151 Part 520—Oral Dosage Form New Animal Drugs

Home , Albendazole, Caramiphen, Dithiazanine iodide, Epsiprantel, Milbemycin, Milbemycin oxime

Food and Drug Administration, HHS Pt. 520

licensed veterinarian. It is a violation 520.390 Chloramphenicol oral dosage forms. of Federal law to use this product 520.390a Chloramphenicol tablets. other than as directed in the labeling. 520.390b Chloramphenicol capsules. 520.390c Chloramphenicol palmitate oral [79 FR 18158, Apr. 1, 2014] suspension. 520.420 Chlorothiazide tablets and boluses. 520.434 Chlorphenesin carbamate tablets. PART 520—ORAL DOSAGE FORM 520.441 Chlortetracycline powder. NEW ANIMAL DRUGS 520.443 Chlortetracycline tablets and boluses. Sec. 520.445 Chlortetracycline and 520.23 Acepromazine. sulfamethazine powder. 520.28 Acetazolamide. 520.446 Clindamycin capsules and tablets. 520.38 Albendazole oral dosage forms. 520.447 Clindamycin solution. 520.38a Albendazole suspension. 520.452 Clenbuterol syrup. 520.38b Albendazole paste. 520.455 Clomipramine tablets. 520.43 Afoxolaner. 520.462 Clorsulon drench. 520.48 Altrenogest. 520.522 Cyclosporine. 520.62 Aminopentamide. 520.530 Cythioate oral liquid. 520.82 Aminopropazine oral dosage forms. 520.531 Cythioate tablets. 520.82a Aminopropazine. 520.534 Decoquinate. 520.82b Aminopropazine and neomycin. 520.538 Deracoxib. 520.88 Amoxicillin oral dosage forms. 520.540 Dexamethasone oral dosage forms. 520.88a Amoxicillin trihydrate film-coated 520.540a Dexamethasone powder. tablets. 520.540b Dexamethasone tablets and 520.88b Amoxicillin trihydrate for oral sus- boluses. pension. 520.540c Dexamethasone chewable tablets. 520.88c Amoxicillin trihydrate oral suspen- 520.563 Dexamethasone chewable tablets. sion. 520.580 Dichlorophene and toluene. 520.88d Amoxicillin trihydrate soluble pow- 520.581 Dichlorophene tablets. der. 520.600 Dichlorvos. 520.88e Amoxicillin trihydrate boluses. 520.606 Diclazuril. 520.88f Amoxicillin trihydrate tablets. 520.608 Dicloxacillin. 520.88g Amoxicillin trihydrate and 520.620 Diethylcarbamazine oral dosage clavulanate potassium film-coated tab- forms. lets. 520.622 Diethylcarbamazine citrate oral dos- 520.88h Amoxicillin trihydrate and age forms. clavulanate potassium for oral suspen- 520.622a Diethylcarbamazine citrate tablets. sion. 520.622b Diethylcarbamazine citrate syrup. 520.90 Ampicillin oral dosage forms. 520.622c Diethylcarbamazine citrate chew- 520.90a [Reserved] able tablets. 520.90b Ampicillin tablets. 520.623 Diethylcarbamazine and 520.90c Ampicillin capsules. oxibendazole chewable tablets. 520.90d Ampicillin for oral suspension. 520.645 Difloxacin. 520.90e Ampicillin for soluble powder. 520.666 Dirlotapide. 520.90f Ampicillin boluses. 520.763 Dithiazanine oral dosage forms. 520.100 Amprolium. 520.763a Dithiazanine tablets. 520.110 Apramycin sulfate soluble powder. 520.763b Dithiazanine powder. 520.154 Bacitracin oral dosage forms. 520.763c Dithiazanine iodide and piperazine 520.154a Bacitracin methylenedisalicylate. citrate suspension. 520.154b Bacitracin methylenedisalicylate 520.766 Domperidone. and streptomycin sulfate powder. 520.784 Doxylamine. 520.154c Bacitracin zinc soluble powder. 520.804 Enalapril. 520.222 Bunamidine hydrochloride. 520.812 Enrofloxacin. 520.246 Butorphanol tablets. 520.816 Epsiprantel. 520.260 n-Butyl chloride. 520.823 Erythromycin. 520.300 Cambendazole oral dosage forms. 520.852 Estriol. 520.300a Cambendazole suspension. 520.863 Ethylisobutrazine. 520.300b Cambendazole pellets. 520.870 Etodolac. 520.300c Cambendazole paste. 520.903 Febantel oral dosage forms. 520.301 Caramiphen ethanedisulfonate and 520.903a Febantel paste. ammonium chloride tablets. 520.903b Febantel suspension. 520.302 Carnidazole tablets. 520.903c [Reserved] 520.304 Carprofen. 520.903d Febantel and praziquantel paste. 520.314 Cefadroxil. 520.903e Febantel tablets. 520.370 Cefpodoxime tablets. 520.905 Fenbendazole oral dosage forms. 520.376 Cephalexin. 520.905a Fenbendazole suspension.

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520.905b Fenbendazole granules. 520.1326b Mebendazole and trichlorfon paste. 520.905c Fenbendazole paste. 520.1330 Meclofenamic acid granules. 520.905d Fenbendazole powder. 520.1331 Meclofenamic acid tablets. 520.905e Fenbendazole blocks. 520.1341 Megestrol. 520.928 Firocoxib tablets. 520.1367 Meloxicam. 520.930 Firocoxib paste. 520.1372 Methimazole. 520.955 Florfenicol. 520.1380 Methocarbamol. 520.960 Flumethasone. 520.1408 Methylprednisolone. 520.970 Flunixin. 520.1409 Methylprednisolone and aspirin. 520.980 Fluoxetine. 520.1422 Metoserpate hydrochloride. 520.998 Fluralaner. 520.1430 Megestrol acetate tablets. 520.1010 Furosemide. 520.1441 Milbemycin oxime. 520.1044 Gentamicin sulfate oral dosage 520.1443 Milbemycin oxime and lufenuron. forms. 520.1445 Milbemycin oxime and 520.1044a Gentamicin sulfate oral solution. praziquantel. 520.1044b Gentamicin sulfate pig pump oral 520.1447 Milbemycin oxime, lufenuron, and solution. praziquantel tablets. 520.1044c Gentamicin sulfate powder. 520.1450 Morantel tartrate oral dosage 520.1060 Glucose and glycine. forms. 520.1100 Griseofulvin. 520.1450a Morantel tartrate bolus. 520.1120 Haloxon oral dosage forms. 520.1450b Morantel tartrate cartridge. 520.1120a Haloxon drench. 520.1450c Morantel tartrate sustained-re- 520.1120b Haloxon boluses. lease trilaminate cylinder/sheet. 520.1130 Hetacillin. 520.1451 Moxidectin tablets. 520.1156 Imidacloprid. 520.1452 Moxidectin gel. 520.1157 Iodinated casein. 520.1158 Iodochlorhydroxyquin. 520.1453 Moxidectin and praziquantel gel. 520.1182 Iron dextran suspension. 520.1454 Moxidectin solution. 520.1192 Ivermectin paste. 520.1468 Naproxen. 520.1193 Ivermectin tablets and chewables. 520.1484 Neomycin. 520.1194 Ivermectin meal. 520.1510 Nitenpyram. 520.1195 Ivermectin liquid. 520.1604 Oclacitinib. 520.1196 Ivermectin and pyrantel tablets. 520.1615 Omeprazole. 520.1197 Ivermectin sustained-release bolus. 520.1616 Orbifloxacin tablets.. 520.1198 Ivermectin and praziquantel paste. 520.1618 Orbifloxacin suspension. 520.1199 Ivermectin, pyrantel, and 520.1628 Oxfendazole powder and pellets. praziquantel tablets. 520.1629 Oxfendazole paste. 520.1200 Ivermectin, fenbendazole, and 520.1630 Oxfendazole suspension. praziquantel tablets. 520.1631 Oxfendazole and trichlorfon paste. 520.1204 Kanamycin, bismuth subcarbonate, 520.1638 Oxibendazole. activated attapulgite. 520.1660 Oxytetracycline. 520.1242 Levamisole. 520.1660a Oxytetracycline and carbomycin 520.1242a Levamisole powder. in combination. 520.1242b Levamisole boluses or oblets. 520.1660b Oxytetracycline hydrochloride 520.1242c Levamisole and piperazine. capsules. 520.1242d Levamisole resinate. 520.1660c Oxytetracycline hydrochloride 520.1242e Levamisole hydrochloride effer- tablets/boluses. vescent tablets. 520.1660d Oxytetracycline powder. 520.1242f Levamisole gel. 520.1696 Penicillin. 520.1242g Levamisole resinate and famphur 520.1696a [Reserved] paste. 520.1696b Penicillin G powder. 520.1263 Lincomycin. 520.1696c Penicillin V powder. 520.1263a Lincomycin tablets and syrup. 520.1696d Penicillin V tablets. 520.1263b [Reserved] 520.1705 Pergolide. 520.1263c Lincomycin powder. 520.1720 Phenylbutazone oral dosage forms. 520.1265 Lincomycin and spectinomycin 520.1720a Phenylbutazone tablets and powder. boluses. 520.1284 Liothyronine. 520.1720b Phenylbutazone granules. 520.1288 Lufenuron tablets. 520.1720c Phenylbutazone paste. 520.1289 Lufenuron suspension. 520.1720d Phenylbutazone gel. 520.1310 Marbofloxacin. 520.1720e Phenylbutazone powder. 520.1315 Maropitant. 520.1760 Phenylpropanolamine. 520.1320 Mebendazole. 520.1780 Pimobendan. 520.1326 Mebendazole and trichlorfon oral 520.1802 Piperazine-carbon disulfide complex dosage forms. oral dosage forms. 520.1326a Mebendazole and trichlorfon pow- 520.1802a Piperazine-carbon disulfide com- der. plex suspension.

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520.1802b Piperazine-carbon disulfide com- 520.2260b Sulfamethazine sustained-release plex boluses. boluses. 520.1802c Piperazine-carbon disulfide com- 520.2260c Sulfamethazine sustained-release plex with phenothiazine suspension. tablets. 520.1803 Piperazine citrate capsules. 520.2261 Sulfamethazine sodium oral dosage 520.1804 Piperazine phosphate capsules. forms. 520.1805 Piperazine phosphate with thenium 520.2261a Sulfamethazine solution. closylate tablets. 520.2261b Sulfamethazine powder. 520.1806 Piperazine suspension. 520.2280 Sulfamethizole and methenamine. 520.1807 Piperazine. 520.2325 Sulfaquinoxaline oral dosage forms. 520.1840 Poloxalene. 520.2325a Sulfaquinoxaline powder and solu- 520.1846 Polyoxyethylene (23) lauryl ether tion. blocks. 520.2325b Sulfaquinoxaline drench. 520.1855 Ponazuril. 520.2330 Sulfisoxazole tablets. 520.1860 Pradofloxacin. 520.2340 Tepoxalin. 520.1870 Praziquantel tablets. 520.2345 Tetracycline. 520.1871 Praziquantel and pyrantel. 520.2345a Tetracycline capsules. 520.1872 Praziquantel, pyrantel pamoate, 520.2345b Tetracycline tablets. and febantel tablets. 520.2345c Tetracycline boluses. 520.1880 Prednisolone. 520.2345d Tetracycline powder. 520.1900 Primidone. 520.2345e Tetracycline solution. 520.1920 Prochlorperazine and isopropamide. 520.2345f Tetracycline phosphate complex 520.1921 Prochlorperazine, isopropamide, and sodium novobiocin capsules. and neomycin. 520.2345g Tetracycline hydrochloride and so- 520.1962 Promazine. dium novobiocin tablets. 520.2002 Propiopromazine. 520.2345h Tetracycline hydrochloride, so- 520.2041 Pyrantel pamoate chewable tablets. dium novobiocin, and prednisolone tab- 520.2042 Pyrantel pamoate tablets. lets. 520.2043 Pyrantel pamoate suspension. 520.2362 Thenium closylate. 520.2044 Pyrantel pamoate paste. 520.2380 Thiabendazole oral dosage forms. 520.2045 Pyrantel tartrate powder. 520.2380a Thiabendazole top dressing and 520.2046 Pyrantel tartrate pellets. mineral protein block. 520.2075 Robenacoxib. 520.2380b Thiabendazole drench or paste. 520.2098 Selegiline. 520.2380c Thiabendazole bolus. 520.2100 Selenium and vitamin E. 520.2380d Thiabendazole and piperazine cit- 520.2123 Spectinomycin oral dosage forms. rate. 520.2123a Spectinomycin tablets. 520.2380e Thiabendazole and trichlorfon. 520.2123b Spectinomycin powder. 520.2380f Thiabendazole and piperazine phos- 520.2123c Spectinomycin solution. phate. 520.2130 Spinosad. 520.2455 Tiamulin. 520.2134 Spinosad and milbemycin. 520.2471 Tilmicosin. 520.2150 Stanozolol. 520.2473 Tioxidazole oral dosage forms. 520.2158 Streptomycin. 520.2473a Tioxidazole granules. 520.2170 Sulfabromomethazine. 520.2473b Tioxidazole paste. 520.2184 Sulfachloropyrazine. 520.2475 Toceranib. 520.2200 Sulfachlorpyridazine. 520.2481 Triamcinolone acetonide tablets. 520.2215 Sulfadiazine/pyrimethamine sus- 520.2482 Triamcinolone acetonide oral pow- pension. der. 520.2218 Sulfamerazine, sulfamethazine, and 520.2483 Triamcinolone. sulfaquinoxaline powder. 520.2520 Trichlorfon oral dosage forms. 520.2220 Sulfadimethoxine oral dosage 520.2520a Trichlorfon and atropine. forms. 520.2520b Trichlorofon boluses. 520.2220a Sulfadimethoxine solution and 520.2520c Trichlorofon granules. soluble powder. 520.2520d Trichlorfon, phenothiazine, and pi- 520.2220b Sulfadimethoxine suspension. perazine dihydrochloride powder. 520.2220c Sulfadimethoxine tablet. 520.2582 Triflupromazine. 520.2220d Sulfadimethoxine bolus. 520.2598 Trilostane. 520.2220e Sulfadimethoxine extended-release 520.2604 Trimeprazine and prednisolone tab- bolus. lets. 520.2220f Sulfadimethoxine and ormetoprim 520.2605 Trimeprazine and prednisolone cap- tablet. sules. 520.2240 Sulfaethoxypyridazine. 520.2610 Trimethoprim and sulfadiazine tab- 520.2240a Sulfaethoxypyridazine solution. lets. 520.2240b Sulfaethoxypyridazine tablets. 520.2611 Trimethoprim and sulfadiazine 520.2260 Sulfamethazine oral dosage forms. paste. 520.2260a Sulfamethazine oblet, tablet, and 520.2612 Trimethoprim and sulfadiazine sus- bolus. pension.

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520.2613 Trimethoprim and sulfadiazine (mg) (4.55 percent) or 113.6 mg (11.36 powder. percent) albendazole. 520.2640 Tylosin. (b) Sponsor. See No. 054771 in § 510.600 520.2645 Tylvalosin. of this chapter. AUTHORITY: 21 U.S.C. 360b. (c) Related tolerances. See § 556.34 of SOURCE: 40 FR 13838, Mar. 27, 1975, unless this chapter. otherwise noted. (d) Special considerations. See § 500.25 of this chapter. § 520.23 Acepromazine. (e) Conditions of use—(1) Cattle. Ad- (a) Specifications. Each tablet con- minister 11.36 percent suspension: tains 5, 10, or 25 milligrams (mg) (i) Amount. 4.54 mg/pound (lb) body acepromazine maleate. weight (10 mg/kilogram (kg)) as a sin- (b) Sponsors. See No. 000010 in gle oral dose using dosing gun or dos- § 510.600(c) of this chapter. ing syringe. (c) Conditions of use—(1) Dogs—(i) (ii) Indications for use. For removal Amount. 0.25 to 1.0 mg per pound (/lb) and control of adult liver flukes body weight orally. (Fasciola hepatica); heads and segments (ii) Indications for use. As an aid in of tapeworms (Moniezia benedeni and M. tranquilization and as a preanesthetic expansa); adult and 4th stage larvae of agent. stomach worms (brown stomach worms (iii) Limitations. Federal law restricts including 4th stage inhibited larvae this drug to use by or on the order of a (Ostertagia ostertagi), barberpole worm licensed veterinarian. (Haemonchus contortus and H. placei), (2) Cats—(i) Amount. 0.5 to 1.0 mg/lb small stomach worm (Trichostrongylus body weight orally. axei)); adult and 4th stage larvae of in- (ii) Indications for use. As a tranquil- testinal worms (thread-necked intes- izer. tinal worm (Nematodirus spathiger and (iii) Limitations. Federal law restricts N. helvetianus), small intestinal worm this drug to use by or on the order of a (Cooperia punctata and C. oncophora)); licensed veterinarian. adult stages of intestinal worms (hookworm (Bunostomum phlebotomum), [75 FR 10165, Mar. 5, 2010] bankrupt worm (Trichostrongylus colubriformis), nodular worm § 520.28 Acetazolamide. (Oesophagostomum radiatum)); adult and (a) Specifications. A powder con- 4th stage larvae of lungworms taining acetazolamide sodium, USP (Dictyocaulus viviparus). equivalent to 25 percent acetazolamide (iii) Limitations. Do not slaughter activity. within 27 days of last treatment. Do (b) Sponsor. See No. 054771 in not use in female dairy cattle of breed- § 510.600(c) of this chapter. ing age: Do not administer to female (c) Conditions of use in dogs—(1) cattle during first 45 days of pregnancy Amount. Administer orally at a dosage or for 45 days after removal of bulls. of 5 to 15 milligrams per pound of body (2) Sheep. Administer 4.45 or 11.36 per- weight daily. cent suspension: (2) Indications for use. As an aid in the (i) Amount. 3.4 mg/lb body weight (7.5 treatment of mild congestive heart mg/kg) as a single oral dose using dos- failure and for rapid reduction of intra- ing gun or dosing syringe. ocular pressure. (ii) Indications for use. For removal (3) Limitations. Federal law restricts and control of adult liver flukes this drug to use by or on the order of a (Fasciola hepatica and Fascioloides licensed veterinarian. magna); heads and segments of common [79 FR 28816, May 20, 2014] tapeworms (Moniezia expansa) and fringed tapeworm (Thysanosoma § 520.38 Albendazole oral dosage actinioides); adult and fourth stage lar- forms. vae of stomach worms (brown stomach worm (Ostertagia circumcinta and § 520.38a Albendazole suspension. Marshallagia marshalli), barberpole (a) Specifications. Each milliliter of worm (Haemonchus contortus), small suspension contains 45.5 milligrams stomach worm (Trichostrongylus axei));

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adult and fourth stage larvae of intes- adult stages of intestinal worms tinal worms (thread-necked intestinal (hookworm (Bunostomum phlebotmum); worm (Nematodirus spathiger and N. bankrupt worm (Trichostrongylus filicollis), Cooper’s worm (Cooperia colubriformis), nodular worm oncophora), bankrupt worm (Oesophagostomum radiatum)); adult and (Trichostrongylus colubriformis), nodular 4th stage larvae of lungworms worm (Oesophagostomum columbianum), (Dictyocaulus viviparus). and large-mouth bowel worm (Chabertia (3) Limitations. Administer as a single ovina)); adult and larval stages of oral dose. Do not slaughter within 27 lungworms (Dictyocaulus filaria). days of last treatment. Do not use in (iii) Limitations. Do not slaughter female dairy cattle of breeding age. Do within 7 days of last treatment. Do not not administer to female cattle during administer to ewes during first 30 days first 45 days of pregnancy or for 45 days of pregnancy or for 30 days after re- after removal of bulls. Consult your moval of rams. veterinarian for assistance in the diag- (3) Goats. Administer 11.36 percent nosis, treatment, and control of para- suspension: sitism. (i) Amount. 4.54 mg/lb body weight (10 [54 FR 51385, Dec. 15, 1989, as amended at 56 mg/kg) as a single oral dose using dos- FR 50653, Oct. 8, 1991; 60 FR 55658, Nov. 2, ing gun or dosing syringe. 1995. Redesignated at 78 FR 66264, Nov. 5, (ii) Indications for use. For the treat- 2013, as amended at 79 FR 28816, May 20, 2014] ment of adult liver flukes (Fasciola hepatica) in nonlactating goats. § 520.43 Afoxolaner. (iii) Limitations. Do not slaughter (a) Specifications. Each chewable tab- within 7 days of last treatment. Do not let contains 11.3, 28.3, 68, or 136 milli- administer to does during the first 30 grams (mg) afoxolaner. days of pregnancy or for 30 days after (b) Sponsor. See No. 050604 in removal of bucks. § 510.600(c) of this chapter. [73 FR 11027, Feb. 29, 2008. Redesignated at 78 (c) Conditions of use—(1) Amount. Ad- FR 66264, Nov. 5, 2013, as amended at 79 FR minister orally once a month at a min- 28816, May 20, 2014] imum dosage of 1.14 mg/pound (lb) (2.5 mg/kilogram (kg)). § 520.38b Albendazole paste. (2) Indications for use. Kills adult (a) Specifications. The product con- fleas; for the treatment and prevention tains 30 percent albendazole. of flea infestations (Ctenocephalides (b) Sponsor. See No. 054771 in felis); for the treatment and control of § 510.600(c) of this chapter. black-legged tick (Ixodes scapularis), (c) Related tolerances. See § 556.34 of American dog tick (Dermacentor this chapter. variabilis), lone star tick (Amblyomma (d) Conditions of use in cattle—(1) americanum), and brown dog tick Amount. Equivalent to 4.54 milligrams (Rhipicephalus sanguineus) infestations per 1 pound of body weight (10 milli- in dogs and puppies 8 weeks of age and grams per kilogram). older, weighing 4 lb of body weight or (2) Indications for use. For removal greater, for 1 month. and control of the following internal (3) Limitations. Federal law restricts parasites of cattle: adult liver flukes this drug to use by or on the order of a (Fasciola hepatica); heads and segments licensed veterinarian. of tapeworms (Moniezia benedeni, M. [78 FR 66264, Nov. 5, 2013, as amended at 79 expansa); adult and 4th stage larvae of FR 37619, July 2, 2014; 80 FR 18775, Apr. 8, stomach worms (brown stomach worms 2015] including 4th stage inhibited larvae (Ostertagia ostertagi); barberpole worm § 520.48 Altrenogest. (Haemonchus contortus, H. placei); small (a) Specifications. Each milliliter stomach worm (Trichostrongylus axei)); (mL) of solution contains 2.2 milli- adult and 4th stages larvae of intes- grams (mg) altrenogest. tinal worms (thread-necked intestinal (b) Sponsors. See Nos. 000061 and worm (Nematodirus spathiger, N. 013744 in § 510.600(c) of this chapter. helvetianus); small intestinal worm (c) Tolerances. See § 556.36 of this (Cooperia punctata and C. oncophora)); chapter.

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(d) Conditions of use—(1) Horses—(i) (3) Limitations. Federal law restricts Amount. 1.0 mL per 110 pounds body this drug to use by or on the order of a weight (0.044 mg/kg) daily for 15 con- licensed veterinarian. secutive days. [79 FR 28816, May 20, 2014] (ii) Indications for use. For suppres- sion of estrus in mares. § 520.82 Aminopropazine oral dosage (iii) Limitations. Do not use in horses forms. intended for human consumption. Fed- § 520.82a Aminopropazine. eral law restricts this drug to use by or on the order of a licensed veterinarian. (a) Specifications. Each tablet con- (2) Swine—(i) Amount. Administer 6.8 tains aminopropazine fumarate equiva- mL (15 mg altrenogest) per gilt once lent to 25 percent aminopropazine base. daily for 14 consecutive days by top- (b) Sponsor. See No. 000061 in dressing on a portion of each gilt’s § 510.600(c) of this chapter. (c) Conditions of use in dogs and cats— daily feed. (1) Amount. Administer orally at a dos- (ii) For synchroni- Indications for use. age of 1 to 2 milligrams per pound of zation of estrus in sexually mature body weight, repeated every 12 hours as gilts that have had at least one estrous indicated. cycle. (2) Indications for use. For reducing (iii) Limitations. Do not use in gilts excessive smooth muscle contractions, having a previous or current history of such as occur in urethral spasms asso- uterine inflammation (i.e., acute, ciated with urolithiasis. subacute or chronic endometritis). (3) Limitations. Federal law restricts Gilts must not be slaughtered for this drug to use by or on the order of a human consumption for 21 days after licensed veterinarian. the last treatment. [79 FR 28816, May 20, 2014] [66 FR 47960, Sept. 17, 2001, as amended at 68 FR 62006, Oct. 31, 2003; 72 FR 9455, Feb. 21, § 520.82b Aminopropazine and neomy- 2008; 74 FR 61516, Nov. 25, 2009; 77 FR 32012, cin. May 31, 2012; 80 FR 34278, June 16, 2015] (a) Specifications. Each tablet contains aminopropazine fumarate equiva- § 520.62 Aminopentamide. lent to 25 percent aminopropazine base (a) Specifications. Each tablet con- and neomycin sulfate equivalent to 50 tains 0.2 milligram (mg) milligrams (mg) of neomycin base. aminopentamide hydrogen sulphate. (b) Sponsor. See No. 000061 in (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. § 510.600(c) of this chapter. (c) Conditions of use in dogs—(1) Amount. Administer orally at a dosage (c) Conditions of use in dogs and cats— of 1 to 2 mg per pound of body weight, (1) Amount. Administer orally every 8 repeated every 12 hours as indicated. to 12 hours as follows: For animals (2) Indications for use. For control of weighing up to 10 pounds (lbs): 0.1 mg; bacterial diarrhea caused by organisms for animals weighing 11 to 20 lbs: 0.2 susceptible to neomycin and to reduce mg; for animals weighing 21 to 50 lbs: smooth muscle contractions. 0.3 mg; for animals weighing 51 to 100 (3) Limitations. Federal law restricts lbs: 0.4 mg; for animal weighing over this drug to use by or on the order of a 100 lbs: 0.5 mg. Dosage may be gradu- licensed veterinarian. ally increased up to a maximum of five times the suggested dosage. Oral ad- [79 FR 28816, May 20, 2014] ministration of tablets may be pre- § 520.88 Amoxicillin oral dosage forms. ceded by subcutaneous or intramuscular use of the injectable § 520.88a Amoxicillin trihydrate film- form of the drug. coated tablets. (2) Indications for use. For the treat- (a) Specifications. Each tablet con- ment of vomiting and/or diarrhea, nau- tains amoxicillin trihydrate equivalent sea, acute abdominal visceral spasm, to 50, 100, 150, 200, or 400 milligrams pylorospasm, or hypertrophic gastritis. (mg) amoxicillin.

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(b) Sponsor. See No. 054771 in caused by Staphylococcus aureus, Strep- § 510.600(c) of this chapter. tococcus spp., Escherichia coli, and Pro- (c) Conditions of use—(1) Dogs—(i) teus mirabilis; genitourinary tract (cys- Amount. Administer orally 5 mg per titis) caused by S. aureus, Streptococcus pound (/lb) of body weight, twice a day spp., E. coli, and P. mirabilis; gastro- for 5 to 7 days. intestinal tract (bacterial (ii) Indications for use. Treatment of gastroenteritis) caused by S. aureus, infections of the respiratory tract (ton- Streptococcus spp., E. coli, and P. sillitis, tracheobronchitis), genito- mirabilis; bacterial dermatitis caused urinary tract (cystitis), gastro- by S. aureus, Streptococcus spp., and P. intestinal tract (bacterial mirabilis; and soft tissues (abscesses, gastroenteritis), and soft tissues (ab- lacerations, and wounds) caused by S. scesses, lacerations, wounds), caused by susceptible strains of Staphylococcus aureus, Streptococcus spp., E. coli, and P. aureus, Streptococcus spp., Escherichia mirabilis. coli, Proteus mirabilis, and bacterial der- (C) Limitations. Federal law restricts matitis caused by S. aureus, Strepto- this drug to use by or on the order of a coccus spp., and P. mirabilis. licensed veterinarian. (iii) Limitations. Federal law restricts (ii) Cats—(A) Amount. Administer this drug to use by or on the order of a orally 5 to 10 mg/lb of body weight, licensed veterinarian. once daily for 5 to 7 days. (2) Cats—(i) Amount. Administer oral- (B) Indications for use. Treatment of ly 5 to 10 mg/lb of body weight, once infections caused by susceptible strains daily for 5 to 7 days. of organisms as follows: upper res- (ii) Indications for use. Treatment of piratory tract due to Staphylococcus infections caused by susceptible orga- spp., Streptococcus spp., Haemophilus nisms as follows: upper respiratory spp., E. coli, Pasteurella spp., and P. tract due to S. aureus, Streptococcus mirabilis; genitourinary tract (cystitis) spp., and genitourinary tract E. coli; due to S. aureus, Streptococcus spp., E. (cystitis) due to S. aureus, Streptococcus coli, P. mirabilis, and Corynebacterium spp., E. coli, and P. mirabilis; gastro- spp.; gastrointestinal tract due to E. intestinal tract due to E. coli; and skin and soft tissue (abscesses, lacerations, coli, Proteus spp., Staphylococcus spp., and wounds) due to S. aureus, Strepto- and Streptococcus spp.; skin and soft tis- coccus spp., E. coli, and Pasteurella sue (abscesses, lacerations, and multocida. wounds) due to Staphylococcus spp., (iii) Limitations. Federal law restricts Streptococcus spp., E. coli, and this drug to use by or on the order of a Pasteurella multocida. licensed veterinarian. (C) Limitations. Federal law restricts this drug to use by or on the order of a [57 FR 37319, Aug. 18, 1992, as amended at 60 FR 55658, Nov. 2, 1995; 79 FR 28816, May 20, licensed veterinarian. 2014] (2) [Reserved] (c) Sponsors. See Nos. 000856 and § 520.88b Amoxicillin trihydrate for 051311 in § 510.600(c) of this chapter. oral suspension. (1) Conditions of use. Dogs—(i) Amount. (a) Specifications. When reconstituted, Administer orally 5 mg/lb of body each milliliter contains amoxicillin weight, twice a day for 5 to 7 days. trihydrate equivalent to 50 milligrams (ii) Indications for use. Treatment of (mg) amoxicillin. bacterial dermatitis due to S. aureus, (b) Sponsor. See No. 054771 in Streptococcus spp., Staphylococcus spp., § 510.600(c) of this chapter. and E. coli, and soft tissue infections (1) Conditions of use—(i) Dogs—(A) (abscesses, wounds, lacerations) due to Amount. Administer orally 5 mg per pound (/lb) of body weight, twice a day S. aureus, Streptococcus spp., E. coli, P. for 5 to 7 days. mirabilis and Staphylococcus spp. (B) Indications for use. Treatment of (iii) Limitations. Federal law restricts infections caused by susceptible strains this drug to use by or on the order of a of organisms as follows: respiratory licensed veterinarian. tract (tonsillitis, tracheobronchitis)

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(2) [Reserved] after the latest treatment. Federal law restricts this drug to use by or on the [57 FR 37319, Aug. 18, 1992; 57 FR 42623, Sept. 15, 1992, as amended at 60 FR 55658, Nov. 2, order of a licensed veterinarian 1995; 62 FR 13302, Mar. 20, 1997; 67 FR 67521, [57 FR 37319, Aug. 18, 1992; 57 FR 42623, Sept. Nov. 6, 2002; 68 FR 54658, Sept. 18, 2003; 68 FR 15, 1992; 58 FR 18304, Apr. 8, 1993, as amended 55824, Sept. 29, 2003; 79 FR 28816, May 20, 2014; at 60 FR 55658, Nov. 2, 1995; 62 FR 5525, Feb. 81 FR 17607, Mar. 30, 2016] 6, 1997; 79 FR 28817, May 20, 2014] § 520.88c Amoxicillin trihydrate oral suspension. § 520.88e Amoxicillin trihydrate boluses. (a) Specifications. Each 0.8-milliliter dose contains amoxicillin trihydrate (a) Specifications. Each bolus contains equivalent to 40 milligrams (mg) amoxicillin trihydrate equivalent to amoxicillin. 400 milligrams (mg) amoxicillin. (b) Sponsor. See No. 054771 in (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. § 510.600(c) of this chapter. (c) Related tolerances. See § 556.510 of (c) Related tolerances. See § 556.38 of this chapter. this chapter. (d) Conditions of use in swine—(1) (d) Conditions of use in cattle—(1) Amount. Administer 40 mg orally twice Amount. Administer 400 mg per 100 a day using a dosing pump. Treat ani- pounds of body weight twice daily. mals for 48 hours after all symptoms Treatment should be continued for 48 have subsided but not beyond 5 days. hours after all symptoms have subsided (2) Indications for use. Treatment of but not to exceed 5 days. baby pigs under 10 pounds for porcine (2) Indications for use. Treatment of colibacillosis caused by Escherichia coli bacterial enteritis when due to suscep- susceptible to amoxicillin. tible Escherichia coli in preruminating (3) Limitations. Do not slaughter dur- calves including veal calves. ing treatment or for 15 days after lat- (3) Limitations. Do not slaughter ani- est treatment. Federal law restricts mals during treatment or for 20 days this drug to use by or on the order of a after the latest treatment. Federal law licensed veterinarian. restricts this drug to use by or on the [57 FR 37319, Aug. 18, 1992, as amended at 60 order of a licensed veterinarian. FR 55658, Nov. 2, 1995; 79 FR 28817, May 20, [57 FR 37320, Aug. 18, 1992, as amended at 60 2014] FR 55659, Nov. 2, 1995; 62 FR 5526, Feb. 6, 1997; § 520.88d Amoxicillin trihydrate solu- 79 FR 28817, May 20, 2014] ble powder. § 520.88f Amoxicillin trihydrate tab- (a) Specifications. Each gram of pow- lets. der contains amoxicillin trihydrate equivalent to 115.4 milligrams (mg) (a) Specifications. Each tablet con- amoxicillin. tains amoxicillin trihydrate equivalent (b) Sponsor. See No. 054771 in to 50, 100, 200, or 400 milligrams (mg) § 510.600(c) of this chapter. amoxicillin. (c) Related tolerances. See § 556.38 of (b) Sponsors. See Nos. 051311 and this chapter. 054771 in § 510.600(c) of this chapter. (d) Conditions of use in preruminating (c) Conditions of use in dogs—(1) calves including veal calves—(1) Amount. Amount. Administer 5 mg per pound of Administer 400 mg per 100 pounds of body weight twice daily for 5 to 7 days body weight twice daily by drench or in or 48 hours after all symptoms have milk. Treatment should be continued subsided. for 48 hours after all symptoms have (2) Indications for use. For treatment subsided but not to exceed 5 days. of bacterial dermatitis due to Staphy- (2) Indications for use. Treatment of lococcus aureus, Streptococcus spp., bacterial enteritis when due to suscep- Staphylococcus spp., and Escherichia tible Escherichia coli in preruminating coli; and soft tissue infections (ab- calves including veal calves. scesses, wounds, lacerations) due to S. (3) Limitations. Do not slaughter ani- aureus, Streptococcus spp., E. coli, Pro- mals during treatment or for 20 days teus mirabilis, and Staphylococcus spp.

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(3) Limitations. Federal law restricts aureus, nonbeta-lactamase producing S. this drug to use by or on the order of a aureus, Staphylococcus spp., Strepto- licensed veterinarian. coccus spp., E. coli, and Pasteurella spp. [79 FR 28817, May 20, 2014] Also, treatment of urinary tract infections (cystitis) due to susceptible § 520.88g Amoxicillin trihydrate and strains of E. coli. clavulanate potassium film-coated (iii) Limitations. Federal law restricts tablets. this drug to use by or on the order of a (a) Specifications. Each tablet con- licensed veterinarian. tains amoxicillin trihydrate and [57 FR 37320, Aug. 18, 1992, as amended at 60 clavulanate potassium, equivalent to FR 55659, Nov. 2, 1995; 63 FR 13121, Mar. 18, either 50 milligrams of amoxicillin and 1998; 79 FR 28817, May 20, 2014; 80 FR 34278, 12.5 milligrams clavulanic acid, or 100 June 16, 2015] milligrams of amoxicillin and 25 milligrams clavulanic acid, or 200 milli- § 520.88h Amoxicillin trihydrate and grams amoxicillin and 50 milligrams clavulanate potassium for oral sus- clavulanic acid or 300 milligrams pension. amoxicillin and 75 milligrams (a) Specifications. When reconstituted, clavulanic acid. each milliliter contains amoxicillin (b) Sponsor. See No. 054771 in trihydrate equivalent to 50 milligrams § 510.600(c) of this chapter. of amoxicillin with clavulanate potas- (c) Conditions of use—(1) Dogs—(i) sium equivalent to 12.5 milligrams of Amount. 6.25 milligrams (equivalent to clavulanic acid. 5 milligrams amoxicillin and 1.25 milli- (b) Sponsor. See No. 054771 in grams clavulanic acid) per pound of § 510.600(c) of this chapter. body weight twice daily for 5 to 7 days (c) Conditions of use—(1) Dogs—(i) or for 48 hours after all signs have sub- Amount. 6.25 milligrams (equivalent to sided. Deep pyoderma may require 5 milligrams amoxicillin and 1.25 milli- treatment for 21 days; do not treat for grams clavulanic acid) per pound of more than 30 days. body weight twice daily for 5 to 7 days (ii) Indications for use. Treatment of or for 48 hours after all signs have sub- skin and soft tissue infections such as sided. Deep pyoderma may require wounds, abscesses, cellulitis, super- treatment for 21 days; do not treat for ficial/juvenile and deep pyoderma due more than 30 days. to susceptible strains of beta- (ii) Indications for use. Treatment of lactamase (penicillinase) Staphy- skin and soft tissue infections such as lococcus aureus, nonbeta-lactamase S. wounds, abscesses, cellulitis, super- aureus, Staphylococcus spp., Strepto- ficial/juvenile and deep pyoderma due coccus spp., and Escherichia coli. Treat- to susceptible strains of beta- ment of periodontal infections due to lactamase (penicillinase) producing susceptible strains of aerobic and an- Staphylococcus aureus, nonbeta- aerobic bacteria. lactamase Staphylococcus aureus, Staph- (iii) Limitations. Federal law restricts ylococcus spp., Streptococcus spp., and this drug to use by or on the order of a Escherichia coli. Treatment of peri- licensed veterinarian. odontal infections due to susceptible (2) Cats—(i) Amount. 62.5 milligrams strains of aerobic and anaerobic bac- (50 milligrams amoxicillin and 12.5 mil- teria. ligrams clavulanic acid) twice daily for (iii) Limitations. Federal law restricts 5 to 7 days or for 48 hours after all this drug to use by or on the order of a signs have subsided. Urinary tract in- licensed veterinarian. fections may require treatment for 10 (2) Cats—(i) Amount. 62.5 milligrams to 14 days or longer. The maximum du- (1 milliliter) (50 milligrams amoxicillin ration of treatment should not exceed and 12.5 milligrams clavulanic acid) 30 days. twice daily. Administer 48 hours after (ii) Indications for use. Treatment of all signs have subsided. Maximum du- skin and soft tissue infections, such as ration of treatment should not exceed wounds, abscesses and cellulitis/derma- 30 days. titis due to susceptible strains of beta- (ii) Indications for use. Treatment of lactamase (penicillinase) producing S. feline skin and soft tissue infections,

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such as wounds, abscesses and to 125, 250, or 500 milligrams of ampi- cellulitis/dermatitis due to susceptible cillin. strains of beta-lactamase (penicil- (b) Sponsor. See No. 054771 in linase) producing S. aureus, nonbeta- § 510.600(c) of this chapter. lactamase S. aureus, Staphylococcus (c) Conditions of use—(1) Dogs—(i) spp., Streptococcus spp., E. coli, Amount. 5 to 10 milligrams per pound of Pasteurella multocida, and Pasteurella body weight two or three times daily. spp. In severe or acute conditions, 10 milli- (iii) Limitations. Federal law restricts grams per pound of body weight, three this drug to use by or on the order of a times daily. Administer 1 to 2 hours licensed veterinarian. prior to feeding. (ii) Indications for use. Treatment [57 FR 37320, Aug. 18, 1992, as amended at 60 FR 55659, Nov. 2, 1995; 63 FR 13121, Mar. 18, against strains of gram-negative and 1998; 79 FR 28817, May 20, 2014] gram-positive organisms sensitive to ampicillin and associated with res- § 520.90 Ampicillin oral dosage forms. piratory tract infections (tracheobronchitis and tonsillitis); uri- § 520.90a [Reserved] nary tract infections (cystitis); bacterial gastroenteritis; generalized in- § 520.90b Ampicillin tablets. fections (septicemia) associated with (a) Specifications. Each tablet con- abscesses, lacerations, and wounds; and tains ampicillin trihydrate equivalent bacterial dermatitis. to 50 or 100 milligrams of ampicillin. (iii) Limitations. Federal law restricts (b) Sponsor. See No. 054771 in this drug to use by or on the order of a § 510.600(c) of this chapter. licensed veterinarian. (c) Conditions of use in dogs—(1) (2) Cats—(i) Amount. 10 to 30 milli- Amount. 5 milligrams per pound of body grams per pound of body weight or weight, at 8-hour intervals, 1 to 2 hours three times daily. Administer 1 to 2 prior to feeding, to be continued 36 to hours prior to feeding. 48 hours after all symptoms have sub- (ii) Indications for use. Treatment sided. If no improvement is seen within against strains of gram-negative and 5 days, stop treatment, reevaluate di- gram-positive organisms sensitive to agnosis, and change therapy. ampicillin and associated with res- (2) Indications for use. Oral treatment piratory tract infections (bacterial of infections caused by susceptible or- pneumonia); urinary tract infections ganisms as follows: Upper respiratory (cystitis); and generalized infections infections, tonsillitis, and bronchitis (septicemia) associated with abscesses, due to Streptococcus spp., Staphylococcus lacerations, and wounds. spp., Escherichia coli, Proteus mirabilis, (iii) Limitations. Federal law restricts and Pasteurella spp., urinary tract in- this drug to use by or on the order of a fections (cystitis) due to Streptococcus licensed veterinarian. spp., Staphylococcus spp., E., coli, P. mirabilis, and Enterococcus spp.; gastro- [57 FR 37321, Aug. 18, 1992, as amended at 58 FR 61016, Nov. 19, 1993; 79 FR 28818, May 20, intestinal infections due to Staphy- 2014] lococcus spp., Streptococcus spp., Enterococcus spp., and E. coli. ; infec- § 520.90d Ampicillin for oral suspen- tions associated with abscesses, lacera- sion. tions, and wounds caused by Staphy- (a) Specifications. When reconstituted lococcus spp., and Streptococcus spp. as directed, each milliliter contains (3) Limitations. Federal law restricts ampicillin trihydrate equivalent to 25 this drug to use by or on the order of a milligrams of ampicillin. licensed veterinarian. (b) Sponsor. See No. 055529 in [57 FR 37321, Aug. 18, 1992, as amended at 60 § 510.600(c) of this chapter. FR 55659, Nov. 2, 1995; 79 FR 28818, May 20, (c) Conditions of use—(1) Dogs—(i) 2014] Amount. Administer to 10 milligrams per pound of body weight orally, 2 or 3 § 520.90c Ampicillin capsules. times daily, 1 to 2 hours prior to feed- (a) Specifications. Each capsule con- ing. In severe or acute conditions, 10 tains ampicillin trihydrate equivalent milligrams per pound of body weight 3

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times daily. Duration of treatment is (c) Related tolerances. See § 556.40 of usually 3 to 5 days. Continue treatment this chapter. 48 hours after the animal’s tempera- (d) Conditions of use. Swine—(1) ture has returned to normal and all Amount. 5 milligrams of ampicillin per other signs of infection have subsided. pound of body weight twice daily, oral- (ii) Indications for use. Treatment of ly by gavage or in drinking water for respiratory tract infections up to 5 days. (tracheobronchitis and tonsillitis) due (2) Indications for use. Oral treatment to Escherichia coli, Pseudomonas spp., of porcine colibacillosis (Escherichia Proteus spp., Staphylococcus spp., and coli) and salmonellosis (Salmonella spp.) Streptococcus spp., urinary tract infec- infections in swine up to 75 pounds of tions (cystitis) due to E. coli, Staphy- body weight, and bacterial pneumonia lococcus spp., Streptococcus spp., and caused by Pasteurella multocida, Staphy- Proteus spp.; bacterial gastroenteritis lococcus spp., Streptococcus spp., and due to E. coli; generalized infections Salmonella spp. (septicemia) associated with abscesses, (3) Limitations. Treated swine must lacerations, and wounds, due to Staphy- not be slaughtered for food during lococcus spp. and Streptococcus spp.; bac- treatment and for 24 hours following terial dermatitis due to Staphylococcus the last treatment. Federal law re- spp., Streptococcus spp., Proteus spp., stricts this drug to use by or on the and Pseudomonas spp. order of a licensed veterinarian. (iii) Limitations. Federal law restricts this drug to use by or on the order of a [57 FR 37322, Aug. 18, 1992, as amended at 58 licensed veterinarian. FR 61016, Nov. 19, 1993; 79 FR 28818, May 20, 2014] (2) Cats—(i) Amount. Administer 10 to 30 milligrams per pound of body weight § 520.90f Ampicillin boluses. orally, 2 or 3 times daily, 1 to 2 hours prior to feeding. Duration of treatment (a) Specifications. Each bolus contains is usually 3 to 5 days. Continue treat- ampicillin trihydrate equivalent to 400 ment 48 hours after the animal’s tem- milligrams of ampicillin. perature has returned to normal and (b) Sponsors. See sponsor numbers in all other signs of infection have sub- § 510.600(c) of this chapter as follows: sided. (1) No. 055529 for use as in paragraph (ii) Indications for use. Treatment of (d)(1) of this section; respiratory tract infections (bacterial (2) No. 054771 for use as in paragraph pneumonia) due to Staphylococcus spp., (d)(2) of this section. Streptococcus spp., E. coli, and Proteus (c) Related tolerances. See § 556.40 of spp.; urinary tract infections (cystitis) this chapter. due to E. coli, Staphylococcus spp., (d) Conditions of use. Nonruminating Streptococcus spp., Proteus spp., and calves—(1) Amount. 5 milligrams per Corynebacterium spp.; generalized infec- pound of body weight twice daily for up tions (septicemia) associated with ab- to 5 days. scesses, lacerations, and wounds, due (i) Indications for use. Oral treatment to Staphylococcus spp., Streptococcus of colibacillosis caused by Escherichia spp., Bacillus spp., and Pasteurella spp. coli, bacterial enteritis caused by Sal- (iii) Limitations. Federal law restricts monella spp., and bacterial pneumonia this drug to use by or on the order of a caused by Pasteurella spp. licensed veterinarian. (ii) Limitations. Treated calves must [57 FR 37321, Aug. 18, 1992, as amended at 58 not be slaughtered for food during FR 61016, Nov. 19, 1993; 79 FR 28818, May 20, treatment and for 15 days after the last 2014] treatment. Federal law restricts this drug to use by or on the order of a li- § 520.90e Ampicillin for soluble pow- censed veterinarian. der. (2) Amount. 5 milligrams per pound of (a) Specifications. Each gram contains body weight twice daily not to exceed 4 ampicillin trihydrate equivalent to 88.2 days. milligrams of ampicillin. (i) Indications for use. Oral treatment (b) Sponsor. See No. 055529 in of bacterial enteritis (colibacillosis) § 510.600(c) of this chapter. caused by E. coli.

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(ii) Limitations. Treated calves must cidiosis caused by Eimeria bovis and E. not be slaughtered for food during zurnii, administer 5 mg per kilogram treatment and for 7 days after the last (mg/kg) body weight for 21 days during treatment. Federal law restricts this periods of exposure or when experience drug to use by or on the order of a li- indicates that coccidiosis is likely to censed veterinarian. be a hazard. (B) As an aid in the treatment of coc- [57 FR 37322, Aug. 18, 1992, as amended at 58 FR 61016, Nov. 19, 1993; 60 FR 55659, Nov. 2, cidiosis caused by E. bovis and E. zurnii, 1995; 79 FR 28818, May 20, 2014] administer 10 mg/kg body weight for 5 days. § 520.100 Amprolium. (ii) Limitations. Withdraw 24 hours be- (a) Specifications. (1) Each milliliter fore slaughter. A withdrawal period has of solution contains 96 milligrams (mg) not been established for this product in amprolium (9.6 percent solution). preruminating calves. Do not use in (2) Each gram of powder contains 200 calves to be processed for veal. Use as mg amprolium (20 percent). the sole source of amprolium. (3) Each ounce (28.4 grams) of crum- [71 FR 56346, Sept. 27, 2006, as amended at 72 bles contains 355 mg amprolium (1.25 FR 60551, Oct. 25, 2007; 73 FR 45611, Aug. 6, percent). 2008; 73 FR 70276, Nov. 20, 2008; 74 FR 10484, (b) Sponsors. See sponsors in 510.600(c) Mar. 11, 2009; 76 FR 38554, July 1, 2011; 76 FR of this chapter. 40808, July 12, 2011; 78 FR 23, Jan. 2, 2013; 78 FR 17596, Mar. 22, 2013; 78 FR 57058, Sept. 17, (1) No. 016592 for use of products de- 2013] scribed in paragraph (a) of this section as in paragraph (d) of this section. § 520.110 Apramycin sulfate soluble (2) No. 066104 for use of product de- powder. scribed in paragraph (a)(1) of this sec- (a) Specifications. A water soluble tion as in paragraph (d) of this section. powder used to make a medicated (3) No. 000859 for use of product de- drinking water containing apramycin scribed in paragraph (a)(1) of this sec- sulfate equivalent to 0.375 gram of tion as in paragraph (d) of this section. apramycin activity per gallon of drink- (4) No. 061623 for use of products de- ing water. scribed in paragraphs (a)(1) and (a)(2) of (b) Sponsor. See No. 000986 in this section as in paragraph (d) of this § 510.600(c) of this chapter. section. (c) Related tolerances. See § 556.52 of (c) Related tolerances. See § 556.50 of this chapter. this chapter. (d) Conditions of use in swine—(1) (d) Conditions of use—(1) Growing Amount. Administer in drinking water chickens, turkeys, and laying hens. It is at the rate of 12.5 milligrams of used in drinking water as follows: apramycin per kilogram (5.7 milli- (i) Amount. Administer at the 0.012 grams per pound) of body weight per percent level in drinking water as soon day for 7 days. as coccidiosis is diagnosed and con- (2) Indications for use. For the control tinue for 3 to 5 days (in severe out- of porcine colibacillosis (weanling pig breaks, give amprolium at the 0.024 scours) caused by strains of Escherichia percent level); continue with 0.006 per- coli sensitive to apramycin. cent amprolium-medicated water for (3) Limitations. Prepare fresh medi- an additional 1 to 2 weeks. cated water daily. Do not slaughter (ii)Indications for use. For the treat- treated swine for 28 days following ment of coccidiosis. treatment. (iii) Limitations. Use as the sole source of amprolium. [47 FR 15771, Apr. 13, 1982, as amended at 49 FR 19642, May 9, 1984; 53 FR 37753, Sept. 28, (2) Calves. Administer crumbles top- 1988; 79 FR 28818, May 20, 2014] dressed on or thoroughly mixed in the daily feed ration; administer con- § 520.154 Bacitracin oral dosage forms. centrate solution or soluble powder as a drench or in drinking water as fol- § 520.154a Bacitracin lows: methylenedisalicylate. (i) Indications for use and amounts— (a) Specifications. Each pound of solu- (A) As an aid in the prevention of coc- ble powder contains the equivalent of

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50 grams of bacitracin activity for use (iii) Limitations. Prepare fresh solu- as in paragraph (d)(1) or (d)(2) of this tion daily. Use as sole source of drink- section, or the equivalent of 200 grams ing water. of bacitracin activity for use as in [57 FR 37322, Aug. 18, 1992; 57 FR 42623, Sept. paragraph (d) of this section. 15, 1992, as amended at 63 FR 38474, July 17, (b) Sponsor. See No. 054771 in 1998; 64 FR 13068, Mar. 17, 1999; 76 FR 53050, § 510.600(c) of this chapter. Aug. 25, 2011; 79 FR 28818, May 20, 2014; 80 FR (c) Related tolerances. See § 556.70 of 34278, June 16, 2015] this chapter. § 520.154b Bacitracin (d) Conditions of use—(1) Growing tur- methylenedisalicylate and strepto- keys—(i) Amount. 400 milligrams (mg) mycin sulfate powder. per gallon (gal) in drinking water. (a) Specifications. Each gram of pow- (ii) Indications for use. Aid in the con- der contains 200 units bacitracin trol of transmissible enteritis com- methylenedisalicylate and strepto- plicated by organisms susceptible to mycin sulfate equivalent to 20 milli- bacitracin methylenedisalicylate. grams of streptomycin. (iii) Limitations. Prepare a fresh solu- (b) Sponsor. See No. 054771 in tion daily. § 510.600(c) of this chapter. (2) Broiler and replacement chickens— (c) Conditions of use in dogs—(1) (i) Amount. 100 mg per gal in drinking Amount. Administer 1 level teaspoonful water. per 10 pounds of body weight three (A) Indications for use. Aid in the pre- times daily, mixed in a small quantity vention of necrotic enteritis caused by of liquid or feed. Clostridium perfringens susceptible to (2) Indications for use. For the treat- bacitracin methylenedisalicylate. ment of bacterial enteritis caused by (B) Limitations. Prepare a fresh solu- pathogens susceptible to bacitracin and tion daily. streptomycin such as Escherichia coli, (ii) Amount. 200 to 400 mg per gal in Proteus spp., Staphylococcus spp., and drinking water. Administer continu- Streptococcus spp., and for the sympto- ously 5 to 7 days or as long as clinical matic treatment of associated diar- signs persist, then reduce to prevention rhea. levels (100 mg/gal). (3) Limitations. Federal law restricts this drug to use by or on the order of a (A) Indications for use. Treatment of licensed veterinarian. necrotic enteritis caused by C. perfringens susceptible to bacitracin [71 FR 17702, Apr. 7, 2006, as amended at 79 methylenedisalicylate. FR 28818, May 20, 2014; 81 FR 17607, Mar. 30, (B) Limitations. Prepare a fresh solu- 2016] tion daily. § 520.154c Bacitracin zinc soluble pow- (3) Swine—(i) Amount. 1 gram per gal- der. lon in drinking water. (a) Specifications. Each pound con- (ii) Indications for use. Treatment of tains the equivalent of not less than 5 swine dysentery associated with grams of bacitracin. Brachyspira hyodysenteriae. Administer (b) Sponsor. See No. 054771 in continuously for 7 days or until signs § 510.600(c) of this chapter. of dysentery disappear. (c) Related tolerances. See § 556.70 of (iii) Limitations. Prepare a fresh solu- this chapter. tion daily. Treatment not to exceed 14 (d) Conditions of use—(1) Broiler chick- days. If symptoms persist after 4 to 5 ens—(i) Amount. 100 milligrams per gal- days consult a veterinarian. Not to be lon in drinking water. given to swine that weigh more than (A) Indications for use. Prevention of 250 pounds. necrotic enteritis caused by Clostridium (4) Growing quail—(i) Amount. 400 mg perfringens susceptible to bacitracin per gal in drinking water. zinc. (ii) Indications for use. For prevention (B) Limitations. Prepare a fresh solu- of ulcerative enteritis due to Clos- tion daily. tridium colinum susceptible to baci- (ii) Amount. 200 to 400 milligrams per tracin methylenedisalicylate. gallon in drinking water.

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(A) Indications for use. Control of ne- § 520.246 Butorphanol tablets. crotic enteritis caused by Clostridium (a) Specifications. Each tablet con- perfringens susceptible to bacitracin tains butorphanol tartrate equivalent zinc. to 1, 5, or 10 milligrams (mg) (B) Limitations. Prepare a fresh solu- butorphanol base. tion daily. (b) Sponsor. See No. 054771 in (2) Growing quail—(i) Amount. 500 mil- § 510.600(c) of this chapter. ligrams per gallon in drinking water (c) Conditions of use in dogs—(1) for 5 days followed by 165 milligrams Amount. Administer 0.25 mg per gallon in drinking water for 10 butorphanol base per pound of body days. weight. Repeat at intervals of 6 to 12 (ii) Indications for use. Control of ul- hours as required. Treatment should cerative enteritis caused by Clostridium not normally be required for longer spp. susceptible to bacitracin zinc. than 7 days. (iii) Limitations. Prepare a fresh solu- (2) Indications for use. For the relief of tion daily. chronic nonproductive cough associ- [57 FR 37322, Aug. 18, 1992, as amended at 67 ated with tracheobronchitis, tracheitis, FR 78355, Dec. 24, 2002; 79 FR 28818, May 20, tonsillitis, laryngitis, and pharyngitis 2014] associated with inflammatory conditions of the upper respiratory tract. § 520.222 Bunamidine hydrochloride. (3) Limitations. Federal law restricts (a) Chemical name. N,N-Dibutyl-4- this drug to use by or on the order of a (hexyloxy)-1-naphthamidine hydro- licensed veterinarian. chloride. [79 FR 28818, May 20, 2014] (b) Specifications. The drug is an oral tablet containing 100, 200, or 400 milli- § 520.260 n-Butyl chloride. grams of bunamidine hydrochloride. (a)(1) Specifications. n-Butyl chloride (c) Sponsor. See No. 000061 in capsules, veterinary contain 272 milli- § 510.600(c) of this chapter. grams or 816 milligrams of n-butyl (d) Conditions of use. (1) The drug is chloride in each capsule. intended for oral administration to (2) Sponsor. See No. 021091 in dogs for the treatment of the tape- § 510.600(c) of this chapter. worms Dipylidium caninum, Taenia (3) Conditions of use. (i) It is used for and pisiformis, Echinococcus granulosus, the removal of ascarids (Toxocara canis and to cats for the treatment of the and Toxascaris leonina) and hookworms tapeworms Dipylidium caninum and (Ancylostoma caninum, Ancylostoma Taenia taeniaeformis. braziliense, and Uncinaria stenocephala) (2) It is administered to cats and dogs from dogs and of the ascarid (Toxocara at the rate of 25 to 50 milligrams per cati) and hookworm (Ancylostoma kilogram of body weight. The drug tubaeforme) from cats. should be given on an empty stomach (ii)(a) Animals should not be fed for and food should not be given for 3 18 to 24 hours before being given the hours following treatment. drug. Puppies and kittens should be (3) Tablets should not be crushed, wormed at 6 weeks of age. However, if mixed with food, or dissolved in liquid. heavily infested, they may be wormed Repeat treatments should not be given at 4 or 5 weeks of age. Administration within 14 days. The drug should not be of the drug should be followed in 1⁄2 to given to male dogs within 28 days prior 1 hour with a teaspoonful to a table- to their use for breeding. Do not ad- spoonful of milk of magnesia or 1 or 2 minister to dogs or cats having known milk of magnesia tablets. Normal ra- heart conditions. tions may be resumed 4 to 8 hours after (4) For use only by or on the order of treatment. Puppies and kittens should a licensed veterinarian. be given a repeat treatment in a week [40 FR 13838, Mar. 27, 1975, as amended at 42 or 10 days. After that they should be FR 13018, Mar. 8, 1977; 46 FR 48642, Oct. 2, treated every 2 months (or as symp- 1981; 61 FR 8873, Mar. 6, 1996; 62 FR 61624, toms reappear) until a year old. When Nov. 19, 1997] the puppy or kitten is a year old, one

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treatment every 3 to 6 months is suffi- (b) The drug is administered orally to cient. dogs. Capsules containing 221 milli- (b) For dogs or cats that have been grams of n-butyl chloride are adminis- wormed regularly, treatment every 3 to tered to dogs weighing under 5 pounds 6 months will be sufficient. If a dog or at a dosage level of 1 capsule per 11⁄4 cat has not been wormed previously pound of body weight. Capsules con- and has the symptoms of large taining 442 milligrams of n-butyl chlo- roundworms a dose should be given and ride are administered to dogs weighing repeated in 10 days. Removal of under 5 pounds at a dosage level of 1 hookworms may require 3 or 4 doses at capsule per 21⁄2 pounds body weight. 10-day intervals. Capsules containing 884 milligrams of (c) Puppies, dogs, cats, or kittens n-butyl chloride are administered to weighing 1 to 3 pounds should be given dogs as follows: Weighing under 5 2 capsules per dose which contain 272 pounds, 1 capsule; weighing 5 to 10 milligrams of n-butyl chloride each. pounds, 2 capsules; weighing 10 to 20 Such animals weighing 4 to 5 pounds pounds, 3 capsules; weighing 20 to 40 should be given 3 such capsules. Ani- pounds, 4 capsules; over 40 pounds, 5 mals weighing 6 to 7 pounds should be capsules. Capsules containing 1,768 mil- given 4 such capsules and animals ligrams of n-butyl chloride are admin- weighing 8 to 9 pounds should be given istered at a dosage level of 1 capsule 5 such capsules. Animals weighing 10 to per dog weighing 5 to 10 pounds. Cap- 20 pounds should be given 3 capsules sules containing 4.42 grams of n-butyl which contain 816 milligrams of n- chloride are administered at a dosage butyl chloride each, animals weighing level of 1 capsule per dog weighing 40 20 to 40 pounds should be given 4 such pounds or over. capsules and animals weighing over 40 (iii) A veterinarian should be con- pounds should be given 5 such capsules sulted before using in severely debili- with the maximum dosage being 5 cap- tated dogs. sules, each of which contains 816 milligrams of n-butyl chloride. [40 FR 13838, Mar. 27, 1975, as amended at 40 FR 39858, Aug. 29, 1975; 44 FR 10059, Feb. 16, (iii) A veterinarian should be con- 1979; 54 FR 38515, Sept. 19, 1989; 55 FR 24556, sulted before using in severely debili- June 18, 1990; 64 FR 15684, Apr. 1, 1999; 70 FR tated dogs or cats and also prior to re- 50182, Aug. 26, 2005; 78 FR 14669, Mar. 7, 2013; peated use in cases which present signs 79 FR 28818, May 20, 2014] of persistent parasitism. EDITORIAL NOTE: At 78 FR 14669, Mar. 7, (b)(1) Specifications. n-Butyl chloride 2013, § 520.260 was amended by adding para- capsules contain 221, 442, 884, or 1,768 graphs (b)(1) through (3); however, the milligrams or 4.42 grams of n-butyl amendment could not be incorporated be- chloride in each capsule. cause (b)(1) through (3) already existed. (2) Sponsors. See No. 023851 in § 510.600(c) of this chapter for 221, 442, § 520.300 Cambendazole oral dosage 884, or 1,768 milligram or 4.42 gram cap- forms. sules; No. 038782 for 884 or 1,768 milli- § 520.300a Cambendazole suspension. gram or 4.42 gram capsules; and No. 054771 for 221 milligram capsules. (a) Specifications. Each fluid ounce (3) Conditions of use. (i) It is used for contains 0.9 gram of cambendazole. the removal of ascarids (Toxocara canis (b) Sponsor. No. 050604 in § 510.600(c) of and Toxascaris leonina) and hookworms this chapter. (Ancylostoma caninum, Ancylostoma (c) Conditions of use in horses—(1) braziliense, and Uncinaria stenocephala) Amount. Administer by stomach tube from dogs. or as a drench at a dose of 0.9 gram of (ii)(a) Dogs should not be fed for 18 to cambendazole per 100 pounds of body 24 hours before being given the drug. weight (20 milligrams per kilogram). Administration of the drug should be (2) Indications for use. For the control followed in 1⁄2 to 1 hour with a mild ca- of large strongyles (Strongylus vulgaris, thartic. Normal feeding may be re- S. edentatus, S. equinus); small sumed 4 to 8 hours after treatment. strongyles (Trichonema, Poteriostomum, Animals subject to reinfection may be Cylicobrachytus, Craterostomum, retreated in 2 weeks. Oesophagodontus); roundworms

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(Parascaris); pinworms (Oxyuris); and the back of the tongue using a dosing threadworms (Strongyloides). gun. For animals maintained on prem- (3) Limitations. Do not use in horses ises where reinfection is likely to intended for human consumption. Fed- occur, re-treatments may be necessary. eral law restricts this drug to use by or For most effective results, re-treat in 6 on the order of a licensed veterinarian. to 8 weeks. [40 FR 13838, Mar. 27, 1975. Redesignated at 41 (2) Indications for use. For the control FR 1276, Jan. 7, 1976, and amended at 42 FR of large strongyles (Strongylus vulgaris, 3838, Jan. 21, 1977; 62 FR 63270, Nov. 28, 1997; S. edentatus, S. equinus); small 79 FR 28818, May 20, 2014] strongyles (Trichonema, Poteriostomum, Cylicobrachytus, Craterostomum, § 520.300b Cambendazole pellets. Oesophagodontus); roundworms (a) Specifications. The drug is in feed (Parascaris); pinworms (Oxyuris); and pellets containing 5.3 percent threadworms (Strongyloides). cambendazole. (3) Limitations. Do not administer to (b) Sponsor. No. 050604 in § 510.600(c) of pregnant mares during first 3 months this chapter. of pregnancy. Do not use in horses in- (c) Conditions of use in horses—(1) tended for human consumption. Con- Amount. Administer 20 milligrams sult your veterinarian for assistance in cambendazole per kilogram body the diagnosis, treatment, and control weight (6 ounces per 1,000 pounds) by of parasitism. mixing with normal grain ration given at one feeding. Doses for individual [41 FR 1276, Jan. 7, 1976, as amended at 42 FR horses should be mixed and fed sepa- 3838, Jan. 21, 1977; 62 FR 63270, Nov. 28, 1997; rately to assure that each horse will 79 FR 28819, May 20, 2014] consume the correct amount. For animals maintained on premises where re- § 520.301 Caramiphen infection is likely to occur, re-treat- ethanedisulfonate and ammonium chloride tablets. ments may be necessary. For most effective results, re-treat in 6 to 8 weeks. (a) Specifications. Each tablet con- (2) Indications for use. For the control tains 10 milligrams of 5st caramiphen of large strongyles (Strongylus vulgaris, ethanedisulfonate and 80 milligrams of S. edentatus, S. equinus); small ammonium chloride. strongyles (Trichonema, Poteriostomum, (b) Sponsor. See No. 054771 in Cylicobrachytus, Craterostomum, § 510.600(c) of this chapter. Oesophagodontus); roundworms (c) Conditions of use in dogs—(1) (Parascaris); pinworms (Oxyuris); and Amount. One tablet per 15 to 30 pounds threadworms (Strongyloides). of body weight every 4 to 6 hours. (3) Limitations. Do not administer to (2) Indications for use. For relief of pregnant mares during first 3 months cough. of pregnancy. Do not use in horses intended for human consumption. Con- [43 FR 55385, Nov. 28, 1978, as amended at 79 sult your veterinarian for assistance in FR 28819, May 20, 2014. Redesignated at 80 FR the diagnosis, treatment, and control 13229, Mar. 13, 2015] of parasitism. § 520.302 Carnidazole tablets. [41 FR 1276, Jan. 7, 1976, as amended at 42 FR (a) Specifications. Each tablet con- 3838, Jan. 21, 1977; 62 FR 63270, Nov. 28, 1997; 79 FR 28818, May 20, 2014] tains 10 milligrams of carnidazole. (b) Sponsor. See 053923 in § 510.600(c) of § 520.300c Cambendazole paste. this chapter. (a) Specifications. The drug is a paste (c) Conditions of use—(1) Amount. containing 45 percent cambendazole. Adult pigeons: 1 tablet (10 milligrams); (b) Sponsor. No. 050604 in § 510.600(c) of newly weaned pigeons: 1⁄2 tablet (5 mil- this chapter. ligrams). (c) Conditions of use in horses—(1) (2) Indications for use. For treating Amount. Administer 20 milligrams trichomoniasis (canker) in ornamental cambendazole per kilogram body and homing pigeons. weight (5 grams per 550 pounds (250 (3) Limitations. Not for use in pigeons kilograms)) by depositing the paste on intended for human food. Consult your

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veterinarian for assistance in the diag- (2) Each milliliter of suspension con- nosis, treatment, and control of para- stituted from powder contains 50 mg of sitism or when severely ill birds do not cefadroxil. respond to treatment. (b) Sponsor. See No. 000010 in § 510.600(c) of this chapter. [54 FR 32336, Aug. 7, 1989. Redesignated at 80 (c) Conditions of use in dogs and cats— FR 13229, Mar. 13, 2015] (1) Amount—(i) Dogs. Administer 10 mg § 520.304 Carprofen. per pound (/lb) body weight twice daily orally. (a) Specifications. (1) Each caplet con- (ii) Cats. Administer 10 mg/lb body tains 25, 75, or 100 milligrams (mg) weight once daily orally. carprofen. (2) Indications for use—(i) Dogs. For (2) Each chewable tablet contains 25, the treatment of skin and soft tissue 75, or 100 mg carprofen. infections including cellulitis, (b) Sponsors. See sponsors in pyoderma, dermatitis, wound infec- § 510.600(c) of this chapter for uses as in tions, and abscesses due to susceptible paragraph (d) of this section. strains of Staphylococcus aureus. For (1) No. 054771 for use of products de- the treatment of genitourinary tract scribed in paragraph (a) of this section infections (cystitis) due to susceptible as in paragraph (d) of this section. strains of Escherichia coli, Proteus (2) Nos. 000859, 026637, 055529, and mirabilis, and S. aureus. 062250 for use of product described in (ii) Cats. For the treatment of skin paragraph (a)(1) as in paragraph (d) of and soft tissue infections including ab- this section. scesses, wound infections, cellulitis, (3) Nos. 026637 and 062250 for use of and dermatitis caused by susceptible product described in paragraph (a)(2) of strains of Pasteurella multocida, S. this section as in paragraph (d) of this aureus, Staphylococcus epidermidis, and section. Streptococcus spp. (3) Limitations. Federal law restricts (c) [Reserved] this drug to use by or on the order of a (d) Conditions of use in dogs—(1) licensed veterinarian. Amount. 2 mg per pound (/lb) of body weight once daily or 1 mg/lb twice [75 FR 10165, Mar. 5, 2010] daily. For the control of postoperative pain, administer approximately 2 hours § 520.370 Cefpodoxime tablets. before the procedure. (a) Specifications. (1) Each tablet con- (2) Indications for use. For the relief of tains cefpodoxime proxetil equivalent pain and inflammation associated with to 100 or 200 milligrams (mg) osteoarthritis and for the control of cefpodoxime. postoperative pain associated with soft (2) Each chewable tablet contains tissue and orthopedic surgeries. cefpodoxime proxetil equivalent to 100 (3) Limitations. Federal Law restricts or 200 mg cefpodoxime. this drug to use by or on the order of a (b) Sponsors. See sponsors in licensed veterinarian. § 510.600(c) of this chapter for uses as follows: [61 FR 66581, Dec. 18, 1996, as amended at 64 (1) No. 026637 for use of product in FR 32181, June 16, 1999; 66 FR 63165, Dec. 5, paragraph (a)(1) of this section as in 2001; 67 FR 6866, Feb. 14, 2002; 67 FR 65038, paragraph (c) of this section. Oct. 23, 2002; 67 FR 65697, Oct. 28, 2002; 70 FR 30626, May 27, 2005; 71 FR 51995, Sept. 1, 2006; (2) No. 054771 for use of products in 72 FR 68478, Dec. 5, 2007; 74 FR 21768, May 11, paragraph (a) of this section as in para- 2009; 78 FR 52853, Aug. 27, 2013; 78 FR 66264, graph (c) of this section. Nov. 5, 2013; 79 FR 28819, May 20, 2014. Redes- (c) Conditions of use in dogs—(1) ignated and amended at 80 FR 13229, Mar. 13, Amount. 5 to 10 mg per kilogram (2.3 to 2015; 80 FR 34278, June 16, 2015; 80 FR 61296, 4.5 mg per pound) body weight daily for Oct. 13, 2015] 5 to 7 days, or for 2 to 3 days beyond the cessation of clinical signs, up to a § 520.314 Cefadroxil. maximum of 28 days. (a) Specifications. (1) Each tablet con- (2) Indications for use. For the treat- tains 50, 100, or 200 milligrams (mg) or ment of skin infections (wounds and 1 gram of cefadroxil. abscesses) caused by susceptible strains

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of Staphylococcus pseudintermedius, S. nary tract, bacterial enteritis, and bac- aureus, Streptococcus canis (group G, -he- terial infections associated with canine molytic), Escherichia coli, Pasteurella distemper caused by susceptible orga- multocida, and Proteus mirabilis. nisms. (3) Limitations. Federal law restricts (ii) For the treatment of bacterial this drug to use by or on the order of a gastroenteritis associated with bac- licensed veterinarian. terial diarrhea, bacterial pulmonary [69 FR 52815, Aug. 30, 2004, as amended at 78 infections, and bacterial infections of FR 5714, Jan. 28, 2013; 79 FR 28819, May 20, the urinary tract caused by susceptible 2014; 80 FR 13229, Mar. 13, 2015] organisms. (3) Limitations. Federal law restricts § 520.376 Cephalexin. this drug to use by or on the order of a (a) Specifications. Each chewable tab- licensed veterinarian. Federal law pro- let contains 75, 150, 300, or 600 milli- hibits the extralabel use of this drug in grams (mg) cephalexin. food-producing animals. (b) Sponsor. See No. 051311 in § 510.600(c) of this chapter. [77 FR 4896, Feb. 1, 2012, as amended at 78 FR 21059, Apr. 9, 2013; 79 FR 28819, May 20, 2014] (c) Conditions of use—(1) Dogs—(i) Amount. Administer 22 mg per kilo- § 520.390b Chloramphenicol capsules. gram of body weight twice daily for 28 days. (a) Specifications. Each capsule con- (ii) Indications for use. For the treat- tains 50, 100, 250, or 500 milligrams (mg) ment of secondary superficial bacterial chloramphenicol. pyoderma in dogs caused by susceptible (b) Sponsors. See Nos. 050057 and strains of Staphylococcus 054771 in § 510.600(c) of this chapter for pseudintermedius. use as in paragraph (d) of this section. (iii) Limitations. Federal law restricts (c) Special considerations. Federal law this drug to use by or on the order of a prohibits the extralabel use of this licensed veterinarian. product in food-producing animals. (2) [Reserved] (d) Conditions of use in dogs—(1) [77 FR 47512, Aug. 9, 2012] Amount. 25 mg per pound of body weight every 6 hours. § 520.390 Chloramphenicol oral dosage (2) Indications for use. For treatment forms. of bacterial pulmonary infections, bacterial infections of the urinary tract, § 520.390a Chloramphenicol tablets. bacterial enteritis, and bacterial infec- (a) Specifications. Each tablet con- tions associated with canine distemper tains 50, 100, 250, or 500 milligrams caused by susceptible organisms. (mg); 1 or 2.5 grams (g) of chloramphen- (3) Limitations. Federal law restricts icol. this drug to use by or on the order of a (b) Sponsors. See § 510.600(c) of this licensed veterinarian. chapter: (1) For use as in paragraphs (c)(1), [70 FR 75398, Dec. 20, 2005, as amended at 73 (c)(2)(i), and (c)(3) of this section: FR 18442, Apr. 4, 2008; 75 FR 55676, Sept. 14, 2010; 79 FR 28819, May 20, 2014] (i) No. 054628 for 100-, 250-, and 500-mg; and 1- and 2.5-g tablets; § 520.390c Chloramphenicol palmitate (ii) No. 054771 for 100-, 250-, and 500- oral suspension. mg tablets; (2) For use as in paragraphs (c)(1), (a) Specifications. Each milliliter con- (c)(2)(ii), and (c)(3) of this section: tains chloramphenicol palmitate equiv- (i) No. 061623 for 50-, 100-, 250-, and alent to 30 milligrams of chloramphen- 500-mg; and 1-g tablets; icol. (ii) [Reserved] (b) Sponsor. See No. 054771 in (c) Conditions of use in dogs—(1) § 510.600(c) of this chapter. Amount. Administer 25 mg per pound of (c) Conditions of use. Dogs—(1) body weight by mouth every 6 hours. Amount. 25 milligrams per pound of (2) Indications for use—(i) For the body weight every 6 hours. If no retreatment of bacterial pulmonary in- sponse is obtained in 3 to 5 days, dis- fections, bacterial infections of the uri- continue use and reevaluate diagnosis.

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(2) Indications for use. Treatment of (b)(1) Specifications. Each bolus con- bacterial pulmonary infections, infec- tains 2 grams of chlorothiazide. tions of the urinary tract, enteritis, (2) Sponsor. See No. 000006 in and infections associated with canine § 510.600(c) of this chapter. distemper that are caused by orga- (3) Conditions of use—(i) Amount. 2 nisms susceptible to chloramphenicol. grams once or twice daily for 3 or 4 (3) Limitations. Not for use in animals days. that are raised for food production. (ii) Indications for use. For use in cat- Must not be used in meat-, egg-, or tle as an aid in reduction of milk-producing animals. The length of time that residues persist in milk or postparturient udder edema. tissues has not been determined. Fed- (iii) Limitations. Animals should be eral law restricts this drug to use by or regularly and carefully observed for on the order of a licensed veterinarian. early signs of fluid and electrolyte imbalance. Take appropriate counter- [57 FR 37323, Aug. 18, 1992; 57 FR 42623, Sept. measures if this should occur. Milk 15, 1992, as amended at 79 FR 28819, May 20, 2014] taken from dairy animals during treatment and for 72 hours (six milkings) § 520.420 Chlorothiazide tablets and after latest treatment must not be boluses. used for food. Federal law restricts this (a)(1) Specifications. Each tablet con- drug to use by or on the order of a li- tains 0.25 gram of chlorothiazide. censed veterinarian. (2) Sponsor. See No. 050604 in [43 FR 39085, Sept. 1, 1978, as amended at 62 § 510.600(c) of this chapter. FR 63270, Nov. 28, 1997; 79 FR 28819, May 20, (3) Conditions of use—(i) Amount. 2014] Usual dosage is 5 to 10 milligrams per pound of body weight two or three § 520.434 Chlorphenesin carbamate times daily. tablets. (ii) Indications for use. For use in dogs for treatment of congestive heart fail- (a) Specifications. Each tablet con- ure and renal edema. tains 400 milligrams of chlorphenesin (iii) Limitations. (a) Dosage must be carbamate. adjusted to meet the changing needs of (b) Sponsor. See No. 054771 in the individual animal. In mild and re- § 510.600(c) of this chapter. sponsive cases, it is suggested that a (c) Conditions of use in dogs—(1) dose of 5 milligrams per pound of body Amount. 50 milligrams per pound of weight be administered two or three body weight on first day; 25 milligrams times daily. In moderately edematous per pound of body weight each fol- and moderately responsive animals, a lowing day. Divide total daily dose into dose of 7.5 to 10 milligrams per pound 2 or 3 equal doses—administer at 12- or of body weight may be administered 8-hour intervals. three times daily. Severe conditions (2) Indications for use. For use as an may require higher doses. Certain ani- adjunct to therapy of acute inflam- mals may respond adequately to inter- matory and traumatic conditions of mittent therapy; in these cases, the skeletal muscles. The drug provides re- drug may be administered either every lief of the signs of discomfort associ- other day or for 3 to 5 days each week. (b) Animals should be regularly and ated with myositis, muscle sprains, carefully observed for early signs of traumatic injuries, stifle injuries—es- fluid and electrolyte imbalance. Take pecially when administered before or appropriate countermeasures if this after surgery—and invertebral disc should occur. In some dogs, syndrome (can be used concurrently hypochloremic alkalosis may occur with adrenal corticosteroids). (that is, excretion of chloride in rela- (3) Limitations. Federal law restricts tion to sodium is excessive; the plasma this drug to use by or on the order of a bicarbonate level increases and licensed veterinarian. alkalosis results). Federal law restricts [44 FR 16009, Mar. 16, 1979, as amended at 79 this drug to use by or on the order of a FR 28819, May 20, 2014] licensed veterinarian.

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§ 520.441 Chlortetracycline powder. days; do not slaughter animals for food (a) Specifications. Chlortetracycline within 24 hours of treatment; do not powder contains not less than 15 milli- administer this product with milk or grams per gram chlortetracycline hy- milk replacers; administer 1 hour be- drochloride, or chlortetracycline bisul- fore or 2 hours after feeding milk or fate equivalent to 25.6, 64 or 102.4 grams milk replacers; a withdrawal period has per pound (56.4, 141 or 225.6 milligrams not been established in preruminating per gram) chlortetracycline hydro- calves; do not use in calves to be proc- chloride. essed for veal. (b) Sponsors. See sponsors in (B) [Reserved] § 510.600(c) of this chapter for use as in (ii) [Reserved] paragraph (d) of this section. (3) [Reserved] (1) No. 069254 for use as in paragraph (4) The following uses of chlortetra- (d) of this section. cycline hydrochloride or chlortetra- (2) Nos. 016592 and 054771 for use as in cycline bisulfate in drinking water or paragraph (d) of this section. drench were reviewed by the National (3) No. 054628 for use as in paragraphs Academy of Sciences/National Re- (d)(4)(i)(A), (d)(4)(i)(B), and (d)(4)(ii) search Council (NAS/NRC) and found through (d)(4)(iv) of this section. effective: (d)(4)(ii) through (iv) of this section. (i) Chickens—(A) Amount. 200 to 400 (4) Nos. 069254 and 076475 for use as in milligrams per gallon. paragraphs (d)(4)(i)(A), (d)(4)(i)(B), (1) Indications for use. Control of in- (d)(4)(ii), and (d)(4)(iii) of this section. fectious synovitis caused by Myco- (c) Related tolerances. See § 556.150 of plasma synoviae. this chapter. (2) Limitations. Prepare fresh solution (d) Conditions of use. (1) Use as chlor- daily; as sole source of chlortetra- tetracycline hydrochloride in drinking cycline; do not use for more than 14 water as follows: days; do not slaughter animals for food (i) Swine—(A) Amount. Ten milli- within 24 hours of treatment; do not grams per pound of body weight daily use in laying chickens. in divided doses. (B) Amount. 400 to 800 milligrams per (1) Indications for use. Control and gallon. treatment of bacterial enteritis (1) Indications for use. Control of (scours) caused by and Escherichia coli chronic respiratory disease and air-sac bacterial pneumonia associated with infections caused by M. gallisepticum Pasteurella spp., Actinobacillus and E. coli. pleuropneumoniae (Haemophilus spp.), (2) Limitations. Prepare fresh solution and Klebsiella spp. daily; as sole source of chlortetra- (2) Limitations. Prepare a fresh solu- cycline; do not use for more than 14 tion twice daily; as sole source of days; do not slaughter animals for food chlortetracycline; administer for not within 24 hours of treatment; do not more than 5 days. (B) [Reserved] use in laying chickens. (ii) [Reserved] (C) Amount. One thousand milligrams (2) Use as chlortetracycline hydro- per gallon. chloride in a drench or drinking water (1) Indications for use. Control of mor- as follows: tality due to fowl cholera caused by (i) Calves—(A) Amount. Ten milli- Pasteurella multocida susceptible to grams per pound of body weight daily chlortetracycline. in divided doses. (2) Limitations. See paragraph (1) Control and treatment of bac- (d)(4)(i)(A)(2) of this section. terial enteritis (scours) caused by E. (ii) Growing turkeys—(A) Amount. 400 coli and bacterial pneumonia (shipping milligrams per gallon. fever) associated with Pasteurella spp., (1) Indications for use. Control of in- A. pleuropneumoniae (Haemophilus spp.), fectious synovitis caused by M. and Klebsiella spp. synoviae. (2) Limitations. Prepare fresh solution (2) Limitations. Prepare fresh solution daily; as sole source of chlortetra- daily; as sole source of chlortetracycline; administer for not more than 5 cycline; do not use for more than 14

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days; do not slaughter animals for food (1) Indications for use. Control of in- within 24 hours of treatment. fectious synovitis caused by M. (B) Amount. 25 milligrams per pound synoviae susceptible to chlortetra- of body weight daily. cycline. (1) Indications for use. Control of com- (2) Limitations. Prepare fresh solution plicating bacterial organisms associ- daily; use as the sole source of chlor- ated with bluecomb (transmissible en- tetracycline; do not use for more than teritis, coronaviral enteritis). 14 consecutive days; do not use in lay- (2) Limitations. Prepare fresh solution ing chickens; do not administer to daily; as sole source of chlortetra- chickens within 24 hours of slaughter. cycline; do not use for more than 14 (B) Amount. 400 to 800 mg/gal, for 7 to days; do not slaughter animals for food 14 days. within 24 hours of treatment. (1) Indications for use. Control of (iii) Swine—(A) Amount. 10 milligrams chronic respiratory disease (CRD) and per pound body weight daily in divided air-sac infections caused by M. doses. gallisepticum and E. coli susceptible to (B) Indications for use. Control and chlortetracycline. treatment of bacterial enteritis (scours) caused by E. coli and Sal- (2) Limitations. As in paragraph monella spp. and bacterial pneumonia (d)(5)(i)(A)(2) of this section. associated with Pasteurella spp., (C) Amount. One thousand mg/gal, for Actinobacillus pleuropneumoniae 7 to 14 days. (Haemophilus spp.), and Klebsiella spp. (1) Indications for use. Control of mor- (C) Limitations. Prepare fresh solution tality due to fowl cholera caused by daily; as sole source of chlortetra- Pasteurella multocida susceptible to cycline; do not use for more than 5 chlortetracycline. days. For Nos. 016592 and 021930, do not (2) Limitations. As in paragraph slaughter animals for food within 5 (d)(5)(i)(A)(2) of this section. days of treatment. For No. 016592, do (ii) Growing Turkeys—(A) Amount. 400 not slaughter animals for food within mg/gal, for 7 to 14 days. 24 hours of treatment. (1) Indications for use. Control of in- (iv) Calves, beef cattle, and nonlac- fectious synovitis caused by Myco- tating dairy cattle—(A) Amount. 10 milli- plasma synoviae susceptible to chlor- grams per pound daily in divided doses. tetracycline. (B) Indications for use. Control and (2) Limitations. Prepare fresh solution treatment of bacterial enteritis daily; use as the sole source of chlor- (scours) caused by E. coli and Sal- tetracycline; do not use for more than monella spp. and bacterial pneumonia 14 consecutive days; do not administer (shipping fever complex) associated to growing turkeys within 24 hours of with Pasteurella spp., A. slaughter. pleuropneumoniae (Haemophilus spp.), (B) Amount. 25 mg/lb body weight and Klebsiella spp. daily, for 7 to 14 days. (C) Limitations. Prepare fresh solution daily; use as a drench; as sole source of (1) Indications for use. Control of com- chlortetracycline; do not use for more plicating bacterial organisms associ- than 5 days; do not slaughter animals ated with bluecomb (transmissible en- for food within 24 hours of treatment; teritis, coronaviral enteritis) suscep- do not use in lactating cattle; do not tible to chlortetracycline. administer this product with milk or (2) Limitations. As in paragraph milk replacers; administer 1 hour be- (d)(5)(ii)(A)(2) of this section. fore or 2 hours after feeding milk or (iii) Swine—(A) Amount. 10 mg/lb body milk replacers; a withdrawal period has weight daily, for 3 to 5 days. not been established in preruminating (B) Indications for use. Control and calves; do not use in calves to be proc- treatment of bacterial enteritis essed for veal. (scours) caused by E. coli and Sal- (5) Use in a drench or drinking water monella spp., and bacterial pneumonia as follows: associated with Pasteurella spp., A. (i) Chickens—(A) Amount. 200 to 400 pleuropneumoniae, and Klebsiella spp. mg/gal, for 7 to 14 days. susceptible to chlortetracycline.

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(C) Limitations. Prepare fresh solution veterinarian; do not use for more than daily; use as the sole source of chlor- 5 days; do not administer within 24 tetracycline; do not use for more than hours of slaughter. 5 days; do not administer to swine (2) Amount. One 25 milligram tablet within 24 hours of slaughter. for each 5 pounds of body weight every (iv) Calves, beef cattle, and nonlac- 12 hours daily for 3 to 5 days. tating dairy cattle—(A) Amount. 10 mg/lb (i) Indications for use. Control and body weight daily in divided doses, for treatment of bacterial enteritis 3 to 5 days. (scours) caused by E. coli and Sal- (B) Indications for use. Control and monella spp. and bacterial pneumonia treatment of bacterial enteritis associated with Pasteurella spp., (scours) caused by Escherichia coli and Haemophilus spp., and Klebsiella spp., Salmonella spp., and bacterial pneu- susceptible to chlortetracycline. monia associated with Pasteurella spp., (ii) Limitations. Administer tablet di- Histophilus spp., and Klebsiella spp. sus- rectly by mouth or crush and dissolve ceptible to chlortetracycline. in water for drenching; if no improve- (C) Limitations. Prepare fresh solution ment is noted after 3 days of treat- daily; use as a drench; use as the sole ment, consult a veterinarian; do not source of chlortetracycline; do not use use for more than 5 days; when feeding for more than 5 days; do not administer milk or milk replacer, administration 1 to cattle within 24 hours of slaughter; hour before or 2 hours after feeding; do do not use in lactating dairy cattle; do not administer within 24 hours of not administer this product with milk slaughter. or milk replacers; administer 1 hour (3) Amount. One 500 milligram bolus before or 2 hours after feeding milk or per 100 pounds of body weight twice a milk replacers; a withdrawal period has day for 3 to 5 days. not been established in preruminating (i) Indications for use. Treatment of calves; do not use in calves to be proc- bacterial enteritis (scours) caused by E. essed for veal. coli and Salmonella spp., and bacterial [57 FR 37324, Aug. 18, 1992] pneumonia associated with Pasteurella EDITORIAL NOTE: For FEDERAL REGISTER ci- spp., Haemophilus spp., and Klebsiella tations affecting § 520.441, see the List of CFR spp., susceptible to chlortetracycline. Sections Affected, which appears in the (ii) Limitations. Administer directly Finding Aids section of the printed volume by mouth or crush and dissolve in and at www.fdsys.gov. water for drenching; if no improvement is noted after 3 days of treatment, con- § 520.443 Chlortetracycline tablets and boluses. sult a veterinarian; do not use for more than 5 days; do not administer within (a) Specifications. Each tablet/bolus 24 hours of slaughter. contains 25, 250, or 500 milligrams (mg) chlortetracycline hydrochloride. [57 FR 37325, Aug. 18, 1992, as amended at 67 (b) Sponsor. See Nos. 016592 and 054628 FR 78355, Dec. 24, 2002. Redesignated and in § 510.600(c) of this chapter. amended at 76 FR 49649, Aug. 11, 2011; 78 FR (c) Related tolerances. See § 556.150 of 21059, Apr. 9, 2013; 81 FR 17607, Mar. 30, 2016] this chapter. § 520.445 Chlortetracycline and (d) Conditions of use in calves—(1) sulfamethazine powder. Amount. One 250 milligram bolus per 50 pounds of body weight twice a day for (a) Specifications. Each pound of solu- 3 to 5 days. ble powder contains chlortetracycline (i) Indications for use. Treatment of bisulfate equivalent to 102.4 grams (g) bacterial enteritis (scours) caused by of chlortetracycline hydrochloride and Escherichia coli and bacterial pneu- sulfamethazine bisulfate equivalent to monia associated with Pasteurella spp., 102.4 g of sulfamethazine. Klesbsiella spp., and Haemophilus spp. (b) Sponsor. See No. 016592 in (ii) Limitations. Administer bolus di- § 510.600(c) of this chapter. rectly by mouth or crush and dissolve (c) Related tolerances. See §§ 556.150 in milk or water for drenching or buck- and 556.670 of this chapter. et feeding; if no improvement is noted (d) Conditions of use in swine. Admin- after 3 days of treatment, consult a ister in drinking water as follows:

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(1) Amount. 250 milligrams (mg) of B. fragilis, P. melaninogenicus, F. chlortetracycline and 250 mg of necrophorum, and C. perfringens, and os- sulfamethazine per gallon. teomyelitis due to susceptible strains (2) Indications for use. For the preven- of S. aureus, B. fragilis, P. tion and treatment of bacterial enter- melaninogenicus, F. necrophorum, and C. itis; as an aid in the reduction of the perfringens. incidence of cervical abscesses; and as (3) Limitations. Federal law restricts an aid in the maintenance of weight this drug to use by or on the order of a gains in the presence of bacterial en- licensed veterinarian. teritis and atrophic rhinitis. (3) Limitations. Use as the sole source [67 FR 54954, Aug. 27, 2002, as amended at 68 of chlortetracycline and sulfonamide. FR 55824, Sept. 29, 2003; 69 FR 32273, June 9, Not to be used for more than 28 con- 2004; 71 FR 39204, July 12, 2006; 73 FR 4077, Jan. 24, 2008; 78 FR 17596, Mar. 22, 2013; 79 FR secutive days. Withdraw 15 days before 28819, May 20, 2014; 80 FR 76386, Dec. 9, 2015; slaughter. 81 FR 17607, Mar. 30, 2016] [76 FR 49649, Aug. 11, 2011, as amended at 81 FR 17607, Mar. 30, 2016] § 520.447 Clindamycin solution. (a) Specifications. Each milliliter of § 520.446 Clindamycin capsules and solution contains the equivalent of 25 tablets. milligrams (mg) clindamycin as the (a) Specifications. (1) Each capsule hydrochloride salt. contains the equivalent of 25, 75, 150, or (b) Sponsors. See Nos. 051311, 054771, 300 milligrams (mg) clindamycin as the 058829, 061623, and 069043 in § 510.600(c) of hydrochloride salt. this chapter. (2) Each tablet contains the equiva- (c) Special considerations. Federal law lent of 25, 75, or 150 mg clindamycin as restricts this drug to use by or on the the hydrochloride salt. order of a licensed veterinarian. (3) Each capsule contains the equivalent of 25, 75, or 150 mg clindamycin as (d) Conditions of use—(1) Dogs—(i) the hydrochloride salt. Amount. Wounds, abscesses, and dental (b) Sponsors. See sponsors in infections: 2.5 to 15 mg per pound (/lb) § 510.600(c) of this chapter as follows: body weight every 12 hours for a max- (1) Nos. 054771 and 069043 for use of imum of 28 days. Osteomyelitis: 5.0 to capsules described in paragraph (a)(1) 15 mg/lb body weight every 12 hours for of this section. a minimum of 28 days. (2) No. 051311 for use of tablets de- (ii) Indications for use. For the treat- scribed in paragraph (a)(2) of this sec- ment of skin infections (wounds and tion. abscesses) due to susceptible strains of (3) No. 043806 for use of tablets de- coagulase-positive staphylococci scribed in paragraph (a)(3) of this sec- (Staphylococcus aureus or S. tion. intermedius), deep wounds and abscesses (c) Conditions of use in dogs—(1) due to susceptible strains of Bacteroides Amount. Wounds, abscesses, and dental fragilis, Prevotella melaninogenicus, infections: 2.5 to 15 mg per pound (/lb) Fusobacterium necrophorum, and Clos- body weight every 12 hours for a max- tridium perfringens; dental infections imum of 28 days. Osteomyelitis: 5.0 to due to susceptible strains of S. aureus, 15 mg/lb body weight every 12 hours for B. fragilis, P. melaninogenicus, F. a minimum of 28 days. necrophorum, and C. perfringens; and os- (2) Indications for use. For the treat- teomyelitis due to susceptible strains ment of skin infections (wounds and of S. aureus, B. fragilis, P. abscesses) due to susceptible strains of melaninogenicus, F. necrophorum, and C. coagulase-positive staphylococci perfringens. (Staphylococcus aureus or S. (2) Cats—(i) Amount. 5.0 to 15.0 mg/lb intermedius), deep wounds and abscesses body weight every 24 hours for a max- due to susceptible strains of Bacteroides imum of 14 days. fragilis, Prevotella melaninogenicus, (ii) Indications for use. For the treat- Fusobacterium necrophorum, and Clos- ment of skin infections (wounds and tridium perfringens, dental infections abscesses) due to susceptible strains of due to susceptible strains of S. aureus, Staphylococcus aureus, S. intermedius,

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Streptococcus spp.; deep wounds and ab- drug to use by or on the order of a li- scesses due to susceptible strains of censed veterinarian. Clostridium perfringens and Bacteroides (2) [Reserved] fragilis; and dental infections due to [63 FR 41419, Aug. 4, 1998] susceptible strains of S. aureus, S. intermedius, Streptococcus spp., C. § 520.455 Clomipramine tablets. perfringens, and B. fragilis. (a) Specifications. Each tablet con- [67 FR 54954, Aug. 27, 2002, as amended at 67 tains 5, 20, 40, or 80 milligrams (mg) FR 78684, Dec. 26, 2002; 68 FR 55824, Sept. 29, clomipramine hydrochloride. 2003; 69 FR 31734, June 7, 2004; 71 FR 39543, (b) Sponsor. See No. 058198 in July 13, 2006; 72 FR 19796, Apr. 20, 2007; 78 FR § 510.600(c) of this chapter. 17596, Mar. 22, 2013; 78 FR 30197, May 22, 2013; (c) Conditions of use—(1) Amount. 2 to 79 FR 28819, May 20, 2014; 81 FR 17607, Mar. 30, 4 milligrams of clomipramine hydro- 2016] chloride per kilogram (0.9 to 1.8 milligrams per pound) of body weight per § 520.452 Clenbuterol syrup. day, administered as a single daily dose (a) Specifications. Each milliliter con- or divided twice daily. tains 72.5 micrograms of clenbuterol (2) Indications for use. For use as part hydrochloride. of a comprehensive behavioral manage- (b) Sponsor. See 000010 in § 510.600(c) of ment program to treat separation anx- this chapter. iety in dogs greater than 6 months of (c) [Reserved] age. (d) Conditions of use—(1) Horses—(i) (3) Limitations. Federal law restricts Amount. Administer orally twice a day this drug to use by or on the order of a (b.i.d.). Initial dose is 0.5 milliliter per licensed veterinarian. 100 pounds body weight (0.8 micrograms [64 FR 1762, Jan. 12, 1999, as amended at 72 per kilogram) for 3 days (6 treatments). FR 262, Jan. 4, 2007] If no improvement, administer 1 milliliter per 100 pounds (1.6 micrograms per § 520.462 Clorsulon drench. kilogram) for 3 days (6 treatments). If (a) Specifications. The drug is a sus- no improvement, administer 1.5 milli- pension containing 8.5 percent liters per 100 pounds (2.4 micrograms clorsulon (85 milligrams per milliliter). per kilogram) for 3 days (6 treatments). (b) Sponsor. See No. 050604 in If no improvement, administer 2.0 mil- § 510.600(c) of this chapter. liliters per 100 pounds (3.2 micrograms (c) Conditions of use. Cattle—(1) per kilogram) for 3 days (6 treatments). Amount. One-quarter fluid ounce per 200 If no improvement, horse is non- pounds of body weight (7 milligrams responder to clenbuterol and treatment per kilogram or 3.2 milligrams per should be discontinued. pound of body weight). (ii) Indications for use. Indicated for (2) Indications for use. For the treat- the management of horses affected ment of immature and adult liver fluke with airway obstruction, such as oc- (Fasciola hepatica) infestations in cat- curs in chronic obstructive pulmonary tle. disease (COPD). (3) Limitations. Using dose syringe, (iii) Limitations. Treat at effective deposit drench over back of tongue. Do dose for 30 days. At the end of the 30- not treat cattle within 8 days of day treatment period, drug should be slaughter. Because a withdrawal time withdrawn. If signs return, the 30-day in milk has not been established, do treatment period may be repeated. If not use in female dairy cattle of breed- repeating treatment, the step-wise dosing age. Consult your veterinarian for age schedule should be repeated. The assistance in the diagnosis, treatment, effect of this drug on breeding stallions and control of parasitism. and brood mares has not been deter- [50 FR 10221, Mar. 14, 1985, as amended at 62 mined. Treatment starting with dos- FR 63270, Nov. 28, 1997] ages higher than the initial dose is not recommended. Federal law prohibits § 520.522 Cyclosporine. the extralabel use of this drug in food (a) Specifications. (1) Each animals. Federal law restricts this cyclosporine capsule, USP (MODIFIED)

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contains 10, 25, 50, or 100 milligrams after treatment with or exposure to (mg) cyclosporine. cholinesterase-inhibiting drugs, insec- (2) Each milliliter of cyclosporine ticides, pesticides, or chemicals. oral solution, USP (MODIFIED) con- (d) Conditions of use—(1) Amount. 15 tains 100 mg cyclosporine. milligrams cythioate per 10 pounds of (b) Sponsor. See No. 058198 in body weight every third day or twice a § 510.600(c) of this chapter. week. (c) [Reserved] (2) Indications for use. Dogs, for con- (d) Conditions of use—(1) Dogs. Use trol of fleas. capsules described in paragraph (a)(1) (3) Limitations. Federal law restricts of this section as follow: this drug to use by or on the order of a (i) Amount. Administer 5 mg per kilo- licensed veterinarian. gram (mg/kg) of body weight given orally as a single daily dose for 30 days. [49 FR 5614, Feb. 14, 1984, as amended at 67 Following this initial daily treatment FR 78355, Dec. 24, 2002; 79 FR 28819, May 20, 2014] period, the dosage may be tapered by decreasing the frequency of adminis- § 520.531 Cythioate tablets. tration to every other day or two times a week, until a minimum frequency is (a) Specifications. Each tablet con- reached which will maintain the de- tains 30 or 90 milligrams (mg) sired therapeutic effect. cythioate. (ii) Indications for use. For the control (b) Sponsors. See sponsor numbers in of atopic dermatitis in dogs weighing § 510.600(c) of this chapter as follows: at least 4 pounds. (1) No. 000859 for use of 30- and 90-mg (iii) Limitations. Federal law restricts tablets; this drug to use by or on the order of a (2) No. 054771 for use of the 30-mg tab- licensed veterinarian. let. (2) Cats. Use the solution described in (c) Conditions of use—(1) Amount. 30 paragraph (a)(2) of this section as fol- milligrams cythioate per 20 pounds of low: body weight every third day or twice a (i) Amount. Administer 7 mg/kg of week. body weight orally as a single daily (2) Indications for use. Dogs, for con- dose for a minimum of 4 to 6 weeks or trol of fleas. until resolution of clinical signs. Fol- (3) Limitations. Federal law restricts lowing this initial daily treatment pe- this drug to use by or on the order of a riod, the dosage may be tapered by de- licensed veterinarian. creasing the frequency of administra- [49 FR 5615, Feb. 14, 1984, as amended at 59 tion to every other day or twice weekly FR 26942, May 25, 1994; 67 FR 78355, Dec. 24, to maintain the desired therapeutic ef- 2002; 79 FR 28819, May 20, 2014] fect. (ii) Indications for use. For the control § 520.534 Decoquinate. of feline allergic dermatitis in cats at (a) Specifications. Each gram of pow- least 6 months of age and weighing at der contains 8 milligrams (0.8 percent) least 3 pounds. decoquinate. (iii) Limitations. Federal law restricts (b) Sponsor. See No. 054771 in this drug to use by or on the order of a § 510.600(c) of this chapter. licensed veterinarian. (c) Related tolerances. See § 556.170 of [68 FR 54804, Sept. 19, 2003, as amended at 76 this chapter. FR 78815, Dec. 20, 2011] (d) Conditions of use. Calves—(1) Amount. Feed 22.7 milligrams per 100 § 520.530 Cythioate oral liquid. pounds of body weight (0.5 milligram (a) Specifications. Each milliliter con- per kilogram) per day. tains 15 milligrams of cythioate. (2) Indications for use. For the preven- (b) Sponsor. See Nos. 000859 and 054771 tion of coccidiosis in ruminating and in § 510.600 of this chapter. nonruminating calves, including veal (c) Special considerations. Cythioate is calves, caused by Eimeria bovis and E. a cholinesterase inhibitor. Do not use zuernii. this product in animals simultaneously (3) Limitations. Feed in whole milk at with or within a few days before or the rate of 22.7 milligrams per 100

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pounds body weight daily (0.5 milli- administration for management or in- gram per kilogram) for at least 28 days. flammatory conditions such as acute [64 FR 10103, Mar. 2, 1999, as amended at 64 arthritic lameness, and for various FR 30386, June 8, 1999; 79 FR 28819, May 20, stress conditions where corticosteroids 2014] are required while the animal is being treated for a specific condition. § 520.538 Deracoxib. (3) Limitations. Federal law restricts (a) Specifications. Each tablet con- this drug to use by or on the order of a tains 12, 25, 50, 75, or 100 milligrams licensed veterinarian. A withdrawal pe- (mg) deracoxib. riod has not been established for this (b) Sponsor. See No. 058198 in product in preruminating calves. Do § 510.600(c) of this chapter. not use in calves to be processed for (c) [Reserved] veal. Do not use in horses intended for (d) Conditions of use in dogs—(1) human consumption. Amount. Administer orally as needed, as a single daily dose based on body [79 FR 28819, May 20, 2014] weight: (i) 1 to 2 mg/kilogram (kg) (0.45 to § 520.540b Dexamethasone tablets and 0.91 mg/pound (lb)), for use as in para- boluses. graph (d)(2)(i) of this section. (a)(1) Specifications. Each bolus is (ii) 1 to 2 mg/kg (0.45 to 0.91 mg/lb) for half-scored and contains 10 milligrams 3 days, for use as in paragraph (d)(2)(ii) of dexamethasone. of this section. (2) Sponsor. See No. 000061 in (iii) 3 to 4 mg/kg (1.4 to 1.8 mg/lb) for § 510.600(c) of this chapter. up to 7 days, for use as in paragraph (3) Conditions of use in cattle and (d)(2)(iii) of this section. horses—(i) Amount. Administer orally 5 (2) Indications for use. (i) For the control of pain and inflammation associ- to 10 milligrams on the first day, then ated with osteoarthritis. 5 milligrams per day as required. (ii) For the control of postoperative (ii) Indications for use. As supportive pain and inflammation associated with therapy following parenteral steroid dental surgery. administration for management or in- (iii) For the control of postoperative flammatory conditions such as acute pain and inflammation associated with arthritic lameness, and for various orthopedic surgery. stress conditions where corticosteroids (3) Limitations. Federal law restricts are required while the animal is being this drug to use by or on the order of a treated for a specific condition. licensed veterinarian. (iii) Limitations. Federal law restricts [67 FR 68760, Nov. 13, 2002, as amended at 68 this drug to use by or on the order of a FR 18882, Apr. 17, 2003; 72 FR 37437, July 10, licensed veterinarian. A withdrawal pe- 2007; 73 FR 33692, June 13, 2008; 77 FR 3928, riod has not been established for this Jan. 26, 2012] product in preruminating calves. Do not use in calves to be processed for § 520.540 Dexamethasone oral dosage forms. veal. Do not use in horses intended for human consumption. § 520.540a Dexamethasone powder. (b)(1) Specifications. Each tablet con- (a) Specifications. Each packet contains 0.25 milligram of dexamethasone. tains 10 milligrams (mg) of dexametha- (2) Sponsors. See Nos. 000061 and 061623 sone. in § 510.600(c) of this chapter. (b) Sponsor. See No. 000061 in (3) Conditions of use in dogs and cats— § 510.600(c) of this chapter. (i) Amount. Dogs: Administer orally 0.25 (c) Conditions of use in cattle and to 1.25 milligrams per day for up to 7 horses—(1) Amount. Administer 5 to 10 days. Cats: Administer orally 0.125 to mg per animal the first day then 5 mg 0.5 milligrams per day for up to 7 days. per day as required by drench or by (ii) Indications for use. As an anti-in- sprinkling on a small amount of feed. flammatory agent. (2) Indications for use. As supportive therapy following parenteral steroid

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(iii) Limitations. Federal law restricts (3) Limitations. Federal law restricts this drug to use by or on the order of a this drug to use by or on the order of a licensed veterinarian. licensed veterinarian. [40 FR 26273, June 23, 1975, as amended at 44 [44 FR 12993, Mar. 9, 1979, as amended at 50 FR 7130, Feb. 6, 1979; 50 FR 49372, Dec. 2, 1985; FR 41489, Oct. 11, 1985; 79 FR 28820, May 20, 52 FR 7832, Mar. 13, 1987; 55 FR 8461, Mar. 8, 2014] 1990; 66 FR 14073, Mar. 9, 2001; 68 FR 4914, Jan. 31, 2003; 70 FR 16934, Apr. 4, 2005; 79 FR 28819, § 520.580 Dichlorophene and toluene. May 20, 2014] (a) Specifications. Each capsule contains 50 milligrams (mg) of § 520.540c Dexamethasone chewable dichlorophene and 60 mg of toluene, or tablets. multiples thereof. (a) Specifications. Each half-scored (b) Sponsors. See sponsors in tablet contains 0.25 milligram of dexa- § 510.600(c) of this chapter for use as in methasone. paragraph (c) of this section: (b) Sponsor. See No. 054771 in (1) Nos. 017135, 023851, 051311, and § 510.600(c) of this chapter. 058670 for use only as a single dose. (c) Conditions of use in dogs—(1) (2) Nos. 000061 and 054771 for use in a Amount. Administer by free-choice single dose or divided-dosage regimen. (c) Required statement. Consult your feeding or crumbled over food 0.25 to veterinarian for assistance in the diag- 1.25 milligrams daily in single or two nosis, treatment, and control of para- divided doses until response is noted or sitism, and before administering to 7 days have elapsed. When response is weak or debilitated animals. attained, dosage should be gradually (d) Conditions of use—(1) Amount. Ad- reduced by 0.125 milligram per day minister as follows: until maintenance level is achieved. (i) Single dose: Administer 100 mg of (2) Indications for use. As supportive dicholorophene and 120 mg of toluene therapy in nonspecific dermatosis and per pound of body weight. inflammatory conditions. (ii) Divided dose: Administer 100 mg (3) Limitations. Federal law restricts of dichlorophene and 120 mg of toluene this drug to use by or on the order of a per 5 pounds of body weight (20 and 24 licensed veterinarian. mg per pound) daily for 6 days. (2) Indications for use. For the re- [44 FR 7130, Feb. 6, 1979, as amended at 56 FR moval of ascarids (Toxocara canis and 50653, Oct. 8, 1991; 60 FR 55659, Nov. 2, 1995; 79 Toxascaris leonina) and hookworms FR 28820, May 20, 2014] (Ancylostoma caninum and Uncinaria § 520.563 Dexamethasone chewable stenocephala); and as an aid in remov- tablets. ing tapeworms (Taenia pisiformis, Dipylidium caninum, and Echinococcus (a) Specifications. Diatrizoate granulosus) from dogs and cats. meglumine oral solution is a water (3) Limitations. Withhold solid foods soluble radiopaque medium containing and milk for at least 12 hours prior to 66 percent diatrizoate meglumine and medication and for 4 hours afterward. 10 percent diatrizoate sodium. Repeat treatment in 2 to 4 weeks in (b) Sponsor. See No. 054771 in animals subject to reinfection. § 510.600(c) of this chapter. [45 FR 10332, Feb. 15, 1980] (c) Conditions of use in dogs and cats— (1) Amount. Administer orally 0.5 to 1.0 EDITORIAL NOTE: For FEDERAL REGISTER ci- milliliter per pound of body weight by tations affecting § 520.580, see the List of CFR Sections Affected, which appears in the gavage or stomach tube. Administered Finding Aids section of the printed volume rectally 0.5 to 1.0 milliliter per pound and at www.fdsys.gov. of body weight diluted with 1 part of the drug to 5 parts of water. § 520.581 Dichlorophene tablets. (2) Indications for use. For radiog- (a) Specifications. Each tablet con- raphy of the gastrointestinal tract. tains 1 gram of dichlorophene. (b) Sponsor. See 023851 in § 510.600(c) of this chapter.

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(c) Required statement. Consult your few days before or after treatment with veterinarian for assistance in the diag- or exposure to cholinesterase inhib- nosis, treatment, and control of para- iting drugs, pesticides, or chemicals. sitism, and before administering to The preparation should be mixed thor- weak or debilitated animals. oughly with the feed on a clean, imper- (d) Conditions of use. Dogs—(1) vious surface. Do not allow swine ac- Amount. Single dose of 1 tablet (1 gram cess to feed other than that containing of dichlorophene) for each 10 pounds of the preparation until treatment is body weight. complete. Do not treat pigs with signs (2) Indications for use. It is used as an of scours until these signs subside or aid in the removal of tapeworms are alleviated by proper medication. (Taenia pisiformis and Dipylidium Resume normal feeding schedule after- caninum). wards. Swine may be retreated in 4 to (3) Limitations. Withhold solid foods and milk for at least 12 hours prior to 5 weeks. medication and for 4 hours afterward. (f) Conditions of use in dogs. (1) For removal of Toxocara canis and Toxascaris [45 FR 10333, Feb. 15, 1980] leonina (roundworms), Ancylostoma caninum and Uncinaria stenocephala § 520.600 Dichlorvos. (hookworms), and Trichuris vulpis (a) Chemical name. 2,2-Dichlorvinyl (whipworm) residing in the lumen of dimethyl phosphate. the gastrointestinal tract. (b) [Reserved] (2) The drug is in capsule form for di- (c) Sponsor. See No. 054628 in rect administration and in pellet form § 510.600(c) of this chapter. for administration in about one-third (d) Related tolerances. See § 556.180 of this chapter. of the regular canned dog food ration (e) Conditions of use in swine. (1) It is or in ground meat. Dogs may be treat- recommended for the removal and con- ed with any combination of capsules trol of sexually mature (adult), sexu- and/or pellets so that the animal re- ally immature and/or 4th stage larvae ceives a single dose equaling 12 to 15 of the whipworm (Trichuris suis), nod- milligrams of the active ingredient per ular worms (Oesophagostomum spp.), pound of body weight. One-half of the large round-worm (Ascaris suum), and single recommended dosage may be the mature thick stomach worm given, and the other half may be ad- (Ascarops strongylina) occurring in the ministered 8 to 24 hours later. This lumen of the gastrointestinal tract of split dosage schedule should be used in pigs, boars, and open or bred gilts and animals which are very old, heavily sows. parasitized, anemic, or otherwise de- (2) The preparation should be added bilitated. The drug should not be used to the indicated amount of feed as set in dogs weighing less than 2 pounds. forth in paragraph (e)(2) of this section (3) In some dogs, efficacy against and administered shortly after mixing, Trichurias vulpis (whipworm) may be er- as follows: ratic. Dogs that do not develop a negative stool for Trichuris vulpis ova 10 to Pounds of Pounds of mixed feed Number of 14 days following initial treatment feed to be to be admin- pigs to be Weight of ani- mixed with istered to treated per should be re-treated. If a negative stool mal in pounds each 0.08 each pig as 0.08 ounce ounce of a single of dichlorvos is not obtained in 10 to 14 days fol- dichlorvos treatment lowing re-treatment, alternate means of therapy should be considered. 20–30 ...... 4 0.33 12 31–40 ...... 5 0.56 9 (4) Do not use in dogs infected with 41–60 ...... 6 1.00 6 Dirofilaria immitis. 61–80 ...... 5 1.00 5 81–100 ...... 4 1.00 4 (5) Do not use with other Adult Gilts, anthelmintics, taeniacides, antifilarial Sows, and agents, muscle relaxants, or tranquil- Boars ...... 16 4.00 4 izers. (3) Do not use this product on ani- (6) The drug is a cholinesterase inhib- mals either simultaneously or within a itor. Not for use simultaneously or

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within a few days before or after treat- exposure to cholinesterase inhibiting ment with or exposure to cholin- drugs, pesticides or chemicals. esterase-inhibiting drugs, pesticides, or (5) Do not use in animals other than chemicals. horses, ponies, and mules. Do not use (7) Federal law restricts this drug to in horses, ponies, and mules intended use by or on the order of a licensed vet- for food purposes. Do not allow fowl ac- erinarian. cess to feed containing this preparation (g) Conditions of use in horses when ad- or to fecal excrement from treated ani- ministered in grain. (1) It is rec- mals. ommended for the removal and control (h) Conditions of use in horses when of bots (Gastrophilus intestinalis, G. na- administered orally by syringe. (1) It is salis), large strongyles (Strongylus recommended for the removal and con- vulgaris, S. equinus, S. edentatus), small trol of first, second, and third instar strongyles (of the genera bots (Gastrophilus intestinalis and G. na- Cyathostomum, Cylicocercus, salis), sexually mature and sexually im- Cylicocyclus, Cylicodontophorus, mature (4th stage) ascarids (Parascaris Triodontophorus, Poteriostomum, equorum) in horses and foals. Gyalocephalus), pinworms (Oxyuris (2) The product is in the form of a gel equi), and large roundworm (Parascaris which is administered directly from a equorum) in horses including ponies and syringe onto the horse’s tongue. The mules. Not for use in foals (sucklings product is administered at a dosage and young weanlings). level of 20 milligrams of dichlorvos per kilogram of body weight for the re- (2) For a satisfactory diagnosis, a mi- moval of bots and ascarids. The same croscopic fecal examination should be dosage level is repeated every 21 to 28 performed by a veterinarian or a diag- days for the control of bots and nostic laboratory prior to worming. ascarids. For the control of bots only, (3) It is administered in the grain the repeat dosage is 10 milligrams per portion of the ration at a dosage of 14.2 kilogram of body weight every 21 to 28 milligrams to 18.5 milligrams per days during bot fly season. pound of body weight as a single dose. (3) Do not use this product in animals It may be administered at one-half of simultaneously or within a few days the single recommended dosage and re- before or after treatment with or expo- peated 8 to 12 hours later in the treat- sure to cholinesterase-inhibiting drugs, ment of very aged, emaciated or debili- pesticides or chemicals. Do not admin- tated subjects or those reluctant to ister in conjunction with or within 1 consume medicated feed. In suspected week of administration of muscle-re- cases of severe ascarid infection suffi- laxant drugs, phenothiazine derived cient to cause concern over mechanical tranquilizers, or central nervous sys- blockage of the intestinal tract, the tem depressants. split dosage should be utilized. (4) Do not use in horses which are (4) Do not use in horses which are se- severly debilitated or suffering from di- verely debilitated, suffering from diar- arrhea or severe constipation, infec- rhea or severe constipation, infectious tious disease, toxemia, or colic. Do not disease, toxemia or colic. Do not ad- administer to horses affected with minister in conjunction with or within chronic alveolar emphysema (heaves) 1 week of administration of muscle re- or other respiratory conditions. laxant drugs, phenothiazine derived (5) Do not use in horses intended for tranquilizers or central nervous system food purposes. depressant drugs. Horses should not be (6) Federal law restricts this drug to subjected to insecticide treatment for 5 use by or on the order of a licensed vet- days prior to or after treating with the erinarian. drug. Do not administer to horses af- (i) Conditions of use in dogs, cats, pup- flicted with chronic alveolar emphy- pies, and kittens. (1) Each tablet con- sema (heaves) or related respiratory tains 2, 5, 10, or 20 milligrams of conditions. The product is a cholin- dichlorvos. esterase inhibitor and should not be (2) It is administered orally at 5 mil- used simultaneously or within a few ligrams of dichlorvos per pound of body days before or after treatment with or weight.

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(3) Dogs and puppies: Removal and (b) Sponsor. See No. 054771 in § 510.600 control of intestinal roundworms (c) of this chapter. (Toxocara canis and Toxascaris leonina) (c) Conditions of use in dogs—(1) and hookworms (Ancylostoma caninum Amount. Administer orally 5 to 10 milli- and Uncinaria stenocephala). grams per pound of body weight, three (4) Cats and kittens: Removal and times daily. In severe cases, up to 25 control of intestinal roundworms milligrams per pound of body weight (Toxocara cati and Toxascaris leonina) three times daily. and hookworms (Ancylostoma (2) Indications for use. For the treat- tubaeforme and Uncinaria stenocephala). ment of pyoderma (pyogenic derma- (5) Dichlorvos is a cholinesterase in- titis) due to penicillinase-producing hibitor. Do not use simultaneously staphylococci sensitive to with or within a few days before or dicloxacillin. after treatment with or exposure to (3) Limitations. Federal law restricts cholinesterase-inhibiting drugs, pes- this drug to use by or on the order of a ticides, or chemicals. (6) Do not use in animals under 10 licensed veterinarian. days of age or 1 pound of body weight. [57 FR 37325, Aug. 18, 1992, as amended at 79 (7) Do not administer to animals FR 28820, May 20, 2014] showing signs of constipation, mechanical blockage of the intestinal tract, § 520.620 Diethylcarbamazine oral dos- impaired liver function, or recently ex- age forms. posed to or showing signs of infectious disease. § 520.622 Diethylcarbamazine citrate (8) Do not use in dogs or puppies in- oral dosage forms. fected with Dirofilaria immitis. (9) Federal law restricts this drug to § 520.622a Diethylcarbamazine citrate tablets. use by or on the order of a licensed veterinarian. (a) Sponsors. (1) [Reserved] (2) See 054771 in § 510.600(c) of this [40 FR 13838, Mar. 27, 1975, as amended at 48 FR 40704, Sept. 9, 1983; 51 FR 28546, Aug. 8, chapter for use of 100, 200, and 300 milli- 1986; 62 FR 35076, June 30, 1997; 64 FR 18571, gram tablets for prevention of heart- Apr. 15, 1999; 78 FR 21059, Apr. 9, 2013] worm disease in dogs and as an aid in the treatment of ascarid infections in § 520.606 Diclazuril. dogs. (a) Specifications. Each 100 grams (g) (3) See 061623 in § 510.600(c) of this of pellets contain 1.56 g diclazuril. chapter for use of 50, 100, 200, 300, or 400 (b) Sponsor. See No. 000061 in milligram tablets for prevention of § 510.600(c) of this chapter. heartworm disease in dogs, as an aid in (c) Conditions of use in horses—(1) the control of ascarid infections in Amount. Administer 1 milligram (mg) dogs, and as an aid in the treatment of per kilogram (0.45 mg per pound) of ascarid infections in dogs and cats. body weight in the daily grain ration (4) [Reserved] for 28 days. (5) See No. 000061 in § 510.600(c) of this (2) Indications for use. For the treat- chapter for use of 60, 120, or 180 milli- ment of equine protozoal gram tablets for prevention of heart- myeloencephalitis (EPM) caused by worm disease in dogs, as an aid in the Sarcocystis neurona. control of ascarid infections in dogs, (3) Limitations. Do not use in horses and as an aid in the treatment of asca- intended for human consumption. Fed- rid infections in dogs and cats. eral law restricts this drug to use by or (6) See No. 054628 in § 510.600(c) of this on the order of a licensed veterinarian. chapter for use of 50, 100, 200, 300, or 400 [72 FR 20943, Apr. 27, 2007] milligram tablets for prevention of heartworm disease in dogs, as an aid in § 520.608 Dicloxacillin. the control of ascarid infections in (a) Specifications. Each capsule con- dogs, and as an aid in the treatment of tains dicloxacillin sodium ascarid infections in dogs and cats. monohydrate equivalent to 50, 100, 200, (b) Conditions of use—(1) Dosage/indi- or 500 milligrams of dicloxacillin. cations for use. (i) Three milligrams per

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pound of body weight daily for preven- microfilaricidal drugs before adminis- tion of heartworm disease (Dirofilaria tration of this drug. immitis) in dogs. (iv) Federal law restricts this drug to (ii) Three milligrams per pound of use by or on the order of a licensed vet- body weight daily as an aid in the con- erinarian. trol of ascarid infections (Toxocara (b) [Reserved] canis) in dogs. (c)(1) Specifications. Each milliliter of (iii) Twenty-five to 50 milligrams per syrup contains 60 milligrams of pound of body weight as an aid in the diethylcarbamazine citrate. treatment of ascarid infections in dogs (2) Sponsor. See No. 054628 in (Toxocara canis) and cats (Toxocara § 510.600(c) of this chapter. canis and Toxascaris leonina). (3) Conditions of use. (i) The drug is (2) Limitations. Federal law restricts used in dogs between 4 weeks and 8 this drug to use by or on the order of a months of age for the removal of licensed veterinarian. ascarids (Toxacara canis) and in animals over 4 weeks of age for the pre- [46 FR 23230, Apr. 24, 1981, as amended at 46 vention of heartworm disease FR 41038, Aug. 14, 1981; 46 FR 46315, Sept. 18, 1981; 46 FR 61653, Dec. 18, 1981; 47 FR 10805, (Dirofilaria immitis). Mar. 12, 1982; 47 FR 14150, Apr. 2, 1982; 50 FR (ii) The drug is administered (a) for 41489, Oct. 11, 1985; 50 FR 49372, Dec. 2, 1985; removal of ascarids at a dosage of 50 53 FR 40056, Oct. 13, 1988; 53 FR 40727, Oct. 18, milligrams per pound of body weight 1988; 55 FR 8461, Mar. 8, 1990; 61 FR 34728, divided into two equal doses and ad- July 3, 1996; 62 FR 35076, June 30, 1997; 66 FR ministered 8 to 12 hours apart (morning 14073, Mar. 9, 2001; 68 FR 4914, Jan. 31, 2003; 76 and night), orally or mixed with either FR 17777, Mar. 31, 2011; 77 FR 4896, Feb. 1, dry or wet food, and (b) for prevention 2012; 78 FR 21059, Apr. 7, 2013; 79 FR 28820, May 20, 2014] of heartworm disease at a dosage of 3 milligrams per pound of body weight § 520.622b Diethylcarbamazine citrate daily, orally or in food, in heartworm syrup. endemic areas, from the beginning of mosquito activity, during the mosquito (a)(1) Specifications. Each milliliter of season, and for 2 months following the syrup contains 60 milligrams of end thereof. diethylcarbamazine citrate. (iii) Dogs older than 8 months of age (2) Sponsor. See No. 054771 in may be infected with Dirofilaria immitis. § 510.600(c) of this chapter. Use of the drug is contraindicated in (3) Conditions of use. (i) The drug is dogs with active D. immitis infections. indicated for use in dogs for the pre- (iv) Federal law restricts this drug to vention of infection with Dirofilaria use by or on the order of a licensed vet- immitis and T. canis and T. leonina. It is erinarian. also indicated for treatment of ascarid infections of T. canis and T. leonina in [40 FR 13838, Mar. 27, 1975, as amended at 41 dogs and T. cati in cats. FR 28265, July 9, 1976; 44 FR 3967, Jan. 19, (ii) For prevention of heartworm and 1979; 47 FR 14150, Apr. 2, 1982; 47 FR 35186, Aug. 13, 1982; 49 FR 33997, Aug. 28, 1984; 50 FR ascarid infections in dogs, the drug 41489, Oct. 11, 1985; 53 FR 47027, Oct. 18, 1988; may be added to the daily diet at a dos- 61 FR 34728, July 3, 1996; 62 FR 35076, June 30, age rate of 3.0 milligrams per pound of 1997; 62 FR 38906, July 21, 1997; 77 FR 4897, body weight per day or given directly Feb. 1, 2012; 78 FR 21059, Apr. 9, 2013; 79 FR by mouth at the same dosage rate. For 28820, May 20, 2014] treatment of ascarid infections in dogs and cats, the drug is administered at a § 520.622c Diethylcarbamazine citrate dosage level of 25 to 50 milligrams per chewable tablets. pound of body weight preferably ad- (a) Specifications. Each chewable tab- ministered immediately after feeding. let contains 30, 45, 60, 120, 150, or 180 (iii) Older dogs should be proven neg- milligrams of diethylcarbamazine cit- ative for the presence of Dirofilaria rate. immitis infection before administration (b) Sponsors. See drug listing nos. in of the drug. Those with proven infec- § 510.600(c) of this chapter for identi- tion of Dirofilaria immitis should be ren- fication of sponsors as follows: dered negative using adulticidal and (1) [Reserved]

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(2) For 054771, use of 60, 120, or 180 gram of body weight (3 milligrams per milligram tablets as in paragraph pound of body weight) and 5.0 milli- (c)(2)(ii) of this section. grams of oxibendazole per kilogram of (3) For 061690, use of 45 or 150 milli- body weight (2.27 milligrams per pound gram tablets as in paragraph (c)(2)(iii) of body weight). of this section. (2) Indications for use. For prevention (4) For 061133, use of 60-, 120-, or 180- of infection with Dirofilaria immitis milligram tablets as in paragraph (heartworm disease) and Ancylostoma (c)(2)(i) of this section. caninum (hookworm infection) and for (5) For 000061, use of 60-milligram removal and control of Trichuris vulpis tablets as in paragraph (c)(2)(i) of this (whipworm infection) and mature and section. immature stages of intestinal Toxocara (6) For 054628, use of 30, 60, 120, or 180 canis (ascarid infection). milligram tablets as in paragraph (3) Limitations. Federal law restricts (c)(2)(i) of this section. this drug to use by or on the order of a (c) Conditions of use—(1) Amount. 3 licensed veterinarian. milligrams per pound of body weight [50 FR 28768, July 16, 1985, as amended at 53 per day for prevention of heartworm FR 45759, Nov. 14, 1988; 54 FR 3776, Jan. 26, disease and control of ascarids; 25 to 50 1989; 54 FR 6804, Feb. 14, 1989; 56 FR 50653, milligrams per pound of body weight as Oct. 8, 1991; 60 FR 55659, Nov. 2, 1995; 79 FR an aid in treatment of ascarid infec- 28820, May 20, 2014] tions. (2) Indications for use. (i) For preven- § 520.645 Difloxacin. tion of heartworm disease (Dirofilaria (a) Specifications. Each tablet con- immitis) in dogs; as an aid in control of tains 11.4, 45.4, or 136 milligrams (mg) ascarids (Toxocara canis) in dogs; as an of difloxacin hydrochloride. aid in treatment of ascarid (Toxocara (b) Sponsor. See No. 000010 in canis and Toxascaris leonina) infections § 510.600(c) of this chapter. in dogs and cats. (c) [Reserved] (ii) For prevention of infection with (d) Conditions of use—(i) Amount. Ad- Dirofilaria immitis (heartworm disease) minister 5 to 10 mg per kilogram (2.3 to in dogs; as an aid in treatment of asca- 4.6 mg per pound) of body weight orally rid (Toxocara canis and Toxascaris once a day for 2 to 3 days beyond ces- leonina) infections in dogs. sation of clinical signs of disease up to (iii) For prevention of heartworm dis- a maximum of 30 days. ease (Dirofilaria immitis) in dogs. (ii) Indications for use. For manage- (3) Limitations. Federal law restricts ment of diseases in dogs associated this drug to use by or on the order of a with bacteria susceptible to difloxacin. licensed veterinarian. (iii) Limitations. Federal law prohibits the extra-label use of this drug in food- [43 FR 6941, Feb. 17, 1978] producing animals. Federal law re- EDITORIAL NOTE: For FEDERAL REGISTER ci- stricts this drug to use by or on the tations affecting § 520.622c, see the List of order of a licensed veterinarian. CFR Sections Affected, which appears in the (2) [Reserved] Finding Aids section of the printed volume and at www.fdsys.gov. [63 FR 8123, Feb. 18, 1998, as amended at 75 FR 10165, Mar. 5, 2010] § 520.623 Diethylcarbamazine and oxibendazole chewable tablets. § 520.666 Dirlotapide. (a) Specifications. Each tablet con- (a) Specifications. Each milliliter tains either 60, 120, or 180 milligrams of (mL) of solution contains 5 milligrams diethylcarbamazine citrate with 45, 91, (mg) dirlotapide. or 136 milligrams of oxibendazole, re- (b) Sponsor. See No. 054771 in spectively. § 510.600(c) of this chapter. (b) Sponsor. See No. 054771 in (c) Conditions of use in dogs—(1) § 510.600(c) of this chapter. Amount. The initial dosage is 0.01 mL/ (c) Conditions of use in dogs—(1) kg (0.0045 mL/lb) body weight for the Amount. Administer orally to dogs at a first 14 days. After the first 14 days of dosage level of 6.6 milligrams of treatment, the dose volume is doubled diethylcarbamazine citrate per kilo- to 0.02 mL/kg (0.009 mL/lb) body weight

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for the next 14 days (days 15 to 28 of (i) For large roundworms (Toxocara treatment). Dogs should be weighed canis, Toxascaris leonina): 10 mg per monthly and the dose volume adjusted pound (/lb) of body weight for 3 to 5 every month, as necessary, to maintain days; a target percent weight loss until the (ii) For hookworms (Ancylostoma desired weight is achieved. caninum, Uncinaria stenocephala) and (2) Indications for use. For the man- whipworms (Trichuris vulpis): 10 mg/lb agement of obesity. of body weight for 7 days; (3) Limitations. Federal law restricts (iii) For Strongyloides (Strongyloides this drug to use by or on the order of a canis, Strongyloides stercoralis): 10 mg/lb licensed veterinarian. of body weight for 10 to 12 days; (iv) For heartworm microfilariae [72 FR 263, Jan. 4, 2007, as amended at 79 FR (Dirofilaria immitus): 3 to 5 mg/lb of 28820, May 20, 2014] body weight for 7 to 10 days. Treatment § 520.763 Dithiazanine oral dosage for heartworm microfilariae should fol- forms. low 6 weeks after therapy for adult worms. § 520.763a Dithiazanine tablets. (2) Limitations. Federal law restricts this drug to use by or on the order of a (a) Specifications. Each tablet con- licensed veterinarian. tains 10, 50, 100, or 200 milligrams (mg) dithiazanine iodide. [79 FR 28820, May 20, 2014] (b) Sponsor. See No. 054628 in § 510.600(c) of this chapter. § 520.763c Dithiazanine iodide and pi- (c) Conditions of use in dogs—(1) Indi- perazine citrate suspension. cations for use and amount. Administer (a) Specifications. Each milliliter of orally immediately after feeding as fol- suspension contains 69 milligrams (mg) lows: dithiazanine iodide and 83 mg piper- (i) For large roundworms (Toxocara azine base (as piperazine citrate). canis, Toxascaris leonina): 10 mg per (b) Sponsor. See No. 054628 in pound (/lb) of body weight for 3 to 5 § 510.600(c) of this chapter. days; (c) Conditions of use in horses—(1) (ii) For hookworms (Ancylostoma Amount. 1 ounce (30 milliliters) per 100 caninum, Uncinaria stenocephala) and pounds of body weight for the first 500 3 whipworms (Trichuris vulpis): 10 mg/lb pounds; ⁄4 ounce for each 100 pounds 1 of body weight for 7 days; thereafter, up to 1,200 pounds; 10 ⁄4 (iii) For Strongyloides (Strongyloides ounces to animals over 1,200 pounds. canis, Strongyloides stercoralis): 10 mg/lb (2) Indications for use. For control of of body weight for 10 to 12 days; large roundworms, Parascaris equorum; small strongyles; large strongyles, (iv) For heartworm microfilariae Strongylus vulgaris; and pinworms, (Dirofilaria immitus): 3 to 5 mg/lb of body weight for 7 to 10 days. Treatment Oxyuris equi. (3) Limitations. Administer by drench for heartworm microfilariae should fol- or mixed with the daily ration as a sin- low 6 weeks after therapy for adult gle dose. Treatment is recommended in worms. spring and fall. In a heavily infested (2) Limitations. Federal law restricts environment, treatment may be re- this drug to use by or on the order of a peated every 30 days. Not for use in licensed veterinarian. horses intended for food purposes. Se- [79 FR 28820, May 20, 2014] verely debilitated animals should not be wormed except on the advice of a § 520.763b Dithiazanine powder. veterinarian. If the drug is for adminis- (a) Specifications. Each tablespoon of tration by stomach tube, it shall be la- powder contains 200 milligrams (mg) beled: ‘‘Federal law restricts this drug dithiazanine iodide. to use by or on the order of a licensed (b) Sponsor. See No. 000010 in veterinarian.’’ § 510.600(c) of this chapter. [47 FR 52696, Nov. 23, 1982, as amended at 48 (c) Conditions of use in dogs—(1) Indi- FR 32342, July 15, 1983; 53 FR 40727, Oct. 18, cations for use and amount. Administer 1988; 62 FR 35076, June 30, 1997; 78 FR 21059, orally by mixing in food as follows: Apr. 9, 2013; 79 FR 28820, May 20, 2014]

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§ 520.766 Domperidone. of enalapril maleate per kilogram of body weight per day. (a) Specifications. Each milliliter of (2) For the treat- gel contains 110 milligrams (mg) Indications for use. ment of mild, moderate, and severe domperidone. (modified New York Heart Association (b) Sponsor. See No. 043264 in § 510.600 Class II, III, IV) heart failure in dogs. of this chapter. (3) Limitations. Federal law restricts (c) Conditions of use in horses—(1) this drug to use by or on the order of a Amount. Administer 0.5 mg per pound licensed veterinarian. (mg/lb) (1.1 mg/kilogram (kg)) by mouth once daily starting 10 to 15 days [79 FR 28821, May 20, 2014, as amended at 80 prior to the expected foaling date. FR 34278, June 16, 2015] Treatment may be continued for up to 5 days after foaling if mares are not § 520.812 Enrofloxacin. producing adequate milk. (a) Specifications. Each tablet con- (2) Indications for use. For prevention tains: of fescue toxicosis in periparturient (1) 22.7, 68.0, or 136.0 milligrams (mg) mares. enrofloxacin; or (3) Limitations. Do not use in horses (2) 22.7, 68.0, 136.0, or 272 mg intended for human consumption. Fed- enrofloxacin. eral law restricts this drug to use by or (b) Sponsors. See sponsor numbers in on the order of a licensed veterinarian. § 510.600(c) of this chapter for use as in [75 FR 67031, Nov. 1, 2010] paragraph (c) of this section. (1) Nos. 000859 and 026637 for use of § 520.784 Doxylamine. product described in paragraph (a)(1) of (a) Specifications. The drug is in tab- this section. let form and contains doxylamine suc- (2) No. 058198 for use of product de- cinate as the active drug ingredient. scribed in paragraph (a)(2) of this sec- (b) Sponsor. See No. 000061 in tion. § 510.600(c) of this chapter. (c) Conditions of use in dogs and cats— (c) Conditions of use—(1) Amount. (1) Amount. Administer orally as a sin- Horses: Administer orally 1 to 2 milli- gle, daily dose or divided into two grams (mg) per pound (/lb) of body equal doses at 12-hour intervals. weight per day divided into 3 or 4 equal (i) Dogs. 5 to 20 mg per kilogram (/kg) doses. Dogs and cats: Administer orally (2.27 to 9.07 mg per pound (/lb)) of body 2 to 3 mg/lb of body weight per day di- weight. vided into 3 or 4 equal doses. (ii) Cats. 5 mg/kg (2.27 mg/lb) of body (2) Indications for use. For use when weight. antihistaminic therapy may be ex- (2) Indications for use. For the man- pected to alleviate some signs of dis- agement of diseases associated with ease in horses, dogs, and cats. bacteria susceptible to enrofloxacin. (3) Limitations. Do not use in horses (3) Limitations. Federal law restricts intended for human consumption. Fed- this drug to use by or on the order of a eral law restricts this drug to use by or licensed veterinarian. Federal law pro- on the order of a licensed veterinarian. hibits the extralabel use of this drug in food-producing animals. [40 FR 13838, Mar. 27, 1975, as amended at 42 FR 60140, Nov. 25, 1977; 46 FR 48642, Oct. 2, [78 FR 30197, May 22, 2013, as amended at 78 1981; 61 FR 8873, Mar. 6, 1996; 62 FR 61624, FR 52853, Aug. 27, 2013] Nov. 19, 1997; 79 FR 28821, May 20, 2014] § 520.816 Epsiprantel. § 520.804 Enalapril. (a) Specifications. Each tablet con- (a) Specifications. Each tablet contains either 12.5, 25, 50, or 100 milli- tains 1.0, 2.5, 5.0, 10, or 20 milligrams grams of epsiprantel. (mg) of enalapril maleate. (b) Sponsor. See No. 050604 in (b) Sponsor. See No. 050604 in § 510.600(c) of this chapter. § 510.600(c) of this chapter. (c) Conditions of use—(1) Dogs—(i) (c) Conditions of use in dogs—(1) Amount. 2.5 milligrams per pound of Amount. Administer orally 0.5 to 1.0 mg body weight.

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(ii) Indications for use. Removal of ca- (3) Growing turkeys—(i) Amount. 0.500 nine cestodes Dipylidium caninum and gram per gallon. Taenia pisiformis. (ii) Indications for use. As an aid in (2) Cats—(i) Amount. 1.25 milligrams the control of blue comb (nonspecific per pound of body weight. infectious enteritis) caused by orga- (ii) Indications for use. Removal of fe- nisms susceptible to erythromycin. line cestodes D. caninum and T. (iii) Limitations. Administer for 7 taeniaeformis. days; do not use in turkeys producing (3) Limitations. Federal law restricts eggs for human consumption; to assure this drug to use by or on the order of a effectiveness, treated birds must con- licensed veterinarian. sume enough medicated water to pro- [54 FR 50615, Dec. 8, 1989, as amended at 56 vide a therapeutic dosage; solutions FR 50653, Oct. 8, 1991; 60 FR 55659, Nov. 2, older than 3 days should not be used; 1995; 79 FR 28821, May 20, 2014] withdraw 1 day before slaughter. § 520.823 Erythromycin. [40 FR 13838, Mar. 27, 1975, as amended at 45 (a) Specifications. Each gram of pow- FR 56798, Aug. 26, 1980; 66 FR 14073, Mar. 9, der contains erythromycin phosphate 2001; 68 FR 4914, Jan. 31, 2003; 79 FR 28821, equivalent to 0.89 gram of erythro- May 20, 2014; 81 FR 17607, Mar. 30, 2016] mycin master standard. (b) Sponsor. See No. 061623 in § 520.852 Estriol. § 510.600(c) of this chapter. (a) Specifications. Each tablet con- (c) Related tolerances. See § 556.230 of tains 1 milligram (mg) estriol. this chapter. (b) Sponsor. See No. 000061 in (d) Conditions of use. It is used in § 510.600(c) of this chapter. drinking water as follows: (c) Conditions of use in dogs—(1) (1) Broiler and replacement chickens— Amount. Administer at an initial dose (i) Amount. 0.500 gram per gallon. of 2 mg per dog per day. The dosage (ii) Indications for use. As an aid in the control of chronic respiratory dis- may be titrated to as low as 0.5 mg per ease due to Mycoplasma gallisepticum dog every second day, depending on re- susceptible to erythromycin. sponse. (iii) Limitations. Administer for 5 (2) Indications for use. For the control days; do not use in replacement pullets of estrogen-responsive urinary inconti- over 16 weeks of age; do not use in nence in ovariohysterectomized female chickens producing eggs for human dogs. consumption; to assure effectiveness, (3) Limitations. Federal law restricts treated birds must consume enough this drug to use by or on the order of a medicated water to provide a thera- licensed veterinarian. peutic dosage; solutions older than 3 days should not be used; withdraw 1 [76 FR 78150, Dec. 16, 2011] day before slaughter. (2) Replacement chickens and chicken § 520.863 Ethylisobutrazine. breeders—(i) Amount. 0.500 gram per gal- (a) Specifications. Each tablet con- lon. tains either 10 milligrams or 50 milli- (ii) Indications for use. As an aid in grams of ethylisobutrazine hydro- the control of infectious coryza due to chloride. Haemophilus gallinarum susceptible to (b) Sponsor. See No. 000061 in erythromycin. § 510.600(c) of this chapter. (iii) Limitations. Administer for 7 (c) Conditions of use in dogs—(1) days; do not use in replacement pullets Amount. Administer orally 2 to 5 milli- over 16 weeks of age; do not use in grams per pound of body weight once chickens producing eggs for human daily. consumption; to assure effectiveness, treated birds must consume enough (2) Indications for use. As a tranquil- medicated water to provide a thera- izer. peutic dosage; solutions older than 3 days should not be used; withdraw 1 day before slaughter.

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(3) Limitations. Federal law restricts the diagnosis, treatment, and control this drug to use by or on the order of a of parasitism. licensed veterinarian. [79 FR 28821, May 20, 2014] [40 FR 13838, Mar. 27, 1975, as amended at 46 FR 48642, Oct. 2, 1981; 61 FR 8873, Mar. 6, 1996; § 520.903b Febantel suspension. 62 FR 61624, Nov. 19, 1997; 79 FR 28821, May 20, (a) Specifications. Each ounce of sus- 2014] pension contains 2.75 grams (9.3 percent ounce) febantel. § 520.870 Etodolac. (b) Sponsor. See No. 000859 in (a) Specifications. Each tablet con- § 510.600(c) of this chapter. tains 150, 300, or 500 milligrams (mg) of (c) Conditions of use in horses—(1) etodolac. Amount. 3 milliliters per 100 pounds (b) Sponsor. See No. 000010 in body weight or 1 fluid ounce per 1000 § 510.600(c) of this chapter. pounds (6 milligrams per kilogram (c) Conditions of use in dogs—(1) body weight). Administer by stomach Amount. Administer 10 to 15 mg per tube or drench, or by mixing well into kilogram (4.5 to 6.8 mg per pound) of a portion of the normal grain ration. body weight per day orally. For animals maintained on premises (2) Indications for use. For the man- where reinfection is likely to occur, re- agement of pain and inflammation as- treatment may be necessary. For most sociated with osteoarthritis. effective results, retreat in 6 to 8 (3) Limitations. Federal law restricts weeks. this drug to use by or on the order of a (2) Indications for use. For removal of licensed veterinarian. ascarids (Parascaris equorum—adult and sexually immature), pinworms (Oxyuris [63 FR 51300, Sept. 25, 1998, as amended at 68 equi—adult and 4th stage larvae), large FR 51705, Aug. 28, 2003; 75 FR 10166, Mar. 5, strongyles (Strongylus vulgaris, S. 2010; 79 FR 28821, May 20, 2014] edentatus, S. equinus), and various small strongyles in horses, breeding § 520.903 Febantel oral dosage forms. stallions and mares, pregnant mares, § 520.903a Febantel paste. foals, and ponies. (3) Limitations. Do not use in horses (a) Specifications. Each gram of paste intended for human consumption. Fed- contains 455 milligrams (45.5 percent) eral law restricts this drug to use by or febantel. on the order of a licensed veterinarian. (b) Sponsor. See No. 000859 in (d) Special considerations. Febantel § 510.600(c) of this chapter. suspension may be used in combination (c) Conditions of use in horses—(1) with trichlorfon oral liquid in accord- Amount. Administer paste orally at 6 ance with the provisions of § 520.2520c, milligrams per kilogram (2.73 milli- this section, and the following condi- grams per pound) of body weight on the tions: base of the tongue or well mixed into a (1) Combine 1 part febantel suspen- portion of the normal grain ration. For sion with 5 parts trichlorfon liquid. animals maintained on premises where (2) Allow animal to consume a por- reinfection is likely to occur, retreat- tion of daily grain ration; administer ment may be necessary. For most ef- mixture by stomach tube at rate of 18 fective results, retreat in 6 to 8 weeks. milliliters per 100 pounds of body (2) Indications for use. For removal of weight. large strongyles (Strongylus vulgaris, S. [45 FR 8587, Feb. 8, 1980, as amended at 79 FR edentatus, S. equinus); ascarids 28821, May 20, 2014] (Parascaris equorum—sexually mature and immature); pinworms (Oxyuris § 520.903c [Reserved] equi—adult and 4th stage larva); and various small strongyles in horses, § 520.903d Febantel and praziquantel foals, and ponies. paste. (3) Limitations. Do not use in horses (a) Specifications. Each gram of paste intended for human consumption. Con- contains 34 milligrams of febantel and sult your veterinarian for assistance in 3.4 milligrams of praziquantel.

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(b) Sponsor. See No. 000859 in (ii) For removal of hookworms § 510.600(c) of this chapter. (Ancylostoma tubaeforme) and ascarids (c) Conditions of use—(1) Amount—(i) (Toxocara cati) in cats and kittens. Dogs and cats (over 6 months of age): 10 (3) Limitations. Federal law restricts milligrams of febantel and 1 milligram this drug to use by or on the order of a of praziquantel per kilogram of body licensed veterinarian. weight (1 gram of paste per 7.5 pounds [56 FR 50655, Oct. 8, 1991, as amended at 79 FR body weight) administered by mouth or 28821, May 20, 2014] in the food once daily for 3 days. (ii) Puppies and kittens (less than 6 § 520.905 Fenbendazole oral dosage months of age): 15 milligrams of forms. febantel and 1.5 milligrams of praziquantel per kilogram of body § 520.905a Fenbendazole suspension. weight (1 gram of paste per 5 pounds (a) Specifications. Each milliliter of body weight) administered by mouth suspension contains 100 milligrams on a full stomach once daily for 3 days. (mg) fenbendazole for use as in para- (2) Indications for use. (i) Dogs and graphs (e)(1), (2), (3), and (4) of this sec- puppies: For removal of hookworms tion; or 200 mg fenbendazole for use as (Ancylostoma caninum and Uncinaria in paragraph (e)(5) of this section. stenocephala), whipworms (Trichuris (b) Sponsor. See No. 000061 in vulpis), ascarids (Toxocara canis and § 510.600(c) of this chapter. Toxascaris leonina), and tapeworms (c) Related tolerances. See § 556.275 of (Dipylidium caninum and Taenia this chapter. pisiformis). (d) Special considerations. (1) See (ii) Cats and kittens: For removal of § 500.25 of this chapter. hookworms (Ancylostoma tubaeforme), (2) Fenbendazole suspension 10 per- ascarids (Toxocara cati) and tapeworms cent and approved forms of trichlorfon, (Dipylidium caninum and Taenia when used concomitantly for treating taeniaeformis). the indications provided in paragraph (3) Limitations. Federal law restricts (e) of this section and for treating in- this drug to use by or on the order of a fections of stomach bot as provided in licensed veterinarian. § 520.2520, have been shown to be compatible and not to interfere with one [50 FR 19167, May 7, 1985, as amended at 53 another. FR 48533, Dec. 1, 1988; 56 FR 50813, Oct. 9, 1991; (e) Conditions of use—(1) Horses—(i) 79 FR 28821, May 20, 2014] Amount. Administer orally 5 mg per § 520.903e Febantel tablets. kilogram (/kg) (2.3 mg per pound (/lb)) for the control of large strongyles, (a) Specifications. Each scored tablet small strongyles, and pinworms; 10 mg/ contains 27.2 milligrams of febantel for kg for the control of ascarids. use in dogs, puppies, cats, and kittens (ii) Indications for use. For the control or 163.3 milligrams of febantel for use of large strongyles (Strongylus in dogs, puppies, and cats. edentatus, S. equinus, S. vulgaris), small (b) Sponsor. See No. 000859 in strongyles (Cyanthostomum spp., § 510.600(c) of this chapter. Cylicocyclus spp., Cylicostephanus spp., (c) Conditions of use—(1) Amount—(i) Triodontophorus spp.), pinworms Dogs and cats. Ten milligrams per kilo- (Oxyuris equi), and ascarids (Parascaris gram body weight. Administer once equorum) in horses. daily for 3 consecutive days. (iii) Limitations. Administer by dose (ii) Puppies and kittens fewer than 6 syringe or suitable plastic syringe. Do months of age. Fifteen milligrams per not use in horses intended for human kilogram body weight. Administer once consumption. daily for 3 consecutive days. (2) Cattle including dairy cows of breed- (2) Indications for use. (i) For removal ing age—(i) Amount. Administer orally 5 of hookworms (Ancylostoma caninum mg/kg of body weight (2.3 mg/lb). Re- and Uncinaria stenocephala), ascarids treatment may be needed after 4 to 6 (Toxocara canis and Toxascaris leonina) weeks. and whipworms (Trichuris vulpis) in (ii) Indications for use. For the re- dogs and puppies. moval and control of lungworm

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(Dictyocaulus viviparus); stomach worm ment chickens intended to become (adults)—brown stomach worm breeding chickens, and for the treat- (Ostertagia ostertagi); stomach worms ment and control of adult A. galli and (adults and 4th-stage larvae)— Heterakis gallinarum in breeding chick- barberpole worm (Haemonchus contortus ens. and H. placei) and small stomach worm (iii) Limitations. Not for use in laying (Trichostongylus axei); intestinal worms hens and replacement chickens in- (adults and 4th-stage larvae)— tended to become laying hens. hookworm (Bunostonmum phlebotomum), [42 FR 59069, Nov. 15, 1977; 43 FR 12311, Mar. threadnecked intestinal worm 24, 1978. Redesignated at 44 FR 1375, Jan. 5, (Nematodirus helvetianus), small intes- 1979, and amended at 46 FR 29464, June 2, tinal worm (Cooperia punctata and C. 1981; 47 FR 15327, Apr. 9, 1982; 48 FR 42809, oncophora), bankrupt worm Sept. 20, 1983; 49 FR 1983, Jan. 17, 1984; 53 FR (Trichostrongylus colubriformis), and 40058, Oct. 13, 1988; 59 FR 26943, May 25, 1994; nodular worm (Oesophagostomum 61 FR 29478, June 11, 1996; 63 FR 63983, Nov. 18, 1998; 66 FR 47960, Sept. 17, 2001; 68 FR radiatum). 26205, May 15, 2003; 74 FR 17770, Apr. 17, 2009; (iii) Limitations. Cattle must not be 74 FR 61516, Nov. 25, 2009; 76 FR 17336, Mar. slaughtered within 8 days following 29, 2011; 80 FR 76386, Dec. 9, 2015] last treatment. A withdrawal period has not been established for this prod- § 520.905b Fenbendazole granules. uct in preruminating calves. Do not (a) Specifications. Each gram of gran- use in calves to be processed for veal. ules contains 222 milligrams (mg) (3) Beef cattle—(i) Amount. Administer fenbendazole. orally 10 mg/kg of body weight (2.3 mg/ (b) Sponsor. See No. 000061 in lb). Retreatment may be needed after 4 § 510.600(c) of this chapter. to 6 weeks. (c) Special considerations. See § 500.25 (ii) Indications for use. For the re- of this chapter. moval and control of stomach worm (d) Conditions of use—(1) Horses—(i) (4th stage inhibited larvae/type II Amount. 5 mg/kilogram (kg) for large ostertagiasis), Ostertagia ostertagi, and strongyles, small strongyles, and tapeworm, Moniezia benedeni. pinworms; 10 mg/kg for ascarids. (iii) Limitations. Cattle must not be (ii) Indications for use. For the control slaughtered within 8 days following of infections of large strongyles last treatment. A withdrawal period (Strongylus edentatus, S. equinus, S. has not been established for this prod- vulgaris), small strongyles, pinworms uct in preruminating calves. Do not (Oxyuris equi), and ascarids (Parascaris use in calves to be processed for veal. equorum). Federal law restricts this drug to use (iii) Limitations. Sprinkle the appro- by or on the order of a licensed veteri- priate amount of drug on a small narian. amount of the usual grain ration. Pre- (4) Goats—(i) Amount. Administer pare for each horse individually. With- orally 5 mg/kg of body weight (2.3 mg/ holding feed or water is not necessary. lb). Retreatment may be needed after 4 Retreat in 6 to 8 weeks if required. Do to 6 weeks. not use in horses intended for food. (ii) Indications for use. For the re- (2) Dogs—(i) Amount. 50 mg/kg daily moval and control of stomach worms for 3 consecutive days. (adults) Haemonchus contortus and (ii) Indications for use. For the treat- Teladorsagia circumcincta. ment and control of ascarids (Toxocara (iii) Limitations. Goats must not be canis, Toxascaris leonina), hookworms slaughtered for food within 6 days fol- (Ancylostoma caninum, Uncinaria lowing last treatment. Do not use in stenocephala), whipworms (Trichuris lactating goats. vulpis), and tapeworms (Taenia (5) Chickens—(i) Amount. Administer pisiformis). orally via drinking water at a daily (iii) Limitations. Mix the appropriate dose of 1 mg/kg body weight (0.454 mg/ amount of drug with a small amount of lb) for 5 consecutive days. the usual food; dry dog food may re- (ii) Indications for use. For the treat- quire slight moistening to facilitate ment and control of adult Ascaridia mixing. Medicated food must be fully galli in broiler chickens and replace- consumed.

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(3) Zoo and wildlife animals—(i) weight. Retreatment at intervals of 6 Amount. 10 mg/kg per day for 3 days. to 8 weeks may be required. (ii) Indications for use. For control of (B) For control of arteritis caused by internal parasites of Felidae and the fourth-stage larvae of S. vulgaris: Ursidae as follows: 4.6 mg/lb of body weight daily for 5 (A) Lion (Panthera leo) and Tiger days. Treatment should be initiated in (Panthera tigris): Ascarid (Toxocara cati, the spring and repeated in 6 months. Toxascaris leonina), Hookworm (C) For treatment of encysted (Ancylostoma spp.). mucosal cyathostome (small strongyle) (B) Cheetah (Acinonyx jubatus): Asca- larvae including early third-stage rid (Toxocara cati, Toxascaris leonina). (hypobiotic), late third-stage, and (C) Puma (Felis concolor), Panther fourth-stage larvae: 4.6 mg/lb of body (Panthera spp.), Leopard (Panthera weight daily for 5 consecutive days. pardus), Jaguar (Panthera onca): Asca- (D) Fenbendazole paste 10 percent rid (Toxocara cati, Toxascaris leonina), may be used concomitantly with ap- Hookworm (Ancylostoma spp.), Tape- worm (Taenia hydatigena, T. krabbei, T. proved forms of trichlorfon for the in- taeniaeformis). dications provided in paragraph (D) Black Bear (Ursus americanus): (e)(1)(i)(A) of this section and for treat- Ascarid (Baylisascaris transfuga, ing infections of stomach bots as pro- Toxascaris leonina), Hookworm vided in § 520.2520. (Ancylostoma caninum), Tapeworm (ii) Limitations. Do not use in horses (Taenia hydatigena, T. krabbei). intended for human consumption. (E) Polar Bear (Ursus maritimus) and (2) Cattle—(i) Amount. 2.3 mg/lb of Grizzly Bear (Ursus horribilis): Ascarid body weight. Retreatment may be (Baylisascaris transfuga, Toxascaris needed after 4 to 6 weeks. leonina). (ii) Indications for use. For the re- (iii) Limitations. Top dress or mix moval and control of lungworms with a small portion of food. Must be (Dictyocaulus viviparus), stomach fully consumed prior to feeding. Fed- worms (Haemonchus contortus, eral law restricts this drug to use by or Ostertagia ostertagi, Trichostrongylus on the order of a licensed veterinarian. axei), and intestinal worms Do not use 14 days before or during the (Bunostomum phlebotomum, Nematodirus hunting season. helvetianus, Cooperia punctata, C. [44 FR 1375, Jan. 5, 1979, as amended at 47 FR oncophora, Trichostrongylus 15327, Apr. 9, 1982; 48 FR 50528, Nov. 2, 1983; 59 colubriformis, and Oesophagostomum FR 35252, July 11, 1994; 66 FR 47960, Sept. 17, radiatum). 2001; 67 FR 47450, July 19, 2002; 71 FR 19429, (iii) Limitations. Cattle must not be Apr. 14, 2006; 74 FR 61516, Nov. 25, 2009] slaughtered within 8 days following last treatment. A withdrawal period § 520.905c Fenbendazole paste. has not been established for this prod- (a) Specifications. Each gram of paste uct in preruminating calves. Do not contains 100 milligrams (mg) use in calves to be processed for veal. fenbendazole (10 percent). (b) Sponsor. See No. 000061 in [72 FR 24185, May 2, 2007, as amended at 74 § 510.600(c) of this chapter. FR 61516, Nov. 25, 2009; 76 FR 17337, Mar. 29, 2011] (c) Related tolerances. See § 556.275 of this chapter. § 520.905d Fenbendazole powder. (d) Special considerations. See § 500.25 of this chapter. (a) Specifications. (1) Each 2-ounce (e) Conditions of use—(1) Horses—(i) packet contains 2.27 grams (4 percent) Indications for use and amounts—(A) For of fenbendazole plus other inert ingre- control of large strongyles (Strongylus dients. edentatus, S. equinus, S. vulgaris), small (2) Each 4-ounce packet contains 1.7 strongyles, pinworms (Oxyuris equi), grams (1.5 percent) of fenbendazole plus and ascarids (Parascaris equorum): 2.3 other inert ingredients. mg per pound (/lb) of body weight, or (b) Sponsors. (1) See No. 000061 in for foals and weanlings (less than 18 § 510.600(c) of this chapter for use of the months of age), 4.6 mg/lb of body 4-percent product.

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(2) See No. 051311 in § 510.600(c) of this Trichostrongylus colubriformis, and chapter for use of the 1.5-percent prod- Oesophagostomum radiatum) in beef cat- uct. tle. (c) Related tolerances. See § 556.275 of (3) Limitations. Administer free choice this chapter. of beef cattle on pasture that have be- (d) Conditions of use. It is adminis- come accustomed to nonmedicated tered to swine as follows: block feeding during an adaptation pe- (1) Amount. 3 milligrams fenbendazole riod of 12 to 19 days. Molasses block: per kilogram body weight per day (1.36 Cattle must not be slaughtered within milligrams per pound per day). 11 days following last treatment. Pro- (2) Indications for use. For removal tein block: Cattle must not be slaugh- and control of large roundworms tered within 16 days following last (Ascaris suum); lungworms treatment; do not use in dairy cattle of (Metastrongylus apri); nodular worms breeding age. Animals maintained (Oesophagostomum dentatum, O. under conditions of constant worm ex- quadrispinulatum); small stomach posure may require retreatment within worms (Hyostrongylus rubidus); 6 to 8 weeks. Consult your veterinarian whipworms (Trichuris suis); and for assistance in the diagnosis, treat- kidneyworms (Stephanurus dentatus— ment, and control of parasitism. mature and immature). (3) Limitations. Thoroughly mix the [51 FR 41783, Nov. 19, 1986, as amended at 54 FR 20787, May 15, 1989; 66 FR 47960, Sept. 17, contents of the packet(s) with swine 2001; 74 FR 61516, Nov. 25, 2009] ration and administer according to label directions. Feed as sole ration for § 520.928 Firocoxib tablets. 3 consecutive days. Can be fed to pregnant sows. No prior withdrawal of feed (a) Specifications. Each chewable tab- or water is necessary. Consult your let contains 57 or 227 milligrams (mg) veterinarian for assistance in the diag- firocoxib. nosis, treatment, and control of para- (b) Sponsor. See No. 050604 in sitism. § 510.600(c) of this chapter. (c) Conditions of use in dogs—(1) [49 FR 18090, Apr. 27, 1984, as amended at 49 Amount. 5 mg/kg (2.27 mg/lb) body FR 20485, May 15, 1984; 66 FR 47960, Sept. 17, weight. Administer once daily for os- 2001; 70 FR 32489, June 3, 2005; 74 FR 61516, teoarthritis. Administer approximately Nov. 25, 2009] 2 hours before soft-tissue or orthopedic § 520.905e Fenbendazole blocks. surgery. (2) Indications for use. For the control (a) Specifications. (1) Each pound of of pain and inflammation associated molasses block contains 750 milligrams with osteoarthritis; and for the control of fenbendazole. of postoperative pain and inflamma- (2) Each pound of protein block con- tion associated with soft-tissue and or- tains 750 milligrams of fenbendazole. thopedic surgery. (b) Sponsor. See 000061 in § 510.600(c) of (3) Limitations. Federal law restricts this chapter. this drug to use by or on the order of a (c) Related tolerances. See § 556.275 of licensed veterinarian. this chapter. (d) Conditions of use—(1) Amount. 0.1 [69 FR 51171, Aug. 18, 2004, as amended at 73 pound of block per 100 pounds of body FR 2808, Jan. 16, 2008; 73 FR 64885, Oct. 31, weight per day for 3 days. Total dose 2008] for the 3-day period is 2.27 milligrams of fenbendazole per pound of body § 520.930 Firocoxib paste. weight for mature cattle. (a) Specifications. Each milligram (2) Indications for use. For removal (mg) of paste contains 0.82 mg and control of infections of lungworms firocoxib. (Dictyocaulus viviparus) and gastro- (b) Sponsors. See No. 050604 in intestinal roundworms (Haemonchus § 510.600(c) of this chapter. contortus, Ostertagia ostertagi, (c) Conditions of use in horses—(1) Trichostrongylus axei, Bunostomum Amount. 0.1 mg per kilogram (0.045 mg phlebotomum, Nematodirus helvetianus, per pound) body weight daily for up to Cooperia oncophora and C. punctata, 14 days.

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(2) Indications for use. For the control (3) Limitations. Federal law restricts of pain and inflammation associated this drug to use by or on the order of a with osteoarthritis. licensed veterinarian. (3) Limitations. Do not use in horses [44 FR 7131, Feb. 6, 1979, as amended at 61 FR intended for human consumption. Fed- 5506, Feb. 13, 1996; 79 FR 28821, May 20, 2014] eral law restricts this drug to use by or on the order of a licensed veterinarian. § 520.970 Flunixin. [71 FR 5788, Feb. 3, 2006] (a) Specifications. (1) Each 10-gram (g) packet of granules contains flunixin § 520.955 Florfenicol. meglumine equivalent to 250 milli- (a) Specifications. Each milliliter grams (mg) of flunixin. (mL) contains 23 milligrams (mg) (2) Each 30-g syringe of paste con- florfenicol. tains flunixin meglumine equivalent to (b) Sponsor. See Nos. 000061 and 058198 1,500 mg of flunixin. in § 510.600(c) of this chapter. (b) Sponsors. See sponsors in (c) Related tolerances. See § 556.283 of § 510.600(c) of this chapter for use as in this chapter. paragraph (c) of this section. (d) Conditions of use in swine—(1) (1) No. 000061 for use of products de- Amount. Administer in drinking water scribed in paragraph (a). ad libitum at 400 mg per gallon (100 (2) No. 061623 for use of the product parts per million (ppm)) for 5 consecu- described in paragraph (a)(2). tive days. (c) Conditions of use in horses—(1) (2) Indications for use. For the treat- Amount. 0.5 mg per pound of body ment of swine respiratory disease weight per day for up to 5 days. (SRD) associated with Actinobacillus (2) Indications for use. For alleviation pleuropneumoniae, Pasteurella multocida, of inflammation and pain associated Salmonella choleraesuis and Strepto- with musculoskeletal disorders. coccus suis. (3) Limitations. Do not use in horses (3) Limitations. Do not slaughter with- intended for human consumption. Fed- in 16 days of last treatment. Federal eral law restricts this drug to use by or law restricts this drug to use by or on on the order of a licensed veterinarian. the order of a licensed veterinarian. [76 FR 53051, Aug. 25, 2011, as amended at 79 [67 FR 78357, Dec. 24, 2002, as amended at 72 FR 74020, Dec. 15, 2014] FR 262, Jan. 4, 2007; 78 FR 52854, Aug. 27, 2013] § 520.980 Fluoxetine. § 520.960 Flumethasone. (a) Specifications. Each chewable tab- (a) Specifications. Each tablet con- let contains 8, 16, 32, or 64 milligrams tains 0.0625 milligram of flumethasone. (mg) fluoxetine hydrochloride. (b) Sponsor. See No. 054771 in (b) Sponsor. See No. 050929 in § 510.600 § 510.600(c) of this chapter. of this chapter. (c) Conditions of use—(1) Amount—(i) (c) Conditions of use in dogs—(1) Dogs: Administer orally from 0.0625 to Amount. 1 to 2 mg per kilogram body 0.25 milligram daily in divided doses. weight once daily. (ii) Cats: Administer orally from (2) Indications for use. For the treat- 0.03125 to 0.125 milligram daily in di- ment of canine separation anxiety in vided doses. conjunction with a behavior modifica- (2) Indications for use—(i) Dogs: It is tion plan. used for musculoskeletal conditions (3) Limitations. Federal law restricts due to inflammation of muscles or this drug to use by or on the order of a joints and accessory structures, where licensed veterinarian. permanent structural changes do not exist, such as arthritis, the disc syn- [72 FR 6463, Feb. 12, 2007, as amended at 79 drome, and myositis. FR 74020, Dec. 15, 2014] (ii) Dogs and cats: It is used in certain acute and chronic dermatoses of vary- § 520.998 Fluralaner. ing etiology to help control the pru- (a) Specifications. Each chewable tab- ritus, irritation, and inflammation as- let contains 112.5, 250, 500, 1000, or 1400 sociated with these conditions. milligrams (mg) fluralaner.

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(b) Sponsor. See No. 000061 in ditions of use in paragraphs (d)(2)(i) § 510.600(c) of this chapter. and (d)(2)(ii)(A). (c) Conditions of use in dogs—(1) (3) Nos. 058829 and 069043 for use of Amount. Administer orally as a single syrup in paragraph (a)(4) of this section dose every 12 weeks according to the for conditions of use in paragraph label dosage schedule to provide a min- (d)(2)(i) and (d)(2)(ii)(A) of this section. imum dose of 11.4 mg per pound (/lb) (25 (c) Special considerations. Federal law mg per kilogram) body weight. May be restricts this drug to use by or on the administered every 8 weeks in case of order of a licensed veterinarian. potential exposure to Amblyomma (d) Conditions of use. It is used as fol- americanum ticks. lows: (2) Indications for use. Kills adult (1) Cattle—(i) Amount. 1 to 2 mg per fleas; for the treatment and prevention pound (/lb) body weight using powder, of flea infestations (Ctenocephalides or one 2-g bolus per animal, per day. felis), and the treatment and control of (ii) Indications for use. For treatment tick infestations [Ixodes scapularis of physiological parturient edema of (black-legged tick), Dermacentor the mammary gland and associated variabilis (American dog tick), and structures. Rhipicephalus sanguineus (brown dog (iii) Limitations. Treatment not to ex- tick)] for 12 weeks in dogs and puppies ceed 48 hours post-parturition. Milk 6 months of age and older, and weigh- taken during treatment and for 48 ing 4.4 lb or greater; for the treatment hours after the last treatment must and control of A. americanum (lone star not be used for food. Cattle must not be tick) infestations for 8 weeks in dogs slaughtered for food within 48 hours and puppies 6 months of age and older, following last treatment. and weighing 4.4 lb or greater. (2) Dogs—(i) Amount. 1 to 2 mg/lb body (3) Limitations. Federal law restricts weight, once or twice daily. this drug to use by or on the order of a (ii) Indications for use—(A) For treat- licensed veterinarian. ment of edema (pulmonary congestion, [79 FR 37619, July 2, 2014] ascites) associated with cardiac insufficiency and acute noninflammatory tis- § 520.1010 Furosemide. sue edema. (a) Specifications. (1) Each tablet con- (B) For treatment of edema (pul- tains 12.5 or 50 milligrams (mg) monary congestion, ascites) associated furosemide. with cardiac insufficiency. (2) Each bolus contains 2 grams (g) (3) Cats—(i) Amount. 1 to 2 mg/lb body furosemide. weight, once or twice daily. (3) Each packet of powder contains 2 (ii) Indications for use. For treatment g furosemide. of edema (pulmonary congestion, asci- (4) Each milliliter of syrup contains tes) associated with cardiac insuffi- 10 mg furosemide. ciency and acute noninflammatory tis- (b) Sponsors. See sponsor numbers in sue edema. § 510.600(c) of this chapter for use of dosage forms and strengths listed in [66 FR 47960, Sept. 17, 2001, as amended at 69 paragraph (a) of this section for uses as FR 74419, Dec. 14, 2004; 70 FR 50182, Aug. 26, 2005; 70 FR 76396, Dec. 27, 2005; 74 FR 61516, in paragraph (d) of this section. Nov. 25, 2009; 78 FR 17596, Mar. 22, 2013; 81 FR (1) No. 000010 for tablets in paragraph 17607, Mar. 30, 2016] (a)(1) of this section for conditions of use in paragraphs (d)(2)(i), (d)(2)(ii)(A), § 520.1044 Gentamicin sulfate oral dos- and (d)(3) of this section. age forms. (2) No. 000061 for tablets in paragraph (a)(1) of this section for conditions of § 520.1044a Gentamicin sulfate oral so- use in paragraphs (d)(2)(i), (d)(2)(ii)(A), lution. and (d)(3) of this section; for boluses in (a) Specifications. Each milliliter of paragraph (a)(2) of this section and aqueous solution contains gentamicin powder in paragraph (a)(3) of this sec- sulfate equivalent to 50 milligrams of tion for conditions of use in paragraph gentamicin. (d)(1) of this section; and for syrup in (b) Sponsor. See Nos. 000061 and 054925 paragraph (a)(4) of this section for con- in § 510.600(c) of this chapter.

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(c) Related tolerances. See § 556.300 of swine for food for at least 14 days fol- this chapter. lowing treatment. (d) Conditions of use—(1) Amount. [49 FR 572, Jan. 5, 1984, as amended at 52 FR Colibacillosis: 1 milliliter per 2 gallons 7832, Mar. 13, 1987; 62 FR 29011, May 29, 1997; of drinking water for 3 consecutive 78 FR 17596, Mar. 22, 2013] days, to provide 0.5 milligram/pound/ day; swine dysentery: 1 milliliter per 1 § 520.1044c Gentamicin sulfate powder. gallon of drinking water for 3 consecu- (a) Specifications. Each gram of pow- tive days, to provide 1.0 milligram/ der contains gentamicin sulfate equiv- pound/day. alent to: (2) Indications for use. In weanling (1) 16.7, 66.7, or 333.3 milligrams (mg) swine for control and treatment of gentamicin. colibacillosis caused by strains of E. (2) 333.3 mg gentamicin. coli sensitive to gentamicin, and in (b) Sponsors. See sponsors in swine for control and treatment of § 510.600(c) of this chapter for use as in swine dysentery associated with paragraph (d) of this section as follows: Treponema hyodysenteriae. (1) No. 000061 for products described (3) Limitations. For use in swine in paragraph (a)(1) of this section. drinking water only. Do not store or (2) Nos. 057561 and 061623 for product offer medicated drinking water in described in paragraph (a)(2) of this rusty containers since the drug is section. quickly destroyed in such containers. (c) Related tolerances. See § 556.300 of Medicated drinking water should be this chapter. prepared daily and be the sole source of drinking water for 3 consecutive days. (d) Conditions of use in swine—(1) Treatment may be repeated if dys- Amount. Administer in drinking water entery recurs. Do not slaughter treated for 3 consecutive days as follows: swine for food for at least 3 days fol- (i) For colibacillosis: Gentamicin sul- lowing treatment. fate equivalent to 25 mg of gentamicin per gallon of drinking water to provide [48 FR 10302, Mar. 11, 1983. Redesignated at 49 0.5 mg per pound of body weight per FR 572, Jan. 5, 1984, and amended at 49 FR day; 14332, Apr. 11, 1984; 52 FR 7832, Mar. 13, 1987; (ii) For swine dysentery: Gentamicin 62 FR 34169, June 25, 1997; 71 FR 13542, Mar. 16, 2006] sulfate equivalent to 50 mg of gentamicin per gallon of drinking § 520.1044b Gentamicin sulfate pig water to provide 1 mg per pound of pump oral solution. body weight per day. Treatment may be repeated if dysentery recurs. (a) Specifications. Each milliliter of pig pump oral solution contains (2) Indications for use. For control and gentamicin sulfate equivalent to 4.35 treatment of colibacillosis in weanling milligrams of gentamicin. swine caused by strains of Escherichia sensitive to gentamicin, and for (b) Sponsor. See Nos. 000061 and 000859 coli in § 510.600(c) of this chapter. control and treatment of swine dysentery associated with Treponema (c) Related tolerances. See § 556.300 of hyodysenteriae. this chapter. (3) Limitations. For use in swine (d) Conditions of use—(1) Amount. Ad- drinking water only. Do not store or minister 1.15 milliliters of pig pump offer medicated drinking water in oral solution (5 milligrams of rusty containers since the drug is gentamicin) orally per pig one time. quickly destroyed in such containers. (2) Indications for use. In neonatal Medicated drinking water should be swine 1 to 3 days of age for control and prepared daily and be the sole source of treatment of colibacillosis caused by drinking water. strains of E. coli sensitive to (4) Withdrawal period. 10 days. gentamicin. (3) Limitations. For use in neonatal [77 FR 4226, Jan. 27, 2012] swine only. Do not slaughter treated

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§ 520.1060 Glucose and glycine. (b) Sponsors. See sponsors in § 510.600(c) of this chapter. (a) Specifications. Each packet of pow- (1) No. 000061 for use of products de- der contains 8.82 grams sodium chlo- scribed in paragraph (a) for use as in ride, 4.20 grams potassium phosphate, paragraph (d) of this section. 0.5 gram citric acid anhydrous, 0.12 (2) No. 061623 for use of the powder de- gram potassium citrate, 6.36 grams scribed in paragraph (a)(1) for use as in aminoacetic acid (glycine), and 44.0 paragraphs (d)(1)(i)(A) and (d)(1)(ii) of grams glucose. this section. (b) Sponsor. See No. 054771 in (c) Special considerations. Federal law § 510.600(c) of this chapter. restricts this drug to use by or on the (c) Conditions of use in calves—(1) order of a licensed veterinarian. Amount. Dissolve each packet in 2 (d) Conditions of use—(1) Horses—(i) quarts of warm water and administer Amount and indications for use—(A) For to each calf as follows: equine ringworm infection caused by (i) Scouring and/or dehydrated calves. Trichophyton equinum or Microsporum Feed 2 quarts of solution, twice daily gypseum, administer soluble powder de- for 2 days (four feedings). No milk or scribed in paragraph (a)(1) of this sec- milk replacer should be fed during this tion daily as a drench or as a top dress- period. For the next four feedings (days ing on feed for not less than 10 days as 3 and 4), use 1 quart of solution to- follows: adults, 2.5 grams; yearlings, gether with 1 quart of milk replacer. 1.25 to 2.5 grams; and foals, 1.25 grams. Thereafter, feed as normal. (B) For treating ringworm infection (ii) Newly purchased calves. Feed 2 caused by T. equinum, administer quarts of solution instead of milk as boluses described in paragraph (a)(2) of the first feed upon arrival. For the next this section daily for not less than 10 scheduled feeding, use 1 quart of solu- days as follows: adults, 1 bolus; year- tion mixed together with 1 quart of lings, one-half to 1 bolus; and foals, milk or milk replacer. Thereafter, feed one-half bolus. as normal. (ii) Limitations. Do not use in horses (2) Indications for use. For control of intended for human consumption. dehydration associated with diarrhea (2) Dogs and cats: (i) Amount. 125- and (scours); and as an early treatment at 500-milligram tablets administered the first signs of scouring. It may also orally as follows: be used as followup treatment fol- (A) Daily (single or divided) dose as lowing intravenous fluid therapy. follows: For animals weighing up to 6 (3) Limitations. The product should pounds: 62.5 milligrams; for animals not be used in animals with severe de- weighing 6 to 18 pounds: 125 milli- hydration (down, comatose, or in a grams; for animals weighing 18 to 36 state of shock). Such animals need in- pounds: 250 milligrams; for animals travenous therapy. A veterinarian weighing 36 to 48 pounds: 375 milli- should be consulted in severely scour- grams; for animal weighing 48 to 75 ing calves. The product is not nutri- pounds: 500 milligrams. tionally complete if administered by (B) Weekly (single) dose: If experi- itself for long periods of time. It should ence indicates that treatment is more not be administered beyond the rec- effective for the drug given in large ommended treatment period without doses, administer at intervals of 7 to 10 the addition of milk or milk replacer. days, a dose equal to 10 milligrams/ pound of body weight × body weight × [79 FR 28821, May 20, 2014] number of days between treatments. Dosage should be adjusted according to § 520.1100 Griseofulvin. response. Administer additional dose (a) Specifications—(1) The powder after the animal is free of infection. complies with U.S.P. for griseofulvin, (ii) Indications for use. For treatment microsize. of fungal infections of the skin, hair, (2) Each bolus contains 2.5 grams and claws caused by Trichophyton griseofulvin. mentagrophytes, T. rubrum, T. (3) Each tablet contains 125 or 500 schoenleini, T. sulphurem, T. verrucosum, milligrams griseofulvin. T. interdigitale, Epidermophyton

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floccosum, Microsporum gypseum, M. (c) Related tolerances. See § 556.310 of canis, M. audouini. this chapter. (d) Conditions of use in cattle—(1) [40 FR 13838, Mar. 27, 1975, as amended at 41 FR 42948, Sept. 29, 1976; 43 FR 28458, June 30, Amount. Administered one bolus per 500 1978; 52 FR 7832, Mar. 13, 1987; 54 FR 30205, pounds body weight (35 to 50 milli- July 19, 1989; 71 FR 38073, July 5, 2006; 77 FR grams per kilogram of body weight). 28253, May 14, 2012; 78 FR 28822, May 20, 2014] Retreat in 3 to 4 weeks. (2) Indications for use. For control of § 520.1120 Haloxon oral dosage forms. gastrointestinal roundworms of the genera Haemonchus, Ostertagia, § 520.1120a Haloxon drench. Trichostrongylus, and Cooperia. (a) Specifications. Each packet con- (3) Limitations. Do not treat dairy tains 141.5 grams haloxon. animals of breeding age or older. Do (b) Sponsor. See No. 000061 in not treat within 1 week of slaughter. § 510.600(c) of this chapter. [40 FR 13838, Mar. 27, 1975, as amended at 44 (c) Special considerations. Do not use FR 61591, Oct. 29, 1979; 46 FR 48642, Oct. 2, any drug, insecticide, pesticide, or 1981; 61 FR 8873, Mar. 6, 1996; 62 FR 61625, other chemical having cholinesterase- Nov. 19, 1997; 78 FR 28822, May 20, 2014] inhibiting activity either simultaneously or within a few days before or § 520.1130 Hetacillin. after treatment with haloxon. (a) Specifications. (1) Each capsule or (d) Related tolerances. See § 556.310 of tablet contains hetacillin potassium this chapter. equivalent to 50, 100, or 200 milligrams (e) Conditions of use in cattle—(1) (mg) of ampicillin. Amount. Dissolve each packet in 32 (2) Each milliliter of suspension con- fluid ounces of water and administer as tains hetacillin potassium equivalent follows: For animals weighing up to 100 to 50 mg of ampicillin. pounds: 1/2 fluid ounce; for animals (b) Sponsor. See No. 000010 in weighing 100 to 150 pounds: 3/4 fluid § 510.600(c) of this chapter. ounce; for animals weighing 150 to 200 (c) Conditions of use in dogs and cats— pounds: 1 fluid ounce; for animals (1) Amount—(i) Dogs. Administer 5 mg weighing 200 to 300 pounds: 1 1/2 fluid per pound (/lb) of body weight orally, ounces; for animals weighing 300 to 450 twice daily. In severe infections, ad- pounds: 2 fluid ounces; for animals minister 5 mg/lb three times daily, or weighing 450 to 700 pounds: 3 fluid up to 10 mg/lb twice daily. For stub- ounces; for animals weighing 700 to born urinary tract infections, admin- 1,000 pounds: 4 fluid ounces; for animals ister up to 20 mg/lb twice daily. weighing 1,000 to 1,200 pounds: 5 fluid (ii) Cats. Administer 50 mg twice ounces; for animals weighing over 1,200 daily. pounds: 6 fluid ounces. Retreat in 3 to (2) Indications for use. For the treat- 4 weeks. ment of respiratory tract infections, (2) Indications for use. For control of urinary tract infections, gastro- gastrointestinal roundworms of the intestinal infections, skin infections, genera Haemonchus, Ostertagia, soft tissue infections, and postsurgical Trichostrongylus, and Cooperia. infections associated with strains of or- (3) Limitations. Do not treat dairy ganisms susceptible to hetacillin po- animals of breeding age. Do not treat tassium. within 1 week of slaughter. (3) Limitations. Federal law restricts this drug to use only by or on the order [40 FR 13838, Mar. 27, 1975, as amended at 45 of a licensed veterinarian. FR 10333, Feb. 15, 1980; 46 FR 48642, Oct. 2, 1981; 61 FR 8873, Mar. 6, 1996; 62 FR 61624, [75 FR 10166, Mar. 5, 2010] Nov. 19, 1997; 78 FR 28822, May 20, 2014] § 520.1156 Imidacloprid. § 520.1120b Haloxon boluses. (a) Specifications. Each chewable tab- (a) Specifications. Each bolus contains let contains 7.5 or 37.5 milligrams (mg) 10.1 grams of haloxon. imidacloprid. (b) Sponsor. See No. 000061 in (b) Sponsor. See No. 000859 in § 510.600(c) of this chapter. § 510.600(c) of this chapter.

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(c) Conditions of use in dogs—(1) § 520.1182 Iron dextran suspension. Amount. Administer daily one 7.5-mg (a) Specifications. Each milliliter chewable tablet to dogs weighing 4 to (mL) of suspension contains 55.56 milli- 22 pounds (lb) or one 37.5-mg chewable grams (mg) iron as ferric hydroxide in table to dogs weighing 23 to 110 lb. complex with a low molecular weight (2) Indications for use. Kills adult fleas dextran. and is indicated for the treatment of (b) Sponsor. See No. 051311 in flea infestations on dogs and puppies 10 § 510.600(c) of this chapter. weeks of age and older and weighing 4 (c) Conditions of use in swine—(1) lb or greater. Amount. Administer 100 mg (1.8 mL) (3) Limitations. Do not give to puppies orally by automatic dose dispenser. younger than 10 weeks of age or to dogs (2) Indications for use. For the preven- weighing less than 4 lb. Do not give tion of iron deficiency anemia in baby more than one tablet a day. pigs. [80 FR 18775, Apr. 8, 2015] (3) Limitations. Treat each pig within 24 hours of farrowing. § 520.1157 Iodinated casein. [70 FR 32489, June 3, 2005] (a) Specifications. Each 1-gram tablet contains 25 milligrams of iodinated ca- § 520.1192 Ivermectin paste. sein. (a) Specifications. Each milligram (b) Sponsor. See No. 017762 in (mg) of paste contains 0.0187 mg (1.87 § 510.600(c) of this chapter. percent) or 0.00153 mg (0.153 percent) of ivermectin. (c) Conditions of use—(1) Amount. 1⁄5 to 1 tablet per 10 pounds of body weight (b) Sponsors. See sponsors in (equivalent to 0.5 to 2.5 milligrams of § 510.600(c) of this chapter for use as in iodinated casein per pound of body paragraph (e) of this section: weight). (1) No. 050604 for use of a 1.87 percent paste as in (e)(1) of this section and a (2) Indications for use. For dogs for ap- 0.153 percent paste for use as in para- parent decreased thyroid activity graph (e)(2) of this section. where the signs are alopecia, scaliness (2) Nos. 000859, 051311, 054925, and of the skin surface, loss of hair, sebor- 061623 for use of a 1.87 percent paste for rhea, thickening of the skin, use as in paragraph (e)(1) of this sec- hyperpigmentation, and lethargy. tion. (3) Limitations. Federal law restricts (c) Related tolerances. See § 556.344 of this drug to use by or on the order of a this chapter. licensed veterinarian. (d) Special considerations. See § 500.25 [49 FR 22469, May 30, 1984, as amended at 78 of this chapter. FR 28822, May 20, 2014] (e) Conditions of use—(1) Horses—(i) Amount. 200 micrograms per kilogram § 520.1158 Iodochlorhydroxyquin. (91 micrograms per pound) of body (a) Specifications. Each bolus contains weight. 10 grams of iodochlorhydroxyquin. (ii) Indications for use. For treatment (b) Sponsor. See No. 054771 in § 510.600 and control of Large Strongyles (c) of this chapter. (adults): Strongylus vulgaris (also early forms in blood vessels), S. edentatus (c) Conditions of use—(1) Amount. 1 (also tissue stages), S. equinus, bolus (10 grams) daily for a 1,000-pound Triodontophorus spp. including T. horse. brevicauda and T. serratus, and (2) Indications for use. For treatment Craterostomum acuticaudatum; Small of equine diarrhea. Strongyles (adults, including those re- (3) Limitations. Do not use in horses sistant to some benzimidazole class intended for human consumption. Fed- compounds): Coronocyclus spp. includ- eral law restricts this drug to use by or ing C. coronatus, C. labiatus, and C. on the order of a licensed veterinarian. labratus, Cyathostomum spp. including [48 FR 8054, Feb. 25, 1983, as amended at 50 C. catinatum and C. pateratum, FR 41489, Oct. 11, 1985; 78 FR 28822, May 20, Cylicocyclus spp. including C. insigne, C. 2014] leptostomum, C. nassatus, and C.

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brevicapsulatus, Cylicodontophorus spp., § 520.1193 Ivermectin tablets and Cylicostephanus spp. including C. chewables. calicatus, C. goldi, C. longibursatus, and (a) Specifications. (1) Each tablet or C. minutus, and Petrovinema poculatum; chewable contains 68, 136, or 272 Small Strongyles (fourth-stage larvae); Pinworms (adults and fourth-stage lar- micrograms (mcg) ivermectin. vae): Oxyuris equi; Ascarids (adults and (2) Each chewable contains 55 or 165 third- and fourth-stage larvae): mcg ivermectin. Parascaris equorum; Hairworms (adults): (b) Sponsors. See sponsors in Trichostrongylus axei; Large mouth § 510.600(c) of this chapter for use as in Stomach Worms (adults): Habronema paragraph (d) of this section. muscae; Bots (oral and gastric stages): (1) No. 050604 for use of tablets or Gasterophilus spp. including G. chewables described in paragraph (a)(1) intestinalis and G. nasalis; Lungworms as in paragraph (d)(1) and chewables de- (adults and fourth-stage larvae): scribed in paragraph (a)(2) as in para- Dictyocaulus arnfieldi; Intestinal graph (d)(2) of this section. Threadworms (adults): Strongyloides (2) Nos. 051311 and 069043 for use of westeri; Summer Sores caused by tablets described in paragraph (a)(1) as Habronema and Draschia spp. cutaneous in paragraph (d)(1) of this section. third-stage larvae; Dermatitis caused (c) Special considerations. Federal law by neck threadworm microfilariae, restricts this drug to use by or on the Onchocerca sp. (iii) Limitations. For oral use only. Do order of a licensed veterinarian. not use in horses intended for human (d) Conditions of use—(1) Dogs. For use consumption. in dogs 6 weeks of age and older as fol- (2) Cattle—(i) Amount. 23 milligrams lows: per 250 pounds of body weight. (i) Amount. 6.0 mcg per kilogram (kg) (ii) Indications for use. It is used in of body weight (2.72 mcg per pound cattle for the treatment and control of (lb)), minimum. Up to 25 lb, 68 mcg; 26 gastrointestinal roundworms (adults to 50 lb, 136 mcg; 51 to 100 lb, 272 mcg; and fourth-stage larvae) (Ostertagia over 100 lb, a combination of the appro- ostertagi (including inhibited forms), O. priate tablets. Administer at monthly lyrata, Haemonchus placei, dosing intervals. Trichostrongylus axei, T. colubriformis, (ii) Indications for use. To prevent ca- Cooperia oncophora, C. punctata, nine heartworm disease by eliminating Nematodirus helvetianus, Bunostomum the tissue stage of heartworm larvae phlebotomum, Strongyloides papillosus (Dirofilaria immitis) for 1 month (30 (adults only), Oesophagostomum days) after infection. radiatum, Trichuris ovis (adults only)); lungworms (adults and fourth-stage (2) Cats. For use in cats 6 weeks of larvae) (Dictyocaulus viviparus); grubs age and older as follows: (first, second, and third instars) (i) Amount. Up to 2.3 kilograms (up to (Hypoderma bovis, H. lineatum); and 5 lb), 55 mcg; 2.3 to 6.8 kilograms (5 to sucking lice (Linognathus vituli, 15 lb), 165 mcg; over 6.8 kilograms (15 Haematopinus eurysternus). lb), a combination of the appropriate (iii) Limitations. For oral use only. Do chewables (recommended minimum not treat cattle within 24 days of dose of 24 mcg/kg of body weight (10.9 slaughter. Because withdrawal time in mcg/lb)). Administer once a month. milk has not been established, do not (ii) Indications for use. To prevent fe- use in female dairy cattle of breeding line heartworm disease by eliminating age. the tissue stage of heartworm larvae [49 FR 22275, May 29, 1984, as amended at 50 Dirofilaria immitis for a month (30 days) FR 27819, July 8, 1985; 51 FR 44449, Dec. 10, after infection, and for removal and 1986; 53 FR 51273, Dec. 21, 1988; 62 FR 63270, control of adult and immature (L4) Nov. 28, 1997; 65 FR 70661, Nov. 27, 2000; 67 FR hookworms Ancylostoma tubaeforme and 71820, Dec. 3, 2002; 68 FR 43294, July 22, 2003; A. braziliense. 69 FR 59131, Oct. 4, 2004; 70 FR 8514, Feb. 22, 2005; 71 FR 40010, July 14, 2006; 71 FR 67298, [67 FR 11230, Mar. 13, 2002, as amended at 67 Nov. 21, 2006; 73 FR 34184, June 17, 2008; 74 FR FR 21996, May 2, 2002; 69 FR 43735, July 22, 6542, Feb. 10, 2009; 78 FR 17596, Mar. 22, 2013] 2004; 81 FR 17607, Mar. 30, 2016]

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§ 520.1194 Ivermectin meal. § 520.1195 Ivermectin liquid. (a) Specifications. Each gram of meal (a) Specifications—(1) Each milliliter contains 6 milligrams ivermectin (0.6 (mL) contains 10 milligrams (mg) percent). ivermectin. (b) Sponsor. See No. 017135 in (2) Each mL of micellar solution con- § 510.600(c) of this chapter. tains 0.8 mg ivermectin. (b) Sponsors. See sponsor numbers in (c) Special considerations. See § 500.25 § 510.600(c) of this chapter. of this chapter. (1) Nos. 000859, 050604, 054925, and (d) Conditions of use in horses—(1) 058005 for use of product described in Amount. Administer 136 micrograms paragraph (a)(1) of this section as in (mcg) ivermectin per pound (/lb) body paragraphs (e)(1)(i), (e)(1)(ii)(A), and weight (300 mcg/kilogram) as a single (e)(1)(iii) of this section. dose on approximately 2 lb grain or (2) No. 058829 for use of product de- sweet feed. scribed in paragraph (a)(1) of this sec- (2) Indications for use. For treatment tion as in paragraphs (e)(1)(i), and control of Large Strongyles (e)(1)(ii)(B), and (e)(1)(iii) of this sec- (adults): Strongylus vulgaris (also early tion. forms in blood vessels), S. edentatus (3) Nos. 050604 and 058829 for use of (also tissue stages), S. equinus, product described in paragraph (a)(2) of Triodontophorus spp. including T. this section as in paragraph (e)(2) of brevicauda and T. serratus, and this section. Craterostomum acuticaudatum; Small (c) Related tolerances. See § 556.344 of Strongyles (adults, including those re- this chapter. sistant to some benzimidazole class (d) Special considerations. See § 500.25 of this chapter. compounds): Coronocyclus spp. includ- (e) Conditions of use—(1) Horses—(i) ing C. coronatus, C. labiatus, and C. Amount. 200 micrograms (mcg) per kilo- labratus, Cyathostomum spp. including gram (/kg) of body weight as a single C. catinatum and C. pateratum, dose by stomach tube or as an oral Cylicocyclus spp. including C. insigne, C. drench. leptostomum, C. nassatus, and C. (ii) Indications for use. For treatment brevicapsulatus, Cylicodontophorus spp., and control of: Cylicostephanus spp. including C. (A) Large Strongyles (adults): calicatus, C. goldi, C. longibursatus, and Strongylus vulgaris (also early forms in C. minutus, and Petrovinema poculatum; blood vessels), S. edentatus (also tissue Small Strongyles (fourth-stage larvae); stages), S. equinus, Triodontophorus spp. Pinworms (adults and fourth stage lar- including T. brevicauda and T. serratus, vae): Oxyuris equi; Ascarids (adults and and Craterostomum acuticaudatum; third- and fourth-stage larvae): Small Strongyles (adults, including Parascaris equorum; Hairworms (adults): those resistant to some benzimidazole Trichostrongylus axei; Large Mouth class compounds): Coronocyclus spp. in- Stomach Worms (adults): Habronema cluding C. coronatus, C. labiatus, and C. muscae; Bots (oral and gastric stages): labratus, Cyathostomum spp. including Gasterophilus spp. including G. C. catinatum and C. pateratum, intestinalis and G. nasalis; Lungworms Cylicocyclus spp. including C. insigne, C. (adults and fourth-stage larvae): leptostomum, C. nassatus, and C. Dictyocaulus arnfieldi; Intestinal brevicapsulatus, Cylicodontophorus spp., Threadworms (adults): Strongyloides Cylicostephanus spp. including C. westeri; Summer Sores caused by calicatus, C. goldi, C. longibursatus, and Habronema and Draschia spp. cutaneous C. minutus, and Petrovinema poculatum; third-stage larvae; Dermatitis caused Small Strongyles (fourth-stage larvae); by neck threadworm microfilariae, Pinworms (adults and fourth stage lar- Onchocerca sp. vae): Oxyuris equi; Ascarids (adults and third- and fourth-stage larvae): Limitations. Do not use in horses in- Parascaris equorum; Hairworms (adults): tended for human consumption. Trichostrongylus axei; Large mouth [70 FR 1817, Jan. 11, 2005, as amended at 70 Stomach Worms (adults): Habronema FR 19262, Apr. 13, 2005] muscae; Bots (oral and gastric stages):

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Gasterophilus spp. including G. (iii) Limitations. For use in sheep intestinalis and G. nasalis; Lungworms only. Do not use in other animal spe- (adults and fourth-stage larvae): cies as severe adverse reactions, in- Dictyocaulus arnfieldi; Intestinal cluding fatalities in dogs, may result. Threadworms (adults), Strongyloides Do not treat sheep within 11 days of westeri; Summer Sores caused by slaughter. Habronema and Draschia spp. cutaneous [67 FR 50597, Aug. 5, 2002, as amended at 69 third-stage larvae; Dermatitis caused FR 57173, Sept. 24, 2004; 71 FR 13542, Mar. 16, by neck threadworm microfilariae, 2006; 71 FR 38072, July 5, 2006; 72 FR 9456, Feb. Onchocerca sp. 21, 2008; 78 FR 17596, Mar. 22, 2013; 79 FR 10964, (B) Large Strongyles (Strongylus Feb. 27, 2014] equinus (adult), S. vulgaris (adult and arterial larval stages), S. endentatus § 520.1196 Ivermectin and pyrantel (adult and migrating tissue stages), tablets. Triodontophorus spp. (adult)); Small (a) Specifications. Each chewable tab- Strongyles including those resistant to let contains either 68 micrograms (μg) some benzimidazole class compounds of ivermectin and 57 milligrams (mg) of (Cyathostomum spp. (adult and fourth- pyrantel (as pamoate salt), or 136 μg stage larvae), Cylicocyclus spp., and 114 mg, or 272 μg and 227 mg, re- Cylicodontophorus spp., Cylicostephanus spectively. spp.); Pinworms (Oxyuris equi (adult (b) Sponsors. See Nos. 050604, 051311, and fourth-stage larvae)); Ascarids and 063604 in § 510.600(c) of this chapter. (Parascaris equorum (adult and third- (c) Conditions of use—(1) Dogs—(i) and fourth-stage larvae)); Hairworms Amount. Administer a minimum of 6 μg (Trichostongylus axei ( adult)); Large of ivermectin and 5 mg of pyrantel per mouth Stomach Worms (Habronema kilogram (2.72 μg and 2.27 mg per muscae (adult)); Stomach Bots pound) of body weight monthly. (Gastrophilus spp. (oral and gastric (ii) Indications for use. To prevent ca- stages)); Lungworms (Dictyocaulus nine heartworm disease by eliminating arnfieldi (adult and fourth-stage lar- the tissue larval stages of Dirofilaria vae)); intestinal threadworms immitis for up to a month (30 days) after (Strongyloides westeri (adult)); Summer infection and treatment and control of Sores caused by Habronema and adult ascarids Toxocara canis and Draschia spp. cutaneous third-stage lar- Toxascaris leonina, and adult vae; and Dermatitis caused by neck hookworms Ancylostoma caninum, A. threadworm microfilariae (Onchocerca braziliense, and Uncinaria stenocephala. spp.). (iii) Limitations. Federal law restricts (iii) Limitations. Do not use in horses this drug to use by or on the order of a intended for human consumption. Fed- licensed veterinarian. eral law restricts this drug to use by or (2) [Reserved] on the order of a licensed veterinarian. [58 FR 8542, Feb. 16, 1993, as amended at 61 (2) Sheep—(i) Amount. 200 mcg/kg (3 FR 15186, Apr. 5, 1996; 61 FR 59004, Nov. 20, mL/26 pounds) of body weight as a sin- 1996; 62 FR 63270, Nov. 28, 1997; 66 FR 35756, gle dose oral drench. July 9, 2001; 67 FR 21996, May 2, 2002; 68 FR (ii) Indications for use. For treatment 55823, Sept. 29, 2003; 78 FR 28822, May 20, 2014] and control of the adult and fourth- stage larvae of gastrointestinal § 520.1197 Ivermectin sustained-re- roundworms (Haemonchus contortus, H. lease bolus. placei (adults only), Ostertagia (a) Specifications. Each sustained-re- circumcincta, Trichostrongylus axei, T. lease bolus contains 1.72 grams of colubriformis, Cooperia oncophora ivermectin. (adults only), C. curticei, (b) Sponsor. See No. 050604 in Oesophagostomum columbianum, O. § 510.600(c) of this chapter. venulosum (adults only), Nematodirus (c) Related tolerances. See § 556.344 of battus, N. spathiger, S. papillosus (adults this chapter. only), Chabertia ovina (adult only), (d) Conditions of use in ruminating Trichuris ovis (adults only)); lungworms calves—(1) Amount. Administer one (D. filaria); and all larval stages of the bolus per calf weighing at least 275 nasal bot Oestrus ovis. pounds (lb) (125 kilograms (kg)) and not

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more than 660 lb (300 kg) on the day of (3) No. 050604 for use of products de- administration. scribed in paragraph (a)(3) of this sec- (2) Indications. For treatment and tion as in paragraphs (d)(1)(iii), control, throughout the grazing season (d)(2)(iii) and (d)(3) of this section. (approximately 130 days), of gastro- (c) Special considerations. See § 500.25 intestinal roundworms Haemonchus of this chapter. placei, Ostertagia ostertagi (including in- (d) Conditions of use in horses—(1) hibited fourth-stage larvae), Amount—(i) 200 micrograms (mcg) per Trichostrongylus axei, T. colubriformis, kilogram (/kg) ivermectin (91 mcg per Cooperia spp., Nematodirus helvetianus, pound (/lb)) and 1 mg/kg praziquantel Bunostomum phlebotomum, (454 mcg/lb) body weight. Oesophagostomum radiatum; lungworms (ii) 200 mcg/kg ivermectin (91 mcg/lb) Dictyocaulus viviparus; grubs Hypoderma and 1.5 mg/kg praziquantel (681 mcg/lb) spp.; sucking lice Linognathus vituli, body weight. Solenopotes capillatus; mange mites (iii) 200 mcg/kg ivermectin (91 mcg/lb) Psoroptes ovis, Sarcoptes scabiei, and and 2.5 mg/kg praziquantel (1.14 mg/lb). ticks Amblyomma americanum. (2) Indications for use—(i) For treat- (3) Limitations. The bolus was specifi- ment and control of the following cally designed for use in cattle; do not parasites: Tapeworms—Anoplocephala use in other animal species. Calves perfoliata; Large Strongyles (adults)— must be ruminating and older than 12 Strongylus vulgaris (also early forms in weeks of age. Do not administer to blood vessels), S. edentatus (also tissue calves weighing less than 275 lb (125 stages), S. equinus, Triodontophorus spp. kg). Do not administer a damaged including T. brevicauda and T. serratus, bolus. Because a milk withdrawal time and Craterostomum acuticaudatum; has not been established, do not use in Small Strongyles (adults, including female dairy cattle of breeding age. Do those resistant to some benzimidazole not slaughter cattle within 180 days of class compounds)—Coronocyclus spp. in- treatment. Consult your veterinarian cluding C. coronatus, C. labiatus, and C. for assistance in the diagnosis, treat- labratus; Cyathostomum spp. including ment, and control of parasitism. C. catinatum and C. pateratum; [61 FR 67452, Dec. 23, 1996, as amended at 62 Cylicocyclus spp. including C. insigne, C. FR 63270, Nov. 28, 1997; 65 FR 45876, July 26, leptostomum, C. nassatus, and C. 2000] brevicapsulatus; Cylicodontophorus spp.; Cylicostephanus spp. including C. § 520.1198 Ivermectin and praziquantel calicatus, C. goldi, C. longibursatus, and paste. C. minutus, and Petrovinema poculatum; (a) Specifications. Each milligram Small Strongyles—fourth-stage larvae; (mg) of paste contains: Pinworms (adults and fourth-stage lar- (1) 0.0155 mg (1.55 percent) ivermectin vae)—Oxyuris equi; Ascarids (adults and and 0.0775 mg (7.75 percent) third- and fourth-stage larvae)— praziquantel. Parascaris equorum; Hairworms (2) 0.0187 mg (1.87 percent) ivermectin (adults)—Trichostrongylus axei; Large- and 0.1403 mg (14.03 percent) mouth Stomach Worms (adults)— praziquantel. Habronema muscae; Bots (oral and gas- (3) 0.0187 mg (1.87 percent) ivermectin tric stages)—Gasterophilus spp. includ- and 0.2338 mg (23.38 percent) ing G. intestinalis and G. nasalis; praziquantel. Lungworms (adults and fourth-stage (b) Sponsors. See sponsors in larvae)—Dictyocaulus arnfieldi; Intes- § 510.600(c) of this chapter for uses as in tinal Threadworms (adults)— paragraph (d) of this section.— Strongyloides westeri; Summer Sores (1) No. 050604 for use of product de- caused by Habronema and Draschia spp. scribed in paragraph (a)(1) of this sec- cutaneous third-stage larvae; Derma- tion as in paragraphs (d)(1)(i), (d)(2)(i) titis caused by neck threadworm and (d)(3) of this section. microfilariae of Onchocerca sp. (2) No. 051311 for use of product de- (ii) For treatment and control of the scribed in paragraph (a)(2) of this sec- following parasites: Tapeworms— tion as in paragraphs (d)(1)(ii), Anoplocephala perfoliata; Large (d)(2)(ii), and (d)(3) of this section. Strongyles (adults)—Strongylus vulgaris

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(also early forms in blood vessels), S. tinal Threadworms (adults)— edentatus (also tissue stages), S. Strongyloides westeri; Summer Sores equinus, Triodontophorus spp.; Small caused by Habronema and Draschia spp. Strongyles (adults, including those re- cutaneous third-stage larvae; Derma- sistant to some benzimidazole class titis caused by neck threadworm compounds)—Cyathostomum spp.; microfilariae of Onchocerca sp. Cylicocyclus spp.; Cylicostephanus spp., (3) Limitations. For oral use only. Do Cylicodontophorus spp.; Small not use in horses intended for human Strongyles—fourth-stage larvae; consumption. Pinworms (adults and fourth-stage larvae)—Oxyuris equi; Ascarids (adults and [68 FR 55309, Sept. 25, 2003, as amended at 69 third- and fourth-stage larvae)— FR 49808, Aug. 12, 2004; 70 FR 65835, Nov. 1, 2005; 79 FR 37619, July 2, 2014] Parascaris equorum; Hairworms (adults)—Trichostrongylus axei; Large- § 520.1199 Ivermectin, pyrantel, and mouth Stomach Worms (adults)— praziquantel tablets. Habronema muscae; Bots (oral and gastric stages)—Gasterophilus spp.; (a) Specifications. Each chewable tab- Lungworms (adults and fourth-stage let contains: larvae)—Dictyocaulus arnfieldi; Intes- (1) 34 micrograms (mcg) ivermectin, tinal Threadworms (adults)— 28.5 milligrams (mg) pyrantel pamoate, Strongyloides westeri; Summer Sores and 28.5 mg praziquantel; caused by Habronema and Draschia spp. (2) 68 mcg ivermectin, 57 mg pyrantel cutaneous third-stage larvae; Derma- pamoate, and 57 mg praziquantel; titis caused by neck threadworm (3) 136 mcg ivermectin, 114 mg microfilariae, Onchocerca sp. pyrantel pamoate, and 114 mg (iii) For treatment and control of the praziquantel; or following parasites in horses over 5 (4) 272 mcg ivermectin, 228 mg months of age: Tapeworms— pyrantel pamoate, and 228 mg Anoplocephala perfoliata; Large praziquantel. Strongyles (adults)—Strongylus vulgaris (b) Sponsor. See No. 051311 in (also early forms in blood vessels), S. § 510.600(c) of this chapter. edentatus (also tissue stages), S. (c) Conditions of use in dogs—(1) equinus, Triodontophorus spp. including Amount. Administer monthly according T. brevicauda and T. serratus, and to body weight as follows: Craterostomum acuticaudatum; Small (i) 6 to 12 lb: one tablet as described Strongyles (adults, including those rein paragraph (a)(1) of this section. sistant to some benzimidazole class (ii) 12.1 to 25 lb: one tablet as de- compounds)—Coronocyclus spp. includ- scribed in paragraph (a)(2) of this sec- ing C. coronatus, C. labiatus, and C. tion. labratus; Cyathostomum spp. including C. catinatum and C. pateratum; (iii) 25.1 to 50 lb: one tablet as de- Cylicocyclus spp. including C. insigne, C. scribed in paragraph (a)(3) of this sec- leptostomum, C. nassatus, and C. tion. brevicapsulatus; Cylicodontophorus spp.; (iv) 50.1 to 100 lb: one tablet as de- Cylicostephanus spp. including C. scribed in paragraph (a)(4) of this sec- calicatus, C. goldi, C. longibursatus, and tion. C. minutus, and Petrovinema poculatum; (v) Greater than 100 lb: use the appro- Small Strongyles—fourth-stage larvae; priate combination of tablets. Pinworms (adults and fourth-stage lar- (2) Indications for use. Prevents ca- vae)—Oxyuris equi; Ascarids (adults and nine heartworm disease by eliminating third- and fourth-stage larvae)— the tissue stage of heartworm larvae Parascaris equorum; Hairworms (Dirofilaria immitis) for 1 month (30 (adults)—Trichostrongylus axei; Large- days) after infection and for the treat- mouth Stomach Worms (adults)— ment and control of roundworm Habronema muscae; Bots (oral and gas- (Toxocara canis, Toxascaris leonina), tric stages)—Gasterophilus spp. includ- hookworm (Ancylostoma caninum, ing G. intestinalis and G. nasalis; Uncinaria stenocephala, Ancylostoma Lungworms (adults and fourth-stage braziliense) and tapeworm (Dipylidium larvae)—Dictyocaulus arnfieldi; Intes- caninum, Taenia pisiformis) infections.

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(3) Limitations. Federal law restricts (2) Indications for use. For the treat- this drug to use by or on the order of a ment of bacterial enteritis caused by licensed veterinarian. organisms susceptible to kanamycin [71 FR 65052, Nov. 7, 2006, as amended at 78 and the symptomatic relief of the asso- FR 28822, May 20, 2014] ciated diarrhea. (3) Limitations. Federal law restricts § 520.1200 Ivermectin, fenbendazole, this drug to use by or on the order of a and praziquantel tablets. licensed veterinarian. (a) Specifications. Each chewable tab- [40 FR 13838, Mar. 27, 1975, as amended at 53 let contains either: FR 27851, July 25, 1988; 56 FR 8710, Mar. 1, (1) 68 micrograms (μg) ivermectin, 1991; 64 FR 403, Jan. 5, 1999; 71 FR 43968, Aug. 1.134 grams fenbendazole, and 57 milli- 3, 2006; 78 FR 28822, May 20, 2014] grams (mg) praziquantel; or (2) 27 μg ivermectin, 454 mg § 520.1242 Levamisole. fenbendazole, and 23 mg praziquantel. (b) Sponsor. See No. 000061 in § 520.1242a Levamisole powder. § 510.600(c) of this chapter. (a) Specifications. Each package of (c) Conditions of use in dogs—(1) powder contains 9.075, 11.7, 18.15, 46.8, Amount. Administer tablets to provide 362.7, or 544.5 grams (g) levamisole hy- μ 6 g per kilogram (/kg) ivermectin, 100 drochloride. mg/kg fenbendazole, and 5 mg/kg (b) Sponsors. See sponsors in praziquantel. § 510.600(c) for use as follows: (2) Indications for use. For the treat- (1) No. 000061 for use of 46.8- and 544.5- ment and control of adult Toxocara g packages as in paragraph (e)(1)(i), canis (roundworm), Ancylostoma (e)(1)(ii)(B), and (e)(1)(iii) of this sec- caninum (hookworm), Trichuris vulpis (whipworm), and Dipylidium caninum tion; for 11.7-, 46.8-, and 544.5-g pack- (tapeworm), and for the prevention of ages as in paragraph (e)(2)(i), heartworm disease caused by Dirofilaria (e)(2)(ii)(B), and (e)(2)(iii) of this sec- immitis in adult dogs. tion; and for an 18.15-g package as in (3) Limitations. Federal law restricts paragraph (e)(3) of this section. this drug to use by or on the order of a (2) No. 054771 for use of a 46.8-g pack- licensed veterinarian. age as in paragraph (e)(1)(i), (e)(1)(ii)(A), and (e)(1)(iii) of this sec- [73 FR 33692, June 13, 2008, as amended at 74 tion; for 11.7- and 46.8-g packages as in FR 61516, Nov. 25, 2009] paragraph (e)(2)(i), (e)(2)(ii)(A), and § 520.1204 Kanamycin, bismuth subcar- (e)(2)(iii) of this section; and for 9.075- bonate, activated attapulgite. and 18.15-g packages as in paragraph (e)(3) of this section. (a) Specifications—(1) Each 5 milli- (3) No. 057561 for use of 46.8- and 544.5- liters (mL) of suspension contains 100 milligrams (mg) kanamycin (as the g packages as in paragraphs (e)(1)(i), sulfate), 250 mg bismuth subcarbonate, (e)(1)(ii)(A), and (e)(1)(iii) and (e)(2)(i), and 500 mg activated attapulgite (alu- (e)(2)(ii)(A), and (e)(2)(iii) of this sec- minum magnesium silicate). tion. (2) Each tablet contains 100 mg (4) No. 059130 for use of 46.8-, 362.7-, kanamycin (as the sulfate), 250 mg bis- and 544.5-g packages as in paragraphs muth subcarbonate, and 500 mg acti- (e)(1)(i), (e)(1)(ii)(B), (e)(1)(iii), (e)(2)(i), vated attapulgite. (e)(2)(ii)(B), and (e)(2)(iii) of this sec- (b) Sponsor. See No. 054771 in tion; and for use of an 18.15-g package § 510.600(c) of this chapter. as in paragraph (e)(3) of this section. (c) Conditions of use in dogs—(1) (c) Related tolerances. See § 556.350 of Amount. 5 mL of suspension or 1 tablet this chapter. per 20 pounds body weight every 8 (d) Special considerations. See § 500.25 hours. Maximum dose: 5 mL of suspen- of this chapter. sion or 3 tablets every 8 hours. Dogs (e) Conditions of use. It is used as an under 10 pounds: 2.5 mL of suspension anthelmintic as follows: or 1⁄2 tablet every 8 hours. A rec- (1) Cattle—(i) Amount. 8 milligrams ommended initial loading dose should per kilogram (mg/kg) body weight as a be twice the amount of a single dose. drench.

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(ii) Indications for use—(A) Effective (Oesophagostomum spp.), intestinal against the following nematode infec- thread worms (Strongyloides ransomi) tions: Stomach worms (Haemonchus, and lungworms (Metastrongylus spp. ). Trichostrongylus, Ostertagia); intestinal (iii) Limitations. Do not administer worms (Trichostrongylus, Cooperia, within 72 hours of slaughter for food. Nematodirus, Bunostomum, Pigs maintained under conditions of Oesophagostomum); and lungworms constant exposure to worms may re- (Dictyocaulus). quire retreatment within 4 to 5 weeks (B) Effective against the following after the first treatment. Consult your adult nematode infections: Stomach veterinarian before administering to worms (Haemonchus placei, Ostertagia sick swine. ostertagi, Trichostrongylus axei); intes- [69 FR 9753, Mar. 2, 2004, as amended at 69 FR tinal worms (T. longispicularis, Cooperia 33839, June 17, 2004; 70 FR 2353, Jan. 13, 2005; oncophora, C. punctata, Nematodirus 77 FR 28253, May 14, 2012; 78 FR 28822, May 20, spathiger, Bunostomum phlebotomum, 2014] Oesophagostomum radiatum); and lungworms (Dictyocaulus viviparus). § 520.1242b Levamisol boluses or (iii) Limitations. Do not slaughter for oblets. food within 48 hours of treatment. Not (a) Specifications. Each bolus contains for use in dairy animals of breeding 2.19 grams levamisol hydrochloride. age. Conditions of constant helminth Each oblet contains 0.184 grams exposure may require retreatment 2 to levamisol hydrochloride. 4 weeks after the first treatment. Con- (b) Sponsors. See Nos. 000061 and sult your veterinarian before using in 054771 in § 510.600(c) of this chapter. severely debilitated animals. (c) Required labeling. Consult your (2) Sheep—(i) Amount. 8 mg/kg body veterinarian for assistance in the diag- weight as a drench. nosis, treatment, and control of para- (ii) Indications for use—(A) Effective sitism. against the following nematode infec- (d) Related tolerances. See § 556.350 of tions: Stomach worms (Haemonchus, this chapter. Trichostrongylus, Ostertagia); intestinal (e) Conditions of use—(1) Cattle—(i) worms (Trichostrongylus, Cooperia, Amount. Administer orally 2.19-gram Nematodirus, Bunostomum, boluses as a single dose as follows: 250 Oesophagostomum, Chabertia); and to 450 pounds, 1⁄2 bolus; 450 to 750 lungworms (Dictyocaulus). pounds, 1 bolus; and 750 to 1,050 pounds, (B) Effective against the following 11⁄2 boluses. adult nematode infections: Stomach (ii) Indications for use. Anthelmintic worms (Haemonchus contortus, effective against the following nema- Trichostrongylus axei, Teladorsagia tode infections: Stomach worms circumcincta); intestinal worms (Haemonchus, Trichostrongylus, (Trichostrongylus colubriformis, Cooperia Ostertagia), intestinal worms curticei, Nematodirus spathiger, (Trichostrongylus, Cooperia, Bunostomum trigonocephalum, Nematodirus, Bunostomum, Oesophagostomum columbianum, Oesophagostomum), and lungworms Chabertia ovina), and lungworms (Dictyocaulus). (Dictyocaulus filaria). (iii) Limitations. Conditions of con- (iii) Limitations. Do not slaughter for stant helminth exposure may require food within 72 hours of treatment. Con- re-treatment within 2 to 4 weeks after ditions of constant helminth exposure the first treatment. Do not slaughter may require retreatment 2 to 4 weeks for food within 48 hours of treatment. after the first treatment. Consult vet- Not for use in dairy animals of breed- erinarian before using in severely de- ing age. Consult veterinarian before bilitated animals. using in severely debilitated animals. (3) Swine—(i) Amount. 8 mg/kg body (2) Sheep—(i) Amount. Administer weight in drinking water. orally one 0.184-gram oblet for each 50 (ii) Indications for use. Effective pounds of body weight. against the following nematode infec- (ii) Indications for use. Anthelmintic tions: Large roundworms (Ascaris effective against the following nema- suum), nodular worms tode infections: Stomach worms

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(Haemonchus, Trichostrongylus, ounce (58.1 gram) packet contains Ostertagia), intestinal worms levamisole equivalent to 5.806 grams of (Trichostrongylus, Cooperia, levamisole hydrochloride. Nematodirus, Bunostomum, (b) Sponsor. See No. 043781 in Oesophagostomum, Chabertia), and § 510.600(c) of this chapter. lungworms (Dictyocaulus). (c) Related tolerances. See § 556.350 of (iii) Limitations. Conditions of con- this chapter. stant helminth exposure may require (d) Conditions of use. In swine it is re-treatment within 2 to 4 weeks after used as follows: the first treatment. Do not slaughter (1) Amount. The equivalent of 8 milli- for food within 72 hours of treatment. grams per kilogram of body weight, as Consult a veterinarian before using in a single dose, mixed in the animal’s ra- severely debilitated animals. tion. (2) Indications for use. For the re- [78 FR 28822, May 20, 2014] moval of and control of the following § 520.1242c Levamisol and piperazine. nematode infections: large roundworms (Ascaris suum), nodular worms (a) Specifications. (1) Each ounce of (Oesophagostomum spp.), lungworms solution contains 0.36 gram of (Metastrongylus spp.), intestinal levamisole hydrochloride and piper- threadworms (Strongyloides ransomi), azine dihydrochloride equivalent to 3.98 and swine kidney worms (Stephanurus grams of piperazine base. dentatum). (2) A soluble powder which when con- (3) Limitations. For pigs from weaning stituted with water contains in each to market weight, mix one 58.1-gram fluid ounce 0.45 gram of levamisole hy- packet of levamisole resinate con- drochloride and piperazine taining the equivalent of 10-percent dihydrochloride equivalent to 5.0 grams levamisole hydrochloride in 40 pounds of piperazine base. of feed and administer 1 pound of medi- (b) Sponsor. See No. 054771 in cated feed per 40 pounds of body weight § 510.600(c) of this chapter. as sole ration. For breeding swine, mix (c) Conditions of use in horses—(1) 1 packet of the 10-percent resinate in 16 Amount. Aqueous solution: administer pounds of feed and administer 1 pound by stomach tube or drench 1 fluid of medicated feed per 100 pounds of ounce per 100 pounds of body weight. body weight as sole ration. Administer Reconstituted soluble powder: admin- as single doses. Withhold regular feed ister by stomach tube 1 fluid ounce per overnight and administer medicated 125 pounds of body weight. If reinfec- feed the following morning. Do not tion occurs, re-treat animals at 6- to 8- withhold water during fasting. Do not week intervals. treat within 72 hours of slaughter. Sali- (2) Indications for use. An anthel- vation or muzzle foam may be ob- mintic effective against infections of served. The reaction will disappear a large strongyles (Strongylus vulgaris, S. short time after feeding. If pigs are in- edentatus), small strongyles fected with mature lungworms, (Cylicocercus spp., Cylicocyclus spp., coughing and vomiting may be ob- Cylicodontophorus spp., Cylicostephanus served. Consult your veterinarian for spp., Cylicotetrapedon spp.), ascarids assistance in the diagnosis, treatment, (Parascaris equorum), and pinworms and control of parasitism. (Oxyuris equi). (3) Limitations. Do not use in horses [43 FR 18171, Apr. 28, 1978, as amended at 45 intended for human consumption. Fed- FR 3574, Jan. 18, 1980] eral law restricts this drug to use by or § 520.1242e Levamisole hydrochloride on the order of a licensed veterinarian. effervescent tablets. [78 FR 28823, May 20, 2014] (a) Specifications. Each tablet contains 907 milligrams of levamisole hy- § 520.1242d Levamisole resinate. drochloride. (a) Specifications. The drug is (b) Sponsor. See No. 054771 in levamisole adsorbed on a resin, in a § 510.600(c) of this chapter. concentration equivalent to 10 percent (c) Related tolerances. See § 556.350 of levamisole hydrochloride. Each 2.05- this chapter.

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(d) Conditions of use. It is used for narian before using in severely debili- swine as follows: tated animals. (1) Amount. The equivalent of 8 milli- (2) Breeding swine—(i) Amount. Eight grams of levamisole hydrochloride per milligrams per kilogram of body kilogram of body weight, as a single weight (3.6 milligrams per pound) as a dose. single oral dose. (2) Indications for use. See (ii) Conditions of use. For treating § 520.1242a(f)(3)(ii). breeding swine infected with the fol- (3) Limitations. Withholding water lowing nematodes: Large roundworms from pigs before treatment is not nec- (Ascaris suum), nodular worms essary. Add one tablet for each 21⁄2 gal- (Oesophagostomum spp.), lungworms lons of water; mix thoroughly. Allow 1 (Metastrongylus spp.), intestinal gallon of medicated water for each 100 threadworms (Strongyloides ransomi), pounds body weight of pigs to be treat- and kidney worms (Stephanurus ed. No other source of water should be dentatus). offered. After pigs have consumed (iii) Limitations. May require retreat- medicated water, resume use of regular ment in 4 to 5 weeks. Do not use within water. Pigs maintained under condi- 11 days of slaughter for food. Consult tions of constant worm exposure may your veterinarian for assistance before require re-treatment within 4 to 5 using in severely debilitated animals weeks. Consult your veterinarian be- and in the diagnosis, treatment, and fore administering to sick swine. Con- control of parasitism. sult your veterinarian for assistance in [47 FR 22517, May 25, 1982; 47 FR 30242, July the diagnosis, treatment, and control 13, 1982, as amended at 48 FR 11429, Mar. 18, of parasitism. Do not administer with- 1983; 51 FR 29215, Aug. 15, 1986; 67 FR 63055, in 72 hours of slaughter for food. Oct. 10, 2002; 78 FR 28823, May 20, 2014] [45 FR 6087, Jan. 25, 1980, as amended at 67 § 520.1242g Levamisole resinate and FR 63055, Oct. 10, 2002; 78 FR 28823, May 20, famphur paste. 2014] (a) Specifications. The drug is a paste § 520.1242f Levamisol gel. containing 11.6 percent levamisole resinate (50 percent potency) and 23.6 per- (a) Specifications. Each gram of gel cent famphur. contains 115 milligrams (11.5 percent) (b) Sponsor. See 000061 in § 510.600(c) of levamisol hydrochloride. this chapter. (b) Sponsor. See No. 054771 in (c) Special considerations. Do not use § 510.600(c) of this chapter. any cholinesterase-inhibiting drugs, (c) Related tolerances. See § 556.350 of pesticides, insecticides, or chemicals this chapter. on cattle simultaneously or within a (d) Conditions of use—(1) Cattle—(i) few days before or after treatment with Amount. Eight milligrams of this product. levamisole hydrochloride per kilogram (d) Related tolerances. See §§ 556.273 of body weight, as a single oral dose. and 556.350 of this chapter. (ii) Indications for use. Anthelmintic (e) Conditions of use in cattle—(1) effective against the following nema- Amount. 8 milligrams of levamisole hy- tode infections: Stomach worms drochloride (equivalent) and 30 milli- (Haemonchus, Trichostrongylus, grams of famphur activity per kilo- Ostertagia), intestinal worms gram of body weight. (Trichostrongylus, Cooperia, (2) Indications for use. For treatment Nematodirus, Bunostomum, of cattle infected with the following Oesophagostomum), and lungworms parasites: Stomach worms (Dictyocaulus). (Haemonchus, Trichostrongylus, (iii) Limitations. Conditions of con- Ostertagia), intestinal worms stant helminth exposure may require (Trichostrongylus, Cooperia, re-treatment within 2 to 4 weeks after Nematodirus, Bunostomum, the first treatment; do not administer Oesophagostomum), lungworms to cattle within 6 days of slaughter for (Dictyocaulus), cattle grubs food; do not administer to dairy ani- (Hypoderma), biting lice (Bovicola), and mals of breeding age; consult veteri- sucking lice (Linognathus, Solenoptes).

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(3) Limitations. Drug is not effective (2) Nos. 054771, 054925, 061623, and against lice eggs. Conditions of con- 076475 for use as in paragraphs (d)(1) stant helminth and ectoparasitic expo- and (d)(2) of this section. sure may require retreatment within 2 (c) Tolerances. See § 556.360 of this to 4 weeks after first treatment. Do not chapter. administer to cattle within 19 days of (d) Conditions of use—(1) Swine—(i) slaughter. Do not administer to dairy Amount. 250 milligrams per gallon of animals of breeding age. Do not use in drinking water to provide 3.8 milli- calves less than 3 months old, or in de- grams per pound of body weight per bilitated animals. Do not treat Brah- day. man bulls. Consult your veterinarian for assistance in the diagnosis, treat- (ii) Indications for use. For the treatment, and control of parasitism. ment of swine dysentery (bloody scours). [53 FR 23757, June 24, 1988, as amended at 54 (iii) Limitations. Discard medicated FR 1353, Jan. 13, 1989; 57 FR 7652, Mar. 4, 1992; drinking water if not used within 2 62 FR 55160, Oct. 23, 1997; 62 FR 61625, Nov. 19, 1997; 78 FR 28823, May 20, 2014] days. Prepare fresh stock solution daily. Do not use for more than 10 days. § 520.1263 Lincomycin. If clinical signs of disease have not improved within 6 days, discontinue § 520.1263a Lincomycin tablets and treatment and reevaluate diagnosis. syrup. The safety of lincomycin has not been (a) Specifications. (1) Each ounce of demonstrated in pregnant swine or syrup contains lincomycin hydro- swine intended for breeding. For No. chloride equivalent to either 25 or 50 051259: Do not slaughter swine for 6 milligrams (mg) lincomycin. days following last treatment. (2) Each tablet contains lincomycin (2) Chickens—(i) Amount. 64 milli- hydrochloride equivalent to either 25 grams per gallon of drinking water. or 50 mg lincomycin. (ii) Indications for use. For the control (b) Sponsor. See No. 054771 in of necrotic enteritis caused by Clos- § 510.600(c) of this chapter. tridium perfringens susceptible to linco- (c) Conditions of use in dogs and cats— mycin in broiler chickens. (1) Amount. Administer orally 10 mg per (iii) Limitations. Discard medicated pound of body weight every 12 hours, or drinking water if not used within 2 7 mg per pound of body weight every 8 days. Prepare fresh stock solution hours, for up to 12 days. daily. Administer for 7 consecutive (2) Indications for use. For infections days. Do not allow rabbits, hamsters, caused by gram-positive organisms which are sensitive to its action, par- guinea pigs, horses, or ruminants ac- ticularly streptococci and cess to water containing lincomycin. staphylococci. Not for use in layer and breeder chick- (3) Limitations. Federal law restricts ens. this drug to use by or on the order of a (3) Honey bees—(i) Amount. Mix 100 licensed veterinarian. milligrams lincomycin with 20 grams confectioners’/powdered sugar and dust [78 FR 28823, May 20, 2014] over the top bars of the brood chamber once weekly for 3 weeks. § 520.1263b [Reserved] (ii) Indications for use. For the control § 520.1263c Lincomycin powder. of American foulbrood (Paenibacillus (a) Specifications. Each gram of solu- larvae). ble powder contains lincomycin hydro- (iii) Limitations. The drug should be chloride equivalent to 0.4 grams of lin- fed early in the spring or late in the comycin. fall and consumed by the bees before (b) Sponsors. See sponsor numbers in the main honey flow begins to avoid § 510.600(c) of this chapter for use as in contamination of production honey. paragraph (d) of this section. (1) No. 054771 for use as in paragraph (d) of this section.

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Complete treatments at least 4 weeks § 520.1284 Liothyronine. before main honey flow. (a) Specifications. Each tablet con- [48 FR 3966, Jan. 28, 1983, as amended at 55 tains 60 or 120 micrograms (μg) FR 3209, Jan. 31, 1990; 60 FR 14217, Mar. 16, liothyronine as the sodium salt. 1995; 62 FR 65020, Dec. 10, 1997; 64 FR 13341, (b) Sponsor. See No. 054771 in Mar. 18, 1999; 64 FR 13508, Mar. 19, 1999; 64 FR § 510.600(c) of this chapter. 66382, Nov. 26, 1999; 65 FR 10705, Feb. 29, 2000; 67 FR 17284, Apr. 10, 2002; 67 FR 71819, Dec. 3, (c) Conditions of use in dogs—(1) 2002; 67 FR 78356, Dec. 24, 2002; 68 FR 3817, Amount. Administer orally to dogs at Jan. 27, 2003; 70 FR 1818, Jan. 11, 2005; 77 FR levels up to 12.8 μg per kilogram (/kg) 20988, Apr. 9, 2012; 77 FR 29217, May 17, 2012; of body weight per day. Dosage should 78 FR 28823, May 20, 2014] be adjusted according to the severity of the condition and the response of the § 520.1265 Lincomycin and patient. Dosage at the total replace- spectinomycin powder. ment level (12.8 μg/kg of body weight) (a) Specifications. The following salts should be considered for initiating of lincomycin and spectinomycin are therapy and then titrated downward present in a soluble powder in the ratio for optimum maintenance effect. Twice of 1 to 2 on the basis of equivalency of daily administration is recommended. lincomycin base to equivalency of (2) Indications for use. For treatment spectinomycin base: of hypothyroidism in dogs. (1) Lincomycin hydrochloride (3) Limitations. Federal law restricts monohydrate and spectinomycin sul- this drug to use by or on the order of a fate tetrahydrate. licensed veterinarian. (2) Lincomycin hydrochloride [78 FR 28823, May 20, 2014] monohydrate and spectinomycin dihydrochloride pentahydrate. § 520.1288 Lufenuron tablets. (b) Sponsors. See sponsors in (a) —(1) Tablets con- § 510.600(c) of this chapter for use as in Specifications taining 45, 90, 204.9, or 409.8 milligrams paragraph (d) of this section. (mg) lufenuron for use as in paragraphs (1) No. 054771 for use of product de- (c)(1)(i), (c)(1)(ii)(A), (c)(1)(iii), (c)(2)(i), scribed in paragraph (a)(1) of this sec- (c)(2)(ii)(A), and (c)(2)(iii) of this section. tion. (2) Nos. 057561, 061623, and 066104 for (2) Flavored tablets containing 45, 90, use of product described in paragraph 204.9, or 409.8 milligrams (mg) (a)(2) of this section. lufenuron for use as in paragraphs (c) Tolerances. See §§ 556.360 and (c)(1)(i), (c)(1)(ii)(A) or (c)(1)(ii)(B), and 556.600 of this chapter. (c)(1)(iii) of this section. (d) Conditions of use in chickens—(1) (3) Flavored tablets containing 90 or Amount. 2 grams of antibiotic activity 204.9 mg lufenuron for use as in para- per gallon of drinking water; admin- graphs (c)(2)(i), (c)(2)(ii)(A) or ister as the sole source of water for the (c)(2)(ii)(B), and (c)(2)(iii) of this sec- first 5 to 7 days of life. tion. (2) Indications for use. As an aid in the (4) Flavored tablets containing 135 or control of airsacculitis caused by ei- 270 mg lufenuron for use as in para- ther Mycoplasma synoviae or M. graphs (c)(2)(i), (c)(2)(ii)(A), and gallisepticum susceptible to lincomycin- (c)(2)(iii) of this section. spectinomycin and complicated chron- (b) Sponsor. See No. 058198 in ic respiratory disease (air sac infec- § 510.600(c) of this chapter. tion) caused by Escherichia coli and M. (c) Conditions of use—(1) Dogs—(i) gallisepticum susceptible to lincomycin- Minimum of 10 mg lufenuron spectinomycin. Amount. per kilogram (4.5 mg per pound (lb)) of [69 FR 13220, Mar. 22, 2004, as amended at 70 body weight, once a month. FR 40881, July 15, 2005; 71 FR 71038, Dec. 8, (ii) Indications for use—(A) For the 2006; 77 FR 56770, Sept. 14, 2012; 78 FR 28823, prevention and control of flea popu- May 20, 2014] lations.

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(B) The concurrent use of flavored § 520.1310 Marbofloxacin. lufenuron tablets described in para- (a) Specifications. Each tablet con- graph (a)(2) of this section as in para- tains 25, 50, 100, or 200 milligrams (mg) graph (c)(1)(ii)(A) of this section with marbofloxacin. nitenpyram tablets as in § 520.1510(d)(1) of this chapter is indicated to kill (b) Sponsor. See No. 054771 in adult fleas and prevent flea eggs from § 510.600(c) of this chapter. hatching. (c) [Reserved] (d) Conditions of use—(1) Amount. 1.25 (iii) Limitations. For use in dogs and mg per pound (/lb) of body weight once puppies 4 weeks of age and older. daily, but may be increased to 2.5 mg/ (2) Cats—(i) Amount. Minimum of 30 lb of body weight once daily. mg lufenuron per kilogram (13.6 mg/lb) (2) Indications for use. For the treat- of body weight, once a month. ment of infections in dogs and cats as- (ii) Indications for use—(A) For the sociated with bacteria susceptible to control of flea populations. marbofloxacin. (B) The concurrent use of flavored (3) Limitations. Federal law restricts lufenuron tablets described in para- this drug to use by or on the order of a graph (a)(3) of this section as in para- licensed veterinarian. Federal law pro- graph (c)(2)(ii)(A) of this section with hibits the extralabel use of this drug in nitenpyram tablets as in § 520.1510(d)(2) food-producing animals. of this chapter is indicated to kill adult fleas and prevent flea eggs from [64 FR 39919, July 23, 1999, as amended at 66 hatching. FR 46369, Sept. 5, 2001; 78 FR 28823, May 20, (iii) Limitations. For use in cats and 2014] kittens 4 weeks of age and older. § 520.1315 Maropitant. [68 FR 51905, Aug. 29, 2003] (a) Specifications. Each tablet contains 16, 24, 60, or 160 milligrams (mg) § 520.1289 Lufenuron suspension. maropitant as maropitant citrate. (a) Specifications. Each individual (b) Sponsor. See No. 054771 in dose pack contains either 135 or 270 § 510.600(c) of this chapter. milligrams of lufenuron. (c) Conditions of use in dogs—(1) Indi- (b) Sponsor. See No. 058198 in cations for use and amount. (i) For pre- § 510.600(c) of this chapter. vention of acute vomiting in dogs 2 to (c) Conditions of use in cats—(1) 7 months of age, administer a min- Amount. Minimum of 13.6 milligrams imum dose of 2.0 mg per kilogram (/kg) per pound of body weight (30 milli- body weight once daily for up to 5 con- grams per kilogram). Recommended secutive days. dose of 135 milligrams for up to 10 (ii) For prevention of acute vomiting pounds of body weight or 270 milli- in dogs 7 months of age and older, ad- grams for 11 to 20 pounds. Cats over 20 minister a minimum dose of 2.0 mg/kg pounds are provided the appropriate body weight once daily until resolution combination of packs. of acute vomiting. (2) Indications for use. For control of (iii) For prevention of vomiting due flea populations. to motion sickness in dogs 4 months of (3) Limitations. For oral use in cats 6 age and older, administer a minimum weeks of age or older, once a month, of 8.0 mg/kg body weight once daily for mixed with food. Administer in con- up to 2 consecutive days. junction with a full meal to ensure ade- (2) Limitations. Federal law restricts quate absorption. Treat all cats in the this drug to use by or on the order of a household to ensure maximum bene- licensed veterinarian. fits. Because the drug has no affect on [72 FR 9243, Mar. 1, 2007, as amended at 78 FR adult fleas, the concurrent use of insec- 28823, May 20, 2014; 80 FR 53459, Sept. 4, 2015] ticides that kill adults may be necessary depending on the severity of the § 520.1320 Mebendazole. infestation. (a) Specifications. (1) Each gram of [60 FR 20402, Apr. 26, 1995, as amended at 62 powder contains either 40 or 166.7 milli- FR 8371, Feb. 25, 1997] grams of mebendazole.

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(2) Each gram of paste contains 200 nasalis), large roundworms (Parascaris milligrams of mebendazole. equorum), large strongyles (Strongylus (3) Each milliliter of suspension con- edentatus, S. equinus, S. vulgaris), small tains 33.3 milligrams of mebendazole. strongyles, and pinworms (Oxyuris (b) Sponsor. See No. 000061 in equi.) § 510.600(c) of this chapter. (3) Limitations. Do not use in horses (c) Conditions of use—(1) Horses—(i) intended for human consumption. Fed- Amount. 1 gram of mebendazole per 250 eral law restricts this drug to use by or pounds of body weight per dose, as an on the order of a licensed veterinarian. oral powder, paste or suspension. (ii) Indications for use. For treatment [45 FR 10759, Feb. 19, 1980, as amended at 46 FR 52330, Oct. 27, 1981. Redesignated at 51 FR of infections caused by large 13212, Apr. 18, 1986, as amended at 62 FR roundworms (Parascaris equorum); large 61625, Nov. 19, 1997; 78 FR 28824, May 20, 2014] strongyles (Strongylus edentatus, S. equinus, S. vulgaris); small strongyles; § 520.1326b Mebendazole and and mature and immature (4th larval trichlorfon paste. stage) pinworms (Oxyuris equi). (a) Specifications. Each gram of paste (iii) Limitations. The drug is compat- contains 100 milligrams of mebendazole ible with carbon disulfide. Do not use and 454 milligrams of trichlorfon. in horses intended for human consump- (b) Sponsor. See No. 000061 in tion. Federal law restricts this drug to § 510.600(c) of this chapter. use by or on the order of a licensed vet- (c) Conditions of use in horses—(1) erinarian. Amount. 8.8 milligrams of mebendazole (2) Dogs—(i) Amount. Administer 100 and 40 milligrams of trichlorfon per milligrams of mebendazole per 10 kilogram of body weight. pounds of body weight, once daily for 3 days, as an oral powder by mixing with (2) Indications for use. It is used in a small quantity of food, preferably be- horses for treatment of infections of fore the regular meal. bots (Gastrophilus intestinalis and G. na- (ii) Indications for use. The drug is salis), large roundworms (Parascaris used for treatment of infections of equorum), large strongyles (Strongylus roundworms (Toxocara canis), edentatus, S. equinus, S. vulgaris), small hookworms (Ancylostoma caninum, strongyles, and pinworms (Oxyuris Uncinaria stenocephala), whipworms equi). (Trichuris vulpis), and tapeworms (3) Limitations. Do not administer (Taenia pisiformis). more than once every 30 days. Do not (iii) Limitations. Federal law restricts treat sick or debilitated animals, foals this drug to use by or on the order of a under 4 months of age, or mares in the licensed veterinarian. last month of pregnancy. Trichlorfon is a cholinesterase inhibitor. Do not ad- [78 FR 28823, May 20, 2014] minister simultaneously or within a few days before or after treatment § 520.1326 Mebendazole and with, or exposure to, cholinesterase-in- trichlorfon oral dosage forms. hibiting drugs, pesticides, or chemi- § 520.1326a Mebendazole and cals. Do not administer intravenous trichlorfon powder. anesthetics, especially muscle relaxants, concurrently. Not for use in (a) Specifications. Each gram of pow- horses intended for food. Consult your der contains 83.3 milligrams of veterinarian for assistance in the diag- mebendazole and 375.0 milligrams of nosis, treatment, and control of para- trichlorofon. sitism. (b) Sponsor. See No. 000061 in § 510.600(c) of this chapter. [51 FR 13212, Apr. 18, 1986, as amended at 62 (c) Conditions of use in horses—(1) FR 61625, Nov. 19, 1997; 78 FR 28824, May 20, Amount. 8.8 milligrams of mebendazole 2014] and 40 milligrams of trichlorofon per kilogram of body weight. § 520.1330 Meclofenamic acid granules. (2) Indications for use. It is used in (a) Specifications. Each gram of gran- horses for the treatment of infections ules contains 5 milligrams (5 percent) of bots (Gastrophilus intestinalis and G. meclofenamic acid.

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(b) Sponsor. See No. 054771 in (2) Indications for use. For the post- § 510.600(c) of this chapter. ponement of estrus and the alleviation (c) Conditions of use in horses—(1) of false pregnancy in female dogs. Amount. Administer 1 milligram per (3) Limitations. Federal law restricts pound of body weight (1 gram per 1000 this drug to use by or on the order of a pounds) once daily for 5 to 7 days by licensed veterinarian. addition to the daily grain ration. [40 FR 13838, Mar. 27, 1975, as amended at 52 (2) Indications for use. For the treat- FR 7832, Mar. 13, 1987; 78 FR 28824, May 20, ment of acute or chronic inflammatory 2014] diseases involving the musculoskeletal system. § 520.1367 Meloxicam. (3) Limitations. Do not use in horses (a) Specifications—(1) Each milliliter intended for human consumption. Fed- of suspension contains 0.5 milligrams eral law restricts this drug to use by or (mg) meloxicam. on the order of a licensed veterinarian. (2) Each milliliter of suspension con- [78 FR 28824, May 20, 2014] tains 1.5 mg meloxicam. (b) Sponsors. See sponsors in § 520.1331 Meclofenamic acid tablets. § 510.600(c) of this chapter for uses as in (a) Specifications. Each tablet con- paragraph (c) of this section: tains either 10 or 20 milligrams of (1) No. 000010 for use of the products meclofenamic acid. described in paragraph (a) of this sec- (b) Sponsor. See No. 054771 in tion; and § 510.600(c) of this chapter. (2) Nos. 013744 and 055529 for use of (c) Conditions of use in dogs—(1) the product described in paragraph Amount. 1.1 milligrams per kilogram (a)(2) of this section. (0.5 milligram per pound) daily for 5 to (c) Conditions of use in dogs—(1) 7 days. Amount. Administer orally as a single (2) Indications for use. For the relief of dose at 0.09 mg per pound (mg/lb) body signs and symptoms of chronic inflam- weight (0.2 mg per kilogram (mg/kg)) matory disease involving the musculo- on the first day of treatment. For all skeletal system. treatment after day 1, administer 0.045 (3) Limitations. Federal law restricts mg/lb (0.1 mg/kg) body weight once this drug to use by or on the order of a daily. licensed veterinarian. (2) Indications for use. For the control of pain and inflammation associated [50 FR 43385, Oct. 25, 1985, as amended at 53 FR 23390, June 22, 1988; 78 FR 28824, May 20, with osteoarthritis. 2014] (3) Limitations. Federal law restricts this drug to use by or on the order of a § 520.1341 Megestrol. licensed veterinarian. (a) Specifications. Each tablet con- [68 FR 42968, July 21, 2003, as amended at 69 tains 5 or 20 milligrams of megestrol FR 69523, Nov. 30, 2004. Redesignated and acetate. amended at 78 FR 57058, Sept. 17, 2013; 80 FR (b) Sponsor. See No. 000061 in 53459, Sept. 4, 2015] § 510.600(c) of this chapter. (c) Conditions of use in dogs—(1) § 520.1372 Methimazole. Amount. Administer orally, intact, or (a) Specifications. Each tablet con- crushed and mixed with food as follows: tains 2.5 or 5 milligrams (mg) (i) For the postponement of estrus by methimazole. proestrus treatment: 1 milligram per (b) Sponsor. See No. 043264 in § 510.600 pound of body weight per day for 8 of this chapter. days. (c) Conditions of use in cats—(1) (ii) For the postponement of estrus Amount. The starting dose is 2.5 mg by anestrus treatment: 0.25 milligram every 12 hours. Following 3 weeks of per pound of body weight per day for 32 treatment, the dose should be titrated days. to effect based on individual serum (iii) For alleviation of false preg- total T4 levels and clinical response. nancy: 1 milligram per pound of body (2) Indications for use. For the treat- weight per day for 8 days. ment of hyperthyroidism.

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(3) Limitations. Federal law restricts (b) Sponsor. See No. 054771 in this drug to use by or on the order of a § 510.600(c) of this chapter. licensed veterinarian. (c) Conditions of use in dogs—(1) Amount. Under 15 pounds, 1⁄4 to 1 tablet [74 FR 27707, June 11, 2009] daily; 15 to 60 pounds, 1 to 2 tablets § 520.1380 Methocarbamol. daily; 60 pounds and over, 2 tablets daily. Administer total daily dose in (a) Specifications. Each tablet con- divided doses 6 to 10 hours apart, with tains 500 milligrams (mg) of a light feeding. When response is at- methocarbamol. tained, dosage should be gradually re- (b) Sponsor. See No. 054771 in duced until maintenance level is § 510.600(c) of this chapter. achieved. (c) Conditions of use in dogs and cats— (2) Indications for use. As an anti-in- (1) Amount. Administer 60 mg per pound flammatory and analgesic agent. of body weight in two or three equally (3) Limitations. Federal law restricts divided doses, followed each following this drug to use by or on the order of a day by 30 to 60 mg per pound of body licensed veterinarian. weight, usually not to exceed 14 to 21 days. [48 FR 21566, May 13, 1983, as amended at 78 (2) Indications for use. As an adjunct FR 28824, May 20, 2014] to therapy for acute inflammatory and traumatic conditions of the skeletal § 520.1422 Metoserpate hydrochloride. muscles in order to reduce muscular (a) Chemical name. Methyl-o-methyl- spasms. 18-epireserpate hydrochloride. (3) Limitations. Federal law restricts (b) Sponsor. See No. 054771 in this drug to use by or on the order of a § 510.600(c) of this chapter. licensed veterinarian. (c) Related tolerances. See § 556.410 of this chapter. [78 FR 28824, May 20, 2014] (d) Conditions of use. It is used in § 520.1408 Methylprednisolone. drinking water for replacement chickens as follows: (a) Specifications. Each tablet con- (1) Amount. 568.5 milligrams per gal- tains 1, 2, or 4 milligrams (mg) of lon (0.015 percent). methylprednisolone. (i) Indications for use. As a tranquil- (b) Sponsors. See sponsors in izer for flock treatment of chickens § 510.600(c) of this chapter. prior to handling. (1) No. 054628 for use of 1- and 2-mg (ii) Limitations. To be used one time tablets. as a treatment for replacement chick- (2) No. 054771 for use of 1- and 4-mg ens up to 16 weeks of age; usual drink- tablets. ing water should be withheld prior to (c) Conditions of use in dogs and cats— treatment to provide adequate con- (1) Amount. 5 to 15 pounds (lbs): 2 mg; 15 sumption of medicated drinking water; to 40 lbs: 2 to 4 mg; 40 to 80 lbs: 4 to 8 not for use in laying chickens; chick- mg. Administer total daily dose orally ens slaughtered within 72 hours fol- in equally divided doses 6 to 10 hours lowing treatment must not be used for apart until response is noted or 7 days food. have elapsed. (2) Amount. 2 to 4 milligrams per 2.2 (2) Indications for use. As an anti-in- pounds of body weight. flammatory agent. (i) Indications for use. As an aid in (3) Limitations. Federal law restricts control of hysteria. this drug to use by or on the order of a (ii) Limitations. To be used as a treat- licensed veterinarian. ment for replacement chickens up to 16 [78 FR 28824, May 20, 2014] weeks of age; usual drinking water should be withheld prior to treatment § 520.1409 Methylprednisolone and as- to provide adequate consumption of pirin. medicated drinking water; the drug (a) Specifications. Each tablet con- should be administered at a dosage tains 0.5 milligram of level of 4 milligrams per 2.2 pounds of methylprednisolone and 300 milligrams body weight followed by 2 treatments of aspirin. at 4-day intervals of 2 milligrams per

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2.2 pounds of body weight; not for use adult roundworm infections caused by in laying chickens; chickens slaugh- Toxocara canis and Toxascaris leonina tered within 72 hours following treat- and whipworm infections caused by ment must not be used for food. Trichuris vulpis in dogs and in puppies 4 [40 FR 13838, Mar. 27, 1975, as amended at 76 weeks of age or greater and 2 pounds of FR 17337, Mar. 29, 2011; 78 FR 28824, May 20, body weight or greater. 2014] (iii) Limitations. Do not use in puppies less than 4 weeks of age and less than § 520.1430 Megestrol acetate tablets. 2 pounds of body weight. Administer (a) Specifications. Each milliliter con- once a month. First dose given within tains 100 micrograms of mibolerone. 1 month after first exposure to mosqui- (b) Sponsor. See No. 054771 in toes and continue regular use until at § 510.600(c) of this chapter. least 1 month after end of mosquito (c) Conditions of use in dogs—(1) season. Federal law restricts this drug Amount. 30 micrograms for animals to use by or on the order of a licensed weighing 1 to 25 pounds; 60 micrograms veterinarian. for animals weighing 26 to 50 pounds; (2) Cats and kittens—(i) Amount. 0.91 120 micrograms for animals weighing 51 milligram per pound of body weight (2.0 to 100 pounds; 180 micrograms for ani- milligrams per kilogram). mals weighing over 100 pounds, German (ii) Indications for use. For prevention Shepherds, or German Shepherd mix. of heartworm disease caused by Administer daily, orally or in a small Dirofilaria immitis and the removal of amount of food, at least 30 days before adult Toxocara cati (roundworm) and expected initiation of heat, and con- Ancylostoma tubaeforme (hookworm) in- tinue daily as long as desired, but not fections in cats 6 weeks of age or great- for more than 24 months. er and 1.5 pounds body weight or great- (2) Indications for use. For the preven- er. tion of estrus (heat) in adult female (iii) Limitations. Do not use in kittens dogs not intended primarily for breed- less than 6 weeks of age or 1.5 pounds ing purposes. body weight. Administer once a month. (3) Limitations. Federal law restricts Federal law restricts this drug to use this drug to use by or on the order of a by or on the order of a licensed veteri- licensed veterinarian. narian. [43 FR 15625, Apr. 14, 1978, as amended at 78 [55 FR 25301, June 21, 1990, as amended at 55 FR 28824, May 20, 2014] FR 49888, Dec. 3, 1990; 58 FR 5608, Jan. 22, 1993; 60 FR 50097, Sept. 28, 1995; 61 FR 43654, § 520.1441 Milbemycin oxime. Aug. 26, 1996; 63 FR 29352, May 29, 1998; 63 FR (a) Specifications—(1) Dogs. Each tab- 41189, Aug. 3, 1998. Redesignated at 77 FR let contains 2.3, 5.75, 11.5, or 23.0 milli- 47512, Aug. 9, 2012] grams of milbemycin oxime. (2) Cats. Each tablet contains 5.75, § 520.1443 Milbemycin oxime and lufenuron. 11.5, or 23.0 milligrams of milbemycin oxime. (a) Specifications—(1) Tablets con- (b) Sponsor. See 058198 in § 510.600(c) of taining: 2.3 milligrams (mg) this chapter. milbemycin oxime and 46 mg (c) [Reserved] lufenuron, 5.75 mg milbemycin oxime (d) Conditions of use—(1) Dogs and and 115 mg lufenuron, 11.5 mg puppies—(i) Amount. For hookworm, milbemycin oxime and 230 mg roundworm, and whipworm, use 0.23 lufenuron, or 23 mg milbemycin oxime milligram per pound of body weight (0.5 and 460 mg lufenuron. milligram per kilogram). For heart- (2) Flavored tablets containing: 2.3 worm, use 0.05 milligram per pound of mg milbemycin oxime and 46 mg body weight (0.1 milligram per kilo- lufenuron, 5.75 mg milbemycin oxime gram). and 115 mg lufenuron, 11.5 mg (ii) Indications for use. For prevention milbemycin oxime and 230 mg of heartworm disease caused by lufenuron, or 23 mg milbemycin oxime Dirofilaria immitis, control of hookworm and 460 mg lufenuron. infections caused by Ancylostoma (b) Sponsor. See No. 051311 in caninum, and removal and control of § 510.600(c) of this chapter.

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(c) [Reserved] caninum), adult whipworm (Trichuris (d) Conditions of use—(1) Dogs—(i) vulpis), and adult tapeworm (Taenia Amount. 0.5 mg milbemycin oxime and pisiformis, Echinococcus multilocularis, 10 mg lufenuron per kilogram of body and E. granulosus) infections in dogs weight, once a month. and puppies 2 pounds of body weight or (ii) Indications for use—(A) For use in greater and 6 weeks of age and older. dogs and puppies for the prevention of (iii) Limitations. Federal law restricts heartworm disease caused by Dirofilaria this drug to use by or on the order of a immitis, for prevention and control of licensed veterinarian. flea populations, for control of adult (2) [Reserved] Ancylostoma caninum (hookworm), and for removal and control of adult [77 FR 47512, Aug. 9, 2012] Toxocara canis, Toxascaris leonina (roundworm), and Trichuris vulpis § 520.1447 Milbemycin oxime, (whipworm) infections. lufenuron, and praziquantel tablets. (B) The concurrent use of flavored (a) Specifications. Each tablet con- milbemycin oxime and lufenuron tab- tains: lets described in paragraph (a)(2) of (1) 2.3 milligrams (mg) milbemycin this section as in paragraph (d)(1)(ii)(A) oxime, 46 mg lufenuron, and 22.8 mg of this section with nitenpyram tablets praziquantel; as in § 520.1510(d)(1) of this chapter is indicated to kill adult fleas and pre- (2) 5.75 mg milbemycin oxime, 115 mg vent flea eggs from hatching. lufenuron, and 57 mg praziquantel; (iii) Limitations. Federal law restricts (3) 11.5 mg milbemycin oxime, 230 mg this drug to use by or on the order of a lufenuron, and 114 mg praziquantel; or licensed veterinarian. (4) 23 mg milbemycin oxime, 460 mg (2) [Reserved] lufenuron, and 228 mg praziquantel. (b) Sponsor. See No. 051311 in [62 FR 28629, May 27, 1997, as amended at 63 FR 41190, Aug. 3, 1998; 68 FR 51905, Aug. 29, § 510.600(c) of this chapter. 2003. Redesignated at 77 FR 47512, Aug. 9, (c) [Reserved] 2012, as amended at 80 FR 18776, Apr. 8, 2015] (d) Conditions of use—(1) Dogs—(i) Amount. 0.5 mg milbemycin oxime, 10 § 520.1445 Milbemycin oxime and mg lufenuron, and 5 mg of praziquantel praziquantel. per kilogram of body weight, once a (a) Specifications. Each chewable tab- month. let contains: (ii) Indications for use. For the pre- (1) 2.3 milligrams (mg) milbemycin vention of heartworm disease caused oxime and 22.8 mg praziquantel; by Dirofilaria immitis; for the prevention (2) 5.75 mg milbemycin oxime and 57 mg praziquantel; and control of flea populations (3) 11.5 mg milbemycin oxime and 114 (Ctenocephalides felis); and for the treat- mg praziquantel; or ment and control of adult roundworm (4) 23 mg milbemycin oxime and 228 (Toxocara canis, Toxascaris leonina), mg praziquantel. adult hookworm (Ancylostoma (b) Sponsor. See No. 058198 in caninum), adult whipworm (Trichuris § 510.600(c) of this chapter. vulpis), and adult tapeworm (Taenia (c) Conditions of use—(1) Dogs—(i) pisiformis, Echinococcus multilocularis, Amount. Administer orally, once a and E. granulosus) infections in dogs month, a minimum dosage of 0.23 mg and puppies 2 pounds of body weight or per pound (mg/lb) of body weight (0.5 greater and 6 weeks of age and older. mg per kilogram (mg/kg)) milbemycin (iii) Limitations. Federal law restricts oxime and 2.28 mg/lb of body weight (5 this drug to use by or on the order of a mg/kg) praziquantel. licensed veterinarian. (ii) Indications for use. For the pre- (2) [Reserved] vention of heartworm disease caused by Dirofilaria immitis and for the treat- [77 FR 4225, Jan. 27, 2012, as amended at 80 ment and control of adult roundworm FR 18776, Apr. 8, 2015] (Toxocara canis, Toxascaris leonina), adult hookworm (Ancylostoma

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§ 520.1450 Morantel tartrate oral dos- (2) Indications for use. For control of age forms. the adult stage of the following gastrointestinal nematode infections in § 520.1450a Morantel tartrate bolus. weaned calves and yearling cattle (a) Specifications. Each bolus contains weighing a minimum of 200 pounds: 2.2 grams morantel tartrate equivalent Ostertagia spp., Trichostrongylus axei, to 1.3 grams of morantel base. Cooperia spp., and Oesophagostomum (b) Sponsor. See No. 054771 in radiatum. § 510.600(c) of this chapter. (3) Limitations. Administer orally (c) Related tolerances. See § 556.425 of with the dosing gun to all cattle that this chapter. will be grazing the same pasture. Effec- (d) Conditions of use—(1) Amount. One tiveness of the drug product is depend- bolus per 500 pounds of body weight (4.4 ent upon continuous control of the gas- milligrams per pound of body weight) trointestinal parasites for approxi- as a single oral dose. Boluses may be mately 90 days following administra- divided in half for more accurate dos- tion. Therefore, treated cattle should ing as follows: up to 325 pounds, 1⁄2 not be moved to pastures grazed in the bolus; 326 to 600 pounds, 1 bolus; 601 to same grazing season/calendar year by 900 pounds, 11⁄2 boluses; and 901 to 1,200 pounds, 2 boluses. untreated cattle. Do not administer to (2) Indications for use. For removal cattle within 106 days of slaughter. and control of mature gastrointestinal Consult your veterinarian before ad- nematode infections of cattle including ministering to severely debilitated ani- stomach worms (Haemonchus spp., mals and for assistance in the diag- Ostertagia spp., Trichostrongylus spp.), nosis, treatment, and control of para- worms of the small intestine (Cooperia sitism. spp., Trichostrongylus spp., Nematodirus [49 FR 47831, Dec. 7, 1984, as amended at 51 spp.), and worms of the large intestine FR 23415, June 27, 1986; 51 FR 41081, Nov. 13, (Oesophagostomum radiatum). 1986; 78 FR 28825, May 20, 2014] (3) Limitations. Conditions of constant worm exposure may require retreat- § 520.1450c Morantel tartrate sus- ment in 2 to 4 weeks. Consult your vet- tained-release trilaminate cylinder/ erinarian before administering to se- sheet. verely debilitated animals and for as- (a) Specifications. The drug product sistance in the diagnosis, treatment, consists of a trilaminated, perforated, and control of parasitism. Do not treat plastic sheet formed into a cylinder within 14 days of slaughter. having plastic plugs in its ends. The [46 FR 50949, Oct. 16, 1981. Redesignated at 49 core lamina contains 19.8 grams of FR 47831, Dec. 7, 1984, and amended at 51 FR morantel tartrate equivalent to 11.8 9005, Mar. 17, 1986; 78 FR 28825, May 20, 2014] grams of morantel base. (b) Sponsor. See 054771 in § 510.600(c) of § 520.1450b Morantel tartrate cartridge. this chapter. (c) Related tolerances. See § 556.425 of (a) Specifications. The drug product this chapter. consists of a stainless-steel cylinder (d) Conditions of use—(1) Amount. having both ends closed with poly- Grazing cattle: Administer 1 cartridge ethylene diffusing discs and containing to each animal at the start of the graz- a morantel tartrate paste. The paste contains 22.7 grams of morantel tar- ing season. trate equivalent to 13.5 grams of (2) Indications for use. For control of morantel base. the adult stage of the following gastro- (b) Sponsor. See No. 054771 in intestinal nematode infections in § 510.600(c) of this chapter. weaned calves and yearling cattle (c) Related tolerances. See § 556.425 of weighing a minimum of 200 pounds: this chapter. Ostertagia spp., Trichostrongylus axei, (d) Conditions of use—(1) Amount. Cooperia spp., and Oesophagostomum Grazing cattle: Administer 1 cartridge radiatum. to each animal at the start of the graz- (3) Limitations. Administer orally ing season. with the dosing gun to all cattle that

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will be grazing the same pasture. Effec- catinatum and C. pateratum; tiveness of the drug product is depend- Cylicocyclus. spp., including C. insigne, ent upon continuous control of the gas- C. leptostomum, C. nassatus, and C. trointestinal parasites for approxi- radiatus; Cyliocostephanus spp., includ- mately 90 days following administra- ing C. calicatus, C. goldi, C. tion. Therefore, treated cattle should longibursatus, and C. minutus; not be moved to pastures grazed in the Coronocyclus spp., including C. same grazing season/calendar year by coronatus, C. labiatus, and C. labratus; untreated cattle. Do not administer to Gyalocephalus capitatus; and cattle within 102 days of slaughter. Petrovinema poculatus; small Consult your veterinarian before ad- strongyles: undifferentiated lumenal ministering to severely debilitated ani- larvae; encysted cyathostomes (late L3 mals and for assistance in the diag- and L4 mucosal cyathostome larvae); nosis, treatment, and control of para- ascarids: Parascaris equorum (adults and sitism. L4 larval stages); pinworms: Oxyuris equi (adults and L4 larval stages); [56 FR 13396, Apr. 2, 1991, as amended at 78 FR 28825, May 20, 2014] hairworms: Trichostrongylus axei (adults); large-mouth stomach worms: § 520.1451 Moxidectin tablets. Habronema muscae (adults); and horse stomach bots: Gasterophilus intestinalis (a) Specifications. Each tablet con- (2nd and 3rd instars) and G. nasalis (3rd tains 30, 68, or 136 micrograms of instars). One dose also suppresses moxidectin. strongyle egg production for 84 days. (b) Sponsor. See No. 054771 in (3) Limitations. Do not use in horses § 510.600(c) of this chapter. intended for human consumption. (c) Conditions of use—(1) Amount. 3 micrograms per kilogram (1.36 [62 FR 42902, Aug. 11, 1997, as amended at 64 micrograms per pound) of body weight. FR 66105, Nov. 24, 1999; 68 FR 51445, Aug. 27, (2) Indications for use. To prevent in- 2003; 69 FR 24959, May 5, 2004; 70 FR 75017, fection by the canine heartworm Dec. 19, 2005; 78 FR 28825, May 20, 2014] Dirofilaria immitis and the subsequent § 520.1453 Moxidectin and development of canine heartworm dis- praziquantel gel. ease. (a) Specifications. Each milliliter of (3) Limitations. Federal law restricts gel contains 20 milligrams (mg) (2.0 this drug to use by or on the order of a percent) moxidectin and 125 mg (12.5 licensed veterinarian. percent) praziquantel. [62 FR 37713, July 15, 1997, as amended at 78 (b) Sponsor. See No. 054771 in FR 28825, May 20, 2014] § 510.600(c) of this chapter. (c) Special considerations. See § 500.25 § 520.1452 Moxidectin gel. of this chapter. (a) Specifications. Each milliliter of (d) Conditions of use in horses and gel contains 20 milligrams (2 percent) ponies—(1) Amount. Administer by moxidectin. mouth as a single dose: 0.4 mg (b) Sponsor. See No. 054771 in moxidectin per kilogram and 2.5 mg § 510.600(c) of this chapter. praziquantel per kilogram (2.2 pounds) (c) Special considerations. See § 500.25 body weight. of this chapter. (2) Indications for use. For the treat- (d) Conditions of use in horses and ment and control of large strongyles: ponies—(1) Amount. 0.4 milligram Strongylus vulgaris (adults and L4/L5 ar- moxidectin per kilogram (2.2 pounds) of terial stages), S. edentatus (adult and body weight. tissue stages), Triodontophorus (2) Indications for use. For the treat- brevicauda (adults), and T. serratus ment and control of large strongyles: (adults); small strongyles (adults): Strongylus vulgaris (adults and L4/L5 ar- (Cyathostomum spp., including C. terial stages), S. edentatus (adult and catinatum and C. pateratum; Cylicocyclus tissue stages), Triodontophorus spp., including C. insigne, C. brevicauda (adults), and T. serratus leptostomum, C. nassatus, and C. (adults); small strongyles (adults): radiatus; Cylicostephanus spp., including Cyathostomum spp., including C. C. calicatus, C. goldi, C. longibursatus,

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and C. minutus; Coronocyclus spp., in- § 520.1468 Naproxen. cluding C. coronatus, C. labiatus, and C. (a) Specifications. Each gram of gran- labratus; Gyalocephalus capitatus; and ules contains 500 milligrams (mg) (50 Petrovinema poculatus; small percent) naproxen. strongyles: undifferentiated lumenal (b) Sponsor. See No. 054771 in larvae; encysted cyathostomes (late L3 § 510.600(c) of this chapter. and L4 mucosal cyathostome larvae); ascarids: Parascaris equorum (adults and (c) Conditions of use in horses—(1) Amount. 10 mg per kilogram of body L4 larval stages); pinworms: Oxyuris weight twice daily top dressed on feed equi (adults and L4 larval stages); for up to 14 consecutive days. hairworms: Trichostrongylus axei (adults); large-mouth stomach worms: (2) Indications for use. For the relief of Habronema muscae (adults); horse stom- inflammation and associated pain and ach bots: Gasterophilus intestinalis (2nd lameness exhibited with arthritis, as well as myositis and other soft tissue and 3rd instars) and G. nasalis (3rd diseases of the musculoskeletal sys- instars); and tapeworms: Anoplocephala tem. perfoliata (adults). One dose also suppresses strongyle egg production for 84 (3) Limitations. Do not use in horses days. intended for human consumption. Fed- eral law restricts this drug to use by or (3) Limitations. Do not use in horses on the order of a licensed veterinarian. intended for human consumption. [78 FR 28825, May 20, 2014] [68 FR 51446, Aug. 27, 2003, as amended at 69 FR 21956, Apr. 23, 2004; 70 FR 75017, Dec. 19, § 520.1484 Neomycin. 2005; 78 FR 28825, May 20, 2014] (a) Specifications—(1) Each ounce of § 520.1454 Moxidectin solution. powder contains 20.3 grams (g) neomy- (a) Specifications. Each milliliter cin sulfate (equivalent to 14.2 g neomy- (mL) of solution contains 1 milligram cin base). (mg) moxidectin. (2) Each milliliter of solution con- (b) Sponsor. See No. 000010 in tains 200 milligrams (mg) neomycin sulfate (equivalent to 140 mg neomycin § 510.600(c) of this chapter. base). (c) Related tolerances. See § 556.426 of (b) Sponsors. See sponsors in this chapter. § 510.600(c) of this chapter for use as in (d) Special considerations. See § 500.25 paragraph (e) of this section. of this chapter. (1) Nos. 054771 and 054925 for use of (e) Conditions of use in sheep—(1) product described in paragraph (a)(1) as Amount. Administer 1 mL per 11 pounds in paragraph (e)(1) of this section. body weight (1 mL per 5 kilograms) by (2) Nos. 054771, 058005, and 061623 for mouth. use of product described in paragraph (2) Indications for use. For the treat- (a)(1) as in paragraphs (e)(1) and (e)(2) ment and control of the adult and L4 of this section. larval stages of Haemonchus contortus, (3) Nos. 000859, 054771, 054925, and Teladorsagia circumcincta, T. trifurcata, 058005 for use of product described in Trichostrongylus axei, T. colubriformis, T. paragraph (a)(2) as in paragraph (e)(1) vitrinus, Cooperia curticei, C. oncophora, of this section. , Oesophagostomum columbianum O. (c) Related tolerances. See § 556.430 of venulosum, Nematodirus battus, N. this chapter. filicollis, and N. spathiger. (d) Special labeling considerations. La- (3) Limitations. Sheep must not be beling shall bear the following warning slaughtered for human consumption statements: ‘‘A withdrawal period has within 7 days of treatment. Because a not been established for use in withholding time in milk has not been preruminating calves. Do not use in established for this product, do not use calves to be processed for veal. Use of in female sheep providing milk for more than one product containing neo- human consumption. mycin or failure to follow withdrawal [70 FR 76163, Dec. 23, 2005, as amended at 76 times may result in illegal drug resi- FR 48714, Aug. 9, 2011] dues.’’

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(e) Conditions of use—(1) Cattle, swine, shall be by or on the order of a licensed sheep, and goats—(i) Amount. 10 mg per veterinarian. pound (/lb) of body weight per day (22 (d) Conditions of use—(1) Dogs—(i) mg per kilogram (/kg)) in divided doses Amount—(A) One 11.4-mg tablet for for a maximum of 14 days. dogs weighing less than 25 pounds (lb) (ii) Indications for use. For the treat- or one 57-mg tablet for dogs weighing ment and control of colibacillosis (bac- more than 25 lb, as needed, for use as in terial enteritis) caused by Escherichia paragraph (d)(1)(ii)(A) of this section. coli susceptible to neomycin sulfate. (B) One 11.4-mg tablet for dogs weigh- (iii) Limitations. Add powder to drinking less than 25 lb or one 57 mg tablet ing water or milk; not for use in liquid for dogs weighing more than 25 lbs, supplements. Administer solution undi- once or twice weekly, for use as in luted or in drinking water. Prepare a paragraph (d)(1)(ii)(B) of this section. fresh solution in drinking water daily. (ii) Indications for use—(A) For the If symptoms persist after using this treatment of flea infestations on dogs preparation for 2 or 3 days, consult a and puppies 4 weeks of age and older veterinarian. Treatment should con- and 2 lbs of body weight or greater. tinue 24 to 48 hours beyond remission of disease symptoms, but not to exceed (B) The concurrent use of nitenpyram a total of 14 consecutive days. Dis- tablets as in paragraph (d)(1)(i)(B) of continue treatment prior to slaughter this section with either flavored as follows: Cattle, 1 day; sheep, 2 days; lufenuron tablets as in § 520.1288(c)(1) of swine and goats, 3 days. this chapter or flavored milbemycin (2) Turkeys—(i) Amount. 10 mg/lb of and lufenuron tablets as in body weight per day (22 mg/kg) for 5 § 520.1443(d)(1) is indicated to kill adult days. fleas and prevent flea eggs from hatch- (ii) Indications for use. For the control ing. of mortality associated with E. coli sus- (2) Cats—(i) Amount—(A) One 11.4-mg ceptible to neomycin sulfate in grow- tablet, as needed, for use as in para- ing turkeys. graph (d)(2)(ii)(A) of this section. (iii) Limitations. Add to drinking (B) One 11.4-mg tablet, once or twice water; not for use in liquid supple- weekly, for use as in paragraph ments. Prepare a fresh solution daily. (d)(2)(ii)(B) of this section. If symptoms persist after using this (ii) Indications for use—(A) For the preparation for 2 or 3 days, consult a treatment of flea infestations on cats veterinarian. Treatment should con- and kittens 4 weeks of age and older tinue 24 to 48 hours beyond remission and 2 lbs of body weight or greater. of disease symptoms, but not to exceed (B) The concurrent use of nitenpyram a total of 5 consecutive days. tablets as in paragraph (d)(2)(i)(B) of [71 FR 56866, Sept. 28, 2006, as amended at 71 this section with flavored lufenuron FR 68738, Nov. 28, 2006; 78 FR 17596, Mar. 22, tablets as in § 520.1288(c)(2) of this chap- 2013; 78 FR 28825, May 20, 2014] ter is indicated to kill adult fleas and prevent flea eggs from hatching. § 520.1510 Nitenpyram. (a) Specifications. Each tablet con- [68 FR 51906, Aug. 29, 2003, as amended at 80 FR 18776, Apr. 8, 2015] tains 11.4 or 57 milligrams (mg) nitenpyram. § 520.1604 Oclacitinib. (b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter: (a) Specifications. Each tablet con- (1) No. 058198 for use as in paragraphs tains 3.6, 5.4, or 16 milligrams (mg) of (d)(1)(i)(A), (d)(1)(ii)(A), and (d)(2) of oclacitinib as oclacitinib maleate. this section. (b) Sponsor. See No. 054771 in (2) No. 051311 for use as in paragraphs § 510.600(c) of this chapter. (d)(1)(i)(B) and (d)(1)(ii)(B) of this sec- (c) Conditions of use—(1) Amount. Ad- tion. minister orally 0.18 to 0.27 mg/per (c) Special considerations. The concur- pound of body weight (0.4 to 0.6 mg/kg rent use of nitenpyram tablets and fla- body weight) twice daily for up to 14 vored milbemycin/lufenuron tablets as days; then administered once daily for in paragraph (d)(1)(ii)(B) of this section maintenance therapy.

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(2) Indications for use. For control of (3) Limitations. Federal law restricts pruritus associated with allergic der- this drug to use by or on the order of a matitis and control of atopic derma- licensed veterinarian. Federal law pro- titis in dogs at least 12 months of age. hibits the extralabel use of this drug in (3) Limitations. Federal law restricts food producing animals. this drug to use by or on the order of a licensed veterinarian. [71 FR 14643, Mar. 23, 2006, as amended at 75 FR 26646, May 12, 2010] [78 FR 42007, July 15, 2013] § 520.1618 Orbifloxacin suspension. § 520.1615 Omeprazole. (a) Specifications. Each milliliter of (a) Specifications. Each gram of paste suspension contains 30 milligrams (mg) contains 0.37 gram omeprazole. orbifloxacin. (b) Sponsor. See No. 050604 in (b) Sponsor. See No. 000061 in § 510.600(c) of this chapter. 510.600(c) of this chapter. (c) Special considerations. When la- (c) Special considerations. Federal law beled for use as in paragraph (d)(2)(i) of restricts this drug to use by or on the this section, product labeling shall order of a licensed veterinarian. Fed- bear: ‘‘Federal law restricts this drug eral law prohibits the extralabel use of to use by or on the order of a licensed this drug in food-producing animals. veterinarian.’’ (d) Conditions of use—(1) Dogs—(i) (d) Conditions of use in horses—(1) Amount. 1.1 to 3.4 mg/lb (2.5 to 7.5 mg/ Amount—(i) For treatment of gastric kg) of body weight once daily. ulcers, 1.8 milligrams per pound (mg/lb) (ii) Indications for use. For the treat- of body weight (4 milligrams per kilo- ment of urinary tract infections (cys- gram (mg/kg)) once daily for 4 weeks. titis) in dogs caused by susceptible For prevention of recurrence of gastric strains of Staphylococcus ulcers, 0.9 mg/lb of body weight (2 mg/ pseudintermedius, Proteus mirabilis, Esch- kg) once daily for at least an addi- erichia coli, and Enterococcus faecalis tional 4 weeks. and skin and soft tissue infections (ii) For prevention of gastric ulcers (wounds and abscesses) in dogs caused using the premarked syringe, one dose by susceptible strains of Staphylococcus per day for 8 or 28 days. Each dose de- pseudintermedius, Staphylococcus aureus, livers at least 1 mg/kg of body weight. coagulase-positive staphylococci, Horses over 1,200 lb body weight should Pasteurella multocida, Proteus mirabilis, receive two doses per day. Pseudomonas spp., Klebsiella (2) Indications for use. (i) For treat- pneumoniae, E. coli, Enterobacter spp., ment and prevention of recurrence of Citrobacter spp., E. faecalis, b-hemolytic gastric ulcers in horses and foals 4 streptococci (Group G), and Strepto- weeks of age and older. coccus equisimilis. (ii) For prevention of gastric ulcers (2) Cats—(i) Amount. 3.4 mg/lb (7.5 mg/ in horses. kg) of body weight once daily. (3) Limitations. Do not use in horses intended for human consumption. (ii) Indications for use. For the treatment of skin infections (wounds and [69 FR 13220, Mar. 22, 2004, as amended at 71 abscesses) in cats caused by susceptible FR 59374, Oct. 10, 2006] strains of S. aureus, E. coli, and P. multocida. § 520.1616 Orbifloxacin tablets. (a) Specifications. Each tablet con- [75 FR 26646, May 12, 2010] tains 5.7, 22.7, or 68 milligrams (mg) orbifloxacin. § 520.1628 Oxfendazole powder and pellets. (b) Sponsor. See No. 000061 in § 510.600(c) of this chapter. (a) Specifications—(1) Powder for sus- (c) Conditions of use in dogs and cats— pension. Each gram of powder contains (1) Amount. 2.5 to 7.5 mg per kilogram 7.57 percent oxfendazole. body weight once daily. (2) Pellets. Each gram of pellets con- (2) Indications for use. For manage- tains 6.49 percent oxfendazole. ment of diseases associated with bac- (b) Sponsor. See No. 054771 in teria susceptible to orbifloxacin. § 510.600(c) of this chapter.

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(c) Conditions of use—(1) Amount. 10 weeks. Withholding feed or water prior milligrams per kilogram of body to use is unnecessary. Administer drug weight. with caution to sick or debilitated (2) Indications for use. The drug is horses. Not for use in horses intended used in horses for removal of the fol- for food. Consult your veterinarian for lowing gastrointestinal worms: Large assistance in the diagnosis, treatment, roundworms (Parascaris equorum), ma- and control of parasitism. ture and immature pinworms (Oxyuris (b)(1) Specifications. Each gram of equi), large strongyles (Strongylus paste contains 185 milligrams of edentatus, Strongylus vulgaris, and oxfendazole (18.5 percent). Strongylus equinus), and small (2) Sponsor. See No. 054771 in strongyles. § 510.600(c) of this chapter. (3) Limitations—(i) Powder for suspen- (3) Related tolerances. See § 556.495 of sion. For gravity administration via this chapter. stomach tube or for positive adminis- (4) Conditions of use—(i) Amount. 4.5 tration via stomach tube and dose sy- milligrams per kilogram of body ringe. Discard unused portions of sus- weight (2.05 milligrams per pound). pension after 24 hours. Mix drug ac- (ii) Indications for use. The drug is cording to directions prior to use. Ad- used in cattle for the removal and con- minister drug with caution to sick or trol of the following worms: lungworms debilitated horses. Not for use in (Dictyocaulus viviparus—adult, L4); horses intended for food. Federal law stomach worms: barberpole worms restricts this drug to use by or on the (Haemonchus contortus and H. placei— order of a licensed veterinarian. adult), small stomach worms (ii) Pellets. The drug is given by sprin- (Trichostrongylus axei—adult), brown kling on the grain portion of the ra- stomach worms (Ostertagia ostertagi— tion. Withholding feed or water prior adult, L4, inhibited L4); intestinal to administration is not necessary. Ad- worms; nodular worms minister drug with caution to sick or (Oesophagostomum radiatum—adult), debilitated horses. Not for use in hookworms (Bunostomum horses intended for food. Consult your phlebotomum—adult), small intestinal veterinarian for assistance in the diag- worms (Cooperia punctata, C. oncophora, nosis, treatment, and control of para- and C. mcmasteri—adult, L4); and tape- sitism. worms (Moniezia benedeni—adult). (iii) Limitations. For use in cattle [44 FR 35211, June 19, 1979, as amended at 46 FR 26301, May 12, 1981; 46 FR 60570, Dec. 11, only. Treatment may be repeated in 4 1981; 49 FR 28549, July 13, 1984; 61 FR 5506, to 6 weeks. Cattle must not be slaugh- Feb. 13, 1996; 78 FR 28825, May 20, 2014] tered until 11 days after treatment. Do not use in female dairy cattle of breed- § 520.1629 Oxfendazole paste. ing age. Consult a veterinarian for as- (a)(1) Specifications. Each gram of sistance in the diagnosis, treatment, paste contains 0.375 gram oxfendazole and control of parasitism. (37.5 percent). [49 FR 38250, Sept. 28, 1984, as amended at 58 (2) Sponsor. See No. 054771 in FR 39443, July 23, 1993; 61 FR 5506, Feb. 13, § 510.600(c) of this chapter. 1996; 78 FR 28825, May 20, 2014] (3) Conditions of use—(i) Amount. 10 milligrams per kilogram (2.2 pounds) of § 520.1630 Oxfendazole suspension. body weight. (a) Specifications. Each milliliter of (ii) Indications for use. The drug is suspension contains: used in horses for removal of the fol- (1) 90.6 milligrams (mg) oxfendazole lowing gastrointestinal worms: Large (9.06 percent). roundworms (Parascaris equorum), ma- (2) 225.0 mg oxfendazole (22.5 percent). ture and 4th stage larvae pinworms (b) Sponsor. See Nos. 000010 and 054771 (Oxyuris equi), large strongyles in § 510.600(c) of this chapter. (Strongylus edentatus, S. vulgaris, and S. (c) Related tolerances. See § 556.495 of equinus), and small strongyles. this chapter. (iii) Limitations. Horses maintained (d) Special considerations. See § 500.25 on premises where reinfection is likely of this chapter. If labeled for adminis- to occur should be retreated in 6 to 8 tration by stomach tube: Federal law

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restricts this drug to use by or on the § 520.1631 Oxfendazole and trichlorfon order of a licensed veterinarian. paste. (e) Conditions of use—(1) Horses. Use (a) Specifications. Each gram of paste the product described in paragraph contains 28.5 milligrams oxfendazole (a)(1) of this section as follows: and 454.5 milligrams trichlorfon. (i) Amount. 10 mg per kilogram (/kg) (b) Sponsor. See 054771 in § 510.600(c) of of body weight by stomach tube or dose this chapter. syringe. Horses maintained on prem- (c) Conditions of use—(1) Amount. 2.5 ises where reinfection is likely to occur milligrams of oxfendazole and 40 milli- should be retreated in 6 to 8 weeks. grams of trichlorfon per kilogram of (ii) Indications for use. For removal of body weight. (2) Indications for use. The drug is large roundworms (Parascaris equorum), used in horses for removal of bots mature and 4th stage larvae pinworms (Gasterophilus intestinalis, 2nd and 3rd (Oxyuris equi), large strongyles instars; G. nasalis, 3rd instar) and the (Strongylus edentatus, S. vulgaris, and S. following gastrointestinal worms: equinus), and small strongyles. Large roundworms (Parascaris (iii) Limitations. Withholding feed or equorum), pinworms (Oxyuris equi), water prior to use is unnecessary. Ad- adult and 4th stage larvae; large minister drug with caution to sick or strongyles (Strongylus edentatus, S. debilitated horses. Do not use in horses vulgaris, and S. equinus); and small intended for human consumption. strongyles. (2) Cattle. Use the products described (3) Limitations. Horses maintained on in paragraphs (a)(1) and (a)(2) of this premises where reinfection is likely to section as follows: occur should be retreated in 6 to 8 (i) Amount. 4.5 mg/kg of body weight weeks. Withholding feed or water be- by dose syringe. Treatment may be re- fore use is unnecessary. Administer with caution to sick or debilitated peated in 4 to 6 weeks. horses. Not for use in horses intended (ii) Indications for use. For the re- for food. Do not administer to mares moval and control of: lungworms during the last month of pregnancy. (Dictyocaulus viviparus—adult, L4); Trichlorfon is a cholinesterase inhib- stomach worms: barberpole worms itor. Do not use this product in ani- (Haemonchus contortus and H. placei— mals simultaneously with, or within a adult), small stomach worms few days before or after treatment with (Trichostrongylus axei—adult), brown or exposure to, cholinesterase-inhib- stomach worms (Ostertagia ostertagi— iting drugs, pesticides, or chemicals. adult, L4, inhibited L4); intestinal Consult your veterinarian for assist- worms; nodular worms ance in the diagnosis, treatment, and (Oesophagostomum radiatum—adult), control of parasitism. hookworms (Bunostomum [50 FR 50291, Dec. 10, 1985, as amended at 61 phlebotomum—adult), small intestinal FR 5506, Feb. 13, 1996; 78 FR 28825, May 20, worms (Cooperia punctata, C. oncophora, 2014] and C. surnabada—adult, L4), and tapeworms (Moniezia benedeni—adult). § 520.1638 Oxibendazole. (iii) Limitations. Cattle must not be (a) Specifications—(1) Each gram of slaughtered until 7 days after treat- paste contains 227 milligrams (mg) (22.7 ment. Because a withdrawal time in percent) oxibendazole. milk has not been established, do not (2) Each milliliter of suspension con- use in female dairy cattle of breeding tains 100 mg (10 percent) oxibendazole. (b) See No. 054771 in age. Sponsor. § 510.600(c) of this chapter. [55 FR 46943, Nov. 8, 1990, as amended at 56 (c) Special considerations—(1) See FR 8710, Mar. 1, 1991; 61 FR 5506, Feb. 13, 1996; § 500.25 of this chapter. 72 FR 10596, Mar. 9, 2007; 73 FR 45610, Aug. 6, (2) Suspension product described in 2008; 75 FR 10166, Mar. 5, 2010; 78 FR 28825, paragraph (a)(2) of this section shall be May 20, 2014] labeled: ‘‘Federal law restricts this drug to use by or on the order of a licensed veterinarian.’’

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(d) Conditions of use in horses—(1) (1) Amount. 1.0 gram of oxytetra- Amount. For uses other than for cycline and 1.0 gram carbomycin per threadworms (Strongyloides westeri), 10 gallon. mg oxibendazole per kilogram (/kg) (2) Indications for use. As an aid in the body weight; for threadworms prevention and treatment of com- (Strongyloides westeri), 15 mg/kg. Horses plicated chronic respiratory disease maintained on premises where reinfec- (air-sac infection) caused by Myco- tion is likely to occur should be re- plasma gallisepticum and secondary bac- treated in 6 to 8 weeks. Administer sus- terial organisms associated with chron- pension product by stomach tube in 3 ic respiratory disease such as E. coli. to 4 pints of warm water, or by top (3) Limitations. Administer for not dressing or mixing into a portion of the more than 5 days; not for use in chick- normal grain ration. ens producing eggs for human consumption; withdraw 24 hours before (2) Indications for use. For removal slaughter. and control of large strongyles (Strongylus edentatus, S. equinus, S. [40 FR 13838, Mar. 27, 1975, as amended at 78 vulgaris); small strongyles (genera FR 28825, May 20, 2014] Cylicostephanus, Cylicocyclus, § 520.1660b Oxytetracycline hydro- Cyathostomum, Triodontophorus, chloride capsules. Cylicodontophorus, and Gyalocephalus); (a) The drug is in cap- large roundworms (Parascaris equorum); Specifications. sule form with each capsule containing pinworms (Oxyuris equi) including var- 125 or 250 milligrams of oxytetracycline ious larval stages; and threadworms hydrochloride. Oxytetracycline is the (Strongyloides westeri). antibiotic substance produced by (3) Limitations. Do not use in horses growth of Streptomyces rimosus or the intended for human consumption. same antibiotic substance produced by [78 FR 28825, May 20, 2014] any other means. (b) Sponsor. See No. 054771 in § 520.1660 Oxytetracycline. § 510.600(c) of this chapter. (c) Conditions of use. (1) It is used in § 520.1660a Oxytetracycline and dogs and cats for the treatment of bac- carbomycin in combination. terial pneumonia caused by Brucella (a) Specifications. (1) Oxytetracycline: bronchiseptica, tonsilitis caused by The antibiotic substance produced by Streptococcus hemolyticus, bacterial en- growth of Streptomyces rimosus or the teritis caused by Escherichia coli, uri- same antibiotic substance produced by nary tract infections caused by Esch- any other means. erichia coli, and wound infections (2) Carbomycin: The antibiotic sub- caused by Staphylococcus aureus. (2) The drug is administered orally to stance produced by growth of dogs and cats at a dosage level of 25–50 Streptomyces halstedii or the same anti- milligrams per pound of body weight biotic substance produced by any other per day in divided doses at 12-hour in- means. tervals. The drug can be used for con- (b) Sponsor. See No. 054771 in tinuation of compatible antibiotic § 510.600(c) of this chapter. therapy following parenteral oxytetra- (c) Special considerations. The quan- cycline administration where rapidly tities of oxytetracycline in paragraph attained, sustained antibiotic blood (e) of this section refer to the activity levels are required. The duration of of oxytetracycline hydrochloride and treatment required to obtain favorable the quantities of carbomycin listed response will depend to some extent on refer to the activity of an appropriate the severity and degree of involvement standard. and the susceptibility of the infectious (d) Related tolerances. See §§ 556.110 agent. Clinical response to antibiotic and 556.500 of this chapter. therapy usually occurs within 48 to 72 (e) Conditions of use. It is used as oxy- hours. If improvement is not observed tetracycline hydrochloride plus within that period, the diagnosis and carbomycin base in drinking water of course of treatment should be reconsid- chickens as follows: ered. To assure adequate treatment,

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administration of the drug should con- calves. Do not use in calves to be proc- tinue for at least 48 hours following fa- essed for veal. vorable clinical response. [46 FR 32440, June 23, 1981, as amended at 50 (3) Federal law restricts this drug to FR 1045, Jan. 9, 1985; 63 FR 70334, Dec. 21, use by or on the order of a licensed vet- 1998; 70 FR 16394, Apr. 4, 2005; 78 FR 28825, erinarian. May 20, 2014]

[40 FR 13838, Mar. 27, 1975, as amended at 78 § 520.1660d Oxytetracycline powder. FR 28825, May 20, 2014] (a) Specifications. The drug is a solu- § 520.1660c Oxytetracycline hydro- ble powder distributed in packets or chloride tablets/boluses. pails having several concentrations of (a) Specifications. Each tablet or bolus oxytetracycline hydrochloride (inde- pendent of the various net weights) as contains 250, 500, or 1,000 milligrams of follows: oxytetracycline hydrochloride. (1) Each 18.14 grams of powder con- (b) Sponsors. For sponsors in tains 1 gram of oxytetracycline hydro- § 510.600(c) of this chapter: See 000010 chloride (OTC HCl) (packets: 4, 6.4, and for use of 500 and 1,000 milligram 16 oz.). boluses. See No. 054771 for use of 250 (2) Each 4.43 grams of powder con- and 500 milligram tablets. tains 1 gram of OTC HCl (packets: 4 (c) Tolerances. See § 556.500 of this and 16 oz.). chapter. (3) Each 1.32 grams of powder con- (d) Conditions of use in beef and dairy tains 1 gram of OTC HCl (packets: 2.39, cattle—(1)(i) Amount. 250 milligrams per 4.78, and 9.55 oz.; jars: 2.25 lbs.; and 100 pounds of body weight every 12 pails: 4.5 lbs.). hours (5 milligrams per pound of body (4) Each 2.73 grams of powder con- weight daily in two doses). tains 1 gram of OTC HCl (packets: 2.46 (ii) Indications for use. For control of and 9.87 oz, 3.09 and 3.91 lb; pail: 3.09 lb). bacterial enteritis caused by Salmonella (5) Each 4.2 grams of powder contains typhimurium and Escherichia coli 1 gram of OTC HCl (packets: 3.8 and (colibacillosis) and bacterial pneu- 15.2 oz; pails: 4.74 and 23.7 lb). monia (shipping fever complex, (6) Each 1.32 grams of powder con- pasteurellosis) caused by Pasteurella tains 1 gram of OTC HCl (packet: 4.78 multocida. oz.; pail: 5 lb). Each 2.73 grams of pow- (2)(i) Amount. 500 milligrams per 100 der contains 1 gram of OTC HCl (pack- pound of body weight every 12 hours (10 et: 9.87 oz). milligrams per pound of body weight (7) Each 1.32 grams of powder con- daily in two doses). tains 1 gram of OTC HCl (packet: 4.78 (ii) Indications for use. For treatment and 9.6 oz.; pails: 2 and 5 lb); each 18.1 of bacterial enteritis caused by Sal- grams of powder contains 1 gram of monella typhimurium and Escherichia coli OTC HCl (packet: 6.4 oz.; pails: 2 and 5 (colibacillosis) and bacterial pneu- lb). monia (shipping fever complex, (8) Each 135.5-gram packet (4.78 pasteurellosis) caused by Pasteurella ounce) contains 102.4 grams of OTC multocida. HCl. Each 677.5-gram packet (23.9 (3) Limitations. Dosage should con- ounce) contains 512 grams of OTC HCl. tinue until the animal returns to nor- (9) Each 2.73 grams of powder con- mal and for 24 hours to 48 hours after tains 1 gram of OTC HCl (packets: 9.87 symptoms have subsided. Treatment and, 19.75 oz, and 3.91 lb; pails: 3.09 and should not exceed 4 consecutive days. 5 lb). Do not exceed 500 milligrams per 100 (10) Each 2.73 grams of powder con- pounds of body weight every 12 hours tains 1 gram of OTC HCl (packets: 9.87 (10 milligrams per pound daily). For and 19.74 oz; pails: 5 lb). sponsor No. 054771: Discontinue treat- (b) Sponsor. See sponsor numbers in ment 7 days prior to slaughter. Not for § 510.600(c) of this chapter as follows: use in lactating dairy cattle. A with- (1) No. 054771 for use of OTC HCl con- drawal period has not been established centrations in paragraphs (a)(1), (a)(2), for this product in preruminating and (a)(3) of this section in chickens,

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turkeys, swine, cattle, sheep, and (2) Indications for use. Control of honey bees. hexamitiasis caused by Hexamita (2) No. 054771 for use of OTC HCl con- meleagridis susceptible to oxytetra- centration in paragraph (a)(4) of this cycline. section in chickens, turkeys, and (3) Limitations. Prepare a fresh solu- swine. tion daily. Administer 7 to 14 days. Not (3) No. 054628 for use of OTC HCl con- to be used for more than 14 consecutive centration in paragraph (a)(5) of this days. Use as sole source of drinking section in turkeys and chickens. water. Do not use in birds producing (4) No. 057561 for use of OTC HCl con- eggs for human consumption. With- centration in paragraph (a)(6) of this draw 5 days prior to slaughter those section in chickens, turkeys, and products sponsored by Nos. 054771, and swine. 061623 in § 510.600(c) of this chapter. (5) No. 061623 for use of OTC HCl con- Withdraw 4 days prior to slaughter centration in paragraph (a)(7) of this those products sponsored by No. 054628. section in chickens, turkeys, swine, Zero-day withdrawal for those products cattle, sheep, and honeybees. sponsored by Nos. 054771, 057561, 061133, (6) No. 069254 for use of OTC HCl con- and 069254. centrations in paragraph (a)(8) of this (B)(1) Amount per gallon. 400 milli- section in chickens, turkeys, swine, grams. cattle, sheep, and honey bees. (2) Indications for use. Control of in- (7) No. 061623 for use of OTC HCl con- fectious synovitis caused by Myco- centration in paragraph (a)(9) of this plasma synoviae susceptible to oxytet- section in chickens, turkeys, and racycline. swine. (c) Related tolerances. See § 556.500 of (3) Limitations. Prepare a fresh solu- this chapter. tion daily. Administer 7 to 14 days. Not (d) Conditions of use. (1) It is used in to be used for more than 14 consecutive drinking water as follows: days. Use as sole source of drinking (i) Chickens—(A)(1) Amount per gallon. water. Do not use in birds producing 200 to 400 milligrams. eggs for human consumption. With- (2) Indications for use. Control of in- draw 5 days prior to slaughter those fectious synovitis caused by Myco- products sponsored by Nos. 054771, and plasma synoviae susceptible to oxytet- 061623 in § 510.600(c) of this chapter. racycline. Withdraw 4 days prior to slaughter (3) Limitations. Prepare a fresh solu- those products sponsored by No. 054628. tion daily. Administer 7 to 14 days. Not Zero-day withdrawal for those products to be used for more than 14 consecutive sponsored by Nos. 054771, 057561, 061133, days. Use as sole source of drinking and 069254. water. Do not use in birds producing (C)(1) Amount. 25 milligrams per eggs for human consumption. pound of body weight. (B)(1) Amount per gallon. 400 to 800 (2) Indications for use. Growing tur- milligrams. keys. Control of complicating bacterial (2) Indications for use. Control of organisms associated with bluecomb chronic respiratory disease (CRD) and (transmissible enteritis, coronaviral air sac infections caused by Myco- enteritis) susceptible to oxytetra- plasma gallisepticum and E. coli suscep- cycline. tible to oxytetracycline; control of (3) Limitations. Prepare a fresh solu- fowl cholera caused by Pasteurella tion daily. Administer 7 to 14 days. Not multocida susceptible to oxytetra- to be used for more than 14 consecutive cycline. days. Use as sole source of drinking (3) Limitations. Prepare a fresh solu- water. Do not use in birds producing tion daily. Administer 7 to 14 days. Not eggs for human consumption. With- to be used for more than 14 consecutive draw 5 days prior to slaughter those days. Use as sole source of drinking products sponsored by Nos. 054771, and water. Do not use in birds producing 061623 in § 510.600(c) of this chapter. eggs for human consumption. Withdraw 4 days prior to slaughter (ii) Turkeys—(A)(1) Amount per gallon. those products sponsored by No. 054628. 200 to 400 milligrams. Zero-day withdrawal for those products

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sponsored by Nos. 054771, 057561, 061133, tive days. Use as sole source of oxytet- and 069254. racycline. Withdraw 5 days prior to (iii) Swine—(A) Amount. 10 milligrams slaughter. per pound of body weight daily. (2) It is used in the food of honey bees (B) Indications for use. Control and as follows: treatment of bacterial enteritis caused (i) Amount. 200 milligrams per colony, by Escherichia coli and Salmonella administered via either a 1:1 sugar choleraesuis and bacterial pneumonia syrup (equal parts of sugar and water caused by Pasteurella multocida suscep- weight to weight) or dusting with a tible to oxytetracycline. For breeding powdered sugar mixture. swine: Control and treatment of lepto- (ii) Indications for use. For control of spirosis (reducing the incidence of American foulbrood caused by abortions and shedding of leptospira) Paenibacillus larvae and European caused by Leptospira pomona suscep- foulbrood caused by Streptococcus tible to oxytetracycline. pluton susceptible to oxytetracycline. (C) Limitations. Prepare a fresh solu- (iii) Limitations. The drug is adminis- tion daily. Use as sole source of OTC. tered in 3 applications of sugar syrup Administer up to 14 days; do not use for or 3 dustings at 4- to 5-day intervals. more than 14 consecutive days; with- The drug should be fed early in the draw zero days prior to slaughter those spring or fall and consumed by the bees products sponsored by Nos. 054771and before main honey flow begins to avoid 061623. Administer up to 5 days; do not contamination of production honey. use for more than 5 consecutive days; Remove at least 6 weeks prior to main withdraw zero days prior to slaughter honey flow. those products sponsored by Nos. 048164, 054771, 057561, and 061133. [40 FR 13838, Mar. 27, 1975] (iv) Calves, beef cattle, and nonlac- EDITORIAL NOTE: For FEDERAL REGISTER ci- tating dairy cattle—(A) Amount. 10 milli- tations affecting § 520.1660d, see the List of grams per pound of body weight daily. CFR Sections Affected, which appears in the (B) Indications for use. Control and Finding Aids section of the printed volume treatment of bacterial enteritis caused and at www.fdsys.gov. by E. coli and bacterial pneumonia (shipping fever complex) caused by P. § 520.1696 Penicillin. multocida susceptible to oxytetra- § 520.1696a [Reserved] cycline. (C) Limitations. Prepare a fresh solu- § 520.1696b Penicillin G powder. tion daily. Administer up to 14 days. Do not use for more than 14 consecu- (a) Specifications. Each gram of pow- tive days. Use as sole source of oxytet- der contains penicillin G potassium racycline. Do not administer this prod- equivalent to 1.54 million units of peni- uct with milk or milk replacers. Ad- cillin G. minister 1 hour before or 2 hours after (b) Sponsors. See Nos. 010515, 054771, feeding milk or milk replacers. With- 059320, 061623 and 076475 in § 510.600(c) of draw 5 days prior to slaughter. A milk this chapter. discard period has not been established (c) Conditions of use in turkeys— (1) for this product in lactating dairy cat- Amount. 1,500,000 units per gallon tle. Do not use in female dairy cattle 20 drinking water for 5 days. months of age or older. (2) Indications for use. Treatment of (v) Sheep—(A) Amount. 10 milligrams erysipelas caused by Erysipelothrix per pound of body weight daily. rhusiopathiae. (B) Indications for use. Control and (3) Limitations. Prepare concentrated treatment of bacterial enteritis caused stock solution for use with medication by E. coli and bacterial pneumonia proportioners fresh every 24 hours. Pre- (shipping fever complex) caused by P. pare recommended use levels for grav- multocida susceptible to oxytetra- ity flow watering system fresh every 12 cycline. hours. For best results, treatment (C) Limitations. Prepare a fresh solu- should be started at the first sign of in- tion daily. Administer up to 14 days. fection. Discontinue treatment at least Do not use for more than 14 consecu- 1 day prior to slaughter. Not for use in

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turkeys producing eggs for human con- § 520.1705 Pergolide. sumption. (a) Specifications. Each tablet con- [57 FR 37326, Aug. 18, 1992, as amended at 59 tains 1 milligram (mg) pergolide FR 42493, Aug. 18, 1994; 60 FR 26359, May 17, mesylate. 1995; 62 FR 55160, Oct. 23, 1997; 65 FR 10705, (b) Sponsor. See No. 000010 in Feb. 29, 2000; 66 FR 14073, Mar. 9, 2001; 68 FR § 510.600(c) of this chapter. 4914, Jan. 31, 2003; 68 FR 26204, May 15, 2003; (c) Conditions of use in horses—(1) 69 FR 9946, Mar. 3, 2004; 69 FR 41428, July 9, Amount. Administer orally at a start- 2004; 77 FR 20988, Apr. 9, 2012; 78 FR 28825, ing dose of 2 micrograms/kilograms (μ/ May 20, 2014] kg) once daily. Dosage may be adjusted μ § 520.1696c Penicillin V powder. to effect, not to exceed 4 g/kg daily. (2) Indications for use. For the control (a) Specifications. When reconstituted, of clinical signs associated with Pitui- each milliliter contains 25 milligrams tary Pars Intermedia Dysfunction (40,000 units) of penicillin V. (Equine Cushing’s Disease). (b) Sponsor. See No. 050604 in (3) Limitations. Federal law restricts § 510.600(c) of this chapter. this drug to use by or on the order of a (c) Conditions of use in dogs and cats— licensed veterinarian. (1) Amount. 10 to 15 milligrams per pound of body weight every 6 to 8 [77 FR 15960, Mar. 19, 2012] hours. § 520.1720 Phenylbutazone oral dosage (2) Indications for use. Treatment of forms. respiratory, urogenital, skin, and soft tissue infections and septicemia caused § 520.1720a Phenylbutazone tablets by pathogens susceptible to penicillin and boluses. V potassium. (a) Specifications. Each tablet con- (3) Limitations. Federal law restricts tains 100, 200, or 400 milligrams (mg), or this drug to use by or on the order of a 1 gram (g) of phenylbutazone. Each licensed veterinarian. bolus contains 1, 2, or 4 gram g of phenylbutazone. [57 FR 37326, Aug. 18, 1992; 57 FR 42623, Sept. 15, 1992; 77 FR 20988, Apr. 9, 2012; 78 FR 28826, (b) Sponsors. See sponsor numbers in May 20, 2014] § 510.600(c) of this chapter, as follows: (1) No. 000061 for use of 100- or 400-mg § 520.1696d Penicillin V tablets. or 1-g tablets, or 2- or 4-g boluses, in (a) Specifications. Each tablet con- dogs and horses. tains penicillin V potassium equivalent (2) Nos. 054628 and 069043 for use of to 125 milligrams (200,000 units) or 250 100- or 200-mg or 1-g tablets in dogs and milligrams (400,000 units) of penicillin horses. V. (3) Nos. 054771 and 061623 for use of 100-mg or 1-g tablets in dogs and (b) Sponsors. See Nos. 050604 and horses. 054771 in § 510.600(c) of this chapter. (4) [Reserved] (c) Conditions of use in dogs and cats— (5) No. 000143 for use of 1-g tablets in (1) Amount. 10 to 15 milligrams per horses. pound of body weight every 6 to 8 (6) No. 058829 for use of 100-mg or 1-g hours. tablets in dogs and horses. (2) Indications for use. Treatment of (c) Conditions of use—(1) Dogs—(i) respiratory, urogenital, skin and soft Amount. 20 mg per pound of body tissue infections and septicemia caused weight daily. by pathogens susceptible to penicillin (ii) Indications for use. For the relief V potassium. of inflammatory conditions associated (3) Limitations. Federal law restricts with the musculoskeletal system. this drug to use by or on the order of a (iii) Limitations. Federal law restricts licensed veterinarian. this drug to use by or on the order of a [57 FR 37327, Aug. 18, 1992, as amended at 59 licensed veterinarian. FR 58775, Nov. 15, 1994; 78 FR 28826, May 20, (2) Horses—(i) Amount. 1 to 2 g per 500 2014] pounds of body weight daily.

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(ii) Indications for use. For the relief per 500 pounds of body weight, not to of inflammatory conditions associated exceed 4 grams daily. with the musculoskeletal system. (2) Indications for use. For relief of in- (iii) Limitations. Do not use in horses flammatory conditions associated with intended for human consumption. Fed- the musculoskeletal system. eral law prohibits the use of this drug (3) Limitations. Do not use in horses in female dairy cattle 20 months of age intended for human consumption. Fed- or older. Federal law restricts this drug eral law prohibits the use of this drug to use by or on the order of a licensed in female dairy cattle 20 months of age veterinarian. or older. Federal law restricts this drug [73 FR 8192, Feb. 13, 2008, as amended at 74 to use by or on the order of a licensed FR 1146, Jan. 12, 2009; 76 FR 11331, Mar. 2, veterinarian. 2011; 76 FR 17777, Mar. 31, 2011; 78 FR 21060, Apr. 9, 2013; 78 FR 28826, May 20, 2014; 81 FR [45 FR 84762, Dec. 23, 1980, as amended at 58 17607, Mar. 30, 2016] FR 29777, May 24, 1993; 61 FR 8873, Mar. 6, 1996; 62 FR 61625, Nov. 19, 1997; 68 FR 43926, § 520.1720b Phenylbutazone granules. July 25, 2003; 72 FR 60550, Oct. 25, 2007; 77 FR 4897, Feb. 1, 2012; 78 FR 28826, May 20, 2014; 79 (a) Specifications. Each package of FR 74020, Dec. 15, 2014] granules contains 1 or 8 grams of phenylbutazone. § 520.1720d Phenylbutazone gel. (b) Sponsors. See sponsors in (a) Specifications. Each 30 grams of gel § 510.600(c) of this chapter. contains 4 grams of phenylbutazone. (1) No. 000061 for 8-gram package. (b) Sponsor. See No. 061623 in (2) No. 059320 for 1-gram package. (c) Conditions of use in horses—(1) § 510.600(c) of this chapter. require bio- Amount. Administer 1 to 2 grams per equivalency and safety information. 500 pounds of body weight, not to ex- (c) Conditions of use in horses—(1) ceed 4 grams, daily as required. by add- Amount. 1 to 2 grams of phenylbutazone ing to a portion of the usual grain ra- per 500 pounds of body weight, not to tion. exceed 4 grams daily. (2) Indications for use. For the treat- (2) Indications for use. For relief of in- ment of inflammatory conditions asso- flammatory conditions associated with ciated with the musculoskeletal sys- the musculoskeletal system of horses. tem. (3) Limitations. Do not use in horses (3) Limitations. Do not use in horses intended for human consumption. Fed- intended for human consumption. Fed- eral law prohibits the use of this drug eral law prohibits the use of this drug in female dairy cattle 20 months of age in female dairy cattle 20 months of age or older. Federal law restricts this drug or older. Federal law restricts this drug to use by or on the order of a licensed to use by or on the order of a licensed veterinarian. veterinarian. [50 FR 13561, Apr. 5, 1985, as amended at 50 [78 FR 28826, May 20, 2014] FR 49372, Dec. 2, 1985; 55 FR 8462, Mar. 8, 1990; 66 FR 14073, Mar. 9, 2001; 68 FR 4915, Jan. 31, § 520.1720c Phenylbutazone paste. 2003; 78 FR 28826, May 20, 2014] (a) Specifications—(1) Each gram of § 520.1720e Phenylbutazone powder. paste contains 0.2 grams phenylbutazone. (a) Specifications—(1) Each 1.15 grams (2) Each gram of paste contains 0.35 (g) of powder contains 1 g grams phenylbutazone. phenylbutazone. (b) Sponsors. See sponsor numbers in (2) Each 10 g of powder contains 1 g § 510.600(c) of this chapter. phenylbutazone. (1) No. 000061 for use of product de- (b) Sponsors. See sponsor numbers in scribed in paragraph (a)(1) of this sec- § 510.600(c) of this chapter. tion. (1) No. 027053 for use of product de- (2) No. 017030 for use of product described in paragraph (a)(1) of this sec- scribed in paragraph (a)(2) of this section. tion. (2) No. 057699 for use of product de- (c) Conditions of use in horses—(1) scribed in paragraph (a)(2) of this sec- Amount. 1 to 2 grams of phenylbutazone tion.

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(c) Conditions of use in horses—(1) heart failure as appropriate on a case- Amount. Administer 1 to 2 g (1 to 2 level by-case basis. scoops, using the scoop provided) per (3) Limitations. Federal law restricts 500 pounds of body weight on a small this drug to use by or on the order of a amount of palatable feed, not exceed 4 licensed veterinarian. g per animal daily. [72 FR 27733, May 17, 2007, as amended at 79 (2) Indications for use. For the relief of FR 18158, Apr. 1, 2014] inflammatory conditions associated with the musculosketetal system. § 520.1802 Piperazine-carbon disulfide (3) Limitations. Do not use in horses complex oral dosage forms. intended for human consumption. Fed- eral law prohibits the extralabel use of § 520.1802a Piperazine-carbon disulfide complex suspension. this product in female cattle 20 months of age or older. Federal law restricts (a) Specifications. Each fluid ounce of this drug to use by or on the order of a suspension contains 7.5 grams of piper- licensed veterinarian. azine-carbon disulfide complex. The piperazine-carbon disulfide complex con- [72 FR 27956, May 18, 2007] tains equimolar parts of piperazine and carbon disulfide (1 gram contains 530 § 520.1760 Phenylpropanolamine. mgs of piperazine and 470 mgs of carbon (a) Specifications. Each chewable tab- disulfide). let contains 25, 50, or 75 milligram (mg) (b) Sponsor. See No. 054771 in phenylpropanolamine hydrochloride. § 510.600(c) of this chapter. (b) Sponsors. See No. 055246 in (c) Conditions of use in horses and § 510.600(c) of this chapter. ponies—(1) Amount. Administer 1 fluid (c) Conditions of use in dogs—(1) ounce per 100 pounds of body weight by Amount. Administer 2 mg/kg of body stomach tube or dose syringe after weight twice daily. withholding feed overnight or for 8 to (2) Indications for use. For the control 10 hours. of urinary incontinence due to urethral (2) Indications for use. For removing sphincter hypotonus in dogs. ascarids (large roundworms, Parascaris (3) Limitations. Federal law restricts equorum), bots (Gastrophilus spp.), small this drug to use by or on the order of a strongyles, large strongyles (Strongyles licensed veterinarian. spp.), and pinworms (Oxyuris equi). (3) Limitations. Do not use in horses [77 FR 15961, Mar. 19, 2012] intended for human consumption. Fed- eral law restricts this drug to use by or § 520.1780 Pimobendan. on the order of a licensed veterinarian. (a) Specifications. Each chewable tab- [45 FR 52781, Aug. 8, 1980, as amended at 78 let contains 1.25, 2.5, 5, or 10 milligrams FR 28826, May 20, 2014] (mg) pimobendan. (b) Sponsor. See No. 000010 in § 520.1802b Piperazine-carbon disul- § 510.600(c) of this chapter. fide complex boluses. (c) Conditions of use in dogs—(1) (a) Specifications. Each bolus contains Amount. Administer orally at a total 20 grams of piperazine-carbon disulfide daily dose of 0.23 mg per pound (0.5 mg complex. per kilogram) body weight, using a (b) Sponsor. See No. 054771 in suitable combination of whole or half § 510.600(c) of this chapter. tablets. The total daily dose should be (c) Conditions of use in horses and divided into two portions administered ponies—(1) Amount. For removal of approximately 12 hours apart. ascarids and small strongyles, 1 bolus (2) Indications for use. For the man- (20 grams) per 500 pounds body weight; agement of the signs of mild, mod- removal of large strongyles, pinworms, erate, or severe (modified New York and bots, 1 bolus per 250 pounds body Heart Association Class II, III, or IV) weight. congestive heart failure due to atrio- (2) Indications for use. For removing ventricular valvular insufficiency or ascarids (large roundworms, Parascaris dilated cardiomyopathy; for use with equorum), large strongyles (Strongylus concurrent therapy for congestive spp.) bots (Gastrophilus spp.), small

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strongyles, and pinworms (Oxyuris (c) Conditions of use in dogs and cats— equi). (1) Amount. The contents of 1 capsule (3) Limitations. Withhold feed over- should be mixed with the food of the night or for 8 to 10 hours. Give water animal for each 5 pounds, or fraction just before and/or after treatment. Re- thereof of body weight, except dogs sume regular feeding 4 to 6 hours after weighing over 25 pounds should be treatment. Treatment of debilitated or given the contents of 6 capsules. The anemic animals is contraindicated. Do drug should be mixed in 1/2 of the reg- not administer to animals that are or ular feeding and when the animal has were recently affected with colic, diar- finished eating the dosed food, the re- rhea, or infected with a serious infec- mainder of the food may be given. Dogs tious disease. As with most and cats may be wormed at 6 to 8 anthelmintics, drastic cathartics or weeks of age. The first treatment other gastrointestinal irritants should should be repeated 10 days later. Rein- not be administered in conjunction with this drug. Animals in poor condi- fection may occur. Repeat treatment if tion or heavily parasitized should be indicated. given one half the recommended dose (2) Indications for use. For the re- and treated again in 2 or 3 weeks. Con- moval of large roundworms (Toxocara sult your veterinarian for assistance in canis and Toxascaris leonina). the diagnosis, treatment, and control (3) Limitations. Severely debilitated of parasitism. animals should not be treated except on the advice of a veterinarian. [45 FR 52782, Aug. 8, 1980, as amended at 78 FR 28826, May 20, 2014] [40 FR 13838, Mar. 27, 1975, as amended at 54 FR 38515, Sept. 19, 1989; 78 FR 28826, May 20, § 520.1802c Piperazine-carbon disul- 2014] fide complex with phenothiazine suspension. § 520.1804 Piperazine phosphate cap- (a) Specifications. Each fluid ounce sules. contains 5 grams of piperazine-carbon (a) Specifications. Each capsule con- disulfide complex and 0.83 gram of tains 120, 300, or 600 milligrams of pi- phenothiazine. perazine phosphate monohydrate. (b) Sponsor. See No. 054771 in (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. § 510.600(c) of this chapter. (c) Conditions of use in horses and (c) Conditions of use—(1) Amount. 60 ponies—(1) Amount. Administer 1 fluid ounce per 100 pounds of body weight by milligrams of piperazine phosphate stomach tube or dose syringe after monohydrate per pound of body weight. withholding feed overnight or for 8 to (2) Indications for use—(i) Dogs. It is 10 hours. used for the removal of large (2) Indications for use. For removing roundworms (ascarids) Toxocara canis ascarids (large roundworms, Parascaris and Toxascaris leonina. equorum), bots (Gastrophilus spp.), small (ii) Cats. It is used for the removal of strongyles, and large strongyles large roundworms (ascarids) Toxocara (Strongylus spp.). mystax and Toxacaris leonina. (3) Limitations. Do not use in horses (3) Limitations. Administer in ani- intended for human consumption. Fed- mal’s food or milk. For animals up to eral law restricts this drug to use by or 1 year of age administer every 2 or 3 on the order of a licensed veterinarian. months; for animals over 1 year old, [45 FR 52782, Aug. 8, 1980, as amended at 78 administer periodically as necessary. FR 28826, May 20, 2014] Consult your veterinarian for assistance in the diagnosis, treatment, and § 520.1803 Piperazine citrate capsules. control of parasitism. (a) Specifications. Each capsule con- [43 FR 6941, Feb. 17, 1978; 43 FR 9804, Mar. 10, tains piperazine citrate equivalent to 1978, as amended at 46 FR 20158, Apr. 3, 1981; 140 milligrams of piperazine base. 69 FR 31878, June 8, 2004; 78 FR 28826, May 20, (b) Sponsor. See No. 021091 in 2014] § 510.600(c) of this chapter.

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§ 520.1805 Piperazine phosphate with unweaned pups or animals less than 3 thenium closylate tablets. weeks of age. (a) Specifications. Each scored tablet [70 FR 17319, Apr. 6, 2005] contains the equivalent of 250 milligrams piperazine hexahydrate (as pi- § 520.1807 Piperazine. perazine phosphate) and 125 milligrams (a) Specifications. A soluble powder or thenium (as thenium closylate) or 500 liquid containing piperazine milligrams piperazine hexahydrate (as dihydrochloride or dipiperazine sulfate, piperazine phosphate) and 250 milli- equivalent to 17, 34, or 230 grams of pi- grams thenium (as thenium closylate). perazine per pound or 100 milliliters. (b) Sponsor. See No. 000061 in (b) Sponsor. See No. 015565 in § 510.600(c) of this chapter. § 510.600(c) of this chapter. (c) Conditions of use—(1) Amount. Ad- (c) Related tolerances. See § 556.513 of minister orally to dogs as follows: this chapter. (d) Conditions of use—(1) Chickens—(i) NUMBER OF TABLETS AT EACH OF THE TWO Amount. 50 milligrams per bird under 6 DOSES weeks, 100 milligrams per bird over 6 Animal weight (lb) 375 mg 750 mg weeks. (ii) Indications for use. For removal of 2 but less than 5 ...... 1⁄2 ...... large roundworm (Ascaridia spp.). 5 but less than 10 ...... 1 1⁄2 10 or heavier ...... 2 1 (iii) Limitations. For use in drinking water or feed. Use as sole source of (2) Indications for use. For removal of drinking water. Prepare fresh solution immature (fourth stage larvae) and daily. Use as 1-day single treatment. adult hookworms (Ancylostoma Withdraw 14 days prior to slaughter. caninum, A. braziliense, and Uncinaria Do not use for chickens producing eggs stenocephala) and ascarids (Toxocara for human consumption. Consult your canis) from weaned pups and adult veterinarian for assistance in the diag- dogs. nosis, treatment, and control of para- (3) Limitations. Federal law restricts sitism. this drug to use by or on the order of a (2) Turkeys—(i) Amount. 100 milli- licensed veterinarian. grams per bird up to 12 weeks and 200 milligrams per bird over 12 weeks. [43 FR 32747, July 28, 1978, as amended at 47 (ii) Indications for use. For removal of FR 55476, Dec. 10, 1982; 61 FR 8873, Mar. 6, 1996; 62 FR 61625, Nov. 19, 1997; 78 FR 28826, large roundworm (Ascaridia spp.). May 20, 2014] (iii) Limitations. For use in drinking water or feed. Use as sole source of § 520.1806 Piperazine suspension. drinking water. Prepare fresh solution (a) Specifications. Each milliliter of daily. Use as 1-day single treatment. suspension contains piperazine Withdraw 14 days prior to slaughter. monohydrochloride equivalent to 33.5 Consult your veterinarian for assist- milligrams (mg) piperazine base. ance in the diagnosis, treatment, and (b) Sponsor. See No. 017135 in control of parasitism. § 510.600(c) of this chapter. (3) Swine—(i) Amount. 50 milligrams (c) Special considerations. See per pound of body weight. § 500.25(c) of this chapter. (ii) Indications for use. For removal of (d) Conditions of use in dogs—(1) Indi- large roundworm (Ascaris suum) and cations for use. For the removal of nodular worms (Oesophagostomum spp.). roundworms (Toxocara canisand (iii) Limitations. For use in drinking Toxascaris leonina). water or feed. Use as sole source of (2) Dosage. Administer 20 to 30 mg pi- drinking water. Prepare fresh solution perazine base per pound body weight as daily. Use as 1-day single treatment. a single dose. Withdraw 21 days prior to slaughter. (3) Limitations. Administer by mixing Consult your veterinarian for assist- into the animal’s ration to be con- ance in the diagnosis, treatment, and sumed at one feeding. For animals in control of parasitism. heavily contaminated areas, reworm at [64 FR 23018, Apr. 29, 1999, as amended at 79 monthly intervals. Not for use in FR 28827, May 20, 2014]

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§ 520.1840 Poloxalene. blocks at least 7 days before exposure to bloat-producing conditions. (a) Specifications. Polyoxypropylene- polyoxyethylene glycol nonionic block [40 FR 13838, Mar. 27, 1975, as amended at 40 polymer. FR 39857, Aug. 29, 1975; 42 FR 41854, Aug. 19, (b) Sponsors. See sponsors in 1977; 50 FR 5385, Feb. 8, 1985; 54 FR 33501, Aug. § 510.600(c) of this chapter for use as in 15, 1989; 56 FR 50653, Oct. 8, 1991; 58 FR 26523, May 4, 1993; 60 FR 55659, Nov. 2, 1995; 66 FR paragraph (d) of this section. 47963, Sept. 17, 2001; 69 FR 62811, Oct. 28, 2004; (1) No. 054771 for use as in paragraphs 70 FR 32489, June 3, 2005; 78 FR 28826, May 20, (d)(1) and (d)(3) of this section. 2014] (2) No. 051311 for use as in paragraph (d)(4) of this section. § 520.1846 Polyoxyethylene (23) lauryl (3) No. 067949 for use as in paragraph ether blocks. (d)(2) of this section. (a) Specifications. Each molasses- (4) No. 066104 for use as in paragraph based block contains 2.2 percent (d)(3) of this section. polyoxyethylene (23) lauryl ether. (c) [Reserved] (b) Sponsor. See No. 067949 in (d) Conditions of use. (1) For treat- § 510.600(c) of this chapter. ment of legume (alfalfa, clover) bloat (c) Conditions of use—(1) Amount. 2 in cattle. Administer as a drench at the grams of polyoxyethylene (23) lauryl rate of 25 grams for animals up to 500 ether per 100 kilograms of body weight pounds and 50 grams for animals over per day (1 pound of block per 500 kilo- 500 pounds of body weight. gram (1,100 pound) animal per day). (2) For control of legume (alfalfa, clo- (2) Indications for use. For reduction ver) bloat in cattle. Administer, in mo- of the incidence of bloat (alfalfa and lasses block containing 6.6 percent clover) in pastured cattle. poloxalene, at the rate of 0.8 oz. of (3) Limitations. Administer free- block (1.5 grams poloxalene) per 100 lbs. choice to beef cattle and nonlactating of body weight per day. dairy cattle only. Initially, provide one (3) For prevention of legume (alfalfa, block per five head of cattle. Start clover) and wheat pasture bloat in cat- treatment 10 to 14 days before exposure tle. A 53-percent poloxalene top dress- to bloat-producing pastures. Do not ing on individual rations of ground allow cattle access to other sources of salt while being fed this product. Do feed. Dosage is 1 gram of poloxalene not feed this product to animals with- per 100 pounds of body weight daily. If out adequate forage/roughage consump- bloating conditions are severe, the dose tion. is doubled. Treatment should be started 2 to 3 days before exposure to bloat- [50 FR 48189, Nov. 22, 1985, as amended at 56 producing conditions. Repeat use of the FR 9841, Mar. 8, 1991; 69 FR 62811, Oct. 28, drug if animals are exposed to bloat- 2004] producing conditions for more than 12 § 520.1855 Ponazuril. hours after the last treatment. Do not exceed the double dose in any 24-hour (a) Specifications. Each gram of paste period. contains 150 milligrams (mg) ponazuril. (4) For control of legume (alfalfa, clo- (b) Sponsor. See No. 050604 in ver) and wheat pasture bloat in cattle. § 510.600(c) of this chapter. Administer in molasses block con- (c) Conditions of use in horses—(1) taining 6.6 percent poloxalene, at the Amount. Administer orally 15 mg per rate of 0.8 ounce of block (1.5 grams of kilogram (kg) (6.81 mg per pound (lb)) poloxalene) per 100 pounds of body body weight as the first dose, followed weight per day. Provide access to 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 treatment of equine protozoal myeloencephalitis caused by Sarcocystis neurona.

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(3) Limitations. Do not use in horses (B) For removal of the canine cestode intended for human consumption. Fed- Echinococcus granulosus, and for re- eral law restricts this drug to use by or moval and control of the canine on the order of a licensed veterinarian. cestode Echinococcus multilocularis. [66 FR 43774, Aug. 21, 2001, as amended at 79 (iii) Limitations—(A) If labeled only FR 28827, May 20, 2014; 80 FR 34278, June 16, for use as in paragraph (c)(1)(ii)(A) of 2015; 80 FR 53459, Sept. 4, 2015] this section: Not intended for use in puppies less than 4 weeks of age. Con- § 520.1860 Pradofloxacin. sult your veterinarian before admin- (a) Specifications. Each milliliter of istering tablets to weak or debilitated suspension contains 25 milligrams (mg) animals and for assistance in the diag- pradofloxacin. nosis, treatment, and control of para- (b) Sponsor. See No. 000859 in sitism. § 510.600(c) of this chapter. (B) If labeled for use as in paragraph (c) Conditions of use in cats—(1) (c)(1)(ii)(B) of this section: Federal law Amount. Administer 3.4 mg/lb (7.5 mg/ restricts this drug to use by or on the kg) body weight once daily for 7 con- order of a licensed veterinarian. secutive days. (2) Cats—(i) Indications for use. For re- (2) Indications for use. For the treat- moval of feline cestodes Dipylidium ment of skin infections (wounds and caninum and Taenia taeniaeformis. abscesses) in cats caused by susceptible (ii) Dosage. Cats 4 pounds and under, strains of Pasteurella multocida, Strepto- 11.5 mg; 5 to 11 pounds, 23 mg; over 11 coccus canis, Staphylococcus aureus, pounds, 34.5 mg. Staphylococcus felis, and Staphylococcus (iii) Limitations. Administer directly pseudintermedius. by mouth or crumbled and in feed. Not (3) Limitations. Federal law prohibits intended for use in kittens less than 6 the extralabel use of this drug in food- weeks of age. For OTC use: Consult producing animals. Federal law re- your veterinarian before administering stricts this drug to use by or on the tablets to weak or debilitated animals, order of a licensed veterinarian. and for assistance in the diagnosis, treatment, and control of parasitism. [77 FR 76863, Dec. 31, 2012, as amended at 79 FR 28827, May 20, 2014] [46 FR 60570, Dec. 11, 1981, as amended at 47 FR 26377, June 18, 1982; 55 FR 2234, Jan. 23, § 520.1870 Praziquantel tablets. 1990; 58 FR 7864, Feb. 10, 1993; 58 FR 42853, (a) Specifications. Each tablet con- Aug. 12, 1993; 68 FR 57351, Oct. 3, 2003; 69 FR tains: 62181, Oct. 25, 2004; 78 FR 17596, Mar. 22, 2013; 81 FR 17607, Mar. 30, 2016] (1) 34 milligrams (mg) praziquantel. (2) 11.5 or 23 mg praziquantel. § 520.1871 Praziquantel and pyrantel. (b) Sponsor. See No. 069043 in § 510.600(c) of this chapter for use of the (a) Specifications. (1) Each tablet con- product described in paragraph (a)(1) of tains 13.6 milligrams (mg) praziquantel this section as in paragraph (c)(1) of and 54.3 mg pyrantel base (as pyrantel this section; and for use of the product pamoate), 18.2 mg praziquantel and 72.6 described in paragraph (a)(2) of this mg pyrantel base (as pyrantel section as in paragraph (c)(2) of this pamoate), or 27.2 mg praziquantel and section. 108.6 mg pyrantel base (as pyrantel (c) Conditions of use—(1) Dogs—(i) pamoate). Amount. 5 pounds (lb) and under, 1⁄2 tab- (2) Each chewable tablet contains 30 let (17 mg); 6 to 10 lb, 1 tablet (34 mg); mg praziquantel and 30 mg pyrantel 11 to 15 lb, 11⁄2 tablets (51 mg); 16 to 30 pamoate or 114 mg praziquantel and 114 lb, 2 tablets (68 mg); 31 to 45 lb, 3 tab- mg pyrantel pamoate. lets (102 mg); 46 to 60 lb, 4 tablets (136 (b) Sponsors. See sponsors in mg); over 60 lb, 5 tablets maximum (170 § 510.600(c) for use as in paragraph (d) of mg). Administer directly by mouth or this chapter. crumbled and in feed. (1) See No. 000859 for use of tablets (ii) Indications for use—(A) For re- described in paragraph (a)(1) of this moval of canine cestodes Dipylidium section for use as in paragraph (d)(1) of caninum and Taenia pisiformis. this section.

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(2) See No. 051311 for use of tablets (b) Sponsor. See 000859 in § 510.600(c) of described in paragraph (a)(2) of this this chapter. section for use as in paragraph (d)(2) of (c) Conditions of use—(1) Dogs—(i) this section. Amount. Administer as a single dose di- (c) Special considerations. See § 500.25 rectly by mouth or in a small amount of this chapter. of food as follows: (d) Conditions of use—(1) Cats—(i) Dos- age. Administer a minimum dose of 2.27 Weight of animal Number of tablets per dose mg praziquantel and 9.2 mg pyrantel Tablet Tablet Tablet pamoate per pound of body weight ac- Kilograms Pounds no. 1 no. 2 no. 3 cording to the dosing tables on label- 0.9 to 1.8 ...... 2 to 4 ...... 1/2. ing. May be given directly by mouth or 2.3 to 3.2 ...... 5 to 7 ...... 1. in a small amount of food. Do not with- 3.6 to 5.4 ...... 8 to 12 ..... 1 1/2. hold food prior to or after treatment. If 5.9 to 8.2 ...... 13 to 18 ... 2. reinfection occurs, treatment may be 8.6 to 11.4 .... 19 to 25 ... 2 1/2. repeated. 11.8 to 13.6 .. 26 to 30 ...... 1. (ii) Indications for use. For removal of 14.1 to 20.0 .. 31 to 44 ...... 1 1/2. 20.4 to 27.2 .. 45 to 60 ...... 2 ...... 1 tapeworms (Dipylidium caninum and 27.7 to 40.9 .. 61 to 90 ...... 1 1/2 Taenia taeniaeformis), hookworms 41.3 to 54.5 .. 91 to 120 ...... 2 (Ancylostoma tubaeforme), and large roundworms (Toxocara cati) in cats and (ii) Indications for use. For the re- kittens. moval of tapeworms (Dipylidium (iii) Limitations. Not for use in kit- caninum, Taenia pisiformis, Echinococcus tens less than 2 months of age or granulosus); hookworms (Ancylostoma weighing less than 2.0 pounds. Consult caninum, Uncinaria stenocephala); your veterinarian before giving to sick ascarids (Toxocara canis, Toxascaris or pregnant animals. leonina); and whipworms (Trichuris (2) Dogs—(i) Amount. Administer a vulpis) and for the removal and control minimum dose of 5 mg praziquantel of tapeworm Echinococcus multilocularis and 5 mg pyrantel pamoate per kilo- in dogs. gram body weight (2.27 mg praziquantel (iii) Limitations. Do not use in preg- and 2.27 mg pyrantel pamoate per nant animals. Do not use in dogs pound body weight) according to the weighing less than 0.9 kilogram (2 dosing tables on labeling. pounds) or puppies less than 3 weeks of (ii) Indications for use. For the treat- age. Federal law restricts this drug to ment and control of roundworms use by or on the order of a licensed vet- (Toxocara canis and Toxascaris leonina), erinarian. hookworms (Ancylostoma caninum, Ancylostoma braziliense, and Uncinaria [59 FR 33908, July 1, 1994, as amended at 61 stenocephala), and tapeworms FR 29651, June 12, 1996; 68 FR 22293, Apr. 28, (Dipylidium caninum and Taenia 2003; 71 FR 6677, Feb. 9, 2006] pisiformis) in dogs and puppies. § 520.1880 Prednisolone. [58 FR 58652, Nov. 3, 1993, as amended at 72 (a) Specifications. Each tablet con- FR 16270, Apr. 4, 2007; 75 FR 54018, Sept. 3, 2010] tains 5 or 20 milligrams prednisolone. (b) Sponsor. See No. 061690 in § 520.1872 Praziquantel, pyrantel § 510.600(c)(2) of this chapter. pamoate, and febantel tablets. (c) Conditions of use in dogs—(1) (a) Specifications. Each tablet or Amount. Administer 2.5 milligrams per chewable tablet contains either: 4.5 kilograms (10 pounds) body weight (1) Tablet No. 1: 22.7 milligrams per day. Administer total daily dose praziquantel, 22.7 milligrams pyrantel orally in equally divided doses 6 to 10 base, and 113.4 milligrams febantel; or hours apart until response is noted or 7 (2) Tablet No. 2: 68 milligrams days have elapsed. When response is at- praziquantel, 68 milligrams pyrantel tained, dosage should be gradually re- base, and 340.2 milligrams febantel. duced until maintenance level is (3) Tablet No. 3: 136 milligrams (mg) achieved. praziquantel, 136 mg pyrantel base, and (2) Indications for use. For use as an 680.4 mg febantel. anti-inflammatory agent.

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(3) Limitations. Federal law restricts twice daily. For dogs weighing less this drug to use by or on the order of a than 4 pounds, administer orally an ap- licensed veterinarian. propriate fraction of the contents of one of these capsules. [57 FR 4718, Feb. 7, 1992, as amended at 60 FR 57832, Nov. 22, 1995; 63 FR 148, Jan. 5, 1998; 79 (ii) Capsules described in paragraph FR 28827, May 20, 2014] (a)(2) of this section are given to dogs weighing 30 pounds and over at the rate § 520.1900 Primidone. of 1 capsule twice daily. (a) Specifications. Each tablet con- (2) Indications for use. For the treat- tains 50 or 250 milligrams of primidone. ment of gastrointestinal disturbances (b) Sponsors. See sponsor numbers in associated with emotional stress. § 510.600(c) of this chapter. (3) Limitations. Federal law restricts (1) No. 054628 for use of 250 milligram this drug to use by or on the order of a tablets. licensed veterinarian. (2) No. 054771 for use of 50 and 250 mil- [79 FR 28827, May 20, 2014] ligram tablets. (c) Conditions of use in dogs—(1) § 520.1921 Prochlorperazine, Amount. Twenty-five milligrams of isopropamide, and neomycin. primidone per pound of body weight (55 (a) Specifications. Each capsule con- milligrams per kilogram of body tains either: weight) daily. (1) Capsule No. 1: 3.33 milligrams of (2) Indications for use. For the control prochlorperazine (as the dimaleate), of convulsions associated with idio- 1.67 milligrams of isopropamide (as the pathic epilepsy, epileptiform convul- iodide), and 25 milligrams of neomycin sions, viral encephalitis, distemper, base (as the sulfate); or and hardpad disease that occurs as a (2) Capsule No. 3: 10 milligrams of clinically recognizable lesion in certain prochlorperazine (as the dimaleate), 5 entities in dogs. milligrams of isopropamide (as the io- (3) Limitations. Federal law restricts dide), and 75 milligrams of neomycin this drug to use by or on the order of a base (as the sulfate). licensed veterinarian. (b) Sponsor. See No. 054771 in [42 FR 61594, Dec. 6, 1977, as amended at 43 § 510.600(c) of this chapter. FR 55386, Nov. 28, 1978; 46 FR 8467, Jan. 27, (c) Conditions of use in dogs—(1) 1981; 46 FR 57477, Nov. 24, 1981; 53 FR 40727, Amount. Administer capsules orally Oct. 18, 1988; 56 FR 37473, Aug. 7, 1991; 62 FR twice daily to dogs as follows: 35076, June 30, 1997; 78 FR 21060, Apr. 9, 2013; 79 FR 28827, May 20, 2014] Number of capsules per dose Animal weight (pounds) § 520.1920 Prochlorperazine and Capsule Capsule isopropamide. No. 1 No. 3

(a) Specifications. Each capsules con- 10 to 20 ...... 1 tains either: 20 to 30 ...... 2 (1) 3.33 milligrams of Over 30 ...... 3 1 prochlorperazine (as the dimaleate) Over 60 ...... 2 and 1.67 milligrams of isopropamide (as (2) For the treat- the iodide); or Indications for use. (2) 10 milligrams of prochlorperazine ment infectious bacterial (as the dimaleate) and 5 milligrams of gastroenteritis associated with emo- isopropamide (as the iodide). tional stress. (b) Sponsor. See No. 054771 in (3) Limitations. Federal law restricts § 510.600(c) of this chapter. this drug to use by or on the order of a (c) Conditions of use in dogs—(1) licensed veterinarian. Amount. (i) Capsules described in para- [49 FR 14103, Apr. 10, 1984, as amended at 56 graph (a)(1) of this section are adminis- FR 50653, Oct. 8, 1991; 60 FR 55659, Nov. 2, tered orally to dogs weighing from 4 to 1995; 79 FR 28827, May 20, 2014] 15 pounds at the rate of 1 capsule twice daily. These capsules are administered § 520.1962 Promazine. orally to dogs weighing from 16 to 30 (a) Specifications. Conforms to N.F. pounds at the rate of 1 or 2 capsules XII for promazine hydrochloride.

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(b) Sponsor. See No. 054771 in hookworms (Ancylostoma caninum; § 510.600(c) of this chapter. Uncinaria stenocephala). (c) Conditions of use in horses—(1) (ii) In puppies and adult dogs and in Amount. Administer 0.45 to 0.9 milli- lactating bitches after whelping. To grams per pound of body weight mixed prevent reinfection of Toxocara canis. with an amount of feed that will be (3) Limitations. Administer to puppies readily consumed. at 2, 3, 4, 6, 8, and 10 weeks of age. Ad- (2) Indications for use. For quieting minister to lactating bitches 2 to 3 excitable, unruly, or intractable weeks after whelping. Retreatment of horses. adult dogs may be necessary at month- (3) Limitations. Do not use in horses ly intervals as determined by labora- intended for human consumption. Fed- eral law restricts this drug to use by or tory fecal examinations. Consult your on the order of a licensed veterinarian. veterinarian for assistance in the diagnosis, treatment, and control of para- [79 FR 28827, May 20, 2014] sitism. § 520.2002 Propiopromazine. [52 FR 37937, Oct. 13, 1987, as amended at 57 (a) Specifications. Each chewable tab- FR 48163, Oct. 22, 1992; 58 FR 44611, Aug. 24, let contains 10 or 20 milligrams of 1993; 66 FR 9650, Feb. 9, 2001; 67 FR 21996, May 2, 2002] propiopromazine hydrochloride. (b) Sponsor. See No. 054771 in § 520.2042 Pyrantel pamoate tablets. § 510.600(c) of this chapter. (c) Conditions of use in dogs—(1) (a) Specifications. Each tablet con- Amount. Administer 0.5 to 2.0 milli- tains pyrantel pamoate equivalent to grams per pound of body weight once 22.7, 45.4, or 113.5 milligrams of or twice daily, depending upon the de- pyrantel base. gree of tranquilization desired. (b) Sponsor. See No. 017135 in (2) Indications for use. For oral admin- § 510.600(c) of this chapter. istration as a tranquilizer. As an aid in (c) Conditions of use. It is used for handling difficult, excited, and unruly dogs as follows: dogs, and in controlling excessive ken- (1) Amount. For dogs weighing over 5 nel barking, car sickness, and severe pounds, use at least 2.27 milligrams of dermatitis. It is also indicated for use pyrantel base per pound of body in minor surgery and prior to routine weight; for dogs weighing 5 pounds or examinations, laboratory procedures, less, use at least 4.54 milligrams of and diagnostic procedures. pyrantel base per pound of body (3) Limitations. Federal law restricts weight. this drug to use by or on the order of a licensed veterinarian. (2) Indications for use. For removal and control of large roundworms [79 FR 28827, May 20, 2014] (ascarids) (Toxocara canis and Toxascaris leonina), and hookworms § 520.2041 Pyrantel pamoate chewable tablets. (Ancylostoma caninum and Uncinaria stenocephala). (a) Specifications. Each tablet con- (3) Limitations. Administer orally di- tains pyrantel pamoate equivalent to rectly or in a small amount of food. To 22.7 or 113.5 milligrams pyrantel base. (b) Sponsor. See Nos. 017135 and 051311 prevent reinfection of T. canis in pup- in § 510.600(c) of this chapter. pies, lactating bitches after whelping, (c) Conditions of use—(1) Amount. Pro- and adult dogs; treat puppies 2, 3, 4, 6, vides at least 2.27 milligrams pyrantel 8, and 10 weeks of age; treat lactating base per pound body weight for dogs bitches 2 to 3 weeks after whelping; weighing more than 5 pounds, and at routinely treat adult dogs monthly. Do least 4.54 milligrams of pyrantel base not withhold food prior to or after per pound body weight for dogs weigh- treatment. The presence of these ing 5 pounds or less. parasites should be confirmed by lab- (2) Indications for use—(i) In dogs and oratory fecal examination. A followup puppies. For removal of ascarids fecal examination should be conducted (Toxocara canis; Toxascaris leonina) and

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2 to 4 weeks after first treatment regi- (i) Dogs and puppies—(A) Amount. 2.27 men to determine the need for re-treat- mg/lb body weight as a single dose in ment. Consult your veterinarian for as- the animal’s feed bowl by itself or sistance in the diagnosis, treatment, mixed in a small quantity of food. and control of parasitism. (B) Indications for use. For the re- [43 FR 52700, Nov. 14, 1978, as amended at 49 moval of large roundworms (Toxocara FR 22073, May 25, 1984; 57 FR 48163, Oct. 22, canis and Toxascaris leonina) and 1992; 58 FR 44611, Aug. 24, 1993] hookworms (Ancylostoma caninum and Uncinaria stenocephala). § 520.2043 Pyrantel pamoate suspen- (C) Limitations. Additional treatment sion. may be required and should be con- (a) Specifications. (1) Each milliliter firmed by fecal examination within 2 (mL) contains pyrantel pamoate equiv- to 4 weeks. alent to 50 milligrams (mg) pyrantel (ii) Dogs, puppies, and lactating bitches base. after whelping—(A) Amount. 2.27 mg/lb (2) Each mL contains pyrantel body weight. pamoate equivalent to 2.27 or 4.54 mg (B) Indications for use. To prevent re- pyrantel base. infections of T. canis. (3) Each mL contains pyrantel (C) Limitations. Administer to puppies pamoate equivalent to 4.54 mg pyrantel at 2, 3, 4, 6, 8, and 10 weeks of age. Ad- base. minister to lactating bitches 2 to 3 (b) Sponsors. See sponsors in weeks after whelping. Adult dogs kept § 510.600(c) of this chapter for uses as in in heavily contaminated quarters may paragraph (d) of this section. be treated at monthly intervals. (1) Nos. 054771, 058829, and 069043 for use of the product described in para- [67 FR 43248, June 27, 2002, as amended at 68 graph (a)(1) as in paragraph (d)(1) of FR 54803, Sept. 19, 2003; 68 FR 55199, Sept. 23, this section. 2003; 68 FR 55825, Sept. 29, 2003; 75 FR 52622, Aug. 27, 2010; 76 FR 17337, Mar. 29, 2011; 78 FR (2) Nos. 000859, 054771, and 058829 for 17596, Mar. 22, 2013; 79 FR 28827, May 20, 2014; use of the products described in para- 80 FR 76386, Dec. 9, 2015; 81 FR 17607, Mar. 30, graph (a)(2) as in paragraph (d)(2) of 2016] this section. (3) No. 023851 for use of the product § 520.2044 Pyrantel pamoate paste. described in paragraph (a)(3) as in para- (a) Specifications—(1) Each milliliter graph (d)(2) of this section. (mL) contains 180 milligrams (mg) (c) Special considerations. See § 500.25 pyrantel base (as pyrantel pamoate). of this chapter. (2) Each mL contains 226 mg pyrantel (d) Conditions of use—(1) Horses and base (as pyrantel pamoate). ponies. It is used as follows: (3) Each mL contains 171 mg pyrantel (i) Amount. 3 mg per pound (/lb) body base (as pyrantel pamoate). weight as a single dose mixed with the usual grain ration, or by stomach tube (b) Sponsors. See sponsors in or dose syringe. § 510.600(c) of this chapter. (ii) Indications for use. For the re- (1) No. 054771 for use of product de- moval and control of mature infections scribed in paragraph (a)(1) of this sec- of large strongyles (Strongylus vulgaris, tion as in paragraph (d)(1)(i) and (d)(2) S. edentatus, S. equinus); pinworms of this section. (Oxyuris equi); large roundworms (2) No. 017135 for use of product de- (Parascaris equorum); and small scribed in paragraph (a)(2) of this sec- strongyles. tion as in paragraph (d) of this section. (iii) Limitations. Do not use in horses (3) No. 061623 for use of product de- intended for human consumption. scribed in paragraph (a)(3) of this sec- When the drug is for administration by tion as in paragraph (d)(1)(i) and (d)(2) stomach tube, it shall be labeled: of this section. ‘‘Federal law restricts this drug to use (c) Special considerations. See § 500.25 by or on the order of a licensed veteri- of this chapter. narian.’’ (d) Conditions of use. It is used in (2) Dogs. It is used as follows: horses and ponies as follows:

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(1) Amounts and indications for use—(i) (ii) Indications for use. For the re- 3 mg per pound (/lb) body weight as sin- moval and control of large roundworms gle oral dose for removal and control of (Ascaris suum) and nodular worm infections from the following mature (Oesophagostomum) infections. parasites: large strongyles (Strongylus (iii) Limitations. Consult veterinarian vulgaris, S. edentatus, S. equinus); small before using in severely debilitated strongyles; pinworms (Oxyuris equi); animals. Do not treat within 24 hours and large roundworms (Parascaris of slaughter. equorum). (ii) 6 mg/lb body weight as single oral [79 FR 28827, May 20, 2014] dose for the removal and control of ma- § 520.2046 Pyrantel tartrate pellets. ture infections of tapeworms (Anoplocephala perfoliata). (a) Specifications. (1) Each gram of (2) Limitations. Do not use in horses pellets contains 12.5 milligrams (mg) intended for human consumption. (1.25 percent) pyrantel tartrate; or (2) Each gram of pellets contains 21.1 [70 FR 29447, May 23, 2005, as amended at 76 mg (2.11 percent) pyrantel tartrate. FR 17337, Mar. 29, 2011; 78 FR 17596, Mar. 22, 2013; 79 FR 28827, May 20, 2014; 81 FR 17607, (b) Sponsors. See sponsor numbers in Mar. 30, 2016] § 510.600(c) of this chapter: (1) No. 054771 for use of products de- § 520.2045 Pyrantel tartrate powder. scribed in paragraph (a) as in para- (a) Specifications. Each gram of pow- graph (c) of this section. der contains 106 milligrams (10.6 per- (2) No. 061623 for use of product de- cent) or 113 milligrams (11.3 percent) scribed in paragraph (a)(1) as in para- pyrantel tartrate. graph (c) of this section. (b) Sponsor. See No. 054771 in (c) Conditions of use in horses—(1) § 510.600(c) of this chapter for use of 11.3 Amount. Administer as a single dose at percent powder as in paragraph (d)(1) 12.5 mg per 2.2 pounds of body weight and 10.6 percent powder as in paragraph mixed with the usual grain ration. (d)(2) and of this section. (2) Indications for use. For the re- (c) Related tolerances. See § 556.560 of moval and control of infections from this chapter. the following mature parasites: Large (d) Conditions of use—(1) Horses—(i) strongyles (Strongylus vulgaris, S. Amount. Administer as a single dose at edentatus, S. equinus), small strongyles 0.57 gram of pyrantel tartrate per 100 (Trichonema spp., Triodontophorus), pounds of body weight mixed with the pinworms (Oxyuris), and large usual grain ration. Do not administer roundworms (Parascaris). by stomach tube or dose syringe. (3) Limitations. Do not treat severely (ii) Indications for use. For the re- debilitated animals with this drug. Do moval and control of infections from not use in horses intended for human the following mature parasites: Large consumption. strongyles (Strongylus vulgaris, S. edentatus, S. equinus), small strongyles [79 FR 28828, May 20, 2014] (Trichonema spp., Triodontophorus), § 520.2075 Robenacoxib. pinworms (Oxyuris), and large roundworms (Parascaris). (a) Specifications. Each tablet con- (iii) Limitations. Do not treat severely tains 6 milligrams (mg) robenacoxib. debilitated animals with this drug. Do (b) Sponsors. See No. 058198 in not use in horses intended for human § 510.600(c) of this chapter. consumption. (c) Conditions of use in cats—(1) (2) Swine—(i) Amount. Add to feed at Amount. Administer 0.45 mg per pound 0.4 gram pyrantel tartrate per pound of (/lb) (1 mg/kilogram (kg)) once daily. non-pelleted ration. The ration is ad- (2) Indications for use. For the control ministered as a single treatment as the of postoperative pain and inflamma- sole ration at the rate of 1 pound per 40 tion associated with orthopedic sur- pounds of animal weight for animals up gery, ovariohysterectomy, and castra- to 200 pounds. Animals 200 pounds and tion in cats weighing at least 5.5 lb (2.5 over are administered 5 pounds of ra- kg) and at least 4 months of age; for up tion per animal. to a maximum of 3 days.

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(3) Limitations. Federal law restricts capsule per 10 pounds of body weight this drug to use by or on the order of a every 3 to 7 days, or longer, as re- licensed veterinarian. quired. (2) Indications for use. As an aid in al- [76 FR 18648, Apr. 5, 2011, as amended at 79 FR 10964, Feb. 27, 2014] leviating and controlling inflammation, pain, and lameness associated § 520.2098 Selegiline. with certain arthropathies. (a) Specifications. Each tablet con- (3) Limitations. Federal law restricts tains 2, 5, 10, 15, or 30 milligrams (mg) this drug to use by or on the order of a selegiline hydrochloride. licensed veterinarian. (b) Sponsor. See No. 054771 in [79 FR 28828, May 20, 2014] § 510.600(c) of this chapter. (c) Conditions of use in dogs—(1) § 520.2123 Spectinomycin oral dosage Amounts and indications for use. (i) Ad- forms. minister 1 mg per kilogram (0.45 mg per pound) of body weight once daily § 520.2123a Spectinomycin tablets. for control of clinical signs associated (a) Specifications. Each tablet con- with uncomplicated pituitary-depend- tains spectinomycin dihydrochloride ent hyperadrenocorticism in dogs. equivalent to 100 milligrams (mg) (ii) Administer 0.5 to 1.0 mg per kilo- spectinomycin. gram of body weight once daily for the (b) Sponsors. See Nos. 054771 and control of clinical signs associated 061623 in § 510.600(c) of this chapter. with canine cognitive dysfunction syn- (c) Conditions of use in dogs—(1) drome. Amount. Administer orally to provide (2) Limitations. Federal law restricts 10 mg per pound (lb) of body weight this drug to use by or on the order of a twice daily. Dosage may be continued licensed veterinarian. for 4 consecutive days. (2) Indications for use. For the treat- [79 FR 28828, May 20, 2014] ment of infectious diarrhea and § 520.2100 Selenium and vitamin E. gastroenteritis caused by organisms susceptible to spectinomycin. (a) Each capsule con- Specifications. (3) Limitations. Federal law restricts tains: this drug to use by or on the order of a (1) 2.19 milligrams (mg) sodium sele- licensed veterinarian. nite (equivalent to 1 mg selenium) and 56.2 mg (68 I.U.) vitamin E as d-alpha [73 FR 6607, Feb. 5, 2008, as amended at 79 FR tocopheryl acid succinate; or 28828, May 20, 2014] (2) 0.548 mg sodium selenite (equivalent to 0.25 mg selenium) and 14 mg (17 § 520.2123b Spectinomycin powder. I.U.) vitamin E as d-alpha tocopheryl (a) Specifications. Each gram (g) of acid succinate. powder contains spectinomycin (b) Sponsor. See No. 000061 in dihydrochloride pentahydrate equiva- § 510.600(c) of this chapter. lent to 0.5 g spectinomycin. (c) Conditions of use in dogs—(1) (b) Sponsor. See No. 061623 in Amount. (i) Dogs over 20 pounds: Ad- § 510.600(c) of this chapter. minister 1 capsule described in para- (c) Related tolerances. See § 556.600 of graph (a)(1) per 20 pounds of body this chapter. weight to a maximum of 5 capsules. Re- (d) Conditions of use in chickens. It is peat at 3 day intervals until a satisfac- administered in the drinking water of tory therapeutic response is observed. growing chickens as follows: Maintenance dosage is 1 capsule per 40 (1) Indications for use and amounts—(i) pounds of body weight every 3 to 7 For increased rate of weight gain and days, or longer, as required. improved feed efficiency in broiler (ii) Dogs under 20 pounds: Administer chickens, administer 0.5 g per gallon of 1 capsule described in paragraph (a)(2) water as the only source of drinking per 5 pounds of body weight with a water for the first 3 days of life and for minimum of 1 capsule. Repeat at 3-day 1 day following each vaccination. intervals until a satisfactory response (ii) As an aid in controlling infec- is observed. Maintenance dosage is 1 tious synovitis due to Mycoplasma

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synoviae in broiler chickens, admin- of flea infestations (Ctenocephalides ister 1 g per gallon of water as the only felis) for 1 month on dogs and puppies source of drinking water for the first 3 14 weeks of age and older and 3.3 to 5 days of life. pounds of body weight or greater. (iii) As an aid in the prevention or (2) Cats—(i) Amount. Administer tab- control of losses due to CRD associated lets once a month at a minimum dos- with M. gallisepticum (PPLO) in grow- age of 22.5 mg per pound (50 mg per ing chickens, administer 2 g per gallon kilogram) of body weight. of water as the only source of drinking (ii) Indications for use. To kill fleas water for the first 3 days of life and for and for the prevention and treatment 1 day following each vaccination. of flea infestations (C. felis) for 1 month (2) Limitations. Do not administer to on cats and kittens 14 weeks of age and laying chickens. Do not administer older and 2 pounds of body weight or within 5 days of slaughter. greater. [73 FR 6607, Feb. 5, 2008] [77 FR 60623, Oct. 4, 2012]

§ 520.2123c Spectinomycin solution. § 520.2134 Spinosad and milbemycin. (a) Specifications. Each milliliter of (a) Specifications. Each chewable tab- solution contains spectinomycin let contains 140 milligrams (mg) dihydrochloride pentahydrate equiva- spinosad and 2.3 mg milbemycin oxime, lent to 50 milligrams (mg) 270 mg spinosad and 4.5 mg milbemycin spectinomycin. oxime, 560 mg spinosad and 9.3 mg (b) Sponsors. See Nos. 000859, 054771, milbemycin oxime, 810 mg spinosad and 061623 in § 510.600(c) of this chapter. and 13.5 mg milbemycin oxime, or 1,620 (c) Related tolerances. See § 556.600 of mg spinosad and 27 mg milbemycin this chapter. oxime. (d) Conditions of use in swine—(1) (b) Sponsor. See No. 000986 in § 510.600 Amount. Administer 5 mg per pound (lb) of this chapter. of body weight orally twice daily for 3 (c) Conditions of use in dogs—(1) to 5 days. Amount. Administer once a month at a (2) Indications for use. For the treat- minimum dosage of 13.5 mg/pound (lb) ment and control of porcine enteric (30 mg/kilogram (kg)) of body weight colibacillosis (scours) caused by E. coli spinosad and 0.2 mg/lb (0.5 mg/kg) of susceptible to spectinomycin in pigs body weight milbemycin oxime. under 4 weeks of age. (2) Indications for use. To kill fleas; (3) Limitations. Do not administer to for the prevention and treatment of pigs over 15 lb body weight or over 4 flea infestations (Ctenocephalides felis); weeks of age. Do not administer within for the prevention of heartworm dis- 21 days of slaughter. ease (Dirofilaria immitis); and for the treatment and control of adult [73 FR 6607, Feb. 5, 2008, as amended at 78 FR hookworm (Ancylostoma caninum), 17596, Mar. 22, 2013; 79 FR 28828, May 20, 2014] adult roundworm (Toxocara canis and § 520.2130 Spinosad. Toxascaris leonina), and adult whipworm (Trichuris vulpis) infections (a) Specifications. Each chewable tab- in dogs and puppies 8 weeks of age or let contains 90, 140, 270, 560, 810, or 1620 older and 5 lbs of body weight or great- milligrams (mg) spinosad. er. (b) Sponsor. See No. 000986 in § 510.600 (3) Limitations. Federal law restricts of this chapter. this drug to use by or on the order of a (c) Special considerations. Federal law licensed veterinarian. restricts this drug to use by or on the order of a licensed veterinarian. [76 FR 12563, Mar. 8, 2011] (d) Conditions of use—(1) Dogs—(i) Amount. Administer tablets once a § 520.2150 Stanozolol. month at a recommended minimum (a) Specifications. Each tablet or dosage of 13.5 mg per pound (30 mg per chewable tablet contains 2 milligrams kilogram) of body weight. stanozolol. (ii) Indications for use. To kill fleas (b) Sponsor. No. 054771 in § 510.600(c) of and for the prevention and treatment this chapter.

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(c) Conditions of use in dogs and cats— drug to use by or on the order of a li- (1) Amount—(i) Dogs: Administered censed veterinarian. orally to small breeds, 1⁄2 to 1 tablet twice daily for several weeks; to large [57 FR 37327, Aug. 18, 1992, as amended at 58 FR 47211, Sept. 8, 1993; 63 FR 51821, Sept. 29, breeds, 1 to 2 tablets twice daily for 1998. Redesignated and amended at 79 FR several weeks. The tablets may be 28828, May 20, 2014; 79 FR 74020, Dec. 15, 2014; crushed and administered in feed. 80 FR 18776, Apr. 8, 2015; 80 FR 61296, Oct. 13, (ii) Cats: Administered orally 1⁄2 to 1 2015] tablet twice daily for several weeks. (2) Indications for use. As an anabolic § 520.2170 Sulfabromomethazine. steroid treatment. (a) Specifications. Each bolus contains (3) Limitations. Federal law restricts 15 grams of sulfabromomethazine so- this drug to use by or on the order of a dium. licensed veterinarian. (b) Sponsor. See No. 050604 in [79 FR 28828, May 20, 2014] § 510.600(c) of this chapter. (c) Related tolerance. See § 556.620 of § 520.2158 Streptomycin. this chapter. (a) Specifications. Each milliliter of (d) Conditions of use in cattle—(1) solution contains 250 milligrams (25 Amount. Administer 90 milligrams per percent) streptomycin sulfate. pound body weight orally. Repeat in 48 (b) Sponsor. See No. 016592 in hours if necessary § 510.600(c) of this chapter. (2) Indications for use. Treatment of (c) Related tolerances. See § 556.610 of necrotic pododermatitis (foot rot) and this chapter. calf diphtheria caused by Fusobacterium (d) Conditions of use. Use in drinking necrophorum; colibacillosis (scours) water as follows: caused by Escherichia coli; bacterial (1) Calves—(i) Amount. 10 to 15 milli- pneumonia and bovine respiratory dis- grams per pound (mg/pound) of body ease complex (shipping fever complex) weight (1.0 to 1.5 grams per gallon) for associated with Pasteurella spp.; acute up to 5 days. metritis and acute mastitis caused by (ii) Indications for use. For the treat- Streptococcus spp. ment of bacterial enteritis caused by (3) Limitations. Milk taken from ani- Escherichia coli and Salmonella spp. sus- mals within 96 hours (8 milkings) of ceptible to streptomycin. latest treatment must not be used for (iii) Limitations. Federal law restricts food. Do not administer within 18 days this drug to use by or on the order of a of slaughter. licensed veterinarian. (2) Swine—(i) Amount. 10 to 15 mg/ [47 FR 30243, July 13, 1982, as amended at 62 FR 63270, Nov. 28, 1997; 79 FR 28829, May 20, pound of body weight (1.0 to 1.5 grams 2014] per gallon) for up to 4 days. (ii) Indications for use. For the treat- § 520.2184 Sulfachloropyrazine. ment of bacterial enteritis caused by Escherichia coli and Salmonella spp. sus- (a) Specifications. Each gram of pow- ceptible to streptomycin. der contains 476 milligrams of sodium (iii) Limitations. Federal law restricts sulfachloropyrazine monohydrate. this drug to use by or on the order of a (b) Sponsor. See No. 054771 in licensed veterinarian. § 510.600(c) of this chapter. (3) Chickens—(i) Amount. 10 to 15 mg/ (c) Related tolerance. See § 556.625 of pound of body weight (0.6 to 0.9 grams this chapter. per gallon) for up to 5 days. (d) Conditions of use in chickens. It is (ii) Indications for use. For the treat- used in the drinking water of broilers, ment of nonspecific infectious enteritis breeder flocks, and replacement chick- caused by organisms susceptible to ens as follows: streptomycin. (1) Amount. Administer in drinking (iii) Limitations. Withdraw 4 days be- water as 0.03 percent solution for 3 fore slaughter. Do not administer to days. chickens producing eggs for human (2) Indications for use. For the treat- consumption. Federal law restricts this ment of coccidiosis.

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(3) Limitations. Administer as sole caused by E. coli, and in the treatment source of drinking water and of sul- of infections caused by other Gram- fonamide medication. Withdraw 4 days positive and Gram-negative organisms prior to slaughter. Do not use in chick- that are susceptible to sulfonamide ens producing eggs for human con- therapy. sumption. (iii) Limitations. Federal law restricts [79 FR 28829, May 20, 2014] this drug to use by or on the order of a licensed veterinarian. § 520.2200 Sulfachlorpyridazine. [75 FR 10166, Mar. 5, 2010, as amended at 79 (a) Specifications. (1) Sodium FR 28829, May 20, 2014; 81 FR 17607, Mar. 30, sulfachlorpyridazine powder. 2016] (2) Each bolus contains 2 grams sulfachlorpyridazine. § 520.2215 Sulfadiazine/pyrimethamine (3) Each tablet contains 250 milli- suspension. grams (mg) sulfachlorpyridazine. (a) Specifications. Each milliliter (b) Sponsor. See No. 016592 in (mL) of suspension contains 250 milli- § 510.600(c) of this chapter. grams (mg) sulfadiazine (as the sodium (c) Related tolerances. See § 556.630 of salt) and 12.5 mg pyrimethamine. this chapter. (b) Sponsor. See No. 055246 in (d) Conditions of use. It is used as fol- § 510.600(c) of this chapter. lows: (c) Conditions of use in horses—(1) (1) Calves—(i) Amount. Administer 30 Amount. Administer orally 20 mg sulfa- to 45 mg sulfachlorpyridazine powder diazine per kilogram (kg) body weight per pound (/lb) of body weight per day and 1 mg/kg pyrimethamine daily. in milk or milk replacer, or in a bolus, (2) Indications for use. For the treat- in divided doses twice daily for 1 to 5 ment of equine protozoal days. myeloencephalitis (EPM) caused by (ii) Indications for use. For the treat- Sarcocystis neurona. ment of diarrhea caused or complicated (3) Limitations. Do not use in horses by (colibacillosis). Escherichia coli intended for human consumption. Fed- (iii) Limitations. Treated ruminating eral law restricts this drug to use by or calves must not be slaughtered for food on the order of a licensed veterinarian. during treatment or for 7 days after the last treatment. A withdrawal pe- [69 FR 70054, Dec. 2, 2004, as amended at 73 riod has not been established for this FR 53686, Sept. 17, 2008; 75 FR 69586, Nov. 15, product in preruminating calves. Do 2010] not use in calves to be processed for veal. § 520.2218 Sulfamerazine, sulfamethazine, and (2) Swine—(i) Amount. Administer 20 sulfaquinoxaline powder. to 35 mg/lb body weight per day, in divided doses twice daily for 1 to 5 days: (a) Specifications. Each 195-gram (g) (A) In drinking water or packet of powder contains 78 g sulfa- (B) For individual treatment, in an merazine, 78 g sulfamethazine, and 39 g oral suspension containing 50 mg per sulfaquinoxaline. milliliter. (b) Sponsor. See No. 054771 in (ii) Indications for use. For the treat- § 510.600(c) of this chapter. ment of diarrhea caused or complicated (c) Related tolerances. See §§ 556.670 by E. coli (colibacillosis). and 556.685 of this chapter. (iii) Limitations. Treated swine must (d) Conditions of use—(1) Chickens—(i) not be slaughtered for food during Amounts and indications for use—(A) As treatment or for 4 days after the last an aid in the control of coccidiosis treatment. caused by Eimeria tenella and E. necatrix (3) Dogs—(i) Amount. Administer tab- susceptible to sulfamerazine, lets orally at 500 mg per 10 to 15 lb of sulfamethazine, and sulfaquinoxaline: body weight daily, in two or three di- Provide medicated water (0.04 percent vided doses. solution) for 2 to 3 days, then plain (ii) Indications for use. As an aid in water for 3 days, then medicated water the treatment of infectious (0.025 percent solution) for 2 days. If tracheobronchitis and infections bloody droppings appear, repeat at 0.025

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percent level for 2 more days. Do not scribed in paragraph (a)(1) of this sec- change litter. tion. (B) As an aid in the control of acute (2) Nos. 054771, 054925, 057561, 058829, fowl cholera caused by Pasteurella 061623, and 066104 for use of the product multocida susceptible to sulfamerazine, described in paragraph (a)(2) of this sulfamethazine, and sulfaquinoxaline: section. Provide medicated water (0.04 percent (c) Related tolerances. See § 556.640 of solution) for 2 to 3 days. If disease re- this chapter. curs, repeat treatment. (d) Conditions of use—(1) Broiler and (ii) Limitations. Make fresh solution replacement chickens—(i) Amount. Ad- daily. Do not treat chickens within 14 minister 1.875 grams per gallon (0.05 days of slaughter for food. Do not percent) of drinking water for 6 con- medicate chickens producing eggs for secutive days. human consumption. (ii) Indications for use. For treatment (2) Turkeys—(i) Amounts and indications for use—(A) As an aid in the con- of outbreaks of coccidiosis, fowl chol- trol of coccidiosis caused by Eimeria era, and infectious coryza. meleagrimitis and E. adenoeides suscep- (iii) Limitations. Do not administer to tible to sulfamerazine, sulfamethazine, chickens over 16 weeks of age. As sole and sulfaquinoxaline: Provide medi- source of drinking water and sul- cated water (0.025 percent solution) for fonamide medication. Withdraw 5 days 2 days, then plain water for 3 days, before slaughter. then medicated water (0.025 percent so- (2) Turkeys—(i) Amount. Administer lution) for 2 days, then plain water for 0.938 grams per gallon (0.025 percent) of 3 days, then medicated water (0.025 per- drinking water for 6 consecutive days. cent solution) for 2 days. Repeat if nec- (ii) Indications for use. Growing tur- essary. Do not change litter. keys: For treatment of disease out- (B) As an aid in the control of acute breaks of coccidiosis and fowl cholera. fowl cholera caused by Pasteurella (iii) Limitations. Do not administer to multocida susceptible to sulfamerazine, turkeys over 24 weeks of age. Use as sulfamethazine, and sulfaquinoxaline: the sole source of drinking water and Provide medicated water (0.04 percent sulfonamide medication. Withdraw 5 solution) for 2 to 3 days. If disease re- days before slaughter. curs, repeat treatment. (3) Cattle—(i) Amount. 1.18 to 2.36 (ii) Limitations. Make fresh solution grams per gallon (0.031 to 0.062 percent) daily. Do not treat turkeys within 14 of drinking water. As a drench, admin- days of slaughter for food. Do not ister 2.5 grams per 100 pounds of body medicate turkeys producing eggs for weight for first day, then 1.25 grams human consumption. per 100 pounds of body weight per day [71 FR 13001, Mar. 14, 2006, as amended at 79 for the next 4 consecutive days. If no FR 28829, May 20, 2014; 80 FR 34278, June 16, improvement within 2 to 3 days, re- 2015] evaluate diagnosis. Do not treat beyond 5 days. § 520.2220 Sulfadimethoxine oral dosage forms. (ii) Indications for use. Dairy calves, dairy heifers, and beef cattle: For the § 520.2220a Sulfadimethoxine solution treatment of shipping fever complex and soluble powder. and bacterial pneumonia associated (a) Specifications. (1) Each ounce of with Pasteurella spp. sensitive to solution contains 3.75 grams (12.5 per- sulfadimethoxine; and calf diphtheria cent) sulfadimethoxine. and foot rot associated with (2) Each 107 grams of powder contains Fusobacterium necrophorum the equivalent of 94.6 grams (Sphaerophorus necrophorus) sensitive sulfadimethoxine as sulfadimethoxine to sulfadimethoxine. sodium. (iii) Limitations. Withdraw 7 days be- (b) Sponsors. See sponsor numbers in fore slaughter. A withdrawal period has § 510.600(c) of this chapter: not been established for this product in (1) Nos. 000859, 054628, 054771, 054925, preruminating calves. Do not use in and 057561 for use of the product de- calves to be processed for veal. Federal

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law prohibits the extralabel use of this by 1.25 grams per 100 pounds body product in lactating dairy cattle. weight per day; treat for 4 to 5 days. (2) Indications for use. For the treat- [79 FR 28829, May 20, 2014] ment of shipping fever complex and § 520.2220b Sulfadimethoxine suspen- bacterial pneumonia associated with sion. Pasteurella spp. sensitive to sulfadimethoxine; and calf diphtheria (a) Specifications. Each milliliter of and foot rot associated with suspension contains 50 milligrams (mg) Fusobacterium necrophorum sensitive to sulfadimethoxine. sulfadimethoxine. (b) Sponsors. See Nos. 000061 and (3) Limitations. Do not administer 054771 in § 510.600(c) of this chapter. within 7 days of slaughter; milk that (c) Conditions of use in dogs and cats— has been taken from animals during (1) Amount. Administer orally 25 mg per treatment and 60 hours (5 milkings) pound of body weight, followed by 12.5 after the latest treatment must not be mg per pound of body weight daily. used for food. A withdrawal period has (2) For the treat- Indications for use. not been established for this product in ment of sulfonamide susceptible bac- preruminating calves. Do not use in terial infections in dogs and cats and calves to be processed for veal. enteritis associated with coccidiosis in dogs. [79 FR 28829, May 20, 2014] (3) Limitations. Federal law restricts this drug to use by or on the order of a § 520.2220e Sulfadimethoxine ex- licensed veterinarian. tended-release bolus. (a) Specifications. Each extended-re- [79 FR 28829, May 20, 2014] lease bolus contains 12.5 grams § 520.2220c Sulfadimethoxine tablet. sulfadimethoxine. (b) Sponsor. See No. 054771 in (a) Specifications. Each tablet con- § 510.600(c) of this chapter. tains 125, 250, or 500 milligrams (mg) (c) Related tolerances. See § 556.640 of sulfadimethoxine. this chapter. (b) Sponsors. See Nos. 000061 and (d) Conditions of use in beef cattle and 054771 in § 510.600(c) of this chapter. non-lactating dairy cattle—(1) Amount. (c) [Reserved] Administer one 12.5-gram-sustained-re- (d) Conditions of use in dogs and cats— lease bolus for the nearest 200 pounds (1) Amount. Administer 25 milligrams of body weight, i.e., 62.5 milligrams per (mg) per pound of body weight on the pound of body weight. Do not repeat first day followed by 12.5 milligrams treatment for 7 days. (mg) per pound of body weight per day (2) Indications for use. For the treat- until the animal is free of symptoms ment of shipping fever complex and for 48 hours. bacterial pneumonia associated with (2) Indications for use. Treatment of Pasteurella spp. sensitive to sulfadimethoxine-susceptible bacterial sulfadimethoxine; and calf diphtheria infections. and foot rot associated with (3) Limitations. Federal law restricts Fusobacterium necrophorum sensitive to this drug to use by or on the order of a sulfadimethoxine. licensed veterinarian. (3) Limitations. Do not use in female [79 FR 28829, May 20, 2014] dairy cattle 20 months of age or older. Do not administer within 12 days of § 520.2220d Sulfadimethoxine bolus. slaughter. Federal law restricts this (a) Specifications. Each bolus contains drug to use by or on the order of a li- 2.5, 5, or 15 grams sulfadimethoxine. censed veterinarian. (b) Sponsor. See No. 054771 in [79 FR 28830, May 20, 2014] § 510.600(c) of this chapter. (c) Related tolerances. See § 556.640 of § 520.2220f Sulfadimethoxine and this chapter. ormetoprim tablet. (d) Conditions of use in cattle—(1) (a) Specifications. Each tablet con- Amount. Administer 2.5 grams per 100 tains 120 milligrams (mg) (100 mg pounds body weight for 1 day followed sulfadimethoxine and 20 mg

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ormetoprim), 240 mg (200 mg rate of 1 gallon per 100 pounds of body sulfadimethoxine and 40 mg weight per day for 4 days. Use as the ormetoprim), 600 mg (500 mg sole source of sulfonamide. sulfadimethoxine and 100 mg (ii) Indications for use. For treatment ormetoprim), or 1200 mg (1000 mg of respiratory infections (pneumonia, sulfadimethoxine and 200 mg shipping fever), foot rot, calf scours; ormetoprim). and as adjunctive therapy in septi- (b) Sponsor. See No. 054771 in cemia accompanying mastitis and me- § 510.600(c) of this chapter. tritis. (c) Conditions of use in dogs—(1) (iii) Limitations. Do not treat within Amount. On the first day of treatment, 16 days of slaughter. Milk that has administer 25 mg per pound (55 mg per been taken from animals during treat- kilogram) of body weight. Then follow ment and for 72 hours (6 milkings) after with a daily dosage of 12.5 mg per latest treatment must not be used for pound (27.5 mg per kilogram) of body food. Federal law restricts this drug to weight. Do not exceed a total of 21 con- use by or on the order of a licensed vet- secutive days. erinarian. (2) Indications of use. Treatment of [79 FR 28830, May 20, 2014] skin and soft tissue infections (wounds and abscesses) in dogs caused by § 520.2240b Sulfaethoxypyridazine tab- strains of Staphylococcus aureus and lets. Escherichia coli and urinary tract infec- (a) Specifications—(1) Each tablet con- tions caused by E. coli, Staphylococcus tains 2.5 or 15 grams spp., and Proteus mirabilus susceptible sulfaethoxypyridazine. to ormetoprim-potentiated (2) Each extended-release tablet con- sulfadimethoxine. tains 5 grams sulfaethoxypyridazine. (3) Limitations. Federal law restricts (b) Sponsor. See No. 054771 § 510.600(c) this drug to use by or on the order of a of this chapter. licensed veterinarian. (c) Related tolerances. See § 556.650 of [79 FR 28830, May 20, 2014] this chapter. (d) Conditions of use in cattle—(1) 2.5- § 520.2240 Sulfaethoxypyridazine. or 15-gram tablets—(i) Amount. Admin- ister 25 milligrams per pound of body § 520.2240a Sulfaethoxypyridazine so- weight per day for 4 days. Use as the lution. sole source of sulfonamide. (a) Specifications. Each milliliter of (ii) Indications for use. For treatment solution contains 62.5 milligrams (mg) of respiratory infections (pneumonia, sodium sulfaethoxypyridazine. shipping fever), foot rot, calf scours; as (b) Sponsor. See No. 054771 § 510.600(c) adjunctive therapy in septicemia ac- of this chapter. companying mastitis and metritis. (c) Related tolerances. See § 556.650 of (iii) Limitations. Do not treat within this chapter. 16 days of slaughter. Milk that has (d) Conditions of use—(1) Swine—(i) been taken from animals during treat- Amount. Administer 3.8 grams per gal- ment and for 72 hours (6 milkings) after lon for first day followed by 1.9 grams latest treatment must not be used for per gallon for not less than 3 days nor food. Federal law restricts this drug to more than 9 days. Use as the sole use by or on the order of a licensed vet- source of sulfonamide. erinarian. (ii) Indications for use. For treatment (2) 15-gram extended-release tablets—(i) of bacterial scours pneumonia enter- Amount. Administer 100 milligrams per itis, bronchitis, septicemia accom- pound of body weight. Use as the sole panying Salmonella choleraesuis infec- source of sulfonamide. tion. (ii) Indications for use. For treatment (iii) Limitations. Do not treat within of foot rot and respiratory infections 10 days of slaughter. Federal law re- (shipping fever and pneumonia) caused stricts this drug to use by or on the by sulfonamide-susceptible pathogens order of a licensed veterinarian. (E. coli, Streptococci, Staphylococci, (2) Cattle—(i) Amount. For use at 2.5 Sphaerophorus necrophorus and Gram- grams per gallon. Administer at the negative rods including Pasteurella);

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and for use prophylactically during pe- 48 hours beyond the remission of dis- riods of stress for reducing losses due ease symptoms, but not to exceed 5 to sulfonamide sensitive disease condi- consecutive days. Follow dosages care- tions. fully. Do not treat cattle within 10 (iii) Limitations. Do not treat within days of slaughter. Do not use in female 16 days of slaughter. Not for use in lac- dairy cattle 20 months of age or older. tating dairy cows. Federal law restricts Use of sulfamethazine in this class of this drug to use by or on the order of a cattle may cause milk residues. A licensed veterinarian. withdrawal period has not been estab- [79 FR 28830, May 20, 2014] lished in preruminating calves. Do not use in calves to be processed for veal. § 520.2260 Sulfamethazine oral dosage Do not use in horses intended for forms. human consumption. § 520.2260a Sulfamethazine oblet, tab- (b)(1) Sponsor. See No. 054771 in let, and bolus. § 510.600(c) of this chapter for use of 5- (a)(1) Sponsor. See No. 016592 in gram sulfamethazine bolus. § 510.600(c) of this chapter for use of 2.5- (2) Related tolerances in edible prod- , 5-, and 15-gram sulfamethazine oblet ucts. See § 556.670 of this chapter. in beef cattle, nonlactating dairy cat- (3) Conditions of use—(i) Amount. Ad- tle, and horses. See No. 061690 in minister 10 grams (2 boluses) of § 510.600(c) of this chapter for use of 5- sulfamethazine per 100 pounds of body , 15-, and 25-gram tablet in beef and weight the first day, then 5 grams (1 nonlactating dairy cattle. bolus) of sulfamethazine per 100 pounds (2) Related tolerance in edible products. of body weight daily for up to 4 addi- See § 556.670 of this chapter. tional consecutive days. (3) Conditions of use—(i) Amount. Ad- (ii) Indications for use. Ruminating minister as a single dose 100 milligrams beef and dairy calves. For treatment of of sulfamethazine per pound of body the following diseases caused by orga- weight the first day and 50 milligrams nisms susceptible to sulfamethazine: per pound of body weight on each fol- bacterial scours (colibacilloosis) caused lowing day. by E. coli; necrotic pododermatitis (foot (ii) Indications for use. For treatment rot) and calf diphtheria caused by F. of diseases caused by organisms susceptible to sulfamethazine. necrophorum; bacterial pneumonia asso- (A) Beef cattle and nonlactating dairy ciated with Pasteurella spp.; and coc- cattle. Treatment of bacterial pneu- cidiosis caused by E. bovis and E. zurnii. monia and bovine respiratory disease (iii) Limitations. Do not administer complex (shipping fever complex) for more than 5 consecutive days. Do (Pasteurella spp.), colibacillosis (bac- not treat calves within 11 days of terial scours) (Escherichia coli), necrotic slaughter. Do not use in calves to be pododermatitis (foot rot) slaughtered under 1 month of age or in (Fusobacterium necrophorum), calf diph- calves being fed an all milk diet. Do theria (Fusobacterium necrophorum), not use in female dairy cattle 20 acute mastitis (Streptococcus spp.), months of age or older; such use may acute metritis (Streptococcus spp.), coc- cause drug residues in milk. Admin- cidiosis (Eimeria bovis and Eimeria ister with adequate supervision. Fol- zurnii). lows recomended dosages carefully. (B) Horses. Treatment of bacterial Fluid intake must be adequate. If pneumonia (secondary infections asso- symptoms persist after 2 or 3 days, con- ciated with Pasteurella spp.), strangles sult a veterinarian. (Streptococcus equi), and bacterial enteritis (Escherichia coli). [54 FR 15751, Apr. 19, 1989; 54 FR 19283, May 4, (iii) Limitations. Administer daily 1989, as amended at 56 FR 50653, Oct. 8, 1991; until animal’s temperature and appear- 59 FR 22754, May 3, 1994; 61 FR 4875, Feb. 9, ance are normal. If symptoms persist 1996; 64 FR 66383, Nov. 26, 1999; 67 FR 78355, after using for 2 or 3 days consult a Dec. 24, 2002; 75 FR 10166, Mar. 5, 2010; 76 FR veterinarian. Fluid intake must be ade- 17337, Mar. 29, 2011; 79 FR 28830, May 20, 2014; 81 FR 17607, Mar. 30, 2016] quate. Treatment should continue 24 to

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§ 520.2260b Sulfamethazine sustained- (2) Conditions of use—(i) Amount. 32.1 release boluses. grams (1 bolus) per 200 pounds of body (a)(1) Sponsor. See No. 000859 in weight. § 510.600(c) of this chapter for use of a (ii) Indications for use. For beef and 22.5-gram sulfamethazine prolonged-re- nonlactating dairy cattle for the treat- lease bolus. ment of diseases caused by (2) Conditions of use—(i) Amount. De- sulfamethazine-sensitive organisms as pending on the duration of therapeutic follows: bacterial pneumonia and bo- levels desired, administer boluses as a vine respiratory disease complex (ship- single dose as follows: 31⁄2 days—1 bolus ping fever complex) caused by (22.5 grams) per 200 pounds of body Pasteurella spp., colibacillosis (bac- weight; 5 days—1 bolus per 100 pounds terial scours) caused by E. coli, necrotic of body weight. pododermatitis (foot rot) and calf diph- (ii) Indications for use. Beef and non- theria caused by Fusobacterium lactating cattle for sustained treat- necrophorum, and acute mastitis and ment of shipping fever pneumonia acute metritis caused by Streptococcus caused or complicated by Pasteurella spp.) multocida; as an aid in the treatment of (iii) Limitations. After 72 hours, all foot rot, mastitis, pneumonia, metritis, animals should be reexamined for per- bacterial enteritis, calf diphtheria, and sistence of observable disease signs. If septicemia when caused or complicated signs are present, consult a veteri- by bacteria susceptible to narian. It is strongly recommended sulfamethazine. that a second dose be given to provide (iii) Limitations. Cattle that are for an additional 72 hours of therapy, acutely ill should be treated particularly in more severe cases. The parenterally with a suitable anti- dosage schedule should be used at each bacterial product to obtain immediate 72-hour interval. Animals should not therapeutic blood levels; do not slaugh- receive more than 2 doses because of ter animals for food within 16 days of the possibility of incurring residue vio- treatment; do not use in lactating lations. This drug, like all dairy cattle; Federal law restricts this sulfonamides, may cause toxic reac- drug to use by or on the order of a li- tions and irreparable injury unless ad- censed veterinarian. ministered with adequate and contin- (b)(1) Sponsor. See No. 054771 in uous supervision; follow dosages care- § 510.600(c) of this chapter for use of a fully. Fluid intake must be adequate at 27-gram sulfamethazine sustained-re- all times throughout the 3-day ther- lease bolus. apy, Do not use in female dairy cattle (2) Conditions of use—(i) Amount. 27 20 months of age or older. Use of grams (1 bolus) for each 150 pounds of sulfamethazine in this class of cattle body weight as a single dose. may cause milk residues. Do not treat (ii) Indications for use. For nonlac- animals within 12 days of slaughter. tating cattle for the treatment of in- (d)(1) Sponsor. See 000859 in § 510.600(c) fections caused by organisms sensitive of this chapter for use of a 22.5-gram to sulfamethazine such as hemorrhagic sulfamethazine sustained release bolus. septicemia (shipping fever complex), (2) Conditions of use—(i) Amount. Ad- bacterial pneumonia, foot rot, and calf minister 1 bolus (22.5 grams) per 200 diphtheria and as an aid in the control pounds of body weight, as a single dose. of bacterial diseases usually associated (ii) Indications for use. Beef and non- with shipping and handling of cattle. lactating dairy cattle for the prolonged (iii) Limitations. If no response within treatment of the following diseases 2 to 3 days, reevaluate therapy; do not when caused by one or more of the list- crush tablets; treated animals must ed pathogenic organisms sensitive to not be slaughtered for food within 28 sulfamethazine: bovine respiratory dis- days after the latest treatment; Fed- ease complex (shipping fever complex) eral law restricts this drug to use by or (Pasteurella spp.), bacterial pneumonia on the order of a licensed veterinarian. (Pasteurella spp.), necrotic (c)(1) Sponsor. See No. 061623 in pododermatitis (foot rot) § 510.600(c) of this chapter for use of a (Fusobacterium necrophorum), 32.1-gram sustained-release bolus. colibacillosis (bacterial scours)

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(Escherichia coli), calf diphtheria nisms sensitive to sulfamethazine: bo- (Fusobacterium necrophorum), acute vine respiratory disease complex (ship- mastitis (Streptococcus spp.) and acute ping fever complex) associated with metritis (Streptococcus spp.). Pasteurella spp.; bacterial pneumonia (iii) Limitations. Cattle that are associated with Pasteurell spp.; necrotic acutely ill should be treated by injec- pododermatitis (foot rot) and calf diph- tion with a suitable antibacterial prod- theria caused by Fusobacterium uct to obtain immediate therapeutic necrophorum; colibacillosis (bacterial blood levels; do not slaughter animals scours) caused by Escherichia coli; coc- for food within 16 days of treatment; do cidiosis caused by Eimeria bovis and E. not use in lactating dairy cattle; if zurnii; acute mastitis and metritis treated animals do not respond within caused by Streptococcus spp. 2 to 3 days, consult a veterinarian. (e)(1) Sponsor. See No. 061623 in (iii) Limitations. For use in beef cattle § 510.600(c) of this chapter for use of an and nonlactating dairy cattle only; if 8.02-gram sulfamethazine sustained-re- symptoms persist for 2 or 3 days after lease bolus. use, consult a veterinarian; do not (2) Conditions of use—(i) Amount. Ad- slaughter animals for food for at least minister 2 boluses (8.02 grams per 8 days after the last dose; do not use in bolus) per 100 pounds of body weight, as lactating dairy cattle; do not admin- a single dose. ister more than two consecutive doses. (ii) Indications for use. Administer (g) Related tolerances. See § 556.670 of orally to ruminating calves for the pro- this chapter. longed treatment of the following dis- (h)(1) Sponsor. See No. 000010 in eases when caused by one or more of § 510.600(c) of this chapter for use of an the listed pathogenic organisms sen- 8.25-gram sulfamethazine sustained-re- sitive to sulfamethazine: bacterial lease bolus. pneumonia (Pasteurella spp.), (2) Conditions of use—(i) Amount. Ad- colibacillosis (bacterial scours) (E. minister at the rate of 1 bolus (8.25 coli), and calf diptheria (Fusobacterium grams per bolus) per 50 pounds of body necrophorum). weight, as a single dose. If signs of dis- (iii) Limitations. For use in rumi- ease are significantly reduced, it is rec- nating replacement calves only; 72 ommended that a second dose be given hours after dosing all animals should be reexamined for persistence of dis- to provide an additional 72 hours of ease signs; if signs are present, consult therapy. a veterinarian; do not slaughter ani- (ii) Indications for use. Administer mals for food for at least 12 days after orally to ruminating beef and dairy the last dose; this product has not been calves for treatment of the following shown to be effective for nonrumi- diseases when caused by one or more of nating calves; exceeding two consecu- the listed pathogenic organisms sus- tive doses may cause violative tissue ceptible to sulfamethazine: bacterial residue to remain beyond the with- pneumonia associated with Pasteurella drawal time; do not use in calves under spp.; colibacillosis (bacterial scours) 1 month of age or calves being fed an caused by Escherichia coli; coccidiosis all milk diet. caused by Eimeria bovis and E. zurnii; (f)(1) Sponsor. See No. 000859 in and calf diphtheria caused by § 510.600(c) of this chapter for use of a Fusobacterium necrophorum. 30-gram sulfamethazine sustained-re- (iii) Limitations. Do not use in calves lease bolus. to be slaughtered under 1 month of age (2) Conditions of use—(i) Amount. Ad- or calves being fed an all milk diet. Do minister at the rate of 1 bolus (30 not use in female dairy cattle 20 grams per bolus) per 200 pounds of body months of age or older. If symptoms weight, as a single dose. persist after 3 days, consult a veteri- (ii) Indications for use. Administer orally to beef cattle and nonlactating narian. Do not administer more than 2 dairy cattle for the treatment of the consecutive doses. Do not slaughter following diseases when caused by one or more of the listed pathogenic orga-

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animals for food for at least 8 days 61 to 89 milligrams of sulfamethazine after the last dose. Do not crush bolus. sodium per pound of body weight per day, and turkeys 53 to 130 milligrams [46 FR 36132, July 14, 1981, as amended at 48 FR 18803, Apr. 26, 1983; 48 FR 32760, July 19, of sulfamethazine sodium per pound of 1983; 49 FR 29057, July 18, 1984; 50 FR 49372, body weight per day, depending upon Dec. 2, 1985; 51 FR 30212, Aug. 25, 1986; 53 FR the dosage, age, and class of chickens 40727, Oct. 18, 1988; 54 FR 14341, Apr. 11, 1989; or turkeys, ambient temperature, and 55 FR 8462, Mar. 8, 1990; 56 FR 50653, Oct. 8, other factors. 1991; 59 FR 22754, May 3, 1994; 61 FR 4875, Feb. (2) Indications for use. For treatment 9, 1996; 62 FR 35076, June 30, 1997; 66 FR 14073, and control of diseases caused by orga- Mar. 9, 2001; 68 FR 4915, Jan. 31, 2003; 70 FR nisms sensitive to sulfamethazine. 8290, Feb. 18, 2005; 78 FR 17596, Mar. 22, 2013; 79 FR 28830, May 20, 2014] (i) Beef and nonlactating dairy cattle. Treatment of bacterial pneumonia and § 520.2260c Sulfamethazine sustained- bovine respiratory disease complex release tablets. (shipping fever complex) (Pasteurella (a) Specifications. Each extended-re- spp.), colibacillosis (bacterial scours) lease tablet contains 8 grams (Escherichia coli), necrotic sulfamethazine. pododermatitis (foot rot) (b) Sponsor. See No. 054771 in (Fusobacterium necrophorum), calf diph- § 510.600(c) of this chapter. theria (Fusobacterium necrophorum), (c) Related tolerances. See § 556.670 of acute mastitis (Streptococcus spp.), and this chapter. acute metritis (Streptococcus spp.). (d) Conditions of use—(1) Amount. 8 (ii) Swine. Treatment of porcine grams (1 tablet) per 45 pounds of body colibacillosis (bacterial scours) weight as a single dose. (Escherichia coli), and bacterial pneu- (2) Indications for use. In calves for monia (Pasteurella spp.). sustained treatment of pneumonia (iii) Chickens and turkeys. In chickens caused by Pasteurella spp., for control of infectious coryza colibacillosis (bacterial scours) caused (Avibacterium paragallinarum), coccidi- by Escherichia coli; and calf diptheria osis (Eimeria tenella, Eimeria necatrix), caused by Fusobacterium necrophorum. acute fowl cholera (Pasteurella (3) Limitations. Treated animals must multocida), and pullorum disease not be slaughtered for food within 18 (Salmonella Pullorum). In turkeys for days after the latest treatment. Fed- control of coccidiosis (Eimeria eral law restricts this drug to use by or meleagrimitis, Eimeria adenoeides). Medi- on the order of a licensed veterinarian. cate as follows: Infectious coryza in chickens, medicate for 2 consecutive [48 FR 26763, June 10, 1983, as amended at 56 days; acute fowl cholera and pullorum FR 50653, Oct. 8, 1991; 59 FR 22754, May 3, 1994; 61 FR 4875, Feb. 9, 1996; 79 FR 28830, May 20, disease, in chickens, medicate for 6 2014] consecutive days; coccidiosis, in chickens and turkeys, medicate as in para- § 520.2261 Sulfamethazine sodium oral graph (c) of this section, then reduce dosage forms. amount of medication to one-half for 4 additional days. § 520.2261a Sulfamethazine solution. (3) Limitations. Add the required dose (a) Specifications. Each milliliter of to that amount of water that will be solution contains 125 milligrams (12.5 consumed in 1 day. Consumption percent) sulfamethazine sodium. should be carefully checked. Have only (b) Sponsors. See Nos. 016592 and medicated water available during 061623 in § 510.600(c) of this chapter. treatment. Withdraw medication from (c) Related tolerances. See § 556.670 of cattle, chickens, and turkeys 10 days this chapter. prior to slaughter for food. Withdraw (d) Conditions of use—(1) Amount. Ad- medication from swine 15 days before minister in drinking water to provide: slaughter for food. Do not medicate Cattle and swine 112.5 milligrams of chickens or turkeys producing eggs for sulfamethazine sodium per pound of human consumption. Treatment of all body weight per day on the first day diseases should be instituted early. and 56.25 milligrams per pound of body Treatment should continue 24 to 48 weight on subsequent days; Chickens, hours beyond the remission of disease

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symptoms, but not to exceed a total of (ii) Indications for use. For control of 5 consecutive days in cattle or swine. coccidiosis (E. meleagrimitis, E. Medicated cattle, swine, chickens, and adenoeides). turkeys must actually consume enough (iii) Limitations. Add the required medicated water which provides the dose to that amount of water that will recommended dosages. Do not use in fe- be consumed in 1 day. Consumption male dairy cattle 20 months of age or should be carefully checked. Have only older. Use of sulfamethazine in this medicated water available during class of cattle may cause milk resi- treatment. Withdraw medication 10 dues. A withdrawal period has not been days prior to slaughter for food. Do not established in preruminating calves. medicate turkeys producing eggs for Do not use in calves to be processed for human consumption. Treatment of all veal. diseases should be instituted early. Treatment should continue 24 to 48 [47 FR 25322, June 11, 1982, as amended at 47 hours beyond the remission of disease FR 25735, June 15, 1982; 67 FR 78355, Dec. 24, symptoms. Medicated turkeys must ac- 2002; 70 FR 32489, June 3, 2005; 74 FR 36112, tually consume enough medicated July 22, 2009; 75 FR 10166, Mar. 5, 2010; 76 FR water which provides the recommended 17337, Mar. 29, 2011; 79 FR 28831, May 20, 2014; dosages. 81 FR 17607, Mar. 30, 2016] (3) Swine—(i) Amount. Administer in drinking water, or as a drench, to pro- § 520.2261b Sulfamethazine powder. vide 108 mg/lb of body weight on the (a) Specifications. A soluble powder first day and 54 mg/lb of body weight composed of 100 percent sulfamethazine per day on the second, third, and fourth sodium. days of administration. (b) Sponsors. See Nos. 016592 and (ii) Indications for use. For treatment 061623 in § 510.600(c) of this chapter. of porcine colibacillosis (bacterial (c) Related tolerances. See § 556.670 of scours) (E. coli), and bacterial pneu- this chapter. monia (Pasteurella spp.). (d) Conditions of use—(1) Chickens—(i) (iii) Limitations. Add the required Amount. Administer in drinking water dose to that amount of water that will to provide 58 to 85 milligrams (mg) per be consumed in 1 day. Consumption pound (/lb) of body weight per day. should be carefully checked. Have only (ii) Indications for use. For control of medicated water available during infectious coryza (Avibacterium treatment. Withdraw medication 15 paragallinarum), coccidiosis (Eimeria days prior to slaughter for food. Treat- tenella, E. necatrix), acute fowl cholera ment of all diseases should be insti- (Pasteurella multocida), and pullorum tuted early. Treatment should continue 24 to 48 hours beyond the remis- disease (Salmonella Pullorum). sion of disease symptoms, but not to (iii) Limitations. Add the required exceed a total of 5 consecutive days. dose to that amount of water that will Medicated swine must actually con- be consumed in 1 day. Consumption sume enough medicated water which should be carefully checked. Have only provides the recommended dosages. medicated water available during (4) Cattle—(i) Amount. Administer in treatment. Withdraw medication 10 drinking water, or as a drench, to pro- days prior to slaughter for food. Do not vide 108 mg/lb of body weight on the medicate chickens producing eggs for first day and 54 mg/lb of body weight human consumption. Treatment of all per day on the second, third, and fourth diseases should be instituted early. days of administration. Treatment should continue 24 to 48 (ii) Indications for use in beef and non- hours beyond the remission of disease lactating dairy cattle. Treatment of bac- symptoms. Medicated chickens must terial pneumonia and bovine res- actually consume enough medicated piratory disease complex (shipping water which provides the recommended fever complex) (Pasteurella spp.), dosages. colibacillosis (bacterial scours) (E. (2) Turkeys—(i) Amount. Administer coli), necrotic pododermatitis (foot rot) in drinking water to provide 50 to 124 (Fusobacterium necrophorum), calf diph- mg/lb of body weight per day theria (F. necrophorum), acute mastitis

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(Streptococcus spp.), and acute metritis (3) Limitations. Federal law restricts (Streptococcus spp.) this drug to use by or on the order of a (iii) Limitations. Add the required licensed veterinarian. dose to that amount of water that will [40 FR 13838, Mar. 27, 1975, as amended at 50 be consumed in 1 day. Consumption FR 13561, Apr. 5, 1985; 79 FR 28831, May 20, should be carefully checked. Have only 2014] medicated water available during treatment. Withdraw medication 10 § 520.2325 Sulfaquinoxaline oral dos- days prior to slaughter for food. Treat- age forms. ment of all diseases should be insti- § 520.2325a Sulfaquinoxaline powder tuted early. Treatment should con- and solution. tinue 24 to 48 hours beyond the remission of disease symptoms, but not to (a) Sponsor. See § 510.600(c) of this exceed a total of 5 consecutive days. chapter for identification of the spon- Medicated cattle must actually con- sors. sume enough medicated water which (1) To No. 000859 for use of a 25-percent sulfaquinoxaline soluble powder provides the recommended dosages. Do and a 20-percent sulfaquinoxaline so- not use in female dairy cattle 20 dium solution as provided for in para- months of age or older. Use of graph (c) of this section. sulfamethazine in this class of cattle (2) To No. 061623 for use of 3.44- and may cause milk residues. Do not use in 12.85-percent sulfaquinoxaline sodium calves under one (1) month of age or solutions as provided for in paragraphs calves being fed an all-milk diet. Use in (c)(1), (c)(2), (c)(3), (c)(4)(i), and (c)(4)(ii) these classes of calves may cause viola- of this section. tive residues to remain beyond the (3) To No. 054771 for use of a 31.92-per- withdrawal time. cent sulfaquinoxaline solution (sodium [71 FR 70303, Dec. 4, 2006, as amended at 75 and potassium salts) as provided for in FR 10166, Mar. 5, 2010; 79 FR 28831, May 20, paragraphs (c)(1), (c)(2), (c)(3), (c)(4)(i), 2014; 80 FR 61296, Oct. 13, 2015; 81 FR 17607, and (c)(4)(ii) of this section. Mar. 30, 2016] (4) No. 053501 for use of a 28.62-percent sulfaquinoxaline sodium solution as § 520.2280 Sulfamethizole and methe- provided in paragraphs (c)(1), (c)(2), and namine. (c)(3) of this section. (a) Specifications. Each tablet con- (b) Related tolerances. See § 556.685 of tains 250 milligrams of sulfamethizole this chapter. and 250 milligrams of methenamine (c) Conditions of use. It is used in mandelate. drinking water as follows: (b) Sponsor. See No. 054771 in (1) Chickens. (i) As an aid in the con- § 510.600(c) of this chapter. trol of outbreaks of coccidiosis caused (c) Conditions of use in dogs and cats— by Eimeria tenella, E. necatrix, E. (1) Amount. Administer orally 1 tablet acervulina, E. maxima, and E. brunetti. per 20 pounds of body weight 3 times (ii) Administer at the 0.04 percent per day until clinical signs are allevi- level for 2 or 3 days, skip 3 days then ated. To reduce the possibility of re- administer at the 0.025 percent level for lapse, continue therapy for a week to 2 more days. If bloody droppings appear, repeat treatment at the 0.025 per- 10 days. cent level for 2 more days. Do not (2) Indications for use. For treatment change litter unless absolutely nec- of urinary tract infections such as cys- essary. Do not give flushing mashes. titis, nephritis, prostatitis, urethritis, (2) Turkeys. (i) As an aid in the con- and pyelonephritis. As an aid in the trol of outbreaks of coccidiosis caused management of complications result- by Eimeria meleagrimitis and E. ing from surgical manipulations of the adenoeides. urinary tract such as removal of (ii) Administer at the 0.025 percent calculi from the bladder, in level for 2 days, skip 3 days, give for 2 ureterostomies, and in instrumenta- days, skip 3 days and give for 2 more tion of the urethra and bladder. days. Repeat if necessary. Do not

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change litter unless absolutely nec- not medicate chickens or turkeys pro- essary. Do not give flushing mashes. ducing eggs for human consumption. (3) Chickens and turkeys. (i) As an aid Make fresh drinking water daily. in the control of acute fowl cholera [48 FR 3964, Jan. 28, 1983, as amended at 48 caused by Pasteurella multocida suscep- FR 26762, June 10, 1983; 55 FR 29843, July 23, tible to sulfaquinoxaline and fowl ty- 1990; 59 FR 28769, June 3, 1994; 59 FR 33197, phoid caused by Salmonella gallinarum June 28, 1994; 61 FR 24443, May 15, 1996; 61 FR susceptible to sulfaquinoxaline. 63711, Dec. 2, 1996; 62 FR 37712, July 15, 1997; (ii) Administer at the 0.04 percent 65 FR 10705, Feb. 29, 2000; 69 FR 41427, July 9, level for 2 or 3 days. Move birds to 2004; 69 FR 60547, Oct. 12, 2004; 74 FR 36112, clean ground. If disease recurs, repeat July 22, 2009; 78 FR 17596, Mar. 22, 2013; 79 FR 28831, May 20, 2014] treatment. If cholera has become established as the respiratory or chronic § 520.2325b Sulfaquinoxaline drench. form, use feed medicated with (a) Specifications. A soluble powder sulfaquinoxaline. Poultry which have containing 25 percent sulfaquinoxaline. survived typhoid outbreaks should not (b) Sponsor. See No. 050749 in be kept for laying house replacements § 510.600(c) of this chapter. or breeders unless tests show they are (c) Conditions of use in cattle—(1) not carriers. Amount. Administer 1 teaspoon of 25 (4) Cattle and calves. (i) For the con- percent sulfaquinoxaline soluble pow- trol and treatment of outbreaks of coc- der for each 125 pounds of body weight cidiosis caused by Eimeria bovis or E. for 3 to 5 days as a drench. zurnii. (2) Indications for use. For the control (ii) Administer at the 0.015-percent and treatment of outbreaks of coccidi- level for 3 to 5 days in drinking water osis in cattle and calves caused by medicated with sulfaquinoxaline solu- Eimeria bovis or E. zuernii. tion. (3) Limitations. Do not give to cattle (iii) In lieu of treatment as provided within 10 days of slaughter for food. in paragraph (e)(4)(ii) of this section, Not for use in lactating dairy cattle. administer 1 teaspoon of 25-percent sulfaquinoxaline soluble powder per [79 FR 28831, May 20, 2014] day for each 125 pounds of body weight § 520.2330 Sulfisoxazole tablets. for 3 to 5 days in drinking water. (d) Limitations. Consult a veterinarian (a) Specifications. Each tablet con- or poultry pathologist for diagnosis. tains 260 milligrams (4 grains) of May cause toxic reactions unless the sulfisoxazole. drug is evenly mixed in water at dos- (b) Sponsor. See No. 054771 in ages indicated and used according to § 510.600(c) of this chapter. directions. For control of outbreaks of (c) Conditions of use—(1) Amount. Ad- disease, medication should be initiated minister one tablet orally per 4 pounds as soon as the diagnosis is determined. of body weight. Medicated chickens, turkeys, cattle, (2) Indications for use. Use in dogs and and calves must actually consume cats as an aid in treatment of bacterial enough medicated water which pro- pneumonia and bacterial enteritis vides a recommended dosage of ap- when caused by organisms sensitive to proximately 10 to 45 milligrams per sulfisoxazole. pound per day in chickens, 3.5 to 55 (3) Limitations. Repeat dosage at 24- milligrams per pound per day in tur- hour intervals until 2 to 3 days after keys, and approximately 6 milligrams disappearance of clinical symptoms. per pound per day in cattle and calves (Administration of one-half daily dos- depending on the age, class of animal, age at 12-hour intervals or one-third ambient temperature, and other fac- daily dosage at 8-hour intervals will tors. A withdrawal period has not been provide a more constant blood level.) established for sulfaquinoxaline in Provide adequate supply of drinking preruminating calves. Do not use in water. If symptoms persist after using calves to be processed for veal. Not for this preparation for 2 or 3 days, consult use in lactating dairy cattle. Do not a veterinarian. give to chickens, turkeys or cattle [43 FR 60895, Dec. 29, 1978, as amended at 79 within 10 days of slaughter for food. Do FR 28831, May 20, 2014]

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§ 520.2340 Tepoxalin. E. coli and urinary tract infections due to Staphylococcus spp. and E. coli. (a) Specifications. Each tablet contains 30, 50, 100, or 200 milligrams (mg) (3) Limitations. Administer orally; tepoxalin. continue treatment until symptoms of (b) Sponsor. See No. 000061 in the disease have subsided and tempera- § 510.600(c) of this chapter. ture is normal for 48 hours; not for use (c) Conditions of use in dogs—(1) in animals raised for food production; Amount. 10 mg per kilogram (/kg) daily; Federal law restricts this drug to use or 20 mg/kg on the initial day of treat- by or on the order of a licensed veteri- ment, followed by 10 mg/kg daily. narian. (2) Indications for use. For the control [57 FR 37327, Aug. 18, 1992, as amended at 79 of pain and inflammation associated FR 28831, May 20, 2014] with osteoarthritis. (3) Limitations. Federal law restricts § 520.2345c Tetracycline boluses. this drug to use by or on the order of a (a) Specifications. Each bolus contains licensed veterinarian. 500 milligrams of tetracycline (as the [68 FR 34795, June 11, 2003] hydrochloride). (b) Sponsor. See No. 054771 in § 520.2345 Tetracycline. § 510.600(c) of this chapter. § 520.2345a Tetracycline capsules. (c) Related tolerances. See § 556.720 of this chapter. (a) Specifications. Each capsule con- (d) Conditions of use. Calves—(1) tains 50, 100, 125, 250, or 500 milligrams Amount. 10 milligrams per pound of (mg) tetracycline hydrochloride. body weight per day in divided doses. (b) Sponsor. See No. 054771 in (i) Control and § 510.600(c) of this chapter. Indications for use. treatment of bacterial enteritis (c) Conditions of use in dogs—(1) Amount. 25 mg per pound of body (scours) caused by E. coli and bacterial weight per day in divided doses every 6 pneumonia caused by Pasteurella spp., hours. Hemophilus spp., and Klebsiella spp. (2) Indications for use. For treatment (ii) Limitations. Administer orally for of infections caused by organisms sen- 3 to 5 days; do not slaughter animals sitive to tetracycline hydrochloride, for food within 14 days of treatment; such as bacterial gastroenteritis due to use as sole source of tetracycline. E. coli and urinary tract infections due (iii) National Academy of Sciences/Na- to Staphylococcus spp. and E. coli. tional Research Council (NAS/NRC) sta- (3) Limitations. Federal law restricts tus. The conditions of use specified in this drug to use by or on the order of a paragraph (d)(1)(i) of this section were licensed veterinarian. NAS/NRC reviewed and found effective. [70 FR 50182, Aug. 26, 2005, as amended at 73 Applications for these uses need not in- FR 18442, Apr. 4, 2008; 79 FR 28831, May 20, clude effectiveness data as specified in 2014] § 514.111 of this chapter, but may require bioequivalency and safety infor- § 520.2345b Tetracycline tablets. mation. (a) Specifications. Each tablet con- (2) Amount. 10 milligrams per pound tains 100, 250, or 500 milligrams of tet- of body weight per day in two divided racycline (as the hydrochloride). doses. (b) Sponsor. See No. 054771 in (i) Indications for use. Treatment of § 510.600(c) of this chapter. bacterial pneumonia caused by orga- (c) Conditions of use. Dogs—(1) nisms susceptible to tetracycline, bac- Amount. 25 milligrams per pound of terial enteritis caused by E. coli, and body weight per day in divided doses salmonella organisms susceptible to every 6 hours. tetracycline. (2) Indications for use. Treatment of (ii) Limitations. Administer orally for infections caused by organisms sen- not more than 5 days; do not slaughter sitive to tetracycline hydrochloride, animals for food within 12 days of such as bacterial gastroenteritis due to

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treatment; use as sole source of tetra- (ii) Indications for use. Control and cycline. treatment of bacterial enteritis [57 FR 37328, Aug. 18, 1992, as amended at 67 (scours) caused by E. coli and bacterial FR 78355, Dec. 24, 2002; 79 FR 28831, May 20, pneumonia associated with Pasteurella 2014] spp., A. pleuropneumoniae (Haemophilus spp.), and Klebsiella spp., susceptible to § 520.2345d Tetracycline powder. tetracycline. (a) Specifications. Each pound of pow- (iii) Limitations. Administer for 3 to 5 der contains 25, 102.4, or 324 grams tet- days; do not slaughter animals for food racycline hydrochloride. within 7 days of treatment for No. (b) Sponsors. See sponsors listed in 016592 and within 4 days of treatment § 510.600(c) of this chapter for condi- for Nos. 054771, 054925, 057561, 059130, and tions of use as in paragraph (d) of this 061623; prepare a fresh solution daily; section: use as the sole source of tetracycline. (1) No. 054771: 25 grams per pound as (3) Chickens—(i) Amount. Chronic resin paragraphs (d)(3) and (d)(4) of this piratory disease: 400 to 800 milligrams section. per gallon. Infectious synovitis: 200 to (2) No. 054628: 25, 102.4, and 324 grams 400 milligrams per gallon. per pound as in paragraph (d) of this (ii) Indications for use. Control of section. chronic respiratory disease (CRD or (3) No. 054771: 25, 102.4, and 324 grams air-sac disease) caused by Mycoplasma per pound as in paragraph (d) of this gallisepticum and E. coli; control of in- section. fectious synovitis caused by M. (4) Nos. 054925, 057561, 061623, and synoviae susceptible to tetracycline. 076475: 324 grams per pound as in para- (iii) Administer for 7 to graph (d) of this section. Limitations. 14 days; do not slaughter for food with- (5) No. 016592: 25 grams per pound as in paragraphs (d)(1) and (d)(2) of this in 4 days of treatment; not for use in section. chickens producing eggs for human (c) Related tolerances. See § 556.720 of consumption; prepare a fresh solution this chapter. daily; use as the sole source of tetra- (d) Conditions of use. It is adminis- cycline. tered in drinking water as follows: (4) Turkeys—(i) Amount. For infec- (1) Calves—(i) Amount. 10 milligrams tious synovitis: 400 milligrams per gal- per pound of body weight per day in di- lon. For complicating bacterial orga- vided doses. nisms associated with bluecomb (trans- (ii) Indications for use. Control and missible enteritis or coronaviral enter- treatment of bacterial enteritis itis): 25 milligrams per pound of body (scours) caused by Escherichia coli and weight per day. bacterial pneumonia (shipping fever (ii) Indications for use. Control of in- complex) associated with Pasteurella fectious synovitis caused by M. spp., Actinobacillus pleuropneumoniae synoviae; control of bluecomb com- (Haemophilus spp.), and Klebsiella spp., plicated by organisms sensitive to tet- susceptible to tetracycline. racycline. (iii) Limitations. Administer for 3 to 5 (iii) Limitations. Administer for 7 to days; do not slaughter animals for food 14 days; do not slaughter for food with- within 4 days of treatment for No. in 4 days of treatment; not for use in 016592 and within 5 days of treatment turkeys producing eggs for human con- for Nos. 054771, 054925, 057561, 059130, and sumption; prepare a fresh solution 061623; prepare a fresh solution daily; use as the sole source of tetracycline. A withdrawal period has not been established 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 divided doses.

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daily; use as the sole source of tetra- § 520.2345f Tetracycline phosphate cycline. complex and sodium novobiocin capsules. [59 FR 17693, Apr. 14, 1994, as amended at 59 FR 19133, Apr. 22, 1994; 62 FR 5319, Feb. 5, (a) Specifications. Each capsule con- 1997; 62 FR 35076, June 30, 1997; 62 FR 46668, tains the equivalent of 60 milligrams of Sept. 4, 1997; 62 FR 55160, Oct. 23, 1997; 64 FR tetracycline hydrochloride and 60 mil- 37673, July 13, 1999; 67 FR 78355, Dec. 24, 2002; ligrams of novobiocin. 70 FR 16934, Apr. 4, 2005; 70 FR 67353, Nov. 7, (b) Sponsor. No. 054771 in § 510.600(c) of 2005; 71 FR 13542, Mar. 16, 2006; 75 FR 10166, Mar. 5, 2010; 75 FR 12981, Mar. 18, 2010; 76 FR this chapter. 17338, Mar. 29, 2011; 77 FR 20988, Apr. 9, 2012; (c) Conditions of use in dogs—(1) 78 FR 21060, Apr. 9, 2013; 79 FR 28831, May 20, Amount. 10 milligrams of each anti- 2014; 81 FR 17607, Mar. 30, 2016] biotic per pound of body weight (1 capsule for each 6 pounds) every 12 hours. § 520.2345e Tetracycline solution. (2) Indications for use. Treatment of (a) Specifications. Each milliliter con- acute or chronic canine respiratory in- tains the equivalent of either 25 or 100 fections such as tonsillitis, bronchitis, milligrams of tetracycline hydro- and tracheobronchitis when caused by chloride. pathogens susceptible to tetracycline (b) Sponsor. See No. 054771 in and/or novobiocin, such as Staphy- § 510.600(c) of this chapter. lococcus spp. and Escherichia coli. (c) Conditions of use—(1) Dogs—(i) (3) Limitations. Federal law restricts Amount. 25 milligrams per pound of this drug to use by or on the order of a body weight per day in divided doses licensed veterinarian. every 6 hours. [57 FR 37329, Aug. 18, 1992, as amended at 79 (ii) Indications for use. Treatment of FR 28831, May 20, 2014] infections caused by organisms sensitive to tetracycline hydrochloride, § 520.2345g Tetracycline hydrochloride such as bacterial gastroenteritis due to and sodium novobiocin tablets. Escherichia coli and urinary tract infec- (a) Specifications. Each tablet con- tions due to Staphylococcus spp. and E. tains the equivalent of 60 milligrams of coli. tetracycline hydrochloride and 60 mil- (iii) Limitations. Administer orally; ligrams of novobiocin, or 180 milli- continue treatment until symptoms grams of tetracycline hydrochloride have subsided and the temperature is and 180 milligrams of novobiocin. normal for 48 hours; not for use in ani- (b) Sponsor. See No. 054771 in mals which are raised for food produc- § 510.600(c) of this chapter. tion; Federal law restricts this drug to (c) —(1) use by or on the order of a licensed vet- Conditions of use in dogs erinarian. Amount. 10 milligrams of each antibiotic per pound of body weight (one (2) Dogs and cats—(i) Amount. 25 milli- single-strength tablet for each 6 pounds grams per pound of body weight per day in divided doses every 6 hours. or one triple-strength tablet for each 18 pounds). (ii) Indications for use. Treatment of infections caused by organisms suscep- (2) Indications for use. Treatment of tible to tetracycline hydrochloride, acute or chronic canine respiratory in- such as bacterial gastroenteritis due to fections such as tonsillitis, bronchitis, E. coli and urinary tract infections due and tracheobronchitis when caused by to Staphylococcus spp. and E. coli. pathogens susceptible to tetracycline (iii) Limitations. Administer orally; and/or novobiocin, such as Staphy- continue treatment until the tempera- lococcus spp. and Escherichia coli. ture has been normal for 48 hours; not (3) Limitations. Federal law restricts for use in food-producing animals; Fed- this drug to use by or on the order of a eral law restricts this drug to use by or licensed veterinarian. on the order of a licensed veterinarian. [57 FR 37329, Aug. 18, 1992, as amended at 79 [57 FR 37329, Aug. 18, 1992, as amended at 79 FR 28831, May 20, 2014] FR 28831, May 20, 2014]

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§ 520.2345h Tetracycline hydro- moval from the intestines of the adult chloride, sodium novobiocin, and forms of the species Ancylostoma prednisolone tablets. caninum and Uncinaria stenocephala (a) Specifications. Each tablet con- (hookworms). tains the equivalent of 60 milligrams of (3) Limitations. Federal law restricts tetracycline hydrochloride, 60 milli- this drug to use by or on the order of a grams of novobiocin, and 1.5 milli- licensed veterinarian. grams of prednisolone or 180 milli- [40 FR 13838, Mar. 27, 1975, as amended at 41 grams of tetracycline hydrochloride, FR 53477, Dec. 7, 1976; 46 FR 48642, Oct. 2, 1981; 180 milligrams of novobiocin, and 4.5 61 FR 8873, Mar. 6, 1996; 62 FR 61625, Nov. 19, milligrams of prednisolone. 1997; 79 FR 28832, May 20, 2014] (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. § 520.2380 Thiabendazole oral dosage (c) Conditions of use in dogs—(1) forms. Amount. 10 milligrams of each anti- § 520.2380a Thiabendazole top dress- biotic and 0.25 milligram of prednis- ing and mineral protein block. olone per pound of body weight (one (a) Conforms to N.F. single-strength tablet for each 6 pounds Specifications. XII. or one triple-strength tablet for each 18 (b) Sponsors. See sponsors in pounds) every 12 hours for 48 hours. § 510.600(c) of this chapter for use as in Treatment is to be continued with paragraph (d) of this section. novobiocin and tetracycline alone at (1) No. 051311 for use as in paragraph the same dose schedule for an addi- (d)(1)(i) of this section. tional 3 days or longer as needed. (2) No. 050604 for use as in paragraph (2) Indications for use. Treatment of (d)(1)(ii) of this section. acute and chronic canine respiratory (3) No. 012286 for use as in paragraph infections such as tonsillitis, bron- (d)(2) of this section. chitis, and tracheobronchitis when (c) Related tolerances. See § 556.730 of caused by pathogens susceptible to tet- this chapter. racycline and/or novobiocin, such as (d) Conditions of use. It is used as fol- Staphylococcus spp. and Escherichia coli, lows: when it is necessary to initially reduce (1) Horses—(i) Route of administration. the severity of associated clinical In feed, as a top dressing. signs. (a) Amount. 2 grams per 100 pounds of (3) Limitations. Federal law restricts body weight. this drug to use by or on the order of a (b) Indications for use. For control of licensed veterinarian. large strongyles, small strongyles, [57 FR 37329, Aug. 18, 1992, as amended at 79 pinworms, and threadworms (including FR 28832, May 20, 2014] members of the genera Strongylus, Cyathostomum, Cylicobrachytus, and re- § 520.2362 Thenium closylate. lated genera, Craterostomum, (a) Specifications. Each tablet con- Oesophagodontus, Poteriostomum, tains thenium closylate equivalent to Oxyuris, and Strongyloides). 500 milligrams thenium base. (c) Limitations. Add to the usual feed (a) Specifications. Thenium closylate of horses mixed into that amount of tablets contain thenium closylate the feed normally consumed at one equivalent to 500 milligrams thenium feeding. Warning: Not for use in horses as base in each tablet. intended for food. (b) Sponsor. See No. 000061 in (ii) Route of administration. In feed. § 510.600(c) of this chapter. (a) Amount. 2 grams per 100 pounds of (c) Conditions of use in dogs—(1) body weight. Amount. Dogs weighing over 10 pounds: (1) Indications for use. For control of Administer 1 tablet as a single dose. large and small strongyles, Dogs weighing 5 to 10 pounds: Adminis- Strongyloides, and pinworms of the gen- tered one-half tablet twice during a era Strongylus, Cyathostomum, single day. Repeat treatment after 2 or Cylicobrachytus and related genera, 3 weeks. Craterostomum, Oesophagodontus, (2) Indications for use. For treatment Poteriostomum, Oxyuris, and of canine ancylostomiasis by the re- Strongyloides.

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(2) Limitations. Administer in a single (i) Amount. 2 grams per 100 pounds of dosage mixed with the normal grain ra- body weight. tion given at one feeding. Warning: Not (a) Indications for use. For the control for use in horses intended for food. of infections of large strongyles (b) Amount. 4 grams per 100 pounds of (Strongylus vulgaris, Strongylus body weight. endentatus), small strongyles (1) Indications for use. For control of (Cyathastomum, Cylicobrachytus and re- ascarids of the genus Parascaris. lated genera, Craterostomum, (2) Limitations. Administer in a single Oesophagodontus, Poteriostomum), dosage mixed with the normal grain ra- pinworms (Oxyuris), and threadworms tion given at one feeding. Warning: Not (Strongyloides). for use in horses intended for food. (b) Limitations. Not for use in horses (2) Cattle—(i) Route of administration. to be slaughtered for food purposes. In feed block. When administered by stomach tube, (ii) Amount. 3.3 percent block con- for use only by or on the order of a li- sumed at the recommended level of 0.11 censed veterinarian. When for use as a pound per 100 pounds of body weight liquid oral drench or an oral paste, con- per day. sult your veterinarian for assistance in (iii) Indications for use. For control of the diagnosis, treatment, and control infections of gastrointestinal of parasitism. roundworms (Trichostrongylus, (ii) Amount. 4 grams per 100 pounds of Haemonchus, Ostertagia and Cooperia). body weight. (iv) Limitations. Administer to cattle (a) Indications for use. For control of on pasture or range accustomed to infections of ascardis (Parascaris). mineral protein block feeding for 3 (b) Limitations. Not for use in horses days. Milk taken from animals during to be slaughtered for food purposes. treatment and within 96 hours (8 When administered by stomach tube, milkings) after the latest treatment use only by or on the order of a li- must not be used for food. Do not treat censed veterinarian. When for use as a cattle within 3 days of slaughter. For a liquid oral drench or an oral paste, con- satisfactory diagnosis, a microscopic sult your veterinarian for assistance in fecal examination should be performed the diagnosis, treatment, and control by a veterinarian or diagnostic labora- of parasitism. tory prior to worming. Animals maintained under conditions of constant (2) Pigs. As an oral paste. worm exposure may require re-treat- (i) Amount. 200 milligrams for each 5 ment within 2 to 3 weeks. Animals that to 7 pounds of body weight per dose. are severely parasitized, sick, or off (ii) Indications for use. For control of feed should be isolated and a veteri- infections with Strongyloides ransomi. narian consulted for advice concerning These infections are commonly found treatment. in Southeastern United States. (iii) Limitations. Administer to baby [40 FR 13838, Mar. 27, 1975, as amended at 41 pigs (1 to 8 weeks of age). Treatment FR 9149, Mar. 3, 1976; 62 FR 63271, Nov. 28, 1997; 70 FR 32489, June 3, 2005; 73 FR 35340, may be repeated in 5 to 7 days if nec- June 23, 2008; 79 FR 28832, May 20, 2014] essary. Before treatment, obtain an accurate diagnosis from a veterinarian or § 520.2380b Thiabendazole drench or diagnostic laboratory. Do not treat paste. within 30 days of slaughter. (a) Specifications. Conforms to N.F. (3) Cattle. Orally as a drench and in XII. paste form using a dosing gun designed (b) Sponsor. See No. 050604 in for the product. § 510.600(c) of this chapter. (i) Amount. 3 grams per 100 pounds of (c) Related tolerances. See § 556.730 of body weight. this chapter. (a) Indications for use. Control of in- (d) Conditions of use. It is used as fol- fections of gastrointestinal lows: roundworms (Trichostrongylus spp., (1) Horses. As a single liquid oral Haemonchus spp., Nematodirus spp., dose, administered as a drench or by Ostertagia spp., and Oesophagostomum stomach tube; or as an oral paste. radiatum).

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(b) Limitations. For most effective re- (i) Amount. 3 grams per 100 pounds of sults, severely parasitized animals or body weight. those constantly exposed to helminth (ii) Indications for use. Control of se- infection should be re-treated every 2 vere infections of gastrointestinal to 3 weeks. Milk taken from treated roundworms (Trichostrongylus spp., animals within 96 hours (8 milkings) Haemonchus spp., Ostertagia spp., after the latest treatment must not be Cooperia spp., Nematodirus spp., used for food. Do not treat cattle with- Bunostomum spp., Strongyloides spp., in 3 days of slaughter. For a satisfac- Chabertia spp., and Oesophagostomum tory diagnosis, a microscopic fecal ex- spp.). amination should be performed prior to (iii) Limitations. As a single oral dose; worming. do not treat animals within 30 days of (ii) Amount. 5 grams per 100 pounds of slaughter; milk taken from treated body weight. animals within 96 hours (8 milkings) (a) Indications for use. Control of in- after the latest treatment must not be fections of Cooperia spp. or severe infec- used for food; treatment should be re- tions of other species in paragraph peated in 2 to 3 weeks. (e)(3)(i)(a) of this section. [40 FR 13838, Mar. 27, 1975, as amended at 41 (b) Limitations. For most effective re- FR 9149, Mar. 3, 1976; 41 FR 47424, Oct. 29, sults, severely parasitized animals or 1976; 62 FR 63271, Nov. 28, 1997; 79 FR 28832, those constantly exposed to helminth May 20, 2014] infection should be re-treated every 2 to 3 weeks. Milk taken from treated § 520.2380c Thiabendazole bolus. animals within 96 hours (8 milkings) (a) Specifications. Conforms to N.F. after the latest treatment must not be XII. used for food. Do not treat cattle with- (b) Sponsor. See No. 050604 in in 3 days of slaughter. For a satisfac- § 510.600(c) of this chapter. tory diagnosis, a microscopic fecal ex- (c) Related tolerances. See § 556.730 of amination should be performed prior to this chapter. worming. (d) Conditions of use. It is used as fol- (4) Sheep and goats. Orally, as a lows: drench. (1) Cattle. In a bolus. (i) Amount. 2 grams per 100 pounds of (i) Amount. 3 grams per 100 pounds of body weight. body weight. (ii) Indications for use. Control of in- (a) Indications for use. Control of infections of gastrointestinal fections of gastrointestinal roundworms in sheep and goats. roundworms (general Trichostrongylus (Trichostrongylus spp., Haemonchus spp., spp., Haemonchus spp., Nematodirus spp., Ostertagia spp., Cooperia spp., Ostertagia spp., and Oesophagostomum Nematodirus spp., Bunostomum spp., radiatum). Strongyloides spp., Chabertia spp., and (b) Limitations. As a single oral dose; Oesophagostomum spp.); also active may repeat once in 2 to 3 weeks; do not from 3 hours to 3 days following treat- treat animals within 3 days of slaugh- ment against ova and larvae passed by ter; milk taken from treated animals sheep (good activity against within 96 hours (8 milkings) after the Trichostrongylus colubriformis and axei, latest treatment must not be used for Ostertagia spp., Bunostomum spp., food. Nematodirus spp., and Strongyloides spp.; (ii) Amount. 5 grams per 100 pounds of less effective against Haemonchus body weight. contortus and Oesophagostomum spp.). (a) Indications for use. Control of se- (iii) Limitations. As a single oral dose; vere infections of gastrointestinal do not treat animals within 30 days of roundworms (genera Trichostrongylus slaughter; milk taken from treated spp., Haemonchus spp., Nematodirus spp., animals within 96 hours (8 milkings) Ostertagia spp., and Oesophagostomum after the latest treatment must not be radiatum). Control of infections with used for food; in severe infections in Cooperia spp. sheep, treatment should be repeated in (b) Limitations. As a single oral dose; 2 to 3 weeks. as a drench or bolus; may repeat once (5) Goats. Orally, as a drench. in 2 to 3 weeks; do not treat animals

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within 3 days of slaughter; milk taken (b) Sponsor. See No. 050604 in from treated animals within 96 hours (8 § 510.600(c) of this chapter. milkings) after the latest treatment (c) Conditions of use in horses—(1) must not be used for food. Amount. Administer 1 ounce of suspen- (2) Sheep and goats. In a bolus. sion per 100 pounds of body weight by (i) Amount. 2 grams per 100 pounds of stomach tube or as a drench. body weight. (2) Indications for use. For the control (ii) Indications for use. Control of in- of large strongyles, small strongyles, fections of gastrointestinal pinworms, Strongyloides and ascarids roundworms in sheep and goats (gen- (including members of the genera eral Trichostrongylus spp., Haemonchus spp., Ostertagia spp., Cooperia spp., Strongylus spp., Cyathostomum spp., Nematodirus spp., Bunostomum spp., Cylicobrachytus spp. and related genera Strongyloides spp., Chabertia spp., and Craterostomum spp., Oesophagodontus Oesophagostomum spp.); also active spp., Poteriostomum spp., Oxyuris spp., from 3 hours to 3 days following treat- Strongyloides spp., and Parascaris spp.). ment against ova and larvae passed by (3) Limitations. Do not use in horses sheep (good activity against T. intended for human consumption. Fed- colubriformis and axei, Ostertagia spp., eral law restricts this drug to use by or Bunostomum spp., Nematodirus spp., and on the order of a licensed veterinarian. Strongyloides spp.; less effective against [40 FR 13838, Mar. 27, 1975, as amended at 62 Haemonchus contortus and FR 63271, Nov. 28, 1997; 79 FR 28832, May 20, Oesophagostomum spp.). 2014] (iii) Limitations. As a single oral dose; do not treat animals within 30 days of § 520.2380e Thiabendazole and slaughter; milk taken from treated triclorfon. animals within 96 hours (8 milkings) after the latest treatment must not be (a) Specifications. The drug contains 5 used for food; in severe infections in grams of thiabendazole with 4.5 grams sheep, treatment should be repeated in of trichlorfon, or 20 grams of 2 to 3 weeks. thiabendazole with 18 grams of (3) Goats. In a bolus. trichlorfon. (i) Amount. 3 grams per 100 pounds of (b) Sponsor. See No. 017135 in body weight. § 510.600(c) of this chapter. (ii) Indications for use. Control of se- (c) Conditions of use in horses—(1) vere infections of gastrointestinal Amount. Administer 2 grams of roundworms (genera Trichostrongylus thiabendazole with 1.8 grams of spp., Haemonchus spp., Ostertagia spp., trichlorfon per 100 pounds of body Cooperia spp., Nematodirus spp., weight sprinkled on the animals’ usual Bunostomum spp., Strongyloides spp., daily ration of feed, or may be mixed in Chabertia spp., and Oesophagostomum 5 to 10 fluid ounces of water and admin- spp.). istered by stomach tube or drench. (iii) Limitations. As a single oral dose; (2) Indications for use. For the treat- do not treat animals within 30 days of ment and control of bots (Gasterophilus slaughter; milk taken from treated spp.), large strongyles (Strongylus spp.), animals within 96 hours (8 milkings) small strongyles (genera after the latest treatment must not be Cyathostomum, Cylicobrachytus, used for food; treatment should be re- Craterostomum, Oesophagodontus, peated in 2 to 3 weeks. Poteriostomum), pinworms (Oxyuris spp., [40 FR 13838, Mar. 27, 1975, as amended at 41 Strongyloides spp.), and ascarids FR 9149, Mar. 3, 1976; 62 FR 63271, Nov. 28, (Parascaris spp.). 1997; 79 FR 28832, May 20, 2014] (3) Limitations. Do not use in horses § 520.2380d Thiabendazole and piper- intended for human consumption. Fed- azine citrate. eral law restricts this drug to use by or (a) Specifications. Each fluid ounce of on the order of a licensed veterinarian. suspension contains 2 grams of [40 FR 23071, May 28, 1975, as amended at 48 thiabendazole and 2.5 grams of piper- FR 48229, Oct. 18, 1983; 79 FR 28832, May 20, azine (from piperazine citrate). 2014]

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§ 520.2380f Thiabendazole and piper- (1) No. 058198 for products described azine phosphate. in paragraphs (a)(1) and (a)(2) of this (a) Specifications. Each ounce of water section. dispersible powder contains 6.67 grams (2) No. 066104 for the product de- of thiabendazole and 8.33 grams of pi- scribed in paragraph (a)(1) of this sec- perazine (as piperazine phosphate). tion. (b) Sponsor. See No. 050604 in (3) No. 054771 for the product de- § 510.600(c) of this chapter. scribed in paragraph (a)(3) of this sec- (c) Conditions of use in horses—(1) tion. Amount. 2 grams of thiabendazole and (c) Related tolerances. See § 556.732 of 2.5 grams of piperazine (0.3 ounce of this chapter. powder) per 100 pounds of body weight. (d) Conditions of use in swine—(1) Use a single oral dose. Administer as a Amounts and indications for use. Admin- drench or by stomach tube suspended ister in drinking water for 5 consecu- in 1 pint of warm water; by dose sy- tive days: ringe suspended in 1⁄2 ounce of water for (i) 3.5 mg per (/) lb of body weight each 100 pounds of body weight; or daily for treatment of swine dysentery sprinkled over a small amount of daily associated with Brachyspira feed. hyodysenteriae susceptible to tiamulin. (2) Indications for use. Treatment of (ii) 10.5 mg/lb of body weight daily for infections of large strongyles (genus treatment of swine pneumonia due to Strongylus), small strongyles (genera Actinobacillus pleuropneumoniae suscep- Cyathostomum, Cylicobrachytus, and re- tible to tiamulin. lated genera Craterostomum, (2) Limitations. Use as only source of Oesophagodontus, Poteriostomum), drinking water. Prepare fresh medi- pinworms (Oxyuris), threadworms cated water daily. Withdraw medica- (Strongyloides), and ascarids (Parascaris) tion 3 days before slaughter following in horses. treatment at 3.5 mg/lb and 7 days be- (3) Limitations. Do not use in horses fore slaughter following treatment at intended for human consumption. If 10.5 mg/lb of body weight. Swine being the label bears directions for adminis- treated with tiamulin should not have tration by stomach tube or drench, it access to feeds containing polyether shall also bear the statement ‘‘Caution: ionophores (e.g., lasalocid, monensin, Federal law restricts this drug to use narasin, salinomycin, or by or on the order of a licensed veteri- semduramycin) as adverse reactions narian.’’; if not labeled for use by stom- may occur. The effects of tiamulin on ach tube or drench, the label shall bear swine reproductive performance, preg- the statement, ‘‘Consult your veteri- nancy, and lactation have not been de- narian for assistance in the diagnosis, termined. treatment, and control of parasitism.’’ [70 FR 75017, Dec. 19, 2005, as amended at 74 [46 FR 18963, Mar. 27, 1981, as amended at 46 FR 7180, Feb. 13, 2009; 75 FR 54492, Sept. 8, FR 52330, Oct. 27, 1981; 62 FR 63271, Nov. 28, 2010; 77 FR 56770, Sept. 14, 2012; 78 FR 17596, 1997; 79 FR 28832, May 20, 2014] Mar. 22, 2013; 80 FR 13229, Mar. 13, 2015]

§ 520.2455 Tiamulin. § 520.2471 Tilmicosin. (a) Specifications. (1) Each gram of (a) Specifications. Each milliliter of soluble powder contains 450 milligrams concentrate solution contains 250 milli- (mg) tiamulin hydrogen fumarate. grams (mg) tilmicosin as tilmicosin (2) Each milliliter (mL) of solution phosphate. contains 125 mg (12.5 percent) tiamulin (b) Sponsor. See No. 000986 in hydrogen fumarate. § 510.600(c) of this chapter. (3) Each mL of solution contains 123 (c) Tolerances. See § 556.735 of this mg (12.3 percent) tiamulin hydrogen fu- chapter. marate. (d) Conditions of use in swine—(1) (b) Sponsors. See sponsor numbers in Amount. Administer in drinking water § 510.600(c) of this chapter for use as in at a concentration of 200 mg per liter paragraph (d) of this section. for 5 consecutive days.

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(2) Indications for use—(i) For the con- (2) [Reserved] trol of swine respiratory disease associ- [50 FR 52772, Dec. 26, 1985; 51 FR 2693, Jan. 21, ated with Pasteurella multocida and 1986, as amended at 52 FR 7832, Mar. 13, 1987] Haemophilus parasuis in groups of swine in buildings where a respiratory dis- § 520.2473b Tioxidazole paste. ease outbreak is diagnosed. (ii) For the control of swine res- (a) Specifications. Each plastic syringe contains 6.25 grams of tioxidazole. piratory disease associated with Myco- plasma hyopneumoniae in the presence (b) Sponsor. See No. 000061 in of Porcine Reproductive and Res- § 510.600(c) of this chapter. piratory Syndrome Virus (PRRSV) in (c) Conditions of use—(1) Horses—(i) groups of swine in buildings where a Amount. 5 milligrams of tioxidazole per respiratory disease outbreak is diag- pound of body weight as a single dose. nosed. (ii) Indications for use. Removal of (3) Limitations. Swine intended for mature large strongyles (Strongylus human consumption must not be edentatus, S. equinus, and S. vulgaris), slaughtered within 7 days of the last mature ascarids (Parascaris equorum), treatment with this product. Federal mature and immature (4th larval law restricts this drug to use by or on stage) pinworms (Oxyuris equi), and ma- the order of a licensed veterinarian. ture small strongyles (Triodontophorus spp.). [79 FR 18158, Apr. 1, 2014, as amended at 81 (iii) Limitations. Administer orally by FR 17608, Mar. 30, 2016] inserting the nozzle of the syringe through the space between front and § 520.2473 Tioxidazole oral dosage back teeth and deposit the required forms. dose on the base of the tongue. Before § 520.2473a Tioxidazole granules. dosing, make sure the horse’s mouth contains no feed. Not for use in horses (a) Specifications. Each gram of gran- intended for food. The reproductive ules contains 200 milligrams of safety of tioxidazole in breeding ani- tioxidazole. mals has not been determined. Consult (b) Sponsor. See No. 000061 in your veterinarian for assistance in the § 510.600(c) of this chapter. diagnosis, treatment, and control of (c) Conditions of use—(1) Horses—(i) parasitism. It is recommended that Amount. 5 milligrams per pound of body this drug be administered with caution weight as a single dose. to sick or debilitated horses. (ii) Indications for use. Removal of (2) [Reserved] mature large strongyles (Strongylus edentatus, S. equinus, and S. vulgaris), [52 FR 43059, Nov. 9, 1987] mature ascarids (Parascaris equorum), § 520.2475 Toceranib. mature and immature (4th larval stage) pinworms (Oxyuris equi), and ma- (a) Specifications. Each tablet con- ture small strongyles (Triodontophorus tains 10, 15, or 50 milligrams (mg) spp.). toceranib as toceranib phosphate. (iii) Limitations. For administration (b) Sponsor. See No. 054771 in § 510.600 with feed: Sprinkle required amount of of this chapter. granules on a small amount of the (c) Conditions of use—(1) Dogs—(i) usual grain ration and mix. Prepare for Amount. Administer an initial dose of each horse individually. Withholding of 3.25 mg per kilogram (1.48 mg per feed or water not necessary. Not for pound) body weight, orally every other use in horses intended for food. The re- day. productive safety of tioxidazole in (ii) Indications for use. For the treat- breeding animals has not been deter- ment of Patnaik grade II or III, recur- mined. Consult your veterinarian for rent, cutaneous mast cell tumors with assistance in the diagnosis, treatment, or without regional lymph node in- and control of parasitism. It is rec- volvement. ommended that this drug be adminis- (iii) Limitations. Federal law restricts tered with caution to sick or debili- this drug to use by or on the order of a tated horses. licensed veterinarian.

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(2) [Reserved] § 520.2520 Trichlorfon oral dosage forms. [74 FR 28875, June 18, 2009, as amended at 79 FR 28832, May 20, 2014] § 520.2520a Trichlorfon and atropine. § 520.2483 Triamcinolone. (a) Specifications. (1) For trichlorfon: O,O-Dimethyl 2,2,2-trichloro-1-hydroxy- (a) Specifications. (1) Each tablet con- ethyl phosphonate. tains 0.5 milligram (mg) or 1.5 mg (2) For atropine: Atropine N.F. triamcinolone acetonide. (b) Sponsor. See No. 054771 in (2) Each 15 grams of powder contains § 510.600(c) of this chapter. 10 mg triamcinolone acetonide. (c) Conditions of use in mice—(1) (b) Sponsor. See No. 000010 in Amount. Administer 1.67 grams of § 510.600(c) of this chapter. trichlorfon and 7.7 milligrams of atro- (c) Special considerations. See § 510.410 pine per liter continuously for 7 to 14 of this chapter. days as the sole source of drinking (d) Conditions of use—(1) Dogs and water. cats. Use tablets described in paragraph (2) Indications for use. For the treat- (a)(1) of this section as follows: ment of Syphacia obvelata (pinworm) in (i) Amount. Administer 0.05 mg per laboratory mice. pound (/lb) of body weight daily by (3) Limitations. Federal law restricts mouth; up to 0.1 mg per pound (/lb) of this drug to use by or on the order of a body weight daily, if response to the licensed veterinarian. smaller dose is inadequate. Therapy [79 FR 28832, May 20, 2014] may be initiated with a single injection of triamcinolone acetonide sus- § 520.2520b Trichlorfon boluses. pension as in § 522.2483 of this chapter, (a) Specifications. Each bolus contains in which case triamcinolone acetonide either 7.3, 10.9, 14.6, or 18.2 g of tablets should be administered begin- trichlorfon. ning 5 to 7 days after the injection. (b) Sponsor. See No. 054771 in (ii) Indications for use. As an anti-in- § 510.600(c) of this chapter. flammatory agent. (c) Conditions of use in horses—(1) (iii) Limitations. Federal law restricts Amount. 18.2 milligrams per pound of this drug to use by or on the order of a body weight, except for strongyles use licensed veterinarian. 36.4 milligrams per pound of body (2) Horses. Use oral powder described weight. in paragraph (a)(2) of this section as (2) Indications for use. For horses for follows: removal of bots (Gastrophilus nasalis, (i) Amount. Administer 0.005 to 0.01 Gastrophilus intestinalis), large mg/lb of body weight twice daily, sprin- strongyles (Strongylus vulgaris), small kled (top-dressed) on a small portion of strongyles, large roundworms feed. Therapy may be initiated with a (ascarids, Parascaris equorum), and single injection of triamcinolone pinworms (Oxyuris equi). acetonide suspension as in § 522.2483 of (3) Limitations. Do not use in horses intended for human consumption. Fed- this chapter, in which case eral law restricts this drug to use by or triamcinolone acetonide oral powder on the order of a licensed veterinarian. should be administered beginning 3 or 4 days after the injection. [45 FR 48127, July 18, 1980. Redesignated and (ii) Indications for use. As an anti-in- amended at 79 FR 28833, May 20, 2014] flammatory agent. § 520.2520c Trichlorfon granules. (iii) Limitations. Federal law restricts this drug to use by or on the order of a (a) Specifications. Each package con- licensed veterinarian. Do not use in tains either 18.2 or 36.4 g of trichlorfon. horses intended for human consump- (b) Sponsor. See No. 054771 in tion. § 510.600(c) of this chapter. (c) Conditions of use in horses—(1) [75 FR 10166, Mar. 5, 2010] Amount. 18.2 milligrams per pound of body weight.

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(2) Indications for use. For horses for (b) Sponsor. See No. 043264 in § 510.600 removal of bots (Gastrophilus nasalis, of this chapter. Gastrophilus intestinalis), large (c) Conditions of use in dogs—(1) roundworms (ascarids, Parascaris Amount. The starting dose is 1.0 to 3.0 equorum), and pinworms (Oxyuris equi). milligrams per pound (2.2 to 6.7 milli- (3) Limitations. Do not use in horses grams per kilogram) once a day. intended for human consumption. Fed- (2) Indications for use. For treatment eral law restricts this drug to use by or of pituitary-dependent on the order of a licensed veterinarian. hyperadrenocorticism. For treatment [45 FR 48128, July 18, 1980. Redesignated and of hyperadrenocorticism due to amended at 79 FR 28833, May 20, 2014] adrenocortical tumor. (3) Limitations. Federal law restricts § 520.2520d Trichlorfon, this drug to use by or on the order of a phenothiazine, and piperazine dihydrochloride powder. licensed veterinarian. (a) Specifications. Each 54.10 grams [74 FR 21767, May 11, 2009, as amended at 74 (1.91 ounces) of water dispersible pow- FR 30464, June 26, 2009; 80 FR 53460, Sept. 4, der contains 9.10 grams of trichlorfon, 2015] 6.25 grams of phenothiazine, and the equivalent of 20.0 grams of piperazine § 520.2604 Trimeprazine and prednisolone tablets. base (as piperazine dihydrochloride). (b) Sponsor. See No. 054771 in (a) Specifications. Each tablet con- § 510.600(c) of this chapter. tains 5 milligrams (mg) trimeprazine tartrate and 2 mg prednisolone. [48 FR 2757, Jan. 21, 1983. Redesignated and amended at 79 FR 28833, May 20, 2014] (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. EDITORIAL NOTE: At 79 FR 28833, May 20, (c) Conditions of use in dogs—(1) 2014, § 520.2520d was amended in part by redes- ignating paragraph (e) as (c). This action Amount. Administer orally an initial could not be performed because paragraph (e) dosage: for dogs weighing up to 10 did not exist. pounds, 1⁄2 tablet twice daily; for dogs weighing 11 to 20 pounds, 1 tablet twice § 520.2582 Triflupromazine. daily; for dogs weighing 21 to 40 (a) Specifications. Each tablet con- pounds, 2 tablets twice daily; and for tains 10 or 25 milligrams (mg) dogs weighing over 40 pounds, 3 tablets triflupromazine hydrochloride. twice daily. After 4 days, reduce dosage (b) Sponsor. See No. 054771 in to one-half the initial dose or to an § 510.600(c) of this chapter. amount sufficient to maintain remis- (c) Conditions of use in dogs and cats— sion of symptoms. (1) Amount. Administer orally 1 to 2 mg (2) Indications for use. For the relief of per pound of body weight daily, fol- itching regardless of cause; and for re- lowed by 1 mg daily. duction of inflammation commonly as- (2) Indications for use. For relief of sociated with most skin disorders of anxiety, to help control psychomotor dogs such as eczema, caused by inter- over-activity, and to increase the toler- nal disorders, otitis, and dermatitis, al- ance of animals to pain and pruritus. lergic, parasitic, pustular and nonspe- For use in various clinical procedures cific. As adjunctive therapy in various which require the aid of a tranquilizer, cough conditions including treatment antiemetic, or preanesthetic. of ‘‘kennel cough’’ or (3) Limitations. Federal law restricts tracheobronchitis, bronchitis including this drug to use by or on the order of a allergic bronchitis, in tonsillitis, acute licensed veterinarian. upper respiratory infections and [79 FR 28833, May 20, 2014] coughs of nonspecific origin. (3) Limitations. Federal law restricts § 520.2598 Trilostane. this drug to use by or on the order of a (a) Specifications. Each capsule con- licensed veterinarian. tains 5, 10, 30, 60, or 120 milligrams [79 FR 28833, May 20, 2014] (mg) trilostane.

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§ 520.2605 Trimeprazine and prednis- (b) Sponsors. See Nos. 000061 and olone capsules. 054771 in § 510.600(c) of this chapter. (a) Specifications. Each capsule con- (c) Conditions of use in dogs—(1) tains: Amount. Administer orally at 30 mg per (1) 3.75 milligrams (mg) trimeprazine kilogram of body weight (14 milligrams in sustained released form (as per pound) once daily. Alternatively, trimeprazine tartrate) and 1 mg pred- especially in severe infections, the ini- nisolone (Capsule No. 1); or tial dose may be followed by one-half (2) 7.5 mg trimeprazine in sustained the recommended daily dose every 12 release form (as trimeprazine tartrate) hours. Administer for 2 to 3 days after and 2 mg prednisolone (Capsule No. 2). symptoms have subsided. Do not treat (b) Sponsor. See No. 054771 in for more than 14 consecutive days. § 510.600(c) of this chapter. (2) Indications for use. The drug is (c) Conditions of use in dogs—(1) used in dogs where systemic anti- Amount. Administer orally once daily bacterial action against sensitive orga- an initial dosage: nisms is required, either alone or as an (i) For dogs weighing up to 10 pounds: adjunct to surgery or debridement with one Capsule No. 1; associated infection. The drug is indi- (ii) For dogs weighing 11 to 20 cated where control of bacterial infec- pounds, one Capsule No. 2 or two Cap- tion is required during the treatment sule No. 1; of acute urinary tract infections, acute (iii) For dogs weighing 21 to 40 bacterial complications of distemper, pounds, two Capsule No. 2 or four Cap- acute respiratory tract infections, sule No. 1; and acute alimentary tract infections, (iv) For dogs weighing over 40 wound infections, and abscesses. pounds, three Capsule No. 2 or six Cap- (3) Limitations. Federal law restricts sule No. 1. After 4 days, the dosage is this drug to use by or on the order of a reduced to approximately 1⁄2 the initial licensed veterinarian. dosage or to an amount just sufficient [79 FR 28833, May 20, 2014] to maintain remission of symptoms. (2) Indications for use. For the relief of § 520.2611 Trimethoprim and sulfa- itching regardless of cause; and for re- diazine paste. duction of inflammation commonly as- (a) Specifications. Each gram (g) of sociated with most skin disorders of paste contains 67 milligrams (mg) dogs such as eczema, caused by inter- trimethoprim and 333 mg sulfadiazine. nal disorders, otitis, and dermatitis, al- (b) Sponsors. See sponsors in lergic, parasitic, pustular and nonspe- § 510.600(c) of this chapter: cific. As adjunctive therapy in various (1) No. 054771 for product adminis- cough conditions including treatment tered as in paragraph (c)(1)(i) of this of ‘‘kennel cough’’ or section. tracheobronchitis, bronchitis including (2) No. 000061 for product adminis- allergic bronchitis, in tonsillitis, acute tered as in paragraph (c)(1)(ii) of this upper respiratory infections and section. coughs of nonspecific origin. (c) Conditions of use in horses—(1) (3) Limitations. Federal law restricts Amount. Administer orally as a single this drug to use by or on the order of a daily dose for 5 to 7 days: licensed veterinarian. (i) 5 g of paste (335 mg trimethoprim [79 FR 28833, May 20, 2014] and 1,665 mg sulfadiazine) per 150 pounds (68 kilograms) of body weight § 520.2610 Trimethoprim and sulfa- per day. diazine tablets. (ii) 3.75 g of paste (250 mg (a) Specifications. Each tablet con- trimethoprim and 1,250 mg sulfa- tains 30 milligrams (mg) (5 mg diazine) per 110 pounds (50 kilograms) trimethoprim and 25 mg sulfadiazine), of body weight per day. 120 mg (20 mg trimethoprim and 100 mg (2) Indications for use. For use where sulfadiazine), 480 mg (80 mg systemic antibacterial action against trimethoprim and 400 mg sulfadiazine) sensitive organisms is required during or 960 mg (160 mg trimethoprim and 800 treatment of acute strangles, res- mg sulfadiazine). piratory infections, acute urogenital

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infections, and wound infections and (iii) Limitations. Do not use in horses abscesses. intended for human consumption. Fed- (3) Limitations. Not for use in horses eral law restricts this drug to use by or intended for human consumption. Fed- on the order of a licensed veterinarian. eral law restricts this drug to use by or [78 FR 63872, Oct. 25, 2013] on the order of a licensed veterinarian. [71 FR 30802, May 31, 2006, as amended at 79 § 520.2613 Trimethoprim and sulfa- FR 28834, May 20, 2014] diazine powder. (a) Specifications. Each gram of pow- § 520.2612 Trimethoprim and sulfa- der contains 67 milligrams (mg) diazine suspension. trimethoprim and 333 mg sulfadiazine. (a) Specifications. Each milliliter (b) Sponsors. See Nos. 054771 and (mL) of suspension contains: 059051 in § 510.600(c) of this chapter. (1) 10 milligrams (mg) trimethoprim (c) Conditions of use in horses—(1) and 50 mg sulfadiazine; or Amount. Administer orally 3.75 grams (2) 400 mg combined active ingredi- of powder per 110 pounds (50 kilograms) ents (67 mg trimethoprim and 333 mg of body weight in a small amount of sulfadiazine). feed, as a single daily dose, for 5 to 7 (b) Sponsors. See sponsor numbers in days. § 510.600 of this chapter: (2) Indications for use. For control of (1) No. 000061 for use of product de- bacterial infections of horses during scribed in paragraph (a)(1) for use as in treatment of acute strangles, res- paragraph (c)(1) of this section. piratory tract infections, acute uro- (2) No. 051072 for use of product de- genital infections, wound infections, scribed in paragraph (a)(2) for use as in and abscesses. paragraph (c)(2) of this section. (3) Limitations. Do not use in horses (c) Conditions of use—(1) Dogs—(i) intended for human consumption. Fed- Amount. Administer 1 mL (10 mg eral law restricts this drug to use by or trimethoprim and 50 mg sulfadiazine) on the order of a licensed veterinarian. per 5 pounds (lb) of body weight once [58 FR 36135, July 6, 1993, as amended at 64 daily, or one-half the recommended FR 68289, Dec. 7, 1999; 79 FR 28834, May 20, daily dose every 12 hours, for up to 14 2014; 79 FR 64116, Oct. 28, 2014] consecutive days. (ii) Indications for use. The drug is § 520.2640 Tylosin. used in dogs where systemic anti- (a) Specifications. Each container of bacterial action against sensitive orga- soluble powder contains tylosin tar- nisms is required, either alone or as an trate equivalent to either 100 or 256 adjunct to surgery or debridement with grams tylosin base. associated infection. The drug is indi- (b) Sponsors—(1) No. 000986 for use as cated where control of bacterial infec- in paragraph (e) of this section. tion is required during the treatment (2) Nos. 016592 and 061623 for use as in of acute urinary tract infections, acute paragraphs (e)(1)(i)(A), (e)(1)(ii), (e)(2), bacterial complications of distemper, (e)(3), and (e)(4) of this section. acute respiratory tract infections, (c) Related tolerances. See § 556.740 of acute alimentary tract infections, this chapter. wound infections, and abscesses. (d) Special considerations. Federal law (iii) Limitations. Federal law restricts restricts this drug to use by or on the this drug to use by or on the order of a order of a licensed veterinarian. licensed veterinarian. (e) Conditions of use—(1) Chickens—(i) (2) Horses—(i) Amount. Administer 24 Amounts and indications for use. (A) Ad- mg combined active ingredients per minister 2 grams per gallon (528 parts kilogram of body weight (2.7 mL/100 lb) per million (ppm)) for 1 to 5 days as an twice daily for 10 days. aid in the treatment of chronic res- (ii) Indications for use. For the treat- piratory disease (CRD) associated with ment of lower respiratory tract infec- Mycoplasma gallisepticum in broiler and tions in horses caused by susceptible replacement chickens. For the control strains of Streptococcus equi subsp. of CRD associated with M. gallisepticum zooepidemicus. at time of vaccination or other stress

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in chickens. For the control of CRD as- (ii) Indications for use. For the control sociated with Mycoplasma synoviae in of American foulbrood (Paenibacillus broiler chickens. Treated chickens larvae). should consume enough medicated (iii) Limitations. The drug should be drinking water to provide 50 milli- fed early in the spring or fall and con- grams (mg) tylosin per pound of body sumed by the bees before the main weight per day. honey flow begins, to avoid contamina- (B) Administer 851 to 1,419 mg/gallon tion of production honey. Complete (225 to 375 ppm) for 5 days for the con- treatments at least 4 weeks before trol of mortality caused by necrotic en- main honey flow. teritis associated with Clostridium [40 FR 13838, Mar. 27, 1975, as amended at 50 perfringens in broiler chickens. FR 49841, Dec. 5, 1985; 59 FR 14365, Mar. 28, (ii) Limitations. Do not use in layers 1994; 62 FR 39443, July 23, 1997; 68 FR 24879, producing eggs for human consump- May 9, 2003; 70 FR 69439, Nov. 16, 2005; 73 FR tion. Do not administer within 24 hours 76946, Dec. 18, 2008; 75 FR 76259, Dec. 8, 2010; of slaughter. 76 FR 59024, Sept. 23, 2011; 77 FR 29217, May (2) Turkeys—(i) Amount. 2 grams per 17, 2012; 79 FR 37620, July 2, 2014; 79 FR 53136, gallon for 2 to 5 days as the sole source Sept. 8, 2014; 79 FR 64116, Oct. 28, 2014; 80 FR of drinking water. Treated turkeys 34278, June 16, 2015] should consume enough medicated § 520.2645 Tylvalosin. drinking water to provide 60 mg tylosin per pound of body weight per day. (a) Specifications. Granules containing (ii) Indications for use. For the reduc- 62.5 percent tylvalosin (w/w) as tion in severity of effects of infectious tylvalosin tartrate. sinusitis associated with Mycoplasma (b) Sponsor. See No. 066916 in gallisepticum. § 510.600(c) of this chapter. (iii) Limitations. Do not use in layers (c) Related tolerances. See § 556.748 of producing eggs for human consump- this chapter. tion. Do not administer within 5 days (d) Conditions of use in swine—(1) of slaughter. Amount. Administer 50 parts per mil- (3) Swine—(i) Amount. 250 mg per gal- lion tylvalosin in drinking water for 5 lon as the only source of drinking consecutive days. water for 3 to 10 days, depending on the (2) Indications for use. For the control severity of the condition being treated. of porcine proliferative enteropathy (ii) Indications for use. (A) For the (PPE) associated with Lawsonia treatment and control of swine dys- intracellularis infection in groups of entery associated with Brachyspira swine in buildings experiencing an out- hyodysenteriae when followed imme- break of PPE. diately by tylosin phosphate medicated (3) Limitations. Federal law restricts feed; and for the control of porcine pro- this drug to use by or on the order of a liferative enteropathies (PPE, ileitis) licensed veterinarian. associated with Lawsonia intracellularis [77 FR 55415, Sept. 10, 2012] when followed immediately by tylosin phosphate medicated feed. PART 522—IMPLANTATION OR (B) For the treatment and control of INJECTABLE DOSAGE FORM NEW swine dysentery associated with ANIMAL DRUGS Brachyspira hyodysenteriae. (iii) Limitations. Do not administer Sec. within 48 hours of slaughter. As indi- 522.23 Acepromazine. cated in paragraph (d)(3)(ii)(A) of this 522.52 Alfaxalone. section, follow with tylosin phosphate 522.56 Amikacin. medicated feed as in § 558.625(f)(1)(vi)(c) 522.62 Aminopentamide. of this chapter. 522.82 Aminopropazine. (4) Honey bees—(i) Amount. Mix 200 522.84 Beta-aminopropionitrile. milligrams tylosin in 20 grams confec- 522.88 Amoxicillin. 522.90 Ampicillin injectable dosage forms. tioners’/powdered sugar. Use imme- 522.90a Ampicillin trihydrate suspension. diately. Apply (dust) this mixture over 522.90b Ampicillin trihydrate powder for in- the top bars of the brood chamber once jection. weekly for 3 weeks. 522.90c Ampicillin sodium.

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