations. Administer tablet di- (ii) Wounds, abscesses, and dental in- rectly by mouth or crush and dissolve fections: 2.5 mg/lb of body weight every in water for drenching; if no improve- 12 hours for a maximum of 28 days. Os- ment is noted after 3 days of treat- teomyelitis: 5.0 mg/lb of body weight ment, consult a veterinarian; do not every 12 hours for a minimum of 28 use for more than 5 days; when feeding days. milk or milk replacer, administration 1 (2) Indications for use—(i) For the hour before or 2 hours after feeding; do treatment of skin infections (wounds not administer within 24 hours of and abscesses) due to susceptible slaughter. strains of coagulase-positive (3) Amount. One 500 milligram bolus staphylococci (Staphylococcus aureus or per 100 pounds of body weight twice a S. intermedius), deep wounds and ab- day for 3 to 5 days. scesses due to susceptible strains of (i) Indications for use. Treatment of Bacteroides fragilis, Prevotella bacterial enteritis (scours) caused by E. melaninogenicus, Fusobacterium coli and Salmonella spp., and bacterial necrophorum, and Clostridium pneumonia associated with Pasteurella perfringens, dental infections due to spp., Hemophilus spp., and Klebsiella susceptible strains of S. aureus, B. spp., susceptible to chlortetracycline. fragilis, P. melaninogenicus, F. (ii) Limitations. Administer directly necrophorum, and C. perfringens, and os- by mouth or crush and dissolve in teomyelitis due to susceptible strains

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of S. aureus, B. fragilis, P. susceptible strains of S. aureus, B. melaninogenicus, F. necrophorum, and C. fragilis, P. melaninogenicus, F. perfringens. necrophorum, and C. perfringens, and os- (ii) For the treatment of soft tissue teomyelitis due to susceptible strains infections (wounds and abscesses), den- of S. aureus, B. fragilis, P. tal infections, and osteomyelitis melaninogenicus, F. necrophorum, and C. caused by susceptible strains of S. perfringens. aureus, soft tissue infections (deep (B) For the treatment of soft tissue wounds and abscesses), dental infec- infections (wounds and abscesses), den- tions, and osteomyelitis caused by or tal infections, and osteomyelitis associated with susceptible strains of caused by susceptible strains of S. B. fragilis, P. melaninogenicus, F. aureus and for soft tissue infections necrophorum, and C. perfringens. (deep wounds and abscesses), dental in- fections, and osteomyelitis caused by [67 FR 54954, Aug. 27, 2002, as amended at 68 FR 55824, Sept. 29, 2003; 69 FR 32273, June 9, or associated with susceptible strains 2004] of B. fragilis, P. melaninogenicus, F. necrophorum, and C. perfringens. § 520.447 Clindamycin liquid. (2) Cats—(i) Amount—(A) 5.0 to 15.0 (a) Specifications. Each milliliter of mg/lb of body weight every 24 hours for solution contains the equivalent of 25 a maximum of 14 days. milligrams (mg) clindamycin as the (B) 5.0 to 10.0 mg/lb of body weight hydrochloride salt. every 24 hours for a maximum of 14 (b) Sponsors. See sponsors in days. § 510.600(c) of this chapter as follows: (ii) Indications for use—(A) For the (1) Nos. 000009 and 059130 for use as in treatment of skin infections (wounds paragraphs (d)(1)(i)(A), (d)(1)(ii)(A), and abscesses) due to susceptible (d)(2)(i)(A), and (d)(2)(ii)(A) of this sec- strains of S. aureus, S. intermedius, tion. Streptococcus spp., deep wounds and ab- (2) No. 059079 for use as in paragraphs scesses due to susceptible strains of (d)(1)(i)(B), (d)(1)(ii)(B), (d)(2)(i)(B), and Clostridium perfringens and Bacteroides (d)(2)(ii)(B) of this section. fragilis, and dental infections due to (c) Special considerations. Federal law susceptible strains of S. aureus, S. restricts this drug to use by or on the intermedius, Streptococcus spp., C. order of a licensed veterinarian. perfringens, and B. fragilis. (d) Conditions of use—(1) Dogs—(i) (B) Aerobic bacteria: Treatment of Amount—(A) Wounds, abscesses, and soft tissue infections (wounds and ab- dental infections: 2.5 to 15 mg per scesses) and dental infections caused pound (/lb) of body weight every 12 by or associated with susceptible hours for a maximum of 28 days. Osteo- strains of S. aureus, S. intermedius, and myelitis: 5.0 to 15 mg/lb of body weight Streptococcus spp. Anaerobic bacteria: every 12 hours for a minimum of 28 Treatment of soft tissue infections days. (deep wounds and abscesses) and dental (B) Wounds, abscesses, and dental in- infections caused by or associated with fections: 2.5 mg per pound (/lb) of body susceptible strains of C. perfringens and weight every 12 hours for a maximum B. fragilis. of 28 days. Osteomyelitis: 5.0 mg/lb of [67 FR 54954, Aug. 27, 2002, as amended at 67 body weight every 12 hours for a min- FR 78684, Dec. 26, 2002; 68 FR 55824, Sept. 29, imum of 28 days. 2003; 69 FR 31734, June 7, 2004] (ii) Indications for use—(A) For the treatment of skin infections (wounds § 520.452 Clenbuterol syrup. and abscesses) due to susceptible (a) Specifications. Each milliliter con- strains of coagulase-positive tains 72.5 micrograms of clenbuterol staphylococci (Staphylococcus aureus or hydrochloride. S. intermedius), deep wounds and ab- (b) Sponsor. See 000010 in § 510.600(c) of scesses due to susceptible strains of this chapter. Bacteroides fragilis, Prevotella (c) [Reserved] melaninogenicus, Fusobacterium (d) Conditions of use—(1) Horses—(i) necrophorum, and Clostridium Amount. Administer orally twice a day perfringens, dental infections due to (b.i.d.). Initial dose is 0.5 milliliter per

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100 pounds body weight (0.8 micrograms (3) Limitations. Federal law restricts per kilogram) for 3 days (6 treatments). this drug to use by or on the order of a If no improvement, administer 1 milli- licensed veterinarian. liter per 100 pounds (1.6 micrograms per [64 FR 1762, Jan. 12, 1999] kilogram) for 3 days (6 treatments). If no improvement, administer 1.5 milli- § 520.462 Clorsulon drench. liters per 100 pounds (2.4 micrograms (a) Specifications. The drug is a sus- per kilogram) for 3 days (6 treatments). pension containing 8.5 percent If no improvement, administer 2.0 mil- clorsulon (85 milligrams per milliliter). liliters per 100 pounds (3.2 micrograms (b) Sponsor. See No. 050604 in per kilogram) for 3 days (6 treatments). § 510.600(c) of this chapter. If no improvement, horse is non- (c) Conditions of use. Cattle—(1) responder to clenbuterol and treatment Amount. One-quarter fluid ounce per 200 should be discontinued. pounds of body weight (7 milligrams (ii) Indications for use. Indicated for per kilogram or 3.2 milligrams per the management of horses affected pound of body weight). with airway obstruction, such as oc- (2) Indications for use. For the treat- curs in chronic obstructive pulmonary ment of immature and adult liver fluke disease (COPD). (Fasciola hepatica) infestations in cat- (iii) Limitations. Treat at effective tle. dose for 30 days. At the end of the 30- (3) Limitations. Using dose syringe, day treatment period, drug should be deposit drench over back of tongue. Do withdrawn. If signs return, the 30-day not treat cattle within 8 days of treatment period may be repeated. If slaughter. Because a withdrawal time repeating treatment, the step-wise dos- in milk has not been established, do age schedule should be repeated. The not use in female dairy cattle of breed- effect of this drug on breeding stallions ing age. Consult your veterinarian for and brood mares has not been deter- assistance in the diagnosis, treatment, mined. Treatment starting with dos- and control of parasitism. ages higher than the initial dose is not [50 FR 10221, Mar. 14, 1985, as amended at 62 recommended. Federal law prohibits FR 63270, Nov. 28, 1997] the extralabel use of this drug in food animals. Federal law restricts this § 520.522 Cyclosporine. drug to use by or on the order of a li- (a) Specifications. Each capsule con- censed veterinarian. tains 10, 25, 50, or 100 milligrams (mg) (2) [Reserved] cyclosporine. [63 FR 41419, Aug. 4, 1998] (b) Sponsor. See No. 058198 in § 510.600(c) of this chapter. § 520.455 Clomipramine hydrochloride (c) [Reserved] tablets. (d) Conditions of use in dogs—(1) (a) Specifications. Each tablet con- Amount. 5 mg per kilogram of body tains 20, 40, or 80 milligrams of weight given orally as a single daily clomipramine hydrochloride. dose for 30 days. Following this initial (b) Sponsor. See No. 058198 in daily treatment period, the dosage may § 510.600(c) of this chapter. be tapered by decreasing the frequency (c) Conditions of use—(1) Amount. 2 to of administration to every other day or 4 milligrams of clomipramine hydro- two times a week, until a minimum chloride per kilogram (0.9 to 1.8 milli- frequency is reached which will main- grams per pound) of body weight per tain the desired therapeutic effect. day, administered as a single daily dose (2) Indications for use. For the control or divided twice daily. of atopic dermatitis in dogs weighing at least 4 pounds body weight. (2) Indications for use. For use as part of a comprehensive behavioral manage- (3) Limitations. Federal law restricts this drug to use by or on the order of a ment program to treat separation anx- licensed veterinarian. iety in dogs greater than 6 months of age. [68 FR 54804, Sept. 19, 2003]

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§ 520.530 Cythioate oral liquid. § 520.534 Decoquinate. (a) Specifications. Each milliliter con- (a) Specifications. The drug is a pow- tains 15 milligrams of cythioate. der containing 0.8 percent decoquinate. (b) Sponsor. See Nos. 000859 and 053501 (b) Sponsor. See No. 046573 in in § 510.600 of this chapter. § 510.600(c) of this chapter. (c) Special considerations. Cythioate is (c) Related tolerances. See § 556.170 of a cholinesterase inhibitor. Do not use this chapter. this product in animals simultaneously (d) Conditions of use. Calves—(1) with or within a few days before or Amount. Feed 22.7 milligrams per 100 after treatment with or exposure to pounds of body weight (0.5 milligram cholinesterase-inhibiting drugs, insec- per kilogram) per day. ticides, pesticides, or chemicals. (2) Indications for use. For the preven- (d) Conditions of use—(1) Amount. 15 tion of coccidiosis in ruminating and milligrams cythioate per 10 pounds of nonruminating calves, including veal body weight every third day or twice a calves, caused by Eimeria bovis and E. week. zuernii. (2) Indications for use. Dogs, for con- (3) Limitations. Feed in whole milk at trol of fleas. the rate of 22.7 milligrams per 100 (3) Limitations. For oral use in dogs pounds body weight daily (0.5 milli- only. Do not use in greyhounds or in gram per kilogram) for at least 28 days. animals that are pregnant, sick, under stress, or recovering from surgery. Fed- [64 FR 10103, Mar. 2, 1999, as amended at 64 eral law restricts this drug to use by or FR 30386, June 8, 1999] on the order of a licensed veterinarian. § 520.538 Deracoxib. [49 FR 5614, Feb. 14, 1984, as amended at 67 (a) Specifications. Each chewable tab- FR 78355, Dec. 24, 2002] let contains 25 or 100 milligrams (mg) § 520.531 Cythioate tablets. deracoxib. (b) Sponsor. See No. 058198 in (a) [Reserved] § 510.600(c) of this chapter. (b) Sponsors. See No. 000859 in (c) [Reserved] § 510.600(c) of this chapter for use of 30- and 90-milligram (mg) tablets and see (d) Conditions of use in dogs—(1) No. 053501 in § 510.600(c) of this chapter Amount. Administer orally as needed, for use of 30-mg tablet. as a single daily dose based on body (c) Special considerations. Cythioate is weight. a cholinesterase inhibitor. Do not use (i) 1 to 2 mg/kilograms (kg) (0.45 to this product in animals simultaneously 0.91 mg/pound (lb), for use as in para- with or within a few days before or graph (d)(2)(i) of this section. after treatment with or exposure to (ii) 3 to 4 mg/kg (1.4 to 1.8 mg/lb) for cholinesterase-inhibiting drugs, insec- up to 7 days, for use as in paragraph ticides, pesticides, or chemicals. (d)(2)(ii) of this section. (d) Conditions of use—(1) Amount. 30 (2) Indications for use. (i) For the con- milligrams cythioate per 20 pounds of trol of pain and inflammation associ- body weight every third day or twice a ated with osteoarthritis. week. (ii) For the control of postoperative (2) Indications for use. Dogs, for con- pain and inflammation associated with trol of fleas. orthopedic surgery in dogs weighing 4 (3) Limitations. For oral use in dogs or more pounds (1.8 kg). only. Do not use in greyhounds or in (3) Limitations. Federal law restricts animals that are pregnant, sick, under this drug to use by or on the order of a stress, or recovering from surgery. Fed- licensed veterinarian. eral law restricts this drug to use by or on the order of a licensed veterinarian. [67 FR 68760, Nov. 13, 2002, as amended at 68 FR 18882, Apr. 17, 2003] [49 FR 5615, Feb. 14, 1984, as amended at 59 FR 26942, May 25, 1994; 67 FR 78355, Dec. 24, 2002]

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§ 520.540 Dexamethasone oral dosage animal is being treated for a specific forms. condition. (ii) Administered orally, 5 to 10 milli- § 520.540a Dexamethasone powder. grams for the first day, then 5 milli- (a) Specifications. Dexamethasone grams per day as required. powder is packaged in packets con- (iii) Do not use in viral infections taining 10 milligrams of dexametha- during the viremic stage. With bac- sone. terial infections, appropriate anti- (b) Sponsor. See No. 000061 in bacterial therapy should be used. § 510.600(c) of this chapter. (iv) Do not use in animals with chronic nephritis and hypercorticalism (c) Conditions of use. (1) Dexametha- (cushingoid syndrome), except for sone powder is indicated in cases where emergency therapy. cattle and horses require additional (v) Clinical and experimental data steroid therapy following its parenteral have demonstrated that corticosteroids administration. The drug is used as administered orally or by injection to supportive therapy for management or animals may induce the first stage of inflammatory conditions such as acute parturition when administered during arthritic lameness, and for various the last trimester of pregnancy and stress conditions where corticosteroids may precipitate premature parturition are required while the animal is being followed by dystocia, fetal death, re- treated for a specific condition. tained placenta, and metritis. (2) The drug is administered at a dos- (vi) Federal law restricts this drug to age level of 5 to 10 milligrams per ani- use by or on the order of a licensed vet- mal the first day then 5 milligrams per erinarian. day as required by drench or by sprin- (b)(1) Specifications. Each tablet con- kling on a small amount of feed. tains 0.25 milligram of dexametha- (3) Clinical and experimental data sone.1 have demonstrated that corticosteroids (2) Sponsors. See Nos. 000061 and 061623 administered orally or parenterally to in § 510.600(c) of this chapter. animals may induce the first stage of (3) Conditions of use—(i) Amount. parturition when administered during Dogs: Administer orally at 0.25 to 1.25 the last trimester of pregnancy and milligrams per day for up to 7 days. may precipitate premature parturition Cats: 0.125 to 0.5 milligram per day for followed by dystocia, fetal death, re- up to 7 days.1 tained placenta, and metritis. (ii) Indications for use. In treatment (4) Federal law restricts this drug to of dogs and cats as an anti-inflam- use by or on the order of a licensed vet- matory agent.1 erinarian. (iii) Limitations. (a) Clinical and ex- perimental data have demonstrated [40 FR 13838, Mar. 27, 1975; 41 FR 9149, Mar. 3, 1976; 52 FR 7832, Mar. 13, 1987] that corticosteriods administered oral- ly or by injection to animals may in- § 520.540b Dexamethasone tablets and duce the first stage of parturition when boluses. administered during the last trimester of pregnancy; and they may precipitate (a)(1) Specifications. Each bolus is premature parturition followed by half-scored and contains 10 milligrams dystocia, fetal death, retained pla- of dexamethasone. centa, and metritis. (2) Sponsor. See No. 000061 in (b) Do not use in viral infections. § 510.600(c) of this chapter. Anti-inflammatory action of (3) Conditions of use. (i) Dexametha- corticosteroids may mask signs of in- sone bolus is indicated in cases where fections. Do not use in animals with cattle and horses require additional tuberculosis, chronic nephritis, steroid therapy following its parenteral cushingoid syndrome, or peptic ulcers, administration. The drug may be used except for emergency therapy.1 as supportive therapy for management of inflammatory conditions such as 1 These conditions are NAS/NRC reviewed acute arthritic lamenesses, and for var- and deemed effective. Applications for these ious stress conditions where uses need not include effectiveness data as corticosteroids are required while the specified by § 514.111 of this chapter.

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(c) Federal law restricts this drug to aminoacetic acid (glycine) 6.36 grams, use by or on the order of a licensed vet- and dextrose 44.0 grams. erinarian.1 (b) Sponsor. See No. 000069 in [40 FR 26273, June 23, 1975, as amended at 44 § 510.600(c) of this chapter. FR 7130, Feb. 6, 1979; 50 FR 49372, Dec. 2, 1985; (c) Conditions of use. (1) Dextrose/gly- 52 FR 7832, Mar. 13, 1987; 55 FR 8461, Mar. 8, cine/electrolyte is indicated for use in 1990; 66 FR 14073, Mar. 9, 2001; 68 FR 4914, Jan. the control of dehydration associated 31, 2003] with diarrhea (scours) in calves. It is § 520.540c Dexamethasone chewable used as an early treatment at the first tablets. signs of scouring. It may also be used (a) Specifications. Each half-scored as followup treatment following intra- tablet contains 0.25 milligram of dexa- venous fluid therapy. methasone.1 (2) Dissolve each packet in two (b) Sponsor. See No. 000069 in quarts of warm water and administer § 510.600(c) of this chapter. to each calf as follows: (c) Conditions of use—(1) Amount. 0.25 (i) Scouring and/or dehydrated calves. to 1.25 milligrams per day.1 Feed 2 quarts of solution, twice daily (2) Indications for use. Supportive for 2 days (four feedings). No milk or therapy in nonspecific dermatosis and milk replacer should be fed during this inflammatory conditions in dogs.1 period. For the next four feedings (days (3) Limitations. (i) Administer by free- 3 and 4), use 1 quart of solution to- choice feeding or crumble over food. gether with 1 quart of milk replacer. Administer 0.25 to 1.25 milligrams daily Thereafter, feed as normal. in single or two divided doses until re- (ii) Newly purchased calves. Feed 2 sponse is noted or 7 days have elapsed. quarts of solution instead of milk as When response is attained, dosage the first feed upon arrival. For the next should be gradually reduced by 0.125 scheduled feeding, use 1 quart of solu- milligram per day until maintenance tion mixed together with 1 quart of level is achieved. milk or milk replacer. Thereafter, feed (ii) Clinical and experimental data as normal. have demonstrated that corticosteriods (3) The product should not be used in administered orally or parenterally to animals with severe dehydration animals may induce the first stage of (down, comatose, or in a state of parturition when administered during shock). Such animals need intravenous the last trimester of pregnancy; and they may precipitate premature partu- therapy. Oral therapy in these cases is rition followed by dystocia, fetal death, too slow. Animals which cannot drink retained placenta, and metritis. after initial intravenous therapy may (iii) Do not use in viral infections. need to be dosed with a stomach tube Anti-inflammatory action of or esophageal tube. Adequate colos- corticosteriods may mask signs of in- trum intake during the first 12 hours is fection. Do not use in animals with tu- essential for healthy, vigorous calves. berculosis, chronic nephritis, Antibacterial therapy is often indi- cushingoid syndrome, or peptic ulcers, cated in bacterial scours due to E. coli except for emergency therapy.1 and/or Salmonella. The product does not (iv) Federal law restricts this drug to contain antibacterial agents. A veteri- use by or on the order of a licensed vet- narian should be consulted in severely erinarian. scouring calves or cases requiring anti- bacterial therapy. The product is not [44 FR 7130, Feb. 6, 1979, as amended at 56 FR 50653, Oct. 8, 1991; 60 FR 55659, Nov. 2, 1995] nutritionally complete if administered by itself for long periods of time. It § 520.550 Dextrose/glycine/electrolyte. should not be administered beyond the (a) Specifications. The product is dis- recommended treatment period with- tributed in packets each of which con- out the addition of milk or milk re- tains the following ingredients: sodium placer. chloride 8.82 grams, potassium phos- [48 FR 38606, Aug. 25, 1983, as amended at 56 phate 4.20 grams, citric acid anhydrous FR 50653, Oct. 8, 1991; 60 FR 55659, Nov. 2, 0.5 gram, potassium citrate 0.12 gram, 1995]

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§ 520.563 Diatrizoate meglumine and Dipylidium caninum, and Echinococcus diatrizoate sodium oral solution. granulosus) from dogs and cats. (a) Specifications. Diatrizoate (3) Limitations. Withhold solid foods meglumine oral solution is a water and milk for at least 12 hours prior to soluble radiopaque medium containing medication and for 4 hours afterward. 66 percent diatrizoate meglumine and Repeat treatment in 2 to 4 weeks in 10 percent diatrizoate sodium. animals subject to reinfection. (b) Sponsor. See No. 053501 in [45 FR 10332, Feb. 15, 1980] § 510.600(c) of this chapter. (c) Conditions of use. (1) It is indicated EDITORIAL NOTE: For FEDERAL REGISTER ci- for radiography of the gastrointestinal tations affecting § 520.580, see the List of CFR tract in dogs and cats. Sections Affected, which appears in the Finding Aids section of the printed volume (2) It is administered orally at a dos- and on GPO Access. age level of 0.5 to 1.0 milliliter per pound of body weight by gavage or § 520.581 Dichlorophene tablets. stomach tube. It is administered rec- tally at a dosage level of 0.5 to 1.0 mil- (a) Specifications. Each tablet con- liliter per pound of body weight diluted tains 1 gram of dichlorophene. with 1 part of the drug to 5 parts of (b) Sponsor. See 023851 in § 510.600(c) of water. this chapter. (3) Federal law restricts this drug to (c) Required statement. Consult your use by or on the order of a licensed vet- veterinarian for assistance in the diag- erinarian. nosis, treatment, and control of para- sitism, and before administering to [44 FR 12993, Mar. 9, 1979, as amended at 50 weak or debilitated animals. FR 41489, Oct. 11, 1985] (d) Conditions of use. Dogs—(1) § 520.580 Dichlorophene and toluene Amount. Single dose of 1 tablet (1 gram capsules. of dichlorophene) for each 10 pounds of (a) Specifications. Each soft gelatin body weight. capsule contains 50 milligrams of (2) Indications for use. It is used as an dichlorophene and 60 milligrams of tol- aid in the removal of tapeworms uene or multiples thereof. (Taenia pisiformis and Dipylidium (b) Sponsor. (1) For single dose only, caninum). see 000010, 000061, 000115, 000842, 010237, (3) Limitations. Withhold solid foods 017135, 023851, 049968, 051311, and 058670 and milk for at least 12 hours prior to in § 510.600(c) of this chapter. medication and for 4 hours afterward. (2) For single and multiple dose, see [45 FR 10333, Feb. 15, 1980] 000010, 000061, and 038782 in § 510.600(c) of this chapter. § 520.600 Dichlorvos. (c) Required statement. Consult your veterinarian for assistance in the diag- (a) Chemical name. 2,2-Dichlorvinyl nosis, treatment, and control of para- dimethyl phosphate. sitism, and before administering to (b) [Reserved] weak or debilitated animals. (c) Sponsor. See No. 000010 in (d) Conditions of use—(1) Amount. (i) § 510.600(c) of this chapter. Single dose of 100 milligrams of (d) Related tolerances. See § 556.180 of dicholorophene and 120 milligrams of this chapter. toluene per pound of body weight. (e) Conditions of use in swine. (1) It is (ii) Divided dose of 100 milligrams of recommended for the removal and con- dichlorophene and 120 milligrams of trol of sexually mature (adult), sexu- toluene per 5 pounds of body weight (20 ally immature and/or 4th stage larvae and 24 milligrams per pound) daily for of the whipworm (Trichuris suis), nod- 6 days. ular worms (Oesophagostomum spp.), (2) Indications for use. It is used for large round-worm (Ascaris suum), and the removal of ascarids (Toxocara canis the mature thick stomach worm and Toxascaris leonina) and hookworms (Ascarops strongylina) occurring in the (Ancylostoma caninum and Uncinaria lumen of the gastrointestinal tract of stenocephala) and as an aid in removing pigs, boars, and open or bred gilts and tapeworms (Taenia pisiformis, sows.

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(2) The preparation should be added (3) In some dogs, efficacy against to the indicated amount of feed as set Trichurias vulpis (whipworm) may be er- forth in paragraph (e)(2) of this section ratic. Dogs that do not develop a nega- and administered shortly after mixing, tive stool for Trichuris vulpis ova 10 to as follows: 14 days following initial treatment should be re-treated. If a negative stool Pounds of Pounds of mixed feed Number of is not obtained in 10 to 14 days fol- Weight of feed to be to be admin- pigs to be animal in mixed with istered to treated per lowing re-treatment, alternate means pounds each 0.08 each pig as 0.08 ounce of therapy should be considered. ounce of a single of dichlorvos dichlorvos treatment (4) Do not use in dogs infected with Dirofilaria immitis. 20–30 ...... 4 0.33 12 31–40 ...... 5 0.56 9 (5) Do not use with other 41–60 ...... 6 1.00 6 anthelmintics, taeniacides, antifilarial 61–80 ...... 5 1.00 5 agents, muscle relaxants, or tranquil- 81–100 ...... 4 1.00 4 Adult Gilts, izers. Sows, and (6) The drug is a cholinesterase inhib- Boars ...... 16 4.00 4 itor. Not for use simultaneously or within a few days before or after treat- (3) Do not use this product on ani- mals either simultaneously or within a ment with or exposure to cholin- few days before or after treatment with esterase-inhibiting drugs, pesticides, or or exposure to cholinesterase inhib- chemicals. iting drugs, pesticides, or chemicals. (7) Federal law restricts this drug to The preparation should be mixed thor- use by or on the order of a licensed vet- oughly with the feed on a clean, imper- erinarian. vious surface. Do not allow swine ac- (g) Conditions of use in horses when ad- cess to feed other than that containing ministered in grain. (1) It is rec- the preparation until treatment is ommended for the removal and control complete. Do not treat pigs with signs of bots (Gastrophilus intestinalis, G. na- of scours until these signs subside or salis), large strongyles (Strongylus are alleviated by proper medication. vulgaris, S. equinus, S. edentatus), small Resume normal feeding schedule after- strongyles (of the genera wards. Swine may be retreated in 4 to Cyathostomum, Cylicocercus, 5 weeks. Cylicocyclus, Cylicodontophorus, (f) Conditions of use in dogs. (1) For re- Triodontophorus, Poteriostomum, moval of Toxocara canis and Toxascaris Gyalocephalus), pinworms (Oxyuris leonina (roundworms), Ancylostoma equi), and large roundworm (Parascaris caninum and Uncinaria stenocephala equorum) in horses including ponies and (hookworms), and Trichuris vulpis mules. Not for use in foals (sucklings (whipworm) residing in the lumen of and young weanlings). the gastrointestinal tract. (2) The drug is in capsule form for di- (2) For a satisfactory diagnosis, a mi- rect administration and in pellet form croscopic fecal examination should be for administration in about one-third performed by a veterinarian or a diag- of the regular canned dog food ration nostic laboratory prior to worming. or in ground meat. Dogs may be treat- (3) It is administered in the grain ed with any combination of capsules portion of the ration at a dosage of 14.2 and/or pellets so that the animal re- milligrams to 18.5 milligrams per ceives a single dose equaling 12 to 15 pound of body weight as a single dose. milligrams of the active ingredient per It may be administered at one-half of pound of body weight. One-half of the the single recommended dosage and re- single recommended dosage may be peated 8 to 12 hours later in the treat- given, and the other half may be ad- ment of very aged, emaciated or debili- ministered 8 to 24 hours later. This tated subjects or those reluctant to split dosage schedule should be used in consume medicated feed. In suspected animals which are very old, heavily cases of severe ascarid infection suffi- parasitized, anemic, or otherwise de- cient to cause concern over mechanical bilitated. The drug should not be used blockage of the intestinal tract, the in dogs weighing less than 2 pounds. split dosage should be utilized.

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(4) Do not use in horses which are se- (4) Do not use in horses which are verely debilitated, suffering from diar- severly debilitated or suffering from di- rhea or severe constipation, infectious arrhea or severe constipation, infec- disease, toxemia or colic. Do not ad- tious disease, toxemia, or colic. Do not minister in conjunction with or within administer to horses affected with 1 week of administration of muscle re- chronic alveolar emphysema (heaves) laxant drugs, phenothiazine derived or other respiratory conditions. tranquilizers or central nervous system (5) Do not use in horses intended for depressant drugs. Horses should not be food purposes. subjected to insecticide treatment for 5 (6) Federal law restricts this drug to days prior to or after treating with the use by or on the order of a licensed vet- drug. Do not administer to horses af- erinarian. flicted with chronic alveolar emphy- (i) Conditions of use in dogs, cats, pup- sema (heaves) or related respiratory pies, and kittens. (1) Each tablet con- conditions. The product is a cholin- tains 2, 5, 10, or 20 milligrams of esterase inhibitor and should not be dichlorvos. used simultaneously or within a few (2) It is administered orally at 5 mil- days before or after treatment with or ligrams of dichlorvos per pound of body exposure to cholinesterase inhibiting weight. drugs, pesticides or chemicals. (3) Dogs and puppies: Removal and (5) Do not use in animals other than control of intestinal roundworms horses, ponies, and mules. Do not use (Toxocara canis and Toxascaris leonina) in horses, ponies, and mules intended and hookworms (Ancylostoma caninum for food purposes. Do not allow fowl ac- and Uncinaria stenocephala). (4) Cats and kittens: Removal and cess to feed containing this preparation control of intestinal roundworms or to fecal excrement from treated ani- (Toxocara cati and Toxascaris leonina) mals. and hookworms (Ancylostoma (h) Conditions of use in horses when tubaeforme and Uncinaria stenocephala). administered orally by syringe. (1) It is (5) Dichlorvos is a cholinesterase in- recommended for the removal and con- hibitor. Do not use simultaneously trol of first, second, and third instar with or within a few days before or bots (Gastrophilus intestinalis and G. na- after treatment with or exposure to salis), sexually mature and sexually im- cholinesterase-inhibiting drugs, pes- mature (4th stage) ascarids (Parascaris ticides, or chemicals. equorum) in horses and foals. (6) Do not use in animals under 10 (2) The product is in the form of a gel days of age or 1 pound of body weight. which is administered directly from a (7) Do not administer to animals syringe onto the horse’s tongue. The showing signs of constipation, mechan- product is administered at a dosage ical blockage of the intestinal tract, level of 20 milligrams of dichlorvos per impaired liver function, or recently ex- kilogram of body weight for the re- posed to or showing signs of infectious moval of bots and ascarids. The same disease. dosage level is repeated every 21 to 28 (8) Do not use in dogs or puppies in- days for the control of bots and fected with Dirofilaria immitis. ascarids. For the control of bots only, (9) Federal law restricts this drug to the repeat dosage is 10 milligrams per use by or on the order of a licensed vet- kilogram of body weight every 21 to 28 erinarian. days during bot fly season. [40 FR 13838, Mar. 27, 1975, as amended at 48 (3) Do not use this product in animals FR 40704, Sept. 9, 1983; 51 FR 28546, Aug. 8, simultaneously or within a few days 1986; 62 FR 35076, June 30, 1997; 64 FR 18571, before or after treatment with or expo- Apr. 15, 1999] sure to cholinesterase-inhibiting drugs, pesticides or chemicals. Do not admin- § 520.608 Dicloxacillin sodium ister in conjunction with or within 1 monohydrate capsules. week of administration of muscle-re- (a) Specifications. Each capsule con- laxant drugs, phenothiazine derived tains dicloxacillin sodium tranquilizers, or central nervous sys- monohydrate equivalent to 50, 100, 200, tem depressants. or 500 milligrams of dicloxacillin.

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(b) Sponsor. See No. 000856 in § 510.600 gram tablets for prevention of heart- (c) of this chapter. worm disease in dogs, as an aid in the (c) Conditions of use. Dogs—(1) control of ascarid infections in dogs, Amount. 5 to 10 milligrams per pound of and as an aid in the treatment of asca- body weight, three times daily. In se- rid infections in dogs and cats. vere cases, up to 25 milligrams per (6) See No. 000010 in § 510.600(c) of this pound of body weight three times chapter for use of 50, 100, 200, 300, or 400 daily. milligram tablets for prevention of (2) Indications for use. Treatment of heartworm disease in dogs, as an aid in pyoderma (pyogenic dermatitis) due to the control of ascarid infections in penicillinase-producing staphylococci dogs, and as an aid in the treatment of sensitive to the drug. ascarid infections in dogs and cats. (3) Limitations. For the treatment of (b) Conditions of use—(1) Dosage/indi- dogs only. Continue treatment for 24 to cations for use. (i) Three milligrams per 48 hours after the animal has become pound of body weight daily for preven- afebrile or asymptomatic, Administer 1 tion of heartworm disease (Dirofilaria to 2 hours before feeding to ensure immitis) in dogs. maximum absorption. Not for use in (ii) Three milligrams per pound of animals which are raised for food pro- body weight daily as an aid in the con- duction. Federal law restricts this drug trol of ascarid infections (Toxocara to use by or on the order of a licensed canis) in dogs. veterinarian. (iii) Twenty-five to 50 milligrams per [57 FR 37325, Aug. 18, 1992] pound of body weight as an aid in the treatment of ascarid infections in dogs § 520.620 Diethylcarbamazine oral dos- (Toxocara canis) and cats (Toxocara age forms. canis and Toxascaris leonina). (2) Limitations. Administer orally ei- § 520.622 Diethylcarbamazine citrate ther pulverized and given in feed or oral dosage forms. water or directly by mouth. For the § 520.622a Diethylcarbamazine citrate treatment of ascarid infections, repeat tablets. in 10 to 20 days to remove immature worms that may enter the intestine (a) Sponsors. (1) See 015579 in from the lungs after the first dose. Do § 510.600(c) of this chapter for use of 50, not treat dogs with established heart- 200, and 400 milligram tablets for pre- worm infections until they have been vention of heartworm disease in dogs converted to a negative status by the and as an aid in the treatment of asca- use of adulticidal and microfilaricidal rid infections in dogs and cats. drugs. Inadvertent administration to (2) See 053501 in § 510.600(c) of this heartworm-infected dogs may cause ad- chapter for use of 100, 200, and 300 milli- verse reactions because of pulmonary gram tablets for prevention of heart- occlusion. Overdosage may cause worm disease in dogs and as an aid in emesis. For prevention of heartworm the treatment of ascarid infections in disease in heartworm-endemic areas, dogs. administration of the drug should start (3) See 061623 in § 510.600(c) of this at the beginning of mosquito activity chapter for use of 50, 100, 200, 300, or 400 and be continued daily throughout the milligram tablets for prevention of mosquito season and for approximately heartworm disease in dogs, as an aid in a month thereafter. Federal law re- the control of ascarid infections in stricts this drug to use by or on the dogs, and as an aid in the treatment of order of a licensed veterinarian. ascarid infections in dogs and cats. (4) See 017030 in § 510.600(c) of this [46 FR 23230, Apr. 24, 1981, as amended at 46 chapter for use of 50, 100, 200, 300, and FR 41038, Aug. 14, 1981; 46 FR 46315, Sept. 18, 400 milligram tablets for prevention of 1981; 46 FR 61653, Dec. 18, 1981; 47 FR 10805, heartworm disease in dogs and as an Mar. 12, 1982; 47 FR 14150, Apr. 2, 1982; 50 FR 41489, Oct. 11, 1985; 50 FR 49372, Dec. 2, 1985; aid in the treatment of ascarid infec- 53 FR 40056, Oct. 13, 1988; 53 FR 40727, Oct. 18, tions in dogs and cats. 1988; 55 FR 8461, Mar. 8, 1990; 61 FR 34728, (5) See 000081 in § 510.600(c) of this July 3, 1996; 62 FR 35076, June 30, 1997; 66 FR chapter for use of 60, 120, or 180 milli- 14073, Mar. 9, 2001; 68 FR 4914, Jan. 31, 2003]

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§ 520.622b Diethylcarbamazine citrate (c) As an aid in treatment of ascarid syrup. infections in dogs (T. canis) and cats (T. (a)(1) Specifications. Each milliliter of canis and T. leonina). syrup contains 60 milligrams of (iii) Limitations. The drug may be diethylcarbamazine citrate. placed on the daily ration or given di- rectly by mouth. For treatment of as- (2) Sponsor. See No. 053501 in carid infections, a repeat dose should § 510.600(c) of this chapter. be given in 10 to 20 days to remove im- (3) Conditions of use. (i) The drug is mature worms which may enter the in- indicated for use in dogs for the pre- testine from the lungs after the first vention of infection with Dirofilaria dose. Older dogs should be proven nega- immitis and T. canis and T. leonina. It is tive for presence of Dirofilaria immitis also indicated for treatment of ascarid infections before administering the infections of T. canis and T. leonina in drug. Dogs with established heartworm dogs and T. cati in cats. infections should not receive the drug (ii) For prevention of heartworm and until they have been converted to a ascarid infections in dogs, the drug negative status by the use of may be added to the daily diet at a dos- adulticidal and microfilaricidal drugs. age rate of 3.0 milligrams per pound of Inadvertent administration to heart- body weight per day or given directly worm-infected dogs may cause adverse by mouth at the same dosage rate. For reactions due to pulmonary occlusion. treatment of ascarid infections in dogs Overdosage may cause emesis. For pre- and cats, the drug is administered at a vention of heartworm disease in heart- dosage level of 25 to 50 milligrams per worm-endemic areas, administration of pound of body weight preferably ad- the drug should start 1 month before ministered immediately after feeding. the mosquito season and be continued (iii) Older dogs should be proven neg- daily throughout the mosquito season ative for the presence of Dirofilaria and for 2 months thereafter. Federal immitis infection before administration law restricts this drug to use by or on of the drug. Those with proven infec- the order of a licensed veterinarian. tion of Dirofilaria immitis should be ren- (c)(1) Specifications. Each milliliter of dered negative using adulticidal and syrup contains 60 milligrams of microfilaricidal drugs before adminis- diethylcarbamazine citrate. tration of this drug. (2) Sponsor. See No. 000010 in (iv) Federal law restricts this drug to § 510.600(c) of this chapter. use by or on the order of a licensed vet- (3) Conditions of use. (i) The drug is erinarian. used in dogs between 4 weeks and 8 (b)(1) Specifications. Each milliliter of months of age for the removal of syrup contains 60 milligrams of ascarids (Toxacara canis) and in ani- diethylcarbamazine citrate. mals over 4 weeks of age for the pre- (2) Sponsors. (i) See No. 017030 for use vention of heartworm disease as in paragraphs (b)(3)(ii)(a) and (Dirofilaria immitis). (b)(3)(ii)(c) of this section. (ii) The drug is administered (a) for (ii) See No. 017030 for use as in para- removal of ascarids at a dosage of 50 graphs (b)(3)(ii) (a) and (c) of this sec- milligrams per pound of body weight tion. divided into two equal doses and ad- (3) Conditions of use—(i) Amount. 3 ministered 8 to 12 hours apart (morning milligrams per pound of body weight and night), orally or mixed with either per day for prevention of heartworm dry or wet food, and (b) for prevention disease and as an aid in control of large of heartworm disease at a dosage of 3 roundworms; 25 to 50 milligrams per milligrams per pound of body weight pound of body weight as an aid in daily, orally or in food, in heartworm treatment of ascarid infections. endemic areas, from the beginning of (ii) Indications for use. (a) For preven- mosquito activity, during the mosquito tion of heartworm disease (Dirofilaria season, and for 2 months following the immitis) in dogs. end thereof. (b) As an aid in control of large (iii) Dogs older than 8 months of age roundworms (T. canis) in dogs. may be infected with Dirofilaria immitis.

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Use of the drug is contraindicated in (iii) For prevention of heartworm dis- dogs with active D. immitis infections. ease (Dirofilaria immitis) in dogs. (iv) Federal law restricts this drug to (3) Limitations. Tablets are adminis- use by or on the order of a licensed vet- tered orally or pulverized and given in erinarian. the feed. For treatment of ascarid in- fections, a repeat dose should be given [40 FR 13838, Mar. 27, 1975, as amended at 41 FR 28265, July 9, 1976; 44 FR 3967, Jan. 19, in 10 to 20 days to remove immature 1979; 47 FR 14150, Apr. 2, 1982; 47 FR 35186, worms which may enter the intestine Aug. 13, 1982; 49 FR 33997, Aug. 28, 1984; 50 FR from the lungs after the first dose. 41489, Oct. 11, 1985; 53 FR 47027, Oct. 18, 1988; Dogs with established heartworm infec- 61 FR 34728, July 3, 1996; 62 FR 35076, June 30, tions should not receive the drug until 1997; 62 FR 38906, July 21, 1997] they have been converted to a negative status by the use of adulticidal and § 520.622c Diethylcarbamazine citrate microfilaricidal drugs. Inadvertent ad- chewable tablets. ministration to heartworm-infected (a) Specifications. Each chewable tab- dogs may cause adverse reactions due let contains 30, 45, 60, 120, 150, or 180 to pulmonary occlusion. Overdosage milligrams of diethylcarbamazine cit- may cause emesis. For prevention of rate. heartworm disease in heartworm-en- (b) Sponsors. See drug listing nos. in demic areas, administration of the § 510.600(c) of this chapter for identi- drug should start at the beginning of fication of sponsors as follows: mosquito activity and be continued (1) For 015579, use of 30 or 120 milli- daily throughout the mosquito season gram tablets as in paragraph (c)(2)(i) of and for approximately a month there- this section. after. Federal law restricts this drug to (2) For 000069, use of 60, 120, or 180 use by or on the order of a licensed vet- milligram tablets as in paragraph erinarian. (c)(2)(ii) of this section. (3) For 061690, use of 45 or 150 milli- [43 FR 6941, Feb. 17, 1978] gram tablets as in paragraph (c)(2)(iii) EDITORIAL NOTE: For FEDERAL REGISTER ci- of this section. tations affecting § 520.622c, see the List of (4) For 061133, use of 60-, 120-, or 180- CFR Sections Affected, which appears in the milligram tablets as in paragraph Finding Aids section of the printed volume (c)(2)(i) of this section. and on GPO Access. (5) For 000061, use of 60-milligram tablets as in paragraph (c)(2)(i) of this § 520.622d Diethylcarbamazine citrate capsules. section. (6) For 000010, use of 30, 60, 120, or 180 (a)(1) Specifications. Each capsule con- milligram tablets as in paragraph tains either 12.5, 50, 200, or 400 milli- (c)(2)(i) of this section. grams of diethylcarbamazine citrate. (7) [Reserved] (2) Sponsor. See 011014 in § 510.600(c) of (c) Conditions of use—(1) Amount. 3 this chapter. milligrams per pound of body weight (3) Conditions of use—(i) Amount/indi- per day for prevention of heartworm cations for use. 3 milligrams per pound disease and control of ascarids; 25 to 50 of body weight daily for prevention of milligrams per pound of body weight as heartworm disease (Dirofilaria immitis) an aid in treatment of ascarid infec- in dogs; 25 to 50 milligrams per pound tions. of body weight in a single dose as an (2) Indications for use. (i) For preven- aid in the treatment of ascarid infec- tion of heartworm disease (Dirofilaria tions in dogs (Toxocara canis and immitis) in dogs; as an aid in control of Toxascaris leonina). ascarids (Toxocara canis) in dogs; as an (ii) Limitations. Administer orally di- aid in treatment of ascarid (Toxocara rectly or added to the daily ration. For canis and Toxascaris leonina) infections ascarid infections, repeat treatment in in dogs and cats. 10 to 20 days to remove immature (ii) For prevention of infection with worms that may enter the intestine Dirofilaria immitis (heartworm disease) from the lungs after the first dose. Do in dogs; as an aid in treatment of asca- not treat dogs with established heart- rid (Toxocara canis and Toxascaris worm infections until they have been leonina) infections in dogs. converted to a negative status by the

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use of adulticidal and microfilaricidal (c) Conditions of use in dogs—(1) drugs. Inadvertent administration to Amount. Administer orally to dogs at a heartworm-infected dogs may cause ad- dosage level of 6.6 milligrams of verse reactions due to pulmonary oc- diethylcarbamazine citrate per kilo- clusion or shock. Overdosage may gram of body weight (3 milligrams per cause emesis. For prevention of heart- pound of body weight) and 5.0 milli- worm disease in heartworm-endemic grams of oxibendazole per kilogram of areas, administration of the drug body weight (2.27 milligrams per pound should begin 1 month before and con- of body weight). tinue 2 months after the mosquito sea- (2) Indications for use. For prevention son. Dogs receiving prophylactic ther- of infection with Dirofilaria immitis apy should be examined every 6 months for the presence of microfilariae. Fed- (heartworm disease) and Ancylostoma eral law restricts this drug to use by or caninum (hookworm infection) and for on the order of a licensed veterinarian. removal and control of Trichuris vulpis (b)(1) Specifications. Each capsule con- (whipworm infection) and mature and tains either 12.5, 50, 200, or 400 milli- immature stages of intestinal Toxocara grams of diethylcarbamazine citrate. canis (ascarid infection). (2) Sponsor. See 023851 in § 510.600(c) of (3) Limitations. Orally administer this chapter. daily during heartworm season. For (3) Conditions of use—(i) Amount/indi- free-choice feeding or broken and cations for use. 3 milligrams per pound placed on or mixed with feed. Do not of body weight daily for prevention of use in dogs that may harbor adult heartworm disease (Dirofilaria immitis) heartworms. Federal law restricts this in dogs. drug to use by or on the order of a li- (ii) Limitations. Capsules may be ad- censed veterinarian. ministered to the dog directly or added to the daily ration. For oral adminis- [50 FR 28768, July 16, 1985, as amended at 53 tration only. Do not treat dogs with es- FR 45759, Nov. 14, 1988; 54 FR 3776, Jan. 26, tablished heartworm infections until 1989; 54 FR 6804, Feb. 14, 1989; 56 FR 50653, they have been converted to a negative Oct. 8, 1991; 60 FR 55659, Nov. 2, 1995] status by the use of adulticidal and § 520.645 Difloxacin. microfilaricidal drugs. Inadvertent ad- ministration to heartworm infected (a) Specifications. Each tablet con- dogs may cause adverse reactions due tains 11.4, 45.4, or 136 milligrams (mg) to pulmonary occlusion or shock. For of difloxacin hydrochloride. prevention of heartworm disease in (b) Sponsor. See No. 000856 in heartworm-endemic areas, administra- § 510.600(c) of this chapter. tion of the drug should begin 1 month (c) [Reserved] before and continue 2 months after the (d) Conditions of use—(1) Dogs—(i) mosquito season. Dogs receiving pro- Amount. 5 to 10 mg per kilogram (2.3 to phylactic therapy should be examined 4.6 mg/pound) of body weight. every 6 months for the presence of (ii) Indications for use. For manage- microfilariae. Federal law restricts ment of diseases in dogs associated this drug to use by or on the order of a licensed veterinarian. with bacteria susceptible to difloxacin. (iii) Limitations. Use once a day for 2 [47 FR 26377, June 18, 1982, as amended at 48 to 3 days beyond cessation of clinical FR 46979, Oct. 17, 1983; 49 FR 5099, Feb. 10, signs of disease up to a maximum of 30 1984] days. Federal law prohibits the extra- § 520.623 Diethylcarbamazine citrate, label use of this drug in food-producing oxibendazole chewable tablets. animals. Federal law restricts this (a) Specifications. Each tablet con- drug to use by or on the order of a li- tains either 60, 120, or 180 milligrams of censed veterinarian. diethylcarbamazine citrate with 45, 91, (2) [Reserved] or 136 milligrams of oxibendazole, re- [63 FR 8123, Feb. 18, 1998] spectively. (b) Sponsor. See 000069 in §510.600(c) of this chapter.

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§ 520.763 Dithiazanine iodide oral dos- § 520.763b Dithiazanine iodide powder. age forms. (a) Chemical name. 3-Ethyl-2-[5-(3- ethyl-2-benzothiazolinylidene)-1,3- § 520.763a Dithiazanine iodide tablets. pentadienyl]-benzothiazoliumiodide. (a) Chemical name. 3-Ethyl-2-[5-(3- (b) Specifications. Dithiazanine iodide ethyl - 2 - benzothiazolinylidene) - 1,3 - powder contains 200 milligrams of pentadienyl]-benzothiazolium iodide. dithiazanine iodide per level standard (b) Specifications. Dithiazanine iodide tablespoon. tablets contain 10 milligrams, 50 milli- (c) Sponsor. See No. 000010 in grams, 100 milligrams, or 200 milli- § 510.600(c) of this chapter. grams of dithiazanine iodide in each (d) Conditions of use. (1) Dithiazanine tablet. iodide powder is administered to dogs by mixing the proper dosage in the (c) Sponsor. See No. 000010 in dog’s food, using the following dosage § 510.600(c) of this chapter. schedule for various parasite infesta- (d) Conditions of use. (1) The tablets tions: are administered orally to dogs imme- diately after feeding using the fol- Milligrams Length of lowing dosage schedule for various per pound treatment— of body days parasite infestations: weight Large roundworms (Toxocara Milligrams per pound Length of canis, Toxascaris leonina) ...... 10 3–5 of body treatment— Hookworms (Ancylostoma weight days caninum, Uncinaria stenocephala) ...... 10 7 Large roundworms (Toxocara Whipworms (Trichuris vulpis) ...... 10 7 canis, Toxascaris leonina) ...... 10 3–5 Strongyloides (Strongyloides Hookworms (Ancylostoma canis, Strongyloides caninum, Uncinaria stercoralis) ...... 10 10–12 stenocephala) ...... 10 7 Heartworm microfilariae (Dirofilaria immitus) ...... 3–5 7–10 Whipworms (Trichuris vulpis) ...... 10 Strongyloides (Strongyloides Note: Treatment with dithiazanine iodide for heartworm canis, Strongyloides microfilariae should follow 6 weeks after therapy for adult stercoralis) ...... 10 10–12 worms. Heartworm microfilariae (2) The drug is contraindicated in (Dirofilaria immitus) ...... 3–5 7–10 animals sensitive to dithiazanine io- Note: Treatment with dithiazanine iodide for heartworm dide and should be used cautiously, if microfilariae should follow 6 weeks after therapy for adult worms. at all, in dogs with reduced renal func- tion. (2) The drug is contraindicated in (3) Federal law restricts this drug to animals sensitive to dithiazanine io- use by or on the order of a licensed vet- dide and should be used cautiously, if erinarian. at all, in dogs with reduced renal func- (e) Use for treating dogs for large tion. roundworms, hookworms, whipworms, (3) Federal law restricts this drug to and strongyloides as provided for in use by or on the order of a licensed vet- this section has been NAS/NRC re- erinarian. viewed and deemed effective. Applica- (e) Use for treating dogs for large tions for these uses need not include ef- roundworms, hookworms, whipworms, fectiveness data as specified by § 514.111 and strongyloides as provided for in of this chapter, but may require bio- this section has been NAS/NRC re- equivalency and safety information. viewed and deemed effective. Applica- [40 FR 13838, Mar. 27, 1975, as amended at 47 tions for these uses need not include ef- FR 51564, Nov. 16, 1982; 48 FR 32342, July 15, fectiveness data as specified by § 514.111 1983; 53 FR 40727, Oct. 18, 1988; 62 FR 35076, of this chapter, but may require bio- June 30, 1997] equivalency and safety information. § 520.763c Dithiazanine iodide and pi- [40 FR 13838, Mar. 27, 1975, as amended at 47 perazine citrate suspension. FR 51564, Nov. 16, 1982; 48 FR 32342, July 15, (a) Specifications. Each milliliter of 1983; 53 FR 40727, Oct. 18, 1988; 62 FR 35076, the drug contains 69 milligrams of June 30, 1997] dithiazanine iodide and 83 milligrams

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of piperazine base (as piperazine cit- per pound of body weight per day di- rate). vided into 3 or 4 equal doses. It is ad- (b) Sponsor. See 000010 in § 510.600(c) of ministered orally to dogs and cats at a this chapter. dosage level of 2 to 3 milligrams per (c) NAS/NRC status. The conditions of pound of body weight per day divided use are NAS/NRC reviewed and found into 3 or 4 equal doses. 1 effective. Applications for these uses (3) Not for use in horses intended for need not include effectiveness data as food. 1 specified by § 514.111 of this chapter, (4) Federal law restricts this drug to but may require bioequivalency and use by or on the order of a licensed vet- safety information. erinarian. 1 (d) Conditions of use—(1) Amount. 1 [40 FR 13838, Mar. 27, 1975, as amended at 42 ounce (30 milliliters) per 100 pounds of FR 60140, Nov. 25, 1977; 46 FR 48642, Oct. 2, 3 body weight for the first 500 pounds; ⁄4 1981; 61 FR 8873, Mar. 6, 1996; 62 FR 61624, ounce for each 100 pounds thereafter, Nov. 19, 1997] up to 1,200 pounds; 101⁄4 ounces to ani- mals over 1,200 pounds. § 520.804 Enalapril tablets. (2) Indications for use. For control of (a) Specifications. Each tablet con- large roundworms, Parascaris equorum; tains either 1.0, 2.5, 5.0, 10.0, or 20.0 mil- small strongyles; large strongyles, ligrams of enalapril maleate. Strongylus vulgaris; and pinworms, (b) Sponsor. See 050604 in § 510.600(c) of Oxyuris equi. this chapter. (3) Limitations. Administer by drench (c) Conditions of use—(1) Dogs—(i) or mixed with the daily ration as a sin- Amount. 0.5 to 1.0 milligram of gle dose. Treatment is recommended in enalapril maleate per kilogram of body spring and fall. In a heavily infested weight per day. environment, treatment may be re- (ii) Indications for use. Treatment of peated every 30 days. Not for use in mild, moderate, and severe (modified horses intended for food purposes. Se- New York Heart Association Class II, verely debilitated animals should not III, IV) heart failure in dogs. be wormed except on the advice of a (iii) Limitations. Use 0.5 milligram per veterinarian. If the drug is for adminis- kilogram once daily. In the absence of tration by stomach tube, it shall be la- adequate clinical response within a 2- beled: ‘‘Federal law restricts this drug week period, use may be increased to to use by or on the order of a licensed twice daily (a total of 1.0 milligram per veterinarian.’’ kilogram). Enalapril maleate is admin- [47 FR 52696, Nov. 23, 1982, as amended at 48 istered as conjunctive therapy with FR 32342, July 15, 1983; 53 FR 40727, Oct. 18, furosemide and digoxin in the treat- 1988; 62 FR 35076, June 30, 1997] ment of dilated cardiomyopathy and furosemide with or without digoxin in § 520.784 Doxylamine succinate tab- the treatment of chronic valvular dis- lets. ease. The safety of enalapril for use in (a) Specifications. The drug is in tab- breeding dogs has not been established. let form and contains doxylamine suc- Use in pregnant bitches is not rec- cinate as the active drug ingredient. ommended. Federal law restricts this (b) Sponsor. See No. 000061 in drug to use by or on the order of a li- § 510.600(c) of this chapter. censed veterinarian. (c) Conditions of use. (1) The drug is (2) [Reserved] used in conditions in which antihis- taminic therapy may be expected to al- [59 FR 17694, Apr. 14, 1994, as amended at 62 leviate some signs of disease in horses, FR 63270, Nov. 28, 1997] 1 dogs, and cats. § 520.812 Enrofloxacin tablets. (2) It is administered orally to horses at a dosage level of 1 to 2 milligrams (a) Specifications. Each tablet con- tains either 22.7, 68.0, or 136.0 milli- 1 These conditions are NAS/NRC reviewed grams of enrofloxacin. and deemed effective. Applications for these (b) Sponsor. See No. 000859 in uses need not include effectiveness data as § 510.600(c) of this chapter. specified by § 514.111 of this chapter. (c) [Reserved]

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(d) Conditions of use—(1) Amount. 5 to § 520.816 Epsiprantel tablets. 20 milligrams per kilogram (2.27 to 9.07 (a) Specifications. Each tablet con- milligrams per pound) of body weight. tains either 12.5, 25, 50, or 100 milli- (2) Indications for use. Dogs and cats grams of epsiprantel. for management of diseases associated (b) Sponsor. See No. 000069 in with bacteria susceptible to § 510.600(c) of this chapter. enrofloxacin. (c) Conditions of use—(1) Dogs—(i) (3) Limitations. Administer orally as a Amount. 2.5 milligrams per pound of single dose or divided into 2 equal doses body weight. at 12 hour intervals, daily. Administer (ii) Indications for use. Removal of ca- for at least 2 to 3 days beyond ces- nine cestodes Dipylidium caninum and sation of clinical symptoms, for a max- Taenia pisiformis. imum of 30 days. Safety in breeding or (2) Cats—(i) Amount. 1.25 milligrams pregnant cats has not been established. per pound of body weight. Federal law restricts this drug to use (ii) Indications for use. Removal of fe- by or on the order of a licensed veteri- line cestodes D. caninum and T. narian. taeniaeformis. [54 FR 3444, Jan. 24, 1989, as amended at 55 (3) Limitations. For oral use only as a FR 43327, Oct. 29, 1990; 62 FR 38906, July 21, single dose. Do not use in animals less 1997; 64 FR 48295, Sept. 3, 1999] than 7 weeks of age. Safety of use in pregnant or breeding animals has not § 520.813 Enrofloxacin oral solution. been established. Federal law restricts (a) Specifications. Each milliliter of this drug to use by or on the order of a concentrate solution contains 32.3 mil- licensed veterinarian. ligrams of enrofloxacin. (b) Sponsor. See No. 000859 in [54 FR 50615, Dec. 8, 1989, as amended at 56 FR 50653, Oct. 8, 1991; 60 FR 55659, Nov. 2, § 510.600(c) of this chapter. 1995] (c) Related tolerances. See § 556.228 of this chapter. § 520.823 Erythromycin phosphate. (d) Conditions of use. It is used in (a) Specifications. Erythromycin phos- drinking water as follows: phate is the phosphate salt of the anti- (1) Chickens and turkeys—(i) Amount. biotic substance produced by the 25 to 50 parts per million of growth of Streptomyces erythreus or the enrofloxacin in drinking water. same antibiotic substance produced by (ii) Indications. Chickens: Control of any other means. One gram of erythro- mortality associated with Escherichia mycin phosphate is equivalent to 0.89 coli susceptible to enrofloxacin. Tur- gram of erythromycin master stand- keys: Control of mortality associated ard. with E. coli and Pasteurella multocida (b) Sponsor. See No. 061623 in (fowl cholera) susceptible to § 510.600(c) of this chapter. enrofloxacin. (c) Related tolerances. See § 556.230 of (iii) Limitations. Do not use in laying this chapter. hens producing eggs for human con- (d) Conditions of use. It is used in sumption. Administer medicated water drinking water as follows: continuously as sole source of drinking (1) Broiler and replacement chickens— water for 3 to 7 days. Prepare fresh (i) Amount. 0.500 gram per gallon. stock solution daily. Effects on the re- (ii) Indications for use. As an aid in productive function of turkeys have the control of chronic respiratory dis- not been determined. Treated animals ease due to Mycoplasma gallisepticum must not be slaughtered for food with- susceptible to erythromycin. in 2 days of the last treatment. Individ- (iii) Limitations. Administer for 5 uals with a history of hypersensitivity days; do not use in replacement pullets to quinolones should avoid exposure to over 16 weeks of age; do not use in this product. Federal law restricts this chickens producing eggs for human drug to use by or on the order of a li- consumption; to assure effectiveness, censed veterinarian. treated birds must consume enough (2) [Reserved] medicated water to provide a thera- [61 FR 56893, Nov. 5, 1996] peutic dosage; solutions older than 3

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days should not be used; withdraw 1 hydrochloride because phenothiazine day before slaughter. may potentiate the toxicity of (2) Replacement chickens and chicken organophosphates and the activity of breeders—(i) Amount. 0.500 gram per gal- procaine hydrochloride.1 lon. (4) Federal law restricts this drug to (ii) Indications for use. As an aid in use by or on the order of a licensed vet- the control of infectious coryza due to erinarian.1 Hemophilus gallinarum susceptible to [40 FR 13838, Mar. 27, 1975, as amended at 46 erythromycin. FR 48642, Oct. 2, 1981; 61 FR 8873, Mar. 6, 1996; (iii) Limitations. Administer for 7 62 FR 61624, Nov. 19, 1997] days; do not use in replacement pullets over 16 weeks of age; do not use in § 520.870 Etodolac. chickens producing eggs for human (a) Specifications. Each tablet con- consumption; to assure effectiveness, tains 150, 300, or 500 milligrams (mg) of treated birds must consume enough etodolac. medicated water to provide a thera- (b) Sponsor. See 053501 in § 510.600(c) of peutic dosage; solutions older than 3 this chapter. days should not be used; withdraw 1 (c) [Reserved] day before slaughter. (d) Conditions of use—(1) Dogs—(i) (3) Growing turkeys—(i) Amount. 0.500 Amount. 10 to 15 mg per kilogram (4.5 gram per gallon. to 6.8 mg/pound) of body weight per (ii) Indications for use. As an aid in day. the control of blue comb (nonspecific (ii) Indications for use. For the man- infectious enteritis) caused by orga- agement of pain and inflammation as- nisms susceptible to erythromycin. sociated with osteoarthritis in dogs. (iii) Limitations. Administer for 7 (iii) Limitations. Use once-a-day. Fed- days; do not use in turkeys producing eral law restricts this drug to use by or eggs for human consumption; to assure on the order of a licensed veterinarian. effectiveness, treated birds must con- (2) [Reserved] sume enough medicated water to pro- vide a therapeutic dosage; solutions [63 FR 51300, Sept. 25, 1998, as amended at 68 older than 3 days should not be used; FR 51705, Aug. 28, 2003] withdraw 1 day before slaughter. § 520.903 Febantel oral dosage forms. [40 FR 13838, Mar. 27, 1975, as amended at 45 FR 56798, Aug. 26, 1980; 66 FR 14073, Mar. 9, § 520.903a Febantel paste. 2001; 68 FR 4914, Jan. 31, 2003] (a) Chemical name. Dimethyl [[2- [(methoxyacetyl)amino]-4-(phenyl- § 520.863 Ethylisobutrazine hydro- chloride tablets. thio)phenyl] carbonimidoyl]bis [carba- mate]. (a) Specifications. Each tablet con- (b) Specifications. The drug is a paste tains either 10 milligrams or 50 milli- containing 45.5 percent febantel. grams of ethylisobutrazine hydro- (c) Sponsor. See No. 000859 in chloride. § 510.600(c) of this chapter. (b) Sponsor. See No. 000061 in (d) Conditions of use—(1) Amount. Six § 510.600(c) of this chapter. milligrams per kilogram (2.73 milli- (c) Conditions of use. (1) It is adminis- grams per pound) of body weight in tered orally to dogs as a tranquilizer.1 horses. (2) It is administered once daily at a (2) Indications for use. For removal of dosage level of 2 to 5 milligrams of large strongyles (Strongylus vulgaris, S. ethylisobutrazine hydrochloride per edentatus, S. equinus); ascarids pound of body weight.1 (Parascaris equorum— sexually mature (3) It is not to be used in conjunction and immature); pinworms (Oxyuris with organophosphates and/or procaine equi— adult and 4th stage larva); and the various small strongyles in horses, 1 These conditions are NAS/NRC reviewed foals, and ponies. and deemed effective. Applications for these uses need not include effectiveness data as (3) Limitations. (i) The paste may be specified by § 514.111 of this chapter, but may administered on the base of the tongue require bioequivalency and safety informa- or well mixed into a portion of the nor- tion. mal grain ration.

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(ii) [Reserved] § 520.903c [Reserved] (iii) For animals maintained on premises where reinfection is likely to § 520.903d Febantel-praziquantel occur, retreatment may be necessary. paste. For most effective results, retreat in 6 (a) Specifications. Each gram of paste to 8 weeks. contains 34 milligrams of febantel and (iv) Not for use in horses intended for 3.4 milligrams of praziquantel. food. (v) Consult your veterinarian for as- (b) Sponsor. See No. 000859 in sistance in the diagnosis, treatment, § 510.600(c) of this chapter. and control of parasitism. (c) Conditions of use—(1) Amount—(i) Dogs and cats (over 6 months of age): 10 [43 FR 8797, Mar. 3, 1978; 43 FR 12311, Mar. 24, milligrams of febantel and 1 milligram 1978, as amended at 43 FR 60882, Dec. 29, 1978. Redesignated at 45 FR 8587, Feb. 8, 1980] of praziquantel per kilogram of body weight (1 gram of paste per 7.5 pounds § 520.903b Febantel suspension. body weight) administered by mouth or (a) Specifications. The suspension con- in the food once daily for 3 days. tains 9.3 percent (2.75 grams per ounce) (ii) Puppies and kittens (less than 6 febantel. months of age): 15 milligrams of (b) Sponsor. See 000859 in § 510.600(c) of febantel and 1.5 milligrams of this chapter. praziquantel per kilogram of body (c) Conditions of use—(1) Amount. 3 weight (1 gram of paste per 5 pounds milliliters per 100 pounds body weight body weight) administered by mouth or 1 fluid ounce per 1000 pounds (6 mil- on a full stomach once daily for 3 days. ligrams per kilogram body weight). (2) Indications for use. (i) Dogs and (2) Indications for use. For removal of puppies: For removal of hookworms ascarids (Parascaris equorum—adult and (Ancylostoma caninum and Uncinaria sexually immature), pinworms (Oxyuris stenocephala), whipworms (Trichuris equi—adult and 4th stage larvae), large vulpis), ascarids (Toxocara canis and strongyles (Strongylus vulgaris, S. Toxascaris leonina), and tapeworms edentatus, S. equinus), and the various (Dipylidium caninum and Taenia small strongyles in horses, breeding stallions and mares, pregnant mares, pisiformis). foals, and ponies. (ii) Cats and kittens: For removal of (3) Limitations. Administer by stom- hookworms (Ancylostoma tubaeforme), ach tube or drench, or by mixing well ascarids (Toxocara cati) and tapeworms into a portion of the normal grain ra- (Dipylidium caninum and Taenia tion. For animals maintained on prem- taeniaeformis). ises where reinfection is likely to (3) Limitations. Do not use in preg- occur, retreatment may be necessary. nant animals. Federal law restricts For most effective results, retreat in 6 this drug to use by or on the order of a to 8 weeks. Not for use in horses in- licensed veterinarian. tended for food. Federal law restricts (4) Special considerations. Consider al- this drug to use by or on the order of a ternative therapy or use with caution licensed veterinarian. in animals with pre-existing liver or (d) Special considerations. Febantel kidney dysfunction. suspension may be used in combination with trichlorfon oral liquid in accord- [50 FR 19167, May 7, 1985, as amended at 53 ance with the provisions of § 520.2520c, FR 48533, Dec. 1, 1988; 56 FR 50813, Oct. 9, this section, and the following condi- 1991] tions: (1) Combine 1 part febantel suspen- § 520.903e Febantel tablets. sion with 5 parts trichlorfon liquid. (a) Specifications. Each scored tablet (2) Allow animal to consume a por- contains 27.2 milligrams of febantel for tion of daily grain ration; administer use in dogs, puppies, cats, and kittens mixture by stomach tube at rate of 18 or 163.3 milligrams of febantel for use milliliters per 100 pounds of body in dogs, puppies, and cats. weight. (b) Sponsor. See 000859 in § 510.600(c)(2) [45 FR 8587, Feb. 8, 1980] of this chapter.

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(c) Conditions of use—(1) Amount—(i) (2) Cattle including dairy cows of breed- Dogs and cats. Ten milligrams per kilo- ing age—(i) Amount. Administer orally 5 gram body weight. Administer once milligrams per kilogram of body daily for 3 consecutive days. weight (2.3 milligrams per pound). (ii) Puppies and kittens fewer than 6 (ii) Indications for use. For the re- months of age. Fifteen milligrams per moval and control of lungworm kilogram body weight. Administer once (Dictyocaulus viviparus); stomach worm daily for 3 consecutive days. (adults)—brown stomach worm (2) Indications for use. (i) For removal (Ostertagia ostertagi); stomach worms of hookworms (Ancylostoma caninum (adults and 4th-stage larvae)— and Uncinaria stenocephala), ascarids barberpole worm (Haemonchus contortus (Toxocara canis and Toxascaris leonina) and H. placei) and small stomach worm and whipworms (Trichuris vulpis) in (Trichostongylus axei); intestinal worms dogs and puppies. (adults and 4th-stage larvae)— (ii) For removal of hookworms hookworm (Bunostonmum phlebotomum), (Ancylostoma tubaeforme) and ascarids threadnecked intestinal worm (Toxocara cati) in cats and kittens. (Nematodirus helvetianus), small intes- (3) Limitations. Do not use in preg- tinal worm (Cooperia punctata and C. nant animals. Consider alternative oncophora), bankrupt worm therapy or use with caution in animals (Trichostrongylus colubriformis), and with preexisting liver or kidney dys- nodular worm (Oesophagostomum function. Administer to puppies and radiatum). kittens on a full stomach. Federal law (iii) Limitations. Retreatment may be restricts this drug to use by or on the needed after 4 to 6 weeks. Cattle must order of a licensed veterinarian. not be slaughtered within 8 days fol- lowing last treatment. Consult a vet- [56 FR 50655, Oct. 8, 1991] erinarian for assistance in the diag- nosis, treatment, and control of para- § 520.905 Fenbendazole oral dosage sitism. forms. (3) Beef cattle—(i) Amount. Administer § 520.905a Fenbendazole suspension. orally 10 milligrams per kilogram of body weight. (a) Specifications. The drug is a sus- (ii) For the removal and control of pension containing 10 percent (100 mil- stomach worm (4th-stage inhibited lar- ligrams per milliliter) fenbendazole. vae/type II ostertagiasis), Ostertagia (b) Sponsor. See No. 057926 in ostertagi, and tapeworm, Moniezia § 510.600(c) of this chapter. benedeni. (c) Related tolerances. See § 556.275 of (iii) Limitations. Retreatment may be this chapter. needed after 4 to 6 weeks. Cattle must (d) Conditions of use—(1) Horses—(i) not be slaughtered within 8 days fol- Amount. 5 milligrams per kilogram (2.3 lowing last treatment. Federal law re- milligrams per pound) for the control stricts this drug to use by or on the of large strongyles, small strongyles, order of a licensed veterinarian. and pinworms; 10 milligrams per kilo- (4) Goats—(i) Amount. Administer gram for the control of ascarids. orally 5 milligrams per kilogram of (ii) Indications for use. For the control body weight (2.3 milligrams per pound). of large strongyles (Strongylus (ii) Indications for use. For the re- edentatus, S. equinus, S. vulgaris), small moval and control of stomach worms strongyles (Cyanthostomum spp., (adults) Haemonchus contortus and Cylicocyclus spp., Cylicostephanus spp., Teladorsagia circumcincta. Triodontophorus spp.), pinworms (iii) Limitations. Retreatment may be (Oxyuris equi), and ascarids (Parascaris needed after 4 to 6 weeks. Goats must equorum) in horses. not be slaughtered for food within 6 (iii) Limitations. Administer orally by days following last treatment. Do not dose syringe or suitable plastic sy- use in lactating goats. ringe. Do not use in horses intended for (e) Special considerations. food. Consult a veterinarian for assist- Fenbendazole suspension 10 percent ance in the diagnosis, treatment, and and approved forms of trichlorfon, control of parasitism. when used concomitantly for treating

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the indications provided in paragraph (ii) Indications for use. For control of (d) of this section and for treating in- internal parasites of Felidae and fections of stomach bot as provided in Ursidae as follows: § 520.2520, have been shown to be com- (A) Lion (Panthera leo) and Tiger patible and not to interfere with one (Panthera tigris): Ascarid (Toxocara cati, another. Toxascaris leonina), Hookworm (Ancylostoma spp.). [42 FR 59069, Nov. 15, 1977; 43 FR 12311, Mar. 24, 1978. Redesignated at 44 FR 1375, Jan. 5, (B) Cheetah (Acinonyx jubatus): Asca- 1979, and amended at 46 FR 29464, June 2, rid (Toxocara cati, Toxascaris leonina). 1981; 47 FR 15327, Apr. 9, 1982; 48 FR 42809, (C) Puma (Felis concolor), Panther Sept. 20, 1983; 49 FR 1983, Jan. 17, 1984; 53 FR (Panthera spp.), Leopard (Panthera 40058, Oct. 13, 1988; 59 FR 26943, May 25, 1994; pardus), Jaguar (Panthera onca): Asca- 61 FR 29478, June 11, 1996; 63 FR 63983, Nov. rid (Toxocara cati, Toxascaris leonina), 18, 1998; 66 FR 47960, Sept. 17, 2001; 68 FR Hookworm (Ancylostoma spp.), Tape- 26205, May 15, 2003] worm (Taenia hydatigena, T. krabbei, T. taeniaeformis). § 520.905b Fenbendazole granules. (D) Black Bear (Ursus americanus): (a) Specifications. Each gram of gran- Ascarid (Baylisascaris transfuga, ules contains 222 milligrams (mg) Toxascaris leonina), Hookworm fenbendazole. (Ancylostoma caninum), Tapeworm (b) Sponsor. See No. 057926 in (Taenia hydatigena, T. krabbei). §510.600(c) of this chapter. (E) Polar Bear (Ursus maritimus) and (c) Special considerations. See § 500.25 Grizzly Bear (Ursus horribilis): Ascarid of this chapter. (Baylisascaris transfuga, Toxascaris (d) Conditions of use—(1) Horses—(i) leonina). Amount. 5 mg/kilogram (kg) for large (iii) Limitations. Top dress or mix strongyles, small strongyles, and with a small portion of food. Must be pinworms; 10 mg/kg for ascarids. fully consumed prior to feeding. Fed- (ii) Indications for use. For the control eral law restricts this drug to use by or of infections of large strongyles on the order of a licensed veterinarian. (Strongylus edentatus, S. equinus, S. Do not use 14 days before or during the vulgaris), small strongyles, pinworms hunting season. (Oxyuris equi), and ascarids (Parascaris [44 FR 1375, Jan. 5, 1979, as amended at 47 FR equorum). 15327, Apr. 9, 1982; 48 FR 50528, Nov. 2, 1983; 59 (iii) Limitations. Sprinkle the appro- FR 35252, July 11, 1994; 66 FR 47960, Sept. 17, priate amount of drug on a small 2001; 67 FR 47450, July 19, 2002] amount of the usual grain ration. Pre- pare for each horse individually. With- § 520.905c Fenbendazole paste. holding feed or water is not necessary. (a) Specifications. The product is an Retreat in 6 to 8 weeks if required. Do aqueous paste containing 10 percent not use in horses intended for food. fenbendazole. (2) Dogs—(i) Amount. 50 mg/kg daily (b) Sponsor. See No. 057926 in for 3 consecutive days. § 510.600(c) of this chapter. (ii) Indications for use. For the re- (c) Related tolerances. See § 556.275 of moval of ascarids (Toxocara canis, this chapter. Toxascaris leonina), hookworms (d) Conditions of use—(1) Horses—(i)(a) (Ancylostoma caninum, Uncinaria Amount. 2.3 milligrams per pound of stenocephala), whipworms (Trichuris body weight (one 2.5-gram fenbendazole vulpis), and tapeworms (Taenia syringe for a 1,100-pound horse). For pisiformis). foals and weanlings (less than 18 (iii) Limitations. Mix the appropriate months of age), 4.6 milligrams per amount of drug with a small amount of pound of body weight (one 2.5-gram the usual food; dry dog food may re- fenbendazole syringe for each 550 quire slight moistening to facilitate pounds of body weight). mixing. Medicated food must be fully (b) Indications for use. For control of consumed. large strongyles (Strongylus edentatus, (3) Zoo and wildlife animals—(i) S. equinus, S. vulgaris), small Amount. 10 mg/kg per day for 3 days. strongyles, pinworms (Oxyuris equi),

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and ascarids (Parascaris equorum) in erinarian for assistance in the diag- horses. nosis, treatment, and control of para- (c) Limitations. Retreatment at inter- sitism. vals of 6 to 8 weeks may be required. (e) Special considerations. Do not use in horses intended for food. Fenbendazole paste 10 percent may be Consult your veterinarian for assist- used concomitantly with approved ance in the diagnosis, treatment, and forms of trichlorfon for the indications control of parasitism. provided in paragraph (d)(1)(i) of this (ii)(a) Amount. 4.6 milligrams per section and for treating infections of pound of body weight (one 2.5-gram stomach bots as provided in § 520.2520. fenbendazole syringe for a 550-pound horse) daily for 5 days. [46 FR 32018, June 19, 1981, as amended at 47 (b) Indications for use. For control of FR 15327, Apr. 9, 1982; 49 FR 8433, Mar. 7, 1984; arteritis caused by the fourth stage 50 FR 26358, June 26, 1985; 61 FR 29478, June larvae of Strongylus vulgaris. 11, 1996; 63 FR 31624, June 10, 1998; 66 FR (c) Limitations. Treatment should be 47960, Sept. 17, 2001] initiated in the spring and repeated in 6 months. Do not use in horses in- § 520.905d Fenbendazole powder. tended for food. Consult your veteri- (a) Specifications. (1) Each 2-ounce narian for assistance in the diagnosis, packet contains 2.27 grams (4 percent) treatment, and control of fourth stage of fenbendazole plus other inert ingre- larvae of S. vulgaris. dients. (iii)(a) Amount. 4.6 milligrams per (2) Each 4-ounce packet contains 1.7 pound of body weight (10 milligrams grams (1.5 percent) of fenbendazole plus per kilogram) daily for 5 consecutive other inert ingredients. days. (b) Sponsors. (1) See No. 057926 in (b) Indications for use. For treatment § 510.600(c) of this chapter for use of the of encysted mucosal cyathostome 4-percent product. (small strongyle) larvae including early third stage (hypobiotic), late (2) See No. 017800 in § 510.600(c) of this third stage, and fourth stage larvae in chapter for use of the 1.5-percent prod- horses. uct. (c) Limitations. (Consult your veteri- (c) Related tolerances. See § 556.275 of narian for assistance in the diagnosis, this chapter. treatment, and control of encysted (d) Conditions of use. It is adminis- mucosal cyathostomes). Do not use in tered to swine as follows: horses intended for food. (1) Amount. 3 milligrams fenbendazole (2) Beef and dairy cattle—(i) Amount. per kilogram body weight per day (1.36 Administer orally 5 milligrams per milligrams per pound per day). kilogram of body weight (2.3 milli- (2) Indications for use. For removal grams per pound). and control of large roundworms (ii) Indications for use. For the re- (Ascaris suum); lungworms moval and control of lungworm (Metastrongylus apri); nodular worms (Dictyocaulus viviparus), barberpole (Oesophagostomum dentatum, O. worm (Haemonchus contortus), brown quadrispinulatum); small stomach stomach worm (Ostertagia ostertagi), worms (Hyostrongylus rubidus); small stomach worm (Trichostrongylus whipworms (Trichuris suis); and axei), hookworm (Bunostomum kidneyworms (Stephanurus dentatus— phlebotomum), thread-necked intestinal worm (Nematodirus helvetianus), small mature and immature). intestinal worms (Cooperia punctata (3) Limitations. Thoroughly mix the and C. oncophora), bankrupt worm contents of the packet(s) with swine (Trichostrongylus colubriformis), and ration and administer according to nodular worm (Oesophagostomum label directions. Feed as sole ration for radiatum). 3 consecutive days. Can be fed to preg- (iii) Limitations. Re-treatment may be nant sows. No prior withdrawal of feed needed after 4 to 6 weeks. Cattle must or water is necessary. Consult your not be slaughtered within 8 days fol- lowing last treatment. Consult a vet-

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veterinarian for assistance in the diag- (b) Sponsor. See No. 050604 in nosis, treatment, and control of para- § 510.600(c) of this chapter. sitism. (c) Conditions of use in dogs—(1) [49 FR 18090, Apr. 27, 1984, as amended at 49 Amount. 5 mg per kilogram (2.27 mg per FR 20485, May 15, 1984; 66 FR 47960, Sept. 17, pound) body weight once daily. 2001] (2) Indications for use. For the control of pain and inflammation associated § 520.905e Fenbendazole blocks. with osteoarthritis. (a) Specifications. (1) Each pound of (3) Limitations. Federal law restricts molasses block contains 750 milligrams this drug to use by or on the order of a of fenbendazole. licensed veterinarian. (2) Each pound of protein block con- [69 FR 51171, Aug. 18, 2004] tains 750 milligrams of fenbendazole. (b) Sponsor. See 057926 in § 510.600(c) of § 520.955 Florfenicol. this chapter. (c) Related tolerances. See § 556.275 of (a) Specifications. Each milliliter this chapter. (mL) contains 23 milligrams (mg) (d) Conditions of use—(1) Amount. 0.1 florfenicol. pound of block per 100 pounds of body (b) Sponsor. See No. 000061 in weight per day for 3 days. Total dose § 510.600(c) of this chapter. for the 3-day period is 2.27 milligrams (c) Related tolerances. See § 556.283 of of fenbendazole per pound of body this chapter. weight for mature cattle. (d) Conditions of use in swine—(1) (2) Indications for use. For removal Amount. Administer in drinking water and control of infections of lungworms ad libitum at 400 mg per gallon (100 (Dictyocaulus viviparus) and gastro- parts per million (ppm)) for 5 consecu- intestinal roundworms (Haemonchus tive days. contortus, Ostertagia ostertagi, (2) Indications for use. For the treat- Trichostrongylus axei, Bunostomum ment of swine respiratory disease phlebotomum, Nematodirus helvetianus, (SRD) associated with Actinobacillus Cooperia oncophora and C. punctata, pleuropneumoniae, Pasteurella multocida, Trichostrongylus colubriformis, and Salmonella choleraesuis and Strepto- Oesophagostomum radiatum) in beef cat- coccus suis Type 2. tle. (3) Limitations. Do not slaughter with- (3) Limitations. Administer free choice in 16 days of last treatment. Federal of beef cattle on pasture that have be- law restricts this drug to use by or on come accustomed to nonmedicated the order of a licensed veterinarian. block feeding during an adaptation pe- riod of 12 to 19 days. Molasses block: [67 FR 78357, Dec. 24, 2002] Cattle must not be slaughtered within 11 days following last treatment. Pro- § 520.960 Flumethasone tablets. tein block: Cattle must not be slaugh- (a) Specifications. Each tablet con- tered within 16 days following last tains 0.0625 milligram of flumethasone. treatment; do not use in dairy cattle of (b) Sponsor. See No. 000856 in breeding age. Animals maintained § 510.600(c) of this chapter. under conditions of constant worm ex- (c) Conditions of use—(1) Amount. (i) posure may require retreatment within Dogs: Administer orally from 0.0625 to 6 to 8 weeks. Consult your veterinarian 0.25 milligram daily in divided doses. for assistance in the diagnosis, treat- (ii) Cats: Administer orally from ment, and control of parasitism. 0.03125 to 0.125 milligram daily in di- [51 FR 41783, Nov. 19, 1986, as amended at 54 vided doses. FR 20787, May 15, 1989; 66 FR 47960, Sept. 17, (2) Indications for use. (i) Dogs: It is 2001] used for musculoskeletal conditions due to inflammation of muscles or § 520.928 Firocoxib. joints and accessory structures, where (a) Specifications. Each chewable tab- permanent structural changes do not let contains 57 or 227 milligrams (mg) exist, such as arthritis, the disc syn- firocoxib. drome, and myositis.

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(ii) Dogs and cats: It is used in certain equivalent to 1,500 milligrams of acute and chronic dermatoses of vary- flunixin. ing etiology to help control the pru- (b) Sponsor. No. 000061 in § 510.600(c) of ritus, irritation, and inflammation as- this chapter. sociated with these conditions. (c) Conditions of use. Horses—(1) (3) Limitations. Do not use in viral in- Amount. 0.5 milligram of flunixin per fections. Anti-inflammatory action of pound of body weight daily. corticosteroids may mask signs of in- (2) Indications for use. For alleviation fection. Do not use in animals with tu- of inflammation and pain associated berculosis, chronic nephritis, with musculoskeletal disorders. cushingoid syndrome, or where peptic (3) Limitations. For oral use only. ulcers occur, except for emergency Treatment should not exceed 5 con- therapy. Clinical and experimental secutive days. The effect of this drug data have demonstrated that on pregnancy has not been determined. corticosteroids administered orally or Not for use in horses intended for food. parenterally to animals may induce Federal law restricts this drug to use the first stage of parturition when ad- by or on the order of a licensed veteri- ministered during last trimester of narian. pregnancy and may precipitate pre- [50 FR 38114, Sept. 20, 1985, as amended at 52 mature parturition followed by FR 7832, Mar. 13, 1987] dystocia, fetal death, retained pla- centa, and metritis. Federal law re- § 520.1010 Furosemide. stricts this drug to use by or on the (a) Specifications. (1) Each tablet con- order of a licensed veterinarian. tains 12.5 or 50 milligrams (mg) [44 FR 7131, Feb. 6, 1979, as amended at 61 FR furosemide. 5506, Feb. 13, 1996] (2) Each bolus contains 2 grams (g) furosemide. § 520.970 Flunixin oral dosage forms. (3) Each packet of powder contains 2 g furosemide. § 520.970a Flunixin meglumine gran- (4) Each milliliter of syrup contains ules. 10 mg furosemide. (a) Specifications. Each 10-gram pack- (b) Sponsors. See sponsor numbers in et contains flunixin meglumine equiva- § 510.600(c) of this chapter for use of lent to 250 milligrams of flunixin. dosage forms and strengths listed in (b) Sponsor. No. 000061 in § 510.600(c) of paragraph (a) of this section for uses as this chapter. in paragraph (d) of this section. (c) Conditions of use—(1) Amount. 0.5 (1) No. 000010 for tablets in paragraph milligram of flunixin per pound of body (a)(1) of this section for conditions of weight (one packet per 500 pounds) per use in paragraphs (d)(2)(i), (d)(2)(ii)(A), day. and (d)(3) of this section. (2) Indications for use. For alleviation (2) No. 000093 for tablets in paragraph of inflammation and pain associated (a)(1) of this section for conditions of with musculoskeletal disorders in the use in paragraphs (d)(2)(i) and horse. (d)(2)(ii)(B) of this section. (3) Limitations. Administer daily dose (3) No. 057926 for tablets in paragraph for up to 5 days by sprinkling on small (a)(1) of this section for conditions of amount of feed. The effect of this drug use in paragraphs (d)(2)(i), (d)(2)(ii)(A), on pregnancy has not been determined. and (d)(3) of this section; for boluses in Not for use in horses intended for food. paragraph (a)(2) of this section and Federal law restricts this drug to use powder in paragraph (a)(3) of this sec- by or on the order of a licensed veteri- tion for conditions of use in paragraph narian. (d)(1) of this section; and for syrup in [44 FR 36381, June 22, 1979. Redesignated at 50 paragraph (a)(4) of this section for con- FR 38114, Sept. 20, 1985, and amended at 52 ditions of use in paragraphs (d)(2)(i) FR 7832, Mar. 13, 1987] and (d)(2)(ii)(A). (4) No. 059130 for use of syrup in para- § 520.970b Flunixin meglumine paste. graph (a)(4) of this section for condi- (a) Specifications. Each 30-gram sy- tions of use in paragraph (d)(2)(i) and ringe contains flunixin meglumine (d)(2)(ii)(A) of this section.

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(c) Special considerations. Federal law tive days, to provide 1.0 milligram/ restricts this drug to use by or on the pound/day. order of a licensed veterinarian. (2) Indications for use. In weanling (d) Conditions of use. It is used as fol- swine for control and treatment of lows: colibacillosis caused by strains of E. (1) Cattle—(i) Amount. 1 to 2 mg per coli sensitive to gentamicin, and in pound (/lb) body weight using powder, swine for control and treatment of or one 2-g bolus per animal, per day. swine dysentery associated with (ii) Indications for use. For treatment Treponema hyodysenteriae. of physiological parturient edema of (3) Limitations. For use in swine the mammary gland and associated drinking water only. Do not store or structures. offer medicated drinking water in (iii) Limitations. Treatment not to ex- rusty containers since the drug is ceed 48 hours post-parturition. Milk quickly destroyed in such containers. Medicated drinking water should be taken during treatment and for 48 prepared daily and be the sole source of hours after the last treatment must drinking water for 3 consecutive days. not be used for food. Cattle must not be Treatment may be repeated if dys- slaughtered for food within 48 hours entery recurs. Do not slaughter treated following last treatment. swine for food for at least 3 days fol- (2) Dogs—(i) Amount. 1 to 2 mg/lb body lowing treatment. weight, once or twice daily. (ii) Indications for use—(A) For treat- [48 FR 10302, Mar. 11, 1983. Redesignated at 49 ment of edema (pulmonary congestion, FR 572, Jan. 5, 1984, and amended at 49 FR ascites) associated with cardiac insuffi- 14332, Apr. 11, 1984; 52 FR 7832, Mar. 13, 1987; 62 FR 34169, June 25, 1997] ciency and acute noninflammatory tis- sue edema. § 520.1044b Gentamicin sulfate pig (B) For treatment of edema (pul- pump oral solution. monary congestion, ascites) associated (a) Specifications. Each milliliter of with cardiac insufficiency. pig pump oral solution contains (3) Cats—(i) Amount. 1 to 2 mg/lb body gentamicin sulfate equivalent to 4.35 weight, once or twice daily. milligrams of gentamicin. (ii) Indications for use. For treatment (b) Sponsor. See Nos. 000061 and 059130 of edema (pulmonary congestion, asci- in § 510.600(c) of this chapter. tes) associated with cardiac insuffi- (c) Related tolerances. See § 556.300 of ciency and acute noninflammatory tis- this chapter. sue edema. (d) Conditions of use—(1) Amount. Ad- [66 FR 47960, Sept. 17, 2001, as amended at 69 minister 1.15 milliliters of pig pump FR 74419, Dec. 14, 2004] oral solution (5 milligrams of gentamicin) orally per pig one time. § 520.1044 Gentamicin sulfate oral dos- (2) Indications for use. In neonatal age forms. swine 1 to 3 days of age for control and treatment of colibacillosis caused by § 520.1044a Gentamicin sulfate oral so- strains of E. coli sensitive to lution. gentamicin. (a) Specifications. Each milliliter of (3) Limitations. For use in neonatal aqueous solution contains gentamicin swine only. Do not slaughter treated sulfate equivalent to 50 milligrams of swine for food for at least 14 days fol- gentamicin. lowing treatment. (b) Sponsor. See Nos. 000061 and 051259 [49 FR 572, Jan. 5, 1984, as amended at 52 FR in § 510.600(c) of this chapter. 7832, Mar. 13, 1987; 62 FR 29011, May 29, 1997] (c) Related tolerances. See § 556.300 of this chapter. § 520.1044c Gentamicin sulfate soluble (d) Conditions of use—(1) Amount. powder. Colibacillosis: 1 milliliter per 2 gallons (a) Specifications. Each gram of of drinking water for 3 consecutive gentamicin sulfate soluble powder con- days, to provide 0.5 milligram/pound/ tains gentamicin sulfate equivalent to day; swine dysentery: 1 milliliter per 1 16.7, 66.7, or 333.3 milligrams of gallon of drinking water for 3 consecu- gentamicin.

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(b) Sponsor. See Nos. 000061 and 057561 (2)(i) Boluses containing 2.5 grams of in § 510.600(c) of this chapter. griseofulvin are used in horses for (c) Related tolerances. See § 556.300 of treating ringworm infection caused by this chapter. Trichophyton equinum. It is adminis- (d) Conditions of use—(1) Amount. tered to adult horses at a level of one Colibacillosis: gentamicin sulfate bolus per day, to yearlings at one-half equivalent to 25 milligrams of to one bolus per day, and to foals at gentamicin per gallon of drinking one-half bolus per day. All three dosage water for 3 consecutive days, to provide levels should be administered for a pe- 0.5 milligram per pound of body weight riod of not less than 10 days. In respon- per day; swine dysentery: gentamicin sive cases, treatment should be contin- sulfate equivalent to 50 milligrams of ued until all infected areas are proven gentamicin per gallon of drinking negative by appropriate culture. Not water for 3 consecutive days, to provide for use in horses intended for food. 1 milligram per pound of body weight (ii) Federal law restricts this drug to per day. use by or on the order of a licensed vet- (2) Indications for use. In weanling erinarian. swine for control and treatment of (3) Dogs and cats: (i) Amount. 125- and colibacillosis caused by strains of E. 500-milligram tablets administered coli sensitive to gentamicin, and in orally as follows: swine for control and treatment of (a) Daily (single or divided) dose: swine dysentery associated with Treponema hyodysenteriae. Dosage Body weight (pounds) (milli- (3) Limitations. For use in swine grams) drinking water only. Do not store or offer medicated drinking water in Up to 6 ...... 62.5 rusty containers since the drug is 6 to 18 ...... 125 18 to 36 ...... 250 quickly destroyed in such containers. 36 to 48 ...... 375 Medicated drinking water should be 48 to 75 ...... 500 prepared daily and be the sole source of drinking water for 3 consecutive days. (b) Weekly (single) dose: If experience Treatment may be repeated if dys- indicates that treatment is more effec- entery recurs. Do not slaughter treated tive for the drug given in large doses, swine for food for at least 10 days fol- administer at intervals of 7 to 10 days, lowing treatment. a dose equal to 10 milligrams/pound of × × [49 FR 29778, July 24, 1984, as amended at 52 body weight body weight number of FR 7832, Mar. 13, 1987; 52 FR 48675, Dec. 24, days between treatments. Dosage 1987; 62 FR 29013, May 29, 1997] should be adjusted according to re- sponse. Administer additional dose § 520.1100 Griseofulvin. after the animal is free of infection. (a) Chemical name. 7-Chloro-2′,4,6- (ii) Indications for use. For treatment trimethoxy-6′-methylspiro [benzofuran- of fungal infections of the skin, hair, 2(3H), 1′-[2]-cyclohexene]-3,4′-dione. and claws caused by Trichophyton (b) Specifications. Complies with mentagrophytes, T. rubrum, T. U.S.P. for griseofulvin microsize. schoenleini, T. sulphurem, T. verrucosum, (c) Sponsor. See No. 000061 in T. interdigitale, Epidermophyton § 510.600(c) of this chapter. floccosum, Microsporum gypseum, M. (d) Conditions of use. (1) As a soluble canis, M. audouini. powder for horses, it is administered as (iii) Limitations. For satisfactory di- a drench or as a top dressing on feed. It agnosis, a microscopic tissue examina- is used for equine ringworm infection tion or culture is recommended prior caused by Trichophyton equinum or to treatment. Treatment should be Microsporum gypseum. Administer for continued for 3 to 4 weeks in skin and not less than 10 days a daily dose as hair infections, and up to 4 months for follows: Adults, 2.5 grams; yearlings, infections involving nails or claws. 1.25 to 2.5 grams; and foals, 1.25 grams. Clipping of hair, nails, and claws to Not for use in horses intended for food. help remove any remaining viable For use only by or on the order of a li- fungi is indicated. Safety for use of censed veterinarian. griseofulvin for pregnant animals has

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not been established. Federal law re- § 520.1120b Haloxon boluses. stricts this drug to use by or on the (a) Chemical name. 3-Chloro-7-hy- order of a licensed veterinarian. droxy-4-methylcoumarin bis (2- [40 FR 13838, Mar. 27, 1975, as amended at 41 chloroethyl) phosphate. FR 42948, Sept. 29, 1976; 43 FR 28458, June 30, (b) Specifications. Each bolus contains 1978; 52 FR 7832, Mar. 13, 1987; 54 FR 30205, 10.1 grams of haloxon. July 19, 1989] (c) Sponsor. See No. 000061 in § 510.600(c) of this chapter. § 520.1120 Haloxon oral dosage forms. (d) Related tolerances. See § 556.310 of this chapter. § 520.1120a Haloxon drench. (e) Conditions of use. (1) Haloxon bolus (a) Chemical name. 3-Choloro-7- is an anthelmintic used in cattle for hydoxy-4-methylcoumarin bis (2- the control of gastrointestinal chloroethyl) phosphate. roundworms of the genera Haemonchus, (b) Specifications. Haloxon assay of Ostertagia, Trichostrongylus and not less than 96 percent by infrared Cooperia. spectrum at 8.62 microns. (2) It is administered by giving one (c) Sponsor. See No. 000061 in bolus per approximately 500 pounds § 510.600(c) of this chapter. body weight (35 to 50 milligrams per (d) Special considerations. Do not use kilogram of body weight). any drug, insecticide, pesticide, or (3) For most effective results, re- other chemical having cholinesterase- treat animals in 3 to 4 weeks. If rein- inhibiting activity either simulta- fection is likely to occur, additional re- neously or within a few days before or treatments may be necessary. after treatment with haloxon. (4) Do not use any drug, pesticide or (e) Related tolerances. See § 556.310 of other chemical having cholinesterase this chapter. inhibiting activity either simulta- neously or within a few days before or (f) Conditions of use. It is used as a after treatment with haloxon. drench as follows: (5) Do not treat animals within one (1) Cattle —(i) Amount. 141.5 grams per week of slaughter. packet. (6) Do not treat dairy animals of (ii) Indications for use. Control of gas- breeding age or older. trointestinal roundworms of the genera Haemonchus, Ostertagia, [40 FR 13838, Mar. 27, 1975, as amended at 44 Trichostrongylus, and Cooperia. FR 61591, Oct. 29, 1979; 46 FR 48642, Oct. 2, 1981; 61 FR 8873, Mar. 6, 1996; 62 FR 61625, (iii) Limitations. (a) Dissolve each Nov. 19, 1997] packet in 32 fluid ounces of water and administer as follows: § 520.1130 Hetacillin oral dosage forms. Weight of animal (pounds) Dose (fluid ounces) § 520.1130a Hetacillin potassium cap-

Up to 100 ...... 1⁄2 sules. 100 to 150 ...... 3⁄4 (a) Specifications. Each capsule con- 150 to 200 ...... 1 tains hetacillin potassium equivalent 200 to 300 ...... 11⁄2 300 to 450 ...... 2 to 50, 100, or 200 milligrams of ampi- 450 to 700 ...... 3 cillin. 700 to 1,000 ...... 4 (b) Sponsor. See No. 000856 in 1,000 to 1,200 ...... 5 § 510.600(c) of this chapter. Over 1,200 ...... 6 (c) Conditions of use. (1) Dogs—(i) Amount. 5 milligrams per pound of body (b) Do not treat within 1 week of weight, twice daily. In severe infec- slaughter; do not treat dairy animals tions, up to three times daily, or up to of breeding age; animals should be re- 10 milligrams per pound of body weight treated in 3 to 4 weeks. twice daily. For stubborn urinary tract [40 FR 13838, Mar. 27, 1975, as amended at 45 infections, up to 20 milligrams per FR 10333, Feb. 15, 1980; 46 FR 48642, Oct. 2, pound of body weight twice daily. 1981; 61 FR 8873, Mar. 6, 1996; 62 FR 61624, (ii) Indications for use. Treatment Nov. 19, 1997] against strains of organisms sensitive

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to hetacillin potassium and associated soft-tissue infections, and postsurgical with respiratory tract infections, uri- infections. nary tract infections, gastrointestinal (iii) Limitations. For use in dogs only. infections, skin infections, soft tissue Not for use in animals raised for food infections, and postsurgical infections. production. Continue treatment 48 to (iii) Limitations. For use in dogs and 72 hours after the animal has become cats only. Continue treatment for 48 to afebrile or asymptomatic. Administer 1 72 hours after the animal has become to 2 hours prior to feeding to ensure afebrile or asymptomatic. Administer 1 maximum absorption. In stubborn in- to 2 hours prior to feeding to ensure fections, therapy may be required for maximum absorption. In stubborn in- several weeks. Federal law restricts fections, therapy may be required for this drug to use by or on the order of a several weeks. Not for use in animals licensed veterinarian. raised for food production. Federal law (2) Cats—(i) Amount. 50 milligrams restricts this drug to use only by or on twice daily. the order of a licensed veterinarian. (ii) Indications for use. Treatment (2) Cats—(i) Amount. Administer 50 against strains of organisms suscep- milligrams twice daily. tible to hetacillin potassium and asso- (ii) Indications for use. Treatment ciated with respiratory tract infec- against strains of organisms sensitive tions, urinary tract infections, gastro- to hetacillin potassium and associated intestinal infections, skin infections, with respiratory tract infections, uri- soft-tissue infections, and postsurgical nary tract infections, gastrointestinal infections. infections, skin infections, soft tissue (iii) Limitations. For use in cats only. infections, and postsurgical infections. Not for use in animals raised for food (3) Limitations. For use in dogs and production. Continue treatment 48 to cats only. Continue treatment for 48 to 72 hours after the animal has become 72 hours after the animal has become afebrile or asymptomatic. Administer 1 afebrile or asymptomatic. Administer to 2 hours prior to feeding to ensure in a fasting state to ensure maximum maximum absorption. In stubborn in- absorption. In stubborn infections, fections, therapy may be required for therapy may be required for several several weeks. Federal law restricts weeks. Not for use in animals raised for this drug to use by or on the order of a food production. Federal law restricts licensed veterinarian. this drug to use only by or on the order [57 FR 37326, Aug. 18, 1992] of a licensed veterinarian. [57 FR 37325, Aug. 18, 1992] § 520.1130c Hetacillin potassium tab- lets. § 520.1130b Hetacillin potassium oral (a) Specifications. Each tablet con- suspension. tains hetacillin potassium equivalent (a) Specifications. Each milliliter con- to 50, 100, or 200 milligrams of ampi- tains hetacillin potassium equivalent cillin. to 50 milligrams of ampicillin. (b) Sponsor. See No. 000856 in (b) Sponsor. See No. 000856 in § 510.600(c) of this chapter. § 510.600(c) of this chapter. (c) Conditions of use—(1) Dogs—(i) (c) Conditions of use—(1) Dogs—(i) Amount. 5 milligrams per pound of body Amount. 5 milligrams per pound of body weight twice daily. In severe infec- weight twice daily. In severe infec- tions, up to three times daily, or up to tions, up to three times daily, or up to 10 milligrams per pound of body weight 10 milligrams per pound of body weight twice daily. For stubborn urinary tract twice daily. For stubborn urinary tract infections, up to 20 milligrams per infections, up to 20 milligrams per pound of body weight twice daily. pound of body weight twice daily. (ii) Indications for use. Oral treatment (ii) Indications for use. Treatment against strains of organisms sensitive against strains of organisms suscep- to hetacillin potassium and associated tible to hetacillin potassium and asso- with respiratory tract infections, uri- ciated with respiratory tract infec- nary tract infections, gastrointestinal tions, urinary tract infections, gastro- infections, skin infections, soft tissue intestinal infections, skin infections, infections, and postsurgical infections.

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(iii) Limitations. For use in dogs and restricts this drug to use by or on the cats only. Continue treatment for 48 to order of a licensed veterinarian. 72 hours after the animal has become [49 FR 22469, May 30, 1984] afebrile or asymptomatic. Administer 1 to 2 hours prior to feeding to ensure § 520.1158 Iodochlorhydroxyquin maximum absorption. In stubborn in- boluses. fections, therapy may be required for (a) Specifications. Each bolus contains several weeks. Not for use in animals 10 grams of iodochlorhydroxyquin. which are raised for food production. (b) Sponsor. See No. 053501 in Federal law restricts this drug to use § 510.600(c) of this chapter. by or on the order of a licensed veteri- (c) Conditions of use—(1) Amount. 1 narian. bolus (10 grams) daily for a 1,000-pound (2) Cats—(i) Amount. 50 milligrams horse. twice daily. (2) Indications for use. For treatment (ii) Indications for use. Treatment of equine diarrhea. against strains of organisms sensitive (3) Limitations. For horses only; not to hetacillin potassium and associated to be administered to food-producing with respiratory tract infections, uri- animals. Do not administer to horses nary tract infections, gastrointestinal intended for use as food. Federal law infections, skin infections, soft tissue restricts this drug to use by or on the infections, and postsurgical infections. order of a licensed veterinarian. (iii) Limitations. For use in dogs and cats only. Continue treatment for 48 to [48 FR 8054, Feb. 25, 1983, as amended at 50 FR 41489, Oct. 11, 1985] 72 hours after the animal has become afebrile or asymptomatic. Administer 1 § 520.1182 Iron dextran oral suspen- to 2 hours prior to feeding to ensure sion. maximum absorption. In stubborn in- (a) Specifications. Each 1.8 milliliter fections, therapy may be required for contains 100 milligrams of elemental several weeks. Not for use in animals iron as ferric hydroxide in complex which are raised for food production. with a low molecular weight dextran Federal law restricts this drug to use and 0.2 percent phenol as a preserva- by or on the order of a licensed veteri- tive. narian. (b) Sponsor. See 017800 in § 510.600(c) of [57 FR 37326, Aug. 18, 1992] this chapter. (c) Conditions of use—(1) Amount. 100 § 520.1157 Iodinated casein tablets. milligrams of elemental iron to each (a) Specifications. Each 1-gram tablet pig. contains 25 milligrams of iodinated ca- (2) Indications for use. Prevention of sein. iron deficiency anemia in baby pigs. (b) Sponsor. See No. 017762 in (3) Limitations. Treat each pig within § 510.600(c) of this chapter. 24 hours of farrowing. Administer 1.8 milliliters orally by automatic dose (c) Conditions of use—(1) Amount. 1⁄5 to 1 tablet per 10 pounds of body weight dispenser. (equivalent to 0.5 to 2.5 milligrams of [45 FR 75199, Nov. 14, 1980] iodinated casein per pound of body weight). § 520.1192 Ivermectin paste. (2) Indications for use. For dogs for ap- (a) Specifications. Each milligram parent decreased thyroid activity (mg) of paste contains 0.0187 mg (1.87 where the signs are alopecia, scaliness percent) or 0.00153 mg (0.153 percent) of of the skin surface, loss of hair, sebor- ivermectin. rhea, thickening of the skin, (b) Sponsors. See sponsors in hyperpigmentation, and lethargy. § 510.600(c) of this chapter for use as in (3) Limitations. If no response is ob- paragraph (e) of this section: served in 30 to 45 days, the drug should (1) No. 050604 for use of a 1.87-percent be withdrawn and the diagnosis recon- paste as in (e)(1)(i), (e)(1)(ii)(A), and sidered. Do not use in the presence of (e)(1)(iii) of this section and a 0.153-per- cardiac disease, ischemia, adrenal in- cent paste for use as in paragraph (e)(2) sufficiency, or nephrosis. Federal law of this section.

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(2) Nos. 051311 and 059130 for use of a (Triodontophorus spp.); Small 1.87-percent paste for use as in para- Strongyles, including those resistant graph (e)(1)(i), (e)(1)(ii)(B), and to some benzimidazole class com- (e)(1)(iii) of this section. pounds (adult and fourth-stage larvae) (3) No. 061623 for use of a 1.87 percent (Cyathostomum spp., Cylicocyclus spp., paste for use as in paragraph (e)(1)(i), Cylicodontophorus spp., Cylicostephanus (e)(1)(ii)(C), and (e)(1)(iii) of this sec- spp.); Pinworms (adult and fourth- tion. stage larvae) (Oxyuris equi); Ascarids (c) Related tolerances. See § 556.344 of (third- and fourth-stage larvae and this chapter. adults) (Parascaris equorum); hairworms (d) Special considerations. See § 500.25 (adult) (Trichostrongylus axei); Large of this chapter. mouth Stomach Worms (adult) (e) Conditions of use—(1) Horses—(i) (Habronema muscae); Stomach Bots Amount. 200 micrograms per kilogram (oral and gastric stages) (Gastrophilus (91 micrograms per pound) of body spp.); Lungworms (adults and fourth- weight. stage larvae) (Dictyocaulus arnfieldi); (ii) Indications for use. For treatment Intestinal Threadworms (adults) and control of: (Strongyloides westeri); Summer Sores (A) Large Strongyles (adults): caused by Habronema and Draschia spp. Strongylus vulgaris (also early forms in cutaneous third-stage larvae; and Der- blood vessels), S. edentatus (also tissue matitis caused by neck threadworm stages), , spp. S. equinus Triodontophorus microfilariae (Onchocerca sp.). including T. brevicauda and T. serratus, (C) Large strongyles (adults)— and Craterostomum acuticaudatum; Strongylus vulgaris (also early forms in Small Strongyles (adults, including blood vessels), (also tissue those resistant to some benzimidazole S. edentatus class compounds): Coronocyclus spp. in- stages), S. equinus, and Triodontophorus cluding C. coronatus, C. labiatus, and C. spp. including T. brevicauda and T. labratus, Cyathostomum spp. including serratus; Small Strongyles (adults, in- C. catinatum and C. pateratum, cluding those resistant to some benz- Cylicocyclus spp. including C. insigne, C. imidazole class compounds)— leptostomum, C. nassatus, and C. Cyathostomum spp. including C. brevicapsulatus, Cylicodontophorus spp., catinatum and C. pateratum, Cylicocyclus Cylicostephanus spp., including C. spp. including C. insigne, C. calicatus, C. goldi, C. longibursatus, and leptostomum, C. nassatus, and C. C. minutus, and Petrovinema poculatum; brevicapsulatus, Cylicodontophorus spp., Small Strongyles (fourth-stage larvae); and Cylicostephanus spp. including C. Pinworms (adults and fourth stage lar- calicatus, C. goldi, C. longibursatus, and vae): Oxyuris equi; Ascarids (adults and C. minutus; Small Strongyles—fourth- third- and fourth-stage larvae): stage larvae; Pinworms (adults and Parascaris equorum; Hairworms (adults): fourth-stage larvae)—Oxyuris equi; Trichostrongylus axei; Large mouth Ascarids (adults and third- and fourth- Stomach Worms (adults), Habronema stage larvae)—Parascaris equorum; muscae; Bots (oral and gastric stages): Hairworms (adults)—Trichostrongylus Gasterophilus spp. including G. axei; Large-mouth Stomach Worms intestinalis and G. nasalis; Lungworms (adults)—Habronema muscae; Bots (oral (adults and fourth-stage larvae): and gastric stages)—Gasterophilus spp. Dictyocaulus arnfieldi; Intestinal including G. intestinalis and G. nasalis; Threadworms (adults): Strongyloides Lungworms (adults and fourth-stage westeri;Summer Sores caused by larvae)—Dictyocaulus arnfieldi; Intes- Habronema and Draschia spp. cutaneous tinal Threadworms (adults)— third-stage larvae; Dermatitis caused Strongyloides westeri; Summer Sores by neck threadworm microfilariae, caused by Habronema and Draschia spp. Onchocerca sp. cutaneous third-stage larvae; Derma- (B) Large Strongyles (adult) titis caused by neck threadworm (Strongylus equinus), (adult and arterial microfilariae, Onchocerca sp. larval stages) (Strongylus vulgaris), (iii) Limitations. For oral use only. Do (adult and migrating tissue stages) not use in horses intended for human (Strongylus edentatus), (adult) consumption.

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(2) Cattle—(i) Amount. 23 milligrams (lb)), minimum. Up to 25 lb, 68 mcg; 26 per 250 pounds of body weight. to 50 lb, 136 mcg; 51 to 100 lb, 272 mcg; (ii) Indications for use. It is used in over 100 lb, a combination of the appro- cattle for the treatment and control of priate tablets. Administer at monthly gastrointestinal roundworms (adults dosing intervals. and fourth-stage larvae) (Ostertagia (ii) Indications for use. To prevent ca- ostertagi (including inhibited forms), O. nine heartworm disease by eliminating lyrata, Haemonchus placei, the tissue stage of heartworm larvae Trichostrongylus axei, T. colubriformis, (Dirofilaria immitis) for 1 month (30 Cooperia oncophora, C. punctata, days) after infection. Nematodirus helvetianus, Bunostomum (2) Cats. For use in cats 6 weeks of phlebotomum, Strongyloides papillosus age and older as follows: (adults only), Oesophagostomum (i) Amount. Up to 2.3 kilograms (up to radiatum, Trichuris ovis (adults only)); 5 lb), 55 mcg; 2.3 to 6.8 kilograms (5 to lungworms (adults and fourth-stage 15 lb), 165 mcg; over 6.8 kilograms (15 larvae) (Dictyocaulus viviparus); grubs lb), a combination of the appropriate (first, second, and third instars) chewables (recommended minimum (Hypoderma bovis, H. lineatum); and dose of 24 mcg/kg of body weight (10.9 sucking lice (Linognathus vituli, mcg/lb)). Administer once a month. Haematopinus eurysternus). (ii) Indications for use. To prevent fe- (iii) Limitations. For oral use only. Do line heartworm disease by eliminating not treat cattle within 24 days of the tissue stage of heartworm larvae slaughter. Because withdrawal time in Dirofilaria immitis for a month (30 days) milk has not been established, do not after infection, and for removal and use in female dairy cattle of breeding control of adult and immature (L4) age. hookworms Ancylostoma tubaeforme and [49 FR 22275, May 29, 1984, as amended at 50 A. braziliense. FR 27819, July 8, 1985; 51 FR 44449, Dec. 10, [67 FR 11230, Mar. 13, 2002, as amended at 67 1986; 53 FR 51273, Dec. 21, 1988; 62 FR 63270, FR 21996, May 2, 2002; 69 FR 43735, July 22, Nov. 28, 1997; 65 FR 70661, Nov. 27, 2000; 67 FR 2004] 71820, Dec. 3, 2002; 68 FR 43294, July 22, 2003; 69 FR 59131, Oct. 4, 2004; 70 FR 8514, Feb. 22, § 520.1194 Ivermectin meal. 2005] (a) Specifications. Each gram of meal § 520.1193 Ivermectin tablets and contains 6 milligrams ivermectin (0.6 chewables. percent). (a) Specifications. (1) Each tablet or (b) Sponsor. See No. 050604 in chewable contains 68, 136, or 272 § 510.600(c) of this chapter. micrograms (mcg) ivermectin. (c) Special considerations. See § 500.25 (2) Each chewable contains 55 or 165 of this chapter. mcg ivermectin. (d) Conditions of use in horses—(1) (b) Sponsors. See sponsors in Amount. Administer 136 micrograms § 510.600(c) of this chapter for use as in (mcg) ivermectin per pound (/lb) body paragraph (d) of this section. weight (300 mcg/kilogram) as a single (1) No. 050604 for use of tablets or dose on approximately 2 lb grain or chewables described in paragraph (a)(1) sweet feed. as in paragraph (d)(1) and chewables de- (2) Indications for use. For treatment scribed in paragraph (a)(2) as in para- and control of Large Strongyles graph (d)(2) of this section. (adults): Strongylus vulgaris (also early (2) Nos. 051311 and 059130 for use of forms in blood vessels), S. edentatus tablets described in paragraph (a)(1) as (also tissue stages), S. equinus, in paragraph (d)(1) of this section. Triodontophorus spp. including T. (c) Special considerations. Federal law brevicauda and T. serratus, and restricts this drug to use by or on the Craterostomum acuticaudatum; Small order of a licensed veterinarian. Strongyles (adults, including those re- (d) Conditions of use—(1) Dogs. For use sistant to some benzimidazole class in dogs 6 weeks of age and older as fol- compounds): Coronocyclus spp. includ- lows: ing C. coronatus, C. labiatus, and C. (i) Amount. 6.0 mcg per kilogram (kg) labratus, Cyathostomum spp. including of body weight (2.72 mcg per pound C. catinatum and C. pateratum,

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Cylicocyclus spp. including C. insigne, C. (ii) Indications for use. For treatment leptostomum, C. nassatus, and C. and control of: brevicapsulatus, Cylicodontophorus spp., (A) Large Strongyles (adults): Cylicostephanus spp. including C. Strongylus vulgaris (also early forms in calicatus, C. goldi, C. longibursatus, and blood vessels), S. edentatus (also tissue C. minutus, and Petrovinema poculatum; stages), S. equinus, Triodontophorus spp. Small Strongyles (fourth-stage larvae); including T. brevicauda and T. serratus, Pinworms (adults and fourth stage lar- and Craterostomum acuticaudatum; vae): Oxyuris equi; Ascarids (adults and Small Strongyles (adults, including third- and fourth-stage larvae): those resistant to some benzimidazole Parascaris equorum; Hairworms (adults): class compounds): Coronocyclus spp. in- Trichostrongylus axei; Large Mouth cluding C. coronatus, C. labiatus, and C. Stomach Worms (adults): Habronema labratus, Cyathostomum spp. including muscae; Bots (oral and gastric stages): C. catinatum and C. pateratum, Gasterophilus spp. including G. Cylicocyclus spp. including C. insigne, C. intestinalis and G. nasalis; Lungworms leptostomum, C. nassatus, and C. (adults and fourth-stage larvae): brevicapsulatus, Cylicodontophorus spp., Dictyocaulus arnfieldi; Intestinal Cylicostephanus spp. including C. Threadworms (adults): Strongyloides calicatus, C. goldi, C. longibursatus, and westeri; Summer Sores caused by C. minutus, and Petrovinema poculatum; Habronema and Draschia spp. cutaneous Small Strongyles (fourth-stage larvae); third-stage larvae; Dermatitis caused Pinworms (adults and fourth stage lar- by neck threadworm microfilariae, vae): Oxyuris equi; Ascarids (adults and Onchocerca sp. third- and fourth-stage larvae): (3) Limitations. Do not use in horses Parascaris equorum; Hairworms (adults): intended for human consumption. Trichostrongylus axei; Large mouth [70 FR 1817, Jan. 11, 2005] Stomach Worms (adults): Habronema muscae; Bots (oral and gastric stages): § 520.1195 Ivermectin liquid. Gasterophilus spp. including G. (a) Specifications—(1) Each milliliter intestinalis and G. nasalis; Lungworms (mL) contains 10 milligrams (mg) (adults and fourth-stage larvae): ivermectin. Dictyocaulus arnfieldi; Intestinal (2) Each mL of micellar solution con- Threadworms (adults), Strongyloides tains 0.8 mg ivermectin. westeri; Summer Sores caused by (b) Sponsors. See sponsor numbers in Habronema and Draschia spp. cutaneous § 510.600(c) of this chapter. third-stage larvae; Dermatitis caused (1) No. 050604 for use of product de- by neck threadworm microfilariae, scribed in paragraph (a)(1) of this sec- Onchocerca sp. tion as in paragraph (e)(1)(i), (B) Large Strongyles (Strongylus (e)(1)(ii)(A), and (e)(1)(iii) of this sec- equinus (adult), S. vulgaris (adult and tion. arterial larval stages), S. endentatus (2) Nos. 051259, 058829, and 059130 for (adult and migrating tissue stages), use of product described in paragraph Triodontophorus spp. (adult)); Small (a)(1) of this section as in paragraph Strongyles including those resistant to (e)(1)(i), (e)(1)(ii)(B), and (e)(1)(iii) of some benzimidazole class compounds this section. (Cyathostomum spp. (adult and fourth- (3) Nos. 050604 and 058829 for use of stage larvae), Cylicocyclus spp., product described in paragraph (a)(2) of Cylicodontophorus spp., Cylicostephanus this section as in paragraph (e)(2) of spp.); Pinworms (Oxyuris equi (adult this section. and fourth-stage larvae)); Ascarids (c) Related tolerances. See § 556.344 of (Parascaris equorum (adult and third- this chapter. and fourth-stage larvae)); Hairworms (d) Special considerations. See § 500.25 (Trichostongylus axei(adult)); Large of this chapter. mouth Stomach Worms (Habronema (e) Conditions of use—(1) Horses—(i) muscae (adult)); Stomach Bots Amount. 200 micrograms (mcg) per kilo- (Gastrophilus spp. (oral and gastric gram (/kg) of body weight as a single stages)); Lungworms (Dictyocaulus dose by stomach tube or as an oral arnfieldi (adult and fourth-stage lar- drench. vae)); intestinal threadworms

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(Strongyloides westeri (adult)); Summer hookworms Ancylostoma caninum, A. Sores caused by Habronema and braziliense, and Uncinaria stenocephala. Draschia spp. cutaneous third-stage lar- (iii) Limitations. Use monthly. Rec- vae; and Dermatitis caused by neck ommended for dogs 6 weeks of age and threadworm microfilariae (Onchocerca older. Federal law restricts this drug to spp.). use by or on the order of a licensed vet- (iii) Limitations. Do not use in horses erinarian. intended for human consumption. Fed- (2) [Reserved] eral law restricts this drug to use by or on the order of a licensed veterinarian. [58 FR 8542, Feb. 16, 1993, as amended at 61 (2) Sheep—(i) Amount. 200 mcg/kg (3 FR 15186, Apr. 5, 1996; 61 FR 59004, Nov. 20, mL/26 pounds) of body weight as a sin- 1996; 62 FR 63270, Nov. 28, 1997; 66 FR 35756, gle dose oral drench. July 9, 2001; 67 FR 21996, May 2, 2002; 68 FR (ii) Indications for use. For treatment 55823, Sept. 29, 2003] and control of the adult and fourth- stage larvae of gastrointestinal § 520.1197 Ivermectin sustained-re- roundworms (Haemonchus contortus, H. lease bolus. placei (adults only), Ostertagia (a) Specifications. Each sustained-re- circumcincta, Trichostrongylus axei, T. lease bolus contains 1.72 grams of colubriformis, Cooperia oncophora ivermectin. (adults only), C. curticei, (b) Sponsor. See No. 050604 in Oesophagostomum columbianum, O. § 510.600(c) of this chapter. venulosum(adults only), Nematodirus (c) Related tolerances. See § 556.344 of battus, N. spathiger, S. papillosus (adults this chapter. only), Chabertia ovina (adult only), (d) Conditions of use in ruminating Trichuris ovis (adults only)); lungworms —(1) Administer one (D. filaria); and all larval stages of the calves Amount. nasal bot Oestrus ovis. bolus per calf weighing at least 275 (iii) Limitations. For use in sheep pounds (lb) (125 kilograms (kg)) and not only. Do not use in other animal spe- more than 660 lb (300 kg) on the day of cies as severe adverse reactions, in- administration. cluding fatalities in dogs, may result. (2) Indications. For treatment and Do not treat sheep within 11 days of control, throughout the grazing season slaughter. (approximately 130 days), of gastro- intestinal roundworms Haemonchus [67 FR 50597, Aug. 5, 2002, as amended at 69 FR 57173, Sept. 24, 2004] placei, Ostertagia ostertagi (including in- hibited fourth-stage larvae), § 520.1196 Ivermectin and pyrantel Trichostrongylus axei, T. colubriformis, pamoate chewable tablets. Cooperia spp., Nematodirus helvetianus, (a) Specifications. Each chewable tab- Bunostomum phlebotomum, let contains either 68 micrograms (µg) Oesophagostomum radiatum; lungworms of ivermectin and 57 milligrams (mg) of Dictyocaulus viviparus; grubs Hypoderma pyrantel (as pamoate salt), or 136 µg spp.; sucking lice Linognathus vituli, and 114 mg, or 272 µg and 227 mg, re- Solenopotes capillatus; mange mites spectively. Psoroptes ovis, Sarcoptes scabiei, and (b) Sponsors. See Nos. 050604, 051311, ticks Amblyomma americanum. and 063604 in § 510.600(c) of this chapter. (3) Limitations. The bolus was specifi- (c) Conditions of use—(1) Dogs—(i) cally designed for use in cattle; do not µ Amount. A minimum of 6 g of use in other animal species. Calves ivermectin and 5 mg of pyrantel (as must be ruminating and older than 12 pamoate salt) per kilogram (2.72 µg and weeks of age. Do not administer to 2.27 mg per pound) of body weight. (ii) Indications for use. To prevent ca- calves weighing less than 275 lb (125 nine heartworm disease by eliminating kg). Do not administer a damaged the tissue larval stages of Dirofilaria bolus. Because a milk withdrawal time immitis for up to a month (30 days) after has not been established, do not use in infection and treatment and control of female dairy cattle of breeding age. Do adult ascarids Toxocara canis and not slaughter cattle within 180 days of Toxascaris leonina, and adult treatment. Consult your veterinarian

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for assistance in the diagnosis, treat- C. minutus, and Petrovinema poculatum; ment, and control of parasitism. Small Strongyles—fourth-stage larvae; [61 FR 67452, Dec. 23, 1996, as amended at 62 Pinworms (adults and fourth stage lar- FR 63270, Nov. 28, 1997; 65 FR 45876, July 26, vae)—Oxyuris equi; Ascarids (adults and 2000] third- and fourth-stage larvae)— Parascaris equorum; Hairworms § 520.1198 Ivermectin and praziquantel (adults)—Trichostrongylus axei; Large- paste. mouth Stomach Worms (adults)— (a) Specifications. Each milligram Habronema muscae; Bots (oral and gas- (mg) of paste contains: tric stages)—Gasterophilus spp. includ- (1) 0.0155 mg (1.55 percent) ivermectin ing G. intestinalis and G. nasalis; and 0.0775 mg (7.75 percent) Lungworms (adults and fourth-stage praziquantel. larvae)—Dictyocaulus arnfieldi; Intes- (2) 0.0187 mg (1.87 percent) ivermectin tinal Threadworms (adults)— and 0.1403 mg (14.03 percent) Strongyloides westeri; Summer Sores praziquantel. caused by Habronema and Draschia spp. (b) Sponsors. See sponsors in cutaneous third-stage larvae; Derma- § 510.600(c) of this chapter for uses as in titis caused by neck threadworm paragraph (d) of this section.—(1) No. microfilariae, Onchocerca sp. 050604 for use of product described in (ii) Tapeworms (Anoplocephala paragraph (a)(1) of this section as in perfoliata); large strongyles (adults) paragraphs (d)(1)(i), (d)(2)(i) and (d)(3) (Strongylus vulgaris (also early forms in of this section. blood vessels), S. edentatus (also tissue (2) No. 051311 for use of product de- stages), S. equinus, Triodontophorus scribed in paragraph (a)(2) of this sec- spp.); small strongyles including those tion as in paragraphs (d)(1)(ii), resistant to some benzimidazole-class (d)(2)(ii), and (d)(3) of this section. compounds (adults and fourth-stage (c) Special considerations. See § 500.25 larvae) (Cyathostomum spp., Cylicocyclus of this chapter. spp., Cylicostephanus spp., (d) Conditions of use in horses—(1) Cylicodontophorus spp.); pinworms Amount—(i) 200 micrograms (mcg) per (adults and fourth-stage larvae) kilogram (/kg) ivermectin (91 mcg per (Oxyuris equi); ascarids (adults and pound (/lb)) and 1 mg/kg praziquantel third- and fourth-stage larvae) (454 mcg/lb) body weight. (Parascaris equorum); hairworms (ii) 200 mcg/kg ivermectin (91 mcg/lb) (adults) (Trichostrongylus axei); large- and 1.5 mg/kg praziquantel (681 mcg/lb) mouth stomach worms (adults) body weight. (Habronema muscae); bots (oral and gas- (2) Indications for use. For treatment tric stages) (Gasterophilus spp.); and control of: lungworms (adults and fourth-stage (i) For treatment and control of the larvae) (Dictyocaulus arnfieldi); intes- following parasites in horses: Tape- tinal threadworms (adults) worms—Anoplocephala perfoliata; Large (Strongyloides westeri); summer sores strongyles (adults)—Strongylus vulgaris caused by Habronema and Draschia spp. (also early forms in blood vessels), S. cutaneous third-stage larvae; and der- edentatus (also tissue stages), S. matitis caused by neck threadworm equinus, Triodontophorus spp. including microfilariae, Onchocerca sp. T. brevicauda and T. serratus, and Craterostomum acuticaudatum; Small (3) Limitations. For oral use only. Do Strongyles (adults, including those re- not use in horses intended for human sistant to some benzimidazole class consumption. compounds)—Coronocyclus spp. includ- [68 FR 55309, Sept. 25, 2003, as amended at 69 ing C. coronatus, C. labiatus, and C. FR 49808, Aug. 12, 2004] labratus, Cyathostomum spp. including C. catinatum and C. pateratum, § 520.1204 Kanamycin sulfate, Cylicocyclus spp. including C. insigne, C. aminopentamide hydrogen sulfate, leptostomum, C. nassatus, and C. pectin, bismuth subcarbonate, acti- brevicapsulatus, Cylicodontophorus spp., vated attapulgite suspension. Cylicostephanus spp. including C. (a) Specifications. Each five milliliters calicatus, C. goldi, C. longibursatus, and of suspension of the drug contains: 100

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milligrams of kanamycin as the sul- § 520.1242 Levamisole hydrochloride fate, 0.033 milligram of oral dosage forms. aminopentamide hydrogen sulfate, 25 milligrams of pectin, 250 milligrams of § 520.1242a Levamisole powder for oral bismuth subcarbonate, and 500 milli- solution. grams of activated attapulgite. (a) Specifications. Each package of (b) Sponsor. See No. 000856 in powder contains 9.075, 11.7, 18.15, 46.8, § 510.600(c) of this chapter. 362.7, or 544.5 grams (g) levamisole hy- (c) Conditions of use. (1) It is adminis- drochloride. tered orally to dogs for the sympto- (b) Sponsors. See sponsors in matic relief of acute bacterial diarrhea § 510.600(c) for use as follows: caused by kanamycin-susceptible orga- (1) No. 000061 for use of 46.8- and 544.5- nisms. g packages as in paragraph (e)(1)(i), (2) The drug is recommended for use (e)(1)(ii)(B), and (e)(1)(iii) of this sec- at the rate of one teaspoonful (5 milli- tion; for 11.7-, 46.8-, and 544.5-g pack- liters) of suspension per 20 pounds of ages as in paragraph (e)(2)(i), body weight every 8 hours. Animals (e)(2)(ii)(B), and (e)(2)(iii) of this sec- weighing under 10 pounds should be tion; and for an 18.15-g package as in given one-half the above amount every paragraph (e)(3) of this section. 8 hours. The initial dose should be (2) No. 053501 for use of a 46.8-g pack- twice the amount of a single dose. Max- age as in paragraph (e)(1)(i), imum dosage should not exceed three (e)(1)(ii)(A), and (e)(1)(iii) of this sec- times the recommended dose. tion; for 11.7- and 46.8-g packages as in (3) For use only by or on the order of paragraph (e)(2)(i), (e)(2)(ii)(A), and a licensed veterinarian. (e)(2)(iii) of this section; and for 9.075- and 18.15-g packages as in paragraph [40 FR 13838, Mar. 27, 1975, as amended at 53 (e)(3) of this section. FR 27851, July 25, 1988; 56 FR 8710, Mar. 1, (3) No. 057561 for use of 46.8- and 544.5- 1991; 64 FR 403, Jan. 5, 1999] g packages as in paragraphs (e)(1)(i), § 520.1205 Kanamycin sulfate, pectin, (e)(1)(ii)(A), and (e)(1)(iii) and (e)(2)(i), bismuth subcarbonate, activated (e)(2)(ii)(A), and (e)(2)(iii) of this sec- attapulgite tablets. tion. (4) No. 059130 for use of 46.8-, 362.7-, (a) Specifications. Each tablet con- and 544.5-g packages as in paragraphs tains 100 milligrams of kanamycin (as (e)(1)(i), (e)(1)(ii)(B), (e)(1)(iii), (e)(2)(i), the sulfate), 25 milligrams of pectin, (e)(2)(ii)(B), and (e)(2)(iii) of this sec- 250 milligrams of bismuth subcar- tion; and for use of an 18.15-g package bonate, and 500 milligrams of activated as in paragraph (e)(3) of this section. attapulgite. (c) Related tolerances. See § 556.350 of (b) Sponsor. See No. 000856 in this chapter. § 510.600(c) of this chapter. (d) Special considerations. See § 500.25 (c) Conditions of use—(1) Amount. One of this chapter. tablet per 44 kilograms (20 pounds) of (e) Conditions of use. It is used as an body weight every 8 hours. Maximum anthelmintic as follows: dose 3 tablets every 8 hours. For ani- (1) Cattle—(i) Amount. 8 milligrams mals under 22 kilograms (10 pounds) 1⁄2 tablet every 8 hours. The initial load- per kilogram (mg/kg) body weight as a ing dose should be twice the amount of drench. a single dose. (ii) Indications for use—(A) Effective against the following nematode infec- (2)Indications for use. For the treat- ment of bacterial enteritis caused by tions: Stomach worms (Haemonchus, organisms susceptible to kanamycin Trichostrongylus, Ostertagia); intestinal and the symptomatic relief of associ- worms (Trichostrongylus, Cooperia, ated diarrhea in dogs. Nematodirus, Bunostomum, Oesophagostomum); and lungworms (3) Limitations. Federal law restricts (Dictyocaulus). this drug to use by or on the order of a (B) Effective against the following licensed veterinarian. adult nematode infections: Stomach [56 FR 8710, Mar. 1, 1991] worms (Haemonchus placei, Ostertagia

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ostertagi, Trichostrongylus axei); intes- veterinarian before administering to tinal worms (T. longispicularis, Cooperia sick swine. oncophora, C. punctata, Nematodirus [69 FR 9753, Mar. 2, 2004, as amended at 69 FR spathiger, Bunostomum phlebotomum, 33839, June 17, 2004; 70 FR 2353, Jan. 13, 2005] Oesophagostomum radiatum); and lungworms (Dictyocaulus viviparus). § 520.1242b Levamisole hydrochloride (iii) Limitations. Do not slaughter for tablet or oblet (bolus). food within 48 hours of treatment. Not (a) Chemical name. (-)-2,3,5,6- for use in dairy animals of breeding Tetrahydro-6-phenylimidazo [2,1-b] thi- age. Conditions of constant helminth azole monohydrochloride. exposure may require retreatment 2 to (b) Specifications. Assay of not less 4 weeks after the first treatment. Con- than 98 percent by nonaqueous titra- sult your veterinarian before using in tion with 0.1 N potassium isopropoxide; severely debilitated animals. 1 isomer minimum 95 percent pure by (2) Sheep—(i) Amount. 8 mg/kg body optical rotation. weight as a drench. (c) Sponsor. See Nos. 000061 and 053501 in § 510.600(c) of this chapter. (ii) Indications for use—(A) Effective (d) Required labeling. Consult your against the following nematode infec- veterinarian for assistance in the diag- tions: Stomach worms (Haemonchus, nosis, treatment, and control of para- Trichostrongylus, Ostertagia); intestinal sitism. worms (Trichostrongylus, Cooperia, (e) Related tolerances. See § 556.350 of Nematodirus, Bunostomum, this chapter. Oesophagostomum, Chabertia); and (f) Conditions of use. (1) It is used in lungworms (Dictyocaulus). an oblet for cattle as follows: (B) Effective against the following (i) Amount. 2.19 grams per oblet. adult nematode infections: Stomach (ii) Indications for use. Anthelmintic worms (Haemonchus contortus, effective against the following nema- Trichostrongylus axei, Teladorsagia tode infections: Stomach worms circumcincta); intestinal worms (Haemonchus, Trichostrongylus, (Trichostrongylus colubriformis, Cooperia Ostertagia), intestinal worms curticei, Nematodirus spathiger, (Trichostrongylus, Cooperia, Bunostomum trigonocephalum, Nematodirus, Bunostomum, Oesophagostomum columbianum, Oesophagostomum), and lungworms Chabertia ovina), and lungworms (Dictyocaulus). (Dictyocaulus filaria). (iii) Limitations. Administer as a sin- (iii) Limitations. Do not slaughter for gle dose as follows: 250 to 450 pounds, 1⁄2 food within 72 hours of treatment. Con- oblet; 450 to 750 pounds, 1 oblet; and 750 ditions of constant helminth exposure to 1,050 pounds, 11⁄2 oblets; conditions of may require retreatment 2 to 4 weeks constant helminth exposure may re- after the first treatment. Consult vet- quire re-treatment within 2 to 4 weeks erinarian before using in severely de- after the first treatment; do not bilitated animals. slaughter for food within 48 hours of treatment; not for use in dairy animals (3) Swine—(i) Amount. 8 mg/kg body of breeding age; consult veterinarian weight in drinking water. before using in severely debilitated (ii) Indications for use. Effective animals. against the following nematode infec- (2) It is used in a tablet for sheep as tions: Large roundworms (Ascaris follows: suum), nodular worms (i) Amount. 0.184 gram per tablet. (Oesophagostomum spp.), intestinal (ii) Indications for use. Anthelmintic thread worms (Strongyloides ransomi) effective against the following nema- and lungworms (Metastrongylus spp. ). tode infections: Stomach worms (iii) Limitations. Do not administer (Haemonchus, Trichostrongylus, within 72 hours of slaughter for food. Ostertagia), intestinal worms Pigs maintained under conditions of (Trichostrongylus, Cooperia, constant exposure to worms may re- Nematodirus, Bunostomum, quire retreatment within 4 to 5 weeks Oesophagostomum, Chabertia), and after the first treatment. Consult your lungworms (Dictyocaulus).

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(iii) Limitations. Administer one tab- concentration equivalent to 10 percent let for each 50 pounds of body weight; levamisole hydrochloride. Each 2.05- conditions of constant helminth expo- ounce (58.1 gram) packet contains sure may require re-treatment within 2 levamisole equivalent to 5.806 grams of to 4 weeks after the first treatment; do levamisole hydrochloride. not slaughter for food within 72 hours (b) Sponsor. See No. 043781 in of treatment; consult a veterinarian § 510.600(c) of this chapter. before using in severely debilitated (c) Related tolerances. See § 556.350 of animals. this chapter. (d) Conditions of use. In swine it is [40 FR 13838, Mar. 27, 1975, as amended at 44 FR 59507, Oct. 16, 1979; 62 FR 61625, Nov. 19, used as follows: 1997; 67 FR 63055, Oct. 10, 2002] (1) Amount. The equivalent of 8 milli- grams per kilogram of body weight, as § 520.1242c Levamisole hydrochloride a single dose, mixed in the animal’s ra- and piperazine dihydrochloride. tion. (a) Specifications. (1) The drug is an (2) Indications for use. For the re- aqueous solution which contains in moval of and control of the following each fluid ounce 0.36 gram of nematode infections: large roundworms levamisole hydrochloride and piper- (Ascaris suum), nodular worms azine dihydrochloride equivalent to 3.98 (Oesophagostomum spp.), lungworms grams of piperazine base. (Metastrongylus spp.), intestinal (2) The drug is a soluble powder threadworms (Strongyloides ransomi), which when reconstituted with water and swine kidney worms (Stephanurus contains in each fluid ounce 0.45 gram dentatum). of levamisole hydrochloride and piper- (3) Limitations. For pigs from weaning azine dihydrochloride equivalent to 5.0 to market weight, mix one 58.1-gram grams of piperazine base. packet of levamisole resinate con- (b) Sponsor. See No. 053501 in taining the equivalent of 10-percent § 510.600(c) of this chapter. levamisole hydrochloride in 40 pounds (c) [Reserved] of feed and administer 1 pound of medi- (d) Conditions of use. It is used as a cated feed per 40 pounds of body weight drench for horses as follows: as sole ration. For breeding swine, mix (1) Indications for use. An anthel- 1 packet of the 10-percent resinate in 16 mintic effective against infections of pounds of feed and administer 1 pound large strongyles (Strongylus vulgaris, S. of medicated feed per 100 pounds of edentatus), small strongyles body weight as sole ration. Administer (Cylicocercus spp., Cylicocylclus spp., as single doses. Withhold regular feed Cylicodontophorus spp., Cylicostephanus overnight and administer medicated spp., Cylicotetrapedon spp. ), ascarids feed the following morning. Do not (Parascaris equorum), and pinworms withhold water during fasting. Do not (Oxyuris equii). treat within 72 hours of slaughter. Sali- (2) Limitations. Aqueous solution: ad- vation or muzzle foam may be ob- minister by stomach tube or drench 1 served. The reaction will disappear a fluid ounce per 100 pounds of body short time after feeding. If pigs are in- weight. Reconstituted soluble powder: fected with mature lungworms, administer by stomach tube 1 fluid coughing and vomiting may be ob- ounce per 125 pounds of body weight. If served. Consult your veterinarian for reinfection occurs, re-treat animals at assistance in the diagnosis, treatment, 6- to 8-week intervals. Do not treat ani- and control of parasitism. mals intended for food. Federal law re- [43 FR 18171, Apr. 28, 1978, as amended at 45 stricts this drug to use by or on the FR 3574, Jan. 18, 1980] order of a licensed veterinarian. [40 FR 32831, Aug. 5, 1975, as amended at 41 § 520.1242e Levamisole hydrochloride FR 48731, Nov. 5, 1976; 43 FR 11176 Mar. 17, effervescent tablets. 1978; 67 FR 63055, Oct. 10, 2002] (a) Specifications. Each tablet con- tains 907 milligrams of levamisole hy- § 520.1242d Levamisole resinate. drochloride. (a) Specifications. The drug is (b) Sponsor. See No. 053501 in levamisole adsorbed on a resin, in a § 510.600(c) of this chapter.

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(c) Related tolerances. See § 556.350 of mals of breeding age; consult veteri- this chapter. narian before using in severely debili- (d) Conditions of use. It is used for tated animals. swine as follows: (2) Breeding swine—(i) Amount. Eight (1) Amount. The equivalent of 8 milli- milligrams per kilogram of body grams of levamisole hydrochloride per weight (3.6 milligrams per pound) as a kilogram of body weight, as a single single oral dose. dose. (ii) Conditions of use. For treating (2) Indications for use. See breeding swine infected with the fol- § 520.1242a(f)(3)(ii). lowing nematodes: Large roundworms (3) Limitations. Withholding water (Ascaris suum), nodular worms from pigs before treatment is not nec- (Oesophagostomum spp.), lungworms essary. Add one tablet for each 21⁄2 gal- (Metastrongylus spp.), intestinal lons of water; mix thoroughly. Allow 1 threadworms (Strongyloides ransomi), gallon of medicated water for each 100 and kidney worms (Stephanurus pounds body weight of pigs to be treat- dentatus). ed. No other source of water should be (iii) Limitations. May require retreat- offered. After pigs have consumed ment in 4 to 5 weeks. Do not use within medicated water, resume use of regular 11 days of slaughter for food. Consult water. Pigs maintained under condi- your veterinarian for assistance before tions of constant worm exposure may using in severely debilitated animals require re-treatment within 4 to 5 and in the diagnosis, treatment, and weeks. Consult your veterinarian be- control of parasitism. fore administering to sick swine. Con- sult your veterinarian for assistance in [47 FR 22517, May 25, 1982; 47 FR 30242, July 13, 1982, as amended at 48 FR 11429, Mar. 18, the diagnosis, treatment, and control 1983; 51 FR 29215, Aug. 15, 1986; 67 FR 63055, of parasitism. Do not administer with- Oct. 10, 2002] in 72 hours of slaughter for food. [45 FR 6087, Jan. 25, 1980, as amended at 67 § 520.1242g Levamisole resinate and FR 63055, Oct. 10, 2002] famphur paste. (a) Chemical name of famphur. O, O- § 520.1242f Levamisole hydrochloride Dimethyl O-[p-(dimethylsulfamoyl) gel. phenyl] phosphorothioate. (a) Specifications. The drug is a gel (b) Specifications. The drug is a paste containing 11.5 percent levamisole hy- containing 11.6 percent levamisole res- drochloride. inate (50 percent potency) and 23.6 per- (b) Sponsor. See No. 053501 in cent famphur. § 510.600(c) of this chapter. (c) Sponsor. See 000061 in § 510.600(c) of (c) Related tolerances. See § 556.350 of this chapter. this chapter. (d) Special considerations. Do not use (d) Conditions of use—(1) Cattle—(i) any cholinesterase-inhibiting drugs, Amount. Eight milligrams of pesticides, insecticides, or chemicals levamisole hydrochloride per kilogram on cattle simultaneously or within a of body weight, as a single oral dose. few days before or after treatment with (ii) Indications for use. Anthelmintic this product. effective against the following nema- (e) Related tolerances. See § 556.350 of tode infections: Stomach worms this chapter for levamisole and § 556.273 (Haemonchus, Trichostrongylus, of this chapter for famphur. Ostertagia), intestinal worms (f) Conditions of use in cattle—(1) (Trichostrongylus, Cooperia, Amount. 8 milligrams of levamisole hy- Nematodirus, Bunostomum, drochloride (equivalent) and 30 milli- Oesophagostomum), and lungworms grams of famphur activity per kilo- (Dictyocaulus). gram of body weight. (iii) Limitations. Conditions of con- (2) Indications for use. For treatment stant helminth exposure may require of cattle infected with the following re-treatment within 2 to 4 weeks after parasites: Stomach worms the first treatment; do not administer (Haemonchus, Trichostrongylus, to cattle within 6 days of slaughter for Ostertagia), intestinal worms food; do not administer to dairy ani- (Trichostrongylus, Cooperia,

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Nematodirus, Bunostomum, chloride equivalent to 0.4 grams of lin- Oesophagostomum), lungworms comycin. (Dictyocaulus), cattle grubs (b) Sponsors. See Nos. 000009, 046573, (Hypoderma), biting lice (Bovicola), and 054925, 059130, and 061623 in § 510.600(c) of sucking lice (Linognathus, Solenoptes). this chapter for use as in paragraph (d) (3) Limitations. Drug is not effective of this section. against lice eggs. Conditions of con- (c) Tolerances. See § 556.360 of this stant helminth and ectoparasitic expo- chapter. sure may require retreatment within 2 (d) Conditions of use—(1) Swine—(i) to 4 weeks after first treatment. Do not Amount. 250 milligrams per gallon of administer to cattle within 19 days of drinking water to provide 3.8 milli- slaughter. Do not administer to dairy grams per pound of body weight per animals of breeding age. Do not use in day. calves less than 3 months old, or in de- (ii) Indications for use. For the treat- bilitated animals. Do not treat Brah- ment of swine dysentery (bloody man bulls. Consult your veterinarian scours). for assistance in the diagnosis, treat- (iii) Limitations. Discard medicated ment, and control of parasitism. drinking water if not used within 2 days. Prepare fresh stock solution [53 FR 23757, June 24, 1988, as amended at 54 daily. Do not use for more than 10 days. FR 1353, Jan. 13, 1989; 57 FR 7652, Mar. 4, 1992; If clinical signs of disease have not im- 62 FR 55160, Oct. 23, 1997; 62 FR 61625, Nov. 19, proved within 6 days, discontinue 1997] treatment and reevaluate diagnosis. The safety of lincomycin has not been § 520.1263 Lincomycin hydrochloride monohydrate oral dosage forms. demonstrated in pregnant swine or swine intended for breeding. For No. § 520.1263a Lincomycin hydrochloride 051259: Do not slaughter swine for 6 monohydrate tablets and sirup. days following last treatment. (2) Chickens—(i) Amount. 64 milli- (a) Specifications. The sirup contains grams per gallon of drinking water. lincomycin hydrochloride equivalent (ii) Indications for use. For the control to either 25 milligrams or 50 milli- of necrotic enteritis caused by Clos- grams of lincomycin. tridium perfringens susceptible to linco- (b) Sponsor. See No. 000009 in mycin in broiler chickens. § 510.600(c) of this chapter. (iii) Limitations. Discard medicated (c) Conditions of use. (1) The drug is drinking water if not used within 2 indicated in infections caused by gram- days. Prepare fresh stock solution positive organisms which are sensitive daily. Administer for 7 consecutive to its action, particularly streptococci days. Do not allow rabbits, hamsters, and staphylococci. guinea pigs, horses, or ruminants ac- (2) It is administered orally to dogs cess to water containing lincomycin. and cats at a dosage level of 10 mgs per Not for use in layer and breeder chick- pound of body weight every 12 hours, or ens. 7 mgs per pound of body weight every 8 [48 FR 3966, Jan. 28, 1983, as amended at 55 hours. Treatment may be continued for FR 3209, Jan. 31, 1990; 60 FR 14217, Mar. 16, periods as long as 12 days if clinical 1995; 62 FR 65020, Dec. 10, 1997; 64 FR 13341, judgment indicates. Mar. 18, 1999; 64 FR 13508, Mar. 19, 1999; 64 FR (3) Federal law restricts this drug to 66382, Nov. 26, 1999; 65 FR 10705, Feb. 29, 2000; use by or on the order of a licensed vet- 67 FR 17284, Apr. 10, 2002; 67 FR 71819, Dec. 3, erinarian. 2002; 67 FR 78356, Dec. 24, 2002; 68 FR 3817, Jan. 27, 2003; 70 FR 1818, Jan. 11, 2005] [40 FR 13838, Mar. 27, 1975, as amended at 44 FR 7130, Feb. 6, 1979; 64 FR 403, Jan. 5, 1999] § 520.1265 Lincomycin and spectinomycin soluble powder. § 520.1263b [Reserved] (a) Specifications. The following salts of lincomycin and spectinomycin are § 520.1263c Lincomycin hydrochloride present in a soluble powder in the ratio soluble powder. of 1 to 2 on the basis of equivalency of (a) Specifications. Each gram of solu- lincomycin base to equivalency of ble powder contains lincomycin hydro- spectinomycin base:

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(1) Lincomycin hydrochloride (3) Federal law restricts this drug to monohydrate and spectinomycin sul- use by or on the order of a licensed vet- fate tetrahydrate. erinarian. (2) Lincomycin hydrochloride [40 FR 13838, Mar. 27, 1975, as amended at 56 monohydrate and spectinomycin FR 50653, Oct. 8, 1991; 60 FR 55659, Nov. 2, dihydrochloride pentahydrate. 1995] (b) Sponsors. See sponsors in § 510.600(c) of this chapter for use as in § 520.1288 Lufenuron tablets. paragraph (d) of this section. (a) Specifications—(1) Tablets con- (1) No. 000009 for use of product de- taining 45, 90, 204.9, or 409.8 milligrams scribed in paragraph (a)(1) of this sec- (mg) lufenuron for use as in paragraphs tion. (c)(1)(i), (c)(1)(ii)(A), (c)(1)(iii), (c)(2)(i), (2) No. 059130 for use of product de- (c)(2)(ii)(A), and (c)(2)(iii) of this sec- scribed in paragraph (a)(2) of this sec- tion. tion. (2) Flavored tablets containing 45, 90, (c) Tolerances. See §§ 556.360 and 204.9, or 409.8 milligrams (mg) 556.600 of this chapter. lufenuron for use as in paragraphs (d) Conditions of use in chickens—(1) (c)(1)(i), (c)(1)(ii)(A) or (c)(1)(ii)(B), and Amount. 2 grams of antibiotic activity (c)(1)(iii) of this section. per gallon of drinking water; admin- (3) Flavored tablets containing 90 or ister as the sole source of water for the 204.9 mg lufenuron for use as in para- first 5 to 7 days of life. graphs (c)(2)(i), (c)(2)(ii)(A) or (c)(2)(ii)(B), and (c)(2)(iii) of this sec- (2) Indications for use. As an aid in the tion. control of airsacculitis caused by ei- (4) Flavored tablets containing 135 or ther Mycoplasma synoviae or M. 270 mg lufenuron for use as in para- gallisepticum susceptible to lincomycin- graphs (c)(2)(i), (c)(2)(ii)(A), and spectinomycin and complicated chron- (c)(2)(iii) of this section. ic respiratory disease (air sac infec- (b) Sponsor. See No. 058198 in tion) caused by Escherichia coli and M. § 510.600(c) of this chapter. gallisepticum susceptible to lincomycin- (c) Conditions of use—(1) Dogs—(i) spectinomycin. Amount. Minimum of 10 mg lufenuron [69 FR 13220, Mar. 22, 2004] per kilogram (4.5 mg per pound (lb)) of body weight, once a month. § 520.1284 Sodium liothyronine tablets. (ii) Indications for use—(A) For the (a) Specifications. Sodium prevention and control of flea popu- lations. liothyronine tablets consist of tablets (B) The concurrent use of flavored intended for oral administration which lufenuron tablets described in para- contain liothyronine at 60 or 120 graph (a)(2) of this section as in para- micrograms per tablet, as the sodium graph (c)(1)(ii)(A) of this section with salt. nitenpyram tablets as in § 520.1510(d)(1) (b) Sponsor. See No. 000069 in of this chapter is indicated to kill § 510.600(c) of this chapter. adult fleas and prevent flea eggs from (c) Conditions of use. (1) It is indicated hatching. in cases of hypothyroidism in dogs. (iii) Limitations. For use in dogs and (2) It is administered orally to dogs puppies 4 weeks of age and older. at levels up to 12.8 micrograms per (2) Cats—(i) Amount. Minimum of 30 kilogram of body weight per day. Dos- mg lufenuron per kilogram (13.6 mg/lb) age should be adjusted according to the of body weight, once a month. severity of the condition and the re- (ii) Indications for use—(A) For the sponse of the patient. Dosage at the control of flea populations. total replacement level (12.8µg per kilo- (B) The concurrent use of flavored gram of body weight) should be consid- lufenuron tablets described in para- ered for initiating therapy and then graph (a)(3) of this section as in para- titrated downward for optimum main- graph (c)(2)(ii)(A) of this section with tenance effect. Twice daily administra- nitenpyram tablets as in § 520.1510(d)(2) tion is recommended. of this chapter is indicated to kill

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adult fleas and prevent flea eggs from hibits the extralabel use of this drug in hatching. food-producing animals. (iii) Limitations. For use in cats and [64 FR 39919, July 23, 1999, as amended at 66 kittens 4 weeks of age and older. FR 46369, Sept. 5, 2001] [68 FR 51905, Aug. 29, 2003] § 520.1320 Mebendazole oral. § 520.1289 Lufenuron suspension. (a) Chemical name. Methyl 5-benzoyl- (a) Specifications. Each individual benzimindazole-2-carbamate. dose pack contains either 135 or 270 (b) Specifications. As oral powder: milligrams of lufenuron. Each gram contains either 40 or 166.7 milligrams of mebendazole. As oral (b) Sponsor. See No. 058198 in paste: Each gram contains 200 milli- § 510.600(c) of this chapter. grams of mebendazole. As oral suspen- (c) Conditions of use in cats—(1) sion: Each milliliter contains 33.3 mil- Amount. Minimum of 13.6 milligrams ligrams of mebendazole. per pound of body weight (30 milli- (c) Sponsor. See No. 000061 in grams per kilogram). Recommended § 510.600(c) of this chapter. dose of 135 milligrams for up to 10 (d) Conditions of use—(1) Horses—(i) pounds of body weight or 270 milli- Amount. 1 gram of mebendazole per 250 grams for 11 to 20 pounds. Cats over 20 pounds of body weight per dose, as an pounds are provided the appropriate oral powder, paste or suspension. combination of packs. (ii) Indications for use. It is used in (2) Indications for use. For control of horses for treatment of infections flea populations. caused by large roundworms (Parascaris (3) Limitations. For oral use in cats 6 equorum); large strongyles (Strongylus weeks of age or older, once a month, edentatus, S. equinus, S. vulgaris); small mixed with food. Administer in con- strongyles; and mature and immature junction with a full meal to ensure ade- (4th larval stage pinworms (Oxyuris quate absorption. Treat all cats in the equi)). household to ensure maximum bene- (iii) Limitations—(a) Oral powder. The fits. Because the drug has no affect on drug is given by sprinkling directly on adult fleas, the concurrent use of insec- the grain portion of the ration or dis- ticides that kill adults may be nec- solving in 2 to 4 pints of water and ad- essary depending on the severity of the ministering by stomach tube. The drug infestation. is compatible with carbon disulfide, which can be used concurrently for [60 FR 20402, Apr. 26, 1995, as amended at 62 both control (Gastrophilus spp. ). Rou- FR 8371, Feb. 25, 1997] tine cautions regarding the use of car- bon disulfide must be observed. Do not § 520.1310 Marbofloxacin tablets. administer to horses intended for use (a) Specifications. Each tablet con- as food. Federal law restricts this drug tains 25, 50, 100, or 200 milligrams (mg) to use by or on the order of a licensed marbofloxacin. veterinarian. (b) Sponsor. See No. 000069 in (b) Oral paste. The drug is given by § 510.600(c) of this chapter. dosing gun (syringe), inserting the tip of the gun at the interdental space in (c) [Reserved] the horse’s mouth and depositing the (d) Conditions of use—(1) Amount. 1.25 paste on the animal’s tongue. The hand mg per pound (/lb) of body weight once is placed under the animal’s jaw, and daily, but may be increased to 2.5 mg/ the head is raised to assure that the lb of body weight once daily. paste is deposited on the roof of the (2) Indications for use. For the treat- mouth. Not for use in horses intended ment of infections in dogs and cats as- for food. Consult your veterinarian for sociated with bacteria susceptible to assistance in the diagnosis, treatment, marbofloxacin. and control of parasitism. (3) Limitations. Federal law restricts (c) Oral suspension. The drug is ad- this drug to use by or on the order of a ministered by stomach tube. Not for licensed veterinarian. Federal law pro- horses intended for food use. Federal

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law restricts this drug to use by or on days before or after treatment with, or the order of a licensed veterinarian. exposure to, cholinesterase-inhibiting (2) Dogs—(i) Amount. One hundred drugs, pesticides or chemicals. Do not milligrams of mebendazole per 10 administer intravenous anesthetics, es- pounds of body weight, once daily for 3 pecially muscle relaxants, concur- days, as an oral powder. rently. Not for horses intended for food (ii) Indications for use. The drug is use. Federal law restricts this drug to used for treatment of infections of use by or on the order of a licensed vet- roundworms (Toxocara canis), erinarian. hookworms (Ancylostoma caninum, [45 FR 10759, Feb. 19, 1980, as amended at 46 Uncinaria stenocephala), whipworms FR 52330, Oct. 27, 1981. Redesignated at 51 FR (Trichuris vulpis), and tapeworms 13212, Apr. 18, 1986, as amended at 62 FR (Taenia pisiformis). 61625, Nov. 19, 1997] (iii) Limitations. Administer as an oral powder by mixing with a small § 520.1326b Mebendazole and quantity of food, preferably before the trichlorfon paste. regular meal. Federal law restricts this (a) Specifications. Each gram of paste drug to use by or on the order of a li- contains 100 milligrams of mebendazole censed veterinarian. and 454 milligrams of trichlorfon. (b) Sponsor. See No. 000061 in [42 FR 61255, Dec. 2, 1977, as amended at 43 § 510.600(c) of this chapter. FR 35686, Aug. 11, 1978; 45 FR 3574, Jan. 18, (c) Conditions of use—(1) Amount. 8.8 1980; 46 FR 47218, Sept. 25, 1981; 46 FR 53658, Oct. 30, 1981; 62 FR 61625, Nov. 19, 1997] milligrams of mebendazole and 40 mil- ligrams of trichlorfon per kilogram of § 520.1326 Mebendazole and body weight. trichlorfon oral dosage forms. (2) Indications for use. It is used in horses for treatment of infections of § 520.1326a Mebendazole and bots (Gastrophilus intestinalis and G. na- trichlorfon powder. salis), large roundworms (Parascaris (a) Specifications. Each gram of pow- equorum), large strongyles (Strongylus der contains 83.3 milligrams of edentatus, S. equinus, S. vulgaris), small mebendazole and 375.0 milligrams of strongyles, and pinworms (Oxyuris trichlorofon. equi). (b) Sponsor. See No. 000061 in (3) Limitations. Do not administer § 510.600(c) of this chapter. more than once every 30 days. Do not (c) Conditions of use. Horses—(1) treat sick or debilitated animals, foals Amount. 8.8 milligrams of mebendazole under 4 months of age, or mares in the and 40 milligrams of trichlorofon per last month of pregnancy. Trichlorfon is kilogram of body weight. a cholinesterase inhibitor. Do not ad- (2) Indications for use. It is used in minister simultaneously or within a horses for the treatment of infections few days before or after treatment of bots (Gastrophilus intestinalis and G. with, or exposure to, cholinesterase-in- nasalis), large roundworms (Parascaris hibiting drugs, pesticides, or chemi- equorum), large strongyles (Strongylus cals. Do not administer intravenous edentatus, S. equinus, S. vulgaris), small anesthetics, especially muscle relax- strongyles, and pinworms (Oxyuris ants, concurrently. Not for use in equi.) horses intended for food. Consult your (3) Limitations. Administer orally as veterinarian for assistance in the diag- an individual dose by stomach tube or nosis, treatment, and control of para- throughly mixed in the ground grain sitism. portion of the ration to be consumed in [51 FR 13212, Apr. 18, 1986, as amended at 62 one feeding. Discard treated feed not FR 61625, Nov. 19, 1997] consumed. Do not administer more than once every 30 days. Do not treat § 520.1330 Meclofenamic acid granules. sick or debilitated animals, foals under (a) Chemical name. N-(2,6-Dichlorom- 4 months of age, or mares in the last tolyl) anthranilic acid. month of pregnancy. Trichlorofon is a (b) Specifications. The drug is in cholinesterase inhibitor. Do not admin- granular form containing 5 percent ister simultaneously or within a few meclofenamic acid.

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(c) Sponsor. See No. 000856 in ment of estrus and the alleviation of § 510.600(c) of this chapter. false pregnancy. (d) Conditions of use. (1) The drug is (2) It is administered orally, intact, used in horses for the treatment of or crushed and mixed with food as fol- acute or chronic inflammatory diseases lows: involving the musculoskeletal system. (i) For the postponement of estrus by (2) It is administered orally at a dos- proestrus treatment, 1 milligram per age of 1 milligram per pound of body pound of body weight per day for 8 weight (1 gram per 1,000 pounds) once days. daily for 5 to 7 days by addition to the (ii) For the postponement of estrus daily grain ration. by anestrus treatment, 0.25 milligram (3) Treatment beyond the initial 5- to per pound of body weight per day for 32 7-day period may be indicated. A main- days. tenance dosage level should be individ- (iii) For alleviation of false preg- ualized for each animal. nancy, 1 milligram per pound of body (4) This drug should not be adminis- weight per day for 8 days. tered to horses with active gastro- (3) Full dosage regimen must be com- intestinal, hepatic, or renal disease. pleted to produce the desired effect. (5) Not for use in horses intended for (4) Examination of vaginal smears is food. recommended to confirm detection of (6) Federal law restricts this drug to proestrus. use by or on the order of a licensed vet- (5) Do not administer for more than erinarian. two consecutive treatments. [41 FR 5632, Feb. 9, 1976, as amended at 53 FR (6) Once therapy is started, the ani- 23390, June 22, 1988] mal should be confined for 3 to 8 days or until cessation of bleeding, since § 520.1331 Meclofenamic acid tablets. dogs in proestrus accept a male. (a) Specifications. Each tablet con- (7) Do not use prior to or during first tains either 10 or 20 milligrams of estrus cycle. meclofenamic acid. (8) Do not use in pregnant animals. (b) Sponsor. See No. 000856 in (9) Do not use in the presence of a § 510.600(c) of this chapter. disease of the reproductive system or (c) Conditions of use in dogs—(1) with mammary tumors. Amount. 1.1 milligrams per kilogram (10) Should estrus occur within 30 (0.5 milligram per pound) daily for 5 to days after cessation of treatment, mat- 7 days. ing should be prevented. (2) Indications for use. For the relief of signs and symptoms of chronic inflam- (11) Federal law restricts this drug to matory disease involving the musculo- use by or on the order of a licensed vet- skeletal system. erinarian. (3) Limitations. For oral use only. [40 FR 13838, Mar. 27, 1975, as amended at 52 Should not be administered to animals FR 7832, Mar. 13, 1987] with congestive heart failure or active gastrointestinal, hepatic, or renal dis- § 520.1350 Meloxicam. ease. Federal law restricts this drug to (a) Specifications. Each milliliter of use by or on the order of a licensed vet- suspension contains 0.5 or 1.5 milli- erinarian. grams (mg) meloxicam. [50 FR 43385, Oct. 25, 1985, as amended at 53 (b) Sponsor. See No. 000010 in FR 23390, June 22, 1988] § 510.600(c) of this chapter for uses as in paragraph (c) of this section. § 520.1341 Megestrol acetate tablets. (c) Conditions of use in dogs—(1) (a) Specifications. Each tablet con- Amount. Administer orally as a single tains 5 or 20 milligrams of megestrol dose at 0.09 mg per pound (mg/lb) body acetate. weight (0.2 mg per kilogram (mg/kg)) (b) Sponsor. No. 000061 in § 510.600(c) of on the first day of treatment. For all this chapter. treatment after day 1, administer 0.045 (c) Conditions of use. (1) The drug is mg/lb (0.1 mg/kg) body weight once used in female dogs for the postpone- daily.

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(2) Indications for use. For the control insecticides may be necessary for ade- of pain and inflammation associated quate control of adult fleas. with osteoarthritis. [65 FR 20730, Apr. 18, 2000] (3) Limitations. Federal law restricts this drug to use by or on the order of a § 520.1408 Methylprednisolone tablets. licensed veterinarian. (a) Specifications. Each table contains [68 FR 42968, July 21, 2003, as amended at 69 1, 2, or 4 milligrams of FR 69523, Nov. 30, 2004] methylprednisolone. (b) Sponsor. See No. 000009 in § 520.1380 Methocarbamol tablets. § 510.600(c) of this chapter for use of 1- and 4-milligram tablets; see No. 000010 (a) Chemical name. 3-(O- for use of 1- and 2-milligram tablets. Methoxyphenoxy)-1,2-propanediol 1- (c) NAS/NRC status. The conditions of carbamate. use have been NAS/NRC reviewed and (b) Specifications. Each tablet con- found effective. NADA’s for approval of tains 500 milligrams of methocarbamol. drugs for these conditions of use need (c) Sponsor. See No. 000856 in not include effectiveness data specified § 510.600(c) of this chapter. by § 514.111 of this chapter, but may re- (d) Conditions of use. (1) The drug is quire bioequivalency and safety infor- administered to dogs and cats as an ad- mation. junct to therapy for acute inflam- (d) Special consideration. (1) Clinical matory and traumatic conditions of and experimental data have dem- the skeletal muscles in order to reduce onstrated that corticosteroids adminis- muscular spasms. tered orally or parenterally to animals (2) Dosage is based upon severity of may induce the first stage of parturi- symptoms and response noted. The tion when administered during the last usual initial dose in 60 milligrams per trimester of pregnancy and may pre- pound of body weight in two or three cipitate premature parturition fol- equally divided doses followed by 30 to lowed by dystocia, fetal death, retained 60 milligrams per pound of body weight placenta, and metritis. (2) Systemic therapy with each following day, usually not to ex- methylprednisolone is contraindicated ceed 14 to 21 days. in animals with arrested tuberculosis, (3) For use only by or on the order of peptic ulcer, acute psychoses, or a licensed veterinarian. cushingoid syndrome. The presence of [40 FR 13838, Mar. 27, 1975, as amended at 67 active tuberculosis, diabetes, FR 67521, Nov. 6, 2002] osteoporosis, chronic psychotic reac- tions, predisposition to § 520.1390 (S)-methoprene. thrombophlebitis, hypertension, con- (a) Specifications. Each capsule con- gestive heart failure, or renal insuffi- tains 154, 308, or 462 milligrams (mg) of ciency necessitates carefully con- (S)-methoprene. trolled use of corticosteroids. Some of these conditions occur only rarely in (b) Sponsor. See No. 011536 in dogs and cats but should be kept in § 510.600(c) of this chapter. mind. (c) [Reserved] (3) Anti-inflammatory action of (d) Conditions of use—(1) Amount. Cap- corticosteroids may mask signs of in- sules are given orally, once per week at fection. the recommended minimum dosage of (e) Conditions of use—(1) Amount. Dogs 10 mg of (S)-methoprene per pound of and cats: 5 to 15 pounds, 2 milligrams; body weight (22 mg/kilograms). 15 to 40 pounds, 2 to 4 milligrams; 40 to (2) Indications for use. For oral use in 80 pounds, 4 to 8 milligrams. dogs, 9 weeks of age and older and 4 (2) Indications for use. For use in dogs pounds body weight or greater, for the and cats as an anti-inflammatory prevention and control of flea popu- agent. lations. (S)-methoprene prevents and (3) Limitations. Administer total daily controls flea populations by preventing dose orally in equally divided doses 6 to the development of flea eggs but does 10 hours apart until response is noted not kill adult fleas. Concurrent use of or 7 days have elapsed. When response

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is attained, dosage should be gradually apart, with a light feeding. When re- reduced until maintenance level is sponse is attained, dosage should be achieved. Hazardous for human use. gradually reduced until maintenance Federal law restricts this drug to use level is achieved. Do not administer to by or on the order of a licensed veteri- cats. Do not overdose. Federal law re- narian. stricts this drug to use by or on the order of a licensed veterinarian. [47 FR 52697, Nov. 23, 1982, as amended at 49 FR 20810, May 17, 1984; 50 FR 32844, Aug. 15, [48 FR 21566, May 13, 1983] 1985; 53 FR 40727, Oct. 18, 1988; 62 FR 35076, June 30, 1997] § 520.1422 Metoserpate hydrochloride. § 520.1409 Methylprednisolone, aspirin (a) Chemical name. Methyl-o-methyl- tablets. 18-epireserpate hydrochloride. (a) Specifications. Each tablet con- (b) Sponsor. See No. 000003 in tains 0.5 milligram of § 510.600(c) of this chapter. methylprednisolone and 300 milligrams (c) Related tolerances. See § 556.410 of of aspirin. this chapter. (b) Sponsor. See No. 000009 in (d) Conditions of use. It is used in § 510.600(c) of this chapter. drinking water for replacement chick- (c) NAS/NRC status. The conditions of ens as follows: use have been NAS/NRC reviewed and (1) Amount. 568.5 milligrams per gal- found effective. New animal drug appli- lon (0.015 percent). cations for approval of drugs for these (i) Indications for use. As a tranquil- conditions of use need not include ef- izer for flock treatment of chickens fectiveness data specified by § 514.111 of prior to handling. this chapter, but may require bio- (ii) Limitations. To be used one time equivalency and safety information. as a treatment for replacement chick- (d) Special considerations. (1) Clinical ens up to 16 weeks of age; usual drink- and experimental data have dem- ing water should be withheld prior to onstrated that corticosteroids adminis- treatment to provide adequate con- tered orally or parenterally to animals sumption of medicated drinking water; may induce the first stage of parturi- not for use in laying chickens; chick- tion when administered during the last ens slaughtered within 72 hours fol- trimester of pregnancy and may pre- lowing treatment must not be used for cipitate premature parturition fol- food. lowed by dystocia, fetal death, retained (2) Amount. 2 to 4 milligrams per 2.2 placenta, and metritis. pounds of body weight. (2) Systemic therapy with (i) Indications for use. As an aid in methylprednisolone is contraindicated control of hysteria. in animals with tuberculosis, chronic (ii) Limitations. To be used as a treat- nephritis, peptic ulcer, or Cushingoid ment for replacement chickens up to 16 syndrome. The presence of diabetes weeks of age; usual drinking water mellitus, osteoporosis, predisposition should be withheld prior to treatment to thrombophlebitis, hypertension, to provide adequate consumption of congestive heart failure, or renal insuf- medicated drinking water; the drug ficiency necessitates carefully con- should be administered at a dosage trolled use of corticosteroids. level of 4 milligrams per 2.2 pounds of (3) Anti-inflammatory action of body weight followed by 2 treatments corticosteroids may mask signs of in- at 4-day intervals of 2 milligrams per fection. 2.2 pounds of body weight; not for use (e) Conditions of use—(1) Amount. Dogs in laying chickens; chickens slaugh- under 15 pounds, 1⁄4 to 1 tablet daily; 15 tered within 72 hours following treat- to 60 pounds, 1 to 2 tablets daily; 60 ment must not be used for food. pounds and over, 2 tablets daily. (2) Indications for use. As an anti-in- § 520.1430 Mibolerone. flammatory and analgesic agent in (a) Specifications. Each milliliter con- dogs. tains 100 micrograms of mibolerone. (3) Limitations. Administer total daily (b) Sponsor. See No. 000009 in dose in divided doses 6 to 10 hours § 510.600(c) of this chapter.

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(c) Conditions of use—(1) Amount. 30 once a month. First dose given within micrograms for animals weighing 1 to 1 month after first exposure to mosqui- 25 pounds; 60 micrograms for animals toes and continue regular use until at weighing 26 to 50 pounds; 120 least 1 month after end of mosquito micrograms for animals weighing 51 to season. Federal law restricts this drug 100 pounds; 180 micrograms for animals to use by or on the order of a licensed weighing over 100 pounds, German veterinarian. Shepherds, or German Shepherd mix. (2) Cats and kittens—(i) Amount. 0.91 (2) Indications for use. For the preven- milligram per pound of body weight (2.0 tion of estrus (heat) in adult female milligrams per kilogram). dogs not intended primarily for breed- (ii) Indications for use. For prevention ing purposes. of heartworm disease caused by (3) Limitations. Administer daily, Dirofilaria immitis and the removal of orally or in a small amount of food, at adult Toxocara cati (roundworm) and least 30 days before expected initiation Ancylostoma tubaeforme (hookworm) in- of heat, and continue daily as long as fections in cats 6 weeks of age or great- desired, but not for more than 24 er and 1.5 pounds body weight or great- months. Mibolerone should not be used er. in bitches before the first estrous pe- (iii) Limitations. Do not use in kittens riod. It is not intended for animals less than 6 weeks of age or 1.5 pounds being used primarily for breeding pur- body weight. Administer once a month. poses. Use orally in adult female dogs Federal law restricts this drug to use only. Federal law restricts this drug to by or on the order of a licensed veteri- use by or on the order of a licensed vet- narian. erinarian. [55 FR 25301, June 21, 1990, as amended at 55 [43 FR 15625, Apr. 14, 1978] FR 49888, Dec. 3, 1990; 58 FR 5608, Jan. 22, 1993; 60 FR 50097, Sept. 28, 1995; 61 FR 43654, § 520.1445 Milbemycin oxime tablets. Aug. 26, 1996; 63 FR 29352, May 29, 1998; 63 FR (a) Specifications—(1) Dogs. Each tab- 41189, Aug. 3, 1998] let contains 2.3, 5.75, 11.5, or 23.0 milli- grams of milbemycin oxime. § 520.1446 Milbemcyin oxime and (2) Cats. Each tablet contains 5.75, lufenuron tablets. 11.5, or 23.0 milligrams of milbemycin (a) Specifications—(1) Tablets con- oxime. taining: 2.3 milligrams (mg) (b) Sponsor. See 058198 in § 510.600(c) of milbemycin oxime and 46 mg this chapter. lufenuron, 5.75 mg milbemycin oxime (c) [Reserved] and 115 mg lufenuron, 11.5 mg (d) Conditions of use—(1) Dogs and milbemycin oxime and 230 mg puppies—(i) Amount. For hookworm, lufenuron, or 23 mg milbemycin oxime roundworm, and whipworm, use 0.23 and 460 mg lufenuron. milligram per pound of body weight (0.5 (2) Flavored tablets containing: 2.3 milligram per kilogram). For heart- mg milbemycin oxime and 46 mg worm, use 0.05 milligram per pound of lufenuron, 5.75 mg milbemycin oxime body weight (0.1 milligram per kilo- and 115 mg lufenuron, 11.5 mg gram). milbemycin oxime and 230 mg (ii) Indications for use. For prevention lufenuron, or 23 mg milbemycin oxime of heartworm disease caused by and 460 mg lufenuron. Dirofilaria immitis, control of hookworm (b) Sponsor. See No. 058198 in infections caused by Ancylostoma § 510.600(c) of this chapter. caninum, and removal and control of (c) [Reserved] adult roundworm infections caused by (d) Conditions of use—(1) Dogs—(i) Toxocara canis and Toxascaris leonina Amount. 0.5 mg milbemycin oxime and and whipworm infections caused by 10 mg lufenuron per kilogram of body Trichuris vulpis in dogs and in puppies 4 weight, once a month. weeks of age or greater and 2 pounds of (ii) Indications for use—(A) For use in body weight or greater. dogs and puppies for the prevention of (iii) Limitations. Do not use in puppies heartworm disease caused by Dirofilaria less than 4 weeks of age and less than immitis, for prevention and control of 2 pounds of body weight. Administer flea populations, for control of adult

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Ancylostoma caninum (hookworm), and erals containing salt. Do not allow for removal and control of adult horses or other equines access to for- Toxocara canis, Toxascaris leonina mulations containing monensin (inges- (roundworm), and Trichuris vulpis tion of monensin by equines has been (whipworm) infections. fatal). The effectiveness of this block (B) The concurrent use of flavored in cull cows and bulls has not been es- milbemycin oxime and lufenuron tab- tablished. lets described in paragraph (a)(2) of (b) [Reserved] this section as in paragraph (d)(1)(ii)(A) (c)(1) Specifications. Each pound of of this section with nitenpyram tablets protein block contains 175 milligrams as in § 520.1510(d)(1) of this chapter is of monensin (0.038 percent) as indicated to kill adult fleas and pre- monensin sodium. vent flea eggs from hatching. (2) Sponsor. See 021676 in § 510.600(c) of (iii) Limitations. Federal law restricts this chapter. this drug to use by or on the order of a (3) Related tolerances. See § 556.420 of licensed veterinarian. this chapter. (2) [Reserved] (4) Conditions of use—(i) Amount. 40 to 200 milligrams of monensin (0.25 to 1.13 [62 FR 28629, May 27, 1997, as amended at 63 FR 41190, Aug. 3, 1998; 68 FR 51905, Aug. 29, pounds or 4 to 18 ounces of block) per 2003] head per day. (ii) Indications for use. Increased rate § 520.1448 Monensin oral dosage forms. of weight gain. Monensin, as the base or the sodium (iii) Limitations. Blocks to be fed free salt, contains a minimum of 90 percent choice to pasture cattle (slaughter, monensin activity derived from stocker, and feeder). Provide at least 1 monensin A and a minimum of 95 per- block per 4 head of cattle. Do not allow cent derived from monensin A plus B. cattle access to salt or mineral while Using thin layer chromatography, the being fed this product. Ingestion by R value must be comparable to a ref- cattle of monensin at levels of 600 mil- f ligrams per head per day and higher erence standard (the Rf value is the dis- tance the spots travel from the start- has been fatal. Do not allow horses or ing line divided by the distance the sol- other equines access to formulations vent front travels from the starting containing monensin (ingestion of line). The loss on drying is not more monensin by equines has been fatal). than 10 percent when dried in vacuum Block’s effectiveness in cull cows and at 60 °C for 2 hours. bulls has not been established. (d)(1) Specifications. Each pound of [55 FR 3586, Feb. 2, 1990] block contains 400 milligrams of monensin (0.088 percent) as monensin § 520.1448a Monensin blocks. sodium. (a)(1) Specifications. Each pound of (2) Sponsor. See 051267 in § 510.600(c) of protein-mineral block contains 400 mil- this chapter. ligrams of monensin (0.088 percent) as (3) Related tolerances. See § 556.420 of monensin sodium. this chapter. (2) Sponsor. See 067949 in § 510.600(c) of (4) Conditions of use—(i) Amount. 50 to this chapter. 200 milligrams of monensin (2 to 8 (3) Related tolerances. See § 556.420 of ounces of block) per head per day. this chapter. (ii) Indications for use. Pasture cattle: (4) Conditions of use—(i) Amount. 80 to Increased rate of weight gain. 200 milligrams of monensin (0.2 to 0.5 (iii) Limitations. Blocks to be fed free pound of block) per head per day. choice to pasture cattle (slaughter, (ii) Indications for use. Increased rate stocker, feeder, and dairy and beef re- of weight gain. placement heifers). Provide at least (iii) Limitations. Block to be fed free one block per five head of cattle. Feed choice to pasture cattle (slaughter, blocks continously. Do not feed salt or stocker, feeder, and dairy and beef re- mineral supplements in addition to the placement heifers). Provide at least 1 blocks. Ingestion by cattle of monensin block per 5 head of cattle. Feed blocks at levels of 600 milligrams per head per continuously. Do not feed salt or min- day and higher has been fatal. Do not

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allow horses or other equines access to ethylene diffusing discs and containing formulations containing monensin (in- a morantel tartrate paste. The paste gestion of monensin by equines has contains 22.7 grams of morantel tar- been fatal). The effectiveness of this trate equivalent to 13.5 grams of block in cull cows and bulls has not morantel base. been established. (b) Sponsor. See No. 000069 in [46 FR 19466, Mar. 31, 1981] § 510.600(c) of this chapter. (c) Related tolerances. See § 556.425 of EDITORIAL NOTE: For FEDERAL REGISTER ci- tations affecting § 520.1448a, see the List of this chapter. CFR Sections Affected, which appears in the (d) Conditions of use—(1) Amount. Finding Aids section of the printed volume Grazing cattle: Administer 1 cartridge and on GPO Access. to each animal at the start of the graz- ing season. § 520.1450 Morantel tartrate oral dos- (2) Indications for use. For control of age forms. the adult stage of the following gastro- § 520.1450a Morantel tartrate bolus. intestinal nematode infections in weaned calves and yearling cattle (a) Specifications. Each bolus contains weighing a minimum of 200 pounds: 2.2 grams morantel tartrate equivalent Ostertagia spp., Trichostrongylus axei, to 1.3 grams of morantel base. Cooperia spp., and Oesophagostomum (b) Sponsor. See No. 000069 in radiatum. § 510.600(c) of this chapter. (3) Limitations. Administer orally (c) Related tolerances. See § 556.425 of with the dosing gun to all cattle that this chapter. will be grazing the same pasture. Effec- (d) Conditions of use—(1) Amount. One tiveness of the drug product is depend- bolus per 500 pounds of body weight (4.4 ent upon continuous control of the gas- milligrams per pound of body weight) trointestinal parasites for approxi- as a single oral dose. Boluses may be mately 90 days following administra- divided in half for more accurate dos- tion. Therefore, treated cattle should ing as follows: up to 325 pounds, 1⁄2 not be moved to pastures grazed in the bolus; 326 to 600 pounds, 1 bolus; 601 to same grazing season/calendar year by 900 pounds, 11⁄2 boluses; and 901 to 1,200 untreated cattle. Do not administer to pounds, 2 boluses. cattle within 106 days of slaughter. (2) Indications for use. For removal and control of mature gastrointestinal Consult your veterinarian before ad- nematode infections of cattle including ministering to severely debilitated ani- mals and for assistance in the diag- stomach worms (Haemonchus spp., nosis, treatment, and control of para- Ostertagia spp., Trichostrongylus spp.), sitism. worms of the small intestine (Cooperia spp., Trichostrongylus spp., Nematodirus [49 FR 47831, Dec. 7, 1984, as amended at 51 spp.), and worms of the large intestine FR 23415, June 27, 1986; 51 FR 41081, Nov. 13, (Oesophagostomum radiatum). 1986] (3) Limitations. Conditions of constant worm exposure may require retreat- § 520.1450c Morantel tartrate sus- ment in 2 to 4 weeks. Consult your vet- tained-release trilaminate cylinder/ erinarian before administering to se- sheet. verely debilitated animals and for as- (a) Specifications. The drug product sistance in the diagnosis, treatment, consists of a trilaminated, perforated, and control of parasitism. Do not treat plastic sheet formed into a cylinder within 14 days of slaughter. having plastic plugs in its ends. The core lamina contains 19.8 grams of [46 FR 50949, Oct. 16, 1981. Redesignated at 49 FR 47831, Dec. 7, 1984, and amended at 51 FR morantel tartrate equivalent to 11.8 9005, Mar. 17, 1986] grams of morantel base. (b) Sponsor. See 000069 in § 510.600(c) of § 520.1450b Morantel tartrate car- this chapter. tridge. (c) Related tolerances. See § 556.425 of (a) Specifications. The drug product this chapter. consists of a stainless-steel cylinder (d) Conditions of use—(1) Amount. having both ends closed with poly- Grazing cattle: Administer 1 cartridge

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to each animal at the start of the graz- (c) Special considerations. See § 500.25 ing season. of this chapter. (2) Indications for use. For control of (d) Conditions of use in horses and the adult stage of the following gastro- ponies—(1) Amount. 0.4 milligram intestinal nematode infections in moxidectin per kilogram (2.2 pounds) of weaned calves and yearling cattle body weight. weighing a minimum of 200 pounds: (2) Indications for use. For the treat- Ostertagia spp., Trichostrongylus axei, ment and control of large strongyles: Cooperia spp., and Oesophagostomum Strongylus vulgaris (adults and L4/L5 ar- radiatum. terial stages), S. edentatus (adult and (3) Limitations. Administer orally tissue stages), Triodontophorus with the dosing gun to all cattle that brevicauda (adults), and T. serratus will be grazing the same pasture. Effec- (adults); small strongyles (adults): tiveness of the drug product is depend- Cyathostomum spp., including C. ent upon continuous control of the gas- catinatum and C. pateratum; trointestinal parasites for approxi- Cylicocyclus. spp., including C. insigne, mately 90 days following administra- C. leptostomum, and C. nassatus; tion. Therefore, treated cattle should Cyliocostephanus. spp., including C. not be moved to pastures grazed in the calicatus, C. goldi, C. longibursatus, and same grazing season/calendar year by C. minutus; Coronocyclus spp., including untreated cattle. Do not administer to C. coronatus, C. labiatus, and C. labratus; cattle within 102 days of slaughter. and Gyalocephalus capitatus; small Consult your veterinarian before ad- strongyles: undifferentiated lumenal ministering to severely debilitated ani- larvae; encysted cyathostomes (late L3 mals and for assistance in the diag- and L4 mucosal cyathostome larvae); nosis, treatment, and control of para- ascarids: Parascaris equorum (adults and sitism. L4 larval stages); pinworms: Oxyuris equi (adults and L4 larval stages); [56 FR 13396, Apr. 2, 1991] hairworms: Trichostrongylus axei (adults); large-mouth stomach worms: § 520.1451 Moxidectin. Habronema muscae (adults); and horse (a) Specifications. Each tablet con- stomach bots: Gasterophilus intestinalis tains 30, 68, or 136 micrograms of (2nd and 3rd instars) and G. nasalis (3rd moxidectin. instars). One dose also suppresses (b) Sponsor. See No. 000856 in strongyle egg production for 84 days. § 510.600(c) of this chapter. (3) Limitations. For oral use in horses (c) [Reserved] and ponies 6 months of age and older. (d) Conditions of use—(1) Amount. 3 Not for use in horses and ponies in- micrograms per kilogram (1.36 tended for food. micrograms per pound) of body [62 FR 42902, Aug. 11, 1997, as amended at 64 weight.– FR 66105, Nov. 24, 1999; 68 FR 51445, Aug. 27, (2) Indications for use. To prevent in- 2003; 69 FR 24959, May 5, 2004] fection by the canine heartworm Dirofilaria immitis and the subsequent § 520.1453 Moxidectin and development of canine heartworm dis- praziquantel gel. ease. (a) Specifications. Each milliliter of (3) Limitations. Use once-a-month in gel contains 20 milligrams (mg) (2.0 dogs at 8 weeks of age or older. Federal percent) moxidectin and 125 mg (12.5 law restricts this drug to use by or on percent) praziquantel. the order of a licensed veterinarian. (b) Sponsor. See No. 000856 in § 510.600(c) of this chapter. [62 FR 37713, July 15, 1997] (c) Special considerations. See § 500.25 of this chapter. § 520.1452 Moxidectin gel. (d) Conditions of use in horses and (a) Specifications. Each milliliter of ponies—(1) Amount. Administer by gel contains 20 milligrams (2 percent) mouth as a single dose: 0.4 mg moxidectin. moxidectin per kilogram and 2.5 mg (b) Sponsor. See No. 000856 in praziquantel per kilogram (2.2 pounds) § 510.600(c) of this chapter. body weight.

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(2) Indications for use. For the treat- (ii) For oral dosage only, administer ment and control of large strongyles: 10 milligrams naproxen per kilogram of Strongylus vulgaris (adults and L4/L5 ar- animal body weight twice daily as a terial stages), S. edentatus (adult and top dressing in the animal’s feed for up tissue stages), Triodontophorus to 14 consecutive days. brevicauda (adults), and T. serratus (3) Not for use in horses intended for (adults); small strongyles (adults): food. (Cyathostomum spp., including C. (4) Federal law restricts this drug to catinatum and C. pateratum; Cylicocyclus use by or on the order of a licensed vet- spp., including C. insigne, C. erinarian. leptostomum, and C. nassatus; [41 FR 14188, Apr. 2, 1976, as amended at 51 Cylicostephanus spp., including C. FR 24525, July 7, 1986; 61 FR 5506, Feb. 13, calicatus, C. goldi, C. longibursatus, and 1996] C. minutus; Coronocyclus spp., including C. coronatus, C. labiatus, and C. labratus; § 520.1484 Neomycin sulfate soluble and Gyalocephalus capitatus; small powder. strongyles: undifferentiated lumenal (a) Specifications. Each ounce of pow- larvae; encysted cyathostomes (late L3 der contains 20.3 grams of neomycin and L4 mucosal cyathostome larvae); sulfate (equivalent to 14.2 grams of ne- ascarids: Parascaris equorum (adults and omycin base). L4 larval stages); pinworms: Oxyuris (b) Sponsors. See sponsors in equi (adults and L4 larval stages); § 510.600(c) of this chapter for use as in hairworms: Trichostrongylus axei paragraph (d) of this section. (adults); large-mouth stomach worms: (1) Nos. 000069 and 051259 for use as in Habronema muscae (adults); horse stom- paragraph (d)(1) of this section. ach bots: Gasterophilus intestinalis (2nd (2) Nos. 000009, 046573, and 061623 for and 3rd instars) and G. nasalis (3rd use as in paragraphs (d)(1) and (d)(2) of instars); and tapeworms: Anoplocephala this section. perfoliata (adults). One dose also sup- (c) Related tolerances. See § 556.430 of presses strongyle egg production for 84 this chapter. days. (d) Conditions of use—(1) Cattle (ex- (3) Limitations. For oral use in horses cluding veal calves), swine, sheep, and and ponies 6 months of age and older. goats. Not for use in horses and ponies in- (i) Amount. 10 milligrams of neomy- tended for food. cin sulfate per pound of body weight per day (22 milligrams per kilogram) in [68 FR 51446, Aug. 27, 2003, as amended at 69 divided doses for a maximum of 14 FR 21956, Apr. 23, 2004] days. § 520.1468 Naproxen granules. (ii) Indications for use. For the treat- ment and control of colibacillosis (bac- (a) Specifications. Naproxen granules terial enteritis) caused by Escherichia contain 50 percent naproxen. coli susceptible to neomycin sulfate in (b) Sponsor. No. 000856 in § 510.600(c) of cattle (excluding veal calves), swine, this chapter. sheep, and goats. (c) Conditions of use—(1) Horses. The (iii) Limitations. Add to drinking drug is used for the relief of inflamma- water or milk; not for use in liquid sup- tion and associated pain and lameness plements. Prepare a fresh solution exhibited with arthritis, as well as my- daily. If symptoms persist after using ositis and other soft tissue diseases of this preparation for 2 or 3 days, consult the musculoskeletal system of the a veterinarian. Treatment should con- horse. tinue 24 to 48 hours beyond remission (2)(i) For oral maintenance therapy of disease symptoms, but not to exceed following initial intravenous dosage, a total of 14 consecutive days. Dis- administer 10 milligrams naproxen per continue treatment prior to slaughter kilogram of animal body weight twice as follows: Cattle (not for use in veal daily as top dressing in the animal’s calves), 1 day; sheep, 2 days; swine and feed for up to 14 consecutive days. The goats, 3 days. initial intravenous dosage is 5 milli- (2) Turkeys—(i) Amount. 10 milligrams grams per kilogram of body weight. of neomycin sulfate per pound of body

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weight per day (22 milligrams per kilo- § 520.1498 Nitazoxanide paste. gram) for 5 days. (a) Specifications. Each milligram (ii) Indications for use. For the control (mg) of paste contains 0.32 mg of mortality associated with E. coli or- nitazoxanide. ganisms susceptible to neomycin sul- (b) Sponsor. See No. 065274 in fate in growing turkeys. § 510.600(c) of this chapter. (iii) Limitations. Add to drinking (c) Conditions of use in horses—(1) water; not for use in liquid supple- Amount. On days 1 through 5, admin- ments. Prepare a fresh solution daily. ister 11.36 mg per pound (/lb) body If symptoms persist after using this weight; on days 6 through 28, admin- preparation for 2 or 3 days, consult a ister 22.72 mg/lb body weight. veterinarian. Treatment should con- tinue 24 to 48 hours beyond remission (2) Indications for use—For the treat- of disease symptoms, but not to exceed ment of equine protozoal a total of 5 consecutive days. myeloencephalitis (EPM) caused by Sarcocystis neurona. [64 FR 31497, June 11, 1999, as amended at 66 (3) Limitations. Federal law restricts FR 14073, Mar. 9, 2001; 67 FR 72366, Dec. 5, this drug to use by or on the order of a 2002; 67 FR 78971, Dec. 27, 2002; 68 FR 4914, licensed veterinarian. Jan. 31, 2003] [69 FR 500, Jan. 6, 2004] § 520.1485 Neomycin sulfate oral solu- tion. § 520.1510 Nitenpyram tablets. (a) Specifications. Each milliliter con- (a) Specifications. Each tablet con- tains 200 milligrams of neomycin sul- tains 11.4 or 57 milligrams (mg) fate (equivalent to 140 milligrams of nitenpyram. neomycin base). (b) Sponsor. See No. 058198 in (b) Sponsors. See Nos. 000009, 051259, § 510.600(c) of this chapter. and 059130 in § 510.600(c) of this chapter. (c) Special considerations. The concur- (c) Related tolerances. See § 556.430 of rent use of nitenpyram tablets and fla- this chapter. vored milbemycin/lufenuron tablets as (d) Conditions of use—(1) Amount. 10 in paragraph (d)(1)(ii)(B) of this section milligrams of neomycin sulfate per shall be by or on the order of a licensed pound of body weight per day in di- veterinarian. vided doses for a maximum of 14 days. (d) Conditions of use—(1) Dogs—(i) (2) Indications for use. For the treat- Amount—(A) One 11.4-mg tablet for ment and control of colibacillosis (bac- dogs weighing less than 25 pounds (lb) terial enteritis) caused by Escherichia or one 57-mg tablet for dogs weighing coli susceptible to neomycin in cattle more than 25 lb, as needed, for use as in (excluding veal calves), swine, sheep, paragraph (d)(1)(ii)(A) of this section. and goats. (B) One 11.4-mg tablet for dogs weigh- (3) Limitations. Administer undiluted ing less than 25 lb or one 57 mg tablet or in drinking water. Prepare a fresh for dogs weighing more than 25 lbs, solution daily. If symptoms persist once or twice weekly, for use as in after using this preparation for 2 or 3 paragraph (d)(1)(ii)(B) of this section. days, consult a veterinarian. Treat- (ii) Indications for use—(A) For the ment should continue 24 to 48 hours be- treatment of flea infestations on dogs yond remission of disease symptoms, and puppies 4 weeks of age and older but not to exceed a total of 14 consecu- and 2 lbs of body weight or greater. tive days. Discontinue treatment prior (B) The concurrent use of nitenpyram to slaughter as follows: 1 day for cat- tablets as in paragraph (d)(1)(i)(B) of tle, 2 days for sheep, and 3 days for this section with either flavored swine and goats. lufenuron tablets as in § 520.1288(c)(1) of this chapter or flavored milbemycin [58 FR 38972, July 21, 1993, as amended at 60 FR 3079, Jan. 13, 1995; 61 FR 31398, June 20, and lufenuron tablets as in 1996; 62 FR 60657, Nov. 12, 1997; 63 FR 45944, § 520.1446(d)(1) of this chapter is indi- Aug. 28, 1998; 65 FR 45877, July 26, 2000; 65 FR cated to kill adult fleas and prevent 53581, Sept. 5, 2000] flea eggs from hatching.

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(2) Cats—(i) Amount—(A) One 11.4-mg (b) Sponsor. See No. 000061 in tablet, as needed, for use as in para- § 510.600(c) of this chapter. graph (d)(2)(ii)(A) of this section. (c) [Reserved] (B) One 11.4-mg tablet, once or twice (d) Conditions of use—(1) Dogs and weekly, for use as in paragraph cats—(i) Amount. 2.5 to 7.5 milligrams (d)(2)(ii)(B) of this section. per kilogram body weight. (ii) Indications for use—(A) For the (ii) Indications for use. For manage- treatment of flea infestations on cats ment of diseases associated with bac- and kittens 4 weeks of age and older teria susceptible to orbifloxacin. and 2 lbs of body weight or greater. (iii) Limitations. Administer orally (B) The concurrent use of nitenpyram once daily for 2 to 3 days beyond ces- tablets as in paragraph (d)(2)(i)(B) of sation of clinical signs for up to a max- this section with flavored lufenuron imum of 30 days. If no improvement is tablets as in § 520.1288(c)(2) of this chap- seen within 5 days, diagnosis should be ter is indicated to kill adult fleas and reevaluated and a different course of prevent flea eggs from hatching. therapy considered. Orbifloxacin is contraindicated in immature dogs and [68 FR 51906, Aug. 29, 2003] cats during the rapid growth phase. § 520.1615 Omeprazole. Orbifloxacin and other quinolones have been shown to cause arthropathy in (a) Specifications. Each gram of paste immature animals of most species. contains 0.37 gram omeprazole. Federal law restricts this drug to use (b) Sponsor. See No. 050604 in by or on the order of a licensed veteri- § 510.600(c) of this chapter. narian. (c) Special considerations. When la- (2) [Reserved] beled for use as in paragraph (d)(2)(i) of this section, product labeling shall [62 FR 29012, May 29, 1997, as amended at 62 bear: ‘‘Federal law restricts this drug FR 61627, Nov. 19, 1997] to use by or on the order of a licensed § 520.1628 Oxfendazole powder and veterinarian.’’ pellets. (d) Conditions of use in horses—(1) Amount—(i) For treatment of gastric (a) Specifications—(1) Powder for sus- ulcers, 1.8 milligrams per pound (mg/lb) pension. Each gram of powder contains of body weight (4 milligrams per kilo- 7.57 percent oxfendazole. gram (mg/kg)) once daily for 4 weeks. (2) Pellets. Each gram of pellets con- For prevention of recurrence of gastric tains 6.49 percent oxfendazole. ulcers, 0.9 mg/lb of body weight (2 mg/ (b) Sponsor. See No. 000856 in kg) once daily for at least an addi- § 510.600(c) of this chapter. tional 4 weeks. (c) Conditions of use—(1) Amount. 10 (ii) For prevention of gastric ulcers milligrams per kilogram of body using the premarked syringe, one dose weight. per day for up to 28 days. Each dose de- (2) Indications for use. The drug is livers at least 1 mg/kg of body weight. used in horses for removal of the fol- Horses over 1,200 lb body weight should lowing gastrointestinal worms: Large receive two doses per day. roundworms (Parascaris equorum), ma- (2) Indications for use. (i) For treat- ture and immature pinworms (Oxyuris ment and prevention of recurrence of equi), large strongyles (Strongylus gastric ulcers in horses and foals 4 edentatus, Strongylus vulgaris, and weeks of age and older. Strongylus equinus), and small (ii) For prevention of gastric ulcers strongyles. in horses. (3) Limitations—(i) Powder for suspen- For gravity administration via (3) Limitations. Do not use in horses sion. intended for human consumption. stomach tube or for positive adminis- tration via stomach tube and dose sy- [69 FR 13220, Mar. 22, 2004] ringe. Discard unused portions of sus- pension after 24 hours. Mix drug ac- § 520.1616 Orbifloxacin tablets. cording to directions prior to use. Ad- (a) Specifications. Each tablet con- minister drug with caution to sick or tains 5.7, 22.7, or 68 milligrams of debilitated horses. Not for use in orbifloxacin. horses intended for food. Federal law

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restricts this drug to use by or on the (Haemonchus contortus and H. placei— order of a licensed veterinarian. adult), small stomach worms (ii) Pellets. The drug is given by sprin- (Trichostrongylus axei—adult), brown kling on the grain portion of the ra- stomach worms (Ostertagia ostertagi— tion. Withholding feed or water prior adult, L4, inhibited L4); intestinal to administration is not necessary. Ad- worms; nodular worms minister drug with caution to sick or (Oesophagostomum radiatum—adult), debilitated horses. Not for use in hookworms (Bunostomum horses intended for food. Consult your phlebotomum—adult), small intestinal veterinarian for assistance in the diag- worms (Cooperia punctata, C. oncophora, nosis, treatment, and control of para- and C. mcmasteri—adult, L4); and tape- sitism. worms (Moniezia benedeni—adult). [44 FR 35211, June 19, 1979, as amended at 46 (iii) Limitations. For use in cattle FR 26301, May 12, 1981; 46 FR 60570, Dec. 11, only. Treatment may be repeated in 4 1981; 49 FR 28549, July 13, 1984; 61 FR 5506, to 6 weeks. Cattle must not be slaugh- Feb. 13, 1996] tered until 11 days after treatment. Do not use in female dairy cattle of breed- § 520.1629 Oxfendazole paste. ing age. Consult a veterinarian for as- (a)(1) Specifications. Each gram of sistance in the diagnosis, treatment, paste contains 0.375 gram oxfendazole and control of parasitism. (37.5 percent). [49 FR 38250, Sept. 28, 1984, as amended at 58 (2) Sponsor. See No. 000856 in FR 39443, July 23, 1993; 61 FR 5506, Feb. 13, § 510.600(c) of this chapter. 1996] (3) Conditions of use—(i) Amount. 10 milligrams per kilogram (2.2 pounds) of § 520.1630 Oxfendazole suspension. body weight. (a) Specifications. Each milliliter con- (ii) Indications for use. The drug is tains 90.6 or 225.0 milligrams used in horses for removal of the fol- oxfendazole (9.06 or 22.5 percent). lowing gastrointestinal worms: Large roundworms (Parascaris equorum), ma- (b) Sponsor. See 000856 in § 510.600(c) of ture and 4th stage larvae pinworms this chapter. (Oxyuris equi), large strongyles (c) Related tolerances. See § 556.495 of (Strongylus edentatus, S. vulgaris, and S. this chapter. equinus), and small strongyles. (d) Conditions of use—(1) Horses (9.06 (iii) Limitations. Horses maintained percent suspension only). on premises where reinfection is likely (i) Amount. 10 milligrams per kilo- to occur should be retreated in 6 to 8 gram (2.2 pounds) of body weight. weeks. Withholding feed or water prior (ii) Indications for use. For removal of to use is unnecessary. Administer drug large roundworms (Parascaris equorum), with caution to sick or debilitated mature and 4th stage larvae pinworms horses. Not for use in horses intended (Oxyuris equi), large strongyles for food. Consult your veterinarian for (Strongylus edentatus, S. vulgaris, and S. assistance in the diagnosis, treatment, equinus), and small strongyles. and control of parasitism. (iii) Limitations. Administer 9.06 per- (b)(1) Specifications. Each gram of cent suspension by stomach tube or paste contains 185 milligrams of dose syringe. Horses maintained on oxfendazole (18.5 percent). premises where reinfection is likely to (2) Sponsor. See No. 000856 in occur should be retreated in 6 to 8 § 510.600(c) of this chapter. weeks. Withholding feed or water prior (3) Related tolerances. See § 556.495 of to use is unnecessary. Administer drug this chapter. with caution to sick or debilitated (4) Conditions of use—(i) Amount. 4.5 horses. Do not use in horses intended milligrams per kilogram of body for food. If administered by stomach weight (2.05 milligrams per pound). tube: Federal law restricts this drug to (ii) Indications for use. The drug is use by or on the order of a licensed vet- used in cattle for the removal and con- erinarian. If administered by dose sy- trol of the following worms: lungworms ringe only: Consult your veterinarian (Dictyocaulus viviparus—adult, L4); for assistance in the diagnosis, treat- stomach worms: barberpole worms ment, and control of parasitism.

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(2) Cattle. (9.06 or 22.5 percent suspen- strongyles (Strongylus edentatus, S. sion). (i) Amount. 4.5 milligrams per vulgaris, and S. equinus); and small kilogram of body weight (2.05 milli- strongyles. grams per pound). (3) Limitations. Horses maintained on (ii) Indications for use. For the re- premises where reinfection is likely to moval and control of: lungworms occur should be retreated in 6 to 8 (Dictyocaulus viviparus—adult, L4); weeks. Withholding feed or water be- stomach worms: barberpole worms fore use is unnecessary. Administer (Haemonchus contortus and H. placei— with caution to sick or debilitated adult), small stomach worms horses. Not for use in horses intended (Trichostrongylus axei—adult), brown for food. Do not administer to mares stomach worms (Ostertagia ostertagi— during the last month of pregnancy. adult, L4, inhibited L4); intestinal Trichlorfon is a cholinesterase inhib- worms; nodular worms itor. Do not use this product in ani- (Oesophagostomum radiatum—adult), mals simultaneously with, or within a hookworms (Bunostomum few days before or after treatment with phlebotomum—adult), small intestinal or exposure to, cholinesterase-inhib- worms (Cooperia punctata, C. oncophora, iting drugs, pesticides, or chemicals. and C. mcmasteri—adult, L4), and tape- Consult your veterinarian for assist- worms (Moniezia benedeni—adult). ance in the diagnosis, treatment, and (iii) Limitations. For use in cattle control of parasitism. only. Administer 9.06 percent suspen- sion orally only with a dose syringe, [50 FR 50291, Dec. 10, 1985, as amended at 61 and 22.5 percent suspension either oral- FR 5506, Feb. 13, 1996] ly with a dose syringe or § 520.1638 Oxibendazole paste. intraruminally with a rumen injector. Treatment may be repeated in 4 to 6 (a) Specifications. The paste contains weeks. Cattle must not be slaughtered 22.7 percent oxibendazole. until 7 days after treatment. Do not (b) Sponsor. See 000069 in § 510.600(c) of use in lactating dairy cattle. For use of this chapter. 9.06 percent suspension orally: Consult (c) Conditions of use in horses—(1) a veterinarian for assistance in the di- Amount. For uses other than for agnosis, treatment, and control of par- threadworms (Strongyloides westeri), 10 asitism. For use of 22.5 percent suspen- milligrams of oxibendazole per kilo- sion orally or intraruminally: Federal gram of body weight; for threadworms law restricts this drug to use by or on (Strongyloides westeri), 15 milligrams the order of a licensed veterinarian. per kilogram. (2) Indications for use. For removal [55 FR 46943, Nov. 8, 1990, as amended at 56 FR 8710, Mar. 1, 1991; 61 FR 5506, Feb. 13, 1996] and control of large strongyles (Strongylus edentatus, S. equinus, S. § 520.1631 Oxfendazole and trichlorfon vulgaris); small strongyles (genera paste. Cylicostephanus, Cylicocyclus, (a) Specifications. Each gram of paste Cyathostomum, Triodontophorus, contains 28.5 milligrams oxfendazole Cylicodontophorus, and Gyalocephalus); and 454.5 milligrams trichlorfon. large roundworms (Parascaris equorum); (b) Sponsor. See 000856 in § 510.600(c) of pinworms (Oxyuris equi) including var- this chapter. ious larval stages; and threadworms (c) Conditions of use—(1) Amount. 2.5 (Strongyloides westeri). milligrams of oxfendazole and 40 milli- (3) Limitations. Administer orally by grams of trichlorfon per kilogram of syringe. Horses maintained on prem- body weight. ises where reinfection is likely to occur (2) Indications for use. The drug is should be re-treated in 6 to 8 weeks. used in horses for removal of bots Not for use in horses intended for food. (Gasterophilus intestinalis, 2nd and 3rd Consult a veterinarian for assistance in instars; G. nasalis, 3rd instar) and the the diagnosis, treatment, and control following gastrointestinal worms: of parasitism. Large roundworms (Parascaris [46 FR 50948, Oct. 16, 1981, as amended at 47 equorum), pinworms (Oxyuris equi), FR 36418, Aug. 20, 1982; 56 FR 50653, Oct. 8, adult and 4th stage larvae; large 1991; 60 FR 55659, Nov. 2, 1995]

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§ 520.1640 Oxibendazole suspension. of oxytetracycline hydrochloride and (a) Specifications. The suspension con- the quantities of carbomycin listed tains 10 percent oxibendazole. refer to the activity of an appropriate (b) Sponsor. See 000069 in § 510.600(c) of standard. this chapter. (d) Related tolerances. See §§ 556.110 (c) Conditions of use in horses—(1) and 556.500 of this chapter. Amount. For use other than (e) Conditions of use. It is used as oxy- threadworms (Strongyloides westeri), 10 tetracycline hydrochloride plus milligrams of oxibendazole per kilo- carbomycin base in drinking water of gram of body weight; for threadworms, chickens as follows: (1) 1.0 gram of oxytetra- 15 milligrams per kilogram of body Amount. cycline and 1.0 gram carbomycin per weight. (2) Indications for use. For removal gallon. (2) As an aid in the and control of large strongyles Indications for use. prevention and treatment of com- (Strongylus edentatus, S. equinus, S. plicated chronic respiratory disease vulgaris); small strongyles (species of (air-sac infection) caused by Myco- the genera Cylicostephanus Cylicocyclus, plasma gallisepticum and secondary bac- Cyathostomum, Triodontophorus, terial organisms associated with chron- Cylicodontophorus, and Gyalocephalus); ic respiratory disease such as E. coli. large roundworms (Parascaris equorum); (3) Limitations. Administer for not pinworms (Oxyuris equi) including var- more than 5 days; not for use in chick- ious larval stages; and threadworms ens producing eggs for human con- (Strongyloides westeri). sumption; withdraw 24 hours before (3) Limitations. Administer by stom- slaughter. ach tube in 3 to 4 pints of warm water, or by top dressing or mixing into a por- § 520.1660b Oxytetracycline hydro- tion of the normal grain ration. Pre- chloride capsules. pare individual doses to ensure that (a) Specifications. The drug is in cap- each animal receives the correct sule form with each capsule containing amount. Horses maintained on prem- 125 or 250 milligrams of oxytetracycline ises where reinfection is likely to occur hydrochloride. Oxytetracycline is the should be re-treated in 6 to 8 weeks. antibiotic substance produced by Not for use in horses intended for food. growth of Streptomyces rimosus or the Federal law restricts this drug to use same antibiotic substance produced by by or on the order of a licensed veteri- any other means. narian. (b) Sponsor. See No. 000069 in [45 FR 78119, Nov. 28, 1980, as amended at 47 § 510.600(c) of this chapter. FR 39812, Sept. 10, 1982; 56 FR 50653, Oct. 8, (c) Conditions of use. (1) It is used in 1991; 60 FR 55659, Nov. 2, 1995] dogs and cats for the treatment of bac- terial pneumonia caused by Brucella § 520.1660 Oxytetracycline. bronchiseptica, tonsilitis caused by Streptococcus hemolyticus, bacterial en- § 520.1660a Oxytetracycline and carbomycin in combination. teritis caused by Escherichia coli, uri- nary tract infections caused by Esch- (a) Specifications. (1) Oxytetracycline: erichia coli, and wound infections The antibiotic substance produced by caused by Staphylococcus aureus. 1 growth of Streptomyces rimosus or the (2) The drug is administered orally to same antibiotic substance produced by dogs and cats at a dosage level of 25–50 any other means. milligrams per pound of body weight (2) Carbomycin: The antibiotic sub- per day in divided doses at 12-hour in- stance produced by growth of tervals. The drug can be used for con- Streptomyces halstedii or the same anti- tinuation of compatible antibiotic biotic substance produced by any other

means. 1 (b) Sponsor. See No. 000069 in These conditions are NAS/NRC reviewed and deemed effective. Applications for these § 510.600(c) of this chapter. uses need not include effectiveness data as (c) Special considerations. The quan- specified by § 514.111 of this chapter, but may tities of oxytetracycline in paragraph require bioequivalency and safety informa- (e) of this section refer to the activity tion.

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therapy following parenteral oxytetra- symptoms have subsided. Treatment cycline administration where rapidly should not exceed 4 consecutive days. attained, sustained antibiotic blood Do not exceed 500 milligrams per 100 levels are required. The duration of pounds of body weight every 12 hours treatment required to obtain favorable (10 milligrams per pound daily). For response will depend to some extent on sponsor 000069: Discontinue treatment 7 the severity and degree of involvement days prior to slaughter. Not for use in and the susceptibility of the infectious lactating dairy cattle. agent. Clinical response to antibiotic [46 FR 32440, June 23, 1981, as amended at 50 therapy usually occurs within 48 to 72 FR 1045, Jan. 9, 1985; 63 FR 70334, Dec. 21, hours. If improvement is not observed 1998] within that period, the diagnosis and course of treatment should be reconsid- § 520.1660d Oxytetracycline hydro- ered. To assure adequate treatment, chloride soluble powder. administration of the drug should con- (a) Specifications. The drug is a solu- tinue for at least 48 hours following fa- ble powder distributed in packets or 1 vorable clinical response. pails having several concentrations of (3) Federal law restricts this drug to oxytetracycline hydrochloride (inde- use by or on the order of a licensed vet- pendent of the various net weights) as 1 erinarian. follows: § 520.1660c Oxytetracycline hydro- (1) Each 18.14 grams of powder con- chloride tablets/boluses. tains 1 gram of oxytetracycline hydro- chloride (OTC HCl) (packets: 4, 6.4, and (a) Specifications. Each tablet or bolus 16 oz.). contains 250, 500, or 1,000 milligrams of oxytetracycline hydrochloride. (2) Each 4.43 grams of powder con- tains 1 gram of OTC HCl (packets: 4 (b) Sponsors. For sponsors in § 510.600(c) of this chapter: See 000010 and 16 oz.). for use of 500 and 1,000 milligram (3) Each 1.32 grams of powder con- boluses. See 000069 for use of 250 and 500 tains 1 gram of OTC HCl (packets: 2.39, milligram tablets. 4.78, and 9.55 oz.; jars: 2.25 lbs.; and (c) Tolerances. See § 556.500 of this pails: 4.5 lbs.). chapter. (4) Each 2.73 grams of powder con- (d) Conditions of use in beef and dairy tains 1 gram of OTC HCl (packets: 2.46 cattle—(1)(i) Amount. 250 milligrams per and 9.87 oz; pail: 3.09 lb). 100 pounds of body weight every 12 (5) Each 4.2 grams of powder contains hours (5 milligrams per pound of body 1 gram of OTC HCl (packets: 3.8 and weight daily in two doses). 15.2 oz; pails: 4.74 and 23.7 lb). (ii) Indications for use. For control of (6) Each 1.32 grams of powder con- bacterial enteritis caused by Salmonella tains 1 gram of OTC HCl (packet: 4.78 typhimurium and Escherichia coli oz.; pail: 5 lb). Each 2.73 grams of pow- (colibacillosis) and bacterial pneu- der contains 1 gram of OTC HCl (pack- monia (shipping fever complex, et: 9.87 oz). pasteurellosis) caused by Pasteurella (7) Each 1.32 grams of powder con- multocida. tains 1 gram of OTC HCl (packet: 4.78 (2)(i) Amount. 500 milligrams per 100 and 9.6 oz.; pails: 2 and 5 lb); each 18.1 pound of body weight every 12 hours (10 grams of powder contains 1 gram of milligrams per pound of body weight OTC HCl (packet: 6.4 oz.; pails: 2 and 5 daily in two doses). lb). (ii) Indications for use. For treatment (8) Each 135.5-gram packet (4.78 of bacterial enteritis caused by Sal- ounce) contains 102.4 grams of OTC monella typhimurium and Escherichia coli HCl. Each 677.5-gram packet (23.9 (colibacillosis) and bacterial pneu- ounce) contains 512 grams of OTC HCl. monia (shipping fever complex, (9) Each 2.73 grams of powder con- pasteurellosis) caused by Pasteurella tains 1 gram of OTC HCl (packets: 9.87 multocida. and, 19.75 oz, and 3.91 lb; pails: 3.09 and (3) Limitations. Dosage should con- 5 lb). tinue until the animal returns to nor- (b) Sponsor. See sponsor numbers in mal and for 24 hours to 48 hours after § 510.600(c) of this chapter as follows:

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(1) No. 000069 for use of OTC HCl con- water. Do not use in birds producing centrations in paragraphs (a)(1), (a)(2), eggs for human consumption. and (a)(3) of this section in chickens, (ii) Turkeys—(A)(1) Amount per gallon. turkeys, swine, cattle, sheep, and 200 to 400 milligrams. honey bees. (2) Indications for use. Control of (2) No. 046573 for use of OTC HCl con- hexamitiasis caused by Hexamita centration in paragraph (a)(4) of this meleagridis susceptible to oxytetra- section in chickens, turkeys, and cycline. swine. (3) Limitations. Prepare a fresh solu- (3) No. 000010 for use of OTC HCl con- tion daily. Administer 7 to 14 days. Not centration in paragraph (a)(5) of this to be used for more than 14 consecutive section in turkeys and chickens. days. Use as sole source of drinking (4) No. 057561 for use of OTC HCl con- water. Do not use in birds producing centration in paragraph (a)(6) of this eggs for human consumption. With- section in chickens, turkeys, and draw 5 days prior to slaughter those swine. products sponsored by Nos. 000069, and (5) No. 059130 for use of OTC HCl con- 059130 in § 510.600(c) of this chapter. centration in paragraph (a)(7) of this Withdraw 4 days prior to slaughter section in chickens, turkeys, swine, those products sponsored by No. 000010. cattle, sheep, and honeybees. Zero-day withdrawal for those products (6) No. 048164 for use of OTC HCl con- sponsored by Nos. 046573, 053389, 057561, centrations in paragraph (a)(8) of this and 061133. section in chickens, turkeys, swine, (B)(1) Amount per gallon. 400 milli- cattle, and sheep. grams. (2) Indications for use. Control of in- (7) No. 061623 for use of OTC HCl con- fectious synovitis caused by Myco- centration in paragraph (a)(9) of this plasma synoviae susceptible to oxytet- section in chickens, turkeys, and racycline. swine. (3) Limitations. Prepare a fresh solu- (c) Related tolerances. See § 556.500 of tion daily. Administer 7 to 14 days. Not this chapter. to be used for more than 14 consecutive (d) Conditions of use. (1) It is used in days. Use as sole source of drinking drinking water as follows: water. Do not use in birds producing (i) Chickens—(A)(1) Amount per gallon. eggs for human consumption. With- 200 to 400 milligrams. draw 5 days prior to slaughter those (2) Indications for use. Control of in- products sponsored by Nos. 000069, and fectious synovitis caused by Myco- 059130 in § 510.600(c) of this chapter. plasma synoviae susceptible to oxytet- Withdraw 4 days prior to slaughter racycline. those products sponsored by No. 000010. (3) Limitations. Prepare a fresh solu- Zero-day withdrawal for those products tion daily. Administer 7 to 14 days. Not sponsored by Nos. 046573, 053389, 057561, to be used for more than 14 consecutive and 061133. days. Use as sole source of drinking (C)(1) Amount. 25 milligrams per water. Do not use in birds producing pound of body weight. eggs for human consumption. (2) Indications for use. Growing tur- (B)(1) Amount per gallon. 400 to 800 keys. Control of complicating bacterial milligrams. organisms associated with bluecomb (2) Indications for use. Control of (transmissible enteritis, coronaviral chronic respiratory disease (CRD) and enteritis) susceptible to oxytetra- air sac infections caused by Myco- cycline. plasma gallisepticum and E. coli suscep- (3) Limitations. Prepare a fresh solu- tible to oxytetracycline; control of tion daily. Administer 7 to 14 days. Not fowl cholera caused by Pasteurella to be used for more than 14 consecutive multocida susceptible to oxytetra- days. Use as sole source of drinking cycline. water. Do not use in birds producing (3) Limitations. Prepare a fresh solu- eggs for human consumption. With- tion daily. Administer 7 to 14 days. Not draw 5 days prior to slaughter those to be used for more than 14 consecutive products sponsored by Nos. 000069, and days. Use as sole source of drinking 059130 in § 510.600(c) of this chapter.

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Withdraw 4 days prior to salughter by E. coli and bacterial pneumonia those products sponsored by No. 000010. (shipping fever complex) caused by P. Zero-day withdrawal for those products multocida susceptible to oxytetra- sponsored by Nos. 046573, 053389, 057561, cycline. and 061133. (C) Limitations. Prepare a fresh solu- (iii) Swine—(A) Amount. 10 milligrams tion daily. Administer up to 14 days. per pound of body weight daily. Do not use for more than 14 consecu- (B) Indications for use. Control and tive days. Use as sole source of oxytet- treatment of bacterial enteritis caused racycline. Withdraw 5 days prior to by Escherichia coli and Salmonella slaughter. choleraesuis and bacterial pneumonia (2) It is used in the food of honey bees caused by Pasteurella multocida suscep- as follows: tible to oxytetracycline. For breeding (i) Amount. 200 milligrams per colony, swine: Control and treatment of lepto- administered via either a 1:1 sugar spirosis (reducing the incidence of syrup (equal parts of sugar and water abortions and shedding of leptospira) weight to weight) or dusting with a caused by Leptospira pomona suscep- powdered sugar mixture. tible to oxytetracycline. (ii) Indications for use. Control and (C) Limitations. Prepare a fresh solu- treatment of American and European tion daily. Use as sole source of OTC. foul brood caused by Bacillus larvae sus- Administer up to 14 days; do not use for ceptible to oxytetracycline. more than 14 consecutive days; with- (iii) Limitations. The drug is adminis- draw zero days prior to slaughter those tered in 3 applications of sugar syrup products sponsored by Nos. 000069 and or 3 dustings at 4- to 5-day intervals. 059130. Administer up to 5 days; do not The drug should be fed early in the use for more than 5 consecutive days; spring or fall and consumed by the bees withdraw zero days prior to slaughter before main honey flow begins to avoid those products sponsored by Nos. contamination of production honey. 046573, 053389, 057561, and 061133. Remove at least 6 weeks prior to main (iv) Calves, beef cattle, and nonlac- honey flow. tating dairy cattle—(A) Amount. 10 milli- [50 FR 32694, Aug. 14, 1985] grams per pound of body weight daily. (B) Indications for use. Control and EDITORIAL NOTE: For FEDERAL REGISTER ci- treatment of bacterial enteritis caused tations affecting § 520.1660d, see the List of by E. coli and bacterial pneumonia CFR Sections Affected, which appears in the Finding Aids section of the printed volume (shipping fever complex) caused by P. and on GPO Access. multocida susceptible to oxytetra- cycline. § 520.1696 Penicillin oral dosage forms. (C) Limitations. Prepare a fresh solu- tion daily. Administer up to 14 days. § 520.1696a Buffered penicillin powder, Do not use for more than 14 consecu- penicillin powder with buffered tive days. Use as sole source of oxytet- aqueous diluent. racycline. Do not administer this prod- (a) Specifications. When reconstituted, uct with milk or milk replacers. Ad- each milliliter contains penicillin G minister 1 hour before or 2 hours after procaine equivalent to 20,000, 25,000, feeding milk or milk replacers. With- 40,000, 50,000, 80,000, or 100,000 units of draw 5 days prior to slaughter. A with- penicillin G. drawal period has not been established (b) Sponsor. [Reserved] for this product in preruminating (c) Related tolerances. See § 556.510 of calves. Do not use in calves to be proc- this chapter. essed for veal. A milk discard period (d) Conditions of use. Chickens—It is has not been established for this prod- used in drinking water as follows: uct in lactating dairy cattle. Do not (1) Amount. 100,000 units per gallon. use in female dairy cattle 20 months of (i) Indications for use. Treatment of age or older. chronic respiratory disease (air-sac in- (v) Sheep—(A) Amount. 10 milligrams fection) and bluecomb (nonspecific in- per pound of body weight daily. fectious enteritis). (B) Indications for use. Control and (ii) Limitations. As penicillin G pro- treatment of bacterial enteritis caused caine; not for use in laying chickens;

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prepare fresh solution daily; withdraw (c) National Academy of Sciences/Na- 1 day before slaughter; as sole source of tional Research Council (NAS/NRC) sta- penicillin. tus. The conditions of use were NAS/ (2) Amount. 50,000 to 100,000 units per NRC reviewed and found effective. Ap- gallon. plications for these uses need not in- (i) Indications for use. Prevention of clude effectiveness data as specified by chronic respiratory disease (air-sac in- § 514.111 of this chapter, but may re- fection) and bluecomb (nonspecific in- quire bioequivalency and safety infor- fectious enteritis). mation. (ii) Limitations. As penicillin G pro- (d) Conditions of use. Dogs and cats— caine; not for use in laying chickens; (1) Amount. 10 to 15 milligrams per prepare fresh solution daily; withdraw pound of body weight every 6 to 8 1 day before slaughter; as sole source of hours. penicillin. (2) Indications for use. Treatment of [57 FR 37326, Aug. 18, 1992] respiratory, urogenital, skin, and soft tissue infections and septicemia caused § 520.1696b Penicillin G potassium in by pathogens susceptible to penicillin drinking water. V potassium. (a) Specifications. When reconstituted, (3) Limitations. Administer orally 1 to each milliliter contains penicillin G 2 hours prior to feeding for maximum potassium equivalent to 20,000, 25,000, absorption. Federal law restricts this 40,000, 50,000, 80,000, or 100,000 units of drug to use by or on the order of a li- penicillin G. censed veterinarian. (b) Sponsors. See Nos. 010515, 046573, 053501, 059130, 059320, and 061623 in [57 FR 37326, Aug. 18, 1992; 57 FR 42623, Sept. § 510.600(c) of this chapter. 15, 1992] (c) Conditions of use. Turkeys—(1) Amount. 1,500,000 units per gallon § 520.1696d Penicillin V potassium tab- lets. drinking water for 5 days. (2) Indications for use. Treatment of (a) Specifications. Each tablet con- erysipelas caused by Erysipelothrix tains penicillin V potassium equivalent rhusiopathiae. to 125 milligrams (200,000 units) or 250 (3) Limitations. Prepare concentrated milligrams (400,000 units) of penicillin stock solution for use with medication V. proportioners fresh every 24 hours. Pre- (b) Sponsors. See Nos. 017144, 050604, pare recommended use levels for grav- and 053501 in § 510.600(c) of this chapter. ity flow watering system fresh every 12 (c) National Academy of Sciences/Na- hours. For best results, treatment tional Research Council (NAS/NRC) sta- should be started at the first sign of in- tus. These conditions of use were NAS/ fection. Discontinue treatment at least NRC reviewed and found effective. Ap- 1 day prior to slaughter. Not for use in plications for these uses need not in- turkeys producing eggs for human con- clude effectiveness data as specified by sumption. § 514.111 of this chapter, but may re- [57 FR 37326, Aug. 18, 1992, as amended at 59 quire bioequivalency and safety infor- FR 42493, Aug. 18, 1994; 60 FR 26359, May 17, mation. 1995; 62 FR 55160, Oct. 23, 1997; 65 FR 10705, (d) Conditions of use. Dogs and Cats— Feb. 29, 2000; 66 FR 14073, Mar. 9, 2001; 68 FR (1) Amount. 10 to 15 milligrams per 4914, Jan. 31, 2003; 68 FR 26204, May 15, 2003; 69 FR 9946, Mar. 3, 2004; 69 FR 41428, July 9, pound of body weight every 6 to 8 2004] hours. (2) Indications for use. Treatment of § 520.1696c Penicillin V potassium for respiratory, urogenital, skin and soft oral solution. tissue infections and septicemia caused (a) Specifications. When reconstituted, by pathogens susceptible to penicillin each milliliter contains 25 milligrams V potassium. (40,000 units) of penicillin V. (3) Limitations. Administer orally 1 to (b) Sponsor. See No. 050604 in 2 hours prior to feeding for maximum § 510.600(c) of this chapter. absorption. Federal law restricts this

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drug to use by or on the order of a li- ally to a maintenance dosage level censed veterinarian. with the lowest dosage maintained at [57 FR 37327, Aug. 18, 1992, as amended at 59 the level capable of producing the de- FR 58775, Nov. 15, 1994] sired clinical response. Not for use in animals intended for food purposes. § 520.1720 Phenylbutazone oral dosage Federal law restricts this drug to use forms. by or on the order of a licensed veteri- narian.1 § 520.1720a Phenylbutazone tablets and boluses. [42 FR 44227, Sept. 2, 1977]

(a) Specifications. Each tablet con- EDITORIAL NOTE: For FEDERAL REGISTER ci- tains 100, 200, or 400 milligrams, or 1 tations affecting § 520.1720a, see the List of gram of phenylbutazone. Each bolus CFR Sections Affected, which appears in the contains 2 or 4 grams of Finding Aids section of the printed volume phenylbutazone. and on GPO Access. (b) Sponsor. See sponsor numbers in § 510.600(c) of this chapter, as follows: § 520.1720b Phenylbutazone granules. (1) No. 000061 for use of 100- or 400- (a) Specifications. The drug is in milligram or 1-gram tablets, or 2- or 4- granular form. It is packaged to con- gram boluses, in dogs and horses. tain either 8 grams of phenylbutazone (2) Nos. 000010 and 059130 for use of per package or 1 gram of 100- or 200- milligrams or 1-gram tab- phenylbutazone per package. lets in dogs and horses. (b) Sponsor. See 000061 in § 510.600(c) (3) Nos. 000856, 058829 and 061623 for for 8-gram package, see 059320 for 1- use of 100-milligram or 1-gram tablets gram package. in dogs and horses. (c) NAS/NRC status. The conditions of (4) No. 055246 for use of 100-milligram tablets in dogs. use have been NAS/NRC reviewed and (5) No. 000143 for use of 1-gram tablets found effective. NADA’s for approval of in horses. drugs for these conditions of use need (c) Conditions of use—(1) Dogs—(i) not include effectiveness data specified Amount. Twenty milligrams per pound by § 514.111 of this chapter, but may re- of body weight daily.1 quire bioequivalency and safety infor- (ii) Indications for use. The drug is mation. used for the relief of inflammatory (d) Conditions of use—(1) Horses—(i) conditions associated with a musculo- Amount. 1 to 2 grams per 500 pounds of skeletal system.1 body weight, not to exceed 4 grams, (iii) Limitations. Administer in three daily, as required. divided doses daily. Do not exceed a (ii) Indications. For the treatment of total daily dose of 800 milligrams re- inflammatory conditions associated gardless of body weight. Administer at with the musculoskeletal system. a relatively high dosage level for the (iii) Limitations. Administer orally by first 48 hours and then reduce gradu- adding to a portion of the usual grain ally to a maintenance dosage level ration. Use a relatively high dose for with the lowest dosage maintained at a the first 48 hours, then gradually re- level capable of producing the desired duce to a maintenance level at the low- clinical response. Federal law restricts est level capable of producing the de- this drug to use by or on the order of a sired clinical response. Treated ani- 1 licensed veterinarian. mals should not be slaughtered for food (2) Horses—(i) Amount. One to two use. Federal law restricts this drug to 1 grams per 500 pounds weight daily. use by or on the order of a licensed vet- (ii) Indications for use. This drug is erinarian. used for the relief of inflammatory conditions associated with the mus- [46 FR 18960, Mar. 27, 1981, as amended at 46 culoskeletal system.1 FR 48642, Oct. 2, 1981; 57 FR 2836, Jan. 24, 1992; (iii) Limitations. Do not exceed a daily 61 FR 8873, Mar. 6, 1996; 62 FR 61625, Nov. 19, dosage of 4 grams per day. Administer 1997; 65 FR 20731, Apr. 18, 2000] at a relatively high dosage level for the first 48 hours and then reduce gradu- 1 See footnote 1 to § 520.1660b.

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§ 520.1720c Phenylbutazone paste. law restricts this drug to use by or on (a) Specifications—(1) Each gram of the order of a licensed veterinarian. paste contains 0.2 grams [50 FR 13561, Apr. 5, 1985, as amended at 50 phenylbutazone. FR 49372, Dec. 2, 1985; 55 FR 8462, Mar. 8, 1990; (2) Each gram of paste contains 0.35 66 FR 14073, Mar. 9, 2001; 68 FR 4915, Jan. 31, grams phenylbutazone. 2003] (b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter. § 520.1802 Piperazine-carbon disulfide (1) Nos. 000061 and 010797 for use of complex oral dosage forms. product described in paragraph (a)(1) of this section. § 520.1802a Piperazine-carbon disul- (2) No. 064847 for use of product de- fide complex suspension. scribed in paragraph (a)(2) of this sec- (a) Specifications. Each fluid ounce of tion. suspension contains 7.5 grams of piper- (c) Conditions of use in horses—(1) azine-carbon disulfide complex. The pi- Amount. 1 to 2 grams of phenylbutazone perazine-carbon disulfide complex con- per 500 pounds of body weight, not to tains equimolar parts of piperazine and exceed 4 grams daily. carbon disulfide (1 gram contains 530 (2) Indications for use. For relief of in- mgs of piperazine and 470 mgs of carbon flammatory conditions associated with disulfide). the musculoskeletal system. (b) Sponsor. See 000009 in § 510.600(c) of (3) Limitations. Use a relatively high this chapter. dose for the first 48 hours, then gradu- (c) Conditions of use. Horses and ally reduce to a maintenance level of ponies—(1) Amount. One fluid ounce per the lowest level capable of producing 100 pounds of body weight.1 the desired clinical response. Not for (2) Indications for use. For removing use in horses intended for food. Federal ascarids (large roundworms, Parascaris law restricts this drug to use by or on the order of a licensed veterinarian. equorum), bots (Gastrophilus spp.), small strongyles, large strongyles (Strongyles [45 FR 84762, Dec. 23, 1980, as amended at 58 spp.), and pinworms (Oxyuris equi).1 FR 29777, May 24, 1993; 61 FR 8873, Mar. 6, (3) Limitations. Administer by stom- 1996; 62 FR 61625, Nov. 19, 1997; 68 FR 43926, ach tube or dose syringe after with- July 25, 2003] holding feed overnight or for 8 to 10 § 520.1720d Phenylbutazone gel. hours. Provide water as usual. Resume regular feeding 4 to 6 hours after treat- (a) Specifications. Each 30 grams of gel ment. Treatment of debilitated or ane- contains 4 grams of phenylbutazone. mic animals is contraindicated. Do not (b) Sponsor. See No. 061623 in § 510.600(c) of this chapter. administer to animals that are or were (c) NAS/NRC status. The conditions of recently affected with colic, diarrhea, use are NAS/NRC reviewed and found or infected with a serious infectious effective. Applications for these uses disease. As with most anthelmintics, need not include effectiveness data as drastic cathartics and other gastro- specified in § 514.111 of this chapter, but intestinal irritants should not be ad- may require bioequivalency and safety ministered in conjunction with this information. drug. Animals in poor condition or (d) Conditions of use in horses—(1) heavily parasitized should be given one Amount. 1 to 2 grams of phenylbutazone half the recommended dose and treated per 500 pounds of body weight, not to again in 2 or 3 weeks. Federal law re- exceed 4 grams daily. stricts this drug to use by or on the 1 (2) Indications for use. For relief of in- order of a licensed veterinarian. flammatory conditions associated with [45 FR 52781, Aug. 8, 1980] the musculoskeletal system of horses. (3) Limitations. Use a relatively high 1 dose for the first 48 hours, then gradu- These conditions are NAS/NRC reviewed and found effective. Applications for these ally reduce to a maintenance level at uses need not include effectiveness data as the lowest level capable of producing specified by § 514.111 of this chapter, but may the desired clinical response. Not for require bioequivalency and safety informa- use in horses intended for food. Federal tion.

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§ 520.1802b Piperazine-carbon disul- (3) Limitations. See § 520.1802a(c)(3). fide complex boluses. [45 FR 52782, Aug. 8, 1980] (a) Specifications. Each bolus contains 20 grams of piperazine-carbon disulfide § 520.1803 Piperazine citrate capsules. complex. (a) Specifications. Piperazine citrate (b) Sponsor. See 000009 in § 510.600(c) of capsules contain piperazine citrate this chapter. equivalent to 140 milligrams of piper- (c) Conditions of use: Horses and azine base in each capsule. ponies—(1) Amount. For removal of (b) Sponsor. See No. 021091 in ascarids and small strongyles, 1 bolus § 510.600(c) of this chapter. (20 grams) per 500 pounds body weight; (c) Conditions of use. (1) It is used in removal of large strongyles, pinworms, dogs and cats for the removal of large and bots, 1 bolus per 250 pounds body roundworms (Toxocara canis and weight.1 Toxascaris leonina). (2) Indications for use. For removing (2) The contents of 1 capsule should ascarids (large roundworms, Parascaris be mixed with the food of the animal equorum), large strongyles (Strongylus for each 5 pounds, or fraction thereof of spp.) bots (Gastrophilus spp.), small body weight, except dogs weighing over strongyles, and pinworms (Oxyuris 25 pounds should be given the contents equi).1 of 6 capsules. The drug should be mixed (3) Limitations. Withhold feed over- in 1⁄2 of the regular feeding and when night or for 8 to 10 hours. Give water the animal has finished eating the just before and/or after treatment. Re- dosed food, the remainder of the food sume regular feeding 4 to 6 hours after may be given. Dogs and cats may be treatment. Treatment of debilitated or wormed at 6 to 8 weeks of age. The first anemic animals is contraindicated. Do treatment should be repeated 10 days not administer to animals that are or later. Reinfection may occur. Repeat were recently affected with colic, diar- treatment if indicated. rhea, or infected with a serious infec- (3) Severely debilitated animals tious disease. As with most should not be wormed except on the ad- anthelmintics, drastic cathartics or vice of a veterinarian. other gastrointestinal irritants should not be administered in conjunction [40 FR 13838, Mar. 27, 1975, as amended at 54 with this drug. Animals in poor condi- FR 38515, Sept. 19, 1989] tion or heavily parasitized should be § 520.1804 Piperazine phosphate cap- given one half the recommended dose sules. and treated again in 2 or 3 weeks. Con- sult your veterinarian for assistance in (a) Specifications. Each capsule con- the diagnosis, treatment, and control tains 120, 300, or 600 milligrams of pi- of parasitism.1 perazine phosphate monohydrate. (b) Sponsor. See No. 051311 in [45 FR 52782, Aug. 8, 1980] § 510.600(c) of this chapter. (c) Conditions of use—(1) Amount. 60 § 520.1802c Piperazine-carbon disul- milligrams of piperazine phosphate fide complex with phenothiazine suspension. monohydrate per pound of body weight.1 (a) Specifications. Each fluid ounce (2) Indications for use—(i) Dogs. It is contains 5 grams of piperazine-carbon used for the removal of large disulfide complex and 0.83 gram of roundworms (ascarids) Toxocara canis phenothiazine. and Toxascaris leonina. 1 (b) Sponsor. See 000009 in § 510.600(c) of (ii) Cats. It is used for the removal of this chapter. large roundworms (ascarids) Toxocara (c) Conditions of use: Horses and mystax and Toxacaris leonina. 1 ponies—(1) Amount. One fluid ounce per 100 pounds of body weight. 1 (2) Indications for use. For removing These conditions are NAS/NRC reviewed and deemed effective. Applications for these ascarids (large roundworms, Parascaris uses need not include effectiveness data as equorum), bots (Gastrophilus spp.), small specified by § 514.111 of this chapter, but may strongyles, and large strongyles require bioequivalency and safety informa- (Strongylus spp.). tion.

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(3) Limitations. Administer in ani- stricts this drug to use by or on the mal’s food or milk. For animals up to order of a licensed veterinarian. 1 year of age administer every 2 or 3 [43 FR 32747, July 28, 1978, as amended at 47 months; for animals over 1 year old, FR 55476, Dec. 10, 1982; 61 FR 8873, Mar. 6, administer periodically as necessary. 1996; 62 FR 61625, Nov. 19, 1997] Consult your veterinarian for assist- ance in the diagnosis, treatment, and § 520.1806 Piperazine control of parasitism.1 monohydrochloride liquid. [43 FR 6941, Feb. 17, 1978; 43 FR 9804, Mar. 10, (a) Specifications. The product con- 1978, as amended at 46 FR 20158, Apr. 3, 1981; tains 4.77 percent piperazine 69 FR 31878, June 8, 2004] monohydrochloride, equivalent to 3.35 percent piperazine base. § 520.1805 Piperazine phosphate with (b) Sponsor. See Nos. 017135 and 063765 thenium closylate tablets. in § 510.600(c) of this chapter. (a) Specifications. Each scored tablet (c) Conditions of use—(1) Indications contains the equivalent of 250 milli- for use. For dogs for the removal of grams piperazine hexahydrate (as pi- roundworms (Toxocara canis and perazine phosphate) and 125 milligrams Toxascaris leonina). thenium (as thenium closylate) or 500 (2) Dosage. Administer 20 to 30 milli- milligrams piperazine hexahydrate (as grams of piperazine base per pound of piperazine phosphate) and 250 milli- body weight as a single dose. grams thenium (as thenium closylate). (3) Limitations. Administer by mixing into the animal’s ration to be con- (b) Sponsor. See No. 000061 in sumed at one feeding. For animals in § 510.600(c) of this chapter. heavily contaminated areas, reworm at (c) Conditions of use—(1) Amount. Ad- monthly intervals. Not for use in minister orally to dogs as follows: unweaned pups or animals less than NUMBER OF TABLETS AT EACH OF THE TWO three weeks of age. Consult your vet- DOSES erinarian for assistance in the diag- nosis, treatment, and control of para- Animal weight (lb) 375 mg 750 mg sitism.

2 but less than 5 ...... 1⁄2 ...... [47 FR 20758, May 14, 1982, as amended at 57 5 but less than 10 ...... 1 1⁄2 FR 48163, Oct. 22, 1992; 58 FR 44611, Aug. 24, 10 or heavier ...... 2 1 1993; 59 FR 28769, June 3, 1994; 63 FR 8348, Feb. 19, 1998] (2) Indications for use. For removal of immature (fourth stage larvae) and § 520.1807 Piperazine. adult hookworms (Ancylostoma (a) Specifications. A soluble powder or caninum, A. braziliense, and Uncinaria liquid containing piperazine stenocephala) and ascarids (Toxocara dihydrochloride or dipiperazine sulfate, canis) from weaned pups and adult equivalent to 17, 34, or 230 grams of pi- dogs. perazine per pound or 100 milliliters. (3) Limitations. Do not use this prod- (b) Sponsor. See 015565 in § 510.600(c) of uct to treat dogs weighing less than 2 this chapter. pounds, unweaned pups, or pups under 5 (c) Related tolerances. See § 556.513 of weeks of age. Maximum efficacy this chapter. against hookworms necessitates two (d) Conditions of use— (1) Chickens—(i) doses in 1 day of treatment. The inter- Amount. 50 milligrams per bird under 6 val between the doses should be not weeks, 100 milligrams per bird over 6 less than 4 hours or more than 24 weeks. hours. Administer the first dose in the (ii) Indications for use. For removal of morning before feeding. Do not permit large roundworm (Ascaridia spp.). dog to chew tablet. Feed the dog be- (iii) Limitations. For use in drinking tween doses. Do not feed milk or other water or feed. Use as sole source of fatty foods during treatment. Retreat- drinking water. Prepare fresh solution ment may be needed in 7 to 28 days as daily. Use as 1-day single treatment. determined by laboratory fecal exami- Withdraw 14 days prior to slaughter. nations or in animals kept in known Do not use for chickens producing eggs contaminated quarters. Federal law re- for human consumption. Consult your

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veterinarian for assistance in the diag- (3) For prevention of legume (alfalfa, nosis, treatment, and control of para- clover) and wheat pasture bloat in cat- sitism. tle. A 53-percent poloxalene top dress- (2) Turkeys—(i) Amount. 100 milli- ing on individual rations of ground grams per bird up to 12 weeks and 200 feed. Dosage is 1 gram of poloxalene milligrams per bird over 12 weeks. per 100 pounds of body weight daily. If (ii) Indications for use. For removal of bloating conditions are severe, the dose large roundworm (Ascaridia spp.). is doubled. Treatment should be start- (iii) Limitations. For use in drinking ed 2 to 3 days before exposure to bloat- water or feed. Use as sole source of producing conditions. Repeat use of the drinking water. Prepare fresh solution daily. Use as 1-day single treatment. drug if animals are exposed to bloat- Withdraw 14 days prior to slaughter. producing conditions for more than 12 Consult your veterinarian for assist- hours after the last treatment. Do not ance in the diagnosis, treatment, and exceed the double dose in any 24-hour control of parasitism. period. (3) Swine—(i) Amount. 50 milligrams (4) For control of legume (alfalfa, clo- per pound of body weight. ver) and wheat pasture bloat in cattle. (ii) Indications for use. For removal of Administer in molasses block con- large roundworm (Ascaris suum) and taining 6.6 percent poloxalene, at the nodular worms (Oesophagostomum spp.). rate of 0.8 ounce of block (1.5 grams of (iii) Limitations. For use in drinking poloxalene) per 100 pounds of body water or feed. Use as sole source of weight per day. Provide access to drinking water. Prepare fresh solution blocks at least 7 days before exposure daily. Use as 1-day single treatment. to bloat-producing conditions. Withdraw 21 days prior to slaughter. Consult your veterinarian for assist- [40 FR 13838, Mar. 27, 1975, as amended at 40 ance in the diagnosis, treatment, and FR 39857, Aug. 29, 1975; 42 FR 41854, Aug. 19, control of parasitism. 1977; 50 FR 5385, Feb. 8, 1985; 54 FR 33501, Aug. 15, 1989; 56 FR 50653, Oct. 8, 1991; 58 FR 26523, [64 FR 23018, Apr. 29, 1999] May 4, 1993; 60 FR 55659, Nov. 2, 1995; 66 FR 47963, Sept. 17, 2001; 69 FR 62811, Oct. 28, 2004] § 520.1840 Poloxalene. (a) Specifications. Polyoxypropylene- § 520.1846 Polyoxyethylene (23) lauryl polyoxyethylene glycol nonionic block ether blocks. polymer. (a) Specifications. Each molasses- (b) Sponsors. See sponsors in based block contains 2.2 percent § 510.600(c) of this chapter for use as in polyoxyethylene (23) lauryl ether. paragraph (d) of this section. (b) Sponsor. See No. 067949 in (1) No. 000069 for use as in paragraphs (d)(1) and (d)(3) of this section. § 510.600(c) of this chapter. (2) No. 017800 for use as in paragraph (c) Conditions of use—(1) Amount. 2 (d)(4) of this section. grams of polyoxyethylene (23) lauryl (3) No. 067949 for use as in paragraph ether per 100 kilograms of body weight (d)(2) of this section. per day (1 pound of block per 500 kilo- (4) No. 066104 for use as in paragraph gram (1,100 pound) animal per day). (d)(3) of this section. (2) Indications for use. For reduction (c) [Reserved] of the incidence of bloat (alfalfa and (d) Conditions of use. (1) For treat- clover) in pastured cattle. ment of legume (alfalfa, clover) bloat (3) Limitations. Administer free- in cattle. Administer as a drench at the choice to beef cattle and nonlactating rate of 25 grams for animals up to 500 dairy cattle only. Initially, provide one pounds and 50 grams for animals over block per five head of cattle. Start 500 pounds of body weight. treatment 10 to 14 days before exposure (2) For control of legume (alfalfa, clo- to bloat-producing pastures. Do not ver) bloat in cattle. Administer, in mo- allow cattle access to other sources of lasses block containing 6.6 percent salt while being fed this product. Do poloxalene, at the rate of 0.8 oz. of block (1.5 grams poloxalene) per 100 lbs. of body weight per day.

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not feed this product to animals with- moval and control of the canine out adequate forage/roughage consump- cestode Echinococcus multilocularis. tion. (iii) Limitations—(A) If labeled only for use as in paragraph (c)(1)(ii)(A) of [50 FR 48189, Nov. 22, 1985, as amended at 56 FR 9841, Mar. 8, 1991; 69 FR 62811, Oct. 28, this section: Not intended for use in 2004] puppies less than 4 weeks of age. Con- sult your veterinarian before admin- § 520.1855 Ponazuril. istering tablets to weak or debilitated animals and for assistance in the diag- (a) Specifications. Each gram of paste nosis, treatment, and control of para- contains 150 milligrams (mg) ponazuril. sitism. (b) Sponsor. See No. 000859 in (B) If labeled for use as in paragraph § 510.600(c) of this chapter. (c)(1)(ii)(B) of this section: Federal law (c) Conditions of use in horses—(1) restricts this drug to use by or on the Amount. 5 mg per kilogram body order of a licensed veterinarian. weight, daily for 28 days. (2) Cats—(i) Indications for use. For re- (2) Indications for use. For the treat- moval of feline cestodes Dipylidium ment of equine protozoal caninum and Taenia taeniaeformis. myeloencephalitis caused by Sarcocystis (ii) Dosage. Cats 4 pounds and under, neurona. 11.5 mg; 5 to 11 pounds, 23 mg; over 11 (3) Limitations. Not for use in horses pounds, 34.5 mg. intended for food. Federal law restricts (iii) Limitations. Administer directly this drug to use by or on the order of a by mouth or crumbled and in feed. Not licensed veterinarian. intended for use in kittens less than 6 [66 FR 43774, Aug. 21, 2001] weeks of age. For OTC use: Consult your veterinarian before administering § 520.1870 Praziquantel tablets. tablets to weak or debilitated animals, and for assistance in the diagnosis, (a) Specifications. Each tablet con- treatment, and control of parasitism. tains: (1) 34 milligrams (mg) praziquantel. [46 FR 60570, Dec. 11, 1981, as amended at 47 (2) 11.5 or 23 mg praziquantel. FR 26377, June 18, 1982; 55 FR 2234, Jan. 23, 1990; 58 FR 7864, Feb. 10, 1993; 58 FR 42853, (b) Sponsors. See sponsors in Aug. 12, 1993; 68 FR 57351, Oct. 3, 2003; 69 FR § 510.600(c) of this chapter: 62181, Oct. 25, 2004] (1) No. 000859 for use of the product described in paragraph (a)(1) of this § 520.1871 Praziquantel/pyrantel section, as in paragraph (c)(1) of this pamoate tablets. section; and for use of the product de- (a) Specifications. Each cat tablet con- scribed in paragraph (a)(2) of this sec- tains 18.2 milligrams (mg) praziquantel tion, as in paragraph (c)(2) of this sec- with 72.6 mg pyrantel (as pyrantel tion. pamoate). (2) No. 059130 for use of the product (b) Sponsor. See 000859 in § 510.600(c) of described in paragraph (a)(1) of this this chapter. section, as in paragraph (c)(1) of this (c) Conditions of use—(1) Cats—(i) Dos- section. age. 1.5 to 1.9 pounds, 1/4 tablet; 2 to 3 (c) Conditions of use—(1) Dogs—(i) pounds, 1/2 tablet; 4 to 8 pounds, 1 tab- Amount. 5 pounds (lb) and under, 1/2 let; 9 to 12 pounds, 1 1/2 tablets; 13 to 16 tablet (17 mg); 6 to 10 lb, 1 tablet (34 pounds, 2 tablets. mg); 11 to 15 lb, 1 1/2 tablets (51 mg); 16 (ii) Indications for use. For removal of to 30 lb, 2 tablets (68 mg); 31 to 45 lb, 3 tapeworms (Dipylidium caninum and tablets (102 mg); 46 to 60 lb, 4 tablets Taenia taeniaeformis), hookworms (136 mg); over 60 lb, 5 tablets maximum (Ancylostoma tubaeforme), and large (170 mg). Administer directly by mouth roundworms (Toxocara cati) in cats and or crumbled and in feed. kittens. (ii) Indications for use—(A) For re- (iii) Limitations. Not for use in kit- moval of canine cestodes Dipylidium tens less than 1 month of age or weigh- caninum and Taenia pisiformis. ing less than 1.5 pounds. May be given (B) For removal of the canine cestode directly by mouth or in a small Echinococcus granulosus, and for re- amount of food. Do not withhold food

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prior to or after treatment. If reinfec- (1) Tablet No. 1: 22.7 milligrams tion occurs, treatment may be re- praziquantel, 22.7 milligrams pyrantel peated. Consult your veterinarian be- base, and 113.4 milligrams febantel; or fore giving to sick or pregnant ani- (2) Tablet No. 2: 68 milligrams mals. Consult your veterinarian for as- praziquantel, 68 milligrams pyrantel sistance in the diagnosis, treatment, base, and 340.2 milligrams febantel. and control of parasitism. (3) Tablet No. 3: 136 milligrams (mg) (2) [Reserved] praziquantel, 136 mg pyrantel base, and 680.4 mg febantel. [58 FR 58652, Nov. 3, 1993] (b) Sponsor. See 000859 in § 510.600(c) of this chapter. § 520.1872 Praziquantel, pyrantel (c) Conditions of use—(1) Dogs—(i) pamoate, and febantel tablets. Amount. Administer as a single dose di- (a) Specifications. Each tablet con- rectly by mouth or in a small amount tains either: of food as follows:

Weight of animal Number of tablets per dose Kilograms Pounds Tablet no. 1 Tablet no. 2 Tablet no. 3

0.9 to 1.8 2 to 4 1/2 2.3 to 3.2 5 to 7 1 3.6 to 5.4 8 to 12 1 1/2 5.9 to 8.2 13 to 18 2 8.6 to 11.4 19 to 25 2 1/2 11.8 to 13.6 26 to 30 1 14.1 to 20.0 31 to 44 1 1/2 20.4 to 27.2 45 to 60 2 1 27.7 to 40.9 61 to 90 1 1/2 41.3 to 54.5 91 to 120 2

(ii) Indications for use. For the re- may induce the first stage of parturi- moval of tapeworms (Dipylidium tion when administered during the last caninum, Taenia pisiformis, Echinococcus trimester of pregnancy and may pre- granulosus); hookworms (Ancylostoma cipitate parturition followed by caninum, Uncinaria stenocephala); dystocia, fetal death, retained pla- ascarids (Toxocara canis, Toxascaris centa, and metritis. leonina); and whipworms (Trichuris (2) Do not use in viral infections. vulpis) and for the removal and control Systemic therapy with prednisolone is of tapeworm Echinococcus multilocularis contraindicated in animals with peptic in dogs. ulcer, corneal ulcer, and Cushingoid (iii) Limitations. Do not use in preg- syndrome. The presence of diabetes, nant animals. Do not use in dogs osteoporosis, predisposition to weighing less than 0.9 kilogram (2 pounds) or puppies less than 3 weeks of thrombophlebitis, hypertension, con- age. Federal law restricts this drug to gestive heart failure, renal insuffi- use by or on the order of a licensed vet- ciency, and active tuberculosis neces- erinarian. sitates carefully controlled use. Some of the above conditions occur only [59 FR 33908, July 1, 1994, as amended at 61 rarely in dogs but should be kept in FR 29651, June 12, 1996; 68 FR 22293, Apr. 28, 2003] mind. (3) Anti-inflammatory action of § 520.1880 Prednisolone tablets. corticosteroids may mask signs of in- (a) Specifications. Each tablet con- fection. tains 5 or 20 milligrams prednisolone. (d) Conditions of use—(1) Amount. (b) Sponsor. See No. 061690 in Dogs: 2.5 milligrams per 4.5 kilograms § 510.600(c)(2) of this chapter. (10 pounds) body weight per day. Ad- (c) Special considerations. (1) Clinical minister total daily dose orally in and experimental data have dem- equally divided doses 6 to 10 hours onstrated that corticosteroids adminis- apart until response is noted or 7 days tered orally or parenterally to animals

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have elapsed. When response is at- § 520.1920 Prochlorperazine, tained, dosage should be gradually re- isopropamide sustained release duced until maintenance level is capsules. achieved. (a) Specifications. Prochlorperazine, (2) Indications for use. For use in dogs isopropamide sustained release cap- as an anti-inflammatory agent. sules contain either: (3) Limitations. Federal law restricts (1) 3.33 milligrams of this drug to use by or on the order of a prochlorperazine (as the dimaleate) licensed veterinarian. and 1.67 milligrams of isopropamide (as the iodide), or [57 FR 4718, Feb. 7, 1992, as amended at 60 FR 57832, Nov. 22, 1995; 63 FR 148, Jan. 5, 1998] (2) 10 milligrams of prochlorperazine (as the dimaleate) and 5 milligrams of § 520.1900 Primidone tablets. isopropamide (as the iodide). (b) Sponsor. See No. 000069 in (a) Specifications. Each tablet con- § 510.600(c) of this chapter. tains 50 or 250 milligrams of primidone. (c) Conditions of use. (1) The drug is (b) Sponsor. See No. 000010 in used for the treatment of dogs in which § 510.600(c) of this chapter for use of 250 gastrointestinal disturbances are asso- milligram tablets; see No. 000856 in ciated with emotional stress. § 510.600(c) of this chapter for use of 50 (2)(i) Capsules described in paragraph and 250 milligram tablets. (a)(1) of this section are administered (c) Conditions of use in dogs—(1) orally to dogs weighing from 4 to 15 Amount. Twenty-five milligrams of pounds at the rate of 1 capsule twice primidone per pound of body weight (55 daily. These capsules are administered milligrams per kilogram of body orally to dogs weighing from 16 to 30 weight) daily.1 pounds at the rate of 1 or 2 capsules (2) Indications for use. For the control twice daily. For dogs weighing less of convulsions associated with idio- than 4 pounds, administer orally an ap- pathic epilepsy, epileptiform convul- propriate fraction of the contents of sions, viral encephalitis, distemper, one of these capsules. and hardpad disease that occurs as a (ii) Capsules described in paragraph clinically recognizable lesion in certain (a)(2) of this section are given to dogs entities in dogs.1 weighing 30 pounds and over at the rate (3) Limitations. The tablets may be of 1 capsule twice daily. administered whole or crushed and (3) For use only by or on the order of mixed with the food. When convulsions a licensed veterinarian. are frequent, the dosage should be di- [40 FR 13838, Mar. 27, 1975, as amended at 56 vided and administered at intervals. FR 50653, Oct. 8, 1991; 60 FR 55659, Nov. 2, Reduction in dosage should be made 1995] gradually and never be abruptly dis- continued. Do not use in feline species, § 520.1921 Prochlorperazine, as primidone appears to have a specific isopropamide, with neomycin sus- neurotoxicity in cats. Federal law re- tained-release capsules. stricts this drug to use by or on the (a) Specifications. Each capsule con- order of a licensed veterinarian.1 tains either: (1) Capsule No. 1: 3.33 milligrams of [42 FR 61594, Dec. 6, 1977, as amended at 43 prochlorperazine (as the dimaleate), FR 55386, Nov 28, 1978; 46 FR 8467, Jan. 27, 1981; 46 FR 57477, Nov. 24, 1981; 53 FR 40727, 1.67 milligrams of isopropamide (as the Oct. 18, 1988; 56 FR 37473, Aug. 7, 1991; 62 FR iodide), and 25 milligrams of neomycin 35076, June 30, 1997] base (as the sulfate); or (2) Capsule No. 3: 10 milligrams of prochlorperazine (as the dimaleate), 5 1 These conditions are NAS/NRC reviewed and deemed effective. Applications for these milligrams of isopropamide (as the io- uses need not include effectiveness data as dide), and 75 milligrams of neomycin specified by § 514.111 of this chapter, but may base (as the sulfate). require bioequivalency and safety informa- (b) Sponsor. See No. 000069 in tion. § 510.600(c) of this chapter.

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(c) Conditions of use—(1) Amount. Ad- § 520.2002 Propiopromazine hydro- minister capsules orally twice daily to chloride. dogs as follows: (a) Chemical name. 1-Propanone, 1-[10- Number of cap- [3-(dimethylamino) propyl] sules per dose phenothiazine-2-yl]-, Animal weight (pounds) Capsule Capsule monohydrochloride. No. 1 No. 3 (b) Specifications. The drug is admin- istered in a chewable tablet containing 10 to 20 ...... 1 20 to 30 ...... 2 10 to 20 milligrams of propiopromazine Over 30 ...... 3 1 hydrochloride. Over 60 ...... 2 (c) Sponsor. See No. 000856 in § 510.600(c) of this chapter. (2) Indications for use. For treatment (d) Conditions of use. (1) The drug is of dogs in which infectious bacterial intended for oral administration to gastroenteritis is associated with emo- dogs as a tranquilizer. It is used as an tional stress. aid in handling difficult, excited, and (3) Limitations. Do not continue medi- unruly dogs, and in controlling exces- cation longer than 5 days. Overdosage sive kennel barking, car sickness, and or prolonged administration may severe dermatitis. It is also indicated produce nephrotoxicity as manifested for use in minor surgery and prior to by albuminuria, presence of granular routine examinations, laboratory pro- casts and depressed urinary output. If cedures, and diagnostic procedures. it is desirable to administer a vasocon- (2) It is administered at the rate of strictor, norepinephrine is the drug of 0.5 to 2 milligrams of propiopromazine choice. Federal law restricts this drug hydrochloride per pound of body weight to use by or on the order of a licensed once or twice daily depending upon the veterinarian. degree of tranquilization desired. [49 FR 14103, Apr. 10, 1984, as amended at 56 NOTE: Not for use with organophosphates FR 50653, Oct. 8, 1991; 60 FR 55659, Nov. 2, and/or procaine hydrochloride, as 1995] phenothiazine may potentiate the toxicity of organophosphates and the activity of pro- § 520.1962 Promazine hydrochloride. caine hydrochloride. Overdosage may produce significant depression. (a)(1) Chemical name. 10-[3- (3) For use only by or on the order of (Dimethylamino)propyl]phenothiazine a licensed veterinarian. monohydrochloride. (2) Specifications. Conforms to N.F. [40 FR 13838, Mar. 27, 1975, as amended at 46 XII. FR 60570, Dec. 11, 1981; 61 FR 5506, Feb. 13, 1996] (3) Sponsor. See No. 000856 in § 510.600(c) of this chapter. § 520.2041 Pyrantel pamoate chewable (4) [Reserved] tablets. (5) Conditions of use. (i) The drug is (a) Specifications. Each tablet con- used for quieting excitable, unruly, or tains pyrantel pamoate equivalent to intractable horses. It is administered 22.7 or 113.5 milligrams pyrantel base. at a dosage level of 0.45 to 0.9 milli- (b) Sponsor. See Nos. 017135 and 051311 grams of promazine hydrochloride per in § 510.600(c) of this chapter. pound of body weight mixed with an (c) Conditions of use—(1) Amount. Pro- amount of feed that will be readily con- vides at least 2.27 milligrams pyrantel sumed. base per pound body weight for dogs (ii) Do not use in horses intended for weighing more than 5 pounds, and at food. least 4.54 milligrams of pyrantel base (iii) Federal law restricts this drug to per pound body weight for dogs weigh- use by or on the order of a licensed vet- ing 5 pounds or less. erinarian. (2) Indications for use—(i) In dogs and (b) [Reserved] puppies. For removal of ascarids [40 FR 13838, Mar. 27, 1975, as amended at 43 (Toxocara canis; Toxascaris leonina) and FR 55386, Nov. 28, 1978; 59 FR 5705, Feb. 8, hookworms (Ancylostoma caninum; 1994] Uncinaria stenocephala).

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(ii) In puppies and adult dogs and in sistance in the diagnosis, treatment, lactating bitches after whelping. To and control of parasitism. prevent reinfection of Toxocara canis. [43 FR 52700, Nov. 14, 1978, as amended at 49 (3) Limitations. Administer to puppies FR 22073, May 25, 1984; 57 FR 48163, Oct. 22, at 2, 3, 4, 6, 8, and 10 weeks of age. Ad- 1992; 58 FR 44611, Aug. 24, 1993] minister to lactating bitches 2 to 3 weeks after whelping. Retreatment of § 520.2043 Pyrantel pamoate suspen- sion. adult dogs may be necessary at month- ly intervals as determined by labora- (a) Specifications. (1) Each milliliter tory fecal examinations. Consult your (mL) contains pyrantel pamoate equiv- veterinarian for assistance in the diag- alent to 50 milligrams (mg) pyrantel nosis, treatment, and control of para- base. sitism. (2) Each mL contains pyrantel pamoate equivalent to 2.27 or 4.54 mg [52 FR 37937, Oct. 13, 1987, as amended at 57 pyrantel base. FR 48163, Oct. 22, 1992; 58 FR 44611, Aug. 24, (3) Each mL contains pyrantel 1993; 66 FR 9650, Feb. 9, 2001; 67 FR 21996, May pamoate equivalent to 4.54 mg pyrantel 2, 2002] base. (b) Sponsors. See sponsors in § 520.2042 Pyrantel pamoate tablets. § 510.600(c) of this chapter for uses as in (a) Specifications. Each tablet con- paragraph (d) of this section. tains pyrantel pamoate equivalent to (1) Nos. 000069, 058829, and 059130 for 22.7, 45.4, or 113.5 milligrams of use of the product described in para- pyrantel base. graph (a)(1) as in paragraph (d)(1) of (b) Sponsor. See No. 017135 in this section. § 510.600(c) of this chapter. (2) Nos. 000069, 010237, 058829, and 059130 for use of the products described (c) Conditions of use. It is used for in paragraph (a)(2) as in paragraph dogs as follows: (d)(2) of this section. (1) Amount. For dogs weighing over 5 (3) No. 023851 for use of the product pounds, use at least 2.27 milligrams of described in paragraph (a)(3) as in para- pyrantel base per pound of body graph (d)(2) of this section. weight; for dogs weighing 5 pounds or (c) Special considerations. See § 500.25 less, use at least 4.54 milligrams of of this chapter. pyrantel base per pound of body (d) Conditions of use—(1) Horses and weight. ponies. It is used as follows: (2) Indications for use. For removal (i) Amount. 3 mg per pound (/lb) body and control of large roundworms weight as a single dose mixed with the (ascarids) (Toxocara canis and usual grain ration, or by stomach tube Toxascaris leonina), and hookworms or dose syringe. (Ancylostoma caninum and Uncinaria (ii) Indications for use. For the re- stenocephala). moval and control of mature infections (3) Limitations. Administer orally di- of large strongyles (Strongylus vulgaris, rectly or in a small amount of food. To S. edentatus, S. equinus); pinworms prevent reinfection of T. canis in pup- (Oxyuris equi); large roundworms (Parascaris equorum); and small pies, lactating bitches after whelping, strongyles. and adult dogs; treat puppies 2, 3, 4, 6, (iii) Limitations. Not for use in horses 8, and 10 weeks of age; treat lactating and ponies to be slaughtered for food bitches 2 to 3 weeks after whelping; purposes. When the drug is for adminis- routinely treat adult dogs monthly. Do tration by stomach tube, it shall be la- not withhold food prior to or after beled: ‘‘Federal law restricts this drug treatment. The presence of these to use by or on the order of a licensed parasites should be confirmed by lab- veterinarian.’’ oratory fecal examination. A followup (2) Dogs. It is used as follows: fecal examination should be conducted (i) Dogs and puppies—(A) Amount. 2.27 2 to 4 weeks after first treatment regi- mg/lb body weight as a single dose in men to determine the need for re-treat- the animal’s feed bowl by itself or ment. Consult your veterinarian for as- mixed in a small quantity of food.

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(B) Indications for use. For the re- recommended that severely debilitated moval of large roundworms (Toxocara animals not be treated with this prepa- canis and Toxascaris leonina) and ration. Consult your veterinarian for hookworms (Ancylostoma caninum and assistance in the diagnosis, treatment, Uncinaria stenocephala). and control of parasitism. (C) Limitations. Additional treatment [47 FR 47377, Oct. 26, 1982; 48 FR 3367, Jan. 25, may be required and should be con- 1983, as amended at 68 FR 13627, Mar. 20, 2003; firmed by fecal examination within 2 68 FR 34533, June 10, 2003] to 4 weeks. (ii) Dogs, puppies, and lactating bitches § 520.2045 Pyrantel tartrate powder; after whelping—(A) Amount. 2.27 mg/lb pyrantel tartrate pellets. body weight. (a) Specifications. (1) Pyrantel tar- (B) Indications for use. To prevent re- trate powder horse wormer contains infections of T. canis. 11.3 percent and swine wormer 10.6 per- (C) Limitations. Administer to puppies cent pyrantel tartrate. at 2, 3, 4, 6, 8, and 10 weeks of age. Ad- (2) Pyrantel tartrate pellets colt and minister to lactating bitches 2 to 3 horse wormer contains 1.25 percent weeks after whelping. Adult dogs kept pyrantel tartrate. in heavily contaminated quarters may (b) Sponsor. (1) See No. 000069 in be treated at monthly intervals. § 510.600(c) of this chapter for condi- [67 FR 43248, June 27, 2002, as amended at 68 tions of use provided for in paragraphs FR 54803, Sept. 19, 2003; 68 FR 55199, Sept. 23, (d) (1) and (2) of this section. 2003; 68 FR 55825, Sept. 29, 2003] (2) See No. 051311 in § 510.600(c) of this chapter, for conditions of use provided § 520.2044 Pyrantel pamoate paste. for in paragraph (d)(3) of this section. (a) Specifications. (1) Each milliliter (c) Related tolerances. See § 556.560 of (mL) contains 180 milligrams (mg) this chapter. pyrantel base (as pyrantel pamoate). (d) Conditions of use. It is used in: (1) (2) Each mL contains 226 mg pyrantel Horses and ponies: base (as pyrantel pamoate). (i) For the removal and control of in- (3) Each mL contains 171 mg pyrantel fections from the following mature base (as pyrantel pamoate). parasites: Large strongyles (Strongylus (b) Sponsors. See sponsors in vulgaris, Strongylus edentatus, § 510.600(c) of this chapter. Strongylus equinus), small strongyles (1) No. 000069 for use of product de- (Trichonema spp., Triodontophorus), scribed in paragraph (a)(1) of this sec- pinworms (Oxyuris), and large tion. roundworms (Parascaris). (2) No. 059130 for use of product de- (ii) It is administered as a single dose scribed in paragraph (a)(2) of this sec- at 0.57 gram of pyrantel tartrate per 100 tion. pounds of body weight mixed with the (3) No. 061623 for use of product de- usual grain ration. scribed in paragraph (a)(3) of this sec- (iii) It is recommended that severely tion. debilitated animals not be treated with (c) Conditions of use. It is used in this drug. Do not administer by stom- horses and ponies as follows: ach tube or dose syringe. The drug (1) Amount. Equivalent of 3 milli- should be used immediately after the grams pyrantel base per pound of body package is opened. weight. (iv) Warning: Not for use in horses (2) Indications for use. For removal and ponies to be slaughtered for food and control of infections from the fol- purposes. lowing mature parasites: large (2) Swine: strongyles (Strongylus vulgaris, S. (i) For the removal and control of edentatus, S. equinus); small strongyles; large roundworms (Ascaris suum) and pinworms (Oxyuris equi); and large nodular worm (Oesophagostomum) infec- roundworms (Parascaris equorum). tions. (3) Limitations. Administer as single (ii) It is added to feed at 0.4 gram dose by depositing paste on dorsum of pyrantel tartrate per pound of the tongue using the dose syringe. Not nonpelleted ration. The ration is ad- for use in horses intended for food. It is ministered as a single treatment as the

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sole ration at the rate of 1 pound per 40 (ii) Indications for use. For increased pounds of animal weight for animals up rate of weight gain, improved feed effi- to 200 pounds. Animals 200 pounds and ciency, and improved pigmentation. over are administered 5 pounds of ra- (iii) Limitations. Administer continu- tion per animal. ously throughout growing period. (iii) Fast pigs over night for optimum Withdraw 5 days before slaughter. Use results. Water should be made avail- as sole source of organic arsenic. able to animals during fasting and (2) Swine—(i) Amount. 0.01 percent treatment periods. Consult veteri- roxarsone in drinking water (one pack- narian before using in severely debili- et per each 50 gallons of drinking tated animals. The drug should be used water); or 30 milliliters of a 1.55 per- immediately after the package is cent roxarsone solution (one packet per opened. 3 pints of water) per 50 pounds of body (iv) Warning: Do not treat within 24 weight as a drench. hours of slaughter. (ii) Indications for use. As an aid in (3) Horses and colts: the treatment of swine dysentery (i) For the removal and control of in- (hemorrhagic enteritis or bloody fections from the following mature scours). parasites: Large strongyles (Strongylus (iii) Limitations. Administer drinking vulgaris, Strongylus edentatus, water continuously for not more than 6 Strongylus equinus), small strongyles days. Administer drench once daily for (Trichonema spp., Triodontophorus), 1 or 2 days. If no improvement is ob- pinworms (Oxyuris), and large served, consult a veterinarian. Treat- roundworms (Parascaris). ment may be repeated after 5 days. (ii) It is administered as a single dose Withdraw 5 days before slaughter. Use at 12.5 milligrams of pyrantel tartrate as sole source of organic arsenic. per 2.2 pounds of body weight mixed [46 FR 41039, Aug. 14, 1981, as amended at 55 with the usual grain ration. FR 8460, Mar. 8, 1990; 57 FR 8577, Mar. 11, 1992; (iii) It is recommended that severely 69 FR 41427, July 9, 2004] debilitated animals not be treated with this drug. § 520.2088 Roxarsone tablets. (iv) Warning: Do not use in horses or (a)(1) Specifications. Each tablet con- colts intended for food. tains 36 milligrams of roxarsone (3- [40 FR 13838, Mar. 27, 1975, as amended at 59 nitro-4-hydroxyphenylarsonic acid). FR 28769, June 3, 1994; 69 FR 41427, July 9, (2) Sponsor. See No. 046573 in 2004] § 510.600(c) of this chapter. (3) Related tolerances. See § 556.60 of § 520.2087 Roxarsone soluble powder. this chapter. (a) Specifications. Each ounce (avoir- (4) NAS/NRC status. The weight gain, dupois) of soluble powder contains 21.7 feed efficiency, and pigmentation grams of roxarsone (monosodium 3- claims are NAS/NRC reviewed and nitro-4-hydroxyphenylarsonate). found effective. NADA’s for these uses (b) Sponsor. See No. 046573 in need not include effectiveness data as § 510.600(c) of this chapter. specified by § 514.111 of this chapter, (c) Related tolerances. See § 556.60 of but may require bioequivalency and this chapter. safety information. (d) NAS/NRC status. These conditions (5) Conditions of use—(i) Growing of use are NAS/NRC reviewed and found chickens and growing turkeys—(a) effective. NADA’s for these uses need Amount. Dissolve 2 tablets in each gal- not include effectiveness data as speci- lon of drinking water (0.002 percent fied by § 514.111 of this chapter, but roxarsone). may require bioequivalency and safety (b) Indications for use. For increased information. rate of weight gain, improved feed effi- (e) Conditions of use—(1) Growing ciency, and improved pigmentation. chickens and growing turkeys—(i) (c) Limitations. Administer continu- Amount. 0.002 percent roxarsone in ously throughout growing period. drinking water (one packet per each 250 Withdraw 5 days before slaughter. Use gallons of drinking water). as sole source of organic arsenic.

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(ii) Growing chickens—(a) Amount. (ii) Indications for use. For improved Dissolve 8 tablets in each gallon of rate of weight gain, improved feed effi- drinking water (0.008 percent ciency, and improved pigmentation. roxarsone). (iii) Limitations. Administer continu- (b) Indications for use. As an aid in the ously throughout growing period. Do prevention of coccidiosis due to Eimeria not administer to chickens producing tenella. eggs for human consumption. With- (c) Limitations. Administer for not draw 5 days before slaughter. Use as more than 10 consecutive days. Treat- sole source of organic arsenic. Over- ment may be repeated after 5 days off dosage or the lack of water intake may medication. Withdraw 5 days before result in weakness or paralysis of legs. slaughter. Use as sole source of organic arsenic. [46 FR 41040, Aug. 14, 1981, as amended at 46 FR 42448, Aug. 21, 1981; 47 FR 15238, Apr. 9, (b)(1) Specifications. Each tablet con- 1982; 55 FR 8460, Mar. 8, 1990; 57 FR 8577, Mar. tains 400 milligrams of roxarsone (3- 11, 1992; 58 FR 65664, Dec. 16, 1993; 65 FR 10705, nitro-4-hydroxyphenylarsonic acid). Feb. 29, 2000] (2) Sponsor. See No. 046573 in § 510.600(c) of this chapter. § 520.2089 Roxarsone liquid. (3) Related tolerances. See § 556.60 of (a) Specifications. Each teaspoon (5 this chapter. milliliters) of solution contains 72 mil- (4) NAS/NRC status. These conditions ligrams of roxarsone (3-nitro-4- are NAS/NRC reviewed and found effec- hydroxyphenylarsonic acid). tive. NADA’s for these uses need not (b) Sponsor. See No. 046573 in include effectiveness data as specified § 510.600(c) of this chapter. by § 514.111 of this chapter, but may re- (c) Related tolerances. See § 556.60 of quire bioequivalency and safety infor- this chapter. mation. (d) Conditions of use in growing chick- (5) Conditions of use—(i) Swine—(a) ens and growing turkeys—(1) Amount. 1 Amount. 1 tablet (400 milligrams) per teaspoon (5 milliliters) to each gallon gallon of drinking water for no more of drinking water (0.002 percent than 6 days, or 1 tablet (400 milligrams) roxarsone). per 2 fluid ounces of warm water per 50 (2) Indications for use. For improved pounds of body weight as a drench once rate of weight gain, improved feed effi- daily for 1 to 2 days. ciency, and improved pigmentation. (b) Indications for use. As an aid in the (3) Limitations. Administer continu- treatment of swine dysentery (hemor- ously throughout growing period. Do rhagic enteritis or bloody scours). not administer to chickens producing (c) Limitations. Treatment may be re- eggs for human consumption. With- peated after 5 days off medication. If draw 5 days before slaughter. Use as no improvement is observed, consult a sole source of organic arsenic. Over- veterinarian. Treated animals must dosage or the lack of water intake may consume enough medicated water to result in weakness or paralysis of legs. provide a therapeutic dose. Withdraw 5 days before slaughter. Use as sole [58 FR 65665, Dec. 16, 1993, as amended at 65 source of organic arsenic. FR 10705, Feb. 29, 2000] (ii) [Reserved] (c)(1) Specifications. Each tablet con- § 520.2098 Selegiline hydrochloride tains 72 milligrams of roxarsone (3- tablets. nitro-4-hydroxyphenylarsonic acid). (a) Specifications. Each tablet con- (2) Sponsor. See No. 046573 in tains either 2, 5, 10, 15, or 30 milligrams § 510.600(c) of this chapter. of selegiline hydrochloride. (3) Related tolerances. See § 556.60 of (b) Sponsor. See No. 000069 in this chapter. § 510.600(c) of this chapter. (4) Conditions of use in growing chick- (c) [Reserved] ens and growing turkeys—(i) Amount. 1 (d) Conditions of use—Dogs—(1) Dos- tablet in each gallon of drinking water age. 1 milligram per kilogram (0.45 mil- (0.002 percent roxarsone). ligram per pound) of body weight.

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(i) Indications for use. For control of weight, the small capsules are adminis- clinical signs associated with uncom- tered orally at a dosage level of 1 per 5 plicated pituitary-dependent pounds of body weight with a minimum hyperadrenocorticism in dogs. of 1 capsule which dosage is repeated at (ii) Limitations. Administer orally 3 day intervals until a satisfactory re- once daily. If no improvement in clin- sponse is observed then a maintenance ical signs or physical examination find- regimen is initiated with 1 capsule per ings after 2 months of therapy, in- 10 pounds of body weight, minimum of crease dose to a maximum of 2 milli- 1 capsule, every 3 days, or 7 days, or grams per kilogram once daily. Federal longer as required to maintain contin- law restricts this drug to use by or on ued improvement or an asymptomatic the order of a licensed veterinarian. condition. (2) Dosage. 0.5 to 1.0 milligram per (3) Federal law restricts this drug to kilogram of body weight once daily. use by or on the order of a licensed vet- (i) Indications for use. For the control erinarian. of clinical signs associated with canine cognitive dysfunction syndrome. [40 FR 13838, Mar. 27, 1975, as amended at 52 FR 7832, Mar. 13, 1987; 52 FR 9756, Mar. 26, (ii) Limitations. Federal law restricts 1987] this drug to use by or on the order of a licensed veterinarian. § 520.2123 Spectinomycin [62 FR 34632, June 27, 1997; 62 FR 55159, Oct. dihydrochloride pentahydrate oral 23, 1997, as amended at 63 FR 29551, June 1, dosage forms. 1998; 64 FR 2122, Jan. 13, 1999] § 520.2123a Spectinomycin § 520.2100 Selenium, vitamin E cap- dihydrochloride pentahydrate tab- sules. lets. (a) Specifications. The capsules con- (a) Specifications. The spectinomycin tain 2.19 milligrams of sodium selenite dihydrochloride pentahydrate used in (equivalent to 1 milligram of selenium) manufacturing the drug is the anti- and 56.2 milligrams of vitamin E (68 biotic substance produced by growth of I.U.) (as d-alpha tocopheryl acid succi- Streptomyces flavopersicus (var. Abbott) nate) or 0.548 milligram of sodium sele- or the same antibiotic substance pro- nite (equivalent to .25 milligram of se- duced by any other means. lenium and 14 milligrams of vitamin E (b) Sponsor. See No. 061623 in (17 I.U.) (as d-alpha tocopheryl acid § 510.600(c) of this chapter. succinate.) (c) Special considerations. The quan- (b) Sponsor. See No. 000061 in tities of spectinomycin cited in this § 510.600(c) of this chapter. section refer to the equivalent weight (c) Conditions of use. (1) The drug is of base activity for the drug. intended for use as an aid in alleviating (d) Conditions of use. (1) The tablets and controlling inflammation, pain, are administered orally to dogs in the and lameness associated with certain treatment of infectious diarrhea and arthropathies in dogs. gastroenteritis caused by organisms (2) The capsules are administered susceptible to spectinomycin. orally with the larger capsules admin- (2) The drug is administered orally to istered at a dosage level of 1 capsule provide 10 milligrams per pound of per 20 pounds of body weight to a max- body weight twice daily. The tablets imum of 5 capsules with the dosage re- may be placed in the animal’s mouth peated at 3 day intervals until a satis- or crushed and administered in milk or factory therapeutic response is ob- in the feed. Dosage may be continued served. A maintenance dosage is then for 4 consecutive days. Should no im- administered consisting of 1 capsule provement be observed, discontinue per 40 pounds of body weight, with a drug and redetermine diagnosis. minimum of 1 capsule per 40 pounds of (3) Federal law restricts this drug to body weight, with a minimum of 1 cap- use by or on the order of a licensed vet- sule, given every 3 days, or 7 days, or erinarian. longer, as required to maintain im- [40 FR 13838, Mar. 27, 1975, as amended at 47 provement or an asymptomatic condi- FR 14149, Apr. 2, 1982; 66 FR 14073, Mar. 9, tion. For dogs under 20 pounds of body 2001; 68 FR 4915, Jan. 31, 2003]

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§ 520.2123b Spectinomycin § 520.2123c Spectinomycin dihydrochloride pentahydrate solu- dihydrochloride pentahydrate solu- ble powder. tion. (a) Specifications. The spectinomycin (a) Specifications. Each milliliter of dihydrochloride pentahydrate used in solution contains 50 milligrams (mg) manufacturing the drug is the anti- spectinomycin activity. biotic substance produced by growth of (b) Sponsors. See Nos. 000856, 059130, and 061623 in § 510.600(c) of this chapter. Streptomyces flavopersicus (var. Abbott) (c) Conditions of use in swine—(1) or the same antibiotic substance pro- Amount. Administer 5 mg per pound (lb) duced by any other means. of body weight orally twice daily for 3 (b) Sponsor. See No. 061623 in to 5 days. § 510.600(c) of this chapter. (2) Indications for use. For the treat- (c) Special considerations. The quan- ment and control of infectious bac- tities of spectinomycin cited in this terial enteritis (white scours) associ- section refer to the equivalent weight ated with E. coli in pigs under 4 weeks of base activity for the drug. of age. (d) Related tolerances. See § 556.600 of (3) Limitations. Do not administer to this chapter. pigs over 15 lb of body weight or over 4 (e) Conditions of use. (1) It is adminis- weeks of age. Do not administer within tered in the drinking water of growing 21 days of slaughter. chickens at 2 grams of spectinomycin [69 FR 52815, Aug. 30, 2004] per gallon of water as the only source of drinking water for the first 3 days of § 520.2150 Stanozolol oral dosage life and for 1 day following each vac- forms. cination It is administered as an aid in § 520.2150a Stanozolol tablets. the prevention or control of losses due (a) Specifications. Each tablet con- to CRD associated with M. gallisepticum tains 2 milligrams of stanozolol. (PPLO). Do not administer to laying (b) Sponsor. No. 000009 in § 510.600(c) of chickens. Do not administer within 5 this chapter. days of slaughter. (c) Conditions of use. (1) Used as an (2) It is administered in the drinking anabolic steroid treatment in dogs and water of floor-raised broiler chickens cats. at 0.5 gram of spectinomycin per gallon (2) Administered orally to cats and of water as the only source of drinking small breeds of dogs, 1⁄2 to 1 tablet water for the first 3 days of life and for twice daily for several weeks; to large 1 day following each vaccination. It is breeds of dogs, 1 to 2 tablets twice administered for increased rate of daily for several weeks. The tablets weight gain and improved feed effi- may be crushed and administered in ciency. Do not administer to laying feed. chickens. Do not administer within 5 (3) Federal law restricts this drug to days of slaughter. use by or on the order of a licensed vet- (3) It is administered in drinking erinarian. water of broiler chickens at 1 gram of [40 FR 46101, Oct. 6, 1975, as amended at 42 FR spectinomycin per gallon of water as 36995, July 19, 1977. Redesignated at 50 FR the only source of drinking water for 38114, Sept. 20, 1985, and amended at 55 FR the first 3 to 5 days of life as an aid in 23076, June 6, 1990] controlling infectious synovitis due to § 520.2150b Stanozolol chewable tab- Mycoplasma synoviae. Do not admin- lets. ister to laying chickens. Do not admin- (a) Specifications. Each chewable tab- ister within 5 days of slaughter. let contains 2 milligrams of stanozolol. [40 FR 13838, Mar. 27, 1975, as amended at 45 (b) Sponsor. No. 000009 in § 510.600(c) of FR 56798, Aug. 26, 1980; 66 FR 14073, Mar. 9, this chapter. 2001; 68 FR 4915, Jan. 31, 2003] (c) Conditions of use. (1) Used as an anabolic steroid treatment in dogs. (2) Administered orally to small breeds of dogs, 1⁄2 to 1 tablet twice daily

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for several weeks; to large breeds of streptomycin. Consult a veterinarian dogs, 1 to 2 tablets twice daily for sev- or animal pathologist for diagnosis. eral weeks. [57 FR 37327, Aug. 18, 1992, as amended at 58 (3) Federal law restricts this drug to FR 47211, Sept. 8, 1993; 63 FR 51821, Sept. 29, use by or on the order of a licensed vet- 1998] erinarian. § 520.2158b Dihydrostreptomycin tab- [50 FR 38114, Sept. 20, 1985, as amended at 55 lets. FR 23076, June 6, 1990] (a) Specifications. Each tablet con- § 520.2158 Streptomycin/dihydro- tains 37.5 milligrams dihydrostrepto- streptomycin oral dosage forms. mycin (as the sulfate) with 375 milli- grams chlorhexidine dihydrochloride. § 520.2158a Streptomycin sulfate oral (b) Sponsor. See No. 000856 in solution. § 510.600(c) of this chapter. (a) Specifications. Solution containing (c) Related tolerances. See §§ 556.120 25 percent streptomycin sulfate. and 556.200 of this chapter. (b) Sponsor. See Nos. 033008 and 055462 (d) Conditions of use. Calves—(1) in § 510.600(c) of this chapter. Amount. 150 milligrams of dihydro- (c) Related tolerances. See § 556.610 of streptomycin and 1.5 grams of this chapter. chlorhexidine dihydrochloride per 100 (d) Conditions of use. Use in drinking pounds of body weight per day. water as follows: (2) Indications for use. Treatment of (1) Calves and swine—(i) Amount. 10 to bacterial scours in calves. 15 milligrams per pound (mg/pound) of (3) Limitations. Administer orally body weight (1.0 to 1.5 grams per gal- once a day for 5 days; withdraw 3 days lon). before slaughter. (ii) Indications for use. Treatment of bacterial enteritis caused by Esch- [57 FR 37327, Aug. 18, 1992; 57 FR 42623, Sept. 15, 1992] erichia coli and Salmonella spp. suscep- tible to streptomycin. § 520.2158c Dihydrostreptomycin oral (iii) Limitations. Calves: Do not ad- suspension. minister for more than 5 days. Swine: (a) Specifications. Each milliliter con- Do not administer for more than 4 tains 1.25 milligrams dihydrostrepto- days. Prepare fresh solution daily. mycin (as the sulfate) with 12.5 milli- Calves: Withdraw 2 days before slaugh- grams chlorhexidine dihydrochloride. ter. As sole source of streptomycin. (b) See No. 000856 in Warning: Certain strains of bacteria Sponsor. § 510.600(c) of this chapter. may develop a tolerance for strepto- mycin. Consult a veterinarian or ani- (c) Related tolerances. See §§ 556.120 mal pathologist for diagnosis. and 556.200 of this chapter. (2) Chickens—(i) Amount. 10 to 15 mg/ (d) Conditions of use. Calves—(1) pound of body weight (0.6 to 0.9 grams Amount. 150 milligrams of dihydro- per gallon). streptomycin and 1.5 grams of chlorhexidine dihydrochloride per 100 (ii) Indications for use. Treatment of pounds of body weight per day. nonspecific infectious enteritis caused by organisms susceptible to strepto- (2) Indications for use. Treatment of mycin. bacterial scours in calves. (iii) Limitations. Chickens: Do not ad- (3) Limitations. Administer orally minister for more than 5 days. With- once a day for 5 days; withdraw 3 days draw 4 days before slaughter. Do not before slaughter. administer to chickens producing eggs [57 FR 37327, Aug. 18, 1992] for human consumption. Prepare fresh solution daily. As sole source of strep- tomycin. Warning: Certain strains of bacteria may develop a tolerance for

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§ 520.2160 Styrylpyridinium, (2) Indications for use. Treatment of diethylcarbamazine oral dosage coccidiosis. forms. (3) Limitations. Administer in drink- ing water for 3 days as sole source of § 520.2170 Sulfabromomethazine so- drinking water and sulfonamide medi- dium boluses. cation; withdraw 4 days prior to (a) Specifications. Each bolus contains slaughter; not to be administered to 15 grams of sulfabromomethazine so- chickens producing eggs for human dium. consumption. (b) Related tolerance. See § 556.620 of this chapter. [40 FR 13838, Mar. 27, 1975, as amended at 50 (c) Sponsor. See No. 050604 in FR 41489, Oct. 11, 1985; 54 FR 12188, Mar. 24, 1989; 55 FR 8460, Mar. 8, 1990; 64 FR 15684, Apr. § 510.600(c) of this chapter. 1, 1999; 67 FR 78355, Dec. 24, 2002] (d) NAS/NRC status. These conditions of use are NAS/NRC reviewed and found § 520.2200 Sulfachlorpyridazine oral effective. NADA’s for these uses need dosage forms. not include effectiveness data as speci- fied by § 514.111 of this chapter, but § 520.2200a Sulfachlorpyridazine may require bioequivalency and safety bolus. information. (a) Chemical name. N′-6-(Chloro-3- (e) Conditions of use. Cattle—(1) pyridazinyl) sulfanilamide. Amount. 90 milligrams per pound body (b) Specifications. Melting point weight. range: 190 °C to 191 °C. (2) Indications for use. Treatment of (c) Sponsor. See No. 053501 in necrotic pododermatitis (foot rot) and § 510.600(c) of this chapter. calf diphtheria caused by Fusobacterium (d) Related tolerances. See § 556.630 of necrophorum; colibacillosis (scours) this chapter. caused by Escherichia coli; bacterial (e) Conditions of use. It is used in pneumonia and bovine respiratory dis- calves as follows: ease complex (shipping fever complex) (1) Amount. 30 to 45 milligrams per associated with Pasteurella spp.; acute pound body weight per day. metritis and acute mastitis caused by (2) Indications for use. Treatment of Streptococcus spp. diarrhea caused or complicated by E. (3) Limitations. Administer orally; re- coli (colibacillosis). peat in 48 hours if necessary; milk taken from animals within 96 hours (8 (3) Limitations. Administer in a bolus milkings) of latest treatment must not containing 2 grams of be used for food; do not administer sulfachlorpyridazine for 1 to 5 days in within 18 days of slaughter; dis- divided doses twice daily; treated continue use if hematuria, crystalluria calves must not be slaughtered for food or severe depression are noticed; if during treatment or for 7 days after signs persist after 2 or 3 days consult a the last treatment. veterinarian. [40 FR 13838, Mar. 27, 1975, as amended at 50 FR 41489, Oct. 11, 1985] [47 FR 30243, July 13, 1982, as amended at 62 FR 63270, Nov. 28, 1997] § 520.2200b Sulfachlorpyridazine medi- § 520.2184 Sodium sulfachloropyrazine cated milk and drinking water. monohydrate. (a) Chemical name. N′-(6-Chloro-3- (a) Chemical name. 2-Sulfamido-6- pyridazinyl) sulfanilamide. chloroxyrazine, sodium. (b) Specifications. Melting point (b) Sponsor. See Nos. 053501 in range: 190 °C to 191 °C. § 510.600(c) of this chapter. (c) Sponsor. See No. 053501 in (c) Related tolerances. See § 556.625 of § 510.600(c) of this chapter. this chapter. (d) Related tolerances. See § 556.630 of (d) Conditions of use. It is used in the this chapter. drinking water of broilers, breeder (e) Conditions of use. It is used as fol- flocks, and replacement chickens as lows: follows: (1) Calves—(i) Amount. 30 to 45 milli- (1) Amount. 0.03 percent. grams per pound body weight per day.

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(ii) Indications for use. Treatment of pounds of body weight daily, in two or diarrhea caused or complicated by E. three divided doses. coli (colibacillosis). (3) The administration of the drug (iii) Limitations. Administer as the so- should be discontinued if a response is dium salt of sulfachlorpyridazine in not noted within 7 to 10 days. milk or milk-replacer formulations for (4) Federal law restricts this drug to 1 to 5 days in divided doses twice daily; use by or on the order of a licensed vet- treated calves must not be slaughtered erinarian. for food during treatment or for 7 days [43 FR 36622, Aug. 18, 1978, as amended at 50 after the last treatment. FR 41489, Oct. 11, 1985] (2) Swine—(i) Amount. 20 to 35 milli- grams per pound body weight per day. § 520.2215 Sulfadiazine/pyrimethamine (a) Indications for use. Treatment of suspension. diarrhea caused or complicated by E. (a) Specifications. Each milliliter coli (colibacillosis). (mL) of suspension contains 250 milli- (b) Limitations. Administer as the so- grams (mg) sulfadiazine (as the sodium dium salt of sulfachlorpyridazine in salt) and 12.5 mg pyrimethamine. drinking water for 1 to 5 days; for indi- (b) Sponsor. See No. 068718 in vidual treatment, administer orally in § 510.600(c) of this chapter. divided doses twice daily; treated swine (c) Conditions of use in horses—(1) must not be slaughtered for food dur- Amount. Administer orally 20 mg sulfa- ing treatment or for 4 days after the diazine per kilogram (kg) body weight last treatment. and 1 mg/kg pyrimethamine daily. (ii) Amount. 20 to 35 milligrams per (2) Indications for use. For the treat- pound body weight per day. ment of equine protozoal (a) Indications for use. Treatment of myeloencephalitis (EPM) caused by diarrhea caused or complicated by E. Sarcocystis neurona. coli (colibacillosis). (3) Limitations. Not for use in horses (b) Limitations. Administer individ- intended for food. Federal law restricts ually in an oral suspension containing this drug to use by or on the order of a 50 milligrams of sulfachlorpyridazine licensed veterinarian. per milliliter in divided doses twice [69 FR 70054, Dec. 2, 2004] daily for 1 to 5 days; treated swine must not be slaughtered for food dur- § 520.2220 Sulfadimethoxine oral dos- ing treatment or for 4 days after the age forms. last treatment. § 520.2220a Sulfadimethoxine oral so- [40 FR 13838, Mar. 27, 1975, as amended at 50 lution and soluble powder. FR 41489, Oct. 11, 1985] (a) Approvals. (1) For oral solution containing 12.5 percent (3.75 grams per § 520.2200c Sulfachlorpyridazine tab- ounce) sulfadimethoxine, see Nos. lets. 000010, 000069, 051259, 057561, and 059130 (a) Specifications. in § 510.600(c). Sulfachlorpyridazine tablets contain (2) For soluble powder, each package 250 milligrams of sulfachlorpyridazine containing the equivalent of 94.6 grams per tablet. of sulfadimethoxine (as the sodium (b) Sponsor. See No. 053501 in salt), see Nos. 000069, 051259, 057561, and § 510.600(c) of this chapter. 059130 in § 510.600(c). (c) Conditions of use. (1) The drug is (b) Special considerations. Chickens used in dogs as a broad spectrum anti- and turkeys that have survived fowl bacterial agent to aid in the treatment cholera outbreaks should not be kept of infectious tracheobronchitis and in- for replacements or breeders. fections caused by E. coli. It can also be (c) Related tolerances. See § 556.640 of used in the treatment of infections this chapter. caused by other gram-positive and (d) Conditions of use. The oral solu- gram-negative organisms that are sus- tion is administered as a cattle drench ceptible to sulfonamide therapy. or diluted as directed to prepare drink- (2) It is administered orally at a dos- ing water. The powder is used to pre- age level of 500 milligrams per 10 to 15 pare a drench or drinking water. The

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concentrations and uses of the various § 520.2220b Sulfadimethoxine tablets solutions are as follows: and boluses. (1) Broiler and replacement chickens (a) Sponsors. Approval to firms iden- only. (i) Amount. 1.875 (0.05 percent) tified in § 510.600(c) of this chapter as grams per gallon. follows: (ii) Indications for use. Treatment of (1) To 000069, approval for use as in disease outbreaks of coccidiosis, fowl paragraphs (d)(1), (d)(2), and (d)(3) of cholera, and infectious coryza. this section. (iii) Limitations. Administer for 6 con- (2) To 000061, approval for use as in secutive days; do not administer to paragraph (d)(2). chickens over 16 weeks of age; as sole (b) Related tolerances. See § 556.640 of source of drinking water and sul- this chapter. fonamide medication; as (c) [Reserved] (d) It is used as follows: sulfadimethoxine solution or (1) Cattle—(i) Amount. 1.25 to 2.5 sulfadimethoxine soluble sodium salt; grams per 100 pounds body weight. withdraw 5 days before slaughter. (ii) Indications for use. Treatment of (2) Meat-producing turkeys only—(i) foot rot, bacterial pneumonia, shipping Amount. 0.938 (0.025 percent) grams per fever, and calf diphtheria. gallon. (iii) Limitations. Administer 2.5 grams (ii) Indications for use. Treatment of per 100 pounds body weight for 1 day disease outbreaks of coccidiosis and followed by 1.25 grams per 100 pounds fowl cholera. body weight per day; treat from 4 to 5 (iii) Limitations. Administer for 6 con- days; do not administer within 7 days secutive days; do not administer to of slaughter; milk that has been taken turkeys over 24 weeks of age; as sole from animals during treatment and 60 source of drinking water and sul- hours (5 milkings) after the latest fonamide medication; as treatment must not be used for food. sulfadimethoxine solution or (2) Dogs and cats. (i) Amount. 12.5 to 25 sulfadimethoxine soluble sodium salt; milligrams per pound of body weight. (ii) Indications for use. Treatment of withdraw 5 days before slaughter. sulfadimethoxine-susceptible bacterial (3) Dairy calves, dairy heifers, and beef infections. cattle only—(i) Amount. 1.18 to 2.36 (0.031 (iii) Limitations. Administer 25 milli- to 0.062 percent) grams per gallon. grams per pound of body weight on the (ii) Indications for use. Treatment of first day followed by 12.5 milligrams shipping fever complex, bacterial pneu- per pound of body weight per day until monia, calf diphtheria, and foot rot. the animal is free of symptoms for 48 (iii) Administer 2.5 grams per 100 hours. Federal law restricts this drug pounds of body weight for first day, to use by or on the order of a licensed then 1.25 grams per 100 pounds of body veterinarian. weight per day for the next 4 consecu- (3) Beef cattle and nonlactating dairy tive days; in drinking water or drench; cattle—(i) Amount. 12.5-gram-sustained- available as a sulfadimethoxine soluble release bolus. powder or a 12.5 percent (ii) Indications for use. Treatment of sulfadimethoxine sodium solution (3.75 shipping fever complex and bacterial grams sulfadimethoxine per fluid pneumonia associated with organisms ounce); if no improvement within 2 to 3 such as Pasteurella spp. sensitive to days, reevaluate diagnosis; do not treat sulfadimethoxine; calf diphtheria and foot rot associated with Sphaerophorus beyond 5 days; withdraw 7 days before necrophorus sensitive to slaughter. sulfadimethoxine. [40 FR 13838, Mar. 27, 1975, as amended at 58 (iii) Limitations. Administer one bolus FR 6092, Jan. 26, 1993; 59 FR 56000, Nov. 10, for the nearest 200 pounds of body 1994; 61 FR 4875, Feb. 9, 1996; 62 FR 8371, Feb. weight, i.e., 62.5 milligrams per pound 25, 1997; 62 FR 23357, Apr. 30, 1997; 62 FR 35076, of body weight. Do not repeat treat- June 30, 1997; 62 FR 40932, July 31, 1997; 63 FR ment for 7 days. Do not use in lac- 59714, Nov. 5, 1998; 64 FR 18572, Apr. 15, 1999] tating dairy cattle. Do not administer within 12 days of slaughter. During

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treatment make certain that animals low with a daily dosage of 12.5 milli- maintain adequate water intake. Fed- grams per pound (27.5 milligrams per eral law restricts this drug to use by or kilogram) of body weight. on the order of a licensed veterinarian. (2) Indications of use. Treatment of [40 FR 13838, Mar. 27, 1975, as amended at 40 skin and soft tissue infections (wounds FR 43488, Sept. 22, 1975; 49 FR 36830, Sept. 20, and abscesses) in dogs caused by 1984; 59 FR 56000, Nov. 10, 1994; 61 FR 4875, strains of Staphylococcus aureus and Feb. 9, 1996; 62 FR 61625, Nov. 19, 1997; 64 FR Escherichia coli and urinary tract infec- 15684, Apr. 1, 1999] tions caused by Escherichia coli, Staphlococcus spp., and Proteus mirabilus § 520.2220c Sulfadimethoxine oral sus- susceptible to ormetoprim-potentiated pension. sulfadimethoxine. (a) Chemical name. N′-(2,6-Dimethoxy- (3) Limitations. Continue treatment 4-pyrimidinyl) sulfanilamide. until patient is asymptomatic for 48 (b) Specifications. Each milliliter of hours, but do not exceed a total of 21 the drug contains 50 milligrams of consecutive days. Maintain adequate sulfadimethoxine. water intake during the treatment pe- (c) Sponsor. See Nos. 000061 and 000069 riod. Safety in breeding animals has in § 510.600(c) of this chapter. not been established. Federal law re- (1) It is intended for use in the treat- stricts this drug to use by or on the ment of sulfonamide susceptible bac- order of a licensed veterinarian. terial infections in dogs and cats and enteritis associated with coccidiosis in [54 FR 48593, Nov. 24, 1989, as amended at 59 dogs. FR 56000, Nov. 10, 1994; 61 FR 4875, Feb. 9, (2) On the first day of treatment ad- 1996; 61 FR 46719, Sept. 5, 1996] minister an oral dose of 25 milligrams § 520.2240 Sulfaethoxypyridazine. per pound of body weight, then follow with a daily dosage of 12.5 milligrams § 520.2240a Sulfaethoxypyridazine per pound of body weight. Length of drinking water. treatment will depend upon clinical re- (a) ′-(6-Ethoxy-3- sponse. Continue treatment until pa- Chemical name. N pyridazinyl) sulfanilamide. tient is asymptomatic for 48 hours. Maintain adequate water intake during (b) Specifications. Melting point range ° ° the treatment period. of 180 C. to 186 C. (3) For use only by or on the order of (c) Sponsor. See No. 053501 in a licensed veterinarian. § 510.600(c) of this chapter. (d) Related tolerances. See § 556.650 of [40 FR 13838, Mar. 27, 1975, as amended at 59 this chapter. FR 56000, Nov. 10, 1994; 61 FR 4875, Feb. 9, 1996; 62 FR 61625, Nov. 19, 1997] (e) Conditions of use. It is used as fol- lows: § 520.2220d Sulfadimethoxine- (1) Swine—(i) Amount. 1.9 to 3.8 grams ormetoprim tablets. per gallon (0.05 percent to 0.1 percent). (a) Specifications. Each tablet con- (ii) Indications for use. Treatment of tains 120 milligrams (100 milligrams of bacterial scours pneumonia enteritis, sulfadimethoxine and 20 milligrams of bronchitis, septicemia accompanying ormetoprim), 240 milligrams (200 milli- Salmonella cholerasuis infection. grams of sulfadimethoxine and 40 milli- (iii) Limitations. Administer 3.8 grams grams of ormetoprim), 600 milligrams per gallon for first day followed by 1.9 (500 milligrams of sulfadimethoxine grams per gallon for not less than 3 and 100 milligrams of ormetoprim), or days nor more than 9 days as sodium 1200 milligrams (1,000 milligrams of sulfaethoxypyridazine; do not treat sulfadimethoxine and 200 milligrams of within 10 days of slaughter; as sole ormetoprim). source of sulfonamide; for use by or on (b) Sponsor. See No. 000069 in the order of a licensed veterinarian. § 510.600(c) of this chapter. (2) Cattle—(i) Amount. 2.5 grams per (c) Conditions of use—(1) Amount. On gallon (0.066 percent). the first day of treatment, administer (ii) Indications for use. Treatment of 25 milligrams per pound (55 milligrams respiratory infections (pneumonia, per kilogram) of body weight. Then fol- shipping fever), foot rot, calf scours; as

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adjunctive therapy in septicemia ac- treat within 16 days of slaughter; as companying mastitis and metritis. sole source of sulfonamide; not for use (iii) Limitations. Administer at the in lactating dairy cows; Federal law re- rate of 1 gallon per 100 pounds of body stricts this drug to use by or on the weight per day for 4 days; as sodium order of a licensed veterinarian. sulfaethoxypyridazine; do not treat within 16 days of slaughter; as sole [40 FR 13838, Mar. 27, 1975, as amended at 67 source of sulfonamide; for use by or on FR 78355, Dec. 24, 2002] the order of a licensed veterinarian; § 520.2260 Sulfamethazine oral dosage milk that has been taken from animals forms. during treatment and for 72 hours (6 milkings) after latest treatment must § 520.2260a Sulfamethazine oblet, tab- not be used for food. let, and bolus. [40 FR 13838, Mar. 27, 1975, as amended at 67 (a)(1) Sponsor. See No. 053501 in FR 78355, Dec. 24, 2002] § 510.600(c) of this chapter for use of 2.5- , 5-, and 15-gram sulfamethazine oblet § 520.2240b Sulfaethoxypyridazine tab- in beef cattle, nonlactating dairy cat- lets. tle, and horses. See No. 061690 in (a) Chemical name. N′-(6-Ethoxy-3- § 510.600(c) of this chapter for use of 5- pyridazinyl) sulfanilamide. , 15-, and 25-gram tablet in beef and (b) Specifications. Melting point range nonlactating dairy cattle. ° ° of 180 C to 186 C. (2) Related tolerance in edible products. (c) Sponsor. See No. 053501 in See § 556.670 of this chapter. § 510.600(c) of this chapter. (3) Conditions of use—(i) Amount. Ad- (d) Related tolerances. See § 556.650 of minister as a single dose 100 milligrams this chapter. of sulfamethazine per pound of body (e) Conditions of use. It is used for cat- weight the first day and 50 milligrams tle as follows: per pound of body weight on each fol- (1) Amount. 2.5 or 15 grams per tablet. lowing day. (i) Indications for use. Treatment of respiratory infections (pneumonia, (ii) Indications for use. For treatment shipping fever), foot rot, calf scours; as of diseases caused by organisms suscep- adjunctive therapy in septicemia ac- tible to sulfamethazine. companying mastitis and metritis. (A) Beef cattle and nonlactating dairy (ii) Limitations. Administer 25 milli- cattle. Treatment of bacterial pneu- grams per pound of animal weight per monia and bovine respiratory disease day for 4 days; do not treat within 16 complex (shipping fever complex) days of slaughter; as sole source of sul- (Pasteurella spp.), colibacillosis (bac- fonamide; milk that has been taken terial scours) (Escherichia coli), necrotic from animals during treatment and for pododermatitis (foot rot) 72 hours (6 milkings) after the latest (Fusobacterium necrophorum), calf diph- treatment must not be used for food; theria (Fusobacterium necrophorum), for use only by or on the order of a li- acute mastitis (Streptococcus spp.), censed veterinarian. acute metritis (Streptococcus spp.), coc- (2) Amount. 15-gram controlled re- cidiosis (Eimeria bovis and Eimeria lease tablets. zurnii). (i) Indications for use. Treatment of (B) Horses. Treatment of bacterial foot rot and respiratory infections pneumonia (secondary infections asso- (shipping fever and pneumonia) caused ciated with Pasteurella spp.), strangles by sulfonamide-susceptible pathogens (Streptococcus equi), and bacterial en- (E. coli, streptococci, staphylococci, teritis (Escherichia coli). Sphaerophorus necrophorus and Gram- (iii) Limitations. Administer daily negative rods including Pasteurella); for until animal’s temperature and appear- use prophylactically in cattle during ance are normal. If symptoms persist periods of stress for reducing losses due after using for 2 or 3 days consult a to sulfonamide sensitive disease condi- veterinarian. Fluid intake must be ade- tions. quate. Treatment should continue 24 to (ii) Limitations. Administer 100 milli- 48 hours beyond the remission of dis- grams per pound of body weight; do not ease symptoms, but not to exceed 5

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consecutive days. Follow dosages care- weight; 5 days—1 bolus per 100 pounds fully. Not for use in lactating dairy of body weight. animals. Do not treat cattle within 10 (ii) Indications for use. Beef and non- days of slaughter. Not to be used in lactating cattle for sustained treat- horses intended for food. ment of shipping fever pneumonia (b)(1) Sponsor. See No. 053501 in caused or complicated by Pasteurella § 510.600(c) of this chapter for use of 5- multocida; as an aid in the treatment of gram sulfamethazine bolus. foot rot, mastitis, pneumonia, metritis, (2) Related tolerances in edible prod- bacterial enteritis, calf diphtheria, and ucts. See § 556.670 of this chapter. septicemia when caused or complicated (3) Conditions of use—(i) Amount. Ad- by bacteria susceptible to minister 10 grams (2 boluses) of sulfamethazine. sulfamethazine per 100 pounds of body (iii) Limitations. Cattle that are weight the first day, then 5 grams (1 acutely ill should be treated bolus) of sulfamethazine per 100 pounds parenterally with a suitable anti- of body weight daily for up to 4 addi- bacterial product to obtain immediate tional consecutive days. therapeutic blood levels; do not slaugh- (ii) Indications for use. Ruminating ter animals for food within 16 days of beef and dairy calves. For treatment of treatment; do not use in lactating the following diseases caused by orga- dairy cattle; Federal law restricts this nisms susceptible to sulfamethazine: drug to use by or on the order of a li- bacterial scours (colibacilloosis) caused censed veterinarian. by E. coli; necrotic pododermatitis (foot (b)(1) Sponsor. See No. 053501 in rot) and calf diphtheria caused by F. § 510.600(c) of this chapter for use of a necrophorum; bacterial pneumonia asso- 27-gram sulfamethazine sustained-re- ciated with Pasteurella spp.; and coc- lease bolus. cidiosis caused by E. bovis and E. zurnii. (2) Conditions of use—(i) Amount. 27 (iii) Limitations. Do not administer grams (1 bolus) for each 150 pounds of for more than 5 consecutive days. Do body weight as a single dose. not treat calves within 11 days of (ii) Indications for use. For nonlac- slaughter. Do not use in calves to be tating cattle for the treatment of in- slaughtered under 1 month of age or in fections caused by organisms sensitive calves being fed an all milk diet. Do to sulfamethazine such as hemorrhagic not use in female dairy cattle 20 septicemia (shipping fever complex), months of age or older; such use may bacterial pneumonia, foot rot, and calf cause drug residues in milk. Admin- diphtheria and as an aid in the control ister with adequate supervision. Fol- of bacterial diseases usually associated lows recomended dosages carefully. with shipping and handling of cattle. Fluid intake must be adequate. If (iii) Limitations. If no response within symptoms persist after 2 or 3 days, con- 2 to 3 days, reevaluate therapy; do not sult a veterinarian. crush tablets; treated animals must [54 FR 15751, Apr. 19, 1989; 54 FR 19283, May 4, not be slaughtered for food within 28 1989, as amended at 56 FR 50653, Oct. 8, 1991; days after the latest treatment; Fed- 59 FR 22754, May 3, 1994; 61 FR 4875, Feb. 9, eral law restricts this drug to use by or 1996; 64 FR 66383, Nov. 26, 1999; 67 FR 78355, on the order of a licensed veterinarian. Dec. 24, 2002] (c)(1) Sponsor. See No. 061623 in § 510.600(c) of this chapter for use of a § 520.2260b Sulfamethazine sustained- release boluses. 32.1-gram sustained-release bolus. (2) Conditions of use—(i) Amount. 32.1 (a)(1) Sponsor. See No. 000859 in grams (1 bolus) per 200 pounds of body § 510.600(c) of this chapter for use of a weight.1 22.5-gram sulfamethazine prolonged-re- lease bolus. 1 (2) Conditions of use—(i) Amount. De- These conditions are NAS/NRC reviewed and found effective. Applications for these pending on the duration of therapeutic uses need not inlcude effectiveness data as levels desired, administer boluses as a specified by § 514.111 of this chapter, but may single dose as follows: 31⁄2 days—1 bolus require bioequivalency and safety informa- (22.5 grams) per 200 pounds of body tion.

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(ii) Indications for use. For beef and (iii) Limitations. Cattle that are nonlactating dairy cattle for the treat- acutely ill should be treated by injec- ment of diseases caused by tion with a suitable antibacterial prod- sulfamethazine-sensitive organisms as uct to obtain immediate therapeutic follows: bacterial pneumonia and bo- blood levels; do not slaughter animals vine respiratory disease complex (ship- for food within 16 days of treatment; do ping fever complex) caused by not use in lactating diary cattle; if Pasteurella spp., colibacillosis (bac- treated animals do not respond within terial scours) caused by E. coli, necrotic 2 to 3 days, consult a veterinarian. pododermatitis (foot rot) and calf diph- (e)(1) Sponsor. See No. 061623 in theria caused by Fusobacterium § 510.600(c) of this chapter for use of an necrophorum, and acute mastitis and 8.02-gram sulfamethazine sustained-re- acute metritis caused by Streptococcus lease bolus. spp.)1 (2) Conditions of use—(i) Amount. Ad- (iii) Limitations. After 72 hours, all minister 2 boluses (8.02 grams per animals should be reexamined for per- bolus) per 100 pounds of body weight, as sistence of observable disease signs. If a single dose. signs are present, consult a veteri- (ii) Indications for use. Administer narian. It is strongly recommended orally to ruminating calves for the pro- that a second dose be given to provide longed treatment of the following dis- for an additional 72 hours of therapy, eases when caused by one or more of particularly in more severe cases. The the listed pathogenic organisms sen- dosage schedule should be used at each sitive to sulfamethazine: bacterial 72-hour interval. Animals should not pneumonia (Pasteurella spp.), receive more than 2 doses because of colibacillosis (bacterial scours) (E. the possibility of incurring residue vio- coli), and calf diptheria (Fusobacterium lations. This drug, like all necrophorum). sulfonamides, may cause toxic reac- (iii) Limitations. For use in rumi- tions and irreparable injury unless ad- nating replacement calves only; 72 hours after dosing all animals should ministered with adequate and contin- be reexamined for persistence of dis- uous supervision; follow dosages care- ease signs; if signs are present, consult fully. Fluid intake must be adequate at a veterinarian; do not slaughter ani- all times throughout the 3-day ther- mals for food for at least 12 days after apy, Do not use in lactating dairy cat- the last dose; this product has not been tle. Do not treat animals within 12 shown to be effective for nonrumi- days of slaughter. nating calves; exceeding two consecu- (d)(1) Sponsor. See 000859 in § 510.600(c) tive doses may cause violative tissue of this chapter for use of a 22.5-gram residue to remain beyond the with- sulfamethazine sustained release bolus. drawal time; do not use in calves under (2) Conditions of use—(i) Amount. Ad- 1 month of age or calves being fed an minister 1 bolus (22.5 grams) per 200 all milk diet. pounds of body weight, as a single dose. (f)(1) Sponsor. See No. 059130 in (ii) Indications for use. Beef and non- § 510.600(c) of this chapter for use of a lactating dairy cattle for the prolonged 30-gram sulfamethazine sustained-re- treatment of the following diseases lease bolus. when caused by one or more of the list- (2) Conditions of use—(i) Amount. Ad- ed pathogenic organisms sensitive to minister at the rate of 1 bolus (30 sulfamethazine: bovine respiratory dis- grams per bolus) per 200 pounds of body ease complex (shipping fever complex) weight, as a single dose. (Pasteurella spp.), bacterial pneumonia (ii) Indications for use. Administer (Pasteurella spp.), necrotic orally to beef cattle and nonlactating pododermatitis (foot rot) dairy cattle for the treatment of the (Fusobacterium necrophorum), following diseases when caused by one colibacillosis (bacterial scours) or more of the listed pathogenic orga- (Escherichia coli), calf diphtheria nisms sensitive to sulfamethazine: bo- (Fusobacterium necrophorum), acute vine respiratory disease complex (ship- mastitis (Streptococcus spp.) and acute ping fever complex) associated with metritis (Streptococcus spp.). Pasteurella spp.; bacterial pneumonia

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associated with Pasteurell spp.; necrotic animals for food for at least 8 days pododermatitis (foot rot) and calf diph- after the last dose. Do not crush bolus. theria caused by Fusobacterium [46 FR 36132, July 14, 1981, as amended at 48 necrophorum; colibacillosis (bacterial FR 18803, Apr. 26, 1983; 48 FR 32760, July 19, scours) caused by Escherichia coli; coc- 1983; 49 FR 29057, July 18, 1984; 50 FR 49372, cidiosis caused by Eimeria bovis and E. Dec. 2, 1985; 51 FR 30212, Aug. 25, 1986; 53 FR zurnii; acute mastitis and metritis 40727, Oct. 18, 1988; 54 FR 14341, Apr. 11, 1989; 55 FR 8462, Mar. 8, 1990; 56 FR 50653, Oct. 8, caused by Streptococcus spp. 1991; 59 FR 22754, May 3, 1994; 61 FR 4875, Feb. (iii) Limitations. For use in beef cattle 9, 1996; 62 FR 35076, June 30, 1997; 66 FR 14073, and nonlactating dairy cattle only; if Mar. 9, 2001; 68 FR 4915, Jan. 31, 2003; 70 FR symptoms persist for 2 or 3 days after 8290, Feb. 18, 2005] use, consult a veterinarian; do not slaughter animals for food for at least § 520.2260c Sulfamethazine sustained- release tablets. 8 days after the last dose; do not use in lactating dairy cattle; do not admin- (a) Sponsor. See No. 053501 in ister more than two consecutive doses. § 510.600(c) of this chapter for use of an 8-gram sulfamethazine sustained-re- (g) Related tolerances. See § 556.670 of lease tablet. this chapter. (b) Conditions of use—(1) Amount. 8 (h)(1) Sponsor. See No. 000010 in grams (1 tablet) per 45 pounds of body § 510.600(c) of this chapter for use of an weight as a single dose. 8.25-gram sulfamethazine sustained-re- (2) Indications for use. In calves for lease bolus. sustained treatment of pneumonia (2) Conditions of use—(i) Amount. Ad- caused by Pasteurella spp., minister at the rate of 1 bolus (8.25 colibacillosis (bacterial scours) caused grams per bolus) per 50 pounds of body by Escherichia coli; and calf diptheria weight, as a single dose. If signs of dis- caused by Fusobacterium necrophorum. ease are significantly reduced, it is rec- (3) Limitations. If there is no response ommended that a second dose be given within 2 to 3 days, reevaluate therapy. to provide an additional 72 hours of Do not crush tablets. Treated animals therapy. must not be slaughtered for food with- (ii) Indications for use. Administer in 18 days after the latest treatment. orally to ruminating beef and dairy Federal law restricts this drug to use calves for treatment of the following by or on the order of a licensed veteri- diseases when caused by one or more of narian. the listed pathogenic organisms sus- [48 FR 26763, June 10, 1983, as amended at 56 ceptible to sulfamethazine: bacterial FR 50653, Oct. 8, 1991; 59 FR 22754, May 3, 1994; pneumonia associated with Pasteurella 61 FR 4875, Feb. 9, 1996] spp.; colibacillosis (bacterial scours) § 520.2261 Sulfamethazine sodium oral caused by Escherichia coli; coccidiosis dosage forms. caused by Eimeria bovis and E. zurnii; and calf diphtheria caused by § 520.2261a Sulfamethazine sodium Fusobacterium necrophorum. drinking water solution. (iii) Limitations. Do not use in calves (a) Sponsors. See Nos. 017800 and to be slaughtered under 1 month of age 053501 in § 510.600(c) of this chapter for or calves being fed an all milk diet. Do use of a 12.5-percent sulfamethazine so- not use in female dairy cattle 20 dium solution. months of age or older. If symptoms (b) Related tolerances in edible prod- persist after 3 days, consult a veteri- ucts. See § 556.670 of this chapter. narian. Do not administer more than 2 (c) Conditions of use—(1) Amount. Ad- consecutive doses. Do not slaughter minister in drinking water to provide: Cattle and swine 112.5 milligrams of sulfamethazine sodium per pound of body weight per day on the first day and 56.25 milligrams per pound of body weight on subsequent days; Chickens, 61 to 89 milligrams of sulfamethazine sodium per pound of body weight per

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day, and turkeys 53 to 130 milligrams Medicated cattle, swine, chickens, and of sulfamethazine sodium per pound of turkeys must actually consume enough body weight per day, depending upon medicated water which provides the the dosage, age, and class of chickens recommended dosages. or turkeys, ambient temperature, and (d) NAS/NRC status. The conditions of other factors. use specified in this section have been (2) Indications for use. For treatment reviewed by NAS/NRC and are found ef- and control of diseases caused by orga- fective. Applications for these uses nisms sensitive to sulfamethazine. need not include effectiveness data as (i) Beef and nonlactating dairy cattle. specified by § 514.111 of this chapter, Treatment of bacterial pneumonia and but may require bioequivalency and bovine respiratory disease complex safety information. (shipping fever complex) (Pasteurella spp.), colibacillosis (bacterial scours) [47 FR 25322, June 11, 1982, as amended at 47 FR 25735, June 15, 1982; 67 FR 78355, Dec. 24, (Escherichia coli), necrotic 2002] pododermatitis (foot rot) (Fusobacterium necrophorum), calf diph- § 520.2261b Sulfamethazine sodium theria (Fusobacterium necrophorum), soluble powder. acute mastitis (Streptococcus spp.), and acute metritis (Streptococcus spp.). (a) Sponsor. See No. 053501 in (ii) Swine. Treatment of porcine § 510.600(c) of this chapter for use of a colibacillosis (bacterial scours) soluble powder composed of 100 percent (Escherichia coli), and bacterial pneu- sulfamethazine sodium. monia (Pasteurella spp.). (b) Related tolerances in edible prod- (iii) Chickens and turkeys. In chickens ucts. See § 556.670 of this chapter. for control of infectious coryza (c) Conditions of use—(1) Amount. Ad- (Haemophilus gallinarum), coccidiosis minister in drinking water to provide: (Eimeria tenella, Eimeria necatrix), acute Chickens 58 to 85 milligrams of fowl cholera (Pasteurella multocida), and sulfamethazine sodium per pound of pullorum disease (Salmonella pullorum). body weight per day; turkeys 50 to 124 In turkeys for control of coccidiosis milligrams of sulfamethazine sodium (Eimeria meleagrimitis, Eimeria per pound of body weight per day; de- adenoeides). Medicate as follows: Infec- pending upon the dosage, age, and class tious coryza in chickens, medicate for 2 of chickens or turkeys, ambient tem- consecutive days; acute fowl cholera perature, and other factors. Administer and pullorum disease, in chickens, to cattle and swine in drinking water, medicate for 6 consecutive days; coc- or as a drench, to provide 108 milli- cidiosis, in chickens and turkeys, grams of sulfamethazine sodium per medicate as in paragraph (c) of this pound of body weight on the first day section, then reduce amount of medica- and 54 milligrams of sulfamethazine so- tion to one-half for 4 additional days. dium per pound of body weight per day (3) Limitations. Add the required dose on the second, third, and fourth days of to that amount of water that will be administration. consumed in 1 day. Consumption (2) Indications for use. For treatment should be carefully checked. Have only and control of disease caused by orga- medicated water available during nisms sensitive to sulfamethazine. treatment. Withdraw medication from (i) Beef and nonlactating dairy cattle. cattle, chickens, and turkeys 10 days Treatment of bacterial pneumonia and prior to slaughter for food. Withdraw bovine respiratory disease complex medication from swine 15 days before (shipping fever complex) (Pasteurella slaughter for food. Not for use in lac- spp.), colibacillosis (bacterial scours) tating dairy cattle. Do not medicate (Escherichia coli), necrotic chickens or turkeys producing eggs for pododermatitis (foot rot) human consumption. Treatment of all (Fusobacterium necrophorum), calf diph- diseases should be instituted early. theria (Fusobacterium necrophorum), Treatment should continue 24 to 48 acute mastitis (Streptococcus spp.), and hours beyond the remission of disease acute metritis (Streptococcus spp.). symptoms, but not to exceed a total of (ii) Swine. Treatment of porcine 5 consecutive days in cattle or swine. colibacillosis (bacterial scours)

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(Escherichia coli), and bacterial pneu- (b) Sponsor. See No. 000856 in monia (Pasteurella spp.). § 510.600(c) of this chapter. (iii) Chickens and turkeys. In chickens (c) Conditions of use. (1) The drug is for control of infectious coryza indicated for the treatment of urinary (Haemophilus gallinarum), coccidiosis tract infections in dogs and cats such (Eimeria tenella, Eimeria necatrix), acute as cystitis, nephritis, prostatitis, ure- fowl cholera (Pasteurella multocida), and thritis, and pyelonephritis. It is also pullorum disease (Salmonella pullorum). used as an aid in the management of In turkeys for control of coccidiosis complications resulting from surgical (Eimeria meleagrimitis, Eimeria manipulations of the urinary tract adenoeides). Medicate as follows: Infec- such as removal of calculi from the tious coryza in chickens, medicate for 2 bladder, in ureterostomies, and in in- consecutive days; acute fowl cholera strumentation of the urethra and blad- and pullorum disease in chickens, der. medicate for 6 consecutive days; coc- (2) It is administered at a dosage cidiosis in chickens and turkeys, medi- level of one tablet for each 20 pounds of cate as in paragraph (c) of this section body weight given three times per day. for 2 days, then reduce drug concentra- The drug should be given until all signs tion to one-half for 4 additional days. are alleviated. To reduce the possi- (3) Limitations. Add the required dose bility of a relapse, it is suggested that to that amount of water that will be therapy be continued for a further pe- consumed in 1 day. Consumption riod of a week to 10 days. should be carefully checked. Have only (3) Federal law restricts this drug to medicated water available during use by or on the order of a licensed vet- treatment. Withdraw medication from erinarian. cattle, chickens, and turkeys 10 days [40 FR 13838, Mar. 27, 1975, as amended at 50 prior to slaughter for food. Withdraw FR 13561, Apr. 5, 1985] medication from swine 15 days prior to slaughter for food. Not for use in lac- § 520.2320 Sulfanitran and aklomide in tating dairy animals. Do not medicate combination. chickens or turkeys producing eggs for (a) Chemical names. (1) Sulfanitran: human consumption. Treatment of all Acetyl-(p-nitrophenyl)-sulfanilamide. diseases should be instituted early. (2) Aklomide: 2-Chloro-4- Treatment should continue 24 to 48 nitrobenzamide. hours beyond the remission of disease (b) Specifications. (1) Sulfanitran con- symptoms, but not to exceed a total of forms to the following specifications: 5 consecutive days in cattle or swine. (i) Melting point range: 260 °C. to 261 Medicated cattle, swine, chickens, and °C. turkeys must actually consume enough medicated water which provides the (ii) Assay (by sodium nitrite titra- recommended dosages. tion): 97 to 100.5 percent. (iii) Moisture (Method No. 6.123, (d) NAS/NRC status. The conditions of ‘‘Toluene Distillation Method—Official use specified in this section have been Final Action’’ in ‘‘Official Methods of reviewed by NAS/NRC and are found ef- Analysis of the Association of Official fective. Applications for these uses Analytical Chemists,’’ 13th Ed., 1980, p. need not include effectiveness data as 83. Copies are available from the Asso- specified by § 514.111 of this chapter, ciation of Official Analytical Chemists, but may require bioequivalency and 2200 Wilson Blvd., Suite 400, Arlington, safety information. VA 22201–3301, or at the National Ar- [47 FR 25322, June 11, 1982, as amended at 67 chives and Records Administration FR 78355, Dec. 24, 2002] (NARA). For information on the avail- ability of this material at NARA, call § 520.2280 Sulfamethizole and methe- 202–741–6030, or go to: http:// namine mandelate tablets. www.archives.gov/federallregister/ (a) Specifications. Each tablet con- codeloflfederallregulations/ tains 250 milligrams of sulfamethizole ibrllocations.html. : Not more than 2.0 and 250 milligrams of methenamine percent. mandelate. (iv) Molecular weight: 335.34.

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(v) Soluble in 0.1N sodium hydroxide, (4) No. 053501 for use of a 28.62-percent reprecipitating unchanged on acidifica- sulfaquinoxaline sodium solution as tion. provided in paragraphs (c)(1), (c)(2), and (2) Aklomide conforms to the fol- (c)(3) of this section. lowing specifications: (b) Related tolerances. See § 556.685 of (i) Minimum melting point: 170 °C. this chapter. (ii) Moisture content: Not to exceed (c) Conditions of use. It is used in 1.0 percent. drinking water as follows: (iii) Purity: Not less than 98 percent (1) Chickens. (i) As an aid in the con- on an anhydrous basis. trol of outbreaks of coccidiosis caused (c) Sponsor. See No. 053501 in by Eimeria tenella, E. necatrix, E. § 510.600(c) of this chapter. acervulina, E. maxima, and E. brunetti. (d) Related tolerances. See §§ 556.30 and (ii) Administer at the 0.04 percent 556.680 of this chapter. level for 2 or 3 days, skip 3 days then administer at the 0.025 percent level for (e) Conditions of use. It is used in the 2 more days. If bloody droppings ap- drinking water of chickens as follows: pear, repeat treatment at the 0.025 per- (1) Amount. 374–747 milligrams of cent level for 2 more days. Do not sulfanitran with 477–954 milligrams of change litter unless absolutely nec- aklomide. essary. Do not give flushing mashes. (2) Indications for use. As an aid in the (2) Turkeys. (i) As an aid in the con- treatment of coccidiosis caused by E. trol of outbreaks of coccidiosis caused tenella, E. necatrix, and E. acervulina. by Eimeria meleagrimitis and E. (3) Limitations. Administer for 2 days adenoeides. at 747 milligrams of sulfanitran per (ii) Administer at the 0.025 percent gallon and 954 milligrams of aklomide level for 2 days, skip 3 days, give for 2 per gallon, followed by 5 days at 374 days, skip 3 days and give for 2 more milligrams of sulfanitran per gallon days. Repeat if necessary. Do not and 477 milligrams of aklomide per gal- change litter unless absolutely nec- lon; do not treat birds over 6 weeks of essary. Do not give flushing mashes. age; do not administer within 5 days of (3) Chickens and turkeys. (i) As an aid slaughter; not for laying chickens. in the control of acute fowl cholera [40 FR 13838, Mar. 27, 1975, as amended at 47 caused by Pasteurella multocida suscep- FR 9396, Mar. 5, 1982; 54 FR 18280, Apr. 28, tible to sulfaquinoxaline and fowl ty- 1989; 55 FR 8460, Mar. 8, 1990] phoid caused by Salmonella gallinarum susceptible to sulfaquinoxaline. § 520.2325 Sulfaquinoxaline oral dos- (ii) Administer at the 0.04 percent age forms. level for 2 or 3 days. Move birds to clean ground. If disease recurs, repeat § 520.2325a Sulfaquinoxaline drinking treatment. If cholera has become es- water. tablished as the respiratory or chronic (a) Sponsor. See § 510.600(c) of this form, use feed medicated with chapter for identification of the spon- sulfaquinoxaline. Poultry which have sors. survived typhoid outbreaks should not (1) To No. 059130 for use of a 25-per- be kept for laying house replacements cent sulfaquinoxaline soluble powder or breeders unless tests show they are and a 20-percent sulfaquinoxaline so- not carriers. dium solution as provided for in para- (4) Cattle and calves. (i) For the con- graph (c) of this section. trol and treatment of outbreaks of coc- (2) To No. 051311 for use of 3.44- and cidiosis caused by Eimeria bovis or E. 12.85-percent sulfaquinoxaline sodium zurnii. solutions as provided for in paragraphs (ii) Administer at the 0.015-percent (c)(1), (c)(2), (c)(3), (c)(4)(i), and (c)(4)(ii) level for 3 to 5 days in drinking water of this section. medicated with sulfaquinoxaline solu- (3) To No. 046573 for use of a 31.92-per- tion. cent sulfaquinoxaline solution (sodium (iii) In lieu of treatment as provided and potassium salts) as provided for in in paragraph (e)(4)(ii) of this section, paragraphs (c)(1), (c)(2), (c)(3), (c)(4)(i), administer 1 teaspoon of 25-percent and (c)(4)(ii) of this section. sulfaquinoxaline soluble powder per

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day for each 125 pounds of body weight calves caused by Eimeria bovis or E. for 3 to 5 days in drinking water. zurnii. (d) Limitations. Consult a veterinarian (2) Give one teaspoon of 25 percent or poultry pathologist for diagnosis. sulfaquinoxaline soluble powder for May cause toxic reactions unless the each 125 pounds of body weight for 3 to drug is evenly mixed in water at dos- 5 days as a drench. ages indicated and used according to (f) Limitations. For control of out- directions. For control of outbreaks of breaks of disease, medication should be disease, medication should be initiated initiated as soon as the diagnosis is de- as soon as the diagnosis is determined. termined. Consult a veterinarian for di- Medicated chickens, turkeys, cattle, agnosis. Do not give to cattle within 10 and calves must actually consume days of slaughter for food. Not for use enough medicated water which pro- in lactating dairy cattle. vides a recommended dosage of ap- [48 FR 3964, Jan. 28, 1983, as amended at 55 proximately 10 to 45 milligrams per FR 29843, July 23, 1990; 59 FR 33197, June 28, pound per day in chickens, 3.5 to 55 1994] milligrams per pound per day in tur- keys, and approximately 6 milligrams § 520.2330 Sulfisoxazole tablets. per pound per day in cattle and calves (a) Specifications. Each tablet con- depending on the age, class of animal, tains 260 milligrams (4 grains) of ambient temperature, and other fac- sulfisoxazole. tors. A withdrawal period has not been (b) Sponsor. See No. 000856 in established for sulfaquinoxaline in § 510.600(c) of this chapter. preruminating calves. Do not use in (c) Conditions of use—(1) Amount. Ad- calves to be processed for veal. Not for minister one tablet orally per 4 pounds 1 use in lactating dairy cattle. Do not of body weight. give to chickens, turkeys or cattle (2) Indications for use. Use in dogs and within 10 days of slaughter for food. Do cats as an aid in treatment of bacterial not medicate chickens or turkeys pro- pneumonia and bacterial enteritis ducing eggs for human consumption. when caused by organisms sensitive to sulfisoxazole. 1 Make fresh drinking water daily. (3) Limitations. Repeat dosage at 24- [48 FR 3964, Jan. 28, 1983, as amended at 48 hour intervals until 2 to 3 days after FR 26762, June 10, 1983; 55 FR 29843, July 23, disappearance of clinical symptoms. 1990; 59 FR 28769, June 3, 1994; 59 FR 33197, (Administration of one-half daily dos- June 28, 1994; 61 FR 24443, May 15, 1996; 61 FR age at 12-hour intervals or one-third 63711, Dec. 2, 1996; 62 FR 37712, July 15, 1997; daily dosage at 8-hour intervals will 65 FR 10705, Feb. 29, 2000; 69 FR 41427, July 9, 2004; 69 FR 60547, Oct. 12, 2004] provide a more constant blood level.) Provide adequate supply of drinking § 520.2325b Sulfaquinoxaline drench. water. If symptoms persist after using this preparation for 2 or 3 days, consult (a)–(b) [Reserved] a veterinarian. 1 (c) Sponsor. See No. 050749 in § 510.600(c) of this chapter. [43 FR 60895, Dec. 29, 1978] (d) NAS/NRC status. The conditions of § 520.2340 Tepoxalin. use specified in this section have been reviewed by NAS/NRC and are found ef- (a) Specifications. Each tablet con- fective. Applications for these uses tains 30, 50, 100, or 200 milligrams (mg) need not include effectiveness data as tepoxalin. specified by § 514.111 of this chapter, (b) Sponsor. See No. 000061 in but may require bioequivalency infor- § 510.600(c) of this chapter. mation. Applications must be accom- (c) Conditions of use in dogs—(1) panied by a written commitment to un- Amount. 10 mg per kilogram (/kg) daily; dertake the human safety studies re- quired by FDA. 1 These conditions are NAS/NRC reviewed (e) Conditions of uses. As a 25-percent and deemed effective. Applications for these uses need not include effectiveness data as sulfaquinoxaline soluble powder. specified by § 514.111 of this chapter, but may (1) For the control and treatment of require bioequivalency and safety informa- outbreaks of coccidiosis in cattle and tion.

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or 20 mg/kg on the initial day of treat- (c) Conditions of use. Dogs—(1) ment, followed by 10 mg/kg daily. Amount. 25 milligrams per pound of (2) Indications for use. For the control body weight per day in divided doses of pain and inflammation associated every 6 hours. with osteoarthritis. (2) Indications for use. Treatment of (3) Limitations. Federal law restricts infections caused by organisms sen- this drug to use by or on the order of a sitive to tetracycline hydrochloride, licensed veterinarian. such as bacterial gastroenteritis due to [68 FR 34795, June 11, 2003] E. coli and urinary tract infections due to Staphylococcus spp. and E. coli. § 520.2345 Tetracycline oral dosage (3) Limitations. Administer orally; forms. continue treatment until symptoms of the disease have subsided and tempera- § 520.2345a Tetracycline hydrochloride ture is normal for 48 hours; not for use capsules. in animals raised for food production; (a) Specifications. Each capsule con- Federal law restricts this drug to use tains 50, 100, 125, 250, or 500 milligrams by or on the order of a licensed veteri- of tetracycline hydrochloride. narian. (b) Sponsor. See § 510.600(c) of this chapter for identification of the spon- [57 FR 37327, Aug. 18, 1992] sors: § 520.2345c Tetracycline boluses. (1) To No. 000009: 250 milligrams per capsule. (a) Specifications. Each bolus contains (2) To No. 000069: 125, 250, and 500 mil- 500 milligrams of tetracycline (as the ligrams per capsule. hydrochloride). (3) To No. 000115: 50, 100, 250, and 500 (b) Sponsors. See No. 053501 in milligrams per capsule. § 510.600(c) of this chapter for use as in (c) Conditions of use. Dogs—(1) paragraph (d)(1) of this section. See No. Amount. 25 milligrams per pound of 000009 in § 510.600(c) of this chapter for body weight per day in divided doses use as in paragraph (d)(2) of this sec- every 6 hours. tion. (2) Indications for use. Treatment of (c) Related tolerances. See § 556.720 of infections caused by organisms sen- this chapter. sitive to tetracycline hydrochloride, (d) Conditions of use. Calves—(1) such as bacterial gastroenteritis due to Amount. 10 milligrams per pound of E. coli and urinary tract infections due body weight per day in divided doses. to Staphylococcus spp. and E. coli. (i) Indications for use. Control and (3) Limitations. Administer orally; treatment of bacterial enteritis continue treatment until symptoms of (scours) caused by E. coli and bacterial the disease have subsided and the tem- pneumonia caused by Pasteurella spp., perature is normal for 48 hours; not for Hemophilus spp., and Klebsiella spp. use in animals raised for food produc- (ii) Limitations. Administer orally for tion; Federal law restricts this drug to 3 to 5 days; do not slaughter animals use by or on the order of a licensed vet- for food within 14 days of treatment; erinarian. use as sole source of tetracycline. [57 FR 37327, Aug. 18, 1992, as amended at 59 (iii) National Academy of Sciences/Na- FR 59365, Nov. 17, 1994; 63 FR 5255, Feb. 2, tional Research Council (NAS/NRC) sta- 1998] tus. The conditions of use specified in paragraph (d)(1)(i) of this section were § 520.2345b Tetracycline tablets. NAS/NRC reviewed and found effective. (a) Specifications. Each tablet con- Applications for these uses need not in- tains 100, 250, or 500 milligrams of tet- clude effectiveness data as specified in racycline (as the hydrochloride). § 514.111 of this chapter, but may re- (b) Sponsor. For 100, 250, or 500 milli- quire bioequivalency and safety infor- grams per tablet, see No. 000069 in mation. § 510.600(c) of this chapter. For 250 mil- (2) Amount. 10 milligrams per pound ligrams per tablet, see No. 000009 in of body weight per day in two divided § 510.600(c) of this chapter. doses.

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(i) Indications for use. Treatment of (ii) Indications for use. Control and bacterial pneumonia caused by orga- treatment of bacterial enteritis nisms susceptible to tetracycline, bac- (scours) caused by E. coli and bacterial terial enteritis caused by E. coli, and pneumonia associated with Pasteurella salmonella organisms susceptible to spp., A. pleuropneumoniae (Hemophilus tetracycline. spp.), and Klebsiella spp., susceptible to (ii) Limitations. Administer orally for tetracycline. not more than 5 days; do not slaughter (iii) Limitations. Administer for 3 to 5 animals for food within 12 days of days; do not slaughter animals for food treatment; use as sole source of tetra- within 7 days of treatment for sponsor cycline. 053501 and within 4 days of treatment [57 FR 37328, Aug. 18, 1992, as amended at 67 for sponsors 046573 and 000010; prepare a FR 78355, Dec. 24, 2002] fresh solution daily; use as the sole source of tetracycline. § 520.2345d Tetracycline hydrochloride (3) Chickens—(i) Amount. Chronic res- soluble powder. piratory disease: 400 to 800 milligrams (a) Sponsors. The following sponsors per gallon. Infectious synovitis: 200 to listed in § 510.600(c) of this chapter hold 400 milligrams per gallon. approvals for the drug concentrations (ii) Indications for use. Control of (i.e., grams of tetracycline hydro- chronic respiratory disease (CRD or chloride per pound) and conditions of air-sac disease) caused by Mycoplasma use indicated: gallisepticum and E. coli; control of in- (1) 000010, 046573, 051259, 057561, and fectious synovitis caused by M. 059130 102.4 and 324 grams per pound as synoviae susceptible to tetracycline. in paragraph (d) of this section. (iii) Limitations. Administer for 7 to (2) 000069, 25 grams per pound as in 14 days; do not slaughter for food with- paragraphs (d)(3) and (d)(4) of this sec- in 4 days of treatment; not for use in tion. chickens producing eggs for human (3) 053501, 102.4 and 324 grams per consumption; prepare a fresh solution pound as in paragraphs (d)(1) and (d)(2) daily; use as the sole source of tetra- of this section. cycline. (4) 046573, 102.4 and 324 grams per (4) Turkeys—(i) Amount. For infec- pound as in paragraph (d)(3) of this sec- tious synovitis: 400 milligrams per gal- tion. lon. For complicating bacterial orga- (b) Related tolerances. See § 556.720 of nisms associated with bluecomb (trans- this chapter. missible enteritis or coronaviral enter- (c) [Reserved] itis): 25 milligrams per pound of body (d) Conditions of use in drinking weight per day. water—(1) Calves—(i) Amount. 10 milli- (ii) Indications for use. Control of in- grams per pound of body weight per fectious synovitis caused by M. day in divided doses. synoviae; control of bluecomb com- (ii) Indications for use. Control and plicated by organisms sensitive to tet- treatment of bacterial enteritis racycline. (scours) caused by Escherichia coli and (iii) Limitations. Administer for 7 to bacterial pneumonia (shipping fever 14 days; do not slaughter for food with- complex) associated with Pasteurella in 4 days of treatment; not for use in spp., Actinobacillus pleuropneumoniae turkeys producing eggs for human con- (Hemophilus spp.), and Klebsiella spp., sumption; prepare a fresh solution susceptible to tetracycline. daily; use as the sole source of tetra- (iii) Limitations. Administer for 3 to 5 cycline. days; do not slaughter animals for food [59 FR 17693, Apr. 14, 1994, as amended at 59 within 4 days of treatment for sponsor FR 19133, Apr. 22, 1994; 62 FR 5319, Feb. 5, 053501 and within 5 days of treatment 1997; 62 FR 35076, June 30, 1997; 62 FR 46668, for sponsors 046573 and 000010; prepare a Sept. 4, 1997; 62 FR 55160, Oct. 23, 1997; 64 FR fresh solution daily; use as the sole 37673, July 13, 1999; 67 FR 78355, Dec. 24, 2002] source of tetracycline. (2) Swine—(i) Amount. 10 milligrams § 520.2345e Tetracycline oral liquid. per pound of body weight per day in di- (a) Specifications. Each milliliter con- vided doses. tains the equivalent of either 25 or 100

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milligrams of tetracycline hydro- tetracycline hydrochloride and 60 mil- chloride. ligrams of novobiocin. (b) Sponsor. See No. 000069, in (b) Sponsor. No. 000009 in § 510.600(c) of § 510.600(c) of this chapter for use of 25 this chapter. or 100 milligrams per milliliter liquid (c) Conditions of use. Dogs—(1) in dogs as in paragraph (c)(1) of this Amount. 10 milligrams of each anti- section; see No. 000009 in § 510.600(c) of biotic per pound of body weight (1 cap- this chapter for use of 100 milligrams sule for each 6 pounds) every 12 hours. per milliliter liquid in dogs and cats as (2) Indications for use. Treatment of in paragraph (c)(2). acute or chronic canine respiratory in- (c) Conditions of use—(1) Dogs—(i) fections such as tonsillitis, bronchitis, Amount. 25 milligrams per pound of body weight per day in divided doses and tracheobronchitis when caused by every 6 hours. pathogens susceptible to tetracycline (ii) Indications for use. Treatment of and/or novobiocin, such as Staphy- infections caused by organisms sen- lococcus spp. and Escherichia coli. sitive to tetracycline hydrochloride, (3) Limitations. Continue treatment such as bacterial gastroenteritis due to for at least 48 hours after the tempera- Escherichia coli and urinary tract infec- ture has returned to normal and all tions due to Staphylococcus spp. and E. evidence of infection has disappeared. coli. As with all antibiotics, appropriate in (iii) Limitations. Administer orally; vitro culturing and susceptibility tests continue treatment until symptoms of samples taken before treatment have subsided and the temperature is should be conducted. Federal law re- normal for 48 hours; not for use in ani- stricts this drug to use by or on the mals which are raised for food produc- order of a licensed veterinarian. tion; Federal law restricts this drug to [57 FR 37329, Aug. 18, 1992] use by or on the order of a licensed vet- erinarian. § 520.2345g Tetracycline hydrochloride (iv) National Academy of Sciences/Na- and sodium novobiocin tablets. tional Research Council (NAS/NRC) sta- tus. These conditions were NAS/NRC (a) Specifications. Each tablet con- reviewed and found effective. Applica- tains the equivalent of 60 milligrams of tions for these uses need not include ef- tetracycline hydrochloride and 60 mil- fectiveness data as specified by § 514.111 ligrams of novobiocin, or 180 milli- of this chapter, but may require bio- grams of tetracycline hydrochloride equivalency and safety information. and 180 milligrams of novobiocin. (2) Dogs and cats—(i) Amount. 25 milli- (b) Sponsor. No. 000009 in § 510.600(c) of grams per pound of body weight per this chapter. day in divided doses every 6 hours. (c) Conditions of use. Dogs—(1) (ii) Indications for use. Treatment of Amount. 10 milligrams of each anti- infections caused by organisms suscep- biotic per pound of body weight (one tible to tetracycline hydrochloride, single-strength tablet for each 6 pounds such as bacterial gastroenteritis due to or one triple-strength tablet for each 18 E. coli and urinary tract infections due pounds). to Staphylococcus spp. and E. coli. (2) Indications for use. Treatment of (iii) Limitations. Administer orally; acute or chronic canine respiratory in- continue treatment until the tempera- fections such as tonsillitis, bronchitis, ture has been normal for 48 hours; not and tracheobronchitis when caused by for use in food-producing animals; Fed- pathogens susceptible to tetracycline eral law restricts this drug to use by or and/or novobiocin, such as Staphy- on the order of a licensed veterinarian. lococcus spp. and Escherichia coli. [57 FR 37329, Aug. 18, 1992] (3) Limitations. Continue treatment for at least 48 hours after the tempera- § 520.2345f Tetracycline phosphate ture has returned to normal and all complex and sodium novobiocin evidence of infection has disappeared. capsules. As with all antibiotics, appropriate in (a) Specifications. Each capsule con- vitro culturing and susceptibility tests tains the equivalent of 60 milligrams of of samples taken before treatment

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should be conducted. Federal law re- stricts this drug to use by or on the stricts this drug to use by or on the order of a licensed veterinarian. order of a licensed veterinarian. [57 FR 37329, Aug. 18, 1992] [57 FR 37329, Aug. 18, 1992] § 520.2362 Thenium closylate tablets. § 520.2345h Tetracycline hydro- (a) Chemical name. (N,N-Dimethyl-N- chloride, sodium novobiocin, and 2-phenoxyethyl-N-2′-thenylammo- prednisolone tablets. nium)-p-chlorobenzene-sulfonate. (a) Specifications. Each tablet con- (b) Specifications. Thenium closylate tains the equivalent of 60 milligrams of tablets contain thenium closylate tetracycline hydrochloride, 60 milli- equivalent to 500 milligrams thenium grams of novobiocin, and 1.5 milli- as base in each tablet. grams of prednisolone or 180 milli- (c) Sponsor. See No. 000061 in grams of tetracycline hydrochloride, § 510.600(c) of this chapter. 180 milligrams of novobiocin, and 4.5 (d) Conditions of use. (1) The tablets milligrams of prednisolone. are administered orally to dogs as a (b) Sponsor. See No. 000009 in single day treatment of canine ancylo- § 510.600(c) of this chapter. stomiasis by the removal from the in- (c) Conditions of use. Dogs—(1) testines of the adult forms of the spe- Amount. 10 milligrams of each anti- cies Ancylostoma caninum and Uncinaria biotic and 0.25 milligram of prednis- stenocephala (hookworms). Dogs weigh- olone per pound of body weight (one ing 10 pounds and over are adminis- single-strength tablet for each 6 pounds tered 1 tablet as a single dose. Dogs or one triple-strength tablet for each 18 weighing 5 to 10 pounds are adminis- pounds) every 12 hours for 48 hours. tered one-half tablet twice during a Treatment is to be continued with single day. All dosages are given for 1 novobiocin and tetracycline alone at day only. The treatment should be re- the same dose schedule for an addi- peated after 2 or 3 weeks. tional 3 days or longer as needed. (2) Suckling puppies or recently weaned puppies weighing less than 5 (2) Indications for use. Treatment of pounds should not be treated with the acute and chronic canine respiratory drug. Animals that are severely in- infections such as tonsillitis, bron- fected, exhibiting evidence of intes- chitis, and tracheobronchitis when tinal hemorrhage, debilitation, and caused by pathogens susceptible to tet- anemia, should be given supportive racycline and/or novobiocin, such as treatment. Staphylococcus spp. and Escherichia coli, (3) Federal law restricts this drug to when it is necessary to initially reduce use by or on the order of a licensed vet- the severity of associated clinical erinarian. signs. (3) Limitations. As with all anti- [40 FR 13838, Mar. 27, 1975, as amended at 41 biotics, appropriate in vitro culturing FR 53477, Dec. 7, 1976; 46 FR 48642, Oct. 2, 1981; and susceptibility tests of samples 61 FR 8873, Mar. 6, 1996; 62 FR 61625, Nov. 19, 1997] taken before treatment should be con- ducted. Administer for 48 hours only. § 520.2380 Thiabendazole oral dosage Continue treatment if needed with tet- forms. racycline/novobiocin alone. The prod- uct is contraindicated in animals with § 520.2380a Thiabendazole top dress- tuberculosis, hyperadrenocorticalism, ing and mineral protein feed block. or peptic ulcers. Clinical and experi- (a) Chemical name. 2-(4-Thiazolyl)- mental data have demonstrated that benzimidazole. corticosteroids administered orally or (b) Specifications. Conforms to N.F. parenterally to animals may induce XII. the first stage of parturition when ad- (c) Sponsor. (1) See No. 017800 in ministered during the last trimester of § 510.600(c) of this chapter for the spon- pregnancy and may precipitate pre- sor of the usage provided by paragraph mature parturition followed by (e)(1)(ii) of this section. dystocia, fetal death, retained pla- (2) See No. 050604 in § 510.600(c) of this centa, and metritis. Federal law re- chapter for the sponsor of the usages

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provided for by paragraph (e)(1)(ii) of roundworms (Trichostrongylus, this section. Haemonchus, Ostertagia and Cooperia). (3) See No. 021930 in § 510.600(c) of this (iv) Limitations. Administer to cattle chapter for the sponsor of the usage on pasture or range accustomed to provided for by paragraph (e)(2) of this mineral protein block feeding for 3 section. days. Milk taken from animals during (d) Related tolerances. See § 556.730 of treatment and within 96 hours (8 this chapter. milkings) after the latest treatment (e) Conditions of use. It is used as fol- must not be used for food. Do not treat lows: cattle within 3 days of slaughter. For a (1) Horses—(i) Route of administration. satisfactory diagnosis, a microscopic In feed, as a top dressing. fecal examination should be performed (a) Amount. 2 grams per 100 pounds of by a veterinarian or diagnostic labora- body weight. tory prior to worming. Animals main- (b) Indications for use. For control of tained under conditions of constant large strongyles, small strongyles, worm exposure may require re-treat- pinworms, and threadworms (including ment within 2 to 3 weeks. Animals that members of the genera Strongylus, are severely parasitized, sick, or off Cyathostomum, Cylicobrachytus, and re- feed should be isolated and a veteri- lated genera, Craterostomum, narian consulted for advice concerning Oesophagodontus, Poteriostomum, treatment. Oxyuris, and Strongyloides). [40 FR 13838, Mar. 27, 1975, as amended at 41 (c) Limitations. Add to the usual feed FR 9149, Mar. 3, 1976; 62 FR 63271, Nov. 28, of horses mixed into that amount of 1997] the feed normally consumed at one feeding. Warning: Not for use in horses § 520.2380b Thiabendazole drench or intended for food. oral paste. (ii) Route of administration. In feed. (a) Chemical name. 2-(4-Thiazolyl) (a) Amount. 2 grams per 100 pounds of benzimidazole. body weight. (b) Specifications. Conforms to N.F. (1) Indications for use. For control of XII. large and small strongyles, (c) Sponsor. See No. 050604 in Strongyloides, and pinworms of the gen- § 510.600(c) of this chapter for the spon- era Strongylus, Cyathostomum, sor of the usages provided for by para- Cylicobrachytus and related genera, graph (e) of this section. Craterostomum, Oesophagodontus, (d) Related tolerances. See § 556.730 of Poteriostomum, Oxyuris, and this chapter. Strongyloides. (e) Conditions of use. It is used as fol- (2) Limitations. Administer in a single lows: dosage mixed with the normal grain ra- (1) Horses. As a single liquid oral tion given at one feeding. Warning: Not dose, administered as a drench or by for use in horses intended for food. stomach tube; or as an oral paste. (b) Amount. 4 grams per 100 pounds of (i) Amount. 2 grams per 100 pounds of body weight. body weight. (1) Indications for use. For control of (a) Indications for use. For the control ascarids of the genus Parascaris. of infections of large strongyles (2) Limitations. Administer in a single (Strongylus vulgaris, Strongylus dosage mixed with the normal grain ra- endentatus), small strongyles tion given at one feeding. Warning: Not (Cyathastomum, Cylicobrachytus and re- for use in horses intended for food. lated genera, Craterostomum, (2) Cattle—(i) Route of administration. Oesophagodontus, Poteriostomum), In feed block. pinworms (Oxyuris), and threadworms (ii) Amount. 3.3 percent block con- (Strongyloides). sumed at the recommended level of 0.11 (b) Limitations. Not for use in horses pound per 100 pounds of body weight to be slaughtered for food purposes. per day. When administered by stomach tube, (iii) Indications for use. For control of for use only by or on the order of a li- infections of gastrointestinal censed veterinarian. When for use as a

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liquid oral drench or an oral paste, con- tions of other species in paragraph sult your veterinarian for assistance in (e)(3)(i)(a) of this section. the diagnosis, treatment, and control (b) Limitations. For most effective re- of parasitism. sults, severely parasitized animals or (ii) Amount. 4 grams per 100 pounds of those constantly exposed to helminth body weight. infection should be re-treated every 2 (a) Indications for use. For control of to 3 weeks. Milk taken from treated infections of ascardis (Parascaris). animals within 96 hours (8 milkings) (b) Limitations. Not for use in horses after the latest treatment must not be to be slaughtered for food purposes. used for food. Do not treat cattle with- When administered by stomach tube, in 3 days of slaughter. For a satisfac- use only by or on the order of a li- tory diagnosis, a microscopic fecal ex- censed veterinarian. When for use as a amination should be performed prior to liquid oral drench or an oral paste, con- worming. sult your veterinarian for assistance in (4) Sheep and goats. Orally, as a the diagnosis, treatment, and control drench. of parasitism. (i) Amount. 2 grams per 100 pounds of (2) Pigs. As an oral paste. body weight. (i) Amount. 200 milligrams for each 5 (ii) Indications for use. Control of in- to 7 pounds of body weight per dose. fections of gastrointestinal (ii) Indications for use. For control of roundworms in sheep and goats. infections with Strongyloides ransomi. (Trichostrongylus spp., Haemonchus spp., These infections are commonly found Ostertagia spp., Cooperia spp., in Southeastern United States. Nematodirus spp., Bunostomum spp., (iii) Limitations. Administer to baby Strongyloides spp., Chabertia spp., and pigs (1 to 8 weeks of age). Treatment Oesophagostomum spp. ); also active may be repeated in 5 to 7 days if nec- from 3 hours to 3 days following treat- essary. Before treatment, obtain an ac- ment against ova and larvae passed by curate diagnosis from a veterinarian or sheep (good activity against diagnostic laboratory. Do not treat Trichostrongylus colubriformis and axei, within 30 days of slaughter. Ostertagia spp., Bunostomum spp., (3) Cattle. Orally as a drench and in Nematodirus spp., and Strongyloides spp.; paste form using a dosing gun designed less effective against Haemonchus for the product. contortus and Oesophagostomum spp. ). (i) Amount. 3 grams per 100 pounds of (iii) Limitations. As a single oral dose; body weight. do not treat animals within 30 days of (a) Indications for use. Control of in- slaughter; milk taken from treated fections of gastrointestinal animals within 96 hours (8 milkings) roundworms (Trichostrongylus spp., after the latest treatment must not be Haemonchus spp., Nematodirus spp., used for food; in severe infections in Ostertagia spp., and Oesophagostomum sheep, treatment should be repeated in radiatum). 2 to 3 weeks. (b) Limitations. For most effective re- (5) Goats. Orally, as a drench. sults, severely parasitized animals or (i) Amount. 3 grams per 100 pounds of those constantly exposed to helminth body weight. infection should be re-treated every 2 (ii) Indications for use. Control of se- to 3 weeks. Milk taken from treated vere infections of gastrointestinal animals within 96 hours (8 milkings) roundworms (Trichostrongylus spp., after the latest treatment must not be Haemonchus spp., Ostertagia spp., used for food. Do not treat cattle with- Cooperia spp., Nematodirus spp., in 3 days of slaughter. For a satisfac- Bunostomum spp., Strongyloides spp., tory diagnosis, a microscopic fecal ex- Chabertia spp., and Oesophagostomum amination should be performed prior to spp. ). worming. (iii) Limitations. As a single oral dose; (ii) Amount. 5 grams per 100 pounds of do not treat animals within 30 days of body weight. slaughter; milk taken from treated (a) Indications for use. Control of in- animals within 96 hours (8 milkings) fections of Cooperia spp. or severe infec- after the latest treatment must not be

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used for food; treatment should be re- Oesophagostomum spp. ); also active peated in 2 to 3 weeks. from 3 hours to 3 days following treat- ment against ova and larvae passed by [40 FR 13838, Mar. 27, 1975, as amended at 41 FR 9149, Mar. 3, 1976; 41 FR 47424, Oct. 29, sheep (good activity against T. 1976; 62 FR 63271, Nov. 28, 1997] colubriformis and axei, Ostertagia spp., Bunostomum spp., Nematodirus spp., and § 520.2380c Thiabendazole bolus. Strongyloides spp.; less effective against (a) Chemical name. 2-(4-Thiazolyl) Haemonchus contortus and benzimidazole. Oesophagostomum spp. ). (b) Specifications. Conforms to N.F. (iii) Limitations. As a single oral dose; XII. do not treat animals within 30 days of (c) Sponsor. See No. 050604 in slaughter; milk taken from treated § 510.600(c) of this chapter. animals within 96 hours (8 milkings) (d) Related tolerances. See § 556.730 of after the latest treatment must not be this chapter. used for food; in severe infections in (e) Conditions of use. It is used as fol- sheep, treatment should be repeated in lows: 2 to 3 weeks. (1) Cattle. In a bolus. (3) Goats. In a bolus. (i) Amount. 3 grams per 100 pounds of (i) Amount. 3 grams per 100 pounds of body weight. body weight. (a) Indications for use. Control of in- (ii) Indications for use. Control of se- fections of gastrointestinal vere infections of gastrointestinal roundworms (general Trichostrongylus roundworms (genera Trichostrongylus spp., Haemonchus spp., Nematodirus spp., spp., Haemonchus spp., Ostertagia spp., Ostertagia spp., and Oesophagostomum Cooperia spp., Nematodirus spp., radiatum). Bunostomum spp., Strongyloides spp., (b) Limitations. As a single oral dose; Chabertia spp., and Oesophagostomum may repeat once in 2 to 3 weeks; do not spp. ). treat animals within 3 days of slaugh- (iii) Limitations. As a single oral dose; ter; milk taken from treated animals do not treat animals within 30 days of within 96 hours (8 milkings) after the slaughter; milk taken from treated latest treatment must not be used for animals within 96 hours (8 milkings) food. after the latest treatment must not be (ii) Amount. 5 grams per 100 pounds of used for food; treatment should be re- body weight. peated in 2 to 3 weeks. (a) Indications for use. Control of se- vere infections of gastrointestinal [40 FR 13838, Mar. 27, 1975, as amended at 41 roundworms (genera Trichostrongylus FR 9149, Mar. 3, 1976; 62 FR 63271, Nov. 28, spp., Haemonchus spp., Nematodirus spp., 1997] Ostertagia spp., and Oesophagostomum § 520.2380d Thiabendazole, piperazine radiatum). Control of infections with citrate suspension. Cooperia spp. (b) Limitations. As a single oral dose; (a) Specifications. Each fluid ounce of as a drench or bolus; may repeat once suspension contains 2 grams of in 2 to 3 weeks; do not treat animals thiabendazole and 2.5 grams of piper- within 3 days of slaughter; milk taken azine (from piperazine citrate). from treated animals within 96 hours (8 (b) Sponsor. See No. 050604 in milkings) after the latest treatment § 510.600(c) of this chapter. must not be used for food. (c) Conditions of use. (1) It is adminis- (2) Sheep and goats. In a bolus. tered to horses by stomach tube or as a (i) Amount. 2 grams per 100 pounds of drench at the rate of 1 fluid ounce of body weight. suspension per 100 pounds of body (ii) Indications for use. Control of in- weight for the control of large fections of gastrointestinal strongyles, small strongyles, roundworms in sheep and goats (gen- pinworms, Strongyloides and ascarids eral Trichostrongylus spp., Haemonchus (including members of the genera spp., Ostertagia spp., Cooperia spp., Strongylus spp., Cyathostomum spp., Nematodirus spp., Bunostomum spp., Cylicobrachytus spp. and related genera Strongyloides spp., Chabertia spp., and Craterostomum spp., Oesophagodontus

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spp., Poteriostomum spp., Oxyuris spp., § 520.2380f Thiabendazole, piperazine Strongyloides spp., and Parascaris spp. ). phosphate powder. (2) Do not use in horses intended to (a) Specifications. Each ounce of water be used for food purposes. dispersible powder contains 6.67 grams (3) For use by or on the order of a li- of thiabendazole and 8.33 grams of pi- censed veterinarian. perazine (as piperazine phosphate). [40 FR 13838, Mar. 27, 1975, as amended at 62 (b) Sponsor. See No. 050604 in FR 63271, Nov. 28, 1997] § 510.600(c) of this chapter. (c) Conditions of use—(1) Amount. 2 § 520.2380e Thiabendazole with grams of thiabendazole and 2.5 grams trichlorfon. of piperazine (0.3 ounce of powder) per (a) Specifications. The drug contains 5 100 pounds of body weight. grams of thiabendazole with 4.5 grams (2) Indications for use. Treatment of of trichlorfon, or 20 grams of infections of large strongyles (genus thiabendazole with 18 grams of Strongylus), small strongyles (genera trichlorfon. Cyathostomum, Cylicobrachytus, and re- (b) Sponsor. See No. 017135 in lated genera Craterostomum, § 510.600(c) of this chapter. Oesophagodontus, Poteriostomum), pinworms (Oxyuris), threadworms (c) Conditions of use. (1) Used for the (Strongyloides), and ascarids (Parascaris) treatment and control of bots in horses. (Gasterophilus spp. ), large strongyles (3) Limitations. Use a single oral dose. (Strongylus spp. ), small strongyles Administer as a drench or by stomach (genera Cyathostomum, Cylicobrachytus, tube suspended in 1 pint of warm Craterostomum, Oesophagodontus, water; by dose syringe suspended in 1⁄2 Poteriostomum), pinworms (Oxyuris spp., ounce of water for each 100 pounds of Strongyloides spp. ), and ascarids body weight; or sprinkled over a small (Parascaris spp. ) in horses. amount of daily feed. Not for animals (2) Administer 2 grams of intended for food use. If the label bears thiabendazole with 1.8 grams of directions for administration by stom- trichlorfon per 100 pounds of body ach tube or drench, it shall also bear weight sprinkled on the animals’ usual the statement ‘‘Caution: Federal law daily ration of feed, or may be mixed in restricts this drug to use by or on the 5 to 10 fluid ounces of water and admin- order of a licensed veterinarian;’’ if not istered by stomach tube or drench. labeled for use by stomach tube or (3) Do not re-treat more than once drench, the label shall bear the state- every 30 days, preferably every 6 to 8 ment, ‘‘Consult your veterinarian for weeks. assistance in the diagonosis, treat- (4) Do not treat animals if sick or de- ment, and control of parasitism.’’ bilitated; less than 4 months of age; or mares in last month of pregnancy. [46 FR 18963, Mar 27, 1981, as amended at 46 (5) Do not administer intravenous an- FR 52330, Oct. 27, 1981; 62 FR 63271, Nov. 28, 1997] esthetics, especially muscle relaxants, within 2 weeks of use. § 520.2455 Tiamulin soluble powder. (6) Not for animals intended for food (a) Specifications. A water-soluble use. powder containing 45 percent tiamulin (7) Do not use within a few days be- used to make a medicated drinking fore or after treatment with or expo- water containing 227 or 677 milligrams sure to cholinesterase-inhibiting drugs, of tiamulin per gallon. pesticides, or chemicals. (b) Sponsors. See Nos. 000010 and (8) If the label bears directions for ad- 059130 in § 510.600(c) of this chapter. ministration of the drug by stomach (c) Related tolerances. See § 556.738 of tube or drench it shall also bear the this chapter. statement: Caution; Federal law re- (d) Conditions of use in swine—(1) stricts this drug to use by or on the Amount. 3.5 milligrams of tiamulin per order of a licensed veterinarian. pound of body weight for 5 days. [40 FR 23071, May 28, 1975, as amended at 48 (i) Indications for use. For treatment FR 48229, Oct. 18, 1983] of swine dysentery associated with

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Brachyspira hyodysenteriae susceptible medicated water daily. Not for use in to tiamulin. swine over 250 pounds body weight. Use (ii) Limitations. Use for 5 consecutive as only source of drinking water. Do days. Withdraw 3 days before slaugh- not allow consumption of feeds con- ter. Prepare fresh water daily. Not for taining polyether ionophores (e.g., use in swine over 250 pounds body monensin, lasalocid, narasin, or weight. Use as only source of drinking salinomycin) as adverse reactions may water. occur. (2) Amount. 10.5 milligrams of tiamulin per pound of body weight for [58 FR 14313, Mar. 17, 1993, as amended at 62 FR 35076, June 30, 1997] 5 days. (i) Indications for use. For treatment § 520.2473 Tioxidazole oral dosage of swine pneumonia due to forms. Actinobacillus pleuropneumoniae suscep- tible to tiamulin. § 520.2473a Tioxidazole granules. (ii) Limitations. Use for 5 consecutive (a) Specifications. Each gram of gran- days. Withdraw 7 days before slaugh- ules contains 200 milligrams of ter. Prepare fresh water daily. Not for tioxidazole. use in swine over 250 pounds body (b) Sponsor. See No. 000061 in weight. Use as only source of drinking § 510.600(c) of this chapter. water. Do not allow consumption of (c) Conditions of use—(1) Horses—(i) feeds containing polyether ionophores Amount. 5 milligrams per pound of body (e.g., monensin, lasalocid, narasin or weight as a single dose. salinomycin) as adverse reactions may (ii) Indications for use. Removal of occur. mature large strongyles (Strongylus [52 FR 15718, Apr. 30, 1987, as amended at 58 edentatus, S. equinus, and S. vulgaris), FR 14313, Mar. 17, 1993; 62 FR 35076, June 30, mature ascarids (Parascaris equorum), 1997; 70 FR 13099, Mar. 18, 2005] mature and immature (4th larval stage) pinworms (Oxyuris equi), and ma- § 520.2456 Tiamulin liquid concentrate. ture small strongyles (Triodontophorus (a) Specifications. A liquid con- spp.) centrate containing 12.3 percent (iii) Limitations. For administration tiamulin used to make a medicated with feed: Sprinkle required amount of drinking water containing 227 milli- granules on a small amount of the grams or 681 milligrams of tiamulin per usual grain ration and mix. Prepare for gallon. each horse individually. Withholding of (b) Sponsor. See 000010 in § 510.600(c) of feed or water not necessary. Not for this chapter. use in horses intended for food. The re- (c) Related tolerances. See § 556.738 of productive safety of tioxidazole in this chapter. breeding animals has not been deter- (d) Conditions of use in swine— (1) mined. Consult your veterinarian for Amount. Dysentery: 3.5 milligrams of assistance in the diagnosis, treatment, tiamulin per pound of body weight and control of parasitism. It is rec- daily. Pneumonia: 10.5 milligrams of ommended that this drug be adminis- tiamulin per pound of body weight tered with caution to sick or debili- daily. tated horses. (2) Indications for use. For treatment (2) [Reserved] of swine dysentery associated with Treponema hyodysenteriae and swine [50 FR 52772, Dec. 26, 1985; 51 FR 2693, Jan. 21, pneumonia due to Actinobacillus 1986, as amended at 52 FR 7832, Mar. 13, 1987] pleuropneumoniae susceptible to tiamulin. § 520.2473b Tioxidazole paste. (3) Limitations. Use for 5 consecutive (a) Specifications. Each plastic syringe days. When a dose is 3.5 milligrams per contains 6.25 grams of tioxidazole. pound of body weight daily, withdraw (b) Sponsor. See No. 000061 in medication 3 days before slaughter. § 510.600(c) of this chapter. When a dose is 10.5 milligrams per (c) Conditions of use—(1) Horses—(i) pound of body weight daily, withdraw 7 Amount. 5 milligrams of tioxidazole per days before slaughter. Prepare fresh pound of body weight as a single dose.

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(ii) Indications for use. Removal of dose of sterile triamcinolone acetonide mature large strongyles (Strongylus suspension veterinary in which case edentatus, S. equinus, and S. vulgaris), the tablet dosage should be adminis- mature ascarids (Parascaris equorum), tered beginning 5 to 7 days after the in- mature and immature (4th larval jection or when symptoms reappear. stage) pinworms (Oxyuris equi), and ma- (3) The labeling shall comply with ture small strongyles (Triodontophorus the requirements of § 510.410 of this spp.). chapter. (iii) Limitations. Administer orally by (4) Federal law restricts this drug to inserting the nozzle of the syringe through the space between front and use by or on the order of a licensed vet- back teeth and deposit the required erinarian. dose on the base of the tongue. Before [40 FR 13838, Mar. 27, 1975, as amended at 51 dosing, make sure the horse’s mouth FR 26002, July 18, 1986; 53 FR 40727, Oct. 18, contains no feed. Not for use in horses 1988; 62 FR 35076, June 30, 1997] intended for food. The reproductive safety of tioxidazole in breeding ani- § 520.2482 Triamcinolone acetonide mals has not been determined. Consult oral powder. your veterinarian for assistance in the (a) Specifications. Each 15 grams of diagnosis, treatment, and control of triamcinolone acetonide oral powder parasitism. It is recommended that contains 10 milligrams of this drug be administered with caution triamcinolone acetonide. to sick or debilitated horses. (2) [Reserved] (b) Sponsor. See No. 053501 in § 510.600(c) of this chapter. [52 FR 43059, Nov. 9, 1987] (c) NAS/NRC status. The conditions of § 520.2481 Triamcinolone acetonide use specified in this section are NAS/ tablets. NRC reviewed and found effective. Ap- plications for these uses need not in- (a) Specifications. Each tablet con- tains either 0.5 milligram or 1.5 milli- clude effectiveness data as specified by grams of the drug. § 514.111 of this chapter, but may re- (b) Sponsor. See Nos. 000010 and 053501 quire bioequivalency and safety infor- in § 510.600(c) of this chapter. mation. (c) NAS/NRC status. The conditions of (d) Conditions of use. (1) The drug is use specified in this section are NAS/ used as an anti-inflammatory agent for NRC reviewed and found effective. Ap- horses. plications for these uses need not in- (2) It is administered at a dosage of clude effectiveness data as specified by 0.005 to 0.01 milligram triamcinolone § 514.111 of this chapter, but may re- acetonide per pound of body weight quire bioequivalency and safety infor- twice daily, sprinkled (top-dressed) on mation. a small portion of feed. Treatment may (d) Conditions of use. (1) The drug is be initiated with a single dose of sterile indicated for use in dogs and cats for triamcinolone acetonide suspension its anti-inflammatory activity. USP followed after 3 or 4 days with the (2) An initial daily dosage of 0.05 mil- use of triamcinolone acetonide oral ligram per pound of body weight is usu- powder. ally sufficient to control symptoms, al- though up to 0.1 milligram per pound of (3) The labeling shall comply with body weight may be given daily if re- the requirements of § 510.410 of this sponse to the smaller dose is inad- chapter. equate. As soon as feasible, and in any (4) Not for use in horses intended for case within 2 weeks, dosage should be food. reduced gradually to maintenance lev- (5) Federal law restricts this drug to els of 0.0125 to 0.025 milligram per use by or on the order of a licensed vet- pound of body weight per day. Therapy erinarian. should be discontinued by a gradual re- [41 FR 24884, June 21, 1976, as amended at 50 duction in dosage after the condition FR 41489, Oct. 11, 1985; 51 FR 26002, July 18, has been controlled for several days. 1986] Therapy may be initiated with a single

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§ 520.2520 Trichlorfon oral dosage (3) Limitations. Do not fast horses be- forms. fore or after treatment. Treatment of mares in late pregnancy is not rec- § 520.2520b Trichlorfon and atropine. ommended. Surgery or any severe (a) Chemical name. (1) For trichlorfon: stress should be avoided for at least 2 O,O-Dimethyl 2,2,2-trichloro-1-hy- weeks before or after treatment. Do droxyethyl phosphonate. not administer to sick, toxic, or debili- (2) For atropine: Atropine N.F. tated horses. Not to be used in horses (b) Sponsor. See No. 000856 in intended for use as food. Federal law § 510.600(c) of this chapter. restricts this drug to use by or on the (c) Conditions of use. (1) The drug is order of a licensed veterinarian. used for the treatment of Syphacia [45 FR 48127, July 18, 1980] obvelata (pinworm) in laboratory mice. (2) It is administered in distilled § 520.2520f Trichlorfon granules. water as sole source of drinking water continuously for 7 to 14 days at 1.67 (a) Specifications. Each package con- grams of trichlorfon and 7.7 milligrams tains either 18.2 or 36.4 g of trichlorfon. of atropine per liter. (b) Sponsor. See 000856 in § 510.600(c) of (3) Prepare fresh solution every 3 this chapter. days. Do not use simultaneously with (c) Special considerations. Trichlorfon other drugs, insecticides, pesticides, or is a cholinesterase inhibitor. Do not chemicals having cholinesterase activ- use this product on animals simulta- ity, nor within 7 days before or after neously with, or within 2 weeks before treatment with any other cholin- or after treatment with or exposure to esterase inhibitor. neuromuscular depolarizing agents (4) Restricted to use by or on the (i.e., succinylcholine) or to cholin- order of a licensed veterinarian. esterase-inhibiting drugs, pesticides, or chemicals. § 520.2520e Trichlorfon boluses. (d) NAS/NRC status. Use of this drug (a) Specifications. Each bolus contains has been NAS/NRC reviewed and found either 7.3, 10.9, 14.6, or 18.2 g of effective. Applications for these uses trichlorfon. need not include effectiveness data as (b) Sponsor. See 000856 in § 510.600(c) of specified by § 514.111 of this chapter. this chapter. (e) Conditions of use—(1) Amount. 18.2 (c) Special considerations. Trichlorfon milligrams per pound of body weight. is a cholinesterase inhibitor. Do not (2) Indications for use. For horses for use this product on animals simulta- removal of bots (Gastrophilus nasalis, neously with, or within 2 weeks, before Gastrophilus intestinalis), large or after treatment with or exposure to, roundworms (ascarids, Parascaris neuromuscular depolarizing agents equorum), and pinworms (Oxyuris equi). (i.e., succinylcholine) or to cholin- (3) Limitations. Do not fast horses be- esterase-inhibiting drugs, pesticides, or fore or after treatment. Treatment of chemicals. mares in late pregnancy is not rec- (d) NAS/NRC status. Use of this drug ommended. Surgery or any severe has been NAS/NRC reviewed and found stress should be avoided for at least 2 effective. Applications for these uses weeks before or after treatment. Do need not include effectiveness data as not administer to sick, toxic, or debili- specified by § 514.111 of this chapter. tated horses. Not to be used in horses (e) Conditions of use—(1) Amount. 18.2 intended for use as food. Federal law milligrams per pound of body weight, restricts this drug to use by or on the except for strongyles use 36.4 milli- order of a licensed veterinarian. grams per pound of body weight. [45 FR 48128, July 18, 1980] (2) Indications for use. For horses for removal of bots (Gastrophilus nasalis, § 520.2520g Trichlorfon, phenothiazine, Gastrophilus intestinalis), large and piperazine dihydrochloride strongyles (Strongylus vulgaris), small powder. strongyles, large roundworms (a) Specifications. Each 54.10 grams (ascarids, Parascaris equorum), and (1.91 ounces) of water dispersible pow- pinworms (Oxyuris equi). der contains 9.10 grams of trichlorfon,

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6.25 grams of phenothiazine, and the the aid of a tranquilizer, antiemetic, or equivalent of 20.0 grams of piperazine preanesthetic.1 base (as piperazine dihydrochloride). (2) The drug is administered orally to (b) Sponsor. See No. 000856 in dogs and cats at a dosage level of 1 to § 510.600(c) of this chapter. 2 milligrams per pound of body weight (c) Special considerations. Labeling daily; an initial dosage at the 2-milli- shall bear the following statements: grams level is suggested followed by The drug is a cholinesterase inhibitor. daily doses at the 1-milligram level. Do not use this product in horses si- Frequently, the drug may be with- multaneously with, or within 2 weeks drawn after 4 to 5 days, with drug ef- before or after treatment with, or expo- fect continuing after withdrawal.1 sure to, neuromuscular depolarizing (3) Do not use in conjunction with agents (e.g., succinylcholine) or to cho- organophosphates and/or procaine hy- linesterase-inhibiting drugs, pesticides, drochloride, because phenothiazines or chemicals. may potentiate the toxicity of (d) Conditions of use—(1) Amount. 18.2 organophosphates and the activity of 1 milligrams of trichlorfon, 12.5 milli- procaine hydrochloride. grams of phenothiazine, and 40.0 milli- (4) Federal law restricts this drug to grams of piperazine base per pound of use by or on the order of a licensed vet- 1 body weight. erinarian. (2) Indications for use. For horses for [40 FR 13838, Mar. 27, 1975, as amended at 50 removal of bots (Gastrophilus nasalis, FR 41489, Oct. 11, 1985] Gastrophilus intestinalis), large strongyles (Strongylus vulgaris), small § 520.2604 Trimeprazine tartrate and strongyles, large roundworms prednisolone tablets. (ascarids, Parascaris equorum), and (a) Specifications. Each tablet con- pinworms (Oxyuris equi). tains: trimeprazine tartrate, 5 milli- (3) Limitations. Mix powder and vial grams; and prednisolone, 2 milligrams. contents together in warm water to (b) Sponsor. See No. 000069 in form suspension. Administer by stom- § 510.600(c) of this chapter. ach tube. Do not fast horses before or (c) Conditions of use. (1) The drug is after treatment. Treatment of mares in administered orally to dogs for the re- late pregnancy is not recommended. lief of itching regardless of cause; re- Surgery or any severe stress should be duction of inflammation commonly as- avoided for at least 2 weeks before or sociated with most skin disorders of after treatment. Do not administer to dogs such as eczema, caused by inter- sick, toxic, or debilitated horses. Not nal disorders, otitis, and dermatitis, al- to be used in horses intended for use as lergic, parasitic, pustular and nonspe- food. Federal law restricts this drug to cific. It is also used in dogs as adjunc- use by or on the order of a licensed vet- tive therapy in various cough condi- erinarian. tions including treatment of ‘‘kennel cough’’ or tracheobronchitis, bron- [48 FR 2757, Jan. 21, 1983] chitis including allergic bronchitis, in tonsillitis, acute upper respiratory in- § 520.2582 Triflupromazine hydro- fections and coughs of nonspecific ori- chloride tablets. gin. The product may also be adminis- (a) Specifications. Each tablet con- tered to dogs suffering from acute or tains either 10 milligrams or 25 milli- chronic bacterial infections, provided grams of triflupromazine hydro- the infection is controlled by appro- chloride. priate antibiotic or chemotherapeutic (b) Sponsor. See No. 053501 in agents.1 § 510.600(c) of this chapter. (2) The drug is administered orally at (c) Conditions of use. (1) The drug is an initial dosage level of 1⁄2 tablet used in dogs and cats to relieve anxiety twice daily to dogs weighing up to 10 and to help control psychomotor over- pounds, one tablet twice daily to dogs activity as well as to increase the tol- weighing 11 to 20 pounds, two tablets erance of animals to pain and pruritus. twice daily to dogs weighing 21 to 40 The drug is indicated in various office pounds, and three tablets twice daily and clinical procedures which require to dogs weighing over 40 pounds. After

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4 days, the dosage is reduced to ap- of inflammation commonly associated proximately 1⁄2 the initial dosage or to with most skin disorders of dogs such an amount just sufficient to maintain as eczema caused by internal disorders, remission of symptoms. Dosages in in- otitis, and dermatitis (allergic, para- dividual cases may vary and should be sitic, pustular, and nonspecific). It is adjusted until proper response is ob- also used in dogs as adjunctive therapy tained.1 in various cough conditions including (3) Do not use the drug in cases of treatment of ‘‘kennel cough’’ or viral infections involving corneal ul- tracheobronchitis, bronchitis including ceration or dendritic ulceration of the allergic bronchitis, tonsillitis, acute cornea.1 upper respiratory infections, and (4) Clinical and experimental data coughs of nonspecific origin. The prod- have demonstrated that corticosteroids uct may also be administered to dogs administered orally or parenterally to suffering from acute or chronic bac- animals may induce the first stage of terial infections, provided the infection parturition when administered during is controlled by appropriate antibiotic the last trimester of pregnancy and or chemotherapeutic agents. may precipitate premature parturition (3) Limitations. After 4 days, reduce followed by dystocia, fetal death, re- dosage to one-half the initial dose or to tained placenta, and metritis.1 an amount sufficient to maintain re- (5) Federal law restricts this drug to mission of symptoms. Dosages in indi- use by or on the order of a licensed vet- vidual cases may vary and should be erinarian.1 adjusted until proper response is ob- [40 FR 13838, Mar. 27, 1975, as amended at 56 tained. Do not use the drug in cases of FR 50653, Oct. 8, 1991; 60 FR 55659, Nov. 2, viral infections involving corneal ul- 1995] ceration or dendritic ulceration of the cornea. Clinical and experimental data § 520.2605 Trimeprazine tartrate and have demonstrated that corticosteroids prednisolone capsules. administered orally or parenterally to (a) Specifications. Each capsule con- animals may induce the first stage of tains 3.75 milligrams of trimeprazine in parturition when administered during sustained released form (as the tar- the last trimester of pregnancy and trate) and 1 milligram of prednisolone may precipitate premature parturition (capsule no. 1) or 7.5 milligrams of followed by dystocia, fetal death, re- trimeprazine in sustained release form tained placenta, and metritis. Federal (as the tartrate) and 2 milligrams of law restricts this drug to use by or on prednisolone (capsule no. 2). the order of a licensed veterinarian. (b) Sponsor. See 000069 in § 510.600(c) of this chapter. [48 FR 19367, Apr. 29, 1983, as amended at 56 FR 50653, Oct. 8, 1991; 60 FR 55659, Nov. 2, (c) Conditions of use—(1) Amount. Ad- 1995] minister either capsule orally once daily to dogs as follows: § 520.2610 Trimethoprim and sulfa- diazine tablets. Number of capsules per dose (a) Specifications. Each tablet con- Animal weight (pounds) Capsule Capsule tains 30 milligrams (5 milligrams of No. 1 No. 2 trimethoprim and 25 milligrams of sul- Up to 10 ...... 1 ...... fadiazine), 120 milligrams (20 milli- 11 to 20 ...... 2 1 grams of trimethoprim and 100 milli- 21 to 40 ...... 4 2 grams of sulfadiazine), 480 milligrams Over 40 ...... 6 3 (80 milligrams of trimethoprim and 400 milligrams of sulfadiazine) or 960 milli- (2) Indications for use. For the relief of grams (160 milligrams of trimethoprim itching regardless of cause, reduction and 800 milligrams of sulfadiazine). (b) Sponsor. See Nos. 000061 and 000856 1 These conditions are NAS/NRC reviewed in § 510.600(c) of this chapter. and deemed effective. Applications for these uses need not include effectiveness data as (c) Conditions of use. (1) The drug is specified by § 514.111 of this chapter, but may used in dogs where systemic anti- require bioequivalency and safety informa- bacterial action against sensitive orga- tion. nisms is required, either alone or as an

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adjunct to surgery or debridement with (7) Federal law restricts this drug to associated infection. The drug is indi- use by or on the order of a licensed vet- cated where control of bacterial infec- erinarian. tion is required during the treatment [41 FR 3853, Jan. 27, 1976, as amended at 44 of acute urinary tract infections, acute FR 32214, June 5, 1979; 46 FR 23231, Apr. 24, bacterial complications of distemper, 1981; 47 FR 36814, Aug. 24, 1982; 50 FR 9800, acute respiratory tract infections, Mar. 12, 1985; 50 FR 11852, Mar. 26, 1985; 61 FR acute alimentary tract infections, 5506, Feb. 13, 1996; 61 FR 8873, Mar. 6, 1996; 62 wound infections, and abscesses. FR 61625, Nov. 19, 1997] (2) The drug is given orally at 30 mil- ligrams per kilogram of body weight § 520.2611 Trimethoprim and sulfa- per day (14 milligrams per pound per diazine oral paste. day), or as follows: (a) Specifications. Each gram of oral paste contains 400 milligrams (67 milli- Number of Animal body weight (pounds) tablets grams of trimethoprim and 333 milli- grams of sulfadiazine). 30 MG TABLETS (b) Sponsor. See No. 000856 in

2.2 ...... 1 § 510.600(c) of this chapter for product 4.4 ...... 2 to be dosed at 5 grams per 150 pounds of 6.6 ...... 3 body weight per day. See No. 000061 in 8.8 ...... 4 § 510.600(c) of this chapter for product to be dosed at 3.75 grams per 110 pounds 120 MG TABLETS of body weight per day. Up to 9 ...... 1 (c) Conditions of use—(1) Dosage. (i) 5 10 to 19 ...... 2 grams (335 milligrams of trimethoprim 20 to 29 ...... 3 30 to 40 ...... 4 and 1,665 milligrams of sulfadiazine) per 150 pounds (68 kilograms) of body 480 MG TABLETS weight per day. (ii) 3.75 grams (250 mil- ligrams of trimethoprim and 1,250 mil- 30 to 40 ...... 1 40 to 60 ...... 11⁄2 ligrams of sulfadiazine) per 110 pounds 60 to 80 ...... 2 (50 kilograms) of body weight per day. 80 to 110 ...... 3 (2) Indications for use. For horses Over 110 ...... 4 where systemic anti-bacterial action against sensitive organisms is required (3) The drug is given once daily. Al- during treatment of acute strangles, ternatively, especially in severe infec- respiratory infections, acute urogenital tions, the initial dose may be followed infections, and wound infections and by one-half the recommended daily abscesses. dose every 12 hours. If no improvement (3) Limitations. Administer orally, is seen in 3 days, discontinue therapy once a day, as a single dose for 5 to 7 and reevaluate diagnosis. days; daily dose may also be halved and (4) Administer for 2 to 3 days after given morning and evening; for acute symptoms have subsided. Do not treat infection therapy continue treatment 2 for more than 14 consecutive days. to 3 days after clinical signs have sub- (5) During long term treatment, peri- sided; if no improvement of acute in- odic platelet counts and white and red fections is seen in 3 to 5 days, reevalu- blood cell counts are recommended. ate diagnosis; a complete blood count (6) The drug should not be used in pa- should be done periodically for pro- tients showing marked liver paren- longed use; not for use in horses in- chymal damage or blood dyscrasia, nor tended for food; Federal law restricts in those with a history of sulfonamide this drug to use by or on the order of a sensitivity. licensed veterinarian. [48 FR 34469, July 29, 1983, as amended at 49 FR 26714, June 29, 1984; 53 FR 11063, Apr. 5, 1988; 61 FR 5506, Feb. 13, 1996; 61 FR 8873, Mar. 6, 1996; 62 FR 61625, Nov. 19, 1997]

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§ 520.2612 Trimethoprim and sulfa- (2) Indications for use. For control of diazine oral suspension. bacterial infections of horses during (a) Specifications. Each milliliter of treatment of acute strangles, res- oral suspension contains 60 milligrams piratory tract infections, acute uro- of drug (10 milligrams of trimethoprim genital infections, wound infections, and 50 milligrams of sulfadiazine). and abscesses. (b) Sponsor. See No. 000061 in § 510.600 (3) Limitations. Administer orally in a of this chapter. small amount of feed, as a single daily (c) Conditions of use. Dogs—(1) Dosage. dose, for 5 to 7 days. Continue therapy 1 milliliter (10 milligrams of for 2 to 3 days after clinical signs have trimethoprim and 50 milligrams of sul- subsided. If no improvement is seen in fadiazine) per 5 pounds of body weight. 3 to 5 days, reevaluate diagnosis. A (2) Indications for use. The drug is complete blood count should be done used in dogs where systemic anti- periodically with prolonged use. Not bacterial action against sensitive orga- for use in horses intended for food. Fed- nisms is required, either alone or as an eral law restricts this drug to use by or adjunct to surgery or debridement with on the order of a licensed veterinarian. associated infection. The drug is indi- [58 FR 36135, July 6, 1993, as amended by 64 cated where control of bacterial infec- FR 68289, Dec. 7, 1999] tion is required during the treatment of acute urinary tract infections, acute § 520.2640 Tylosin. bacterial complications of distemper, (a) Specifications. Tylosin is the anti- acute respiratory tract infections, biotic substance produced by growth of acute alimentary tract infections, Streptromyces fradiae or the same anti- wound infections, and abscesses. biotic substance produced by any other (3) Limitations. For oral use only. Ad- means. Tylosin, present as the tartrate minister the recommended dose once salt, conforms to the appropriate anti- daily or one-half the recommended biotic standard. Tylosin contains at daily dose every 12 hours. Administer least 95 percent tylosin as a combina- for 2 to 3 days after symptoms have tion of tylosin A, tylosin B, tylosin C, subsided. If no improvement is seen in and tylosin D of which at least 80 per- 3 days, discontinue therapy and re- cent is tylosin A as determined by a evaluate diagnosis. Do not treat for method entitled ‘‘Determination of more than 14 consecutive days. During Factor Content in Tylosin by High Per- long-term treatment, a complete blood formance Liquid Chromatography,’’ count is recommended. The drug which is incorporated by reference. should not be used in patients showing Copies are available from the Division marked liver parenchymal damage or of Dockets Management (HFA–305), blood dyscrasia, nor in those with a Food and Drug Administration, 5630 history of sulfonamide sensitivity. Fishers Lane, rm. 1061, Rockville, MD Federal law restricts this drug to use 20852, or at the National Archives and by or on the order of a licensed veteri- Records Administration (NARA). For narian. information on the availability of this [50 FR 19168, May 7, 1985, as amended at 61 material at NARA, call 202–741–6030, or FR 8873, Mar. 6, 1996; 62 FR 61625, Nov. 19, go to: http://www.archives.gov/ 1997] federallregister/ codeloflfederallregulations/ § 520.2613 Trimethoprim and sulfa- ibrllocations.html. diazine powder. (b) Sponsor. See No. 000986 in (a) Specifications. Each gram of pow- § 510.600(c) of this chapter. der contains 67 milligrams of (c) Special considerations. The quan- trimethoprim and 333 milligrams of tities of antibiotic in paragraph (e) of sulfadiazine. this section refer to the activity of the (b) Sponsor. See No. 000009 and 058711 appropriate standard. in § 510.600(c) of this chapter. (d) Related tolerances. See § 556.740 of (c) Conditions of use: Horses—(1) Dos- this chapter. age. 3.75 grams of powder per 110 pounds (e) Conditions of use. It is used in (50 kilograms) of body weight per day. drinking water of animals as follows:

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(1) Chickens—(i) Amount. 2 grams per medication must be withheld from ani- gallon. mals 48 hours prior to slaughter. (ii) Indications for use. Aid in the [40 FR 13838, Mar. 27, 1975, as amended at 50 treatment of chronic respiratory dis- FR 49841, Dec. 5, 1985; 59 FR 14365, Mar. 28, ease (CRD) caused by Mycoplasma 1994; 62 FR 39443, July 23, 1997; 68 FR 24879, gallisepticum sensitive to tylosin in May 9, 2003] broiler and replacement chickens. For the control of chronic respiratory dis- PART 522—IMPLANTATION OR ease (CRD) caused by Mycoplasma INJECTABLE DOSAGE FORM NEW gallisepticum sensitive to tylosin at ANIMAL DRUGS time of vaccination or other stress in chickens. For the control of chronic Sec. respiratory disease (CRD) caused by 522.23 Acepromazine maleate injection. Mycoplasma synoviae sensitive to 522.44 Sterile sodium acetazolamide. 522.46 Alfaprostol. tylosin in broiler chickens. 522.56 Amikacin sulfate injection. (iii) Limitations. Do not use in layers 522.62 Aminopentamide hydrogen sulfate in- producing eggs for human consump- jection. tion; administer from 1 to 5 days as 522.82 Aminopropazine fumarate sterile so- sole source of drinking water; treated lution injection. 522.84 Beta-aminopropionitrile fumarate. chickens should consume enough medi- 522.88 Sterile amoxicillin trihydrate for sus- cated drinking water to provide 50 mil- pension. ligrams of tylosin per pound of body 522.90 Ampicillin implantation and weight per day; prepare a fresh solu- injectible dosage forms. tion every 3 days; do not administer 522.90a Ampicillin trihydrate sterile suspen- sion. within 24 hours of slaughter . 522.90b Ampicillin trihydrate for sterile sus- (2) Turkeys—(i) Amount. 2 grams per pension. gallon. 522.90c Ampicillin sodium for aqueous injec- (ii) Indications for use. Maintaining tion. weight gains and feed efficiency in the 522.144 Arsenamide sodium aqueous injec- tion. presence of infectious sinusitis caused 522.147 Atipamezole hydrochloride. by Mycoplasma gallisepticum sensitive 522.150 Azaperone injection. to tylosin. 522.161 Betamethasone acetate and (iii) Limitations. Do not use in layers betamethasone disodium phosphate aque- producing eggs for human consump- ous suspension. 522.163 Betamethasone dipropionate and tion; administer from 2 to 5 days as betamethasone sodium phosphate aque- sole source of drinking water; treated ous suspension. turkeys should consume enough medi- 522.204 Boldenone undecylenate injection. cated drinking water to provide 60 mil- 522.234 Butamisole hydrochloride. ligrams of tylosin per pound of body 522.246 Butorphanol tartrate injection. 522.275 N-Butylscopolammonium bromide. weight per day; prepare a fresh solu- 522.311 Carfentanil citrate injection. tion every 3 days; when sinus swelling 522.312 Carprofen. is present, inject the sinus with tylosin 522.313 Ceftiofur sodium powder for injec- injectable simultaneously with the tion. drinking water treatment; do not ad- 522.314 Ceftiofur hydrochloride. 522.315 Ceftiofur crystalline free acid. minister within 5 days of slaughter. 522.380 Chloral hydrate, pentobarbital, and (3) Swine—(i) Amount. 0.25 gram per magnesium sulfate sterile aqueous solu- gallon. tion. (ii) Indications for use. For the control 522.390 Chloramphenicol injection. and treatment of swine dysentery 522.460 Cloprostenol sodium. 522.468 Colistimethate sodium powder for (bloody scours) caused by pathogens injection. sensitive to tylosin. 522.480 Repository corticotropin injection. (iii) Limitations. As only source of 522.518 Cupric glycinate injection. drinking water for 3 to 10 days, depend- 522.522 Danofloxacin. ing on the severity of the condition 522.533 Deslorelin acetate. 522.535 Desoxycorticosterone pivalate. being treated: mix fresh solution daily; 522.536 Detomidine hydrochloride injection. 522.540 Dexamethasone injection.

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