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Electronic Code of Federal Regulations

e-CFR Data is current as of April 15, 2014

Title 21: Food and Drugs


PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS


Contents
§520.23   Acepromazine.
§520.28   Acetazolamide sodium soluble powder.
§520.38   Albendazole oral dosage forms.
§520.38a   Albendazole suspension.
§520.38b   Albendazole paste.
§520.43   Afoxolaner.
§520.48   Altrenogest.
§520.62   Aminopentamide hydrogen sulphate tablets.
§520.82   Aminopropazine fumarate oral dosage forms.
§520.82a   Aminopropazine fumarate tablets.
§520.82b   Aminopropazine fumarate, neomycin sulfate tablets.
§520.88   Amoxicillin oral dosage forms.
§520.88a   Amoxicillin trihydrate film-coated tablets.
§520.88b   Amoxicillin trihydrate for oral suspension.
§520.88c   Amoxicillin trihydrate oral suspension.
§520.88d   Amoxicillin trihydrate soluble powder.
§520.88e   Amoxicillin trihydrate boluses.
§520.88f   Amoxicillin trihydrate tablets.
§520.88g   Amoxicillin trihydrate and clavulanate potassium film-coated tablets.
§520.88h   Amoxicillin trihydrate and clavulanate potassium for oral suspension.
§520.90   Ampicillin oral dosage forms.
§520.90a   Ampicillin capsules.
§520.90b   Ampicillin trihydrate tablets.
§520.90c   Ampicillin trihydrate capsules.
§520.90d   Ampicillin trihydrate for oral suspension.
§520.90e   Ampicillin trihydrate soluble powder.
§520.90f   Ampicillin trihydrate boluses.
§520.100   Amprolium.
§520.110   Apramycin sulfate soluble powder.
§520.154   Bacitracin oral dosage forms.
§520.154a   Bacitracin methylene disalicylate.
§520.154b   Bacitracin methylene disalicylate and streptomycin sulfate powder.
§520.154c   Bacitracin zinc soluble powder.
§520.222   Bunamidine hydrochloride.
§520.246   Butorphanol tartrate tablets.
§520.260   n-Butyl chloride.
§520.300   Cambendazole oral dosage forms.
§520.300a   Cambendazole suspension.
§520.300b   Cambendazole pellets.
§520.300c   Cambendazole paste.
§520.309   Carprofen.
§520.310   Caramiphen ethanedisulfonate and ammonium chloride tablets.
§520.312   Carnidazole tablets.
§520.314   Cefadroxil.
§520.370   Cefpodoxime tablets.
§520.376   Cephalexin.
§520.390   Chloramphenicol oral dosage forms.
§520.390a   Chloramphenicol tablets.
§520.390b   Chloramphenicol capsules.
§520.390c   Chloramphenicol palmitate oral suspension.
§520.420   Chlorothiazide tablets and boluses.
§520.434   Chlorphenesin carbamate tablets.
§520.441   Chlortetracycline powder.
§520.443   Chlortetracycline tablets and boluses.
§520.445   Chlortetracycline and sulfamethazine powder.
§520.446   Clindamycin capsules and tablets.
§520.447   Clindamycin solution.
§520.452   Clenbuterol syrup.
§520.455   Clomipramine tablets.
§520.462   Clorsulon drench.
§520.522   Cyclosporine.
§520.530   Cythioate oral liquid.
§520.531   Cythioate tablets.
§520.534   Decoquinate.
§520.538   Deracoxib.
§520.540   Dexamethasone oral dosage forms.
§520.540a   Dexamethasone powder.
§520.540b   Dexamethasone tablets and boluses.
§520.540c   Dexamethasone chewable tablets.
§520.550   Glucose/glycine/electrolyte.
§520.563   Diatrizoate meglumine and diatrizoate sodium oral solution.
§520.580   Dichlorophene and toluene.
§520.581   Dichlorophene tablets.
§520.600   Dichlorvos.
§520.606   Diclazuril.
§520.608   Dicloxacillin sodium monohydrate capsules.
§520.620   Diethylcarbamazine oral dosage forms.
§520.622   Diethylcarbamazine citrate oral dosage forms.
§520.622a   Diethylcarbamazine citrate tablets.
§520.622b   Diethylcarbamazine citrate syrup.
§520.622c   Diethylcarbamazine citrate chewable tablets.
§520.623   Diethylcarbamazine citrate, oxibendazole chewable tablets.
§520.645   Difloxacin.
§520.666   Dirlotapide.
§520.763   Dithiazanine iodide oral dosage forms.
§520.763a   Dithiazanine iodide tablets.
§520.763b   Dithiazanine iodide powder.
§520.763c   Dithiazanine iodide and piperazine citrate suspension.
§520.766   Domperidone.
§520.784   Doxylamine succinate tablets.
§520.804   Enalapril tablets.
§520.812   Enrofloxacin.
§520.816   Epsiprantel tablets.
§520.823   Erythromycin phosphate.
§520.852   Estriol.
§520.863   Ethylisobutrazine hydrochloride tablets.
§520.870   Etodolac.
§520.903   Febantel oral dosage forms.
§520.903a   Febantel paste.
§520.903b   Febantel suspension.
§520.903c   [Reserved]
§520.903d   Febantel-praziquantel paste.
§520.903e   Febantel tablets.
§520.905   Fenbendazole oral dosage forms.
§520.905a   Fenbendazole suspension.
§520.905b   Fenbendazole granules.
§520.905c   Fenbendazole paste.
§520.905d   Fenbendazole powder.
§520.905e   Fenbendazole blocks.
§520.928   Firocoxib tablets.
§520.930   Firocoxib paste.
§520.955   Florfenicol.
§520.960   Flumethasone tablets.
§520.970   Flunixin.
§520.980   Fluoxetine.
§520.1010   Furosemide.
§520.1044   Gentamicin sulfate oral dosage forms.
§520.1044a   Gentamicin sulfate oral solution.
§520.1044b   Gentamicin sulfate pig pump oral solution.
§520.1044c   Gentamicin sulfate powder.
§520.1100   Griseofulvin.
§520.1120   Haloxon oral dosage forms.
§520.1120a   Haloxon drench.
§520.1120b   Haloxon boluses.
§520.1130   Hetacillin.
§520.1157   Iodinated casein tablets.
§520.1158   Iodochlorhydroxyquin boluses.
§520.1182   Iron dextran suspension.
§520.1192   Ivermectin paste.
§520.1193   Ivermectin tablets and chewables.
§520.1194   Ivermectin meal.
§520.1195   Ivermectin liquid.
§520.1196   Ivermectin and pyrantel pamoate chewable tablets.
§520.1197   Ivermectin sustained-release bolus.
§520.1198   Ivermectin and praziquantel paste.
§520.1199   Ivermectin, pyrantel, and praziquantel tablets.
§520.1200   Ivermectin, fenbendazole, and praziquantel tablets.
§520.1204   Kanamycin, bismuth subcarbonate, activated attapulgite.
§520.1242   Levamisole.
§520.1242a   Levamisole powder.
§520.1242b   Levamisole hydrochloride tablet or oblet (bolus).
§520.1242c   Levamisole hydrochloride and piperazine dihydrochloride.
§520.1242d   Levamisole resinate.
§520.1242e   Levamisole hydrochloride effervescent tablets.
§520.1242f   Levamisole hydrochloride gel.
§520.1242g   Levamisole resinate and famphur paste.
§520.1263   Lincomycin.
§520.1263a   Lincomycin hydrochloride monohydrate tablets and sirup.
§520.1263b   [Reserved]
§520.1263c   Lincomycin powder.
§520.1265   Lincomycin and spectinomycin powder.
§520.1284   Sodium liothyronine tablets.
§520.1288   Lufenuron tablets.
§520.1289   Lufenuron suspension.
§520.1310   Marbofloxacin tablets.
§520.1315   Maropitant.
§520.1320   Mebendazole oral.
§520.1326   Mebendazole and trichlorfon oral dosage forms.
§520.1326a   Mebendazole and trichlorfon powder.
§520.1326b   Mebendazole and trichlorfon paste.
§520.1330   Meclofenamic acid granules.
§520.1331   Meclofenamic acid tablets.
§520.1341   Megestrol acetate tablets.
§520.1367   Meloxicam.
§520.1372   Methimazole.
§520.1380   Methocarbamol tablets.
§520.1408   Methylprednisolone tablets.
§520.1409   Methylprednisolone, aspirin tablets.
§520.1422   Metoserpate hydrochloride.
§520.1430   Mibolerone.
§520.1441   Milbemycin oxime.
§520.1443   Milbemycin oxime and lufenuron.
§520.1445   Milbemycin oxime and praziquantel.
§520.1447   Milbemycin oxime, lufenuron, and praziquantel tablets.
§520.1450   Morantel tartrate oral dosage forms.
§520.1450a   Morantel tartrate bolus.
§520.1450b   Morantel tartrate cartridge.
§520.1450c   Morantel tartrate sustained-release trilaminate cylinder/sheet.
§520.1451   Moxidectin tablets.
§520.1452   Moxidectin gel.
§520.1453   Moxidectin and praziquantel gel.
§520.1454   Moxidectin solution.
§520.1468   Naproxen granules.
§520.1484   Neomycin.
§520.1510   Nitenpyram tablets.
§520.1604   Oclacitinib.
§520.1615   Omeprazole.
§520.1616   Orbifloxacin tablets.
§520.1618   Orbifloxacin suspension.
§520.1628   Oxfendazole powder and pellets.
§520.1629   Oxfendazole paste.
§520.1630   Oxfendazole suspension.
§520.1631   Oxfendazole and trichlorfon paste.
§520.1638   Oxibendazole paste.
§520.1640   Oxibendazole suspension.
§520.1660   Oxytetracycline.
§520.1660a   Oxytetracycline and carbomycin in combination.
§520.1660b   Oxytetracycline hydrochloride capsules.
§520.1660c   Oxytetracycline hydrochloride tablets/boluses.
§520.1660d   Oxytetracycline powder.
§520.1696   Penicillin.
§520.1696a   [Reserved]
§520.1696b   Penicillin G powder.
§520.1696c   Penicillin V powder.
§520.1696d   Penicillin V tablets.
§520.1705   Pergolide.
§520.1720   Phenylbutazone oral dosage forms.
§520.1720a   Phenylbutazone tablets and boluses.
§520.1720b   Phenylbutazone granules.
§520.1720c   Phenylbutazone paste.
§520.1720d   Phenylbutazone gel.
§520.1720e   Phenylbutazone powder.
§520.1760   Phenylpropanolamine.
§520.1780   Pimobendan.
§520.1802   Piperazine-carbon disulfide complex oral dosage forms.
§520.1802a   Piperazine-carbon disulfide complex suspension.
§520.1802b   Piperazine-carbon disulfide complex boluses.
§520.1802c   Piperazine-carbon disulfide complex with phenothiazine suspension.
§520.1803   Piperazine citrate capsules.
§520.1804   Piperazine phosphate capsules.
§520.1805   Piperazine phosphate with thenium closylate tablets.
§520.1806   Piperazine suspension.
§520.1807   Piperazine.
§520.1840   Poloxalene.
§520.1846   Polyoxyethylene (23) lauryl ether blocks.
§520.1855   Ponazuril.
§520.1860   Pradofloxacin.
§520.1870   Praziquantel tablets.
§520.1871   Praziquantel and pyrantel.
§520.1872   Praziquantel, pyrantel pamoate, and febantel tablets.
§520.1880   Prednisolone tablets.
§520.1900   Primidone tablets.
§520.1920   Prochlorperazine, isopropamide sustained release capsules.
§520.1921   Prochlorperazine, isopropamide, with neomycin sustained-release capsules.
§520.1962   Promazine hydrochloride.
§520.2002   Propiopromazine hydrochloride.
§520.2041   Pyrantel pamoate chewable tablets.
§520.2042   Pyrantel pamoate tablets.
§520.2043   Pyrantel pamoate suspension.
§520.2044   Pyrantel pamoate paste.
§520.2045   Pyrantel tartrate powder; pyrantel tartrate pellets.
§520.2075   Robenacoxib.
§520.2098   Selegiline hydrochloride tablets.
§520.2100   Selenium, vitamin E capsules.
§520.2123   Spectinomycin oral dosage forms.
§520.2123a   Spectinomycin tablets.
§520.2123b   Spectinomycin powder.
§520.2123c   Spectinomycin solution.
§520.2130   Spinosad.
§520.2134   Spinosad and milbemycin.
§520.2150   Stanozolol oral dosage forms.
§520.2150a   Stanozolol tablets.
§520.2150b   Stanozolol chewable tablets.
§520.2158   Streptomycin/dihydrostreptomycin oral dosage forms.
§520.2158a   Streptomycin sulfate oral solution.
§520.2158b   Dihydrostreptomycin tablets.
§520.2158c   Dihydrostreptomycin oral suspension.
§520.2160   Styrylpyridinium, diethylcarbamazine oral dosage forms.
§520.2170   Sulfabromomethazine sodium boluses.
§520.2184   Sodium sulfachloropyrazine monohydrate.
§520.2200   Sulfachlorpyridazine.
§520.2215   Sulfadiazine/pyrimethamine suspension.
§520.2218   Sulfamerazine, sulfamethazine, and sulfaquinoxaline powder.
§520.2220   Sulfadimethoxine oral dosage forms.
§520.2220a   Sulfadimethoxine oral solution and soluble powder.
§520.2220b   Sulfadimethoxine tablets and boluses.
§520.2220c   Sulfadimethoxine oral suspension.
§520.2220d   Sulfadimethoxine-ormetoprim tablets.
§520.2240   Sulfaethoxypyridazine.
§520.2240a   Sulfaethoxypyridazine drinking water.
§520.2240b   Sulfaethoxypyridazine tablets.
§520.2260   Sulfamethazine oral dosage forms.
§520.2260a   Sulfamethazine oblet, tablet, and bolus.
§520.2260b   Sulfamethazine sustained-release boluses.
§520.2260c   Sulfamethazine sustained-release tablets.
§520.2261   Sulfamethazine sodium oral dosage forms.
§520.2261a   Sulfamethazine solution.
§520.2261b   Sulfamethazine powder.
§520.2280   Sulfamethizole and methenamine mandelate tablets.
§520.2325   Sulfaquinoxaline oral dosage forms.
§520.2325a   Sulfaquinoxaline drinking water.
§520.2325b   Sulfaquinoxaline drench.
§520.2330   Sulfisoxazole tablets.
§520.2340   Tepoxalin.
§520.2345   Tetracycline.
§520.2345a   Tetracycline hydrochloride capsules.
§520.2345b   Tetracycline tablets.
§520.2345c   Tetracycline boluses.
§520.2345d   Tetracycline powder.
§520.2345e   Tetracycline oral liquid.
§520.2345f   Tetracycline phosphate complex and sodium novobiocin capsules.
§520.2345g   Tetracycline hydrochloride and sodium novobiocin tablets.
§520.2345h   Tetracycline hydrochloride, sodium novobiocin, and prednisolone tablets.
§520.2362   Thenium closylate tablets.
§520.2380   Thiabendazole oral dosage forms.
§520.2380a   Thiabendazole top dressing and mineral protein block.
§520.2380b   Thiabendazole drench or oral paste.
§520.2380c   Thiabendazole bolus.
§520.2380d   Thiabendazole, piperazine citrate suspension.
§520.2380e   Thiabendazole with trichlorfon.
§520.2380f   Thiabendazole, piperazine phosphate powder.
§520.2455   Tiamulin.
§520.2471   Tilmicosin.
§520.2473   Tioxidazole oral dosage forms.
§520.2473a   Tioxidazole granules.
§520.2473b   Tioxidazole paste.
§520.2475   Toceranib.
§520.2483   Triamcinolone.
§520.2520   Trichlorfon oral dosage forms.
§520.2520b   Trichlorfon and atropine.
§520.2520e   Trichlorfon boluses.
§520.2520f   Trichlorfon granules.
§520.2520g   Trichlorfon, phenothiazine, and piperazine dihydrochloride powder.
§520.2582   Triflupromazine hydrochloride tablets.
§520.2598   Trilostane.
§520.2604   Trimeprazine tartrate and prednisolone tablets.
§520.2605   Trimeprazine tartrate and prednisolone capsules.
§520.2610   Trimethoprim and sulfadiazine tablets.
§520.2611   Trimethoprim and sulfadiazine paste.
§520.2612   Trimethoprim and sulfadiazine suspension.
§520.2613   Trimethoprim and sulfadiazine powder.
§520.2640   Tylosin.
§520.2645   Tylvalosin.

Authority: 21 U.S.C. 360b.

Source: 40 FR 13838, Mar. 27, 1975, unless otherwise noted.

§520.23   Acepromazine.

(a) Specifications. Each tablet contains 5, 10, or 25 milligrams (mg) acepromazine maleate.

(b) Sponsors. See No. 000010 in §510.600(c) of this chapter.

(c) Conditions of use(1) Dogs—(i) Amount. 0.25 to 1.0 mg per pound (/lb) body weight orally.

(ii) Indications for use. As an aid in tranquilization and as a preanesthetic agent.

(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) Cats—(i) Amount. 0.5 to 1.0 mg/lb body weight orally.

(ii) Indications for use. As a tranquilizer.

(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[75 FR 10165, Mar. 5, 2010]

§520.28   Acetazolamide sodium soluble powder.

(a) Specifications. The drug is in a powder form containing acetazolamide sodium, USP equivalent to 25 percent acetazolamide activity.

(b) Sponsor. See No. 053501 in §510.600(c) of this chapter.

(c) Conditions of use. (1) It is used in dogs as an aid in the treatment of mild congestive heart failure and for rapid reduction of intraocular pressure.1

1These conditions are NAS/NRC reviewed and deemed effective. Applications for these uses need not include effectiveness data as specified by §514.111 of this chapter, but may require bioequivalency and safety information.

(2) It is administered orally at a dosage level of 5 to 15 milligrams per pound of body weight daily.1

(3) For use only by or on the order of a licensed veterinarian.1

[40 FR 13838, Mar. 27, 1975, as amended at 67 FR 78355, Dec. 24, 2002. Redesignated at 78 FR 66264, Nov. 5, 2013.]

§520.38   Albendazole oral dosage forms.

§520.38a   Albendazole suspension.

(a) Specifications. Each milliliter of suspension contains 45.5 milligrams (mg) (4.55 percent) or 113.6 mg (11.36 percent) albendazole.

(b) Sponsor. See No. 000069 in §510.600 of this chapter.

(c) Related tolerances. See §556.34 of this chapter.

(d) Special considerations. See §500.25 of this chapter.

(e) Conditions of use(1) Cattle. Administer 11.36 percent suspension:

(i) Amount. 4.54 mg/pound (lb) body weight (10 mg/kilogram (kg)) as a single oral dose using dosing gun or dosing syringe.

(ii) Indications for use. For removal and control of adult liver flukes (Fasciola hepatica); heads and segments of tapeworms (Moniezia benedeni and M. expansa); adult and 4th stage larvae of stomach worms (brown stomach worms including 4th stage inhibited larvae (Ostertagia ostertagi), barberpole worm (Haemonchus contortus and H. placei), small stomach worm (Trichostrongylus axei)); adult and 4th stage larvae of intestinal worms (thread-necked intestinal worm (Nematodirus spathiger and N. helvetianus), small intestinal worm (Cooperia punctata and C. oncophora)); adult stages of intestinal worms (hookworm (Bunostomum phlebotomum), bankrupt worm (Trichostrongylus colubriformis), nodular worm (Oesophagostomum radiatum)); adult and 4th stage larvae of lungworms (Dictyocaulus viviparus).

(iii) Limitations. Do not slaughter within 27 days of last treatment. Do not use in female dairy cattle of breeding age: Do not administer to female cattle during first 45 days of pregnancy or for 45 days after removal of bulls.

(2) Sheep. Administer 4.45 or 11.36 percent suspension:

(i) Amount. 3.4 mg/lb body weight (7.5 mg/kg) as a single oral dose using dosing gun or dosing syringe.

(ii) Indications for use. For removal and control of adult liver flukes (Fasciola hepatica and Fascioloides magna); heads and segments of common tapeworms (Moniezia expansa) and fringed tapeworm (Thysanosoma actinioides); adult and fourth stage larvae of stomach worms (brown stomach worm (Ostertagia circumcinta and Marshallagia marshalli), barberpole worm (Haemonchus contortus), small stomach worm (Trichostrongylus axei)); adult and fourth stage larvae of intestinal worms (thread-necked intestinal worm (Nematodirus spathiger and N. filicollis), Cooper's worm (Cooperia oncophora), bankrupt worm (Trichostrongylus colubriformis), nodular worm (Oesophagostomum columbianum), and large-mouth bowel worm (Chabertia ovina)); adult and larval stages of lungworms (Dictyocaulus filaria).

(iii) Limitations. Do not slaughter within 7 days of last treatment. Do not administer to ewes during first 30 days of pregnancy or for 30 days after removal of rams.

(3) Goats. Administer 11.36 percent suspension:

(i) Amount. 4.54 mg/lb body weight (10 mg/kg) as a single oral dose using dosing gun or dosing syringe.

(ii) Indications for use. For the treatment of adult liver flukes (Fasciola hepatica) in nonlactating goats.

(iii) Limitations. Do not slaughter within 7 days of last treatment. Do not administer to does during the first 30 days of pregnancy or for 30 days after removal of bucks.

[73 FR 11027, Feb. 29, 2008. Redesignated at 78 FR 66264, Nov. 5, 2013.]

§520.38b   Albendazole paste.

(a) Specifications. The product contains 30 percent albendazole.

(b) Sponsor. See No. 000069 in §510.600(c) of this chapter.

(c) Related tolerances. See §556.34 of this chapter.

(d) Conditions of use in cattle(1) Amount. Equivalent to 4.54 milligrams per 1 pound of body weight (10 milligrams per kilogram).

(2) Indications for use. For removal and control of the following internal parasites of cattle: adult liver flukes (Fasciola hepatica); heads and segments of tapeworms (Moniezia benedeni, M. expansa); adult and 4th stage larvae of stomach worms (brown stomach worms including 4th stage inhibited larvae (Ostertagia ostertagi); barberpole worm (Haemonchus contortus, H. placei); small stomach worm (Trichostrongylus axei)); adult and 4th stages larvae of intestinal worms (thread-necked intestinal worm (Nematodirus spathiger, N. helvetianus); small intestinal worm (Cooperia punctata and C. oncophora)); adult stages of intestinal worms (hookworm (Bunostomum phlebotmum); bankrupt worm (Trichostrongylus colubriformis), nodular worm (Oesophagostomum radiatum)); adult and 4th stage larvae of lungworms (Dictyocaulus viviparus).

(3) Limitations. Administer as a single oral dose. Do not slaughter within 27 days of last treatment. Do not use in female dairy cattle of breeding age. Do not administer to female cattle during first 45 days of pregnancy or for 45 days after removal of bulls. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.

[54 FR 51385, Dec. 15, 1989, as amended at 56 FR 50653, Oct. 8, 1991; 60 FR 55658, Nov. 2, 1995. Redesignated at 78 FR 66264, Nov. 5, 2013.]

§520.43   Afoxolaner.

(a) Specifications. Each chewable tablet contains 11.3, 28.3, 68, or 136 milligrams (mg) afoxolaner.

(b) Sponsor. See No. 050604 in §510.600(c) of this chapter.

(c) Conditions of use(1) Amount. Administer orally once a month at a minimum dosage of 1.14 mg/pound (lb) (2.5 mg/kilogram (kg)).

(2) Indications for use. For the treatment and prevention of flea infestations (Ctenocephalides felis), and the treatment and control of American dog tick (Dermacentor variabilis) infestations in dogs and puppies 8 weeks of age and older, weighing 4 pounds of body weight or greater, for 1 month.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[78 FR 66264, Nov. 5, 2013]

§520.48   Altrenogest.

(a) Specifications. Each milliliter (mL) of solution contains 2.2 milligrams (mg) altrenogest.

(b) Sponsors. See sponsor listings in §510.600(c) of this chapter:

(1) No. 000061 for use as in paragraph (d) of this section.

(2) No. 013744 for use as in paragraph (d)(1) of this section.

(c) Tolerances. See §556.36 of this chapter.

(d) Conditions of use—(1) Horses—(i) Amount. 1.0 mL per 110 pounds body weight (0.044 mg/kg) daily for 15 consecutive days.

(ii) Indications for use. For suppression of estrus in mares.

(iii) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) Swine—(i) Amount. Administer 6.8 mL (15 mg altrenogest) per gilt once daily for 14 consecutive days by top-dressing on a portion of each gilt's daily feed.

(ii) Indications for use. For synchronization of estrus in sexually mature gilts that have had at least one estrous cycle.

(iii) Limitations. Do not use in gilts having a previous or current history of uterine inflammation (i.e., acute, subacute or chronic endometritis). Gilts must not be slaughtered for human consumption for 21 days after the last treatment.

[66 FR 47960, Sept. 17, 2001, as amended at 68 FR 62006, Oct. 31, 2003; 72 FR 9455, Feb. 21, 2008; 74 FR 61516, Nov. 25, 2009; 77 FR 32012, May 31, 2012]

§520.62   Aminopentamide hydrogen sulphate tablets.

(a) Chemical name. 4-(Dimethylamino)-2,2-diphenylvaleramide hydrogen sulfate.

(b) Specifications. Each tablet contains 0.2 milligram of the drug.

(c) Sponsor. See No. 000856 in §510.600(c) of this chapter.

(d) Conditions of use. (1) It is intended for use in dogs and cats only for the treatment of vomiting and/or diarrhea, nausea, acute abdominal visceral spasm, pylorospasm, or hypertrophic gastritis.

Note: Not for use in animals with glaucoma because of the occurrence of mydriasis.

(2) Dosage is administered by oral tablet every 8 to 12 hours, as follows:

Weight of animal in poundsDosage in milligrams
Up to 100.1
11 to 200.2
21 to 500.3
51 to 1000.4
Over 1000.5

Dosage may be gradually increased up to a maximum of five times the suggested dosage. Oral administration of tablets may be preceded by subcutaneous or intramuscular use of the injectable form of the drug.

(3) For use only by or on the order of a licensed veterinarian.

[40 FR 13838, Mar. 27, 1975, as amended at 53 FR 27851, July 25, 1988]

§520.82   Aminopropazine fumarate oral dosage forms.

§520.82a   Aminopropazine fumarate tablets.

(a) Specifications. The drug is in tablet form. Each tablet contains aminopropazine fumarate equivalent to 25 milligrams of aminopropazine base.

(b) Sponsor. See No. 000061 in §510.600(c) of this chapter.

(c) Conditions of use. (1) The drug is used in dogs and cats for reducing excessive smooth muscle contractions, such as occur in urethral spasms associated with urolithiasis.1

(2) It is administered at a dosage level of 1 to 2 milligrams per pound of body weight. The dosage can be repeated every 12 hours, as indicated.1

(3) Not for use in animals intended for food purposes.

(4) For use only by or on the order of a licensed veterinarian.1

[40 FR 13838, Mar. 27, 1975, as amended at 46 FR 48642, Oct. 2, 1981; 61 FR 8873, Mar. 6, 1996; 62 FR 61624, Nov. 19, 1997]

§520.82b   Aminopropazine fumarate, neomycin sulfate tablets.

(a) Specifications. The drug is in tablet form. Each tablet contains both aminopropazine fumarate equivalent to 25 milligrams of aminopropazine base and neomycin sulfate equivalent to 50 milligrams of neomycin base.

(b) Sponsor. See No. 000061 in §510.600(c) of this chapter.

(c) Conditions of use. (1) The drug is used in dogs to control bacterial diarrhea caused by organisms susceptible to neomycin and to reduce smooth muscle contractions.1

1These conditions are NAS/NRC reviewed and deemed effective. Applications for these uses need not include effectiveness data as specified by §514.111 of this chapter, but may require bioequivalency and safety information.

(2) It is administered at a dosage level of one to two tablets per 10 pounds of body weight twice daily for 3 days.1

(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian.1

[40 FR 13838, Mar. 27, 1975, as amended at 46 FR 48642, Oct. 2, 1981; 61 FR 8873, Mar. 6, 1996; 62 FR 61624, Nov. 19, 1997]

§520.88   Amoxicillin oral dosage forms.

§520.88a   Amoxicillin trihydrate film-coated tablets.

(a) Specifications. Each tablet contains amoxicillin trihydrate equivalent to 50, 100, 150, 200, or 400 milligrams of amoxicillin.

(b) Sponsor. See No. 000069 in §510.600(c) of this chapter.

(c) Conditions of use—(1) Dogs—(i) Amount. 5 milligrams per pound of body weight, twice a day.

(ii) Indications for use. Treatment of infections of the respiratory tract (tonsillitis, tracheobronchitis), genitourinary tract (cystitis), gastrointestinal tract (bacterial gastroenteritis), and soft tissues (abscesses, lacerations, wounds), caused by susceptible strains of Staphylococcus aureus, Streptococcus spp., Escherichia coli, Proteus mirabilis, and bacterial dermatitis caused by S. aureus, Streptococcus spp., and P. mirabilis.

(iii) Limitations. Administer for 5 to 7 days or 48 hours after all symptoms have subsided. If no improvement is seen in 5 days, review diagnosis and change therapy. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) Cats—(i) Amount. 50 milligrams (5 to 10 milligrams per pound of body weight) once a day.

(ii) Indications for use. Treatment of infections caused by susceptible organisms as follows: upper respiratory tract due to S. aureus, Streptococcus spp., and E. coli; genitourinary tract (cystitis) due to S. aureus, Streptococcus spp., E. coli, and P. mirabilis; gastrointestinal tract due to E. coli; and skin and soft tissue (abscesses, lacerations, and wounds) due to S. aureus, Streptococcus spp., E. coli, and Pasteurella multocida.

(iii) Limitations. Administer for 5 to 7 days or 48 hours after all symptoms have subsided. If no improvement is seen in 5 days, review diagnosis and change therapy. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[57 FR 37319, Aug. 18, 1992, as amended at 60 FR 55658, Nov. 2, 1995]

§520.88b   Amoxicillin trihydrate for oral suspension.

(a) Specifications. When reconstituted, each milliliter contains amoxicillin trihydrate equivalent to 50 milligrams of amoxicillin.

(b) Sponsor. See No. 000069 in §510.600(c) of this chapter.

(1) Conditions of use—(i) Dogs—(A) Amount. 5 milligrams per pound of body weight twice daily.

(B) Indications for use. Treatment of infections caused by susceptible strains of organisms as follows: respiratory tract (tonsillitis, tracheobronchitis) caused by Staphylococcus aureus, Streptococcus spp., Escherichia coli, and Proteus mirabilis; genitourinary tract (cystitis) caused by S. aureus, Streptococcus spp., E. coli, and P. mirabilis; gastrointestinal tract (bacterial gastroenteritis) caused by S. aureus, Streptococcus spp., E. coli, and P. mirabilis; bacterial dermatitis caused by S. aureus, Streptococcus spp., and P. mirabilis; and soft tissues (abscesses, lacerations, and wounds) caused by S. aureus, Streptococcus spp., E. coli, and P. mirabilis.

(C) Limitations. Use for 5 to 7 days or 48 hours after all symptoms have subsided. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(ii) Cats—(A) Amount. 50 milligrams (5 to 10 milligrams per pound) once daily.

(B) Indications for use. Treatment of infections caused by susceptible strains of organisms as follows: upper respiratory tract due to Staphylococcus spp., Streptococcus spp., Hemophilus spp., E. coli, Pasteurella spp., and P. mirabilis; genitourinary tract (cystitis) due to S. aureus, Streptococcus spp., E. coli, P. mirabilis, and Corynebacterium spp.; gastrointestinal tract due to E. coli, Proteus spp., Staphylococcus spp., and Streptococcus spp.; skin and soft tissue (abscesses, lacerations, and wounds) due to Staphylococcus spp., Streptococcus spp., E. coli, and Pasteurella multocida.

(C) Limitations. Use for 5 to 7 days or 48 hours after all symptoms have subsided. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) [Reserved]

(c) Sponsors. See Nos. 000856 and 051311 in §510.600(c) of this chapter.

(1) Conditions of use. Dogs—(i) Amount. 5 milligrams per pound of body weight twice daily.

(ii) Indications for use. Treatment of bacterial dermatitis due to S. aureus, Streptococcus spp., Staphylococcus spp., and E. coli, and soft tissue infections (abscesses, wounds, lacerations) due to S. aureus, Streptococcus spp., E. coli, P. mirabilis and Staphylococcus spp.

(iii) Limitations. Use for 5 to 7 days. Continue for 48 hours after all symptoms have subsided. If no improvement is seen in 5 days, review diagnosis and change therapy. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) [Reserved]

[57 FR 37319, Aug. 18, 1992; 57 FR 42623, Sept. 15, 1992, as amended at 60 FR 55658, Nov. 2, 1995; 62 FR 13302, Mar. 20, 1997; 67 FR 67521, Nov. 6, 2002; 68 FR 54658, Sept. 18, 2003; 68 FR 55824, Sept. 29, 2003]

§520.88c   Amoxicillin trihydrate oral suspension.

(a) Specifications. Each 0.8-milliliter dose contains amoxicillin trihydrate equivalent to 40 milligrams of amoxicillin.

(b) Sponsor. See No. 000069 in §510.600(c) of this chapter.

(c) Related tolerances. See §556.510 of this chapter.

(d) Conditions of use. Swine(1) Amount. 40 milligrams orally, twice a day using a dosing pump.

(2) Indications for use. Treatment of baby pigs under 10 pounds for porcine colibacillosis caused by Escherichia coli susceptible to amoxicillin.

(3) Limitations. Treat animals for 48 hours after all symptoms have subsided but not beyond 5 days. Do not slaughter during treatment or for 15 days after latest treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[57 FR 37319, Aug. 18, 1992, as amended at 60 FR 55658, Nov. 2, 1995]

§520.88d   Amoxicillin trihydrate soluble powder.

(a) Specifications. Each gram contains amoxicillin trihydrate equivalent to 115.4 milligrams of amoxicillin.

(b) Sponsor. See No. 000069 in §510.600(c) of this chapter.

(c) Related tolerances. See §556.38 of this chapter.

(d) Conditions of use. Preruminating calves including veal calves—(1) Amount. 400 milligrams per 100 pounds of body weight twice daily.

(2) Indications for use. Treatment of bacterial enteritis when due to susceptible Escherichia coli in preruminating calves including veal calves.

(3) Limitations. Administer by drench or by mixing in milk. Treatment should be continued for 48 hours after all symptoms have subsided but not to exceed 5 days. For use in preruminating calves including veal calves only, not for use in other animals which are raised for food production. Do not slaughter animals during treatment or for 20 days after the latest treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[57 FR 37319, Aug. 18, 1992; 57 FR 42623, Sept. 15, 1992; 58 FR 18304, Apr. 8, 1993, as amended at 60 FR 55658, Nov. 2, 1995; 62 FR 5525, Feb. 6, 1997]

§520.88e   Amoxicillin trihydrate boluses.

(a) Specifications. Each bolus contains the equivalent of 400 milligrams of amoxicillin.

(b) Sponsor. See No. 000069 in §510.600(c) of this chapter.

(c) Related tolerances. See §556.38 of this chapter.

(d) Conditions of use. Preruminating calves including veal calves(1) Amount. 400 milligrams per 100 pounds of body weight twice daily.

(2) Indications for use. Treatment of bacterial enteritis when due to susceptible Escherichia coli in preruminating calves including veal calves.

(3) Limitations. For oral use in preruminating calves including veal calves only, not for use in other animals which are raised for food production. Treatment should be continued for 48 hours after all symptoms have subsided but not to exceed 5 days. Do not slaughter animals during treatment or for 20 days after the latest treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[57 FR 37320, Aug. 18, 1992, as amended at 60 FR 55659, Nov. 2, 1995; 62 FR 5526, Feb. 6, 1997]

§520.88f   Amoxicillin trihydrate tablets.

(a) Specifications. Each tablet contains amoxicillin trihydrate equivalent to 50, 100, 200, or 400 milligrams of amoxicillin.

(b) Sponsors. See Nos. 000856 and 051311 in §510.600(c) of this chapter.

(c) Conditions of use—(1) Dogs—(i) Amount. 5 milligrams per pound of body weight twice a day.

(ii) Indications for use. Treatment of bacterial dermatitis due to Staphylococcus aureus, Streptococcus spp., Staphylococcus spp., and Escherichia coli; and soft tissue infections (abscesses, wounds, lacerations) due to S. aureus, Streptococcus spp., E. coli, Proteus mirabilis, and Staphylococcus spp.

(iii) Limitations. Use for 5 to 7 days or 48 hours after all symptoms have subsided. If no improvement is seen in 5 days, review diagnosis and change therapy. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) [Reserved]

[57 FR 37320, Aug. 18, 1992, as amended at 62 FR 13302, Mar. 20, 1997; 67 FR 67521, Nov. 6, 2002; 68 FR 54658, Sept. 18, 2003; 68 FR 55824, Sept. 29, 2003]

§520.88g   Amoxicillin trihydrate and clavulanate potassium film-coated tablets.

(a) Specifications. Each tablet contains amoxicillin trihydrate and clavulanate potassium, equivalent to either 50 milligrams of amoxicillin and 12.5 milligrams clavulanic acid, or 100 milligrams of amoxicillin and 25 milligrams clavulanic acid, or 200 milligrams amoxicillin and 50 milligrams clavulanic acid or 300 milligrams amoxicillin and 75 milligrams clavulanic acid.

(b) Sponsor. See No. 000069 in §510.600(c) of this chapter.

(c) Conditions of use(1) Dogs—(i) Amount. 6.25 milligrams (equivalent to 5 milligrams amoxicillin and 1.25 milligrams clavulanic acid) per pound of body weight twice daily.

(ii) Indications for use. Treatment of skin and soft tissue infections such as wounds, abscesses, cellulitis, superficial/juvenile and deep pyoderma due to susceptible strains of beta-lactamase (penicillinase) Staphylococcus aureus, nonbeta-lactamase S. aureus, Staphylococcus spp., Streptococcus spp., and Escherichia coli. Treatment of periodontal infections due to susceptible strains of aerobic and anaerobic bacteria.

(iii) Limitations. Wounds, abscesses, cellulitis, and superficial/juvenile pyoderma: Treat for 5 to 7 days or for 48 hours after all signs have subsided. If no improvement is seen after 5 days of treatment, discontinue therapy and reevaluate diagnosis. Deep pyoderma may require treatment for 21 days; do not treat for more than 30 days. Not for use in dogs maintained for breeding. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) Cats—(i) Amount. 62.5 milligrams (1 milliliter) (50 milligrams amoxicillin and 12.5 milligrams clavulanic acid) twice daily.

(ii) Indications for use. Treatment of skin and soft tissue infections, such as wounds, abscesses and cellulitis/dermatitis due to susceptible strains of beta-lactamase (penicillinase) producing S. aureus, nonbeta-lactamase producing S. aureus, Staphylococcus spp., Streptococcus spp., E. coli, and Pasteurella spp. Also, treatment of urinary tract infections (cystitis) due to susceptible strains of E. coli.

(iii) Limitations. Skin and soft tissue infections: abscesses, cellulitis/dermatitis should be treated for 5 to 7 days or for 48 hours after all signs have subsided. If no response is seen after 3 days of treatment, therapy should be discontinued and diagnosis reevaluated. Urinary tract infections may require treatment for 10 to 14 days or longer. The maximum duration of treatment should not exceed 30 days. Safety of use in pregnant or breeding animals has not been established. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[57 FR 37320, Aug. 18, 1992, as amended at 60 FR 55659, Nov. 2, 1995; 63 FR 13121, Mar. 18, 1998]

§520.88h   Amoxicillin trihydrate and clavulanate potassium for oral suspension.

(a) Specifications. When reconstituted, each milliliter contains amoxicillin trihydrate equivalent to 50 milligrams of amoxicillin with clavulanate potassium equivalent to 12.5 milligrams of clavulanic acid.

(b) Sponsor. See No. 000069 in §510.600(c) of this chapter.

(c) Conditions of use(1) Dogs—(i) Amount. 6.25 milligrams (equivalent to 5 milligrams amoxicillin and 1.25 milligrams clavulanic acid) per pound of body weight twice daily.

(ii) Indications for use. Treatment of skin and soft tissue infections such as wounds, abscesses, cellulitis, superficial/juvenile and deep pyoderma due to susceptible strains of beta-lactamase (penicillinase) producing Staphylococcus aureus, nonbeta-lactamase Staphylococcus aureus, Staphylococcus spp., Streptococcus spp., and Escherichia coli. Treatment of periodontal infections due to susceptible strains of aerobic and anaerobic bacteria.

(iii) Limitations. Administer for 5 to 7 days or 48 hours after all symptoms subsided. Deep pyoderma may require 21 days, not to exceed 30 days. If no improvement is seen in 5 days, discontinue therapy and reevaluate the case. Not for use in dogs maintained for breeding. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) Cats—(i) Amount. 62.5 milligrams (1 milliliter) (50 milligrams of amoxicillin and 12.5 milligrams clavulanic acid) twice daily.

(ii) Indications for use. Treatment of feline skin and soft tissue infections, such as wounds, abscesses and cellulitis/dermatitis due to susceptible strains of beta-lactamase (penicillinase) producing S. aureus, nonbeta-lactamase S. aureus, Staphylococcus spp., Streptococcus spp., E. coli, Pasteurella multocida, and Pasteurella spp.

(iii) Limitations. Administer 48 hours after all symptoms have subsided. If no improvement is seen after 3 days of treatment, discontinue therapy and reevaluate diagnosis. Maximum duration of treatment should not exceed 30 days. Not for use in cats maintained for breeding. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[57 FR 37320, Aug. 18, 1992, as amended at 60 FR 55659, Nov. 2, 1995; 63 FR 13121, Mar. 18, 1998]

§520.90   Ampicillin oral dosage forms.

§520.90a   Ampicillin capsules.

(a) Specifications. Each capsule contains 125 milligrams or 250 milligrams of ampicillin.

(b) Sponsor. See No. 000008 in §510.600(c) of this chapter.

(c) Conditions of use(1) Dogs—(i) Amount. 5 to 10 milligrams per pound of body weight, e.g., one 125 mg capsule per 14 to 25 pounds, given 2 to 4 times daily; for animals weighing 6 to 14 pounds, one capsule twice daily.

(ii) Indications for use. Treatment of urinary tract infections (cystitis) due to Proteus spp., hemolytic and nonhemolytic streptococci, beta hemolytic streptococci, and Escherichia coli. In upper respiratory tract infections tracheobronchitis (kennel cough), tonsillitis due to alpha and beta hemolytic streptococci, hemolytic positive staphylococci, E. coli, and Proteus spp. In infections associated with abscesses, lacerations, and wounds due to Staphylococcus spp. and Streptococcus spp.

(iii) Limitations. Bacteriologic studies to determine the causative organisms and their susceptibility to ampicillin should be performed. Use of the drug is contraindicated in animals with a history of an allergic reaction to any of the penicillins. Ampicillin is contraindicated in infections caused by penicillinase-producing organisms. Not for use in animals which are raised for food production. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) Cats—(i) Amount. 125 milligrams twice daily; in more acute conditions three times daily.

(ii) Indications for use. Treatment of respiratory tract infections (bacterial pneumonia) due to alpha and beta hemolytic streptococci, hemolytic positive staphylococci, E. coli, and Proteus spp. In infections associated with abscesses, lacerations, and wounds due to Staphylococcus spp. and Streptococcus spp.

(iii) Limitations. Bacteriologic studies to determine the causative organisms and their susceptibility to ampicillin should be performed. Use of the drug is contraindicated in animals with a history of an allergic reaction to any of the penicillins. Ampicillin is contraindicated in infections caused by penicillinase-producing organisms. Not for use in animals which are raised for food production. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[57 FR 37321, Aug. 18, 1992]

§520.90b   Ampicillin trihydrate tablets.

(a) Specifications. Each tablet contains ampicillin trihydrate equivalent to 50 or 100 milligrams of ampicillin.

(b) Sponsor. See No. 000069 in §510.600(c) of this chapter.

(c) Conditions of use. Dogs(1) Amount. 5 milligrams per pound of body weight, at 8-hour intervals, 1 to 2 hours prior to feeding, to be continued 36 to 48 hours after all symptoms have subsided. If no improvement is seen within 5 days, stop treatment, reevaluate diagnosis, and change therapy.

(2) Indications for use. Oral treatment of infections caused by susceptible organisms as follows: Upper respiratory infections, tonsillitis, and bronchitis due to Streptococcus spp., Staphylococcus spp., Escherichia coli, Proteus mirabilis, and Pasteurella spp., urinary tract infections (cystitis) due to Streptococcus spp., Staphylococcus spp., E., coli, P. mirabilis, and Enterococcus spp.; gastrointestinal infections due to Staphylococcus spp., Streptococcus spp., Enterococcus spp., and E. coli. ; infections associated with abscesses, lacerations, and wounds caused by Staphylococcus spp., and Streptococcus spp.

(3) Limitations. Not for use in animals which have shown hypersensitivity to penicillin or for infections caused by penicillinase-producing organisms. Not for use in animals which are raised for food production. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[57 FR 37321, Aug. 18, 1992, as amended at 60 FR 55659, Nov. 2, 1995]

§520.90c   Ampicillin trihydrate capsules.

(a) Specifications. Each capsule contains ampicillin trihydrate equivalent to 125, 250, or 500 milligrams of ampicillin.

(b) Sponsor. See No. 055529 in §510.600(c) of this chapter.

(c) Conditions of use(1) Dogs—(i) Amount. 5 to 10 milligrams per pound of body weight two or three times daily. In severe or acute conditions, 10 milligrams per pound of body weight, three times daily. Administer 1 to 2 hours prior to feeding.

(ii) Indications for use. Treatment against strains of gram-negative and gram-positive organisms sensitive to ampicillin and associated with respiratory tract infections (tracheobronchitis and tonsillitis); urinary tract infections (cystitis); bacterial gastroenteritis; generalized infections (septicemia) associated with abscesses, lacerations, and wounds; and bacterial dermatitis.

(iii) Limitations. The drug may be given as an emergency measure; however, in vitro sensitivity tests on samples collected prior to treatment should be made. Ampicillin is contraindicated for use in infections caused by penicillinase-producing organisms and for use in animals known to be allergic to any of the penicillins. Not for use in animals raised for food production. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) Cats—(i) Amount. 10 to 30 milligrams per pound of body weight or three times daily. Administer 1 to 2 hours prior to feeding.

(ii) Indications for use. Treatment against strains of gram-negative and gram-positive organisms sensitive to ampicillin and associated with respiratory tract infections (bacterial pneumonia); urinary tract infections (cystitis); and generalized infections (septicemia) associated with abscesses, lacerations, and wounds.

(iii) Limitations. The drug may be given as an emergency measure; however, in vitro sensitivity tests on samples collected prior to treatment should be made. Ampicillin is contraindicated for use in infections caused by penicillinase-producing organisms and for use in animals known to be allergic to any of the penicillins. Not for use in animals raised for food production. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[57 FR 37321, Aug. 18, 1992, as amended at 58 FR 61016, Nov. 19, 1993]

§520.90d   Ampicillin trihydrate for oral suspension.

(a) Specifications. When reconstituted as directed, each milliliter contains ampicillin trihydrate equivalent to 25 milligrams of ampicillin.

(b) Sponsor. See No. 055529 in §510.600(c) of this chapter.

(c) Conditions of use(1) Dogs—(i) Amount. 5 to 10 milligrams per pound of body weight orally, 2 or 3 times daily, 1 to 2 hours prior to feeding. In severe or acute conditions, 10 milligrams per pound of body weight 3 times daily.

(ii) Indications for use. Treatment of respiratory tract infections (tracheobronchitis and tonsillitis) due to Escherichia coli, Pseudomonas spp., Proteus spp., Staphylococcus spp., and Streptococcus spp., urinary tract infections (cystitis) due to E. coli, Staphylococcus spp., Streptococcus spp., and Proteus spp.; bacterial gastroenteritis due to E. coli; generalized infections (septicemia) associated with abscesses, lacerations, and wounds, due to Staphylococcus spp. and Streptococcus spp.; bacterial dermatitis due to Staphylococcus spp., Streptococcus spp., Proteus spp., and Pseudomonas spp.

(iii) Limitations. Duration of treatment is usually 3 to 5 days. Continue treatment 48 hours after the animal's temperature has returned to normal and all other signs of infection have subsided. If no response is obtained within 3 to 5 days, reevaluate diagnosis and treatment. Appropriate laboratory tests should be conducted, including in vitro culturing and susceptibility tests on samples collected prior to treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) Cats—(i) Amount. 10 to 30 milligrams per pound of body weight orally, 2 or 3 times daily, 1 to 2 hours prior to feeding.

(ii) Indications for use. Treatment of respiratory tract infections (bacterial pneumonia) due to Staphylococcus spp., Streptococcus spp., E. coli, and Proteus spp.; urinary tract infections (cystitis) due to E. coli, Staphylococcus spp., Streptococcus spp., Proteus spp., and Corynebacterium spp.; generalized infections (septicemia) associated with abscesses, lacerations, and wounds, due to Staphylococcus spp., Streptococcus spp., Bacillus spp., and Pasteurella spp.

(iii) Limitations. Duration of treatment is usually 3 to 5 days. Continue treatment 48 hours after the animal's temperature has returned to normal and all other signs of infection have subsided. If no response is obtained within 3 to 5 days, reevaluate diagnosis and treatment. Appropriate laboratory tests should be conducted, including in vitro culturing and susceptibility tests on samples collected prior to treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[57 FR 37321, Aug. 18, 1992, as amended at 58 FR 61016, Nov. 19, 1993]

§520.90e   Ampicillin trihydrate soluble powder.

(a) Specifications. Each gram contains ampicillin trihydrate equivalent to 88.2 milligrams of ampicillin.

(b) Sponsor. See No. 055529 in §510.600(c) of this chapter.

(c) Related tolerances. See §556.40 of this chapter.

(d) Conditions of use. Swine(1) Amount. 5 milligrams of ampicillin per pound of body weight twice daily, orally by gavage or in drinking water for up to 5 days.

(2) Indications for use. Oral treatment of porcine colibacillosis (Escherichia coli) and salmonellosis (Salmonella spp.) infections in swine up to 75 pounds of body weight, and bacterial pneumonia caused by Pasteurella multocida, Staphylococcus spp., Streptococcus spp., and Salmonella spp.

(3) Limitations. For use in swine only. Not for use in other animals which are raised for food production. Treated swine must not be slaughtered for food during treatment and for 24 hours following the last treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[57 FR 37322, Aug. 18, 1992, as amended at 58 FR 61016, Nov. 19, 1993]

§520.90f   Ampicillin trihydrate boluses.

(a) Specifications. Each bolus contains ampicillin trihydrate equivalent to 400 milligrams of ampicillin.

(b) Sponsor. See No. 055529 in §510.600(c) of this chapter for use as in paragraph (d)(1), 000069 for use as in paragraph (d)(2).

(c) Related tolerances. See §556.40 of this chapter.

(d) Conditions of use. Nonruminating calves(1) Amount. 5 milligrams per pound of body weight twice daily for up to 5 days.

(i) Indications for use. Oral treatment of colibacillosis caused by Escherichia coli, bacterial enteritis caused by Salmonella spp., and bacterial pneumonia caused by Pasteurella spp.

(ii) Limitations. Treated calves must not be slaughtered for food during treatment and for 15 days after the last treatment. Not for use in other animals raised for food production. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) Amount. 5 milligrams per pound of body weight twice daily not to exceed 4 days.

(i) Indications for use. Oral treatment of bacterial enteritis (colibacillosis) caused by E. coli.

(ii) Limitations. Treated calves must not be slaughtered for food during treatment and for 7 days after the last treatment. Not for use in other animals raised for food production. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[57 FR 37322, Aug. 18, 1992, as amended at 58 FR 61016, Nov. 19, 1993; 60 FR 55659, Nov. 2, 1995]

§520.100   Amprolium.

(a) Specifications(1) Each milliliter of solution contains 96 milligrams (mg) amprolium (9.6 percent solution).

(2) Each gram of powder contains 200 mg amprolium (20 percent).

(3) Each ounce (28.4 grams) of crumbles contains 355 mg amprolium (1.25 percent).

(b) Sponsors. See sponsors in 510.600(c) of this chapter.

(1) No. 016592 for use of products described in paragraph (a) of this section as in paragraph (d) of this section.

(2) No. 066104 for use of product described in paragraph (a)(1) of this section as in paragraph (d) of this section.

(3) No. 000859 for use of product described in paragraph (a)(1) of this section as in paragraph (d) of this section.

(4) No. 061623 for use of products described in paragraphs (a)(1) and (a)(2) of this section as in paragraph (d) of this section.

(c) Related tolerances. See §556.50 of this chapter.

(d) Conditions of use(1) Growing chickens, turkeys, and laying hens. It is used in drinking water as follows:

(i) Amount. Administer at the 0.012 percent level in drinking water as soon as coccidiosis is diagnosed and continue for 3 to 5 days (in severe outbreaks, give amprolium at the 0.024 percent level); continue with 0.006 percent amprolium-medicated water for an additional 1 to 2 weeks.

(ii)Indications for use. For the treatment of coccidiosis.

(iii) Limitations. Use as the sole source of amprolium.

(2) Calves. Administer crumbles top-dressed on or thoroughly mixed in the daily feed ration; administer concentrate solution or soluble powder as a drench or in drinking water as follows:

(i) Indications for use and amounts—(A) As an aid in the prevention of coccidiosis caused by Eimeria bovis and E. zurnii, administer 5 mg per kilogram (mg/kg) body weight for 21 days during periods of exposure or when experience indicates that coccidiosis is likely to be a hazard.

(B) As an aid in the treatment of coccidiosis caused by E. bovis and E. zurnii, administer 10 mg/kg body weight for 5 days.

(ii) Limitations. Withdraw 24 hours before slaughter. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Use as the sole source of amprolium.

[71 FR 56346, Sept. 27, 2006, as amended at 72 FR 60551, Oct. 25, 2007; 73 FR 45611, Aug. 6, 2008; 73 FR 70276, Nov. 20, 2008; 74 FR 10484, Mar. 11, 2009; 76 FR 38554, July 1, 2011; 76 FR 40808, July 12, 2011; 78 FR 23, Jan. 2, 2013; 78 FR 17596, Mar. 22, 2013; 78 FR 57058, Sept. 17, 2013]

§520.110   Apramycin sulfate soluble powder.

(a) Specifications. A water soluble powder used to make a medicated drinking water containing apramycin sulfate equivalent to 0.375 gram of apramycin activity per gallon of drinking water.

(b) Sponsor. See No. 000986 in §510.600(c) of this chapter.

(c) Related tolerances. See §556.52 of this chapter.

(d) Conditions of use. (1) In swine for control of porcine colibacillosis (weanling pig scours) caused by strains of E. coli sensitive to apramycin.

(2) It is administered for 7 days in drinking water at the rate of 12.5 milligrams of apramycin per kilogram (5.7 milligrams per pound) of body weight per day. Swine will normally consume 1 gallon per day of medicated water containing 375 milligrams of apramycin for each 66 pounds of body weight. Water consumption should be monitored to determine that the required amount of apramycin is being consumed. The drug concentration should be adjusted according to water consumption which varies depending on ambient temperature, humidity, and other factors.

(3) Prepare fresh medicated water daily.

(4) Do not slaughter treated swine for 28 days following treatment

[47 FR 15771, Apr. 13, 1982, as amended at 49 FR 19642, May 9, 1984; 53 FR 37753, Sept. 28, 1988]

§520.154   Bacitracin oral dosage forms.

§520.154a   Bacitracin methylene disalicylate.

(a) Specifications. Each pound of soluble powder contains the equivalent of 50 grams of bacitracin activity for use as in paragraph (d)(1) or (d)(2) of this section, or the equivalent of 200 grams of bacitracin activity for use as in paragraph (d) of this section.

(b) Sponsor. See No. 046573 in §510.600(c) of this chapter.

(c) Related tolerances. See §556.70 of this chapter.

(d) Conditions of use(1) Growing turkeys—(i) Amount. 400 milligrams (mg) per gallon (gal) in drinking water.

(ii) Indications for use. Aid in the control of transmissible enteritis complicated by organisms susceptible to bacitracin methylene disalicylate.

(iii) Limitations. Prepare a fresh solution daily.

(2) Broiler and replacement chickens—(i) Amount. 100 mg per gal in drinking water.

(A) Indications for use. Aid in the prevention of necrotic enteritis caused by Clostridium perfringens susceptible to bacitracin methylene disalicylate.

(B) Limitations. Prepare a fresh solution daily.

(ii) Amount. 200 to 400 mg per gal in drinking water. Administer continuously 5 to 7 days or as long as clinical signs persist, then reduce to prevention levels (100 mg/gal).

(A) Indications for use. Treatment of necrotic enteritis caused by C. perfringens susceptible to bacitracin methylene disalicylate.

(B) Limitations. Prepare a fresh solution daily.

(3) Swine—(i) Amount. 1 gram per gallon in drinking water.

(ii) Indications for use. Treatment of swine dysentery associated with Treponema hyodysenteriae. Administer continuously for 7 days or until signs of dysentery disappear.

(iii) Limitations. Prepare a fresh solution daily. Treatment not to exceed 14 days. If symptoms persist after 4 to 5 days consult a veterinarian. Not to be given to swine that weigh more than 250 pounds.

(4) Growing quail—(i) Amount. 400 mg per gal in drinking water.

(ii) Indications for use. For prevention of ulcerative enteritis due to Clostridium colinum susceptible to bacitracin methylene disalicylate.

(iii) Limitations. Prepare fresh solution daily. Use as sole source of drinking water.

[57 FR 37322, Aug. 18, 1992; 57 FR 42623, Sept. 15, 1992, as amended at 63 FR 38474, July 17, 1998; 64 FR 13068, Mar. 17, 1999; 76 FR 53050, Aug. 25, 2011]

§520.154b   Bacitracin methylene disalicylate and streptomycin sulfate powder.

(a) Specifications. Each gram of powder contains 200 units bacitracin methylene disalicylate and streptomycin sulfate equivalent to 20 milligrams of streptomycin.

(b) Sponsor. See No. 046573 in §510.600(c) of this chapter.

(c) Conditions of use in dogs(1) Amount. Administer 1 level teaspoonful per 10 pounds of body weight three times daily, mixed in a small quantity of liquid or feed.

(2) Indications for use. For the treatment of bacterial enteritis caused by pathogens susceptible to bacitracin and streptomycin such as Escherichia coli, Proteus spp., Staphylococcus spp., and Streptococcus spp., and for the symptomatic treatment of associated diarrhea.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[71 FR 17702, Apr. 7, 2006]

§520.154c   Bacitracin zinc soluble powder.

(a) Specifications. Each pound contains the equivalent of not less than 5 grams of bacitracin.

(b) Sponsor. See No. 053501 in §510.600(c) of this chapter.

(c) Related tolerances. See §556.70 of this chapter.

(d) Conditions of use—(1) Broiler chickens—(i) Amount. 100 milligrams per gallon in drinking water.

(A) Indications for use. Prevention of necrotic enteritis caused by Clostridium perfringens susceptible to bacitracin zinc.

(B) Limitations. Prepare a fresh solution daily.

(ii) Amount. 200 to 400 milligrams per gallon in drinking water.

(A) Indications for use. Control of necrotic enteritis caused by Clostridium perfringens susceptible to bacitracin zinc.

(B) Limitations. Prepare a fresh solution daily.

(2) Growing quail—(i) Amount. 500 milligrams per gallon in drinking water for 5 days followed by 165 milligrams per gallon in drinking water for 10 days.

(ii) Indications for use. Control of ulcerative enteritis caused by Clostridium spp. susceptible to bacitracin zinc.

(iii) Limitations. Prepare a fresh solution daily.

[57 FR 37322, Aug. 18, 1992, as amended at 67 FR 78355, Dec. 24, 2002]

§520.222   Bunamidine hydrochloride.

(a) Chemical name. N,N-Dibutyl-4-(hexyloxy)-1-naphthamidine hydrochloride.

(b) Specifications. The drug is an oral tablet containing 100, 200, or 400 milligrams of bunamidine hydrochloride.

(c) Sponsor. See No. 000061 in §510.600(c) of this chapter.

(d) Conditions of use. (1) The drug is intended for oral administration to dogs for the treatment of the tapeworms Dipylidium caninum, Taenia pisiformis, and Echinococcus granulosus, and to cats for the treatment of the tapeworms Dipylidium caninum and Taenia taeniaeformis.

(2) It is administered to cats and dogs at the rate of 25 to 50 milligrams per kilogram of body weight. The drug should be given on an empty stomach and food should not be given for 3 hours following treatment.

(3) Tablets should not be crushed, mixed with food, or dissolved in liquid. Repeat treatments should not be given within 14 days. The drug should not be given to male dogs within 28 days prior to their use for breeding. Do not administer to dogs or cats having known heart conditions.

(4) For use only by or on the order of a licensed veterinarian.

[40 FR 13838, Mar. 27, 1975, as amended at 42 FR 13018, Mar. 8, 1977; 46 FR 48642, Oct. 2, 1981; 61 FR 8873, Mar. 6, 1996; 62 FR 61624, Nov. 19, 1997]

§520.246   Butorphanol tartrate tablets.

(a) Specifications. Each tablet contains 1, 5, or 10 milligrams of butorphanol base activity as butorphanol tartrate.

(b) Sponsor. See No. 000856 in §510.600(c) of this chapter.

(c) Conditions of use. The drug is used for the treatment of dogs as follows:

(1) Amount. 0.25 milligram of butorphanol base activity per pound of body weight.

(2) Indications for use. For the relief of chronic nonproductive cough associated with tracheo-bronchitis, tracheitis, tonsillitis, laryngitis, and pharyngitis associated with inflammatory conditions of the upper respiratory tract.

(3) Limitations. For oral use in dogs only. Repeat at intervals of 6 to 12 hours as required. If necessary, increase dose to a maximum of 0.5 milligram per pound of body weight. Treatment should not normally be required for longer than 7 days. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[47 FR 14702, Apr. 6, 1982, as amended at 53 FR 27851, July 25, 1988]

§520.260   n-Butyl chloride.

(a)(1) Specifications. n-Butyl chloride capsules, veterinary contain 272 milligrams or 816 milligrams of n-butyl chloride in each capsule.

(2) Sponsor. See No. 021091 in §510.600(c) of this chapter.

(3) Conditions of use. (i) It is used for the removal of ascarids (Toxocara canis and Toxascaris leonina) and hookworms (Ancylostoma caninum, Ancylostoma braziliense, and Uncinaria stenocephala) from dogs and of the ascarid (Toxocara cati) and hookworm (Ancylostoma tubaeforme) from cats.

(ii)(a) Animals should not be fed for 18 to 24 hours before being given the drug. Puppies and kittens should be wormed at 6 weeks of age. However, if heavily infested, they may be wormed at 4 or 5 weeks of age. Administration of the drug should be followed in 12 to 1 hour with a teaspoonful to a tablespoonful of milk of magnesia or 1 or 2 milk of magnesia tablets. Normal rations may be resumed 4 to 8 hours after treatment. Puppies and kittens should be given a repeat treatment in a week or 10 days. After that they should be treated every 2 months (or as symptoms reappear) until a year old. When the puppy or kitten is a year old, one treatment every 3 to 6 months is sufficient.

(b) For dogs or cats that have been wormed regularly, treatment every 3 to 6 months will be sufficient. If a dog or cat has not been wormed previously and has the symptoms of large roundworms a dose should be given and repeated in 10 days. Removal of hookworms may require 3 or 4 doses at 10-day intervals.

(c) Puppies, dogs, cats, or kittens weighing 1 to 3 pounds should be given 2 capsules per dose which contain 272 milligrams of n-butyl chloride each. Such animals weighing 4 to 5 pounds should be given 3 such capsules. Animals weighing 6 to 7 pounds should be given 4 such capsules and animals weighing 8 to 9 pounds should be given 5 such capsules. Animals weighing 10 to 20 pounds should be given 3 capsules which contain 816 milligrams of n-butyl chloride each, animals weighing 20 to 40 pounds should be given 4 such capsules and animals weighing over 40 pounds should be given 5 such capsules with the maximum dosage being 5 capsules, each of which contains 816 milligrams of n-butyl chloride.

(iii) A veterinarian should be consulted before using in severely debilitated dogs or cats and also prior to repeated use in cases which present signs of persistent parasitism.

(b)(1) Specifications. n-Butyl chloride capsules contain 221, 442, 884, or 1,768 milligrams or 4.42 grams of n-butyl chloride in each capsule.1

1These conditions are NAS/NRC reviewed and deemed effective. Applications for these uses need not include effectiveness data as specified by §514.111 of this chapter.

(2) Sponsors. See No. 023851 in §510.600(c) of this chapter for 221, 442, 884, or 1,768 milligram or 4.42 gram capsules; No. 038782 for 884 or 1,768 milligram or 4.42 gram capsules; and No. 000069 for 221 milligram capsules.

(3) Conditions of use. (i) It is used for the removal of ascarids (Toxocara canis and Toxascaris leonina) and hookworms (Ancylostoma caninum, Ancylostoma braziliense, and Uncinaria stenocephala) from dogs.1

(ii)(a) Dogs should not be fed for 18 to 24 hours before being given the drug. Administration of the drug should be followed in 12 to 1 hour with a mild cathartic. Normal feeding may be resumed 4 to 8 hours after treatment. Animals subject to reinfection may be retreated in 2 weeks.1

(b) The drug is administered orally to dogs. Capsules containing 221 milligrams of n-butyl chloride are administered to dogs weighing under 5 pounds at a dosage level of 1 capsule per 114 pound of body weight. Capsules containing 442 milligrams of n-butyl chloride are administered to dogs weighing under 5 pounds at a dosage level of 1 capsule per 212 pounds body weight. Capsules containing 884 milligrams of n-butyl chloride are administered to dogs as follows: Weighing under 5 pounds, 1 capsule; weighing 5 to 10 pounds, 2 capsules; weighing 10 to 20 pounds, 3 capsules; weighing 20 to 40 pounds, 4 capsules; over 40 pounds, 5 capsules. Capsules containing 1,768 milligrams of n-butyl chloride are administered at a dosage level of 1 capsule per dog weighing 5 to 10 pounds. Capsules containing 4.42 grams of n-butyl chloride are administered at a dosage level of 1 capsule per dog weighing 40 pounds or over.1

(iii) A veterinarian should be consulted before using in severely debilitated dogs.1

[40 FR 13838, Mar. 27, 1975, as amended at 40 FR 39858, Aug. 29, 1975; 44 FR 10059, Feb. 16, 1979; 54 FR 38515, Sept. 19, 1989; 55 FR 24556, June 18, 1990; 64 FR 15684, Apr. 1, 1999; 70 FR 50182, Aug. 26, 2005; 78 FR 14669, Mar. 7, 2013]

Editorial Note: At 78 FR 14669, Mar. 7, 2013, §520.260 was amended by adding paragraphs (b)(1) through (3); however, the amendment could not be incorporated because (b)(1) through (3) already exist.

§520.300   Cambendazole oral dosage forms.

§520.300a   Cambendazole suspension.

(a) Specifications. Each fluid ounce contains 0.9 gram of cambendazole.

(b) Sponsor. No. 050604 in §510.600(c) of this chapter.

(c) Conditions of use. (1) It is used in horses for the control of large strongyles (Strongylus vulgaris, S. edentatus, S. equinus); small strongyles (Trichonema, Poteriostomum, Cylicobrachytus, Craterostomum, Oesophagodontus); roundworms (Parascaris); pinworms. (Oxyuris); and threadworms (Strongyloides).

(2) It is administered by stomach tube or as a drench at a dose of 0.9 gram of cambendazole per 100 pounds of body weight (20 milligrams per kilogram).

(3) For animals maintained on premises where reinfection is likely to occur, re-treatments may be necessary. For most effective results, re-treat in 6 to 8 weeks.

(4) Not for use in horses intended for food.

(5) Caution: Do not administer to pregnant mares during first 3 months of pregnancy.

(6) Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[40 FR 13838, Mar. 27, 1975. Redesignated at 41 FR 1276, Jan. 7, 1976, and amended at 42 FR 3838, Jan. 21, 1977; 62 FR 63270, Nov. 28, 1997]

§520.300b   Cambendazole pellets.

(a) Specifications. The drug is in feed pellets containing 5.3 percent cambendazole.

(b) Sponsor. No. 050604 in §510.600(c) of this chapter.

(c) Conditions of use. (1) It is used in horses for the control of large strongyles (Strongylus vulgaris, S. edentatus, S. equinus); small strongyles (Trichonema, Poteriostomum, Cylicobrachytus, Craterostomum, Oesophagodontus); roundworms (Parascaris); pinworms (Oxyuris); and threadworms (Strongyloides).

(2) Administer 20 milligrams cambendazole per kilogram body weight (6 ounces per 1,000 pounds) by mixing with normal grain ration given at one feeding. Doses for individual horses should be mixed and fed separately to assure that each horse will consume the correct amount.

(3) For animals maintained on premises where reinfection is likely to occur, re-treatments may be necessary. For most effective results, re-treat in 6 to 8 weeks.

(4) Not for use in horses intended for food.

(5) Caution: Do not administer to pregnant mares during first 3 months of pregnancy.

(6) Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.

[41 FR 1276, Jan. 7, 1976, as amended at 42 FR 3838, Jan. 21, 1977; 62 FR 63270, Nov. 28, 1997]

§520.300c   Cambendazole paste.

(a) Specifications. The drug is a paste containing 45 percent cambendazole.

(b) Sponsor. No. 050604 in §510.600(c) of this chapter.

(c) Conditions of use. (1) It is used in horses for the control of large strongyles (Strongylus vulgaris, S. edentatus, S. equinus); small strongyles (Trichonema, Poteriostomum, Cylicobrachytus, Craterostomum, Oesophagodontus); roundworms (Parascaris); pinworms (Oxyuris); and threadworms (Strongyloides).

(2) Administer 20 milligrams cambendazole per kilogram body weight (5 grams per 550 pounds (250 kilograms)) by depositing the paste on the back of the tongue using a dosing gun.

(3) For animals maintained on premises where reinfection is likely to occur, re-treatments may be necessary. For most effective results, re-treat in 6 to 8 weeks.

(4) Not for use in horses intended for food.

(5) Caution: Do not administer to pregnant mares during first 3 months of pregnancy.

(6) Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.

[41 FR 1276, Jan. 7, 1976, as amended at 42 FR 3838, Jan. 21, 1977; 62 FR 63270, Nov. 28, 1997]

§520.309   Carprofen.

(a) Specifications. (1) Each caplet contains 25, 75, or 100 milligrams (mg) carprofen.

(2) Each chewable tablet contains 25, 75, or 100 mg carprofen.

(b) Sponsors. See sponsors in §510.600(c) of this chapter for uses as in paragraph (d) of this section.

(1) No. 000069 for use of products described in paragraph (a) of this section as in paragraph (d) of this section.

(2) Nos. 000115, 000859, 055529, and 062250 for use of product described in paragraph (a)(1) as in paragraph (d) of this section.

(c) [Reserved]

(d) Conditions of use in dogs(1) Amount. 2 mg per pound (/lb) of body weight once daily or 1 mg/lb twice daily. For the control of postoperative pain, administer approximately 2 hours before the procedure.

(2) Indications for use. For the relief of pain and inflammation associated with osteoarthritis and for the control of postoperative pain associated with soft tissue and orthopedic surgeries.

(3) Limitations. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

[61 FR 66581, Dec. 18, 1996, as amended at 64 FR 32181, June 16, 1999; 66 FR 63165, Dec. 5, 2001; 67 FR 6866, Feb. 14, 2002; 67 FR 65038, Oct. 23, 2002; 67 FR 65697, Oct. 28, 2002; 70 FR 30626, May 27, 2005; 71 FR 51995, Sept. 1, 2006; 72 FR 68478, Dec. 5, 2007; 74 FR 21768, May 11, 2009; 78 FR 52853, Aug. 27, 2013; 78 FR 66264, Nov. 5, 2013]

§520.310   Caramiphen ethanedisulfonate and ammonium chloride tablets.

(a) Specifications. Each tablet contains 10 milligrams of 5st caramiphen ethanedisulfonate and 80 milligrams of ammonium chloride.1

1These conditions are NAS/NRC reviewed and deemed effective. Applications for these uses need not include effectiveness data as specified by §514.111 of this chapter, but may require bioequivalency and safety information.

(b) Sponsor. See No. 000856 in §510.600(c) of this chapter.

(c) Conditions of use in dogs(1) Amount. One tablet per 15 to 30 pounds of body weight every 4 to 6 hours.1

(2) Indications for use. For relief of cough.1

[43 FR 55385, Nov. 28, 1978]

§520.312   Carnidazole tablets.

(a) Specifications. Each tablet contains 10 milligrams of carnidazole.

(b) Sponsor. See 053923 in §510.600(c) of this chapter.

(c) Conditions of use(1) Amount. Adult pigeons: 1 tablet (10 milligrams); newly weaned pigeons: 12 tablet (5 milligrams).

(2) Indications for use. For treating trichomoniasis (canker) in ornamental and homing pigeons.

(3) Limitations. Not for use in pigeons intended for human food. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism or when severely ill birds do not respond to treatment.

[54 FR 32336, Aug. 7, 1989]

§520.314   Cefadroxil.

(a) Specifications.(1) Each tablet contains 50, 100, or 200 milligrams (mg) or 1 gram of cefadroxil.

(2) Each milliliter of suspension constituted from powder contains 50 mg of cefadroxil.

(b) Sponsor. See No. 000010 in §510.600(c) of this chapter.

(c) Conditions of use in dogs and cats—(1) Amount—(i) Dogs. Administer 10 mg per pound (/lb) body weight twice daily orally.

(ii) Cats. Administer 10 mg/lb body weight once daily orally.

(2) Indications for use—(i) Dogs. For the treatment of skin and soft tissue infections including cellulitis, pyoderma, dermatitis, wound infections, and abscesses due to susceptible strains of Staphylococcus aureus. For the treatment of genitourinary tract infections (cystitis) due to susceptible strains of Escherichia coli, Proteus mirabilis, and S. aureus.

(ii) Cats. For the treatment of skin and soft tissue infections including abscesses, wound infections, cellulitis, and dermatitis caused by susceptible strains of Pasteurella multocida, S. aureus, Staphylococcus epidermidis, and Streptococcus spp.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[75 FR 10165, Mar. 5, 2010]

§520.370   Cefpodoxime tablets.

(a) Specifications. Each tablet contains cefpodoxime proxetil equivalent to 100 or 200 milligrams (mg) cefpodoxime.

(b) Sponsors. See Nos. 000009 and 026637 in §510.600(c) of this chapter.

(c) Conditions of use in dogs(1) Amount. 5 to 10 mg per kilogram (2.3 to 4.5 mg per pound) body weight daily for 5 to 7 days, or for 2 to 3 days beyond the cessation of clinical signs, up to a maximum of 28 days.

(2) Indications for use. For the treatment of skin infections (wounds and abscesses) caused by susceptible strains of Staphylococcus intermedius, S. aureus, Streptococcus canis (group G, -hemolytic), Escherichia coli, Pasteurella multocida, and Proteus mirabilis.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[69 FR 52815, Aug. 30, 2004, as amended at 78 FR 5714, Jan. 28, 2013]

§520.376   Cephalexin.

(a) Specifications. Each chewable tablet contains 75, 150, 300, or 600 milligrams (mg) cephalexin.

(b) Sponsor. See No. 051311 in §510.600(c) of this chapter.

(c) Conditions of use—(1) Dogs—(i) Amount. Administer 22 mg per kilogram of body weight twice daily for 28 days.

(ii) Indications for use. For the treatment of secondary superficial bacterial pyoderma in dogs caused by susceptible strains of Staphylococcus pseudintermedius.

(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) [Reserved]

[77 FR 47512, Aug. 9, 2012]

§520.390   Chloramphenicol oral dosage forms.

§520.390a   Chloramphenicol tablets.

(a) Specifications. Each tablet contains 50, 100, 250, or 500 milligrams (mg); 1 or 2.5 grams (g) of chloramphenicol.

(b) Sponsors. See §510.600(c) of this chapter:

(1) For use as in paragraphs (c)(1), (c)(2)(i), and (c)(3) of this section:

(i) No. 054628 for 100-, 250-, and 500-mg; and 1- and 2.5-g tablets;

(ii) No. 000856 for 100-, 250-, and 500-mg tablets;

(iii) No. 000069 for 250-mg tablets.

(2) For use as in paragraphs (c)(1), (c)(2)(ii), and (c)(3) of this section:

(i) No. 061623 for 50-, 100-, 250-, and 500-mg; and 1-g tablets;

(ii) [Reserved]

(c) Conditions of use in dogs(1) Amount. Administer 25 mg per pound of body weight by mouth every 6 hours.

(2) Indications for use—(i) For the treatment of bacterial pulmonary infections, bacterial infections of the urinary tract, bacterial enteritis, and bacterial infections associated with canine distemper caused by susceptible organisms.

(ii) For the treatment of bacterial gastroenteritis associated with bacterial diarrhea, bacterial pulmonary infections, and bacterial infections of the urinary tract caused by susceptible organisms.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits the extralabel use of this drug in food-producing animals.

[77 FR 4896, Feb. 1, 2012, as amended at 78 FR 21059, Apr. 9, 2013]

§520.390b   Chloramphenicol capsules.

(a) Specifications. Each capsule contains 50, 100, 250, or 500 milligrams (mg) chloramphenicol.

(b) Sponsors. See Nos. 000069 and 050057 in §510.600(c) of this chapter for use as in paragraph (d) of this section.

(c) Special considerations. Federal law prohibits the extralabel use of this product in food-producing animals.

(d) Conditions of use in dogs(1) Amount. 25 mg per pound of body weight every 6 hours.

(2) Indications for use. For treatment of bacterial pulmonary infections, bacterial infections of the urinary tract, bacterial enteritis, and bacterial infections associated with canine distemper caused by susceptible organisms.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[70 FR 75398, Dec. 20, 2005, as amended at 73 FR 18442, Apr. 4, 2008; 75 FR 55676, Sept. 14, 2010]

§520.390c   Chloramphenicol palmitate oral suspension.

(a) Specifications. Each milliliter contains chloramphenicol palmitate equivalent to 30 milligrams of chloramphenicol.

(b) Sponsor. See No. 000856 in §510.600(c) of this chapter.

(c) Conditions of use. Dogs(1) Amount. 25 milligrams per pound of body weight every 6 hours. If no response is obtained in 3 to 5 days, discontinue use and reevaluate diagnosis.

(2) Indications for use. Treatment of bacterial pulmonary infections, infections of the urinary tract, enteritis, and infections associated with canine distemper that are caused by organisms susceptible to chloramphenicol.

(3) Limitations. Not for use in animals that are raised for food production. Must not be used in meat-, egg-, or milk-producing animals. The length of time that residues persist in milk or tissues has not been determined. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[57 FR 37323, Aug. 18, 1992; 57 FR 42623, Sept. 15, 1992]

§520.420   Chlorothiazide tablets and boluses.

(a)(1) Specifications. Each tablet contains 0.25 gram of chlorothiazide.

(2) Sponsor. See No. 050604 in §510.600(c) of this chapter.

(3) Conditions of use—(i) Amount. Usual dosage is 5 to 10 milligrams per pound of body weight two or three times daily.1

1These conditions are NAS/NRC reviewed and deemed effective. Applications for these uses need not include effectiveness data as specified by §514.111 of this chapter, but may require bioequivalency and safety information.

(ii) Indications for use. For use in dogs for treatment of congestive heart failure and renal edema.1

(iii) Limitations. (a) Dosage must be adjusted to meet the changing needs of the individual animal. In mild and responsive cases, it is suggested that a dose of 5 milligrams per pound of body weight be administered two or three times daily. In moderately edematous and moderately responsive animals, a dose of 7.5 to 10 milligrams per pound of body weight may be administered three times daily. Severe conditions may require higher doses. Certain animals may respond adequately to intermittent therapy; in these cases, the drug may be administered either every other day or for 3 to 5 days each week.

(b) Animals should be regularly and carefully observed for early signs of fluid and electrolyte imbalance. Take appropriate countermeasures if this should occur. In some dogs, hypochloremic alkalosis may occur (that is, excretion of chloride in relation to sodium is excessive; the plasma bicarbonate level increases and alkalosis results). Federal law restricts this drug to use by or on the order of a licensed veterinarian.1

(b)(1) Specifications. Each bolus contains 2 grams of chlorothiazide.

(2) Sponsor. See No. 000006 in §510.600(c) of this chapter.

(3) Conditions of use—(i) Amount. 2 grams once or twice daily for 3 or 4 days.1

(ii) Indications for use. For use in cattle as an aid in reduction of postparturient udder edema.1

(iii) Limitations. Animals should be regularly and carefully observed for early signs of fluid and electrolyte imbalance. Take appropriate countermeasures if this should occur. Milk taken from dairy animals during treatment and for 72 hours (six milkings) after latest treatment must not be used for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian.1

[43 FR 39085, Sept. 1, 1978, as amended at 62 FR 63270, Nov. 28, 1997]

§520.434   Chlorphenesin carbamate tablets.

(a)  Specifications. Each tablet contains 400 milligrams of chlorphenesin carbamate.

(b)  Sponsor. See No. 000009 in §510.600(c) of this chapter.

(c)  Conditions of use in dogs(1) Amount. 50 milligrams per pound of body weight on first day; 25 milligrams per pound of body weight each following day. Divide total daily dose into 2 or 3 equal doses—administer at 12- or 8-hour intervals.

(2)  Indications for use. For use as an adjunct to therapy of acute inflammatory and traumatic conditions of skeletal muscles. The drug provides relief of the signs of discomfort associated with myositis, muscle sprains, traumatic injuries, stifle injuries—especially when administered before or after surgery—and invertebral disc syndrome (can be used concurrently with adrenal corticosteroids).

(3)  Limitations. Not recommended for pregnant animals or those with a known hepatic dysfunction. Periodic liver function studies are recommended for animals on prolonged treatment. If no response is evident within 5 days of the beginning of treatment, the diagnosis should be redetermined and appropriate therapy instituted. Not recommended for use with general anesthetics other than the barbiturates. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[44 FR 16009, Mar. 16, 1979]

§520.441   Chlortetracycline powder.

(a) Specifications. Chlortetracycline powder contains not less than 15 milligrams per gram chlortetracycline hydrochloride, or chlortetracycline bisulfate equivalent to 25.6, 64 or 102.4 grams per pound (56.4, 141 or 225.6 milligrams per gram) chlortetracycline hydrochloride.

(b) Sponsors. See sponsors in §510.600(c) of this chapter for use as in paragraph (d) of this section.

(1) No. 048164 for use as in paragraph (d) of this section.

(2) Nos. 046573 and 000010 for use as in paragraph (d) of this section.

(3) No. 054628 for use as in paragraphs (d)(4)(i)(A), (d)(4)(i)(B), and (d)(4)(ii) through (d)(4)(iv) of this section. (d)(4)(ii) through (iv) of this section.

(4) Nos. 012286 and 076475 for use as in paragraphs (d)(4)(i)(A), (d)(4)(i)(B), (d)(4)(ii), and (d)(4)(iii) of this section.

(c) Related tolerances. See §556.150 of this chapter.

(d) Conditions of use. (1) Use as chlortetracycline hydrochloride in drinking water as follows:

(i) Swine—(A) Amount. Ten milligrams per pound of body weight daily in divided doses.

(1) Indications for use. Control and treatment of bacterial enteritis (scours) caused by Escherichia coli and bacterial pneumonia associated with Pasteurella spp., Actinobacillus pleuropneumoniae (Hemophilus spp.), and Klebsiella spp.

(2) Limitations. Prepare a fresh solution twice daily; as sole source of chlortetracycline; administer for not more than 5 days.

(B) [Reserved]

(ii) [Reserved]

(2) Use as chlortetracycline hydrochloride in a drench or drinking water as follows:

(i) Calves—(A) Amount. Ten milligrams per pound of body weight daily in divided doses.

(1) Control and treatment of bacterial enteritis (scours) caused by E. coli and bacterial pneumonia (shipping fever) associated with Pasteurella spp., A. pleuropneumoniae (Hemophilus spp.), and Klebsiella spp.

(2) Limitations. Prepare fresh solution daily; as sole source of chlortetracycline; administer for not more than 5 days; do not slaughter animals for food within 24 hours of treatment; do not administer this product with milk or milk replacers; administer 1 hour before or 2 hours after feeding milk or milk replacers; a withdrawal period has not been established in preruminating calves; do not use in calves to be processed for veal.

(B) [Reserved]

(ii) [Reserved]

(3) [Reserved]

(4) The following uses of chlortetracycline hydrochloride or chlortetracycline bisulfate in drinking water or drench were reviewed by the National Academy of Sciences/National Research Council (NAS/NRC) and found effective:

(i) Chickens—(A) Amount. 200 to 400 milligrams per gallon.

(1) Indications for use. Control of infectious synovitis caused by Mycoplasma synoviae.

(2) Limitations. Prepare fresh solution daily; as sole source of chlortetracycline; do not use for more than 14 days; do not slaughter animals for food within 24 hours of treatment; do not use in laying chickens.

(B) Amount. 400 to 800 milligrams per gallon.

(1) Indications for use. Control of chronic respiratory disease and air-sac infections caused by M. gallisepticum and E. coli.

(2) Limitations. Prepare fresh solution daily; as sole source of chlortetracycline; do not use for more than 14 days; do not slaughter animals for food within 24 hours of treatment; do not use in laying chickens.

(C) Amount. One thousand milligrams per gallon.

(1) Indications for use. Control of mortality due to fowl cholera caused by Pasteurella multocida susceptible to chlortetracycline.

$(2) Limitations. See paragraph (d)(4)(i)(A)(2) of this section.

(ii) Growing turkeys—(A) Amount. 400 milligrams per gallon.

(1) Indications for use. Control of infectious synovitis caused by M. synoviae.

(2) Limitations. Prepare fresh solution daily; as sole source of chlortetracycline; do not use for more than 14 days; do not slaughter animals for food within 24 hours of treatment.

(B) Amount. 25 milligrams per pound of body weight daily.

(1) Indications for use. Control of complicating bacterial organisms associated with bluecomb (transmissible enteritis, coronaviral enteritis).

(2) Limitations. Prepare fresh solution daily; as sole source of chlortetracycline; do not use for more than 14 days; do not slaughter animals for food within 24 hours of treatment.

(iii) Swine—(A) Amount. 10 milligrams per pound body weight daily in divided doses.

(B) Indications for use. Control and treatment of bacterial enteritis (scours) caused by E. coli and Salmonella spp. and bacterial pneumonia associated with Pasteurella spp., Actinobacillus pleuropneumoniae (Hemophilus spp.), and Klebsiella spp.

(C) Limitations. Prepare fresh solution daily; as sole source of chlortetracycline; do not use for more than 5 days. For Nos. 000010 and 021930, do not slaughter animals for food within 5 days of treatment. For No. 000010, do not slaughter animals for food within 24 hours of treatment.

(iv) Calves, beef cattle, and nonlactating dairy cattle—(A) Amount. 10 milligrams per pound daily in divided doses.

(B) Indications for use. Control and treatment of bacterial enteritis (scours) caused by E. coli and Salmonella spp. and bacterial pneumonia (shipping fever complex) associated with Pasteurella spp., A. pleuropneumoniae (Hemophilus spp.), and Klebsiella spp.

(C) Limitations. Prepare fresh solution daily; use as a drench; as sole source of chlortetracycline; do not use for more than 5 days; do not slaughter animals for food within 24 hours of treatment; do not use in lactating cattle; do not administer this product with milk or milk replacers; administer 1 hour before or 2 hours after feeding milk or milk replacers; a withdrawal period has not been established in preruminating calves; do not use in calves to be processed for veal.

(5) Use in a drench or drinking water as follows:

(i) Chickens—(A) Amount. 200 to 400 mg/gal, for 7 to 14 days.

(1) Indications for use. Control of infectious synovitis caused by M. synoviae susceptible to chlortetracycline.

(2) Limitations. Prepare fresh solution daily; use as the sole source of chlortetracycline; do not use for more than 14 consecutive days; do not use in laying chickens; do not administer to chickens within 24 hours of slaughter.

(B) Amount. 400 to 800 mg/gal, for 7 to 14 days.

(1) Indications for use. Control of chronic respiratory disease (CRD) and air-sac infections caused by M. gallisepticum and E. coli susceptible to chlortetracycline.

(2) Limitations. As in paragraph (d)(5)(i)(A)(2) of this section.

(C) Amount. One thousand mg/gal, for 7 to 14 days.

(1) Indications for use. Control of mortality due to fowl cholera caused by Pasteurella multocida susceptible to chlortetracycline.

(2) Limitations. As in paragraph (d)(5)(i)(A)(2) of this section.

(ii) Growing Turkeys—(A) Amount. 400 mg/gal, for 7 to 14 days.

(1) Indications for use. Control of infectious synovitis caused by Mycoplasma synoviae susceptible to chlortetracycline.

(2) Limitations. Prepare fresh solution daily; use as the sole source of chlortetracycline; do not use for more than 14 consecutive days; do not administer to growing turkeys within 24 hours of slaughter.

(B) Amount. 25 mg/lb body weight daily, for 7 to 14 days.

(1) Indications for use. Control of complicating bacterial organisms associated with bluecomb (transmissible enteritis, coronaviral enteritis) susceptible to chlortetracycline.

(2) Limitations. As in paragraph (d)(5)(ii)(A)(2) of this section.

(iii) Swine—(A) Amount. 10 mg/lb body weight daily, for 3 to 5 days.

(B) Indications for use. Control and treatment of bacterial enteritis (scours) caused by E. coli and Salmonella spp., and bacterial pneumonia associated with Pasteurella spp., A. pleuropneumoniae, and Klebsiella spp. susceptible to chlortetracycline.

(C) Limitations. Prepare fresh solution daily; use as the sole source of chlortetracycline; do not use for more than 5 days; do not administer to swine within 24 hours of slaughter.

(iv) Calves, beef cattle, and nonlactating dairy cattle—(A) Amount. 10 mg/lb body weight daily in divided doses, for 3 to 5 days.

(B) Indications for use. Control and treatment of bacterial enteritis (scours) caused by Escherichia coli and Salmonella spp., and bacterial pneumonia associated with Pasteurella spp., Histophilus spp., and Klebsiella spp. susceptible to chlortetracycline.

(C) Limitations. Prepare fresh solution daily; use as a drench; use as the sole source of chlortetracycline; do not use for more than 5 days; do not administer to cattle within 24 hours of slaughter; do not use in lactating dairy cattle; do not administer this product with milk or milk replacers; administer 1 hour before or 2 hours after feeding milk or milk replacers; a withdrawal period has not been established in preruminating calves; do not use in calves to be processed for veal.

[57 FR 37324, Aug. 18, 1992]

Editorial Note: For Federal Register citations affecting §520.441, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.fdsys.gov.

§520.443   Chlortetracycline tablets and boluses.

(a) Specifications. Each tablet/bolus contains 25, 250, or 500 milligrams (mg) chlortetracycline hydrochloride.

(b) Sponsor. See No. 054628 in §510.600(c) of this chapter.

(c) Related tolerances. See §556.150 of this chapter.

(d) Conditions of use in calves(1) Amount. One 250 milligram bolus per 50 pounds of body weight twice a day for 3 to 5 days.

(i) Indications for use. Treatment of bacterial enteritis (scours) caused by Escherichia coli and bacterial pneumonia associated with Pasteurella spp., Klesbsiella spp., and Hemophilus spp.

(ii) Limitations. Administer bolus directly by mouth or crush and dissolve in milk or water for drenching or bucket feeding; if no improvement is noted after 3 days of treatment, consult a veterinarian; do not use for more than 5 days; do not administer within 24 hours of slaughter.

(2) Amount. One 25 milligram tablet for each 5 pounds of body weight every 12 hours daily for 3 to 5 days.

(i) Indications for use. Control and treatment of bacterial enteritis (scours) caused by E. coli and Salmonella spp. and bacterial pneumonia associated with Pasteurella spp., Hemophilus spp., and Klebsiella spp., susceptible to chlortetracycline.

(ii) Limitations. Administer tablet directly by mouth or crush and dissolve in water for drenching; if no improvement is noted after 3 days of treatment, consult a veterinarian; do not use for more than 5 days; when feeding milk or milk replacer, administration 1 hour before or 2 hours after feeding; do not administer within 24 hours of slaughter.

(3) Amount. One 500 milligram bolus per 100 pounds of body weight twice a day for 3 to 5 days.

(i) Indications for use. Treatment of bacterial enteritis (scours) caused by E. coli and Salmonella spp., and bacterial pneumonia associated with Pasteurella spp., Hemophilus spp., and Klebsiella spp., susceptible to chlortetracycline.

(ii) Limitations. Administer directly by mouth or crush and dissolve in water for drenching; if no improvement is noted after 3 days of treatment, consult a veterinarian; do not use for more than 5 days; do not administer within 24 hours of slaughter.

[57 FR 37325, Aug. 18, 1992, as amended at 67 FR 78355, Dec. 24, 2002. Redesignated and amended at 76 FR 49649, Aug. 11, 2011; 78 FR 21059, Apr. 9, 2013]

§520.445   Chlortetracycline and sulfamethazine powder.

(a) Specifications. Each pound of soluble powder contains chlortetracycline bisulfate equivalent to 102.4 grams (g) of chlortetracycline hydrochloride and sulfamethazine bisulfate equivalent to 102.4 g of sulfamethazine.

(b) Sponsor. See No. 000010 in §510.600(c) of this chapter.

(c) Related tolerances. See §§556.150 and 556.670 of this chapter.

(d) Conditions of use in swine. Administer in drinking water as follows:

(1) Amount. 250 milligrams (mg) of chlortetracycline and 250 mg of sulfamethazine per gallon.

(2) Indications for use. For the prevention and treatment of bacterial enteritis; as an aid in the reduction of the incidence of cervical abscesses; and as an aid in the maintenance of weight gains in the presence of bacterial enteritis and atrophic rhinitis.

(3) Limitations. Use as the sole source of chlortetracycline and sulfonamide. Not to be used for more than 28 consecutive days. Withdraw 15 days before slaughter.

[76 FR 49649, Aug. 11, 2011]

§520.446   Clindamycin capsules and tablets.

(a) Specifications(1) Each capsule contains the equivalent of 25, 75, 150, or 300 milligrams (mg) clindamycin as the hydrochloride salt.

(2) Each tablet contains the equivalent of 25, 75, or 150 mg clindamycin as the hydrochloride salt.

(3) Each capsule contains the equivalent of 25, 75, or 150 mg clindamycin as the hydrochloride salt.

(b) Sponsors. See sponsors in §510.600(c) of this chapter as follows:

(1) Nos. 000009 and 000859 for use of capsules described in paragraph (a)(1) of this section.

(2) No. 051311 for use of tablets described in paragraph (a)(2) of this section.

(3) No. 043806 for use of tablets described in paragraph (a)(3) of this section.

(c) Conditions of use in dogs(1) Amount. Wounds, abscesses, and dental infections: 2.5 to 15 mg per pound (/lb) body weight every 12 hours for a maximum of 28 days. Osteomyelitis: 5.0 to 15 mg/lb body weight every 12 hours for a minimum of 28 days.

(2) Indications for use. For the treatment of skin infections (wounds and abscesses) due to susceptible strains of coagulase-positive staphylococci (Staphylococcus aureus or S. intermedius), deep wounds and abscesses due to susceptible strains of Bacteroides fragilis, Prevotella melaninogenicus, Fusobacterium necrophorum, and Clostridium perfringens, dental infections due to susceptible strains of S. aureus, B. fragilis, P. melaninogenicus, F. necrophorum, and C. perfringens, and osteomyelitis due to susceptible strains of S. aureus, B. fragilis, P. melaninogenicus, F. necrophorum, and C. perfringens.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[67 FR 54954, Aug. 27, 2002, as amended at 68 FR 55824, Sept. 29, 2003; 69 FR 32273, June 9, 2004; 71 FR 39204, July 12, 2006; 73 FR 4077, Jan. 24, 2008; 78 FR 17596, Mar. 22, 2013]

§520.447   Clindamycin solution.

(a) Specifications. Each milliliter of solution contains the equivalent of 25 milligrams (mg) clindamycin as the hydrochloride salt.

(b) Sponsors. See Nos. 000009, 000859, 051311, 058829, and 061623 in §510.600(c) of this chapter.

(c) Special considerations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(d) Conditions of use(1) Dogs—(i) Amount. Wounds, abscesses, and dental infections: 2.5 to 15 mg per pound (/lb) body weight every 12 hours for a maximum of 28 days. Osteomyelitis: 5.0 to 15 mg/lb body weight every 12 hours for a minimum of 28 days.

(ii) Indications for use. For the treatment of skin infections (wounds and abscesses) due to susceptible strains of coagulase-positive staphylococci (Staphylococcus aureus or S. intermedius), deep wounds and abscesses due to susceptible strains of Bacteroides fragilis, Prevotella melaninogenicus, Fusobacterium necrophorum, and Clostridium perfringens; dental infections due to susceptible strains of S. aureus, B. fragilis, P. melaninogenicus, F. necrophorum, and C. perfringens; and osteomyelitis due to susceptible strains of S. aureus, B. fragilis, P. melaninogenicus, F. necrophorum, and C. perfringens.

(2) Cats—(i) Amount. 5.0 to 15.0 mg/lb body weight every 24 hours for a maximum of 14 days.

(ii) Indications for use. For the treatment of skin infections (wounds and abscesses) due to susceptible strains of Staphylococcus aureus, S. intermedius, Streptococcus spp.; deep wounds and abscesses due to susceptible strains of Clostridium perfringens and Bacteroides fragilis; and dental infections due to susceptible strains of S. aureus, S. intermedius, Streptococcus spp., C. perfringens, and B. fragilis.

[67 FR 54954, Aug. 27, 2002, as amended at 67 FR 78684, Dec. 26, 2002; 68 FR 55824, Sept. 29, 2003; 69 FR 31734, June 7, 2004; 71 FR 39543, July 13, 2006; 72 FR 19796, Apr. 20, 2007; 78 FR 17596, Mar. 22, 2013; 78 FR 30197, May 22, 2013]

§520.452   Clenbuterol syrup.

(a) Specifications. Each milliliter contains 72.5 micrograms of clenbuterol hydrochloride.

(b) Sponsor. See 000010 in §510.600(c) of this chapter.

(c) [Reserved]

(d) Conditions of use(1) Horses—(i) Amount. Administer orally twice a day (b.i.d.). Initial dose is 0.5 milliliter per 100 pounds body weight (0.8 micrograms per kilogram) for 3 days (6 treatments). If no improvement, administer 1 milliliter per 100 pounds (1.6 micrograms per kilogram) for 3 days (6 treatments). If no improvement, administer 1.5 milliliters per 100 pounds (2.4 micrograms per kilogram) for 3 days (6 treatments). If no improvement, administer 2.0 milliliters per 100 pounds (3.2 micrograms per kilogram) for 3 days (6 treatments). If no improvement, horse is nonresponder to clenbuterol and treatment should be discontinued.

(ii) Indications for use. Indicated for the management of horses affected with airway obstruction, such as occurs in chronic obstructive pulmonary disease (COPD).

(iii) Limitations. Treat at effective dose for 30 days. At the end of the 30-day treatment period, drug should be withdrawn. If signs return, the 30-day treatment period may be repeated. If repeating treatment, the step-wise dosage schedule should be repeated. The effect of this drug on breeding stallions and brood mares has not been determined. Treatment starting with dosages higher than the initial dose is not recommended. Federal law prohibits the extralabel use of this drug in food animals. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) [Reserved]

[63 FR 41419, Aug. 4, 1998]

§520.455   Clomipramine tablets.

(a) Specifications. Each tablet contains 5, 20, 40, or 80 milligrams (mg) clomipramine hydrochloride.

(b) Sponsor. See No. 058198 in §510.600(c) of this chapter.

(c) Conditions of use(1) Amount. 2 to 4 milligrams of clomipramine hydrochloride per kilogram (0.9 to 1.8 milligrams per pound) of body weight per day, administered as a single daily dose or divided twice daily.

(2) Indications for use. For use as part of a comprehensive behavioral management program to treat separation anxiety in dogs greater than 6 months of age.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[64 FR 1762, Jan. 12, 1999, as amended at 72 FR 262, Jan. 4, 2007]

§520.462   Clorsulon drench.

(a) Specifications. The drug is a suspension containing 8.5 percent clorsulon (85 milligrams per milliliter).

(b) Sponsor. See No. 050604 in §510.600(c) of this chapter.

(c) Conditions of use. Cattle(1) Amount. One-quarter fluid ounce per 200 pounds of body weight (7 milligrams per kilogram or 3.2 milligrams per pound of body weight).

(2) Indications for use. For the treatment of immature and adult liver fluke (Fasciola hepatica) infestations in cattle.

(3) Limitations. Using dose syringe, deposit drench over back of tongue. Do not treat cattle within 8 days of slaughter. Because a withdrawal time in milk has not been established, do not use in female dairy cattle of breeding age. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.

[50 FR 10221, Mar. 14, 1985, as amended at 62 FR 63270, Nov. 28, 1997]

§520.522   Cyclosporine.

(a) Specifications(1) Each cyclosporine capsule, USP (MODIFIED) contains 10, 25, 50, or 100 milligrams (mg) cyclosporine.

(2) Each milliliter of cyclosporine oral solution, USP (MODIFIED) contains 100 mg cyclosporine.

(b) Sponsor. See No. 058198 in §510.600(c) of this chapter.

(c) [Reserved]

(d) Conditions of use(1) Dogs. Use capsules described in paragraph (a)(1) of this section as follow:

(i) Amount. Administer 5 mg per kilogram (mg/kg) of body weight given orally as a single daily dose for 30 days. Following this initial daily treatment period, the dosage may be tapered by decreasing the frequency of administration to every other day or two times a week, until a minimum frequency is reached which will maintain the desired therapeutic effect.

(ii) Indications for use. For the control of atopic dermatitis in dogs weighing at least 4 pounds.

(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) Cats. Use the solution described in paragraph (a)(2) of this section as follow:

(i) Amount. Administer 7 mg/kg of body weight orally as a single daily dose for a minimum of 4 to 6 weeks or until resolution of clinical signs. Following this initial daily treatment period, the dosage may be tapered by decreasing the frequency of administration to every other day or twice weekly to maintain the desired therapeutic effect.

(ii) Indications for use. For the control of feline allergic dermatitis in cats at least 6 months of age and weighing at least 3 pounds.

(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[68 FR 54804, Sept. 19, 2003, as amended at 76 FR 78815, Dec. 20, 2011]

§520.530   Cythioate oral liquid.

(a) Specifications. Each milliliter contains 15 milligrams of cythioate.

(b) Sponsor. See Nos. 000859 and 053501 in §510.600 of this chapter.

(c) Special considerations. Cythioate is a cholinesterase inhibitor. Do not use this product in animals simultaneously with or within a few days before or after treatment with or exposure to cholinesterase-inhibiting drugs, insecticides, pesticides, or chemicals.

(d) Conditions of use(1) Amount. 15 milligrams cythioate per 10 pounds of body weight every third day or twice a week.

(2) Indications for use. Dogs, for control of fleas.

(3) Limitations. For oral use in dogs only. Do not use in greyhounds or in animals that are pregnant, sick, under stress, or recovering from surgery. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[49 FR 5614, Feb. 14, 1984, as amended at 67 FR 78355, Dec. 24, 2002]

§520.531   Cythioate tablets.

(a) [Reserved]

(b) Sponsors. See No. 000859 in §510.600(c) of this chapter for use of 30- and 90-milligram (mg) tablets and see No. 053501 in §510.600(c) of this chapter for use of 30-mg tablet.

(c) Special considerations. Cythioate is a cholinesterase inhibitor. Do not use this product in animals simultaneously with or within a few days before or after treatment with or exposure to cholinesterase-inhibiting drugs, insecticides, pesticides, or chemicals.

(d) Conditions of use(1) Amount. 30 milligrams cythioate per 20 pounds of body weight every third day or twice a week.

(2) Indications for use. Dogs, for control of fleas.

(3) Limitations. For oral use in dogs only. Do not use in greyhounds or in animals that are pregnant, sick, under stress, or recovering from surgery. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[49 FR 5615, Feb. 14, 1984, as amended at 59 FR 26942, May 25, 1994; 67 FR 78355, Dec. 24, 2002]

§520.534   Decoquinate.

(a) Specifications. The drug is a powder containing 0.8 percent decoquinate.

(b) Sponsor. See No. 046573 in §510.600(c) of this chapter.

(c) Related tolerances. See §556.170 of this chapter.

(d) Conditions of use. Calves(1) Amount. Feed 22.7 milligrams per 100 pounds of body weight (0.5 milligram per kilogram) per day.

(2) Indications for use. For the prevention of coccidiosis in ruminating and nonruminating calves, including veal calves, caused by Eimeria bovis and E. zuernii.

(3) Limitations. Feed in whole milk at the rate of 22.7 milligrams per 100 pounds body weight daily (0.5 milligram per kilogram) for at least 28 days.

[64 FR 10103, Mar. 2, 1999, as amended at 64 FR 30386, June 8, 1999]

§520.538   Deracoxib.

(a) Specifications. Each tablet contains 12, 25, 50, 75, or 100 milligrams (mg) deracoxib.

(b) Sponsor. See No. 058198 in §510.600(c) of this chapter.

(c) [Reserved]

(d) Conditions of use in dogs—(1) Amount. Administer orally as needed, as a single daily dose based on body weight:

(i) 1 to 2 mg/kilogram (kg) (0.45 to 0.91 mg/pound (lb)), for use as in paragraph (d)(2)(i) of this section.

(ii) 1 to 2 mg/kg (0.45 to 0.91 mg/lb) for 3 days, for use as in paragraph (d)(2)(ii) of this section.

(iii) 3 to 4 mg/kg (1.4 to 1.8 mg/lb) for up to 7 days, for use as in paragraph (d)(2)(iii) of this section.

(2) Indications for use. (i) For the control of pain and inflammation associated with osteoarthritis.

(ii) For the control of postoperative pain and inflammation associated with dental surgery.

(iii) For the control of postoperative pain and inflammation associated with orthopedic surgery.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[67 FR 68760, Nov. 13, 2002, as amended at 68 FR 18882, Apr. 17, 2003; 72 FR 37437, July 10, 2007; 73 FR 33692, June 13, 2008; 77 FR 3928, Jan. 26, 2012]

§520.540   Dexamethasone oral dosage forms.

§520.540a   Dexamethasone powder.

(a) Specifications. Dexamethasone powder is packaged in packets containing 10 milligrams of dexamethasone.

(b) Sponsor. See No. 000061 in §510.600(c) of this chapter.

(c) Conditions of use. (1) Dexamethasone powder is indicated in cases where cattle and horses require additional steroid therapy following its parenteral administration. The drug is used as supportive therapy for management or inflammatory conditions such as acute arthritic lameness, and for various stress conditions where corticosteroids are required while the animal is being treated for a specific condition.

(2) The drug is administered at a dosage level of 5 to 10 milligrams per animal the first day then 5 milligrams per day as required by drench or by sprinkling on a small amount of feed.

(3) Clinical and experimental data have demonstrated that corticosteroids administered orally or parenterally to animals may induce the first stage of parturition when administered during the last trimester of pregnancy and may precipitate premature parturition followed by dystocia, fetal death, retained placenta, and metritis.

(4) Federal law restricts this drug to use by or on the order of a licensed veterinarian. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.

[40 FR 13838, Mar. 27, 1975; 41 FR 9149, Mar. 3, 1976; 52 FR 7832, Mar. 13, 1987; 70 FR 16934, Apr. 4, 2005]

§520.540b   Dexamethasone tablets and boluses.

(a)(1) Specifications. Each bolus is half-scored and contains 10 milligrams of dexamethasone.

(2) Sponsor. See No. 000061 in §510.600(c) of this chapter.

(3) Conditions of use. (i) Dexamethasone bolus is indicated in cases where cattle and horses require additional steroid therapy following its parenteral administration. The drug may be used as supportive therapy for management of inflammatory conditions such as acute arthritic lamenesses, and for various stress conditions where corticosteroids are required while the animal is being treated for a specific condition.

(ii) Administered orally, 5 to 10 milligrams for the first day, then 5 milligrams per day as required.

(iii) Do not use in viral infections during the viremic stage. With bacterial infections, appropriate antibacterial therapy should be used.

(iv) Do not use in animals with chronic nephritis and hypercorticalism (cushingoid syndrome), except for emergency therapy.

(v) Clinical and experimental data have demonstrated that corticosteroids administered orally or by injection to animals may induce the first stage of parturition when administered during the last trimester of pregnancy and may precipitate premature parturition followed by dystocia, fetal death, retained placenta, and metritis.

(vi) Federal law restricts this drug to use by or on the order of a licensed veterinarian. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.

(b)(1) Specifications. Each tablet contains 0.25 milligram of dexamethasone.1

(2) Sponsors. See Nos. 000061 and 061623 in §510.600(c) of this chapter.

(3) Conditions of use—(i) Amount. Dogs: Administer orally at 0.25 to 1.25 milligrams per day for up to 7 days. Cats: 0.125 to 0.5 milligram per day for up to 7 days.1

(ii) Indications for use. In treatment of dogs and cats as an anti-inflammatory agent.1

1These conditions are NAS/NRC reviewed and deemed effective. Applications for these uses need not include effectiveness data as specified by §514.111 of this chapter.

(iii) Limitations. (a) Clinical and experimental data have demonstrated that corticosteriods administered orally or by injection to animals may induce the first stage of parturition when administered during the last trimester of pregnancy; and they may precipitate premature parturition followed by dystocia, fetal death, retained placenta, and metritis.

(b) Do not use in viral infections. Anti-inflammatory action of corticosteroids may mask signs of infections. Do not use in animals with tuberculosis, chronic nephritis, cushingoid syndrome, or peptic ulcers, except for emergency therapy.1

(c) Federal law restricts this drug to use by or on the order of a licensed veterinarian.1

[40 FR 26273, June 23, 1975, as amended at 44 FR 7130, Feb. 6, 1979; 50 FR 49372, Dec. 2, 1985; 52 FR 7832, Mar. 13, 1987; 55 FR 8461, Mar. 8, 1990; 66 FR 14073, Mar. 9, 2001; 68 FR 4914, Jan. 31, 2003; 70 FR 16934, Apr. 4, 2005]

§520.540c   Dexamethasone chewable tablets.

(a) Specifications. Each half-scored tablet contains 0.25 milligram of dexamethasone.1

(b) Sponsor. See No. 000069 in §510.600(c) of this chapter.

(c) Conditions of use(1) Amount. 0.25 to 1.25 milligrams per day.1

(2) Indications for use. Supportive therapy in nonspecific dermatosis and inflammatory conditions in dogs.1

(3) Limitations. (i) Administer by free-choice feeding or crumble over food. Administer 0.25 to 1.25 milligrams daily in single or two divided doses until response is noted or 7 days have elapsed. When response is attained, dosage should be gradually reduced by 0.125 milligram per day until maintenance level is achieved.

(ii) Clinical and experimental data have demonstrated that corticosteriods administered orally or parenterally to animals may induce the first stage of parturition when administered during the last trimester of pregnancy; and they may precipitate premature parturition followed by dystocia, fetal death, retained placenta, and metritis.

(iii) Do not use in viral infections. Anti-inflammatory action of corticosteriods may mask signs of infection. Do not use in animals with tuberculosis, chronic nephritis, cushingoid syndrome, or peptic ulcers, except for emergency therapy.1

(iv) Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[44 FR 7130, Feb. 6, 1979, as amended at 56 FR 50653, Oct. 8, 1991; 60 FR 55659, Nov. 2, 1995]

§520.550   Glucose/glycine/electrolyte.

(a) Specifications. The product is distributed in packets each of which contains the following ingredients: Sodium chloride 8.82 grams, potassium phosphate 4.20 grams, citric acid anhydrous 0.5 gram, potassium citrate 0.12 gram, aminoacetic acid (glycine) 6.36 grams, and glucose 44.0 grams.

(b) Sponsor. See No. 000069 in §510.600(c) of this chapter.

(c) Conditions of use. (1) Glucose/glycine/electrolyte is indicated for use in the control of dehydration associated with diarrhea (scours) in calves. It is used as an early treatment at the first signs of scouring. It may also be used as followup treatment following intravenous fluid therapy.

(2) Dissolve each packet in two quarts of warm water and administer to each calf as follows:

(i) Scouring and/or dehydrated calves. Feed 2 quarts of solution, twice daily for 2 days (four feedings). No milk or milk replacer should be fed during this period. For the next four feedings (days 3 and 4), use 1 quart of solution together with 1 quart of milk replacer. Thereafter, feed as normal.

(ii) Newly purchased calves. Feed 2 quarts of solution instead of milk as the first feed upon arrival. For the next scheduled feeding, use 1 quart of solution mixed together with 1 quart of milk or milk replacer. Thereafter, feed as normal.

(3) The product should not be used in animals with severe dehydration (down, comatose, or in a state of shock). Such animals need intravenous therapy. A veterinarian should be consulted in severely scouring calves. The product is not nutritionally complete if administered by itself for long periods of time. It should not be administered beyond the recommended treatment period without the addition of milk or milk replacer.

[48 FR 38606, Aug. 25, 1983, as amended at 56 FR 50653, Oct. 8, 1991; 60 FR 55659, Nov. 2, 1995; 76 FR 17336, Mar. 29, 2011]

§520.563   Diatrizoate meglumine and diatrizoate sodium oral solution.

(a) Specifications. Diatrizoate meglumine oral solution is a water soluble radiopaque medium containing 66 percent diatrizoate meglumine and 10 percent diatrizoate sodium.

(b) Sponsor. See No. 053501 in §510.600(c) of this chapter.

(c) Conditions of use. (1) It is indicated for radiography of the gastrointestinal tract in dogs and cats.

(2) It is administered orally at a dosage level of 0.5 to 1.0 milliliter per pound of body weight by gavage or stomach tube. It is administered rectally at a dosage level of 0.5 to 1.0 milliliter per pound of body weight diluted with 1 part of the drug to 5 parts of water.

(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[44 FR 12993, Mar. 9, 1979, as amended at 50 FR 41489, Oct. 11, 1985]

§520.580   Dichlorophene and toluene.

(a) Specifications. Each capsule contains 50 milligrams (mg) of dichlorophene and 60 mg of toluene, or multiples thereof.

(b) Sponsors. See sponsors in §510.600(c) of this chapter for use as in paragraph (c) of this section:

(1) Nos. 017135, 023851, 051311, and 058670 for use only as a single dose.

(2) Nos. 000061 and 054628 for use in a single dose or divided-dosage regimen.

(c) Required statement. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism, and before administering to weak or debilitated animals.

(1) Amount. Administer as follows:

(i) Single dose: Administer 100 mg of dicholorophene and 120 mg of toluene per pound of body weight.

(ii) Divided dose: Administer 100 mg of dichlorophene and 120 mg of toluene per 5 pounds of body weight (20 and 24 mg per pound) daily for 6 days.

(2) Indications for use. For the removal of ascarids (Toxocara canis and Toxascaris leonina) and hookworms (Ancylostoma caninum and Uncinaria stenocephala); and as an aid in removing tapeworms (Taenia pisiformis, Dipylidium caninum, and Echinococcus granulosus) from dogs and cats.

(3) Limitations. Withhold solid foods and milk for at least 12 hours prior to medication and for 4 hours afterward. Repeat treatment in 2 to 4 weeks in animals subject to reinfection.

[45 FR 10332, Feb. 15, 1980]

Editorial Note: For Federal Register citations affecting §520.580, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.fdsys.gov.

§520.581   Dichlorophene tablets.

(a) Specifications. Each tablet contains 1 gram of dichlorophene.

(b) Sponsor. See 023851 in §510.600(c) of this chapter.

(c) Required statement. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism, and before administering to weak or debilitated animals.

(d) Conditions of use. Dogs(1) Amount. Single dose of 1 tablet (1 gram of dichlorophene) for each 10 pounds of body weight.

(2) Indications for use. It is used as an aid in the removal of tapeworms (Taenia pisiformis and Dipylidium caninum).

(3) Limitations. Withhold solid foods and milk for at least 12 hours prior to medication and for 4 hours afterward.

[45 FR 10333, Feb. 15, 1980]

§520.600   Dichlorvos.

(a) Chemical name. 2,2-Dichlorvinyl dimethyl phosphate.

(b) [Reserved]

(c) Sponsor. See No. 054628 in §510.600(c) of this chapter.

(d) Related tolerances. See §556.180 of this chapter.

(e) Conditions of use in swine. (1) It is recommended for the removal and control of sexually mature (adult), sexually immature and/or 4th stage larvae of the whipworm (Trichuris suis), nodular worms (Oesophagostomum spp.), large round-worm (Ascaris suum), and the mature thick stomach worm (Ascarops strongylina) occurring in the lumen of the gastrointestinal tract of pigs, boars, and open or bred gilts and sows.

(2) The preparation should be added to the indicated amount of feed as set forth in paragraph (e)(2) of this section and administered shortly after mixing, as follows:

Weight of animal in poundsPounds of feed to be mixed with each 0.08 ounce of dichlorvosPounds of mixed feed to be administered to each pig as a single treatmentNumber of pigs to be treated per 0.08 ounce of dichlorvos
20-3040.3312
31-4050.569
41-6061.006
61-8051.005
81-10041.004
Adult Gilts, Sows, and Boars164.004

(3) Do not use this product on animals either simultaneously or within a few days before or after treatment with or exposure to cholinesterase inhibiting drugs, pesticides, or chemicals. The preparation should be mixed thoroughly with the feed on a clean, impervious surface. Do not allow swine access to feed other than that containing the preparation until treatment is complete. Do not treat pigs with signs of scours until these signs subside or are alleviated by proper medication. Resume normal feeding schedule afterwards. Swine may be retreated in 4 to 5 weeks.

(f) Conditions of use in dogs. (1) For removal of Toxocara canis and Toxascaris leonina (roundworms), Ancylostoma caninum and Uncinaria stenocephala (hookworms), and Trichuris vulpis (whipworm) residing in the lumen of the gastrointestinal tract.

(2) The drug is in capsule form for direct administration and in pellet form for administration in about one-third of the regular canned dog food ration or in ground meat. Dogs may be treated with any combination of capsules and/or pellets so that the animal receives a single dose equaling 12 to 15 milligrams of the active ingredient per pound of body weight. One-half of the single recommended dosage may be given, and the other half may be administered 8 to 24 hours later. This split dosage schedule should be used in animals which are very old, heavily parasitized, anemic, or otherwise debilitated. The drug should not be used in dogs weighing less than 2 pounds.

(3) In some dogs, efficacy against Trichurias vulpis (whipworm) may be erratic. Dogs that do not develop a negative stool for Trichuris vulpis ova 10 to 14 days following initial treatment should be re-treated. If a negative stool is not obtained in 10 to 14 days following re-treatment, alternate means of therapy should be considered.

(4) Do not use in dogs infected with Dirofilaria immitis.

(5) Do not use with other anthelmintics, taeniacides, antifilarial agents, muscle relaxants, or tranquilizers.

(6) The drug is a cholinesterase inhibitor. Not for use simultaneously or within a few days before or after treatment with or exposure to cholinesterase-inhibiting drugs, pesticides, or chemicals.

(7) Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(g) Conditions of use in horses when administered in grain. (1) It is recommended for the removal and control of bots (Gastrophilus intestinalis, G. nasalis), large strongyles (Strongylus vulgaris, S. equinus, S. edentatus), small strongyles (of the genera Cyathostomum, Cylicocercus, Cylicocyclus, Cylicodontophorus, Triodontophorus, Poteriostomum, Gyalocephalus), pinworms (Oxyuris equi), and large roundworm (Parascaris equorum) in horses including ponies and mules. Not for use in foals (sucklings and young weanlings).

(2) For a satisfactory diagnosis, a microscopic fecal examination should be performed by a veterinarian or a diagnostic laboratory prior to worming.

(3) It is administered in the grain portion of the ration at a dosage of 14.2 milligrams to 18.5 milligrams per pound of body weight as a single dose. It may be administered at one-half of the single recommended dosage and repeated 8 to 12 hours later in the treatment of very aged, emaciated or debilitated subjects or those reluctant to consume medicated feed. In suspected cases of severe ascarid infection sufficient to cause concern over mechanical blockage of the intestinal tract, the split dosage should be utilized.

(4) Do not use in horses which are severely debilitated, suffering from diarrhea or severe constipation, infectious disease, toxemia or colic. Do not administer in conjunction with or within 1 week of administration of muscle relaxant drugs, phenothiazine derived tranquilizers or central nervous system depressant drugs. Horses should not be subjected to insecticide treatment for 5 days prior to or after treating with the drug. Do not administer to horses afflicted with chronic alveolar emphysema (heaves) or related respiratory conditions. The product is a cholinesterase inhibitor and should not be used simultaneously or within a few days before or after treatment with or exposure to cholinesterase inhibiting drugs, pesticides or chemicals.

(5) Do not use in animals other than horses, ponies, and mules. Do not use in horses, ponies, and mules intended for food purposes. Do not allow fowl access to feed containing this preparation or to fecal excrement from treated animals.

(h) Conditions of use in horses when administered orally by syringe. (1) It is recommended for the removal and control of first, second, and third instar bots (Gastrophilus intestinalis and G. nasalis), sexually mature and sexually immature (4th stage) ascarids (Parascaris equorum) in horses and foals.

(2) The product is in the form of a gel which is administered directly from a syringe onto the horse's tongue. The product is administered at a dosage level of 20 milligrams of dichlorvos per kilogram of body weight for the removal of bots and ascarids. The same dosage level is repeated every 21 to 28 days for the control of bots and ascarids. For the control of bots only, the repeat dosage is 10 milligrams per kilogram of body weight every 21 to 28 days during bot fly season.

(3) Do not use this product in animals simultaneously or within a few days before or after treatment with or exposure to cholinesterase-inhibiting drugs, pesticides or chemicals. Do not administer in conjunction with or within 1 week of administration of muscle-relaxant drugs, phenothiazine derived tranquilizers, or central nervous system depressants.

(4) Do not use in horses which are severly debilitated or suffering from diarrhea or severe constipation, infectious disease, toxemia, or colic. Do not administer to horses affected with chronic alveolar emphysema (heaves) or other respiratory conditions.

(5) Do not use in horses intended for food purposes.

(6) Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(i) Conditions of use in dogs, cats, puppies, and kittens. (1) Each tablet contains 2, 5, 10, or 20 milligrams of dichlorvos.

(2) It is administered orally at 5 milligrams of dichlorvos per pound of body weight.

(3) Dogs and puppies: Removal and control of intestinal roundworms (Toxocara canis and Toxascaris leonina) and hookworms (Ancylostoma caninum and Uncinaria stenocephala).

(4) Cats and kittens: Removal and control of intestinal roundworms (Toxocara cati and Toxascaris leonina) and hookworms (Ancylostoma tubaeforme and Uncinaria stenocephala).

(5) Dichlorvos is a cholinesterase inhibitor. Do not use simultaneously with or within a few days before or after treatment with or exposure to cholinesterase-inhibiting drugs, pesticides, or chemicals.

(6) Do not use in animals under 10 days of age or 1 pound of body weight.

(7) Do not administer to animals showing signs of constipation, mechanical blockage of the intestinal tract, impaired liver function, or recently exposed to or showing signs of infectious disease.

(8) Do not use in dogs or puppies infected with Dirofilaria immitis.

(9) Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[40 FR 13838, Mar. 27, 1975, as amended at 48 FR 40704, Sept. 9, 1983; 51 FR 28546, Aug. 8, 1986; 62 FR 35076, June 30, 1997; 64 FR 18571, Apr. 15, 1999; 78 FR 21059, Apr. 9, 2013]

§520.606   Diclazuril.

(a) Specifications. Each 100 grams (g) of pellets contain 1.56 g diclazuril.

(b) Sponsor. See No. 000061 in §510.600(c) of this chapter.

(c) Conditions of use in horses(1) Amount. Administer 1 milligram (mg) per kilogram (0.45 mg per pound) of body weight in the daily grain ration for 28 days.

(2) Indications for use. For the treatment of equine protozoal myeloencephalitis (EPM) caused by Sarcocystis neurona.

(3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[72 FR 20943, Apr. 27, 2007]

§520.608   Dicloxacillin sodium monohydrate capsules.

(a) Specifications. Each capsule contains dicloxacillin sodium monohydrate equivalent to 50, 100, 200, or 500 milligrams of dicloxacillin.

(b) Sponsor. See No. 000856 in §510.600 (c) of this chapter.

(c) Conditions of use. Dogs(1) Amount. 5 to 10 milligrams per pound of body weight, three times daily. In severe cases, up to 25 milligrams per pound of body weight three times daily.

(2) Indications for use. Treatment of pyoderma (pyogenic dermatitis) due to penicillinase-producing staphylococci sensitive to the drug.

(3) Limitations. For the treatment of dogs only. Continue treatment for 24 to 48 hours after the animal has become afebrile or asymptomatic, Administer 1 to 2 hours before feeding to ensure maximum absorption. Not for use in animals which are raised for food production. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[57 FR 37325, Aug. 18, 1992]

§520.620   Diethylcarbamazine oral dosage forms.

§520.622   Diethylcarbamazine citrate oral dosage forms.

§520.622a   Diethylcarbamazine citrate tablets.

(a) Sponsors. (1) [Reserved]

(2) See 053501 in §510.600(c) of this chapter for use of 100, 200, and 300 milligram tablets for prevention of heartworm disease in dogs and as an aid in the treatment of ascarid infections in dogs.

(3) See 061623 in §510.600(c) of this chapter for use of 50, 100, 200, 300, or 400 milligram tablets for prevention of heartworm disease in dogs, as an aid in the control of ascarid infections in dogs, and as an aid in the treatment of ascarid infections in dogs and cats.

(4) [Reserved]

(5) See No. 000061 in §510.600(c) of this chapter for use of 60, 120, or 180 milligram tablets for prevention of heartworm disease in dogs, as an aid in the control of ascarid infections in dogs, and as an aid in the treatment of ascarid infections in dogs and cats.

(6) See No. 054628 in §510.600(c) of this chapter for use of 50, 100, 200, 300, or 400 milligram tablets for prevention of heartworm disease in dogs, as an aid in the control of ascarid infections in dogs, and as an aid in the treatment of ascarid infections in dogs and cats.

(b) Conditions of use(1) Dosage/indications for use. (i) Three milligrams per pound of body weight daily for prevention of heartworm disease (Dirofilaria immitis) in dogs.

(ii) Three milligrams per pound of body weight daily as an aid in the control of ascarid infections (Toxocara canis) in dogs.

(iii) Twenty-five to 50 milligrams per pound of body weight as an aid in the treatment of ascarid infections in dogs (Toxocara canis) and cats (Toxocara canis and Toxascaris leonina).

(2) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[46 FR 23230, Apr. 24, 1981, as amended at 46 FR 41038, Aug. 14, 1981; 46 FR 46315, Sept. 18, 1981; 46 FR 61653, Dec. 18, 1981; 47 FR 10805, Mar. 12, 1982; 47 FR 14150, Apr. 2, 1982; 50 FR 41489, Oct. 11, 1985; 50 FR 49372, Dec. 2, 1985; 53 FR 40056, Oct. 13, 1988; 53 FR 40727, Oct. 18, 1988; 55 FR 8461, Mar. 8, 1990; 61 FR 34728, July 3, 1996; 62 FR 35076, June 30, 1997; 66 FR 14073, Mar. 9, 2001; 68 FR 4914, Jan. 31, 2003; 76 FR 17777, Mar. 31, 2011; 77 FR 4896, Feb. 1, 2012]

§520.622b   Diethylcarbamazine citrate syrup.

(a)(1) Specifications. Each milliliter of syrup contains 60 milligrams of diethylcarbamazine citrate.

(2) Sponsor. See No. 053501 in §510.600(c) of this chapter.

(3) Conditions of use. (i) The drug is indicated for use in dogs for the prevention of infection with Dirofilaria immitis and T. canis and T. leonina. It is also indicated for treatment of ascarid infections of T. canis and T. leonina in dogs and T. cati in cats.

(ii) For prevention of heartworm and ascarid infections in dogs, the drug may be added to the daily diet at a dosage rate of 3.0 milligrams per pound of body weight per day or given directly by mouth at the same dosage rate. For treatment of ascarid infections in dogs and cats, the drug is administered at a dosage level of 25 to 50 milligrams per pound of body weight preferably administered immediately after feeding.

(iii) Older dogs should be proven negative for the presence of Dirofilaria immitis infection before administration of the drug. Those with proven infection of Dirofilaria immitis should be rendered negative using adulticidal and microfilaricidal drugs before administration of this drug.

(iv) Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(b) [Reserved]

(c)(1) Specifications. Each milliliter of syrup contains 60 milligrams of diethylcarbamazine citrate.

(2) Sponsor. See No. 054628 in §510.600(c) of this chapter.

(3) Conditions of use. (i) The drug is used in dogs between 4 weeks and 8 months of age for the removal of ascarids (Toxacara canis) and in animals over 4 weeks of age for the prevention of heartworm disease (Dirofilaria immitis).

(ii) The drug is administered (a) for removal of ascarids at a dosage of 50 milligrams per pound of body weight divided into two equal doses and administered 8 to 12 hours apart (morning and night), orally or mixed with either dry or wet food, and (b) for prevention of heartworm disease at a dosage of 3 milligrams per pound of body weight daily, orally or in food, in heartworm endemic areas, from the beginning of mosquito activity, during the mosquito season, and for 2 months following the end thereof.

(iii) Dogs older than 8 months of age may be infected with Dirofilaria immitis. Use of the drug is contraindicated in dogs with active D. immitis infections.

(iv) Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[40 FR 13838, Mar. 27, 1975, as amended at 41 FR 28265, July 9, 1976; 44 FR 3967, Jan. 19, 1979; 47 FR 14150, Apr. 2, 1982; 47 FR 35186, Aug. 13, 1982; 49 FR 33997, Aug. 28, 1984; 50 FR 41489, Oct. 11, 1985; 53 FR 47027, Oct. 18, 1988; 61 FR 34728, July 3, 1996; 62 FR 35076, June 30, 1997; 62 FR 38906, July 21, 1997; 77 FR 4897, Feb. 1, 2012; 78 FR 21059, Apr. 9, 2013]

§520.622c   Diethylcarbamazine citrate chewable tablets.

(a) Specifications. Each chewable tablet contains 30, 45, 60, 120, 150, or 180 milligrams of diethylcarbamazine citrate.

(b) Sponsors. See drug listing nos. in §510.600(c) of this chapter for identification of sponsors as follows:

(1) [Reserved]

(2) For 000069, use of 60, 120, or 180 milligram tablets as in paragraph (c)(2)(ii) of this section.

(3) For 061690, use of 45 or 150 milligram tablets as in paragraph (c)(2)(iii) of this section.

(4) For 061133, use of 60-, 120-, or 180-milligram tablets as in paragraph (c)(2)(i) of this section.

(5) For 000061, use of 60-milligram tablets as in paragraph (c)(2)(i) of this section.

(6) For 054628, use of 30, 60, 120, or 180 milligram tablets as in paragraph (c)(2)(i) of this section.

(c) Conditions of use(1) Amount. 3 milligrams per pound of body weight per day for prevention of heartworm disease and control of ascarids; 25 to 50 milligrams per pound of body weight as an aid in treatment of ascarid infections.

(2) Indications for use. (i) For prevention of heartworm disease (Dirofilaria immitis) in dogs; as an aid in control of ascarids (Toxocara canis) in dogs; as an aid in treatment of ascarid (Toxocara canis and Toxascaris leonina) infections in dogs and cats.

(ii) For prevention of infection with Dirofilaria immitis (heartworm disease) in dogs; as an aid in treatment of ascarid (Toxocara canis and Toxascaris leonina) infections in dogs.

(iii) For prevention of heartworm disease (Dirofilaria immitis) in dogs.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[43 FR 6941, Feb. 17, 1978]

Editorial Note: For Federal Register citations affecting §520.622c, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.fdsys.gov.

§520.623   Diethylcarbamazine citrate, oxibendazole chewable tablets.

(a) Specifications. Each tablet contains either 60, 120, or 180 milligrams of diethylcarbamazine citrate with 45, 91, or 136 milligrams of oxibendazole, respectively.

(b) Sponsor. See 000069 in §510.600(c) of this chapter.

(c) Conditions of use in dogs—(1) Amount. Administer orally to dogs at a dosage level of 6.6 milligrams of diethylcarbamazine citrate per kilogram of body weight (3 milligrams per pound of body weight) and 5.0 milligrams of oxibendazole per kilogram of body weight (2.27 milligrams per pound of body weight).

(2) Indications for use. For prevention of infection with Dirofilaria immitis (heartworm disease) and Ancylostoma caninum (hookworm infection) and for removal and control of Trichuris vulpis (whipworm infection) and mature and immature stages of intestinal Toxocara canis (ascarid infection).

(3) Limitations. Orally administer daily during heartworm season. For free-choice feeding or broken and placed on or mixed with feed. Do not use in dogs that may harbor adult heartworms. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[50 FR 28768, July 16, 1985, as amended at 53 FR 45759, Nov. 14, 1988; 54 FR 3776, Jan. 26, 1989; 54 FR 6804, Feb. 14, 1989; 56 FR 50653, Oct. 8, 1991; 60 FR 55659, Nov. 2, 1995]

§520.645   Difloxacin.

(a) Specifications. Each tablet contains 11.4, 45.4, or 136 milligrams (mg) of difloxacin hydrochloride.

(b) Sponsor. See No. 000010 in §510.600(c) of this chapter.

(c) [Reserved]

(d) Conditions of use—(i) Amount. Administer 5 to 10 mg per kilogram (2.3 to 4.6 mg per pound) of body weight orally once a day for 2 to 3 days beyond cessation of clinical signs of disease up to a maximum of 30 days.

(ii) Indications for use. For management of diseases in dogs associated with bacteria susceptible to difloxacin.

(iii) Limitations. Federal law prohibits the extra-label use of this drug in food-producing animals. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) [Reserved]

[63 FR 8123, Feb. 18, 1998, as amended at 75 FR 10165, Mar. 5, 2010]

§520.666   Dirlotapide.

(a) Specifications. Each milliliter (mL) of solution contains 5 milligrams (mg) dirlotapide.

(b) Sponsor. See No. 000069 in §510.600(c) of this chapter.

(c) Conditions of use in dogs—(1) Amount. The initial dosage is 0.01 mL/kg (0.0045 mL/lb) body weight for the first 14 days. After the first 14 days of treatment, the dose volume is doubled to 0.02 mL/kg (0.009 mL/lb) body weight for the next 14 days (days 15 to 28 of treatment). Dogs should be weighed monthly and the dose volume adjusted every month, as necessary, to maintain a target percent weight loss until the desired weight is achieved.

(2) Indications for use. For the management of obesity.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[72 FR 263, Jan. 4, 2007]

§520.763   Dithiazanine iodide oral dosage forms.

§520.763a   Dithiazanine iodide tablets.

(a) [Reserved]

(b) Specifications. Dithiazanine iodide tablets contain 10 milligrams, 50 milligrams, 100 milligrams, or 200 milligrams of dithiazanine iodide in each tablet.

(c) Sponsor. See No. 054628 in §510.600(c) of this chapter.

(d) Conditions of use. (1) The tablets are administered orally to dogs immediately after feeding using the following dosage schedule for various parasite infestations:

  Milligrams per pound of body weightLength of treatment—days
Large roundworms (Toxocara canis, Toxascaris leonina)103-5
Hookworms (Ancylostoma caninum, Uncinaria stenocephala)107
Whipworms (Trichuris vulpis)10
Strongyloides (Strongyloides canis, Strongyloides stercoralis)1010-12
Heartworm microfilariae (Dirofilaria immitus)3-57-10

Note: Treatment with dithiazanine iodide for heartworm microfilariae should follow 6 weeks after therapy for adult worms.

(2) The drug is contraindicated in animals sensitive to dithiazanine iodide and should be used cautiously, if at all, in dogs with reduced renal function.

(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(e) Use for treating dogs for large roundworms, hookworms, whipworms, and strongyloides as provided for in this section has been NAS/NRC reviewed and deemed effective. Applications for these uses need not include effectiveness data as specified by §514.111 of this chapter, but may require bioequivalency and safety information.

[40 FR 13838, Mar. 27, 1975, as amended at 47 FR 51564, Nov. 16, 1982; 48 FR 32342, July 15, 1983; 53 FR 40727, Oct. 18, 1988; 62 FR 35076, June 30, 1997; 78 FR 21059, Apr. 9, 2013]

§520.763b   Dithiazanine iodide powder.

(a) Chemical name. 3-Ethyl-2-[5-(3-ethyl-2-benzothiazolinylidene)-1,3-pentadienyl]-benzothiazoliumiodide.

(b) Specifications. Dithiazanine iodide powder contains 200 milligrams of dithiazanine iodide per level standard tablespoon.

(c) Sponsor. See No. 000010 in §510.600(c) of this chapter.

(d) Conditions of use. (1) Dithiazanine iodide powder is administered to dogs by mixing the proper dosage in the dog's food, using the following dosage schedule for various parasite infestations:

  Milligrams per pound of body weightLength of treatment—days
Large roundworms (Toxocara canis, Toxascaris leonina)103-5
Hookworms (Ancylostoma caninum, Uncinaria stenocephala)107
Whipworms (Trichuris vulpis)107
Strongyloides (Strongyloides canis, Strongyloides stercoralis)1010-12
Heartworm microfilariae (Dirofilaria immitus)3-57-10

Note: Treatment with dithiazanine iodide for heartworm microfilariae should follow 6 weeks after therapy for adult worms.

(2) The drug is contraindicated in animals sensitive to dithiazanine iodide and should be used cautiously, if at all, in dogs with reduced renal function.

(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(e) Use for treating dogs for large roundworms, hookworms, whipworms, and strongyloides as provided for in this section has been NAS/NRC reviewed and deemed effective. Applications for these uses need not include effectiveness data as specified by §514.111 of this chapter, but may require bioequivalency and safety information.

[40 FR 13838, Mar. 27, 1975, as amended at 47 FR 51564, Nov. 16, 1982; 48 FR 32342, July 15, 1983; 53 FR 40727, Oct. 18, 1988; 62 FR 35076, June 30, 1997]

§520.763c   Dithiazanine iodide and piperazine citrate suspension.

(a) Specifications. Each milliliter of the drug contains 69 milligrams of dithiazanine iodide and 83 milligrams of piperazine base (as piperazine citrate).

(b) Sponsor. See 054628 in §510.600(c) of this chapter.

(c) [Reserved]

(d) Conditions of use—(1) Amount. 1 ounce (30 milliliters) per 100 pounds of body weight for the first 500 pounds; 34 ounce for each 100 pounds thereafter, up to 1,200 pounds; 1014 ounces to animals over 1,200 pounds.

(2) Indications for use. For control of large roundworms, Parascaris equorum; small strongyles; large strongyles, Strongylus vulgaris; and pinworms, Oxyuris equi.

(3) Limitations. Administer by drench or mixed with the daily ration as a single dose. Treatment is recommended in spring and fall. In a heavily infested environment, treatment may be repeated every 30 days. Not for use in horses intended for food purposes. Severely debilitated animals should not be wormed except on the advice of a veterinarian. If the drug is for administration by stomach tube, it shall be labeled: “Federal law restricts this drug to use by or on the order of a licensed veterinarian.”

[47 FR 52696, Nov. 23, 1982, as amended at 48 FR 32342, July 15, 1983; 53 FR 40727, Oct. 18, 1988; 62 FR 35076, June 30, 1997; 78 FR 21059, Apr. 9, 2013]

§520.766   Domperidone.

(a) Specifications. Each milliliter of gel contains 110 milligrams (mg) domperidone.

(b) Sponsor. See No. 043264 in §510.600 of this chapter.

(c) Conditions of use in horses—(1) Amount. Administer 0.5 mg per pound (mg/lb) (1.1 mg/kilogram (kg)) by mouth once daily starting 10 to 15 days prior to the expected foaling date. Treatment may be continued for up to 5 days after foaling if mares are not producing adequate milk.

(2) Indications for use. For prevention of fescue toxicosis in periparturient mares.

(3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[75 FR 67031, Nov. 1, 2010]

§520.784   Doxylamine succinate tablets.

(a) Specifications. The drug is in tablet form and contains doxylamine succinate as the active drug ingredient.

(b) Sponsor. See No. 000061 in §510.600(c) of this chapter.

(c) Conditions of use. (1) The drug is used in conditions in which antihistaminic therapy may be expected to alleviate some signs of disease in horses, dogs, and cats.1

1These conditions are NAS/NRC reviewed and deemed effective. Applications for these uses need not include effectiveness data as specified by §514.111 of this chapter.

(2) It is administered orally to horses at a dosage level of 1 to 2 milligrams per pound of body weight per day divided into 3 or 4 equal doses. It is administered orally to dogs and cats at a dosage level of 2 to 3 milligrams per pound of body weight per day divided into 3 or 4 equal doses.1

(3) Not for use in horses intended for food.1

(4) Federal law restricts this drug to use by or on the order of a licensed veterinarian.1

[40 FR 13838, Mar. 27, 1975, as amended at 42 FR 60140, Nov. 25, 1977; 46 FR 48642, Oct. 2, 1981; 61 FR 8873, Mar. 6, 1996; 62 FR 61624, Nov. 19, 1997]

§520.804   Enalapril tablets.

(a) Specifications. Each tablet contains either 1.0, 2.5, 5.0, 10.0, or 20.0 milligrams of enalapril maleate.

(b) Sponsor. See 050604 in §510.600(c) of this chapter.

(c) Conditions of use—(1) Dogs—(i) Amount. 0.5 to 1.0 milligram of enalapril maleate per kilogram of body weight per day.

(ii) Indications for use. Treatment of mild, moderate, and severe (modified New York Heart Association Class II, III, IV) heart failure in dogs.

(iii) Limitations. Use 0.5 milligram per kilogram once daily. In the absence of adequate clinical response within a 2-week period, use may be increased to twice daily (a total of 1.0 milligram per kilogram). Enalapril maleate is administered as conjunctive therapy with furosemide and digoxin in the treatment of dilated cardiomyopathy and furosemide with or without digoxin in the treatment of chronic valvular disease. The safety of enalapril for use in breeding dogs has not been established. Use in pregnant bitches is not recommended. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) [Reserved]

[59 FR 17694, Apr. 14, 1994, as amended at 62 FR 63270, Nov. 28, 1997]

§520.812   Enrofloxacin.

(a) Specifications. Each tablet contains:

(1) 22.7, 68.0, or 136.0 milligrams (mg) enrofloxacin; or

(2) 22.7, 68.0, 136.0, or 272 mg enrofloxacin.

(b) Sponsors. See sponsor numbers in §510.600(c) of this chapter for use as in paragraph (c) of this section.

(1) Nos. 000859 and 026637 for use of product described in paragraph (a)(1) of this section.

(2) No. 058198 for use of product described in paragraph (a)(2) of this section.

(c) Conditions of use in dogs and cats—(1) Amount. Administer orally as a single, daily dose or divided into two equal doses at 12-hour intervals.

(i) Dogs. 5 to 20 mg per kilogram (/kg) (2.27 to 9.07 mg per pound (/lb)) of body weight.

(ii) Cats. 5 mg/kg (2.27 mg/lb) of body weight.

(2) Indications for use. For the management of diseases associated with bacteria susceptible to enrofloxacin.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits the extralabel use of this drug in food-producing animals.

[78 FR 30197, May 22, 2013, as amended at 78 FR 52853, Aug. 27, 2013]

§520.816   Epsiprantel tablets.

(a) Specifications. Each tablet contains either 12.5, 25, 50, or 100 milligrams of epsiprantel.

(b) Sponsor. See No. 000069 in §510.600(c) of this chapter.

(c) Conditions of use—(1) Dogs—(i) Amount. 2.5 milligrams per pound of body weight.

(ii) Indications for use. Removal of canine cestodes Dipylidium caninum and Taenia pisiformis.

(2) Cats—(i) Amount. 1.25 milligrams per pound of body weight.

(ii) Indications for use. Removal of feline cestodes D. caninum and T. taeniaeformis.

(3) Limitations. For oral use only as a single dose. Do not use in animals less than 7 weeks of age. Safety of use in pregnant or breeding animals has not been established. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[54 FR 50615, Dec. 8, 1989, as amended at 56 FR 50653, Oct. 8, 1991; 60 FR 55659, Nov. 2, 1995]

§520.823   Erythromycin phosphate.

(a) Specifications. Erythromycin phosphate is the phosphate salt of the antibiotic substance produced by the growth of Streptomyces erythreus or the same antibiotic substance produced by any other means. One gram of erythromycin phosphate is equivalent to 0.89 gram of erythromycin master standard.

(b) Sponsor. See No. 061623 in §510.600(c) of this chapter.

(c) Related tolerances. See §556.230 of this chapter.

(d) Conditions of use. It is used in drinking water as follows:

(1) Broiler and replacement chickens—(i) Amount. 0.500 gram per gallon.

(ii) Indications for use. As an aid in the control of chronic respiratory disease due to Mycoplasma gallisepticum susceptible to erythromycin.

(iii) Limitations. Administer for 5 days; do not use in replacement pullets over 16 weeks of age; do not use in chickens producing eggs for human consumption; to assure effectiveness, treated birds must consume enough medicated water to provide a therapeutic dosage; solutions older than 3 days should not be used; withdraw 1 day before slaughter.

(2) Replacement chickens and chicken breeders—(i) Amount. 0.500 gram per gallon.

(ii) Indications for use. As an aid in the control of infectious coryza due to Hemophilus gallinarum susceptible to erythromycin.

(iii) Limitations. Administer for 7 days; do not use in replacement pullets over 16 weeks of age; do not use in chickens producing eggs for human consumption; to assure effectiveness, treated birds must consume enough medicated water to provide a therapeutic dosage; solutions older than 3 days should not be used; withdraw 1 day before slaughter.

(3) Growing turkeys—(i) Amount. 0.500 gram per gallon.

(ii) Indications for use. As an aid in the control of blue comb (nonspecific infectious enteritis) caused by organisms susceptible to erythromycin.

(iii) Limitations. Administer for 7 days; do not use in turkeys producing eggs for human consumption; to assure effectiveness, treated birds must consume enough medicated water to provide a therapeutic dosage; solutions older than 3 days should not be used; withdraw 1 day before slaughter.

[40 FR 13838, Mar. 27, 1975, as amended at 45 FR 56798, Aug. 26, 1980; 66 FR 14073, Mar. 9, 2001; 68 FR 4914, Jan. 31, 2003]

§520.852   Estriol.

(a) Specifications. Each tablet contains 1 milligram (mg) estriol.

(b) Sponsor. See No. 000061 in §510.600(c) of this chapter.

(c) Conditions of use in dogs—(1) Amount. Administer at an initial dose of 2 mg per dog per day. The dosage may be titrated to as low as 0.5 mg per dog every second day, depending on response.

(2) Indications for use. For the control of estrogen-responsive urinary incontinence in ovariohysterectomized female dogs.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[76 FR 78150, Dec. 16, 2011]

§520.863   Ethylisobutrazine hydrochloride tablets.

(a) Specifications. Each tablet contains either 10 milligrams or 50 milligrams of ethylisobutrazine hydrochloride.

(b) Sponsor. See No. 000061 in §510.600(c) of this chapter.

(c) Conditions of use. (1) It is administered orally to dogs as a tranquilizer.1

1These conditions are NAS/NRC reviewed and deemed effective. Applications for these uses need not include effectiveness data as specified by §514.111 of this chapter, but may require bioequivalency and safety information.

(2) It is administered once daily at a dosage level of 2 to 5 milligrams of ethylisobutrazine hydrochloride per pound of body weight.1

(3) It is not to be used in conjunction with organophosphates and/or procaine hydrochloride because phenothiazine may potentiate the toxicity of organophosphates and the activity of procaine hydrochloride.1

(4) Federal law restricts this drug to use by or on the order of a licensed veterinarian.1

[40 FR 13838, Mar. 27, 1975, as amended at 46 FR 48642, Oct. 2, 1981; 61 FR 8873, Mar. 6, 1996; 62 FR 61624, Nov. 19, 1997]

§520.870   Etodolac.

(a) Specifications. Each tablet contains 150, 300, or 500 milligrams (mg) of etodolac.

(b) Sponsor. See No. 000010 in §510.600(c) of this chapter.

(c) [Reserved]

(d) Conditions of use—(i) Amount. Administer 10 to 15 mg per kilogram (4.5 to 6.8 mg per pound) of body weight per day orally.

(ii) Indications for use. For the management of pain and inflammation associated with osteoarthritis in dogs.

(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) [Reserved]

[63 FR 51300, Sept. 25, 1998, as amended at 68 FR 51705, Aug. 28, 2003; 75 FR 10166, Mar. 5, 2010]

§520.903   Febantel oral dosage forms.

§520.903a   Febantel paste.

(a) Chemical name. Dimethyl [[2-[(methoxyacetyl)amino]-4-(phenyl-thio)phenyl] carbonimidoyl]bis [carbamate].

(b) Specifications. The drug is a paste containing 45.5 percent febantel.

(c) Sponsor. See No. 000859 in §510.600(c) of this chapter.

(d) Conditions of use—(1) Amount. Six milligrams per kilogram (2.73 milligrams per pound) of body weight in horses.

(2) Indications for use. For removal of large strongyles (Strongylus vulgaris, S. edentatus, S. equinus); ascarids (Parascaris equorum— sexually mature and immature); pinworms (Oxyuris equi— adult and 4th stage larva); and the various small strongyles in horses, foals, and ponies.

(3) Limitations. (i) The paste may be administered on the base of the tongue or well mixed into a portion of the normal grain ration.

(ii) [Reserved]

(iii) For animals maintained on premises where reinfection is likely to occur, retreatment may be necessary. For most effective results, retreat in 6 to 8 weeks.

(iv) Not for use in horses intended for food.

(v) Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.

[43 FR 8797, Mar. 3, 1978; 43 FR 12311, Mar. 24, 1978, as amended at 43 FR 60882, Dec. 29, 1978. Redesignated at 45 FR 8587, Feb. 8, 1980]

§520.903b   Febantel suspension.

(a) Specifications. The suspension contains 9.3 percent (2.75 grams per ounce) febantel.

(b) Sponsor. See 000859 in §510.600(c) of this chapter.

(c) Conditions of use—(1) Amount. 3 milliliters per 100 pounds body weight or 1 fluid ounce per 1000 pounds (6 milligrams per kilogram body weight).

(2) Indications for use. For removal of ascarids (Parascaris equorum—adult and sexually immature), pinworms (Oxyuris equi—adult and 4th stage larvae), large strongyles (Strongylus vulgaris, S. edentatus, S. equinus), and the various small strongyles in horses, breeding stallions and mares, pregnant mares, foals, and ponies.

(3) Limitations. Administer by stomach tube or drench, or by mixing well into a portion of the normal grain ration. For animals maintained on premises where reinfection is likely to occur, retreatment may be necessary. For most effective results, retreat in 6 to 8 weeks. Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(d) Special considerations. Febantel suspension may be used in combination with trichlorfon oral liquid in accordance with the provisions of §520.2520c, this section, and the following conditions:

(1) Combine 1 part febantel suspension with 5 parts trichlorfon liquid.

(2) Allow animal to consume a portion of daily grain ration; administer mixture by stomach tube at rate of 18 milliliters per 100 pounds of body weight.

[45 FR 8587, Feb. 8, 1980]

§520.903c   [Reserved]

§520.903d   Febantel-praziquantel paste.

(a) Specifications. Each gram of paste contains 34 milligrams of febantel and 3.4 milligrams of praziquantel.

(b) Sponsor. See No. 000859 in §510.600(c) of this chapter.

(c) Conditions of use—(1) Amount—(i) Dogs and cats (over 6 months of age): 10 milligrams of febantel and 1 milligram of praziquantel per kilogram of body weight (1 gram of paste per 7.5 pounds body weight) administered by mouth or in the food once daily for 3 days.

(ii) Puppies and kittens (less than 6 months of age): 15 milligrams of febantel and 1.5 milligrams of praziquantel per kilogram of body weight (1 gram of paste per 5 pounds body weight) administered by mouth on a full stomach once daily for 3 days.

(2) Indications for use. (i) Dogs and puppies: For removal of hookworms (Ancylostoma caninum and Uncinaria stenocephala), whipworms (Trichuris vulpis), ascarids (Toxocara canis and Toxascaris leonina), and tapeworms (Dipylidium caninum and Taenia pisiformis).

(ii) Cats and kittens: For removal of hookworms (Ancylostoma tubaeforme), ascarids (Toxocara cati) and tapeworms (Dipylidium caninum and Taenia taeniaeformis).

(3) Limitations. Do not use in pregnant animals. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(4) Special considerations. Consider alternative therapy or use with caution in animals with pre-existing liver or kidney dysfunction.

[50 FR 19167, May 7, 1985, as amended at 53 FR 48533, Dec. 1, 1988; 56 FR 50813, Oct. 9, 1991]

§520.903e   Febantel tablets.

(a) Specifications. Each scored tablet contains 27.2 milligrams of febantel for use in dogs, puppies, cats, and kittens or 163.3 milligrams of febantel for use in dogs, puppies, and cats.

(b) Sponsor. See 000859 in §510.600(c)(2) of this chapter.

(c) Conditions of use—(1) Amount—(i) Dogs and cats. Ten milligrams per kilogram body weight. Administer once daily for 3 consecutive days.

(ii) Puppies and kittens fewer than 6 months of age. Fifteen milligrams per kilogram body weight. Administer once daily for 3 consecutive days.

(2) Indications for use. (i) For removal of hookworms (Ancylostoma caninum and Uncinaria stenocephala), ascarids (Toxocara canis and Toxascaris leonina) and whipworms (Trichuris vulpis) in dogs and puppies.

(ii) For removal of hookworms (Ancylostoma tubaeforme) and ascarids (Toxocara cati) in cats and kittens.

(3) Limitations. Do not use in pregnant animals. Consider alternative therapy or use with caution in animals with preexisting liver or kidney dysfunction. Administer to puppies and kittens on a full stomach. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[56 FR 50655, Oct. 8, 1991]

§520.905   Fenbendazole oral dosage forms.

§520.905a   Fenbendazole suspension.

(a) Specifications. Each milliliter of suspension contains 100 milligrams (mg) fenbendazole.

(b) Sponsor. See No. 000061 in §510.600(c) of this chapter.

(c) Related tolerances. See §556.275 of this chapter.

(d) Special considerations. (1) See §500.25 of this chapter.

(2) Fenbendazole suspension 10 percent and approved forms of trichlorfon, when used concomitantly for treating the indications provided in paragraph (e) of this section and for treating infections of stomach bot as provided in §520.2520, have been shown to be compatible and not to interfere with one another.

(e) Conditions of use—(1) Horses—(i) Amount. Administer orally 5 mg per kilogram (/kg) (2.3 mg per pound (/lb)) for the control of large strongyles, small strongyles, and pinworms; 10 mg/kg for the control of ascarids.

(ii) Indications for use. For the control of large strongyles (Strongylus edentatus, S. equinus, S. vulgaris), small strongyles (Cyanthostomum spp., Cylicocyclus spp., Cylicostephanus spp., Triodontophorus spp.), pinworms (Oxyuris equi), and ascarids (Parascaris equorum) in horses.

(iii) Limitations. Administer by dose syringe or suitable plastic syringe. Do not use in horses intended for human consumption.

(2) Cattle including dairy cows of breeding age—(i) Amount. Administer orally 5 mg/kg of body weight (2.3 mg/lb). Retreatment may be needed after 4 to 6 weeks.

(ii) Indications for use. For the removal and control of lungworm (Dictyocaulus viviparus); stomach worm (adults)—brown stomach worm (Ostertagia ostertagi); stomach worms (adults and 4th-stage larvae)—barberpole worm (Haemonchus contortus and H. placei) and small stomach worm (Trichostongylus axei); intestinal worms (adults and 4th-stage larvae)—hookworm (Bunostonmum phlebotomum), threadnecked intestinal worm (Nematodirus helvetianus), small intestinal worm (Cooperia punctata and C. oncophora), bankrupt worm (Trichostrongylus colubriformis), and nodular worm (Oesophagostomum radiatum).

(iii) Limitations. Cattle must not be slaughtered within 8 days following last treatment. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.

(3) Beef cattle—(i) Amount. Administer orally 10 mg/kg of body weight (2.3 mg/lb). Retreatment may be needed after 4 to 6 weeks.

(ii) Indications for use. For the removal and control of stomach worm (4th stage inhibited larvae/type II ostertagiasis), Ostertagia ostertagi, and tapeworm, Moniezia benedeni.

(iii) Limitations. Cattle must not be slaughtered within 8 days following last treatment. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(4) Goats—(i) Amount. Administer orally 5 mg/kg of body weight (2.3 mg/lb).

(ii) Indications for use. For the removal and control of stomach worms (adults) Haemonchus contortus and Teladorsagia circumcincta.

(iii) Limitations. Retreatment may be needed after 4 to 6 weeks. Goats must not be slaughtered for food within 6 days following last treatment. Do not use in lactating goats.

[42 FR 59069, Nov. 15, 1977; 43 FR 12311, Mar. 24, 1978. Redesignated at 44 FR 1375, Jan. 5, 1979, and amended at 46 FR 29464, June 2, 1981; 47 FR 15327, Apr. 9, 1982; 48 FR 42809, Sept. 20, 1983; 49 FR 1983, Jan. 17, 1984; 53 FR 40058, Oct. 13, 1988; 59 FR 26943, May 25, 1994; 61 FR 29478, June 11, 1996; 63 FR 63983, Nov. 18, 1998; 66 FR 47960, Sept. 17, 2001; 68 FR 26205, May 15, 2003; 74 FR 17770, Apr. 17, 2009; 74 FR 61516, Nov. 25, 2009; 76 FR 17336, Mar. 29, 2011]

§520.905b   Fenbendazole granules.

(a) Specifications. Each gram of granules contains 222 milligrams (mg) fenbendazole.

(b) Sponsor. See No. 000061 in §510.600(c) of this chapter.

(c) Special considerations. See §500.25 of this chapter.

(d) Conditions of use—(1) Horses—(i) Amount. 5 mg/kilogram (kg) for large strongyles, small strongyles, and pinworms; 10 mg/kg for ascarids.

(ii) Indications for use. For the control of infections of large strongyles (Strongylus edentatus, S. equinus, S. vulgaris), small strongyles, pinworms (Oxyuris equi), and ascarids (Parascaris equorum).

(iii) Limitations. Sprinkle the appropriate amount of drug on a small amount of the usual grain ration. Prepare for each horse individually. Withholding feed or water is not necessary. Retreat in 6 to 8 weeks if required. Do not use in horses intended for food.

(2) Dogs—(i) Amount. 50 mg/kg daily for 3 consecutive days.

(ii) Indications for use. For the treatment and control of ascarids (Toxocara canis, Toxascaris leonina), hookworms (Ancylostoma caninum, Uncinaria stenocephala), whipworms (Trichuris vulpis), and tapeworms (Taenia pisiformis).

(iii) Limitations. Mix the appropriate amount of drug with a small amount of the usual food; dry dog food may require slight moistening to facilitate mixing. Medicated food must be fully consumed.

(3) Zoo and wildlife animals—(i) Amount. 10 mg/kg per day for 3 days.

(ii) Indications for use. For control of internal parasites of Felidae and Ursidae as follows:

(A) Lion (Panthera leo) and Tiger (Panthera tigris): Ascarid (Toxocara cati, Toxascaris leonina), Hookworm (Ancylostoma spp.).

(B) Cheetah (Acinonyx jubatus): Ascarid (Toxocara cati, Toxascaris leonina).

(C) Puma (Felis concolor), Panther (Panthera spp.), Leopard (Panthera pardus), Jaguar (Panthera onca): Ascarid (Toxocara cati, Toxascaris leonina), Hookworm (Ancylostoma spp.), Tapeworm (Taenia hydatigena, T. krabbei, T. taeniaeformis).

(D) Black Bear (Ursus americanus): Ascarid (Baylisascaris transfuga, Toxascaris leonina), Hookworm (Ancylostoma caninum), Tapeworm (Taenia hydatigena, T. krabbei).

(E) Polar Bear (Ursus maritimus) and Grizzly Bear (Ursus horribilis): Ascarid (Baylisascaris transfuga, Toxascaris leonina).

(iii) Limitations. Top dress or mix with a small portion of food. Must be fully consumed prior to feeding. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use 14 days before or during the hunting season.

[44 FR 1375, Jan. 5, 1979, as amended at 47 FR 15327, Apr. 9, 1982; 48 FR 50528, Nov. 2, 1983; 59 FR 35252, July 11, 1994; 66 FR 47960, Sept. 17, 2001; 67 FR 47450, July 19, 2002; 71 FR 19429, Apr. 14, 2006; 74 FR 61516, Nov. 25, 2009]

§520.905c   Fenbendazole paste.

(a) Specifications. Each gram of paste contains 100 milligrams (mg) fenbendazole (10 percent).

(b) Sponsor. See No. 000061 in §510.600(c) of this chapter.

(c) Related tolerances. See §556.275 of this chapter.

(d) Special considerations. See §500.25 of this chapter.

(e) Conditions of use—(1) Horses—(i) Indications for use and amounts—(A) For control of large strongyles (Strongylus edentatus, S. equinus, S. vulgaris), small strongyles, pinworms (Oxyuris equi), and ascarids (Parascaris equorum): 2.3 mg per pound (/lb) of body weight, or for foals and weanlings (less than 18 months of age), 4.6 mg/lb of body weight. Retreatment at intervals of 6 to 8 weeks may be required.

(B) For control of arteritis caused by the fourth-stage larvae of S. vulgaris: 4.6 mg/lb of body weight daily for 5 days. Treatment should be initiated in the spring and repeated in 6 months.

(C) For treatment of encysted mucosal cyathostome (small strongyle) larvae including early third-stage (hypobiotic), late third-stage, and fourth-stage larvae: 4.6 mg/lb of body weight daily for 5 consecutive days.

(D) Fenbendazole paste 10 percent may be used concomitantly with approved forms of trichlorfon for the indications provided in paragraph (e)(1)(i)(A) of this section and for treating infections of stomach bots as provided in §520.2520.

(ii) Limitations. Do not use in horses intended for human consumption.

(2) Cattle—(i) Amount. 2.3 mg/lb of body weight. Retreatment may be needed after 4 to 6 weeks.

(ii) Indications for use. For the removal and control of lungworms (Dictyocaulus viviparus), stomach worms (Haemonchus contortus, Ostertagia ostertagi, Trichostrongylus axei), and intestinal worms (Bunostomum phlebotomum, Nematodirus helvetianus, Cooperia punctata, C. oncophora, Trichostrongylus colubriformis, and Oesophagostomum radiatum).

(iii) Limitations. Cattle must not be slaughtered within 8 days following last treatment. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.

[72 FR 24185, May 2, 2007, as amended at 74 FR 61516, Nov. 25, 2009; 76 FR 17337, Mar. 29, 2011]

§520.905d   Fenbendazole powder.

(a) Specifications. (1) Each 2-ounce packet contains 2.27 grams (4 percent) of fenbendazole plus other inert ingredients.

(2) Each 4-ounce packet contains 1.7 grams (1.5 percent) of fenbendazole plus other inert ingredients.

(b) Sponsors. (1) See No. 000061 in §510.600(c) of this chapter for use of the 4-percent product.

(2) See No. 051311 in §510.600(c) of this chapter for use of the 1.5-percent product.

(c) Related tolerances. See §556.275 of this chapter.

(d) Conditions of use. It is administered to swine as follows:

(1) Amount. 3 milligrams fenbendazole per kilogram body weight per day (1.36 milligrams per pound per day).

(2) Indications for use. For removal and control of large roundworms (Ascaris suum); lungworms (Metastrongylus apri); nodular worms (Oesophagostomum dentatum, O. quadrispinulatum); small stomach worms (Hyostrongylus rubidus); whipworms (Trichuris suis); and kidneyworms (Stephanurus dentatus— mature and immature).

(3) Limitations. Thoroughly mix the contents of the packet(s) with swine ration and administer according to label directions. Feed as sole ration for 3 consecutive days. Can be fed to pregnant sows. No prior withdrawal of feed or water is necessary. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.

[49 FR 18090, Apr. 27, 1984, as amended at 49 FR 20485, May 15, 1984; 66 FR 47960, Sept. 17, 2001; 70 FR 32489, June 3, 2005; 74 FR 61516, Nov. 25, 2009]

§520.905e   Fenbendazole blocks.

(a) Specifications. (1) Each pound of molasses block contains 750 milligrams of fenbendazole.

(2) Each pound of protein block contains 750 milligrams of fenbendazole.

(b) Sponsor. See 000061 in §510.600(c) of this chapter.

(c) Related tolerances. See §556.275 of this chapter.

(d) Conditions of use—(1) Amount. 0.1 pound of block per 100 pounds of body weight per day for 3 days. Total dose for the 3-day period is 2.27 milligrams of fenbendazole per pound of body weight for mature cattle.

(2) Indications for use. For removal and control of infections of lungworms (Dictyocaulus viviparus) and gastrointestinal roundworms (Haemonchus contortus, Ostertagia ostertagi, Trichostrongylus axei, Bunostomum phlebotomum, Nematodirus helvetianus, Cooperia oncophora and C. punctata, Trichostrongylus colubriformis, and Oesophagostomum radiatum) in beef cattle.

(3) Limitations. Administer free choice of beef cattle on pasture that have become accustomed to nonmedicated block feeding during an adaptation period of 12 to 19 days. Molasses block: Cattle must not be slaughtered within 11 days following last treatment. Protein block: Cattle must not be slaughtered within 16 days following last treatment; do not use in dairy cattle of breeding age. Animals maintained under conditions of constant worm exposure may require retreatment within 6 to 8 weeks. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.

[51 FR 41783, Nov. 19, 1986, as amended at 54 FR 20787, May 15, 1989; 66 FR 47960, Sept. 17, 2001; 74 FR 61516, Nov. 25, 2009]

§520.928   Firocoxib tablets.

(a) Specifications. Each chewable tablet contains 57 or 227 milligrams (mg) firocoxib.

(b) Sponsor. See No. 050604 in §510.600(c) of this chapter.

(c) Conditions of use in dogs—(1) Amount. 5 mg/kg (2.27 mg/lb) body weight. Administer once daily for osteoarthritis. Administer approximately 2 hours before soft-tissue or orthopedic surgery.

(2) Indications for use. For the control of pain and inflammation associated with osteoarthritis; and for the control of postoperative pain and inflammation associated with soft-tissue and orthopedic surgery.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[69 FR 51171, Aug. 18, 2004, as amended at 73 FR 2808, Jan. 16, 2008; 73 FR 64885, Oct. 31, 2008]

§520.930   Firocoxib paste.

(a) Specifications. Each milligram (mg) of paste contains 0.82 mg firocoxib.

(b) Sponsors. See No. 050604 in §510.600(c) of this chapter.

(c) Conditions of use in horses—(1) Amount. 0.1 mg per kilogram (0.045 mg per pound) body weight daily for up to 14 days.

(2) Indications for use. For the control of pain and inflammation associated with osteoarthritis.

(3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[71 FR 5788, Feb. 3, 2006]

§520.955   Florfenicol.

(a) Specifications. Each milliliter (mL) contains 23 milligrams (mg) florfenicol.

(b) Sponsor. See Nos. 000061 and 058198 in §510.600(c) of this chapter.

(c) Related tolerances. See §556.283 of this chapter.

(d) Conditions of use in swine—(1) Amount. Administer in drinking water ad libitum at 400 mg per gallon (100 parts per million (ppm)) for 5 consecutive days.

(2) Indications for use. For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Salmonella choleraesuis and Streptococcus suis.

(3) Limitations. Do not slaughter within 16 days of last treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[67 FR 78357, Dec. 24, 2002, as amended at 72 FR 262, Jan. 4, 2007; 78 FR 52854, Aug. 27, 2013]

§520.960   Flumethasone tablets.

(a) Specifications. Each tablet contains 0.0625 milligram of flumethasone.

(b) Sponsor. See No. 000856 in §510.600(c) of this chapter.

(c) Conditions of use—(1) Amount. (i) Dogs: Administer orally from 0.0625 to 0.25 milligram daily in divided doses.

(ii) Cats: Administer orally from 0.03125 to 0.125 milligram daily in divided doses.

(2) Indications for use. (i) Dogs: It is used for musculoskeletal conditions due to inflammation of muscles or joints and accessory structures, where permanent structural changes do not exist, such as arthritis, the disc syndrome, and myositis.

(ii) Dogs and cats: It is used in certain acute and chronic dermatoses of varying etiology to help control the pruritus, irritation, and inflammation associated with these conditions.

(3) Limitations. Do not use in viral infections. Anti-inflammatory action of corticosteroids may mask signs of infection. Do not use in animals with tuberculosis, chronic nephritis, cushingoid syndrome, or where peptic ulcers occur, except for emergency therapy. Clinical and experimental data have demonstrated that corticosteroids administered orally or parenterally to animals may induce the first stage of parturition when administered during last trimester of pregnancy and may precipitate premature parturition followed by dystocia, fetal death, retained placenta, and metritis. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[44 FR 7131, Feb. 6, 1979, as amended at 61 FR 5506, Feb. 13, 1996]

§520.970   Flunixin.

(a) Specifications. (1) Each 10-gram (g) packet of granules contains flunixin meglumine equivalent to 250 milligrams (mg) of flunixin.

(2) Each 30-g syringe of paste contains flunixin meglumine equivalent to 1,500 mg of flunixin.

(b) Sponsor. See No. 000061 in §510.600(c) of this chapter.

(c) Conditions of use in horses—(1) Amount. 0.5 mg of flunixin per pound of body weight per day.

(2) Indications for use. For alleviation of inflammation and pain associated with musculoskeletal disorders.

(3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[76 FR 53051, Aug. 25, 2011]

§520.980   Fluoxetine.

(a) Specifications. Each chewable tablet contains 8, 16, 32, or 64 milligrams (mg) fluoxetine hydrochloride.

(b) Sponsor. See No. 000986 in §510.600 of this chapter.

(c) Conditions of use in dogs—(1) Amount. 1 to 2 mg per kilogram body weight once daily.

(2) Indications for use. For the treatment of canine separation anxiety in conjunction with a behavior modification plan.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[72 FR 6463, Feb. 12, 2007]

§520.1010   Furosemide.

(a) Specifications. (1) Each tablet contains 12.5 or 50 milligrams (mg) furosemide.

(2) Each bolus contains 2 grams (g) furosemide.

(3) Each packet of powder contains 2 g furosemide.

(4) Each milliliter of syrup contains 10 mg furosemide.

(b) Sponsors. See sponsor numbers in §510.600(c) of this chapter for use of dosage forms and strengths listed in paragraph (a) of this section for uses as in paragraph (d) of this section.

(1) No. 000010 for tablets in paragraph (a)(1) of this section for conditions of use in paragraphs (d)(2)(i), (d)(2)(ii)(A), and (d)(3) of this section.

(2) No. 000061 for tablets in paragraph (a)(1) of this section for conditions of use in paragraphs (d)(2)(i), (d)(2)(ii)(A), and (d)(3) of this section; for boluses in paragraph (a)(2) of this section and powder in paragraph (a)(3) of this section for conditions of use in paragraph (d)(1) of this section; and for syrup in paragraph (a)(4) of this section for conditions of use in paragraphs (d)(2)(i) and (d)(2)(ii)(A).

(3) Nos. 000859 and 058829 for use of syrup in paragraph (a)(4) of this section for conditions of use in paragraph (d)(2)(i) and (d)(2)(ii)(A) of this section.

(c) Special considerations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(d) Conditions of use. It is used as follows:

(1) Cattle—(i) Amount. 1 to 2 mg per pound (/lb) body weight using powder, or one 2-g bolus per animal, per day.

(ii) Indications for use. For treatment of physiological parturient edema of the mammary gland and associated structures.

(iii) Limitations. Treatment not to exceed 48 hours post-parturition. Milk taken during treatment and for 48 hours after the last treatment must not be used for food. Cattle must not be slaughtered for food within 48 hours following last treatment.

(2) Dogs—(i) Amount. 1 to 2 mg/lb body weight, once or twice daily.

(ii) Indications for use—(A) For treatment of edema (pulmonary congestion, ascites) associated with cardiac insufficiency and acute noninflammatory tissue edema.

(B) For treatment of edema (pulmonary congestion, ascites) associated with cardiac insufficiency.

(3) Cats—(i) Amount. 1 to 2 mg/lb body weight, once or twice daily.

(ii) Indications for use. For treatment of edema (pulmonary congestion, ascites) associated with cardiac insufficiency and acute noninflammatory tissue edema.

[66 FR 47960, Sept. 17, 2001, as amended at 69 FR 74419, Dec. 14, 2004; 70 FR 50182, Aug. 26, 2005; 70 FR 76396, Dec. 27, 2005; 74 FR 61516, Nov. 25, 2009; 78 FR 17596, Mar. 22, 2013]

§520.1044   Gentamicin sulfate oral dosage forms.

§520.1044a   Gentamicin sulfate oral solution.

(a) Specifications. Each milliliter of aqueous solution contains gentamicin sulfate equivalent to 50 milligrams of gentamicin.

(b) Sponsor. See Nos. 000061 and 054925 in §510.600(c) of this chapter.

(c) Related tolerances. See §556.300 of this chapter.

(d) Conditions of use—(1) Amount. Colibacillosis: 1 milliliter per 2 gallons of drinking water for 3 consecutive days, to provide 0.5 milligram/pound/day; swine dysentery: 1 milliliter per 1 gallon of drinking water for 3 consecutive days, to provide 1.0 milligram/pound/day.

(2) Indications for use. In weanling swine for control and treatment of colibacillosis caused by strains of E. coli sensitive to gentamicin, and in swine for control and treatment of swine dysentery associated with Treponema hyodysenteriae.

(3) Limitations. For use in swine drinking water only. Do not store or offer medicated drinking water in rusty containers since the drug is quickly destroyed in such containers. Medicated drinking water should be prepared daily and be the sole source of drinking water for 3 consecutive days. Treatment may be repeated if dysentery recurs. Do not slaughter treated swine for food for at least 3 days following treatment.

[48 FR 10302, Mar. 11, 1983. Redesignated at 49 FR 572, Jan. 5, 1984, and amended at 49 FR 14332, Apr. 11, 1984; 52 FR 7832, Mar. 13, 1987; 62 FR 34169, June 25, 1997; 71 FR 13542, Mar. 16, 2006]

§520.1044b   Gentamicin sulfate pig pump oral solution.

(a) Specifications. Each milliliter of pig pump oral solution contains gentamicin sulfate equivalent to 4.35 milligrams of gentamicin.

(b) Sponsor. See Nos. 000061 and 000859 in §510.600(c) of this chapter.

(c) Related tolerances. See §556.300 of this chapter.

(d) Conditions of use—(1) Amount. Administer 1.15 milliliters of pig pump oral solution (5 milligrams of gentamicin) orally per pig one time.

(2) Indications for use. In neonatal swine 1 to 3 days of age for control and treatment of colibacillosis caused by strains of E. coli sensitive to gentamicin.

(3) Limitations. For use in neonatal swine only. Do not slaughter treated swine for food for at least 14 days following treatment.

[49 FR 572, Jan. 5, 1984, as amended at 52 FR 7832, Mar. 13, 1987; 62 FR 29011, May 29, 1997; 78 FR 17596, Mar. 22, 2013]

§520.1044c   Gentamicin sulfate powder.

(a) Specifications. Each gram of powder contains gentamicin sulfate equivalent to:

(1) 16.7, 66.7, or 333.3 milligrams (mg) gentamicin.

(2) 333.3 mg gentamicin.

(b) Sponsors. See sponsors in §510.600(c) of this chapter for use as in paragraph (d) of this section as follows:

(1) No. 000061 for products described in paragraph (a)(1) of this section.

(2) Nos. 057561 and 061623 for product described in paragraph (a)(2) of this section.

(c) Related tolerances. See §556.300 of this chapter.

(d) Conditions of use in swine—(1) Amount. Administer in drinking water for 3 consecutive days as follows:

(i) For colibacillosis: Gentamicin sulfate equivalent to 25 mg of gentamicin per gallon of drinking water to provide 0.5 mg per pound of body weight per day;

(ii) For swine dysentery: Gentamicin sulfate equivalent to 50 mg of gentamicin per gallon of drinking water to provide 1 mg per pound of body weight per day. Treatment may be repeated if dysentery recurs.

(2) Indications for use. For control and treatment of colibacillosis in weanling swine caused by strains of Escherichia coli sensitive to gentamicin, and for control and treatment of swine dysentery associated with Treponema hyodysenteriae.

(3) Limitations. For use in swine drinking water only. Do not store or offer medicated drinking water in rusty containers since the drug is quickly destroyed in such containers. Medicated drinking water should be prepared daily and be the sole source of drinking water.

(4) Withdrawal period. 10 days.

[77 FR 4226, Jan. 27, 2012]

§520.1100   Griseofulvin.

(a) Specifications—(1) The powder complies with U.S.P. for griseofulvin, microsize.

(2) Each bolus contains 2.5 grams griseofulvin.

(3) Each tablet contains 125 or 500 milligrams griseofulvin.

(b) Sponsors. See sponsors in §510.600(c) of this chapter.

(1) No. 000061 for use of products described in paragraph (a) for use as in paragraph (d) of this section.

(2) No. 061623 for use of the powder described in paragraph (a)(1) for use as in paragraphs (d)(1)(i)(A) and (d)(1)(ii) of this section.

(c) Special considerations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(d) Conditions of use—(1) Horses—(i) Amount and indications for use—(A) For equine ringworm infection caused by Trichophyton equinum or Microsporum gypseum, administer soluble powder described in paragraph (a)(1) of this section daily as a drench or as a top dressing on feed for not less than 10 days as follows: adults, 2.5 grams; yearlings, 1.25 to 2.5 grams; and foals, 1.25 grams.

(B) For treating ringworm infection caused by T. equinum, administer boluses described in paragraph (a)(2) of this section daily for not less than 10 days as follows: adults, 1 bolus; yearlings, one-half to 1 bolus; and foals, one-half bolus.

(ii) Limitations. Not for use in horses intended for food.

(2) Dogs and cats: (i) Amount. 125- and 500-milligram tablets administered orally as follows:

(A) Daily (single or divided) dose:

Body weight (pounds)Dosage (milligrams)
Up to 662.5
6 to 18125
18 to 36250
36 to 48375
48 to 75500

(B) Weekly (single) dose: If experience indicates that treatment is more effective for the drug given in large doses, administer at intervals of 7 to 10 days, a dose equal to 10 milligrams/pound of body weight × body weight × number of days between treatments. Dosage should be adjusted according to response. Administer additional dose after the animal is free of infection.

(ii) Indications for use. For treatment of fungal infections of the skin, hair, and claws caused by Trichophyton mentagrophytes, T. rubrum, T. schoenleini, T. sulphurem, T. verrucosum, T. interdigitale, Epidermophyton floccosum, Microsporum gypseum, M. canis, M. audouini.

[40 FR 13838, Mar. 27, 1975, as amended at 41 FR 42948, Sept. 29, 1976; 43 FR 28458, June 30, 1978; 52 FR 7832, Mar. 13, 1987; 54 FR 30205, July 19, 1989; 71 FR 38073, July 5, 2006; 77 FR 28253, May 14, 2012]

§520.1120   Haloxon oral dosage forms.

§520.1120a   Haloxon drench.

(a) Chemical name. 3-Choloro-7-hydoxy-4-methylcoumarin bis (2-chloroethyl) phosphate.

(b) Specifications. Haloxon assay of not less than 96 percent by infrared spectrum at 8.62 microns.

(c) Sponsor. See No. 000061 in §510.600(c) of this chapter.

(d) Special considerations. Do not use any drug, insecticide, pesticide, or other chemical having cholinesterase-inhibiting activity either simultaneously or within a few days before or after treatment with haloxon.

(e) Related tolerances. See §556.310 of this chapter.

(f) Conditions of use. It is used as a drench as follows:

(1) Cattle—(i) Amount. 141.5 grams per packet.

(ii) Indications for use. Control of gastrointestinal roundworms of the genera Haemonchus, Ostertagia, Trichostrongylus, and Cooperia.

(iii) Limitations. (a) Dissolve each packet in 32 fluid ounces of water and administer as follows:

Weight of animal (pounds)Dose (fluid ounces)
Up to 1001/2
100 to 1503/4
150 to 2001
200 to 30011/2
300 to 4502
450 to 7003
700 to 1,0004
1,000 to 1,2005
Over 1,2006

(b) Do not treat within 1 week of slaughter; do not treat dairy animals of breeding age; animals should be retreated in 3 to 4 weeks.

[40 FR 13838, Mar. 27, 1975, as amended at 45 FR 10333, Feb. 15, 1980; 46 FR 48642, Oct. 2, 1981; 61 FR 8873, Mar. 6, 1996; 62 FR 61624, Nov. 19, 1997]

§520.1120b   Haloxon boluses.

(a) Chemical name. 3-Chloro-7-hydroxy-4-methylcoumarin bis (2-chloroethyl) phosphate.

(b) Specifications. Each bolus contains 10.1 grams of haloxon.

(c) Sponsor. See No. 000061 in §510.600(c) of this chapter.

(d) Related tolerances. See §556.310 of this chapter.

(e) Conditions of use. (1) Haloxon bolus is an anthelmintic used in cattle for the control of gastrointestinal roundworms of the genera Haemonchus, Ostertagia, Trichostrongylus and Cooperia.

(2) It is administered by giving one bolus per approximately 500 pounds body weight (35 to 50 milligrams per kilogram of body weight).

(3) For most effective results, re-treat animals in 3 to 4 weeks. If reinfection is likely to occur, additional re-treatments may be necessary.

(4) Do not use any drug, pesticide or other chemical having cholinesterase inhibiting activity either simultaneously or within a few days before or after treatment with haloxon.

(5) Do not treat animals within one week of slaughter.

(6) Do not treat dairy animals of breeding age or older.

[40 FR 13838, Mar. 27, 1975, as amended at 44 FR 61591, Oct. 29, 1979; 46 FR 48642, Oct. 2, 1981; 61 FR 8873, Mar. 6, 1996; 62 FR 61625, Nov. 19, 1997]

§520.1130   Hetacillin.

(a) Specifications.—(1) Each capsule or tablet contains hetacillin potassium equivalent to 50, 100, or 200 milligrams (mg) of ampicillin.

(2) Each milliliter of suspension contains hetacillin potassium equivalent to 50 mg of ampicillin.

(b) Sponsor. See No. 000010 in §510.600(c) of this chapter.

(c) Conditions of use in dogs and cats—(1) Amount—(i) Dogs. Administer 5 mg per pound (/lb) of body weight orally, twice daily. In severe infections, administer 5 mg/lb three times daily, or up to 10 mg/lb twice daily. For stubborn urinary tract infections, administer up to 20 mg/lb twice daily.

(ii) Cats. Administer 50 mg twice daily.

(2) Indications for use. For the treatment of respiratory tract infections, urinary tract infections, gastrointestinal infections, skin infections, soft tissue infections, and postsurgical infections associated with strains of organisms susceptible to hetacillin potassium.

(3) Limitations. Federal law restricts this drug to use only by or on the order of a licensed veterinarian.

[75 FR 10166, Mar. 5, 2010]

§520.1157   Iodinated casein tablets.

(a) Specifications. Each 1-gram tablet contains 25 milligrams of iodinated casein.

(b) Sponsor. See No. 017762 in §510.600(c) of this chapter.

(c) Conditions of use—(1) Amount. 15 to 1 tablet per 10 pounds of body weight (equivalent to 0.5 to 2.5 milligrams of iodinated casein per pound of body weight).

(2) Indications for use. For dogs for apparent decreased thyroid activity where the signs are alopecia, scaliness of the skin surface, loss of hair, seborrhea, thickening of the skin, hyperpigmentation, and lethargy.

(3) Limitations. If no response is observed in 30 to 45 days, the drug should be withdrawn and the diagnosis reconsidered. Do not use in the presence of cardiac disease, ischemia, adrenal insufficiency, or nephrosis. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[49 FR 22469, May 30, 1984]

§520.1158   Iodochlorhydroxyquin boluses.

(a) Specifications. Each bolus contains 10 grams of iodochlorhydroxyquin.

(b) Sponsor. See No. 053501 in §510.600(c) of this chapter.

(c) Conditions of use—(1) Amount. 1 bolus (10 grams) daily for a 1,000-pound horse.

(2) Indications for use. For treatment of equine diarrhea.

(3) Limitations. For horses only; not to be administered to food-producing animals. Do not administer to horses intended for use as food. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[48 FR 8054, Feb. 25, 1983, as amended at 50 FR 41489, Oct. 11, 1985]

§520.1182   Iron dextran suspension.

(a) Specifications. Each milliliter (mL) of suspension contains 55.56 milligrams (mg) iron as ferric hydroxide in complex with a low molecular weight dextran.

(b) Sponsor. See No. 051311 in §510.600(c) of this chapter.

(c) Conditions of use in swine—(1) Amount. Administer 100 mg (1.8 mL) orally by automatic dose dispenser.

(2) Indications for use. For the prevention of iron deficiency anemia in baby pigs.

(3) Limitations. Treat each pig within 24 hours of farrowing.

[70 FR 32489, June 3, 2005]

§520.1192   Ivermectin paste.

(a) Specifications. Each milligram (mg) of paste contains 0.0187 mg (1.87 percent) or 0.00153 mg (0.153 percent) of ivermectin.

(b) Sponsors. See sponsors in §510.600(c) of this chapter for use as in paragraph (e) of this section:

(1) No. 050604 for use of a 1.87 percent paste as in (e)(1) of this section and a 0.153 percent paste for use as in paragraph (e)(2) of this section.

(2) Nos. 000859, 051311, 054925, and 061623 for use of a 1.87 percent paste for use as in paragraph (e)(1) of this section.

(c) Related tolerances. See §556.344 of this chapter.

(d) Special considerations. See §500.25 of this chapter.

(e) Conditions of use—(1) Horses—(i) Amount. 200 micrograms per kilogram (91 micrograms per pound) of body weight.

(ii) Indications for use. For treatment and control of Large Strongyles (adults): Strongylus vulgaris (also early forms in blood vessels), S. edentatus (also tissue stages), S. equinus, Triodontophorus spp. including T. brevicauda and T. serratus, and Craterostomum acuticaudatum; Small Strongyles (adults, including those resistant to some benzimidazole class compounds): Coronocyclus spp. including C. coronatus, C. labiatus, and C. labratus, Cyathostomum spp. including C. catinatum and C. pateratum, Cylicocyclus spp. including C. insigne, C. leptostomum, C. nassatus, and C. brevicapsulatus, Cylicodontophorus spp., Cylicostephanus spp. including C. calicatus, C. goldi, C. longibursatus, and C. minutus, and Petrovinema poculatum; Small Strongyles (fourth-stage larvae); Pinworms (adults and fourth-stage larvae): Oxyuris equi; Ascarids (adults and third- and fourth-stage larvae): Parascaris equorum; Hairworms (adults): Trichostrongylus axei; Large mouth Stomach Worms (adults): Habronema muscae; Bots (oral and gastric stages): Gasterophilus spp. including G. intestinalis and G. nasalis; Lungworms (adults and fourth-stage larvae): Dictyocaulus arnfieldi; Intestinal Threadworms (adults): Strongyloides westeri; Summer Sores caused by Habronema and Draschia spp. cutaneous third-stage larvae; Dermatitis caused by neck threadworm microfilariae, Onchocerca sp.

(iii) Limitations. For oral use only. Do not use in horses intended for human consumption.

(2) Cattle—(i) Amount. 23 milligrams per 250 pounds of body weight.

(ii) Indications for use. It is used in cattle for the treatment and control of gastrointestinal roundworms (adults and fourth-stage larvae) (Ostertagia ostertagi (including inhibited forms), O. lyrata, Haemonchus placei, Trichostrongylus axei, T. colubriformis, Cooperia oncophora, C. punctata, Nematodirus helvetianus, Bunostomum phlebotomum, Strongyloides papillosus (adults only), Oesophagostomum radiatum, Trichuris ovis (adults only)); lungworms (adults and fourth-stage larvae) (Dictyocaulus viviparus); grubs (first, second, and third instars) (Hypoderma bovis, H. lineatum); and sucking lice (Linognathus vituli, Haematopinus eurysternus).

(iii) Limitations. For oral use only. Do not treat cattle within 24 days of slaughter. Because withdrawal time in milk has not been established, do not use in female dairy cattle of breeding age.

[49 FR 22275, May 29, 1984, as amended at 50 FR 27819, July 8, 1985; 51 FR 44449, Dec. 10, 1986; 53 FR 51273, Dec. 21, 1988; 62 FR 63270, Nov. 28, 1997; 65 FR 70661, Nov. 27, 2000; 67 FR 71820, Dec. 3, 2002; 68 FR 43294, July 22, 2003; 69 FR 59131, Oct. 4, 2004; 70 FR 8514, Feb. 22, 2005; 71 FR 40010, July 14, 2006; 71 FR 67298, Nov. 21, 2006; 73 FR 34184, June 17, 2008; 74 FR 6542, Feb. 10, 2009; 78 FR 17596, Mar. 22, 2013]

§520.1193   Ivermectin tablets and chewables.

(a) Specifications. (1) Each tablet or chewable contains 68, 136, or 272 micrograms (mcg) ivermectin.

(2) Each chewable contains 55 or 165 mcg ivermectin.

(b) Sponsors. See sponsors in §510.600(c) of this chapter for use as in paragraph (d) of this section.

(1) No. 050604 for use of tablets or chewables described in paragraph (a)(1) as in paragraph (d)(1) and chewables described in paragraph (a)(2) as in paragraph (d)(2) of this section.

(2) Nos. 051311 and 059130 for use of tablets described in paragraph (a)(1) as in paragraph (d)(1) of this section.

(c) Special considerations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(d) Conditions of use—(1) Dogs. For use in dogs 6 weeks of age and older as follows:

(i) Amount. 6.0 mcg per kilogram (kg) of body weight (2.72 mcg per pound (lb)), minimum. Up to 25 lb, 68 mcg; 26 to 50 lb, 136 mcg; 51 to 100 lb, 272 mcg; over 100 lb, a combination of the appropriate tablets. Administer at monthly dosing intervals.

(ii) Indications for use. To prevent canine heartworm disease by eliminating the tissue stage of heartworm larvae (Dirofilaria immitis) for 1 month (30 days) after infection.

(2) Cats. For use in cats 6 weeks of age and older as follows:

(i) Amount. Up to 2.3 kilograms (up to 5 lb), 55 mcg; 2.3 to 6.8 kilograms (5 to 15 lb), 165 mcg; over 6.8 kilograms (15 lb), a combination of the appropriate chewables (recommended minimum dose of 24 mcg/kg of body weight (10.9 mcg/lb)). Administer once a month.

(ii) Indications for use. To prevent feline heartworm disease by eliminating the tissue stage of heartworm larvae Dirofilaria immitis for a month (30 days) after infection, and for removal and control of adult and immature (L4) hookworms Ancylostoma tubaeforme and A. braziliense.

[67 FR 11230, Mar. 13, 2002, as amended at 67 FR 21996, May 2, 2002; 69 FR 43735, July 22, 2004]

§520.1194   Ivermectin meal.

(a) Specifications. Each gram of meal contains 6 milligrams ivermectin (0.6 percent).

(b) Sponsor. See No. 017135 in §510.600(c) of this chapter.

(c) Special considerations. See §500.25 of this chapter.

(d) Conditions of use in horses—(1) Amount. Administer 136 micrograms (mcg) ivermectin per pound (/lb) body weight (300 mcg/kilogram) as a single dose on approximately 2 lb grain or sweet feed.

(2) Indications for use. For treatment and control of Large Strongyles (adults): Strongylus vulgaris (also early forms in blood vessels), S. edentatus (also tissue stages), S. equinus, Triodontophorus spp. including T. brevicauda and T. serratus, and Craterostomum acuticaudatum; Small Strongyles (adults, including those resistant to some benzimidazole class compounds): Coronocyclus spp. including C. coronatus, C. labiatus, and C. labratus, Cyathostomum spp. including C. catinatum and C. pateratum, Cylicocyclus spp. including C. insigne, C. leptostomum, C. nassatus, and C. brevicapsulatus, Cylicodontophorus spp., Cylicostephanus spp. including C. calicatus, C. goldi, C. longibursatus, and C. minutus, and Petrovinema poculatum; Small Strongyles (fourth-stage larvae); Pinworms (adults and fourth stage larvae): Oxyuris equi; Ascarids (adults and third- and fourth-stage larvae): Parascaris equorum; Hairworms (adults): Trichostrongylus axei; Large Mouth Stomach Worms (adults): Habronema muscae; Bots (oral and gastric stages): Gasterophilus spp. including G. intestinalis and G. nasalis; Lungworms (adults and fourth-stage larvae): Dictyocaulus arnfieldi; Intestinal Threadworms (adults): Strongyloides westeri; Summer Sores caused by Habronema and Draschia spp. cutaneous third-stage larvae; Dermatitis caused by neck threadworm microfilariae, Onchocerca sp.

Limitations. Do not use in horses intended for human consumption.

[70 FR 1817, Jan. 11, 2005, as amended at 70 FR 19262, Apr. 13, 2005]

§520.1195   Ivermectin liquid.

(a) Specifications—(1) Each milliliter (mL) contains 10 milligrams (mg) ivermectin.

(2) Each mL of micellar solution contains 0.8 mg ivermectin.

(b) Sponsors. See sponsor numbers in §510.600(c) of this chapter.

(1) Nos. 000859, 050604, 054925, and 058005 for use of product described in paragraph (a)(1) of this section as in paragraphs (e)(1)(i), (e)(1)(ii)(A), and (e)(1)(iii) of this section.

(2) No. 058829 for use of product described in paragraph (a)(1) of this section as in paragraphs (e)(1)(i), (e)(1)(ii)(B), and (e)(1)(iii) of this section.

(3) Nos. 050604 and 058829 for use of product described in paragraph (a)(2) of this section as in paragraph (e)(2) of this section.

(c) Related tolerances. See §556.344 of this chapter.

(d) Special considerations. See §500.25 of this chapter.

(e) Conditions of use—(1) Horses—(i) Amount. 200 micrograms (mcg) per kilogram (/kg) of body weight as a single dose by stomach tube or as an oral drench.

(ii) Indications for use. For treatment and control of:

(A) Large Strongyles (adults): Strongylus vulgaris (also early forms in blood vessels), S. edentatus (also tissue stages), S. equinus, Triodontophorus spp. including T. brevicauda and T. serratus, and Craterostomum acuticaudatum; Small Strongyles (adults, including those resistant to some benzimidazole class compounds): Coronocyclus spp. including C. coronatus, C. labiatus, and C. labratus, Cyathostomum spp. including C. catinatum and C. pateratum, Cylicocyclus spp. including C. insigne, C. leptostomum, C. nassatus, and C. brevicapsulatus, Cylicodontophorus spp., Cylicostephanus spp. including C. calicatus, C. goldi, C. longibursatus, and C. minutus, and Petrovinema poculatum; Small Strongyles (fourth-stage larvae); Pinworms (adults and fourth stage larvae): Oxyuris equi; Ascarids (adults and third- and fourth-stage larvae): Parascaris equorum; Hairworms (adults): Trichostrongylus axei; Large mouth Stomach Worms (adults): Habronema muscae; Bots (oral and gastric stages): Gasterophilus spp. including G. intestinalis and G. nasalis; Lungworms (adults and fourth-stage larvae): Dictyocaulus arnfieldi; Intestinal Threadworms (adults), Strongyloides westeri; Summer Sores caused by Habronema and Draschia spp. cutaneous third-stage larvae; Dermatitis caused by neck threadworm microfilariae, Onchocerca sp.

(B) Large Strongyles (Strongylus equinus (adult), S. vulgaris (adult and arterial larval stages), S. endentatus (adult and migrating tissue stages), Triodontophorus spp. (adult)); Small Strongyles including those resistant to some benzimidazole class compounds (Cyathostomum spp. (adult and fourth-stage larvae), Cylicocyclus spp., Cylicodontophorus spp., Cylicostephanus spp.); Pinworms (Oxyuris equi (adult and fourth-stage larvae)); Ascarids (Parascaris equorum (adult and third- and fourth-stage larvae)); Hairworms (Trichostongylus axei(adult)); Large mouth Stomach Worms (Habronema muscae (adult)); Stomach Bots (Gastrophilus spp. (oral and gastric stages)); Lungworms (Dictyocaulus arnfieldi (adult and fourth-stage larvae)); intestinal threadworms (Strongyloides westeri (adult)); Summer Sores caused by Habronema and Draschia spp. cutaneous third-stage larvae; and Dermatitis caused by neck threadworm microfilariae (Onchocerca spp.).

(iii) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) Sheep—(i) Amount. 200 mcg/kg (3 mL/26 pounds) of body weight as a single dose oral drench.

(ii) Indications for use. For treatment and control of the adult and fourth-stage larvae of gastrointestinal roundworms (Haemonchus contortus, H. placei (adults only), Ostertagia circumcincta, Trichostrongylus axei, T. colubriformis, Cooperia oncophora (adults only), C. curticei, Oesophagostomum columbianum, O. venulosum(adults only), Nematodirus battus, N. spathiger, S. papillosus (adults only), Chabertia ovina (adult only), Trichuris ovis (adults only)); lungworms (D. filaria); and all larval stages of the nasal bot Oestrus ovis.

(iii) Limitations. For use in sheep only. Do not use in other animal species as severe adverse reactions, including fatalities in dogs, may result. Do not treat sheep within 11 days of slaughter.

[67 FR 50597, Aug. 5, 2002, as amended at 69 FR 57173, Sept. 24, 2004; 71 FR 13542, Mar. 16, 2006; 71 FR 38072, July 5, 2006; 72 FR 9456, Feb. 21, 2008; 78 FR 17596, Mar. 22, 2013; 79 FR 10964, Feb. 27, 2014]

§520.1196   Ivermectin and pyrantel pamoate chewable tablets.

(a) Specifications. Each chewable tablet contains either 68 micrograms (µg) of ivermectin and 57 milligrams (mg) of pyrantel (as pamoate salt), or 136 µg and 114 mg, or 272 µg and 227 mg, respectively.

(b) Sponsors. See Nos. 050604, 051311, and 063604 in §510.600(c) of this chapter.

(c) Conditions of use—(1) Dogs—(i) Amount. A minimum of 6 µg of ivermectin and 5 mg of pyrantel (as pamoate salt) per kilogram (2.72 µg and 2.27 mg per pound) of body weight.

(ii) Indications for use. To prevent canine heartworm disease by eliminating the tissue larval stages of Dirofilaria immitis for up to a month (30 days) after infection and treatment and control of adult ascarids Toxocara canis and Toxascaris leonina, and adult hookworms Ancylostoma caninum, A. braziliense, and Uncinaria stenocephala.

(iii) Limitations. Use monthly. Recommended for dogs 6 weeks of age and older. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) [Reserved]

[58 FR 8542, Feb. 16, 1993, as amended at 61 FR 15186, Apr. 5, 1996; 61 FR 59004, Nov. 20, 1996; 62 FR 63270, Nov. 28, 1997; 66 FR 35756, July 9, 2001; 67 FR 21996, May 2, 2002; 68 FR 55823, Sept. 29, 2003]

§520.1197   Ivermectin sustained-release bolus.

(a) Specifications. Each sustained-release bolus contains 1.72 grams of ivermectin.

(b) Sponsor. See No. 050604 in §510.600(c) of this chapter.

(c) Related tolerances. See §556.344 of this chapter.

(d) Conditions of use in ruminating calves—(1) Amount. Administer one bolus per calf weighing at least 275 pounds (lb) (125 kilograms (kg)) and not more than 660 lb (300 kg) on the day of administration.

(2) Indications. For treatment and control, throughout the grazing season (approximately 130 days), of gastrointestinal roundworms Haemonchus placei, Ostertagia ostertagi (including inhibited fourth-stage larvae), Trichostrongylus axei, T. colubriformis, Cooperia spp., Nematodirus helvetianus, Bunostomum phlebotomum, Oesophagostomum radiatum; lungworms Dictyocaulus viviparus; grubs Hypoderma spp.; sucking lice Linognathus vituli, Solenopotes capillatus; mange mites Psoroptes ovis, Sarcoptes scabiei, and ticks Amblyomma americanum.

(3) Limitations. The bolus was specifically designed for use in cattle; do not use in other animal species. Calves must be ruminating and older than 12 weeks of age. Do not administer to calves weighing less than 275 lb (125 kg). Do not administer a damaged bolus. Because a milk withdrawal time has not been established, do not use in female dairy cattle of breeding age. Do not slaughter cattle within 180 days of treatment. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.

[61 FR 67452, Dec. 23, 1996, as amended at 62 FR 63270, Nov. 28, 1997; 65 FR 45876, July 26, 2000]

§520.1198   Ivermectin and praziquantel paste.

(a) Specifications. Each milligram (mg) of paste contains:

(1) 0.0155 mg (1.55 percent) ivermectin and 0.0775 mg (7.75 percent) praziquantel.

(2) 0.0187 mg (1.87 percent) ivermectin and 0.1403 mg (14.03 percent) praziquantel.

(b) Sponsors. See sponsors in §510.600(c) of this chapter for uses as in paragraph (d) of this section.—

(1) No. 050604 for use of product described in paragraph (a)(1) of this section as in paragraphs (d)(1)(i), (d)(2)(i) and (d)(3) of this section.

(2) No. 051311 for use of product described in paragraph (a)(2) of this section as in paragraphs (d)(1)(ii), (d)(2)(ii), and (d)(3) of this section.

(c) Special considerations. See §500.25 of this chapter.

(d) Conditions of use in horses—(1) Amount—(i) 200 micrograms (mcg) per kilogram (/kg) ivermectin (91 mcg per pound (/lb)) and 1 mg/kg praziquantel (454 mcg/lb) body weight.

(ii) 200 mcg/kg ivermectin (91 mcg/lb) and 1.5 mg/kg praziquantel (681 mcg/lb) body weight.

(2) Indications for use. For treatment and control of:

(i) Tapeworms—Anoplocephala perfoliata; Large strongyles (adults)—Strongylus vulgaris (also early forms in blood vessels), S. edentatus (also tissue stages), S. equinus, Triodontophorus spp. including T. brevicauda and T. serratus, and Craterostomum acuticaudatum; Small Strongyles (adults, including those resistant to some benzimidazole class compounds)—Coronocyclus spp. including C. coronatus, C. labiatus, and C. labratus, Cyathostomum spp. including C. catinatum and C. pateratum, Cylicocyclus spp. including C. insigne, C. leptostomum, C. nassatus, and C. brevicapsulatus, Cylicodontophorus spp., Cylicostephanus spp. including C. calicatus, C. goldi, C. longibursatus, and C. minutus, and Petrovinema poculatum; Small Strongyles—fourth-stage larvae; Pinworms (adults and fourth-stage larvae)—Oxyuris equi; Ascarids (adults and third- and fourth-stage larvae)—Parascaris equorum; Hairworms (adults)—Trichostrongylus axei; Large-mouth Stomach Worms (adults)—Habronema muscae; Bots (oral and gastric stages)—Gasterophilus spp. including G. intestinalis and G. nasalis; Lungworms (adults and fourth-stage larvae)—Dictyocaulus arnfieldi; Intestinal Threadworms (adults)—Strongyloides westeri; Summer Sores caused by Habronema and Draschia spp. cutaneous third-stage larvae; Dermatitis caused by neck threadworm microfilariae, Onchocerca sp.

(ii) Tapeworms—Anoplocephala perfoliata; Large Strongyles (adults)—Strongylus vulgaris (also early forms in blood vessels), S.edentatus (also tissue stages), S. equinus, Triodontophorus spp.; Small Strongyles (adults, including those resistant to some benzimidazole class compounds)—Cyathostomum spp., Cylicocyclus spp., Cylicostephanus spp., Cylicodontophorus spp.; Small Strongyles—fourth-stage larvae; Pinworms (adults and fourth-stage larvae)—Oxyuris equi; Ascarids (adults and third- and fourth-stage larvae)—Parascaris equorum; Hairworms (adults)—Trichostrongylus axei; Large-mouth Stomach Worms (adults)—Habronema muscae; Bots (oral and gastric stages)—Gasterophilus spp.; Lungworms (adults and fourth-stage larvae)—Dictyocaulus arnfieldi; Intestinal Threadworms (adults)—Strongyloides westeri; Summer Sores caused by Habronema and Draschia spp. cutaneous third-stage larvae; Dermatitis caused by neck threadworm microfilariae, Onchocerca sp.

(3) Limitations. For oral use only. Do not use in horses intended for human consumption.

[68 FR 55309, Sept. 25, 2003, as amended at 69 FR 49808, Aug. 12, 2004; 70 FR 65835, Nov. 1, 2005]

§520.1199   Ivermectin, pyrantel, and praziquantel tablets.

(a) Specifications. Each chewable tablet contains:

(1) 34 micrograms (mcg) ivermectin, 28.5 milligrams (mg) pyrantel pamoate, and 28.5 mg praziquantel;

(2) 68 mcg ivermectin, 57 mg pyrantel pamoate, and 57 mg praziquantel;

(3) 136 mcg ivermectin, 114 mg pyrantel pamoate, and 114 mg praziquantel; or

(4) 272 mcg ivermectin, 228 mg pyrantel pamoate, and 228 mg praziquantel.

(b) Sponsors. See No. 051311 in §510.600(c) of this chapter.

(c) Conditions of use in dogs—(1) Amount. Administer monthly according to body weight as follows:

(i) 6 to 12 lb: one tablet as described in paragraph (a)(1) of this section.

(ii) 12.1 to 25 lb: one tablet as described in paragraph (a)(2) of this section.

(iii) 25.1 to 50 lb: one tablet as described in paragraph (a)(3) of this section.

(iv) 50.1 to 100 lb: one tablet as described in paragraph (a)(4) of this section.

(v) Greater than 100 lb: use the appropriate combination of tablets.

(2) Indications for use. Prevents canine heartworm disease by eliminating the tissue stage of heartworm larvae (Dirofilaria immitis) for 1 month (30 days) after infection and for the treatment and control of roundworm (Toxocara canis, Toxascaris leonina), hookworm (Ancylostoma caninum, Uncinaria stenocephala, Ancylostoma braziliense) and tapeworm (Dipylidium caninum, Taenia pisiformis) infections.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[71 FR 65052, Nov. 7, 2006]

§520.1200   Ivermectin, fenbendazole, and praziquantel tablets.

(a) Specifications. Each chewable tablet contains either:

(1) 68 micrograms (µg) ivermectin, 1.134 grams fenbendazole, and 57 milligrams (mg) praziquantel; or

(2) 27 µg ivermectin, 454 mg fenbendazole, and 23 mg praziquantel.

(b) Sponsor. See No. 000061 in §510.600(c) of this chapter.

(c) Conditions of use in dogs—(1) Amount. Administer tablets to provide 6 µg per kilogram (/kg) ivermectin, 100 mg/kg fenbendazole, and 5 mg/kg praziquantel.

(2) Indications for use. For the treatment and control of adult Toxocara canis (roundworm), Ancylostoma caninum (hookworm), Trichuris vulpis (whipworm), and Dipylidium caninum (tapeworm), and for the prevention of heartworm disease caused by Dirofilaria immitis in adult dogs.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[73 FR 33692, June 13, 2008, as amended at 74 FR 61516, Nov. 25, 2009]

§520.1204   Kanamycin, bismuth subcarbonate, activated attapulgite.

(a) Specifications—(1) Each 5 milliliters (mL) of suspension contains 100 milligrams (mg) kanamycin (as the sulfate), 250 mg bismuth subcarbonate, and 500 mg activated attapulgite (aluminum magnesium silicate).

(2) Each tablet contains 100 mg kanamycin (as the sulfate), 250 mg bismuth subcarbonate, and 500 mg activated attapulgite.

(b) Sponsor. See No. 000856 in §510.600(c) of this chapter.

(c) Conditions of use in dogs—(1) Amount. 5 mL of suspension or 1 tablet per 20 pounds body weight every 8 hours. Maximum dose: 5 mL of suspension or 3 tablets every 8 hours. Dogs under 10 pounds: 2.5 mL of suspension or 12 tablet every 8 hours. A recommended initial loading dose should be twice the amount of a single dose.

(2) Indications for use. For the treatment of bacterial enteritis caused by organisms susceptible to kanamycin and the symptomatic relief of the associated diarrhea.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[40 FR 13838, Mar. 27, 1975, as amended at 53 FR 27851, July 25, 1988; 56 FR 8710, Mar. 1, 1991; 64 FR 403, Jan. 5, 1999; 71 FR 43968, Aug. 3, 2006]

§520.1242   Levamisole.

§520.1242a   Levamisole powder.

(a) Specifications. Each package of powder contains 9.075, 11.7, 18.15, 46.8, 362.7, or 544.5 grams (g) levamisole hydrochloride.

(b) Sponsors. See sponsors in §510.600(c) for use as follows:

(1) No. 000061 for use of 46.8- and 544.5-g packages as in paragraph (e)(1)(i), (e)(1)(ii)(B), and (e)(1)(iii) of this section; for 11.7-, 46.8-, and 544.5-g packages as in paragraph (e)(2)(i), (e)(2)(ii)(B), and (e)(2)(iii) of this section; and for an 18.15-g package as in paragraph (e)(3) of this section.

(2) No. 053501 for use of a 46.8-g package as in paragraph (e)(1)(i), (e)(1)(ii)(A), and (e)(1)(iii) of this section; for 11.7- and 46.8-g packages as in paragraph (e)(2)(i), (e)(2)(ii)(A), and (e)(2)(iii) of this section; and for 9.075- and 18.15-g packages as in paragraph (e)(3) of this section.

(3) No. 057561 for use of 46.8- and 544.5-g packages as in paragraphs (e)(1)(i), (e)(1)(ii)(A), and (e)(1)(iii) and (e)(2)(i), (e)(2)(ii)(A), and (e)(2)(iii) of this section.

(4) No. 059130 for use of 46.8-, 362.7-, and 544.5-g packages as in paragraphs (e)(1)(i), (e)(1)(ii)(B), (e)(1)(iii), (e)(2)(i), (e)(2)(ii)(B), and (e)(2)(iii) of this section; and for use of an 18.15-g package as in paragraph (e)(3) of this section.

(c) Related tolerances. See §556.350 of this chapter.

(d) Special considerations. See §500.25 of this chapter.

(e) Conditions of use. It is used as an anthelmintic as follows:

(1) Cattle—(i) Amount. 8 milligrams per kilogram (mg/kg) body weight as a drench.

(ii) Indications for use—(A) Effective against the following nematode infections: Stomach worms (Haemonchus, Trichostrongylus, Ostertagia); intestinal worms (Trichostrongylus, Cooperia, Nematodirus, Bunostomum, Oesophagostomum); and lungworms (Dictyocaulus).

(B) Effective against the following adult nematode infections: Stomach worms (Haemonchus placei, Ostertagia ostertagi, Trichostrongylus axei); intestinal worms (T. longispicularis, Cooperia oncophora, C. punctata, Nematodirus spathiger, Bunostomum phlebotomum, Oesophagostomum radiatum); and lungworms (Dictyocaulus viviparus).

(iii) Limitations. Do not slaughter for food within 48 hours of treatment. Not for use in dairy animals of breeding age. Conditions of constant helminth exposure may require retreatment 2 to 4 weeks after the first treatment. Consult your veterinarian before using in severely debilitated animals.

(2) Sheep—(i) Amount. 8 mg/kg body weight as a drench.

(ii) Indications for use—(A) Effective against the following nematode infections: Stomach worms (Haemonchus, Trichostrongylus, Ostertagia); intestinal worms (Trichostrongylus, Cooperia, Nematodirus, Bunostomum, Oesophagostomum, Chabertia); and lungworms (Dictyocaulus).

(B) Effective against the following adult nematode infections: Stomach worms (Haemonchus contortus, Trichostrongylus axei, Teladorsagia circumcincta); intestinal worms (Trichostrongylus colubriformis, Cooperia curticei, Nematodirus spathiger, Bunostomum trigonocephalum, Oesophagostomum columbianum, Chabertia ovina), and lungworms (Dictyocaulus filaria).

(iii) Limitations. Do not slaughter for food within 72 hours of treatment. Conditions of constant helminth exposure may require retreatment 2 to 4 weeks after the first treatment. Consult veterinarian before using in severely debilitated animals.

(3) Swine—(i) Amount. 8 mg/kg body weight in drinking water.

(ii) Indications for use. Effective against the following nematode infections: Large roundworms (Ascaris suum), nodular worms (Oesophagostomum spp.), intestinal thread worms (Strongyloides ransomi) and lungworms (Metastrongylus spp. ).

(iii) Limitations. Do not administer within 72 hours of slaughter for food. Pigs maintained under conditions of constant exposure to worms may require retreatment within 4 to 5 weeks after the first treatment. Consult your veterinarian before administering to sick swine.

[69 FR 9753, Mar. 2, 2004, as amended at 69 FR 33839, June 17, 2004; 70 FR 2353, Jan. 13, 2005; 77 FR 28253, May 14, 2012]

§520.1242b   Levamisole hydrochloride tablet or oblet (bolus).

(a) Chemical name. (-)-2,3,5,6-Tetrahydro-6-phenylimidazo [2,1-b] thiazole monohydrochloride.

(b) Specifications. Assay of not less than 98 percent by nonaqueous titration with 0.1 N potassium isopropoxide; 1 isomer minimum 95 percent pure by optical rotation.

(c) Sponsor. See Nos. 000061 and 053501 in §510.600(c) of this chapter.

(d) Required labeling. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.

(e) Related tolerances. See §556.350 of this chapter.

(f) Conditions of use. (1) It is used in an oblet for cattle as follows:

(i) Amount. 2.19 grams per oblet.

(ii) Indications for use. Anthelmintic effective against the following nematode infections: Stomach worms (Haemonchus, Trichostrongylus, Ostertagia), intestinal worms (Trichostrongylus, Cooperia, Nematodirus, Bunostomum, Oesophagostomum), and lungworms (Dictyocaulus).

(iii) Limitations. Administer as a single dose as follows: 250 to 450 pounds, 12 oblet; 450 to 750 pounds, 1 oblet; and 750 to 1,050 pounds, 112 oblets; conditions of constant helminth exposure may require re-treatment within 2 to 4 weeks after the first treatment; do not slaughter for food within 48 hours of treatment; not for use in dairy animals of breeding age; consult veterinarian before using in severely debilitated animals.

(2) It is used in a tablet for sheep as follows:

(i) Amount. 0.184 gram per tablet.

(ii) Indications for use. Anthelmintic effective against the following nematode infections: Stomach worms (Haemonchus, Trichostrongylus, Ostertagia), intestinal worms (Trichostrongylus, Cooperia, Nematodirus, Bunostomum, Oesophagostomum, Chabertia), and lungworms (Dictyocaulus).

(iii) Limitations. Administer one tablet for each 50 pounds of body weight; conditions of constant helminth exposure may require re-treatment within 2 to 4 weeks after the first treatment; do not slaughter for food within 72 hours of treatment; consult a veterinarian before using in severely debilitated animals.

[40 FR 13838, Mar. 27, 1975, as amended at 44 FR 59507, Oct. 16, 1979; 62 FR 61625, Nov. 19, 1997; 67 FR 63055, Oct. 10, 2002]

§520.1242c   Levamisole hydrochloride and piperazine dihydrochloride.

(a) Specifications. (1) The drug is an aqueous solution which contains in each fluid ounce 0.36 gram of levamisole hydrochloride and piperazine dihydrochloride equivalent to 3.98 grams of piperazine base.

(2) The drug is a soluble powder which when reconstituted with water contains in each fluid ounce 0.45 gram of levamisole hydrochloride and piperazine dihydrochloride equivalent to 5.0 grams of piperazine base.

(b) Sponsor. See No. 053501 in §510.600(c) of this chapter.

(c) [Reserved]

(d) Conditions of use. It is used as a drench for horses as follows:

(1) Indications for use. An anthelmintic effective against infections of large strongyles (Strongylus vulgaris, S. edentatus), small strongyles (Cylicocercus spp., Cylicocylclus spp., Cylicodontophorus spp., Cylicostephanus spp., Cylicotetrapedon spp. ), ascarids (Parascaris equorum), and pinworms (Oxyuris equii).

(2) Limitations. Aqueous solution: administer by stomach tube or drench 1 fluid ounce per 100 pounds of body weight. Reconstituted soluble powder: administer by stomach tube 1 fluid ounce per 125 pounds of body weight. If reinfection occurs, re-treat animals at 6- to 8-week intervals. Do not treat animals intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[40 FR 32831, Aug. 5, 1975, as amended at 41 FR 48731, Nov. 5, 1976; 43 FR 11176 Mar. 17, 1978; 67 FR 63055, Oct. 10, 2002]

§520.1242d   Levamisole resinate.

(a) Specifications. The drug is levamisole adsorbed on a resin, in a concentration equivalent to 10 percent levamisole hydrochloride. Each 2.05-ounce (58.1 gram) packet contains levamisole equivalent to 5.806 grams of levamisole hydrochloride.

(b) Sponsor. See No. 043781 in §510.600(c) of this chapter.

(c) Related tolerances. See §556.350 of this chapter.

(d) Conditions of use. In swine it is used as follows:

(1) Amount. The equivalent of 8 milligrams per kilogram of body weight, as a single dose, mixed in the animal's ration.

(2) Indications for use. For the removal of and control of the following nematode infections: large roundworms (Ascaris suum), nodular worms (Oesophagostomum spp.), lungworms (Metastrongylus spp.), intestinal threadworms (Strongyloides ransomi), and swine kidney worms (Stephanurus dentatum).

(3) Limitations. For pigs from weaning to market weight, mix one 58.1-gram packet of levamisole resinate containing the equivalent of 10-percent levamisole hydrochloride in 40 pounds of feed and administer 1 pound of medicated feed per 40 pounds of body weight as sole ration. For breeding swine, mix 1 packet of the 10-percent resinate in 16 pounds of feed and administer 1 pound of medicated feed per 100 pounds of body weight as sole ration. Administer as single doses. Withhold regular feed overnight and administer medicated feed the following morning. Do not withhold water during fasting. Do not treat within 72 hours of slaughter. Salivation or muzzle foam may be observed. The reaction will disappear a short time after feeding. If pigs are infected with mature lungworms, coughing and vomiting may be observed. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.

[43 FR 18171, Apr. 28, 1978, as amended at 45 FR 3574, Jan. 18, 1980]

§520.1242e   Levamisole hydrochloride effervescent tablets.

(a) Specifications. Each tablet contains 907 milligrams of levamisole hydrochloride.

(b) Sponsor. See No. 053501 in §510.600(c) of this chapter.

(c) Related tolerances. See §556.350 of this chapter.

(d) Conditions of use. It is used for swine as follows:

(1) Amount. The equivalent of 8 milligrams of levamisole hydrochloride per kilogram of body weight, as a single dose.

(2) Indications for use. See §520.1242a(f)(3)(ii).

(3) Limitations. Withholding water from pigs before treatment is not necessary. Add one tablet for each 212 gallons of water; mix thoroughly. Allow 1 gallon of medicated water for each 100 pounds body weight of pigs to be treated. No other source of water should be offered. After pigs have consumed medicated water, resume use of regular water. Pigs maintained under conditions of constant worm exposure may require re-treatment within 4 to 5 weeks. Consult your veterinarian before administering to sick swine. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. Do not administer within 72 hours of slaughter for food.

[45 FR 6087, Jan. 25, 1980, as amended at 67 FR 63055, Oct. 10, 2002]

§520.1242f   Levamisole hydrochloride gel.

(a) Specifications. The drug is a gel containing 11.5 percent levamisole hydrochloride.

(b) Sponsor. See No. 053501 in §510.600(c) of this chapter.

(c) Related tolerances. See §556.350 of this chapter.

(d) Conditions of use—(1) Cattle—(i) Amount. Eight milligrams of levamisole hydrochloride per kilogram of body weight, as a single oral dose.

(ii) Indications for use. Anthelmintic effective against the following nematode infections: Stomach worms (Haemonchus, Trichostrongylus, Ostertagia), intestinal worms (Trichostrongylus, Cooperia, Nematodirus, Bunostomum, Oesophagostomum), and lungworms (Dictyocaulus).

(iii) Limitations. Conditions of constant helminth exposure may require re-treatment within 2 to 4 weeks after the first treatment; do not administer to cattle within 6 days of slaughter for food; do not administer to dairy animals of breeding age; consult veterinarian before using in severely debilitated animals.

(2) Breeding swine—(i) Amount. Eight milligrams per kilogram of body weight (3.6 milligrams per pound) as a single oral dose.

(ii) Conditions of use. For treating breeding swine infected with the following nematodes: Large roundworms (Ascaris suum), nodular worms (Oesophagostomum spp.), lungworms (Metastrongylus spp.), intestinal threadworms (Strongyloides ransomi), and kidney worms (Stephanurus dentatus).

(iii) Limitations. May require retreatment in 4 to 5 weeks. Do not use within 11 days of slaughter for food. Consult your veterinarian for assistance before using in severely debilitated animals and in the diagnosis, treatment, and control of parasitism.

[47 FR 22517, May 25, 1982; 47 FR 30242, July 13, 1982, as amended at 48 FR 11429, Mar. 18, 1983; 51 FR 29215, Aug. 15, 1986; 67 FR 63055, Oct. 10, 2002]

§520.1242g   Levamisole resinate and famphur paste.

(a) Chemical name of famphur. O, O-Dimethyl O-[p-(dimethylsulfamoyl) phenyl] phosphorothioate.

(b) Specifications. The drug is a paste containing 11.6 percent levamisole resinate (50 percent potency) and 23.6 percent famphur.

(c) Sponsor. See 000061 in §510.600(c) of this chapter.

(d) Special considerations. Do not use any cholinesterase-inhibiting drugs, pesticides, insecticides, or chemicals on cattle simultaneously or within a few days before or after treatment with this product.

(e) Related tolerances. See §556.350 of this chapter for levamisole and §556.273 of this chapter for famphur.

(f) Conditions of use in cattle—(1) Amount. 8 milligrams of levamisole hydrochloride (equivalent) and 30 milligrams of famphur activity per kilogram of body weight.

(2) Indications for use. For treatment of cattle infected with the following parasites: Stomach worms (Haemonchus, Trichostrongylus, Ostertagia), intestinal worms (Trichostrongylus, Cooperia, Nematodirus, Bunostomum, Oesophagostomum), lungworms (Dictyocaulus), cattle grubs (Hypoderma), biting lice (Bovicola), and sucking lice (Linognathus, Solenoptes).

(3) Limitations. Drug is not effective against lice eggs. Conditions of constant helminth and ectoparasitic exposure may require retreatment within 2 to 4 weeks after first treatment. Do not administer to cattle within 19 days of slaughter. Do not administer to dairy animals of breeding age. Do not use in calves less than 3 months old, or in debilitated animals. Do not treat Brahman bulls. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.

[53 FR 23757, June 24, 1988, as amended at 54 FR 1353, Jan. 13, 1989; 57 FR 7652, Mar. 4, 1992; 62 FR 55160, Oct. 23, 1997; 62 FR 61625, Nov. 19, 1997]

§520.1263   Lincomycin.

§520.1263a   Lincomycin hydrochloride monohydrate tablets and sirup.

(a) Specifications. The sirup contains lincomycin hydrochloride equivalent to either 25 milligrams or 50 milligrams of lincomycin.

(b) Sponsor. See No. 000009 in §510.600(c) of this chapter.

(c) Conditions of use. (1) The drug is indicated in infections caused by gram-positive organisms which are sensitive to its action, particularly streptococci and staphylococci.

(2) It is administered orally to dogs and cats at a dosage level of 10 mgs per pound of body weight every 12 hours, or 7 mgs per pound of body weight every 8 hours. Treatment may be continued for periods as long as 12 days if clinical judgment indicates.

(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[40 FR 13838, Mar. 27, 1975, as amended at 44 FR 7130, Feb. 6, 1979; 64 FR 403, Jan. 5, 1999]

§520.1263b   [Reserved]

§520.1263c   Lincomycin powder.

(a) Specifications. Each gram of soluble powder contains lincomycin hydrochloride equivalent to 0.4 grams of lincomycin.

(b) Sponsors. See sponsor numbers in §510.600(c) of this chapter for use as in paragraph (d) of this section.

(1) No. 000009 for use as in paragraph (d) of this section.

(2) Nos. 046573, 054925, 061623, and 076475 for use as in paragraphs (d)(1) and (d)(2) of this section.

(c) Tolerances. See §556.360 of this chapter.

(d) Conditions of use—(1) Swine—(i) Amount. 250 milligrams per gallon of drinking water to provide 3.8 milligrams per pound of body weight per day.

(ii) Indications for use. For the treatment of swine dysentery (bloody scours).

(iii) Limitations. Discard medicated drinking water if not used within 2 days. Prepare fresh stock solution daily. Do not use for more than 10 days. If clinical signs of disease have not improved within 6 days, discontinue treatment and reevaluate diagnosis. The safety of lincomycin has not been demonstrated in pregnant swine or swine intended for breeding. For No. 051259: Do not slaughter swine for 6 days following last treatment.

(2) Chickens—(i) Amount. 64 milligrams per gallon of drinking water.

(ii) Indications for use. For the control of necrotic enteritis caused by Clostridium perfringens susceptible to lincomycin in broiler chickens.

(iii) Limitations. Discard medicated drinking water if not used within 2 days. Prepare fresh stock solution daily. Administer for 7 consecutive days. Do not allow rabbits, hamsters, guinea pigs, horses, or ruminants access to water containing lincomycin. Not for use in layer and breeder chickens.

(3) Honey bees—(i) Amount. Mix 100 milligrams lincomycin with 20 grams confectioners'/powdered sugar and dust over the top bars of the brood chamber once weekly for 3 weeks.

(ii) Indications for use. For the control of American foulbrood (Paenibacillus larvae).

(iii) Limitations. The drug should be fed early in the spring or late in the fall and consumed by the bees before the main honey flow begins to avoid contamination of production honey. Complete treatments at least 4 weeks before main honey flow.

[48 FR 3966, Jan. 28, 1983, as amended at 55 FR 3209, Jan. 31, 1990; 60 FR 14217, Mar. 16, 1995; 62 FR 65020, Dec. 10, 1997; 64 FR 13341, Mar. 18, 1999; 64 FR 13508, Mar. 19, 1999; 64 FR 66382, Nov. 26, 1999; 65 FR 10705, Feb. 29, 2000; 67 FR 17284, Apr. 10, 2002; 67 FR 71819, Dec. 3, 2002; 67 FR 78356, Dec. 24, 2002; 68 FR 3817, Jan. 27, 2003; 70 FR 1818, Jan. 11, 2005; 77 FR 20988, Apr. 9, 2012; 77 FR 29217, May 17, 2012]

§520.1265   Lincomycin and spectinomycin powder.

(a) Specifications. The following salts of lincomycin and spectinomycin are present in a soluble powder in the ratio of 1 to 2 on the basis of equivalency of lincomycin base to equivalency of spectinomycin base:

(1) Lincomycin hydrochloride monohydrate and spectinomycin sulfate tetrahydrate.

(2) Lincomycin hydrochloride monohydrate and spectinomycin dihydrochloride pentahydrate.

(b) Sponsors. See sponsors in §510.600(c) of this chapter for use as in paragraph (d) of this section.

(1) No. 000009 for use of product described in paragraph (a)(1) of this section.

(2) Nos. 057561, 061623, and 066104 for use of product described in paragraph (a)(2) of this section.

(c) Tolerances. See §§556.360 and 556.600 of this chapter.

(d) Conditions of use in chickens—(1) Amount. 2 grams of antibiotic activity per gallon of drinking water; administer as the sole source of water for the first 5 to 7 days of life.

(2) Indications for use. As an aid in the control of airsacculitis caused by either Mycoplasma synoviae or M. gallisepticum susceptible to lincomycin-spectinomycin and complicated chronic respiratory disease (air sac infection) caused by Escherichia coli and M. gallisepticum susceptible to lincomycin-spectinomycin.

[69 FR 13220, Mar. 22, 2004, as amended at 70 FR 40881, July 15, 2005; 71 FR 71038, Dec. 8, 2006; 77 FR 56770, Sept. 14, 2012]

§520.1284   Sodium liothyronine tablets.

(a) Specifications. Sodium liothyronine tablets consist of tablets intended for oral administration which contain liothyronine at 60 or 120 micrograms per tablet, as the sodium salt.

(b) Sponsor. See No. 000069 in §510.600(c) of this chapter.

(c) Conditions of use. (1) It is indicated in cases of hypothyroidism in dogs.

(2) It is administered orally to dogs at levels up to 12.8 micrograms per kilogram of body weight per day. Dosage should be adjusted according to the severity of the condition and the response of the patient. Dosage at the total replacement level (12.8µg per kilogram of body weight) should be considered for initiating therapy and then titrated downward for optimum maintenance effect. Twice daily administration is recommended.

(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[40 FR 13838, Mar. 27, 1975, as amended at 56 FR 50653, Oct. 8, 1991; 60 FR 55659, Nov. 2, 1995]

§520.1288   Lufenuron tablets.

(a) Specifications—(1) Tablets containing 45, 90, 204.9, or 409.8 milligrams (mg) lufenuron for use as in paragraphs (c)(1)(i), (c)(1)(ii)(A), (c)(1)(iii), (c)(2)(i), (c)(2)(ii)(A), and (c)(2)(iii) of this section.

(2) Flavored tablets containing 45, 90, 204.9, or 409.8 milligrams (mg) lufenuron for use as in paragraphs (c)(1)(i), (c)(1)(ii)(A) or (c)(1)(ii)(B), and (c)(1)(iii) of this section.

(3) Flavored tablets containing 90 or 204.9 mg lufenuron for use as in paragraphs (c)(2)(i), (c)(2)(ii)(A) or (c)(2)(ii)(B), and (c)(2)(iii) of this section.

(4) Flavored tablets containing 135 or 270 mg lufenuron for use as in paragraphs (c)(2)(i), (c)(2)(ii)(A), and (c)(2)(iii) of this section.

(b) Sponsor. See No. 058198 in §510.600(c) of this chapter.

(c) Conditions of use—(1) Dogs—(i) Amount. Minimum of 10 mg lufenuron per kilogram (4.5 mg per pound (lb)) of body weight, once a month.

(ii) Indications for use—(A) For the prevention and control of flea populations.

(B) The concurrent use of flavored lufenuron tablets described in paragraph (a)(2) of this section as in paragraph (c)(1)(ii)(A) of this section with nitenpyram tablets as in §520.1510(d)(1) of this chapter is indicated to kill adult fleas and prevent flea eggs from hatching.

(iii) Limitations. For use in dogs and puppies 4 weeks of age and older.

(2) Cats—(i) Amount. Minimum of 30 mg lufenuron per kilogram (13.6 mg/lb) of body weight, once a month.

(ii) Indications for use—(A) For the control of flea populations.

(B) The concurrent use of flavored lufenuron tablets described in paragraph (a)(3) of this section as in paragraph (c)(2)(ii)(A) of this section with nitenpyram tablets as in §520.1510(d)(2) of this chapter is indicated to kill adult fleas and prevent flea eggs from hatching.

(iii) Limitations. For use in cats and kittens 4 weeks of age and older.

[68 FR 51905, Aug. 29, 2003]

§520.1289   Lufenuron suspension.

(a) Specifications. Each individual dose pack contains either 135 or 270 milligrams of lufenuron.

(b) Sponsor. See No. 058198 in §510.600(c) of this chapter.

(c) Conditions of use in cats—(1) Amount. Minimum of 13.6 milligrams per pound of body weight (30 milligrams per kilogram). Recommended dose of 135 milligrams for up to 10 pounds of body weight or 270 milligrams for 11 to 20 pounds. Cats over 20 pounds are provided the appropriate combination of packs.

(2) Indications for use. For control of flea populations.

(3) Limitations. For oral use in cats 6 weeks of age or older, once a month, mixed with food. Administer in conjunction with a full meal to ensure adequate absorption. Treat all cats in the household to ensure maximum benefits. Because the drug has no affect on adult fleas, the concurrent use of insecticides that kill adults may be necessary depending on the severity of the infestation.

[60 FR 20402, Apr. 26, 1995, as amended at 62 FR 8371, Feb. 25, 1997]

§520.1310   Marbofloxacin tablets.

(a) Specifications. Each tablet contains 25, 50, 100, or 200 milligrams (mg) marbofloxacin.

(b) Sponsor. See No. 000069 in §510.600(c) of this chapter.

(c) [Reserved]

(d) Conditions of use—(1) Amount. 1.25 mg per pound (/lb) of body weight once daily, but may be increased to 2.5 mg/lb of body weight once daily.

(2) Indications for use. For the treatment of infections in dogs and cats associated with bacteria susceptible to marbofloxacin.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits the extralabel use of this drug in food-producing animals.

[64 FR 39919, July 23, 1999, as amended at 66 FR 46369, Sept. 5, 2001]

§520.1315   Maropitant.

(a) Specifications. Each tablet contains 16, 24, 60, or 160 milligrams (mg) maropitant as maropitant citrate.

(b) Sponsor. See No. 000069 in §510.600(c) of this chapter.

(c) Conditions of use in dogs—(1) Indications for use and amount. For the prevention of acute vomiting, administer a minimum of 2.0 mg per kilogram (/kg) body weight once daily for up to 5 consecutive days. For the prevention of vomiting due to motion sickness, administer a minimum of 8.0 mg/kg body weight once daily for up to 2 consecutive days.

(2) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[72 FR 9243, Mar. 1, 2007]

§520.1320   Mebendazole oral.

(a) Chemical name. Methyl 5-benzoyl-benzimindazole-2-carbamate.

(b) Specifications. As oral powder: Each gram contains either 40 or 166.7 milligrams of mebendazole. As oral paste: Each gram contains 200 milligrams of mebendazole. As oral suspension: Each milliliter contains 33.3 milligrams of mebendazole.

(c) Sponsor. See No. 000061 in §510.600(c) of this chapter.

(d) Conditions of use—(1) Horses—(i) Amount. 1 gram of mebendazole per 250 pounds of body weight per dose, as an oral powder, paste or suspension.

(ii) Indications for use. It is used in horses for treatment of infections caused by large roundworms (Parascaris equorum); large strongyles (Strongylus edentatus, S. equinus, S. vulgaris); small strongyles; and mature and immature (4th larval stage pinworms (Oxyuris equi)).

(iii) Limitations—(a) Oral powder. The drug is given by sprinkling directly on the grain portion of the ration or dissolving in 2 to 4 pints of water and administering by stomach tube. The drug is compatible with carbon disulfide, which can be used concurrently for both control (Gastrophilus spp. ). Routine cautions regarding the use of carbon disulfide must be observed. Do not administer to horses intended for use as food. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(b) Oral paste. The drug is given by dosing gun (syringe), inserting the tip of the gun at the interdental space in the horse's mouth and depositing the paste on the animal's tongue. The hand is placed under the animal's jaw, and the head is raised to assure that the paste is deposited on the roof of the mouth. Not for use in horses intended for food. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.

(c) Oral suspension. The drug is administered by stomach tube. Not for horses intended for food use. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) Dogs—(i) Amount. One hundred milligrams of mebendazole per 10 pounds of body weight, once daily for 3 days, as an oral powder.

(ii) Indications for use. The drug is used for treatment of infections of roundworms (Toxocara canis), hookworms (Ancylostoma caninum, Uncinaria stenocephala), whipworms (Trichuris vulpis), and tapeworms (Taenia pisiformis).

(iii) Limitations. Administer as an oral powder by mixing with a small quantity of food, preferably before the regular meal. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[42 FR 61255, Dec. 2, 1977, as amended at 43 FR 35686, Aug. 11, 1978; 45 FR 3574, Jan. 18, 1980; 46 FR 47218, Sept. 25, 1981; 46 FR 53658, Oct. 30, 1981; 62 FR 61625, Nov. 19, 1997]

§520.1326   Mebendazole and trichlorfon oral dosage forms.

§520.1326a   Mebendazole and trichlorfon powder.

(a) Specifications. Each gram of powder contains 83.3 milligrams of mebendazole and 375.0 milligrams of trichlorofon.

(b) Sponsor. See No. 000061 in §510.600(c) of this chapter.

(c) Conditions of use. Horses—(1) Amount. 8.8 milligrams of mebendazole and 40 milligrams of trichlorofon per kilogram of body weight.

(2) Indications for use. It is used in horses for the treatment of infections of bots (Gastrophilus intestinalis and G. nasalis), large roundworms (Parascaris equorum), large strongyles (Strongylus edentatus, S. equinus, S. vulgaris), small strongyles, and pinworms (Oxyuris equi.)

(3) Limitations. Administer orally as an individual dose by stomach tube or throughly mixed in the ground grain portion of the ration to be consumed in one feeding. Discard treated feed not consumed. Do not administer more than once every 30 days. Do not treat sick or debilitated animals, foals under 4 months of age, or mares in the last month of pregnancy. Trichlorofon is a cholinesterase inhibitor. Do not administer simultaneously or within a few days before or after treatment with, or exposure to, cholinesterase-inhibiting drugs, pesticides or chemicals. Do not administer intravenous anesthetics, especially muscle relaxants, concurrently. Not for horses intended for food use. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[45 FR 10759, Feb. 19, 1980, as amended at 46 FR 52330, Oct. 27, 1981. Redesignated at 51 FR 13212, Apr. 18, 1986, as amended at 62 FR 61625, Nov. 19, 1997]

§520.1326b   Mebendazole and trichlorfon paste.

(a) Specifications. Each gram of paste contains 100 milligrams of mebendazole and 454 milligrams of trichlorfon.

(b) Sponsor. See No. 000061 in §510.600(c) of this chapter.

(c) Conditions of use—(1) Amount. 8.8 milligrams of mebendazole and 40 milligrams of trichlorfon per kilogram of body weight.

(2) Indications for use. It is used in horses for treatment of infections of bots (Gastrophilus intestinalis and G. nasalis), large roundworms (Parascaris equorum), large strongyles (Strongylus edentatus, S. equinus, S. vulgaris), small strongyles, and pinworms (Oxyuris equi).

(3) Limitations. Do not administer more than once every 30 days. Do not treat sick or debilitated animals, foals under 4 months of age, or mares in the last month of pregnancy. Trichlorfon is a cholinesterase inhibitor. Do not administer simultaneously or within a few days before or after treatment with, or exposure to, cholinesterase-inhibiting drugs, pesticides, or chemicals. Do not administer intravenous anesthetics, especially muscle relaxants, concurrently. Not for use in horses intended for food. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.

[51 FR 13212, Apr. 18, 1986, as amended at 62 FR 61625, Nov. 19, 1997]

§520.1330   Meclofenamic acid granules.

(a) Chemical name. N-(2,6-Dichlorom-tolyl) anthranilic acid.

(b) Specifications. The drug is in granular form containing 5 percent meclofenamic acid.

(c) Sponsor. See No. 000856 in §510.600(c) of this chapter.

(d) Conditions of use. (1) The drug is used in horses for the treatment of acute or chronic inflammatory diseases involving the musculoskeletal system.

(2) It is administered orally at a dosage of 1 milligram per pound of body weight (1 gram per 1,000 pounds) once daily for 5 to 7 days by addition to the daily grain ration.

(3) Treatment beyond the initial 5- to 7-day period may be indicated. A maintenance dosage level should be individualized for each animal.

(4) This drug should not be administered to horses with active gastrointestinal, hepatic, or renal disease.

(5) Not for use in horses intended for food.

(6) Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[41 FR 5632, Feb. 9, 1976, as amended at 53 FR 23390, June 22, 1988]

§520.1331   Meclofenamic acid tablets.

(a) Specifications. Each tablet contains either 10 or 20 milligrams of meclofenamic acid.

(b) Sponsor. See No. 000856 in §510.600(c) of this chapter.

(c) Conditions of use in dogs—(1) Amount. 1.1 milligrams per kilogram (0.5 milligram per pound) daily for 5 to 7 days.

(2) Indications for use. For the relief of signs and symptoms of chronic inflammatory disease involving the musculoskeletal system.

(3) Limitations. For oral use only. Should not be administered to animals with congestive heart failure or active gastrointestinal, hepatic, or renal disease. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[50 FR 43385, Oct. 25, 1985, as amended at 53 FR 23390, June 22, 1988]

§520.1341   Megestrol acetate tablets.

(a) Specifications. Each tablet contains 5 or 20 milligrams of megestrol acetate.

(b) Sponsor. No. 000061 in §510.600(c) of this chapter.

(c) Conditions of use. (1) The drug is used in female dogs for the postponement of estrus and the alleviation of false pregnancy.

(2) It is administered orally, intact, or crushed and mixed with food as follows:

(i) For the postponement of estrus by proestrus treatment, 1 milligram per pound of body weight per day for 8 days.

(ii) For the postponement of estrus by anestrus treatment, 0.25 milligram per pound of body weight per day for 32 days.

(iii) For alleviation of false pregnancy, 1 milligram per pound of body weight per day for 8 days.

(3) Full dosage regimen must be completed to produce the desired effect.

(4) Examination of vaginal smears is recommended to confirm detection of proestrus.

(5) Do not administer for more than two consecutive treatments.

(6) Once therapy is started, the animal should be confined for 3 to 8 days or until cessation of bleeding, since dogs in proestrus accept a male.

(7) Do not use prior to or during first estrus cycle.

(8) Do not use in pregnant animals.

(9) Do not use in the presence of a disease of the reproductive system or with mammary tumors.

(10) Should estrus occur within 30 days after cessation of treatment, mating should be prevented.

(11) Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[40 FR 13838, Mar. 27, 1975, as amended at 52 FR 7832, Mar. 13, 1987]

§520.1367   Meloxicam.

(a) Specifications—(1) Each milliliter of suspension contains 0.5 milligrams (mg) meloxicam.

(2) Each milliliter of suspension contains 1.5 mg meloxicam.

(b) Sponsors. See sponsors in §510.600(c) of this chapter for uses as in paragraph (c) of this section:

(1) No. 000010 for use of the products described in paragraph (a) of this section; and

(2) No. 013744 for use of the product described in paragraph (a)(2) of this section.

(c) Conditions of use in dogs—(1) Amount. Administer orally as a single dose at 0.09 mg per pound (mg/lb) body weight (0.2 mg per kilogram (mg/kg)) on the first day of treatment. For all treatment after day 1, administer 0.045 mg/lb (0.1 mg/kg) body weight once daily.

(2) Indications for use. For the control of pain and inflammation associated with osteoarthritis.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[68 FR 42968, July 21, 2003, as amended at 69 FR 69523, Nov. 30, 2004. Redesignated and amended at 78 FR 57058, Sept. 17, 2013]

§520.1372   Methimazole.

(a) Specifications. Each tablet contains 2.5 or 5 milligrams (mg) methimazole.

(b) Sponsor. See No. 043264 in §510.600 of this chapter.

(c) Conditions of use in cats—(1) Amount. The starting dose is 2.5 mg every 12 hours. Following 3 weeks of treatment, the dose should be titrated to effect based on individual serum total T4 levels and clinical response.

(2) Indications for use. For the treatment of hyperthyroidism.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[74 FR 27707, June 11, 2009]

§520.1380   Methocarbamol tablets.

(a) Chemical name. 3-(O-Methoxyphenoxy)-1,2-propanediol 1-carbamate.

(b) Specifications. Each tablet contains 500 milligrams of methocarbamol.

(c) Sponsor. See No. 000856 in §510.600(c) of this chapter.

(d) Conditions of use. (1) The drug is administered to dogs and cats as an adjunct to therapy for acute inflammatory and traumatic conditions of the skeletal muscles in order to reduce muscular spasms.

(2) Dosage is based upon severity of symptoms and response noted. The usual initial dose in 60 milligrams per pound of body weight in two or three equally divided doses followed by 30 to 60 milligrams per pound of body weight each following day, usually not to exceed 14 to 21 days.

(3) For use only by or on the order of a licensed veterinarian.

[40 FR 13838, Mar. 27, 1975, as amended at 67 FR 67521, Nov. 6, 2002]

§520.1408   Methylprednisolone tablets.

(a) Specifications. Each table contains 1, 2, or 4 milligrams of methylprednisolone.

(b) Sponsor. See No. 000009 in §510.600(c) of this chapter for use of 1- and 4-milligram tablets; see No. 054628 for use of 1- and 2-milligram tablets.

(c) [Reserved]

(d) Special consideration. (1) Clinical and experimental data have demonstrated that corticosteroids administered orally or parenterally to animals may induce the first stage of parturition when administered during the last trimester of pregnancy and may precipitate premature parturition followed by dystocia, fetal death, retained placenta, and metritis.

(2) Systemic therapy with methylprednisolone is contraindicated in animals with arrested tuberculosis, peptic ulcer, acute psychoses, or cushingoid syndrome. The presence of active tuberculosis, diabetes, osteoporosis, chronic psychotic reactions, predisposition to thrombophlebitis, hypertension, congestive heart failure, or renal insufficiency necessitates carefully controlled use of corticosteroids. Some of these conditions occur only rarely in dogs and cats but should be kept in mind.

(3) Anti-inflammatory action of corticosteroids may mask signs of infection.

(e) Conditions of use—(1) Amount. Dogs and cats: 5 to 15 pounds, 2 milligrams; 15 to 40 pounds, 2 to 4 milligrams; 40 to 80 pounds, 4 to 8 milligrams.

(2) Indications for use. For use in dogs and cats as an anti-inflammatory agent.

(3) Limitations. Administer total daily dose orally in equally divided doses 6 to 10 hours apart until response is noted or 7 days have elapsed. When response is attained, dosage should be gradually reduced until maintenance level is achieved. Hazardous for human use. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[47 FR 52697, Nov. 23, 1982, as amended at 49 FR 20810, May 17, 1984; 50 FR 32844, Aug. 15, 1985; 53 FR 40727, Oct. 18, 1988; 62 FR 35076, June 30, 1997; 78 FR 21059, Apr. 9, 2013]

§520.1409   Methylprednisolone, aspirin tablets.

(a) Specifications. Each tablet contains 0.5 milligram of methylprednisolone and 300 milligrams of aspirin.

(b) Sponsor. See No. 000009 in §510.600(c) of this chapter.

(c) NAS/NRC status. The conditions of use have been NAS/NRC reviewed and found effective. New animal drug applications for approval of drugs for these conditions of use need not include effectiveness data specified by §514.111 of this chapter, but may require bioequivalency and safety information.

(d) Special considerations. (1) Clinical and experimental data have demonstrated that corticosteroids administered orally or parenterally to animals may induce the first stage of parturition when administered during the last trimester of pregnancy and may precipitate premature parturition followed by dystocia, fetal death, retained placenta, and metritis.

(2) Systemic therapy with methylprednisolone is contraindicated in animals with tuberculosis, chronic nephritis, peptic ulcer, or Cushingoid syndrome. The presence of diabetes mellitus, osteoporosis, predisposition to thrombophlebitis, hypertension, congestive heart failure, or renal insufficiency necessitates carefully controlled use of corticosteroids.

(3) Anti-inflammatory action of corticosteroids may mask signs of infection.

(e) Conditions of use—(1) Amount. Dogs under 15 pounds, 14 to 1 tablet daily; 15 to 60 pounds, 1 to 2 tablets daily; 60 pounds and over, 2 tablets daily.

(2) Indications for use. As an anti-inflammatory and analgesic agent in dogs.

(3) Limitations. Administer total daily dose in divided doses 6 to 10 hours apart, with a light feeding. When response is attained, dosage should be gradually reduced until maintenance level is achieved. Do not administer to cats. Do not overdose. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[48 FR 21566, May 13, 1983]

§520.1422   Metoserpate hydrochloride.

(a) Chemical name. Methyl-o-methyl-18-epireserpate hydrochloride.

(b) Sponsor. See No. 053501 in §510.600(c) of this chapter.

(c) Related tolerances. See §556.410 of this chapter.

(d) Conditions of use. It is used in drinking water for replacement chickens as follows:

(1) Amount. 568.5 milligrams per gallon (0.015 percent).

(i) Indications for use. As a tranquilizer for flock treatment of chickens prior to handling.

(ii) Limitations. To be used one time as a treatment for replacement chickens up to 16 weeks of age; usual drinking water should be withheld prior to treatment to provide adequate consumption of medicated drinking water; not for use in laying chickens; chickens slaughtered within 72 hours following treatment must not be used for food.

(2) Amount. 2 to 4 milligrams per 2.2 pounds of body weight.

(i) Indications for use. As an aid in control of hysteria.

(ii) Limitations. To be used as a treatment for replacement chickens up to 16 weeks of age; usual drinking water should be withheld prior to treatment to provide adequate consumption of medicated drinking water; the drug should be administered at a dosage level of 4 milligrams per 2.2 pounds of body weight followed by 2 treatments at 4-day intervals of 2 milligrams per 2.2 pounds of body weight; not for use in laying chickens; chickens slaughtered within 72 hours following treatment must not be used for food.

[40 FR 13838, Mar. 27, 1975, as amended at 76 FR 17337, Mar. 29, 2011]

§520.1430   Mibolerone.

(a) Specifications. Each milliliter contains 100 micrograms of mibolerone.

(b) Sponsor. See No. 000009 in §510.600(c) of this chapter.

(c) Conditions of use—(1) Amount. 30 micrograms for animals weighing 1 to 25 pounds; 60 micrograms for animals weighing 26 to 50 pounds; 120 micrograms for animals weighing 51 to 100 pounds; 180 micrograms for animals weighing over 100 pounds, German Shepherds, or German Shepherd mix.

(2) Indications for use. For the prevention of estrus (heat) in adult female dogs not intended primarily for breeding purposes.

(3) Limitations. Administer daily, orally or in a small amount of food, at least 30 days before expected initiation of heat, and continue daily as long as desired, but not for more than 24 months. Mibolerone should not be used in bitches before the first estrous period. It is not intended for animals being used primarily for breeding purposes. Use orally in adult female dogs only. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[43 FR 15625, Apr. 14, 1978]

§520.1441   Milbemycin oxime.

(a) Specifications—(1) Dogs. Each tablet contains 2.3, 5.75, 11.5, or 23.0 milligrams of milbemycin oxime.

(2) Cats. Each tablet contains 5.75, 11.5, or 23.0 milligrams of milbemycin oxime.

(b) Sponsor. See 058198 in §510.600(c) of this chapter.

(c) [Reserved]

(d) Conditions of use—(1) Dogs and puppies—(i) Amount. For hookworm, roundworm, and whipworm, use 0.23 milligram per pound of body weight (0.5 milligram per kilogram). For heartworm, use 0.05 milligram per pound of body weight (0.1 milligram per kilogram).

(ii) Indications for use. For prevention of heartworm disease caused by Dirofilaria immitis, control of hookworm infections caused by Ancylostoma caninum, and removal and control of adult roundworm infections caused by Toxocara canis and Toxascaris leonina and whipworm infections caused by Trichuris vulpis in dogs and in puppies 4 weeks of age or greater and 2 pounds of body weight or greater.

(iii) Limitations. Do not use in puppies less than 4 weeks of age and less than 2 pounds of body weight. Administer once a month. First dose given within 1 month after first exposure to mosquitoes and continue regular use until at least 1 month after end of mosquito season. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) Cats and kittens—(i) Amount. 0.91 milligram per pound of body weight (2.0 milligrams per kilogram).

(ii) Indications for use. For prevention of heartworm disease caused by Dirofilaria immitis and the removal of adult Toxocara cati (roundworm) and Ancylostoma tubaeforme (hookworm) infections in cats 6 weeks of age or greater and 1.5 pounds body weight or greater.

(iii) Limitations. Do not use in kittens less than 6 weeks of age or 1.5 pounds body weight. Administer once a month. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[55 FR 25301, June 21, 1990, as amended at 55 FR 49888, Dec. 3, 1990; 58 FR 5608, Jan. 22, 1993; 60 FR 50097, Sept. 28, 1995; 61 FR 43654, Aug. 26, 1996; 63 FR 29352, May 29, 1998; 63 FR 41189, Aug. 3, 1998. Redesignated at 77 FR 47512, Aug. 9, 2012]

§520.1443   Milbemycin oxime and lufenuron.

(a) Specifications—(1) Tablets containing: 2.3 milligrams (mg) milbemycin oxime and 46 mg lufenuron, 5.75 mg milbemycin oxime and 115 mg lufenuron, 11.5 mg milbemycin oxime and 230 mg lufenuron, or 23 mg milbemycin oxime and 460 mg lufenuron.

(2) Flavored tablets containing: 2.3 mg milbemycin oxime and 46 mg lufenuron, 5.75 mg milbemycin oxime and 115 mg lufenuron, 11.5 mg milbemycin oxime and 230 mg lufenuron, or 23 mg milbemycin oxime and 460 mg lufenuron.

(b) Sponsor. See No. 058198 in §510.600(c) of this chapter.

(c) [Reserved]

(d) Conditions of use—(1) Dogs—(i) Amount. 0.5 mg milbemycin oxime and 10 mg lufenuron per kilogram of body weight, once a month.

(ii) Indications for use—(A) For use in dogs and puppies for the prevention of heartworm disease caused by Dirofilaria immitis, for prevention and control of flea populations, for control of adult Ancylostoma caninum (hookworm), and for removal and control of adult Toxocara canis, Toxascaris leonina (roundworm), and Trichuris vulpis (whipworm) infections.

(B) The concurrent use of flavored milbemycin oxime and lufenuron tablets described in paragraph (a)(2) of this section as in paragraph (d)(1)(ii)(A) of this section with nitenpyram tablets as in §520.1510(d)(1) of this chapter is indicated to kill adult fleas and prevent flea eggs from hatching.

(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) [Reserved]

[62 FR 28629, May 27, 1997, as amended at 63 FR 41190, Aug. 3, 1998; 68 FR 51905, Aug. 29, 2003. Redesignated at 77 FR 47512, Aug. 9, 2012]

§520.1445   Milbemycin oxime and praziquantel.

(a) Specifications. Each chewable tablet contains:

(1) 2.3 milligrams (mg) milbemycin oxime and 22.8 mg praziquantel;

(2) 5.75 mg milbemycin oxime and 57 mg praziquantel;

(3) 11.5 mg milbemycin oxime and 114 mg praziquantel; or

(4) 23 mg milbemycin oxime and 228 mg praziquantel.

(b) Sponsor. See No. 058198 in §510.600(c) of this chapter.

(c) Conditions of use—(1) Dogs—(i) Amount. Administer orally, once a month, a minimum dosage of 0.23 mg per pound (mg/lb) of body weight (0.5 mg per kilogram (mg/kg)) milbemycin oxime and 2.28 mg/lb of body weight (5 mg/kg) praziquantel.

(ii) Indications for use. For the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment and control of adult roundworm (Toxocara canis, Toxascaris leonina), adult hookworm (Ancylostoma caninum), adult whipworm (Trichuris vulpis), and adult tapeworm (Taenia pisiformis, Echinococcus multilocularis, and E. granulosus) infections in dogs and puppies 2 pounds of body weight or greater and 6 weeks of age and older.

(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) [Reserved]

[77 FR 47512, Aug. 9, 2012]

§520.1447   Milbemycin oxime, lufenuron, and praziquantel tablets.

(a) Specifications. Each tablet contains:

(1) 2.3 milligrams (mg) milbemycin oxime, 46 mg lufenuron, and 22.8 mg praziquantel;

(2) 5.75 mg milbemycin oxime, 115 mg lufenuron, and 57 mg praziquantel;

(3) 11.5 mg milbemycin oxime, 230 mg lufenuron, and 114 mg praziquantel; or

(4) 23 mg milbemycin oxime, 460 mg lufenuron, and 228 mg praziquantel.

(b) Sponsor. See No. 058198 in §510.600(c) of this chapter.

(c) [Reserved]

(d) Conditions of use—(1) Dogs—(i) Amount. 0.5 mg milbemycin oxime, 10 mg lufenuron, and 5 mg of praziquantel per kilogram of body weight, once a month.

(ii) Indications for use. For the prevention of heartworm disease caused by Dirofilaria immitis; for the prevention and control of flea populations (Ctenocephalides felis); and for the treatment and control of adult roundworm (Toxocara canis, Toxascaris leonina), adult hookworm (Ancylostoma caninum), adult whipworm (Trichuris vulpis), and adult tapeworm (Taenia pisiformis, Echinococcus multilocularis, and E. granulosus) infections in dogs and puppies 2 pounds of body weight or greater and 6 weeks of age and older.

(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) [Reserved]

[77 FR 4225, Jan. 27, 2012]

§520.1450   Morantel tartrate oral dosage forms.

§520.1450a   Morantel tartrate bolus.

(a) Specifications. Each bolus contains 2.2 grams morantel tartrate equivalent to 1.3 grams of morantel base.

(b) Sponsor. See No. 000069 in §510.600(c) of this chapter.

(c) Related tolerances. See §556.425 of this chapter.

(d) Conditions of use—(1) Amount. One bolus per 500 pounds of body weight (4.4 milligrams per pound of body weight) as a single oral dose. Boluses may be divided in half for more accurate dosing as follows: up to 325 pounds, 12 bolus; 326 to 600 pounds, 1 bolus; 601 to 900 pounds, 112 boluses; and 901 to 1,200 pounds, 2 boluses.

(2) Indications for use. For removal and control of mature gastrointestinal nematode infections of cattle including stomach worms (Haemonchus spp., Ostertagia spp., Trichostrongylus spp.), worms of the small intestine (Cooperia spp., Trichostrongylus spp., Nematodirus spp.), and worms of the large intestine (Oesophagostomum radiatum).

(3) Limitations. Conditions of constant worm exposure may require retreatment in 2 to 4 weeks. Consult your veterinarian before administering to severely debilitated animals and for assistance in the diagnosis, treatment, and control of parasitism. Do not treat within 14 days of slaughter.

[46 FR 50949, Oct. 16, 1981. Redesignated at 49 FR 47831, Dec. 7, 1984, and amended at 51 FR 9005, Mar. 17, 1986]

§520.1450b   Morantel tartrate cartridge.

(a) Specifications. The drug product consists of a stainless-steel cylinder having both ends closed with polyethylene diffusing discs and containing a morantel tartrate paste. The paste contains 22.7 grams of morantel tartrate equivalent to 13.5 grams of morantel base.

(b) Sponsor. See No. 000069 in §510.600(c) of this chapter.

(c) Related tolerances. See §556.425 of this chapter.

(d) Conditions of use—(1) Amount. Grazing cattle: Administer 1 cartridge to each animal at the start of the grazing season.

(2) Indications for use. For control of the adult stage of the following gastrointestinal nematode infections in weaned calves and yearling cattle weighing a minimum of 200 pounds: Ostertagia spp., Trichostrongylus axei, Cooperia spp., and Oesophagostomum radiatum.

(3) Limitations. Administer orally with the dosing gun to all cattle that will be grazing the same pasture. Effectiveness of the drug product is dependent upon continuous control of the gastrointestinal parasites for approximately 90 days following administration. Therefore, treated cattle should not be moved to pastures grazed in the same grazing season/calendar year by untreated cattle. Do not administer to cattle within 106 days of slaughter. Consult your veterinarian before administering to severely debilitated animals and for assistance in the diagnosis, treatment, and control of parasitism.

[49 FR 47831, Dec. 7, 1984, as amended at 51 FR 23415, June 27, 1986; 51 FR 41081, Nov. 13, 1986]

§520.1450c   Morantel tartrate sustained-release trilaminate cylinder/sheet.

(a) Specifications. The drug product consists of a trilaminated, perforated, plastic sheet formed into a cylinder having plastic plugs in its ends. The core lamina contains 19.8 grams of morantel tartrate equivalent to 11.8 grams of morantel base.

(b) Sponsor. See 000069 in §510.600(c) of this chapter.

(c) Related tolerances. See §556.425 of this chapter.

(d) Conditions of use—(1) Amount. Grazing cattle: Administer 1 cartridge to each animal at the start of the grazing season.

(2) Indications for use. For control of the adult stage of the following gastrointestinal nematode infections in weaned calves and yearling cattle weighing a minimum of 200 pounds: Ostertagia spp., Trichostrongylus axei, Cooperia spp., and Oesophagostomum radiatum.

(3) Limitations. Administer orally with the dosing gun to all cattle that will be grazing the same pasture. Effectiveness of the drug product is dependent upon continuous control of the gastrointestinal parasites for approximately 90 days following administration. Therefore, treated cattle should not be moved to pastures grazed in the same grazing season/calendar year by untreated cattle. Do not administer to cattle within 102 days of slaughter. Consult your veterinarian before administering to severely debilitated animals and for assistance in the diagnosis, treatment, and control of parasitism.

[56 FR 13396, Apr. 2, 1991]

§520.1451   Moxidectin tablets.

(a) Specifications. Each tablet contains 30, 68, or 136 micrograms of moxidectin.

(b) Sponsor. See No. 000856 in §510.600(c) of this chapter.

(c) [Reserved]

(d) Conditions of use—(1) Amount. 3 micrograms per kilogram (1.36 micrograms per pound) of body weight.

(2) Indications for use. To prevent infection by the canine heartworm Dirofilaria immitis and the subsequent development of canine heartworm disease.

(3) Limitations. Use once-a-month in dogs at 8 weeks of age or older. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[62 FR 37713, July 15, 1997]

§520.1452   Moxidectin gel.

(a) Specifications. Each milliliter of gel contains 20 milligrams (2 percent) moxidectin.

(b) Sponsor. See No. 000856 in §510.600(c) of this chapter.

(c) Special considerations. See §500.25 of this chapter.

(d) Conditions of use in horses and ponies—(1) Amount. 0.4 milligram moxidectin per kilogram (2.2 pounds) of body weight.

(2) Indications for use. For the treatment and control of large strongyles: Strongylus vulgaris (adults and L4/L5 arterial stages), S. edentatus (adult and tissue stages), Triodontophorus brevicauda (adults), and T. serratus (adults); small strongyles (adults): Cyathostomum spp., including C. catinatum and C. pateratum; Cylicocyclus. spp., including C. insigne, C. leptostomum, C. nassatus, and C. radiatus; Cyliocostephanus spp., including C. calicatus, C. goldi, C. longibursatus, and C. minutus; Coronocyclus spp., including C. coronatus, C. labiatus, and C. labratus; Gyalocephalus capitatus; and Petrovinema poculatus; small strongyles: undifferentiated lumenal larvae; encysted cyathostomes (late L3 and L4 mucosal cyathostome larvae); ascarids: Parascaris equorum (adults and L4 larval stages); pinworms: Oxyuris equi (adults and L4 larval stages); hairworms: Trichostrongylus axei (adults); large-mouth stomach worms: Habronema muscae (adults); and horse stomach bots: Gasterophilus intestinalis (2nd and 3rd instars) and G. nasalis (3rd instars). One dose also suppresses strongyle egg production for 84 days.

(3) Limitations. For oral use in horses and ponies 6 months of age and older. Not for use in horses and ponies intended for food.

[62 FR 42902, Aug. 11, 1997, as amended at 64 FR 66105, Nov. 24, 1999; 68 FR 51445, Aug. 27, 2003; 69 FR 24959, May 5, 2004; 70 FR 75017, Dec. 19, 2005]

§520.1453   Moxidectin and praziquantel gel.

(a) Specifications. Each milliliter of gel contains 20 milligrams (mg) (2.0 percent) moxidectin and 125 mg (12.5 percent) praziquantel.

(b) Sponsor. See No. 000856 in §510.600(c) of this chapter.

(c) Special considerations. See §500.25 of this chapter.

(d) Conditions of use in horses and ponies—(1) Amount. Administer by mouth as a single dose: 0.4 mg moxidectin per kilogram and 2.5 mg praziquantel per kilogram (2.2 pounds) body weight.

(2) Indications for use. For the treatment and control of large strongyles: Strongylus vulgaris (adults and L4/L5 arterial stages), S. edentatus (adult and tissue stages), Triodontophorus brevicauda (adults), and T. serratus (adults); small strongyles (adults): (Cyathostomum spp., including C. catinatum and C. pateratum; Cylicocyclus spp., including C. insigne, C. leptostomum, C. nassatus, and C. radiatus; Cylicostephanus spp., including C. calicatus, C. goldi, C. longibursatus, and C. minutus; Coronocyclus spp., including C. coronatus, C. labiatus, and C. labratus; Gyalocephalus capitatus; and Petrovinema poculatus; small strongyles: undifferentiated lumenal larvae; encysted cyathostomes (late L3 and L4 mucosal cyathostome larvae); ascarids: Parascaris equorum (adults and L4 larval stages); pinworms: Oxyuris equi (adults and L4 larval stages); hairworms: Trichostrongylus axei (adults); large-mouth stomach worms: Habronema muscae (adults); horse stomach bots: Gasterophilus intestinalis (2nd and 3rd instars) and G. nasalis (3rd instars); and tapeworms: Anoplocephala perfoliata (adults). One dose also suppresses strongyle egg production for 84 days.

(3) Limitations. For oral use in horses and ponies 6 months of age and older. Not for use in horses and ponies intended for food.

[68 FR 51446, Aug. 27, 2003, as amended at 69 FR 21956, Apr. 23, 2004; 70 FR 75017, Dec. 19, 2005]

§520.1454   Moxidectin solution.

(a) Specifications. Each milliliter (mL) of solution contains 1 milligram (mg) moxidectin.

(b) Sponsor. See No. 000010 in §510.600(c) of this chapter.

(c) Related tolerances. See §556.426 of this chapter.

(d) Special considerations. See §500.25 of this chapter.

(e) Conditions of use in sheep—(1) Amount. Administer 1 mL per 11 pounds body weight (1 mL per 5 kilograms) by mouth.

(2) Indications for use. For the treatment and control of the adult and L4 larval stages of Haemonchus contortus, Teladorsagia circumcincta, T. trifurcata, Trichostrongylus axei, T. colubriformis, T. vitrinus, Cooperia curticei, C. oncophora, Oesophagostomum columbianum, O. venulosum, Nematodirus battus, N. filicollis, and N. spathiger.

(3) Limitations. Sheep must not be slaughtered for human consumption within 7 days of treatment. Because a withholding time in milk has not been established for this product, do not use in female sheep providing milk for human consumption.

[70 FR 76163, Dec. 23, 2005, as amended at 76 FR 48714, Aug. 9, 2011]

§520.1468   Naproxen granules.

(a) Specifications. Naproxen granules contain 50 percent naproxen.

(b) Sponsor. No. 000856 in §510.600(c) of this chapter.

(c) Conditions of use—(1) Horses. The drug is used for the relief of inflammation and associated pain and lameness exhibited with arthritis, as well as myositis and other soft tissue diseases of the musculoskeletal system of the horse.

(2)(i) For oral maintenance therapy following initial intravenous dosage, administer 10 milligrams naproxen per kilogram of animal body weight twice daily as top dressing in the animal's feed for up to 14 consecutive days. The initial intravenous dosage is 5 milligrams per kilogram of body weight.

(ii) For oral dosage only, administer 10 milligrams naproxen per kilogram of animal body weight twice daily as a top dressing in the animal's feed for up to 14 consecutive days.

(3) Not for use in horses intended for food.

(4) Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[41 FR 14188, Apr. 2, 1976, as amended at 51 FR 24525, July 7, 1986; 61 FR 5506, Feb. 13, 1996]

§520.1484   Neomycin.

(a) Specifications—(1) Each ounce of powder contains 20.3 grams (g) neomycin sulfate (equivalent to 14.2 g neomycin base).

(2) Each milliliter of solution contains 200 milligrams (mg) neomycin sulfate (equivalent to 140 mg neomycin base).

(b) Sponsors. See sponsors in §510.600(c) of this chapter for use as in paragraph (e) of this section.

(1) Nos. 000069 and 054925 for use of product described in paragraph (a)(1) as in paragraph (e)(1) of this section.

(2) Nos. 000009, 046573, 058005, and 061623 for use of product described in paragraph (a)(1) as in paragraphs (e)(1) and (e)(2) of this section.

(3) Nos. 000009, 000859, 054925, and 058005 for use of product described in paragraph (a)(2) as in paragraph (e)(1) of this section.

(c) Related tolerances. See §556.430 of this chapter.

(d) Special labeling considerations. Labeling shall bear the following warning statements: “A withdrawal period has not been established for use in preruminating calves. Do not use in calves to be processed for veal. Use of more than one product containing neomycin or failure to follow withdrawal times may result in illegal drug residues.”

(e) Conditions of use—(1) Cattle, swine, sheep, and goats—(i) Amount. 10 mg per pound (/lb) of body weight per day (22 mg per kilogram (/kg)) in divided doses for a maximum of 14 days.

(ii) Indications for use. For the treatment and control of colibacillosis (bacterial enteritis) caused by Escherichia coli susceptible to neomycin sulfate.

(iii) Limitations. Add powder to drinking water or milk; not for use in liquid supplements. Administer solution undiluted or in drinking water. Prepare a fresh solution in drinking water daily. If symptoms persist after using this preparation for 2 or 3 days, consult a veterinarian. Treatment should continue 24 to 48 hours beyond remission of disease symptoms, but not to exceed a total of 14 consecutive days. Discontinue treatment prior to slaughter as follows: Cattle, 1 day; sheep, 2 days; swine and goats, 3 days.

(2) Turkeys—(i) Amount. 10 mg/lb of body weight per day (22 mg/kg) for 5 days.

(ii) Indications for use. For the control of mortality associated with E. coli susceptible to neomycin sulfate in growing turkeys.

(iii) Limitations. Add to drinking water; not for use in liquid supplements. Prepare a fresh solution daily. If symptoms persist after using this preparation for 2 or 3 days, consult a veterinarian. Treatment should continue 24 to 48 hours beyond remission of disease symptoms, but not to exceed a total of 5 consecutive days.

[71 FR 56866, Sept. 28, 2006, as amended at 71 FR 68738, Nov. 28, 2006; 78 FR 17596, Mar. 22, 2013]

§520.1510   Nitenpyram tablets.

(a) Specifications. Each tablet contains 11.4 or 57 milligrams (mg) nitenpyram.

(b) Sponsor. See No. 058198 in §510.600(c) of this chapter.

(c) Special considerations. The concurrent use of nitenpyram tablets and flavored milbemycin/lufenuron tablets as in paragraph (d)(1)(ii)(B) of this section shall be by or on the order of a licensed veterinarian.

(d) Conditions of use—(1) Dogs—(i) Amount—(A) One 11.4-mg tablet for dogs weighing less than 25 pounds (lb) or one 57-mg tablet for dogs weighing more than 25 lb, as needed, for use as in paragraph (d)(1)(ii)(A) of this section.

(B) One 11.4-mg tablet for dogs weighing less than 25 lb or one 57 mg tablet for dogs weighing more than 25 lbs, once or twice weekly, for use as in paragraph (d)(1)(ii)(B) of this section.

(ii) Indications for use—(A) For the treatment of flea infestations on dogs and puppies 4 weeks of age and older and 2 lbs of body weight or greater.

(B) The concurrent use of nitenpyram tablets as in paragraph (d)(1)(i)(B) of this section with either flavored lufenuron tablets as in §520.1288(c)(1) of this chapter or flavored milbemycin and lufenuron tablets as in §520.1446(d)(1) of this chapter is indicated to kill adult fleas and prevent flea eggs from hatching.

(2) Cats—(i) Amount—(A) One 11.4-mg tablet, as needed, for use as in paragraph (d)(2)(ii)(A) of this section.

(B) One 11.4-mg tablet, once or twice weekly, for use as in paragraph (d)(2)(ii)(B) of this section.

(ii) Indications for use—(A) For the treatment of flea infestations on cats and kittens 4 weeks of age and older and 2 lbs of body weight or greater.

(B) The concurrent use of nitenpyram tablets as in paragraph (d)(2)(i)(B) of this section with flavored lufenuron tablets as in §520.1288(c)(2) of this chapter is indicated to kill adult fleas and prevent flea eggs from hatching.

[68 FR 51906, Aug. 29, 2003]

§520.1604   Oclacitinib.

(a) Specifications. Each tablet contains 3.6, 5.4, or 16 milligrams (mg) of oclacitinib as oclacitinib maleate.

(b) Sponsor. See No. 054771 in §510.600(c) of this chapter.

(c) Conditions of use—(1) Amount. Administer orally 0.18 to 0.27 mg/per pound of body weight (0.4 to 0.6 mg/kg body weight) twice daily for up to 14 days; then administered once daily for maintenance therapy.

(2) Indications for use. For control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[78 FR 42007, July 15, 2013]

§520.1615   Omeprazole.

(a) Specifications. Each gram of paste contains 0.37 gram omeprazole.

(b) Sponsor. See No. 050604 in §510.600(c) of this chapter.

(c) Special considerations. When labeled for use as in paragraph (d)(2)(i) of this section, product labeling shall bear: “Federal law restricts this drug to use by or on the order of a licensed veterinarian.”

(d) Conditions of use in horses—(1) Amount—(i) For treatment of gastric ulcers, 1.8 milligrams per pound (mg/lb) of body weight (4 milligrams per kilogram (mg/kg)) once daily for 4 weeks. For prevention of recurrence of gastric ulcers, 0.9 mg/lb of body weight (2 mg/kg) once daily for at least an additional 4 weeks.

(ii) For prevention of gastric ulcers using the premarked syringe, one dose per day for 8 or 28 days. Each dose delivers at least 1 mg/kg of body weight. Horses over 1,200 lb body weight should receive two doses per day.

(2) Indications for use. (i) For treatment and prevention of recurrence of gastric ulcers in horses and foals 4 weeks of age and older.

(ii) For prevention of gastric ulcers in horses.

(3) Limitations. Do not use in horses intended for human consumption.

[69 FR 13220, Mar. 22, 2004, as amended at 71 FR 59374, Oct. 10, 2006]

§520.1616   Orbifloxacin tablets.

(a) Specifications. Each tablet contains 5.7, 22.7, or 68 milligrams (mg) orbifloxacin.

(b) Sponsor. See No. 000061 in §510.600(c) of this chapter.

(c) Conditions of use in dogs and cats—(1) Amount. 2.5 to 7.5 mg per kilogram body weight once daily.

(2) Indications for use. For management of diseases associated with bacteria susceptible to orbifloxacin.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits the extralabel use of this drug in food producing animals.

[71 FR 14643, Mar. 23, 2006, as amended at 75 FR 26646, May 12, 2010]

§520.1618   Orbifloxacin suspension.

(a) Specifications. Each milliliter of suspension contains 30 milligrams (mg) orbifloxacin.

(b) Sponsor. See No. 000061 in 510.600(c) of this chapter.

(c) Special considerations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits the extralabel use of this drug in food-producing animals.

(d) Conditions of use—(1) Dogs—(i) Amount. 1.1 to 3.4 mg/lb (2.5 to 7.5 mg/kg) of body weight once daily.

(ii) Indications for use. For the treatment of urinary tract infections (cystitis) in dogs caused by susceptible strains of Staphylococcus pseudintermedius, Proteus mirabilis, Escherichia coli, and Enterococcus faecalis and skin and soft tissue infections (wounds and abscesses) in dogs caused by susceptible strains of Staphylococcus pseudintermedius, Staphylococcus aureus, coagulase-positive staphylococci, Pasteurella multocida, Proteus mirabilis, Pseudomonas spp., Klebsiella pneumoniae, E. coli, Enterobacter spp., Citrobacter spp., E. faecalis, β-hemolytic streptococci (Group G), and Streptococcus equisimilis.

(2) Cats—(i) Amount. 3.4 mg/lb (7.5 mg/kg) of body weight once daily.

(ii) Indications for use. For the treatment of skin infections (wounds and abscesses) in cats caused by susceptible strains of S. aureus, E. coli, and P. multocida.

[75 FR 26646, May 12, 2010]

§520.1628   Oxfendazole powder and pellets.

(a) Specifications—(1) Powder for suspension. Each gram of powder contains 7.57 percent oxfendazole.

(2) Pellets. Each gram of pellets contains 6.49 percent oxfendazole.

(b) Sponsor. See No. 000856 in §510.600(c) of this chapter.

(c) Conditions of use—(1) Amount. 10 milligrams per kilogram of body weight.

(2) Indications for use. The drug is used in horses for removal of the following gastrointestinal worms: Large roundworms (Parascaris equorum), mature and immature pinworms (Oxyuris equi), large strongyles (Strongylus edentatus, Strongylus vulgaris, and Strongylus equinus), and small strongyles.

(3) Limitations—(i) Powder for suspension. For gravity administration via stomach tube or for positive administration via stomach tube and dose syringe. Discard unused portions of suspension after 24 hours. Mix drug according to directions prior to use. Administer drug with caution to sick or debilitated horses. Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(ii) Pellets. The drug is given by sprinkling on the grain portion of the ration. Withholding feed or water prior to administration is not necessary. Administer drug with caution to sick or debilitated horses. Not for use in horses intended for food. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.

[44 FR 35211, June 19, 1979, as amended at 46 FR 26301, May 12, 1981; 46 FR 60570, Dec. 11, 1981; 49 FR 28549, July 13, 1984; 61 FR 5506, Feb. 13, 1996]

§520.1629   Oxfendazole paste.

(a)(1) Specifications. Each gram of paste contains 0.375 gram oxfendazole (37.5 percent).

(2) Sponsor. See No. 000856 in §510.600(c) of this chapter.

(3) Conditions of use—(i) Amount. 10 milligrams per kilogram (2.2 pounds) of body weight.

(ii) Indications for use. The drug is used in horses for removal of the following gastrointestinal worms: Large roundworms (Parascaris equorum), mature and 4th stage larvae pinworms (Oxyuris equi), large strongyles (Strongylus edentatus, S. vulgaris, and S. equinus), and small strongyles.

(iii) Limitations. Horses maintained on premises where reinfection is likely to occur should be retreated in 6 to 8 weeks. Withholding feed or water prior to use is unnecessary. Administer drug with caution to sick or debilitated horses. Not for use in horses intended for food. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.

(b)(1) Specifications. Each gram of paste contains 185 milligrams of oxfendazole (18.5 percent).

(2) Sponsor. See No. 000856 in §510.600(c) of this chapter.

(3) Related tolerances. See §556.495 of this chapter.

(4) Conditions of use—(i) Amount. 4.5 milligrams per kilogram of body weight (2.05 milligrams per pound).

(ii) Indications for use. The drug is used in cattle for the removal and control of the following worms: lungworms (Dictyocaulus viviparus—adult, L4); stomach worms: barberpole worms (Haemonchus contortus and H. placei—adult), small stomach worms (Trichostrongylus axei—adult), brown stomach worms (Ostertagia ostertagi—adult, L4, inhibited L4); intestinal worms; nodular worms (Oesophagostomum radiatum—adult), hookworms (Bunostomum phlebotomum—adult), small intestinal worms (Cooperia punctata, C. oncophora, and C. mcmasteri—adult, L4); and tapeworms (Moniezia benedeni—adult).

(iii) Limitations. For use in cattle only. Treatment may be repeated in 4 to 6 weeks. Cattle must not be slaughtered until 11 days after treatment. Do not use in female dairy cattle of breeding age. Consult a veterinarian for assistance in the diagnosis, treatment, and control of parasitism.

[49 FR 38250, Sept. 28, 1984, as amended at 58 FR 39443, July 23, 1993; 61 FR 5506, Feb. 13, 1996]

§520.1630   Oxfendazole suspension.

(a) Specifications. Each milliliter of suspension contains:

(1) 90.6 milligrams (mg) oxfendazole (9.06 percent).

(2) 225.0 mg oxfendazole (22.5 percent).

(b) Sponsor. See No. 000010 in §510.600(c) of this chapter.

(c) Related tolerances. See §556.495 of this chapter.

(d) Special considerations. See §500.25 of this chapter. If labeled for administration by stomach tube: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(e) Conditions of use—(1) Horses. Use the product described in paragraph (a)(1) of this section as follows:

(i) Amount. 10 mg per kilogram (/kg) of body weight by stomach tube or dose syringe. Horses maintained on premises where reinfection is likely to occur should be retreated in 6 to 8 weeks.

(ii) Indications for use. For removal of large roundworms (Parascaris equorum), mature and 4th stage larvae pinworms (Oxyuris equi), large strongyles (Strongylus edentatus, S. vulgaris, and S. equinus), and small strongyles.

(iii) Limitations. Withholding feed or water prior to use is unnecessary. Administer drug with caution to sick or debilitated horses. Do not use in horses intended for human consumption.

(2) Cattle. Use the products described in paragraphs (a)(1) and (a)(2) of this section as follows:

(i) Amount. 4.5 mg/kg of body weight by dose syringe. Treatment may be repeated in 4 to 6 weeks.

(ii) Indications for use. For the removal and control of: lungworms (Dictyocaulus viviparus—adult, L4); stomach worms: barberpole worms (Haemonchus contortus and H. placei—adult), small stomach worms (Trichostrongylus axei—adult), brown stomach worms (Ostertagia ostertagi—adult, L4, inhibited L4); intestinal worms; nodular worms (Oesophagostomum radiatum—adult), hookworms (Bunostomum phlebotomum—adult), small intestinal worms (Cooperia punctata, C. oncophora, and C. surnabada—adult, L4), and tapeworms (Moniezia benedeni—adult).

(iii) Limitations. Cattle must not be slaughtered until 7 days after treatment. Because a withdrawal time in milk has not been established, do not use in female dairy cattle of breeding age.

[55 FR 46943, Nov. 8, 1990, as amended at 56 FR 8710, Mar. 1, 1991; 61 FR 5506, Feb. 13, 1996; 72 FR 10596, Mar. 9, 2007; 73 FR 45610, Aug. 6, 2008; 75 FR 10166, Mar. 5, 2010]

§520.1631   Oxfendazole and trichlorfon paste.

(a) Specifications. Each gram of paste contains 28.5 milligrams oxfendazole and 454.5 milligrams trichlorfon.

(b) Sponsor. See 000856 in §510.600(c) of this chapter.

(c) Conditions of use—(1) Amount. 2.5 milligrams of oxfendazole and 40 milligrams of trichlorfon per kilogram of body weight.

(2) Indications for use. The drug is used in horses for removal of bots (Gasterophilus intestinalis, 2nd and 3rd instars; G. nasalis, 3rd instar) and the following gastrointestinal worms: Large roundworms (Parascaris equorum), pinworms (Oxyuris equi), adult and 4th stage larvae; large strongyles (Strongylus edentatus, S. vulgaris, and S. equinus); and small strongyles.

(3) Limitations. Horses maintained on premises where reinfection is likely to occur should be retreated in 6 to 8 weeks. Withholding feed or water before use is unnecessary. Administer with caution to sick or debilitated horses. Not for use in horses intended for food. Do not administer to mares during the last month of pregnancy. Trichlorfon is a cholinesterase inhibitor. Do not use this product in animals simultaneously with, or within a few days before or after treatment with or exposure to, cholinesterase-inhibiting drugs, pesticides, or chemicals. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.

[50 FR 50291, Dec. 10, 1985, as amended at 61 FR 5506, Feb. 13, 1996]

§520.1638   Oxibendazole paste.

(a) Specifications. The paste contains 22.7 percent oxibendazole.

(b) Sponsor. See 000069 in §510.600(c) of this chapter.

(c) Conditions of use in horses—(1) Amount. For uses other than for threadworms (Strongyloides westeri), 10 milligrams of oxibendazole per kilogram of body weight; for threadworms (Strongyloides westeri), 15 milligrams per kilogram.

(2) Indications for use. For removal and control of large strongyles (Strongylus edentatus, S. equinus, S. vulgaris); small strongyles (genera Cylicostephanus, Cylicocyclus, Cyathostomum, Triodontophorus, Cylicodontophorus, and Gyalocephalus); large roundworms (Parascaris equorum); pinworms (Oxyuris equi) including various larval stages; and threadworms (Strongyloides westeri).

(3) Limitations. Administer orally by syringe. Horses maintained on premises where reinfection is likely to occur should be re-treated in 6 to 8 weeks. Not for use in horses intended for human consumption. Consult a veterinarian for assistance in the diagnosis, treatment, and control of parasitism.

[46 FR 50948, Oct. 16, 1981, as amended at 47 FR 36418, Aug. 20, 1982; 56 FR 50653, Oct. 8, 1991; 60 FR 55659, Nov. 2, 1995; 71 FR 33237, June 8, 2006]

§520.1640   Oxibendazole suspension.

(a) Specifications. The suspension contains 10 percent oxibendazole.

(b) Sponsor. See 000069 in §510.600(c) of this chapter.

(c) Conditions of use in horses—(1) Amount. For use other than threadworms (Strongyloides westeri), 10 milligrams of oxibendazole per kilogram of body weight; for threadworms, 15 milligrams per kilogram of body weight.

(2) Indications for use. For removal and control of large strongyles (Strongylus edentatus, S. equinus, S. vulgaris); small strongyles (species of the genera Cylicostephanus Cylicocyclus, Cyathostomum, Triodontophorus, Cylicodontophorus, and Gyalocephalus); large roundworms (Parascaris equorum); pinworms (Oxyuris equi) including various larval stages; and threadworms (Strongyloides westeri).

(3) Limitations. Administer by stomach tube in 3 to 4 pints of warm water, or by top dressing or mixing into a portion of the normal grain ration. Prepare individual doses to ensure that each animal receives the correct amount. Horses maintained on premises where reinfection is likely to occur should be re-treated in 6 to 8 weeks. Not for use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[45 FR 78119, Nov. 28, 1980, as amended at 47 FR 39812, Sept. 10, 1982; 56 FR 50653, Oct. 8, 1991; 60 FR 55659, Nov. 2, 1995; 71 FR 33237, June 8, 2006]

§520.1660   Oxytetracycline.

§520.1660a   Oxytetracycline and carbomycin in combination.

(a) Specifications. (1) Oxytetracycline: The antibiotic substance produced by growth of Streptomyces rimosus or the same antibiotic substance produced by any other means.

(2) Carbomycin: The antibiotic substance produced by growth of Streptomyces halstedii or the same antibiotic substance produced by any other means.

(b) Sponsor. See No. 000069 in §510.600(c) of this chapter.

(c) Special considerations. The quantities of oxytetracycline in paragraph (e) of this section refer to the activity of oxytetracycline hydrochloride and the quantities of carbomycin listed refer to the activity of an appropriate standard.

(d) Related tolerances. See §§556.110 and 556.500 of this chapter.

(e) Conditions of use. It is used as oxytetracycline hydrochloride plus carbomycin base in drinking water of chickens as follows:

(1) Amount. 1.0 gram of oxytetracycline and 1.0 gram carbomycin per gallon.

(2) Indications for use. As an aid in the prevention and treatment of complicated chronic respiratory disease (air-sac infection) caused by Mycoplasma gallisepticum and secondary bacterial organisms associated with chronic respiratory disease such as E. coli.

(3) Limitations. Administer for not more than 5 days; not for use in chickens producing eggs for human consumption; withdraw 24 hours before slaughter.

§520.1660b   Oxytetracycline hydrochloride capsules.

(a) Specifications. The drug is in capsule form with each capsule containing 125 or 250 milligrams of oxytetracycline hydrochloride. Oxytetracycline is the antibiotic substance produced by growth of Streptomyces rimosus or the same antibiotic substance produced by any other means.

(b) Sponsor. See No. 000069 in §510.600(c) of this chapter.

(c) Conditions of use. (1) It is used in dogs and cats for the treatment of bacterial pneumonia caused by Brucella bronchiseptica, tonsilitis caused by Streptococcus hemolyticus, bacterial enteritis caused by Escherichia coli, urinary tract infections caused by Escherichia coli, and wound infections caused by Staphylococcus aureus.1

1These conditions are NAS/NRC reviewed and deemed effective. Applications for these uses need not include effectiveness data as specified by §514.111 of this chapter, but may require bioequivalency and safety information.

(2) The drug is administered orally to dogs and cats at a dosage level of 25-50 milligrams per pound of body weight per day in divided doses at 12-hour intervals. The drug can be used for continuation of compatible antibiotic therapy following parenteral oxytetracycline administration where rapidly attained, sustained antibiotic blood levels are required. The duration of treatment required to obtain favorable response will depend to some extent on the severity and degree of involvement and the susceptibility of the infectious agent. Clinical response to antibiotic therapy usually occurs within 48 to 72 hours. If improvement is not observed within that period, the diagnosis and course of treatment should be reconsidered. To assure adequate treatment, administration of the drug should continue for at least 48 hours following favorable clinical response.1

(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian.1

§520.1660c   Oxytetracycline hydrochloride tablets/boluses.

(a) Specifications. Each tablet or bolus contains 250, 500, or 1,000 milligrams of oxytetracycline hydrochloride.

(b) Sponsors. For sponsors in §510.600(c) of this chapter: See 000010 for use of 500 and 1,000 milligram boluses. See 000069 for use of 250 and 500 milligram tablets.

(c) Tolerances. See §556.500 of this chapter.

(d) Conditions of use in beef and dairy cattle—(1)(i) Amount. 250 milligrams per 100 pounds of body weight every 12 hours (5 milligrams per pound of body weight daily in two doses).

(ii) Indications for use. For control of bacterial enteritis caused by Salmonella typhimurium and Escherichia coli (colibacillosis) and bacterial pneumonia (shipping fever complex, pasteurellosis) caused by Pasteurella multocida.

(2)(i) Amount. 500 milligrams per 100 pound of body weight every 12 hours (10 milligrams per pound of body weight daily in two doses).

(ii) Indications for use. For treatment of bacterial enteritis caused by Salmonella typhimurium and Escherichia coli (colibacillosis) and bacterial pneumonia (shipping fever complex, pasteurellosis) caused by Pasteurella multocida.

(3) Limitations. Dosage should continue until the animal returns to normal and for 24 hours to 48 hours after symptoms have subsided. Treatment should not exceed 4 consecutive days. Do not exceed 500 milligrams per 100 pounds of body weight every 12 hours (10 milligrams per pound daily). For sponsor 000069: Discontinue treatment 7 days prior to slaughter. Not for use in lactating dairy cattle. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.

[46 FR 32440, June 23, 1981, as amended at 50 FR 1045, Jan. 9, 1985; 63 FR 70334, Dec. 21, 1998; 70 FR 16394, Apr. 4, 2005]

§520.1660d   Oxytetracycline powder.

(a) Specifications. The drug is a soluble powder distributed in packets or pails having several concentrations of oxytetracycline hydrochloride (independent of the various net weights) as follows:

(1) Each 18.14 grams of powder contains 1 gram of oxytetracycline hydrochloride (OTC HCl) (packets: 4, 6.4, and 16 oz.).

(2) Each 4.43 grams of powder contains 1 gram of OTC HCl (packets: 4 and 16 oz.).

(3) Each 1.32 grams of powder contains 1 gram of OTC HCl (packets: 2.39, 4.78, and 9.55 oz.; jars: 2.25 lbs.; and pails: 4.5 lbs.).

(4) Each 2.73 grams of powder contains 1 gram of OTC HCl (packets: 2.46 and 9.87 oz; pail: 3.09 lb).

(5) Each 4.2 grams of powder contains 1 gram of OTC HCl (packets: 3.8 and 15.2 oz; pails: 4.74 and 23.7 lb).

(6) Each 1.32 grams of powder contains 1 gram of OTC HCl (packet: 4.78 oz.; pail: 5 lb). Each 2.73 grams of powder contains 1 gram of OTC HCl (packet: 9.87 oz).

(7) Each 1.32 grams of powder contains 1 gram of OTC HCl (packet: 4.78 and 9.6 oz.; pails: 2 and 5 lb); each 18.1 grams of powder contains 1 gram of OTC HCl (packet: 6.4 oz.; pails: 2 and 5 lb).

(8) Each 135.5-gram packet (4.78 ounce) contains 102.4 grams of OTC HCl. Each 677.5-gram packet (23.9 ounce) contains 512 grams of OTC HCl.

(9) Each 2.73 grams of powder contains 1 gram of OTC HCl (packets: 9.87 and, 19.75 oz, and 3.91 lb; pails: 3.09 and 5 lb).

(10) Each 2.73 grams of powder contains 1 gram of OTC HCl (packets: 9.87 and 19.74 oz; pails: 5 lb).

(b) Sponsor. See sponsor numbers in §510.600(c) of this chapter as follows:

(1) No. 000069 for use of OTC HCl concentrations in paragraphs (a)(1), (a)(2), and (a)(3) of this section in chickens, turkeys, swine, cattle, sheep, and honey bees.

(2) No. 046573 for use of OTC HCl concentration in paragraph (a)(4) of this section in chickens, turkeys, and swine.

(3) No. 054628 for use of OTC HCl concentration in paragraph (a)(5) of this section in turkeys and chickens.

(4) No. 057561 for use of OTC HCl concentration in paragraph (a)(6) of this section in chickens, turkeys, and swine.

(5) No. 061623 for use of OTC HCl concentration in paragraph (a)(7) of this section in chickens, turkeys, swine, cattle, sheep, and honeybees.

(6) No. 048164 for use of OTC HCl concentrations in paragraph (a)(8) of this section in chickens, turkeys, swine, cattle, sheep, and honey bees.

(7) No. 061623 for use of OTC HCl concentration in paragraph (a)(9) of this section in chickens, turkeys, and swine.

(8) No. 059320 for use of OTC concentration in paragraph (a)(10) of this section in chickens, turkeys, and swine as in paragraph (d) of this section.

(c) Related tolerances. See §556.500 of this chapter.

(d) Conditions of use. (1) It is used in drinking water as follows:

(i) Chickens—(A)(1) Amount per gallon. 200 to 400 milligrams.

(2) Indications for use. Control of infectious synovitis caused by Mycoplasma synoviae susceptible to oxytetracycline.

(3) Limitations. Prepare a fresh solution daily. Administer 7 to 14 days. Not to be used for more than 14 consecutive days. Use as sole source of drinking water. Do not use in birds producing eggs for human consumption.

(B)(1) Amount per gallon. 400 to 800 milligrams.

(2) Indications for use. Control of chronic respiratory disease (CRD) and air sac infections caused by Mycoplasma gallisepticum and E. coli susceptible to oxytetracycline; control of fowl cholera caused by Pasteurella multocida susceptible to oxytetracycline.

(3) Limitations. Prepare a fresh solution daily. Administer 7 to 14 days. Not to be used for more than 14 consecutive days. Use as sole source of drinking water. Do not use in birds producing eggs for human consumption.

(ii) Turkeys—(A)(1) Amount per gallon. 200 to 400 milligrams.

(2) Indications for use. Control of hexamitiasis caused by Hexamita meleagridis susceptible to oxytetracycline.

(3) Limitations. Prepare a fresh solution daily. Administer 7 to 14 days. Not to be used for more than 14 consecutive days. Use as sole source of drinking water. Do not use in birds producing eggs for human consumption. Withdraw 5 days prior to slaughter those products sponsored by Nos. 000069, and 061623 in §510.600(c) of this chapter. Withdraw 4 days prior to slaughter those products sponsored by No. 054628. Zero-day withdrawal for those products sponsored by Nos. 046573, 053389, 057561, 059320, and 061133.

(B)(1) Amount per gallon. 400 milligrams.

(2) Indications for use. Control of infectious synovitis caused by Mycoplasma synoviae susceptible to oxytetracycline.

(3) Limitations. Prepare a fresh solution daily. Administer 7 to 14 days. Not to be used for more than 14 consecutive days. Use as sole source of drinking water. Do not use in birds producing eggs for human consumption. Withdraw 5 days prior to slaughter those products sponsored by Nos. 000069, and 061623 in §510.600(c) of this chapter. Withdraw 4 days prior to slaughter those products sponsored by No. 054628. Zero-day withdrawal for those products sponsored by Nos. 046573, 053389, 057561, 059320, and 061133.

(C)(1) Amount. 25 milligrams per pound of body weight.

(2) Indications for use. Growing turkeys. Control of complicating bacterial organisms associated with bluecomb (transmissible enteritis, coronaviral enteritis) susceptible to oxytetracycline.

(3) Limitations. Prepare a fresh solution daily. Administer 7 to 14 days. Not to be used for more than 14 consecutive days. Use as sole source of drinking water. Do not use in birds producing eggs for human consumption. Withdraw 5 days prior to slaughter those products sponsored by Nos. 000069, and 061623 in §510.600(c) of this chapter. Withdraw 4 days prior to salughter those products sponsored by No. 054628. Zero-day withdrawal for those products sponsored by Nos. 046573, 053389, 057561, 059320, and 061133.

(iii) Swine—(A) Amount. 10 milligrams per pound of body weight daily.

(B) Indications for use. Control and treatment of bacterial enteritis caused by Escherichia coli and Salmonella choleraesuis and bacterial pneumonia caused by Pasteurella multocida susceptible to oxytetracycline. For breeding swine: Control and treatment of leptospirosis (reducing the incidence of abortions and shedding of leptospira) caused by Leptospira pomona susceptible to oxytetracycline.

(C) Limitations. Prepare a fresh solution daily. Use as sole source of OTC. Administer up to 14 days; do not use for more than 14 consecutive days; withdraw zero days prior to slaughter those products sponsored by Nos. 000069 and 061623. Administer up to 5 days; do not use for more than 5 consecutive days; withdraw zero days prior to slaughter those products sponsored by Nos. 046573, 053389, 057561, 059320, and 061133.

(iv) Calves, beef cattle, and nonlactating dairy cattle—(A) Amount. 10 milligrams per pound of body weight daily.

(B) Indications for use. Control and treatment of bacterial enteritis caused by E. coli and bacterial pneumonia (shipping fever complex) caused by P. multocida susceptible to oxytetracycline.

(C) Limitations. Prepare a fresh solution daily. Administer up to 14 days. Do not use for more than 14 consecutive days. Use as sole source of oxytetracycline. Do not administer this product with milk or milk replacers. Administer 1 hour before or 2 hours after feeding milk or milk replacers. Withdraw 5 days prior to slaughter. A milk discard period has not been established for this product in lactating dairy cattle. Do not use in female dairy cattle 20 months of age or older.

(v) Sheep—(A) Amount. 10 milligrams per pound of body weight daily.

(B) Indications for use. Control and treatment of bacterial enteritis caused by E. coli and bacterial pneumonia (shipping fever complex) caused by P. multocida susceptible to oxytetracycline.

(C) Limitations. Prepare a fresh solution daily. Administer up to 14 days. Do not use for more than 14 consecutive days. Use as sole source of oxytetracycline. Withdraw 5 days prior to slaughter.

(2) It is used in the food of honey bees as follows:

(i) Amount. 200 milligrams per colony, administered via either a 1:1 sugar syrup (equal parts of sugar and water weight to weight) or dusting with a powdered sugar mixture.

(ii) Indications for use. For control of American foulbrood caused by Paenibacillus larvae and European foulbrood caused by Streptococcus pluton susceptible to oxytetracycline.

(iii) Limitations. The drug is administered in 3 applications of sugar syrup or 3 dustings at 4- to 5-day intervals. The drug should be fed early in the spring or fall and consumed by the bees before main honey flow begins to avoid contamination of production honey. Remove at least 6 weeks prior to main honey flow.

[50 FR 32694, Aug. 14, 1985]

Editorial Note: For Federal Register citations affecting §520.1660d, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.fdsys.gov.

§520.1696   Penicillin.

§520.1696a   [Reserved]

§520.1696b   Penicillin G powder.

(a) Specifications. Each gram of powder contains penicillin G potassium equivalent to 1.54 million units of penicillin G.

(b) Sponsors. See Nos. 010515, 046573, 053501, 059320, 061623 and 076475 in §510.600(c) of this chapter.

(c) Conditions of use in turkeys— (1) Amount. 1,500,000 units per gallon drinking water for 5 days.

(2) Indications for use. Treatment of erysipelas caused by Erysipelothrix rhusiopathiae.

(3) Limitations. Prepare concentrated stock solution for use with medication proportioners fresh every 24 hours. Prepare recommended use levels for gravity flow watering system fresh every 12 hours. For best results, treatment should be started at the first sign of infection. Discontinue treatment at least 1 day prior to slaughter. Not for use in turkeys producing eggs for human consumption.

[57 FR 37326, Aug. 18, 1992, as amended at 59 FR 42493, Aug. 18, 1994; 60 FR 26359, May 17, 1995; 62 FR 55160, Oct. 23, 1997; 65 FR 10705, Feb. 29, 2000; 66 FR 14073, Mar. 9, 2001; 68 FR 4914, Jan. 31, 2003; 68 FR 26204, May 15, 2003; 69 FR 9946, Mar. 3, 2004; 69 FR 41428, July 9, 2004; 77 FR 20988, Apr. 9, 2012]

§520.1696c   Penicillin V powder.

(a) Specifications. When reconstituted, each milliliter contains 25 milligrams (40,000 units) of penicillin V.

(b) Sponsor. See No. 050604 in §510.600(c) of this chapter.

(c) [Reserved]

(d) Conditions of use. Dogs and cats—(1) Amount. 10 to 15 milligrams per pound of body weight every 6 to 8 hours.

(2) Indications for use. Treatment of respiratory, urogenital, skin, and soft tissue infections and septicemia caused by pathogens susceptible to penicillin V potassium.

(3) Limitations. Administer orally 1 to 2 hours prior to feeding for maximum absorption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[57 FR 37326, Aug. 18, 1992; 57 FR 42623, Sept. 15, 1992; 77 FR 20988, Apr. 9, 2012]

§520.1696d   Penicillin V tablets.

(a) Specifications. Each tablet contains penicillin V potassium equivalent to 125 milligrams (200,000 units) or 250 milligrams (400,000 units) of penicillin V.

(b) Sponsors. See Nos. 050604 and 053501 in §510.600(c) of this chapter.

(c) [Reserved]

(d) Conditions of use. Dogs and Cats—(1) Amount. 10 to 15 milligrams per pound of body weight every 6 to 8 hours.

(2) Indications for use. Treatment of respiratory, urogenital, skin and soft tissue infections and septicemia caused by pathogens susceptible to penicillin V potassium.

(3) Limitations. Administer orally 1 to 2 hours prior to feeding for maximum absorption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[57 FR 37327, Aug. 18, 1992, as amended at 59 FR 58775, Nov. 15, 1994]

§520.1705   Pergolide.

(a) Specifications. Each tablet contains 1 milligram (mg) pergolide mesylate.

(b) Sponsor. See No. 000010 in §510.600(c) of this chapter.

(c) Conditions of use in horses—(1) Amount. Administer orally at a starting dose of 2 micrograms/kilograms (µ/kg) once daily. Dosage may be adjusted to effect, not to exceed 4 µg/kg daily.

(2) Indications for use. For the control of clinical signs associated with Pituitary Pars Intermedia Dysfunction (Equine Cushing's Disease).

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[77 FR 15960, Mar. 19, 2012]

§520.1720   Phenylbutazone oral dosage forms.

§520.1720a   Phenylbutazone tablets and boluses.

(a) Specifications. Each tablet contains 100, 200, or 400 milligrams (mg), or 1 gram (g) of phenylbutazone. Each bolus contains 1, 2, or 4 gram g of phenylbutazone.

(b) Sponsors. See sponsor numbers in §510.600(c) of this chapter, as follows:

(1) No. 000061 for use of 100- or 400-mg or 1-g tablets, or 2- or 4-g boluses, in dogs and horses.

(2) Nos. 000859 and 054628 for use of 100- or 200-mg or 1-g tablets in dogs and horses.

(3) Nos. 000856 and 061623 for use of 100-mg or 1-g tablets in dogs and horses.

(4) [Reserved]

(5) No. 000143 for use of 1-g tablets in horses.

(6) No. 058829 for use of 100-mg or 1-g tablets in dogs and horses.

(c) Conditions of use—(1) Dogs—(i) Amount. 20 mg per pound of body weight daily.

(ii) Indications for use. For the relief of inflammatory conditions associated with the musculoskeletal system.

(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) Horses—(i) Amount. 1 to 2 g per 500 pounds of body weight daily.

(ii) Indications for use. For the relief of inflammatory conditions associated with the musculoskeletal system.

(iii) Limitations. Do not use in horses intended for human consumption. Federal law prohibits the use of this drug in female dairy cattle 20 months of age or older. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[73 FR 8192, Feb. 13, 2008, as amended at 74 FR 1146, Jan. 12, 2009; 76 FR 11331, Mar. 2, 2011; 76 FR 17777, Mar. 31, 2011; 78 FR 17596, Mar. 22, 2013]

§520.1720b   Phenylbutazone granules.

(a) Specifications. The drug is in granular form. It is packaged to contain either 8 grams of phenylbutazone per package or 1 gram of phenylbutazone per package.

(b) Sponsor. See 000061 in §510.600(c) for 8-gram package, see 059320 for 1-gram package.

(c) NAS/NRC status. The conditions of use have been NAS/NRC reviewed and found effective. NADA's for approval of drugs for these conditions of use need not include effectiveness data specified by §514.111 of this chapter, but may require bioequivalency and safety information.

(d) Conditions of use—(1) Horses—(i) Amount. 1 to 2 grams per 500 pounds of body weight, not to exceed 4 grams, daily, as required.

(ii) Indications. For the treatment of inflammatory conditions associated with the musculoskeletal system.

(iii) Limitations. Administer orally by adding to a portion of the usual grain ration. Use a relatively high dose for the first 48 hours, then gradually reduce to a maintenance level at the lowest level capable of producing the desired clinical response. Treated animals should not be slaughtered for food use. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[46 FR 18960, Mar. 27, 1981, as amended at 46 FR 48642, Oct. 2, 1981; 57 FR 2836, Jan. 24, 1992; 61 FR 8873, Mar. 6, 1996; 62 FR 61625, Nov. 19, 1997; 65 FR 20731, Apr. 18, 2000]

§520.1720c   Phenylbutazone paste.

(a) Specifications—(1) Each gram of paste contains 0.2 grams phenylbutazone.

(2) Each gram of paste contains 0.35 grams phenylbutazone.

(b) Sponsors. See sponsor numbers in §510.600(c) of this chapter.

(1) No. 000061 for use of product described in paragraph (a)(1) of this section.

(2) No. 064847 for use of product described in paragraph (a)(2) of this section.

(c) Conditions of use in horses—(1) Amount. 1 to 2 grams of phenylbutazone per 500 pounds of body weight, not to exceed 4 grams daily.

(2) Indications for use. For relief of inflammatory conditions associated with the musculoskeletal system.

(3) Limitations. Use a relatively high dose for the first 48 hours, then gradually reduce to a maintenance level of the lowest level capable of producing the desired clinical response. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[45 FR 84762, Dec. 23, 1980, as amended at 58 FR 29777, May 24, 1993; 61 FR 8873, Mar. 6, 1996; 62 FR 61625, Nov. 19, 1997; 68 FR 43926, July 25, 2003; 72 FR 60550, Oct. 25, 2007; 77 FR 4897, Feb. 1, 2012]

§520.1720d   Phenylbutazone gel.

(a) Specifications. Each 30 grams of gel contains 4 grams of phenylbutazone.

(b) Sponsor. See No. 061623 in §510.600(c) of this chapter.

(c) NAS/NRC status. The conditions of use are NAS/NRC reviewed and found effective. Applications for these uses need not include effectiveness data as specified in §514.111 of this chapter, but may require bioequivalency and safety information.

(d) Conditions of use in horses—(1) Amount. 1 to 2 grams of phenylbutazone per 500 pounds of body weight, not to exceed 4 grams daily.

(2) Indications for use. For relief of inflammatory conditions associated with the musculoskeletal system of horses.

(3) Limitations. Use a relatively high dose for the first 48 hours, then gradually reduce to a maintenance level at the lowest level capable of producing the desired clinical response. Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[50 FR 13561, Apr. 5, 1985, as amended at 50 FR 49372, Dec. 2, 1985; 55 FR 8462, Mar. 8, 1990; 66 FR 14073, Mar. 9, 2001; 68 FR 4915, Jan. 31, 2003]

§520.1720e   Phenylbutazone powder.

(a) Specifications—(1) Each 1.15 grams (g) of powder contains 1 g phenylbutazone.

(2) Each 10 g of powder contains 1 g phenylbutazone.

(b) Sponsors. See sponsor numbers in §510.600(c) of this chapter.

(1) No. 027053 for use of product described in paragraph (a)(1) of this section.

(2) No. 057699 for use of product described in paragraph (a)(2) of this section.

(c) Conditions of use in horses—(1) Amount. Administer 1 to 2 g (1 to 2 level scoops, using the scoop provided) per 500 pounds of body weight on a small amount of palatable feed, not exceed 4 g per animal daily.

(2) Indications for use. For the relief of inflammatory conditions associated with the musculosketetal system.

(3) Limitations. Do not use in horses intended for human consumption. Federal law prohibits the extralabel use of this product in female cattle 20 months of age or older. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[72 FR 27956, May 18, 2007]

§520.1760   Phenylpropanolamine.

(a) Specifications. Each chewable tablet contains 25, 50, or 75 milligram (mg) phenylpropanolamine hydrochloride.

(b) Sponsors. See No. 055246 in §510.600(c) of this chapter.

(c) Conditions of use in dogs—(1) Amount. Administer 2 mg/kg of body weight twice daily.

(2) Indications for use. For the control of urinary incontinence due to urethral sphincter hypotonus in dogs.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[77 FR 15961, Mar. 19, 2012]

§520.1780   Pimobendan.

(a) Specifications. Each chewable tablet contains 1.25, 2.5, 5, or 10 milligrams (mg) pimobendan.

(b) Sponsor. See No. 000010 in §510.600(c) of this chapter.

(c) Conditions of use in dogs—(1) Amount. Administer orally at a total daily dose of 0.23 mg per pound (0.5 mg per kilogram) body weight, using a suitable combination of whole or half tablets. The total daily dose should be divided into two portions administered approximately 12 hours apart.

(2) Indications for use. For the management of the signs of mild, moderate, or severe (modified New York Heart Association Class II, III, or IV) congestive heart failure due to atrioventricular valvular insufficiency or dilated cardiomyopathy; for use with concurrent therapy for congestive heart failure as appropriate on a case-by-case basis.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[72 FR 27733, May 17, 2007, as amended at 79 FR 18158, Apr. 1, 2014]

§520.1802   Piperazine-carbon disulfide complex oral dosage forms.

§520.1802a   Piperazine-carbon disulfide complex suspension.

(a) Specifications. Each fluid ounce of suspension contains 7.5 grams of piperazine-carbon disulfide complex. The piperazine-carbon disulfide complex contains equimolar parts of piperazine and carbon disulfide (1 gram contains 530 mgs of piperazine and 470 mgs of carbon disulfide).

(b) Sponsor. See 000009 in §510.600(c) of this chapter.

(c) Conditions of use. Horses and ponies—(1) Amount. One fluid ounce per 100 pounds of body weight.1

1These conditions are NAS/NRC reviewed and found effective. Applications for these uses need not include effectiveness data as specified by §514.111 of this chapter, but may require bioequivalency and safety information.

(2) Indications for use. For removing ascarids (large roundworms, Parascaris equorum), bots (Gastrophilus spp.), small strongyles, large strongyles (Strongyles spp.), and pinworms (Oxyuris equi).1

(3) Limitations. Administer by stomach tube or dose syringe after withholding feed overnight or for 8 to 10 hours. Provide water as usual. Resume regular feeding 4 to 6 hours after treatment. Treatment of debilitated or anemic animals is contraindicated. Do not administer to animals that are or were recently affected with colic, diarrhea, or infected with a serious infectious disease. As with most anthelmintics, drastic cathartics and other gastrointestinal irritants should not be administered in conjunction with this drug. Animals in poor condition or heavily parasitized should be given one half the recommended dose and treated again in 2 or 3 weeks. Federal law restricts this drug to use by or on the order of a licensed veterinarian.1

[45 FR 52781, Aug. 8, 1980]

§520.1802b   Piperazine-carbon disulfide complex boluses.

(a) Specifications. Each bolus contains 20 grams of piperazine-carbon disulfide complex.

(b) Sponsor. See 000009 in §510.600(c) of this chapter.

(c) Conditions of use: Horses and ponies—(1) Amount. For removal of ascarids and small strongyles, 1 bolus (20 grams) per 500 pounds body weight; removal of large strongyles, pinworms, and bots, 1 bolus per 250 pounds body weight.1

(2) Indications for use. For removing ascarids (large roundworms, Parascaris equorum), large strongyles (Strongylus spp.) bots (Gastrophilus spp.), small strongyles, and pinworms (Oxyuris equi).1

(3) Limitations. Withhold feed overnight or for 8 to 10 hours. Give water just before and/or after treatment. Resume regular feeding 4 to 6 hours after treatment. Treatment of debilitated or anemic animals is contraindicated. Do not administer to animals that are or were recently affected with colic, diarrhea, or infected with a serious infectious disease. As with most anthelmintics, drastic cathartics or other gastrointestinal irritants should not be administered in conjunction with this drug. Animals in poor condition or heavily parasitized should be given one half the recommended dose and treated again in 2 or 3 weeks. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.1

[45 FR 52782, Aug. 8, 1980]

§520.1802c   Piperazine-carbon disulfide complex with phenothiazine suspension.

(a) Specifications. Each fluid ounce contains 5 grams of piperazine-carbon disulfide complex and 0.83 gram of phenothiazine.

(b) Sponsor. See 000009 in §510.600(c) of this chapter.

(c) Conditions of use: Horses and ponies—(1) Amount. One fluid ounce per 100 pounds of body weight.

(2) Indications for use. For removing ascarids (large roundworms, Parascaris equorum), bots (Gastrophilus spp.), small strongyles, and large strongyles (Strongylus spp.).

(3) Limitations. See §520.1802a(c)(3).

[45 FR 52782, Aug. 8, 1980]

§520.1803   Piperazine citrate capsules.

(a) Specifications. Piperazine citrate capsules contain piperazine citrate equivalent to 140 milligrams of piperazine base in each capsule.

(b) Sponsor. See No. 021091 in §510.600(c) of this chapter.

(c) Conditions of use. (1) It is used in dogs and cats for the removal of large roundworms (Toxocara canis and Toxascaris leonina).

(2) The contents of 1 capsule should be mixed with the food of the animal for each 5 pounds, or fraction thereof of body weight, except dogs weighing over 25 pounds should be given the contents of 6 capsules. The drug should be mixed in 12 of the regular feeding and when the animal has finished eating the dosed food, the remainder of the food may be given. Dogs and cats may be wormed at 6 to 8 weeks of age. The first treatment should be repeated 10 days later. Reinfection may occur. Repeat treatment if indicated.

(3) Severely debilitated animals should not be wormed except on the advice of a veterinarian.

[40 FR 13838, Mar. 27, 1975, as amended at 54 FR 38515, Sept. 19, 1989]

§520.1804   Piperazine phosphate capsules.

(a) Specifications. Each capsule contains 120, 300, or 600 milligrams of piperazine phosphate monohydrate.

(b) Sponsor. See No. 051311 in §510.600(c) of this chapter.

(c) Conditions of use—(1) Amount. 60 milligrams of piperazine phosphate monohydrate per pound of body weight.1

1These conditions are NAS/NRC reviewed and deemed effective. Applications for these uses need not include effectiveness data as specified by §514.111 of this chapter, but may require bioequivalency and safety information.

(2) Indications for use—(i) Dogs. It is used for the removal of large roundworms (ascarids) Toxocara canis and Toxascaris leonina.1

(ii) Cats. It is used for the removal of large roundworms (ascarids) Toxocara mystax and Toxacaris leonina.1

(3) Limitations. Administer in animal's food or milk. For animals up to 1 year of age administer every 2 or 3 months; for animals over 1 year old, administer periodically as necessary. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.1

[43 FR 6941, Feb. 17, 1978; 43 FR 9804, Mar. 10, 1978, as amended at 46 FR 20158, Apr. 3, 1981; 69 FR 31878, June 8, 2004]

§520.1805   Piperazine phosphate with thenium closylate tablets.

(a) Specifications. Each scored tablet contains the equivalent of 250 milligrams piperazine hexahydrate (as piperazine phosphate) and 125 milligrams thenium (as thenium closylate) or 500 milligrams piperazine hexahydrate (as piperazine phosphate) and 250 milligrams thenium (as thenium closylate).

(b) Sponsor. See No. 000061 in §510.600(c) of this chapter.

(c) Conditions of use—(1) Amount. Administer orally to dogs as follows:

Number of Tablets at Each of the Two Doses

Animal weight (lb)375 mg750 mg
2 but less than 51/2
5 but less than 1011/2
10 or heavier21

(2) Indications for use. For removal of immature (fourth stage larvae) and adult hookworms (Ancylostoma caninum, A. braziliense, and Uncinaria stenocephala) and ascarids (Toxocara canis) from weaned pups and adult dogs.

(3) Limitations. Do not use this product to treat dogs weighing less than 2 pounds, unweaned pups, or pups under 5 weeks of age. Maximum efficacy against hookworms necessitates two doses in 1 day of treatment. The interval between the doses should be not less than 4 hours or more than 24 hours. Administer the first dose in the morning before feeding. Do not permit dog to chew tablet. Feed the dog between doses. Do not feed milk or other fatty foods during treatment. Retreatment may be needed in 7 to 28 days as determined by laboratory fecal examinations or in animals kept in known contaminated quarters. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[43 FR 32747, July 28, 1978, as amended at 47 FR 55476, Dec. 10, 1982; 61 FR 8873, Mar. 6, 1996; 62 FR 61625, Nov. 19, 1997]

§520.1806   Piperazine suspension.

(a) Specifications. Each milliliter of suspension contains piperazine monohydrochloride equivalent to 33.5 milligrams (mg) piperazine base.

(b) Sponsor. See No. 017135 in §510.600(c) of this chapter.

(c) Special considerations. See §500.25(c) of this chapter.

(d) Conditions of use in dogs—(1) Indications for use. For the removal of roundworms (Toxocara canisand Toxascaris leonina).

(2) Dosage. Administer 20 to 30 mg piperazine base per pound body weight as a single dose.

(3) Limitations. Administer by mixing into the animal's ration to be consumed at one feeding. For animals in heavily contaminated areas, reworm at monthly intervals. Not for use in unweaned pups or animals less than 3 weeks of age.

[70 FR 17319, Apr. 6, 2005]

§520.1807   Piperazine.

(a) Specifications. A soluble powder or liquid containing piperazine dihydrochloride or dipiperazine sulfate, equivalent to 17, 34, or 230 grams of piperazine per pound or 100 milliliters.

(b) Sponsor. See 015565 in §510.600(c) of this chapter.

(c) Related tolerances. See §556.513 of this chapter.

(d) Conditions of use—(1) Chickens—(i) Amount. 50 milligrams per bird under 6 weeks, 100 milligrams per bird over 6 weeks.

(ii) Indications for use. For removal of large roundworm (Ascaridia spp.).

(iii) Limitations. For use in drinking water or feed. Use as sole source of drinking water. Prepare fresh solution daily. Use as 1-day single treatment. Withdraw 14 days prior to slaughter. Do not use for chickens producing eggs for human consumption. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.

(2) Turkeys—(i) Amount. 100 milligrams per bird up to 12 weeks and 200 milligrams per bird over 12 weeks.

(ii) Indications for use. For removal of large roundworm (Ascaridia spp.).

(iii) Limitations. For use in drinking water or feed. Use as sole source of drinking water. Prepare fresh solution daily. Use as 1-day single treatment. Withdraw 14 days prior to slaughter. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.

(3) Swine—(i) Amount. 50 milligrams per pound of body weight.

(ii) Indications for use. For removal of large roundworm (Ascaris suum) and nodular worms (Oesophagostomum spp.).

(iii) Limitations. For use in drinking water or feed. Use as sole source of drinking water. Prepare fresh solution daily. Use as 1-day single treatment. Withdraw 21 days prior to slaughter. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.

[64 FR 23018, Apr. 29, 1999]

§520.1840   Poloxalene.

(a) Specifications. Polyoxypropylene-polyoxyethylene glycol nonionic block polymer.

(b) Sponsors. See sponsors in §510.600(c) of this chapter for use as in paragraph (d) of this section.

(1) No. 000069 for use as in paragraphs (d)(1) and (d)(3) of this section.

(2) No. 051311 for use as in paragraph (d)(4) of this section.

(3) No. 067949 for use as in paragraph (d)(2) of this section.

(4) No. 066104 for use as in paragraph (d)(3) of this section.

(c) [Reserved]

(d) Conditions of use. (1) For treatment of legume (alfalfa, clover) bloat in cattle. Administer as a drench at the rate of 25 grams for animals up to 500 pounds and 50 grams for animals over 500 pounds of body weight.

(2) For control of legume (alfalfa, clover) bloat in cattle. Administer, in molasses block containing 6.6 percent poloxalene, at the rate of 0.8 oz. of block (1.5 grams poloxalene) per 100 lbs. of body weight per day.

(3) For prevention of legume (alfalfa, clover) and wheat pasture bloat in cattle. A 53-percent poloxalene top dressing on individual rations of ground feed. Dosage is 1 gram of poloxalene per 100 pounds of body weight daily. If bloating conditions are severe, the dose is doubled. Treatment should be started 2 to 3 days before exposure to bloat-producing conditions. Repeat use of the drug if animals are exposed to bloat-producing conditions for more than 12 hours after the last treatment. Do not exceed the double dose in any 24-hour period.

(4) For control of legume (alfalfa, clover) and wheat pasture bloat in cattle. Administer in molasses block containing 6.6 percent poloxalene, at the rate of 0.8 ounce of block (1.5 grams of poloxalene) per 100 pounds of body weight per day. Provide access to blocks at least 7 days before exposure to bloat-producing conditions.

[40 FR 13838, Mar. 27, 1975, as amended at 40 FR 39857, Aug. 29, 1975; 42 FR 41854, Aug. 19, 1977; 50 FR 5385, Feb. 8, 1985; 54 FR 33501, Aug. 15, 1989; 56 FR 50653, Oct. 8, 1991; 58 FR 26523, May 4, 1993; 60 FR 55659, Nov. 2, 1995; 66 FR 47963, Sept. 17, 2001; 69 FR 62811, Oct. 28, 2004; 70 FR 32489, June 3, 2005]

§520.1846   Polyoxyethylene (23) lauryl ether blocks.

(a) Specifications. Each molasses-based block contains 2.2 percent polyoxyethylene (23) lauryl ether.

(b) Sponsor. See No. 067949 in §510.600(c) of this chapter.

(c) Conditions of use—(1) Amount. 2 grams of polyoxyethylene (23) lauryl ether per 100 kilograms of body weight per day (1 pound of block per 500 kilogram (1,100 pound) animal per day).

(2) Indications for use. For reduction of the incidence of bloat (alfalfa and clover) in pastured cattle.

(3) Limitations. Administer free-choice to beef cattle and nonlactating dairy cattle only. Initially, provide one block per five head of cattle. Start treatment 10 to 14 days before exposure to bloat-producing pastures. Do not allow cattle access to other sources of salt while being fed this product. Do not feed this product to animals without adequate forage/roughage consumption.

[50 FR 48189, Nov. 22, 1985, as amended at 56 FR 9841, Mar. 8, 1991; 69 FR 62811, Oct. 28, 2004]

§520.1855   Ponazuril.

(a) Specifications. Each gram of paste contains 150 milligrams (mg) ponazuril.

(b) Sponsor. See No. 000859 in §510.600(c) of this chapter.

(c) Conditions of use in horses—(1) Amount. 5 mg per kilogram body weight, daily for 28 days.

(2) Indications for use. For the treatment of equine protozoal myeloencephalitis caused by Sarcocystis neurona.

(3) Limitations. Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[66 FR 43774, Aug. 21, 2001]

§520.1860   Pradofloxacin.

(a) Specifications. Each milliliter of suspension contains 25 milligrams (mg) pradofloxacin.

(b) Sponsor. See No. 000859 in §510.600(c) of this chapter.

(c) Special considerations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits the extralabel use of this drug in food-producing animals.

(d) Conditions of use in cats—(1) Amount. Administer 3.4 mg/lb (7.5 mg/kg) body weight once daily for 7 consecutive days.

(2) Indications for use. For the treatment of skin infections (wounds and abscesses) in cats caused by susceptible strains of Pasteurella multocida, Streptococcus canis, Staphylococcus aureus, Staphylococcus felis, and Staphylococcus pseudintermedius.

[77 FR 76863, Dec. 31, 2012]

§520.1870   Praziquantel tablets.

(a) Specifications. Each tablet contains:

(1) 34 milligrams (mg) praziquantel.

(2) 11.5 or 23 mg praziquantel.

(b) Sponsors. See sponsors in §510.600(c) of this chapter:

(1) No. 000859 for use of the product described in paragraph (a)(1) of this section, as in paragraph (c)(1) of this section; and for use of the product described in paragraph (a)(2) of this section, as in paragraph (c)(2) of this section.

(2) No. 000859 for use of the product described in paragraph (a)(1) of this section, as in paragraph (c)(1) of this section.

(c) Conditions of use—(1) Dogs—(i) Amount. 5 pounds (lb) and under, 12 tablet (17 mg); 6 to 10 lb, 1 tablet (34 mg); 11 to 15 lb, 112 tablets (51 mg); 16 to 30 lb, 2 tablets (68 mg); 31 to 45 lb, 3 tablets (102 mg); 46 to 60 lb, 4 tablets (136 mg); over 60 lb, 5 tablets maximum (170 mg). Administer directly by mouth or crumbled and in feed.

(ii) Indications for use—(A) For removal of canine cestodes Dipylidium caninum and Taenia pisiformis.

(B) For removal of the canine cestode Echinococcus granulosus, and for removal and control of the canine cestode Echinococcus multilocularis.

(iii) Limitations—(A) If labeled only for use as in paragraph (c)(1)(ii)(A) of this section: Not intended for use in puppies less than 4 weeks of age. Consult your veterinarian before administering tablets to weak or debilitated animals and for assistance in the diagnosis, treatment, and control of parasitism.

(B) If labeled for use as in paragraph (c)(1)(ii)(B) of this section: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) Cats—(i) Indications for use. For removal of feline cestodes Dipylidium caninum and Taenia taeniaeformis.

(ii) Dosage. Cats 4 pounds and under, 11.5 mg; 5 to 11 pounds, 23 mg; over 11 pounds, 34.5 mg.

(iii) Limitations. Administer directly by mouth or crumbled and in feed. Not intended for use in kittens less than 6 weeks of age. For OTC use: Consult your veterinarian before administering tablets to weak or debilitated animals, and for assistance in the diagnosis, treatment, and control of parasitism.

[46 FR 60570, Dec. 11, 1981, as amended at 47 FR 26377, June 18, 1982; 55 FR 2234, Jan. 23, 1990; 58 FR 7864, Feb. 10, 1993; 58 FR 42853, Aug. 12, 1993; 68 FR 57351, Oct. 3, 2003; 69 FR 62181, Oct. 25, 2004; 78 FR 17596, Mar. 22, 2013]

§520.1871   Praziquantel and pyrantel.

(a) Specifications. (1) Each tablet contains 13.6 milligrams (mg) praziquantel and 54.3 mg pyrantel base (as pyrantel pamoate), 18.2 mg praziquantel and 72.6 mg pyrantel base (as pyrantel pamoate), or 27.2 mg praziquantel and 108.6 mg pyrantel base (as pyrantel pamoate).

(2) Each chewable tablet contains 30 mg praziquantel and 30 mg pyrantel pamoate or 114 mg praziquantel and 114 mg pyrantel pamoate.

(b) Sponsors. See sponsors in §510.600(c) for use as in paragraph (d) of this chapter.

(1) See No. 000859 for use of tablets described in paragraph (a)(1) of this section for use as in paragraph (d)(1) of this section.

(2) See No. 051311 for use of tablets described in paragraph (a)(2) of this section for use as in paragraph (d)(2) of this section.

(c) Special considerations. See §500.25 of this chapter.

(d) Conditions of use—(1) Cats—(i) Dosage. Administer a minimum dose of 2.27 mg praziquantel and 9.2 mg pyrantel pamoate per pound of body weight according to the dosing tables on labeling. May be given directly by mouth or in a small amount of food. Do not withhold food prior to or after treatment. If reinfection occurs, treatment may be repeated.

(ii) Indications for use. For removal of tapeworms (Dipylidium caninum and Taenia taeniaeformis), hookworms (Ancylostoma tubaeforme), and large roundworms (Toxocara cati) in cats and kittens.

(iii) Limitations. Not for use in kittens less than 2 months of age or weighing less than 2.0 pounds. Consult your veterinarian before giving to sick or pregnant animals.

(2) Dogs—(i) Amount. Administer a minimum dose of 5 mg praziquantel and 5 mg pyrantel pamoate per kilogram body weight (2.27 mg praziquantel and 2.27 mg pyrantel pamoate per pound body weight) according to the dosing tables on labeling.

(ii) Indications for use. For the treatment and control of roundworms (Toxocara canis and Toxascaris leonina), hookworms (Ancylostoma caninum, Ancylostoma braziliense, and Uncinaria stenocephala), and tapeworms (Dipylidium caninum and Taenia pisiformis) in dogs and puppies.

[58 FR 58652, Nov. 3, 1993, as amended at 72 FR 16270, Apr. 4, 2007; 75 FR 54018, Sept. 3, 2010]

§520.1872   Praziquantel, pyrantel pamoate, and febantel tablets.

(a) Specifications. Each tablet or chewable tablet contains either:

(1) Tablet No. 1: 22.7 milligrams praziquantel, 22.7 milligrams pyrantel base, and 113.4 milligrams febantel; or

(2) Tablet No. 2: 68 milligrams praziquantel, 68 milligrams pyrantel base, and 340.2 milligrams febantel.

(3) Tablet No. 3: 136 milligrams (mg) praziquantel, 136 mg pyrantel base, and 680.4 mg febantel.

(b) Sponsor. See 000859 in §510.600(c) of this chapter.

(c) Conditions of use—(1) Dogs—(i) Amount. Administer as a single dose directly by mouth or in a small amount of food as follows:

Weight of animalNumber of tablets per dose
KilogramsPoundsTablet no. 1Tablet no. 2Tablet no. 3
0.9 to 1.82 to 41/2
2.3 to 3.25 to 71
3.6 to 5.48 to 121 1/2
5.9 to 8.213 to 182
8.6 to 11.419 to 252 1/2
11.8 to 13.626 to 30   1
14.1 to 20.031 to 44   1 1/2
20.4 to 27.245 to 60   21
27.7 to 40.961 to 90      1 1/2
41.3 to 54.591 to 120      2

(ii) Indications for use. For the removal of tapeworms (Dipylidium caninum, Taenia pisiformis, Echinococcus granulosus); hookworms (Ancylostoma caninum, Uncinaria stenocephala); ascarids (Toxocara canis, Toxascaris leonina); and whipworms (Trichuris vulpis) and for the removal and control of tapeworm Echinococcus multilocularis in dogs.

(iii) Limitations. Do not use in pregnant animals. Do not use in dogs weighing less than 0.9 kilogram (2 pounds) or puppies less than 3 weeks of age. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[59 FR 33908, July 1, 1994, as amended at 61 FR 29651, June 12, 1996; 68 FR 22293, Apr. 28, 2003; 71 FR 6677, Feb. 9, 2006]

§520.1880   Prednisolone tablets.

(a) Specifications. Each tablet contains 5 or 20 milligrams prednisolone.

(b) Sponsor. See No. 061690 in §510.600(c)(2) of this chapter.

(c) Special considerations. (1) Clinical and experimental data have demonstrated that corticosteroids administered orally or parenterally to animals may induce the first stage of parturition when administered during the last trimester of pregnancy and may precipitate parturition followed by dystocia, fetal death, retained placenta, and metritis.

(2) Do not use in viral infections. Systemic therapy with prednisolone is contraindicated in animals with peptic ulcer, corneal ulcer, and Cushingoid syndrome. The presence of diabetes, osteoporosis, predisposition to thrombophlebitis, hypertension, congestive heart failure, renal insufficiency, and active tuberculosis necessitates carefully controlled use. Some of the above conditions occur only rarely in dogs but should be kept in mind.

(3) Anti-inflammatory action of corticosteroids may mask signs of infection.

(d) Conditions of use—(1) Amount. Dogs: 2.5 milligrams per 4.5 kilograms (10 pounds) body weight per day. Administer total daily dose orally in equally divided doses 6 to 10 hours apart until response is noted or 7 days have elapsed. When response is attained, dosage should be gradually reduced until maintenance level is achieved.

(2) Indications for use. For use in dogs as an anti-inflammatory agent.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[57 FR 4718, Feb. 7, 1992, as amended at 60 FR 57832, Nov. 22, 1995; 63 FR 148, Jan. 5, 1998]

§520.1900   Primidone tablets.

(a) Specifications. Each tablet contains 50 or 250 milligrams of primidone.

(b) Sponsor. See No. 054628 in §510.600(c) of this chapter for use of 250 milligram tablets; see No. 000856 in §510.600(c) of this chapter for use of 50 and 250 milligram tablets.

(c) Conditions of use in dogs—(1) Amount. Twenty-five milligrams of primidone per pound of body weight (55 milligrams per kilogram of body weight) daily.

(2) Indications for use. For the control of convulsions associated with idiopathic epilepsy, epileptiform convulsions, viral encephalitis, distemper, and hardpad disease that occurs as a clinically recognizable lesion in certain entities in dogs.

(3) Limitations. The tablets may be administered whole or crushed and mixed with the food. When convulsions are frequent, the dosage should be divided and administered at intervals. Reduction in dosage should be made gradually and never be abruptly discontinued. Do not use in feline species, as primidone appears to have a specific neurotoxicity in cats. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[42 FR 61594, Dec. 6, 1977, as amended at 43 FR 55386, Nov. 28, 1978; 46 FR 8467, Jan. 27, 1981; 46 FR 57477, Nov. 24, 1981; 53 FR 40727, Oct. 18, 1988; 56 FR 37473, Aug. 7, 1991; 62 FR 35076, June 30, 1997; 78 FR 21060, Apr. 9, 2013]

§520.1920   Prochlorperazine, isopropamide sustained release capsules.

(a) Specifications. Prochlorperazine, isopropamide sustained release capsules contain either:

(1) 3.33 milligrams of prochlorperazine (as the dimaleate) and 1.67 milligrams of isopropamide (as the iodide), or

(2) 10 milligrams of prochlorperazine (as the dimaleate) and 5 milligrams of isopropamide (as the iodide).

(b) Sponsor. See No. 000069 in §510.600(c) of this chapter.

(c) Conditions of use. (1) The drug is used for the treatment of dogs in which gastrointestinal disturbances are associated with emotional stress.

(2)(i) Capsules described in paragraph (a)(1) of this section are administered orally to dogs weighing from 4 to 15 pounds at the rate of 1 capsule twice daily. These capsules are administered orally to dogs weighing from 16 to 30 pounds at the rate of 1 or 2 capsules twice daily. For dogs weighing less than 4 pounds, administer orally an appropriate fraction of the contents of one of these capsules.

(ii) Capsules described in paragraph (a)(2) of this section are given to dogs weighing 30 pounds and over at the rate of 1 capsule twice daily.

(3) For use only by or on the order of a licensed veterinarian.

[40 FR 13838, Mar. 27, 1975, as amended at 56 FR 50653, Oct. 8, 1991; 60 FR 55659, Nov. 2, 1995]

§520.1921   Prochlorperazine, isopropamide, with neomycin sustained-release capsules.

(a) Specifications. Each capsule contains either:

(1) Capsule No. 1: 3.33 milligrams of prochlorperazine (as the dimaleate), 1.67 milligrams of isopropamide (as the iodide), and 25 milligrams of neomycin base (as the sulfate); or

(2) Capsule No. 3: 10 milligrams of prochlorperazine (as the dimaleate), 5 milligrams of isopropamide (as the iodide), and 75 milligrams of neomycin base (as the sulfate).

(b) Sponsor. See No. 000069 in §510.600(c) of this chapter.

(c) Conditions of use—(1) Amount. Administer capsules orally twice daily to dogs as follows:

Animal weight (pounds)Number of capsules per dose
Capsule No. 1Capsule No. 3
10 to 201
20 to 302
Over 3031
Over 602

(2) Indications for use. For treatment of dogs in which infectious bacterial gastroenteritis is associated with emotional stress.

(3) Limitations. Do not continue medication longer than 5 days. Overdosage or prolonged administration may produce nephrotoxicity as manifested by albuminuria, presence of granular casts and depressed urinary output. If it is desirable to administer a vasoconstrictor, norepinephrine is the drug of choice. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[49 FR 14103, Apr. 10, 1984, as amended at 56 FR 50653, Oct. 8, 1991; 60 FR 55659, Nov. 2, 1995]

§520.1962   Promazine hydrochloride.

(a)(1) Chemical name. 10-[3-(Dimethylamino)propyl]phenothiazine monohydrochloride.

(2) Specifications. Conforms to N.F. XII.

(3) Sponsor. See No. 000856 in §510.600(c) of this chapter.

(4) [Reserved]

(5) Conditions of use. (i) The drug is used for quieting excitable, unruly, or intractable horses. It is administered at a dosage level of 0.45 to 0.9 milligrams of promazine hydrochloride per pound of body weight mixed with an amount of feed that will be readily consumed.

(ii) Do not use in horses intended for food.

(iii) Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(b) [Reserved]

[40 FR 13838, Mar. 27, 1975, as amended at 43 FR 55386, Nov. 28, 1978; 59 FR 5705, Feb. 8, 1994]

§520.2002   Propiopromazine hydrochloride.

(a) Chemical name. 1-Propanone, 1-[10-[3-(dimethylamino) propyl] phenothiazine-2-yl]-, monohydrochloride.

(b) Specifications. The drug is administered in a chewable tablet containing 10 to 20 milligrams of propiopromazine hydrochloride.

(c) Sponsor. See No. 000856 in §510.600(c) of this chapter.

(d) Conditions of use. (1) The drug is intended for oral administration to dogs as a tranquilizer. It is used as an aid in handling difficult, excited, and unruly dogs, and in controlling excessive kennel barking, car sickness, and severe dermatitis. It is also indicated for use in minor surgery and prior to routine examinations, laboratory procedures, and diagnostic procedures.

(2) It is administered at the rate of 0.5 to 2 milligrams of propiopromazine hydrochloride per pound of body weight once or twice daily depending upon the degree of tranquilization desired.

Note: Not for use with organophosphates and/or procaine hydrochloride, as phenothiazine may potentiate the toxicity of organophosphates and the activity of procaine hydrochloride. Overdosage may produce significant depression.

(3) For use only by or on the order of a licensed veterinarian.

[40 FR 13838, Mar. 27, 1975, as amended at 46 FR 60570, Dec. 11, 1981; 61 FR 5506, Feb. 13, 1996]

§520.2041   Pyrantel pamoate chewable tablets.

(a) Specifications. Each tablet contains pyrantel pamoate equivalent to 22.7 or 113.5 milligrams pyrantel base.

(b) Sponsor. See Nos. 017135 and 051311 in §510.600(c) of this chapter.

(c) Conditions of use—(1) Amount. Provides at least 2.27 milligrams pyrantel base per pound body weight for dogs weighing more than 5 pounds, and at least 4.54 milligrams of pyrantel base per pound body weight for dogs weighing 5 pounds or less.

(2) Indications for use—(i) In dogs and puppies. For removal of ascarids (Toxocara canis; Toxascaris leonina) and hookworms (Ancylostoma caninum; Uncinaria stenocephala).

(ii) In puppies and adult dogs and in lactating bitches after whelping. To prevent reinfection of Toxocara canis.

(3) Limitations. Administer to puppies at 2, 3, 4, 6, 8, and 10 weeks of age. Administer to lactating bitches 2 to 3 weeks after whelping. Retreatment of adult dogs may be necessary at monthly intervals as determined by laboratory fecal examinations. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.

[52 FR 37937, Oct. 13, 1987, as amended at 57 FR 48163, Oct. 22, 1992; 58 FR 44611, Aug. 24, 1993; 66 FR 9650, Feb. 9, 2001; 67 FR 21996, May 2, 2002]

§520.2042   Pyrantel pamoate tablets.

(a) Specifications. Each tablet contains pyrantel pamoate equivalent to 22.7, 45.4, or 113.5 milligrams of pyrantel base.

(b) Sponsor. See No. 017135 in §510.600(c) of this chapter.

(c) Conditions of use. It is used for dogs as follows:

(1) Amount. For dogs weighing over 5 pounds, use at least 2.27 milligrams of pyrantel base per pound of body weight; for dogs weighing 5 pounds or less, use at least 4.54 milligrams of pyrantel base per pound of body weight.

(2) Indications for use. For removal and control of large roundworms (ascarids) (Toxocara canis and Toxascaris leonina), and hookworms (Ancylostoma caninum and Uncinaria stenocephala).

(3) Limitations. Administer orally directly or in a small amount of food. To prevent reinfection of T. canis in puppies, lactating bitches after whelping, and adult dogs; treat puppies 2, 3, 4, 6, 8, and 10 weeks of age; treat lactating bitches 2 to 3 weeks after whelping; routinely treat adult dogs monthly. Do not withhold food prior to or after treatment. The presence of these parasites should be confirmed by laboratory fecal examination. A followup fecal examination should be conducted 2 to 4 weeks after first treatment regimen to determine the need for re-treatment. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.

[43 FR 52700, Nov. 14, 1978, as amended at 49 FR 22073, May 25, 1984; 57 FR 48163, Oct. 22, 1992; 58 FR 44611, Aug. 24, 1993]

§520.2043   Pyrantel pamoate suspension.

(a) Specifications. (1) Each milliliter (mL) contains pyrantel pamoate equivalent to 50 milligrams (mg) pyrantel base.

(2) Each mL contains pyrantel pamoate equivalent to 2.27 or 4.54 mg pyrantel base.

(3) Each mL contains pyrantel pamoate equivalent to 4.54 mg pyrantel base.

(b) Sponsors. See sponsors in §510.600(c) of this chapter for uses as in paragraph (d) of this section.

(1) Nos. 000069, 000859, and 058829 for use of the product described in paragraph (a)(1) as in paragraph (d)(1) of this section.

(2) Nos. 000069, 055246, 058829, and 059130 for use of the products described in paragraph (a)(2) as in paragraph (d)(2) of this section.

(3) No. 023851 for use of the product described in paragraph (a)(3) as in paragraph (d)(2) of this section.

(c) Special considerations. See §500.25 of this chapter.

(d) Conditions of use—(1) Horses and ponies. It is used as follows:

(i) Amount. 3 mg per pound (/lb) body weight as a single dose mixed with the usual grain ration, or by stomach tube or dose syringe.

(ii) Indications for use. For the removal and control of mature infections of large strongyles (Strongylus vulgaris, S. edentatus, S. equinus); pinworms (Oxyuris equi); large roundworms (Parascaris equorum); and small strongyles.

(iii) Limitations. Do not use in horses intended for human consumption. When the drug is for administration by stomach tube, it shall be labeled: “Federal law restricts this drug to use by or on the order of a licensed veterinarian.”

(2) Dogs. It is used as follows:

(i) Dogs and puppies—(A) Amount. 2.27 mg/lb body weight as a single dose in the animal's feed bowl by itself or mixed in a small quantity of food.

(B) Indications for use. For the removal of large roundworms (Toxocara canis and Toxascaris leonina) and hookworms (Ancylostoma caninum and Uncinaria stenocephala).

(C) Limitations. Additional treatment may be required and should be confirmed by fecal examination within 2 to 4 weeks.

(ii) Dogs, puppies, and lactating bitches after whelping—(A) Amount. 2.27 mg/lb body weight.

(B) Indications for use. To prevent reinfections of T. canis.

(C) Limitations. Administer to puppies at 2, 3, 4, 6, 8, and 10 weeks of age. Administer to lactating bitches 2 to 3 weeks after whelping. Adult dogs kept in heavily contaminated quarters may be treated at monthly intervals.

[67 FR 43248, June 27, 2002, as amended at 68 FR 54803, Sept. 19, 2003; 68 FR 55199, Sept. 23, 2003; 68 FR 55825, Sept. 29, 2003; 75 FR 52622, Aug. 27, 2010; 76 FR 17337, Mar. 29, 2011; 78 FR 17596, Mar. 22, 2013]

§520.2044   Pyrantel pamoate paste.

(a) Specifications—(1) Each milliliter (mL) contains 180 milligrams (mg) pyrantel base (as pyrantel pamoate).

(2) Each mL contains 226 mg pyrantel base (as pyrantel pamoate).

(3) Each mL contains 171 mg pyrantel base (as pyrantel pamoate).

(b) Sponsors. See sponsors in §510.600(c) of this chapter.

(1) No. 000069 for use of product described in paragraph (a)(1) of this section as in paragraph (d)(1)(i) and (d)(2) of this section.

(2) No. 000859 for use of product described in paragraph (a)(2) of this section as in paragraph (d) of this section.

(3) No. 061623 for use of product described in paragraph (a)(3) of this section as in paragraph (d)(1)(i) and (d)(2) of this section.

(c) Special considerations. See §500.25 of this chapter.

(d) Conditions of use. It is used in horses and ponies as follows:

(1) Amounts and indications for use—(i) 3 mg per pound (/lb) body weight as single oral dose for removal and control of infections from the following mature parasites: large strongyles (Strongylus vulgaris, S. edentatus, S. equinus); small strongyles; pinworms (Oxyuris equi); and large roundworms (Parascaris equorum).

(ii) 6 mg/lb body weight as single oral dose for the removal and control of mature infections of tapeworms (Anoplocephala perfoliata).

(2) Limitations. Do not use in horses intended for human consumption.

[70 FR 29447, May 23, 2005, as amended at 76 FR 17337, Mar. 29, 2011; 78 FR 17596, Mar. 22, 2013]

§520.2045   Pyrantel tartrate powder; pyrantel tartrate pellets.

(a) Specifications. (1) Pyrantel tartrate powder horse wormer contains 11.3 percent and swine wormer 10.6 percent pyrantel tartrate.

(2) Pyrantel tartrate pellets colt and horse wormer contains 1.25 percent pyrantel tartrate.

(b) Sponsor. (1) See No. 000069 in §510.600(c) of this chapter for conditions of use provided for in paragraphs (d) (1) and (2) of this section.

(2) See No. 061623 in §510.600(c) of this chapter, for conditions of use provided for in paragraph (d)(3) of this section.

(c) Related tolerances. See §556.560 of this chapter.

(d) Conditions of use. It is used in: (1) Horses and ponies:

(i) For the removal and control of infections from the following mature parasites: Large strongyles (Strongylus vulgaris, Strongylus edentatus, Strongylus equinus), small strongyles (Trichonema spp., Triodontophorus), pinworms (Oxyuris), and large roundworms (Parascaris).

(ii) It is administered as a single dose at 0.57 gram of pyrantel tartrate per 100 pounds of body weight mixed with the usual grain ration.

(iii) It is recommended that severely debilitated animals not be treated with this drug. Do not administer by stomach tube or dose syringe. The drug should be used immediately after the package is opened.

(iv) Warning: Not for use in horses and ponies to be slaughtered for food purposes.

(2) Swine:

(i) For the removal and control of large roundworms (Ascaris suum) and nodular worm (Oesophagostomum) infections.

(ii) It is added to feed at 0.4 gram pyrantel tartrate per pound of nonpelleted ration. The ration is administered as a single treatment as the sole ration at the rate of 1 pound per 40 pounds of animal weight for animals up to 200 pounds. Animals 200 pounds and over are administered 5 pounds of ration per animal.

(iii) Fast pigs over night for optimum results. Water should be made available to animals during fasting and treatment periods. Consult veterinarian before using in severely debilitated animals. The drug should be used immediately after the package is opened.

(iv) Warning: Do not treat within 24 hours of slaughter.

(3) Horses and colts:

(i) For the removal and control of infections from the following mature parasites: Large strongyles (Strongylus vulgaris, Strongylus edentatus, Strongylus equinus), small strongyles (Trichonema spp., Triodontophorus), pinworms (Oxyuris), and large roundworms (Parascaris).

(ii) It is administered as a single dose at 12.5 milligrams of pyrantel tartrate per 2.2 pounds of body weight mixed with the usual grain ration.

(iii) It is recommended that severely debilitated animals not be treated with this drug.

(iv) Warning: Do not use in horses or colts intended for food.

[40 FR 13838, Mar. 27, 1975, as amended at 59 FR 28769, June 3, 1994; 69 FR 41427, July 9, 2004; 76 FR 40229, July 8, 2011]

§520.2075   Robenacoxib.

(a) Specifications. Each tablet contains 6 milligrams (mg) robenacoxib.

(b) Sponsors. See No. 058198 in §510.600(c) of this chapter.

(c) Conditions of use in cats—(1) Amount. Administer 0.45 mg per pound (/lb) (1 mg/kilogram (kg)) once daily.

(2) Indications for use. For the control of postoperative pain and inflammation associated with orthopedic surgery, ovariohysterectomy, and castration in cats weighing at least 5.5 lb (2.5 kg) and at least 4 months of age; for up to a maximum of 3 days.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[76 FR 18648, Apr. 5, 2011, as amended at 79 FR 10964, Feb. 27, 2014]

§520.2098   Selegiline hydrochloride tablets.

(a) Specifications. Each tablet contains either 2, 5, 10, 15, or 30 milligrams of selegiline hydrochloride.

(b) Sponsor. See No. 000069 in §510.600(c) of this chapter.

(c) [Reserved]

(d) Conditions of use—Dogs—(1) Dosage. 1 milligram per kilogram (0.45 milligram per pound) of body weight.

(i) Indications for use. For control of clinical signs associated with uncomplicated pituitary-dependent hyperadrenocorticism in dogs.

(ii) Limitations. Administer orally once daily. If no improvement in clinical signs or physical examination findings after 2 months of therapy, increase dose to a maximum of 2 milligrams per kilogram once daily. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) Dosage. 0.5 to 1.0 milligram per kilogram of body weight once daily.

(i) Indications for use. For the control of clinical signs associated with canine cognitive dysfunction syndrome.

(ii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[62 FR 34632, June 27, 1997; 62 FR 55159, Oct. 23, 1997, as amended at 63 FR 29551, June 1, 1998; 64 FR 2122, Jan. 13, 1999]

§520.2100   Selenium, vitamin E capsules.

(a) Specifications. The capsules contain 2.19 milligrams of sodium selenite (equivalent to 1 milligram of selenium) and 56.2 milligrams of vitamin E (68 I.U.) (as d-alpha tocopheryl acid succinate) or 0.548 milligram of sodium selenite (equivalent to .25 milligram of selenium and 14 milligrams of vitamin E (17 I.U.) (as d-alpha tocopheryl acid succinate.)

(b) Sponsor. See No. 000061 in §510.600(c) of this chapter.

(c) Conditions of use. (1) The drug is intended for use as an aid in alleviating and controlling inflammation, pain, and lameness associated with certain arthropathies in dogs.

(2) The capsules are administered orally with the larger capsules administered at a dosage level of 1 capsule per 20 pounds of body weight to a maximum of 5 capsules with the dosage repeated at 3 day intervals until a satisfactory therapeutic response is observed. A maintenance dosage is then administered consisting of 1 capsule per 40 pounds of body weight, with a minimum of 1 capsule per 40 pounds of body weight, with a minimum of 1 capsule, given every 3 days, or 7 days, or longer, as required to maintain improvement or an asymptomatic condition. For dogs under 20 pounds of body weight, the small capsules are administered orally at a dosage level of 1 per 5 pounds of body weight with a minimum of 1 capsule which dosage is repeated at 3 day intervals until a satisfactory response is observed then a maintenance regimen is initiated with 1 capsule per 10 pounds of body weight, minimum of 1 capsule, every 3 days, or 7 days, or longer as required to maintain continued improvement or an asymptomatic condition.

(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[40 FR 13838, Mar. 27, 1975, as amended at 52 FR 7832, Mar. 13, 1987; 52 FR 9756, Mar. 26, 1987]

§520.2123   Spectinomycin oral dosage forms.

§520.2123a   Spectinomycin tablets.

(a) Specifications. Each tablet contains spectinomycin dihydrochloride pentahydrate equivalent to 100 milligrams (mg) spectinomycin.

(b) Sponsor. See No. 061623 in §510.600(c) of this chapter.

(c) Conditions of use in dogs—(1) Amount. Administer orally to provide 10 mg per pound (lb) of body weight twice daily. Dosage may be continued for 4 consecutive days.

(2) Indications for use. For the treatment of infectious diarrhea and gastroenteritis caused by organisms susceptible to spectinomycin.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[73 FR 6607, Feb. 5, 2008]

§520.2123b   Spectinomycin powder.

(a) Specifications. Each gram (g) of powder contains spectinomycin dihydrochloride pentahydrate equivalent to 0.5 g spectinomycin.

(b) Sponsor. See No. 061623 in §510.600(c) of this chapter.

(c) Related tolerances. See §556.600 of this chapter.

(d) Conditions of use in chickens. It is administered in the drinking water of growing chickens as follows:

(1) Indications for use and amounts—(i) For increased rate of weight gain and improved feed efficiency in broiler chickens, administer 0.5 g per gallon of water as the only source of drinking water for the first 3 days of life and for 1 day following each vaccination.

(ii) As an aid in controlling infectious synovitis due to Mycoplasma synoviae in broiler chickens, administer 1 g per gallon of water as the only source of drinking water for the first 3 to 5 days of life.

(iii) As an aid in the prevention or control of losses due to CRD associated with M. gallisepticum (PPLO) in growing chickens, administer 2 g per gallon of water as the only source of drinking water for the first 3 days of life and for 1 day following each vaccination.

(2) Limitations. Do not administer to laying chickens. Do not administer within 5 days of slaughter.

[73 FR 6607, Feb. 5, 2008]

§520.2123c   Spectinomycin solution.

(a) Specifications. Each milliliter of solution contains spectinomycin dihydrochloride pentahydrate equivalent to 50 milligrams (mg) spectinomycin.

(b) Sponsors. See Nos. 000856, 000859, and 061623 in §510.600(c) of this chapter.

(c) Related tolerances. See §556.600 of this chapter.

(d) Conditions of use in swine—(1) Amount. Administer 5 mg per pound (lb) of body weight orally twice daily for 3 to 5 days.

(2) Indications for use. For the treatment and control of porcine enteric colibacillosis (scours) caused by E. coli susceptible to spectinomycin in pigs under 4 weeks of age.

(3) Limitations. Do not administer to pigs over 15 lb body weight or over 4 weeks of age. Do not administer within 21 days of slaughter.

[73 FR 6607, Feb. 5, 2008]

§520.2130   Spinosad.

(a) Specifications. Each chewable tablet contains 90, 140, 270, 560, 810, or 1620 milligrams (mg) spinosad.

(b) Sponsor. See No. 000986 in §510.600 of this chapter.

(c) Special considerations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(d) Conditions of use—(1) Dogs—(i) Amount. Administer tablets once a month at a recommended minimum dosage of 13.5 mg per pound (30 mg per kilogram) of body weight.

(ii) Indications for use. To kill fleas and for the prevention and treatment of flea infestations (Ctenocephalides felis) for 1 month on dogs and puppies 14 weeks of age and older and 3.3 pounds of body weight or greater.

(2) Cats—(i) Amount. Administer tablets once a month at a minimum dosage of 22.5 mg per pound (50 mg per kilogram) of body weight.

(ii) Indications for use. To kill fleas and for the prevention and treatment of flea infestations (C. felis) for 1 month on cats and kittens 14 weeks of age and older and 2 pounds of body weight or greater.

[77 FR 60623, Oct. 4, 2012]

§520.2134   Spinosad and milbemycin.

(a) Specifications. Each chewable tablet contains 140 milligrams (mg) spinosad and 2.3 mg milbemycin oxime, 270 mg spinosad and 4.5 mg milbemycin oxime, 560 mg spinosad and 9.3 mg milbemycin oxime, 810 mg spinosad and 13.5 mg milbemycin oxime, or 1,620 mg spinosad and 27 mg milbemycin oxime.

(b) Sponsor. See No. 000986 in §510.600 of this chapter.

(c) Conditions of use in dogs—(1) Amount. Administer once a month at a minimum dosage of 13.5 mg/pound (lb) (30 mg/kilogram (kg)) of body weight spinosad and 0.2 mg/lb (0.5 mg/kg) of body weight milbemycin oxime.

(2) Indications for use. To kill fleas; for the prevention and treatment of flea infestations (Ctenocephalides felis); for the prevention of heartworm disease (Dirofilaria immitis); and for the treatment and control of adult hookworm (Ancylostoma caninum), adult roundworm (Toxocara canis and Toxascaris leonina), and adult whipworm (Trichuris vulpis) infections in dogs and puppies 8 weeks of age or older and 5 lbs of body weight or greater.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[76 FR 12563, Mar. 8, 2011]

§520.2150   Stanozolol oral dosage forms.

§520.2150a   Stanozolol tablets.

(a) Specifications. Each tablet contains 2 milligrams of stanozolol.

(b) Sponsor. No. 000009 in §510.600(c) of this chapter.

(c) Conditions of use. (1) Used as an anabolic steroid treatment in dogs and cats.

(2) Administered orally to cats and small breeds of dogs, 12 to 1 tablet twice daily for several weeks; to large breeds of dogs, 1 to 2 tablets twice daily for several weeks. The tablets may be crushed and administered in feed.

(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[40 FR 46101, Oct. 6, 1975, as amended at 42 FR 36995, July 19, 1977. Redesignated at 50 FR 38114, Sept. 20, 1985, and amended at 55 FR 23076, June 6, 1990]

§520.2150b   Stanozolol chewable tablets.

(a) Specifications. Each chewable tablet contains 2 milligrams of stanozolol.

(b) Sponsor. No. 000009 in §510.600(c) of this chapter.

(c) Conditions of use. (1) Used as an anabolic steroid treatment in dogs.

(2) Administered orally to small breeds of dogs, 12 to 1 tablet twice daily for several weeks; to large breeds of dogs, 1 to 2 tablets twice daily for several weeks.

(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[50 FR 38114, Sept. 20, 1985, as amended at 55 FR 23076, June 6, 1990]

§520.2158   Streptomycin/dihydrostreptomycin oral dosage forms.

§520.2158a   Streptomycin sulfate oral solution.

(a) Specifications. Solution containing 25 percent streptomycin sulfate.

(b) Sponsor. See Nos. 033008 and 055462 in §510.600(c) of this chapter.

(c) Related tolerances. See §556.610 of this chapter.

(d) Conditions of use. Use in drinking water as follows:

(1) Calves and swine—(i) Amount. 10 to 15 milligrams per pound (mg/pound) of body weight (1.0 to 1.5 grams per gallon).

(ii) Indications for use. Treatment of bacterial enteritis caused by Escherichia coli and Salmonella spp. susceptible to streptomycin.

(iii) Limitations. Calves: Do not administer for more than 5 days. Swine: Do not administer for more than 4 days. Prepare fresh solution daily. Calves: Withdraw 2 days before slaughter. As sole source of streptomycin. Warning: Certain strains of bacteria may develop a tolerance for streptomycin. Consult a veterinarian or animal pathologist for diagnosis.

(2) Chickens—(i) Amount. 10 to 15 mg/pound of body weight (0.6 to 0.9 grams per gallon).

(ii) Indications for use. Treatment of nonspecific infectious enteritis caused by organisms susceptible to streptomycin.

(iii) Limitations. Chickens: Do not administer for more than 5 days. Withdraw 4 days before slaughter. Do not administer to chickens producing eggs for human consumption. Prepare fresh solution daily. As sole source of streptomycin. Warning: Certain strains of bacteria may develop a tolerance for streptomycin. Consult a veterinarian or animal pathologist for diagnosis.

[57 FR 37327, Aug. 18, 1992, as amended at 58 FR 47211, Sept. 8, 1993; 63 FR 51821, Sept. 29, 1998]

§520.2158b   Dihydrostreptomycin tablets.

(a) Specifications. Each tablet contains 37.5 milligrams dihydrostreptomycin (as the sulfate) with 375 milligrams chlorhexidine dihydrochloride.

(b) Sponsor. See No. 000856 in §510.600(c) of this chapter.

(c) Related tolerances. See §§556.120 and 556.200 of this chapter.

(d) Conditions of use. Calves—(1) Amount. 150 milligrams of dihydrostreptomycin and 1.5 grams of chlorhexidine dihydrochloride per 100 pounds of body weight per day.

(2) Indications for use. Treatment of bacterial scours in calves.

(3) Limitations. Administer orally once a day for 5 days; withdraw 3 days before slaughter.

[57 FR 37327, Aug. 18, 1992; 57 FR 42623, Sept. 15, 1992]

§520.2158c   Dihydrostreptomycin oral suspension.

(a) Specifications. Each milliliter contains 1.25 milligrams dihydrostreptomycin (as the sulfate) with 12.5 milligrams chlorhexidine dihydrochloride.

(b) Sponsor. See No. 000856 in §510.600(c) of this chapter.

(c) Related tolerances. See §§556.120 and 556.200 of this chapter.

(d) Conditions of use. Calves—(1) Amount. 150 milligrams of dihydrostreptomycin and 1.5 grams of chlorhexidine dihydrochloride per 100 pounds of body weight per day.

(2) Indications for use. Treatment of bacterial scours in calves.

(3) Limitations. Administer orally once a day for 5 days; withdraw 3 days before slaughter.

[57 FR 37327, Aug. 18, 1992]

§520.2160   Styrylpyridinium, diethylcarbamazine oral dosage forms.

§520.2170   Sulfabromomethazine sodium boluses.

(a) Specifications. Each bolus contains 15 grams of sulfabromomethazine sodium.

(b) Related tolerance. See §556.620 of this chapter.

(c) Sponsor. See No. 050604 in §510.600(c) of this chapter.

(d) NAS/NRC status. These conditions of use are NAS/NRC reviewed and found effective. NADA's for these uses need not include effectiveness data as specified by §514.111 of this chapter, but may require bioequivalency and safety information.

(e) Conditions of use. Cattle—(1) Amount. 90 milligrams per pound body weight.

(2) Indications for use. Treatment of necrotic pododermatitis (foot rot) and calf diphtheria caused by Fusobacterium necrophorum; colibacillosis (scours) caused by Escherichia coli; bacterial pneumonia and bovine respiratory disease complex (shipping fever complex) associated with Pasteurella spp.; acute metritis and acute mastitis caused by Streptococcus spp.

(3) Limitations. Administer orally; repeat in 48 hours if necessary; milk taken from animals within 96 hours (8 milkings) of latest treatment must not be used for food; do not administer within 18 days of slaughter; discontinue use if hematuria, crystalluria or severe depression are noticed; if signs persist after 2 or 3 days consult a veterinarian.

[47 FR 30243, July 13, 1982, as amended at 62 FR 63270, Nov. 28, 1997]

§520.2184   Sodium sulfachloropyrazine monohydrate.

(a) Chemical name. 2-Sulfamido-6-chloroxyrazine, sodium.

(b) Sponsor. See Nos. 053501 in §510.600(c) of this chapter.

(c) Related tolerances. See §556.625 of this chapter.

(d) Conditions of use. It is used in the drinking water of broilers, breeder flocks, and replacement chickens as follows:

(1) Amount. 0.03 percent.

(2) Indications for use. Treatment of coccidiosis.

(3) Limitations. Administer in drinking water for 3 days as sole source of drinking water and sulfonamide medication; withdraw 4 days prior to slaughter; not to be administered to chickens producing eggs for human consumption.

[40 FR 13838, Mar. 27, 1975, as amended at 50 FR 41489, Oct. 11, 1985; 54 FR 12188, Mar. 24, 1989; 55 FR 8460, Mar. 8, 1990; 64 FR 15684, Apr. 1, 1999; 67 FR 78355, Dec. 24, 2002]

§520.2200   Sulfachlorpyridazine.

(a) Specifications.—(1) Sodium sulfachlorpyridazine powder.

(2) Each bolus contains 2 grams sulfachlorpyridazine.

(3) Each tablet contains 250 milligrams (mg) sulfachlorpyridazine.

(b) Sponsor. See No. 000010 in §510.600(c) of this chapter.

(c) Related tolerances. See §556.630 of this chapter.

(d) Conditions of use. It is used as follows:

(1) Calves—(i) Amount. Administer 30 to 45 mg sulfachlorpyridazine powder per pound (/lb) of body weight per day in milk or milk replacer, or in a bolus, in divided doses twice daily for 1 to 5 days.

(ii) Indications for use. For the treatment of diarrhea caused or complicated by Escherichia coli (colibacillosis).

(iii) Limitations. Treated ruminating calves must not be slaughtered for food during treatment or for 7 days after the last treatment. A withdrawal 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. Administer 20 to 35 mg/lb body weight per day, in divided doses twice daily for 1 to 5 days:

(A) In drinking water or

(B) For individual treatment, in an oral suspension containing 50 mg per milliliter.

(ii) Indications for use. For the treatment of diarrhea caused or complicated by E. coli (colibacillosis).

(iii) Limitations. Treated swine must not be slaughtered for food during treatment or for 4 days after the last treatment.

(3) Dogs—(i) Amount. Administer tablets orally at 500 mg per 10 to 15 lb of body weight daily, in two or three divided doses.

(ii) Indications for use. As an aid in the treatment of infectious tracheobronchitis and infections caused by E. coli, and in the treatment of infections caused by other Gram-positive and Gram-negative organisms that are susceptible to sulfonamide therapy.

(iii) Limitations. Federal law restricts this drug to use only by or on the order of a licensed veterinarian.

[75 FR 10166, Mar. 5, 2010]

§520.2215   Sulfadiazine/pyrimethamine suspension.

(a) Specifications. Each milliliter (mL) of suspension contains 250 milligrams (mg) sulfadiazine (as the sodium salt) and 12.5 mg pyrimethamine.

(b) Sponsor. See No. 055246 in §510.600(c) of this chapter.

(c) Conditions of use in horses—(1) Amount. Administer orally 20 mg sulfadiazine per kilogram (kg) body weight and 1 mg/kg pyrimethamine daily.

(2) Indications for use. For the treatment of equine protozoal myeloencephalitis (EPM) caused by Sarcocystis neurona.

(3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[69 FR 70054, Dec. 2, 2004, as amended at 73 FR 53686, Sept. 17, 2008; 75 FR 69586, Nov. 15, 2010]

§520.2218   Sulfamerazine, sulfamethazine, and sulfaquinoxaline powder.

(a) Specifications. Each 195-gram (g) packet of powder contains 78 g sulfamerazine, 78 g sulfamethazine, and 39 g sulfaquinoxaline.

(b) Sponsor. See No. 046573 in §510.600(c) of this chapter.

(c) Related tolerances. See §§556.670 and 556.685 of this chapter.

(d) Conditions of use—(1) Chickens—(i) Amounts and indications for use—(A) As an aid in the control of coccidiosis caused by Eimeria tenella and E. necatrix susceptible to sulfamerazine, sulfamethazine, and sulfaquinoxaline: provide medicated water (0.4 percent solution) for 2 to 3 days, then plain water for 3 days, then medicated water (0.25 percent solution) for 2 days. If bloody droppings appear, repeat at 0.25 percent level for 2 more days. Do not change litter.

(B) As an aid in the control of acute fowl cholera caused by Pasteurella multocida susceptible to sulfamerazine, sulfamethazine, and sulfaquinoxaline: provide medicated water (0.4 percent solution) for 2 to 3 days. If disease recurs, repeat treatment.

(ii) Limitations. Make fresh solution daily. Do not treat chickens within 14 days of slaughter for food. Do not medicate chickens producing eggs for human consumption.

(2) Turkeys—(i) Amounts and indications for use—(A) As an aid in the control of coccidiosis caused by Eimeria meleagrimitis and E. adenoeides susceptible to sulfamerazine, sulfamethazine, and sulfaquinoxaline: provide medicated water (0.25 percent solution) for 2 days, then plain water for 3 days, then medicated water (0.25 percent solution) for 2 days, then plain water for 3 days, then medicated water (0.25 percent solution) for 2 days. Repeat if necessary. Do not change litter.

(B) As an aid in the control of acute fowl cholera caused by Pasteurella multocida susceptible to sulfamerazine, sulfamethazine, and sulfaquinoxaline: provide medicated water (0.4 percent solution) for 2 to 3 days. If disease recurs, repeat treatment.

(ii) Limitations. Make fresh solution daily. Do not treat turkeys within 14 days of slaughter for food. Do not medicate turkeys producing eggs for human consumption.

[71 FR 13001, Mar. 14, 2006]

§520.2220   Sulfadimethoxine oral dosage forms.

§520.2220a   Sulfadimethoxine oral solution and soluble powder.

(a) Approvals. (1) For oral solution containing 12.5 percent (3.75 grams per ounce) sulfadimethoxine, see Nos. 000069, 000859, 054628, 054925, and 057561 in §510.600(c).

(2) For soluble powder, each 107 grams contain the equivalent of 94.6 grams of sulfadimethoxine (as the sodium salt); see Nos. 000069, 054925, 057561, 058829, 061623, and 066104 in §510.600(c) of this chapter.

(b) Special considerations. Federal law prohibits the extralabel use of this product in lactating dairy cattle.

(c) Related tolerances. See §556.640 of this chapter.

(d) Conditions of use. The oral solution is administered as a cattle drench or diluted as directed to prepare drinking water. The powder is used to prepare a drench or drinking water. The concentrations and uses of the various solutions are as follows:

(1) Broiler and replacement chickens only—(i) Amount. 1.875 (0.05 percent) grams per gallon.

(ii) Indications for use. Treatment of disease outbreaks of coccidiosis, fowl cholera, and infectious coryza.

(iii) Limitations. Administer for 6 consecutive days; do not administer to chickens over 16 weeks of age; as sole source of drinking water and sulfonamide medication; as sulfadimethoxine solution or sulfadimethoxine soluble sodium salt; withdraw 5 days before slaughter.

(2) Meat-producing turkeys only—(i) Amount. 0.938 (0.025 percent) grams per gallon.

(ii) Indications for use. Treatment of disease outbreaks of coccidiosis and fowl cholera.

(iii) Limitations. Administer for 6 consecutive days; do not administer to turkeys over 24 weeks of age; as sole source of drinking water and sulfonamide medication; as sulfadimethoxine solution or sulfadimethoxine soluble sodium salt; withdraw 5 days before slaughter.

(3) Dairy calves, dairy heifers, and beef cattle only—(i) Amount. 1.18 to 2.36 (0.031 to 0.062 percent) grams per gallon.

(ii) Indications for use. For the treatment of shipping fever complex and bacterial pneumonia associated with Pasteurella spp. sensitive to sulfadimethoxine; and calf diphtheria and foot rot associated with Fusobacterium necrophorum (Sphaerophorus necrophorus) sensitive to sulfadimethoxine.

(iii) Administer 2.5 grams per 100 pounds of body weight for first day, then 1.25 grams per 100 pounds of body weight per day for the next 4 consecutive days; in drinking water or drench; available as a sulfadimethoxine soluble powder or a 12.5 percent sulfadimethoxine sodium solution (3.75 grams sulfadimethoxine per fluid ounce); if no improvement within 2 to 3 days, reevaluate diagnosis; do not treat beyond 5 days; withdraw 7 days before slaughter. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.

[40 FR 13838, Mar. 27, 1975, as amended at 58 FR 6092, Jan. 26, 1993; 59 FR 56000, Nov. 10, 1994; 61 FR 4875, Feb. 9, 1996; 62 FR 8371, Feb. 25, 1997; 62 FR 23357, Apr. 30, 1997; 62 FR 35076, June 30, 1997; 62 FR 40932, July 31, 1997; 63 FR 59714, Nov. 5, 1998; 64 FR 18572, Apr. 15, 1999; 70 FR 73137, Dec. 9, 2005; 71 FR 13542, Mar. 16, 2006; 74 FR 60156, Nov. 20, 2009; 76 FR 17337, Mar. 29, 2011; 77 FR 56770, Sept. 14, 2012; 78 FR 17596, Mar. 22, 2013; 78 FR 21060, Apr. 9, 2013]

§520.2220b   Sulfadimethoxine tablets and boluses.

(a) Sponsors. Approval to firms identified in §510.600(c) of this chapter as follows:

(1) To 000069, approval for use as in paragraphs (d)(1), (d)(2), and (d)(3) of this section.

(2) To 000061, approval for use as in paragraph (d)(2).

(b) Related tolerances. See §556.640 of this chapter.

(c) [Reserved]

(d) Conditions of use—(1) Cattle—(i) Amount. Administer 2.5 grams per 100 pounds body weight for 1 day followed by 1.25 grams per 100 pounds body weight per day; treat for 4 to 5 days.

(ii) Indications for use. For the treatment of shipping fever complex and bacterial pneumonia associated with Pasteurella spp. sensitive to sulfadimethoxine; and calf diphtheria and foot rot associated with Fusobacterium necrophorum sensitive to sulfadimethoxine.

(iii) Limitations. Do not administer within 7 days of slaughter; milk that has been taken from animals during treatment and 60 hours (5 milkings) after the latest treatment must not be used for food. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.

(2) Dogs and cats—(i) Amount. Administer 25 milligrams per pound of body weight on the first day followed by 12.5 milligrams per pound of body weight per day until the animal is free of symptoms for 48 hours.

(ii) Indications for use. Treatment of sulfadimethoxine-susceptible bacterial infections.

(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(3) Beef cattle and nonlactating dairy cattle—(i) Amount. Administer one 12.5-gram-sustained-release bolus for the nearest 200 pounds of body weight, i.e., 62.5 milligrams per pound of body weight. Do not repeat treatment for 7 days.

(ii) Indications for use. Treatment of shipping fever complex and bacterial pneumonia associated with organisms such as Pasteurella spp. sensitive to sulfadimethoxine; calf diphtheria and foot rot associated with Fusobacterium necrophorum sensitive to sulfadimethoxine.

(iii) Limitations. Do not use in female dairy cattle 20 months of age or older. Do not administer within 12 days of slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[40 FR 13838, Mar. 27, 1975, as amended at 40 FR 43488, Sept. 22, 1975; 49 FR 36830, Sept. 20, 1984; 59 FR 56000, Nov. 10, 1994; 61 FR 4875, Feb. 9, 1996; 62 FR 61625, Nov. 19, 1997; 64 FR 15684, Apr. 1, 1999; 70 FR 16934, Apr. 4, 2005; 76 FR 17337, Mar. 29, 2011]

§520.2220c   Sulfadimethoxine oral suspension.

(a) Chemical name. N′-(2,6-Dimethoxy-4-pyrimidinyl) sulfanilamide.

(b) Specifications. Each milliliter of the drug contains 50 milligrams of sulfadimethoxine.

(c) Sponsor. See Nos. 000061 and 000069 in §510.600(c) of this chapter.

(1) It is intended for use in the treatment of sulfonamide susceptible bacterial infections in dogs and cats and enteritis associated with coccidiosis in dogs.

(2) On the first day of treatment administer an oral dose of 25 milligrams per pound of body weight, then follow with a daily dosage of 12.5 milligrams per pound of body weight. Length of treatment will depend upon clinical response. Continue treatment until patient is asymptomatic for 48 hours. Maintain adequate water intake during the treatment period.

(3) For use only by or on the order of a licensed veterinarian.

[40 FR 13838, Mar. 27, 1975, as amended at 59 FR 56000, Nov. 10, 1994; 61 FR 4875, Feb. 9, 1996; 62 FR 61625, Nov. 19, 1997]

§520.2220d   Sulfadimethoxine-ormetoprim tablets.

(a) Specifications. Each tablet contains 120 milligrams (100 milligrams of sulfadimethoxine and 20 milligrams of ormetoprim), 240 milligrams (200 milligrams of sulfadimethoxine and 40 milligrams of ormetoprim), 600 milligrams (500 milligrams of sulfadimethoxine and 100 milligrams of ormetoprim), or 1200 milligrams (1,000 milligrams of sulfadimethoxine and 200 milligrams of ormetoprim).

(b) Sponsor. See No. 000069 in §510.600(c) of this chapter.

(c) Conditions of use—(1) Amount. On the first day of treatment, administer 25 milligrams per pound (55 milligrams per kilogram) of body weight. Then follow with a daily dosage of 12.5 milligrams per pound (27.5 milligrams per kilogram) of body weight.

(2) Indications of use. Treatment of skin and soft tissue infections (wounds and abscesses) in dogs caused by strains of Staphylococcus aureus and Escherichia coli and urinary tract infections caused by Escherichia coli, Staphlococcus spp., and Proteus mirabilus susceptible to ormetoprim-potentiated sulfadimethoxine.

(3) Limitations. Continue treatment until patient is asymptomatic for 48 hours, but do not exceed a total of 21 consecutive days. Maintain adequate water intake during the treatment period. Safety in breeding animals has not been established. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[54 FR 48593, Nov. 24, 1989, as amended at 59 FR 56000, Nov. 10, 1994; 61 FR 4875, Feb. 9, 1996; 61 FR 46719, Sept. 5, 1996]

§520.2240   Sulfaethoxypyridazine.

§520.2240a   Sulfaethoxypyridazine drinking water.

(a) Chemical name. N′-(6-Ethoxy-3-pyridazinyl) sulfanilamide.

(b) Specifications. Melting point range of 180 °C. to 186 °C.

(c) Sponsor. See No. 053501 in §510.600(c) of this chapter.

(d) Related tolerances. See §556.650 of this chapter.

(e) Conditions of use. It is used as follows:

(1) Swine—(i) Amount. 1.9 to 3.8 grams per gallon (0.05 percent to 0.1 percent).

(ii) Indications for use. Treatment of bacterial scours pneumonia enteritis, bronchitis, septicemia accompanying Salmonella cholerasuis infection.

(iii) Limitations. Administer 3.8 grams per gallon for first day followed by 1.9 grams per gallon for not less than 3 days nor more than 9 days as sodium sulfaethoxypyridazine; do not treat within 10 days of slaughter; as sole source of sulfonamide; for use by or on the order of a licensed veterinarian.

(2) Cattle—(i) Amount. 2.5 grams per gallon (0.066 percent).

(ii) Indications for use. Treatment of respiratory infections (pneumonia, shipping fever), foot rot, calf scours; as adjunctive therapy in septicemia accompanying mastitis and metritis.

(iii) Limitations. Administer at the rate of 1 gallon per 100 pounds of body weight per day for 4 days; as sodium sulfaethoxypyridazine; do not treat within 16 days of slaughter; as sole source of sulfonamide; for use by or on the order of a licensed veterinarian; milk that has been taken from animals during treatment and for 72 hours (6 milkings) after latest treatment must not be used for food.

[40 FR 13838, Mar. 27, 1975, as amended at 67 FR 78355, Dec. 24, 2002]

§520.2240b   Sulfaethoxypyridazine tablets.

(a) Chemical name. N′-(6-Ethoxy-3-pyridazinyl) sulfanilamide.

(b) Specifications. Melting point range of 180 °C to 186 °C.

(c) Sponsor. See No. 053501 in §510.600(c) of this chapter.

(d) Related tolerances. See §556.650 of this chapter.

(e) Conditions of use. It is used for cattle as follows:

(1) Amount. 2.5 or 15 grams per tablet.

(i) Indications for use. Treatment of respiratory infections (pneumonia, shipping fever), foot rot, calf scours; as adjunctive therapy in septicemia accompanying mastitis and metritis.

(ii) Limitations. Administer 25 milligrams per pound of animal weight per day for 4 days; do not treat within 16 days of slaughter; as sole source of sulfonamide; milk that has been taken from animals during treatment and for 72 hours (6 milkings) after the latest treatment must not be used for food; for use only by or on the order of a licensed veterinarian.

(2) Amount. 15-gram controlled release tablets.

(i) Indications for use. Treatment of foot rot and respiratory infections (shipping fever and pneumonia) caused by sulfonamide-susceptible pathogens (E. coli, streptococci, staphylococci, Sphaerophorus necrophorus and Gram-negative rods including Pasteurella); for use prophylactically in cattle during periods of stress for reducing losses due to sulfonamide sensitive disease conditions.

(ii) Limitations. Administer 100 milligrams per pound of body weight; do not treat within 16 days of slaughter; as sole source of sulfonamide; not for use in lactating dairy cows; Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[40 FR 13838, Mar. 27, 1975, as amended at 67 FR 78355, Dec. 24, 2002]

§520.2260   Sulfamethazine oral dosage forms.

§520.2260a   Sulfamethazine oblet, tablet, and bolus.

(a)(1) Sponsor. See No. 000010 in §510.600(c) of this chapter for use of 2.5-, 5-, and 15-gram sulfamethazine oblet in beef cattle, nonlactating dairy cattle, and horses. See No. 061690 in §510.600(c) of this chapter for use of 5-, 15-, and 25-gram tablet in beef and nonlactating dairy cattle.

(2) Related tolerance in edible products. See §556.670 of this chapter.

(3) Conditions of use—(i) Amount. Administer as a single dose 100 milligrams of sulfamethazine per pound of body weight the first day and 50 milligrams per pound of body weight on each following day.

(ii) Indications for use. For treatment of diseases caused by organisms susceptible to sulfamethazine.

(A) Beef cattle and nonlactating dairy cattle. Treatment of bacterial pneumonia and bovine respiratory disease complex (shipping fever complex) (Pasteurella spp.), colibacillosis (bacterial scours) (Escherichia coli), necrotic pododermatitis (foot rot) (Fusobacterium necrophorum), calf diphtheria (Fusobacterium necrophorum), acute mastitis (Streptococcus spp.), acute metritis (Streptococcus spp.), coccidiosis (Eimeria bovis and Eimeria zurnii).

(B) Horses. Treatment of bacterial pneumonia (secondary infections associated with Pasteurella spp.), strangles (Streptococcus equi), and bacterial enteritis (Escherichia coli).

(iii) Limitations. Administer daily until animal's temperature and appearance are normal. If symptoms persist after using for 2 or 3 days consult a veterinarian. Fluid intake must be adequate. Treatment should continue 24 to 48 hours beyond the remission of disease symptoms, but not to exceed 5 consecutive days. Follow dosages carefully. Do not treat cattle within 10 days of slaughter. Do not use in female dairy cattle 20 months of age or older. Use of sulfamethazine in this class of cattle may cause milk residues. A withdrawal period has not been established in preruminating calves. Do not use in calves to be processed for veal. Do not use in horses intended for human consumption.

(b)(1) Sponsor. See No. 053501 in §510.600(c) of this chapter for use of 5-gram sulfamethazine bolus.

(2) Related tolerances in edible products. See §556.670 of this chapter.

(3) Conditions of use—(i) Amount. Administer 10 grams (2 boluses) of sulfamethazine per 100 pounds of body weight the first day, then 5 grams (1 bolus) of sulfamethazine per 100 pounds of body weight daily for up to 4 additional consecutive days.

(ii) Indications for use. Ruminating beef and dairy calves. For treatment of the following diseases caused by organisms susceptible to sulfamethazine: bacterial scours (colibacilloosis) caused by E. coli; necrotic pododermatitis (foot rot) and calf diphtheria caused by F. necrophorum; bacterial pneumonia associated with Pasteurella spp.; and coccidiosis caused by E. bovis and E. zurnii.

(iii) Limitations. Do not administer for more than 5 consecutive days. Do not treat calves within 11 days of slaughter. Do not use in calves to be slaughtered under 1 month of age or in calves being fed an all milk diet. Do not use in female dairy cattle 20 months of age or older; such use may cause drug residues in milk. Administer with adequate supervision. Follows recomended dosages carefully. Fluid intake must be adequate. If symptoms persist after 2 or 3 days, consult a veterinarian.

[54 FR 15751, Apr. 19, 1989; 54 FR 19283, May 4, 1989, as amended at 56 FR 50653, Oct. 8, 1991; 59 FR 22754, May 3, 1994; 61 FR 4875, Feb. 9, 1996; 64 FR 66383, Nov. 26, 1999; 67 FR 78355, Dec. 24, 2002; 75 FR 10166, Mar. 5, 2010; 76 FR 17337, Mar. 29, 2011]

§520.2260b   Sulfamethazine sustained-release boluses.

(a)(1) Sponsor. See No. 000859 in §510.600(c) of this chapter for use of a 22.5-gram sulfamethazine prolonged-release bolus.

(2) Conditions of use—(i) Amount. Depending on the duration of therapeutic levels desired, administer boluses as a single dose as follows: 312 days—1 bolus (22.5 grams) per 200 pounds of body weight; 5 days—1 bolus per 100 pounds of body weight.

(ii) Indications for use. Beef and nonlactating cattle for sustained treatment of shipping fever pneumonia caused or complicated by Pasteurella multocida; as an aid in the treatment of foot rot, mastitis, pneumonia, metritis, bacterial enteritis, calf diphtheria, and septicemia when caused or complicated by bacteria susceptible to sulfamethazine.

(iii) Limitations. Cattle that are acutely ill should be treated parenterally with a suitable antibacterial product to obtain immediate therapeutic blood levels; do not slaughter animals for food within 16 days of treatment; do not use in lactating dairy cattle; Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(b)(1) Sponsor. See No. 053501 in §510.600(c) of this chapter for use of a 27-gram sulfamethazine sustained-release bolus.

(2) Conditions of use—(i) Amount. 27 grams (1 bolus) for each 150 pounds of body weight as a single dose.

(ii) Indications for use. For nonlactating cattle for the treatment of infections caused by organisms sensitive to sulfamethazine such as hemorrhagic septicemia (shipping fever complex), bacterial pneumonia, foot rot, and calf diphtheria and as an aid in the control of bacterial diseases usually associated with shipping and handling of cattle.

(iii) Limitations. If no response within 2 to 3 days, reevaluate therapy; do not crush tablets; treated animals must not be slaughtered for food within 28 days after the latest treatment; Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(c)(1) Sponsor. See No. 061623 in §510.600(c) of this chapter for use of a 32.1-gram sustained-release bolus.

(2) Conditions of use—(i) Amount. 32.1 grams (1 bolus) per 200 pounds of body weight.1

1These conditions are NAS/NRC reviewed and found effective. Applications for these uses need not inlcude effectiveness data as specified by §514.111 of this chapter, but may require bioequivalency and safety information.

(ii) Indications for use. For beef and nonlactating dairy cattle for the treatment of diseases caused by sulfamethazine-sensitive organisms as follows: bacterial pneumonia and bovine respiratory disease complex (shipping fever complex) caused by Pasteurella spp., colibacillosis (bacterial scours) caused by E. coli, necrotic pododermatitis (foot rot) and calf diphtheria caused by Fusobacterium necrophorum, and acute mastitis and acute metritis caused by Streptococcus spp.)1

(iii) Limitations. After 72 hours, all animals should be reexamined for persistence of observable disease signs. If signs are present, consult a veterinarian. It is strongly recommended that a second dose be given to provide for an additional 72 hours of therapy, particularly in more severe cases. The dosage schedule should be used at each 72-hour interval. Animals should not receive more than 2 doses because of the possibility of incurring residue violations. This drug, like all sulfonamides, may cause toxic reactions and irreparable injury unless administered with adequate and continuous supervision; follow dosages carefully. Fluid intake must be adequate at all times throughout the 3-day therapy, Do not use in lactating dairy cattle. Do not treat animals within 12 days of slaughter.

(d)(1) Sponsor. See 000859 in §510.600(c) of this chapter for use of a 22.5-gram sulfamethazine sustained release bolus.

(2) Conditions of use—(i) Amount. Administer 1 bolus (22.5 grams) per 200 pounds of body weight, as a single dose.

(ii) Indications for use. Beef and nonlactating dairy cattle for the prolonged treatment of the following diseases when caused by one or more of the listed pathogenic organisms sensitive to sulfamethazine: bovine respiratory disease complex (shipping fever complex) (Pasteurella spp.), bacterial pneumonia (Pasteurella spp.), necrotic pododermatitis (foot rot) (Fusobacterium necrophorum), colibacillosis (bacterial scours) (Escherichia coli), calf diphtheria (Fusobacterium necrophorum), acute mastitis (Streptococcus spp.) and acute metritis (Streptococcus spp.).

(iii) Limitations. Cattle that are acutely ill should be treated by injection with a suitable antibacterial product to obtain immediate therapeutic blood levels; do not slaughter animals for food within 16 days of treatment; do not use in lactating dairy cattle; if treated animals do not respond within 2 to 3 days, consult a veterinarian.

(e)(1) Sponsor. See No. 061623 in §510.600(c) of this chapter for use of an 8.02-gram sulfamethazine sustained-release bolus.

(2) Conditions of use—(i) Amount. Administer 2 boluses (8.02 grams per bolus) per 100 pounds of body weight, as a single dose.

(ii) Indications for use. Administer orally to ruminating calves for the prolonged treatment of the following diseases when caused by one or more of the listed pathogenic organisms sensitive to sulfamethazine: bacterial pneumonia (Pasteurella spp.), colibacillosis (bacterial scours) (E. coli), and calf diptheria (Fusobacterium necrophorum).

(iii) Limitations. For use in ruminating replacement calves only; 72 hours after dosing all animals should be reexamined for persistence of disease signs; if signs are present, consult a veterinarian; do not slaughter animals for food for at least 12 days after the last dose; this product has not been shown to be effective for nonruminating calves; exceeding two consecutive doses may cause violative tissue residue to remain beyond the withdrawal time; do not use in calves under 1 month of age or calves being fed an all milk diet.

(f)(1) Sponsor. See No. 000859 in §510.600(c) of this chapter for use of a 30-gram sulfamethazine sustained-release bolus.

(2) Conditions of use—(i) Amount. Administer at the rate of 1 bolus (30 grams per bolus) per 200 pounds of body weight, as a single dose.

(ii) Indications for use. Administer orally to beef cattle and nonlactating dairy cattle for the treatment of the following diseases when caused by one or more of the listed pathogenic organisms sensitive to sulfamethazine: bovine respiratory disease complex (shipping fever complex) associated with Pasteurella spp.; bacterial pneumonia associated with Pasteurell spp.; necrotic pododermatitis (foot rot) and calf diphtheria caused by Fusobacterium necrophorum; colibacillosis (bacterial scours) caused by Escherichia coli; coccidiosis caused by Eimeria bovis and E. zurnii; acute mastitis and metritis caused by Streptococcus spp.

(iii) Limitations. For use in beef cattle and nonlactating dairy cattle only; if symptoms persist for 2 or 3 days after use, consult a veterinarian; do not slaughter animals for food for at least 8 days after the last dose; do not use in lactating dairy cattle; do not administer more than two consecutive doses.

(g) Related tolerances. See §556.670 of this chapter.

(h)(1) Sponsor. See No. 000010 in §510.600(c) of this chapter for use of an 8.25-gram sulfamethazine sustained-release bolus.

(2) Conditions of use—(i) Amount. Administer at the rate of 1 bolus (8.25 grams per bolus) per 50 pounds of body weight, as a single dose. If signs of disease are significantly reduced, it is recommended that a second dose be given to provide an additional 72 hours of therapy.

(ii) Indications for use. Administer orally to ruminating beef and dairy calves for treatment of the following diseases when caused by one or more of the listed pathogenic organisms susceptible to sulfamethazine: bacterial pneumonia associated with Pasteurella spp.; colibacillosis (bacterial scours) caused by Escherichia coli; coccidiosis caused by Eimeria bovis and E. zurnii; and calf diphtheria caused by Fusobacterium necrophorum.

(iii) Limitations. Do not use in calves to be slaughtered under 1 month of age or calves being fed an all milk diet. Do not use in female dairy cattle 20 months of age or older. If symptoms persist after 3 days, consult a veterinarian. Do not administer more than 2 consecutive doses. Do not slaughter animals for food for at least 8 days after the last dose. Do not crush bolus.

[46 FR 36132, July 14, 1981, as amended at 48 FR 18803, Apr. 26, 1983; 48 FR 32760, July 19, 1983; 49 FR 29057, July 18, 1984; 50 FR 49372, Dec. 2, 1985; 51 FR 30212, Aug. 25, 1986; 53 FR 40727, Oct. 18, 1988; 54 FR 14341, Apr. 11, 1989; 55 FR 8462, Mar. 8, 1990; 56 FR 50653, Oct. 8, 1991; 59 FR 22754, May 3, 1994; 61 FR 4875, Feb. 9, 1996; 62 FR 35076, June 30, 1997; 66 FR 14073, Mar. 9, 2001; 68 FR 4915, Jan. 31, 2003; 70 FR 8290, Feb. 18, 2005; 78 FR 17596, Mar. 22, 2013]

§520.2260c   Sulfamethazine sustained-release tablets.

(a) Sponsor. See No. 053501 in §510.600(c) of this chapter for use of an 8-gram sulfamethazine sustained-release tablet.

(b) Conditions of use—(1) Amount. 8 grams (1 tablet) per 45 pounds of body weight as a single dose.

(2) Indications for use. In calves for sustained treatment of pneumonia caused by Pasteurella spp., colibacillosis (bacterial scours) caused by Escherichia coli; and calf diptheria caused by Fusobacterium necrophorum.

(3) Limitations. If there is no response within 2 to 3 days, reevaluate therapy. Do not crush tablets. Treated animals must not be slaughtered for food within 18 days after the latest treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[48 FR 26763, June 10, 1983, as amended at 56 FR 50653, Oct. 8, 1991; 59 FR 22754, May 3, 1994; 61 FR 4875, Feb. 9, 1996]

§520.2261   Sulfamethazine sodium oral dosage forms.

§520.2261a   Sulfamethazine solution.

(a) Sponsors. See Nos. 000010 and 061623 in §510.600(c) of this chapter for use of a 12.5-percent sulfamethazine sodium solution.

(b) Related tolerances in edible products. See §556.670 of this chapter.

(c) Conditions of use—(1) Amount. Administer in drinking water to provide: Cattle and swine 112.5 milligrams of sulfamethazine sodium per pound of body weight per day on the first day and 56.25 milligrams per pound of body weight on subsequent days; Chickens, 61 to 89 milligrams of sulfamethazine sodium per pound of body weight per day, and turkeys 53 to 130 milligrams of sulfamethazine sodium per pound of body weight per day, depending upon the dosage, age, and class of chickens or turkeys, ambient temperature, and other factors.

(2) Indications for use. For treatment and control of diseases caused by organisms sensitive to sulfamethazine.

(i) Beef and nonlactating dairy cattle. Treatment of bacterial pneumonia and bovine respiratory disease complex (shipping fever complex) (Pasteurella spp.), colibacillosis (bacterial scours) (Escherichia coli), necrotic pododermatitis (foot rot) (Fusobacterium necrophorum), calf diphtheria (Fusobacterium necrophorum), acute mastitis (Streptococcus spp.), and acute metritis (Streptococcus spp.).

(ii) Swine. Treatment of porcine colibacillosis (bacterial scours) (Escherichia coli), and bacterial pneumonia (Pasteurella spp.).

(iii) Chickens and turkeys. In chickens for control of infectious coryza (Avibacterium paragallinarum), coccidiosis (Eimeria tenella, Eimeria necatrix), acute fowl cholera (Pasteurella multocida), and pullorum disease (Salmonella pullorum). In turkeys for control of coccidiosis (Eimeria meleagrimitis, Eimeria adenoeides). Medicate as follows: Infectious coryza in chickens, medicate for 2 consecutive days; acute fowl cholera and pullorum disease, in chickens, medicate for 6 consecutive days; coccidiosis, in chickens and turkeys, medicate as in paragraph (c) of this section, then reduce amount of medication to one-half for 4 additional days.

(3) Limitations. Add the required dose to that amount of water that will be consumed in 1 day. Consumption should be carefully checked. Have only medicated water available during treatment. Withdraw medication from cattle, chickens, and turkeys 10 days prior to slaughter for food. Withdraw medication from swine 15 days before slaughter for food. Do not medicate chickens or turkeys producing eggs for human consumption. Treatment of all diseases should be instituted early. Treatment should continue 24 to 48 hours beyond the remission of disease symptoms, but not to exceed a total of 5 consecutive days in cattle or swine. Medicated cattle, swine, chickens, and turkeys must actually consume enough medicated water which provides the recommended dosages. Do not use in female dairy cattle 20 months of age or older. Use of sulfamethazine in this class of cattle may cause milk residues. A withdrawal period has not been established in preruminating calves. Do not use in calves to be processed for veal.

(d) NAS/NRC status. The conditions of use specified in this section have been reviewed by NAS/NRC and are found effective. Applications for these uses need not include effectiveness data as specified by §514.111 of this chapter, but may require bioequivalency and safety information.

[47 FR 25322, June 11, 1982, as amended at 47 FR 25735, June 15, 1982; 67 FR 78355, Dec. 24, 2002; 70 FR 32489, June 3, 2005; 74 FR 36112, July 22, 2009; 75 FR 10166, Mar. 5, 2010; 76 FR 17337, Mar. 29, 2011]

§520.2261b   Sulfamethazine powder.

(a) Specifications. A soluble powder composed of 100 percent sulfamethazine sodium.

(b) Sponsors. See Nos. 000010 and 061623 in §510.600(c) of this chapter.

(c) Related tolerances. See §556.670 of this chapter.

(d) Conditions of use—(1) Chickens—(i) Amount. Administer in drinking water to provide 58 to 85 milligrams (mg) per pound (/lb) of body weight per day.

(ii) Indications for use. For control of infectious coryza (Haemophilus gallinarum), coccidiosis (Eimeria tenella, E. necatrix), acute fowl cholera (Pasteurella multocida), and pullorum disease (Salmonella pullorum).

(iii) Limitations. Add the required dose to that amount of water that will be consumed in 1 day. Consumption should be carefully checked. Have only medicated water available during treatment. Withdraw medication 10 days prior to slaughter for food. Do not medicate chickens producing eggs for human consumption. Treatment of all diseases should be instituted early. Treatment should continue 24 to 48 hours beyond the remission of disease symptoms. Medicated chickens must actually consume enough medicated water which provides the recommended dosages.

(2) Turkeys—(i) Amount. Administer in drinking water to provide 50 to 124 mg/lb of body weight per day

(ii) Indications for use. For control of coccidiosis (E. meleagrimitis, E. adenoeides).

(iii) Limitations. Add the required dose to that amount of water that will be consumed in 1 day. Consumption should be carefully checked. Have only medicated water available during treatment. Withdraw medication 10 days prior to slaughter for food. Do not medicate turkeys producing eggs for human consumption. Treatment of all diseases should be instituted early. Treatment should continue 24 to 48 hours beyond the remission of disease symptoms. Medicated turkeys must actually consume enough medicated water which provides the recommended dosages.

(3) Swine—(i) Amount. Administer in drinking water, or as a drench, to provide 108 mg/lb of body weight on the first day and 54 mg/lb of body weight per day on the second, third, and fourth days of administration.

(ii) Indications for use. For treatment of porcine colibacillosis (bacterial scours) (E. coli), and bacterial pneumonia (Pasteurella spp.).

(iii) Limitations. Add the required dose to that amount of water that will be consumed in 1 day. Consumption should be carefully checked. Have only medicated water available during treatment. Withdraw medication 15 days prior to slaughter for food. Treatment of all diseases should be instituted early. Treatment should continue 24 to 48 hours beyond the remission of disease symptoms, but not to exceed a total of 5 consecutive days. Medicated swine must actually consume enough medicated water which provides the recommended dosages.

(4) Cattle—(i) Amount. Administer in drinking water, or as a drench, to provide 108 mg/lb of body weight on the first day and 54 mg/lb of body weight per day on the second, third, and fourth days of administration.

(ii) Indications for use in beef and nonlactating dairy cattle. Treatment of bacterial pneumonia and bovine respiratory disease complex (shipping fever complex) (Pasteurella spp.), colibacillosis (bacterial scours) (E. coli), necrotic pododermatitis (foot rot) (Fusobacterium necrophorum), calf diphtheria (F. necrophorum), acute mastitis (Streptococcus spp.), and acute metritis (Streptococcus spp.)

(iii) Limitations. Add the required dose to that amount of water that will be consumed in 1 day. Consumption should be carefully checked. Have only medicated water available during treatment. Withdraw medication 10 days prior to slaughter for food. Treatment of all diseases should be instituted early. Treatment should continue 24 to 48 hours beyond the remission of disease symptoms, but not to exceed a total of 5 consecutive days. Medicated cattle must actually consume enough medicated water which provides the recommended dosages.

[71 FR 70303, Dec. 4, 2006, as amended at 75 FR 10166, Mar. 5, 2010]

§520.2280   Sulfamethizole and methenamine mandelate tablets.

(a) Specifications. Each tablet contains 250 milligrams of sulfamethizole and 250 milligrams of methenamine mandelate.

(b) Sponsor. See No. 000856 in §510.600(c) of this chapter.

(c) Conditions of use. (1) The drug is indicated for the treatment of urinary tract infections in dogs and cats such as cystitis, nephritis, prostatitis, urethritis, and pyelonephritis. It is also used as an aid in the management of complications resulting from surgical manipulations of the urinary tract such as removal of calculi from the bladder, in ureterostomies, and in instrumentation of the urethra and bladder.

(2) It is administered at a dosage level of one tablet for each 20 pounds of body weight given three times per day. The drug should be given until all signs are alleviated. To reduce the possibility of a relapse, it is suggested that therapy be continued for a further period of a week to 10 days.

(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[40 FR 13838, Mar. 27, 1975, as amended at 50 FR 13561, Apr. 5, 1985]

§520.2325   Sulfaquinoxaline oral dosage forms.

§520.2325a   Sulfaquinoxaline drinking water.

(a) Sponsor. See §510.600(c) of this chapter for identification of the sponsors.

(1) To No. 000859 for use of a 25-percent sulfaquinoxaline soluble powder and a 20-percent sulfaquinoxaline sodium solution as provided for in paragraph (c) of this section.

(2) To No. 061623 for use of 3.44- and 12.85-percent sulfaquinoxaline sodium solutions as provided for in paragraphs (c)(1), (c)(2), (c)(3), (c)(4)(i), and (c)(4)(ii) of this section.

(3) To No. 046573 for use of a 31.92-percent sulfaquinoxaline solution (sodium and potassium salts) as provided for in paragraphs (c)(1), (c)(2), (c)(3), (c)(4)(i), and (c)(4)(ii) of this section.

(4) No. 053501 for use of a 28.62-percent sulfaquinoxaline sodium solution as provided in paragraphs (c)(1), (c)(2), and (c)(3) of this section.

(b) Related tolerances. See §556.685 of this chapter.

(c) Conditions of use. It is used in drinking water as follows:

(1) Chickens. (i) As an aid in the control of outbreaks of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, and E. brunetti.

(ii) Administer at the 0.04 percent level for 2 or 3 days, skip 3 days then administer at the 0.025 percent level for 2 more days. If bloody droppings appear, repeat treatment at the 0.025 percent level for 2 more days. Do not change litter unless absolutely necessary. Do not give flushing mashes.

(2) Turkeys. (i) As an aid in the control of outbreaks of coccidiosis caused by Eimeria meleagrimitis and E. adenoeides.

(ii) Administer at the 0.025 percent level for 2 days, skip 3 days, give for 2 days, skip 3 days and give for 2 more days. Repeat if necessary. Do not change litter unless absolutely necessary. Do not give flushing mashes.

(3) Chickens and turkeys. (i) As an aid in the control of acute fowl cholera caused by Pasteurella multocida susceptible to sulfaquinoxaline and fowl typhoid caused by Salmonella gallinarum susceptible to sulfaquinoxaline.

(ii) Administer at the 0.04 percent level for 2 or 3 days. Move birds to clean ground. If disease recurs, repeat treatment. If cholera has become established as the respiratory or chronic form, use feed medicated with sulfaquinoxaline. Poultry which have survived typhoid outbreaks should not be kept for laying house replacements or breeders unless tests show they are not carriers.

(4) Cattle and calves. (i) For the control and treatment of outbreaks of coccidiosis caused by Eimeria bovis or E. zurnii.

(ii) Administer at the 0.015-percent level for 3 to 5 days in drinking water medicated with sulfaquinoxaline solution.

(iii) In lieu of treatment as provided in paragraph (e)(4)(ii) of this section, administer 1 teaspoon of 25-percent sulfaquinoxaline soluble powder per day for each 125 pounds of body weight for 3 to 5 days in drinking water.

(d) Limitations. Consult a veterinarian or poultry pathologist for diagnosis. May cause toxic reactions unless the drug is evenly mixed in water at dosages indicated and used according to directions. For control of outbreaks of disease, medication should be initiated as soon as the diagnosis is determined. Medicated chickens, turkeys, cattle, and calves must actually consume enough medicated water which provides a recommended dosage of approximately 10 to 45 milligrams per pound per day in chickens, 3.5 to 55 milligrams per pound per day in turkeys, and approximately 6 milligrams per pound per day in cattle and calves depending on the age, class of animal, ambient temperature, and other factors. A withdrawal period has not been established for sulfaquinoxaline in preruminating calves. Do not use in calves to be processed for veal. Not for use in lactating dairy cattle. Do not give to chickens, turkeys or cattle within 10 days of slaughter for food. Do not medicate chickens or turkeys producing eggs for human consumption. Make fresh drinking water daily.

[48 FR 3964, Jan. 28, 1983, as amended at 48 FR 26762, June 10, 1983; 55 FR 29843, July 23, 1990; 59 FR 28769, June 3, 1994; 59 FR 33197, June 28, 1994; 61 FR 24443, May 15, 1996; 61 FR 63711, Dec. 2, 1996; 62 FR 37712, July 15, 1997; 65 FR 10705, Feb. 29, 2000; 69 FR 41427, July 9, 2004; 69 FR 60547, Oct. 12, 2004; 74 FR 36112, July 22, 2009; 78 FR 17596, Mar. 22, 2013]

§520.2325b   Sulfaquinoxaline drench.

(a)-(b) [Reserved]

(c) Sponsor. See No. 050749 in §510.600(c) of this chapter.

(d) NAS/NRC status. The conditions of use specified in this section have been reviewed by NAS/NRC and are found effective. Applications for these uses need not include effectiveness data as specified by §514.111 of this chapter, but may require bioequivalency information. Applications must be accompanied by a written commitment to undertake the human safety studies required by FDA.

(e) Conditions of uses. As a 25-percent sulfaquinoxaline soluble powder.

(1) For the control and treatment of outbreaks of coccidiosis in cattle and calves caused by Eimeria bovis or E. zurnii.

(2) Give one teaspoon of 25 percent sulfaquinoxaline soluble powder for each 125 pounds of body weight for 3 to 5 days as a drench.

(f) Limitations. For control of outbreaks of disease, medication should be initiated as soon as the diagnosis is determined. Consult a veterinarian for diagnosis. Do not give to cattle within 10 days of slaughter for food. Not for use in lactating dairy cattle.

[48 FR 3964, Jan. 28, 1983, as amended at 55 FR 29843, July 23, 1990; 59 FR 33197, June 28, 1994]

§520.2330   Sulfisoxazole tablets.

(a) Specifications. Each tablet contains 260 milligrams (4 grains) of sulfisoxazole.

(b) Sponsor. See No. 000856 in §510.600(c) of this chapter.

(c) Conditions of use—(1) Amount. Administer one tablet orally per 4 pounds of body weight.1

1These conditions are NAS/NRC reviewed and deemed effective. Applications for these uses need not include effectiveness data as specified by §514.111 of this chapter, but may require bioequivalency and safety information.

(2) Indications for use. Use in dogs and cats as an aid in treatment of bacterial pneumonia and bacterial enteritis when caused by organisms sensitive to sulfisoxazole.1

(3) Limitations. Repeat dosage at 24-hour intervals until 2 to 3 days after disappearance of clinical symptoms. (Administration of one-half daily dosage at 12-hour intervals or one-third daily dosage at 8-hour intervals will provide a more constant blood level.) Provide adequate supply of drinking water. If symptoms persist after using this preparation for 2 or 3 days, consult a veterinarian.1

[43 FR 60895, Dec. 29, 1978]

§520.2340   Tepoxalin.

(a) Specifications. Each tablet contains 30, 50, 100, or 200 milligrams (mg) tepoxalin.

(b) Sponsor. See No. 000061 in §510.600(c) of this chapter.

(c) Conditions of use in dogs—(1) Amount. 10 mg per kilogram (/kg) daily; or 20 mg/kg on the initial day of treatment, followed by 10 mg/kg daily.

(2) Indications for use. For the control of pain and inflammation associated with osteoarthritis.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[68 FR 34795, June 11, 2003]

§520.2345   Tetracycline.

§520.2345a   Tetracycline hydrochloride capsules.

(a) Specifications. Each capsule contains 50, 100, 125, 250, or 500 milligrams (mg) tetracycline hydrochloride.

(b) Sponsor. See sponsors in §510.600(c) of this chapter for use as in paragraph (c) of this section:

(1) No. 000009: 250 mg per capsule.

(2) No. 000069: 125, 250, or 500 mg per capsule.

(c) Conditions of use in dogs—(1) Amount. 25 mg per pound of body weight per day in divided doses every 6 hours.

(2) Indications for use. For treatment of infections caused by organisms sensitive to tetracycline hydrochloride, such as bacterial gastroenteritis due to E. coli and urinary tract infections due to Staphylococcus spp. and E. coli.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[70 FR 50182, Aug. 26, 2005, as amended at 73 FR 18442, Apr. 4, 2008]

§520.2345b   Tetracycline tablets.

(a) Specifications. Each tablet contains 100, 250, or 500 milligrams of tetracycline (as the hydrochloride).

(b) Sponsor. For 100, 250, or 500 milligrams per tablet, see No. 000069 in §510.600(c) of this chapter. For 250 milligrams per tablet, see No. 000009 in §510.600(c) of this chapter.

(c) Conditions of use. Dogs—(1) Amount. 25 milligrams per pound of body weight per day in divided doses every 6 hours.

(2) Indications for use. Treatment of infections caused by organisms sensitive to tetracycline hydrochloride, such as bacterial gastroenteritis due to E. coli and urinary tract infections due to Staphylococcus spp. and E. coli.

(3) Limitations. Administer orally; continue treatment until symptoms of the disease have subsided and temperature is normal for 48 hours; not for use in animals raised for food production; Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[57 FR 37327, Aug. 18, 1992]

§520.2345c   Tetracycline boluses.

(a) Specifications. Each bolus contains 500 milligrams of tetracycline (as the hydrochloride).

(b) Sponsors. See No. 053501 in §510.600(c) of this chapter for use as in paragraph (d)(1) of this section. See No. 000009 in §510.600(c) of this chapter for use as in paragraph (d)(2) of this section.

(c) Related tolerances. See §556.720 of this chapter.

(d) Conditions of use. Calves—(1) Amount. 10 milligrams per pound of body weight per day in divided doses.

(i) Indications for use. Control and treatment of bacterial enteritis (scours) caused by E. coli and bacterial pneumonia caused by Pasteurella spp., Hemophilus spp., and Klebsiella spp.

(ii) Limitations. Administer orally for 3 to 5 days; do not slaughter animals for food within 14 days of treatment; use as sole source of tetracycline.

(iii) National Academy of Sciences/National Research Council (NAS/NRC) status. The conditions of use specified in paragraph (d)(1)(i) of this section were NAS/NRC reviewed and found effective. Applications for these uses need not include effectiveness data as specified in §514.111 of this chapter, but may require bioequivalency and safety information.

(2) Amount. 10 milligrams per pound of body weight per day in two divided doses.

(i) Indications for use. Treatment of bacterial pneumonia caused by organisms susceptible to tetracycline, bacterial enteritis caused by E. coli, and salmonella organisms susceptible to tetracycline.

(ii) Limitations. Administer orally for not more than 5 days; do not slaughter animals for food within 12 days of treatment; use as sole source of tetracycline.

[57 FR 37328, Aug. 18, 1992, as amended at 67 FR 78355, Dec. 24, 2002]

§520.2345d   Tetracycline powder.

(a) Specifications. Each pound of powder contains 25, 102.4, or 324 grams tetracycline hydrochloride.

(b) Sponsors. See sponsors listed in §510.600(c) of this chapter for conditions of use as in paragraph (d) of this section:

(1) No. 000069: 25 grams per pound as in paragraphs (d)(3) and (d)(4) of this section.

(2) No. 054628: 25, 102.4, and 324 grams per pound as in paragraph (d) of this section.

(3) No. 046573: 25, 102.4, and 324 grams per pound as in paragraph (d) of this section.

(4) Nos. 054925, 057561, 061623, and 076475: 324 grams per pound as in paragraph (d) of this section.

(c) Related tolerances. See §556.720 of this chapter.

(d) Conditions of use. It is administered in drinking water as follows:

(1) Calves—(i) Amount. 10 milligrams per pound of body weight per day in divided doses.

(ii) Indications for use. Control and treatment of bacterial enteritis (scours) caused by Escherichia coli and bacterial pneumonia (shipping fever complex) associated with Pasteurella spp., Actinobacillus pleuropneumoniae (Hemophilus spp.), and Klebsiella spp., susceptible to tetracycline.

(iii) Limitations. Administer for 3 to 5 days; do not slaughter animals for food within 4 days of treatment for No. 000010 and within 5 days of treatment for Nos. 046573, 054925, 057561, 059130, and 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.

(ii) Indications for use. Control and treatment of bacterial enteritis (scours) caused by E. coli and bacterial pneumonia associated with Pasteurella spp., A. pleuropneumoniae (Hemophilus spp.), and Klebsiella spp., susceptible to tetracycline.

(iii) Limitations. Administer for 3 to 5 days; do not slaughter animals for food within 7 days of treatment for No. 000010 and within 4 days of treatment for Nos. 046573, 054925, 057561, 059130, and 061623; prepare a fresh solution daily; use as the sole source of tetracycline.

(3) Chickens—(i) Amount. Chronic respiratory disease: 400 to 800 milligrams per gallon. Infectious synovitis: 200 to 400 milligrams per gallon.

(ii) Indications for use. Control of chronic respiratory disease (CRD or air-sac disease) caused by Mycoplasma gallisepticum and E. coli; control of infectious synovitis caused by M. synoviae susceptible to tetracycline.

(iii) Limitations. Administer for 7 to 14 days; do not slaughter for food within 4 days of treatment; not for use in chickens producing eggs for human consumption; prepare a fresh solution daily; use as the sole source of tetracycline.

(4) Turkeys—(i) Amount. For infectious synovitis: 400 milligrams per gallon. For complicating bacterial organisms associated with bluecomb (transmissible enteritis or coronaviral enteritis): 25 milligrams per pound of body weight per day.

(ii) Indications for use. Control of infectious synovitis caused by M. synoviae; control of bluecomb complicated by organisms sensitive to tetracycline.

(iii) Limitations. Administer for 7 to 14 days; do not slaughter for food within 4 days of treatment; not for use in turkeys producing eggs for human consumption; prepare a fresh solution daily; use as the sole source of tetracycline.

[59 FR 17693, Apr. 14, 1994, as amended at 59 FR 19133, Apr. 22, 1994; 62 FR 5319, Feb. 5, 1997; 62 FR 35076, June 30, 1997; 62 FR 46668, Sept. 4, 1997; 62 FR 55160, Oct. 23, 1997; 64 FR 37673, July 13, 1999; 67 FR 78355, Dec. 24, 2002; 70 FR 16934, Apr. 4, 2005; 70 FR 67353, Nov. 7, 2005; 71 FR 13542, Mar. 16, 2006; 75 FR 10166, Mar. 5, 2010; 75 FR 12981, Mar. 18, 2010; 76 FR 17338, Mar. 29, 2011; 77 FR 20988, Apr. 9, 2012; 78 FR 21060, Apr. 9, 2013]

§520.2345e   Tetracycline oral liquid.

(a) Specifications. Each milliliter contains the equivalent of either 25 or 100 milligrams of tetracycline hydrochloride.

(b) Sponsor. See No. 000069, in §510.600(c) of this chapter for use of 25 or 100 milligrams per milliliter liquid in dogs as in paragraph (c)(1) of this section; see No. 000009 in §510.600(c) of this chapter for use of 100 milligrams per milliliter liquid in dogs and cats as in paragraph (c)(2).

(c) Conditions of use—(1) Dogs—(i) Amount. 25 milligrams per pound of body weight per day in divided doses every 6 hours.

(ii) Indications for use. Treatment of infections caused by organisms sensitive to tetracycline hydrochloride, such as bacterial gastroenteritis due to Escherichia coli and urinary tract infections due to Staphylococcus spp. and E. coli.

(iii) Limitations. Administer orally; continue treatment until symptoms have subsided and the temperature is normal for 48 hours; not for use in animals which are raised for food production; Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(iv) National Academy of Sciences/National Research Council (NAS/NRC) status. These conditions were NAS/NRC reviewed and found effective. Applications for these uses need not include effectiveness data as specified by §514.111 of this chapter, but may require bioequivalency and safety information.

(2) Dogs and cats—(i) Amount. 25 milligrams per pound of body weight per day in divided doses every 6 hours.

(ii) Indications for use. Treatment of infections caused by organisms susceptible to tetracycline hydrochloride, such as bacterial gastroenteritis due to E. coli and urinary tract infections due to Staphylococcus spp. and E. coli.

(iii) Limitations. Administer orally; continue treatment until the temperature has been normal for 48 hours; not for use in food-producing animals; Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[57 FR 37329, Aug. 18, 1992]

§520.2345f   Tetracycline phosphate complex and sodium novobiocin capsules.

(a) Specifications. Each capsule contains the equivalent of 60 milligrams of tetracycline hydrochloride and 60 milligrams of novobiocin.

(b) Sponsor. No. 000009 in §510.600(c) of this chapter.

(c) Conditions of use. Dogs—(1) Amount. 10 milligrams of each antibiotic per pound of body weight (1 capsule for each 6 pounds) every 12 hours.

(2) Indications for use. Treatment of acute or chronic canine respiratory infections such as tonsillitis, bronchitis, and tracheobronchitis when caused by pathogens susceptible to tetracycline and/or novobiocin, such as Staphylococcus spp. and Escherichia coli.

(3) Limitations. Continue treatment for at least 48 hours after the temperature has returned to normal and all evidence of infection has disappeared. As with all antibiotics, appropriate in vitro culturing and susceptibility tests of samples taken before treatment should be conducted. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[57 FR 37329, Aug. 18, 1992]

§520.2345g   Tetracycline hydrochloride and sodium novobiocin tablets.

(a) Specifications. Each tablet contains the equivalent of 60 milligrams of tetracycline hydrochloride and 60 milligrams of novobiocin, or 180 milligrams of tetracycline hydrochloride and 180 milligrams of novobiocin.

(b) Sponsor. No. 000009 in §510.600(c) of this chapter.

(c) Conditions of use. Dogs—(1) Amount. 10 milligrams of each antibiotic per pound of body weight (one single-strength tablet for each 6 pounds or one triple-strength tablet for each 18 pounds).

(2) Indications for use. Treatment of acute or chronic canine respiratory infections such as tonsillitis, bronchitis, and tracheobronchitis when caused by pathogens susceptible to tetracycline and/or novobiocin, such as Staphylococcus spp. and Escherichia coli.

(3) Limitations. Continue treatment for at least 48 hours after the temperature has returned to normal and all evidence of infection has disappeared. As with all antibiotics, appropriate in vitro culturing and susceptibility tests of samples taken before treatment should be conducted. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[57 FR 37329, Aug. 18, 1992]

§520.2345h   Tetracycline hydrochloride, sodium novobiocin, and prednisolone tablets.

(a) Specifications. Each tablet contains the equivalent of 60 milligrams of tetracycline hydrochloride, 60 milligrams of novobiocin, and 1.5 milligrams of prednisolone or 180 milligrams of tetracycline hydrochloride, 180 milligrams of novobiocin, and 4.5 milligrams of prednisolone.

(b) Sponsor. See No. 000009 in §510.600(c) of this chapter.

(c) Conditions of use. Dogs—(1) Amount. 10 milligrams of each antibiotic and 0.25 milligram of prednisolone per pound of body weight (one single-strength tablet for each 6 pounds or one triple-strength tablet for each 18 pounds) every 12 hours for 48 hours. Treatment is to be continued with novobiocin and tetracycline alone at the same dose schedule for an additional 3 days or longer as needed.

(2) Indications for use. Treatment of acute and chronic canine respiratory infections such as tonsillitis, bronchitis, and tracheobronchitis when caused by pathogens susceptible to tetracycline and/or novobiocin, such as Staphylococcus spp. and Escherichia coli, when it is necessary to initially reduce the severity of associated clinical signs.

(3) Limitations. As with all antibiotics, appropriate in vitro culturing and susceptibility tests of samples taken before treatment should be conducted. Administer for 48 hours only. Continue treatment if needed with tetracycline/novobiocin alone. The product is contraindicated in animals with tuberculosis, hyperadrenocorticalism, or peptic ulcers. Clinical and experimental data have demonstrated that corticosteroids administered orally or parenterally to animals may induce the first stage of parturition when administered during the last trimester of pregnancy and may precipitate premature parturition followed by dystocia, fetal death, retained placenta, and metritis. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[57 FR 37329, Aug. 18, 1992]

§520.2362   Thenium closylate tablets.

(a) Chemical name. (N,N-Dimethyl-N-2-phenoxyethyl-N-2′-thenylammo-nium)-p-chlorobenzene-sulfonate.

(b) Specifications. Thenium closylate tablets contain thenium closylate equivalent to 500 milligrams thenium as base in each tablet.

(c) Sponsor. See No. 000061 in §510.600(c) of this chapter.

(d) Conditions of use. (1) The tablets are administered orally to dogs as a single day treatment of canine ancylostomiasis by the removal from the intestines of the adult forms of the species Ancylostoma caninum and Uncinaria stenocephala (hookworms). Dogs weighing 10 pounds and over are administered 1 tablet as a single dose. Dogs weighing 5 to 10 pounds are administered one-half tablet twice during a single day. All dosages are given for 1 day only. The treatment should be repeated after 2 or 3 weeks.

(2) Suckling puppies or recently weaned puppies weighing less than 5 pounds should not be treated with the drug. Animals that are severely infected, exhibiting evidence of intestinal hemorrhage, debilitation, and anemia, should be given supportive treatment.

(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[40 FR 13838, Mar. 27, 1975, as amended at 41 FR 53477, Dec. 7, 1976; 46 FR 48642, Oct. 2, 1981; 61 FR 8873, Mar. 6, 1996; 62 FR 61625, Nov. 19, 1997]

§520.2380   Thiabendazole oral dosage forms.

§520.2380a   Thiabendazole top dressing and mineral protein block.

(a) Chemical name. 2-(4-Thiazolyl)-benzimidazole.

(b) Specifications. Conforms to N.F. XII.

(c) Sponsors. See sponsors in §510.600(c) of this chapter for use as in paragraph (e) of this section.

(1) No. 051311 for use as in paragraph (e)(1)(i) of this section.

(2) No. 050604 for use as in paragraph (e)(1)(ii) of this section.

(3) No. 012286 for use as in paragraph (e)(2) of this section.

(d) Related tolerances. See §556.730 of this chapter.

(e) Conditions of use. It is used as follows:

(1) Horses—(i) Route of administration. In feed, as a top dressing.

(a) Amount. 2 grams per 100 pounds of body weight.

(b) Indications for use. For control of large strongyles, small strongyles, pinworms, and threadworms (including members of the genera Strongylus, Cyathostomum, Cylicobrachytus, and related genera, Craterostomum, Oesophagodontus, Poteriostomum, Oxyuris, and Strongyloides).

(c) Limitations. Add to the usual feed of horses mixed into that amount of the feed normally consumed at one feeding. Warning: Not for use in horses intended for food.

(ii) Route of administration. In feed.

(a) Amount. 2 grams per 100 pounds of body weight.

(1) Indications for use. For control of large and small strongyles, Strongyloides, and pinworms of the genera Strongylus, Cyathostomum, Cylicobrachytus and related genera, Craterostomum, Oesophagodontus, Poteriostomum, Oxyuris, and Strongyloides.

(2) Limitations. Administer in a single dosage mixed with the normal grain ration given at one feeding. Warning: Not for use in horses intended for food.

(b) Amount. 4 grams per 100 pounds of body weight.

(1) Indications for use. For control of ascarids of the genus Parascaris.

(2) Limitations. Administer in a single dosage mixed with the normal grain ration given at one feeding. Warning: Not for use in horses intended for food.

(2) Cattle—(i) Route of administration. In feed block.

(ii) Amount. 3.3 percent block consumed at the recommended level of 0.11 pound per 100 pounds of body weight per day.

(iii) Indications for use. For control of infections of gastrointestinal roundworms (Trichostrongylus, Haemonchus, Ostertagia and Cooperia).

(iv) Limitations. Administer to cattle on pasture or range accustomed to mineral protein block feeding for 3 days. Milk taken from animals during treatment and within 96 hours (8 milkings) after the latest treatment must not be used for food. Do not treat cattle within 3 days of slaughter. For a satisfactory diagnosis, a microscopic fecal examination should be performed by a veterinarian or diagnostic laboratory prior to worming. Animals maintained under conditions of constant worm exposure may require re-treatment within 2 to 3 weeks. Animals that are severely parasitized, sick, or off feed should be isolated and a veterinarian consulted for advice concerning treatment.

[40 FR 13838, Mar. 27, 1975, as amended at 41 FR 9149, Mar. 3, 1976; 62 FR 63271, Nov. 28, 1997; 70 FR 32489, June 3, 2005; 73 FR 35340, June 23, 2008]

§520.2380b   Thiabendazole drench or oral paste.

(a) Chemical name. 2-(4-Thiazolyl) benzimidazole.

(b) Specifications. Conforms to N.F. XII.

(c) Sponsor. See No. 050604 in §510.600(c) of this chapter for the sponsor of the usages provided for by paragraph (e) of this section.

(d) Related tolerances. See §556.730 of this chapter.

(e) Conditions of use. It is used as follows:

(1) Horses. As a single liquid oral dose, administered as a drench or by stomach tube; or as an oral paste.

(i) Amount. 2 grams per 100 pounds of body weight.

(a) Indications for use. For the control of infections of large strongyles (Strongylus vulgaris, Strongylus endentatus), small strongyles (Cyathastomum, Cylicobrachytus and related genera, Craterostomum, Oesophagodontus, Poteriostomum), pinworms (Oxyuris), and threadworms (Strongyloides).

(b) Limitations. Not for use in horses to be slaughtered for food purposes. When administered by stomach tube, for use only by or on the order of a licensed veterinarian. When for use as a liquid oral drench or an oral paste, consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.

(ii) Amount. 4 grams per 100 pounds of body weight.

(a) Indications for use. For control of infections of ascardis (Parascaris).

(b) Limitations. Not for use in horses to be slaughtered for food purposes. When administered by stomach tube, use only by or on the order of a licensed veterinarian. When for use as a liquid oral drench or an oral paste, consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.

(2) Pigs. As an oral paste.

(i) Amount. 200 milligrams for each 5 to 7 pounds of body weight per dose.

(ii) Indications for use. For control of infections with Strongyloides ransomi. These infections are commonly found in Southeastern United States.

(iii) Limitations. Administer to baby pigs (1 to 8 weeks of age). Treatment may be repeated in 5 to 7 days if necessary. Before treatment, obtain an accurate diagnosis from a veterinarian or diagnostic laboratory. Do not treat within 30 days of slaughter.

(3) Cattle. Orally as a drench and in paste form using a dosing gun designed for the product.

(i) Amount. 3 grams per 100 pounds of body weight.

(a) Indications for use. Control of infections of gastrointestinal roundworms (Trichostrongylus spp., Haemonchus spp., Nematodirus spp., Ostertagia spp., and Oesophagostomum radiatum).

(b) Limitations. For most effective results, severely parasitized animals or those constantly exposed to helminth infection should be re-treated every 2 to 3 weeks. Milk taken from treated animals within 96 hours (8 milkings) after the latest treatment must not be used for food. Do not treat cattle within 3 days of slaughter. For a satisfactory diagnosis, a microscopic fecal examination should be performed prior to worming.

(ii) Amount. 5 grams per 100 pounds of body weight.

(a) Indications for use. Control of infections of Cooperia spp. or severe infections of other species in paragraph (e)(3)(i)(a) of this section.

(b) Limitations. For most effective results, severely parasitized animals or those constantly exposed to helminth infection should be re-treated every 2 to 3 weeks. Milk taken from treated animals within 96 hours (8 milkings) after the latest treatment must not be used for food. Do not treat cattle within 3 days of slaughter. For a satisfactory diagnosis, a microscopic fecal examination should be performed prior to worming.

(4) Sheep and goats. Orally, as a drench.

(i) Amount. 2 grams per 100 pounds of body weight.

(ii) Indications for use. Control of infections of gastrointestinal roundworms in sheep and goats. (Trichostrongylus spp., Haemonchus spp., Ostertagia spp., Cooperia spp., Nematodirus spp., Bunostomum spp., Strongyloides spp., Chabertia spp., and Oesophagostomum spp. ); also active from 3 hours to 3 days following treatment against ova and larvae passed by sheep (good activity against Trichostrongylus colubriformis and axei, Ostertagia spp., Bunostomum spp., Nematodirus spp., and Strongyloides spp.; less effective against Haemonchus contortus and Oesophagostomum spp. ).

(iii) Limitations. As a single oral dose; do not treat animals within 30 days of slaughter; milk taken from treated animals within 96 hours (8 milkings) after the latest treatment must not be used for food; in severe infections in sheep, treatment should be repeated in 2 to 3 weeks.

(5) Goats. Orally, as a drench.

(i) Amount. 3 grams per 100 pounds of body weight.

(ii) Indications for use. Control of severe infections of gastrointestinal roundworms (Trichostrongylus spp., Haemonchus spp., Ostertagia spp., Cooperia spp., Nematodirus spp., Bunostomum spp., Strongyloides spp., Chabertia spp., and Oesophagostomum spp. ).

(iii) Limitations. As a single oral dose; do not treat animals within 30 days of slaughter; milk taken from treated animals within 96 hours (8 milkings) after the latest treatment must not be used for food; treatment should be repeated in 2 to 3 weeks.

[40 FR 13838, Mar. 27, 1975, as amended at 41 FR 9149, Mar. 3, 1976; 41 FR 47424, Oct. 29, 1976; 62 FR 63271, Nov. 28, 1997]

§520.2380c   Thiabendazole bolus.

(a) Chemical name. 2-(4-Thiazolyl) benzimidazole.

(b) Specifications. Conforms to N.F. XII.

(c) Sponsor. See No. 050604 in §510.600(c) of this chapter.

(d) Related tolerances. See §556.730 of this chapter.

(e) Conditions of use. It is used as follows:

(1) Cattle. In a bolus.

(i) Amount. 3 grams per 100 pounds of body weight.

(a) Indications for use. Control of infections of gastrointestinal roundworms (general Trichostrongylus spp., Haemonchus spp., Nematodirus spp., Ostertagia spp., and Oesophagostomum radiatum).

(b) Limitations. As a single oral dose; may repeat once in 2 to 3 weeks; do not treat animals within 3 days of slaughter; milk taken from treated animals within 96 hours (8 milkings) after the latest treatment must not be used for food.

(ii) Amount. 5 grams per 100 pounds of body weight.

(a) Indications for use. Control of severe infections of gastrointestinal roundworms (genera Trichostrongylus spp., Haemonchus spp., Nematodirus spp., Ostertagia spp., and Oesophagostomum radiatum). Control of infections with Cooperia spp.

(b) Limitations. As a single oral dose; as a drench or bolus; may repeat once in 2 to 3 weeks; do not treat animals within 3 days of slaughter; milk taken from treated animals within 96 hours (8 milkings) after the latest treatment must not be used for food.

(2) Sheep and goats. In a bolus.

(i) Amount. 2 grams per 100 pounds of body weight.

(ii) Indications for use. Control of infections of gastrointestinal roundworms in sheep and goats (general Trichostrongylus spp., Haemonchus spp., Ostertagia spp., Cooperia spp., Nematodirus spp., Bunostomum spp., Strongyloides spp., Chabertia spp., and Oesophagostomum spp. ); also active from 3 hours to 3 days following treatment against ova and larvae passed by sheep (good activity against T. colubriformis and axei, Ostertagia spp., Bunostomum spp., Nematodirus spp., and Strongyloides spp.; less effective against Haemonchus contortus and Oesophagostomum spp. ).

(iii) Limitations. As a single oral dose; do not treat animals within 30 days of slaughter; milk taken from treated animals within 96 hours (8 milkings) after the latest treatment must not be used for food; in severe infections in sheep, treatment should be repeated in 2 to 3 weeks.

(3) Goats. In a bolus.

(i) Amount. 3 grams per 100 pounds of body weight.

(ii) Indications for use. Control of severe infections of gastrointestinal roundworms (genera Trichostrongylus spp., Haemonchus spp., Ostertagia spp., Cooperia spp., Nematodirus spp., Bunostomum spp., Strongyloides spp., Chabertia spp., and Oesophagostomum spp. ).

(iii) Limitations. As a single oral dose; do not treat animals within 30 days of slaughter; milk taken from treated animals within 96 hours (8 milkings) after the latest treatment must not be used for food; treatment should be repeated in 2 to 3 weeks.

[40 FR 13838, Mar. 27, 1975, as amended at 41 FR 9149, Mar. 3, 1976; 62 FR 63271, Nov. 28, 1997]

§520.2380d   Thiabendazole, piperazine citrate suspension.

(a) Specifications. Each fluid ounce of suspension contains 2 grams of thiabendazole and 2.5 grams of piperazine (from piperazine citrate).

(b) Sponsor. See No. 050604 in §510.600(c) of this chapter.

(c) Conditions of use. (1) It is administered to horses by stomach tube or as a drench at the rate of 1 fluid ounce of suspension per 100 pounds of body weight for the control of large strongyles, small strongyles, pinworms, Strongyloides and ascarids (including members of the genera Strongylus spp., Cyathostomum spp., Cylicobrachytus spp. and related genera Craterostomum spp., Oesophagodontus spp., Poteriostomum spp., Oxyuris spp., Strongyloides spp., and Parascaris spp. ).

(2) Do not use in horses intended to be used for food purposes.

(3) For use by or on the order of a licensed veterinarian.

[40 FR 13838, Mar. 27, 1975, as amended at 62 FR 63271, Nov. 28, 1997]

§520.2380e   Thiabendazole with trichlorfon.

(a) Specifications. The drug contains 5 grams of thiabendazole with 4.5 grams of trichlorfon, or 20 grams of thiabendazole with 18 grams of trichlorfon.

(b) Sponsor. See No. 017135 in §510.600(c) of this chapter.

(c) Conditions of use. (1) Used for the treatment and control of bots (Gasterophilus spp. ), large strongyles (Strongylus spp. ), small strongyles (genera Cyathostomum, Cylicobrachytus, Craterostomum, Oesophagodontus, Poteriostomum), pinworms (Oxyuris spp., Strongyloides spp. ), and ascarids (Parascaris spp. ) in horses.

(2) Administer 2 grams of thiabendazole with 1.8 grams of trichlorfon per 100 pounds of body weight sprinkled on the animals' usual daily ration of feed, or may be mixed in 5 to 10 fluid ounces of water and administered by stomach tube or drench.

(3) Do not re-treat more than once every 30 days, preferably every 6 to 8 weeks.

(4) Do not treat animals if sick or debilitated; less than 4 months of age; or mares in last month of pregnancy.

(5) Do not administer intravenous anesthetics, especially muscle relaxants, within 2 weeks of use.

(6) Not for animals intended for food use.

(7) Do not use within a few days before or after treatment with or exposure to cholinesterase-inhibiting drugs, pesticides, or chemicals.

(8) If the label bears directions for administration of the drug by stomach tube or drench it shall also bear the statement: Caution; Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[40 FR 23071, May 28, 1975, as amended at 48 FR 48229, Oct. 18, 1983]

§520.2380f   Thiabendazole, piperazine phosphate powder.

(a) Specifications. Each ounce of water dispersible powder contains 6.67 grams of thiabendazole and 8.33 grams of piperazine (as piperazine phosphate).

(b) Sponsor. See No. 050604 in §510.600(c) of this chapter.

(c) Conditions of use—(1) Amount. 2 grams of thiabendazole and 2.5 grams of piperazine (0.3 ounce of powder) per 100 pounds of body weight.

(2) Indications for use. Treatment of infections of large strongyles (genus Strongylus), small strongyles (genera Cyathostomum, Cylicobrachytus, and related genera Craterostomum, Oesophagodontus, Poteriostomum), pinworms (Oxyuris), threadworms (Strongyloides), and ascarids (Parascaris) in horses.

(3) Limitations. Use a single oral dose. Administer as a drench or by stomach tube suspended in 1 pint of warm water; by dose syringe suspended in 12 ounce of water for each 100 pounds of body weight; or sprinkled over a small amount of daily feed. Not for animals intended for food use. If the label bears directions for administration by stomach tube or drench, it shall also bear the statement “Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian;” if not labeled for use by stomach tube or drench, the label shall bear the statement, “Consult your veterinarian for assistance in the diagonosis, treatment, and control of parasitism.”

[46 FR 18963, Mar. 27, 1981, as amended at 46 FR 52330, Oct. 27, 1981; 62 FR 63271, Nov. 28, 1997]

§520.2455   Tiamulin.

(a) Specifications. (1) Each gram of soluble powder contains 450 milligrams (mg) tiamulin hydrogen fumarate.

(2) Each milliliter (mL) of solution contains 125 mg (12.5 percent) tiamulin hydrogen fumarate.

(3) Each mL of solution contains 123 mg (12.3 percent) tiamulin hydrogen fumarate.

(b) Sponsors. See sponsor numbers in §510.600(c) of this chapter for use as in paragraph (d) of this section.

(1) No. 058198 for products described in paragraphs (a)(1) and (a)(2) of this section.

(2) No. 066104 for the product described in paragraph (a)(1) of this section.

(3) No. 000859 for the product described in paragraph (a)(3) of this section.

(c) Related tolerances. See §556.738 of this chapter.

(d) Conditions of use in swine—(1) Amounts and indications for use. Administer in drinking water for 5 consecutive days:

(i) 3.5 mg per (/) lb of body weight daily for treatment of swine dysentery associated with Brachyspira hyodysenteriae susceptible to tiamulin.

(ii) 10.5 mg/lb of body weight daily for treatment of swine pneumonia due to Actinobacillus pleuropneumoniae susceptible to tiamulin.

(2) Limitations. Use as only source of drinking water. Prepare fresh medicated water daily. Withdraw medication 3 days before slaughter following treatment at 3.5 mg/lb and 7 days before slaughter following treatment at 10.5 mg/lb of body weight. Swine being treated with tiamulin should not have access to feeds containing polyether ionophores (e.g., lasalocid, monensin, narasin, salinomycin, or semduramycin) as adverse reactions may occur. The effects of tiamulin on swine reproductive performance, pregnancy, and lactation have not been determined.

[70 FR 75017, Dec. 19, 2005, as amended at 74 FR 7180, Feb. 13, 2009; 75 FR 54492, Sept. 8, 2010; 77 FR 56770, Sept. 14, 2012; 78 FR 17596, Mar. 22, 2013]

§520.2471   Tilmicosin.

(a) Specifications. Each milliliter of concentrate solution contains 250 milligrams (mg) tilmicosin as tilmicosin phosphate.

(b) Sponsor. See No. 000986 in §510.600(c) of this chapter.

(c) Tolerances. See §556.735 of this chapter.

(d) Conditions of use in swine—(1) Amount. Administer in drinking water at a concentration of 200 mg per liter for 5 consecutive days.

(2) Indication for use. For the control of swine respiratory disease associated with Pasteurella multocida and Haemophilus parasuis in groups of swine in buildings where a respiratory disease outbreak is diagnosed.

(3) Limitations. Swine intended for human consumption must not be slaughtered within 7 days of the last treatment with this product. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[79 FR 18158, Apr. 1, 2014]

§520.2473   Tioxidazole oral dosage forms.

§520.2473a   Tioxidazole granules.

(a) Specifications. Each gram of granules contains 200 milligrams of tioxidazole.

(b) Sponsor. See No. 000061 in §510.600(c) of this chapter.

(c) Conditions of use—(1) Horses—(i) Amount. 5 milligrams per pound of body weight as a single dose.

(ii) Indications for use. Removal of mature large strongyles (Strongylus edentatus, S. equinus, and S. vulgaris), mature ascarids (Parascaris equorum), mature and immature (4th larval stage) pinworms (Oxyuris equi), and mature small strongyles (Triodontophorus spp.).

(iii) Limitations. For administration with feed: Sprinkle required amount of granules on a small amount of the usual grain ration and mix. Prepare for each horse individually. Withholding of feed or water not necessary. Not for use in horses intended for food. The reproductive safety of tioxidazole in breeding animals has not been determined. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. It is recommended that this drug be administered with caution to sick or debilitated horses.

(2) [Reserved]

[50 FR 52772, Dec. 26, 1985; 51 FR 2693, Jan. 21, 1986, as amended at 52 FR 7832, Mar. 13, 1987]

§520.2473b   Tioxidazole paste.

(a) Specifications. Each plastic syringe contains 6.25 grams of tioxidazole.

(b) Sponsor. See No. 000061 in §510.600(c) of this chapter.

(c) Conditions of use—(1) Horses—(i) Amount. 5 milligrams of tioxidazole per pound of body weight as a single dose.

(ii) Indications for use. Removal of mature large strongyles (Strongylus edentatus, S. equinus, and S. vulgaris), mature ascarids (Parascaris equorum), mature and immature (4th larval stage) pinworms (Oxyuris equi), and mature small strongyles (Triodontophorus spp.).

(iii) Limitations. Administer orally by inserting the nozzle of the syringe through the space between front and back teeth and deposit the required dose on the base of the tongue. Before dosing, make sure the horse's mouth contains no feed. Not for use in horses intended for food. The reproductive safety of tioxidazole in breeding animals has not been determined. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. It is recommended that this drug be administered with caution to sick or debilitated horses.

(2) [Reserved]

[52 FR 43059, Nov. 9, 1987]

§520.2475   Toceranib.

(a) Specifications. Each tablet contains 10, 15, or 50 milligrams (mg) toceranib as toceranib phosphate.

(b) Sponsor. See No. 000009 in §510.600 of this chapter.

(c) Conditions of use—(1) Dogs—(i) Amount. Administer an initial dose of 3.25 mg per kilogram (1.48 mg per pound) body weight, orally every other day.

(ii) Indications for use. For the treatment of Patnaik grade II or III, recurrent, cutaneous mast cell tumors with or without regional lymph node involvement.

(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) [Reserved]

[74 FR 28875, June 18, 2009]

§520.2483   Triamcinolone.

(a) Specifications.—(1) Each tablet contains 0.5 milligram (mg) or 1.5 mg triamcinolone acetonide.

(2) Each 15 grams of powder contains 10 mg triamcinolone acetonide.

(b) Sponsor. See No. 000010 in §510.600(c) of this chapter.

(c) Special considerations. See §510.410 of this chapter.

(d) Conditions of use—(1) Dogs and cats. Use tablets described in paragraph (a)(1) of this section as follows:

(i) Amount. Administer 0.05 mg per pound (/lb) of body weight daily by mouth; up to 0.1 mg per pound (/lb) of body weight daily, if response to the smaller dose is inadequate. Therapy may be initiated with a single injection of triamcinolone acetonide suspension as in §522.2483 of this chapter, in which case triamcinolone acetonide tablets should be administered beginning 5 to 7 days after the injection.

(ii) Indications for use. As an anti-inflammatory agent.

(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) Horses. Use oral powder described in paragraph (a)(2) of this section as follows:

(i) Amount. Administer 0.005 to 0.01 mg/lb of body weight twice daily, sprinkled (top-dressed) on a small portion of feed. Therapy may be initiated with a single injection of triamcinolone acetonide suspension as in §522.2483 of this chapter, in which case triamcinolone acetonide oral powder should be administered beginning 3 or 4 days after the injection.

(ii) Indications for use. As an anti-inflammatory agent.

(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use in horses intended for human consumption.

[75 FR 10166, Mar. 5, 2010]

§520.2520   Trichlorfon oral dosage forms.

§520.2520b   Trichlorfon and atropine.

(a) Chemical name. (1) For trichlorfon: O,O-Dimethyl 2,2,2-trichloro-1-hydroxyethyl phosphonate.

(2) For atropine: Atropine N.F.

(b) Sponsor. See No. 000856 in §510.600(c) of this chapter.

(c) Conditions of use. (1) The drug is used for the treatment of Syphacia obvelata (pinworm) in laboratory mice.

(2) It is administered in distilled water as sole source of drinking water continuously for 7 to 14 days at 1.67 grams of trichlorfon and 7.7 milligrams of atropine per liter.

(3) Prepare fresh solution every 3 days. Do not use simultaneously with other drugs, insecticides, pesticides, or chemicals having cholinesterase activity, nor within 7 days before or after treatment with any other cholinesterase inhibitor.

(4) Restricted to use by or on the order of a licensed veterinarian.

§520.2520e   Trichlorfon boluses.

(a) Specifications. Each bolus contains either 7.3, 10.9, 14.6, or 18.2 g of trichlorfon.

(b) Sponsor. See 000856 in §510.600(c) of this chapter.

(c) Special considerations. Trichlorfon is a cholinesterase inhibitor. Do not use this product on animals simultaneously with, or within 2 weeks, before or after treatment with or exposure to, neuromuscular depolarizing agents (i.e., succinylcholine) or to cholinesterase-inhibiting drugs, pesticides, or chemicals.

(d) NAS/NRC status. Use of this drug has been NAS/NRC reviewed and found effective. Applications for these uses need not include effectiveness data as specified by §514.111 of this chapter.

(e) Conditions of use—(1) Amount. 18.2 milligrams per pound of body weight, except for strongyles use 36.4 milligrams per pound of body weight.

(2) Indications for use. For horses for removal of bots (Gastrophilus nasalis, Gastrophilus intestinalis), large strongyles (Strongylus vulgaris), small strongyles, large roundworms (ascarids, Parascaris equorum), and pinworms (Oxyuris equi).

(3) Limitations. Do not fast horses before or after treatment. Treatment of mares in late pregnancy is not recommended. Surgery or any severe stress should be avoided for at least 2 weeks before or after treatment. Do not administer to sick, toxic, or debilitated horses. Not to be used in horses intended for use as food. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[45 FR 48127, July 18, 1980]

§520.2520f   Trichlorfon granules.

(a) Specifications. Each package contains either 18.2 or 36.4 g of trichlorfon.

(b) Sponsor. See 000856 in §510.600(c) of this chapter.

(c) Special considerations. Trichlorfon is a cholinesterase inhibitor. Do not use this product on animals simultaneously with, or within 2 weeks before or after treatment with or exposure to neuromuscular depolarizing agents (i.e., succinylcholine) or to cholinesterase-inhibiting drugs, pesticides, or chemicals.

(d) NAS/NRC status. Use of this drug has been NAS/NRC reviewed and found effective. Applications for these uses need not include effectiveness data as specified by §514.111 of this chapter.

(e) Conditions of use—(1) Amount. 18.2 milligrams per pound of body weight.

(2) Indications for use. For horses for removal of bots (Gastrophilus nasalis, Gastrophilus intestinalis), large roundworms (ascarids, Parascaris equorum), and pinworms (Oxyuris equi).

(3) Limitations. Do not fast horses before or after treatment. Treatment of mares in late pregnancy is not recommended. Surgery or any severe stress should be avoided for at least 2 weeks before or after treatment. Do not administer to sick, toxic, or debilitated horses. Not to be used in horses intended for use as food. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[45 FR 48128, July 18, 1980]

§520.2520g   Trichlorfon, phenothiazine, and piperazine dihydrochloride powder.

(a) Specifications. Each 54.10 grams (1.91 ounces) of water dispersible powder contains 9.10 grams of trichlorfon, 6.25 grams of phenothiazine, and the equivalent of 20.0 grams of piperazine base (as piperazine dihydrochloride).

(b) Sponsor. See No. 000856 in §510.600(c) of this chapter.

(c) Special considerations. Labeling shall bear the following statements: The drug is a cholinesterase inhibitor. Do not use this product in horses simultaneously with, or within 2 weeks before or after treatment with, or exposure to, neuromuscular depolarizing agents (e.g., succinylcholine) or to cholinesterase-inhibiting drugs, pesticides, or chemicals.

(d) Conditions of use—(1) Amount. 18.2 milligrams of trichlorfon, 12.5 milligrams of phenothiazine, and 40.0 milligrams of piperazine base per pound of body weight.

(2) Indications for use. For horses for removal of bots (Gastrophilus nasalis, Gastrophilus intestinalis), large strongyles (Strongylus vulgaris), small strongyles, large roundworms (ascarids, Parascaris equorum), and pinworms (Oxyuris equi).

(3) Limitations. Mix powder and vial contents together in warm water to form suspension. Administer by stomach tube. Do not fast horses before or after treatment. Treatment of mares in late pregnancy is not recommended. Surgery or any severe stress should be avoided for at least 2 weeks before or after treatment. Do not administer to sick, toxic, or debilitated horses. Not to be used in horses intended for use as food. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[48 FR 2757, Jan. 21, 1983]

§520.2582   Triflupromazine hydrochloride tablets.

(a) Specifications. Each tablet contains either 10 milligrams or 25 milligrams of triflupromazine hydrochloride.

(b) Sponsor. See No. 053501 in §510.600(c) of this chapter.

(c) Conditions of use. (1) The drug is used in dogs and cats to relieve anxiety and to help control psychomotor overactivity as well as to increase the tolerance of animals to pain and pruritus. The drug is indicated in various office and clinical procedures which require the aid of a tranquilizer, antiemetic, or preanesthetic.1

(2) The drug is administered orally to dogs and cats at a dosage level of 1 to 2 milligrams per pound of body weight daily; an initial dosage at the 2-milligrams level is suggested followed by daily doses at the 1-milligram level. Frequently, the drug may be withdrawn after 4 to 5 days, with drug effect continuing after withdrawal.1

(3) Do not use in conjunction with organophosphates and/or procaine hydrochloride, because phenothiazines may potentiate the toxicity of organophosphates and the activity of procaine hydrochloride.1

(4) Federal law restricts this drug to use by or on the order of a licensed veterinarian.1

[40 FR 13838, Mar. 27, 1975, as amended at 50 FR 41489, Oct. 11, 1985]

§520.2598   Trilostane.

(a) Specifications. Each capsule contains 10, 30, or 60 milligrams (mg) trilostane.

(b) Sponsor. See No. 043264 in §510.600 of this chapter.

(c) Conditions of use in dogs—(1) Amount. The starting dose is 1.0 to 3.0 milligrams per pound (2.2 to 6.7 milligrams per kilogram) once a day.

(2) Indications for use. For treatment of pituitary-dependent hyperadrenocorticism. For treatment of hyperadrenocorticism due to adrenocortical tumor.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[74 FR 21767, May 11, 2009, as amended at 74 FR 30464, June 26, 2009]

§520.2604   Trimeprazine tartrate and prednisolone tablets.

(a) Specifications. Each tablet contains: trimeprazine tartrate, 5 milligrams; and prednisolone, 2 milligrams.

(b) Sponsor. See No. 000069 in §510.600(c) of this chapter.

(c) Conditions of use. (1) The drug is administered orally to dogs for the relief of itching regardless of cause; reduction of inflammation commonly associated with most skin disorders of dogs such as eczema, caused by internal disorders, otitis, and dermatitis, allergic, parasitic, pustular and nonspecific. It is also used in dogs as adjunctive therapy in various cough conditions including treatment of “kennel cough” or tracheobronchitis, bronchitis including allergic bronchitis, in tonsillitis, acute upper respiratory infections and coughs of nonspecific origin. The product may also be administered to dogs suffering from acute or chronic bacterial infections, provided the infection is controlled by appropriate antibiotic or chemotherapeutic agents.1

(2) The drug is administered orally at an initial dosage level of 12 tablet twice daily to dogs weighing up to 10 pounds, one tablet twice daily to dogs weighing 11 to 20 pounds, two tablets twice daily to dogs weighing 21 to 40 pounds, and three tablets twice daily to dogs weighing over 40 pounds. After 4 days, the dosage is reduced to approximately 12 the initial dosage or to an amount just sufficient to maintain remission of symptoms. Dosages in individual cases may vary and should be adjusted until proper response is obtained.1

(3) Do not use the drug in cases of viral infections involving corneal ulceration or dendritic ulceration of the cornea.1

(4) Clinical and experimental data have demonstrated that corticosteroids administered orally or parenterally to animals may induce the first stage of parturition when administered during the last trimester of pregnancy and may precipitate premature parturition followed by dystocia, fetal death, retained placenta, and metritis.1

(5) Federal law restricts this drug to use by or on the order of a licensed veterinarian.1

1These conditions are NAS/NRC reviewed and deemed effective. Applications for these uses need not include effectiveness data as specified by §514.111 of this chapter, but may require bioequivalency and safety information.

[40 FR 13838, Mar. 27, 1975, as amended at 56 FR 50653, Oct. 8, 1991; 60 FR 55659, Nov. 2, 1995]

§520.2605   Trimeprazine tartrate and prednisolone capsules.

(a) Specifications. Each capsule contains 3.75 milligrams of trimeprazine in sustained released form (as the tartrate) and 1 milligram of prednisolone (capsule no. 1) or 7.5 milligrams of trimeprazine in sustained release form (as the tartrate) and 2 milligrams of prednisolone (capsule no. 2).

(b) Sponsor. See 000069 in §510.600(c) of this chapter.

(c) Conditions of use—(1) Amount. Administer either capsule orally once daily to dogs as follows:

Animal weight (pounds)Number of capsules per dose
Capsule No. 1Capsule No. 2
Up to 101
11 to 2021
21 to 4042
Over 4063

(2) Indications for use. For the relief of itching regardless of cause, reduction of inflammation commonly associated with most skin disorders of dogs such as eczema caused by internal disorders, otitis, and dermatitis (allergic, parasitic, pustular, and nonspecific). It is also used in dogs as adjunctive therapy in various cough conditions including treatment of “kennel cough” or tracheobronchitis, bronchitis including allergic bronchitis, tonsillitis, acute upper respiratory infections, and coughs of nonspecific origin. The product may also be administered to dogs suffering from acute or chronic bacterial infections, provided the infection is controlled by appropriate antibiotic or chemotherapeutic agents.

(3) Limitations. After 4 days, reduce dosage to one-half the initial dose or to an amount sufficient to maintain remission of symptoms. Dosages in individual cases may vary and should be adjusted until proper response is obtained. Do not use the drug in cases of viral infections involving corneal ulceration or dendritic ulceration of the cornea. Clinical and experimental data have demonstrated that corticosteroids administered orally or parenterally to animals may induce the first stage of parturition when administered during the last trimester of pregnancy and may precipitate premature parturition followed by dystocia, fetal death, retained placenta, and metritis. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[48 FR 19367, Apr. 29, 1983, as amended at 56 FR 50653, Oct. 8, 1991; 60 FR 55659, Nov. 2, 1995]

§520.2610   Trimethoprim and sulfadiazine tablets.

(a) Specifications. Each tablet contains 30 milligrams (5 milligrams of trimethoprim and 25 milligrams of sulfadiazine), 120 milligrams (20 milligrams of trimethoprim and 100 milligrams of sulfadiazine), 480 milligrams (80 milligrams of trimethoprim and 400 milligrams of sulfadiazine) or 960 milligrams (160 milligrams of trimethoprim and 800 milligrams of sulfadiazine).

(b) Sponsor. See Nos. 000061 and 000856 in §510.600(c) of this chapter.

(c) Conditions of use. (1) The drug is used in dogs where systemic antibacterial action against sensitive organisms is required, either alone or as an adjunct to surgery or debridement with associated infection. The drug is indicated where control of bacterial infection is required during the treatment of acute urinary tract infections, acute bacterial complications of distemper, acute respiratory tract infections, acute alimentary tract infections, wound infections, and abscesses.

(2) The drug is given orally at 30 milligrams per kilogram of body weight per day (14 milligrams per pound per day), or as follows:

Animal body weight (pounds)Number of tablets
30 mg tablets
2.21
4.42
6.63
8.84
120 mg tablets
Up to 91
10 to 192
20 to 293
30 to 404
480 mg tablets
30 to 401
40 to 6011/2
60 to 802
80 to 1103
Over 1104

(3) The drug is given once daily. Alternatively, especially in severe infections, the initial dose may be followed by one-half the recommended daily dose every 12 hours. If no improvement is seen in 3 days, discontinue therapy and reevaluate diagnosis.

(4) Administer for 2 to 3 days after symptoms have subsided. Do not treat for more than 14 consecutive days.

(5) During long term treatment, periodic platelet counts and white and red blood cell counts are recommended.

(6) The drug should not be used in patients showing marked liver parenchymal damage or blood dyscrasia, nor in those with a history of sulfonamide sensitivity.

(7) Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[41 FR 3853, Jan. 27, 1976, as amended at 44 FR 32214, June 5, 1979; 46 FR 23231, Apr. 24, 1981; 47 FR 36814, Aug. 24, 1982; 50 FR 9800, Mar. 12, 1985; 50 FR 11852, Mar. 26, 1985; 61 FR 5506, Feb. 13, 1996; 61 FR 8873, Mar. 6, 1996; 62 FR 61625, Nov. 19, 1997]

§520.2611   Trimethoprim and sulfadiazine paste.

(a) Specifications. Each gram (g) of paste contains 67 milligrams (mg) trimethoprim and 333 mg sulfadiazine.

(b) Sponsors. See sponsors in §510.600(c) of this chapter:

(1) No. 000856 for product administered as in paragraph (c)(1)(i) of this section.

(2) No. 000061 for product administered as in paragraph (c)(1)(ii) of this section.

(c) Conditions of use in horses—(1) Amount. Administer orally as a single daily dose for 5 to 7 days:

(i) 5 g of paste (335 mg trimethoprim and 1,665 mg sulfadiazine) per 150 pounds (68 kilograms) of body weight per day.

(ii) 3.75 g of paste (250 mg trimethoprim and 1,250 mg sulfadiazine) per 110 pounds (50 kilograms) of body weight per day.

(2) Indications for use. For use where systemic antibacterial action against sensitive organisms is required during treatment of acute strangles, respiratory infections, acute urogenital infections, and wound infections and abscesses.

(3) Limitations. Not for use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[71 FR 30802, May 31, 2006]

§520.2612   Trimethoprim and sulfadiazine suspension.

(a) Specifications. Each milliliter (mL) of suspension contains:

(1) 10 milligrams (mg) trimethoprim and 50 mg sulfadiazine; or

(2) 400 mg combined active ingredients (67 mg trimethoprim and 333 mg sulfadiazine).

(b) Sponsors. See sponsor numbers in §510.600 of this chapter:

(1) No. 000061 for use of product described in paragraph (a)(1) for use as in paragraph (c)(1) of this section.

(2) No. 051072 for use of product described in paragraph (a)(2) for use as in paragraph (c)(2) of this section.

(c) Conditions of use—(1) Dogs—(i) Amount. Administer 1 mL (10 mg trimethoprim and 50 mg sulfadiazine) per 5 pounds (lb) of body weight once daily, or one-half the recommended daily dose every 12 hours, for up to 14 consecutive days.

(ii) Indications for use. The drug is used in dogs where systemic antibacterial action against sensitive organisms is required, either alone or as an adjunct to surgery or debridement with associated infection. The drug is indicated where control of bacterial infection is required during the treatment of acute urinary tract infections, acute bacterial complications of distemper, acute respiratory tract infections, acute alimentary tract infections, wound infections, and abscesses.

(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) Horses—(i) Amount. Administer 24 mg combined active ingredients per kilogram of body weight (2.7 mL/100 lb) twice daily for 10 days.

(ii) Indications for use. For the treatment of lower respiratory tract infections in horses caused by susceptible strains of Streptococcus equi subsp. zooepidemicus.

(iii) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[78 FR 63872, Oct. 25, 2013]

§520.2613   Trimethoprim and sulfadiazine powder.

(a) Specifications. Each gram of powder contains 67 milligrams of trimethoprim and 333 milligrams of sulfadiazine.

(b) Sponsor. See No. 000009 and 058711 in §510.600(c) of this chapter.

(c) Conditions of use: Horses—(1) Dosage. 3.75 grams of powder per 110 pounds (50 kilograms) of body weight per day.

(2) Indications for use. For control of bacterial infections of horses during treatment of acute strangles, respiratory tract infections, acute urogenital infections, wound infections, and abscesses.

(3) Limitations. Administer orally in a small amount of feed, as a single daily dose, for 5 to 7 days. Continue therapy for 2 to 3 days after clinical signs have subsided. If no improvement is seen in 3 to 5 days, reevaluate diagnosis. A complete blood count should be done periodically with prolonged use. Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[58 FR 36135, July 6, 1993, as amended at 64 FR 68289, Dec. 7, 1999]

§520.2640   Tylosin.

(a) Specifications. Each container of soluble powder contains tylosin tartrate equivalent to either 100 or 256 grams tylosin base.

(b) Sponsors. See Nos. 000986, 016592, and 061623 in §510.600(c) of this chapter.

(1) No. 000986 for use of a 100-gram jar as in paragraph (d) of this section.

(2) No. 016592 for use of a 100-gram jar or pouch as in paragraphs (d)(1), (d)(2), (d)(3)(i), (d)(3)(ii)(B), (d)(3)(iii), and (d)(4) of this section.

(3) No. 061623 for use of a 100- or 256-gram jar or pouch as in paragraphs (d)(1), (d)(2), (d)(3)(i), (d)(3)(ii)(B), (d)(3)(iii), and (d)(4) of this section.

(c) Related tolerances. See §556.740 of this chapter.

(d) Conditions of use—(1) Chickens—(i) Amount. 2 grams per gallon for 1 to 5 days as the sole source of drinking water. Treated chickens should consume enough medicated drinking water to provide 50 milligrams (mg) tylosin per pound of body weight per day.

(ii) Indications for use. For maintaining weight gain and feed efficiency in the presence of infectious sinusitis associated with Mycoplasma gallisepticum sensitive to tylosin.

(iii) Limitations. Prepare a fresh solution every 3 days. Do not use in layers producing eggs for human consumption. Do not administer within 24 hours of slaughter.

(2) Turkeys—(i) Amount. 2 grams per gallon for 2 to 5 days as the sole source of drinking water. Treated turkeys should consume enough medicated drinking water to provide 60 mg tylosin per pound of body weight per day.

(ii) Indications for use. For maintaining weight gains and feed efficiency in the presence of infectious sinusitis associated with Mycoplasma gallisepticum sensitive to tylosin.

(iii) Limitations. Prepare a fresh solution every 3 days. Do not use in layers producing eggs for human consumption. Do not administer within 5 days of slaughter.

(3) Swine—(i) Amount. 250 mg per gallon as the only source of drinking water for 3 to 10 days, depending on the severity of the condition being treated.

(ii) Indications for use. (A) For the treatment and control of swine dysentery associated with Brachyspira hyodysenteriae when followed immediately by tylosin phosphate medicated feed; and for the control of porcine proliferative enteropathies (PPE, ileitis) associated with Lawsonia intracellularis when followed immediately by tylosin phosphate medicated feed.

(B) For the treatment and control of swine dysentery associated with Brachyspira hyodysenteriae.

(iii) Limitations. Prepare a fresh solution daily. Do not administer within 48 hours of slaughter. As indicated in paragraph (d)(3)(ii)(A) of this section, follow with tylosin phosphate medicated feed as in §558.625(f)(1)(vi)(c) of this chapter.

(4) Honey bees—(i) Amount. Mix 200 milligrams tylosin in 20 grams confectioners'/powdered sugar. Use immediately. Apply (dust) this mixture over the top bars of the brood chamber once weekly for 3 weeks.

(ii) Indications for use. For the control of American foulbrood (Paenibacillus larvae).

(iii) Limitations. The drug should be fed early in the spring or fall and consumed by the bees before the main honey flow begins, to avoid contamination of production honey. Complete treatments at least 4 weeks before main honey flow.

[40 FR 13838, Mar. 27, 1975, as amended at 50 FR 49841, Dec. 5, 1985; 59 FR 14365, Mar. 28, 1994; 62 FR 39443, July 23, 1997; 68 FR 24879, May 9, 2003; 70 FR 69439, Nov. 16, 2005; 73 FR 76946, Dec. 18, 2008; 75 FR 76259, Dec. 8, 2010; 76 FR 59024, Sept. 23, 2011; 77 FR 29217, May 17, 2012]

§520.2645   Tylvalosin.

(a) Specifications. Granules containing 62.5 percent tylvalosin (w/w) as tylvalosin tartrate.

(b) Sponsor. See No. 066916 in §510.600(c) of this chapter.

(c) Related tolerances. See §556.748 of this chapter.

(d) Conditions of use in swine—(1) Amount. Administer 50 parts per million tylvalosin in drinking water for 5 consecutive days.

(2) Indications for use. For the control of porcine proliferative enteropathy (PPE) associated with Lawsonia intracellularis infection in groups of swine in buildings experiencing an outbreak of PPE.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[77 FR 55415, Sept. 10, 2012]



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