Oral dosage form new animal drugs (21 CFR 520.23-520.2645)

151 Food and Drug Administration, HHS Pt. 520 licensed veterinarian. It is a violation of Federal law to use this product other than as directed in the labeling. [79 FR 18158, Apr. 1, 2014] PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS Sec. 520.23 Acepromazine. 520.28 Acetazolamide. 520.38 Albendazole oral dosage forms. 520.38a Albendazole suspension. 520.38b Albendazole paste. 520.43 Afoxolaner. 520.48 Altrenogest. 520.62 Aminopentamide. 520.82 Aminopropazine oral dosage forms. 520.82a Aminopropazine. 520.82b Aminopropazine and neomycin. 520.88 Amoxicillin oral dosage forms. 520.88a Amoxicillin trihydrate film-coated tablets. 520.88b Amoxicillin trihydrate for oral sus pension. 520.88c Amoxicillin trihydrate oral suspen sion. 520.88d Amoxicillin trihydrate soluble pow der. 520.88e Amoxicillin trihydrate boluses. 520.88f Amoxicillin trihydrate tablets. 520.88g Amoxicillin trihydrate and clavulanate potassium film-coated tab lets. 520.88h Amoxicillin trihydrate and clavulanate potassium for oral suspen sion. 520.90 Ampicillin oral dosage forms. 520.90a [Reserved] 520.90b Ampicillin tablets. 520.90c Ampicillin capsules. 520.90d Ampicillin for oral suspension. 520.90e Ampicillin for soluble powder. 520.90f Ampicillin boluses. 520.100 Amprolium. 520.110 Apramycin sulfate soluble powder. 520.154 Bacitracin oral dosage forms. 520.154a Bacitracin methylenedisalicylate. 520.154b Bacitracin methylenedisalicylate and streptomycin sulfate powder. 520.154c Bacitracin zinc soluble powder. 520.222 Bunamidine hydrochloride. 520.246 Butorphanol tablets. 520.260 n-Butyl chloride. 520.300 Cambendazole oral dosage forms. 520.300a Cambendazole suspension. 520.300b Cambendazole pellets. 520.300c Cambendazole paste. 520.301 Caramiphen ethanedisulfonate and ammonium chloride tablets. 520.302 Carnidazole tablets. 520.304 Carprofen. 520.314 Cefadroxil. 520.370 Cefpodoxime tablets. 520.376 Cephalexin. 520.390 Chloramphenicol oral dosage forms. 520.390a Chloramphenicol tablets. 520.390b Chloramphenicol capsules. 520.390c Chloramphenicol palmitate oral suspension. 520.420 Chlorothiazide tablets and boluses. 520.434 Chlorphenesin carbamate tablets. 520.441 Chlortetracycline powder. 520.443 Chlortetracycline tablets and boluses. 520.445 Chlortetracycline and sulfamethazine powder. 520.446 Clindamycin capsules and tablets. 520.447 Clindamycin solution. 520.452 Clenbuterol syrup. 520.455 Clomipramine tablets. 520.462 Clorsulon drench. 520.522 Cyclosporine. 520.530 Cythioate oral liquid. 520.531 Cythioate tablets. 520.534 Decoquinate. 520.538 Deracoxib. 520.540 Dexamethasone oral dosage forms. 520.540a Dexamethasone powder. 520.540b Dexamethasone tablets and boluses. 520.540c Dexamethasone chewable tablets. 520.563 Dexamethasone chewable tablets. 520.580 Dichlorophene and toluene. 520.581 Dichlorophene tablets. 520.600 Dichlorvos. 520.606 Diclazuril. 520.608 Dicloxacillin. 520.620 Diethylcarbamazine oral dosage forms. 520.622 Diethylcarbamazine citrate oral dos age forms. 520.622a Diethylcarbamazine citrate tablets. 520.622b Diethylcarbamazine citrate syrup. 520.622c Diethylcarbamazine citrate chew able tablets. 520.623 Diethylcarbamazine and oxibendazole chewable tablets. 520.645 Difloxacin. 520.666 Dirlotapide. 520.763 Dithiazanine oral dosage forms. 520.763a Dithiazanine tablets. 520.763b Dithiazanine powder. 520.763c Dithiazanine iodide and piperazine citrate suspension. 520.766 Domperidone. 520.784 Doxylamine. 520.804 Enalapril. 520.812 Enrofloxacin. 520.816 Epsiprantel. 520.823 Erythromycin. 520.852 Estriol. 520.863 Ethylisobutrazine. 520.870 Etodolac. 520.903 Febantel oral dosage forms. 520.903a Febantel paste. 520.903b Febantel suspension. 520.903c [Reserved] 520.903d Febantel and praziquantel paste. 520.903e Febantel tablets. 520.905 Fenbendazole oral dosage forms. 520.905a Fenbendazole suspension. 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I (4–1–16 Edition) Pt. 520 520.905b Fenbendazole granules. 520.905c Fenbendazole paste. 520.905d Fenbendazole powder. 520.905e Fenbendazole blocks. 520.928 Firocoxib tablets. 520.930 Firocoxib paste. 520.955 Florfenicol. 520.960 Flumethasone. 520.970 Flunixin. 520.980 Fluoxetine. 520.998 Fluralaner. 520.1010 Furosemide. 520.1044 Gentamicin sulfate oral dosage forms. 520.1044a Gentamicin sulfate oral solution. 520.1044b Gentamicin sulfate pig pump oral solution. 520.1044c Gentamicin sulfate powder. 520.1060 Glucose and glycine. 520.1100 Griseofulvin. 520.1120 Haloxon oral dosage forms. 520.1120a Haloxon drench. 520.1120b Haloxon boluses. 520.1130 Hetacillin. 520.1156 Imidacloprid. 520.1157 Iodinated casein. 520.1158 Iodochlorhydroxyquin. 520.1182 Iron dextran suspension. 520.1192 Ivermectin paste. 520.1193 Ivermectin tablets and chewables. 520.1194 Ivermectin meal. 520.1195 Ivermectin liquid. 520.1196 Ivermectin and pyrantel tablets. 520.1197 Ivermectin sustained-release bolus. 520.1198 Ivermectin and praziquantel paste. 520.1199 Ivermectin, pyrantel, and praziquantel tablets. 520.1200 Ivermectin, fenbendazole, and praziquantel tablets. 520.1204 Kanamycin, bismuth subcarbonate, activated attapulgite. 520.1242 Levamisole. 520.1242a Levamisole powder. 520.1242b Levamisole boluses or oblets. 520.1242c Levamisole and piperazine. 520.1242d Levamisole resinate. 520.1242e Levamisole hydrochloride effer vescent tablets. 520.1242f Levamisole gel. 520.1242g Levamisole resinate and famphur paste. 520.1263 Lincomycin. 520.1263a Lincomycin tablets and syrup. 520.1263b [Reserved] 520.1263c Lincomycin powder. 520.1265 Lincomycin and spectinomycin powder. 520.1284 Liothyronine. 520.1288 Lufenuron tablets. 520.1289 Lufenuron suspension. 520.1310 Marbofloxacin. 520.1315 Maropitant. 520.1320 Mebendazole. 520.1326 Mebendazole and trichlorfon oral dosage forms. 520.1326a Mebendazole and trichlorfon pow der. 520.1326b Mebendazole and trichlorfon paste. 520.1330 Meclofenamic acid granules. 520.1331 Meclofenamic acid tablets. 520.1341 Megestrol. 520.1367 Meloxicam. 520.1372 Methimazole. 520.1380 Methocarbamol. 520.1408 Methylprednisolone. 520.1409 Methylprednisolone and aspirin. 520.1422 Metoserpate hydrochloride. 520.1430 Megestrol acetate tablets. 520.1441 Milbemycin oxime. 520.1443 Milbemycin oxime and lufenuron. 520.1445 Milbemycin oxime and praziquantel. 520.1447 Milbemycin oxime, lufenuron, and praziquantel tablets. 520.1450 Morantel tartrate oral dosage forms. 520.1450a Morantel tartrate bolus. 520.1450b Morantel tartrate cartridge. 520.1450c Morantel tartrate sustained-re lease trilaminate cylinder/sheet. 520.1451 Moxidectin tablets. 520.1452 Moxidectin gel. 520.1453 Moxidectin and praziquantel gel. 520.1454 Moxidectin solution. 520.1468 Naproxen. 520.1484 Neomycin. 520.1510 Nitenpyram. 520.1604 Oclacitinib. 520.1615 Omeprazole. 520.1616 Orbifloxacin tablets.. 520.1618 Orbifloxacin suspension. 520.1628 Oxfendazole powder and pellets. 520.1629 Oxfendazole paste. 520.1630 Oxfendazole suspension. 520.1631 Oxfendazole and trichlorfon paste. 520.1638 Oxibendazole. 520.1660 Oxytetracycline. 520.1660a Oxytetracycline and carbomycin in combination. 520.1660b Oxytetracycline hydrochloride capsules. 520.1660c Oxytetracycline hydrochloride tablets/boluses. 520.1660d Oxytetracycline powder. 520.1696 Penicillin. 520.1696a [Reserved] 520.1696b Penicillin G powder. 520.1696c Penicillin V powder. 520.1696d Penicillin V tablets. 520.1705 Pergolide. 520.1720 Phenylbutazone oral dosage forms. 520.1720a Phenylbutazone tablets and boluses. 520.1720b Phenylbutazone granules. 520.1720c Phenylbutazone paste. 520.1720d Phenylbutazone gel. 520.1720e Phenylbutazone powder. 520.1760 Phenylpropanolamine. 520.1780 Pimobendan. 520.1802 Piperazine-carbon disulfide complex oral dosage forms. 520.1802a Piperazine-carbon disulfide com plex suspension. VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00162 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 153 Food and Drug Administration, HHS Pt. 520 520.1802b Piperazine-carbon disulfide com plex boluses. 520.1802c Piperazine-carbon disulfide com plex with phenothiazine suspension. 520.1803 Piperazine citrate capsules. 520.1804 Piperazine phosphate capsules. 520.1805 Piperazine phosphate with thenium closylate tablets. 520.1806 Piperazine suspension. 520.1807 Piperazine. 520.1840 Poloxalene. 520.1846 Polyoxyethylene (23) lauryl ether blocks. 520.1855 Ponazuril. 520.1860 Pradofloxacin. 520.1870 Praziquantel tablets. 520.1871 Praziquantel and pyrantel. 520.1872 Praziquantel, pyrantel pamoate, and febantel tablets. 520.1880 Prednisolone. 520.1900 Primidone. 520.1920 Prochlorperazine and isopropamide. 520.1921 Prochlorperazine, isopropamide, and neomycin. 520.1962 Promazine. 520.2002 Propiopromazine. 520.2041 Pyrantel pamoate chewable tablets. 520.2042 Pyrantel pamoate tablets. 520.2043 Pyrantel pamoate suspension. 520.2044 Pyrantel pamoate paste. 520.2045 Pyrantel tartrate powder. 520.2046 Pyrantel tartrate pellets. 520.2075 Robenacoxib. 520.2098 Selegiline. 520.2100 Selenium and vitamin E. 520.2123 Spectinomycin oral dosage forms. 520.2123a Spectinomycin tablets. 520.2123b Spectinomycin powder. 520.2123c Spectinomycin solution. 520.2130 Spinosad. 520.2134 Spinosad and milbemycin. 520.2150 Stanozolol. 520.2158 Streptomycin. 520.2170 Sulfabromomethazine. 520.2184 Sulfachloropyrazine. 520.2200 Sulfachlorpyridazine. 520.2215 Sulfadiazine/pyrimethamine sus pension. 520.2218 Sulfamerazine, sulfamethazine, and sulfaquinoxaline powder. 520.2220 Sulfadimethoxine oral dosage forms. 520.2220a Sulfadimethoxine solution and soluble powder. 520.2220b Sulfadimethoxine suspension. 520.2220c Sulfadimethoxine tablet. 520.2220d Sulfadimethoxine bolus. 520.2220e Sulfadimethoxine extended-release bolus. 520.2220f Sulfadimethoxine and ormetoprim tablet. 520.2240 Sulfaethoxypyridazine. 520.2240a Sulfaethoxypyridazine solution. 520.2240b Sulfaethoxypyridazine tablets. 520.2260 Sulfamethazine oral dosage forms. 520.2260a Sulfamethazine oblet, tablet, and bolus. 520.2260b Sulfamethazine sustained-release boluses. 520.2260c Sulfamethazine sustained-release tablets. 520.2261 Sulfamethazine sodium oral dosage forms. 520.2261a Sulfamethazine solution. 520.2261b Sulfamethazine powder. 520.2280 Sulfamethizole and methenamine. 520.2325 Sulfaquinoxaline oral dosage forms. 520.2325a Sulfaquinoxaline powder and solu tion. 520.2325b Sulfaquinoxaline drench. 520.2330 Sulfisoxazole tablets. 520.2340 Tepoxalin. 520.2345 Tetracycline. 520.2345a Tetracycline capsules. 520.2345b Tetracycline tablets. 520.2345c Tetracycline boluses. 520.2345d Tetracycline powder. 520.2345e Tetracycline solution. 520.2345f Tetracycline phosphate complex and sodium novobiocin capsules. 520.2345g Tetracycline hydrochloride and so dium novobiocin tablets. 520.2345h Tetracycline hydrochloride, so dium novobiocin, and prednisolone tab lets. 520.2362 Thenium closylate. 520.2380 Thiabendazole oral dosage forms. 520.2380a Thiabendazole top dressing and mineral protein block. 520.2380b Thiabendazole drench or paste. 520.2380c Thiabendazole bolus. 520.2380d Thiabendazole and piperazine cit rate. 520.2380e Thiabendazole and trichlorfon. 520.2380f Thiabendazole and piperazine phos phate. 520.2455 Tiamulin. 520.2471 Tilmicosin. 520.2473 Tioxidazole oral dosage forms. 520.2473a Tioxidazole granules. 520.2473b Tioxidazole paste. 520.2475 Toceranib. 520.2481 Triamcinolone acetonide tablets. 520.2482 Triamcinolone acetonide oral pow der. 520.2483 Triamcinolone. 520.2520 Trichlorfon oral dosage forms. 520.2520a Trichlorfon and atropine. 520.2520b Trichlorofon boluses. 520.2520c Trichlorofon granules. 520.2520d Trichlorfon, phenothiazine, and pi perazine dihydrochloride powder. 520.2582 Triflupromazine. 520.2598 Trilostane. 520.2604 Trimeprazine and prednisolone tab lets. 520.2605 Trimeprazine and prednisolone cap sules. 520.2610 Trimethoprim and sulfadiazine tab lets. 520.2611 Trimethoprim and sulfadiazine paste. 520.2612 Trimethoprim and sulfadiazine sus pension. VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00163 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 154 21 CFR Ch. I (4–1–16 Edition) § 520.23 520.2613 Trimethoprim and sulfadiazine powder. 520.2640 Tylosin. 520.2645 Tylvalosin. AUTHORITY: 21 U.S.C. 360b. SOURCE: 40 FR 13838, Mar. 27, 1975, unless otherwise noted. § 520.23 Acepromazine. (a) Specifications. Each tablet con tains 5, 10, or 25 milligrams (mg) acepromazine maleate. (b) Sponsors. See No. 000010 in § 510.600(c) of this chapter. (c) Conditions of use—(1) Dogs—(i) Amount. 0.25 to 1.0 mg per pound (/lb) body weight orally. (ii) Indications for use. As an aid in tranquilization and as a preanesthetic agent. (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (2) Cats—(i) Amount. 0.5 to 1.0 mg/lb body weight orally. (ii) Indications for use. As a tranquil izer. (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [75 FR 10165, Mar. 5, 2010] § 520.28 Acetazolamide. (a) Specifications. A powder con taining acetazolamide sodium, USP equivalent to 25 percent acetazolamide activity. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Conditions of use in dogs—(1) Amount. Administer orally at a dosage of 5 to 15 milligrams per pound of body weight daily. (2) Indications for use. As an aid in the treatment of mild congestive heart failure and for rapid reduction of intra ocular pressure. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [79 FR 28816, May 20, 2014] § 520.38 Albendazole oral dosage forms. § 520.38a Albendazole suspension. (a) Specifications. Each milliliter of suspension contains 45.5 milligrams (mg) (4.55 percent) or 113.6 mg (11.36 percent) albendazole. (b) Sponsor. See No. 054771 in § 510.600 of this chapter. (c) Related tolerances. See § 556.34 of this chapter. (d) Special considerations. See § 500.25 of this chapter. (e) Conditions of use—(1) Cattle. Ad minister 11.36 percent suspension: (i) Amount. 4.54 mg/pound (lb) body weight (10 mg/kilogram (kg)) as a sin gle oral dose using dosing gun or dos ing syringe. (ii) Indications for use. For removal and control of adult liver flukes (Fasciola hepatica); heads and segments of tapeworms (Moniezia benedeni and M. expansa); adult and 4th stage larvae of stomach worms (brown stomach worms including 4th stage inhibited larvae (Ostertagia ostertagi), barberpole worm (Haemonchus contortus and H. placei), small stomach worm (Trichostrongylus axei)); adult and 4th stage larvae of in testinal worms (thread-necked intes tinal worm (Nematodirus spathiger and N. helvetianus), small intestinal worm (Cooperia punctata and C. oncophora)); adult stages of intestinal worms (hookworm (Bunostomum phlebotomum), bankrupt worm (Trichostrongylus colubriformis), nodular worm (Oesophagostomum radiatum)); adult and 4th stage larvae of lungworms (Dictyocaulus viviparus). (iii) Limitations. Do not slaughter within 27 days of last treatment. Do not use in female dairy cattle of breed ing age: Do not administer to female cattle during first 45 days of pregnancy or for 45 days after removal of bulls. (2) Sheep. Administer 4.45 or 11.36 per cent suspension: (i) Amount. 3.4 mg/lb body weight (7.5 mg/kg) as a single oral dose using dos ing gun or dosing syringe. (ii) Indications for use. For removal and control of adult liver flukes (Fasciola hepatica and Fascioloides magna); heads and segments of common tapeworms (Moniezia expansa) and fringed tapeworm (Thysanosoma actinioides); adult and fourth stage lar vae of stomach worms (brown stomach worm (Ostertagia circumcinta and Marshallagia marshalli), barberpole worm (Haemonchus contortus), small stomach worm (Trichostrongylus axei)); VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00164 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 155 Food and Drug Administration, HHS § 520.48 adult and fourth stage larvae of intes tinal worms (thread-necked intestinal worm (Nematodirus spathiger and N. filicollis), Cooper’s worm (Cooperia oncophora), bankrupt worm (Trichostrongylus colubriformis), nodular worm (Oesophagostomum columbianum), and large-mouth bowel worm (Chabertia ovina)); adult and larval stages of lungworms (Dictyocaulus filaria). (iii) Limitations. Do not slaughter within 7 days of last treatment. Do not administer to ewes during first 30 days of pregnancy or for 30 days after re moval of rams. (3) Goats. Administer 11.36 percent suspension: (i) Amount. 4.54 mg/lb body weight (10 mg/kg) as a single oral dose using dos ing gun or dosing syringe. (ii) Indications for use. For the treat ment of adult liver flukes (Fasciola he patica) in nonlactating goats. (iii) Limitations. Do not slaughter within 7 days of last treatment. Do not administer to does during the first 30 days of pregnancy or for 30 days after removal of bucks. [73 FR 11027, Feb. 29, 2008. Redesignated at 78 FR 66264, Nov. 5, 2013, as amended at 79 FR 28816, May 20, 2014] § 520.38b Albendazole paste. (a) Specifications. The product con tains 30 percent albendazole. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.34 of this chapter. (d) Conditions of use in cattle—(1) Amount. Equivalent to 4.54 milligrams per 1 pound of body weight (10 milli grams per kilogram). (2) Indications for use. For removal and control of the following internal parasites of cattle: adult liver flukes (Fasciola hepatica); heads and segments of tapeworms (Moniezia benedeni, M. expansa); adult and 4th stage larvae of stomach worms (brown stomach worms including 4th stage inhibited larvae (Ostertagia ostertagi); barberpole worm (Haemonchus contortus, H. placei); small stomach worm (Trichostrongylus axei)); adult and 4th stages larvae of intes tinal worms (thread-necked intestinal worm (Nematodirus spathiger, N. helvetianus); small intestinal worm (Cooperia punctata and C. oncophora)); adult stages of intestinal worms (hookworm (Bunostomum phlebotmum); bankrupt worm (Trichostrongylus colubriformis), nodular worm (Oesophagostomum radiatum)); adult and 4th stage larvae of lungworms (Dictyocaulus viviparus). (3) Limitations. Administer as a single oral dose. Do not slaughter within 27 days of last treatment. Do not use in female dairy cattle of breeding age. Do not administer to female cattle during first 45 days of pregnancy or for 45 days after removal of bulls. Consult your veterinarian for assistance in the diag nosis, treatment, and control of para sitism. [54 FR 51385, Dec. 15, 1989, as amended at 56 FR 50653, Oct. 8, 1991; 60 FR 55658, Nov. 2, 1995. Redesignated at 78 FR 66264, Nov. 5, 2013, as amended at 79 FR 28816, May 20, 2014] § 520.43 Afoxolaner. (a) Specifications. Each chewable tab let contains 11.3, 28.3, 68, or 136 milli grams (mg) afoxolaner. (b) Sponsor. See No. 050604 in § 510.600(c) of this chapter. (c) Conditions of use—(1) Amount. Ad minister orally once a month at a min imum dosage of 1.14 mg/pound (lb) (2.5 mg/kilogram (kg)). (2) Indications for use. Kills adult fleas; for the treatment and prevention of flea infestations (Ctenocephalides felis); for the treatment and control of black-legged tick (Ixodes scapularis), American dog tick (Dermacentor variabilis), lone star tick (Amblyomma americanum), and brown dog tick (Rhipicephalus sanguineus) infestations in dogs and puppies 8 weeks of age and older, weighing 4 lb of body weight or greater, for 1 month. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [78 FR 66264, Nov. 5, 2013, as amended at 79 FR 37619, July 2, 2014; 80 FR 18775, Apr. 8, 2015] § 520.48 Altrenogest. (a) Specifications. Each milliliter (mL) of solution contains 2.2 milli grams (mg) altrenogest. (b) Sponsors. See Nos. 000061 and 013744 in § 510.600(c) of this chapter. (c) Tolerances. See § 556.36 of this chapter. VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00165 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 156 21 CFR Ch. I (4–1–16 Edition) § 520.62 (d) Conditions of use—(1) Horses—(i) Amount. 1.0 mL per 110 pounds body weight (0.044 mg/kg) daily for 15 con secutive days. (ii) Indications for use. For suppres sion of estrus in mares. (iii) Limitations. Do not use in horses intended for human consumption. Fed eral law restricts this drug to use by or on the order of a licensed veterinarian. (2) Swine—(i) Amount. Administer 6.8 mL (15 mg altrenogest) per gilt once daily for 14 consecutive days by top dressing on a portion of each gilt’s daily feed. (ii) Indications for use. For synchroni zation of estrus in sexually mature gilts that have had at least one estrous cycle. (iii) Limitations. Do not use in gilts having a previous or current history of uterine inflammation (i.e., acute, subacute or chronic endometritis). Gilts must not be slaughtered for human consumption for 21 days after the last treatment. [66 FR 47960, Sept. 17, 2001, as amended at 68 FR 62006, Oct. 31, 2003; 72 FR 9455, Feb. 21, 2008; 74 FR 61516, Nov. 25, 2009; 77 FR 32012, May 31, 2012; 80 FR 34278, June 16, 2015] § 520.62 Aminopentamide. (a) Specifications. Each tablet con tains 0.2 milligram (mg) aminopentamide hydrogen sulphate. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Conditions of use in dogs and cats— (1) Amount. Administer orally every 8 to 12 hours as follows: For animals weighing up to 10 pounds (lbs): 0.1 mg; for animals weighing 11 to 20 lbs: 0.2 mg; for animals weighing 21 to 50 lbs: 0.3 mg; for animals weighing 51 to 100 lbs: 0.4 mg; for animal weighing over 100 lbs: 0.5 mg. Dosage may be gradu ally increased up to a maximum of five times the suggested dosage. Oral ad ministration of tablets may be pre ceded by subcutaneous or intramuscular use of the injectable form of the drug. (2) Indications for use. For the treat ment of vomiting and/or diarrhea, nau sea, acute abdominal visceral spasm, pylorospasm, or hypertrophic gastritis. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [79 FR 28816, May 20, 2014] § 520.82 Aminopropazine oral dosage forms. § 520.82a Aminopropazine. (a) Specifications. Each tablet con tains aminopropazine fumarate equiva lent to 25 percent aminopropazine base. (b) Sponsor. See No. 000061 in § 510.600(c) of this chapter. (c) Conditions of use in dogs and cats— (1) Amount. Administer orally at a dos age of 1 to 2 milligrams per pound of body weight, repeated every 12 hours as indicated. (2) Indications for use. For reducing excessive smooth muscle contractions, such as occur in urethral spasms asso ciated with urolithiasis. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [79 FR 28816, May 20, 2014] § 520.82b Aminopropazine and neomy cin. (a) Specifications. Each tablet con tains aminopropazine fumarate equiva lent to 25 percent aminopropazine base and neomycin sulfate equivalent to 50 milligrams (mg) of neomycin base. (b) Sponsor. See No. 000061 in § 510.600(c) of this chapter. (c) Conditions of use in dogs—(1) Amount. Administer orally at a dosage of 1 to 2 mg per pound of body weight, repeated every 12 hours as indicated. (2) Indications for use. For control of bacterial diarrhea caused by organisms susceptible to neomycin and to reduce smooth muscle contractions. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [79 FR 28816, May 20, 2014] § 520.88 Amoxicillin oral dosage forms. § 520.88a Amoxicillin trihydrate film coated tablets. (a) Specifications. Each tablet con tains amoxicillin trihydrate equivalent to 50, 100, 150, 200, or 400 milligrams (mg) amoxicillin. VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00166 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 157 Food and Drug Administration, HHS § 520.88b (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Conditions of use—(1) Dogs—(i) Amount. Administer orally 5 mg per pound (/lb) of body weight, twice a day for 5 to 7 days. (ii) Indications for use. Treatment of infections of the respiratory tract (ton sillitis, tracheobronchitis), genito urinary tract (cystitis), gastro intestinal tract (bacterial gastroenteritis), and soft tissues (ab scesses, lacerations, wounds), caused by susceptible strains of Staphylococcus aureus, Streptococcus spp., Escherichia coli, Proteus mirabilis, and bacterial der matitis caused by S. aureus, Strepto coccus spp., and P. mirabilis. (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (2) Cats—(i) Amount. Administer oral ly 5 to 10 mg/lb of body weight, once daily for 5 to 7 days. (ii) Indications for use. Treatment of infections caused by susceptible orga nisms as follows: upper respiratory tract due to S. aureus, Streptococcus spp., and E. coli; genitourinary tract (cystitis) due to S. aureus, Streptococcus spp., E. coli, and P. mirabilis; gastro intestinal tract due to E. coli; and skin and soft tissue (abscesses, lacerations, and wounds) due to S. aureus, Strepto coccus spp., E. coli, and Pasteurella multocida. (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [57 FR 37319, Aug. 18, 1992, as amended at 60 FR 55658, Nov. 2, 1995; 79 FR 28816, May 20, 2014] § 520.88b Amoxicillin trihydrate for oral suspension. (a) Specifications. When reconstituted, each milliliter contains amoxicillin trihydrate equivalent to 50 milligrams (mg) amoxicillin. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (1) Conditions of use—(i) Dogs—(A) Amount. Administer orally 5 mg per pound (/lb) of body weight, twice a day for 5 to 7 days. (B) Indications for use. Treatment of infections caused by susceptible strains of organisms as follows: respiratory tract (tonsillitis, tracheobronchitis) caused by Staphylococcus aureus, Strep tococcus spp., Escherichia coli, and Pro teus mirabilis; genitourinary tract (cys titis) caused by S. aureus, Streptococcus spp., E. coli, and P. mirabilis; gastro intestinal tract (bacterial gastroenteritis) caused by S. aureus, Streptococcus spp., E. coli, and P. mirabilis; bacterial dermatitis caused by S. aureus, Streptococcus spp., and P. mirabilis; and soft tissues (abscesses, lacerations, and wounds) caused by S. aureus, Streptococcus spp., E. coli, and P. mirabilis. (C) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (ii) Cats—(A) Amount. Administer orally 5 to 10 mg/lb of body weight, once daily for 5 to 7 days. (B) Indications for use. Treatment of infections caused by susceptible strains of organisms as follows: upper res piratory tract due to Staphylococcus spp., Streptococcus spp., Haemophilus spp., E. coli, Pasteurella spp., and P. mirabilis; genitourinary tract (cystitis) due to S. aureus, Streptococcus spp., E. coli, P. mirabilis, and Corynebacterium spp.; gastrointestinal tract due to E. coli, Proteus spp., Staphylococcus spp., and Streptococcus spp.; skin and soft tis sue (abscesses, lacerations, and wounds) due to Staphylococcus spp., Streptococcus spp., E. coli, and Pasteurella multocida. (C) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (2) [Reserved] (c) Sponsors. See Nos. 000856 and 051311 in § 510.600(c) of this chapter. (1) Conditions of use. Dogs—(i) Amount. Administer orally 5 mg/lb of body weight, twice a day for 5 to 7 days. (ii) Indications for use. Treatment of bacterial dermatitis due to S. aureus, Streptococcus spp., Staphylococcus spp., and E. coli, and soft tissue infections (abscesses, wounds, lacerations) due to S. aureus, Streptococcus spp., E. coli, P. mirabilis and Staphylococcus spp. (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00167 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 158 21 CFR Ch. I (4–1–16 Edition) § 520.88c (2) [Reserved] [57 FR 37319, Aug. 18, 1992; 57 FR 42623, Sept. 15, 1992, as amended at 60 FR 55658, Nov. 2, 1995; 62 FR 13302, Mar. 20, 1997; 67 FR 67521, Nov. 6, 2002; 68 FR 54658, Sept. 18, 2003; 68 FR 55824, Sept. 29, 2003; 79 FR 28816, May 20, 2014; 81 FR 17607, Mar. 30, 2016] § 520.88c Amoxicillin trihydrate oral suspension. (a) Specifications. Each 0.8-milliliter dose contains amoxicillin trihydrate equivalent to 40 milligrams (mg) amoxicillin. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.510 of this chapter. (d) Conditions of use in swine—(1) Amount. Administer 40 mg orally twice a day using a dosing pump. Treat ani mals for 48 hours after all symptoms have subsided but not beyond 5 days. (2) Indications for use. Treatment of baby pigs under 10 pounds for porcine colibacillosis caused by Escherichia coli susceptible to amoxicillin. (3) Limitations. Do not slaughter dur ing treatment or for 15 days after lat est treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [57 FR 37319, Aug. 18, 1992, as amended at 60 FR 55658, Nov. 2, 1995; 79 FR 28817, May 20, 2014] § 520.88d Amoxicillin trihydrate solu ble powder. (a) Specifications. Each gram of pow der contains amoxicillin trihydrate equivalent to 115.4 milligrams (mg) amoxicillin. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.38 of this chapter. (d) Conditions of use in preruminating calves including veal calves—(1) Amount. Administer 400 mg per 100 pounds of body weight twice daily by drench or in milk. Treatment should be continued for 48 hours after all symptoms have subsided but not to exceed 5 days. (2) Indications for use. Treatment of bacterial enteritis when due to suscep tible Escherichia coli in preruminating calves including veal calves. (3) Limitations. Do not slaughter ani mals during treatment or for 20 days after the latest treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian [57 FR 37319, Aug. 18, 1992; 57 FR 42623, Sept. 15, 1992; 58 FR 18304, Apr. 8, 1993, as amended at 60 FR 55658, Nov. 2, 1995; 62 FR 5525, Feb. 6, 1997; 79 FR 28817, May 20, 2014] § 520.88e Amoxicillin trihydrate boluses. (a) Specifications. Each bolus contains amoxicillin trihydrate equivalent to 400 milligrams (mg) amoxicillin. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.38 of this chapter. (d) Conditions of use in cattle—(1) Amount. Administer 400 mg per 100 pounds of body weight twice daily. Treatment should be continued for 48 hours after all symptoms have subsided but not to exceed 5 days. (2) Indications for use. Treatment of bacterial enteritis when due to suscep tible Escherichia coli in preruminating calves including veal calves. (3) Limitations. Do not slaughter ani mals during treatment or for 20 days after the latest treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [57 FR 37320, Aug. 18, 1992, as amended at 60 FR 55659, Nov. 2, 1995; 62 FR 5526, Feb. 6, 1997; 79 FR 28817, May 20, 2014] § 520.88f Amoxicillin trihydrate tab lets. (a) Specifications. Each tablet con tains amoxicillin trihydrate equivalent to 50, 100, 200, or 400 milligrams (mg) amoxicillin. (b) Sponsors. See Nos. 051311 and 054771 in § 510.600(c) of this chapter. (c) Conditions of use in dogs—(1) Amount. Administer 5 mg per pound of body weight twice daily for 5 to 7 days or 48 hours after all symptoms have subsided. (2) Indications for use. For treatment of bacterial dermatitis due to Staphy lococcus aureus, Streptococcus spp., Staphylococcus spp., and Escherichia coli; and soft tissue infections (ab scesses, wounds, lacerations) due to S. aureus, Streptococcus spp., E. coli, Pro teus mirabilis, and Staphylococcus spp. VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00168 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 159 Food and Drug Administration, HHS § 520.88h (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [79 FR 28817, May 20, 2014] § 520.88g Amoxicillin trihydrate and clavulanate potassium film-coated tablets. (a) Specifications. Each tablet con tains amoxicillin trihydrate and clavulanate potassium, equivalent to either 50 milligrams of amoxicillin and 12.5 milligrams clavulanic acid, or 100 milligrams of amoxicillin and 25 milli grams clavulanic acid, or 200 milli grams amoxicillin and 50 milligrams clavulanic acid or 300 milligrams amoxicillin and 75 milligrams clavulanic acid. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Conditions of use—(1) Dogs—(i) Amount. 6.25 milligrams (equivalent to 5 milligrams amoxicillin and 1.25 milli grams clavulanic acid) per pound of body weight twice daily for 5 to 7 days or for 48 hours after all signs have sub sided. Deep pyoderma may require treatment for 21 days; do not treat for more than 30 days. (ii) Indications for use. Treatment of skin and soft tissue infections such as wounds, abscesses, cellulitis, super ficial/juvenile and deep pyoderma due to susceptible strains of beta lactamase (penicillinase) Staphy lococcus aureus, nonbeta-lactamase S. aureus, Staphylococcus spp., Strepto coccus spp., and Escherichia coli. Treat ment of periodontal infections due to susceptible strains of aerobic and an aerobic bacteria. (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (2) Cats—(i) Amount. 62.5 milligrams (50 milligrams amoxicillin and 12.5 mil ligrams clavulanic acid) twice daily for 5 to 7 days or for 48 hours after all signs have subsided. Urinary tract in fections may require treatment for 10 to 14 days or longer. The maximum du ration of treatment should not exceed 30 days. (ii) Indications for use. Treatment of skin and soft tissue infections, such as wounds, abscesses and cellulitis/derma titis due to susceptible strains of beta lactamase (penicillinase) producing S. aureus, nonbeta-lactamase producing S. aureus, Staphylococcus spp., Strepto coccus spp., E. coli, and Pasteurella spp. Also, treatment of urinary tract infec tions (cystitis) due to susceptible strains of E. coli. (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [57 FR 37320, Aug. 18, 1992, as amended at 60 FR 55659, Nov. 2, 1995; 63 FR 13121, Mar. 18, 1998; 79 FR 28817, May 20, 2014; 80 FR 34278, June 16, 2015] § 520.88h Amoxicillin trihydrate and clavulanate potassium for oral sus pension. (a) Specifications. When reconstituted, each milliliter contains amoxicillin trihydrate equivalent to 50 milligrams of amoxicillin with clavulanate potas sium equivalent to 12.5 milligrams of clavulanic acid. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Conditions of use—(1) Dogs—(i) Amount. 6.25 milligrams (equivalent to 5 milligrams amoxicillin and 1.25 milli grams clavulanic acid) per pound of body weight twice daily for 5 to 7 days or for 48 hours after all signs have sub sided. Deep pyoderma may require treatment for 21 days; do not treat for more than 30 days. (ii) Indications for use. Treatment of skin and soft tissue infections such as wounds, abscesses, cellulitis, super ficial/juvenile and deep pyoderma due to susceptible strains of beta lactamase (penicillinase) producing Staphylococcus aureus, nonbeta lactamase Staphylococcus aureus, Staph ylococcus spp., Streptococcus spp., and Escherichia coli. Treatment of peri odontal infections due to susceptible strains of aerobic and anaerobic bac teria. (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (2) Cats—(i) Amount. 62.5 milligrams (1 milliliter) (50 milligrams amoxicillin and 12.5 milligrams clavulanic acid) twice daily. Administer 48 hours after all signs have subsided. Maximum du ration of treatment should not exceed 30 days. (ii) Indications for use. Treatment of feline skin and soft tissue infections, VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00169 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 160 21 CFR Ch. I (4–1–16 Edition) § 520.90 such as wounds, abscesses and cellulitis/dermatitis due to susceptible strains of beta-lactamase (penicil linase) producing S. aureus, nonbeta lactamase S. aureus, Staphylococcus spp., Streptococcus spp., E. coli, Pasteurella multocida, and Pasteurella spp. (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [57 FR 37320, Aug. 18, 1992, as amended at 60 FR 55659, Nov. 2, 1995; 63 FR 13121, Mar. 18, 1998; 79 FR 28817, May 20, 2014] § 520.90 Ampicillin oral dosage forms. § 520.90a [Reserved] § 520.90b Ampicillin tablets. (a) Specifications. Each tablet con tains ampicillin trihydrate equivalent to 50 or 100 milligrams of ampicillin. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Conditions of use in dogs—(1) Amount. 5 milligrams per pound of body weight, at 8-hour intervals, 1 to 2 hours prior to feeding, to be continued 36 to 48 hours after all symptoms have sub sided. If no improvement is seen within 5 days, stop treatment, reevaluate di agnosis, and change therapy. (2) Indications for use. Oral treatment of infections caused by susceptible or ganisms as follows: Upper respiratory infections, tonsillitis, and bronchitis due to Streptococcus spp., Staphylococcus spp., Escherichia coli, Proteus mirabilis, and Pasteurella spp., urinary tract in fections (cystitis) due to Streptococcus spp., Staphylococcus spp., E., coli, P. mirabilis, and Enterococcus spp.; gastro intestinal infections due to Staphy lococcus spp., Streptococcus spp., Enterococcus spp., and E. coli. ; infec tions associated with abscesses, lacera tions, and wounds caused by Staphy lococcus spp., and Streptococcus spp. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [57 FR 37321, Aug. 18, 1992, as amended at 60 FR 55659, Nov. 2, 1995; 79 FR 28818, May 20, 2014] § 520.90c Ampicillin capsules. (a) Specifications. Each capsule con tains ampicillin trihydrate equivalent to 125, 250, or 500 milligrams of ampi cillin. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Conditions of use—(1) Dogs—(i) Amount. 5 to 10 milligrams per pound of body weight two or three times daily. In severe or acute conditions, 10 milli grams per pound of body weight, three times daily. Administer 1 to 2 hours prior to feeding. (ii) Indications for use. Treatment against strains of gram-negative and gram-positive organisms sensitive to ampicillin and associated with res piratory tract infections (tracheobronchitis and tonsillitis); uri nary tract infections (cystitis); bac terial gastroenteritis; generalized in fections (septicemia) associated with abscesses, lacerations, and wounds; and bacterial dermatitis. (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (2) Cats—(i) Amount. 10 to 30 milli grams per pound of body weight or three times daily. Administer 1 to 2 hours prior to feeding. (ii) Indications for use. Treatment against strains of gram-negative and gram-positive organisms sensitive to ampicillin and associated with res piratory tract infections (bacterial pneumonia); urinary tract infections (cystitis); and generalized infections (septicemia) associated with abscesses, lacerations, and wounds. (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [57 FR 37321, Aug. 18, 1992, as amended at 58 FR 61016, Nov. 19, 1993; 79 FR 28818, May 20, 2014] § 520.90d Ampicillin for oral suspen sion. (a) Specifications. When reconstituted as directed, each milliliter contains ampicillin trihydrate equivalent to 25 milligrams of ampicillin. (b) Sponsor. See No. 055529 in § 510.600(c) of this chapter. (c) Conditions of use—(1) Dogs—(i) Amount. Administer to 10 milligrams per pound of body weight orally, 2 or 3 times daily, 1 to 2 hours prior to feed ing. In severe or acute conditions, 10 milligrams per pound of body weight 3 VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00170 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 161 Food and Drug Administration, HHS § 520.90f times daily. Duration of treatment is usually 3 to 5 days. Continue treatment 48 hours after the animal’s tempera ture has returned to normal and all other signs of infection have subsided. (ii) Indications for use. Treatment of respiratory tract infections (tracheobronchitis and tonsillitis) due to Escherichia coli, Pseudomonas spp., Proteus spp., Staphylococcus spp., and Streptococcus spp., urinary tract infec tions (cystitis) due to E. coli, Staphy lococcus spp., Streptococcus spp., and Proteus spp.; bacterial gastroenteritis due to E. coli; generalized infections (septicemia) associated with abscesses, lacerations, and wounds, due to Staphy lococcus spp. and Streptococcus spp.; bac terial dermatitis due to Staphylococcus spp., Streptococcus spp., Proteus spp., and Pseudomonas spp. (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (2) Cats—(i) Amount. Administer 10 to 30 milligrams per pound of body weight orally, 2 or 3 times daily, 1 to 2 hours prior to feeding. Duration of treatment is usually 3 to 5 days. Continue treat ment 48 hours after the animal’s tem perature has returned to normal and all other signs of infection have sub sided. (ii) Indications for use. Treatment of respiratory tract infections (bacterial pneumonia) due to Staphylococcus spp., Streptococcus spp., E. coli, and Proteus spp.; urinary tract infections (cystitis) due to E. coli, Staphylococcus spp., Streptococcus spp., Proteus spp., and Corynebacterium spp.; generalized infec tions (septicemia) associated with ab scesses, lacerations, and wounds, due to Staphylococcus spp., Streptococcus spp., Bacillus spp., and Pasteurella spp. (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [57 FR 37321, Aug. 18, 1992, as amended at 58 FR 61016, Nov. 19, 1993; 79 FR 28818, May 20, 2014] § 520.90e Ampicillin for soluble pow der. (a) Specifications. Each gram contains ampicillin trihydrate equivalent to 88.2 milligrams of ampicillin. (b) Sponsor. See No. 055529 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.40 of this chapter. (d) Conditions of use. Swine—(1) Amount. 5 milligrams of ampicillin per pound of body weight twice daily, oral ly by gavage or in drinking water for up to 5 days. (2) Indications for use. Oral treatment of porcine colibacillosis (Escherichia coli) and salmonellosis (Salmonella spp.) infections in swine up to 75 pounds of body weight, and bacterial pneumonia caused by Pasteurella multocida, Staphy lococcus spp., Streptococcus spp., and Salmonella spp. (3) Limitations. Treated swine must not be slaughtered for food during treatment and for 24 hours following the last treatment. Federal law re stricts this drug to use by or on the order of a licensed veterinarian. [57 FR 37322, Aug. 18, 1992, as amended at 58 FR 61016, Nov. 19, 1993; 79 FR 28818, May 20, 2014] § 520.90f Ampicillin boluses. (a) Specifications. Each bolus contains ampicillin trihydrate equivalent to 400 milligrams of ampicillin. (b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter as follows: (1) No. 055529 for use as in paragraph (d)(1) of this section; (2) No. 054771 for use as in paragraph (d)(2) of this section. (c) Related tolerances. See § 556.40 of this chapter. (d) Conditions of use. Nonruminating calves—(1) Amount. 5 milligrams per pound of body weight twice daily for up to 5 days. (i) Indications for use. Oral treatment of colibacillosis caused by Escherichia coli, bacterial enteritis caused by Sal monella spp., and bacterial pneumonia caused by Pasteurella spp. (ii) Limitations. Treated calves must not be slaughtered for food during treatment and for 15 days after the last treatment. Federal law restricts this drug to use by or on the order of a li censed veterinarian. (2) Amount. 5 milligrams per pound of body weight twice daily not to exceed 4 days. (i) Indications for use. Oral treatment of bacterial enteritis (colibacillosis) caused by E. coli. VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00171 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 162 21 CFR Ch. I (4–1–16 Edition) § 520.100 (ii) Limitations. Treated calves must not be slaughtered for food during treatment and for 7 days after the last treatment. Federal law restricts this drug to use by or on the order of a li censed veterinarian. [57 FR 37322, Aug. 18, 1992, as amended at 58 FR 61016, Nov. 19, 1993; 60 FR 55659, Nov. 2, 1995; 79 FR 28818, May 20, 2014] § 520.100 Amprolium. (a) Specifications. (1) Each milliliter of solution contains 96 milligrams (mg) amprolium (9.6 percent solution). (2) Each gram of powder contains 200 mg amprolium (20 percent). (3) Each ounce (28.4 grams) of crum bles contains 355 mg amprolium (1.25 percent). (b) Sponsors. See sponsors in 510.600(c) of this chapter. (1) No. 016592 for use of products de scribed in paragraph (a) of this section as in paragraph (d) of this section. (2) No. 066104 for use of product de scribed in paragraph (a)(1) of this sec tion as in paragraph (d) of this section. (3) No. 000859 for use of product de scribed in paragraph (a)(1) of this sec tion as in paragraph (d) of this section. (4) No. 061623 for use of products de scribed in paragraphs (a)(1) and (a)(2) of this section as in paragraph (d) of this section. (c) Related tolerances. See § 556.50 of this chapter. (d) Conditions of use—(1) Growing chickens, turkeys, and laying hens. It is used in drinking water as follows: (i) Amount. Administer at the 0.012 percent level in drinking water as soon as coccidiosis is diagnosed and con tinue for 3 to 5 days (in severe out breaks, give amprolium at the 0.024 percent level); continue with 0.006 per cent amprolium-medicated water for an additional 1 to 2 weeks. (ii)Indications for use. For the treat ment of coccidiosis. (iii) Limitations. Use as the sole source of amprolium. (2) Calves. Administer crumbles top dressed on or thoroughly mixed in the daily feed ration; administer con centrate solution or soluble powder as a drench or in drinking water as fol lows: (i) Indications for use and amounts— (A) As an aid in the prevention of coc cidiosis caused by Eimeria bovis and E. zurnii, administer 5 mg per kilogram (mg/kg) body weight for 21 days during periods of exposure or when experience indicates that coccidiosis is likely to be a hazard. (B) As an aid in the treatment of coc cidiosis caused by E. bovis and E. zurnii, administer 10 mg/kg body weight for 5 days. (ii) Limitations. Withdraw 24 hours be fore slaughter. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Use as the sole source of amprolium. [71 FR 56346, Sept. 27, 2006, as amended at 72 FR 60551, Oct. 25, 2007; 73 FR 45611, Aug. 6, 2008; 73 FR 70276, Nov. 20, 2008; 74 FR 10484, Mar. 11, 2009; 76 FR 38554, July 1, 2011; 76 FR 40808, July 12, 2011; 78 FR 23, Jan. 2, 2013; 78 FR 17596, Mar. 22, 2013; 78 FR 57058, Sept. 17, 2013] § 520.110 Apramycin sulfate soluble powder. (a) Specifications. A water soluble powder used to make a medicated drinking water containing apramycin sulfate equivalent to 0.375 gram of apramycin activity per gallon of drink ing water. (b) Sponsor. See No. 000986 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.52 of this chapter. (d) Conditions of use in swine—(1) Amount. Administer in drinking water at the rate of 12.5 milligrams of apramycin per kilogram (5.7 milli grams per pound) of body weight per day for 7 days. (2) Indications for use. For the control of porcine colibacillosis (weanling pig scours) caused by strains of Escherichia coli sensitive to apramycin. (3) Limitations. Prepare fresh medi cated water daily. Do not slaughter treated swine for 28 days following treatment. [47 FR 15771, Apr. 13, 1982, as amended at 49 FR 19642, May 9, 1984; 53 FR 37753, Sept. 28, 1988; 79 FR 28818, May 20, 2014] § 520.154 Bacitracin oral dosage forms. § 520.154a Bacitracin methylenedisalicylate. (a) Specifications. Each pound of solu ble powder contains the equivalent of VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00172 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 163 Food and Drug Administration, HHS § 520.154c 50 grams of bacitracin activity for use as in paragraph (d)(1) or (d)(2) of this section, or the equivalent of 200 grams of bacitracin activity for use as in paragraph (d) of this section. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.70 of this chapter. (d) Conditions of use—(1) Growing tur keys—(i) Amount. 400 milligrams (mg) per gallon (gal) in drinking water. (ii) Indications for use. Aid in the con trol of transmissible enteritis com plicated by organisms susceptible to bacitracin methylenedisalicylate. (iii) Limitations. Prepare a fresh solu tion daily. (2) Broiler and replacement chickens— (i) Amount. 100 mg per gal in drinking water. (A) Indications for use. Aid in the pre vention of necrotic enteritis caused by Clostridium perfringens susceptible to bacitracin methylenedisalicylate. (B) Limitations. Prepare a fresh solu tion daily. (ii) Amount. 200 to 400 mg per gal in drinking water. Administer continu ously 5 to 7 days or as long as clinical signs persist, then reduce to prevention levels (100 mg/gal). (A) Indications for use. Treatment of necrotic enteritis caused by C. perfringens susceptible to bacitracin methylenedisalicylate. (B) Limitations. Prepare a fresh solu tion daily. (3) Swine—(i) Amount. 1 gram per gal lon in drinking water. (ii) Indications for use. Treatment of swine dysentery associated with Brachyspira hyodysenteriae. Administer continuously for 7 days or until signs of dysentery disappear. (iii) Limitations. Prepare a fresh solu tion daily. Treatment not to exceed 14 days. If symptoms persist after 4 to 5 days consult a veterinarian. Not to be given to swine that weigh more than 250 pounds. (4) Growing quail—(i) Amount. 400 mg per gal in drinking water. (ii) Indications for use. For prevention of ulcerative enteritis due to Clos tridium colinum susceptible to baci tracin methylenedisalicylate. (iii) Limitations. Prepare fresh solu tion daily. Use as sole source of drink ing water. [57 FR 37322, Aug. 18, 1992; 57 FR 42623, Sept. 15, 1992, as amended at 63 FR 38474, July 17, 1998; 64 FR 13068, Mar. 17, 1999; 76 FR 53050, Aug. 25, 2011; 79 FR 28818, May 20, 2014; 80 FR 34278, June 16, 2015] § 520.154b Bacitracin methylenedisalicylate and strepto mycin sulfate powder. (a) Specifications. Each gram of pow der contains 200 units bacitracin methylenedisalicylate and strepto mycin sulfate equivalent to 20 milli grams of streptomycin. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Conditions of use in dogs—(1) Amount. Administer 1 level teaspoonful per 10 pounds of body weight three times daily, mixed in a small quantity of liquid or feed. (2) Indications for use. For the treat ment of bacterial enteritis caused by pathogens susceptible to bacitracin and streptomycin such as Escherichia coli, Proteus spp., Staphylococcus spp., and Streptococcus spp., and for the sympto matic treatment of associated diar rhea. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [71 FR 17702, Apr. 7, 2006, as amended at 79 FR 28818, May 20, 2014; 81 FR 17607, Mar. 30, 2016] § 520.154c Bacitracin zinc soluble pow der. (a) Specifications. Each pound con tains the equivalent of not less than 5 grams of bacitracin. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.70 of this chapter. (d) Conditions of use—(1) Broiler chick ens—(i) Amount. 100 milligrams per gal lon in drinking water. (A) Indications for use. Prevention of necrotic enteritis caused by Clostridium perfringens susceptible to bacitracin zinc. (B) Limitations. Prepare a fresh solu tion daily. (ii) Amount. 200 to 400 milligrams per gallon in drinking water. VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00173 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 164 21 CFR Ch. I (4–1–16 Edition) § 520.222 (A) Indications for use. Control of ne crotic enteritis caused by Clostridium perfringens susceptible to bacitracin zinc. (B) Limitations. Prepare a fresh solu tion daily. (2) Growing quail—(i) Amount. 500 mil ligrams per gallon in drinking water for 5 days followed by 165 milligrams per gallon in drinking water for 10 days. (ii) Indications for use. Control of ul cerative enteritis caused by Clostridium spp. susceptible to bacitracin zinc. (iii) Limitations. Prepare a fresh solu tion daily. [57 FR 37322, Aug. 18, 1992, as amended at 67 FR 78355, Dec. 24, 2002; 79 FR 28818, May 20, 2014] § 520.222 Bunamidine hydrochloride. (a) Chemical name. N,N-Dibutyl-4 (hexyloxy)-1-naphthamidine hydro chloride. (b) Specifications. The drug is an oral tablet containing 100, 200, or 400 milli grams of bunamidine hydrochloride. (c) Sponsor. See No. 000061 in § 510.600(c) of this chapter. (d) Conditions of use. (1) The drug is intended for oral administration to dogs for the treatment of the tape worms Dipylidium caninum, Taenia pisiformis, and Echinococcus granulosus, and to cats for the treatment of the tapeworms Dipylidium caninum and Taenia taeniaeformis. (2) It is administered to cats and dogs at the rate of 25 to 50 milligrams per kilogram of body weight. The drug should be given on an empty stomach and food should not be given for 3 hours following treatment. (3) Tablets should not be crushed, mixed with food, or dissolved in liquid. Repeat treatments should not be given within 14 days. The drug should not be given to male dogs within 28 days prior to their use for breeding. Do not ad minister to dogs or cats having known heart conditions. (4) For use only by or on the order of a licensed veterinarian. [40 FR 13838, Mar. 27, 1975, as amended at 42 FR 13018, Mar. 8, 1977; 46 FR 48642, Oct. 2, 1981; 61 FR 8873, Mar. 6, 1996; 62 FR 61624, Nov. 19, 1997] § 520.246 Butorphanol tablets. (a) Specifications. Each tablet con tains butorphanol tartrate equivalent to 1, 5, or 10 milligrams (mg) butorphanol base. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Conditions of use in dogs—(1) Amount. Administer 0.25 mg butorphanol base per pound of body weight. Repeat at intervals of 6 to 12 hours as required. Treatment should not normally be required for longer than 7 days. (2) Indications for use. For the relief of chronic nonproductive cough associ ated with tracheobronchitis, tracheitis, tonsillitis, laryngitis, and pharyngitis associated with inflammatory condi tions of the upper respiratory tract. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [79 FR 28818, May 20, 2014] § 520.260 n-Butyl chloride. (a)(1) Specifications. n-Butyl chloride capsules, veterinary contain 272 milli grams or 816 milligrams of n-butyl chloride in each capsule. (2) Sponsor. See No. 021091 in § 510.600(c) of this chapter. (3) Conditions of use. (i) It is used for the removal of ascarids (Toxocara canis and Toxascaris leonina) and hookworms (Ancylostoma caninum, Ancylostoma braziliense, and Uncinaria stenocephala) from dogs and of the ascarid (Toxocara cati) and hookworm (Ancylostoma tubaeforme) from cats. (ii)(a) Animals should not be fed for 18 to 24 hours before being given the drug. Puppies and kittens should be wormed at 6 weeks of age. However, if heavily infested, they may be wormed at 4 or 5 weeks of age. Administration of the drug should be followed in 1⁄2 to 1 hour with a teaspoonful to a table spoonful of milk of magnesia or 1 or 2 milk of magnesia tablets. Normal ra tions may be resumed 4 to 8 hours after treatment. Puppies and kittens should be given a repeat treatment in a week or 10 days. After that they should be treated every 2 months (or as symp toms reappear) until a year old. When the puppy or kitten is a year old, one VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00174 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 165 Food and Drug Administration, HHS § 520.300a treatment every 3 to 6 months is suffi cient. (b) For dogs or cats that have been wormed regularly, treatment every 3 to 6 months will be sufficient. If a dog or cat has not been wormed previously and has the symptoms of large roundworms a dose should be given and repeated in 10 days. Removal of hookworms may require 3 or 4 doses at 10-day intervals. (c) Puppies, dogs, cats, or kittens weighing 1 to 3 pounds should be given 2 capsules per dose which contain 272 milligrams of n-butyl chloride each. Such animals weighing 4 to 5 pounds should be given 3 such capsules. Ani mals weighing 6 to 7 pounds should be given 4 such capsules and animals weighing 8 to 9 pounds should be given 5 such capsules. Animals weighing 10 to 20 pounds should be given 3 capsules which contain 816 milligrams of n butyl chloride each, animals weighing 20 to 40 pounds should be given 4 such capsules and animals weighing over 40 pounds should be given 5 such capsules with the maximum dosage being 5 cap sules, each of which contains 816 milli grams of n-butyl chloride. (iii) A veterinarian should be con sulted before using in severely debili tated dogs or cats and also prior to re peated use in cases which present signs of persistent parasitism. (b)(1) Specifications. n-Butyl chloride capsules contain 221, 442, 884, or 1,768 milligrams or 4.42 grams of n-butyl chloride in each capsule. (2) Sponsors. See No. 023851 in § 510.600(c) of this chapter for 221, 442, 884, or 1,768 milligram or 4.42 gram cap sules; No. 038782 for 884 or 1,768 milli gram or 4.42 gram capsules; and No. 054771 for 221 milligram capsules. (3) Conditions of use. (i) It is used for the removal of ascarids (Toxocara canis and Toxascaris leonina) and hookworms (Ancylostoma caninum, Ancylostoma braziliense, and Uncinaria stenocephala) from dogs. (ii)(a) Dogs should not be fed for 18 to 24 hours before being given the drug. Administration of the drug should be followed in 1⁄2 to 1 hour with a mild ca thartic. Normal feeding may be re sumed 4 to 8 hours after treatment. Animals subject to reinfection may be retreated in 2 weeks. (b) The drug is administered orally to dogs. Capsules containing 221 milli grams of n-butyl chloride are adminis tered to dogs weighing under 5 pounds at a dosage level of 1 capsule per 11⁄4 pound of body weight. Capsules con taining 442 milligrams of n-butyl chlo ride are administered to dogs weighing under 5 pounds at a dosage level of 1 capsule per 21⁄2 pounds body weight. Capsules containing 884 milligrams of n-butyl chloride are administered to dogs as follows: Weighing under 5 pounds, 1 capsule; weighing 5 to 10 pounds, 2 capsules; weighing 10 to 20 pounds, 3 capsules; weighing 20 to 40 pounds, 4 capsules; over 40 pounds, 5 capsules. Capsules containing 1,768 mil ligrams of n-butyl chloride are admin istered at a dosage level of 1 capsule per dog weighing 5 to 10 pounds. Cap sules containing 4.42 grams of n-butyl chloride are administered at a dosage level of 1 capsule per dog weighing 40 pounds or over. (iii) A veterinarian should be con sulted before using in severely debili tated dogs. [40 FR 13838, Mar. 27, 1975, as amended at 40 FR 39858, Aug. 29, 1975; 44 FR 10059, Feb. 16, 1979; 54 FR 38515, Sept. 19, 1989; 55 FR 24556, June 18, 1990; 64 FR 15684, Apr. 1, 1999; 70 FR 50182, Aug. 26, 2005; 78 FR 14669, Mar. 7, 2013; 79 FR 28818, May 20, 2014] EDITORIAL NOTE: At 78 FR 14669, Mar. 7, 2013, § 520.260 was amended by adding para graphs (b)(1) through (3); however, the amendment could not be incorporated be cause (b)(1) through (3) already existed. § 520.300 Cambendazole oral dosage forms. § 520.300a Cambendazole suspension. (a) Specifications. Each fluid ounce contains 0.9 gram of cambendazole. (b) Sponsor. No. 050604 in § 510.600(c) of this chapter. (c) Conditions of use in horses—(1) Amount. Administer by stomach tube or as a drench at a dose of 0.9 gram of cambendazole per 100 pounds of body weight (20 milligrams per kilogram). (2) Indications for use. For the control of large strongyles (Strongylus vulgaris, S. edentatus, S. equinus); small strongyles (Trichonema, Poteriostomum, Cylicobrachytus, Craterostomum, Oesophagodontus); roundworms VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00175 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 166 21 CFR Ch. I (4–1–16 Edition) § 520.300b (Parascaris); pinworms (Oxyuris); and threadworms (Strongyloides). (3) Limitations. Do not use in horses intended for human consumption. Fed eral law restricts this drug to use by or on the order of a licensed veterinarian. [40 FR 13838, Mar. 27, 1975. Redesignated at 41 FR 1276, Jan. 7, 1976, and amended at 42 FR 3838, Jan. 21, 1977; 62 FR 63270, Nov. 28, 1997; 79 FR 28818, May 20, 2014] § 520.300b Cambendazole pellets. (a) Specifications. The drug is in feed pellets containing 5.3 percent cambendazole. (b) Sponsor. No. 050604 in § 510.600(c) of this chapter. (c) Conditions of use in horses—(1) Amount. Administer 20 milligrams cambendazole per kilogram body weight (6 ounces per 1,000 pounds) by mixing with normal grain ration given at one feeding. Doses for individual horses should be mixed and fed sepa rately to assure that each horse will consume the correct amount. For ani mals maintained on premises where re infection is likely to occur, re-treat ments may be necessary. For most ef fective results, re-treat in 6 to 8 weeks. (2) Indications for use. For the control of large strongyles (Strongylus vulgaris, S. edentatus, S. equinus); small strongyles (Trichonema, Poteriostomum, Cylicobrachytus, Craterostomum, Oesophagodontus); roundworms (Parascaris); pinworms (Oxyuris); and threadworms (Strongyloides). (3) Limitations. Do not administer to pregnant mares during first 3 months of pregnancy. Do not use in horses in tended for human consumption. Con sult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. [41 FR 1276, Jan. 7, 1976, as amended at 42 FR 3838, Jan. 21, 1977; 62 FR 63270, Nov. 28, 1997; 79 FR 28818, May 20, 2014] § 520.300c Cambendazole paste. (a) Specifications. The drug is a paste containing 45 percent cambendazole. (b) Sponsor. No. 050604 in § 510.600(c) of this chapter. (c) Conditions of use in horses—(1) Amount. Administer 20 milligrams cambendazole per kilogram body weight (5 grams per 550 pounds (250 kilograms)) by depositing the paste on the back of the tongue using a dosing gun. For animals maintained on prem ises where reinfection is likely to occur, re-treatments may be necessary. For most effective results, re-treat in 6 to 8 weeks. (2) Indications for use. For the control of large strongyles (Strongylus vulgaris, S. edentatus, S. equinus); small strongyles (Trichonema, Poteriostomum, Cylicobrachytus, Craterostomum, Oesophagodontus); roundworms (Parascaris); pinworms (Oxyuris); and threadworms (Strongyloides). (3) Limitations. Do not administer to pregnant mares during first 3 months of pregnancy. Do not use in horses in tended for human consumption. Con sult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. [41 FR 1276, Jan. 7, 1976, as amended at 42 FR 3838, Jan. 21, 1977; 62 FR 63270, Nov. 28, 1997; 79 FR 28819, May 20, 2014] § 520.301 Caramiphen ethanedisulfonate and ammonium chloride tablets. (a) Specifications. Each tablet con tains 10 milligrams of 5st caramiphen ethanedisulfonate and 80 milligrams of ammonium chloride. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Conditions of use in dogs—(1) Amount. One tablet per 15 to 30 pounds of body weight every 4 to 6 hours. (2) Indications for use. For relief of cough. [43 FR 55385, Nov. 28, 1978, as amended at 79 FR 28819, May 20, 2014. Redesignated at 80 FR 13229, Mar. 13, 2015] § 520.302 Carnidazole tablets. (a) Specifications. Each tablet con tains 10 milligrams of carnidazole. (b) Sponsor. See 053923 in § 510.600(c) of this chapter. (c) Conditions of use—(1) Amount. Adult pigeons: 1 tablet (10 milligrams); newly weaned pigeons: 1⁄2 tablet (5 mil ligrams). (2) Indications for use. For treating trichomoniasis (canker) in ornamental and homing pigeons. (3) Limitations. Not for use in pigeons intended for human food. Consult your VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00176 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 167 Food and Drug Administration, HHS § 520.370 veterinarian for assistance in the diag nosis, treatment, and control of para sitism or when severely ill birds do not respond to treatment. [54 FR 32336, Aug. 7, 1989. Redesignated at 80 FR 13229, Mar. 13, 2015] § 520.304 Carprofen. (a) Specifications. (1) Each caplet con tains 25, 75, or 100 milligrams (mg) carprofen. (2) Each chewable tablet contains 25, 75, or 100 mg carprofen. (b) Sponsors. See sponsors in § 510.600(c) of this chapter for uses as in paragraph (d) of this section. (1) No. 054771 for use of products de scribed in paragraph (a) of this section as in paragraph (d) of this section. (2) Nos. 000859, 026637, 055529, and 062250 for use of product described in paragraph (a)(1) as in paragraph (d) of this section. (3) Nos. 026637 and 062250 for use of product described in paragraph (a)(2) of this section as in paragraph (d) of this section. (c) [Reserved] (d) Conditions of use in dogs—(1) Amount. 2 mg per pound (/lb) of body weight once daily or 1 mg/lb twice daily. For the control of postoperative pain, administer approximately 2 hours before the procedure. (2) Indications for use. For the relief of pain and inflammation associated with osteoarthritis and for the control of postoperative pain associated with soft tissue and orthopedic surgeries. (3) Limitations. Federal Law restricts this drug to use by or on the order of a licensed veterinarian. [61 FR 66581, Dec. 18, 1996, as amended at 64 FR 32181, June 16, 1999; 66 FR 63165, Dec. 5, 2001; 67 FR 6866, Feb. 14, 2002; 67 FR 65038, Oct. 23, 2002; 67 FR 65697, Oct. 28, 2002; 70 FR 30626, May 27, 2005; 71 FR 51995, Sept. 1, 2006; 72 FR 68478, Dec. 5, 2007; 74 FR 21768, May 11, 2009; 78 FR 52853, Aug. 27, 2013; 78 FR 66264, Nov. 5, 2013; 79 FR 28819, May 20, 2014. Redes ignated and amended at 80 FR 13229, Mar. 13, 2015; 80 FR 34278, June 16, 2015; 80 FR 61296, Oct. 13, 2015] § 520.314 Cefadroxil. (a) Specifications. (1) Each tablet con tains 50, 100, or 200 milligrams (mg) or 1 gram of cefadroxil. (2) Each milliliter of suspension con stituted from powder contains 50 mg of cefadroxil. (b) Sponsor. See No. 000010 in § 510.600(c) of this chapter. (c) Conditions of use in dogs and cats— (1) Amount—(i) Dogs. Administer 10 mg per pound (/lb) body weight twice daily orally. (ii) Cats. Administer 10 mg/lb body weight once daily orally. (2) Indications for use—(i) Dogs. For the treatment of skin and soft tissue infections including cellulitis, pyoderma, dermatitis, wound infec tions, and abscesses due to susceptible strains of Staphylococcus aureus. For the treatment of genitourinary tract infections (cystitis) due to susceptible strains of Escherichia coli, Proteus mirabilis, and S. aureus. (ii) Cats. For the treatment of skin and soft tissue infections including ab scesses, wound infections, cellulitis, and dermatitis caused by susceptible strains of Pasteurella multocida, S. aureus, Staphylococcus epidermidis, and Streptococcus spp. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [75 FR 10165, Mar. 5, 2010] § 520.370 Cefpodoxime tablets. (a) Specifications. (1) Each tablet con tains cefpodoxime proxetil equivalent to 100 or 200 milligrams (mg) cefpodoxime. (2) Each chewable tablet contains cefpodoxime proxetil equivalent to 100 or 200 mg cefpodoxime. (b) Sponsors. See sponsors in § 510.600(c) of this chapter for uses as follows: (1) No. 026637 for use of product in paragraph (a)(1) of this section as in paragraph (c) of this section. (2) No. 054771 for use of products in paragraph (a) of this section as in para graph (c) of this section. (c) Conditions of use in dogs—(1) Amount. 5 to 10 mg per kilogram (2.3 to 4.5 mg per pound) body weight daily for 5 to 7 days, or for 2 to 3 days beyond the cessation of clinical signs, up to a maximum of 28 days. (2) Indications for use. For the treat ment of skin infections (wounds and abscesses) caused by susceptible strains VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00177 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 168 21 CFR Ch. I (4–1–16 Edition) § 520.376 of Staphylococcus pseudintermedius, S. aureus, Streptococcus canis (group G, -he molytic), Escherichia coli, Pasteurella multocida, and Proteus mirabilis. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [69 FR 52815, Aug. 30, 2004, as amended at 78 FR 5714, Jan. 28, 2013; 79 FR 28819, May 20, 2014; 80 FR 13229, Mar. 13, 2015] § 520.376 Cephalexin. (a) Specifications. Each chewable tab let contains 75, 150, 300, or 600 milli grams (mg) cephalexin. (b) Sponsor. See No. 051311 in § 510.600(c) of this chapter. (c) Conditions of use—(1) Dogs—(i) Amount. Administer 22 mg per kilo gram of body weight twice daily for 28 days. (ii) Indications for use. For the treat ment of secondary superficial bacterial pyoderma in dogs caused by susceptible strains of Staphylococcus pseudintermedius. (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (2) [Reserved] [77 FR 47512, Aug. 9, 2012] § 520.390 Chloramphenicol oral dosage forms. § 520.390a Chloramphenicol tablets. (a) Specifications. Each tablet con tains 50, 100, 250, or 500 milligrams (mg); 1 or 2.5 grams (g) of chloramphen icol. (b) Sponsors. See § 510.600(c) of this chapter: (1) For use as in paragraphs (c)(1), (c)(2)(i), and (c)(3) of this section: (i) No. 054628 for 100-, 250-, and 500-mg; and 1- and 2.5-g tablets; (ii) No. 054771 for 100-, 250-, and 500 mg tablets; (2) For use as in paragraphs (c)(1), (c)(2)(ii), and (c)(3) of this section: (i) No. 061623 for 50-, 100-, 250-, and 500-mg; and 1-g tablets; (ii) [Reserved] (c) Conditions of use in dogs—(1) Amount. Administer 25 mg per pound of body weight by mouth every 6 hours. (2) Indications for use—(i) For the treatment of bacterial pulmonary in fections, bacterial infections of the uri nary tract, bacterial enteritis, and bac terial infections associated with canine distemper caused by susceptible orga nisms. (ii) For the treatment of bacterial gastroenteritis associated with bac terial diarrhea, bacterial pulmonary infections, and bacterial infections of the urinary tract caused by susceptible organisms. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law pro hibits the extralabel use of this drug in food-producing animals. [77 FR 4896, Feb. 1, 2012, as amended at 78 FR 21059, Apr. 9, 2013; 79 FR 28819, May 20, 2014] § 520.390b Chloramphenicol capsules. (a) Specifications. Each capsule con tains 50, 100, 250, or 500 milligrams (mg) chloramphenicol. (b) Sponsors. See Nos. 050057 and 054771 in § 510.600(c) of this chapter for use as in paragraph (d) of this section. (c) Special considerations. Federal law prohibits the extralabel use of this product in food-producing animals. (d) Conditions of use in dogs—(1) Amount. 25 mg per pound of body weight every 6 hours. (2) Indications for use. For treatment of bacterial pulmonary infections, bac terial infections of the urinary tract, bacterial enteritis, and bacterial infec tions associated with canine distemper caused by susceptible organisms. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [70 FR 75398, Dec. 20, 2005, as amended at 73 FR 18442, Apr. 4, 2008; 75 FR 55676, Sept. 14, 2010; 79 FR 28819, May 20, 2014] § 520.390c Chloramphenicol palmitate oral suspension. (a) Specifications. Each milliliter con tains chloramphenicol palmitate equiv alent to 30 milligrams of chloramphen icol. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Conditions of use. Dogs—(1) Amount. 25 milligrams per pound of body weight every 6 hours. If no re sponse is obtained in 3 to 5 days, dis continue use and reevaluate diagnosis. VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00178 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 169 Food and Drug Administration, HHS § 520.434 (2) Indications for use. Treatment of bacterial pulmonary infections, infec tions of the urinary tract, enteritis, and infections associated with canine distemper that are caused by orga nisms susceptible to chloramphenicol. (3) Limitations. Not for use in animals that are raised for food production. Must not be used in meat-, egg-, or milk-producing animals. The length of time that residues persist in milk or tissues has not been determined. Fed eral law restricts this drug to use by or on the order of a licensed veterinarian. [57 FR 37323, Aug. 18, 1992; 57 FR 42623, Sept. 15, 1992, as amended at 79 FR 28819, May 20, 2014] § 520.420 Chlorothiazide tablets and boluses. (a)(1) Specifications. Each tablet con tains 0.25 gram of chlorothiazide. (2) Sponsor. See No. 050604 in § 510.600(c) of this chapter. (3) Conditions of use—(i) Amount. Usual dosage is 5 to 10 milligrams per pound of body weight two or three times daily. (ii) Indications for use. For use in dogs for treatment of congestive heart fail ure and renal edema. (iii) Limitations. (a) Dosage must be adjusted to meet the changing needs of the individual animal. In mild and re sponsive cases, it is suggested that a dose of 5 milligrams per pound of body weight be administered two or three times daily. In moderately edematous and moderately responsive animals, a dose of 7.5 to 10 milligrams per pound of body weight may be administered three times daily. Severe conditions may require higher doses. Certain ani mals may respond adequately to inter mittent therapy; in these cases, the drug may be administered either every other day or for 3 to 5 days each week. (b) Animals should be regularly and carefully observed for early signs of fluid and electrolyte imbalance. Take appropriate countermeasures if this should occur. In some dogs, hypochloremic alkalosis may occur (that is, excretion of chloride in rela tion to sodium is excessive; the plasma bicarbonate level increases and alkalosis results). Federal law restricts this drug to use by or on the order of a licensed veterinarian. (b)(1) Specifications. Each bolus con tains 2 grams of chlorothiazide. (2) Sponsor. See No. 000006 in § 510.600(c) of this chapter. (3) Conditions of use—(i) Amount. 2 grams once or twice daily for 3 or 4 days. (ii) Indications for use. For use in cat tle as an aid in reduction of postparturient udder edema. (iii) Limitations. Animals should be regularly and carefully observed for early signs of fluid and electrolyte im balance. Take appropriate counter measures if this should occur. Milk taken from dairy animals during treat ment and for 72 hours (six milkings) after latest treatment must not be used for food. Federal law restricts this drug to use by or on the order of a li censed veterinarian. [43 FR 39085, Sept. 1, 1978, as amended at 62 FR 63270, Nov. 28, 1997; 79 FR 28819, May 20, 2014] § 520.434 Chlorphenesin carbamate tablets. (a) Specifications. Each tablet con tains 400 milligrams of chlorphenesin carbamate. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Conditions of use in dogs—(1) Amount. 50 milligrams per pound of body weight on first day; 25 milligrams per pound of body weight each fol lowing day. Divide total daily dose into 2 or 3 equal doses—administer at 12- or 8-hour intervals. (2) Indications for use. For use as an adjunct to therapy of acute inflam matory and traumatic conditions of skeletal muscles. The drug provides re lief of the signs of discomfort associ ated with myositis, muscle sprains, traumatic injuries, stifle injuries—es pecially when administered before or after surgery—and invertebral disc syndrome (can be used concurrently with adrenal corticosteroids). (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [44 FR 16009, Mar. 16, 1979, as amended at 79 FR 28819, May 20, 2014] VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00179 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 170 21 CFR Ch. I (4–1–16 Edition) § 520.441 § 520.441 Chlortetracycline powder. (a) Specifications. Chlortetracycline powder contains not less than 15 milli grams per gram chlortetracycline hy drochloride, or chlortetracycline bisul fate equivalent to 25.6, 64 or 102.4 grams per pound (56.4, 141 or 225.6 milligrams per gram) chlortetracycline hydro chloride. (b) Sponsors. See sponsors in § 510.600(c) of this chapter for use as in paragraph (d) of this section. (1) No. 069254 for use as in paragraph (d) of this section. (2) Nos. 016592 and 054771 for use as in paragraph (d) of this section. (3) No. 054628 for use as in paragraphs (d)(4)(i)(A), (d)(4)(i)(B), and (d)(4)(ii) through (d)(4)(iv) of this section. (d)(4)(ii) through (iv) of this section. (4) Nos. 069254 and 076475 for use as in paragraphs (d)(4)(i)(A), (d)(4)(i)(B), (d)(4)(ii), and (d)(4)(iii) of this section. (c) Related tolerances. See § 556.150 of this chapter. (d) Conditions of use. (1) Use as chlor tetracycline hydrochloride in drinking water as follows: (i) Swine—(A) Amount. Ten milli grams per pound of body weight daily in divided doses. (1) Indications for use. Control and treatment of bacterial enteritis (scours) caused by Escherichia coli and bacterial pneumonia associated with Pasteurella spp., Actinobacillus pleuropneumoniae (Haemophilus spp.), and Klebsiella spp. (2) Limitations. Prepare a fresh solu tion twice daily; as sole source of chlortetracycline; administer for not more than 5 days. (B) [Reserved] (ii) [Reserved] (2) Use as chlortetracycline hydro chloride in a drench or drinking water as follows: (i) Calves—(A) Amount. Ten milli grams per pound of body weight daily in divided doses. (1) Control and treatment of bac terial enteritis (scours) caused by E. coli and bacterial pneumonia (shipping fever) associated with Pasteurella spp., A. pleuropneumoniae (Haemophilus spp.), and Klebsiella spp. (2) Limitations. Prepare fresh solution daily; as sole source of chlortetra cycline; administer for not more than 5 days; do not slaughter animals for food within 24 hours of treatment; do not administer this product with milk or milk replacers; administer 1 hour be fore or 2 hours after feeding milk or milk replacers; a withdrawal period has not been established in preruminating calves; do not use in calves to be proc essed for veal. (B) [Reserved] (ii) [Reserved] (3) [Reserved] (4) The following uses of chlortetra cycline hydrochloride or chlortetra cycline bisulfate in drinking water or drench were reviewed by the National Academy of Sciences/National Re search Council (NAS/NRC) and found effective: (i) Chickens—(A) Amount. 200 to 400 milligrams per gallon. (1) Indications for use. Control of in fectious synovitis caused by Myco plasma synoviae. (2) Limitations. Prepare fresh solution daily; as sole source of chlortetra cycline; do not use for more than 14 days; do not slaughter animals for food within 24 hours of treatment; do not use in laying chickens. (B) Amount. 400 to 800 milligrams per gallon. (1) Indications for use. Control of chronic respiratory disease and air-sac infections caused by M. gallisepticum and E. coli. (2) Limitations. Prepare fresh solution daily; as sole source of chlortetra cycline; do not use for more than 14 days; do not slaughter animals for food within 24 hours of treatment; do not use in laying chickens. (C) Amount. One thousand milligrams per gallon. (1) Indications for use. Control of mor tality due to fowl cholera caused by Pasteurella multocida susceptible to chlortetracycline. (2) Limitations. See paragraph (d)(4)(i)(A)(2) of this section. (ii) Growing turkeys—(A) Amount. 400 milligrams per gallon. (1) Indications for use. Control of in fectious synovitis caused by M. synoviae. (2) Limitations. Prepare fresh solution daily; as sole source of chlortetra cycline; do not use for more than 14 VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00180 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 171 Food and Drug Administration, HHS § 520.441 days; do not slaughter animals for food within 24 hours of treatment. (B) Amount. 25 milligrams per pound of body weight daily. (1) Indications for use. Control of com plicating bacterial organisms associ ated with bluecomb (transmissible en teritis, coronaviral enteritis). (2) Limitations. Prepare fresh solution daily; as sole source of chlortetra cycline; do not use for more than 14 days; do not slaughter animals for food within 24 hours of treatment. (iii) Swine—(A) Amount. 10 milligrams per pound body weight daily in divided doses. (B) Indications for use. Control and treatment of bacterial enteritis (scours) caused by E. coli and Sal monella spp. and bacterial pneumonia associated with Pasteurella spp., Actinobacillus pleuropneumoniae (Haemophilus spp.), and Klebsiella spp. (C) Limitations. Prepare fresh solution daily; as sole source of chlortetra cycline; do not use for more than 5 days. For Nos. 016592 and 021930, do not slaughter animals for food within 5 days of treatment. For No. 016592, do not slaughter animals for food within 24 hours of treatment. (iv) Calves, beef cattle, and nonlac tating dairy cattle—(A) Amount. 10 milli grams per pound daily in divided doses. (B) Indications for use. Control and treatment of bacterial enteritis (scours) caused by E. coli and Sal monella spp. and bacterial pneumonia (shipping fever complex) associated with Pasteurella spp., A. pleuropneumoniae (Haemophilus spp.), and Klebsiella spp. (C) Limitations. Prepare fresh solution daily; use as a drench; as sole source of chlortetracycline; do not use for more than 5 days; do not slaughter animals for food within 24 hours of treatment; do not use in lactating cattle; do not administer this product with milk or milk replacers; administer 1 hour be fore or 2 hours after feeding milk or milk replacers; a withdrawal period has not been established in preruminating calves; do not use in calves to be proc essed for veal. (5) Use in a drench or drinking water as follows: (i) Chickens—(A) Amount. 200 to 400 mg/gal, for 7 to 14 days. (1) Indications for use. Control of in fectious synovitis caused by M. synoviae susceptible to chlortetra cycline. (2) Limitations. Prepare fresh solution daily; use as the sole source of chlor tetracycline; do not use for more than 14 consecutive days; do not use in lay ing chickens; do not administer to chickens within 24 hours of slaughter. (B) Amount. 400 to 800 mg/gal, for 7 to 14 days. (1) Indications for use. Control of chronic respiratory disease (CRD) and air-sac infections caused by M. gallisepticum and E. coli susceptible to chlortetracycline. (2) Limitations. As in paragraph (d)(5)(i)(A)(2) of this section. (C) Amount. One thousand mg/gal, for 7 to 14 days. (1) Indications for use. Control of mor tality due to fowl cholera caused by Pasteurella multocida susceptible to chlortetracycline. (2) Limitations. As in paragraph (d)(5)(i)(A)(2) of this section. (ii) Growing Turkeys—(A) Amount. 400 mg/gal, for 7 to 14 days. (1) Indications for use. Control of in fectious synovitis caused by Myco plasma synoviae susceptible to chlor tetracycline. (2) Limitations. Prepare fresh solution daily; use as the sole source of chlor tetracycline; do not use for more than 14 consecutive days; do not administer to growing turkeys within 24 hours of slaughter. (B) Amount. 25 mg/lb body weight daily, for 7 to 14 days. (1) Indications for use. Control of com plicating bacterial organisms associ ated with bluecomb (transmissible en teritis, coronaviral enteritis) suscep tible to chlortetracycline. (2) Limitations. As in paragraph (d)(5)(ii)(A)(2) of this section. (iii) Swine—(A) Amount. 10 mg/lb body weight daily, for 3 to 5 days. (B) Indications for use. Control and treatment of bacterial enteritis (scours) caused by E. coli and Sal monella spp., and bacterial pneumonia associated with Pasteurella spp., A. pleuropneumoniae, and Klebsiella spp. susceptible to chlortetracycline. VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00181 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 172 21 CFR Ch. I (4–1–16 Edition) § 520.443 (C) Limitations. Prepare fresh solution daily; use as the sole source of chlor tetracycline; do not use for more than 5 days; do not administer to swine within 24 hours of slaughter. (iv) Calves, beef cattle, and nonlac tating dairy cattle—(A) Amount. 10 mg/lb body weight daily in divided doses, for 3 to 5 days. (B) Indications for use. Control and treatment of bacterial enteritis (scours) caused by Escherichia coli and Salmonella spp., and bacterial pneu monia associated with Pasteurella spp., Histophilus spp., and Klebsiella spp. sus ceptible to chlortetracycline. (C) Limitations. Prepare fresh solution daily; use as a drench; use as the sole source of chlortetracycline; do not use for more than 5 days; do not administer to cattle within 24 hours of slaughter; do not use in lactating dairy cattle; do not administer this product with milk or milk replacers; administer 1 hour before or 2 hours after feeding milk or milk replacers; a withdrawal period has not been established in preruminating calves; do not use in calves to be proc essed for veal. [57 FR 37324, Aug. 18, 1992] EDITORIAL NOTE: For FEDERAL REGISTER ci tations affecting § 520.441, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.fdsys.gov. § 520.443 Chlortetracycline tablets and boluses. (a) Specifications. Each tablet/bolus contains 25, 250, or 500 milligrams (mg) chlortetracycline hydrochloride. (b) Sponsor. See Nos. 016592 and 054628 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.150 of this chapter. (d) Conditions of use in calves—(1) Amount. One 250 milligram bolus per 50 pounds of body weight twice a day for 3 to 5 days. (i) Indications for use. Treatment of bacterial enteritis (scours) caused by Escherichia coli and bacterial pneu monia associated with Pasteurella spp., Klesbsiella spp., and Haemophilus spp. (ii) Limitations. Administer bolus di rectly by mouth or crush and dissolve in milk or water for drenching or buck et feeding; if no improvement is noted after 3 days of treatment, consult a veterinarian; do not use for more than 5 days; do not administer within 24 hours of slaughter. (2) Amount. One 25 milligram tablet for each 5 pounds of body weight every 12 hours daily for 3 to 5 days. (i) Indications for use. Control and treatment of bacterial enteritis (scours) caused by E. coli and Sal monella spp. and bacterial pneumonia associated with Pasteurella spp., Haemophilus spp., and Klebsiella spp., susceptible to chlortetracycline. (ii) Limitations. Administer tablet di rectly by mouth or crush and dissolve in water for drenching; if no improve ment is noted after 3 days of treat ment, consult a veterinarian; do not use for more than 5 days; when feeding milk or milk replacer, administration 1 hour before or 2 hours after feeding; do not administer within 24 hours of slaughter. (3) Amount. One 500 milligram bolus per 100 pounds of body weight twice a day for 3 to 5 days. (i) Indications for use. Treatment of bacterial enteritis (scours) caused by E. coli and Salmonella spp., and bacterial pneumonia associated with Pasteurella spp., Haemophilus spp., and Klebsiella spp., susceptible to chlortetracycline. (ii) Limitations. Administer directly by mouth or crush and dissolve in water for drenching; if no improvement is noted after 3 days of treatment, con sult a veterinarian; do not use for more than 5 days; do not administer within 24 hours of slaughter. [57 FR 37325, Aug. 18, 1992, as amended at 67 FR 78355, Dec. 24, 2002. Redesignated and amended at 76 FR 49649, Aug. 11, 2011; 78 FR 21059, Apr. 9, 2013; 81 FR 17607, Mar. 30, 2016] § 520.445 Chlortetracycline and sulfamethazine powder. (a) Specifications. Each pound of solu ble powder contains chlortetracycline bisulfate equivalent to 102.4 grams (g) of chlortetracycline hydrochloride and sulfamethazine bisulfate equivalent to 102.4 g of sulfamethazine. (b) Sponsor. See No. 016592 in § 510.600(c) of this chapter. (c) Related tolerances. See §§ 556.150 and 556.670 of this chapter. (d) Conditions of use in swine. Admin ister in drinking water as follows: VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00182 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 173 Food and Drug Administration, HHS § 520.447 (1) Amount. 250 milligrams (mg) of chlortetracycline and 250 mg of sulfamethazine per gallon. (2) Indications for use. For the preven tion and treatment of bacterial enter itis; as an aid in the reduction of the incidence of cervical abscesses; and as an aid in the maintenance of weight gains in the presence of bacterial en teritis and atrophic rhinitis. (3) Limitations. Use as the sole source of chlortetracycline and sulfonamide. Not to be used for more than 28 con secutive days. Withdraw 15 days before slaughter. [76 FR 49649, Aug. 11, 2011, as amended at 81 FR 17607, Mar. 30, 2016] § 520.446 Clindamycin capsules and tablets. (a) Specifications. (1) Each capsule contains the equivalent of 25, 75, 150, or 300 milligrams (mg) clindamycin as the hydrochloride salt. (2) Each tablet contains the equiva lent of 25, 75, or 150 mg clindamycin as the hydrochloride salt. (3) Each capsule contains the equiva lent of 25, 75, or 150 mg clindamycin as the hydrochloride salt. (b) Sponsors. See sponsors in § 510.600(c) of this chapter as follows: (1) Nos. 054771 and 069043 for use of capsules described in paragraph (a)(1) of this section. (2) No. 051311 for use of tablets de scribed in paragraph (a)(2) of this sec tion. (3) No. 043806 for use of tablets de scribed in paragraph (a)(3) of this sec tion. (c) Conditions of use in dogs—(1) Amount. Wounds, abscesses, and dental infections: 2.5 to 15 mg per pound (/lb) body weight every 12 hours for a max imum of 28 days. Osteomyelitis: 5.0 to 15 mg/lb body weight every 12 hours for a minimum of 28 days. (2) Indications for use. For the treat ment of skin infections (wounds and abscesses) due to susceptible strains of coagulase-positive staphylococci (Staphylococcus aureus or S. intermedius), deep wounds and abscesses due to susceptible strains of Bacteroides fragilis, Prevotella melaninogenicus, Fusobacterium necrophorum, and Clos tridium perfringens, dental infections due to susceptible strains of S. aureus, B. fragilis, P. melaninogenicus, F. necrophorum, and C. perfringens, and os teomyelitis due to susceptible strains of S. aureus, B. fragilis, P. melaninogenicus, F. necrophorum, and C. perfringens. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [67 FR 54954, Aug. 27, 2002, as amended at 68 FR 55824, Sept. 29, 2003; 69 FR 32273, June 9, 2004; 71 FR 39204, July 12, 2006; 73 FR 4077, Jan. 24, 2008; 78 FR 17596, Mar. 22, 2013; 79 FR 28819, May 20, 2014; 80 FR 76386, Dec. 9, 2015; 81 FR 17607, Mar. 30, 2016] § 520.447 Clindamycin solution. (a) Specifications. Each milliliter of solution contains the equivalent of 25 milligrams (mg) clindamycin as the hydrochloride salt. (b) Sponsors. See Nos. 051311, 054771, 058829, 061623, and 069043 in § 510.600(c) of this chapter. (c) Special considerations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (d) Conditions of use—(1) Dogs—(i) Amount. Wounds, abscesses, and dental infections: 2.5 to 15 mg per pound (/lb) body weight every 12 hours for a max imum of 28 days. Osteomyelitis: 5.0 to 15 mg/lb body weight every 12 hours for a minimum of 28 days. (ii) Indications for use. For the treat ment of skin infections (wounds and abscesses) due to susceptible strains of coagulase-positive staphylococci (Staphylococcus aureus or S. intermedius), deep wounds and abscesses due to susceptible strains of Bacteroides fragilis, Prevotella melaninogenicus, Fusobacterium necrophorum, and Clos tridium perfringens; dental infections due to susceptible strains of S. aureus, B. fragilis, P. melaninogenicus, F. necrophorum, and C. perfringens; and os teomyelitis due to susceptible strains of S. aureus, B. fragilis, P. melaninogenicus, F. necrophorum, and C. perfringens. (2) Cats—(i) Amount. 5.0 to 15.0 mg/lb body weight every 24 hours for a max imum of 14 days. (ii) Indications for use. For the treat ment of skin infections (wounds and abscesses) due to susceptible strains of Staphylococcus aureus, S. intermedius, VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00183 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 174 21 CFR Ch. I (4–1–16 Edition) § 520.452 Streptococcus spp.; deep wounds and ab scesses due to susceptible strains of Clostridium perfringens and Bacteroides fragilis; and dental infections due to susceptible strains of S. aureus, S. intermedius, Streptococcus spp., C. perfringens, and B. fragilis. [67 FR 54954, Aug. 27, 2002, as amended at 67 FR 78684, Dec. 26, 2002; 68 FR 55824, Sept. 29, 2003; 69 FR 31734, June 7, 2004; 71 FR 39543, July 13, 2006; 72 FR 19796, Apr. 20, 2007; 78 FR 17596, Mar. 22, 2013; 78 FR 30197, May 22, 2013; 79 FR 28819, May 20, 2014; 81 FR 17607, Mar. 30, 2016] § 520.452 Clenbuterol syrup. (a) Specifications. Each milliliter con tains 72.5 micrograms of clenbuterol hydrochloride. (b) Sponsor. See 000010 in § 510.600(c) of this chapter. (c) [Reserved] (d) Conditions of use—(1) Horses—(i) Amount. Administer orally twice a day (b.i.d.). Initial dose is 0.5 milliliter per 100 pounds body weight (0.8 micrograms per kilogram) for 3 days (6 treatments). If no improvement, administer 1 milli liter per 100 pounds (1.6 micrograms per kilogram) for 3 days (6 treatments). If no improvement, administer 1.5 milli liters per 100 pounds (2.4 micrograms per kilogram) for 3 days (6 treatments). If no improvement, administer 2.0 mil liliters per 100 pounds (3.2 micrograms per kilogram) for 3 days (6 treatments). If no improvement, horse is non responder to clenbuterol and treatment should be discontinued. (ii) Indications for use. Indicated for the management of horses affected with airway obstruction, such as oc curs in chronic obstructive pulmonary disease (COPD). (iii) Limitations. Treat at effective dose for 30 days. At the end of the 30 day treatment period, drug should be withdrawn. If signs return, the 30-day treatment period may be repeated. If repeating treatment, the step-wise dos age schedule should be repeated. The effect of this drug on breeding stallions and brood mares has not been deter mined. Treatment starting with dos ages higher than the initial dose is not recommended. Federal law prohibits the extralabel use of this drug in food animals. Federal law restricts this drug to use by or on the order of a li censed veterinarian. (2) [Reserved] [63 FR 41419, Aug. 4, 1998] § 520.455 Clomipramine tablets. (a) Specifications. Each tablet con tains 5, 20, 40, or 80 milligrams (mg) clomipramine hydrochloride. (b) Sponsor. See No. 058198 in § 510.600(c) of this chapter. (c) Conditions of use—(1) Amount. 2 to 4 milligrams of clomipramine hydro chloride per kilogram (0.9 to 1.8 milli grams per pound) of body weight per day, administered as a single daily dose or divided twice daily. (2) Indications for use. For use as part of a comprehensive behavioral manage ment program to treat separation anx iety in dogs greater than 6 months of age. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [64 FR 1762, Jan. 12, 1999, as amended at 72 FR 262, Jan. 4, 2007] § 520.462 Clorsulon drench. (a) Specifications. The drug is a sus pension containing 8.5 percent clorsulon (85 milligrams per milliliter). (b) Sponsor. See No. 050604 in § 510.600(c) of this chapter. (c) Conditions of use. Cattle—(1) Amount. One-quarter fluid ounce per 200 pounds of body weight (7 milligrams per kilogram or 3.2 milligrams per pound of body weight). (2) Indications for use. For the treat ment of immature and adult liver fluke (Fasciola hepatica) infestations in cat tle. (3) Limitations. Using dose syringe, deposit drench over back of tongue. Do not treat cattle within 8 days of slaughter. Because a withdrawal time in milk has not been established, do not use in female dairy cattle of breed ing age. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. [50 FR 10221, Mar. 14, 1985, as amended at 62 FR 63270, Nov. 28, 1997] § 520.522 Cyclosporine. (a) Specifications. (1) Each cyclosporine capsule, USP (MODIFIED) VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00184 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 175 Food and Drug Administration, HHS § 520.534 contains 10, 25, 50, or 100 milligrams (mg) cyclosporine. (2) Each milliliter of cyclosporine oral solution, USP (MODIFIED) con tains 100 mg cyclosporine. (b) Sponsor. See No. 058198 in § 510.600(c) of this chapter. (c) [Reserved] (d) Conditions of use—(1) Dogs. Use capsules described in paragraph (a)(1) of this section as follow: (i) Amount. Administer 5 mg per kilo gram (mg/kg) of body weight given orally as a single daily dose for 30 days. Following this initial daily treatment period, the dosage may be tapered by decreasing the frequency of adminis tration to every other day or two times a week, until a minimum frequency is reached which will maintain the de sired therapeutic effect. (ii) Indications for use. For the control of atopic dermatitis in dogs weighing at least 4 pounds. (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (2) Cats. Use the solution described in paragraph (a)(2) of this section as fol low: (i) Amount. Administer 7 mg/kg of body weight orally as a single daily dose for a minimum of 4 to 6 weeks or until resolution of clinical signs. Fol lowing this initial daily treatment pe riod, the dosage may be tapered by de creasing the frequency of administra tion to every other day or twice weekly to maintain the desired therapeutic ef fect. (ii) Indications for use. For the control of feline allergic dermatitis in cats at least 6 months of age and weighing at least 3 pounds. (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [68 FR 54804, Sept. 19, 2003, as amended at 76 FR 78815, Dec. 20, 2011] § 520.530 Cythioate oral liquid. (a) Specifications. Each milliliter con tains 15 milligrams of cythioate. (b) Sponsor. See Nos. 000859 and 054771 in § 510.600 of this chapter. (c) Special considerations. Cythioate is a cholinesterase inhibitor. Do not use this product in animals simultaneously with or within a few days before or after treatment with or exposure to cholinesterase-inhibiting drugs, insec ticides, pesticides, or chemicals. (d) Conditions of use—(1) Amount. 15 milligrams cythioate per 10 pounds of body weight every third day or twice a week. (2) Indications for use. Dogs, for con trol of fleas. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [49 FR 5614, Feb. 14, 1984, as amended at 67 FR 78355, Dec. 24, 2002; 79 FR 28819, May 20, 2014] § 520.531 Cythioate tablets. (a) Specifications. Each tablet con tains 30 or 90 milligrams (mg) cythioate. (b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter as follows: (1) No. 000859 for use of 30- and 90-mg tablets; (2) No. 054771 for use of the 30-mg tab let. (c) Conditions of use—(1) Amount. 30 milligrams cythioate per 20 pounds of body weight every third day or twice a week. (2) Indications for use. Dogs, for con trol of fleas. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [49 FR 5615, Feb. 14, 1984, as amended at 59 FR 26942, May 25, 1994; 67 FR 78355, Dec. 24, 2002; 79 FR 28819, May 20, 2014] § 520.534 Decoquinate. (a) Specifications. Each gram of pow der contains 8 milligrams (0.8 percent) decoquinate. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.170 of this chapter. (d) Conditions of use. Calves—(1) Amount. Feed 22.7 milligrams per 100 pounds of body weight (0.5 milligram per kilogram) per day. (2) Indications for use. For the preven tion of coccidiosis in ruminating and nonruminating calves, including veal calves, caused by Eimeria bovis and E. zuernii. (3) Limitations. Feed in whole milk at the rate of 22.7 milligrams per 100 VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00185 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 176 21 CFR Ch. I (4–1–16 Edition) § 520.538 pounds body weight daily (0.5 milli gram per kilogram) for at least 28 days. [64 FR 10103, Mar. 2, 1999, as amended at 64 FR 30386, June 8, 1999; 79 FR 28819, May 20, 2014] § 520.538 Deracoxib. (a) Specifications. Each tablet con tains 12, 25, 50, 75, or 100 milligrams (mg) deracoxib. (b) Sponsor. See No. 058198 in § 510.600(c) of this chapter. (c) [Reserved] (d) Conditions of use in dogs—(1) Amount. Administer orally as needed, as a single daily dose based on body weight: (i) 1 to 2 mg/kilogram (kg) (0.45 to 0.91 mg/pound (lb)), for use as in para graph (d)(2)(i) of this section. (ii) 1 to 2 mg/kg (0.45 to 0.91 mg/lb) for 3 days, for use as in paragraph (d)(2)(ii) of this section. (iii) 3 to 4 mg/kg (1.4 to 1.8 mg/lb) for up to 7 days, for use as in paragraph (d)(2)(iii) of this section. (2) Indications for use. (i) For the con trol of pain and inflammation associ ated with osteoarthritis. (ii) For the control of postoperative pain and inflammation associated with dental surgery. (iii) For the control of postoperative pain and inflammation associated with orthopedic surgery. (3) Limitations. Federal 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; 72 FR 37437, July 10, 2007; 73 FR 33692, June 13, 2008; 77 FR 3928, Jan. 26, 2012] § 520.540 Dexamethasone oral dosage forms. § 520.540a Dexamethasone powder. (a) Specifications. Each packet con tains 10 milligrams (mg) of dexametha sone. (b) Sponsor. See No. 000061 in § 510.600(c) of this chapter. (c) Conditions of use in cattle and horses—(1) Amount. Administer 5 to 10 mg per animal the first day then 5 mg per day as required by drench or by sprinkling on a small amount of feed. (2) Indications for use. As supportive therapy following parenteral steroid administration for management or in flammatory conditions such as acute arthritic lameness, and for various stress conditions where corticosteroids are required while the animal is being treated for a specific condition. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. A withdrawal pe riod has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Do not use in horses intended for human consumption. [79 FR 28819, May 20, 2014] § 520.540b Dexamethasone tablets and boluses. (a)(1) Specifications. Each bolus is half-scored and contains 10 milligrams of dexamethasone. (2) Sponsor. See No. 000061 in § 510.600(c) of this chapter. (3) Conditions of use in cattle and horses—(i) Amount. Administer orally 5 to 10 milligrams on the first day, then 5 milligrams per day as required. (ii) Indications for use. As supportive therapy following parenteral steroid administration for management or in flammatory conditions such as acute arthritic lameness, and for various stress conditions where corticosteroids are required while the animal is being treated for a specific condition. (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. A withdrawal pe riod has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Do not use in horses intended for human consumption. (b)(1) Specifications. Each tablet con tains 0.25 milligram of dexamethasone. (2) Sponsors. See Nos. 000061 and 061623 in § 510.600(c) of this chapter. (3) Conditions of use in dogs and cats— (i) Amount. Dogs: Administer orally 0.25 to 1.25 milligrams per day for up to 7 days. Cats: Administer orally 0.125 to 0.5 milligrams per day for up to 7 days. (ii) Indications for use. As an anti-in flammatory agent. VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00186 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 177 Food and Drug Administration, HHS § 520.581 (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [40 FR 26273, June 23, 1975, as amended at 44 FR 7130, Feb. 6, 1979; 50 FR 49372, Dec. 2, 1985; 52 FR 7832, Mar. 13, 1987; 55 FR 8461, Mar. 8, 1990; 66 FR 14073, Mar. 9, 2001; 68 FR 4914, Jan. 31, 2003; 70 FR 16934, Apr. 4, 2005; 79 FR 28819, May 20, 2014] § 520.540c Dexamethasone chewable tablets. (a) Specifications. Each half-scored tablet contains 0.25 milligram of dexa methasone. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Conditions of use in dogs—(1) Amount. Administer by free-choice feeding or crumbled over food 0.25 to 1.25 milligrams daily in single or two divided doses until response is noted or 7 days have elapsed. When response is attained, dosage should be gradually reduced by 0.125 milligram per day until maintenance level is achieved. (2) Indications for use. As supportive therapy in nonspecific dermatosis and inflammatory conditions. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [44 FR 7130, Feb. 6, 1979, as amended at 56 FR 50653, Oct. 8, 1991; 60 FR 55659, Nov. 2, 1995; 79 FR 28820, May 20, 2014] § 520.563 Dexamethasone chewable tablets. (a) Specifications. Diatrizoate meglumine oral solution is a water soluble radiopaque medium containing 66 percent diatrizoate meglumine and 10 percent diatrizoate sodium. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Conditions of use in dogs and cats— (1) Amount. Administer orally 0.5 to 1.0 milliliter per pound of body weight by gavage or stomach tube. Administered rectally 0.5 to 1.0 milliliter per pound of body weight diluted with 1 part of the drug to 5 parts of water. (2) Indications for use. For radiog raphy of the gastrointestinal tract. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [44 FR 12993, Mar. 9, 1979, as amended at 50 FR 41489, Oct. 11, 1985; 79 FR 28820, May 20, 2014] § 520.580 Dichlorophene and toluene. (a) Specifications. Each capsule con tains 50 milligrams (mg) of dichlorophene and 60 mg of toluene, or multiples thereof. (b) Sponsors. See sponsors in § 510.600(c) of this chapter for use as in paragraph (c) of this section: (1) Nos. 017135, 023851, 051311, and 058670 for use only as a single dose. (2) Nos. 000061 and 054771 for use in a single dose or divided-dosage regimen. (c) Required statement. Consult your veterinarian for assistance in the diag nosis, treatment, and control of para sitism, and before administering to weak or debilitated animals. (d) Conditions of use—(1) Amount. Ad minister as follows: (i) Single dose: Administer 100 mg of dicholorophene and 120 mg of toluene per pound of body weight. (ii) Divided dose: Administer 100 mg of dichlorophene and 120 mg of toluene per 5 pounds of body weight (20 and 24 mg per pound) daily for 6 days. (2) Indications for use. For the re moval of ascarids (Toxocara canis and Toxascaris leonina) and hookworms (Ancylostoma caninum and Uncinaria stenocephala); and as an aid in remov ing tapeworms (Taenia pisiformis, Dipylidium caninum, and Echinococcus granulosus) from dogs and cats. (3) Limitations. Withhold solid foods and milk for at least 12 hours prior to medication and for 4 hours afterward. Repeat treatment in 2 to 4 weeks in animals subject to reinfection. [45 FR 10332, Feb. 15, 1980] EDITORIAL NOTE: For FEDERAL REGISTER ci tations affecting § 520.580, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.fdsys.gov. § 520.581 Dichlorophene tablets. (a) Specifications. Each tablet con tains 1 gram of dichlorophene. (b) Sponsor. See 023851 in § 510.600(c) of this chapter. VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00187 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 178 21 CFR Ch. I (4–1–16 Edition) § 520.600 (c) Required statement. Consult your veterinarian for assistance in the diag nosis, treatment, and control of para sitism, and before administering to weak or debilitated animals. (d) Conditions of use. Dogs—(1) Amount. Single dose of 1 tablet (1 gram of dichlorophene) for each 10 pounds of body weight. (2) Indications for use. It is used as an aid in the removal of tapeworms (Taenia pisiformis and Dipylidium caninum). (3) Limitations. Withhold solid foods and milk for at least 12 hours prior to medication and for 4 hours afterward. [45 FR 10333, Feb. 15, 1980] § 520.600 Dichlorvos. (a) Chemical name. 2,2-Dichlorvinyl dimethyl phosphate. (b) [Reserved] (c) Sponsor. See No. 054628 in § 510.600(c) of this chapter. (d) Related tolerances. See § 556.180 of this chapter. (e) Conditions of use in swine. (1) It is recommended for the removal and con trol of sexually mature (adult), sexu ally immature and/or 4th stage larvae of the whipworm (Trichuris suis), nod ular worms (Oesophagostomum spp.), large round-worm (Ascaris suum), and the mature thick stomach worm (Ascarops strongylina) occurring in the lumen of the gastrointestinal tract of pigs, boars, and open or bred gilts and sows. (2) The preparation should be added to the indicated amount of feed as set forth in paragraph (e)(2) of this section and administered shortly after mixing, as follows: Weight of ani mal in pounds Pounds of feed to be mixed with each 0.08 ounce of dichlorvos Pounds of mixed feed to be admin istered to each pig as a single treatment Number of pigs to be treated per 0.08 ounce of dichlorvos 20–30 .............. 4 0.33 12 31–40 .............. 5 0.56 9 41–60 .............. 6 1.00 6 61–80 .............. 5 1.00 5 81–100 ............ 4 1.00 4 Adult Gilts, Sows, and Boars ........... 16 4.00 4 (3) Do not use this product on ani mals either simultaneously or within a few days before or after treatment with or exposure to cholinesterase inhib iting drugs, pesticides, or chemicals. The preparation should be mixed thor oughly with the feed on a clean, imper vious surface. Do not allow swine ac cess to feed other than that containing the preparation until treatment is complete. Do not treat pigs with signs of scours until these signs subside or are alleviated by proper medication. Resume normal feeding schedule after wards. Swine may be retreated in 4 to 5 weeks. (f) Conditions of use in dogs. (1) For re moval of Toxocara canis and Toxascaris leonina (roundworms), Ancylostoma caninum and Uncinaria stenocephala (hookworms), and Trichuris vulpis (whipworm) residing in the lumen of the gastrointestinal tract. (2) The drug is in capsule form for di rect administration and in pellet form for administration in about one-third of the regular canned dog food ration or in ground meat. Dogs may be treat ed with any combination of capsules and/or pellets so that the animal re ceives a single dose equaling 12 to 15 milligrams of the active ingredient per pound of body weight. One-half of the single recommended dosage may be given, and the other half may be ad ministered 8 to 24 hours later. This split dosage schedule should be used in animals which are very old, heavily parasitized, anemic, or otherwise de bilitated. The drug should not be used in dogs weighing less than 2 pounds. (3) In some dogs, efficacy against Trichurias vulpis (whipworm) may be er ratic. Dogs that do not develop a nega tive stool for Trichuris vulpis ova 10 to 14 days following initial treatment should be re-treated. If a negative stool is not obtained in 10 to 14 days fol lowing re-treatment, alternate means of therapy should be considered. (4) Do not use in dogs infected with Dirofilaria immitis. (5) Do not use with other anthelmintics, taeniacides, antifilarial agents, muscle relaxants, or tranquil izers. (6) The drug is a cholinesterase inhib itor. Not for use simultaneously or VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00188 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 179 Food and Drug Administration, HHS § 520.600 within a few days before or after treat ment with or exposure to cholin esterase-inhibiting drugs, pesticides, or chemicals. (7) Federal law restricts this drug to use by or on the order of a licensed vet erinarian. (g) Conditions of use in horses when ad ministered in grain. (1) It is rec ommended for the removal and control of bots (Gastrophilus intestinalis, G. na salis), large strongyles (Strongylus vulgaris, S. equinus, S. edentatus), small strongyles (of the genera Cyathostomum, Cylicocercus, Cylicocyclus, Cylicodontophorus, Triodontophorus, Poteriostomum, Gyalocephalus), pinworms (Oxyuris equi), and large roundworm (Parascaris equorum) in horses including ponies and mules. Not for use in foals (sucklings and young weanlings). (2) For a satisfactory diagnosis, a mi croscopic fecal examination should be performed by a veterinarian or a diag nostic laboratory prior to worming. (3) It is administered in the grain portion of the ration at a dosage of 14.2 milligrams to 18.5 milligrams per pound of body weight as a single dose. It may be administered at one-half of the single recommended dosage and re peated 8 to 12 hours later in the treat ment of very aged, emaciated or debili tated subjects or those reluctant to consume medicated feed. In suspected cases of severe ascarid infection suffi cient to cause concern over mechanical blockage of the intestinal tract, the split dosage should be utilized. (4) Do not use in horses which are se verely debilitated, suffering from diar rhea or severe constipation, infectious disease, toxemia or colic. Do not ad minister in conjunction with or within 1 week of administration of muscle re laxant drugs, phenothiazine derived tranquilizers or central nervous system depressant drugs. Horses should not be subjected to insecticide treatment for 5 days prior to or after treating with the drug. Do not administer to horses af flicted with chronic alveolar emphy sema (heaves) or related respiratory conditions. The product is a cholin esterase inhibitor and should not be used simultaneously or within a few days before or after treatment with or exposure to cholinesterase inhibiting drugs, pesticides or chemicals. (5) Do not use in animals other than horses, ponies, and mules. Do not use in horses, ponies, and mules intended for food purposes. Do not allow fowl ac cess to feed containing this preparation or to fecal excrement from treated ani mals. (h) Conditions of use in horses when administered orally by syringe. (1) It is recommended for the removal and con trol of first, second, and third instar bots (Gastrophilus intestinalis and G. na salis), sexually mature and sexually im mature (4th stage) ascarids (Parascaris equorum) in horses and foals. (2) The product is in the form of a gel which is administered directly from a syringe onto the horse’s tongue. The product is administered at a dosage level of 20 milligrams of dichlorvos per kilogram of body weight for the re moval of bots and ascarids. The same dosage level is repeated every 21 to 28 days for the control of bots and ascarids. For the control of bots only, the repeat dosage is 10 milligrams per kilogram of body weight every 21 to 28 days during bot fly season. (3) Do not use this product in animals simultaneously or within a few days before or after treatment with or expo sure to cholinesterase-inhibiting drugs, pesticides or chemicals. Do not admin ister in conjunction with or within 1 week of administration of muscle-re laxant drugs, phenothiazine derived tranquilizers, or central nervous sys tem depressants. (4) Do not use in horses which are severly debilitated or suffering from di arrhea or severe constipation, infec tious disease, toxemia, or colic. Do not administer to horses affected with chronic alveolar emphysema (heaves) or other respiratory conditions. (5) Do not use in horses intended for food purposes. (6) Federal law restricts this drug to use by or on the order of a licensed vet erinarian. (i) Conditions of use in dogs, cats, pup pies, and kittens. (1) Each tablet con tains 2, 5, 10, or 20 milligrams of dichlorvos. (2) It is administered orally at 5 mil ligrams of dichlorvos per pound of body weight. VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00189 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 180 21 CFR Ch. I (4–1–16 Edition) § 520.606 (3) Dogs and puppies: Removal and control of intestinal roundworms (Toxocara canis and Toxascaris leonina) and hookworms (Ancylostoma caninum and Uncinaria stenocephala). (4) Cats and kittens: Removal and control of intestinal roundworms (Toxocara cati and Toxascaris leonina) and hookworms (Ancylostoma tubaeforme and Uncinaria stenocephala). (5) Dichlorvos is a cholinesterase in hibitor. Do not use simultaneously with or within a few days before or after treatment with or exposure to cholinesterase-inhibiting drugs, pes ticides, or chemicals. (6) Do not use in animals under 10 days of age or 1 pound of body weight. (7) Do not administer to animals showing signs of constipation, mechan ical blockage of the intestinal tract, impaired liver function, or recently ex posed to or showing signs of infectious disease. (8) Do not use in dogs or puppies in fected with Dirofilaria immitis. (9) Federal law restricts this drug to use by or on the order of a licensed vet erinarian. [40 FR 13838, Mar. 27, 1975, as amended at 48 FR 40704, Sept. 9, 1983; 51 FR 28546, Aug. 8, 1986; 62 FR 35076, June 30, 1997; 64 FR 18571, Apr. 15, 1999; 78 FR 21059, Apr. 9, 2013] § 520.606 Diclazuril. (a) Specifications. Each 100 grams (g) of pellets contain 1.56 g diclazuril. (b) Sponsor. See No. 000061 in § 510.600(c) of this chapter. (c) Conditions of use in horses—(1) Amount. Administer 1 milligram (mg) per kilogram (0.45 mg per pound) of body weight in the daily grain ration for 28 days. (2) Indications for use. For the treat ment of equine protozoal myeloencephalitis (EPM) caused by Sarcocystis neurona. (3) Limitations. Do not use in horses intended for human consumption. Fed eral law restricts this drug to use by or on the order of a licensed veterinarian. [72 FR 20943, Apr. 27, 2007] § 520.608 Dicloxacillin. (a) Specifications. Each capsule con tains dicloxacillin sodium monohydrate equivalent to 50, 100, 200, or 500 milligrams of dicloxacillin. (b) Sponsor. See No. 054771 in § 510.600 (c) of this chapter. (c) Conditions of use in dogs—(1) Amount. Administer orally 5 to 10 milli grams per pound of body weight, three times daily. In severe cases, up to 25 milligrams per pound of body weight three times daily. (2) Indications for use. For the treat ment of pyoderma (pyogenic derma titis) due to penicillinase-producing staphylococci sensitive to dicloxacillin. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [57 FR 37325, Aug. 18, 1992, as amended at 79 FR 28820, May 20, 2014] § 520.620 Diethylcarbamazine oral dos age forms. § 520.622 Diethylcarbamazine citrate oral dosage forms. § 520.622a Diethylcarbamazine citrate tablets. (a) Sponsors. (1) [Reserved] (2) See 054771 in § 510.600(c) of this chapter for use of 100, 200, and 300 milli gram tablets for prevention of heart worm disease in dogs and as an aid in the treatment of ascarid infections in dogs. (3) See 061623 in § 510.600(c) of this chapter for use of 50, 100, 200, 300, or 400 milligram tablets for prevention of heartworm disease in dogs, as an aid in the control of ascarid infections in dogs, and as an aid in the treatment of ascarid infections in dogs and cats. (4) [Reserved] (5) See No. 000061 in § 510.600(c) of this chapter for use of 60, 120, or 180 milli gram tablets for prevention of heart worm disease in dogs, as an aid in the control of ascarid infections in dogs, and as an aid in the treatment of asca rid infections in dogs and cats. (6) See No. 054628 in § 510.600(c) of this chapter for use of 50, 100, 200, 300, or 400 milligram tablets for prevention of heartworm disease in dogs, as an aid in the control of ascarid infections in dogs, and as an aid in the treatment of ascarid infections in dogs and cats. (b) Conditions of use—(1) Dosage/indi cations for use. (i) Three milligrams per VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00190 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 181 Food and Drug Administration, HHS § 520.622c pound of body weight daily for preven tion of heartworm disease (Dirofilaria immitis) in dogs. (ii) Three milligrams per pound of body weight daily as an aid in the con trol of ascarid infections (Toxocara canis) in dogs. (iii) Twenty-five to 50 milligrams per pound of body weight as an aid in the treatment of ascarid infections in dogs (Toxocara canis) and cats (Toxocara canis and Toxascaris leonina). (2) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [46 FR 23230, Apr. 24, 1981, as amended at 46 FR 41038, Aug. 14, 1981; 46 FR 46315, Sept. 18, 1981; 46 FR 61653, Dec. 18, 1981; 47 FR 10805, Mar. 12, 1982; 47 FR 14150, Apr. 2, 1982; 50 FR 41489, Oct. 11, 1985; 50 FR 49372, Dec. 2, 1985; 53 FR 40056, Oct. 13, 1988; 53 FR 40727, Oct. 18, 1988; 55 FR 8461, Mar. 8, 1990; 61 FR 34728, July 3, 1996; 62 FR 35076, June 30, 1997; 66 FR 14073, Mar. 9, 2001; 68 FR 4914, Jan. 31, 2003; 76 FR 17777, Mar. 31, 2011; 77 FR 4896, Feb. 1, 2012; 78 FR 21059, Apr. 7, 2013; 79 FR 28820, May 20, 2014] § 520.622b Diethylcarbamazine citrate syrup. (a)(1) Specifications. Each milliliter of syrup contains 60 milligrams of diethylcarbamazine citrate. (2) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (3) Conditions of use. (i) The drug is indicated for use in dogs for the pre vention of infection with Dirofilaria immitis and T. canis and T. leonina. It is also indicated for treatment of ascarid infections of T. canis and T. leonina in dogs and T. cati in cats. (ii) For prevention of heartworm and ascarid infections in dogs, the drug may be added to the daily diet at a dos age rate of 3.0 milligrams per pound of body weight per day or given directly by mouth at the same dosage rate. For treatment of ascarid infections in dogs and cats, the drug is administered at a dosage level of 25 to 50 milligrams per pound of body weight preferably ad ministered immediately after feeding. (iii) Older dogs should be proven neg ative for the presence of Dirofilaria immitis infection before administration of the drug. Those with proven infec tion of Dirofilaria immitis should be ren dered negative using adulticidal and microfilaricidal drugs before adminis tration of this drug. (iv) Federal law restricts this drug to use by or on the order of a licensed vet erinarian. (b) [Reserved] (c)(1) Specifications. Each milliliter of syrup contains 60 milligrams of diethylcarbamazine citrate. (2) Sponsor. See No. 054628 in § 510.600(c) of this chapter. (3) Conditions of use. (i) The drug is used in dogs between 4 weeks and 8 months of age for the removal of ascarids (Toxacara canis) and in ani mals over 4 weeks of age for the pre vention of heartworm disease (Dirofilaria immitis). (ii) The drug is administered (a) for removal of ascarids at a dosage of 50 milligrams per pound of body weight divided into two equal doses and ad ministered 8 to 12 hours apart (morning and night), orally or mixed with either dry or wet food, and (b) for prevention of heartworm disease at a dosage of 3 milligrams per pound of body weight daily, orally or in food, in heartworm endemic areas, from the beginning of mosquito activity, during the mosquito season, and for 2 months following the end thereof. (iii) Dogs older than 8 months of age may be infected with Dirofilaria immitis. Use of the drug is contraindicated in dogs with active D. immitis infections. (iv) Federal law restricts this drug to use by or on the order of a licensed vet erinarian. [40 FR 13838, Mar. 27, 1975, as amended at 41 FR 28265, July 9, 1976; 44 FR 3967, Jan. 19, 1979; 47 FR 14150, Apr. 2, 1982; 47 FR 35186, Aug. 13, 1982; 49 FR 33997, Aug. 28, 1984; 50 FR 41489, Oct. 11, 1985; 53 FR 47027, Oct. 18, 1988; 61 FR 34728, July 3, 1996; 62 FR 35076, June 30, 1997; 62 FR 38906, July 21, 1997; 77 FR 4897, Feb. 1, 2012; 78 FR 21059, Apr. 9, 2013; 79 FR 28820, May 20, 2014] § 520.622c Diethylcarbamazine citrate chewable tablets. (a) Specifications. Each chewable tab let contains 30, 45, 60, 120, 150, or 180 milligrams of diethylcarbamazine cit rate. (b) Sponsors. See drug listing nos. in § 510.600(c) of this chapter for identi fication of sponsors as follows: (1) [Reserved] VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00191 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 182 21 CFR Ch. I (4–1–16 Edition) § 520.623 (2) For 054771, use of 60, 120, or 180 milligram tablets as in paragraph (c)(2)(ii) of this section. (3) For 061690, use of 45 or 150 milli gram tablets as in paragraph (c)(2)(iii) of this section. (4) For 061133, use of 60-, 120-, or 180 milligram tablets as in paragraph (c)(2)(i) of this section. (5) For 000061, use of 60-milligram tablets as in paragraph (c)(2)(i) of this section. (6) For 054628, use of 30, 60, 120, or 180 milligram tablets as in paragraph (c)(2)(i) of this section. (c) Conditions of use—(1) Amount. 3 milligrams per pound of body weight per day for prevention of heartworm disease and control of ascarids; 25 to 50 milligrams per pound of body weight as an aid in treatment of ascarid infec tions. (2) Indications for use. (i) For preven tion of heartworm disease (Dirofilaria immitis) in dogs; as an aid in control of ascarids (Toxocara canis) in dogs; as an aid in treatment of ascarid (Toxocara canis and Toxascaris leonina) infections in dogs and cats. (ii) For prevention of infection with Dirofilaria immitis (heartworm disease) in dogs; as an aid in treatment of asca rid (Toxocara canis and Toxascaris leonina) infections in dogs. (iii) For prevention of heartworm dis ease (Dirofilaria immitis) in dogs. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [43 FR 6941, Feb. 17, 1978] EDITORIAL NOTE: For FEDERAL REGISTER ci tations affecting § 520.622c, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.fdsys.gov. § 520.623 Diethylcarbamazine and oxibendazole chewable tablets. (a) Specifications. Each tablet con tains either 60, 120, or 180 milligrams of diethylcarbamazine citrate with 45, 91, or 136 milligrams of oxibendazole, re spectively. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Conditions of use in dogs—(1) Amount. Administer orally to dogs at a dosage level of 6.6 milligrams of diethylcarbamazine citrate per kilo gram of body weight (3 milligrams per pound of body weight) and 5.0 milli grams of oxibendazole per kilogram of body weight (2.27 milligrams per pound of body weight). (2) Indications for use. For prevention of infection with Dirofilaria immitis (heartworm disease) and Ancylostoma caninum (hookworm infection) and for removal and control of Trichuris vulpis (whipworm infection) and mature and immature stages of intestinal Toxocara canis (ascarid infection). (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [50 FR 28768, July 16, 1985, as amended at 53 FR 45759, Nov. 14, 1988; 54 FR 3776, Jan. 26, 1989; 54 FR 6804, Feb. 14, 1989; 56 FR 50653, Oct. 8, 1991; 60 FR 55659, Nov. 2, 1995; 79 FR 28820, May 20, 2014] § 520.645 Difloxacin. (a) Specifications. Each tablet con tains 11.4, 45.4, or 136 milligrams (mg) of difloxacin hydrochloride. (b) Sponsor. See No. 000010 in § 510.600(c) of this chapter. (c) [Reserved] (d) Conditions of use—(i) Amount. Ad minister 5 to 10 mg per kilogram (2.3 to 4.6 mg per pound) of body weight orally once a day for 2 to 3 days beyond ces sation of clinical signs of disease up to a maximum of 30 days. (ii) Indications for use. For manage ment of diseases in dogs associated with bacteria susceptible to difloxacin. (iii) Limitations. Federal law prohibits the extra-label use of this drug in food producing animals. Federal law re stricts this drug to use by or on the order of a licensed veterinarian. (2) [Reserved] [63 FR 8123, Feb. 18, 1998, as amended at 75 FR 10165, Mar. 5, 2010] § 520.666 Dirlotapide. (a) Specifications. Each milliliter (mL) of solution contains 5 milligrams (mg) dirlotapide. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Conditions of use in dogs—(1) Amount. The initial dosage is 0.01 mL/ kg (0.0045 mL/lb) body weight for the first 14 days. After the first 14 days of treatment, the dose volume is doubled to 0.02 mL/kg (0.009 mL/lb) body weight VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00192 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 183 Food and Drug Administration, HHS § 520.763c for the next 14 days (days 15 to 28 of treatment). Dogs should be weighed monthly and the dose volume adjusted every month, as necessary, to maintain a target percent weight loss until the desired weight is achieved. (2) Indications for use. For the man agement of obesity. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [72 FR 263, Jan. 4, 2007, as amended at 79 FR 28820, May 20, 2014] § 520.763 Dithiazanine oral dosage forms. § 520.763a Dithiazanine tablets. (a) Specifications. Each tablet con tains 10, 50, 100, or 200 milligrams (mg) dithiazanine iodide. (b) Sponsor. See No. 054628 in § 510.600(c) of this chapter. (c) Conditions of use in dogs—(1) Indi cations for use and amount. Administer orally immediately after feeding as fol lows: (i) For large roundworms (Toxocara canis, Toxascaris leonina): 10 mg per pound (/lb) of body weight for 3 to 5 days; (ii) For hookworms (Ancylostoma caninum, Uncinaria stenocephala) and whipworms (Trichuris vulpis): 10 mg/lb of body weight for 7 days; (iii) For Strongyloides (Strongyloides canis, Strongyloides stercoralis): 10 mg/lb of body weight for 10 to 12 days; (iv) For heartworm microfilariae (Dirofilaria immitus): 3 to 5 mg/lb of body weight for 7 to 10 days. Treatment for heartworm microfilariae should fol low 6 weeks after therapy for adult worms. (2) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [79 FR 28820, May 20, 2014] § 520.763b Dithiazanine powder. (a) Specifications. Each tablespoon of powder contains 200 milligrams (mg) dithiazanine iodide. (b) Sponsor. See No. 000010 in § 510.600(c) of this chapter. (c) Conditions of use in dogs—(1) Indi cations for use and amount. Administer orally by mixing in food as follows: (i) For large roundworms (Toxocara canis, Toxascaris leonina): 10 mg per pound (/lb) of body weight for 3 to 5 days; (ii) For hookworms (Ancylostoma caninum, Uncinaria stenocephala) and whipworms (Trichuris vulpis): 10 mg/lb of body weight for 7 days; (iii) For Strongyloides (Strongyloides canis, Strongyloides stercoralis): 10 mg/lb of body weight for 10 to 12 days; (iv) For heartworm microfilariae (Dirofilaria immitus): 3 to 5 mg/lb of body weight for 7 to 10 days. Treatment for heartworm microfilariae should fol low 6 weeks after therapy for adult worms. (2) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [79 FR 28820, May 20, 2014] § 520.763c Dithiazanine iodide and pi perazine citrate suspension. (a) Specifications. Each milliliter of suspension contains 69 milligrams (mg) dithiazanine iodide and 83 mg piper azine base (as piperazine citrate). (b) Sponsor. See No. 054628 in § 510.600(c) of this chapter. (c) Conditions of use in horses—(1) Amount. 1 ounce (30 milliliters) per 100 pounds of body weight for the first 500 pounds; 3⁄4 ounce for each 100 pounds thereafter, up to 1,200 pounds; 101⁄4 ounces to animals over 1,200 pounds. (2) Indications for use. For control of large roundworms, Parascaris equorum; small strongyles; large strongyles, Strongylus vulgaris; and pinworms, Oxyuris equi. (3) Limitations. Administer by drench or mixed with the daily ration as a sin gle dose. Treatment is recommended in spring and fall. In a heavily infested environment, treatment may be re peated every 30 days. Not for use in horses intended for food purposes. Se verely debilitated animals should not be wormed except on the advice of a veterinarian. If the drug is for adminis tration by stomach tube, it shall be la beled: ‘‘Federal law restricts this drug to use by or on the order of a licensed veterinarian.’’ [47 FR 52696, Nov. 23, 1982, as amended at 48 FR 32342, July 15, 1983; 53 FR 40727, Oct. 18, 1988; 62 FR 35076, June 30, 1997; 78 FR 21059, Apr. 9, 2013; 79 FR 28820, May 20, 2014] VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00193 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 184 21 CFR Ch. I (4–1–16 Edition) § 520.766 § 520.766 Domperidone. (a) Specifications. Each milliliter of gel contains 110 milligrams (mg) domperidone. (b) Sponsor. See No. 043264 in § 510.600 of this chapter. (c) Conditions of use in horses—(1) Amount. Administer 0.5 mg per pound (mg/lb) (1.1 mg/kilogram (kg)) by mouth once daily starting 10 to 15 days prior to the expected foaling date. Treatment may be continued for up to 5 days after foaling if mares are not producing adequate milk. (2) Indications for use. For prevention of fescue toxicosis in periparturient mares. (3) Limitations. Do not use in horses intended for human consumption. Fed eral law restricts this drug to use by or on the order of a licensed veterinarian. [75 FR 67031, Nov. 1, 2010] § 520.784 Doxylamine. (a) Specifications. The drug is in tab let form and contains doxylamine suc cinate as the active drug ingredient. (b) Sponsor. See No. 000061 in § 510.600(c) of this chapter. (c) Conditions of use—(1) Amount. Horses: Administer orally 1 to 2 milli grams (mg) per pound (/lb) of body weight per day divided into 3 or 4 equal doses. Dogs and cats: Administer orally 2 to 3 mg/lb of body weight per day di vided into 3 or 4 equal doses. (2) Indications for use. For use when antihistaminic therapy may be ex pected to alleviate some signs of dis ease in horses, dogs, and cats. (3) Limitations. Do not use in horses intended for human consumption. Fed eral law restricts this drug to use by or on the order of a licensed veterinarian. [40 FR 13838, Mar. 27, 1975, as amended at 42 FR 60140, Nov. 25, 1977; 46 FR 48642, Oct. 2, 1981; 61 FR 8873, Mar. 6, 1996; 62 FR 61624, Nov. 19, 1997; 79 FR 28821, May 20, 2014] § 520.804 Enalapril. (a) Specifications. Each tablet con tains 1.0, 2.5, 5.0, 10, or 20 milligrams (mg) of enalapril maleate. (b) Sponsor. See No. 050604 in § 510.600(c) of this chapter. (c) Conditions of use in dogs—(1) Amount. Administer orally 0.5 to 1.0 mg of enalapril maleate per kilogram of body weight per day. (2) Indications for use. For the treat ment of mild, moderate, and severe (modified New York Heart Association Class II, III, IV) heart failure in dogs. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [79 FR 28821, May 20, 2014, as amended at 80 FR 34278, June 16, 2015] § 520.812 Enrofloxacin. (a) Specifications. Each tablet con tains: (1) 22.7, 68.0, or 136.0 milligrams (mg) enrofloxacin; or (2) 22.7, 68.0, 136.0, or 272 mg enrofloxacin. (b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter for use as in paragraph (c) of this section. (1) Nos. 000859 and 026637 for use of product described in paragraph (a)(1) of this section. (2) No. 058198 for use of product de scribed in paragraph (a)(2) of this sec tion. (c) Conditions of use in dogs and cats— (1) Amount. Administer orally as a sin gle, daily dose or divided into two equal doses at 12-hour intervals. (i) Dogs. 5 to 20 mg per kilogram (/kg) (2.27 to 9.07 mg per pound (/lb)) of body weight. (ii) Cats. 5 mg/kg (2.27 mg/lb) of body weight. (2) Indications for use. For the man agement of diseases associated with bacteria susceptible to enrofloxacin. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law pro hibits the extralabel use of this drug in food-producing animals. [78 FR 30197, May 22, 2013, as amended at 78 FR 52853, Aug. 27, 2013] § 520.816 Epsiprantel. (a) Specifications. Each tablet con tains either 12.5, 25, 50, or 100 milli grams of epsiprantel. (b) Sponsor. See No. 050604 in § 510.600(c) of this chapter. (c) Conditions of use—(1) Dogs—(i) Amount. 2.5 milligrams per pound of body weight. VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00194 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 185 Food and Drug Administration, HHS § 520.863 (ii) Indications for use. Removal of ca nine cestodes Dipylidium caninum and Taenia pisiformis. (2) Cats—(i) Amount. 1.25 milligrams per pound of body weight. (ii) Indications for use. Removal of fe line cestodes D. caninum and T. taeniaeformis. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [54 FR 50615, Dec. 8, 1989, as amended at 56 FR 50653, Oct. 8, 1991; 60 FR 55659, Nov. 2, 1995; 79 FR 28821, May 20, 2014] § 520.823 Erythromycin. (a) Specifications. Each gram of pow der contains erythromycin phosphate equivalent to 0.89 gram of erythro mycin master standard. (b) Sponsor. See No. 061623 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.230 of this chapter. (d) Conditions of use. It is used in drinking water as follows: (1) Broiler and replacement chickens— (i) Amount. 0.500 gram per gallon. (ii) Indications for use. As an aid in the control of chronic respiratory dis ease due to Mycoplasma gallisepticum susceptible to erythromycin. (iii) Limitations. Administer for 5 days; do not use in replacement pullets over 16 weeks of age; do not use in chickens producing eggs for human consumption; to assure effectiveness, treated birds must consume enough medicated water to provide a thera peutic dosage; solutions older than 3 days should not be used; withdraw 1 day before slaughter. (2) Replacement chickens and chicken breeders—(i) Amount. 0.500 gram per gal lon. (ii) Indications for use. As an aid in the control of infectious coryza due to Haemophilus gallinarum susceptible to erythromycin. (iii) Limitations. Administer for 7 days; do not use in replacement pullets over 16 weeks of age; do not use in chickens producing eggs for human consumption; to assure effectiveness, treated birds must consume enough medicated water to provide a thera peutic dosage; solutions older than 3 days should not be used; withdraw 1 day before slaughter. (3) Growing turkeys—(i) Amount. 0.500 gram per gallon. (ii) Indications for use. As an aid in the control of blue comb (nonspecific infectious enteritis) caused by orga nisms susceptible to erythromycin. (iii) Limitations. Administer for 7 days; do not use in turkeys producing eggs for human consumption; to assure effectiveness, treated birds must con sume enough medicated water to pro vide a therapeutic dosage; solutions older than 3 days should not be used; withdraw 1 day before slaughter. [40 FR 13838, Mar. 27, 1975, as amended at 45 FR 56798, Aug. 26, 1980; 66 FR 14073, Mar. 9, 2001; 68 FR 4914, Jan. 31, 2003; 79 FR 28821, May 20, 2014; 81 FR 17607, Mar. 30, 2016] § 520.852 Estriol. (a) Specifications. Each tablet con tains 1 milligram (mg) estriol. (b) Sponsor. See No. 000061 in § 510.600(c) of this chapter. (c) Conditions of use in dogs—(1) Amount. Administer at an initial dose of 2 mg per dog per day. The dosage may be titrated to as low as 0.5 mg per dog every second day, depending on re sponse. (2) Indications for use. For the control of estrogen-responsive urinary inconti nence in ovariohysterectomized female dogs. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [76 FR 78150, Dec. 16, 2011] § 520.863 Ethylisobutrazine. (a) Specifications. Each tablet con tains either 10 milligrams or 50 milli grams of ethylisobutrazine hydro chloride. (b) Sponsor. See No. 000061 in § 510.600(c) of this chapter. (c) Conditions of use in dogs—(1) Amount. Administer orally 2 to 5 milli grams per pound of body weight once daily. (2) Indications for use. As a tranquil izer. VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00195 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 186 21 CFR Ch. I (4–1–16 Edition) § 520.870 (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [40 FR 13838, Mar. 27, 1975, as amended at 46 FR 48642, Oct. 2, 1981; 61 FR 8873, Mar. 6, 1996; 62 FR 61624, Nov. 19, 1997; 79 FR 28821, May 20, 2014] § 520.870 Etodolac. (a) Specifications. Each tablet con tains 150, 300, or 500 milligrams (mg) of etodolac. (b) Sponsor. See No. 000010 in § 510.600(c) of this chapter. (c) Conditions of use in dogs—(1) Amount. Administer 10 to 15 mg per kilogram (4.5 to 6.8 mg per pound) of body weight per day orally. (2) Indications for use. For the man agement of pain and inflammation as sociated with osteoarthritis. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [63 FR 51300, Sept. 25, 1998, as amended at 68 FR 51705, Aug. 28, 2003; 75 FR 10166, Mar. 5, 2010; 79 FR 28821, May 20, 2014] § 520.903 Febantel oral dosage forms. § 520.903a Febantel paste. (a) Specifications. Each gram of paste contains 455 milligrams (45.5 percent) febantel. (b) Sponsor. See No. 000859 in § 510.600(c) of this chapter. (c) Conditions of use in horses—(1) Amount. Administer paste orally at 6 milligrams per kilogram (2.73 milli grams per pound) of body weight on the base of the tongue or well mixed into a portion of the normal grain ration. For animals maintained on premises where reinfection is likely to occur, retreat ment may be necessary. For most ef fective results, retreat in 6 to 8 weeks. (2) Indications for use. For removal of large strongyles (Strongylus vulgaris, S. edentatus, S. equinus); ascarids (Parascaris equorum—sexually mature and immature); pinworms (Oxyuris equi—adult and 4th stage larva); and various small strongyles in horses, foals, and ponies. (3) Limitations. Do not use in horses intended for human consumption. Con sult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. [79 FR 28821, May 20, 2014] § 520.903b Febantel suspension. (a) Specifications. Each ounce of sus pension contains 2.75 grams (9.3 percent ounce) febantel. (b) Sponsor. See No. 000859 in § 510.600(c) of this chapter. (c) Conditions of use in horses—(1) Amount. 3 milliliters per 100 pounds body weight or 1 fluid ounce per 1000 pounds (6 milligrams per kilogram body weight). Administer by stomach tube or drench, or by mixing well into a portion of the normal grain ration. For animals maintained on premises where reinfection is likely to occur, re treatment may be necessary. For most effective results, retreat in 6 to 8 weeks. (2) Indications for use. For removal of ascarids (Parascaris equorum—adult and sexually immature), pinworms (Oxyuris equi—adult and 4th stage larvae), large strongyles (Strongylus vulgaris, S. edentatus, S. equinus), and various small strongyles in horses, breeding stallions and mares, pregnant mares, foals, and ponies. (3) Limitations. Do not use in horses intended for human consumption. Fed eral law restricts this drug to use by or on the order of a licensed veterinarian. (d) Special considerations. Febantel suspension may be used in combination with trichlorfon oral liquid in accord ance with the provisions of § 520.2520c, this section, and the following condi tions: (1) Combine 1 part febantel suspen sion with 5 parts trichlorfon liquid. (2) Allow animal to consume a por tion of daily grain ration; administer mixture by stomach tube at rate of 18 milliliters per 100 pounds of body weight. [45 FR 8587, Feb. 8, 1980, as amended at 79 FR 28821, May 20, 2014] § 520.903c [Reserved] § 520.903d Febantel and praziquantel paste. (a) Specifications. Each gram of paste contains 34 milligrams of febantel and 3.4 milligrams of praziquantel. VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00196 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 187 Food and Drug Administration, HHS § 520.905a (b) Sponsor. See No. 000859 in § 510.600(c) of this chapter. (c) Conditions of use—(1) Amount—(i) Dogs and cats (over 6 months of age): 10 milligrams of febantel and 1 milligram of praziquantel per kilogram of body weight (1 gram of paste per 7.5 pounds body weight) administered by mouth or in the food once daily for 3 days. (ii) Puppies and kittens (less than 6 months of age): 15 milligrams of febantel and 1.5 milligrams of praziquantel per kilogram of body weight (1 gram of paste per 5 pounds body weight) administered by mouth on a full stomach once daily for 3 days. (2) Indications for use. (i) Dogs and puppies: For removal of hookworms (Ancylostoma caninum and Uncinaria stenocephala), whipworms (Trichuris vulpis), ascarids (Toxocara canis and Toxascaris leonina), and tapeworms (Dipylidium caninum and Taenia pisiformis). (ii) Cats and kittens: For removal of hookworms (Ancylostoma tubaeforme), ascarids (Toxocara cati) and tapeworms (Dipylidium caninum and Taenia taeniaeformis). (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [50 FR 19167, May 7, 1985, as amended at 53 FR 48533, Dec. 1, 1988; 56 FR 50813, Oct. 9, 1991; 79 FR 28821, May 20, 2014] § 520.903e Febantel tablets. (a) Specifications. Each scored tablet contains 27.2 milligrams of febantel for use in dogs, puppies, cats, and kittens or 163.3 milligrams of febantel for use in dogs, puppies, and cats. (b) Sponsor. See No. 000859 in § 510.600(c) of this chapter. (c) Conditions of use—(1) Amount—(i) Dogs and cats. Ten milligrams per kilo gram body weight. Administer once daily for 3 consecutive days. (ii) Puppies and kittens fewer than 6 months of age. Fifteen milligrams per kilogram body weight. Administer once daily for 3 consecutive days. (2) Indications for use. (i) For removal of hookworms (Ancylostoma caninum and Uncinaria stenocephala), ascarids (Toxocara canis and Toxascaris leonina) and whipworms (Trichuris vulpis) in dogs and puppies. (ii) For removal of hookworms (Ancylostoma tubaeforme) and ascarids (Toxocara cati) in cats and kittens. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [56 FR 50655, Oct. 8, 1991, as amended at 79 FR 28821, May 20, 2014] § 520.905 Fenbendazole oral dosage forms. § 520.905a Fenbendazole suspension. (a) Specifications. Each milliliter of suspension contains 100 milligrams (mg) fenbendazole for use as in para graphs (e)(1), (2), (3), and (4) of this sec tion; or 200 mg fenbendazole for use as in paragraph (e)(5) of this section. (b) Sponsor. See No. 000061 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.275 of this chapter. (d) Special considerations. (1) See § 500.25 of this chapter. (2) Fenbendazole suspension 10 per cent and approved forms of trichlorfon, when used concomitantly for treating the indications provided in paragraph (e) of this section and for treating in fections of stomach bot as provided in § 520.2520, have been shown to be com patible and not to interfere with one another. (e) Conditions of use—(1) Horses—(i) Amount. Administer orally 5 mg per kilogram (/kg) (2.3 mg per pound (/lb)) for the control of large strongyles, small strongyles, and pinworms; 10 mg/ kg for the control of ascarids. (ii) Indications for use. For the control of large strongyles (Strongylus edentatus, S. equinus, S. vulgaris), small strongyles (Cyanthostomum spp., Cylicocyclus spp., Cylicostephanus spp., Triodontophorus spp.), pinworms (Oxyuris equi), and ascarids (Parascaris equorum) in horses. (iii) Limitations. Administer by dose syringe or suitable plastic syringe. Do not use in horses intended for human consumption. (2) Cattle including dairy cows of breed ing age—(i) Amount. Administer orally 5 mg/kg of body weight (2.3 mg/lb). Re treatment may be needed after 4 to 6 weeks. (ii) Indications for use. For the re moval and control of lungworm VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00197 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 188 21 CFR Ch. I (4–1–16 Edition) § 520.905b (Dictyocaulus viviparus); stomach worm (adults)—brown stomach worm (Ostertagia ostertagi); stomach worms (adults and 4th-stage larvae)— barberpole worm (Haemonchus contortus and H. placei) and small stomach worm (Trichostongylus axei); intestinal worms (adults and 4th-stage larvae)— hookworm (Bunostonmum phlebotomum), threadnecked intestinal worm (Nematodirus helvetianus), small intes tinal worm (Cooperia punctata and C. oncophora), bankrupt worm (Trichostrongylus colubriformis), and nodular worm (Oesophagostomum radiatum). (iii) Limitations. Cattle must not be slaughtered within 8 days following last treatment. A withdrawal period has not been established for this prod uct in preruminating calves. Do not use in calves to be processed for veal. (3) Beef cattle—(i) Amount. Administer orally 10 mg/kg of body weight (2.3 mg/ lb). Retreatment may be needed after 4 to 6 weeks. (ii) Indications for use. For the re moval and control of stomach worm (4th stage inhibited larvae/type II ostertagiasis), Ostertagia ostertagi, and tapeworm, Moniezia benedeni. (iii) Limitations. Cattle must not be slaughtered within 8 days following last treatment. A withdrawal period has not been established for this prod uct in preruminating calves. Do not use in calves to be processed for veal. Federal law restricts this drug to use by or on the order of a licensed veteri narian. (4) Goats—(i) Amount. Administer orally 5 mg/kg of body weight (2.3 mg/ lb). Retreatment may be needed after 4 to 6 weeks. (ii) Indications for use. For the re moval and control of stomach worms (adults) Haemonchus contortus and Teladorsagia circumcincta. (iii) Limitations. Goats must not be slaughtered for food within 6 days fol lowing last treatment. Do not use in lactating goats. (5) Chickens—(i) Amount. Administer orally via drinking water at a daily dose of 1 mg/kg body weight (0.454 mg/ lb) for 5 consecutive days. (ii) Indications for use. For the treat ment and control of adult Ascaridia galli in broiler chickens and replace ment chickens intended to become breeding chickens, and for the treat ment and control of adult A. galli and Heterakis gallinarum in breeding chick ens. (iii) Limitations. Not for use in laying hens and replacement chickens in tended to become laying hens. [42 FR 59069, Nov. 15, 1977; 43 FR 12311, Mar. 24, 1978. Redesignated at 44 FR 1375, Jan. 5, 1979, and amended at 46 FR 29464, June 2, 1981; 47 FR 15327, Apr. 9, 1982; 48 FR 42809, Sept. 20, 1983; 49 FR 1983, Jan. 17, 1984; 53 FR 40058, Oct. 13, 1988; 59 FR 26943, May 25, 1994; 61 FR 29478, June 11, 1996; 63 FR 63983, Nov. 18, 1998; 66 FR 47960, Sept. 17, 2001; 68 FR 26205, May 15, 2003; 74 FR 17770, Apr. 17, 2009; 74 FR 61516, Nov. 25, 2009; 76 FR 17336, Mar. 29, 2011; 80 FR 76386, Dec. 9, 2015] § 520.905b Fenbendazole granules. (a) Specifications. Each gram of gran ules contains 222 milligrams (mg) fenbendazole. (b) Sponsor. See No. 000061 in § 510.600(c) of this chapter. (c) Special considerations. See § 500.25 of this chapter. (d) Conditions of use—(1) Horses—(i) Amount. 5 mg/kilogram (kg) for large strongyles, small strongyles, and pinworms; 10 mg/kg for ascarids. (ii) Indications for use. For the control of infections of large strongyles (Strongylus edentatus, S. equinus, S. vulgaris), small strongyles, pinworms (Oxyuris equi), and ascarids (Parascaris equorum). (iii) Limitations. Sprinkle the appro priate amount of drug on a small amount of the usual grain ration. Pre pare for each horse individually. With holding feed or water is not necessary. Retreat in 6 to 8 weeks if required. Do not use in horses intended for food. (2) Dogs—(i) Amount. 50 mg/kg daily for 3 consecutive days. (ii) Indications for use. For the treat ment and control of ascarids (Toxocara canis, Toxascaris leonina), hookworms (Ancylostoma caninum, Uncinaria stenocephala), whipworms (Trichuris vulpis), and tapeworms (Taenia pisiformis). (iii) Limitations. Mix the appropriate amount of drug with a small amount of the usual food; dry dog food may re quire slight moistening to facilitate mixing. Medicated food must be fully consumed. VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00198 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 189 Food and Drug Administration, HHS § 520.905d (3) Zoo and wildlife animals—(i) Amount. 10 mg/kg per day for 3 days. (ii) Indications for use. For control of internal parasites of Felidae and Ursidae as follows: (A) Lion (Panthera leo) and Tiger (Panthera tigris): Ascarid (Toxocara cati, Toxascaris leonina), Hookworm (Ancylostoma spp.). (B) Cheetah (Acinonyx jubatus): Asca rid (Toxocara cati, Toxascaris leonina). (C) Puma (Felis concolor), Panther (Panthera spp.), Leopard (Panthera pardus), Jaguar (Panthera onca): Asca rid (Toxocara cati, Toxascaris leonina), Hookworm (Ancylostoma spp.), Tape worm (Taenia hydatigena, T. krabbei, T. taeniaeformis). (D) Black Bear (Ursus americanus): Ascarid (Baylisascaris transfuga, Toxascaris leonina), Hookworm (Ancylostoma caninum), Tapeworm (Taenia hydatigena, T. krabbei). (E) Polar Bear (Ursus maritimus) and Grizzly Bear (Ursus horribilis): Ascarid (Baylisascaris transfuga, Toxascaris leonina). (iii) Limitations. Top dress or mix with a small portion of food. Must be fully consumed prior to feeding. Fed eral law restricts this drug to use by or on the order of a licensed veterinarian. Do not use 14 days before or during the hunting season. [44 FR 1375, Jan. 5, 1979, as amended at 47 FR 15327, Apr. 9, 1982; 48 FR 50528, Nov. 2, 1983; 59 FR 35252, July 11, 1994; 66 FR 47960, Sept. 17, 2001; 67 FR 47450, July 19, 2002; 71 FR 19429, Apr. 14, 2006; 74 FR 61516, Nov. 25, 2009] § 520.905c Fenbendazole paste. (a) Specifications. Each gram of paste contains 100 milligrams (mg) fenbendazole (10 percent). (b) Sponsor. See No. 000061 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.275 of this chapter. (d) Special considerations. See § 500.25 of this chapter. (e) Conditions of use—(1) Horses—(i) Indications for use and amounts—(A) For control of large strongyles (Strongylus edentatus, S. equinus, S. vulgaris), small strongyles, pinworms (Oxyuris equi), and ascarids (Parascaris equorum): 2.3 mg per pound (/lb) of body weight, or for foals and weanlings (less than 18 months of age), 4.6 mg/lb of body weight. Retreatment at intervals of 6 to 8 weeks may be required. (B) For control of arteritis caused by the fourth-stage larvae of S. vulgaris: 4.6 mg/lb of body weight daily for 5 days. Treatment should be initiated in the spring and repeated in 6 months. (C) For treatment of encysted mucosal cyathostome (small strongyle) larvae including early third-stage (hypobiotic), late third-stage, and fourth-stage larvae: 4.6 mg/lb of body weight daily for 5 consecutive days. (D) Fenbendazole paste 10 percent may be used concomitantly with ap proved forms of trichlorfon for the in dications provided in paragraph (e)(1)(i)(A) of this section and for treat ing infections of stomach bots as pro vided in § 520.2520. (ii) Limitations. Do not use in horses intended for human consumption. (2) Cattle—(i) Amount. 2.3 mg/lb of body weight. Retreatment may be needed after 4 to 6 weeks. (ii) Indications for use. For the re moval and control of lungworms (Dictyocaulus viviparus), stomach worms (Haemonchus contortus, Ostertagia ostertagi, Trichostrongylus axei), and intestinal worms (Bunostomum phlebotomum, Nematodirus helvetianus, Cooperia punctata, C. oncophora, Trichostrongylus colubriformis, and Oesophagostomum radiatum). (iii) Limitations. Cattle must not be slaughtered within 8 days following last treatment. A withdrawal period has not been established for this prod uct in preruminating calves. Do not use in calves to be processed for veal. [72 FR 24185, May 2, 2007, as amended at 74 FR 61516, Nov. 25, 2009; 76 FR 17337, Mar. 29, 2011] § 520.905d Fenbendazole powder. (a) Specifications. (1) Each 2-ounce packet contains 2.27 grams (4 percent) of fenbendazole plus other inert ingre dients. (2) Each 4-ounce packet contains 1.7 grams (1.5 percent) of fenbendazole plus other inert ingredients. (b) Sponsors. (1) See No. 000061 in § 510.600(c) of this chapter for use of the 4-percent product. VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00199 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 190 21 CFR Ch. I (4–1–16 Edition) § 520.905e (2) See No. 051311 in § 510.600(c) of this chapter for use of the 1.5-percent prod uct. (c) Related tolerances. See § 556.275 of this chapter. (d) Conditions of use. It is adminis tered to swine as follows: (1) Amount. 3 milligrams fenbendazole per kilogram body weight per day (1.36 milligrams per pound per day). (2) Indications for use. For removal and control of large roundworms (Ascaris suum); lungworms (Metastrongylus apri); nodular worms (Oesophagostomum dentatum, O. quadrispinulatum); small stomach worms (Hyostrongylus rubidus); whipworms (Trichuris suis); and kidneyworms (Stephanurus dentatus— mature and immature). (3) Limitations. Thoroughly mix the contents of the packet(s) with swine ration and administer according to label directions. Feed as sole ration for 3 consecutive days. Can be fed to preg nant sows. No prior withdrawal of feed or water is necessary. Consult your veterinarian for assistance in the diag nosis, treatment, and control of para sitism. [49 FR 18090, Apr. 27, 1984, as amended at 49 FR 20485, May 15, 1984; 66 FR 47960, Sept. 17, 2001; 70 FR 32489, June 3, 2005; 74 FR 61516, Nov. 25, 2009] § 520.905e Fenbendazole blocks. (a) Specifications. (1) Each pound of molasses block contains 750 milligrams of fenbendazole. (2) Each pound of protein block con tains 750 milligrams of fenbendazole. (b) Sponsor. See 000061 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.275 of this chapter. (d) Conditions of use—(1) Amount. 0.1 pound of block per 100 pounds of body weight per day for 3 days. Total dose for the 3-day period is 2.27 milligrams of fenbendazole per pound of body weight for mature cattle. (2) Indications for use. For removal and control of infections of lungworms (Dictyocaulus viviparus) and gastro intestinal roundworms (Haemonchus contortus, Ostertagia ostertagi, Trichostrongylus axei, Bunostomum phlebotomum, Nematodirus helvetianus, Cooperia oncophora and C. punctata, Trichostrongylus colubriformis, and Oesophagostomum radiatum) in beef cat tle. (3) Limitations. Administer free choice of beef cattle on pasture that have be come accustomed to nonmedicated block feeding during an adaptation pe riod of 12 to 19 days. Molasses block: Cattle must not be slaughtered within 11 days following last treatment. Pro tein block: Cattle must not be slaugh tered within 16 days following last treatment; do not use in dairy cattle of breeding age. Animals maintained under conditions of constant worm ex posure may require retreatment within 6 to 8 weeks. Consult your veterinarian for assistance in the diagnosis, treat ment, and control of parasitism. [51 FR 41783, Nov. 19, 1986, as amended at 54 FR 20787, May 15, 1989; 66 FR 47960, Sept. 17, 2001; 74 FR 61516, Nov. 25, 2009] § 520.928 Firocoxib tablets. (a) Specifications. Each chewable tab let contains 57 or 227 milligrams (mg) firocoxib. (b) Sponsor. See No. 050604 in § 510.600(c) of this chapter. (c) Conditions of use in dogs—(1) Amount. 5 mg/kg (2.27 mg/lb) body weight. Administer once daily for os teoarthritis. Administer approximately 2 hours before soft-tissue or orthopedic surgery. (2) Indications for use. For the control of pain and inflammation associated with osteoarthritis; and for the control of postoperative pain and inflamma tion associated with soft-tissue and or thopedic surgery. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [69 FR 51171, Aug. 18, 2004, as amended at 73 FR 2808, Jan. 16, 2008; 73 FR 64885, Oct. 31, 2008] § 520.930 Firocoxib paste. (a) Specifications. Each milligram (mg) of paste contains 0.82 mg firocoxib. (b) Sponsors. See No. 050604 in § 510.600(c) of this chapter. (c) Conditions of use in horses—(1) Amount. 0.1 mg per kilogram (0.045 mg per pound) body weight daily for up to 14 days. VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00200 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 191 Food and Drug Administration, HHS § 520.998 (2) Indications for use. For the control of pain and inflammation associated with osteoarthritis. (3) Limitations. Do not use in horses intended for human consumption. Fed eral law restricts this drug to use by or on the order of a licensed veterinarian. [71 FR 5788, Feb. 3, 2006] § 520.955 Florfenicol. (a) Specifications. Each milliliter (mL) contains 23 milligrams (mg) florfenicol. (b) Sponsor. See Nos. 000061 and 058198 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.283 of this chapter. (d) Conditions of use in swine—(1) Amount. Administer in drinking water ad libitum at 400 mg per gallon (100 parts per million (ppm)) for 5 consecu tive days. (2) Indications for use. For the treat ment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Salmonella choleraesuis and Strepto coccus suis. (3) Limitations. Do not slaughter with in 16 days of last treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [67 FR 78357, Dec. 24, 2002, as amended at 72 FR 262, Jan. 4, 2007; 78 FR 52854, Aug. 27, 2013] § 520.960 Flumethasone. (a) Specifications. Each tablet con tains 0.0625 milligram of flumethasone. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Conditions of use—(1) Amount—(i) Dogs: Administer orally from 0.0625 to 0.25 milligram daily in divided doses. (ii) Cats: Administer orally from 0.03125 to 0.125 milligram daily in di vided doses. (2) Indications for use—(i) Dogs: It is used for musculoskeletal conditions due to inflammation of muscles or joints and accessory structures, where permanent structural changes do not exist, such as arthritis, the disc syn drome, and myositis. (ii) Dogs and cats: It is used in certain acute and chronic dermatoses of vary ing etiology to help control the pru ritus, irritation, and inflammation as sociated with these conditions. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [44 FR 7131, Feb. 6, 1979, as amended at 61 FR 5506, Feb. 13, 1996; 79 FR 28821, May 20, 2014] § 520.970 Flunixin. (a) Specifications. (1) Each 10-gram (g) packet of granules contains flunixin meglumine equivalent to 250 milli grams (mg) of flunixin. (2) Each 30-g syringe of paste con tains flunixin meglumine equivalent to 1,500 mg of flunixin. (b) Sponsors. See sponsors in § 510.600(c) of this chapter for use as in paragraph (c) of this section. (1) No. 000061 for use of products de scribed in paragraph (a). (2) No. 061623 for use of the product described in paragraph (a)(2). (c) Conditions of use in horses—(1) Amount. 0.5 mg per pound of body weight per day for up to 5 days. (2) Indications for use. For alleviation of inflammation and pain associated with musculoskeletal disorders. (3) Limitations. Do not use in horses intended for human consumption. Fed eral law restricts this drug to use by or on the order of a licensed veterinarian. [76 FR 53051, Aug. 25, 2011, as amended at 79 FR 74020, Dec. 15, 2014] § 520.980 Fluoxetine. (a) Specifications. Each chewable tab let contains 8, 16, 32, or 64 milligrams (mg) fluoxetine hydrochloride. (b) Sponsor. See No. 050929 in § 510.600 of this chapter. (c) Conditions of use in dogs—(1) Amount. 1 to 2 mg per kilogram body weight once daily. (2) Indications for use. For the treat ment of canine separation anxiety in conjunction with a behavior modifica tion plan. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [72 FR 6463, Feb. 12, 2007, as amended at 79 FR 74020, Dec. 15, 2014] § 520.998 Fluralaner. (a) Specifications. Each chewable tab let contains 112.5, 250, 500, 1000, or 1400 milligrams (mg) fluralaner. VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00201 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 192 21 CFR Ch. I (4–1–16 Edition) § 520.1010 (b) Sponsor. See No. 000061 in § 510.600(c) of this chapter. (c) Conditions of use in dogs—(1) Amount. Administer orally as a single dose every 12 weeks according to the label dosage schedule to provide a min imum dose of 11.4 mg per pound (/lb) (25 mg per kilogram) body weight. May be administered every 8 weeks in case of potential exposure to Amblyomma americanum ticks. (2) Indications for use. Kills adult fleas; for the treatment and prevention of flea infestations (Ctenocephalides felis), and the treatment and control of tick infestations [Ixodes scapularis (black-legged tick), Dermacentor variabilis (American dog tick), and Rhipicephalus sanguineus (brown dog tick)] for 12 weeks in dogs and puppies 6 months of age and older, and weigh ing 4.4 lb or greater; for the treatment and control of A. americanum (lone star tick) infestations for 8 weeks in dogs and puppies 6 months of age and older, and weighing 4.4 lb or greater. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [79 FR 37619, July 2, 2014] § 520.1010 Furosemide. (a) Specifications. (1) Each tablet con tains 12.5 or 50 milligrams (mg) furosemide. (2) Each bolus contains 2 grams (g) furosemide. (3) Each packet of powder contains 2 g furosemide. (4) Each milliliter of syrup contains 10 mg furosemide. (b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter for use of dosage forms and strengths listed in paragraph (a) of this section for uses as in paragraph (d) of this section. (1) No. 000010 for tablets in paragraph (a)(1) of this section for conditions of use in paragraphs (d)(2)(i), (d)(2)(ii)(A), and (d)(3) of this section. (2) No. 000061 for tablets in paragraph (a)(1) of this section for conditions of use in paragraphs (d)(2)(i), (d)(2)(ii)(A), and (d)(3) of this section; for boluses in paragraph (a)(2) of this section and powder in paragraph (a)(3) of this sec tion for conditions of use in paragraph (d)(1) of this section; and for syrup in paragraph (a)(4) of this section for con ditions of use in paragraphs (d)(2)(i) and (d)(2)(ii)(A). (3) Nos. 058829 and 069043 for use of syrup in paragraph (a)(4) of this section for conditions of use in paragraph (d)(2)(i) and (d)(2)(ii)(A) of this section. (c) Special considerations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (d) Conditions of use. It is used as fol lows: (1) Cattle—(i) Amount. 1 to 2 mg per pound (/lb) body weight using powder, or one 2-g bolus per animal, per day. (ii) Indications for use. For treatment of physiological parturient edema of the mammary gland and associated structures. (iii) Limitations. Treatment not to ex ceed 48 hours post-parturition. Milk taken during treatment and for 48 hours after the last treatment must not be used for food. Cattle must not be slaughtered for food within 48 hours following last treatment. (2) Dogs—(i) Amount. 1 to 2 mg/lb body weight, once or twice daily. (ii) Indications for use—(A) For treat ment of edema (pulmonary congestion, ascites) associated with cardiac insuffi ciency and acute noninflammatory tis sue edema. (B) For treatment of edema (pul monary congestion, ascites) associated with cardiac insufficiency. (3) Cats—(i) Amount. 1 to 2 mg/lb body weight, once or twice daily. (ii) Indications for use. For treatment of edema (pulmonary congestion, asci tes) associated with cardiac insuffi ciency and acute noninflammatory tis sue edema. [66 FR 47960, Sept. 17, 2001, as amended at 69 FR 74419, Dec. 14, 2004; 70 FR 50182, Aug. 26, 2005; 70 FR 76396, Dec. 27, 2005; 74 FR 61516, Nov. 25, 2009; 78 FR 17596, Mar. 22, 2013; 81 FR 17607, Mar. 30, 2016] § 520.1044 Gentamicin sulfate oral dos age forms. § 520.1044a Gentamicin sulfate oral so lution. (a) Specifications. Each milliliter of aqueous solution contains gentamicin sulfate equivalent to 50 milligrams of gentamicin. (b) Sponsor. See Nos. 000061 and 054925 in § 510.600(c) of this chapter. VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00202 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 193 Food and Drug Administration, HHS § 520.1044c (c) Related tolerances. See § 556.300 of this chapter. (d) Conditions of use—(1) Amount. Colibacillosis: 1 milliliter per 2 gallons of drinking water for 3 consecutive days, to provide 0.5 milligram/pound/ day; swine dysentery: 1 milliliter per 1 gallon of drinking water for 3 consecu tive days, to provide 1.0 milligram/ pound/day. (2) Indications for use. In weanling swine for control and treatment of colibacillosis caused by strains of E. coli sensitive to gentamicin, and in swine for control and treatment of swine dysentery associated with Treponema hyodysenteriae. (3) Limitations. For use in swine drinking water only. Do not store or offer medicated drinking water in rusty containers since the drug is quickly destroyed in such containers. Medicated drinking water should be prepared daily and be the sole source of drinking water for 3 consecutive days. Treatment may be repeated if dys entery recurs. Do not slaughter treated swine for food for at least 3 days fol lowing treatment. [48 FR 10302, Mar. 11, 1983. Redesignated at 49 FR 572, Jan. 5, 1984, and amended at 49 FR 14332, Apr. 11, 1984; 52 FR 7832, Mar. 13, 1987; 62 FR 34169, June 25, 1997; 71 FR 13542, Mar. 16, 2006] § 520.1044b Gentamicin sulfate pig pump oral solution. (a) Specifications. Each milliliter of pig pump oral solution contains gentamicin sulfate equivalent to 4.35 milligrams of gentamicin. (b) Sponsor. See Nos. 000061 and 000859 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.300 of this chapter. (d) Conditions of use—(1) Amount. Ad minister 1.15 milliliters of pig pump oral solution (5 milligrams of gentamicin) orally per pig one time. (2) Indications for use. In neonatal swine 1 to 3 days of age for control and treatment of colibacillosis caused by strains of E. coli sensitive to gentamicin. (3) Limitations. For use in neonatal swine only. Do not slaughter treated swine for food for at least 14 days fol lowing treatment. [49 FR 572, Jan. 5, 1984, as amended at 52 FR 7832, Mar. 13, 1987; 62 FR 29011, May 29, 1997; 78 FR 17596, Mar. 22, 2013] § 520.1044c Gentamicin sulfate powder. (a) Specifications. Each gram of pow der contains gentamicin sulfate equiv alent to: (1) 16.7, 66.7, or 333.3 milligrams (mg) gentamicin. (2) 333.3 mg gentamicin. (b) Sponsors. See sponsors in § 510.600(c) of this chapter for use as in paragraph (d) of this section as follows: (1) No. 000061 for products described in paragraph (a)(1) of this section. (2) Nos. 057561 and 061623 for product described in paragraph (a)(2) of this section. (c) Related tolerances. See § 556.300 of this chapter. (d) Conditions of use in swine—(1) Amount. Administer in drinking water for 3 consecutive days as follows: (i) For colibacillosis: Gentamicin sul fate equivalent to 25 mg of gentamicin per gallon of drinking water to provide 0.5 mg per pound of body weight per day; (ii) For swine dysentery: Gentamicin sulfate equivalent to 50 mg of gentamicin per gallon of drinking water to provide 1 mg per pound of body weight per day. Treatment may be repeated if dysentery recurs. (2) Indications for use. For control and treatment of colibacillosis in weanling swine caused by strains of Escherichia coli sensitive to gentamicin, and for control and treatment of swine dys entery associated with Treponema hyodysenteriae. (3) Limitations. For use in swine drinking water only. Do not store or offer medicated drinking water in rusty containers since the drug is quickly destroyed in such containers. Medicated drinking water should be prepared daily and be the sole source of drinking water. (4) Withdrawal period. 10 days. [77 FR 4226, Jan. 27, 2012] VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00203 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 194 21 CFR Ch. I (4–1–16 Edition) § 520.1060 § 520.1060 Glucose and glycine. (a) Specifications. Each packet of pow der contains 8.82 grams sodium chlo ride, 4.20 grams potassium phosphate, 0.5 gram citric acid anhydrous, 0.12 gram potassium citrate, 6.36 grams aminoacetic acid (glycine), and 44.0 grams glucose. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Conditions of use in calves—(1) Amount. Dissolve each packet in 2 quarts of warm water and administer to each calf as follows: (i) Scouring and/or dehydrated calves. Feed 2 quarts of solution, twice daily for 2 days (four feedings). No milk or milk replacer should be fed during this period. For the next four feedings (days 3 and 4), use 1 quart of solution to gether with 1 quart of milk replacer. Thereafter, feed as normal. (ii) Newly purchased calves. Feed 2 quarts of solution instead of milk as the first feed upon arrival. For the next scheduled feeding, use 1 quart of solu tion mixed together with 1 quart of milk or milk replacer. Thereafter, feed as normal. (2) Indications for use. For control of dehydration associated with diarrhea (scours); and as an early treatment at the first signs of scouring. It may also be used as followup treatment fol lowing intravenous fluid therapy. (3) Limitations. The product should not be used in animals with severe de hydration (down, comatose, or in a state of shock). Such animals need in travenous therapy. A veterinarian should be consulted in severely scour ing calves. The product is not nutri tionally complete if administered by itself for long periods of time. It should not be administered beyond the rec ommended treatment period without the addition of milk or milk replacer. [79 FR 28821, May 20, 2014] § 520.1100 Griseofulvin. (a) Specifications—(1) The powder complies with U.S.P. for griseofulvin, microsize. (2) Each bolus contains 2.5 grams griseofulvin. (3) Each tablet contains 125 or 500 milligrams griseofulvin. (b) Sponsors. See sponsors in § 510.600(c) of this chapter. (1) No. 000061 for use of products de scribed in paragraph (a) for use as in paragraph (d) of this section. (2) No. 061623 for use of the powder de scribed in paragraph (a)(1) for use as in paragraphs (d)(1)(i)(A) and (d)(1)(ii) of this section. (c) Special considerations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (d) Conditions of use—(1) Horses—(i) Amount and indications for use—(A) For equine ringworm infection caused by Trichophyton equinum or Microsporum gypseum, administer soluble powder de scribed in paragraph (a)(1) of this sec tion daily as a drench or as a top dress ing on feed for not less than 10 days as follows: adults, 2.5 grams; yearlings, 1.25 to 2.5 grams; and foals, 1.25 grams. (B) For treating ringworm infection caused by T. equinum, administer boluses described in paragraph (a)(2) of this section daily for not less than 10 days as follows: adults, 1 bolus; year lings, one-half to 1 bolus; and foals, one-half bolus. (ii) Limitations. Do not use in horses intended for human consumption. (2) Dogs and cats: (i) Amount. 125- and 500-milligram tablets administered orally as follows: (A) Daily (single or divided) dose as follows: For animals weighing up to 6 pounds: 62.5 milligrams; for animals weighing 6 to 18 pounds: 125 milli grams; for animals weighing 18 to 36 pounds: 250 milligrams; for animals weighing 36 to 48 pounds: 375 milli grams; for animal weighing 48 to 75 pounds: 500 milligrams. (B) Weekly (single) dose: If experi ence indicates that treatment is more effective for the drug given in large doses, administer at intervals of 7 to 10 days, a dose equal to 10 milligrams/ pound of body weight × body weight × number of days between treatments. Dosage should be adjusted according to response. Administer additional dose after the animal is free of infection. (ii) Indications for use. For treatment of fungal infections of the skin, hair, and claws caused by Trichophyton mentagrophytes, T. rubrum, T. schoenleini, T. sulphurem, T. verrucosum, T. interdigitale, Epidermophyton VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00204 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 195 Food and Drug Administration, HHS § 520.1156 floccosum, Microsporum gypseum, M. canis, M. audouini. [40 FR 13838, Mar. 27, 1975, as amended at 41 FR 42948, Sept. 29, 1976; 43 FR 28458, June 30, 1978; 52 FR 7832, Mar. 13, 1987; 54 FR 30205, July 19, 1989; 71 FR 38073, July 5, 2006; 77 FR 28253, May 14, 2012; 78 FR 28822, May 20, 2014] § 520.1120 Haloxon oral dosage forms. § 520.1120a Haloxon drench. (a) Specifications. Each packet con tains 141.5 grams haloxon. (b) Sponsor. See No. 000061 in § 510.600(c) of this chapter. (c) Special considerations. Do not use any drug, insecticide, pesticide, or other chemical having cholinesterase inhibiting activity either simulta neously or within a few days before or after treatment with haloxon. (d) Related tolerances. See § 556.310 of this chapter. (e) Conditions of use in cattle—(1) Amount. Dissolve each packet in 32 fluid ounces of water and administer as follows: For animals weighing up to 100 pounds: 1/2 fluid ounce; for animals weighing 100 to 150 pounds: 3/4 fluid ounce; for animals weighing 150 to 200 pounds: 1 fluid ounce; for animals weighing 200 to 300 pounds: 1 1/2 fluid ounces; for animals weighing 300 to 450 pounds: 2 fluid ounces; for animals weighing 450 to 700 pounds: 3 fluid ounces; for animals weighing 700 to 1,000 pounds: 4 fluid ounces; for animals weighing 1,000 to 1,200 pounds: 5 fluid ounces; for animals weighing over 1,200 pounds: 6 fluid ounces. Retreat in 3 to 4 weeks. (2) Indications for use. For control of gastrointestinal roundworms of the genera Haemonchus, Ostertagia, Trichostrongylus, and Cooperia. (3) Limitations. Do not treat dairy animals of breeding age. Do not treat within 1 week of slaughter. [40 FR 13838, Mar. 27, 1975, as amended at 45 FR 10333, Feb. 15, 1980; 46 FR 48642, Oct. 2, 1981; 61 FR 8873, Mar. 6, 1996; 62 FR 61624, Nov. 19, 1997; 78 FR 28822, May 20, 2014] § 520.1120b Haloxon boluses. (a) Specifications. Each bolus contains 10.1 grams of haloxon. (b) Sponsor. See No. 000061 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.310 of this chapter. (d) Conditions of use in cattle—(1) Amount. Administered one bolus per 500 pounds body weight (35 to 50 milli grams per kilogram of body weight). Retreat in 3 to 4 weeks. (2) Indications for use. For control of gastrointestinal roundworms of the genera Haemonchus, Ostertagia, Trichostrongylus, and Cooperia. (3) Limitations. Do not treat dairy animals of breeding age or older. Do not treat within 1 week of slaughter. [40 FR 13838, Mar. 27, 1975, as amended at 44 FR 61591, Oct. 29, 1979; 46 FR 48642, Oct. 2, 1981; 61 FR 8873, Mar. 6, 1996; 62 FR 61625, Nov. 19, 1997; 78 FR 28822, May 20, 2014] § 520.1130 Hetacillin. (a) Specifications. (1) Each capsule or tablet contains hetacillin potassium equivalent to 50, 100, or 200 milligrams (mg) of ampicillin. (2) Each milliliter of suspension con tains hetacillin potassium equivalent to 50 mg of ampicillin. (b) Sponsor. See No. 000010 in § 510.600(c) of this chapter. (c) Conditions of use in dogs and cats— (1) Amount—(i) Dogs. Administer 5 mg per pound (/lb) of body weight orally, twice daily. In severe infections, ad minister 5 mg/lb three times daily, or up to 10 mg/lb twice daily. For stub born urinary tract infections, admin ister up to 20 mg/lb twice daily. (ii) Cats. Administer 50 mg twice daily. (2) Indications for use. For the treat ment of respiratory tract infections, urinary tract infections, gastro intestinal infections, skin infections, soft tissue infections, and postsurgical infections associated with strains of or ganisms susceptible to hetacillin po tassium. (3) Limitations. Federal law restricts this drug to use only by or on the order of a licensed veterinarian. [75 FR 10166, Mar. 5, 2010] § 520.1156 Imidacloprid. (a) Specifications. Each chewable tab let contains 7.5 or 37.5 milligrams (mg) imidacloprid. (b) Sponsor. See No. 000859 in § 510.600(c) of this chapter. VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00205 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 196 21 CFR Ch. I (4–1–16 Edition) § 520.1157 (c) Conditions of use in dogs—(1) Amount. Administer daily one 7.5-mg chewable tablet to dogs weighing 4 to 22 pounds (lb) or one 37.5-mg chewable table to dogs weighing 23 to 110 lb. (2) Indications for use. Kills adult fleas and is indicated for the treatment of flea infestations on dogs and puppies 10 weeks of age and older and weighing 4 lb or greater. (3) Limitations. Do not give to puppies younger than 10 weeks of age or to dogs weighing less than 4 lb. Do not give more than one tablet a day. [80 FR 18775, Apr. 8, 2015] § 520.1157 Iodinated casein. (a) Specifications. Each 1-gram tablet contains 25 milligrams of iodinated ca sein. (b) Sponsor. See No. 017762 in § 510.600(c) of this chapter. (c) Conditions of use—(1) Amount. 1⁄5 to 1 tablet per 10 pounds of body weight (equivalent to 0.5 to 2.5 milligrams of iodinated casein per pound of body weight). (2) Indications for use. For dogs for ap parent decreased thyroid activity where the signs are alopecia, scaliness of the skin surface, loss of hair, sebor rhea, thickening of the skin, hyperpigmentation, and lethargy. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [49 FR 22469, May 30, 1984, as amended at 78 FR 28822, May 20, 2014] § 520.1158 Iodochlorhydroxyquin. (a) Specifications. Each bolus contains 10 grams of iodochlorhydroxyquin. (b) Sponsor. See No. 054771 in § 510.600 (c) of this chapter. (c) Conditions of use—(1) Amount. 1 bolus (10 grams) daily for a 1,000-pound horse. (2) Indications for use. For treatment of equine diarrhea. (3) Limitations. Do not use in horses intended for human consumption. Fed eral law restricts this drug to use by or on the order of a licensed veterinarian. [48 FR 8054, Feb. 25, 1983, as amended at 50 FR 41489, Oct. 11, 1985; 78 FR 28822, May 20, 2014] § 520.1182 Iron dextran suspension. (a) Specifications. Each milliliter (mL) of suspension contains 55.56 milli grams (mg) iron as ferric hydroxide in complex with a low molecular weight dextran. (b) Sponsor. See No. 051311 in § 510.600(c) of this chapter. (c) Conditions of use in swine—(1) Amount. Administer 100 mg (1.8 mL) orally by automatic dose dispenser. (2) Indications for use. For the preven tion of iron deficiency anemia in baby pigs. (3) Limitations. Treat each pig within 24 hours of farrowing. [70 FR 32489, June 3, 2005] § 520.1192 Ivermectin paste. (a) Specifications. Each milligram (mg) of paste contains 0.0187 mg (1.87 percent) or 0.00153 mg (0.153 percent) of ivermectin. (b) Sponsors. See sponsors in § 510.600(c) of this chapter for use as in paragraph (e) of this section: (1) No. 050604 for use of a 1.87 percent paste as in (e)(1) of this section and a 0.153 percent paste for use as in para graph (e)(2) of this section. (2) Nos. 000859, 051311, 054925, and 061623 for use of a 1.87 percent paste for use as in paragraph (e)(1) of this sec tion. (c) Related tolerances. See § 556.344 of this chapter. (d) Special considerations. See § 500.25 of this chapter. (e) Conditions of use—(1) Horses—(i) Amount. 200 micrograms per kilogram (91 micrograms per pound) of body weight. (ii) Indications for use. For treatment and control of Large Strongyles (adults): Strongylus vulgaris (also early forms in blood vessels), S. edentatus (also tissue stages), S. equinus, Triodontophorus spp. including T. brevicauda and T. serratus, and Craterostomum acuticaudatum; Small Strongyles (adults, including those re sistant to some benzimidazole class compounds): Coronocyclus spp. includ ing C. coronatus, C. labiatus, and C. labratus, Cyathostomum spp. including C. catinatum and C. pateratum, Cylicocyclus spp. including C. insigne, C. leptostomum, C. nassatus, and C. VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00206 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 197 Food and Drug Administration, HHS § 520.1193 brevicapsulatus, Cylicodontophorus spp., Cylicostephanus spp. including C. calicatus, C. goldi, C. longibursatus, and C. minutus, and Petrovinema poculatum; Small Strongyles (fourth-stage larvae); Pinworms (adults and fourth-stage lar vae): Oxyuris equi; Ascarids (adults and third- and fourth-stage larvae): Parascaris equorum; Hairworms (adults): Trichostrongylus axei; Large mouth Stomach Worms (adults): Habronema muscae; Bots (oral and gastric stages): Gasterophilus spp. including G. intestinalis and G. nasalis; Lungworms (adults and fourth-stage larvae): Dictyocaulus arnfieldi; Intestinal Threadworms (adults): Strongyloides westeri; Summer Sores caused by Habronema and Draschia spp. cutaneous third-stage larvae; Dermatitis caused by neck threadworm microfilariae, Onchocerca sp. (iii) Limitations. For oral use only. Do not use in horses intended for human consumption. (2) Cattle—(i) Amount. 23 milligrams per 250 pounds of body weight. (ii) Indications for use. It is used in cattle for the treatment and control of gastrointestinal roundworms (adults and fourth-stage larvae) (Ostertagia ostertagi (including inhibited forms), O. lyrata, Haemonchus placei, Trichostrongylus axei, T. colubriformis, Cooperia oncophora, C. punctata, Nematodirus helvetianus, Bunostomum phlebotomum, Strongyloides papillosus (adults only), Oesophagostomum radiatum, Trichuris ovis (adults only)); lungworms (adults and fourth-stage larvae) (Dictyocaulus viviparus); grubs (first, second, and third instars) (Hypoderma bovis, H. lineatum); and sucking lice (Linognathus vituli, Haematopinus eurysternus). (iii) Limitations. For oral use only. Do not treat cattle within 24 days of slaughter. Because withdrawal time in milk has not been established, do not use in female dairy cattle of breeding age. [49 FR 22275, May 29, 1984, as amended at 50 FR 27819, July 8, 1985; 51 FR 44449, Dec. 10, 1986; 53 FR 51273, Dec. 21, 1988; 62 FR 63270, Nov. 28, 1997; 65 FR 70661, Nov. 27, 2000; 67 FR 71820, Dec. 3, 2002; 68 FR 43294, July 22, 2003; 69 FR 59131, Oct. 4, 2004; 70 FR 8514, Feb. 22, 2005; 71 FR 40010, July 14, 2006; 71 FR 67298, Nov. 21, 2006; 73 FR 34184, June 17, 2008; 74 FR 6542, Feb. 10, 2009; 78 FR 17596, Mar. 22, 2013] § 520.1193 Ivermectin tablets and chewables. (a) Specifications. (1) Each tablet or chewable contains 68, 136, or 272 micrograms (mcg) ivermectin. (2) Each chewable contains 55 or 165 mcg ivermectin. (b) Sponsors. See sponsors in § 510.600(c) of this chapter for use as in paragraph (d) of this section. (1) No. 050604 for use of tablets or chewables described in paragraph (a)(1) as in paragraph (d)(1) and chewables de scribed in paragraph (a)(2) as in para graph (d)(2) of this section. (2) Nos. 051311 and 069043 for use of tablets described in paragraph (a)(1) as in paragraph (d)(1) of this section. (c) Special considerations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (d) Conditions of use—(1) Dogs. For use in dogs 6 weeks of age and older as fol lows: (i) Amount. 6.0 mcg per kilogram (kg) of body weight (2.72 mcg per pound (lb)), minimum. Up to 25 lb, 68 mcg; 26 to 50 lb, 136 mcg; 51 to 100 lb, 272 mcg; over 100 lb, a combination of the appro priate tablets. Administer at monthly dosing intervals. (ii) Indications for use. To prevent ca nine heartworm disease by eliminating the tissue stage of heartworm larvae (Dirofilaria immitis) for 1 month (30 days) after infection. (2) Cats. For use in cats 6 weeks of age and older as follows: (i) Amount. Up to 2.3 kilograms (up to 5 lb), 55 mcg; 2.3 to 6.8 kilograms (5 to 15 lb), 165 mcg; over 6.8 kilograms (15 lb), a combination of the appropriate chewables (recommended minimum dose of 24 mcg/kg of body weight (10.9 mcg/lb)). Administer once a month. (ii) Indications for use. To prevent fe line heartworm disease by eliminating the tissue stage of heartworm larvae Dirofilaria immitis for a month (30 days) after infection, and for removal and control of adult and immature (L4) hookworms Ancylostoma tubaeforme and A. braziliense. [67 FR 11230, Mar. 13, 2002, as amended at 67 FR 21996, May 2, 2002; 69 FR 43735, July 22, 2004; 81 FR 17607, Mar. 30, 2016] VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00207 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 198 21 CFR Ch. I (4–1–16 Edition) § 520.1194 § 520.1194 Ivermectin meal. (a) Specifications. Each gram of meal contains 6 milligrams ivermectin (0.6 percent). (b) Sponsor. See No. 017135 in § 510.600(c) of this chapter. (c) Special considerations. See § 500.25 of this chapter. (d) Conditions of use in horses—(1) Amount. Administer 136 micrograms (mcg) ivermectin per pound (/lb) body weight (300 mcg/kilogram) as a single dose on approximately 2 lb grain or sweet feed. (2) Indications for use. For treatment and control of Large Strongyles (adults): Strongylus vulgaris (also early forms in blood vessels), S. edentatus (also tissue stages), S. equinus, Triodontophorus spp. including T. brevicauda and T. serratus, and Craterostomum acuticaudatum; Small Strongyles (adults, including those re sistant to some benzimidazole class compounds): Coronocyclus spp. includ ing C. coronatus, C. labiatus, and C. labratus, Cyathostomum spp. including C. catinatum and C. pateratum, Cylicocyclus spp. including C. insigne, C. leptostomum, C. nassatus, and C. brevicapsulatus, Cylicodontophorus spp., Cylicostephanus spp. including C. calicatus, C. goldi, C. longibursatus, and C. minutus, and Petrovinema poculatum; Small Strongyles (fourth-stage larvae); Pinworms (adults and fourth stage lar vae): Oxyuris equi; Ascarids (adults and third- and fourth-stage larvae): Parascaris equorum; Hairworms (adults): Trichostrongylus axei; Large Mouth Stomach Worms (adults): Habronema muscae; Bots (oral and gastric stages): Gasterophilus spp. including G. intestinalis and G. nasalis; Lungworms (adults and fourth-stage larvae): Dictyocaulus arnfieldi; Intestinal Threadworms (adults): Strongyloides westeri; Summer Sores caused by Habronema and Draschia spp. cutaneous third-stage larvae; Dermatitis caused by neck threadworm microfilariae, Onchocerca sp. Limitations. Do not use in horses in tended for human consumption. [70 FR 1817, Jan. 11, 2005, as amended at 70 FR 19262, Apr. 13, 2005] § 520.1195 Ivermectin liquid. (a) Specifications—(1) Each milliliter (mL) contains 10 milligrams (mg) ivermectin. (2) Each mL of micellar solution con tains 0.8 mg ivermectin. (b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter. (1) Nos. 000859, 050604, 054925, and 058005 for use of product described in paragraph (a)(1) of this section as in paragraphs (e)(1)(i), (e)(1)(ii)(A), and (e)(1)(iii) of this section. (2) No. 058829 for use of product de scribed in paragraph (a)(1) of this sec tion as in paragraphs (e)(1)(i), (e)(1)(ii)(B), and (e)(1)(iii) of this sec tion. (3) Nos. 050604 and 058829 for use of product described in paragraph (a)(2) of this section as in paragraph (e)(2) of this section. (c) Related tolerances. See § 556.344 of this chapter. (d) Special considerations. See § 500.25 of this chapter. (e) Conditions of use—(1) Horses—(i) Amount. 200 micrograms (mcg) per kilo gram (/kg) of body weight as a single dose by stomach tube or as an oral drench. (ii) Indications for use. For treatment and control of: (A) Large Strongyles (adults): Strongylus vulgaris (also early forms in blood vessels), S. edentatus (also tissue stages), S. equinus, Triodontophorus spp. including T. brevicauda and T. serratus, and Craterostomum acuticaudatum; Small Strongyles (adults, including those resistant to some benzimidazole class compounds): Coronocyclus spp. in cluding C. coronatus, C. labiatus, and C. labratus, Cyathostomum spp. including C. catinatum and C. pateratum, Cylicocyclus spp. including C. insigne, C. leptostomum, C. nassatus, and C. brevicapsulatus, Cylicodontophorus spp., Cylicostephanus spp. including C. calicatus, C. goldi, C. longibursatus, and C. minutus, and Petrovinema poculatum; Small Strongyles (fourth-stage larvae); Pinworms (adults and fourth stage lar vae): Oxyuris equi; Ascarids (adults and third- and fourth-stage larvae): Parascaris equorum; Hairworms (adults): Trichostrongylus axei; Large mouth Stomach Worms (adults): Habronema muscae; Bots (oral and gastric stages): VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00208 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 199 Food and Drug Administration, HHS § 520.1197 Gasterophilus spp. including G. intestinalis and G. nasalis; Lungworms (adults and fourth-stage larvae): Dictyocaulus arnfieldi; Intestinal Threadworms (adults), Strongyloides westeri; Summer Sores caused by Habronema and Draschia spp. cutaneous third-stage larvae; Dermatitis caused by neck threadworm microfilariae, Onchocerca sp. (B) Large Strongyles (Strongylus equinus (adult), S. vulgaris (adult and arterial larval stages), S. endentatus (adult and migrating tissue stages), Triodontophorus spp. (adult)); Small Strongyles including those resistant to some benzimidazole class compounds (Cyathostomum spp. (adult and fourth stage larvae), Cylicocyclus spp., Cylicodontophorus spp., Cylicostephanus spp.); Pinworms (Oxyuris equi (adult and fourth-stage larvae)); Ascarids (Parascaris equorum (adult and third and fourth-stage larvae)); Hairworms (Trichostongylus axei ( adult)); Large mouth Stomach Worms (Habronema muscae (adult)); Stomach Bots (Gastrophilus spp. (oral and gastric stages)); Lungworms (Dictyocaulus arnfieldi (adult and fourth-stage lar vae)); intestinal threadworms (Strongyloides westeri (adult)); Summer Sores caused by Habronema and Draschia spp. cutaneous third-stage lar vae; and Dermatitis caused by neck threadworm microfilariae (Onchocerca spp.). (iii) Limitations. Do not use in horses intended for human consumption. Fed eral law restricts this drug to use by or on the order of a licensed veterinarian. (2) Sheep—(i) Amount. 200 mcg/kg (3 mL/26 pounds) of body weight as a sin gle dose oral drench. (ii) Indications for use. For treatment and control of the adult and fourth stage larvae of gastrointestinal roundworms (Haemonchus contortus, H. placei (adults only), Ostertagia circumcincta, Trichostrongylus axei, T. colubriformis, Cooperia oncophora (adults only), C. curticei, Oesophagostomum columbianum, O. venulosum (adults only), Nematodirus battus, N. spathiger, S. papillosus (adults only), Chabertia ovina (adult only), Trichuris ovis (adults only)); lungworms (D. filaria); and all larval stages of the nasal bot Oestrus ovis. (iii) Limitations. For use in sheep only. Do not use in other animal spe cies as severe adverse reactions, in cluding fatalities in dogs, may result. Do not treat sheep within 11 days of slaughter. [67 FR 50597, Aug. 5, 2002, as amended at 69 FR 57173, Sept. 24, 2004; 71 FR 13542, Mar. 16, 2006; 71 FR 38072, July 5, 2006; 72 FR 9456, Feb. 21, 2008; 78 FR 17596, Mar. 22, 2013; 79 FR 10964, Feb. 27, 2014] § 520.1196 Ivermectin and pyrantel tablets. (a) Specifications. Each chewable tab let contains either 68 micrograms (μg) of ivermectin and 57 milligrams (mg) of pyrantel (as pamoate salt), or 136 μg and 114 mg, or 272 μg and 227 mg, re spectively. (b) Sponsors. See Nos. 050604, 051311, and 063604 in § 510.600(c) of this chapter. (c) Conditions of use—(1) Dogs—(i) Amount. Administer a minimum of 6 μg of ivermectin and 5 mg of pyrantel per kilogram (2.72 μg and 2.27 mg per pound) of body weight monthly. (ii) Indications for use. To prevent ca nine heartworm disease by eliminating the tissue larval stages of Dirofilaria immitis for up to a month (30 days) after infection and treatment and control of adult ascarids Toxocara canis and Toxascaris leonina, and adult hookworms Ancylostoma caninum, A. braziliense, and Uncinaria stenocephala. (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (2) [Reserved] [58 FR 8542, Feb. 16, 1993, as amended at 61 FR 15186, Apr. 5, 1996; 61 FR 59004, Nov. 20, 1996; 62 FR 63270, Nov. 28, 1997; 66 FR 35756, July 9, 2001; 67 FR 21996, May 2, 2002; 68 FR 55823, Sept. 29, 2003; 78 FR 28822, May 20, 2014] § 520.1197 Ivermectin sustained-re lease bolus. (a) Specifications. Each sustained-re lease bolus contains 1.72 grams of ivermectin. (b) Sponsor. See No. 050604 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.344 of this chapter. (d) Conditions of use in ruminating calves—(1) Amount. Administer one bolus per calf weighing at least 275 pounds (lb) (125 kilograms (kg)) and not VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00209 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 200 21 CFR Ch. I (4–1–16 Edition) § 520.1198 more than 660 lb (300 kg) on the day of administration. (2) Indications. For treatment and control, throughout the grazing season (approximately 130 days), of gastro intestinal roundworms Haemonchus placei, Ostertagia ostertagi (including in hibited fourth-stage larvae), Trichostrongylus axei, T. colubriformis, Cooperia spp., Nematodirus helvetianus, Bunostomum phlebotomum, Oesophagostomum radiatum; lungworms Dictyocaulus viviparus; grubs Hypoderma spp.; sucking lice Linognathus vituli, Solenopotes capillatus; mange mites Psoroptes ovis, Sarcoptes scabiei, and ticks Amblyomma americanum. (3) Limitations. The bolus was specifi cally designed for use in cattle; do not use in other animal species. Calves must be ruminating and older than 12 weeks of age. Do not administer to calves weighing less than 275 lb (125 kg). Do not administer a damaged bolus. Because a milk withdrawal time has not been established, do not use in female dairy cattle of breeding age. Do not slaughter cattle within 180 days of treatment. Consult your veterinarian for assistance in the diagnosis, treat ment, and control of parasitism. [61 FR 67452, Dec. 23, 1996, as amended at 62 FR 63270, Nov. 28, 1997; 65 FR 45876, July 26, 2000] § 520.1198 Ivermectin and praziquantel paste. (a) Specifications. Each milligram (mg) of paste contains: (1) 0.0155 mg (1.55 percent) ivermectin and 0.0775 mg (7.75 percent) praziquantel. (2) 0.0187 mg (1.87 percent) ivermectin and 0.1403 mg (14.03 percent) praziquantel. (3) 0.0187 mg (1.87 percent) ivermectin and 0.2338 mg (23.38 percent) praziquantel. (b) Sponsors. See sponsors in § 510.600(c) of this chapter for uses as in paragraph (d) of this section.— (1) No. 050604 for use of product de scribed in paragraph (a)(1) of this sec tion as in paragraphs (d)(1)(i), (d)(2)(i) and (d)(3) of this section. (2) No. 051311 for use of product de scribed in paragraph (a)(2) of this sec tion as in paragraphs (d)(1)(ii), (d)(2)(ii), and (d)(3) of this section. (3) No. 050604 for use of products de scribed in paragraph (a)(3) of this sec tion as in paragraphs (d)(1)(iii), (d)(2)(iii) and (d)(3) of this section. (c) Special considerations. See § 500.25 of this chapter. (d) Conditions of use in horses—(1) Amount—(i) 200 micrograms (mcg) per kilogram (/kg) ivermectin (91 mcg per pound (/lb)) and 1 mg/kg praziquantel (454 mcg/lb) body weight. (ii) 200 mcg/kg ivermectin (91 mcg/lb) and 1.5 mg/kg praziquantel (681 mcg/lb) body weight. (iii) 200 mcg/kg ivermectin (91 mcg/lb) and 2.5 mg/kg praziquantel (1.14 mg/lb). (2) Indications for use—(i) For treat ment and control of the following parasites: Tapeworms—Anoplocephala perfoliata; Large Strongyles (adults)— Strongylus vulgaris (also early forms in blood vessels), S. edentatus (also tissue stages), S. equinus, Triodontophorus spp. including T. brevicauda and T. serratus, and Craterostomum acuticaudatum; Small Strongyles (adults, including those resistant to some benzimidazole class compounds)—Coronocyclus spp. in cluding C. coronatus, C. labiatus, and C. labratus; Cyathostomum spp. including C. catinatum and C. pateratum; Cylicocyclus spp. including C. insigne, C. leptostomum, C. nassatus, and C. brevicapsulatus; Cylicodontophorus spp.; Cylicostephanus spp. including C. calicatus, C. goldi, C. longibursatus, and C. minutus, and Petrovinema poculatum; Small Strongyles—fourth-stage larvae; Pinworms (adults and fourth-stage lar vae)—Oxyuris equi; Ascarids (adults and third- and fourth-stage larvae)— Parascaris equorum; Hairworms (adults)—Trichostrongylus axei; Large mouth Stomach Worms (adults)— Habronema muscae; Bots (oral and gas tric stages)—Gasterophilus spp. includ ing G. intestinalis and G. nasalis; Lungworms (adults and fourth-stage larvae)—Dictyocaulus arnfieldi; Intes tinal Threadworms (adults)— Strongyloides westeri; Summer Sores caused by Habronema and Draschia spp. cutaneous third-stage larvae; Derma titis caused by neck threadworm microfilariae of Onchocerca sp. (ii) For treatment and control of the following parasites: Tapeworms— Anoplocephala perfoliata; Large Strongyles (adults)—Strongylus vulgaris VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00210 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 201 Food and Drug Administration, HHS § 520.1199 (also early forms in blood vessels), S. edentatus (also tissue stages), S. equinus, Triodontophorus spp.; Small Strongyles (adults, including those re sistant to some benzimidazole class compounds)—Cyathostomum spp.; Cylicocyclus spp.; Cylicostephanus spp., Cylicodontophorus spp.; Small Strongyles—fourth-stage larvae; Pinworms (adults and fourth-stage lar vae)—Oxyuris equi; Ascarids (adults and third- and fourth-stage larvae)— Parascaris equorum; Hairworms (adults)—Trichostrongylus axei; Large mouth Stomach Worms (adults)— Habronema muscae; Bots (oral and gas tric stages)—Gasterophilus spp.; Lungworms (adults and fourth-stage larvae)—Dictyocaulus arnfieldi; Intes tinal Threadworms (adults)— Strongyloides westeri; Summer Sores caused by Habronema and Draschia spp. cutaneous third-stage larvae; Derma titis caused by neck threadworm microfilariae, Onchocerca sp. (iii) For treatment and control of the following parasites in horses over 5 months of age: Tapeworms— Anoplocephala perfoliata; Large Strongyles (adults)—Strongylus vulgaris (also early forms in blood vessels), S. edentatus (also tissue stages), S. equinus, Triodontophorus spp. including T. brevicauda and T. serratus, and Craterostomum acuticaudatum; Small Strongyles (adults, including those re sistant to some benzimidazole class compounds)—Coronocyclus spp. includ ing C. coronatus, C. labiatus, and C. labratus; Cyathostomum spp. including C. catinatum and C. pateratum; Cylicocyclus spp. including C. insigne, C. leptostomum, C. nassatus, and C. brevicapsulatus; Cylicodontophorus spp.; Cylicostephanus spp. including C. calicatus, C. goldi, C. longibursatus, and C. minutus, and Petrovinema poculatum; Small Strongyles—fourth-stage larvae; Pinworms (adults and fourth-stage lar vae)—Oxyuris equi; Ascarids (adults and third- and fourth-stage larvae)— Parascaris equorum; Hairworms (adults)—Trichostrongylus axei; Large mouth Stomach Worms (adults)— Habronema muscae; Bots (oral and gas tric stages)—Gasterophilus spp. includ ing G. intestinalis and G. nasalis; Lungworms (adults and fourth-stage larvae)—Dictyocaulus arnfieldi; Intes tinal Threadworms (adults)— Strongyloides westeri; Summer Sores caused by Habronema and Draschia spp. cutaneous third-stage larvae; Derma titis caused by neck threadworm microfilariae of Onchocerca sp. (3) Limitations. For oral use only. Do not use in horses intended for human consumption. [68 FR 55309, Sept. 25, 2003, as amended at 69 FR 49808, Aug. 12, 2004; 70 FR 65835, Nov. 1, 2005; 79 FR 37619, July 2, 2014] § 520.1199 Ivermectin, pyrantel, and praziquantel tablets. (a) Specifications. Each chewable tab let contains: (1) 34 micrograms (mcg) ivermectin, 28.5 milligrams (mg) pyrantel pamoate, and 28.5 mg praziquantel; (2) 68 mcg ivermectin, 57 mg pyrantel pamoate, and 57 mg praziquantel; (3) 136 mcg ivermectin, 114 mg pyrantel pamoate, and 114 mg praziquantel; or (4) 272 mcg ivermectin, 228 mg pyrantel pamoate, and 228 mg praziquantel. (b) Sponsor. See No. 051311 in § 510.600(c) of this chapter. (c) Conditions of use in dogs—(1) Amount. Administer monthly according to body weight as follows: (i) 6 to 12 lb: one tablet as described in paragraph (a)(1) of this section. (ii) 12.1 to 25 lb: one tablet as de scribed in paragraph (a)(2) of this sec tion. (iii) 25.1 to 50 lb: one tablet as de scribed in paragraph (a)(3) of this sec tion. (iv) 50.1 to 100 lb: one tablet as de scribed in paragraph (a)(4) of this sec tion. (v) Greater than 100 lb: use the appro priate combination of tablets. (2) Indications for use. Prevents ca nine heartworm disease by eliminating the tissue stage of heartworm larvae (Dirofilaria immitis) for 1 month (30 days) after infection and for the treat ment and control of roundworm (Toxocara canis, Toxascaris leonina), hookworm (Ancylostoma caninum, Uncinaria stenocephala, Ancylostoma braziliense) and tapeworm (Dipylidium caninum, Taenia pisiformis) infections. VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00211 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 202 21 CFR Ch. I (4–1–16 Edition) § 520.1200 (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [71 FR 65052, Nov. 7, 2006, as amended at 78 FR 28822, May 20, 2014] § 520.1200 Ivermectin, fenbendazole, and praziquantel tablets. (a) Specifications. Each chewable tab let contains either: (1) 68 micrograms (μg) ivermectin, 1.134 grams fenbendazole, and 57 milli grams (mg) praziquantel; or (2) 27 μg ivermectin, 454 mg fenbendazole, and 23 mg praziquantel. (b) Sponsor. See No. 000061 in § 510.600(c) of this chapter. (c) Conditions of use in dogs—(1) Amount. Administer tablets to provide 6 μg per kilogram (/kg) ivermectin, 100 mg/kg fenbendazole, and 5 mg/kg praziquantel. (2) Indications for use. For the treat ment and control of adult Toxocara canis (roundworm), Ancylostoma caninum (hookworm), Trichuris vulpis (whipworm), and Dipylidium caninum (tapeworm), and for the prevention of heartworm disease caused by Dirofilaria immitis in adult dogs. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [73 FR 33692, June 13, 2008, as amended at 74 FR 61516, Nov. 25, 2009] § 520.1204 Kanamycin, bismuth subcar bonate, activated attapulgite. (a) Specifications—(1) Each 5 milli liters (mL) of suspension contains 100 milligrams (mg) kanamycin (as the sulfate), 250 mg bismuth subcarbonate, and 500 mg activated attapulgite (alu minum magnesium silicate). (2) Each tablet contains 100 mg kanamycin (as the sulfate), 250 mg bis muth subcarbonate, and 500 mg acti vated attapulgite. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Conditions of use in dogs—(1) Amount. 5 mL of suspension or 1 tablet per 20 pounds body weight every 8 hours. Maximum dose: 5 mL of suspen sion or 3 tablets every 8 hours. Dogs under 10 pounds: 2.5 mL of suspension or 1⁄2 tablet every 8 hours. A rec ommended initial loading dose should be twice the amount of a single dose. (2) Indications for use. For the treat ment of bacterial enteritis caused by organisms susceptible to kanamycin and the symptomatic relief of the asso ciated diarrhea. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [40 FR 13838, Mar. 27, 1975, as amended at 53 FR 27851, July 25, 1988; 56 FR 8710, Mar. 1, 1991; 64 FR 403, Jan. 5, 1999; 71 FR 43968, Aug. 3, 2006; 78 FR 28822, May 20, 2014] § 520.1242 Levamisole. § 520.1242a Levamisole powder. (a) Specifications. Each package of powder contains 9.075, 11.7, 18.15, 46.8, 362.7, or 544.5 grams (g) levamisole hy drochloride. (b) Sponsors. See sponsors in § 510.600(c) for use as follows: (1) No. 000061 for use of 46.8- and 544.5 g packages as in paragraph (e)(1)(i), (e)(1)(ii)(B), and (e)(1)(iii) of this sec tion; for 11.7-, 46.8-, and 544.5-g pack ages as in paragraph (e)(2)(i), (e)(2)(ii)(B), and (e)(2)(iii) of this sec tion; and for an 18.15-g package as in paragraph (e)(3) of this section. (2) No. 054771 for use of a 46.8-g pack age as in paragraph (e)(1)(i), (e)(1)(ii)(A), and (e)(1)(iii) of this sec tion; for 11.7- and 46.8-g packages as in paragraph (e)(2)(i), (e)(2)(ii)(A), and (e)(2)(iii) of this section; and for 9.075 and 18.15-g packages as in paragraph (e)(3) of this section. (3) No. 057561 for use of 46.8- and 544.5 g packages as in paragraphs (e)(1)(i), (e)(1)(ii)(A), and (e)(1)(iii) and (e)(2)(i), (e)(2)(ii)(A), and (e)(2)(iii) of this sec tion. (4) No. 059130 for use of 46.8-, 362.7-, and 544.5-g packages as in paragraphs (e)(1)(i), (e)(1)(ii)(B), (e)(1)(iii), (e)(2)(i), (e)(2)(ii)(B), and (e)(2)(iii) of this sec tion; and for use of an 18.15-g package as in paragraph (e)(3) of this section. (c) Related tolerances. See § 556.350 of this chapter. (d) Special considerations. See § 500.25 of this chapter. (e) Conditions of use. It is used as an anthelmintic as follows: (1) Cattle—(i) Amount. 8 milligrams per kilogram (mg/kg) body weight as a drench. VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00212 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 203 Food and Drug Administration, HHS § 520.1242b (ii) Indications for use—(A) Effective against the following nematode infec tions: Stomach worms (Haemonchus, Trichostrongylus, Ostertagia); intestinal worms (Trichostrongylus, Cooperia, Nematodirus, Bunostomum, Oesophagostomum); and lungworms (Dictyocaulus). (B) Effective against the following adult nematode infections: Stomach worms (Haemonchus placei, Ostertagia ostertagi, Trichostrongylus axei); intes tinal worms (T. longispicularis, Cooperia oncophora, C. punctata, Nematodirus spathiger, Bunostomum phlebotomum, Oesophagostomum radiatum); and lungworms (Dictyocaulus viviparus). (iii) Limitations. Do not slaughter for food within 48 hours of treatment. Not for use in dairy animals of breeding age. Conditions of constant helminth exposure may require retreatment 2 to 4 weeks after the first treatment. Con sult your veterinarian before using in severely debilitated animals. (2) Sheep—(i) Amount. 8 mg/kg body weight as a drench. (ii) Indications for use—(A) Effective against the following nematode infec tions: Stomach worms (Haemonchus, Trichostrongylus, Ostertagia); intestinal worms (Trichostrongylus, Cooperia, Nematodirus, Bunostomum, Oesophagostomum, Chabertia); and lungworms (Dictyocaulus). (B) Effective against the following adult nematode infections: Stomach worms (Haemonchus contortus, Trichostrongylus axei, Teladorsagia circumcincta); intestinal worms (Trichostrongylus colubriformis, Cooperia curticei, Nematodirus spathiger, Bunostomum trigonocephalum, Oesophagostomum columbianum, Chabertia ovina), and lungworms (Dictyocaulus filaria). (iii) Limitations. Do not slaughter for food within 72 hours of treatment. Con ditions of constant helminth exposure may require retreatment 2 to 4 weeks after the first treatment. Consult vet erinarian before using in severely de bilitated animals. (3) Swine—(i) Amount. 8 mg/kg body weight in drinking water. (ii) Indications for use. Effective against the following nematode infec tions: Large roundworms (Ascaris suum), nodular worms (Oesophagostomum spp.), intestinal thread worms (Strongyloides ransomi) and lungworms (Metastrongylus spp. ). (iii) Limitations. Do not administer within 72 hours of slaughter for food. Pigs maintained under conditions of constant exposure to worms may re quire retreatment within 4 to 5 weeks after the first treatment. Consult your veterinarian before administering to sick swine. [69 FR 9753, Mar. 2, 2004, as amended at 69 FR 33839, June 17, 2004; 70 FR 2353, Jan. 13, 2005; 77 FR 28253, May 14, 2012; 78 FR 28822, May 20, 2014] § 520.1242b Levamisol boluses or oblets. (a) Specifications. Each bolus contains 2.19 grams levamisol hydrochloride. Each oblet contains 0.184 grams levamisol hydrochloride. (b) Sponsors. See Nos. 000061 and 054771 in § 510.600(c) of this chapter. (c) Required labeling. Consult your veterinarian for assistance in the diag nosis, treatment, and control of para sitism. (d) Related tolerances. See § 556.350 of this chapter. (e) Conditions of use—(1) Cattle—(i) Amount. Administer orally 2.19-gram boluses as a single dose as follows: 250 to 450 pounds, 1⁄2 bolus; 450 to 750 pounds, 1 bolus; and 750 to 1,050 pounds, 11⁄2 boluses. (ii) Indications for use. Anthelmintic effective against the following nema tode infections: Stomach worms (Haemonchus, Trichostrongylus, Ostertagia), intestinal worms (Trichostrongylus, Cooperia, Nematodirus, Bunostomum, Oesophagostomum), and lungworms (Dictyocaulus). (iii) Limitations. Conditions of con stant helminth exposure may require re-treatment within 2 to 4 weeks after the first treatment. Do not slaughter for food within 48 hours of treatment. Not for use in dairy animals of breed ing age. Consult veterinarian before using in severely debilitated animals. (2) Sheep—(i) Amount. Administer orally one 0.184-gram oblet for each 50 pounds of body weight. (ii) Indications for use. Anthelmintic effective against the following nema tode infections: Stomach worms VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00213 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 204 21 CFR Ch. I (4–1–16 Edition) § 520.1242c (Haemonchus, Trichostrongylus, Ostertagia), intestinal worms (Trichostrongylus, Cooperia, Nematodirus, Bunostomum, Oesophagostomum, Chabertia), and lungworms (Dictyocaulus). (iii) Limitations. Conditions of con stant helminth exposure may require re-treatment within 2 to 4 weeks after the first treatment. Do not slaughter for food within 72 hours of treatment. Consult a veterinarian before using in severely debilitated animals. [78 FR 28822, May 20, 2014] § 520.1242c Levamisol and piperazine. (a) Specifications. (1) Each ounce of solution contains 0.36 gram of levamisole hydrochloride and piper azine dihydrochloride equivalent to 3.98 grams of piperazine base. (2) A soluble powder which when con stituted with water contains in each fluid ounce 0.45 gram of levamisole hy drochloride and piperazine dihydrochloride equivalent to 5.0 grams of piperazine base. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Conditions of use in horses—(1) Amount. Aqueous solution: administer by stomach tube or drench 1 fluid ounce per 100 pounds of body weight. Reconstituted soluble powder: admin ister by stomach tube 1 fluid ounce per 125 pounds of body weight. If reinfec tion occurs, re-treat animals at 6- to 8 week intervals. (2) Indications for use. An anthel mintic effective against infections of large strongyles (Strongylus vulgaris, S. edentatus), small strongyles (Cylicocercus spp., Cylicocyclus spp., Cylicodontophorus spp., Cylicostephanus spp., Cylicotetrapedon spp.), ascarids (Parascaris equorum), and pinworms (Oxyuris equi). (3) Limitations. Do not use in horses intended for human consumption. Fed eral law restricts this drug to use by or on the order of a licensed veterinarian. [78 FR 28823, May 20, 2014] § 520.1242d Levamisole resinate. (a) Specifications. The drug is levamisole adsorbed on a resin, in a concentration equivalent to 10 percent levamisole hydrochloride. Each 2.05 ounce (58.1 gram) packet contains levamisole equivalent to 5.806 grams of levamisole hydrochloride. (b) Sponsor. See No. 043781 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.350 of this chapter. (d) Conditions of use. In swine it is used as follows: (1) Amount. The equivalent of 8 milli grams per kilogram of body weight, as a single dose, mixed in the animal’s ra tion. (2) Indications for use. For the re moval of and control of the following nematode infections: large roundworms (Ascaris suum), nodular worms (Oesophagostomum spp.), lungworms (Metastrongylus spp.), intestinal threadworms (Strongyloides ransomi), and swine kidney worms (Stephanurus dentatum). (3) Limitations. For pigs from weaning to market weight, mix one 58.1-gram packet of levamisole resinate con taining the equivalent of 10-percent levamisole hydrochloride in 40 pounds of feed and administer 1 pound of medi cated feed per 40 pounds of body weight as sole ration. For breeding swine, mix 1 packet of the 10-percent resinate in 16 pounds of feed and administer 1 pound of medicated feed per 100 pounds of body weight as sole ration. Administer as single doses. Withhold regular feed overnight and administer medicated feed the following morning. Do not withhold water during fasting. Do not treat within 72 hours of slaughter. Sali vation or muzzle foam may be ob served. The reaction will disappear a short time after feeding. If pigs are in fected with mature lungworms, coughing and vomiting may be ob served. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. [43 FR 18171, Apr. 28, 1978, as amended at 45 FR 3574, Jan. 18, 1980] § 520.1242e Levamisole hydrochloride effervescent tablets. (a) Specifications. Each tablet con tains 907 milligrams of levamisole hy drochloride. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.350 of this chapter. VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00214 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 205 Food and Drug Administration, HHS § 520.1242g (d) Conditions of use. It is used for swine as follows: (1) Amount. The equivalent of 8 milli grams of levamisole hydrochloride per kilogram of body weight, as a single dose. (2) Indications for use. See § 520.1242a(f)(3)(ii). (3) Limitations. Withholding water from pigs before treatment is not nec essary. Add one tablet for each 21⁄2 gal lons of water; mix thoroughly. Allow 1 gallon of medicated water for each 100 pounds body weight of pigs to be treat ed. No other source of water should be offered. After pigs have consumed medicated water, resume use of regular water. Pigs maintained under condi tions of constant worm exposure may require re-treatment within 4 to 5 weeks. Consult your veterinarian be fore administering to sick swine. Con sult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. Do not administer with in 72 hours of slaughter for food. [45 FR 6087, Jan. 25, 1980, as amended at 67 FR 63055, Oct. 10, 2002; 78 FR 28823, May 20, 2014] § 520.1242f Levamisol gel. (a) Specifications. Each gram of gel contains 115 milligrams (11.5 percent) levamisol hydrochloride. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.350 of this chapter. (d) Conditions of use—(1) Cattle—(i) Amount. Eight milligrams of levamisole hydrochloride per kilogram of body weight, as a single oral dose. (ii) Indications for use. Anthelmintic effective against the following nema tode infections: Stomach worms (Haemonchus, Trichostrongylus, Ostertagia), intestinal worms (Trichostrongylus, Cooperia, Nematodirus, Bunostomum, Oesophagostomum), and lungworms (Dictyocaulus). (iii) Limitations. Conditions of con stant helminth exposure may require re-treatment within 2 to 4 weeks after the first treatment; do not administer to cattle within 6 days of slaughter for food; do not administer to dairy ani mals of breeding age; consult veteri narian before using in severely debili tated animals. (2) Breeding swine—(i) Amount. Eight milligrams per kilogram of body weight (3.6 milligrams per pound) as a single oral dose. (ii) Conditions of use. For treating breeding swine infected with the fol lowing nematodes: Large roundworms (Ascaris suum), nodular worms (Oesophagostomum spp.), lungworms (Metastrongylus spp.), intestinal threadworms (Strongyloides ransomi), and kidney worms (Stephanurus dentatus). (iii) Limitations. May require retreat ment in 4 to 5 weeks. Do not use within 11 days of slaughter for food. Consult your veterinarian for assistance before using in severely debilitated animals and in the diagnosis, treatment, and control of parasitism. [47 FR 22517, May 25, 1982; 47 FR 30242, July 13, 1982, as amended at 48 FR 11429, Mar. 18, 1983; 51 FR 29215, Aug. 15, 1986; 67 FR 63055, Oct. 10, 2002; 78 FR 28823, May 20, 2014] § 520.1242g Levamisole resinate and famphur paste. (a) Specifications. The drug is a paste containing 11.6 percent levamisole res inate (50 percent potency) and 23.6 per cent famphur. (b) Sponsor. See 000061 in § 510.600(c) of this chapter. (c) Special considerations. Do not use any cholinesterase-inhibiting drugs, pesticides, insecticides, or chemicals on cattle simultaneously or within a few days before or after treatment with this product. (d) Related tolerances. See §§ 556.273 and 556.350 of this chapter. (e) Conditions of use in cattle—(1) Amount. 8 milligrams of levamisole hy drochloride (equivalent) and 30 milli grams of famphur activity per kilo gram of body weight. (2) Indications for use. For treatment of cattle infected with the following parasites: Stomach worms (Haemonchus, Trichostrongylus, Ostertagia), intestinal worms (Trichostrongylus, Cooperia, Nematodirus, Bunostomum, Oesophagostomum), lungworms (Dictyocaulus), cattle grubs (Hypoderma), biting lice (Bovicola), and sucking lice (Linognathus, Solenoptes). VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00215 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 206 21 CFR Ch. I (4–1–16 Edition) § 520.1263 (3) Limitations. Drug is not effective against lice eggs. Conditions of con stant helminth and ectoparasitic expo sure may require retreatment within 2 to 4 weeks after first treatment. Do not administer to cattle within 19 days of slaughter. Do not administer to dairy animals of breeding age. Do not use in calves less than 3 months old, or in de bilitated animals. Do not treat Brah man bulls. Consult your veterinarian for assistance in the diagnosis, treat ment, and control of parasitism. [53 FR 23757, June 24, 1988, as amended at 54 FR 1353, Jan. 13, 1989; 57 FR 7652, Mar. 4, 1992; 62 FR 55160, Oct. 23, 1997; 62 FR 61625, Nov. 19, 1997; 78 FR 28823, May 20, 2014] § 520.1263 Lincomycin. § 520.1263a Lincomycin tablets and syrup. (a) Specifications. (1) Each ounce of syrup contains lincomycin hydro chloride equivalent to either 25 or 50 milligrams (mg) lincomycin. (2) Each tablet contains lincomycin hydrochloride equivalent to either 25 or 50 mg lincomycin. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Conditions of use in dogs and cats— (1) Amount. Administer orally 10 mg per pound of body weight every 12 hours, or 7 mg per pound of body weight every 8 hours, for up to 12 days. (2) Indications for use. For infections caused by gram-positive organisms which are sensitive to its action, par ticularly streptococci and staphylococci. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [78 FR 28823, May 20, 2014] § 520.1263b [Reserved] § 520.1263c Lincomycin powder. (a) Specifications. Each gram of solu ble powder contains lincomycin hydro chloride equivalent to 0.4 grams of lin comycin. (b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter for use as in paragraph (d) of this section. (1) No. 054771 for use as in paragraph (d) of this section. (2) Nos. 054771, 054925, 061623, and 076475 for use as in paragraphs (d)(1) and (d)(2) of this section. (c) Tolerances. See § 556.360 of this chapter. (d) Conditions of use—(1) Swine—(i) Amount. 250 milligrams per gallon of drinking water to provide 3.8 milli grams per pound of body weight per day. (ii) Indications for use. For the treat ment of swine dysentery (bloody scours). (iii) Limitations. Discard medicated drinking water if not used within 2 days. Prepare fresh stock solution daily. Do not use for more than 10 days. If clinical signs of disease have not im proved within 6 days, discontinue treatment and reevaluate diagnosis. The safety of lincomycin has not been demonstrated in pregnant swine or swine intended for breeding. For No. 051259: Do not slaughter swine for 6 days following last treatment. (2) Chickens—(i) Amount. 64 milli grams per gallon of drinking water. (ii) Indications for use. For the control of necrotic enteritis caused by Clos tridium perfringens susceptible to linco mycin in broiler chickens. (iii) Limitations. Discard medicated drinking water if not used within 2 days. Prepare fresh stock solution daily. Administer for 7 consecutive days. Do not allow rabbits, hamsters, guinea pigs, horses, or ruminants ac cess to water containing lincomycin. Not for use in layer and breeder chick ens. (3) Honey bees—(i) Amount. Mix 100 milligrams lincomycin with 20 grams confectioners’/powdered sugar and dust over the top bars of the brood chamber once weekly for 3 weeks. (ii) Indications for use. For the control of American foulbrood (Paenibacillus larvae). (iii) Limitations. The drug should be fed early in the spring or late in the fall and consumed by the bees before the main honey flow begins to avoid contamination of production honey. VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00216 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 207 Food and Drug Administration, HHS § 520.1288 Complete treatments at least 4 weeks before main honey flow. [48 FR 3966, Jan. 28, 1983, as amended at 55 FR 3209, Jan. 31, 1990; 60 FR 14217, Mar. 16, 1995; 62 FR 65020, Dec. 10, 1997; 64 FR 13341, Mar. 18, 1999; 64 FR 13508, Mar. 19, 1999; 64 FR 66382, Nov. 26, 1999; 65 FR 10705, Feb. 29, 2000; 67 FR 17284, Apr. 10, 2002; 67 FR 71819, Dec. 3, 2002; 67 FR 78356, Dec. 24, 2002; 68 FR 3817, Jan. 27, 2003; 70 FR 1818, Jan. 11, 2005; 77 FR 20988, Apr. 9, 2012; 77 FR 29217, May 17, 2012; 78 FR 28823, May 20, 2014] § 520.1265 Lincomycin and spectinomycin powder. (a) Specifications. The following salts of lincomycin and spectinomycin are present in a soluble powder in the ratio of 1 to 2 on the basis of equivalency of lincomycin base to equivalency of spectinomycin base: (1) Lincomycin hydrochloride monohydrate and spectinomycin sul fate tetrahydrate. (2) Lincomycin hydrochloride monohydrate and spectinomycin dihydrochloride pentahydrate. (b) Sponsors. See sponsors in § 510.600(c) of this chapter for use as in paragraph (d) of this section. (1) No. 054771 for use of product de scribed in paragraph (a)(1) of this sec tion. (2) Nos. 057561, 061623, and 066104 for use of product described in paragraph (a)(2) of this section. (c) Tolerances. See §§ 556.360 and 556.600 of this chapter. (d) Conditions of use in chickens—(1) Amount. 2 grams of antibiotic activity per gallon of drinking water; admin ister as the sole source of water for the first 5 to 7 days of life. (2) Indications for use. As an aid in the control of airsacculitis caused by ei ther Mycoplasma synoviae or M. gallisepticum susceptible to lincomycin spectinomycin and complicated chron ic respiratory disease (air sac infec tion) caused by Escherichia coli and M. gallisepticum susceptible to lincomycin spectinomycin. [69 FR 13220, Mar. 22, 2004, as amended at 70 FR 40881, July 15, 2005; 71 FR 71038, Dec. 8, 2006; 77 FR 56770, Sept. 14, 2012; 78 FR 28823, May 20, 2014] § 520.1284 Liothyronine. (a) Specifications. Each tablet con tains 60 or 120 micrograms (μg) liothyronine as the sodium salt. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Conditions of use in dogs—(1) Amount. Administer orally to dogs at levels up to 12.8 μg per kilogram (/kg) of body weight per day. Dosage should be adjusted according to the severity of the condition and the response of the patient. Dosage at the total replace ment level (12.8 μg/kg of body weight) should be considered for initiating therapy and then titrated downward for optimum maintenance effect. Twice daily administration is recommended. (2) Indications for use. For treatment of hypothyroidism in dogs. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [78 FR 28823, May 20, 2014] § 520.1288 Lufenuron tablets. (a) Specifications—(1) Tablets con taining 45, 90, 204.9, or 409.8 milligrams (mg) lufenuron for use as in paragraphs (c)(1)(i), (c)(1)(ii)(A), (c)(1)(iii), (c)(2)(i), (c)(2)(ii)(A), and (c)(2)(iii) of this sec tion. (2) Flavored tablets containing 45, 90, 204.9, or 409.8 milligrams (mg) lufenuron for use as in paragraphs (c)(1)(i), (c)(1)(ii)(A) or (c)(1)(ii)(B), and (c)(1)(iii) of this section. (3) Flavored tablets containing 90 or 204.9 mg lufenuron for use as in para graphs (c)(2)(i), (c)(2)(ii)(A) or (c)(2)(ii)(B), and (c)(2)(iii) of this sec tion. (4) Flavored tablets containing 135 or 270 mg lufenuron for use as in para graphs (c)(2)(i), (c)(2)(ii)(A), and (c)(2)(iii) of this section. (b) Sponsor. See No. 058198 in § 510.600(c) of this chapter. (c) Conditions of use—(1) Dogs—(i) Amount. Minimum of 10 mg lufenuron per kilogram (4.5 mg per pound (lb)) of body weight, once a month. (ii) Indications for use—(A) For the prevention and control of flea popu lations. VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00217 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 208 21 CFR Ch. I (4–1–16 Edition) § 520.1289 (B) The concurrent use of flavored lufenuron tablets described in para graph (a)(2) of this section as in para graph (c)(1)(ii)(A) of this section with nitenpyram tablets as in § 520.1510(d)(1) of this chapter is indicated to kill adult fleas and prevent flea eggs from hatching. (iii) Limitations. For use in dogs and puppies 4 weeks of age and older. (2) Cats—(i) Amount. Minimum of 30 mg lufenuron per kilogram (13.6 mg/lb) of body weight, once a month. (ii) Indications for use—(A) For the control of flea populations. (B) The concurrent use of flavored lufenuron tablets described in para graph (a)(3) of this section as in para graph (c)(2)(ii)(A) of this section with nitenpyram tablets as in § 520.1510(d)(2) of this chapter is indicated to kill adult fleas and prevent flea eggs from hatching. (iii) Limitations. For use in cats and kittens 4 weeks of age and older. [68 FR 51905, Aug. 29, 2003] § 520.1289 Lufenuron suspension. (a) Specifications. Each individual dose pack contains either 135 or 270 milligrams of lufenuron. (b) Sponsor. See No. 058198 in § 510.600(c) of this chapter. (c) Conditions of use in cats—(1) Amount. Minimum of 13.6 milligrams per pound of body weight (30 milli grams per kilogram). Recommended dose of 135 milligrams for up to 10 pounds of body weight or 270 milli grams for 11 to 20 pounds. Cats over 20 pounds are provided the appropriate combination of packs. (2) Indications for use. For control of flea populations. (3) Limitations. For oral use in cats 6 weeks of age or older, once a month, mixed with food. Administer in con junction with a full meal to ensure ade quate absorption. Treat all cats in the household to ensure maximum bene fits. Because the drug has no affect on adult fleas, the concurrent use of insec ticides that kill adults may be nec essary depending on the severity of the infestation. [60 FR 20402, Apr. 26, 1995, as amended at 62 FR 8371, Feb. 25, 1997] § 520.1310 Marbofloxacin. (a) Specifications. Each tablet con tains 25, 50, 100, or 200 milligrams (mg) marbofloxacin. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) [Reserved] (d) Conditions of use—(1) Amount. 1.25 mg per pound (/lb) of body weight once daily, but may be increased to 2.5 mg/ lb of body weight once daily. (2) Indications for use. For the treat ment of infections in dogs and cats as sociated with bacteria susceptible to marbofloxacin. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law pro hibits the extralabel use of this drug in food-producing animals. [64 FR 39919, July 23, 1999, as amended at 66 FR 46369, Sept. 5, 2001; 78 FR 28823, May 20, 2014] § 520.1315 Maropitant. (a) Specifications. Each tablet con tains 16, 24, 60, or 160 milligrams (mg) maropitant as maropitant citrate. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Conditions of use in dogs—(1) Indi cations for use and amount. (i) For pre vention of acute vomiting in dogs 2 to 7 months of age, administer a min imum dose of 2.0 mg per kilogram (/kg) body weight once daily for up to 5 con secutive days. (ii) For prevention of acute vomiting in dogs 7 months of age and older, ad minister a minimum dose of 2.0 mg/kg body weight once daily until resolution of acute vomiting. (iii) For prevention of vomiting due to motion sickness in dogs 4 months of age and older, administer a minimum of 8.0 mg/kg body weight once daily for up to 2 consecutive days. (2) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [72 FR 9243, Mar. 1, 2007, as amended at 78 FR 28823, May 20, 2014; 80 FR 53459, Sept. 4, 2015] § 520.1320 Mebendazole. (a) Specifications. (1) Each gram of powder contains either 40 or 166.7 milli grams of mebendazole. VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00218 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 209 Food and Drug Administration, HHS § 520.1330 (2) Each gram of paste contains 200 milligrams of mebendazole. (3) Each milliliter of suspension con tains 33.3 milligrams of mebendazole. (b) Sponsor. See No. 000061 in § 510.600(c) of this chapter. (c) Conditions of use—(1) Horses—(i) Amount. 1 gram of mebendazole per 250 pounds of body weight per dose, as an oral powder, paste or suspension. (ii) Indications for use. For treatment of infections caused by large roundworms (Parascaris equorum); large strongyles (Strongylus edentatus, S. equinus, S. vulgaris); small strongyles; and mature and immature (4th larval stage) pinworms (Oxyuris equi). (iii) Limitations. The drug is compat ible with carbon disulfide. Do not use in horses intended for human consump tion. Federal law restricts this drug to use by or on the order of a licensed vet erinarian. (2) Dogs—(i) Amount. Administer 100 milligrams of mebendazole per 10 pounds of body weight, once daily for 3 days, as an oral powder by mixing with a small quantity of food, preferably be fore the regular meal. (ii) Indications for use. The drug is used for treatment of infections of roundworms (Toxocara canis), hookworms (Ancylostoma caninum, Uncinaria stenocephala), whipworms (Trichuris vulpis), and tapeworms (Taenia pisiformis). (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [78 FR 28823, May 20, 2014] § 520.1326 Mebendazole and trichlorfon oral dosage forms. § 520.1326a Mebendazole and trichlorfon powder. (a) Specifications. Each gram of pow der contains 83.3 milligrams of mebendazole and 375.0 milligrams of trichlorofon. (b) Sponsor. See No. 000061 in § 510.600(c) of this chapter. (c) Conditions of use in horses—(1) Amount. 8.8 milligrams of mebendazole and 40 milligrams of trichlorofon per kilogram of body weight. (2) Indications for use. It is used in horses for the treatment of infections of bots (Gastrophilus intestinalis and G. nasalis), large roundworms (Parascaris equorum), large strongyles (Strongylus edentatus, S. equinus, S. vulgaris), small strongyles, and pinworms (Oxyuris equi.) (3) Limitations. Do not use in horses intended for human consumption. Fed eral law restricts this drug to use by or on the order of a licensed veterinarian. [45 FR 10759, Feb. 19, 1980, as amended at 46 FR 52330, Oct. 27, 1981. Redesignated at 51 FR 13212, Apr. 18, 1986, as amended at 62 FR 61625, Nov. 19, 1997; 78 FR 28824, May 20, 2014] § 520.1326b Mebendazole and trichlorfon paste. (a) Specifications. Each gram of paste contains 100 milligrams of mebendazole and 454 milligrams of trichlorfon. (b) Sponsor. See No. 000061 in § 510.600(c) of this chapter. (c) Conditions of use in horses—(1) Amount. 8.8 milligrams of mebendazole and 40 milligrams of trichlorfon per kilogram of body weight. (2) Indications for use. It is used in horses for treatment of infections of bots (Gastrophilus intestinalis and G. na salis), large roundworms (Parascaris equorum), large strongyles (Strongylus edentatus, S. equinus, S. vulgaris), small strongyles, and pinworms (Oxyuris equi). (3) Limitations. Do not administer more than once every 30 days. Do not treat sick or debilitated animals, foals under 4 months of age, or mares in the last month of pregnancy. Trichlorfon is a cholinesterase inhibitor. Do not ad minister simultaneously or within a few days before or after treatment with, or exposure to, cholinesterase-in hibiting drugs, pesticides, or chemi cals. Do not administer intravenous anesthetics, especially muscle relax ants, concurrently. Not for use in horses intended for food. Consult your veterinarian for assistance in the diag nosis, treatment, and control of para sitism. [51 FR 13212, Apr. 18, 1986, as amended at 62 FR 61625, Nov. 19, 1997; 78 FR 28824, May 20, 2014] § 520.1330 Meclofenamic acid granules. (a) Specifications. Each gram of gran ules contains 5 milligrams (5 percent) meclofenamic acid. VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00219 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 210 21 CFR Ch. I (4–1–16 Edition) § 520.1331 (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Conditions of use in horses—(1) Amount. Administer 1 milligram per pound of body weight (1 gram per 1000 pounds) once daily for 5 to 7 days by addition to the daily grain ration. (2) Indications for use. For the treat ment of acute or chronic inflammatory diseases involving the musculoskeletal system. (3) Limitations. Do not use in horses intended for human consumption. Fed eral law restricts this drug to use by or on the order of a licensed veterinarian. [78 FR 28824, May 20, 2014] § 520.1331 Meclofenamic acid tablets. (a) Specifications. Each tablet con tains either 10 or 20 milligrams of meclofenamic acid. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Conditions of use in dogs—(1) Amount. 1.1 milligrams per kilogram (0.5 milligram per pound) daily for 5 to 7 days. (2) Indications for use. For the relief of signs and symptoms of chronic inflam matory disease involving the musculo skeletal system. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [50 FR 43385, Oct. 25, 1985, as amended at 53 FR 23390, June 22, 1988; 78 FR 28824, May 20, 2014] § 520.1341 Megestrol. (a) Specifications. Each tablet con tains 5 or 20 milligrams of megestrol acetate. (b) Sponsor. See No. 000061 in § 510.600(c) of this chapter. (c) Conditions of use in dogs—(1) Amount. Administer orally, intact, or crushed and mixed with food as follows: (i) For the postponement of estrus by proestrus treatment: 1 milligram per pound of body weight per day for 8 days. (ii) For the postponement of estrus by anestrus treatment: 0.25 milligram per pound of body weight per day for 32 days. (iii) For alleviation of false preg nancy: 1 milligram per pound of body weight per day for 8 days. (2) Indications for use. For the post ponement of estrus and the alleviation of false pregnancy in female dogs. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [40 FR 13838, Mar. 27, 1975, as amended at 52 FR 7832, Mar. 13, 1987; 78 FR 28824, May 20, 2014] § 520.1367 Meloxicam. (a) Specifications—(1) Each milliliter of suspension contains 0.5 milligrams (mg) meloxicam. (2) Each milliliter of suspension con tains 1.5 mg meloxicam. (b) Sponsors. See sponsors in § 510.600(c) of this chapter for uses as in paragraph (c) of this section: (1) No. 000010 for use of the products described in paragraph (a) of this sec tion; and (2) Nos. 013744 and 055529 for use of the product described in paragraph (a)(2) of this section. (c) Conditions of use in dogs—(1) Amount. Administer orally as a single dose at 0.09 mg per pound (mg/lb) body weight (0.2 mg per kilogram (mg/kg)) on the first day of treatment. For all treatment after day 1, administer 0.045 mg/lb (0.1 mg/kg) body weight once daily. (2) Indications for use. For the control of pain and inflammation associated with osteoarthritis. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [68 FR 42968, July 21, 2003, as amended at 69 FR 69523, Nov. 30, 2004. Redesignated and amended at 78 FR 57058, Sept. 17, 2013; 80 FR 53459, Sept. 4, 2015] § 520.1372 Methimazole. (a) Specifications. Each tablet con tains 2.5 or 5 milligrams (mg) methimazole. (b) Sponsor. See No. 043264 in § 510.600 of this chapter. (c) Conditions of use in cats—(1) Amount. The starting dose is 2.5 mg every 12 hours. Following 3 weeks of treatment, the dose should be titrated to effect based on individual serum total T4 levels and clinical response. (2) Indications for use. For the treat ment of hyperthyroidism. VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00220 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 211 Food and Drug Administration, HHS § 520.1422 (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [74 FR 27707, June 11, 2009] § 520.1380 Methocarbamol. (a) Specifications. Each tablet con tains 500 milligrams (mg) of methocarbamol. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Conditions of use in dogs and cats— (1) Amount. Administer 60 mg per pound of body weight in two or three equally divided doses, followed each following day by 30 to 60 mg per pound of body weight, usually not to exceed 14 to 21 days. (2) Indications for use. As an adjunct to therapy for acute inflammatory and traumatic conditions of the skeletal muscles in order to reduce muscular spasms. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [78 FR 28824, May 20, 2014] § 520.1408 Methylprednisolone. (a) Specifications. Each tablet con tains 1, 2, or 4 milligrams (mg) of methylprednisolone. (b) Sponsors. See sponsors in § 510.600(c) of this chapter. (1) No. 054628 for use of 1- and 2-mg tablets. (2) No. 054771 for use of 1- and 4-mg tablets. (c) Conditions of use in dogs and cats— (1) Amount. 5 to 15 pounds (lbs): 2 mg; 15 to 40 lbs: 2 to 4 mg; 40 to 80 lbs: 4 to 8 mg. Administer total daily dose orally in equally divided doses 6 to 10 hours apart until response is noted or 7 days have elapsed. (2) Indications for use. As an anti-in flammatory agent. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [78 FR 28824, May 20, 2014] § 520.1409 Methylprednisolone and as pirin. (a) Specifications. Each tablet con tains 0.5 milligram of methylprednisolone and 300 milligrams of aspirin. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Conditions of use in dogs—(1) Amount. Under 15 pounds, 1⁄4 to 1 tablet daily; 15 to 60 pounds, 1 to 2 tablets daily; 60 pounds and over, 2 tablets daily. Administer total daily dose in divided doses 6 to 10 hours apart, with a light feeding. When response is at tained, dosage should be gradually re duced until maintenance level is achieved. (2) Indications for use. As an anti-in flammatory and analgesic agent. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [48 FR 21566, May 13, 1983, as amended at 78 FR 28824, May 20, 2014] § 520.1422 Metoserpate hydrochloride. (a) Chemical name. Methyl-o-methyl 18-epireserpate hydrochloride. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.410 of this chapter. (d) Conditions of use. It is used in drinking water for replacement chick ens as follows: (1) Amount. 568.5 milligrams per gal lon (0.015 percent). (i) Indications for use. As a tranquil izer for flock treatment of chickens prior to handling. (ii) Limitations. To be used one time as a treatment for replacement chick ens up to 16 weeks of age; usual drink ing water should be withheld prior to treatment to provide adequate con sumption of medicated drinking water; not for use in laying chickens; chick ens slaughtered within 72 hours fol lowing treatment must not be used for food. (2) Amount. 2 to 4 milligrams per 2.2 pounds of body weight. (i) Indications for use. As an aid in control of hysteria. (ii) Limitations. To be used as a treat ment for replacement chickens up to 16 weeks of age; usual drinking water should be withheld prior to treatment to provide adequate consumption of medicated drinking water; the drug should be administered at a dosage level of 4 milligrams per 2.2 pounds of body weight followed by 2 treatments at 4-day intervals of 2 milligrams per VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00221 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 212 21 CFR Ch. I (4–1–16 Edition) § 520.1430 2.2 pounds of body weight; not for use in laying chickens; chickens slaugh tered within 72 hours following treat ment must not be used for food. [40 FR 13838, Mar. 27, 1975, as amended at 76 FR 17337, Mar. 29, 2011; 78 FR 28824, May 20, 2014] § 520.1430 Megestrol acetate tablets. (a) Specifications. Each milliliter con tains 100 micrograms of mibolerone. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Conditions of use in dogs—(1) Amount. 30 micrograms for animals weighing 1 to 25 pounds; 60 micrograms for animals weighing 26 to 50 pounds; 120 micrograms for animals weighing 51 to 100 pounds; 180 micrograms for ani mals weighing over 100 pounds, German Shepherds, or German Shepherd mix. Administer daily, orally or in a small amount of food, at least 30 days before expected initiation of heat, and con tinue daily as long as desired, but not for more than 24 months. (2) Indications for use. For the preven tion of estrus (heat) in adult female dogs not intended primarily for breed ing purposes. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [43 FR 15625, Apr. 14, 1978, as amended at 78 FR 28824, May 20, 2014] § 520.1441 Milbemycin oxime. (a) Specifications—(1) Dogs. Each tab let contains 2.3, 5.75, 11.5, or 23.0 milli grams of milbemycin oxime. (2) Cats. Each tablet contains 5.75, 11.5, or 23.0 milligrams of milbemycin oxime. (b) Sponsor. See 058198 in § 510.600(c) of this chapter. (c) [Reserved] (d) Conditions of use—(1) Dogs and puppies—(i) Amount. For hookworm, roundworm, and whipworm, use 0.23 milligram per pound of body weight (0.5 milligram per kilogram). For heart worm, use 0.05 milligram per pound of body weight (0.1 milligram per kilo gram). (ii) Indications for use. For prevention of heartworm disease caused by Dirofilaria immitis, control of hookworm infections caused by Ancylostoma caninum, and removal and control of adult roundworm infections caused by Toxocara canis and Toxascaris leonina and whipworm infections caused by Trichuris vulpis in dogs and in puppies 4 weeks of age or greater and 2 pounds of body weight or greater. (iii) Limitations. Do not use in puppies less than 4 weeks of age and less than 2 pounds of body weight. Administer once a month. First dose given within 1 month after first exposure to mosqui toes and continue regular use until at least 1 month after end of mosquito season. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (2) Cats and kittens—(i) Amount. 0.91 milligram per pound of body weight (2.0 milligrams per kilogram). (ii) Indications for use. For prevention of heartworm disease caused by Dirofilaria immitis and the removal of adult Toxocara cati (roundworm) and Ancylostoma tubaeforme (hookworm) in fections in cats 6 weeks of age or great er and 1.5 pounds body weight or great er. (iii) Limitations. Do not use in kittens less than 6 weeks of age or 1.5 pounds body weight. Administer once a month. Federal law restricts this drug to use by or on the order of a licensed veteri narian. [55 FR 25301, June 21, 1990, as amended at 55 FR 49888, Dec. 3, 1990; 58 FR 5608, Jan. 22, 1993; 60 FR 50097, Sept. 28, 1995; 61 FR 43654, Aug. 26, 1996; 63 FR 29352, May 29, 1998; 63 FR 41189, Aug. 3, 1998. Redesignated at 77 FR 47512, Aug. 9, 2012] § 520.1443 Milbemycin oxime and lufenuron. (a) Specifications—(1) Tablets con taining: 2.3 milligrams (mg) milbemycin oxime and 46 mg lufenuron, 5.75 mg milbemycin oxime and 115 mg lufenuron, 11.5 mg milbemycin oxime and 230 mg lufenuron, or 23 mg milbemycin oxime and 460 mg lufenuron. (2) Flavored tablets containing: 2.3 mg milbemycin oxime and 46 mg lufenuron, 5.75 mg milbemycin oxime and 115 mg lufenuron, 11.5 mg milbemycin oxime and 230 mg lufenuron, or 23 mg milbemycin oxime and 460 mg lufenuron. (b) Sponsor. See No. 051311 in § 510.600(c) of this chapter. VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00222 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 213 Food and Drug Administration, HHS § 520.1447 (c) [Reserved] (d) Conditions of use—(1) Dogs—(i) Amount. 0.5 mg milbemycin oxime and 10 mg lufenuron per kilogram of body weight, once a month. (ii) Indications for use—(A) For use in dogs and puppies for the prevention of heartworm disease caused by Dirofilaria immitis, for prevention and control of flea populations, for control of adult Ancylostoma caninum (hookworm), and for removal and control of adult Toxocara canis, Toxascaris leonina (roundworm), and Trichuris vulpis (whipworm) infections. (B) The concurrent use of flavored milbemycin oxime and lufenuron tab lets described in paragraph (a)(2) of this section as in paragraph (d)(1)(ii)(A) of this section with nitenpyram tablets as in § 520.1510(d)(1) of this chapter is indicated to kill adult fleas and pre vent flea eggs from hatching. (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (2) [Reserved] [62 FR 28629, May 27, 1997, as amended at 63 FR 41190, Aug. 3, 1998; 68 FR 51905, Aug. 29, 2003. Redesignated at 77 FR 47512, Aug. 9, 2012, as amended at 80 FR 18776, Apr. 8, 2015] § 520.1445 Milbemycin oxime and praziquantel. (a) Specifications. Each chewable tab let contains: (1) 2.3 milligrams (mg) milbemycin oxime and 22.8 mg praziquantel; (2) 5.75 mg milbemycin oxime and 57 mg praziquantel; (3) 11.5 mg milbemycin oxime and 114 mg praziquantel; or (4) 23 mg milbemycin oxime and 228 mg praziquantel. (b) Sponsor. See No. 058198 in § 510.600(c) of this chapter. (c) Conditions of use—(1) Dogs—(i) Amount. Administer orally, once a month, a minimum dosage of 0.23 mg per pound (mg/lb) of body weight (0.5 mg per kilogram (mg/kg)) milbemycin oxime and 2.28 mg/lb of body weight (5 mg/kg) praziquantel. (ii) Indications for use. For the pre vention of heartworm disease caused by Dirofilaria immitis and for the treat ment and control of adult roundworm (Toxocara canis, Toxascaris leonina), adult hookworm (Ancylostoma caninum), adult whipworm (Trichuris vulpis), and adult tapeworm (Taenia pisiformis, Echinococcus multilocularis, and E. granulosus) infections in dogs and puppies 2 pounds of body weight or greater and 6 weeks of age and older. (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (2) [Reserved] [77 FR 47512, Aug. 9, 2012] § 520.1447 Milbemycin oxime, lufenuron, and praziquantel tablets. (a) Specifications. Each tablet con tains: (1) 2.3 milligrams (mg) milbemycin oxime, 46 mg lufenuron, and 22.8 mg praziquantel; (2) 5.75 mg milbemycin oxime, 115 mg lufenuron, and 57 mg praziquantel; (3) 11.5 mg milbemycin oxime, 230 mg lufenuron, and 114 mg praziquantel; or (4) 23 mg milbemycin oxime, 460 mg lufenuron, and 228 mg praziquantel. (b) Sponsor. See No. 051311 in § 510.600(c) of this chapter. (c) [Reserved] (d) Conditions of use—(1) Dogs—(i) Amount. 0.5 mg milbemycin oxime, 10 mg lufenuron, and 5 mg of praziquantel per kilogram of body weight, once a month. (ii) Indications for use. For the pre vention of heartworm disease caused by Dirofilaria immitis; for the prevention and control of flea populations (Ctenocephalides felis); and for the treat ment and control of adult roundworm (Toxocara canis, Toxascaris leonina), adult hookworm (Ancylostoma caninum), adult whipworm (Trichuris vulpis), and adult tapeworm (Taenia pisiformis, Echinococcus multilocularis, and E. granulosus) infections in dogs and puppies 2 pounds of body weight or greater and 6 weeks of age and older. (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (2) [Reserved] [77 FR 4225, Jan. 27, 2012, as amended at 80 FR 18776, Apr. 8, 2015] VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00223 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 214 21 CFR Ch. I (4–1–16 Edition) § 520.1450 § 520.1450 Morantel tartrate oral dos age forms. § 520.1450a Morantel tartrate bolus. (a) Specifications. Each bolus contains 2.2 grams morantel tartrate equivalent to 1.3 grams of morantel base. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.425 of this chapter. (d) Conditions of use—(1) Amount. One bolus per 500 pounds of body weight (4.4 milligrams per pound of body weight) as a single oral dose. Boluses may be divided in half for more accurate dos ing as follows: up to 325 pounds, 1⁄2 bolus; 326 to 600 pounds, 1 bolus; 601 to 900 pounds, 11⁄2 boluses; and 901 to 1,200 pounds, 2 boluses. (2) Indications for use. For removal and control of mature gastrointestinal nematode infections of cattle including stomach worms (Haemonchus spp., Ostertagia spp., Trichostrongylus spp.), worms of the small intestine (Cooperia spp., Trichostrongylus spp., Nematodirus spp.), and worms of the large intestine (Oesophagostomum radiatum). (3) Limitations. Conditions of constant worm exposure may require retreat ment in 2 to 4 weeks. Consult your vet erinarian before administering to se verely debilitated animals and for as sistance in the diagnosis, treatment, and control of parasitism. Do not treat within 14 days of slaughter. [46 FR 50949, Oct. 16, 1981. Redesignated at 49 FR 47831, Dec. 7, 1984, and amended at 51 FR 9005, Mar. 17, 1986; 78 FR 28825, May 20, 2014] § 520.1450b Morantel tartrate car tridge. (a) Specifications. The drug product consists of a stainless-steel cylinder having both ends closed with poly ethylene diffusing discs and containing a morantel tartrate paste. The paste contains 22.7 grams of morantel tar trate equivalent to 13.5 grams of morantel base. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.425 of this chapter. (d) Conditions of use—(1) Amount. Grazing cattle: Administer 1 cartridge to each animal at the start of the graz ing season. (2) Indications for use. For control of the adult stage of the following gastro intestinal nematode infections in weaned calves and yearling cattle weighing a minimum of 200 pounds: Ostertagia spp., Trichostrongylus axei, Cooperia spp., and Oesophagostomum radiatum. (3) Limitations. Administer orally with the dosing gun to all cattle that will be grazing the same pasture. Effec tiveness of the drug product is depend ent upon continuous control of the gas trointestinal parasites for approxi mately 90 days following administra tion. Therefore, treated cattle should not be moved to pastures grazed in the same grazing season/calendar year by untreated cattle. Do not administer to cattle within 106 days of slaughter. Consult your veterinarian before ad ministering to severely debilitated ani mals and for assistance in the diag nosis, treatment, and control of para sitism. [49 FR 47831, Dec. 7, 1984, as amended at 51 FR 23415, June 27, 1986; 51 FR 41081, Nov. 13, 1986; 78 FR 28825, May 20, 2014] § 520.1450c Morantel tartrate sus tained-release trilaminate cylinder/ sheet. (a) Specifications. The drug product consists of a trilaminated, perforated, plastic sheet formed into a cylinder having plastic plugs in its ends. The core lamina contains 19.8 grams of morantel tartrate equivalent to 11.8 grams of morantel base. (b) Sponsor. See 054771 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.425 of this chapter. (d) Conditions of use—(1) Amount. Grazing cattle: Administer 1 cartridge to each animal at the start of the graz ing season. (2) Indications for use. For control of the adult stage of the following gastro intestinal nematode infections in weaned calves and yearling cattle weighing a minimum of 200 pounds: Ostertagia spp., Trichostrongylus axei, Cooperia spp., and Oesophagostomum radiatum. (3) Limitations. Administer orally with the dosing gun to all cattle that VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00224 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 215 Food and Drug Administration, HHS § 520.1453 will be grazing the same pasture. Effec tiveness of the drug product is depend ent upon continuous control of the gas trointestinal parasites for approxi mately 90 days following administra tion. Therefore, treated cattle should not be moved to pastures grazed in the same grazing season/calendar year by untreated cattle. Do not administer to cattle within 102 days of slaughter. Consult your veterinarian before ad ministering to severely debilitated ani mals and for assistance in the diag nosis, treatment, and control of para sitism. [56 FR 13396, Apr. 2, 1991, as amended at 78 FR 28825, May 20, 2014] § 520.1451 Moxidectin tablets. (a) Specifications. Each tablet con tains 30, 68, or 136 micrograms of moxidectin. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Conditions of use—(1) Amount. 3 micrograms per kilogram (1.36 micrograms per pound) of body weight. (2) Indications for use. To prevent in fection by the canine heartworm Dirofilaria immitis and the subsequent development of canine heartworm dis ease. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [62 FR 37713, July 15, 1997, as amended at 78 FR 28825, May 20, 2014] § 520.1452 Moxidectin gel. (a) Specifications. Each milliliter of gel contains 20 milligrams (2 percent) moxidectin. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Special considerations. See § 500.25 of this chapter. (d) Conditions of use in horses and ponies—(1) Amount. 0.4 milligram moxidectin per kilogram (2.2 pounds) of body weight. (2) Indications for use. For the treat ment and control of large strongyles: Strongylus vulgaris (adults and L4/L5 ar terial stages), S. edentatus (adult and tissue stages), Triodontophorus brevicauda (adults), and T. serratus (adults); small strongyles (adults): Cyathostomum spp., including C. catinatum and C. pateratum; Cylicocyclus. spp., including C. insigne, C. leptostomum, C. nassatus, and C. radiatus; Cyliocostephanus spp., includ ing C. calicatus, C. goldi, C. longibursatus, and C. minutus; Coronocyclus spp., including C. coronatus, C. labiatus, and C. labratus; Gyalocephalus capitatus; and Petrovinema poculatus; small strongyles: undifferentiated lumenal larvae; encysted cyathostomes (late L3 and L4 mucosal cyathostome larvae); ascarids: Parascaris equorum (adults and L4 larval stages); pinworms: Oxyuris equi (adults and L4 larval stages); hairworms: Trichostrongylus axei (adults); large-mouth stomach worms: Habronema muscae (adults); and horse stomach bots: Gasterophilus intestinalis (2nd and 3rd instars) and G. nasalis (3rd instars). One dose also suppresses strongyle egg production for 84 days. (3) Limitations. Do not use in horses intended for human consumption. [62 FR 42902, Aug. 11, 1997, as amended at 64 FR 66105, Nov. 24, 1999; 68 FR 51445, Aug. 27, 2003; 69 FR 24959, May 5, 2004; 70 FR 75017, Dec. 19, 2005; 78 FR 28825, May 20, 2014] § 520.1453 Moxidectin and praziquantel gel. (a) Specifications. Each milliliter of gel contains 20 milligrams (mg) (2.0 percent) moxidectin and 125 mg (12.5 percent) praziquantel. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Special considerations. See § 500.25 of this chapter. (d) Conditions of use in horses and ponies—(1) Amount. Administer by mouth as a single dose: 0.4 mg moxidectin per kilogram and 2.5 mg praziquantel per kilogram (2.2 pounds) body weight. (2) Indications for use. For the treat ment and control of large strongyles: Strongylus vulgaris (adults and L4/L5 ar terial stages), S. edentatus (adult and tissue stages), Triodontophorus brevicauda (adults), and T. serratus (adults); small strongyles (adults): (Cyathostomum spp., including C. catinatum and C. pateratum; Cylicocyclus spp., including C. insigne, C. leptostomum, C. nassatus, and C. radiatus; Cylicostephanus spp., including C. calicatus, C. goldi, C. longibursatus, VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00225 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 216 21 CFR Ch. I (4–1–16 Edition) § 520.1454 and C. minutus; Coronocyclus spp., in cluding C. coronatus, C. labiatus, and C. labratus; Gyalocephalus capitatus; and Petrovinema poculatus; small strongyles: undifferentiated lumenal larvae; encysted cyathostomes (late L3 and L4 mucosal cyathostome larvae); ascarids: Parascaris equorum (adults and L4 larval stages); pinworms: Oxyuris equi (adults and L4 larval stages); hairworms: Trichostrongylus axei (adults); large-mouth stomach worms: Habronema muscae (adults); horse stom ach bots: Gasterophilus intestinalis (2nd and 3rd instars) and G. nasalis (3rd instars); and tapeworms: Anoplocephala perfoliata (adults). One dose also sup presses strongyle egg production for 84 days. (3) Limitations. Do not use in horses intended for human consumption. [68 FR 51446, Aug. 27, 2003, as amended at 69 FR 21956, Apr. 23, 2004; 70 FR 75017, Dec. 19, 2005; 78 FR 28825, May 20, 2014] § 520.1454 Moxidectin solution. (a) Specifications. Each milliliter (mL) of solution contains 1 milligram (mg) moxidectin. (b) Sponsor. See No. 000010 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.426 of this chapter. (d) Special considerations. See § 500.25 of this chapter. (e) Conditions of use in sheep—(1) Amount. Administer 1 mL per 11 pounds body weight (1 mL per 5 kilograms) by mouth. (2) Indications for use. For the treat ment and control of the adult and L4 larval stages of Haemonchus contortus, Teladorsagia circumcincta, T. trifurcata, Trichostrongylus axei, T. colubriformis, T. vitrinus, Cooperia curticei, C. oncophora, Oesophagostomum columbianum, O. venulosum, Nematodirus battus, N. filicollis, and N. spathiger. (3) Limitations. Sheep must not be slaughtered for human consumption within 7 days of treatment. Because a withholding time in milk has not been established for this product, do not use in female sheep providing milk for human consumption. [70 FR 76163, Dec. 23, 2005, as amended at 76 FR 48714, Aug. 9, 2011] § 520.1468 Naproxen. (a) Specifications. Each gram of gran ules contains 500 milligrams (mg) (50 percent) naproxen. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Conditions of use in horses—(1) Amount. 10 mg per kilogram of body weight twice daily top dressed on feed for up to 14 consecutive days. (2) Indications for use. For the relief of inflammation and associated pain and lameness exhibited with arthritis, as well as myositis and other soft tissue diseases of the musculoskeletal sys tem. (3) Limitations. Do not use in horses intended for human consumption. Fed eral law restricts this drug to use by or on the order of a licensed veterinarian. [78 FR 28825, May 20, 2014] § 520.1484 Neomycin. (a) Specifications—(1) Each ounce of powder contains 20.3 grams (g) neomy cin sulfate (equivalent to 14.2 g neomy cin base). (2) Each milliliter of solution con tains 200 milligrams (mg) neomycin sulfate (equivalent to 140 mg neomycin base). (b) Sponsors. See sponsors in § 510.600(c) of this chapter for use as in paragraph (e) of this section. (1) Nos. 054771 and 054925 for use of product described in paragraph (a)(1) as in paragraph (e)(1) of this section. (2) Nos. 054771, 058005, and 061623 for use of product described in paragraph (a)(1) as in paragraphs (e)(1) and (e)(2) of this section. (3) Nos. 000859, 054771, 054925, and 058005 for use of product described in paragraph (a)(2) as in paragraph (e)(1) of this section. (c) Related tolerances. See § 556.430 of this chapter. (d) Special labeling considerations. La beling shall bear the following warning statements: ‘‘A withdrawal period has not been established for use in preruminating calves. Do not use in calves to be processed for veal. Use of more than one product containing neo mycin or failure to follow withdrawal times may result in illegal drug resi dues.’’ VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00226 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 217 Food and Drug Administration, HHS § 520.1604 (e) Conditions of use—(1) Cattle, swine, sheep, and goats—(i) Amount. 10 mg per pound (/lb) of body weight per day (22 mg per kilogram (/kg)) in divided doses for a maximum of 14 days. (ii) Indications for use. For the treat ment and control of colibacillosis (bac terial enteritis) caused by Escherichia coli susceptible to neomycin sulfate. (iii) Limitations. Add powder to drink ing water or milk; not for use in liquid supplements. Administer solution undi luted or in drinking water. Prepare a fresh solution in drinking water daily. If symptoms persist after using this preparation for 2 or 3 days, consult a veterinarian. Treatment should con tinue 24 to 48 hours beyond remission of disease symptoms, but not to exceed a total of 14 consecutive days. Dis continue treatment prior to slaughter as follows: Cattle, 1 day; sheep, 2 days; swine and goats, 3 days. (2) Turkeys—(i) Amount. 10 mg/lb of body weight per day (22 mg/kg) for 5 days. (ii) Indications for use. For the control of mortality associated with E. coli sus ceptible to neomycin sulfate in grow ing turkeys. (iii) Limitations. Add to drinking water; not for use in liquid supple ments. Prepare a fresh solution daily. If symptoms persist after using this preparation for 2 or 3 days, consult a veterinarian. Treatment should con tinue 24 to 48 hours beyond remission of disease symptoms, but not to exceed a total of 5 consecutive days. [71 FR 56866, Sept. 28, 2006, as amended at 71 FR 68738, Nov. 28, 2006; 78 FR 17596, Mar. 22, 2013; 78 FR 28825, May 20, 2014] § 520.1510 Nitenpyram. (a) Specifications. Each tablet con tains 11.4 or 57 milligrams (mg) nitenpyram. (b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter: (1) No. 058198 for use as in paragraphs (d)(1)(i)(A), (d)(1)(ii)(A), and (d)(2) of this section. (2) No. 051311 for use as in paragraphs (d)(1)(i)(B) and (d)(1)(ii)(B) of this sec tion. (c) Special considerations. The concur rent use of nitenpyram tablets and fla vored milbemycin/lufenuron tablets as in paragraph (d)(1)(ii)(B) of this section shall be by or on the order of a licensed veterinarian. (d) Conditions of use—(1) Dogs—(i) Amount—(A) One 11.4-mg tablet for dogs weighing less than 25 pounds (lb) or one 57-mg tablet for dogs weighing more than 25 lb, as needed, for use as in paragraph (d)(1)(ii)(A) of this section. (B) One 11.4-mg tablet for dogs weigh ing less than 25 lb or one 57 mg tablet for dogs weighing more than 25 lbs, once or twice weekly, for use as in paragraph (d)(1)(ii)(B) of this section. (ii) Indications for use—(A) For the treatment of flea infestations on dogs and puppies 4 weeks of age and older and 2 lbs of body weight or greater. (B) The concurrent use of nitenpyram tablets as in paragraph (d)(1)(i)(B) of this section with either flavored lufenuron tablets as in § 520.1288(c)(1) of this chapter or flavored milbemycin and lufenuron tablets as in § 520.1443(d)(1) is indicated to kill adult fleas and prevent flea eggs from hatch ing. (2) Cats—(i) Amount—(A) One 11.4-mg tablet, as needed, for use as in para graph (d)(2)(ii)(A) of this section. (B) One 11.4-mg tablet, once or twice weekly, for use as in paragraph (d)(2)(ii)(B) of this section. (ii) Indications for use—(A) For the treatment of flea infestations on cats and kittens 4 weeks of age and older and 2 lbs of body weight or greater. (B) The concurrent use of nitenpyram tablets as in paragraph (d)(2)(i)(B) of this section with flavored lufenuron tablets as in § 520.1288(c)(2) of this chap ter is indicated to kill adult fleas and prevent flea eggs from hatching. [68 FR 51906, Aug. 29, 2003, as amended at 80 FR 18776, Apr. 8, 2015] § 520.1604 Oclacitinib. (a) Specifications. Each tablet con tains 3.6, 5.4, or 16 milligrams (mg) of oclacitinib as oclacitinib maleate. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Conditions of use—(1) Amount. Ad minister orally 0.18 to 0.27 mg/per pound of body weight (0.4 to 0.6 mg/kg body weight) twice daily for up to 14 days; then administered once daily for maintenance therapy. VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00227 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 218 21 CFR Ch. I (4–1–16 Edition) § 520.1615 (2) Indications for use. For control of pruritus associated with allergic der matitis and control of atopic derma titis in dogs at least 12 months of age. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [78 FR 42007, July 15, 2013] § 520.1615 Omeprazole. (a) Specifications. Each gram of paste contains 0.37 gram omeprazole. (b) Sponsor. See No. 050604 in § 510.600(c) of this chapter. (c) Special considerations. When la beled for use as in paragraph (d)(2)(i) of this section, product labeling shall bear: ‘‘Federal law restricts this drug to use by or on the order of a licensed veterinarian.’’ (d) Conditions of use in horses—(1) Amount—(i) For treatment of gastric ulcers, 1.8 milligrams per pound (mg/lb) of body weight (4 milligrams per kilo gram (mg/kg)) once daily for 4 weeks. For prevention of recurrence of gastric ulcers, 0.9 mg/lb of body weight (2 mg/ kg) once daily for at least an addi tional 4 weeks. (ii) For prevention of gastric ulcers using the premarked syringe, one dose per day for 8 or 28 days. Each dose de livers at least 1 mg/kg of body weight. Horses over 1,200 lb body weight should receive two doses per day. (2) Indications for use. (i) For treat ment and prevention of recurrence of gastric ulcers in horses and foals 4 weeks of age and older. (ii) For prevention of gastric ulcers in horses. (3) Limitations. Do not use in horses intended for human consumption. [69 FR 13220, Mar. 22, 2004, as amended at 71 FR 59374, Oct. 10, 2006] § 520.1616 Orbifloxacin tablets. (a) Specifications. Each tablet con tains 5.7, 22.7, or 68 milligrams (mg) orbifloxacin. (b) Sponsor. See No. 000061 in § 510.600(c) of this chapter. (c) Conditions of use in dogs and cats— (1) Amount. 2.5 to 7.5 mg per kilogram body weight once daily. (2) Indications for use. For manage ment of diseases associated with bac teria susceptible to orbifloxacin. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law pro hibits the extralabel use of this drug in food producing animals. [71 FR 14643, Mar. 23, 2006, as amended at 75 FR 26646, May 12, 2010] § 520.1618 Orbifloxacin suspension. (a) Specifications. Each milliliter of suspension contains 30 milligrams (mg) orbifloxacin. (b) Sponsor. See No. 000061 in 510.600(c) of this chapter. (c) Special considerations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Fed eral law prohibits the extralabel use of this drug in food-producing animals. (d) Conditions of use—(1) Dogs—(i) Amount. 1.1 to 3.4 mg/lb (2.5 to 7.5 mg/ kg) of body weight once daily. (ii) Indications for use. For the treat ment of urinary tract infections (cys titis) in dogs caused by susceptible strains of Staphylococcus pseudintermedius, Proteus mirabilis, Esch erichia coli, and Enterococcus faecalis and skin and soft tissue infections (wounds and abscesses) in dogs caused by susceptible strains of Staphylococcus pseudintermedius, Staphylococcus aureus, coagulase-positive staphylococci, Pasteurella multocida, Proteus mirabilis, Pseudomonas spp., Klebsiella pneumoniae, E. coli, Enterobacter spp., Citrobacter spp., E. faecalis, b-hemolytic streptococci (Group G), and Strepto coccus equisimilis. (2) Cats—(i) Amount. 3.4 mg/lb (7.5 mg/ kg) of body weight once daily. (ii) Indications for use. For the treat ment of skin infections (wounds and abscesses) in cats caused by susceptible strains of S. aureus, E. coli, and P. multocida. [75 FR 26646, May 12, 2010] § 520.1628 Oxfendazole powder and pellets. (a) Specifications—(1) Powder for sus pension. Each gram of powder contains 7.57 percent oxfendazole. (2) Pellets. Each gram of pellets con tains 6.49 percent oxfendazole. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00228 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 219 Food and Drug Administration, HHS § 520.1630 (c) Conditions of use—(1) Amount. 10 milligrams per kilogram of body weight. (2) Indications for use. The drug is used in horses for removal of the fol lowing gastrointestinal worms: Large roundworms (Parascaris equorum), ma ture and immature pinworms (Oxyuris equi), large strongyles (Strongylus edentatus, Strongylus vulgaris, and Strongylus equinus), and small strongyles. (3) Limitations—(i) Powder for suspen sion. For gravity administration via stomach tube or for positive adminis tration via stomach tube and dose sy ringe. Discard unused portions of sus pension after 24 hours. Mix drug ac cording to directions prior to use. Ad minister drug with caution to sick or debilitated horses. Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (ii) Pellets. The drug is given by sprin kling on the grain portion of the ra tion. Withholding feed or water prior to administration is not necessary. Ad minister drug with caution to sick or debilitated horses. Not for use in horses intended for food. Consult your veterinarian for assistance in the diag nosis, treatment, and control of para sitism. [44 FR 35211, June 19, 1979, as amended at 46 FR 26301, May 12, 1981; 46 FR 60570, Dec. 11, 1981; 49 FR 28549, July 13, 1984; 61 FR 5506, Feb. 13, 1996; 78 FR 28825, May 20, 2014] § 520.1629 Oxfendazole paste. (a)(1) Specifications. Each gram of paste contains 0.375 gram oxfendazole (37.5 percent). (2) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (3) Conditions of use—(i) Amount. 10 milligrams per kilogram (2.2 pounds) of body weight. (ii) Indications for use. The drug is used in horses for removal of the fol lowing gastrointestinal worms: Large roundworms (Parascaris equorum), ma ture and 4th stage larvae pinworms (Oxyuris equi), large strongyles (Strongylus edentatus, S. vulgaris, and S. equinus), and small strongyles. (iii) Limitations. Horses maintained on premises where reinfection is likely to occur should be retreated in 6 to 8 weeks. Withholding feed or water prior to use is unnecessary. Administer drug with caution to sick or debilitated horses. Not for use in horses intended for food. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. (b)(1) Specifications. Each gram of paste contains 185 milligrams of oxfendazole (18.5 percent). (2) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (3) Related tolerances. See § 556.495 of this chapter. (4) Conditions of use—(i) Amount. 4.5 milligrams per kilogram of body weight (2.05 milligrams per pound). (ii) Indications for use. The drug is used in cattle for the removal and con trol of the following worms: lungworms (Dictyocaulus viviparus—adult, L4); stomach worms: barberpole worms (Haemonchus contortus and H. placei— adult), small stomach worms (Trichostrongylus axei—adult), brown stomach worms (Ostertagia ostertagi— adult, L4, inhibited L4); intestinal worms; nodular worms (Oesophagostomum radiatum—adult), hookworms (Bunostomum phlebotomum—adult), small intestinal worms (Cooperia punctata, C. oncophora, and C. mcmasteri—adult, L4); and tape worms (Moniezia benedeni—adult). (iii) Limitations. For use in cattle only. Treatment may be repeated in 4 to 6 weeks. Cattle must not be slaugh tered until 11 days after treatment. Do not use in female dairy cattle of breed ing age. Consult a veterinarian for as sistance in the diagnosis, treatment, and control of parasitism. [49 FR 38250, Sept. 28, 1984, as amended at 58 FR 39443, July 23, 1993; 61 FR 5506, Feb. 13, 1996; 78 FR 28825, May 20, 2014] § 520.1630 Oxfendazole suspension. (a) Specifications. Each milliliter of suspension contains: (1) 90.6 milligrams (mg) oxfendazole (9.06 percent). (2) 225.0 mg oxfendazole (22.5 percent). (b) Sponsor. See Nos. 000010 and 054771 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.495 of this chapter. (d) Special considerations. See § 500.25 of this chapter. If labeled for adminis tration by stomach tube: Federal law VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00229 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 220 21 CFR Ch. I (4–1–16 Edition) § 520.1631 restricts this drug to use by or on the order of a licensed veterinarian. (e) Conditions of use—(1) Horses. Use the product described in paragraph (a)(1) of this section as follows: (i) Amount. 10 mg per kilogram (/kg) of body weight by stomach tube or dose syringe. Horses maintained on prem ises where reinfection is likely to occur should be retreated in 6 to 8 weeks. (ii) Indications for use. For removal of large roundworms (Parascaris equorum), mature and 4th stage larvae pinworms (Oxyuris equi), large strongyles (Strongylus edentatus, S. vulgaris, and S. equinus), and small strongyles. (iii) Limitations. Withholding feed or water prior to use is unnecessary. Ad minister drug with caution to sick or debilitated horses. Do not use in horses intended for human consumption. (2) Cattle. Use the products described in paragraphs (a)(1) and (a)(2) of this section as follows: (i) Amount. 4.5 mg/kg of body weight by dose syringe. Treatment may be re peated in 4 to 6 weeks. (ii) Indications for use. For the re moval and control of: lungworms (Dictyocaulus viviparus—adult, L4); stomach worms: barberpole worms (Haemonchus contortus and H. placei— adult), small stomach worms (Trichostrongylus axei—adult), brown stomach worms (Ostertagia ostertagi— adult, L4, inhibited L4); intestinal worms; nodular worms (Oesophagostomum radiatum—adult), hookworms (Bunostomum phlebotomum—adult), small intestinal worms (Cooperia punctata, C. oncophora, and C. surnabada—adult, L4), and tape worms (Moniezia benedeni—adult). (iii) Limitations. Cattle must not be slaughtered until 7 days after treat ment. Because a withdrawal time in milk has not been established, do not use in female dairy cattle of breeding age. [55 FR 46943, Nov. 8, 1990, as amended at 56 FR 8710, Mar. 1, 1991; 61 FR 5506, Feb. 13, 1996; 72 FR 10596, Mar. 9, 2007; 73 FR 45610, Aug. 6, 2008; 75 FR 10166, Mar. 5, 2010; 78 FR 28825, May 20, 2014] § 520.1631 Oxfendazole and trichlorfon paste. (a) Specifications. Each gram of paste contains 28.5 milligrams oxfendazole and 454.5 milligrams trichlorfon. (b) Sponsor. See 054771 in § 510.600(c) of this chapter. (c) Conditions of use—(1) Amount. 2.5 milligrams of oxfendazole and 40 milli grams of trichlorfon per kilogram of body weight. (2) Indications for use. The drug is used in horses for removal of bots (Gasterophilus intestinalis, 2nd and 3rd instars; G. nasalis, 3rd instar) and the following gastrointestinal worms: Large roundworms (Parascaris equorum), pinworms (Oxyuris equi), adult and 4th stage larvae; large strongyles (Strongylus edentatus, S. vulgaris, and S. equinus); and small strongyles. (3) Limitations. Horses maintained on premises where reinfection is likely to occur should be retreated in 6 to 8 weeks. Withholding feed or water be fore use is unnecessary. Administer with caution to sick or debilitated horses. Not for use in horses intended for food. Do not administer to mares during the last month of pregnancy. Trichlorfon is a cholinesterase inhib itor. Do not use this product in ani mals simultaneously with, or within a few days before or after treatment with or exposure to, cholinesterase-inhib iting drugs, pesticides, or chemicals. Consult your veterinarian for assist ance in the diagnosis, treatment, and control of parasitism. [50 FR 50291, Dec. 10, 1985, as amended at 61 FR 5506, Feb. 13, 1996; 78 FR 28825, May 20, 2014] § 520.1638 Oxibendazole. (a) Specifications—(1) Each gram of paste contains 227 milligrams (mg) (22.7 percent) oxibendazole. (2) Each milliliter of suspension con tains 100 mg (10 percent) oxibendazole. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Special considerations—(1) See § 500.25 of this chapter. (2) Suspension product described in paragraph (a)(2) of this section shall be labeled: ‘‘Federal law restricts this drug to use by or on the order of a li censed veterinarian.’’ VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00230 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 221 Food and Drug Administration, HHS § 520.1660b (d) Conditions of use in horses—(1) Amount. For uses other than for threadworms (Strongyloides westeri), 10 mg oxibendazole per kilogram (/kg) body weight; for threadworms (Strongyloides westeri), 15 mg/kg. Horses maintained on premises where reinfec tion is likely to occur should be re treated in 6 to 8 weeks. Administer sus pension product by stomach tube in 3 to 4 pints of warm water, or by top dressing or mixing into a portion of the normal grain ration. (2) Indications for use. For removal and control of large strongyles (Strongylus edentatus, S. equinus, S. vulgaris); small strongyles (genera Cylicostephanus, Cylicocyclus, Cyathostomum, Triodontophorus, Cylicodontophorus, and Gyalocephalus); large roundworms (Parascaris equorum); pinworms (Oxyuris equi) including var ious larval stages; and threadworms (Strongyloides westeri). (3) Limitations. Do not use in horses intended for human consumption. [78 FR 28825, May 20, 2014] § 520.1660 Oxytetracycline. § 520.1660a Oxytetracycline and carbomycin in combination. (a) Specifications. (1) Oxytetracycline: The antibiotic substance produced by growth of Streptomyces rimosus or the same antibiotic substance produced by any other means. (2) Carbomycin: The antibiotic sub stance produced by growth of Streptomyces halstedii or the same anti biotic substance produced by any other means. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Special considerations. The quan tities of oxytetracycline in paragraph (e) of this section refer to the activity of oxytetracycline hydrochloride and the quantities of carbomycin listed refer to the activity of an appropriate standard. (d) Related tolerances. See §§ 556.110 and 556.500 of this chapter. (e) Conditions of use. It is used as oxy tetracycline hydrochloride plus carbomycin base in drinking water of chickens as follows: (1) Amount. 1.0 gram of oxytetra cycline and 1.0 gram carbomycin per gallon. (2) Indications for use. As an aid in the prevention and treatment of com plicated chronic respiratory disease (air-sac infection) caused by Myco plasma gallisepticum and secondary bac terial organisms associated with chron ic respiratory disease such as E. coli. (3) Limitations. Administer for not more than 5 days; not for use in chick ens producing eggs for human con sumption; withdraw 24 hours before slaughter. [40 FR 13838, Mar. 27, 1975, as amended at 78 FR 28825, May 20, 2014] § 520.1660b Oxytetracycline hydro chloride capsules. (a) Specifications. The drug is in cap sule form with each capsule containing 125 or 250 milligrams of oxytetracycline hydrochloride. Oxytetracycline is the antibiotic substance produced by growth of Streptomyces rimosus or the same antibiotic substance produced by any other means. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Conditions of use. (1) It is used in dogs and cats for the treatment of bac terial pneumonia caused by Brucella bronchiseptica, tonsilitis caused by Streptococcus hemolyticus, bacterial en teritis caused by Escherichia coli, uri nary tract infections caused by Esch erichia coli, and wound infections caused by Staphylococcus aureus. (2) The drug is administered orally to dogs and cats at a dosage level of 25–50 milligrams per pound of body weight per day in divided doses at 12-hour in tervals. The drug can be used for con tinuation of compatible antibiotic therapy following parenteral oxytetra cycline administration where rapidly attained, sustained antibiotic blood levels are required. The duration of treatment required to obtain favorable response will depend to some extent on the severity and degree of involvement and the susceptibility of the infectious agent. Clinical response to antibiotic therapy usually occurs within 48 to 72 hours. If improvement is not observed within that period, the diagnosis and course of treatment should be reconsid ered. To assure adequate treatment, VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00231 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 222 21 CFR Ch. I (4–1–16 Edition) § 520.1660c administration of the drug should con tinue for at least 48 hours following fa vorable clinical response. (3) Federal law restricts this drug to use by or on the order of a licensed vet erinarian. [40 FR 13838, Mar. 27, 1975, as amended at 78 FR 28825, May 20, 2014] § 520.1660c Oxytetracycline hydro chloride tablets/boluses. (a) Specifications. Each tablet or bolus contains 250, 500, or 1,000 milligrams of oxytetracycline hydrochloride. (b) Sponsors. For sponsors in § 510.600(c) of this chapter: See 000010 for use of 500 and 1,000 milligram boluses. See No. 054771 for use of 250 and 500 milligram tablets. (c) Tolerances. See § 556.500 of this chapter. (d) Conditions of use in beef and dairy cattle—(1)(i) Amount. 250 milligrams per 100 pounds of body weight every 12 hours (5 milligrams per pound of body weight daily in two doses). (ii) Indications for use. For control of bacterial enteritis caused by Salmonella typhimurium and Escherichia coli (colibacillosis) and bacterial pneu monia (shipping fever complex, pasteurellosis) caused by Pasteurella multocida. (2)(i) Amount. 500 milligrams per 100 pound of body weight every 12 hours (10 milligrams per pound of body weight daily in two doses). (ii) Indications for use. For treatment of bacterial enteritis caused by Sal monella typhimurium and Escherichia coli (colibacillosis) and bacterial pneu monia (shipping fever complex, pasteurellosis) caused by Pasteurella multocida. (3) Limitations. Dosage should con tinue until the animal returns to nor mal and for 24 hours to 48 hours after symptoms have subsided. Treatment should not exceed 4 consecutive days. Do not exceed 500 milligrams per 100 pounds of body weight every 12 hours (10 milligrams per pound daily). For sponsor No. 054771: Discontinue treat ment 7 days prior to slaughter. Not for use in lactating dairy cattle. A with drawal period has not been established for this product in preruminating calves. Do not use in calves to be proc essed for veal. [46 FR 32440, June 23, 1981, as amended at 50 FR 1045, Jan. 9, 1985; 63 FR 70334, Dec. 21, 1998; 70 FR 16394, Apr. 4, 2005; 78 FR 28825, May 20, 2014] § 520.1660d Oxytetracycline powder. (a) Specifications. The drug is a solu ble powder distributed in packets or pails having several concentrations of oxytetracycline hydrochloride (inde pendent of the various net weights) as follows: (1) Each 18.14 grams of powder con tains 1 gram of oxytetracycline hydro chloride (OTC HCl) (packets: 4, 6.4, and 16 oz.). (2) Each 4.43 grams of powder con tains 1 gram of OTC HCl (packets: 4 and 16 oz.). (3) Each 1.32 grams of powder con tains 1 gram of OTC HCl (packets: 2.39, 4.78, and 9.55 oz.; jars: 2.25 lbs.; and pails: 4.5 lbs.). (4) Each 2.73 grams of powder con tains 1 gram of OTC HCl (packets: 2.46 and 9.87 oz, 3.09 and 3.91 lb; pail: 3.09 lb). (5) Each 4.2 grams of powder contains 1 gram of OTC HCl (packets: 3.8 and 15.2 oz; pails: 4.74 and 23.7 lb). (6) Each 1.32 grams of powder con tains 1 gram of OTC HCl (packet: 4.78 oz.; pail: 5 lb). Each 2.73 grams of pow der contains 1 gram of OTC HCl (pack et: 9.87 oz). (7) Each 1.32 grams of powder con tains 1 gram of OTC HCl (packet: 4.78 and 9.6 oz.; pails: 2 and 5 lb); each 18.1 grams of powder contains 1 gram of OTC HCl (packet: 6.4 oz.; pails: 2 and 5 lb). (8) Each 135.5-gram packet (4.78 ounce) contains 102.4 grams of OTC HCl. Each 677.5-gram packet (23.9 ounce) contains 512 grams of OTC HCl. (9) Each 2.73 grams of powder con tains 1 gram of OTC HCl (packets: 9.87 and, 19.75 oz, and 3.91 lb; pails: 3.09 and 5 lb). (10) Each 2.73 grams of powder con tains 1 gram of OTC HCl (packets: 9.87 and 19.74 oz; pails: 5 lb). (b) Sponsor. See sponsor numbers in § 510.600(c) of this chapter as follows: (1) No. 054771 for use of OTC HCl con centrations in paragraphs (a)(1), (a)(2), and (a)(3) of this section in chickens, VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00232 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 223 Food and Drug Administration, HHS § 520.1660d turkeys, swine, cattle, sheep, and honey bees. (2) No. 054771 for use of OTC HCl con centration in paragraph (a)(4) of this section in chickens, turkeys, and swine. (3) No. 054628 for use of OTC HCl con centration in paragraph (a)(5) of this section in turkeys and chickens. (4) No. 057561 for use of OTC HCl con centration in paragraph (a)(6) of this section in chickens, turkeys, and swine. (5) No. 061623 for use of OTC HCl con centration in paragraph (a)(7) of this section in chickens, turkeys, swine, cattle, sheep, and honeybees. (6) No. 069254 for use of OTC HCl con centrations in paragraph (a)(8) of this section in chickens, turkeys, swine, cattle, sheep, and honey bees. (7) No. 061623 for use of OTC HCl con centration in paragraph (a)(9) of this section in chickens, turkeys, and swine. (c) Related tolerances. See § 556.500 of this chapter. (d) Conditions of use. (1) It is used in drinking water as follows: (i) Chickens—(A)(1) Amount per gallon. 200 to 400 milligrams. (2) Indications for use. Control of in fectious synovitis caused by Myco plasma synoviae susceptible to oxytet racycline. (3) Limitations. Prepare a fresh solu tion daily. Administer 7 to 14 days. Not to be used for more than 14 consecutive days. Use as sole source of drinking water. Do not use in birds producing eggs for human consumption. (B)(1) Amount per gallon. 400 to 800 milligrams. (2) Indications for use. Control of chronic respiratory disease (CRD) and air sac infections caused by Myco plasma gallisepticum and E. coli suscep tible to oxytetracycline; control of fowl cholera caused by Pasteurella multocida susceptible to oxytetra cycline. (3) Limitations. Prepare a fresh solu tion daily. Administer 7 to 14 days. Not to be used for more than 14 consecutive days. Use as sole source of drinking water. Do not use in birds producing eggs for human consumption. (ii) Turkeys—(A)(1) Amount per gallon. 200 to 400 milligrams. (2) Indications for use. Control of hexamitiasis caused by Hexamita meleagridis susceptible to oxytetra cycline. (3) Limitations. Prepare a fresh solu tion daily. Administer 7 to 14 days. Not to be used for more than 14 consecutive days. Use as sole source of drinking water. Do not use in birds producing eggs for human consumption. With draw 5 days prior to slaughter those products sponsored by Nos. 054771, and 061623 in § 510.600(c) of this chapter. Withdraw 4 days prior to slaughter those products sponsored by No. 054628. Zero-day withdrawal for those products sponsored by Nos. 054771, 057561, 061133, and 069254. (B)(1) Amount per gallon. 400 milli grams. (2) Indications for use. Control of in fectious synovitis caused by Myco plasma synoviae susceptible to oxytet racycline. (3) Limitations. Prepare a fresh solu tion daily. Administer 7 to 14 days. Not to be used for more than 14 consecutive days. Use as sole source of drinking water. Do not use in birds producing eggs for human consumption. With draw 5 days prior to slaughter those products sponsored by Nos. 054771, and 061623 in § 510.600(c) of this chapter. Withdraw 4 days prior to slaughter those products sponsored by No. 054628. Zero-day withdrawal for those products sponsored by Nos. 054771, 057561, 061133, and 069254. (C)(1) Amount. 25 milligrams per pound of body weight. (2) Indications for use. Growing tur keys. Control of complicating bacterial organisms associated with bluecomb (transmissible enteritis, coronaviral enteritis) susceptible to oxytetra cycline. (3) Limitations. Prepare a fresh solu tion daily. Administer 7 to 14 days. Not to be used for more than 14 consecutive days. Use as sole source of drinking water. Do not use in birds producing eggs for human consumption. With draw 5 days prior to slaughter those products sponsored by Nos. 054771, and 061623 in § 510.600(c) of this chapter. Withdraw 4 days prior to slaughter those products sponsored by No. 054628. Zero-day withdrawal for those products VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00233 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 224 21 CFR Ch. I (4–1–16 Edition) § 520.1696 sponsored by Nos. 054771, 057561, 061133, and 069254. (iii) Swine—(A) Amount. 10 milligrams per pound of body weight daily. (B) Indications for use. Control and treatment of bacterial enteritis caused by Escherichia coli and Salmonella choleraesuis and bacterial pneumonia caused by Pasteurella multocida suscep tible to oxytetracycline. For breeding swine: Control and treatment of lepto spirosis (reducing the incidence of abortions and shedding of leptospira) caused by Leptospira pomona suscep tible to oxytetracycline. (C) Limitations. Prepare a fresh solu tion daily. Use as sole source of OTC. Administer up to 14 days; do not use for more than 14 consecutive days; with draw zero days prior to slaughter those products sponsored by Nos. 054771and 061623. Administer up to 5 days; do not use for more than 5 consecutive days; withdraw zero days prior to slaughter those products sponsored by Nos. 048164, 054771, 057561, and 061133. (iv) Calves, beef cattle, and nonlac tating dairy cattle—(A) Amount. 10 milli grams per pound of body weight daily. (B) Indications for use. Control and treatment of bacterial enteritis caused by E. coli and bacterial pneumonia (shipping fever complex) caused by P. multocida susceptible to oxytetra cycline. (C) Limitations. Prepare a fresh solu tion daily. Administer up to 14 days. Do not use for more than 14 consecu tive days. Use as sole source of oxytet racycline. Do not administer this prod uct with milk or milk replacers. Ad minister 1 hour before or 2 hours after feeding milk or milk replacers. With draw 5 days prior to slaughter. A milk discard period has not been established for this product in lactating dairy cat tle. Do not use in female dairy cattle 20 months of age or older. (v) Sheep—(A) Amount. 10 milligrams per pound of body weight daily. (B) Indications for use. Control and treatment of bacterial enteritis caused by E. coli and bacterial pneumonia (shipping fever complex) caused by P. multocida susceptible to oxytetra cycline. (C) Limitations. Prepare a fresh solu tion daily. Administer up to 14 days. Do not use for more than 14 consecu tive days. Use as sole source of oxytet racycline. Withdraw 5 days prior to slaughter. (2) It is used in the food of honey bees as follows: (i) Amount. 200 milligrams per colony, administered via either a 1:1 sugar syrup (equal parts of sugar and water weight to weight) or dusting with a powdered sugar mixture. (ii) Indications for use. For control of American foulbrood caused by Paenibacillus larvae and European foulbrood caused by Streptococcus pluton susceptible to oxytetracycline. (iii) Limitations. The drug is adminis tered in 3 applications of sugar syrup or 3 dustings at 4- to 5-day intervals. The drug should be fed early in the spring or fall and consumed by the bees before main honey flow begins to avoid contamination of production honey. Remove at least 6 weeks prior to main honey flow. [40 FR 13838, Mar. 27, 1975] EDITORIAL NOTE: For FEDERAL REGISTER ci tations affecting § 520.1660d, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.fdsys.gov. § 520.1696 Penicillin. § 520.1696a [Reserved] § 520.1696b Penicillin G powder. (a) Specifications. Each gram of pow der contains penicillin G potassium equivalent to 1.54 million units of peni cillin G. (b) Sponsors. See Nos. 010515, 054771, 059320, 061623 and 076475 in § 510.600(c) of this chapter. (c) Conditions of use in turkeys— (1) Amount. 1,500,000 units per gallon drinking water for 5 days. (2) Indications for use. Treatment of erysipelas caused by Erysipelothrix rhusiopathiae. (3) Limitations. Prepare concentrated stock solution for use with medication proportioners fresh every 24 hours. Pre pare recommended use levels for grav ity flow watering system fresh every 12 hours. For best results, treatment should be started at the first sign of in fection. Discontinue treatment at least 1 day prior to slaughter. Not for use in VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00234 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 225 Food and Drug Administration, HHS § 520.1720a turkeys producing eggs for human con sumption. [57 FR 37326, Aug. 18, 1992, as amended at 59 FR 42493, Aug. 18, 1994; 60 FR 26359, May 17, 1995; 62 FR 55160, Oct. 23, 1997; 65 FR 10705, Feb. 29, 2000; 66 FR 14073, Mar. 9, 2001; 68 FR 4914, Jan. 31, 2003; 68 FR 26204, May 15, 2003; 69 FR 9946, Mar. 3, 2004; 69 FR 41428, July 9, 2004; 77 FR 20988, Apr. 9, 2012; 78 FR 28825, May 20, 2014] § 520.1696c Penicillin V powder. (a) Specifications. When reconstituted, each milliliter contains 25 milligrams (40,000 units) of penicillin V. (b) Sponsor. See No. 050604 in § 510.600(c) of this chapter. (c) Conditions of use in dogs and cats— (1) Amount. 10 to 15 milligrams per pound of body weight every 6 to 8 hours. (2) Indications for use. Treatment of respiratory, urogenital, skin, and soft tissue infections and septicemia caused by pathogens susceptible to penicillin V potassium. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [57 FR 37326, Aug. 18, 1992; 57 FR 42623, Sept. 15, 1992; 77 FR 20988, Apr. 9, 2012; 78 FR 28826, May 20, 2014] § 520.1696d Penicillin V tablets. (a) Specifications. Each tablet con tains penicillin V potassium equivalent to 125 milligrams (200,000 units) or 250 milligrams (400,000 units) of penicillin V. (b) Sponsors. See Nos. 050604 and 054771 in § 510.600(c) of this chapter. (c) Conditions of use in dogs and cats— (1) Amount. 10 to 15 milligrams per pound of body weight every 6 to 8 hours. (2) Indications for use. Treatment of respiratory, urogenital, skin and soft tissue infections and septicemia caused by pathogens susceptible to penicillin V potassium. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [57 FR 37327, Aug. 18, 1992, as amended at 59 FR 58775, Nov. 15, 1994; 78 FR 28826, May 20, 2014] § 520.1705 Pergolide. (a) Specifications. Each tablet con tains 1 milligram (mg) pergolide mesylate. (b) Sponsor. See No. 000010 in § 510.600(c) of this chapter. (c) Conditions of use in horses—(1) Amount. Administer orally at a start ing dose of 2 micrograms/kilograms (μ/ kg) once daily. Dosage may be adjusted to effect, not to exceed 4 μg/kg daily. (2) Indications for use. For the control of clinical signs associated with Pitui tary Pars Intermedia Dysfunction (Equine Cushing’s Disease). (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [77 FR 15960, Mar. 19, 2012] § 520.1720 Phenylbutazone oral dosage forms. § 520.1720a Phenylbutazone tablets and boluses. (a) Specifications. Each tablet con tains 100, 200, or 400 milligrams (mg), or 1 gram (g) of phenylbutazone. Each bolus contains 1, 2, or 4 gram g of phenylbutazone. (b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter, as follows: (1) No. 000061 for use of 100- or 400-mg or 1-g tablets, or 2- or 4-g boluses, in dogs and horses. (2) Nos. 054628 and 069043 for use of 100- or 200-mg or 1-g tablets in dogs and horses. (3) Nos. 054771 and 061623 for use of 100-mg or 1-g tablets in dogs and horses. (4) [Reserved] (5) No. 000143 for use of 1-g tablets in horses. (6) No. 058829 for use of 100-mg or 1-g tablets in dogs and horses. (c) Conditions of use—(1) Dogs—(i) Amount. 20 mg per pound of body weight daily. (ii) Indications for use. For the relief of inflammatory conditions associated with the musculoskeletal system. (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (2) Horses—(i) Amount. 1 to 2 g per 500 pounds of body weight daily. VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00235 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 226 21 CFR Ch. I (4–1–16 Edition) § 520.1720b (ii) Indications for use. For the relief of inflammatory conditions associated with the musculoskeletal system. (iii) Limitations. Do not use in horses intended for human consumption. Fed eral law prohibits the use of this drug in female dairy cattle 20 months of age or older. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [73 FR 8192, Feb. 13, 2008, as amended at 74 FR 1146, Jan. 12, 2009; 76 FR 11331, Mar. 2, 2011; 76 FR 17777, Mar. 31, 2011; 78 FR 21060, Apr. 9, 2013; 78 FR 28826, May 20, 2014; 81 FR 17607, Mar. 30, 2016] § 520.1720b Phenylbutazone granules. (a) Specifications. Each package of granules contains 1 or 8 grams of phenylbutazone. (b) Sponsors. See sponsors in § 510.600(c) of this chapter. (1) No. 000061 for 8-gram package. (2) No. 059320 for 1-gram package. (c) Conditions of use in horses—(1) Amount. Administer 1 to 2 grams per 500 pounds of body weight, not to ex ceed 4 grams, daily as required. by add ing to a portion of the usual grain ra tion. (2) Indications for use. For the treat ment of inflammatory conditions asso ciated with the musculoskeletal sys tem. (3) Limitations. Do not use in horses intended for human consumption. Fed eral law prohibits the use of this drug in female dairy cattle 20 months of age or older. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [78 FR 28826, May 20, 2014] § 520.1720c Phenylbutazone paste. (a) Specifications—(1) Each gram of paste contains 0.2 grams phenylbutazone. (2) Each gram of paste contains 0.35 grams phenylbutazone. (b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter. (1) No. 000061 for use of product de scribed in paragraph (a)(1) of this sec tion. (2) No. 017030 for use of product de scribed in paragraph (a)(2) of this sec tion. (c) Conditions of use in horses—(1) Amount. 1 to 2 grams of phenylbutazone per 500 pounds of body weight, not to exceed 4 grams daily. (2) Indications for use. For relief of in flammatory conditions associated with the musculoskeletal system. (3) Limitations. Do not use in horses intended for human consumption. Fed eral law prohibits the use of this drug in female dairy cattle 20 months of age or older. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [45 FR 84762, Dec. 23, 1980, as amended at 58 FR 29777, May 24, 1993; 61 FR 8873, Mar. 6, 1996; 62 FR 61625, Nov. 19, 1997; 68 FR 43926, July 25, 2003; 72 FR 60550, Oct. 25, 2007; 77 FR 4897, Feb. 1, 2012; 78 FR 28826, May 20, 2014; 79 FR 74020, Dec. 15, 2014] § 520.1720d Phenylbutazone gel. (a) Specifications. Each 30 grams of gel contains 4 grams of phenylbutazone. (b) Sponsor. See No. 061623 in § 510.600(c) of this chapter. require bio equivalency and safety information. (c) Conditions of use in horses—(1) Amount. 1 to 2 grams of phenylbutazone per 500 pounds of body weight, not to exceed 4 grams daily. (2) Indications for use. For relief of in flammatory conditions associated with the musculoskeletal system of horses. (3) Limitations. Do not use in horses intended for human consumption. Fed eral law prohibits the use of this drug in female dairy cattle 20 months of age or older. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [50 FR 13561, Apr. 5, 1985, as amended at 50 FR 49372, Dec. 2, 1985; 55 FR 8462, Mar. 8, 1990; 66 FR 14073, Mar. 9, 2001; 68 FR 4915, Jan. 31, 2003; 78 FR 28826, May 20, 2014] § 520.1720e Phenylbutazone powder. (a) Specifications—(1) Each 1.15 grams (g) of powder contains 1 g phenylbutazone. (2) Each 10 g of powder contains 1 g phenylbutazone. (b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter. (1) No. 027053 for use of product de scribed in paragraph (a)(1) of this sec tion. (2) No. 057699 for use of product de scribed in paragraph (a)(2) of this sec tion. VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00236 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 227 Food and Drug Administration, HHS § 520.1802b (c) Conditions of use in horses—(1) Amount. Administer 1 to 2 g (1 to 2 level scoops, using the scoop provided) per 500 pounds of body weight on a small amount of palatable feed, not exceed 4 g per animal daily. (2) Indications for use. For the relief of inflammatory conditions associated with the musculosketetal system. (3) Limitations. Do not use in horses intended for human consumption. Fed eral law prohibits the extralabel use of this product in female cattle 20 months of age or older. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [72 FR 27956, May 18, 2007] § 520.1760 Phenylpropanolamine. (a) Specifications. Each chewable tab let contains 25, 50, or 75 milligram (mg) phenylpropanolamine hydrochloride. (b) Sponsors. See No. 055246 in § 510.600(c) of this chapter. (c) Conditions of use in dogs—(1) Amount. Administer 2 mg/kg of body weight twice daily. (2) Indications for use. For the control of urinary incontinence due to urethral sphincter hypotonus in dogs. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [77 FR 15961, Mar. 19, 2012] § 520.1780 Pimobendan. (a) Specifications. Each chewable tab let contains 1.25, 2.5, 5, or 10 milligrams (mg) pimobendan. (b) Sponsor. See No. 000010 in § 510.600(c) of this chapter. (c) Conditions of use in dogs—(1) Amount. Administer orally at a total daily dose of 0.23 mg per pound (0.5 mg per kilogram) body weight, using a suitable combination of whole or half tablets. The total daily dose should be divided into two portions administered approximately 12 hours apart. (2) Indications for use. For the man agement of the signs of mild, mod erate, or severe (modified New York Heart Association Class II, III, or IV) congestive heart failure due to atrio ventricular valvular insufficiency or dilated cardiomyopathy; for use with concurrent therapy for congestive heart failure as appropriate on a case by-case basis. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [72 FR 27733, May 17, 2007, as amended at 79 FR 18158, Apr. 1, 2014] § 520.1802 Piperazine-carbon disulfide complex oral dosage forms. § 520.1802a Piperazine-carbon disul fide complex suspension. (a) Specifications. Each fluid ounce of suspension contains 7.5 grams of piper azine-carbon disulfide complex. The pi perazine-carbon disulfide complex con tains equimolar parts of piperazine and carbon disulfide (1 gram contains 530 mgs of piperazine and 470 mgs of carbon disulfide). (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Conditions of use in horses and ponies—(1) Amount. Administer 1 fluid ounce per 100 pounds of body weight by stomach tube or dose syringe after withholding feed overnight or for 8 to 10 hours. (2) Indications for use. For removing ascarids (large roundworms, Parascaris equorum), bots (Gastrophilus spp.), small strongyles, large strongyles (Strongyles spp.), and pinworms (Oxyuris equi). (3) Limitations. Do not use in horses intended for human consumption. Fed eral law restricts this drug to use by or on the order of a licensed veterinarian. [45 FR 52781, Aug. 8, 1980, as amended at 78 FR 28826, May 20, 2014] § 520.1802b Piperazine-carbon disul fide complex boluses. (a) Specifications. Each bolus contains 20 grams of piperazine-carbon disulfide complex. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Conditions of use in horses and ponies—(1) Amount. For removal of ascarids and small strongyles, 1 bolus (20 grams) per 500 pounds body weight; removal of large strongyles, pinworms, and bots, 1 bolus per 250 pounds body weight. (2) Indications for use. For removing ascarids (large roundworms, Parascaris equorum), large strongyles (Strongylus spp.) bots (Gastrophilus spp.), small VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00237 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 228 21 CFR Ch. I (4–1–16 Edition) § 520.1802c strongyles, and pinworms (Oxyuris equi). (3) Limitations. Withhold feed over night or for 8 to 10 hours. Give water just before and/or after treatment. Re sume regular feeding 4 to 6 hours after treatment. Treatment of debilitated or anemic animals is contraindicated. Do not administer to animals that are or were recently affected with colic, diar rhea, or infected with a serious infec tious disease. As with most anthelmintics, drastic cathartics or other gastrointestinal irritants should not be administered in conjunction with this drug. Animals in poor condi tion or heavily parasitized should be given one half the recommended dose and treated again in 2 or 3 weeks. Con sult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. [45 FR 52782, Aug. 8, 1980, as amended at 78 FR 28826, May 20, 2014] § 520.1802c Piperazine-carbon disul fide complex with phenothiazine suspension. (a) Specifications. Each fluid ounce contains 5 grams of piperazine-carbon disulfide complex and 0.83 gram of phenothiazine. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Conditions of use in horses and ponies—(1) Amount. Administer 1 fluid ounce per 100 pounds of body weight by stomach tube or dose syringe after withholding feed overnight or for 8 to 10 hours. (2) Indications for use. For removing ascarids (large roundworms, Parascaris equorum), bots (Gastrophilus spp.), small strongyles, and large strongyles (Strongylus spp.). (3) Limitations. Do not use in horses intended for human consumption. Fed eral law restricts this drug to use by or on the order of a licensed veterinarian. [45 FR 52782, Aug. 8, 1980, as amended at 78 FR 28826, May 20, 2014] § 520.1803 Piperazine citrate capsules. (a) Specifications. Each capsule con tains piperazine citrate equivalent to 140 milligrams of piperazine base. (b) Sponsor. See No. 021091 in § 510.600(c) of this chapter. (c) Conditions of use in dogs and cats— (1) Amount. The contents of 1 capsule should be mixed with the food of the animal for each 5 pounds, or fraction thereof of body weight, except dogs weighing over 25 pounds should be given the contents of 6 capsules. The drug should be mixed in 1/2 of the reg ular feeding and when the animal has finished eating the dosed food, the re mainder of the food may be given. Dogs and cats may be wormed at 6 to 8 weeks of age. The first treatment should be repeated 10 days later. Rein fection may occur. Repeat treatment if indicated. (2) Indications for use. For the re moval of large roundworms (Toxocara canis and Toxascaris leonina). (3) Limitations. Severely debilitated animals should not be treated except on the advice of a veterinarian. [40 FR 13838, Mar. 27, 1975, as amended at 54 FR 38515, Sept. 19, 1989; 78 FR 28826, May 20, 2014] § 520.1804 Piperazine phosphate cap sules. (a) Specifications. Each capsule con tains 120, 300, or 600 milligrams of pi perazine phosphate monohydrate. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Conditions of use—(1) Amount. 60 milligrams of piperazine phosphate monohydrate per pound of body weight. (2) Indications for use—(i) Dogs. It is used for the removal of large roundworms (ascarids) Toxocara canis and Toxascaris leonina. (ii) Cats. It is used for the removal of large roundworms (ascarids) Toxocara mystax and Toxacaris leonina. (3) Limitations. Administer in ani mal’s food or milk. For animals up to 1 year of age administer every 2 or 3 months; for animals over 1 year old, administer periodically as necessary. Consult your veterinarian for assist ance in the diagnosis, treatment, and control of parasitism. [43 FR 6941, Feb. 17, 1978; 43 FR 9804, Mar. 10, 1978, as amended at 46 FR 20158, Apr. 3, 1981; 69 FR 31878, June 8, 2004; 78 FR 28826, May 20, 2014] VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00238 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 229 Food and Drug Administration, HHS § 520.1807 § 520.1805 Piperazine phosphate with thenium closylate tablets. (a) Specifications. Each scored tablet contains the equivalent of 250 milli grams piperazine hexahydrate (as pi perazine phosphate) and 125 milligrams thenium (as thenium closylate) or 500 milligrams piperazine hexahydrate (as piperazine phosphate) and 250 milli grams thenium (as thenium closylate). (b) Sponsor. See No. 000061 in § 510.600(c) of this chapter. (c) Conditions of use—(1) Amount. Ad minister orally to dogs as follows: NUMBER OF TABLETS AT EACH OF THE TWO DOSES Animal weight (lb) 375 mg 750 mg 2 but less than 5 ............................... 1⁄2 ................ 5 but less than 10 ............................. 1 1⁄2 10 or heavier ..................................... 2 1 (2) Indications for use. For removal of immature (fourth stage larvae) and adult hookworms (Ancylostoma caninum, A. braziliense, and Uncinaria stenocephala) and ascarids (Toxocara canis) from weaned pups and adult dogs. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [43 FR 32747, July 28, 1978, as amended at 47 FR 55476, Dec. 10, 1982; 61 FR 8873, Mar. 6, 1996; 62 FR 61625, Nov. 19, 1997; 78 FR 28826, May 20, 2014] § 520.1806 Piperazine suspension. (a) Specifications. Each milliliter of suspension contains piperazine monohydrochloride equivalent to 33.5 milligrams (mg) piperazine base. (b) Sponsor. See No. 017135 in § 510.600(c) of this chapter. (c) Special considerations. See § 500.25(c) of this chapter. (d) Conditions of use in dogs—(1) Indi cations for use. For the removal of roundworms (Toxocara canisand Toxascaris leonina). (2) Dosage. Administer 20 to 30 mg pi perazine base per pound body weight as a single dose. (3) Limitations. Administer by mixing into the animal’s ration to be con sumed at one feeding. For animals in heavily contaminated areas, reworm at monthly intervals. Not for use in unweaned pups or animals less than 3 weeks of age. [70 FR 17319, Apr. 6, 2005] § 520.1807 Piperazine. (a) Specifications. A soluble powder or liquid containing piperazine dihydrochloride or dipiperazine sulfate, equivalent to 17, 34, or 230 grams of pi perazine per pound or 100 milliliters. (b) Sponsor. See No. 015565 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.513 of this chapter. (d) Conditions of use—(1) Chickens—(i) Amount. 50 milligrams per bird under 6 weeks, 100 milligrams per bird over 6 weeks. (ii) Indications for use. For removal of large roundworm (Ascaridia spp.). (iii) Limitations. For use in drinking water or feed. Use as sole source of drinking water. Prepare fresh solution daily. Use as 1-day single treatment. Withdraw 14 days prior to slaughter. Do not use for chickens producing eggs for human consumption. Consult your veterinarian for assistance in the diag nosis, treatment, and control of para sitism. (2) Turkeys—(i) Amount. 100 milli grams per bird up to 12 weeks and 200 milligrams per bird over 12 weeks. (ii) Indications for use. For removal of large roundworm (Ascaridia spp.). (iii) Limitations. For use in drinking water or feed. Use as sole source of drinking water. Prepare fresh solution daily. Use as 1-day single treatment. Withdraw 14 days prior to slaughter. Consult your veterinarian for assist ance in the diagnosis, treatment, and control of parasitism. (3) Swine—(i) Amount. 50 milligrams per pound of body weight. (ii) Indications for use. For removal of large roundworm (Ascaris suum) and nodular worms (Oesophagostomum spp.). (iii) Limitations. For use in drinking water or feed. Use as sole source of drinking water. Prepare fresh solution daily. Use as 1-day single treatment. Withdraw 21 days prior to slaughter. Consult your veterinarian for assist ance in the diagnosis, treatment, and control of parasitism. [64 FR 23018, Apr. 29, 1999, as amended at 79 FR 28827, May 20, 2014] VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00239 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 230 21 CFR Ch. I (4–1–16 Edition) § 520.1840 § 520.1840 Poloxalene. (a) Specifications. Polyoxypropylene polyoxyethylene glycol nonionic block polymer. (b) Sponsors. See sponsors in § 510.600(c) of this chapter for use as in paragraph (d) of this section. (1) No. 054771 for use as in paragraphs (d)(1) and (d)(3) of this section. (2) No. 051311 for use as in paragraph (d)(4) of this section. (3) No. 067949 for use as in paragraph (d)(2) of this section. (4) No. 066104 for use as in paragraph (d)(3) of this section. (c) [Reserved] (d) Conditions of use. (1) For treat ment of legume (alfalfa, clover) bloat in cattle. Administer as a drench at the rate of 25 grams for animals up to 500 pounds and 50 grams for animals over 500 pounds of body weight. (2) For control of legume (alfalfa, clo ver) bloat in cattle. Administer, in mo lasses block containing 6.6 percent poloxalene, at the rate of 0.8 oz. of block (1.5 grams poloxalene) per 100 lbs. of body weight per day. (3) For prevention of legume (alfalfa, clover) and wheat pasture bloat in cat tle. A 53-percent poloxalene top dress ing on individual rations of ground feed. Dosage is 1 gram of poloxalene per 100 pounds of body weight daily. If bloating conditions are severe, the dose is doubled. Treatment should be start ed 2 to 3 days before exposure to bloat producing conditions. Repeat use of the drug if animals are exposed to bloat producing conditions for more than 12 hours after the last treatment. Do not exceed the double dose in any 24-hour period. (4) For control of legume (alfalfa, clo ver) and wheat pasture bloat in cattle. Administer in molasses block con taining 6.6 percent poloxalene, at the rate of 0.8 ounce of block (1.5 grams of poloxalene) per 100 pounds of body weight per day. Provide access to blocks at least 7 days before exposure to bloat-producing conditions. [40 FR 13838, Mar. 27, 1975, as amended at 40 FR 39857, Aug. 29, 1975; 42 FR 41854, Aug. 19, 1977; 50 FR 5385, Feb. 8, 1985; 54 FR 33501, Aug. 15, 1989; 56 FR 50653, Oct. 8, 1991; 58 FR 26523, May 4, 1993; 60 FR 55659, Nov. 2, 1995; 66 FR 47963, Sept. 17, 2001; 69 FR 62811, Oct. 28, 2004; 70 FR 32489, June 3, 2005; 78 FR 28826, May 20, 2014] § 520.1846 Polyoxyethylene (23) lauryl ether blocks. (a) Specifications. Each molasses based block contains 2.2 percent polyoxyethylene (23) lauryl ether. (b) Sponsor. See No. 067949 in § 510.600(c) of this chapter. (c) Conditions of use—(1) Amount. 2 grams of polyoxyethylene (23) lauryl ether per 100 kilograms of body weight per day (1 pound of block per 500 kilo gram (1,100 pound) animal per day). (2) Indications for use. For reduction of the incidence of bloat (alfalfa and clover) in pastured cattle. (3) Limitations. Administer free choice to beef cattle and nonlactating dairy cattle only. Initially, provide one block per five head of cattle. Start treatment 10 to 14 days before exposure to bloat-producing pastures. Do not allow cattle access to other sources of salt while being fed this product. Do not feed this product to animals with out adequate forage/roughage consump tion. [50 FR 48189, Nov. 22, 1985, as amended at 56 FR 9841, Mar. 8, 1991; 69 FR 62811, Oct. 28, 2004] § 520.1855 Ponazuril. (a) Specifications. Each gram of paste contains 150 milligrams (mg) ponazuril. (b) Sponsor. See No. 050604 in § 510.600(c) of this chapter. (c) Conditions of use in horses—(1) Amount. Administer orally 15 mg per kilogram (kg) (6.81 mg per pound (lb)) body weight as the first dose, followed by 5 mg/kg (2.27 mg/lb) body weight once daily for a period of 27 additional days. (2) Indications for use. For the treat ment of equine protozoal myeloencephalitis caused by Sarcocystis neurona. VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00240 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 231 Food and Drug Administration, HHS § 520.1871 (3) Limitations. Do not use in horses intended for human consumption. Fed eral law restricts this drug to use by or on the order of a licensed veterinarian. [66 FR 43774, Aug. 21, 2001, as amended at 79 FR 28827, May 20, 2014; 80 FR 34278, June 16, 2015; 80 FR 53459, Sept. 4, 2015] § 520.1860 Pradofloxacin. (a) Specifications. Each milliliter of suspension contains 25 milligrams (mg) pradofloxacin. (b) Sponsor. See No. 000859 in § 510.600(c) of this chapter. (c) Conditions of use in cats—(1) Amount. Administer 3.4 mg/lb (7.5 mg/ kg) body weight once daily for 7 con secutive days. (2) Indications for use. For the treat ment of skin infections (wounds and abscesses) in cats caused by susceptible strains of Pasteurella multocida, Strepto coccus canis, Staphylococcus aureus, Staphylococcus felis, and Staphylococcus pseudintermedius. (3) Limitations. Federal law prohibits the extralabel use of this drug in food producing animals. Federal law re stricts this drug to use by or on the order of a licensed veterinarian. [77 FR 76863, Dec. 31, 2012, as amended at 79 FR 28827, May 20, 2014] § 520.1870 Praziquantel tablets. (a) Specifications. Each tablet con tains: (1) 34 milligrams (mg) praziquantel. (2) 11.5 or 23 mg praziquantel. (b) Sponsor. See No. 069043 in § 510.600(c) of this chapter for use of the product described in paragraph (a)(1) of this section as in paragraph (c)(1) of this section; and for use of the product described in paragraph (a)(2) of this section as in paragraph (c)(2) of this section. (c) Conditions of use—(1) Dogs—(i) Amount. 5 pounds (lb) and under, 1⁄2 tab let (17 mg); 6 to 10 lb, 1 tablet (34 mg); 11 to 15 lb, 11⁄2 tablets (51 mg); 16 to 30 lb, 2 tablets (68 mg); 31 to 45 lb, 3 tab lets (102 mg); 46 to 60 lb, 4 tablets (136 mg); over 60 lb, 5 tablets maximum (170 mg). Administer directly by mouth or crumbled and in feed. (ii) Indications for use—(A) For re moval of canine cestodes Dipylidium caninum and Taenia pisiformis. (B) For removal of the canine cestode Echinococcus granulosus, and for re moval and control of the canine cestode Echinococcus multilocularis. (iii) Limitations—(A) If labeled only for use as in paragraph (c)(1)(ii)(A) of this section: Not intended for use in puppies less than 4 weeks of age. Con sult your veterinarian before admin istering tablets to weak or debilitated animals and for assistance in the diag nosis, treatment, and control of para sitism. (B) If labeled for use as in paragraph (c)(1)(ii)(B) of this section: Federal law restricts this drug to use by or on the order of a licensed veterinarian. (2) Cats—(i) Indications for use. For re moval of feline cestodes Dipylidium caninum and Taenia taeniaeformis. (ii) Dosage. Cats 4 pounds and under, 11.5 mg; 5 to 11 pounds, 23 mg; over 11 pounds, 34.5 mg. (iii) Limitations. Administer directly by mouth or crumbled and in feed. Not intended for use in kittens less than 6 weeks of age. For OTC use: Consult your veterinarian before administering tablets to weak or debilitated animals, and for assistance in the diagnosis, treatment, and control of parasitism. [46 FR 60570, Dec. 11, 1981, as amended at 47 FR 26377, June 18, 1982; 55 FR 2234, Jan. 23, 1990; 58 FR 7864, Feb. 10, 1993; 58 FR 42853, Aug. 12, 1993; 68 FR 57351, Oct. 3, 2003; 69 FR 62181, Oct. 25, 2004; 78 FR 17596, Mar. 22, 2013; 81 FR 17607, Mar. 30, 2016] § 520.1871 Praziquantel and pyrantel. (a) Specifications. (1) Each tablet con tains 13.6 milligrams (mg) praziquantel and 54.3 mg pyrantel base (as pyrantel pamoate), 18.2 mg praziquantel and 72.6 mg pyrantel base (as pyrantel pamoate), or 27.2 mg praziquantel and 108.6 mg pyrantel base (as pyrantel pamoate). (2) Each chewable tablet contains 30 mg praziquantel and 30 mg pyrantel pamoate or 114 mg praziquantel and 114 mg pyrantel pamoate. (b) Sponsors. See sponsors in § 510.600(c) for use as in paragraph (d) of this chapter. (1) See No. 000859 for use of tablets described in paragraph (a)(1) of this section for use as in paragraph (d)(1) of this section. VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00241 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 232 21 CFR Ch. I (4–1–16 Edition) § 520.1872 (2) See No. 051311 for use of tablets described in paragraph (a)(2) of this section for use as in paragraph (d)(2) of this section. (c) Special considerations. See § 500.25 of this chapter. (d) Conditions of use—(1) Cats—(i) Dos age. Administer a minimum dose of 2.27 mg praziquantel and 9.2 mg pyrantel pamoate per pound of body weight ac cording to the dosing tables on label ing. May be given directly by mouth or in a small amount of food. Do not with hold food prior to or after treatment. If reinfection occurs, treatment may be repeated. (ii) Indications for use. For removal of tapeworms (Dipylidium caninum and Taenia taeniaeformis), hookworms (Ancylostoma tubaeforme), and large roundworms (Toxocara cati) in cats and kittens. (iii) Limitations. Not for use in kit tens less than 2 months of age or weighing less than 2.0 pounds. Consult your veterinarian before giving to sick or pregnant animals. (2) Dogs—(i) Amount. Administer a minimum dose of 5 mg praziquantel and 5 mg pyrantel pamoate per kilo gram body weight (2.27 mg praziquantel and 2.27 mg pyrantel pamoate per pound body weight) according to the dosing tables on labeling. (ii) Indications for use. For the treat ment and control of roundworms (Toxocara canis and Toxascaris leonina), hookworms (Ancylostoma caninum, Ancylostoma braziliense, and Uncinaria stenocephala), and tapeworms (Dipylidium caninum and Taenia pisiformis) in dogs and puppies. [58 FR 58652, Nov. 3, 1993, as amended at 72 FR 16270, Apr. 4, 2007; 75 FR 54018, Sept. 3, 2010] § 520.1872 Praziquantel, pyrantel pamoate, and febantel tablets. (a) Specifications. Each tablet or chewable tablet contains either: (1) Tablet No. 1: 22.7 milligrams praziquantel, 22.7 milligrams pyrantel base, and 113.4 milligrams febantel; or (2) Tablet No. 2: 68 milligrams praziquantel, 68 milligrams pyrantel base, and 340.2 milligrams febantel. (3) Tablet No. 3: 136 milligrams (mg) praziquantel, 136 mg pyrantel base, and 680.4 mg febantel. (b) Sponsor. See 000859 in § 510.600(c) of this chapter. (c) Conditions of use—(1) Dogs—(i) Amount. Administer as a single dose di rectly by mouth or in a small amount 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 moval of tapeworms (Dipylidium caninum, Taenia pisiformis, Echinococcus granulosus); hookworms (Ancylostoma caninum, Uncinaria stenocephala); ascarids (Toxocara canis, Toxascaris leonina); and whipworms (Trichuris vulpis) and for the removal and control of tapeworm Echinococcus multilocularis in dogs. (iii) Limitations. Do not use in preg nant animals. Do not use in dogs weighing less than 0.9 kilogram (2 pounds) or puppies less than 3 weeks of age. Federal law restricts this drug to use by or on the order of a licensed vet erinarian. [59 FR 33908, July 1, 1994, as amended at 61 FR 29651, June 12, 1996; 68 FR 22293, Apr. 28, 2003; 71 FR 6677, Feb. 9, 2006] § 520.1880 Prednisolone. (a) Specifications. Each tablet con tains 5 or 20 milligrams prednisolone. (b) Sponsor. See No. 061690 in § 510.600(c)(2) of this chapter. (c) Conditions of use in dogs—(1) Amount. Administer 2.5 milligrams per 4.5 kilograms (10 pounds) body weight per day. Administer total daily dose orally in equally divided doses 6 to 10 hours apart until response is noted or 7 days have elapsed. When response is at tained, dosage should be gradually re duced until maintenance level is achieved. (2) Indications for use. For use as an anti-inflammatory agent. VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00242 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 233 Food and Drug Administration, HHS § 520.1962 (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [57 FR 4718, Feb. 7, 1992, as amended at 60 FR 57832, Nov. 22, 1995; 63 FR 148, Jan. 5, 1998; 79 FR 28827, May 20, 2014] § 520.1900 Primidone. (a) Specifications. Each tablet con tains 50 or 250 milligrams of primidone. (b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter. (1) No. 054628 for use of 250 milligram tablets. (2) No. 054771 for use of 50 and 250 mil ligram tablets. (c) Conditions of use in dogs—(1) Amount. Twenty-five milligrams of primidone per pound of body weight (55 milligrams per kilogram of body weight) daily. (2) Indications for use. For the control of convulsions associated with idio pathic epilepsy, epileptiform convul sions, viral encephalitis, distemper, and hardpad disease that occurs as a clinically recognizable lesion in certain entities in dogs. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [42 FR 61594, Dec. 6, 1977, as amended at 43 FR 55386, Nov. 28, 1978; 46 FR 8467, Jan. 27, 1981; 46 FR 57477, Nov. 24, 1981; 53 FR 40727, Oct. 18, 1988; 56 FR 37473, Aug. 7, 1991; 62 FR 35076, June 30, 1997; 78 FR 21060, Apr. 9, 2013; 79 FR 28827, May 20, 2014] § 520.1920 Prochlorperazine and isopropamide. (a) Specifications. Each capsules con tains either: (1) 3.33 milligrams of prochlorperazine (as the dimaleate) and 1.67 milligrams of isopropamide (as the iodide); or (2) 10 milligrams of prochlorperazine (as the dimaleate) and 5 milligrams of isopropamide (as the iodide). (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Conditions of use in dogs—(1) Amount. (i) Capsules described in para graph (a)(1) of this section are adminis tered orally to dogs weighing from 4 to 15 pounds at the rate of 1 capsule twice daily. These capsules are administered orally to dogs weighing from 16 to 30 pounds at the rate of 1 or 2 capsules twice daily. For dogs weighing less than 4 pounds, administer orally an ap propriate fraction of the contents of one of these capsules. (ii) Capsules described in paragraph (a)(2) of this section are given to dogs weighing 30 pounds and over at the rate of 1 capsule twice daily. (2) Indications for use. For the treat ment of gastrointestinal disturbances associated with emotional stress. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [79 FR 28827, May 20, 2014] § 520.1921 Prochlorperazine, isopropamide, and neomycin. (a) Specifications. Each capsule con tains either: (1) Capsule No. 1: 3.33 milligrams of prochlorperazine (as the dimaleate), 1.67 milligrams of isopropamide (as the iodide), and 25 milligrams of neomycin base (as the sulfate); or (2) Capsule No. 3: 10 milligrams of prochlorperazine (as the dimaleate), 5 milligrams of isopropamide (as the io dide), and 75 milligrams of neomycin base (as the sulfate). (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Conditions of use in dogs—(1) Amount. Administer capsules orally twice daily to dogs as follows: Animal weight (pounds) Number of cap sules per dose Capsule No. 1 Capsule No. 3 10 to 20 ................................................. 1 20 to 30 ................................................. 2 Over 30 .................................................. 3 1 Over 60 .................................................. 2 (2) Indications for use. For the treat ment infectious bacterial gastroenteritis associated with emo tional stress. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [49 FR 14103, Apr. 10, 1984, as amended at 56 FR 50653, Oct. 8, 1991; 60 FR 55659, Nov. 2, 1995; 79 FR 28827, May 20, 2014] § 520.1962 Promazine. (a) Specifications. Conforms to N.F. XII for promazine hydrochloride. VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00243 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 234 21 CFR Ch. I (4–1–16 Edition) § 520.2002 (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Conditions of use in horses—(1) Amount. Administer 0.45 to 0.9 milli grams per pound of body weight mixed with an amount of feed that will be readily consumed. (2) Indications for use. For quieting excitable, unruly, or intractable horses. (3) Limitations. Do not use in horses intended for human consumption. Fed eral law restricts this drug to use by or on the order of a licensed veterinarian. [79 FR 28827, May 20, 2014] § 520.2002 Propiopromazine. (a) Specifications. Each chewable tab let contains 10 or 20 milligrams of propiopromazine hydrochloride. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Conditions of use in dogs—(1) Amount. Administer 0.5 to 2.0 milli grams per pound of body weight once or twice daily, depending upon the de gree of tranquilization desired. (2) Indications for use. For oral admin istration as a tranquilizer. As an aid in handling difficult, excited, and unruly dogs, and in controlling excessive ken nel barking, car sickness, and severe dermatitis. It is also indicated for use in minor surgery and prior to routine examinations, laboratory procedures, and diagnostic procedures. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [79 FR 28827, May 20, 2014] § 520.2041 Pyrantel pamoate chewable tablets. (a) Specifications. Each tablet con tains pyrantel pamoate equivalent to 22.7 or 113.5 milligrams pyrantel base. (b) Sponsor. See Nos. 017135 and 051311 in § 510.600(c) of this chapter. (c) Conditions of use—(1) Amount. Pro vides at least 2.27 milligrams pyrantel base per pound body weight for dogs weighing more than 5 pounds, and at least 4.54 milligrams of pyrantel base per pound body weight for dogs weigh ing 5 pounds or less. (2) Indications for use—(i) In dogs and puppies. For removal of ascarids (Toxocara canis; Toxascaris leonina) and hookworms (Ancylostoma caninum; Uncinaria stenocephala). (ii) In puppies and adult dogs and in lactating bitches after whelping. To prevent reinfection of Toxocara canis. (3) Limitations. Administer to puppies at 2, 3, 4, 6, 8, and 10 weeks of age. Ad minister to lactating bitches 2 to 3 weeks after whelping. Retreatment of adult dogs may be necessary at month ly intervals as determined by labora tory fecal examinations. Consult your veterinarian for assistance in the diag nosis, treatment, and control of para sitism. [52 FR 37937, Oct. 13, 1987, as amended at 57 FR 48163, Oct. 22, 1992; 58 FR 44611, Aug. 24, 1993; 66 FR 9650, Feb. 9, 2001; 67 FR 21996, May 2, 2002] § 520.2042 Pyrantel pamoate tablets. (a) Specifications. Each tablet con tains pyrantel pamoate equivalent to 22.7, 45.4, or 113.5 milligrams of pyrantel base. (b) Sponsor. See No. 017135 in § 510.600(c) of this chapter. (c) Conditions of use. It is used for dogs as follows: (1) Amount. For dogs weighing over 5 pounds, use at least 2.27 milligrams of pyrantel base per pound of body weight; for dogs weighing 5 pounds or less, use at least 4.54 milligrams of pyrantel base per pound of body weight. (2) Indications for use. For removal and control of large roundworms (ascarids) (Toxocara canis and Toxascaris leonina), and hookworms (Ancylostoma caninum and Uncinaria stenocephala). (3) Limitations. Administer orally di rectly or in a small amount of food. To prevent reinfection of T. canis in pup pies, lactating bitches after whelping, and adult dogs; treat puppies 2, 3, 4, 6, 8, and 10 weeks of age; treat lactating bitches 2 to 3 weeks after whelping; routinely treat adult dogs monthly. Do not withhold food prior to or after treatment. The presence of these parasites should be confirmed by lab oratory fecal examination. A followup fecal examination should be conducted VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00244 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 235 Food and Drug Administration, HHS § 520.2044 2 to 4 weeks after first treatment regi men to determine the need for re-treat ment. Consult your veterinarian for as sistance in the diagnosis, treatment, and control of parasitism. [43 FR 52700, Nov. 14, 1978, as amended at 49 FR 22073, May 25, 1984; 57 FR 48163, Oct. 22, 1992; 58 FR 44611, Aug. 24, 1993] § 520.2043 Pyrantel pamoate suspen sion. (a) Specifications. (1) Each milliliter (mL) contains pyrantel pamoate equiv alent to 50 milligrams (mg) pyrantel base. (2) Each mL contains pyrantel pamoate equivalent to 2.27 or 4.54 mg pyrantel base. (3) Each mL contains pyrantel pamoate equivalent to 4.54 mg pyrantel base. (b) Sponsors. See sponsors in § 510.600(c) of this chapter for uses as in paragraph (d) of this section. (1) Nos. 054771, 058829, and 069043 for use of the product described in para graph (a)(1) as in paragraph (d)(1) of this section. (2) Nos. 000859, 054771, and 058829 for use of the products described in para graph (a)(2) as in paragraph (d)(2) of this section. (3) No. 023851 for use of the product described in paragraph (a)(3) as in para graph (d)(2) of this section. (c) Special considerations. See § 500.25 of this chapter. (d) Conditions of use—(1) Horses and ponies. It is used as follows: (i) Amount. 3 mg per pound (/lb) body weight as a single dose mixed with the usual grain ration, or by stomach tube or dose syringe. (ii) Indications for use. For the re moval and control of mature infections of large strongyles (Strongylus vulgaris, S. edentatus, S. equinus); pinworms (Oxyuris equi); large roundworms (Parascaris equorum); and small strongyles. (iii) Limitations. Do not use in horses intended for human consumption. When the drug is for administration by stomach tube, it shall be labeled: ‘‘Federal law restricts this drug to use by or on the order of a licensed veteri narian.’’ (2) Dogs. It is used as follows: (i) Dogs and puppies—(A) Amount. 2.27 mg/lb body weight as a single dose in the animal’s feed bowl by itself or mixed in a small quantity of food. (B) Indications for use. For the re moval of large roundworms (Toxocara canis and Toxascaris leonina) and hookworms (Ancylostoma caninum and Uncinaria stenocephala). (C) Limitations. Additional treatment may be required and should be con firmed by fecal examination within 2 to 4 weeks. (ii) Dogs, puppies, and lactating bitches after whelping—(A) Amount. 2.27 mg/lb body weight. (B) Indications for use. To prevent re infections of T. canis. (C) Limitations. Administer to puppies at 2, 3, 4, 6, 8, and 10 weeks of age. Ad minister to lactating bitches 2 to 3 weeks after whelping. Adult dogs kept in heavily contaminated quarters may be treated at monthly intervals. [67 FR 43248, June 27, 2002, as amended at 68 FR 54803, Sept. 19, 2003; 68 FR 55199, Sept. 23, 2003; 68 FR 55825, Sept. 29, 2003; 75 FR 52622, Aug. 27, 2010; 76 FR 17337, Mar. 29, 2011; 78 FR 17596, Mar. 22, 2013; 79 FR 28827, May 20, 2014; 80 FR 76386, Dec. 9, 2015; 81 FR 17607, Mar. 30, 2016] § 520.2044 Pyrantel pamoate paste. (a) Specifications—(1) Each milliliter (mL) contains 180 milligrams (mg) pyrantel base (as pyrantel pamoate). (2) Each mL contains 226 mg pyrantel base (as pyrantel pamoate). (3) Each mL contains 171 mg pyrantel base (as pyrantel pamoate). (b) Sponsors. See sponsors in § 510.600(c) of this chapter. (1) No. 054771 for use of product de scribed in paragraph (a)(1) of this sec tion as in paragraph (d)(1)(i) and (d)(2) of this section. (2) No. 017135 for use of product de scribed in paragraph (a)(2) of this sec tion as in paragraph (d) of this section. (3) No. 061623 for use of product de scribed in paragraph (a)(3) of this sec tion as in paragraph (d)(1)(i) and (d)(2) of this section. (c) Special considerations. See § 500.25 of this chapter. (d) Conditions of use. It is used in horses and ponies as follows: VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00245 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 236 21 CFR Ch. I (4–1–16 Edition) § 520.2045 (1) Amounts and indications for use—(i) 3 mg per pound (/lb) body weight as sin gle oral dose for removal and control of infections from the following mature parasites: large strongyles (Strongylus vulgaris, S. edentatus, S. equinus); small strongyles; pinworms (Oxyuris equi); and large roundworms (Parascaris equorum). (ii) 6 mg/lb body weight as single oral dose for the removal and control of ma ture infections of tapeworms (Anoplocephala perfoliata). (2) Limitations. Do not use in horses intended for human consumption. [70 FR 29447, May 23, 2005, as amended at 76 FR 17337, Mar. 29, 2011; 78 FR 17596, Mar. 22, 2013; 79 FR 28827, May 20, 2014; 81 FR 17607, Mar. 30, 2016] § 520.2045 Pyrantel tartrate powder. (a) Specifications. Each gram of pow der contains 106 milligrams (10.6 per cent) or 113 milligrams (11.3 percent) pyrantel tartrate. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter for use of 11.3 percent powder as in paragraph (d)(1) and 10.6 percent powder as in paragraph (d)(2) and of this section. (c) Related tolerances. See § 556.560 of this chapter. (d) Conditions of use—(1) Horses—(i) Amount. Administer as a single dose at 0.57 gram of pyrantel tartrate per 100 pounds of body weight mixed with the usual grain ration. Do not administer by stomach tube or dose syringe. (ii) Indications for use. For the re moval and control of infections from the following mature parasites: Large strongyles (Strongylus vulgaris, S. edentatus, S. equinus), small strongyles (Trichonema spp., Triodontophorus), pinworms (Oxyuris), and large roundworms (Parascaris). (iii) Limitations. Do not treat severely debilitated animals with this drug. Do not use in horses intended for human consumption. (2) Swine—(i) Amount. Add to feed at 0.4 gram pyrantel tartrate per pound of non-pelleted ration. The ration is ad ministered as a single treatment as the sole ration at the rate of 1 pound per 40 pounds of animal weight for animals up to 200 pounds. Animals 200 pounds and over are administered 5 pounds of ra tion per animal. (ii) Indications for use. For the re moval and control of large roundworms (Ascaris suum) and nodular worm (Oesophagostomum) infections. (iii) Limitations. Consult veterinarian before using in severely debilitated animals. Do not treat within 24 hours of slaughter. [79 FR 28827, May 20, 2014] § 520.2046 Pyrantel tartrate pellets. (a) Specifications. (1) Each gram of pellets contains 12.5 milligrams (mg) (1.25 percent) pyrantel tartrate; or (2) Each gram of pellets contains 21.1 mg (2.11 percent) pyrantel tartrate. (b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter: (1) No. 054771 for use of products de scribed in paragraph (a) as in para graph (c) of this section. (2) No. 061623 for use of product de scribed in paragraph (a)(1) as in para graph (c) of this section. (c) Conditions of use in horses—(1) Amount. Administer as a single dose at 12.5 mg per 2.2 pounds of body weight mixed with the usual grain ration. (2) Indications for use. For the re moval and control of infections from the following mature parasites: Large strongyles (Strongylus vulgaris, S. edentatus, S. equinus), small strongyles (Trichonema spp., Triodontophorus), pinworms (Oxyuris), and large roundworms (Parascaris). (3) Limitations. Do not treat severely debilitated animals with this drug. Do not use in horses intended for human consumption. [79 FR 28828, May 20, 2014] § 520.2075 Robenacoxib. (a) Specifications. Each tablet con tains 6 milligrams (mg) robenacoxib. (b) Sponsors. See No. 058198 in § 510.600(c) of this chapter. (c) Conditions of use in cats—(1) Amount. Administer 0.45 mg per pound (/lb) (1 mg/kilogram (kg)) once daily. (2) Indications for use. For the control of postoperative pain and inflamma tion associated with orthopedic sur gery, ovariohysterectomy, and castra tion in cats weighing at least 5.5 lb (2.5 kg) and at least 4 months of age; for up to a maximum of 3 days. VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00246 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 237 Food and Drug Administration, HHS § 520.2123b (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [76 FR 18648, Apr. 5, 2011, as amended at 79 FR 10964, Feb. 27, 2014] § 520.2098 Selegiline. (a) Specifications. Each tablet con tains 2, 5, 10, 15, or 30 milligrams (mg) selegiline hydrochloride. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Conditions of use in dogs—(1) Amounts and indications for use. (i) Ad minister 1 mg per kilogram (0.45 mg per pound) of body weight once daily for control of clinical signs associated with uncomplicated pituitary-depend ent hyperadrenocorticism in dogs. (ii) Administer 0.5 to 1.0 mg per kilo gram of body weight once daily for the control of clinical signs associated with canine cognitive dysfunction syn drome. (2) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [79 FR 28828, May 20, 2014] § 520.2100 Selenium and vitamin E. (a) Specifications. Each capsule con tains: (1) 2.19 milligrams (mg) sodium sele nite (equivalent to 1 mg selenium) and 56.2 mg (68 I.U.) vitamin E as d-alpha tocopheryl acid succinate; or (2) 0.548 mg sodium selenite (equiva lent to 0.25 mg selenium) and 14 mg (17 I.U.) vitamin E as d-alpha tocopheryl acid succinate. (b) Sponsor. See No. 000061 in § 510.600(c) of this chapter. (c) Conditions of use in dogs—(1) Amount. (i) Dogs over 20 pounds: Ad minister 1 capsule described in para graph (a)(1) per 20 pounds of body weight to a maximum of 5 capsules. Re peat at 3 day intervals until a satisfac tory therapeutic response is observed. Maintenance dosage is 1 capsule per 40 pounds of body weight every 3 to 7 days, or longer, as required. (ii) Dogs under 20 pounds: Administer 1 capsule described in paragraph (a)(2) per 5 pounds of body weight with a minimum of 1 capsule. Repeat at 3-day intervals until a satisfactory response is observed. Maintenance dosage is 1 capsule per 10 pounds of body weight every 3 to 7 days, or longer, as re quired. (2) Indications for use. As an aid in al leviating and controlling inflamma tion, pain, and lameness associated with certain arthropathies. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [79 FR 28828, May 20, 2014] § 520.2123 Spectinomycin oral dosage forms. § 520.2123a Spectinomycin tablets. (a) Specifications. Each tablet con tains spectinomycin dihydrochloride equivalent to 100 milligrams (mg) spectinomycin. (b) Sponsors. See Nos. 054771 and 061623 in § 510.600(c) of this chapter. (c) Conditions of use in dogs—(1) Amount. Administer orally to provide 10 mg per pound (lb) of body weight twice daily. Dosage may be continued for 4 consecutive days. (2) Indications for use. For the treat ment of infectious diarrhea and gastroenteritis caused by organisms susceptible to spectinomycin. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [73 FR 6607, Feb. 5, 2008, as amended at 79 FR 28828, May 20, 2014] § 520.2123b Spectinomycin powder. (a) Specifications. Each gram (g) of powder contains spectinomycin dihydrochloride pentahydrate equiva lent to 0.5 g spectinomycin. (b) Sponsor. See No. 061623 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.600 of this chapter. (d) Conditions of use in chickens. It is administered in the drinking water of growing chickens as follows: (1) Indications for use and amounts—(i) For increased rate of weight gain and improved feed efficiency in broiler chickens, administer 0.5 g per gallon of water as the only source of drinking water for the first 3 days of life and for 1 day following each vaccination. (ii) As an aid in controlling infec tious synovitis due to Mycoplasma VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00247 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 238 21 CFR Ch. I (4–1–16 Edition) § 520.2123c synoviae in broiler chickens, admin ister 1 g per gallon of water as the only source of drinking water for the first 3 to 5 days of life. (iii) As an aid in the prevention or control of losses due to CRD associated with M. gallisepticum (PPLO) in grow ing chickens, administer 2 g per gallon of water as the only source of drinking water for the first 3 days of life and for 1 day following each vaccination. (2) Limitations. Do not administer to laying chickens. Do not administer within 5 days of slaughter. [73 FR 6607, Feb. 5, 2008] § 520.2123c Spectinomycin solution. (a) Specifications. Each milliliter of solution contains spectinomycin dihydrochloride pentahydrate equiva lent to 50 milligrams (mg) spectinomycin. (b) Sponsors. See Nos. 000859, 054771, and 061623 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.600 of this chapter. (d) Conditions of use in swine—(1) Amount. Administer 5 mg per pound (lb) of body weight orally twice daily for 3 to 5 days. (2) Indications for use. For the treat ment and control of porcine enteric colibacillosis (scours) caused by E. coli susceptible to spectinomycin in pigs under 4 weeks of age. (3) Limitations. Do not administer to pigs over 15 lb body weight or over 4 weeks of age. Do not administer within 21 days of slaughter. [73 FR 6607, Feb. 5, 2008, as amended at 78 FR 17596, Mar. 22, 2013; 79 FR 28828, May 20, 2014] § 520.2130 Spinosad. (a) Specifications. Each chewable tab let contains 90, 140, 270, 560, 810, or 1620 milligrams (mg) spinosad. (b) Sponsor. See No. 000986 in § 510.600 of this chapter. (c) Special considerations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (d) Conditions of use—(1) Dogs—(i) Amount. Administer tablets once a month at a recommended minimum dosage of 13.5 mg per pound (30 mg per kilogram) of body weight. (ii) Indications for use. To kill fleas and for the prevention and treatment of flea infestations (Ctenocephalides felis) for 1 month on dogs and puppies 14 weeks of age and older and 3.3 pounds of body weight or greater. (2) Cats—(i) Amount. Administer tab lets once a month at a minimum dos age of 22.5 mg per pound (50 mg per kilogram) of body weight. (ii) Indications for use. To kill fleas and for the prevention and treatment of flea infestations (C. felis) for 1 month on cats and kittens 14 weeks of age and older and 2 pounds of body weight or greater. [77 FR 60623, Oct. 4, 2012] § 520.2134 Spinosad and milbemycin. (a) Specifications. Each chewable tab let contains 140 milligrams (mg) spinosad and 2.3 mg milbemycin oxime, 270 mg spinosad and 4.5 mg milbemycin oxime, 560 mg spinosad and 9.3 mg milbemycin oxime, 810 mg spinosad and 13.5 mg milbemycin oxime, or 1,620 mg spinosad and 27 mg milbemycin oxime. (b) Sponsor. See No. 000986 in § 510.600 of this chapter. (c) Conditions of use in dogs—(1) Amount. Administer once a month at a minimum dosage of 13.5 mg/pound (lb) (30 mg/kilogram (kg)) of body weight spinosad and 0.2 mg/lb (0.5 mg/kg) of body weight milbemycin oxime. (2) Indications for use. To kill fleas; for the prevention and treatment of flea infestations (Ctenocephalides felis); for the prevention of heartworm dis ease (Dirofilaria immitis); and for the treatment and control of adult hookworm (Ancylostoma caninum), adult roundworm (Toxocara canis and Toxascaris leonina), and adult whipworm (Trichuris vulpis) infections in dogs and puppies 8 weeks of age or older and 5 lbs of body weight or great er. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [76 FR 12563, Mar. 8, 2011] § 520.2150 Stanozolol. (a) Specifications. Each tablet or chewable tablet contains 2 milligrams stanozolol. (b) Sponsor. No. 054771 in § 510.600(c) of this chapter. VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00248 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 239 Food and Drug Administration, HHS § 520.2184 (c) Conditions of use in dogs and cats— (1) Amount—(i) Dogs: Administered orally to small breeds, 1⁄2 to 1 tablet twice daily for several weeks; to large breeds, 1 to 2 tablets twice daily for several weeks. The tablets may be crushed and administered in feed. (ii) Cats: Administered orally 1⁄2 to 1 tablet twice daily for several weeks. (2) Indications for use. As an anabolic steroid treatment. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [79 FR 28828, May 20, 2014] § 520.2158 Streptomycin. (a) Specifications. Each milliliter of solution contains 250 milligrams (25 percent) streptomycin sulfate. (b) Sponsor. See No. 016592 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.610 of this chapter. (d) Conditions of use. Use in drinking water as follows: (1) Calves—(i) Amount. 10 to 15 milli grams per pound (mg/pound) of body weight (1.0 to 1.5 grams per gallon) for up to 5 days. (ii) Indications for use. For the treat ment of bacterial enteritis caused by Escherichia coli and Salmonella spp. sus ceptible to streptomycin. (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (2) Swine—(i) Amount. 10 to 15 mg/ pound of body weight (1.0 to 1.5 grams per gallon) for up to 4 days. (ii) Indications for use. For the treat ment of bacterial enteritis caused by Escherichia coli and Salmonella spp. sus ceptible to streptomycin. (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (3) Chickens—(i) Amount. 10 to 15 mg/ pound of body weight (0.6 to 0.9 grams per gallon) for up to 5 days. (ii) Indications for use. For the treat ment of nonspecific infectious enteritis caused by organisms susceptible to streptomycin. (iii) Limitations. Withdraw 4 days be fore slaughter. Do not administer to chickens producing eggs for human consumption. Federal law restricts this drug to use by or on the order of a li censed veterinarian. [57 FR 37327, Aug. 18, 1992, as amended at 58 FR 47211, Sept. 8, 1993; 63 FR 51821, Sept. 29, 1998. Redesignated and amended at 79 FR 28828, May 20, 2014; 79 FR 74020, Dec. 15, 2014; 80 FR 18776, Apr. 8, 2015; 80 FR 61296, Oct. 13, 2015] § 520.2170 Sulfabromomethazine. (a) Specifications. Each bolus contains 15 grams of sulfabromomethazine so dium. (b) Sponsor. See No. 050604 in § 510.600(c) of this chapter. (c) Related tolerance. See § 556.620 of this chapter. (d) Conditions of use in cattle—(1) Amount. Administer 90 milligrams per pound body weight orally. Repeat in 48 hours if necessary (2) Indications for use. Treatment of necrotic pododermatitis (foot rot) and calf diphtheria caused by Fusobacterium necrophorum; colibacillosis (scours) caused by Escherichia coli; bacterial pneumonia and bovine respiratory dis ease complex (shipping fever complex) associated with Pasteurella spp.; acute metritis and acute mastitis caused by Streptococcus spp. (3) Limitations. Milk taken from ani mals within 96 hours (8 milkings) of latest treatment must not be used for food. Do not administer within 18 days of slaughter. [47 FR 30243, July 13, 1982, as amended at 62 FR 63270, Nov. 28, 1997; 79 FR 28829, May 20, 2014] § 520.2184 Sulfachloropyrazine. (a) Specifications. Each gram of pow der contains 476 milligrams of sodium sulfachloropyrazine monohydrate. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Related tolerance. See § 556.625 of this chapter. (d) Conditions of use in chickens. It is used in the drinking water of broilers, breeder flocks, and replacement chick ens as follows: (1) Amount. Administer in drinking water as 0.03 percent solution for 3 days. (2) Indications for use. For the treat ment of coccidiosis. VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00249 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 240 21 CFR Ch. I (4–1–16 Edition) § 520.2200 (3) Limitations. Administer as sole source of drinking water and of sul fonamide medication. Withdraw 4 days prior to slaughter. Do not use in chick ens producing eggs for human con sumption. [79 FR 28829, May 20, 2014] § 520.2200 Sulfachlorpyridazine. (a) Specifications. (1) Sodium sulfachlorpyridazine powder. (2) Each bolus contains 2 grams sulfachlorpyridazine. (3) Each tablet contains 250 milli grams (mg) sulfachlorpyridazine. (b) Sponsor. See No. 016592 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.630 of this chapter. (d) Conditions of use. It is used as fol lows: (1) Calves—(i) Amount. Administer 30 to 45 mg sulfachlorpyridazine powder per pound (/lb) of body weight per day in milk or milk replacer, or in a bolus, in divided doses twice daily for 1 to 5 days. (ii) Indications for use. For the treat ment of diarrhea caused or complicated by Escherichia coli (colibacillosis). (iii) Limitations. Treated ruminating calves must not be slaughtered for food during treatment or for 7 days after the last treatment. A withdrawal pe riod has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. (2) Swine—(i) Amount. Administer 20 to 35 mg/lb body weight per day, in di vided doses twice daily for 1 to 5 days: (A) In drinking water or (B) For individual treatment, in an oral suspension containing 50 mg per milliliter. (ii) Indications for use. For the treat ment of diarrhea caused or complicated by E. coli (colibacillosis). (iii) Limitations. Treated swine must not be slaughtered for food during treatment or for 4 days after the last treatment. (3) Dogs—(i) Amount. Administer tab lets orally at 500 mg per 10 to 15 lb of body weight daily, in two or three di vided doses. (ii) Indications for use. As an aid in the treatment of infectious tracheobronchitis and infections caused by E. coli, and in the treatment of infections caused by other Gram positive and Gram-negative organisms that are susceptible to sulfonamide therapy. (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [75 FR 10166, Mar. 5, 2010, as amended at 79 FR 28829, May 20, 2014; 81 FR 17607, Mar. 30, 2016] § 520.2215 Sulfadiazine/pyrimethamine suspension. (a) Specifications. Each milliliter (mL) of suspension contains 250 milli grams (mg) sulfadiazine (as the sodium salt) and 12.5 mg pyrimethamine. (b) Sponsor. See No. 055246 in § 510.600(c) of this chapter. (c) Conditions of use in horses—(1) Amount. Administer orally 20 mg sulfa diazine per kilogram (kg) body weight and 1 mg/kg pyrimethamine daily. (2) Indications for use. For the treat ment of equine protozoal myeloencephalitis (EPM) caused by Sarcocystis neurona. (3) Limitations. Do not use in horses intended for human consumption. Fed eral law restricts this drug to use by or on the order of a licensed veterinarian. [69 FR 70054, Dec. 2, 2004, as amended at 73 FR 53686, Sept. 17, 2008; 75 FR 69586, Nov. 15, 2010] § 520.2218 Sulfamerazine, sulfamethazine, and sulfaquinoxaline powder. (a) Specifications. Each 195-gram (g) packet of powder contains 78 g sulfa merazine, 78 g sulfamethazine, and 39 g sulfaquinoxaline. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Related tolerances. See §§ 556.670 and 556.685 of this chapter. (d) Conditions of use—(1) Chickens—(i) Amounts and indications for use—(A) As an aid in the control of coccidiosis caused by Eimeria tenella and E. necatrix susceptible to sulfamerazine, sulfamethazine, and sulfaquinoxaline: Provide medicated water (0.04 percent solution) for 2 to 3 days, then plain water for 3 days, then medicated water (0.025 percent solution) for 2 days. If bloody droppings appear, repeat at 0.025 VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00250 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 241 Food and Drug Administration, HHS § 520.2220a percent level for 2 more days. Do not change litter. (B) As an aid in the control of acute fowl cholera caused by Pasteurella multocida susceptible to sulfamerazine, sulfamethazine, and sulfaquinoxaline: Provide medicated water (0.04 percent solution) for 2 to 3 days. If disease re curs, repeat treatment. (ii) Limitations. Make fresh solution daily. Do not treat chickens within 14 days of slaughter for food. Do not medicate chickens producing eggs for human consumption. (2) Turkeys—(i) Amounts and indica tions for use—(A) As an aid in the con trol of coccidiosis caused by Eimeria meleagrimitis and E. adenoeides suscep tible to sulfamerazine, sulfamethazine, and sulfaquinoxaline: Provide medi cated water (0.025 percent solution) for 2 days, then plain water for 3 days, then medicated water (0.025 percent so lution) for 2 days, then plain water for 3 days, then medicated water (0.025 per cent solution) for 2 days. Repeat if nec essary. Do not change litter. (B) As an aid in the control of acute fowl cholera caused by Pasteurella multocida susceptible to sulfamerazine, sulfamethazine, and sulfaquinoxaline: Provide medicated water (0.04 percent solution) for 2 to 3 days. If disease re curs, repeat treatment. (ii) Limitations. Make fresh solution daily. Do not treat turkeys within 14 days of slaughter for food. Do not medicate turkeys producing eggs for human consumption. [71 FR 13001, Mar. 14, 2006, as amended at 79 FR 28829, May 20, 2014; 80 FR 34278, June 16, 2015] § 520.2220 Sulfadimethoxine oral dos age forms. § 520.2220a Sulfadimethoxine solution and soluble powder. (a) Specifications. (1) Each ounce of solution contains 3.75 grams (12.5 per cent) sulfadimethoxine. (2) Each 107 grams of powder contains the equivalent of 94.6 grams sulfadimethoxine as sulfadimethoxine sodium. (b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter: (1) Nos. 000859, 054628, 054771, 054925, and 057561 for use of the product de scribed in paragraph (a)(1) of this sec tion. (2) Nos. 054771, 054925, 057561, 058829, 061623, and 066104 for use of the product described in paragraph (a)(2) of this section. (c) Related tolerances. See § 556.640 of this chapter. (d) Conditions of use—(1) Broiler and replacement chickens—(i) Amount. Ad minister 1.875 grams per gallon (0.05 percent) of drinking water for 6 con secutive days. (ii) Indications for use. For treatment of outbreaks of coccidiosis, fowl chol era, and infectious coryza. (iii) Limitations. Do not administer to chickens over 16 weeks of age. As sole source of drinking water and sul fonamide medication. Withdraw 5 days before slaughter. (2) Turkeys—(i) Amount. Administer 0.938 grams per gallon (0.025 percent) of drinking water for 6 consecutive days. (ii) Indications for use. Growing tur keys: For treatment of disease out breaks of coccidiosis and fowl cholera. (iii) Limitations. Do not administer to turkeys over 24 weeks of age. Use as the sole source of drinking water and sulfonamide medication. Withdraw 5 days before slaughter. (3) Cattle—(i) Amount. 1.18 to 2.36 grams per gallon (0.031 to 0.062 percent) of drinking water. As a drench, admin ister 2.5 grams per 100 pounds of body weight for first day, then 1.25 grams per 100 pounds of body weight per day for the next 4 consecutive days. If no improvement within 2 to 3 days, re evaluate diagnosis. Do not treat be yond 5 days. (ii) Indications for use. Dairy calves, dairy heifers, and beef cattle: For the treatment of shipping fever complex and bacterial pneumonia associated with Pasteurella spp. sensitive to sulfadimethoxine; and calf diphtheria and foot rot associated with Fusobacterium necrophorum (Sphaerophorus necrophorus) sensitive to sulfadimethoxine. (iii) Limitations. Withdraw 7 days be fore slaughter. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Federal VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00251 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 242 21 CFR Ch. I (4–1–16 Edition) § 520.2220b law prohibits the extralabel use of this product in lactating dairy cattle. [79 FR 28829, May 20, 2014] § 520.2220b Sulfadimethoxine suspen sion. (a) Specifications. Each milliliter of suspension contains 50 milligrams (mg) sulfadimethoxine. (b) Sponsors. See Nos. 000061 and 054771 in § 510.600(c) of this chapter. (c) Conditions of use in dogs and cats— (1) Amount. Administer orally 25 mg per pound of body weight, followed by 12.5 mg per pound of body weight daily. (2) Indications for use. For the treat ment of sulfonamide susceptible bac terial infections in dogs and cats and enteritis associated with coccidiosis in dogs. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [79 FR 28829, May 20, 2014] § 520.2220c Sulfadimethoxine tablet. (a) Specifications. Each tablet con tains 125, 250, or 500 milligrams (mg) sulfadimethoxine. (b) Sponsors. See Nos. 000061 and 054771 in § 510.600(c) of this chapter. (c) [Reserved] (d) Conditions of use in dogs and cats— (1) Amount. Administer 25 milligrams (mg) per pound of body weight on the first day followed by 12.5 milligrams (mg) per pound of body weight per day until the animal is free of symptoms for 48 hours. (2) Indications for use. Treatment of sulfadimethoxine-susceptible bacterial infections. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [79 FR 28829, May 20, 2014] § 520.2220d Sulfadimethoxine bolus. (a) Specifications. Each bolus contains 2.5, 5, or 15 grams sulfadimethoxine. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.640 of this chapter. (d) Conditions of use in cattle—(1) Amount. Administer 2.5 grams per 100 pounds body weight for 1 day followed by 1.25 grams per 100 pounds body weight per day; treat for 4 to 5 days. (2) Indications for use. For the treat ment of shipping fever complex and bacterial pneumonia associated with Pasteurella spp. sensitive to sulfadimethoxine; and calf diphtheria and foot rot associated with Fusobacterium necrophorum sensitive to sulfadimethoxine. (3) Limitations. Do not administer within 7 days of slaughter; milk that has been taken from animals during treatment and 60 hours (5 milkings) after the latest treatment must not be used for food. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. [79 FR 28829, May 20, 2014] § 520.2220e Sulfadimethoxine ex tended-release bolus. (a) Specifications. Each extended-re lease bolus contains 12.5 grams sulfadimethoxine. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.640 of this chapter. (d) Conditions of use in beef cattle and non-lactating dairy cattle—(1) Amount. Administer one 12.5-gram-sustained-re lease bolus for the nearest 200 pounds of body weight, i.e., 62.5 milligrams per pound of body weight. Do not repeat treatment for 7 days. (2) Indications for use. For the treat ment of shipping fever complex and bacterial pneumonia associated with Pasteurella spp. sensitive to sulfadimethoxine; and calf diphtheria and foot rot associated with Fusobacterium necrophorum sensitive to sulfadimethoxine. (3) Limitations. Do not use in female dairy cattle 20 months of age or older. Do not administer within 12 days of slaughter. Federal law restricts this drug to use by or on the order of a li censed veterinarian. [79 FR 28830, May 20, 2014] § 520.2220f Sulfadimethoxine and ormetoprim tablet. (a) Specifications. Each tablet con tains 120 milligrams (mg) (100 mg sulfadimethoxine and 20 mg VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00252 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 243 Food and Drug Administration, HHS § 520.2240b ormetoprim), 240 mg (200 mg sulfadimethoxine and 40 mg ormetoprim), 600 mg (500 mg sulfadimethoxine and 100 mg ormetoprim), or 1200 mg (1000 mg sulfadimethoxine and 200 mg ormetoprim). (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Conditions of use in dogs—(1) Amount. On the first day of treatment, administer 25 mg per pound (55 mg per kilogram) of body weight. Then follow with a daily dosage of 12.5 mg per pound (27.5 mg per kilogram) of body weight. Do not exceed a total of 21 con secutive days. (2) Indications of use. Treatment of skin and soft tissue infections (wounds and abscesses) in dogs caused by strains of Staphylococcus aureus and Escherichia coli and urinary tract infec tions caused by E. coli, Staphylococcus spp., and Proteus mirabilus susceptible to ormetoprim-potentiated sulfadimethoxine. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [79 FR 28830, May 20, 2014] § 520.2240 Sulfaethoxypyridazine. § 520.2240a Sulfaethoxypyridazine so lution. (a) Specifications. Each milliliter of solution contains 62.5 milligrams (mg) sodium sulfaethoxypyridazine. (b) Sponsor. See No. 054771 § 510.600(c) of this chapter. (c) Related tolerances. See § 556.650 of this chapter. (d) Conditions of use—(1) Swine—(i) Amount. Administer 3.8 grams per gal lon for first day followed by 1.9 grams per gallon for not less than 3 days nor more than 9 days. Use as the sole source of sulfonamide. (ii) Indications for use. For treatment of bacterial scours pneumonia enter itis, bronchitis, septicemia accom panying Salmonella choleraesuis infec tion. (iii) Limitations. Do not treat within 10 days of slaughter. Federal law re stricts this drug to use by or on the order of a licensed veterinarian. (2) Cattle—(i) Amount. For use at 2.5 grams per gallon. Administer at the rate of 1 gallon per 100 pounds of body weight per day for 4 days. Use as the sole source of sulfonamide. (ii) Indications for use. For treatment of respiratory infections (pneumonia, shipping fever), foot rot, calf scours; and as adjunctive therapy in septi cemia accompanying mastitis and me tritis. (iii) Limitations. Do not treat within 16 days of slaughter. Milk that has been taken from animals during treat ment and for 72 hours (6 milkings) after latest treatment must not be used for food. Federal law restricts this drug to use by or on the order of a licensed vet erinarian. [79 FR 28830, May 20, 2014] § 520.2240b Sulfaethoxypyridazine tab lets. (a) Specifications—(1) Each tablet con tains 2.5 or 15 grams sulfaethoxypyridazine. (2) Each extended-release tablet con tains 5 grams sulfaethoxypyridazine. (b) Sponsor. See No. 054771 § 510.600(c) of this chapter. (c) Related tolerances. See § 556.650 of this chapter. (d) Conditions of use in cattle—(1) 2.5 or 15-gram tablets—(i) Amount. Admin ister 25 milligrams per pound of body weight per day for 4 days. Use as the sole source of sulfonamide. (ii) Indications for use. For treatment of respiratory infections (pneumonia, shipping fever), foot rot, calf scours; as adjunctive therapy in septicemia ac companying mastitis and metritis. (iii) Limitations. Do not treat within 16 days of slaughter. Milk that has been taken from animals during treat ment and for 72 hours (6 milkings) after latest treatment must not be used for food. Federal law restricts this drug to use by or on the order of a licensed vet erinarian. (2) 15-gram extended-release tablets—(i) Amount. Administer 100 milligrams per pound of body weight. Use as the sole source of sulfonamide. (ii) Indications for use. For treatment of foot rot and respiratory infections (shipping fever and pneumonia) caused by sulfonamide-susceptible pathogens (E. coli, Streptococci, Staphylococci, Sphaerophorus necrophorus and Gram negative rods including Pasteurella); VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00253 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 244 21 CFR Ch. I (4–1–16 Edition) § 520.2260 and for use prophylactically during pe riods of stress for reducing losses due to sulfonamide sensitive disease condi tions. (iii) Limitations. Do not treat within 16 days of slaughter. Not for use in lac tating dairy cows. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [79 FR 28830, May 20, 2014] § 520.2260 Sulfamethazine oral dosage forms. § 520.2260a Sulfamethazine oblet, tab let, and bolus. (a)(1) Sponsor. See No. 016592 in § 510.600(c) of this chapter for use of 2.5 , 5-, and 15-gram sulfamethazine oblet in beef cattle, nonlactating dairy cat tle, and horses. See No. 061690 in § 510.600(c) of this chapter for use of 5 , 15-, and 25-gram tablet in beef and nonlactating dairy cattle. (2) Related tolerance in edible products. See § 556.670 of this chapter. (3) Conditions of use—(i) Amount. Ad minister as a single dose 100 milligrams of sulfamethazine per pound of body weight the first day and 50 milligrams per pound of body weight on each fol lowing day. (ii) Indications for use. For treatment of diseases caused by organisms suscep tible to sulfamethazine. (A) Beef cattle and nonlactating dairy cattle. Treatment of bacterial pneu monia and bovine respiratory disease complex (shipping fever complex) (Pasteurella spp.), colibacillosis (bac terial scours) (Escherichia coli), necrotic pododermatitis (foot rot) (Fusobacterium necrophorum), calf diph theria (Fusobacterium necrophorum), acute mastitis (Streptococcus spp.), acute metritis (Streptococcus spp.), coc cidiosis (Eimeria bovis and Eimeria zurnii). (B) Horses. Treatment of bacterial pneumonia (secondary infections asso ciated with Pasteurella spp.), strangles (Streptococcus equi), and bacterial en teritis (Escherichia coli). (iii) Limitations. Administer daily until animal’s temperature and appear ance are normal. If symptoms persist after using for 2 or 3 days consult a veterinarian. Fluid intake must be ade quate. Treatment should continue 24 to 48 hours beyond the remission of dis ease symptoms, but not to exceed 5 consecutive days. Follow dosages care fully. Do not treat cattle within 10 days of slaughter. Do not use in female dairy cattle 20 months of age or older. Use of sulfamethazine in this class of cattle may cause milk residues. A withdrawal period has not been estab lished in preruminating calves. Do not use in calves to be processed for veal. Do not use in horses intended for human consumption. (b)(1) Sponsor. See No. 054771 in § 510.600(c) of this chapter for use of 5 gram sulfamethazine bolus. (2) Related tolerances in edible prod ucts. See § 556.670 of this chapter. (3) Conditions of use—(i) Amount. Ad minister 10 grams (2 boluses) of sulfamethazine per 100 pounds of body weight the first day, then 5 grams (1 bolus) of sulfamethazine per 100 pounds of body weight daily for up to 4 addi tional consecutive days. (ii) Indications for use. Ruminating beef and dairy calves. For treatment of the following diseases caused by orga nisms susceptible to sulfamethazine: bacterial scours (colibacilloosis) caused by E. coli; necrotic pododermatitis (foot rot) and calf diphtheria caused by F. necrophorum; bacterial pneumonia asso ciated with Pasteurella spp.; and coc cidiosis caused by E. bovis and E. zurnii. (iii) Limitations. Do not administer for more than 5 consecutive days. Do not treat calves within 11 days of slaughter. Do not use in calves to be slaughtered under 1 month of age or in calves being fed an all milk diet. Do not use in female dairy cattle 20 months of age or older; such use may cause drug residues in milk. Admin ister with adequate supervision. Fol lows recomended dosages carefully. Fluid intake must be adequate. If symptoms persist after 2 or 3 days, con sult a veterinarian. [54 FR 15751, Apr. 19, 1989; 54 FR 19283, May 4, 1989, as amended at 56 FR 50653, Oct. 8, 1991; 59 FR 22754, May 3, 1994; 61 FR 4875, Feb. 9, 1996; 64 FR 66383, Nov. 26, 1999; 67 FR 78355, Dec. 24, 2002; 75 FR 10166, Mar. 5, 2010; 76 FR 17337, Mar. 29, 2011; 79 FR 28830, May 20, 2014; 81 FR 17607, Mar. 30, 2016] VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00254 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 245 Food and Drug Administration, HHS § 520.2260b § 520.2260b Sulfamethazine sustained release boluses. (a)(1) Sponsor. See No. 000859 in § 510.600(c) of this chapter for use of a 22.5-gram sulfamethazine prolonged-re lease bolus. (2) Conditions of use—(i) Amount. De pending on the duration of therapeutic levels desired, administer boluses as a single dose as follows: 31⁄2 days—1 bolus (22.5 grams) per 200 pounds of body weight; 5 days—1 bolus per 100 pounds of body weight. (ii) Indications for use. Beef and non lactating cattle for sustained treat ment of shipping fever pneumonia caused or complicated by Pasteurella multocida; as an aid in the treatment of foot rot, mastitis, pneumonia, metritis, bacterial enteritis, calf diphtheria, and septicemia when caused or complicated by bacteria susceptible to sulfamethazine. (iii) Limitations. Cattle that are acutely ill should be treated parenterally with a suitable anti bacterial product to obtain immediate therapeutic blood levels; do not slaugh ter animals for food within 16 days of treatment; do not use in lactating dairy cattle; Federal law restricts this drug to use by or on the order of a li censed veterinarian. (b)(1) Sponsor. See No. 054771 in § 510.600(c) of this chapter for use of a 27-gram sulfamethazine sustained-re lease bolus. (2) Conditions of use—(i) Amount. 27 grams (1 bolus) for each 150 pounds of body weight as a single dose. (ii) Indications for use. For nonlac tating cattle for the treatment of in fections caused by organisms sensitive to sulfamethazine such as hemorrhagic septicemia (shipping fever complex), bacterial pneumonia, foot rot, and calf diphtheria and as an aid in the control of bacterial diseases usually associated with shipping and handling of cattle. (iii) Limitations. If no response within 2 to 3 days, reevaluate therapy; do not crush tablets; treated animals must not be slaughtered for food within 28 days after the latest treatment; Fed eral law restricts this drug to use by or on the order of a licensed veterinarian. (c)(1) Sponsor. See No. 061623 in § 510.600(c) of this chapter for use of a 32.1-gram sustained-release bolus. (2) Conditions of use—(i) Amount. 32.1 grams (1 bolus) per 200 pounds of body weight. (ii) Indications for use. For beef and nonlactating dairy cattle for the treat ment of diseases caused by sulfamethazine-sensitive organisms as follows: bacterial pneumonia and bo vine respiratory disease complex (ship ping fever complex) caused by Pasteurella spp., colibacillosis (bac terial scours) caused by E. coli, necrotic pododermatitis (foot rot) and calf diph theria caused by Fusobacterium necrophorum, and acute mastitis and acute metritis caused by Streptococcus spp.) (iii) Limitations. After 72 hours, all animals should be reexamined for per sistence of observable disease signs. If signs are present, consult a veteri narian. It is strongly recommended that a second dose be given to provide for an additional 72 hours of therapy, particularly in more severe cases. The dosage schedule should be used at each 72-hour interval. Animals should not receive more than 2 doses because of the possibility of incurring residue vio lations. This drug, like all sulfonamides, may cause toxic reac tions and irreparable injury unless ad ministered with adequate and contin uous supervision; follow dosages care fully. Fluid intake must be adequate at all times throughout the 3-day ther apy, Do not use in female dairy cattle 20 months of age or older. Use of sulfamethazine in this class of cattle may cause milk residues. Do not treat animals within 12 days of slaughter. (d)(1) Sponsor. See 000859 in § 510.600(c) of this chapter for use of a 22.5-gram sulfamethazine sustained release bolus. (2) Conditions of use—(i) Amount. Ad minister 1 bolus (22.5 grams) per 200 pounds of body weight, as a single dose. (ii) Indications for use. Beef and non lactating dairy cattle for the prolonged treatment of the following diseases when caused by one or more of the list ed pathogenic organisms sensitive to sulfamethazine: bovine respiratory dis ease complex (shipping fever complex) (Pasteurella spp.), bacterial pneumonia (Pasteurella spp.), necrotic pododermatitis (foot rot) (Fusobacterium necrophorum), colibacillosis (bacterial scours) VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00255 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 246 21 CFR Ch. I (4–1–16 Edition) § 520.2260b (Escherichia coli), calf diphtheria (Fusobacterium necrophorum), acute mastitis (Streptococcus spp.) and acute metritis (Streptococcus spp.). (iii) Limitations. Cattle that are acutely ill should be treated by injec tion with a suitable antibacterial prod uct to obtain immediate therapeutic blood levels; do not slaughter animals for food within 16 days of treatment; do not use in lactating dairy cattle; if treated animals do not respond within 2 to 3 days, consult a veterinarian. (e)(1) Sponsor. See No. 061623 in § 510.600(c) of this chapter for use of an 8.02-gram sulfamethazine sustained-re lease bolus. (2) Conditions of use—(i) Amount. Ad minister 2 boluses (8.02 grams per bolus) per 100 pounds of body weight, as a single dose. (ii) Indications for use. Administer orally to ruminating calves for the pro longed treatment of the following dis eases when caused by one or more of the listed pathogenic organisms sen sitive to sulfamethazine: bacterial pneumonia (Pasteurella spp.), colibacillosis (bacterial scours) (E. coli), and calf diptheria (Fusobacterium necrophorum). (iii) Limitations. For use in rumi nating replacement calves only; 72 hours after dosing all animals should be reexamined for persistence of dis ease signs; if signs are present, consult a veterinarian; do not slaughter ani mals for food for at least 12 days after the last dose; this product has not been shown to be effective for nonrumi nating calves; exceeding two consecu tive doses may cause violative tissue residue to remain beyond the with drawal time; do not use in calves under 1 month of age or calves being fed an all milk diet. (f)(1) Sponsor. See No. 000859 in § 510.600(c) of this chapter for use of a 30-gram sulfamethazine sustained-re lease bolus. (2) Conditions of use—(i) Amount. Ad minister at the rate of 1 bolus (30 grams per bolus) per 200 pounds of body weight, as a single dose. (ii) Indications for use. Administer orally to beef cattle and nonlactating dairy cattle for the treatment of the following diseases when caused by one or more of the listed pathogenic orga nisms sensitive to sulfamethazine: bo vine respiratory disease complex (ship ping fever complex) associated with Pasteurella spp.; bacterial pneumonia associated with Pasteurell spp.; necrotic pododermatitis (foot rot) and calf diph theria caused by Fusobacterium necrophorum; colibacillosis (bacterial scours) caused by Escherichia coli; coc cidiosis caused by Eimeria bovis and E. zurnii; acute mastitis and metritis caused by Streptococcus spp. (iii) Limitations. For use in beef cattle and nonlactating dairy cattle only; if symptoms persist for 2 or 3 days after use, consult a veterinarian; do not slaughter animals for food for at least 8 days after the last dose; do not use in lactating dairy cattle; do not admin ister more than two consecutive doses. (g) Related tolerances. See § 556.670 of this chapter. (h)(1) Sponsor. See No. 000010 in § 510.600(c) of this chapter for use of an 8.25-gram sulfamethazine sustained-re lease bolus. (2) Conditions of use—(i) Amount. Ad minister at the rate of 1 bolus (8.25 grams per bolus) per 50 pounds of body weight, as a single dose. If signs of dis ease are significantly reduced, it is rec ommended that a second dose be given to provide an additional 72 hours of therapy. (ii) Indications for use. Administer orally to ruminating beef and dairy calves for treatment of the following diseases when caused by one or more of the listed pathogenic organisms sus ceptible to sulfamethazine: bacterial pneumonia associated with Pasteurella spp.; colibacillosis (bacterial scours) caused by Escherichia coli; coccidiosis caused by Eimeria bovis and E. zurnii; and calf diphtheria caused by Fusobacterium necrophorum. (iii) Limitations. Do not use in calves to be slaughtered under 1 month of age or calves being fed an all milk diet. Do not use in female dairy cattle 20 months of age or older. If symptoms persist after 3 days, consult a veteri narian. Do not administer more than 2 consecutive doses. Do not slaughter VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00256 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 247 Food and Drug Administration, HHS § 520.2261a animals for food for at least 8 days after the last dose. Do not crush bolus. [46 FR 36132, July 14, 1981, as amended at 48 FR 18803, Apr. 26, 1983; 48 FR 32760, July 19, 1983; 49 FR 29057, July 18, 1984; 50 FR 49372, Dec. 2, 1985; 51 FR 30212, Aug. 25, 1986; 53 FR 40727, Oct. 18, 1988; 54 FR 14341, Apr. 11, 1989; 55 FR 8462, Mar. 8, 1990; 56 FR 50653, Oct. 8, 1991; 59 FR 22754, May 3, 1994; 61 FR 4875, Feb. 9, 1996; 62 FR 35076, June 30, 1997; 66 FR 14073, Mar. 9, 2001; 68 FR 4915, Jan. 31, 2003; 70 FR 8290, Feb. 18, 2005; 78 FR 17596, Mar. 22, 2013; 79 FR 28830, May 20, 2014] § 520.2260c Sulfamethazine sustained release tablets. (a) Specifications. Each extended-re lease tablet contains 8 grams sulfamethazine. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.670 of this chapter. (d) Conditions of use—(1) Amount. 8 grams (1 tablet) per 45 pounds of body weight as a single dose. (2) Indications for use. In calves for sustained treatment of pneumonia caused by Pasteurella spp., colibacillosis (bacterial scours) caused by Escherichia coli; and calf diptheria caused by Fusobacterium necrophorum. (3) Limitations. Treated animals must not be slaughtered for food within 18 days after the latest treatment. Fed eral law restricts this drug to use by or on the order of a licensed veterinarian. [48 FR 26763, June 10, 1983, as amended at 56 FR 50653, Oct. 8, 1991; 59 FR 22754, May 3, 1994; 61 FR 4875, Feb. 9, 1996; 79 FR 28830, May 20, 2014] § 520.2261 Sulfamethazine sodium oral dosage forms. § 520.2261a Sulfamethazine solution. (a) Specifications. Each milliliter of solution contains 125 milligrams (12.5 percent) sulfamethazine sodium. (b) Sponsors. See Nos. 016592 and 061623 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.670 of this chapter. (d) Conditions of use—(1) Amount. Ad 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 day, and turkeys 53 to 130 milligrams of sulfamethazine sodium per pound of body weight per day, depending upon the dosage, age, and class of chickens or turkeys, ambient temperature, and other factors. (2) Indications for use. For treatment and control of diseases caused by orga nisms sensitive to sulfamethazine. (i) Beef and nonlactating dairy cattle. Treatment of bacterial pneumonia and bovine respiratory disease complex (shipping fever complex) (Pasteurella spp.), colibacillosis (bacterial scours) (Escherichia coli), necrotic pododermatitis (foot rot) (Fusobacterium necrophorum), calf diph theria (Fusobacterium necrophorum), acute mastitis (Streptococcus spp.), and acute metritis (Streptococcus spp.). (ii) Swine. Treatment of porcine colibacillosis (bacterial scours) (Escherichia coli), and bacterial pneu monia (Pasteurella spp.). (iii) Chickens and turkeys. In chickens for control of infectious coryza (Avibacterium paragallinarum), coccidi osis (Eimeria tenella, Eimeria necatrix), acute fowl cholera (Pasteurella multocida), and pullorum disease (Salmonella Pullorum). In turkeys for control of coccidiosis (Eimeria meleagrimitis, Eimeria adenoeides). Medi cate as follows: Infectious coryza in chickens, medicate for 2 consecutive days; acute fowl cholera and pullorum disease, in chickens, medicate for 6 consecutive days; coccidiosis, in chick ens and turkeys, medicate as in para graph (c) of this section, then reduce amount of medication to one-half for 4 additional days. (3) Limitations. Add the required dose to that amount of water that will be consumed in 1 day. Consumption should be carefully checked. Have only medicated water available during treatment. Withdraw medication from cattle, chickens, and turkeys 10 days prior to slaughter for food. Withdraw medication from swine 15 days before slaughter for food. Do not medicate chickens or turkeys producing eggs for human consumption. Treatment of all diseases should be instituted early. Treatment should continue 24 to 48 hours beyond the remission of disease VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00257 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 248 21 CFR Ch. I (4–1–16 Edition) § 520.2261b symptoms, but not to exceed a total of 5 consecutive days in cattle or swine. Medicated cattle, swine, chickens, and turkeys must actually consume enough medicated water which provides the recommended dosages. Do not use in fe male dairy cattle 20 months of age or older. Use of sulfamethazine in this class of cattle may cause milk resi dues. A withdrawal period has not been established in preruminating calves. Do not use in calves to be processed for veal. [47 FR 25322, June 11, 1982, as amended at 47 FR 25735, June 15, 1982; 67 FR 78355, Dec. 24, 2002; 70 FR 32489, June 3, 2005; 74 FR 36112, July 22, 2009; 75 FR 10166, Mar. 5, 2010; 76 FR 17337, Mar. 29, 2011; 79 FR 28831, May 20, 2014; 81 FR 17607, Mar. 30, 2016] § 520.2261b Sulfamethazine powder. (a) Specifications. A soluble powder composed of 100 percent sulfamethazine sodium. (b) Sponsors. See Nos. 016592 and 061623 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.670 of this chapter. (d) Conditions of use—(1) Chickens—(i) Amount. Administer in drinking water to provide 58 to 85 milligrams (mg) per pound (/lb) of body weight per day. (ii) Indications for use. For control of infectious coryza (Avibacterium paragallinarum), coccidiosis (Eimeria tenella, E. necatrix), acute fowl cholera (Pasteurella multocida), and pullorum disease (Salmonella Pullorum). (iii) Limitations. Add the required dose to that amount of water that will be consumed in 1 day. Consumption should be carefully checked. Have only medicated water available during treatment. Withdraw medication 10 days prior to slaughter for food. Do not medicate chickens producing eggs for human consumption. Treatment of all diseases should be instituted early. Treatment should continue 24 to 48 hours beyond the remission of disease symptoms. Medicated chickens must actually consume enough medicated water which provides the recommended dosages. (2) Turkeys—(i) Amount. Administer in drinking water to provide 50 to 124 mg/lb of body weight per day (ii) Indications for use. For control of coccidiosis (E. meleagrimitis, E. adenoeides). (iii) Limitations. Add the required dose to that amount of water that will be consumed in 1 day. Consumption should be carefully checked. Have only medicated water available during treatment. Withdraw medication 10 days prior to slaughter for food. Do not medicate turkeys producing eggs for human consumption. Treatment of all diseases should be instituted early. Treatment should continue 24 to 48 hours beyond the remission of disease symptoms. Medicated turkeys must ac tually consume enough medicated water which provides the recommended dosages. (3) Swine—(i) Amount. Administer in drinking water, or as a drench, to pro vide 108 mg/lb of body weight on the first day and 54 mg/lb of body weight per day on the second, third, and fourth days of administration. (ii) Indications for use. For treatment of porcine colibacillosis (bacterial scours) (E. coli), and bacterial pneu monia (Pasteurella spp.). (iii) Limitations. Add the required dose to that amount of water that will be consumed in 1 day. Consumption should be carefully checked. Have only medicated water available during treatment. Withdraw medication 15 days prior to slaughter for food. Treat ment of all diseases should be insti tuted early. Treatment should con tinue 24 to 48 hours beyond the remis sion of disease symptoms, but not to exceed a total of 5 consecutive days. Medicated swine must actually con sume enough medicated water which provides the recommended dosages. (4) Cattle—(i) Amount. Administer in drinking water, or as a drench, to pro vide 108 mg/lb of body weight on the first day and 54 mg/lb of body weight per day on the second, third, and fourth days of administration. (ii) Indications for use in beef and non lactating dairy cattle. Treatment of bac terial pneumonia and bovine res piratory disease complex (shipping fever complex) (Pasteurella spp.), colibacillosis (bacterial scours) (E. coli), necrotic pododermatitis (foot rot) (Fusobacterium necrophorum), calf diph theria (F. necrophorum), acute mastitis VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00258 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 249 Food and Drug Administration, HHS § 520.2325a (Streptococcus spp.), and acute metritis (Streptococcus spp.) (iii) Limitations. Add the required dose to that amount of water that will be consumed in 1 day. Consumption should be carefully checked. Have only medicated water available during treatment. Withdraw medication 10 days prior to slaughter for food. Treat ment of all diseases should be insti tuted early. Treatment should con tinue 24 to 48 hours beyond the remis sion of disease symptoms, but not to exceed a total of 5 consecutive days. Medicated cattle must actually con sume enough medicated water which provides the recommended dosages. Do not use in female dairy cattle 20 months of age or older. Use of sulfamethazine in this class of cattle may cause milk residues. Do not use in calves under one (1) month of age or calves being fed an all-milk diet. Use in these classes of calves may cause viola tive residues to remain beyond the withdrawal time. [71 FR 70303, Dec. 4, 2006, as amended at 75 FR 10166, Mar. 5, 2010; 79 FR 28831, May 20, 2014; 80 FR 61296, Oct. 13, 2015; 81 FR 17607, Mar. 30, 2016] § 520.2280 Sulfamethizole and methe namine. (a) Specifications. Each tablet con tains 250 milligrams of sulfamethizole and 250 milligrams of methenamine mandelate. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Conditions of use in dogs and cats— (1) Amount. Administer orally 1 tablet per 20 pounds of body weight 3 times per day until clinical signs are allevi ated. To reduce the possibility of re lapse, continue therapy for a week to 10 days. (2) Indications for use. For treatment of urinary tract infections such as cys titis, nephritis, prostatitis, urethritis, and pyelonephritis. As an aid in the management of complications result ing from surgical manipulations of the urinary tract such as removal of calculi from the bladder, in ureterostomies, and in instrumenta tion of the urethra and bladder. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [40 FR 13838, Mar. 27, 1975, as amended at 50 FR 13561, Apr. 5, 1985; 79 FR 28831, May 20, 2014] § 520.2325 Sulfaquinoxaline oral dos age forms. § 520.2325a Sulfaquinoxaline powder and solution. (a) Sponsor. See § 510.600(c) of this chapter for identification of the spon sors. (1) To No. 000859 for use of a 25-per cent sulfaquinoxaline soluble powder and a 20-percent sulfaquinoxaline so dium solution as provided for in para graph (c) of this section. (2) To No. 061623 for use of 3.44- and 12.85-percent sulfaquinoxaline sodium solutions as provided for in paragraphs (c)(1), (c)(2), (c)(3), (c)(4)(i), and (c)(4)(ii) of this section. (3) To No. 054771 for use of a 31.92-per cent sulfaquinoxaline solution (sodium and potassium salts) as provided for in paragraphs (c)(1), (c)(2), (c)(3), (c)(4)(i), and (c)(4)(ii) of this section. (4) No. 053501 for use of a 28.62-percent sulfaquinoxaline sodium solution as provided in paragraphs (c)(1), (c)(2), and (c)(3) of this section. (b) Related tolerances. See § 556.685 of this chapter. (c) Conditions of use. It is used in drinking water as follows: (1) Chickens. (i) As an aid in the con trol of outbreaks of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, and E. brunetti. (ii) Administer at the 0.04 percent level for 2 or 3 days, skip 3 days then administer at the 0.025 percent level for 2 more days. If bloody droppings ap pear, repeat treatment at the 0.025 per cent level for 2 more days. Do not change litter unless absolutely nec essary. Do not give flushing mashes. (2) Turkeys. (i) As an aid in the con trol of outbreaks of coccidiosis caused by Eimeria meleagrimitis and E. adenoeides. (ii) Administer at the 0.025 percent level for 2 days, skip 3 days, give for 2 days, skip 3 days and give for 2 more days. Repeat if necessary. Do not VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00259 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 250 21 CFR Ch. I (4–1–16 Edition) § 520.2325b change litter unless absolutely nec essary. Do not give flushing mashes. (3) Chickens and turkeys. (i) As an aid in the control of acute fowl cholera caused by Pasteurella multocida suscep tible to sulfaquinoxaline and fowl ty phoid caused by Salmonella gallinarum susceptible to sulfaquinoxaline. (ii) Administer at the 0.04 percent level for 2 or 3 days. Move birds to clean ground. If disease recurs, repeat treatment. If cholera has become es tablished as the respiratory or chronic form, use feed medicated with sulfaquinoxaline. Poultry which have survived typhoid outbreaks should not be kept for laying house replacements or breeders unless tests show they are not carriers. (4) Cattle and calves. (i) For the con trol and treatment of outbreaks of coc cidiosis caused by Eimeria bovis or E. zurnii. (ii) Administer at the 0.015-percent level for 3 to 5 days in drinking water medicated with sulfaquinoxaline solu tion. (iii) In lieu of treatment as provided in paragraph (e)(4)(ii) of this section, administer 1 teaspoon of 25-percent sulfaquinoxaline soluble powder per day for each 125 pounds of body weight for 3 to 5 days in drinking water. (d) Limitations. Consult a veterinarian or poultry pathologist for diagnosis. May cause toxic reactions unless the drug is evenly mixed in water at dos ages indicated and used according to directions. For control of outbreaks of disease, medication should be initiated as soon as the diagnosis is determined. Medicated chickens, turkeys, cattle, and calves must actually consume enough medicated water which pro vides a recommended dosage of ap proximately 10 to 45 milligrams per pound per day in chickens, 3.5 to 55 milligrams per pound per day in tur keys, and approximately 6 milligrams per pound per day in cattle and calves depending on the age, class of animal, ambient temperature, and other fac tors. A withdrawal period has not been established for sulfaquinoxaline in preruminating calves. Do not use in calves to be processed for veal. Not for use in lactating dairy cattle. Do not give to chickens, turkeys or cattle within 10 days of slaughter for food. Do not medicate chickens or turkeys pro ducing eggs for human consumption. Make fresh drinking water daily. [48 FR 3964, Jan. 28, 1983, as amended at 48 FR 26762, June 10, 1983; 55 FR 29843, July 23, 1990; 59 FR 28769, June 3, 1994; 59 FR 33197, June 28, 1994; 61 FR 24443, May 15, 1996; 61 FR 63711, Dec. 2, 1996; 62 FR 37712, July 15, 1997; 65 FR 10705, Feb. 29, 2000; 69 FR 41427, July 9, 2004; 69 FR 60547, Oct. 12, 2004; 74 FR 36112, July 22, 2009; 78 FR 17596, Mar. 22, 2013; 79 FR 28831, May 20, 2014] § 520.2325b Sulfaquinoxaline drench. (a) Specifications. A soluble powder containing 25 percent sulfaquinoxaline. (b) Sponsor. See No. 050749 in § 510.600(c) of this chapter. (c) Conditions of use in cattle—(1) Amount. Administer 1 teaspoon of 25 percent sulfaquinoxaline soluble pow der for each 125 pounds of body weight for 3 to 5 days as a drench. (2) Indications for use. For the control and treatment of outbreaks of coccidi osis in cattle and calves caused by Eimeria bovis or E. zuernii. (3) Limitations. Do not give to cattle within 10 days of slaughter for food. Not for use in lactating dairy cattle. [79 FR 28831, May 20, 2014] § 520.2330 Sulfisoxazole tablets. (a) Specifications. Each tablet con tains 260 milligrams (4 grains) of sulfisoxazole. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Conditions of use—(1) Amount. Ad minister one tablet orally per 4 pounds of body weight. (2) Indications for use. Use in dogs and cats as an aid in treatment of bacterial pneumonia and bacterial enteritis when caused by organisms sensitive to sulfisoxazole. (3) Limitations. Repeat dosage at 24 hour intervals until 2 to 3 days after disappearance of clinical symptoms. (Administration of one-half daily dos age at 12-hour intervals or one-third daily dosage at 8-hour intervals will provide a more constant blood level.) Provide adequate supply of drinking water. If symptoms persist after using this preparation for 2 or 3 days, consult a veterinarian. [43 FR 60895, Dec. 29, 1978, as amended at 79 FR 28831, May 20, 2014] VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00260 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 251 Food and Drug Administration, HHS § 520.2345c § 520.2340 Tepoxalin. (a) Specifications. Each tablet con tains 30, 50, 100, or 200 milligrams (mg) tepoxalin. (b) Sponsor. See No. 000061 in § 510.600(c) of this chapter. (c) Conditions of use in dogs—(1) Amount. 10 mg per kilogram (/kg) daily; or 20 mg/kg on the initial day of treat ment, followed by 10 mg/kg daily. (2) Indications for use. For the control of pain and inflammation associated with osteoarthritis. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [68 FR 34795, June 11, 2003] § 520.2345 Tetracycline. § 520.2345a Tetracycline capsules. (a) Specifications. Each capsule con tains 50, 100, 125, 250, or 500 milligrams (mg) tetracycline hydrochloride. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Conditions of use in dogs—(1) Amount. 25 mg per pound of body weight per day in divided doses every 6 hours. (2) Indications for use. For treatment of infections caused by organisms sen sitive to tetracycline hydrochloride, such as bacterial gastroenteritis due to E. coli and urinary tract infections due to Staphylococcus spp. and E. coli. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [70 FR 50182, Aug. 26, 2005, as amended at 73 FR 18442, Apr. 4, 2008; 79 FR 28831, May 20, 2014] § 520.2345b Tetracycline tablets. (a) Specifications. Each tablet con tains 100, 250, or 500 milligrams of tet racycline (as the hydrochloride). (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Conditions of use. Dogs—(1) Amount. 25 milligrams per pound of body weight per day in divided doses every 6 hours. (2) Indications for use. Treatment of infections caused by organisms sen sitive to tetracycline hydrochloride, such as bacterial gastroenteritis due to E. coli and urinary tract infections due to Staphylococcus spp. and E. coli. (3) Limitations. Administer orally; continue treatment until symptoms of the disease have subsided and tempera ture is normal for 48 hours; not for use in animals raised for food production; Federal law restricts this drug to use by or on the order of a licensed veteri narian. [57 FR 37327, Aug. 18, 1992, as amended at 79 FR 28831, May 20, 2014] § 520.2345c Tetracycline boluses. (a) Specifications. Each bolus contains 500 milligrams of tetracycline (as the hydrochloride). (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.720 of this chapter. (d) Conditions of use. Calves—(1) Amount. 10 milligrams per pound of body weight per day in divided doses. (i) Indications for use. Control and treatment of bacterial enteritis (scours) caused by E. coli and bacterial pneumonia caused by Pasteurella spp., Hemophilus spp., and Klebsiella spp. (ii) Limitations. Administer orally for 3 to 5 days; do not slaughter animals for food within 14 days of treatment; use as sole source of tetracycline. (iii) National Academy of Sciences/Na tional Research Council (NAS/NRC) sta tus. The conditions of use specified in paragraph (d)(1)(i) of this section were NAS/NRC reviewed and found effective. Applications for these uses need not in clude effectiveness data as specified in § 514.111 of this chapter, but may re quire bioequivalency and safety infor mation. (2) Amount. 10 milligrams per pound of body weight per day in two divided doses. (i) Indications for use. Treatment of bacterial pneumonia caused by orga nisms susceptible to tetracycline, bac terial enteritis caused by E. coli, and salmonella organisms susceptible to tetracycline. (ii) Limitations. Administer orally for not more than 5 days; do not slaughter animals for food within 12 days of VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00261 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 252 21 CFR Ch. I (4–1–16 Edition) § 520.2345d treatment; use as sole source of tetra cycline. [57 FR 37328, Aug. 18, 1992, as amended at 67 FR 78355, Dec. 24, 2002; 79 FR 28831, May 20, 2014] § 520.2345d Tetracycline powder. (a) Specifications. Each pound of pow der contains 25, 102.4, or 324 grams tet racycline hydrochloride. (b) Sponsors. See sponsors listed in § 510.600(c) of this chapter for condi tions of use as in paragraph (d) of this section: (1) No. 054771: 25 grams per pound as in paragraphs (d)(3) and (d)(4) of this section. (2) No. 054628: 25, 102.4, and 324 grams per pound as in paragraph (d) of this section. (3) No. 054771: 25, 102.4, and 324 grams per pound as in paragraph (d) of this section. (4) Nos. 054925, 057561, 061623, and 076475: 324 grams per pound as in para graph (d) of this section. (5) No. 016592: 25 grams per pound as in paragraphs (d)(1) and (d)(2) of this section. (c) Related tolerances. See § 556.720 of this chapter. (d) Conditions of use. It is adminis tered in drinking water as follows: (1) Calves—(i) Amount. 10 milligrams per pound of body weight per day in di vided doses. (ii) Indications for use. Control and treatment of bacterial enteritis (scours) caused by Escherichia coli and bacterial pneumonia (shipping fever complex) associated with Pasteurella spp., Actinobacillus pleuropneumoniae (Haemophilus spp.), and Klebsiella spp., susceptible to tetracycline. (iii) Limitations. Administer for 3 to 5 days; do not slaughter animals for food within 4 days of treatment for No. 016592 and within 5 days of treatment for Nos. 054771, 054925, 057561, 059130, and 061623; prepare a fresh solution daily; use as the sole source of tetracycline. A withdrawal period has not been es tablished for this product in preruminating calves. Do not use in calves to be processed for veal. (2) Swine—(i) Amount. 10 milligrams per pound of body weight per day in di vided doses. (ii) Indications for use. Control and treatment of bacterial enteritis (scours) caused by E. coli and bacterial pneumonia associated with Pasteurella spp., A. pleuropneumoniae (Haemophilus spp.), and Klebsiella spp., susceptible to tetracycline. (iii) Limitations. Administer for 3 to 5 days; do not slaughter animals for food within 7 days of treatment for No. 016592 and within 4 days of treatment for Nos. 054771, 054925, 057561, 059130, and 061623; prepare a fresh solution daily; use as the sole source of tetracycline. (3) Chickens—(i) Amount. Chronic res piratory disease: 400 to 800 milligrams per gallon. Infectious synovitis: 200 to 400 milligrams per gallon. (ii) Indications for use. Control of chronic respiratory disease (CRD or air-sac disease) caused by Mycoplasma gallisepticum and E. coli; control of in fectious synovitis caused by M. synoviae susceptible to tetracycline. (iii) Limitations. Administer for 7 to 14 days; do not slaughter for food with in 4 days of treatment; not for use in chickens producing eggs for human consumption; prepare a fresh solution daily; use as the sole source of tetra cycline. (4) Turkeys—(i) Amount. For infec tious synovitis: 400 milligrams per gal lon. For complicating bacterial orga nisms associated with bluecomb (trans missible enteritis or coronaviral enter itis): 25 milligrams per pound of body weight per day. (ii) Indications for use. Control of in fectious synovitis caused by M. synoviae; control of bluecomb com plicated by organisms sensitive to tet racycline. (iii) Limitations. Administer for 7 to 14 days; do not slaughter for food with in 4 days of treatment; not for use in turkeys producing eggs for human con sumption; prepare a fresh solution VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00262 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 253 Food and Drug Administration, HHS § 520.2345g daily; use as the sole source of tetra cycline. [59 FR 17693, Apr. 14, 1994, as amended at 59 FR 19133, Apr. 22, 1994; 62 FR 5319, Feb. 5, 1997; 62 FR 35076, June 30, 1997; 62 FR 46668, Sept. 4, 1997; 62 FR 55160, Oct. 23, 1997; 64 FR 37673, July 13, 1999; 67 FR 78355, Dec. 24, 2002; 70 FR 16934, Apr. 4, 2005; 70 FR 67353, Nov. 7, 2005; 71 FR 13542, Mar. 16, 2006; 75 FR 10166, Mar. 5, 2010; 75 FR 12981, Mar. 18, 2010; 76 FR 17338, Mar. 29, 2011; 77 FR 20988, Apr. 9, 2012; 78 FR 21060, Apr. 9, 2013; 79 FR 28831, May 20, 2014; 81 FR 17607, Mar. 30, 2016] § 520.2345e Tetracycline solution. (a) Specifications. Each milliliter con tains the equivalent of either 25 or 100 milligrams of tetracycline hydro chloride. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Conditions of use—(1) Dogs—(i) Amount. 25 milligrams per pound of body weight per day in divided doses every 6 hours. (ii) Indications for use. Treatment of infections caused by organisms sen sitive to tetracycline hydrochloride, such as bacterial gastroenteritis due to Escherichia coli and urinary tract infec tions due to Staphylococcus spp. and E. coli. (iii) Limitations. Administer orally; continue treatment until symptoms have subsided and the temperature is normal for 48 hours; not for use in ani mals which are raised for food produc tion; Federal law restricts this drug to use by or on the order of a licensed vet erinarian. (2) Dogs and cats—(i) Amount. 25 milli grams per pound of body weight per day in divided doses every 6 hours. (ii) Indications for use. Treatment of infections caused by organisms suscep tible to tetracycline hydrochloride, such as bacterial gastroenteritis due to E. coli and urinary tract infections due to Staphylococcus spp. and E. coli. (iii) Limitations. Administer orally; continue treatment until the tempera ture has been normal for 48 hours; not for use in food-producing animals; Fed eral law restricts this drug to use by or on the order of a licensed veterinarian. [57 FR 37329, Aug. 18, 1992, as amended at 79 FR 28831, May 20, 2014] § 520.2345f Tetracycline phosphate complex and sodium novobiocin capsules. (a) Specifications. Each capsule con tains the equivalent of 60 milligrams of tetracycline hydrochloride and 60 mil ligrams of novobiocin. (b) Sponsor. No. 054771 in § 510.600(c) of this chapter. (c) Conditions of use in dogs—(1) Amount. 10 milligrams of each anti biotic per pound of body weight (1 cap sule for each 6 pounds) every 12 hours. (2) Indications for use. Treatment of acute or chronic canine respiratory in fections such as tonsillitis, bronchitis, and tracheobronchitis when caused by pathogens susceptible to tetracycline and/or novobiocin, such as Staphy lococcus spp. and Escherichia coli. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [57 FR 37329, Aug. 18, 1992, as amended at 79 FR 28831, May 20, 2014] § 520.2345g Tetracycline hydrochloride and sodium novobiocin tablets. (a) Specifications. Each tablet con tains the equivalent of 60 milligrams of tetracycline hydrochloride and 60 mil ligrams of novobiocin, or 180 milli grams of tetracycline hydrochloride and 180 milligrams of novobiocin. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Conditions of use in dogs—(1) Amount. 10 milligrams of each anti biotic per pound of body weight (one single-strength tablet for each 6 pounds or one triple-strength tablet for each 18 pounds). (2) Indications for use. Treatment of acute or chronic canine respiratory in fections such as tonsillitis, bronchitis, and tracheobronchitis when caused by pathogens susceptible to tetracycline and/or novobiocin, such as Staphy lococcus spp. and Escherichia coli. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [57 FR 37329, Aug. 18, 1992, as amended at 79 FR 28831, May 20, 2014] VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00263 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 254 21 CFR Ch. I (4–1–16 Edition) § 520.2345h § 520.2345h Tetracycline hydro chloride, sodium novobiocin, and prednisolone tablets. (a) Specifications. Each tablet con tains the equivalent of 60 milligrams of tetracycline hydrochloride, 60 milli grams of novobiocin, and 1.5 milli grams of prednisolone or 180 milli grams of tetracycline hydrochloride, 180 milligrams of novobiocin, and 4.5 milligrams of prednisolone. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Conditions of use in dogs—(1) Amount. 10 milligrams of each anti biotic and 0.25 milligram of prednis olone per pound of body weight (one single-strength tablet for each 6 pounds or one triple-strength tablet for each 18 pounds) every 12 hours for 48 hours. Treatment is to be continued with novobiocin and tetracycline alone at the same dose schedule for an addi tional 3 days or longer as needed. (2) Indications for use. Treatment of acute and chronic canine respiratory infections such as tonsillitis, bron chitis, and tracheobronchitis when caused by pathogens susceptible to tet racycline and/or novobiocin, such as Staphylococcus spp. and Escherichia coli, when it is necessary to initially reduce the severity of associated clinical signs. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [57 FR 37329, Aug. 18, 1992, as amended at 79 FR 28832, May 20, 2014] § 520.2362 Thenium closylate. (a) Specifications. Each tablet con tains thenium closylate equivalent to 500 milligrams thenium base. (a) Specifications. Thenium closylate tablets contain thenium closylate equivalent to 500 milligrams thenium as base in each tablet. (b) Sponsor. See No. 000061 in § 510.600(c) of this chapter. (c) Conditions of use in dogs—(1) Amount. Dogs weighing over 10 pounds: Administer 1 tablet as a single dose. Dogs weighing 5 to 10 pounds: Adminis tered one-half tablet twice during a single day. Repeat treatment after 2 or 3 weeks. (2) Indications for use. For treatment of canine ancylostomiasis by the re moval from the intestines of the adult forms of the species Ancylostoma caninum and Uncinaria stenocephala (hookworms). (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [40 FR 13838, Mar. 27, 1975, as amended at 41 FR 53477, Dec. 7, 1976; 46 FR 48642, Oct. 2, 1981; 61 FR 8873, Mar. 6, 1996; 62 FR 61625, Nov. 19, 1997; 79 FR 28832, May 20, 2014] § 520.2380 Thiabendazole oral dosage forms. § 520.2380a Thiabendazole top dress ing and mineral protein block. (a) Specifications. Conforms to N.F. XII. (b) Sponsors. See sponsors in § 510.600(c) of this chapter for use as in paragraph (d) of this section. (1) No. 051311 for use as in paragraph (d)(1)(i) of this section. (2) No. 050604 for use as in paragraph (d)(1)(ii) of this section. (3) No. 012286 for use as in paragraph (d)(2) of this section. (c) Related tolerances. See § 556.730 of this chapter. (d) Conditions of use. It is used as fol lows: (1) Horses—(i) Route of administration. In feed, as a top dressing. (a) Amount. 2 grams per 100 pounds of body weight. (b) Indications for use. For control of large strongyles, small strongyles, pinworms, and threadworms (including members of the genera Strongylus, Cyathostomum, Cylicobrachytus, and re lated genera, Craterostomum, Oesophagodontus, Poteriostomum, Oxyuris, and Strongyloides). (c) Limitations. Add to the usual feed of horses mixed into that amount of the feed normally consumed at one feeding. Warning: Not for use in horses intended for food. (ii) Route of administration. In feed. (a) Amount. 2 grams per 100 pounds of body weight. (1) Indications for use. For control of large and small strongyles, Strongyloides, and pinworms of the gen era Strongylus, Cyathostomum, Cylicobrachytus and related genera, Craterostomum, Oesophagodontus, Poteriostomum, Oxyuris, and Strongyloides. VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00264 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 255 Food and Drug Administration, HHS § 520.2380b (2) Limitations. Administer in a single dosage mixed with the normal grain ra tion given at one feeding. Warning: Not for use in horses intended for food. (b) Amount. 4 grams per 100 pounds of body weight. (1) Indications for use. For control of ascarids of the genus Parascaris. (2) Limitations. Administer in a single dosage mixed with the normal grain ra tion given at one feeding. Warning: Not for use in horses intended for food. (2) Cattle—(i) Route of administration. In feed block. (ii) Amount. 3.3 percent block con sumed at the recommended level of 0.11 pound per 100 pounds of body weight per day. (iii) Indications for use. For control of infections of gastrointestinal roundworms (Trichostrongylus, Haemonchus, Ostertagia and Cooperia). (iv) Limitations. Administer to cattle on pasture or range accustomed to mineral protein block feeding for 3 days. Milk taken from animals during treatment and within 96 hours (8 milkings) after the latest treatment must not be used for food. Do not treat cattle within 3 days of slaughter. For a satisfactory diagnosis, a microscopic fecal examination should be performed by a veterinarian or diagnostic labora tory prior to worming. Animals main tained under conditions of constant worm exposure may require re-treat ment within 2 to 3 weeks. Animals that are severely parasitized, sick, or off feed should be isolated and a veteri narian consulted for advice concerning treatment. [40 FR 13838, Mar. 27, 1975, as amended at 41 FR 9149, Mar. 3, 1976; 62 FR 63271, Nov. 28, 1997; 70 FR 32489, June 3, 2005; 73 FR 35340, June 23, 2008; 79 FR 28832, May 20, 2014] § 520.2380b Thiabendazole drench or paste. (a) Specifications. Conforms to N.F. XII. (b) Sponsor. See No. 050604 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.730 of this chapter. (d) Conditions of use. It is used as fol lows: (1) Horses. As a single liquid oral dose, administered as a drench or by stomach tube; or as an oral paste. (i) Amount. 2 grams per 100 pounds of body weight. (a) Indications for use. For the control of infections of large strongyles (Strongylus vulgaris, Strongylus endentatus), small strongyles (Cyathastomum, Cylicobrachytus and re lated genera, Craterostomum, Oesophagodontus, Poteriostomum), pinworms (Oxyuris), and threadworms (Strongyloides). (b) Limitations. Not for use in horses to be slaughtered for food purposes. When administered by stomach tube, for use only by or on the order of a li censed veterinarian. When for use as a liquid oral drench or an oral paste, con sult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. (ii) Amount. 4 grams per 100 pounds of body weight. (a) Indications for use. For control of infections of ascardis (Parascaris). (b) Limitations. Not for use in horses to be slaughtered for food purposes. When administered by stomach tube, use only by or on the order of a li censed veterinarian. When for use as a liquid oral drench or an oral paste, con sult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. (2) Pigs. As an oral paste. (i) Amount. 200 milligrams for each 5 to 7 pounds of body weight per dose. (ii) Indications for use. For control of infections with Strongyloides ransomi. These infections are commonly found in Southeastern United States. (iii) Limitations. Administer to baby pigs (1 to 8 weeks of age). Treatment may be repeated in 5 to 7 days if nec essary. Before treatment, obtain an ac curate diagnosis from a veterinarian or diagnostic laboratory. Do not treat within 30 days of slaughter. (3) Cattle. Orally as a drench and in paste form using a dosing gun designed for the product. (i) Amount. 3 grams per 100 pounds of body weight. (a) Indications for use. Control of in fections of gastrointestinal roundworms (Trichostrongylus spp., Haemonchus spp., Nematodirus spp., Ostertagia spp., and Oesophagostomum radiatum). VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00265 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 256 21 CFR Ch. I (4–1–16 Edition) § 520.2380c (b) Limitations. For most effective re sults, severely parasitized animals or those constantly exposed to helminth infection should be re-treated every 2 to 3 weeks. Milk taken from treated animals within 96 hours (8 milkings) after the latest treatment must not be used for food. Do not treat cattle with in 3 days of slaughter. For a satisfac tory diagnosis, a microscopic fecal ex amination should be performed prior to worming. (ii) Amount. 5 grams per 100 pounds of body weight. (a) Indications for use. Control of in fections of Cooperia spp. or severe infec tions of other species in paragraph (e)(3)(i)(a) of this section. (b) Limitations. For most effective re sults, severely parasitized animals or those constantly exposed to helminth infection should be re-treated every 2 to 3 weeks. Milk taken from treated animals within 96 hours (8 milkings) after the latest treatment must not be used for food. Do not treat cattle with in 3 days of slaughter. For a satisfac tory diagnosis, a microscopic fecal ex amination should be performed prior to worming. (4) Sheep and goats. Orally, as a drench. (i) Amount. 2 grams per 100 pounds of body weight. (ii) Indications for use. Control of in fections of gastrointestinal roundworms in sheep and goats. (Trichostrongylus spp., Haemonchus spp., Ostertagia spp., Cooperia spp., Nematodirus spp., Bunostomum spp., Strongyloides spp., Chabertia spp., and Oesophagostomum spp.); also active from 3 hours to 3 days following treat ment against ova and larvae passed by sheep (good activity against Trichostrongylus colubriformis and axei, Ostertagia spp., Bunostomum spp., Nematodirus spp., and Strongyloides spp.; less effective against Haemonchus contortus and Oesophagostomum spp.). (iii) Limitations. As a single oral dose; do not treat animals within 30 days of slaughter; milk taken from treated animals within 96 hours (8 milkings) after the latest treatment must not be used for food; in severe infections in sheep, treatment should be repeated in 2 to 3 weeks. (5) Goats. Orally, as a drench. (i) Amount. 3 grams per 100 pounds of body weight. (ii) Indications for use. Control of se vere infections of gastrointestinal roundworms (Trichostrongylus spp., Haemonchus spp., Ostertagia spp., Cooperia spp., Nematodirus spp., Bunostomum spp., Strongyloides spp., Chabertia spp., and Oesophagostomum spp.). (iii) Limitations. As a single oral dose; do not treat animals within 30 days of slaughter; milk taken from treated animals within 96 hours (8 milkings) after the latest treatment must not be used for food; treatment should be re peated in 2 to 3 weeks. [40 FR 13838, Mar. 27, 1975, as amended at 41 FR 9149, Mar. 3, 1976; 41 FR 47424, Oct. 29, 1976; 62 FR 63271, Nov. 28, 1997; 79 FR 28832, May 20, 2014] § 520.2380c Thiabendazole bolus. (a) Specifications. Conforms to N.F. XII. (b) Sponsor. See No. 050604 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.730 of this chapter. (d) Conditions of use. It is used as fol lows: (1) Cattle. In a bolus. (i) Amount. 3 grams per 100 pounds of body weight. (a) Indications for use. Control of in fections of gastrointestinal roundworms (general Trichostrongylus spp., Haemonchus spp., Nematodirus spp., Ostertagia spp., and Oesophagostomum radiatum). (b) Limitations. As a single oral dose; may repeat once in 2 to 3 weeks; do not treat animals within 3 days of slaugh ter; milk taken from treated animals within 96 hours (8 milkings) after the latest treatment must not be used for food. (ii) Amount. 5 grams per 100 pounds of body weight. (a) Indications for use. Control of se vere infections of gastrointestinal roundworms (genera Trichostrongylus spp., Haemonchus spp., Nematodirus spp., Ostertagia spp., and Oesophagostomum radiatum). Control of infections with Cooperia spp. (b) Limitations. As a single oral dose; as a drench or bolus; may repeat once in 2 to 3 weeks; do not treat animals VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00266 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 257 Food and Drug Administration, HHS § 520.2380e within 3 days of slaughter; milk taken from treated animals within 96 hours (8 milkings) after the latest treatment must not be used for food. (2) Sheep and goats. In a bolus. (i) Amount. 2 grams per 100 pounds of body weight. (ii) Indications for use. Control of in fections of gastrointestinal roundworms in sheep and goats (gen eral Trichostrongylus spp., Haemonchus spp., Ostertagia spp., Cooperia spp., Nematodirus spp., Bunostomum spp., Strongyloides spp., Chabertia spp., and Oesophagostomum spp.); also active from 3 hours to 3 days following treat ment against ova and larvae passed by sheep (good activity against T. colubriformis and axei, Ostertagia spp., Bunostomum spp., Nematodirus spp., and Strongyloides spp.; less effective against Haemonchus contortus and Oesophagostomum spp.). (iii) Limitations. As a single oral dose; do not treat animals within 30 days of slaughter; milk taken from treated animals within 96 hours (8 milkings) after the latest treatment must not be used for food; in severe infections in sheep, treatment should be repeated in 2 to 3 weeks. (3) Goats. In a bolus. (i) Amount. 3 grams per 100 pounds of body weight. (ii) Indications for use. Control of se vere infections of gastrointestinal roundworms (genera Trichostrongylus spp., Haemonchus spp., Ostertagia spp., Cooperia spp., Nematodirus spp., Bunostomum spp., Strongyloides spp., Chabertia spp., and Oesophagostomum spp.). (iii) Limitations. As a single oral dose; do not treat animals within 30 days of slaughter; milk taken from treated animals within 96 hours (8 milkings) after the latest treatment must not be used for food; treatment should be re peated in 2 to 3 weeks. [40 FR 13838, Mar. 27, 1975, as amended at 41 FR 9149, Mar. 3, 1976; 62 FR 63271, Nov. 28, 1997; 79 FR 28832, May 20, 2014] § 520.2380d Thiabendazole and piper azine citrate. (a) Specifications. Each fluid ounce of suspension contains 2 grams of thiabendazole and 2.5 grams of piper azine (from piperazine citrate). (b) Sponsor. See No. 050604 in § 510.600(c) of this chapter. (c) Conditions of use in horses—(1) Amount. Administer 1 ounce of suspen sion per 100 pounds of body weight by stomach tube or as a drench. (2) Indications for use. For the control of large strongyles, small strongyles, pinworms, Strongyloides and ascarids (including members of the genera Strongylus spp., Cyathostomum spp., Cylicobrachytus spp. and related genera Craterostomum spp., Oesophagodontus spp., Poteriostomum spp., Oxyuris spp., Strongyloides spp., and Parascaris spp.). (3) Limitations. Do not use in horses intended for human consumption. Fed eral law restricts this drug to use by or on the order of a licensed veterinarian. [40 FR 13838, Mar. 27, 1975, as amended at 62 FR 63271, Nov. 28, 1997; 79 FR 28832, May 20, 2014] § 520.2380e Thiabendazole and triclorfon. (a) Specifications. The drug contains 5 grams of thiabendazole with 4.5 grams of trichlorfon, or 20 grams of thiabendazole with 18 grams of trichlorfon. (b) Sponsor. See No. 017135 in § 510.600(c) of this chapter. (c) Conditions of use in horses—(1) Amount. Administer 2 grams of thiabendazole with 1.8 grams of trichlorfon per 100 pounds of body weight sprinkled on the animals’ usual daily ration of feed, or may be mixed in 5 to 10 fluid ounces of water and admin istered by stomach tube or drench. (2) Indications for use. For the treat ment and control of bots (Gasterophilus spp.), large strongyles (Strongylus spp.), small strongyles (genera Cyathostomum, Cylicobrachytus, Craterostomum, Oesophagodontus, Poteriostomum), pinworms (Oxyuris spp., Strongyloides spp.), and ascarids (Parascaris spp.). (3) Limitations. Do not use in horses intended for human consumption. Fed eral law restricts this drug to use by or on the order of a licensed veterinarian. [40 FR 23071, May 28, 1975, as amended at 48 FR 48229, Oct. 18, 1983; 79 FR 28832, May 20, 2014] VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00267 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 258 21 CFR Ch. I (4–1–16 Edition) § 520.2380f § 520.2380f Thiabendazole and piper azine phosphate. (a) Specifications. Each ounce of water dispersible powder contains 6.67 grams of thiabendazole and 8.33 grams of pi perazine (as piperazine phosphate). (b) Sponsor. See No. 050604 in § 510.600(c) of this chapter. (c) Conditions of use in horses—(1) Amount. 2 grams of thiabendazole and 2.5 grams of piperazine (0.3 ounce of powder) per 100 pounds of body weight. Use a single oral dose. Administer as a drench or by stomach tube suspended in 1 pint of warm water; by dose sy ringe suspended in 1⁄2 ounce of water for each 100 pounds of body weight; or sprinkled over a small amount of daily feed. (2) Indications for use. Treatment of infections of large strongyles (genus Strongylus), small strongyles (genera Cyathostomum, Cylicobrachytus, and re lated genera Craterostomum, Oesophagodontus, Poteriostomum), pinworms (Oxyuris), threadworms (Strongyloides), and ascarids (Parascaris) in horses. (3) Limitations. Do not use in horses intended for human consumption. If the label bears directions for adminis tration by stomach tube or drench, it shall also bear the statement ‘‘Caution: Federal law restricts this drug to use by or on the order of a licensed veteri narian.’’; if not labeled for use by stom ach tube or drench, the label shall bear the statement, ‘‘Consult your veteri narian for assistance in the diagnosis, treatment, and control of parasitism.’’ [46 FR 18963, Mar. 27, 1981, as amended at 46 FR 52330, Oct. 27, 1981; 62 FR 63271, Nov. 28, 1997; 79 FR 28832, May 20, 2014] § 520.2455 Tiamulin. (a) Specifications. (1) Each gram of soluble powder contains 450 milligrams (mg) tiamulin hydrogen fumarate. (2) Each milliliter (mL) of solution contains 125 mg (12.5 percent) tiamulin hydrogen fumarate. (3) Each mL of solution contains 123 mg (12.3 percent) tiamulin hydrogen fu marate. (b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter for use as in paragraph (d) of this section. (1) No. 058198 for products described in paragraphs (a)(1) and (a)(2) of this section. (2) No. 066104 for the product de scribed in paragraph (a)(1) of this sec tion. (3) No. 054771 for the product de scribed in paragraph (a)(3) of this sec tion. (c) Related tolerances. See § 556.732 of this chapter. (d) Conditions of use in swine—(1) Amounts and indications for use. Admin ister in drinking water for 5 consecu tive days: (i) 3.5 mg per (/) lb of body weight daily for treatment of swine dysentery associated with Brachyspira hyodysenteriae susceptible to tiamulin. (ii) 10.5 mg/lb of body weight daily for treatment of swine pneumonia due to Actinobacillus pleuropneumoniae suscep tible to tiamulin. (2) Limitations. Use as only source of drinking water. Prepare fresh medi cated water daily. Withdraw medica tion 3 days before slaughter following treatment at 3.5 mg/lb and 7 days be fore slaughter following treatment at 10.5 mg/lb of body weight. Swine being treated with tiamulin should not have access to feeds containing polyether ionophores (e.g., lasalocid, monensin, narasin, salinomycin, or semduramycin) as adverse reactions may occur. The effects of tiamulin on swine reproductive performance, preg nancy, and lactation have not been de termined. [70 FR 75017, Dec. 19, 2005, as amended at 74 FR 7180, Feb. 13, 2009; 75 FR 54492, Sept. 8, 2010; 77 FR 56770, Sept. 14, 2012; 78 FR 17596, Mar. 22, 2013; 80 FR 13229, Mar. 13, 2015] § 520.2471 Tilmicosin. (a) Specifications. Each milliliter of concentrate solution contains 250 milli grams (mg) tilmicosin as tilmicosin phosphate. (b) Sponsor. See No. 000986 in § 510.600(c) of this chapter. (c) Tolerances. See § 556.735 of this chapter. (d) Conditions of use in swine—(1) Amount. Administer in drinking water at a concentration of 200 mg per liter for 5 consecutive days. VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00268 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 259 Food and Drug Administration, HHS § 520.2475 (2) Indications for use—(i) For the con trol of swine respiratory disease associ ated with Pasteurella multocida and Haemophilus parasuis in groups of swine in buildings where a respiratory dis ease outbreak is diagnosed. (ii) For the control of swine res piratory disease associated with Myco plasma hyopneumoniae in the presence of Porcine Reproductive and Res piratory Syndrome Virus (PRRSV) in groups of swine in buildings where a respiratory disease outbreak is diag nosed. (3) Limitations. Swine intended for human consumption must not be slaughtered within 7 days of the last treatment with this product. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [79 FR 18158, Apr. 1, 2014, as amended at 81 FR 17608, Mar. 30, 2016] § 520.2473 Tioxidazole oral dosage forms. § 520.2473a Tioxidazole granules. (a) Specifications. Each gram of gran ules contains 200 milligrams of tioxidazole. (b) Sponsor. See No. 000061 in § 510.600(c) of this chapter. (c) Conditions of use—(1) Horses—(i) Amount. 5 milligrams per pound of body weight as a single dose. (ii) Indications for use. Removal of mature large strongyles (Strongylus edentatus, S. equinus, and S. vulgaris), mature ascarids (Parascaris equorum), mature and immature (4th larval stage) pinworms (Oxyuris equi), and ma ture small strongyles (Triodontophorus spp.). (iii) Limitations. For administration with feed: Sprinkle required amount of granules on a small amount of the usual grain ration and mix. Prepare for each horse individually. Withholding of feed or water not necessary. Not for use in horses intended for food. The re productive safety of tioxidazole in breeding animals has not been deter mined. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. It is rec ommended that this drug be adminis tered with caution to sick or debili tated horses. (2) [Reserved] [50 FR 52772, Dec. 26, 1985; 51 FR 2693, Jan. 21, 1986, as amended at 52 FR 7832, Mar. 13, 1987] § 520.2473b Tioxidazole paste. (a) Specifications. Each plastic syringe contains 6.25 grams of tioxidazole. (b) Sponsor. See No. 000061 in § 510.600(c) of this chapter. (c) Conditions of use—(1) Horses—(i) Amount. 5 milligrams of tioxidazole per pound of body weight as a single dose. (ii) Indications for use. Removal of mature large strongyles (Strongylus edentatus, S. equinus, and S. vulgaris), mature ascarids (Parascaris equorum), mature and immature (4th larval stage) pinworms (Oxyuris equi), and ma ture small strongyles (Triodontophorus spp.). (iii) Limitations. Administer orally by inserting the nozzle of the syringe through the space between front and back teeth and deposit the required dose on the base of the tongue. Before dosing, make sure the horse’s mouth contains no feed. Not for use in horses intended for food. The reproductive safety of tioxidazole in breeding ani mals has not been determined. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. It is recommended that this drug be administered with caution to sick or debilitated horses. (2) [Reserved] [52 FR 43059, Nov. 9, 1987] § 520.2475 Toceranib. (a) Specifications. Each tablet con tains 10, 15, or 50 milligrams (mg) toceranib as toceranib phosphate. (b) Sponsor. See No. 054771 in § 510.600 of this chapter. (c) Conditions of use—(1) Dogs—(i) Amount. Administer an initial dose of 3.25 mg per kilogram (1.48 mg per pound) body weight, orally every other day. (ii) Indications for use. For the treat ment of Patnaik grade II or III, recur rent, cutaneous mast cell tumors with or without regional lymph node in volvement. (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00269 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 260 21 CFR Ch. I (4–1–16 Edition) § 520.2483 (2) [Reserved] [74 FR 28875, June 18, 2009, as amended at 79 FR 28832, May 20, 2014] § 520.2483 Triamcinolone. (a) Specifications. (1) Each tablet con tains 0.5 milligram (mg) or 1.5 mg triamcinolone acetonide. (2) Each 15 grams of powder contains 10 mg triamcinolone acetonide. (b) Sponsor. See No. 000010 in § 510.600(c) of this chapter. (c) Special considerations. See § 510.410 of this chapter. (d) Conditions of use—(1) Dogs and cats. Use tablets described in paragraph (a)(1) of this section as follows: (i) Amount. Administer 0.05 mg per pound (/lb) of body weight daily by mouth; up to 0.1 mg per pound (/lb) of body weight daily, if response to the smaller dose is inadequate. Therapy may be initiated with a single injec tion of triamcinolone acetonide sus pension as in § 522.2483 of this chapter, in which case triamcinolone acetonide tablets should be administered begin ning 5 to 7 days after the injection. (ii) Indications for use. As an anti-in flammatory agent. (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (2) Horses. Use oral powder described in paragraph (a)(2) of this section as follows: (i) Amount. Administer 0.005 to 0.01 mg/lb of body weight twice daily, sprin kled (top-dressed) on a small portion of feed. Therapy may be initiated with a single injection of triamcinolone acetonide suspension as in § 522.2483 of this chapter, in which case triamcinolone acetonide oral powder should be administered beginning 3 or 4 days after the injection. (ii) Indications for use. As an anti-in flammatory agent. (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use in horses intended for human consump tion. [75 FR 10166, Mar. 5, 2010] § 520.2520 Trichlorfon oral dosage forms. § 520.2520a Trichlorfon and atropine. (a) Specifications. (1) For trichlorfon: O,O-Dimethyl 2,2,2-trichloro-1-hydroxy ethyl phosphonate. (2) For atropine: Atropine N.F. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Conditions of use in mice—(1) Amount. Administer 1.67 grams of trichlorfon and 7.7 milligrams of atro pine per liter continuously for 7 to 14 days as the sole source of drinking water. (2) Indications for use. For the treat ment of Syphacia obvelata (pinworm) in laboratory mice. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [79 FR 28832, May 20, 2014] § 520.2520b Trichlorfon boluses. (a) Specifications. Each bolus contains either 7.3, 10.9, 14.6, or 18.2 g of trichlorfon. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Conditions of use in horses—(1) Amount. 18.2 milligrams per pound of body weight, except for strongyles use 36.4 milligrams per pound of body weight. (2) Indications for use. For horses for removal of bots (Gastrophilus nasalis, Gastrophilus intestinalis), large strongyles (Strongylus vulgaris), small strongyles, large roundworms (ascarids, Parascaris equorum), and pinworms (Oxyuris equi). (3) Limitations. Do not use in horses intended for human consumption. Fed eral law restricts this drug to use by or on the order of a licensed veterinarian. [45 FR 48127, July 18, 1980. Redesignated and amended at 79 FR 28833, May 20, 2014] § 520.2520c Trichlorfon granules. (a) Specifications. Each package con tains either 18.2 or 36.4 g of trichlorfon. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Conditions of use in horses—(1) Amount. 18.2 milligrams per pound of body weight. VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00270 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 261 Food and Drug Administration, HHS § 520.2604 (2) Indications for use. For horses for removal of bots (Gastrophilus nasalis, Gastrophilus intestinalis), large roundworms (ascarids, Parascaris equorum), and pinworms (Oxyuris equi). (3) Limitations. Do not use in horses intended for human consumption. Fed eral law restricts this drug to use by or on the order of a licensed veterinarian. [45 FR 48128, July 18, 1980. Redesignated and amended at 79 FR 28833, May 20, 2014] § 520.2520d Trichlorfon, phenothiazine, and piperazine dihydrochloride powder. (a) Specifications. Each 54.10 grams (1.91 ounces) of water dispersible pow der contains 9.10 grams of trichlorfon, 6.25 grams of phenothiazine, and the equivalent of 20.0 grams of piperazine base (as piperazine dihydrochloride). (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. [48 FR 2757, Jan. 21, 1983. Redesignated and amended at 79 FR 28833, May 20, 2014] EDITORIAL NOTE: At 79 FR 28833, May 20, 2014, § 520.2520d was amended in part by redes ignating paragraph (e) as (c). This action could not be performed because paragraph (e) did not exist. § 520.2582 Triflupromazine. (a) Specifications. Each tablet con tains 10 or 25 milligrams (mg) triflupromazine hydrochloride. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Conditions of use in dogs and cats— (1) Amount. Administer orally 1 to 2 mg per pound of body weight daily, fol lowed by 1 mg daily. (2) Indications for use. For relief of anxiety, to help control psychomotor over-activity, and to increase the toler ance of animals to pain and pruritus. For use in various clinical procedures which require the aid of a tranquilizer, antiemetic, or preanesthetic. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [79 FR 28833, May 20, 2014] § 520.2598 Trilostane. (a) Specifications. Each capsule con tains 5, 10, 30, 60, or 120 milligrams (mg) trilostane. (b) Sponsor. See No. 043264 in § 510.600 of this chapter. (c) Conditions of use in dogs—(1) Amount. The starting dose is 1.0 to 3.0 milligrams per pound (2.2 to 6.7 milli grams per kilogram) once a day. (2) Indications for use. For treatment of pituitary-dependent hyperadrenocorticism. For treatment of hyperadrenocorticism due to adrenocortical tumor. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [74 FR 21767, May 11, 2009, as amended at 74 FR 30464, June 26, 2009; 80 FR 53460, Sept. 4, 2015] § 520.2604 Trimeprazine and prednis olone tablets. (a) Specifications. Each tablet con tains 5 milligrams (mg) trimeprazine tartrate and 2 mg prednisolone. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Conditions of use in dogs—(1) Amount. Administer orally an initial dosage: for dogs weighing up to 10 pounds, 1⁄2 tablet twice daily; for dogs weighing 11 to 20 pounds, 1 tablet twice daily; for dogs weighing 21 to 40 pounds, 2 tablets twice daily; and for dogs weighing over 40 pounds, 3 tablets twice daily. After 4 days, reduce dosage to one-half the initial dose or to an amount sufficient to maintain remis sion of symptoms. (2) Indications for use. For the relief of itching regardless of cause; and for re duction of inflammation commonly as sociated with most skin disorders of dogs such as eczema, caused by inter nal disorders, otitis, and dermatitis, al lergic, parasitic, pustular and nonspe cific. As adjunctive therapy in various cough conditions including treatment of ‘‘kennel cough’’ or tracheobronchitis, bronchitis including allergic bronchitis, in tonsillitis, acute upper respiratory infections and coughs of nonspecific origin. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [79 FR 28833, May 20, 2014] VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00271 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 262 21 CFR Ch. I (4–1–16 Edition) § 520.2605 § 520.2605 Trimeprazine and prednis olone capsules. (a) Specifications. Each capsule con tains: (1) 3.75 milligrams (mg) trimeprazine in sustained released form (as trimeprazine tartrate) and 1 mg pred nisolone (Capsule No. 1); or (2) 7.5 mg trimeprazine in sustained release form (as trimeprazine tartrate) and 2 mg prednisolone (Capsule No. 2). (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Conditions of use in dogs—(1) Amount. Administer orally once daily an initial dosage: (i) For dogs weighing up to 10 pounds: one Capsule No. 1; (ii) For dogs weighing 11 to 20 pounds, one Capsule No. 2 or two Cap sule No. 1; (iii) For dogs weighing 21 to 40 pounds, two Capsule No. 2 or four Cap sule No. 1; and (iv) For dogs weighing over 40 pounds, three Capsule No. 2 or six Cap sule No. 1. After 4 days, the dosage is reduced to approximately 1⁄2 the initial dosage or to an amount just sufficient to maintain remission of symptoms. (2) Indications for use. For the relief of itching regardless of cause; and for re duction of inflammation commonly as sociated with most skin disorders of dogs such as eczema, caused by inter nal disorders, otitis, and dermatitis, al lergic, parasitic, pustular and nonspe cific. As adjunctive therapy in various cough conditions including treatment of ‘‘kennel cough’’ or tracheobronchitis, bronchitis including allergic bronchitis, in tonsillitis, acute upper respiratory infections and coughs of nonspecific origin. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [79 FR 28833, May 20, 2014] § 520.2610 Trimethoprim and sulfa diazine tablets. (a) Specifications. Each tablet con tains 30 milligrams (mg) (5 mg trimethoprim and 25 mg sulfadiazine), 120 mg (20 mg trimethoprim and 100 mg sulfadiazine), 480 mg (80 mg trimethoprim and 400 mg sulfadiazine) or 960 mg (160 mg trimethoprim and 800 mg sulfadiazine). (b) Sponsors. See Nos. 000061 and 054771 in § 510.600(c) of this chapter. (c) Conditions of use in dogs—(1) Amount. Administer orally at 30 mg per kilogram of body weight (14 milligrams per pound) once daily. Alternatively, especially in severe infections, the ini tial dose may be followed by one-half the recommended daily dose every 12 hours. Administer for 2 to 3 days after symptoms have subsided. Do not treat for more than 14 consecutive days. (2) Indications for use. The drug is used in dogs where systemic anti bacterial action against sensitive orga nisms is required, either alone or as an adjunct to surgery or debridement with associated infection. The drug is indi cated where control of bacterial infec tion is required during the treatment of acute urinary tract infections, acute bacterial complications of distemper, acute respiratory tract infections, acute alimentary tract infections, wound infections, and abscesses. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [79 FR 28833, May 20, 2014] § 520.2611 Trimethoprim and sulfa diazine paste. (a) Specifications. Each gram (g) of paste contains 67 milligrams (mg) trimethoprim and 333 mg sulfadiazine. (b) Sponsors. See sponsors in § 510.600(c) of this chapter: (1) No. 054771 for product adminis tered as in paragraph (c)(1)(i) of this section. (2) No. 000061 for product adminis tered as in paragraph (c)(1)(ii) of this section. (c) Conditions of use in horses—(1) Amount. Administer orally as a single daily dose for 5 to 7 days: (i) 5 g of paste (335 mg trimethoprim and 1,665 mg sulfadiazine) per 150 pounds (68 kilograms) of body weight per day. (ii) 3.75 g of paste (250 mg trimethoprim and 1,250 mg sulfa diazine) per 110 pounds (50 kilograms) of body weight per day. (2) Indications for use. For use where systemic antibacterial action against sensitive organisms is required during treatment of acute strangles, res piratory infections, acute urogenital VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00272 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 263 Food and Drug Administration, HHS § 520.2640 infections, and wound infections and abscesses. (3) Limitations. Not for use in horses intended for human consumption. Fed eral law restricts this drug to use by or on the order of a licensed veterinarian. [71 FR 30802, May 31, 2006, as amended at 79 FR 28834, May 20, 2014] § 520.2612 Trimethoprim and sulfa diazine suspension. (a) Specifications. Each milliliter (mL) of suspension contains: (1) 10 milligrams (mg) trimethoprim and 50 mg sulfadiazine; or (2) 400 mg combined active ingredi ents (67 mg trimethoprim and 333 mg sulfadiazine). (b) Sponsors. See sponsor numbers in § 510.600 of this chapter: (1) No. 000061 for use of product de scribed in paragraph (a)(1) for use as in paragraph (c)(1) of this section. (2) No. 051072 for use of product de scribed in paragraph (a)(2) for use as in paragraph (c)(2) of this section. (c) Conditions of use—(1) Dogs—(i) Amount. Administer 1 mL (10 mg trimethoprim and 50 mg sulfadiazine) per 5 pounds (lb) of body weight once daily, or one-half the recommended daily dose every 12 hours, for up to 14 consecutive days. (ii) Indications for use. The drug is used in dogs where systemic anti bacterial action against sensitive orga nisms is required, either alone or as an adjunct to surgery or debridement with associated infection. The drug is indi cated where control of bacterial infec tion is required during the treatment of acute urinary tract infections, acute bacterial complications of distemper, acute respiratory tract infections, acute alimentary tract infections, wound infections, and abscesses. (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (2) Horses—(i) Amount. Administer 24 mg combined active ingredients per kilogram of body weight (2.7 mL/100 lb) twice daily for 10 days. (ii) Indications for use. For the treat ment of lower respiratory tract infec tions in horses caused by susceptible strains of Streptococcus equi subsp. zooepidemicus. (iii) Limitations. Do not use in horses intended for human consumption. Fed eral law restricts this drug to use by or on the order of a licensed veterinarian. [78 FR 63872, Oct. 25, 2013] § 520.2613 Trimethoprim and sulfa diazine powder. (a) Specifications. Each gram of pow der contains 67 milligrams (mg) trimethoprim and 333 mg sulfadiazine. (b) Sponsors. See Nos. 054771 and 059051 in § 510.600(c) of this chapter. (c) Conditions of use in horses—(1) Amount. Administer orally 3.75 grams of powder per 110 pounds (50 kilograms) of body weight in a small amount of feed, as a single daily dose, for 5 to 7 days. (2) Indications for use. For control of bacterial infections of horses during treatment of acute strangles, res piratory tract infections, acute uro genital infections, wound infections, and abscesses. (3) Limitations. Do not use in horses intended for human consumption. Fed eral law restricts this drug to use by or on the order of a licensed veterinarian. [58 FR 36135, July 6, 1993, as amended at 64 FR 68289, Dec. 7, 1999; 79 FR 28834, May 20, 2014; 79 FR 64116, Oct. 28, 2014] § 520.2640 Tylosin. (a) Specifications. Each container of soluble powder contains tylosin tar trate equivalent to either 100 or 256 grams tylosin base. (b) Sponsors—(1) No. 000986 for use as in paragraph (e) of this section. (2) Nos. 016592 and 061623 for use as in paragraphs (e)(1)(i)(A), (e)(1)(ii), (e)(2), (e)(3), and (e)(4) of this section. (c) Related tolerances. See § 556.740 of this chapter. (d) Special considerations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (e) Conditions of use—(1) Chickens—(i) Amounts and indications for use. (A) Ad minister 2 grams per gallon (528 parts per million (ppm)) for 1 to 5 days as an aid in the treatment of chronic res piratory disease (CRD) associated with Mycoplasma gallisepticum in broiler and replacement chickens. For the control of CRD associated with M. gallisepticum at time of vaccination or other stress VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00273 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 264 21 CFR Ch. I (4–1–16 Edition) § 520.2645 in chickens. For the control of CRD as sociated with Mycoplasma synoviae in broiler chickens. Treated chickens should consume enough medicated drinking water to provide 50 milli grams (mg) tylosin per pound of body weight per day. (B) Administer 851 to 1,419 mg/gallon (225 to 375 ppm) for 5 days for the con trol of mortality caused by necrotic en teritis associated with Clostridium perfringens in broiler chickens. (ii) Limitations. Do not use in layers producing eggs for human consump tion. Do not administer within 24 hours of slaughter. (2) Turkeys—(i) Amount. 2 grams per gallon for 2 to 5 days as the sole source of drinking water. Treated turkeys should consume enough medicated drinking water to provide 60 mg tylosin per pound of body weight per day. (ii) Indications for use. For the reduc tion in severity of effects of infectious sinusitis associated with Mycoplasma gallisepticum. (iii) Limitations. Do not use in layers producing eggs for human consump tion. Do not administer within 5 days of slaughter. (3) Swine—(i) Amount. 250 mg per gal lon as the only source of drinking water for 3 to 10 days, depending on the severity of the condition being treated. (ii) Indications for use. (A) For the treatment and control of swine dys entery associated with Brachyspira hyodysenteriae when followed imme diately by tylosin phosphate medicated feed; and for the control of porcine pro liferative enteropathies (PPE, ileitis) associated with Lawsonia intracellularis when followed immediately by tylosin phosphate medicated feed. (B) For the treatment and control of swine dysentery associated with Brachyspira hyodysenteriae. (iii) Limitations. Do not administer within 48 hours of slaughter. As indi cated in paragraph (d)(3)(ii)(A) of this section, follow with tylosin phosphate medicated feed as in § 558.625(f)(1)(vi)(c) of this chapter. (4) Honey bees—(i) Amount. Mix 200 milligrams tylosin in 20 grams confec tioners’/powdered sugar. Use imme diately. Apply (dust) this mixture over the top bars of the brood chamber once weekly for 3 weeks. (ii) Indications for use. For the control of American foulbrood (Paenibacillus larvae). (iii) Limitations. The drug should be fed early in the spring or fall and con sumed by the bees before the main honey flow begins, to avoid contamina tion of production honey. Complete treatments at least 4 weeks before main honey flow. [40 FR 13838, Mar. 27, 1975, as amended at 50 FR 49841, Dec. 5, 1985; 59 FR 14365, Mar. 28, 1994; 62 FR 39443, July 23, 1997; 68 FR 24879, May 9, 2003; 70 FR 69439, Nov. 16, 2005; 73 FR 76946, Dec. 18, 2008; 75 FR 76259, Dec. 8, 2010; 76 FR 59024, Sept. 23, 2011; 77 FR 29217, May 17, 2012; 79 FR 37620, July 2, 2014; 79 FR 53136, Sept. 8, 2014; 79 FR 64116, Oct. 28, 2014; 80 FR 34278, June 16, 2015] § 520.2645 Tylvalosin. (a) Specifications. Granules containing 62.5 percent tylvalosin (w/w) as tylvalosin tartrate. (b) Sponsor. See No. 066916 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.748 of this chapter. (d) Conditions of use in swine—(1) Amount. Administer 50 parts per mil lion tylvalosin in drinking water for 5 consecutive days. (2) Indications for use. For the control of porcine proliferative enteropathy (PPE) associated with Lawsonia intracellularis infection in groups of swine in buildings experiencing an out break of PPE. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [77 FR 55415, Sept. 10, 2012] PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS Sec. 522.23 Acepromazine. 522.52 Alfaxalone. 522.56 Amikacin. 522.62 Aminopentamide. 522.82 Aminopropazine. 522.84 Beta-aminopropionitrile. 522.88 Amoxicillin. 522.90 Ampicillin injectable dosage forms. 522.90a Ampicillin trihydrate suspension. 522.90b Ampicillin trihydrate powder for in jection. 522.90c Ampicillin sodium. VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00274 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B