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§ 516.1684 21 CFR Ch. I (4–1–14 Edition)

§ 516.1684 . 520.88h Amoxicillin trihydrate and clavulanate potassium for oral suspen- (a) Specifications. Each vial of powder sion. contains 60 milligrams (mg) paclitaxel. 520.90 Ampicillin oral dosage forms. Each milliliter of constituted solution 520.90a Ampicillin capsules. contains 1 mg paclitaxel. 520.90b Ampicillin trihydrate tablets. (b) Sponsor. See No. 052818 in 520.90c Ampicillin trihydrate capsules. 510.600(c) of this chapter. 520.90d Ampicillin trihydrate for oral sus- pension. (c) Conditions of use in —(1) 520.90e Ampicillin trihydrate soluble pow- Amount. Administer 150 mg per square der. meter of body surface area intra- 520.90f Ampicillin trihydrate boluses. venously over 15 to 30 minutes, once 520.100 Amprolium. every 3 weeks, for up to 4 doses. 520.110 Apramycin sulfate soluble powder. (2) Indications for use. For the treat- 520.154 Bacitracin oral dosage forms. ment of nonresectable stage III, IV, or 520.154a Bacitracin methylene disalicylate. V mammary carcinoma in dogs that 520.154b Bacitracin methylene disalicylate and streptomycin sulfate powder. have not received previous chemo- 520.154c Bacitracin zinc soluble powder. therapy or radiotherapy. For the treat- 520.222 Bunamidine hydrochloride. ment of resectable and nonresectable 520.246 Butorphanol tartrate tablets. squamous cell carcinoma in dogs that 520.260 n-Butyl chloride. have not received previous chemo- 520.300 Cambendazole oral dosage forms. therapy or radiotherapy. 520.300a Cambendazole suspension. (3) Limitations. Federal law restricts 520.300b Cambendazole pellets. 520.300c Cambendazole paste. this drug to use by or on the order of a 520.309 Carprofen. licensed veterinarian. It is a violation 520.310 Caramiphen ethanedisulfonate and of Federal law to use this product ammonium chloride tablets. other than as directed in the labeling. 520.312 Carnidazole tablets. 520.314 Cefadroxil. [79 FR 18158, Apr. 1, 2014] 520.370 Cefpodoxime tablets. 520.376 Cephalexin. PART 520—ORAL DOSAGE FORM 520.390 Chloramphenicol oral dosage forms. 520.390a Chloramphenicol tablets. NEW ANIMAL DRUGS 520.390b Chloramphenicol capsules. 520.390c Chloramphenicol palmitate oral Sec. suspension. 520.23 Acepromazine. 520.420 Chlorothiazide tablets and boluses. 520.28 Acetazolamide sodium soluble pow- 520.434 Chlorphenesin carbamate tablets. der. 520.441 Chlortetracycline powder. 520.38 oral dosage forms. 520.443 Chlortetracycline tablets and 520.38a Albendazole suspension. boluses. 520.38b Albendazole paste. 520.445 Chlortetracycline and 520.43 Afoxolaner. sulfamethazine powder. 520.48 Altrenogest. 520.446 capsules and tablets. 520.62 Aminopentamide hydrogen sulphate 520.447 Clindamycin solution. tablets. 520.452 Clenbuterol syrup. 520.82 Aminopropazine fumarate oral dosage 520.455 Clomipramine tablets. forms. 520.462 Clorsulon drench. 520.82a Aminopropazine fumarate tablets. 520.522 Cyclosporine. 520.82b Aminopropazine fumarate, neomy- 520.530 Cythioate oral liquid. cin sulfate tablets. 520.531 Cythioate tablets. 520.88 Amoxicillin oral dosage forms. 520.534 Decoquinate. 520.88a Amoxicillin trihydrate film-coated 520.538 Deracoxib. tablets. 520.540 oral dosage forms. 520.88b Amoxicillin trihydrate for oral sus- 520.540a Dexamethasone powder. pension. 520.540b Dexamethasone tablets and 520.88c Amoxicillin trihydrate oral suspen- boluses. sion. 520.540c Dexamethasone chewable tablets. 520.88d Amoxicillin trihydrate soluble pow- 520.550 Glucose/glycine/electrolyte. der. 520.563 meglumine and dia- 520.88e Amoxicillin trihydrate boluses. trizoate sodium oral solution. 520.88f Amoxicillin trihydrate tablets. 520.580 Dichlorophene and toluene. 520.88g Amoxicillin trihydrate and 520.581 Dichlorophene tablets. clavulanate potassium film-coated tab- 520.600 . lets. 520.606 .

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520.608 sodium monohydrate 520.1196 and pamoate capsules. chewable tablets. 520.620 oral dosage 520.1197 Ivermectin sustained-release bolus. forms. 520.1198 Ivermectin and paste. 520.622 Diethylcarbamazine citrate oral dos- 520.1199 Ivermectin, pyrantel, and age forms. praziquantel tablets. 520.622a Diethylcarbamazine citrate tablets. 520.1200 Ivermectin, fenbendazole, and 520.622b Diethylcarbamazine citrate syrup. praziquantel tablets. 520.622c Diethylcarbamazine citrate chew- 520.1204 Kanamycin, bismuth subcarbonate, able tablets. activated attapulgite. 520.623 Diethylcarbamazine citrate, 520.1242 . chewable tablets. 520.1242a Levamisole powder. 520.645 Difloxacin. 520.1242b Levamisole hydrochloride tablet 520.666 Dirlotapide. or oblet (bolus). 520.763 oral dosage 520.1242c Levamisole hydrochloride and pi- forms. perazine dihydrochloride. 520.763a Dithiazanine iodide tablets. 520.1242d Levamisole resinate. 520.763b Dithiazanine iodide powder. 520.1242e Levamisole hydrochloride effer- 520.763c Dithiazanine iodide and vescent tablets. citrate suspension. 520.1242f Levamisole hydrochloride gel. 520.766 Domperidone. 520.1242g Levamisole resinate and famphur 520.784 Doxylamine succinate tablets. paste. 520.804 Enalapril tablets. 520.1263 Lincomycin. 520.812 Enrofloxacin. 520.1263a Lincomycin hydrochloride 520.816 tablets. monohydrate tablets and sirup. 520.823 phosphate. 520.1263b [Reserved] 520.852 Estriol. 520.1263c Lincomycin powder. 520.863 Ethylisobutrazine hydrochloride 520.1265 Lincomycin and spectinomycin tablets. powder. 520.870 Etodolac. 520.1284 Sodium liothyronine tablets. 520.903 Febantel oral dosage forms. 520.1288 Lufenuron tablets. 520.903a Febantel paste. 520.1289 Lufenuron suspension. 520.903b Febantel suspension. 520.1310 Marbofloxacin tablets. 520.903c [Reserved] 520.1315 Maropitant. 520.903d Febantel-praziquantel paste. 520.1320 oral. 520.903e Febantel tablets. 520.1326 Mebendazole and trichlorfon oral 520.905 Fenbendazole oral dosage forms. dosage forms. 520.905a Fenbendazole suspension. 520.1326a Mebendazole and trichlorfon pow- 520.905b Fenbendazole granules. der. 520.905c Fenbendazole paste. 520.1326b Mebendazole and trichlorfon paste. 520.905d Fenbendazole powder. 520.1330 Meclofenamic acid granules. 520.905e Fenbendazole blocks. 520.1331 Meclofenamic acid tablets. 520.928 Firocoxib tablets. 520.1341 Megestrol acetate tablets. 520.930 Firocoxib paste. 520.1367 Meloxicam. 520.955 Florfenicol. 520.1372 Methimazole. 520.960 Flumethasone tablets. 520.1380 Methocarbamol tablets. 520.970 Flunixin. 520.1408 tablets. 520.980 Fluoxetine. 520.1409 Methylprednisolone, aspirin tab- 520.1010 Furosemide. lets. 520.1044 Gentamicin sulfate oral dosage 520.1422 Metoserpate hydrochloride. forms. 520.1430 Mibolerone. 520.1044a Gentamicin sulfate oral solution. 520.1441 oxime. 520.1044b Gentamicin sulfate pig pump oral 520.1443 and lufenuron. solution. 520.1445 Milbemycin oxime and 520.1044c Gentamicin sulfate powder. praziquantel. 520.1100 . 520.1447 Milbemycin oxime, lufenuron, and 520.1120 Haloxon oral dosage forms. praziquantel tablets. 520.1120a Haloxon drench. 520.1450 tartrate oral dosage 520.1120b Haloxon boluses. forms. 520.1130 . 520.1450a Morantel tartrate bolus. 520.1157 Iodinated casein tablets. 520.1450b Morantel tartrate cartridge. 520.1158 Iodochlorhydroxyquin boluses. 520.1450c Morantel tartrate sustained-re- 520.1182 Iron dextran suspension. lease trilaminate cylinder/sheet. 520.1192 Ivermectin paste. 520.1451 tablets. 520.1193 Ivermectin tablets and chewables. 520.1452 Moxidectin gel. 520.1194 Ivermectin meal. 520.1453 Moxidectin and praziquantel gel. 520.1195 Ivermectin liquid. 520.1454 Moxidectin solution.

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520.1468 Naproxen granules. 520.2002 Propiopromazine hydrochloride. 520.1484 Neomycin. 520.2041 Pyrantel pamoate chewable tablets. 520.1510 Nitenpyram tablets. 520.2042 Pyrantel pamoate tablets. 520.1604 Oclacitinib. 520.2043 Pyrantel pamoate suspension. 520.1615 . 520.2044 Pyrantel pamoate paste. 520.1616 Orbifloxacin tablets.. 520.2045 Pyrantel tartrate powder; pyrantel 520.1618 Orbifloxacin suspension. tartrate pellets. 520.1628 powder and pellets. 520.2075 Robenacoxib. 520.1629 Oxfendazole paste. 520.2098 Selegiline hydrochloride tablets. 520.1630 Oxfendazole suspension. 520.2100 Selenium, vitamin E capsules. 520.1631 Oxfendazole and trichlorfon paste. 520.2123 Spectinomycin oral dosage forms. 520.1638 Oxibendazole paste. 520.2123a Spectinomycin tablets. 520.1640 Oxibendazole suspension. 520.2123b Spectinomycin powder. 520.1660 Oxytetracycline. 520.2123c Spectinomycin solution. 520.1660a Oxytetracycline and carbomycin 520.2130 Spinosad. in combination. 520.2134 Spinosad and milbemycin. 520.1660b Oxytetracycline hydrochloride 520.2150 Stanozolol oral dosage forms. capsules. 520.2150a Stanozolol tablets. 520.1660c Oxytetracycline hydrochloride 520.2150b Stanozolol chewable tablets. tablets/boluses. 520.2158 Streptomycin/dihydrostreptomycin 520.1660d Oxytetracycline powder. oral dosage forms. 520.1696 Penicillin. 520.2158a Streptomycin sulfate oral solu- 520.1696a [Reserved] tion. 520.1696b Penicillin G powder. 520.2158b Dihydrostreptomycin tablets. 520.1696c Penicillin V powder. 520.2158c Dihydrostreptomycin oral suspen- 520.1696d Penicillin V tablets. sion. 520.1705 Pergolide. 520.2160 Styrylpyridinium, 520.1720 Phenylbutazone oral dosage forms. diethylcarbamazine oral dosage forms. 520.1720a Phenylbutazone tablets and 520.2170 Sulfabromomethazine sodium boluses. boluses. 520.1720b Phenylbutazone granules. 520.2184 Sodium sulfachloropyrazine 520.1720c Phenylbutazone paste. monohydrate. 520.1720d Phenylbutazone gel. 520.2200 Sulfachlorpyridazine. 520.1720e Phenylbutazone powder. 520.2215 Sulfadiazine/pyrimethamine sus- 520.1760 Phenylpropanolamine. pension. 520.1780 Pimobendan. 520.2218 Sulfamerazine, sulfamethazine, and 520.1802 Piperazine-carbon disulfide complex sulfaquinoxaline powder. oral dosage forms. 520.2220 Sulfadimethoxine oral dosage 520.1802a Piperazine-carbon disulfide com- forms. plex suspension. 520.2220a Sulfadimethoxine oral solution 520.1802b Piperazine-carbon disulfide com- and soluble powder. plex boluses. 520.2220b Sulfadimethoxine tablets and 520.1802c Piperazine-carbon disulfide com- boluses. plex with phenothiazine suspension. 520.2220c Sulfadimethoxine oral suspension. 520.1803 Piperazine citrate capsules. 520.2220d Sulfadimethoxine-ormetoprim 520.1804 Piperazine phosphate capsules. tablets. 520.1805 Piperazine phosphate with thenium 520.2240 Sulfaethoxypyridazine. closylate tablets. 520.2240a Sulfaethoxypyridazine drinking 520.1806 Piperazine suspension. water. 520.1807 Piperazine. 520.2240b Sulfaethoxypyridazine tablets. 520.1840 Poloxalene. 520.2260 Sulfamethazine oral dosage forms. 520.1846 Polyoxyethylene (23) lauryl ether 520.2260a Sulfamethazine oblet, tablet, and blocks. bolus. 520.1855 Ponazuril. 520.2260b Sulfamethazine sustained-release 520.1860 Pradofloxacin. boluses. 520.1870 Praziquantel tablets. 520.2260c Sulfamethazine sustained-release 520.1871 Praziquantel and pyrantel. tablets. 520.1872 Praziquantel, pyrantel pamoate, 520.2261 Sulfamethazine sodium oral dosage and febantel tablets. forms. 520.1880 tablets. 520.2261a Sulfamethazine solution. 520.1900 Primidone tablets. 520.2261b Sulfamethazine powder. 520.1920 Prochlorperazine, isopropamide sus- 520.2280 Sulfamethizole and methenamine tained release capsules. mandelate tablets. 520.1921 Prochlorperazine, isopropamide, 520.2325 Sulfaquinoxaline oral dosage forms. with neomycin sustained-release cap- 520.2325a Sulfaquinoxaline drinking water. sules. 520.2325b Sulfaquinoxaline drench. 520.1962 Promazine hydrochloride. 520.2330 Sulfisoxazole tablets.

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520.2340 Tepoxalin. § 520.23 Acepromazine. 520.2345 . 520.2345a Tetracycline hydrochloride cap- (a) Specifications. Each tablet con- sules. tains 5, 10, or 25 milligrams (mg) 520.2345b Tetracycline tablets. acepromazine maleate. 520.2345c Tetracycline boluses. (b) Sponsors. See No. 000010 in 520.2345d Tetracycline powder. § 510.600(c) of this chapter. 520.2345e Tetracycline oral liquid. (c) Conditions of use(1) Dogs—(i) 520.2345f Tetracycline phosphate complex Amount. 0.25 to 1.0 mg per pound (/lb) and sodium novobiocin capsules. body weight orally. 520.2345g Tetracycline hydrochloride and so- (ii) Indications for use. As an aid in dium novobiocin tablets. tranquilization and as a preanesthetic 520.2345h Tetracycline hydrochloride, so- agent. dium novobiocin, and prednisolone tab- lets. (iii) Limitations. Federal law restricts 520.2362 Thenium closylate tablets. this drug to use by or on the order of a 520.2380 Thiabendazole oral dosage forms. licensed veterinarian. 520.2380a Thiabendazole top dressing and (2) Cats—(i) Amount. 0.5 to 1.0 mg/lb mineral protein block. body weight orally. 520.2380b Thiabendazole drench or oral (ii) Indications for use. As a tranquil- paste. izer. 520.2380c Thiabendazole bolus. (iii) Limitations. Federal law restricts 520.2380d Thiabendazole, piperazine citrate this drug to use by or on the order of a suspension. licensed veterinarian. 520.2380e Thiabendazole with trichlorfon. 520.2380f Thiabendazole, piperazine phos- [75 FR 10165, Mar. 5, 2010] phate powder. 520.2455 Tiamulin. § 520.28 Acetazolamide sodium soluble 520.2471 Tilmicosin. powder. 520.2473 Tioxidazole oral dosage forms. (a) Specifications. The drug is in a 520.2473a Tioxidazole granules. powder form containing acetazolamide 520.2473b Tioxidazole paste. sodium, USP equivalent to 25 percent 520.2475 Toceranib. 520.2481 Triamcinolone acetonide tablets. acetazolamide activity. 520.2482 Triamcinolone acetonide oral pow- (b) Sponsor. See No. 053501 in der. § 510.600(c) of this chapter. 520.2483 Triamcinolone. (c) Conditions of use. (1) It is used in 520.2520 Trichlorfon oral dosage forms. dogs as an aid in the treatment of mild 520.2520b Trichlorfon and atropine. congestive heart failure and for rapid 520.2520e Trichlorofon boluses. reduction of intraocular pressure.1 520.2520f Trichlorofon granules. (2) It is administered orally at a dos- 520.2520g Trichlorfon, phenothiazine, and pi- age level of 5 to 15 milligrams per perazine dihydrochloride powder. pound of body weight daily.1 520.2582 Triflupromazine hydrochloride tab- (3) For use only by or on the order of lets. 1 520.2598 Trilostane. a licensed veterinarian. 520.2604 Trimeprazine tartrate and prednis- [40 FR 13838, Mar. 27, 1975, as amended at 67 olone tablets. FR 78355, Dec. 24, 2002. Redesignated at 78 FR 520.2605 Trimeprazine tartrate and prednis- 66264, Nov. 5, 2013] olone capsules. 520.2610 Trimethoprim and sulfadiazine tab- § 520.38 Albendazole oral dosage lets. forms. 520.2611 Trimethoprim and sulfadiazine paste. § 520.38a Albendazole suspension. 520.2612 Trimethoprim and sulfadiazine sus- (a) Specifications. Each milliliter of pension. 520.2613 Trimethoprim and sulfadiazine suspension contains 45.5 milligrams powder. 520.2640 Tylosin. 1 These conditions are NAS/NRC reviewed 520.2645 Tylvalosin. and deemed effective. Applications for these uses need not include effectiveness data as AUTHORITY: 21 U.S.C. 360b. specified by § 514.111 of this chapter, but may SOURCE: 40 FR 13838, Mar. 27, 1975, unless require bioequivalency and safety informa- otherwise noted. tion.

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(mg) (4.55 percent) or 113.6 mg (11.36 adult and fourth stage larvae of intes- percent) albendazole. tinal worms (thread-necked intestinal (b) Sponsor. See No. 000069 in § 510.600 worm (Nematodirus spathiger and N. of this chapter. filicollis), Cooper’s worm (Cooperia (c) Related tolerances. See § 556.34 of oncophora), bankrupt worm this chapter. (Trichostrongylus colubriformis), nodular (d) Special considerations. See § 500.25 worm (Oesophagostomum columbianum), of this chapter. and large-mouth bowel worm (Chabertia (e) Conditions of use(1) Cattle. Admin- ovina)); adult and larval stages of ister 11.36 percent suspension: ( filaria). (i) Amount. 4.54 mg/pound (lb) body (iii) Limitations. Do not slaughter weight (10 mg/kilogram (kg)) as a sin- within 7 days of last treatment. Do not gle oral dose using dosing gun or dos- administer to ewes during first 30 days ing syringe. of pregnancy or for 30 days after re- (ii) Indications for use. For removal moval of rams. and control of adult liver flukes (3) Goats. Administer 11.36 percent (Fasciola hepatica); heads and segments suspension: of tapeworms (Moniezia benedeni and M. (i) Amount. 4.54 mg/lb body weight (10 expansa); adult and 4th stage larvae of mg/kg) as a single oral dose using dos- stomach worms (brown stomach worms ing gun or dosing syringe. including 4th stage inhibited larvae (ii) Indications for use. For the treat- (Ostertagia ostertagi), barberpole worm ment of adult liver flukes (Fasciola he- (Haemonchus contortus and H. placei), patica) in nonlactating goats. small stomach worm (Trichostrongylus (iii) Limitations. Do not slaughter axei)); adult and 4th stage larvae of in- within 7 days of last treatment. Do not testinal worms (thread-necked intes- administer to does during the first 30 tinal worm (Nematodirus spathiger and days of pregnancy or for 30 days after N. helvetianus), small intestinal worm removal of bucks. (Cooperia punctata and C. oncophora)); [73 FR 11027, Feb. 29, 2008. Redesignated at 78 adult stages of intestinal worms FR 66264, Nov. 5, 2013] (hookworm (Bunostomum phlebotomum), bankrupt worm (Trichostrongylus § 520.38b Albendazole paste. colubriformis), nodular worm (a) Specifications. The product con- (Oesophagostomum radiatum)); adult and tains 30 percent albendazole. 4th stage larvae of lungworms (b) Sponsor. See No. 000069 in (Dictyocaulus viviparus). § 510.600(c) of this chapter. (iii) Limitations. Do not slaughter (c) Related tolerances. See § 556.34 of within 27 days of last treatment. Do this chapter. not use in female dairy cattle of breed- (d) Conditions of use in cattle(1) ing age: Do not administer to female Amount. Equivalent to 4.54 milligrams cattle during first 45 days of pregnancy per 1 pound of body weight (10 milli- or for 45 days after removal of bulls. grams per kilogram). (2) Sheep. Administer 4.45 or 11.36 per- (2) Indications for use. For removal cent suspension: and control of the following internal (i) Amount. 3.4 mg/lb body weight (7.5 parasites of cattle: adult liver flukes mg/kg) as a single oral dose using dos- (Fasciola hepatica); heads and segments ing gun or dosing syringe. of tapeworms (Moniezia benedeni, M. (ii) Indications for use. For removal expansa); adult and 4th stage larvae of and control of adult liver flukes stomach worms (brown stomach worms (Fasciola hepatica and Fascioloides including 4th stage inhibited larvae magna); heads and segments of common (Ostertagia ostertagi); barberpole worm tapeworms (Moniezia expansa) and (Haemonchus contortus, H. placei); small fringed tapeworm (Thysanosoma stomach worm (Trichostrongylus axei)); actinioides); adult and fourth stage lar- adult and 4th stages larvae of intes- vae of stomach worms (brown stomach tinal worms (thread-necked intestinal worm (Ostertagia circumcinta and worm (Nematodirus spathiger, N. Marshallagia marshalli), barberpole helvetianus); small intestinal worm worm (Haemonchus contortus), small (Cooperia punctata and C. oncophora)); stomach worm (Trichostrongylus axei)); adult stages of intestinal worms

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(hookworm (Bunostomum phlebotmum); weight (0.044 mg/kg) daily for 15 con- bankrupt worm (Trichostrongylus secutive days. colubriformis), nodular worm (ii) Indications for use. For suppres- (Oesophagostomum radiatum)); adult and sion of estrus in mares. 4th stage larvae of lungworms (iii) Limitations. Do not use in horses (Dictyocaulus viviparus). intended for human consumption. Fed- (3) Limitations. Administer as a single eral law restricts this drug to use by or oral dose. Do not slaughter within 27 on the order of a licensed veterinarian. days of last treatment. Do not use in (2) Swine—(i) Amount. Administer 6.8 female dairy cattle of breeding age. Do mL (15 mg altrenogest) per gilt once not administer to female cattle during daily for 14 consecutive days by top- first 45 days of pregnancy or for 45 days dressing on a portion of each gilt’s after removal of bulls. Consult your daily feed. veterinarian for assistance in the diag- nosis, treatment, and control of para- (ii) Indications for use. For synchroni- sitism. zation of estrus in sexually mature gilts that have had at least one estrous [54 FR 51385, Dec. 15, 1989, as amended at 56 cycle. FR 50653, Oct. 8, 1991; 60 FR 55658, Nov. 2, (iii) Limitations. Do not use in gilts 1995. Redesignated at 78 FR 66264, Nov. 5, 2013.] having a previous or current history of uterine inflammation (i.e., acute, § 520.43 Afoxolaner. subacute or chronic endometritis). (a) Specifications. Each chewable tab- Gilts must not be slaughtered for let contains 11.3, 28.3, 68, or 136 milli- human consumption for 21 days after grams (mg) afoxolaner. the last treatment. (b) Sponsor. See No. 050604 in [66 FR 47960, Sept. 17, 2001, as amended at 68 § 510.600(c) of this chapter. FR 62006, Oct. 31, 2003; 72 FR 9455, Feb. 21, (c) Conditions of use(1) Amount. Ad- 2008; 74 FR 61516, Nov. 25, 2009; 77 FR 32012, minister orally once a month at a min- May 31, 2012] imum dosage of 1.14 mg/pound (lb) (2.5 mg/kilogram (kg)). § 520.62 Aminopentamide hydrogen (2) Indications for use. For the treat- sulphate tablets. ment and prevention of flea infesta- (a) Chemical name. 4- tions (Ctenocephalides felis), and the (Dimethylamino)-2,2- treatment and control of American diphenylvaleramide hydrogen sulfate. tick (Dermacentor variabilis) infesta- (b) Specifications. Each tablet con- tions in dogs and puppies 8 weeks of tains 0.2 milligram of the drug. age and older, weighing 4 pounds of (c) Sponsor. See No. 000856 in body weight or greater, for 1 month. § 510.600(c) of this chapter. (3) Limitations. Federal law restricts this drug to use by or on the order of a (d) Conditions of use. (1) It is intended licensed veterinarian. for use in dogs and cats only for the treatment of vomiting and/or diarrhea, [78 FR 66264, Nov. 5, 2013] nausea, acute abdominal visceral spasm, pylorospasm, or hypertrophic § 520.48 Altrenogest. gastritis. (a) Specifications. Each milliliter (mL) of solution contains 2.2 milli- NOTE: Not for use in animals with glau- grams (mg) altrenogest. coma because of the occurrence of mydriasis. (b) Sponsors. See sponsor listings in (2) Dosage is administered by oral § 510.600(c) of this chapter: tablet every 8 to 12 hours, as follows: (1) No. 000061 for use as in paragraph (d) of this section. Weight of animal in pounds Dosage in (2) No. 013744 for use as in paragraph milligrams (d)(1) of this section. Up to 10 ...... 0.1 (c) Tolerances. See § 556.36 of this 11 to 20 ...... 0.2 chapter. 21 to 50 ...... 0.3 (d) Conditions of use—(1) Horses—(i) 51 to 100 ...... 0.4 Amount. 1.0 mL per 110 pounds body Over 100 ...... 0.5

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Dosage may be gradually increased up (2) It is administered at a dosage to a maximum of five times the sug- level of one to two tablets per 10 gested dosage. Oral administration of pounds of body weight twice daily for 3 tablets may be preceded by subcuta- days.1 neous or intramuscular use of the (3) Federal law restricts this drug to injectable form of the drug. use by or on the order of a licensed vet- (3) For use only by or on the order of erinarian.1 a licensed veterinarian. [40 FR 13838, Mar. 27, 1975, as amended at 46 [40 FR 13838, Mar. 27, 1975, as amended at 53 FR 48642, Oct. 2, 1981; 61 FR 8873, Mar. 6, 1996; FR 27851, July 25, 1988] 62 FR 61624, Nov. 19, 1997]

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

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and wounds) due to S. aureus, Strepto- spp.; gastrointestinal tract due to E. coccus spp., E. coli, and Pasteurella coli, Proteus spp., Staphylococcus spp., multocida. and Streptococcus spp.; skin and soft tis- (iii) Limitations. Administer for 5 to 7 sue (abscesses, lacerations, and days or 48 hours after all symptoms wounds) due to Staphylococcus spp., have subsided. If no improvement is Streptococcus spp., E. coli, and seen in 5 days, review diagnosis and Pasteurella multocida. change therapy. Federal law restricts (C) Limitations. Use for 5 to 7 days or this drug to use by or on the order of a 48 hours after all symptoms have sub- licensed veterinarian. sided. Federal law restricts this drug to [57 FR 37319, Aug. 18, 1992, as amended at 60 use by or on the order of a licensed vet- FR 55658, Nov. 2, 1995] erinarian. (2) [Reserved] § 520.88b Amoxicillin trihydrate for (c) Sponsors. See Nos. 000856 and oral suspension. 051311 in § 510.600(c) of this chapter. (a) Specifications. When reconstituted, (1) Conditions of use. Dogs—(i) Amount. each milliliter contains amoxicillin 5 milligrams per pound of body weight trihydrate equivalent to 50 milligrams twice daily. of amoxicillin. (ii) Indications for use. Treatment of (b) Sponsor. See No. 000069 in bacterial dermatitis due to S. aureus, § 510.600(c) of this chapter. Streptococcus spp., Staphylococcus spp., (1) Conditions of use—(i) Dogs—(A) and E. coli, and soft tissue infections Amount. 5 milligrams per pound of body (abscesses, wounds, lacerations) due to weight twice daily. S. aureus, Streptococcus spp., E. coli, P. (B) Indications for use. Treatment of mirabilis and Staphylococcus spp. infections caused by susceptible strains (iii) Limitations. Use for 5 to 7 days. of organisms as follows: respiratory Continue for 48 hours after all symp- tract (tonsillitis, tracheobronchitis) toms have subsided. If no improvement caused by Staphylococcus aureus, Strep- is seen in 5 days, review diagnosis and tococcus spp., Escherichia coli, and Pro- change therapy. Federal law restricts teus mirabilis; genitourinary tract (cys- this drug to use by or on the order of a titis) caused by S. aureus, Streptococcus licensed veterinarian. spp., E. coli, and P. mirabilis; gastro- (2) [Reserved] intestinal tract (bacterial gastroenteritis) caused by S. aureus, [57 FR 37319, Aug. 18, 1992; 57 FR 42623, Sept. Streptococcus spp., E. coli, and P. 15, 1992, as amended at 60 FR 55658, Nov. 2, mirabilis; bacterial dermatitis caused 1995; 62 FR 13302, Mar. 20, 1997; 67 FR 67521, by S. aureus, Streptococcus spp., and P. Nov. 6, 2002; 68 FR 54658, Sept. 18, 2003; 68 FR 55824, Sept. 29, 2003] mirabilis; and soft tissues (abscesses, lacerations, and wounds) caused by S. § 520.88c Amoxicillin trihydrate oral aureus, Streptococcus spp., E. coli, and P. suspension. mirabilis. (C) Limitations. Use for 5 to 7 days or (a) Specifications. Each 0.8-milliliter 48 hours after all symptoms have sub- dose contains amoxicillin trihydrate sided. Federal law restricts this drug to equivalent to 40 milligrams of use by or on the order of a licensed vet- amoxicillin. erinarian. (b) Sponsor. See No. 000069 in (ii) Cats—(A) Amount. 50 milligrams § 510.600(c) of this chapter. (5 to 10 milligrams per pound) once (c) Related tolerances. See § 556.510 of daily. this chapter. (B) Indications for use. Treatment of (d) Conditions of use. Swine(1) Amount. infections caused by susceptible strains 40 milligrams orally, twice a day using of organisms as follows: upper res- a dosing pump. piratory tract due to Staphylococcus (2) Indications for use. Treatment of spp., Streptococcus spp., Hemophilus baby pigs under 10 pounds for porcine spp., E. coli, Pasteurella spp., and P. colibacillosis caused by Escherichia coli mirabilis; genitourinary tract (cystitis) susceptible to amoxicillin. due to S. aureus, Streptococcus spp., E. (3) Limitations. Treat animals for 48 coli, P. mirabilis, and Corynebacterium hours after all symptoms have subsided

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but not beyond 5 days. Do not slaugh- tible Escherichia coli in preruminating ter during treatment or for 15 days calves including veal calves. after latest treatment. Federal law re- (3) Limitations. For oral use in stricts this drug to use by or on the preruminating calves including veal order of a licensed veterinarian. calves only, not for use in other ani- [57 FR 37319, Aug. 18, 1992, as amended at 60 mals which are raised for food produc- FR 55658, Nov. 2, 1995] tion. Treatment should be continued for 48 hours after all symptoms have § 520.88d Amoxicillin trihydrate solu- subsided but not to exceed 5 days. Do ble powder. not slaughter animals during treat- (a) Specifications. Each gram contains ment or for 20 days after the latest amoxicillin trihydrate equivalent to treatment. Federal law restricts this 115.4 milligrams of amoxicillin. drug to use by or on the order of a li- (b) Sponsor. See No. 000069 in censed veterinarian. § 510.600(c) of this chapter. [57 FR 37320, Aug. 18, 1992, as amended at 60 (c) Related tolerances. See § 556.38 of FR 55659, Nov. 2, 1995; 62 FR 5526, Feb. 6, 1997] this chapter. (d) Conditions of use. Preruminating § 520.88f Amoxicillin trihydrate tab- calves including veal calves—(1) Amount. lets. 400 milligrams per 100 pounds of body (a) Specifications. Each tablet con- weight twice daily. tains amoxicillin trihydrate equivalent (2) Indications for use. Treatment of to 50, 100, 200, or 400 milligrams of bacterial enteritis when due to suscep- amoxicillin. tible Escherichia coli in preruminating (b) Sponsors. See Nos. 000856 and calves including veal calves. 051311 in § 510.600(c) of this chapter. (3) Limitations. Administer by drench (c) Conditions of use—(1) Dogs—(i) or by mixing in milk. Treatment should be continued for 48 hours after Amount. 5 milligrams per pound of body all symptoms have subsided but not to weight twice a day. exceed 5 days. For use in (ii) Indications for use. Treatment of preruminating calves including veal bacterial dermatitis due to Staphy- calves only, not for use in other ani- lococcus aureus, Streptococcus spp., mals which are raised for food produc- Staphylococcus spp., and Escherichia tion. Do not slaughter animals during coli; and soft tissue infections (ab- treatment or for 20 days after the lat- scesses, wounds, lacerations) due to S. est treatment. Federal law restricts aureus, Streptococcus spp., E. coli, Pro- this drug to use by or on the order of a teus mirabilis, and Staphylococcus spp. licensed veterinarian. (iii) Limitations. Use for 5 to 7 days or 48 hours after all symptoms have sub- [57 FR 37319, Aug. 18, 1992; 57 FR 42623, Sept. sided. If no improvement is seen in 5 15, 1992; 58 FR 18304, Apr. 8, 1993, as amended at 60 FR 55658, Nov. 2, 1995; 62 FR 5525, Feb. days, review diagnosis and change ther- 6, 1997] apy. Federal law restricts this drug to use by or on the order of a licensed vet- § 520.88e Amoxicillin trihydrate erinarian. boluses. (2) [Reserved] (a) Specifications. Each bolus contains [57 FR 37320, Aug. 18, 1992, as amended at 62 the equivalent of 400 milligrams of FR 13302, Mar. 20, 1997; 67 FR 67521, Nov. 6, amoxicillin. 2002; 68 FR 54658, Sept. 18, 2003; 68 FR 55824, (b) Sponsor. See No. 000069 in Sept. 29, 2003] § 510.600(c) of this chapter. (c) Related tolerances. See § 556.38 of § 520.88g Amoxicillin trihydrate and this chapter. clavulanate potassium film-coated (d) Conditions of use. Preruminating tablets. calves including veal calves(1) Amount. (a) Specifications. Each tablet con- 400 milligrams per 100 pounds of body tains amoxicillin trihydrate and weight twice daily. clavulanate potassium, equivalent to (2) Indications for use. Treatment of either 50 milligrams of amoxicillin and bacterial enteritis when due to suscep- 12.5 milligrams clavulanic acid, or 100

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milligrams of amoxicillin and 25 milli- tinued and diagnosis reevaluated. Uri- grams clavulanic acid, or 200 milli- nary tract infections may require grams amoxicillin and 50 milligrams treatment for 10 to 14 days or longer. clavulanic acid or 300 milligrams The maximum duration of treatment amoxicillin and 75 milligrams should not exceed 30 days. Safety of use clavulanic acid. in pregnant or breeding animals has (b) Sponsor. See No. 000069 in not been established. Federal law re- § 510.600(c) of this chapter. stricts this drug to use by or on the (c) Conditions of use(1) Dogs—(i) order of a licensed veterinarian. Amount. 6.25 milligrams (equivalent to [57 FR 37320, Aug. 18, 1992, as amended at 60 5 milligrams amoxicillin and 1.25 milli- FR 55659, Nov. 2, 1995; 63 FR 13121, Mar. 18, grams clavulanic acid) per pound of 1998] body weight twice daily. (ii) Indications for use. Treatment of § 520.88h Amoxicillin trihydrate and skin and soft tissue infections such as clavulanate potassium for oral sus- wounds, abscesses, cellulitis, super- pension. ficial/juvenile and deep pyoderma due (a) Specifications. When reconstituted, to susceptible strains of beta- each milliliter contains amoxicillin lactamase (penicillinase) Staphy- trihydrate equivalent to 50 milligrams lococcus aureus, nonbeta-lactamase S. of amoxicillin with clavulanate potas- aureus, Staphylococcus spp., Strepto- sium equivalent to 12.5 milligrams of coccus spp., and Escherichia coli. Treat- clavulanic acid. ment of periodontal infections due to (b) Sponsor. See No. 000069 in susceptible strains of aerobic and an- § 510.600(c) of this chapter. aerobic bacteria. (c) Conditions of use(1) Dogs—(i) (iii) Limitations. Wounds, abscesses, Amount. 6.25 milligrams (equivalent to cellulitis, and superficial/juvenile 5 milligrams amoxicillin and 1.25 milli- pyoderma: Treat for 5 to 7 days or for grams clavulanic acid) per pound of 48 hours after all signs have subsided. body weight twice daily. If no improvement is seen after 5 days (ii) Indications for use. Treatment of of treatment, discontinue therapy and skin and soft tissue infections such as reevaluate diagnosis. Deep pyoderma wounds, abscesses, cellulitis, super- may require treatment for 21 days; do ficial/juvenile and deep pyoderma due not treat for more than 30 days. Not for to susceptible strains of beta- use in dogs maintained for breeding. lactamase (penicillinase) producing Federal law restricts this drug to use Staphylococcus aureus, nonbeta- by or on the order of a licensed veteri- lactamase Staphylococcus aureus, Staph- narian. ylococcus spp., Streptococcus spp., and (2) Cats—(i) Amount. 62.5 milligrams Escherichia coli. Treatment of peri- (1 milliliter) (50 milligrams amoxicillin odontal infections due to susceptible and 12.5 milligrams clavulanic acid) strains of aerobic and anaerobic bac- twice daily. teria. (ii) Indications for use. Treatment of (iii) Limitations. Administer for 5 to 7 skin and soft tissue infections, such as days or 48 hours after all symptoms wounds, abscesses and cellulitis/derma- subsided. Deep pyoderma may require titis due to susceptible strains of beta- 21 days, not to exceed 30 days. If no im- lactamase (penicillinase) producing S. provement is seen in 5 days, dis- aureus, nonbeta-lactamase producing S. continue therapy and reevaluate the aureus, Staphylococcus spp., Strepto- case. Not for use in dogs maintained coccus spp., E. coli, and Pasteurella spp. for breeding. Federal law restricts this Also, treatment of urinary tract infec- drug to use by or on the order of a li- tions (cystitis) due to susceptible censed veterinarian. strains of E. coli. (2) Cats—(i) Amount. 62.5 milligrams (iii) Limitations. Skin and soft tissue (1 milliliter) (50 milligrams of infections: abscesses, cellulitis/derma- amoxicillin and 12.5 milligrams titis should be treated for 5 to 7 days or clavulanic acid) twice daily. for 48 hours after all signs have sub- (ii) Indications for use. Treatment of sided. If no response is seen after 3 days feline skin and soft tissue infections, of treatment, therapy should be discon- such as wounds, abscesses and

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cellulitis/dermatitis due to susceptible this drug to use by or on the order of a strains of beta-lactamase (penicil- licensed veterinarian. linase) producing S. aureus, nonbeta- (2) Cats—(i) Amount. 125 milligrams lactamase S. aureus, Staphylococcus twice daily; in more acute conditions spp., Streptococcus spp., E. coli, three times daily. Pasteurella multocida, and Pasteurella (ii) Indications for use. Treatment of spp. respiratory tract infections (bacterial (iii) Limitations. Administer 48 hours pneumonia) due to alpha and beta he- after all symptoms have subsided. If no molytic streptococci, hemolytic posi- improvement is seen after 3 days of tive staphylococci, E. coli, and Proteus treatment, discontinue therapy and re- spp. In infections associated with ab- evaluate diagnosis. Maximum duration scesses, lacerations, and wounds due to of treatment should not exceed 30 days. Staphylococcus spp. and Streptococcus Not for use in cats maintained for spp. breeding. Federal law restricts this (iii) Limitations. Bacteriologic studies drug to use by or on the order of a li- to determine the causative organisms censed veterinarian. and their susceptibility to ampicillin should be performed. Use of the drug is [57 FR 37320, Aug. 18, 1992, as amended at 60 contraindicated in animals with a his- FR 55659, Nov. 2, 1995; 63 FR 13121, Mar. 18, tory of an allergic reaction to any of 1998] the penicillins. Ampicillin is contra- § 520.90 Ampicillin oral dosage forms. indicated in infections caused by peni- cillinase-producing organisms. Not for § 520.90a Ampicillin capsules. use in animals which are raised for (a) Specifications. Each capsule con- food production. Federal law restricts tains 125 milligrams or 250 milligrams this drug to use by or on the order of a of ampicillin. licensed veterinarian. (b) Sponsor. See No. 000008 in [57 FR 37321, Aug. 18, 1992] § 510.600(c) of this chapter. (c) Conditions of use(1) Dogs—(i) § 520.90b Ampicillin trihydrate tablets. Amount. 5 to 10 milligrams per pound of (a) Specifications. Each tablet con- body weight, e.g., one 125 mg capsule tains ampicillin trihydrate equivalent per 14 to 25 pounds, given 2 to 4 times to 50 or 100 milligrams of ampicillin. daily; for animals weighing 6 to 14 (b) Sponsor. See No. 000069 in pounds, one capsule twice daily. § 510.600(c) of this chapter. (ii) Indications for use. Treatment of (c) Conditions of use. Dogs(1) Amount. 5 urinary tract infections (cystitis) due milligrams per pound of body weight, to Proteus spp., hemolytic and non- at 8-hour intervals, 1 to 2 hours prior to hemolytic streptococci, beta hemolytic feeding, to be continued 36 to 48 hours streptococci, and Escherichia coli. In after all symptoms have subsided. If no upper respiratory tract infections improvement is seen within 5 days, tracheobronchitis (kennel cough), ton- stop treatment, reevaluate diagnosis, sillitis due to alpha and beta hemolytic and change therapy. streptococci, hemolytic positive (2) Indications for use. Oral treatment staphylococci, E. coli, and Proteus spp. of infections caused by susceptible or- In infections associated with abscesses, ganisms as follows: Upper respiratory lacerations, and wounds due to Staphy- infections, tonsillitis, and bronchitis lococcus spp. and Streptococcus spp. due to Streptococcus spp., Staphylococcus (iii) Limitations. Bacteriologic studies spp., Escherichia coli, Proteus mirabilis, to determine the causative organisms and Pasteurella spp., urinary tract in- and their susceptibility to ampicillin fections (cystitis) due to Streptococcus should be performed. Use of the drug is spp., Staphylococcus spp., E., coli, P. contraindicated in animals with a his- mirabilis, and Enterococcus spp.; gastro- tory of an allergic reaction to any of intestinal infections due to Staphy- the penicillins. Ampicillin is contra- lococcus spp., Streptococcus spp., indicated in infections caused by peni- Enterococcus spp., and E. coli. ; infec- cillinase-producing organisms. Not for tions associated with abscesses, lacera- use in animals which are raised for tions, and wounds caused by Staphy- food production. Federal law restricts lococcus spp., and Streptococcus spp.

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(3) Limitations. Not for use in animals pneumonia); urinary tract infections which have shown hypersensitivity to (cystitis); and generalized infections penicillin or for infections caused by (septicemia) associated with abscesses, penicillinase-producing organisms. Not lacerations, and wounds. for use in animals which are raised for (iii) Limitations. The drug may be food production. Federal law restricts given as an emergency measure; how- this drug to use by or on the order of a ever, in vitro sensitivity tests on sam- licensed veterinarian. ples collected prior to treatment should be made. Ampicillin is contra- [57 FR 37321, Aug. 18, 1992, as amended at 60 FR 55659, Nov. 2, 1995] indicated for use in infections caused by penicillinase-producing organisms § 520.90c Ampicillin trihydrate cap- and for use in animals known to be al- sules. lergic to any of the penicillins. Not for (a) Specifications. Each capsule con- use in animals raised for food produc- tains ampicillin trihydrate equivalent tion. Federal law restricts this drug to to 125, 250, or 500 milligrams of ampi- use by or on the order of a licensed vet- cillin. erinarian. (b) Sponsor. See No. 055529 in [57 FR 37321, Aug. 18, 1992, as amended at 58 § 510.600(c) of this chapter. FR 61016, Nov. 19, 1993] (c) Conditions of use(1) Dogs—(i) Amount. 5 to 10 milligrams per pound of § 520.90d Ampicillin trihydrate for oral body weight two or three times daily. suspension. In severe or acute conditions, 10 milli- (a) Specifications. When reconstituted grams per pound of body weight, three as directed, each milliliter contains times daily. Administer 1 to 2 hours ampicillin trihydrate equivalent to 25 prior to feeding. milligrams of ampicillin. (ii) Indications for use. Treatment (b) Sponsor. See No. 055529 in against strains of gram-negative and § 510.600(c) of this chapter. gram-positive organisms sensitive to (c) Conditions of use(1) Dogs—(i) ampicillin and associated with res- Amount. 5 to 10 milligrams per pound of piratory tract infections body weight orally, 2 or 3 times daily, (tracheobronchitis and tonsillitis); uri- 1 to 2 hours prior to feeding. In severe nary tract infections (cystitis); bac- or acute conditions, 10 milligrams per terial gastroenteritis; generalized in- pound of body weight 3 times daily. fections (septicemia) associated with (ii) Indications for use. Treatment of abscesses, lacerations, and wounds; and respiratory tract infections bacterial dermatitis. (tracheobronchitis and tonsillitis) due (iii) Limitations. The drug may be to Escherichia coli, Pseudomonas spp., given as an emergency measure; how- Proteus spp., Staphylococcus spp., and ever, in vitro sensitivity tests on sam- Streptococcus spp., urinary tract infec- ples collected prior to treatment tions (cystitis) due to E. coli, Staphy- should be made. Ampicillin is contra- lococcus spp., Streptococcus spp., and indicated for use in infections caused Proteus spp.; bacterial gastroenteritis by penicillinase-producing organisms due to E. coli; generalized infections and for use in animals known to be al- (septicemia) associated with abscesses, lergic to any of the penicillins. Not for lacerations, and wounds, due to Staphy- use in animals raised for food produc- lococcus spp. and Streptococcus spp.; bac- tion. Federal law restricts this drug to terial dermatitis due to Staphylococcus use by or on the order of a licensed vet- spp., Streptococcus spp., Proteus spp., erinarian. and Pseudomonas spp. (2) Cats—(i) Amount. 10 to 30 milli- (iii) Limitations. Duration of treat- grams per pound of body weight or ment is usually 3 to 5 days. Continue three times daily. Administer 1 to 2 treatment 48 hours after the animal’s hours prior to feeding. temperature has returned to normal (ii) Indications for use. Treatment and all other signs of infection have against strains of gram-negative and subsided. If no response is obtained gram-positive organisms sensitive to within 3 to 5 days, reevaluate diagnosis ampicillin and associated with res- and treatment. Appropriate laboratory piratory tract infections (bacterial tests should be conducted, including in

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vitro culturing and susceptibility tests lococcus spp., Streptococcus spp., and on samples collected prior to treat- Salmonella spp. ment. Federal law restricts this drug (3) Limitations. For use in swine only. to use by or on the order of a licensed Not for use in other animals which are veterinarian. raised for food production. Treated (2) Cats—(i) Amount. 10 to 30 milli- swine must not be slaughtered for food grams per pound of body weight orally, during treatment and for 24 hours fol- 2 or 3 times daily, 1 to 2 hours prior to lowing the last treatment. Federal law feeding. restricts this drug to use by or on the (ii) Indications for use. Treatment of order of a licensed veterinarian. respiratory tract infections (bacterial pneumonia) due to Staphylococcus spp., [57 FR 37322, Aug. 18, 1992, as amended at 58 Streptococcus spp., E. coli, and Proteus FR 61016, Nov. 19, 1993] spp.; urinary tract infections (cystitis) due to E. coli, Staphylococcus spp., § 520.90f Ampicillin trihydrate boluses. Streptococcus spp., Proteus spp., and (a) Specifications. Each bolus contains Corynebacterium spp.; generalized infec- ampicillin trihydrate equivalent to 400 tions (septicemia) associated with ab- milligrams of ampicillin. scesses, lacerations, and wounds, due (b) Sponsor. See No. 055529 in to Staphylococcus spp., Streptococcus § 510.600(c) of this chapter for use as in spp., Bacillus spp., and Pasteurella spp. paragraph (d)(1), 000069 for use as in (iii) Limitations. Duration of treat- paragraph (d)(2). ment is usually 3 to 5 days. Continue (c) Related tolerances. See § 556.40 of treatment 48 hours after the animal’s this chapter. temperature has returned to normal (d) Conditions of use. Nonruminating and all other signs of infection have subsided. If no response is obtained calves(1) Amount. 5 milligrams per within 3 to 5 days, reevaluate diagnosis pound of body weight twice daily for up and treatment. Appropriate laboratory to 5 days. tests should be conducted, including in (i) Indications for use. Oral treatment vitro culturing and susceptibility tests of colibacillosis caused by Escherichia on samples collected prior to treat- coli, bacterial enteritis caused by Sal- ment. Federal law restricts this drug monella spp., and bacterial pneumonia to use by or on the order of a licensed caused by Pasteurella spp. veterinarian. (ii) Limitations. Treated calves must not be slaughtered for food during [57 FR 37321, Aug. 18, 1992, as amended at 58 FR 61016, Nov. 19, 1993] treatment and for 15 days after the last treatment. Not for use in other ani- § 520.90e Ampicillin trihydrate soluble mals raised for food production. Fed- powder. eral law restricts this drug to use by or (a) Specifications. Each gram contains on the order of a licensed veterinarian. ampicillin trihydrate equivalent to 88.2 (2) Amount. 5 milligrams per pound of milligrams of ampicillin. body weight twice daily not to exceed 4 (b) Sponsor. See No. 055529 in days. § 510.600(c) of this chapter. (i) Indications for use. Oral treatment (c) Related tolerances. See § 556.40 of of bacterial enteritis (colibacillosis) this chapter. caused by E. coli. (d) Conditions of use. Swine(1) Amount. (ii) Limitations. Treated calves must 5 milligrams of ampicillin per pound of not be slaughtered for food during body weight twice daily, orally by ga- treatment and for 7 days after the last vage or in drinking water for up to 5 treatment. Not for use in other ani- days. mals raised for food production. Fed- (2) Indications for use. Oral treatment eral law restricts this drug to use by or of porcine colibacillosis (Escherichia on the order of a licensed veterinarian. coli) and salmonellosis (Salmonella spp.) infections in swine up to 75 pounds of [57 FR 37322, Aug. 18, 1992, as amended at 58 body weight, and bacterial pneumonia FR 61016, Nov. 19, 1993; 60 FR 55659, Nov. 2, caused by Pasteurella multocida, Staphy- 1995]

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§ 520.100 Amprolium. (ii) Limitations. Withdraw 24 hours be- (a) Specifications(1) Each milliliter of fore slaughter. A withdrawal period has solution contains 96 milligrams (mg) not been established for this product in amprolium (9.6 percent solution). preruminating calves. Do not use in (2) Each gram of powder contains 200 calves to be processed for veal. Use as mg amprolium (20 percent). the sole source of amprolium. (3) Each ounce (28.4 grams) of crum- [71 FR 56346, Sept. 27, 2006, as amended at 72 bles contains 355 mg amprolium (1.25 FR 60551, Oct. 25, 2007; 73 FR 45611, Aug. 6, percent). 2008; 73 FR 70276, Nov. 20, 2008; 74 FR 10484, (b) Sponsors. See sponsors in 510.600(c) Mar. 11, 2009; 76 FR 38554, July 1, 2011; 76 FR of this chapter. 40808, July 12, 2011; 78 FR 23, Jan. 2, 2013; 78 (1) No. 016592 for use of products de- FR 17596, Mar. 22, 2013; 78 FR 57058, Sept. 17, scribed in paragraph (a) of this section 2013] as in paragraph (d) of this section. (2) No. 066104 for use of product de- § 520.110 Apramycin sulfate soluble scribed in paragraph (a)(1) of this sec- powder. tion as in paragraph (d) of this section. (a) Specifications. A water soluble (3) No. 000859 for use of product de- powder used to make a medicated scribed in paragraph (a)(1) of this sec- drinking water containing apramycin tion as in paragraph (d) of this section. sulfate equivalent to 0.375 gram of (4) No. 061623 for use of products de- scribed in paragraphs (a)(1) and (a)(2) of apramycin activity per gallon of drink- this section as in paragraph (d) of this ing water. section. (b) Sponsor. See No. 000986 in (c) Related tolerances. See § 556.50 of § 510.600(c) of this chapter. this chapter. (c) Related tolerances. See § 556.52 of (d) Conditions of use(1) Growing chick- this chapter. ens, turkeys, and laying hens. It is used (d) Conditions of use. (1) In swine for in drinking water as follows: control of porcine colibacillosis (i) Amount. Administer at the 0.012 (weanling pig scours) caused by strains percent level in drinking water as soon of E. coli sensitive to apramycin. as coccidiosis is diagnosed and con- (2) It is administered for 7 days in tinue for 3 to 5 days (in severe out- drinking water at the rate of 12.5 milli- breaks, give amprolium at the 0.024 grams of apramycin per kilogram (5.7 percent level); continue with 0.006 per- milligrams per pound) of body weight cent amprolium-medicated water for per day. Swine will normally consume an additional 1 to 2 weeks. 1 gallon per day of medicated water (ii)Indications for use. For the treat- containing 375 milligrams of ment of coccidiosis. (iii) Limitations. Use as the sole apramycin for each 66 pounds of body source of amprolium. weight. Water consumption should be (2) Calves. Administer crumbles top- monitored to determine that the re- dressed on or thoroughly mixed in the quired amount of apramycin is being daily feed ration; administer con- consumed. The drug concentration centrate solution or soluble powder as should be adjusted according to water a drench or in drinking water as fol- consumption which varies depending lows: on ambient temperature, humidity, (i) Indications for use and amounts— and other factors. (A) As an aid in the prevention of coc- (3) Prepare fresh medicated water cidiosis caused by Eimeria bovis and E. daily. zurnii, administer 5 mg per kilogram (4) Do not slaughter treated swine for (mg/kg) body weight for 21 days during 28 days following treatment periods of exposure or when experience indicates that coccidiosis is likely to [47 FR 15771, Apr. 13, 1982, as amended at 49 be a hazard. FR 19642, May 9, 1984; 53 FR 37753, Sept. 28, (B) As an aid in the treatment of coc- 1988] cidiosis caused by E. bovis and E. zurnii, administer 10 mg/kg body weight for 5 days.

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§ 520.154 Bacitracin oral dosage forms. (ii) Indications for use. For prevention of ulcerative enteritis due to Clos- § 520.154a Bacitracin methylene disa- tridium colinum susceptible to baci- licylate. tracin methylene disalicylate. (a) Specifications. Each pound of solu- (iii) Limitations. Prepare fresh solu- ble powder contains the equivalent of tion daily. Use as sole source of drink- 50 grams of bacitracin activity for use ing water. as in paragraph (d)(1) or (d)(2) of this [57 FR 37322, Aug. 18, 1992; 57 FR 42623, Sept. section, or the equivalent of 200 grams 15, 1992, as amended at 63 FR 38474, July 17, of bacitracin activity for use as in 1998; 64 FR 13068, Mar. 17, 1999; 76 FR 53050, paragraph (d) of this section. Aug. 25, 2011] (b) Sponsor. See No. 046573 in § 510.600(c) of this chapter. § 520.154b Bacitracin methylene disa- (c) Related tolerances. See § 556.70 of licylate and streptomycin sulfate this chapter. powder. (d) Conditions of use(1) Growing tur- (a) Specifications. Each gram of pow- keys—(i) Amount. 400 milligrams (mg) der contains 200 units bacitracin meth- per gallon (gal) in drinking water. ylene disalicylate and streptomycin (ii) Indications for use. Aid in the con- sulfate equivalent to 20 milligrams of trol of transmissible enteritis com- streptomycin. plicated by organisms susceptible to (b) Sponsor. See No. 046573 in bacitracin methylene disalicylate. § 510.600(c) of this chapter. (iii) Limitations. Prepare a fresh solu- (c) Conditions of use in dogs(1) Amount. tion daily. Administer 1 level teaspoonful per 10 (2) Broiler and replacement chickens— pounds of body weight three times (i) Amount. 100 mg per gal in drinking daily, mixed in a small quantity of liq- water. uid or feed. (A) Indications for use. Aid in the pre- (2) Indications for use. For the treat- vention of necrotic enteritis caused by ment of bacterial enteritis caused by Clostridium perfringens susceptible to pathogens susceptible to bacitracin and bacitracin methylene disalicylate. streptomycin such as Escherichia coli, (B) Limitations. Prepare a fresh solu- Proteus spp., Staphylococcus spp., and tion daily. Streptococcus spp., and for the sympto- (ii) Amount. 200 to 400 mg per gal in matic treatment of associated diar- drinking water. Administer continu- rhea. ously 5 to 7 days or as long as clinical (3) Limitations. Federal law restricts signs persist, then reduce to prevention this drug to use by or on the order of a levels (100 mg/gal). licensed veterinarian. (A) Indications for use. Treatment of necrotic enteritis caused by C. [71 FR 17702, Apr. 7, 2006] perfringens susceptible to bacitracin methylene disalicylate. § 520.154c Bacitracin zinc soluble pow- der. (B) Limitations. Prepare a fresh solu- tion daily. (a) Specifications. Each pound con- (3) Swine—(i) Amount. 1 gram per gal- tains the equivalent of not less than 5 lon in drinking water. grams of bacitracin. (ii) Indications for use. Treatment of (b) Sponsor. See No. 053501 in swine dysentery associated with § 510.600(c) of this chapter. Treponema hyodysenteriae. Administer (c) Related tolerances. See § 556.70 of continuously for 7 days or until signs this chapter. of dysentery disappear. (d) Conditions of use—(1) Broiler chick- (iii) Limitations. Prepare a fresh solu- ens—(i) Amount. 100 milligrams per gal- tion daily. Treatment not to exceed 14 lon in drinking water. days. If symptoms persist after 4 to 5 (A) Indications for use. Prevention of days consult a veterinarian. Not to be necrotic enteritis caused by Clostridium given to swine that weigh more than perfringens susceptible to bacitracin 250 pounds. zinc. (4) Growing quail—(i) Amount. 400 mg (B) Limitations. Prepare a fresh solu- per gal in drinking water. tion daily.

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(ii) Amount. 200 to 400 milligrams per § 520.246 Butorphanol tartrate tablets. gallon in drinking water. (a) Specifications. Each tablet con- (A) Indications for use. Control of ne- tains 1, 5, or 10 milligrams of crotic enteritis caused by Clostridium butorphanol base activity as perfringens susceptible to bacitracin butorphanol tartrate. zinc. (b) Sponsor. See No. 000856 in (B) Limitations. Prepare a fresh solu- § 510.600(c) of this chapter. tion daily. (c) Conditions of use. The drug is used (2) Growing quail—(i) Amount. 500 mil- for the treatment of dogs as follows: ligrams per gallon in drinking water (1) Amount. 0.25 milligram of for 5 days followed by 165 milligrams butorphanol base activity per pound of per gallon in drinking water for 10 body weight. days. (2) Indications for use. For the relief of (ii) Indications for use. Control of ul- chronic nonproductive cough associ- cerative enteritis caused by Clostridium ated with tracheo-bronchitis, tra- spp. susceptible to bacitracin zinc. cheitis, tonsillitis, laryngitis, and (iii) Limitations. Prepare a fresh solu- pharyngitis associated with inflam- tion daily. matory conditions of the upper res- [57 FR 37322, Aug. 18, 1992, as amended at 67 piratory tract. FR 78355, Dec. 24, 2002] (3) Limitations. For oral use in dogs only. Repeat at intervals of 6 to 12 § 520.222 Bunamidine hydrochloride. hours as required. If necessary, in- (a) Chemical name. N,N-Dibutyl-4- crease dose to a maximum of 0.5 milli- (hexyloxy)-1-naphthamidine hydro- gram per pound of body weight. Treat- chloride. ment should not normally be required (b) Specifications. The drug is an oral for longer than 7 days. Federal law re- tablet containing 100, 200, or 400 milli- stricts this drug to use by or on the grams of bunamidine hydrochloride. order of a licensed veterinarian. (c) Sponsor. See No. 000061 in [47 FR 14702, Apr. 6, 1982, as amended at 53 § 510.600(c) of this chapter. FR 27851, July 25, 1988] (d) Conditions of use. (1) The drug is intended for oral administration to § 520.260 n-Butyl chloride. dogs for the treatment of the tape- (a)(1) Specifications. n-Butyl chloride worms Dipylidium caninum, capsules, veterinary contain 272 milli- pisiformis, and Echinococcus granulosus, grams or 816 milligrams of n-butyl and to cats for the treatment of the chloride in each capsule. tapeworms Dipylidium caninum and (2) Sponsor. See No. 021091 in Taenia taeniaeformis. § 510.600(c) of this chapter. (2) It is administered to cats and dogs (3) Conditions of use. (i) It is used for at the rate of 25 to 50 milligrams per the removal of ascarids ( kilogram of body weight. The drug and ) and hookworms should be given on an empty stomach (, Ancylostoma and food should not be given for 3 braziliense, and ) hours following treatment. from dogs and of the ascarid (Toxocara (3) Tablets should not be crushed, cati) and hookworm (Ancylostoma mixed with food, or dissolved in liquid. tubaeforme) from cats. Repeat treatments should not be given (ii)(a) Animals should not be fed for within 14 days. The drug should not be 18 to 24 hours before being given the given to male dogs within 28 days prior drug. Puppies and kittens should be to their use for breeding. Do not ad- wormed at 6 weeks of age. However, if minister to dogs or cats having known heavily infested, they may be wormed heart conditions. at 4 or 5 weeks of age. Administration (4) For use only by or on the order of of the drug should be followed in 1⁄2 to a licensed veterinarian. 1 hour with a teaspoonful to a table- [40 FR 13838, Mar. 27, 1975, as amended at 42 spoonful of milk of magnesia or 1 or 2 FR 13018, Mar. 8, 1977; 46 FR 48642, Oct. 2, milk of magnesia tablets. Normal ra- 1981; 61 FR 8873, Mar. 6, 1996; 62 FR 61624, tions may be resumed 4 to 8 hours after Nov. 19, 1997] treatment. Puppies and kittens should

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be given a repeat treatment in a week braziliense, and Uncinaria stenocephala) or 10 days. After that they should be from dogs. 1 treated every 2 months (or as symp- (ii)(a) Dogs should not be fed for 18 to toms reappear) until a year old. When 24 hours before being given the drug. the puppy or kitten is a year old, one Administration of the drug should be treatment every 3 to 6 months is suffi- followed in 1⁄2 to 1 hour with a mild ca- cient. thartic. Normal feeding may be re- (b) For dogs or cats that have been sumed 4 to 8 hours after treatment. wormed regularly, treatment every 3 to Animals subject to reinfection may be 6 months will be sufficient. If a dog or retreated in 2 weeks. 1 cat has not been wormed previously (b) The drug is administered orally to and has the symptoms of large dogs. Capsules containing 221 milli- roundworms a dose should be given and grams of n-butyl chloride are adminis- repeated in 10 days. Removal of tered to dogs weighing under 5 pounds hookworms may require 3 or 4 doses at at a dosage level of 1 capsule per 11⁄4 10-day intervals. pound of body weight. Capsules con- (c) Puppies, dogs, cats, or kittens taining 442 milligrams of n-butyl chlo- weighing 1 to 3 pounds should be given ride are administered to dogs weighing 2 capsules per dose which contain 272 under 5 pounds at a dosage level of 1 milligrams of n-butyl chloride each. capsule per 21⁄2 pounds body weight. Such animals weighing 4 to 5 pounds Capsules containing 884 milligrams of should be given 3 such capsules. Ani- n-butyl chloride are administered to mals weighing 6 to 7 pounds should be dogs as follows: Weighing under 5 given 4 such capsules and animals pounds, 1 capsule; weighing 5 to 10 weighing 8 to 9 pounds should be given pounds, 2 capsules; weighing 10 to 20 5 such capsules. Animals weighing 10 to pounds, 3 capsules; weighing 20 to 40 20 pounds should be given 3 capsules pounds, 4 capsules; over 40 pounds, 5 which contain 816 milligrams of n- capsules. Capsules containing 1,768 mil- butyl chloride each, animals weighing ligrams of n-butyl chloride are admin- 20 to 40 pounds should be given 4 such istered at a dosage level of 1 capsule capsules and animals weighing over 40 per dog weighing 5 to 10 pounds. Cap- pounds should be given 5 such capsules sules containing 4.42 grams of n-butyl with the maximum dosage being 5 cap- chloride are administered at a dosage sules, each of which contains 816 milli- level of 1 capsule per dog weighing 40 1 grams of n-butyl chloride. pounds or over. (iii) A veterinarian should be con- (iii) A veterinarian should be con- sulted before using in severely debili- sulted before using in severely debili- tated dogs. 1 tated dogs or cats and also prior to re- peated use in cases which present signs [40 FR 13838, Mar. 27, 1975, as amended at 40 of persistent parasitism. FR 39858, Aug. 29, 1975; 44 FR 10059, Feb. 16, (b)(1) Specifications. n-Butyl chloride 1979; 54 FR 38515, Sept. 19, 1989; 55 FR 24556, capsules contain 221, 442, 884, or 1,768 June 18, 1990; 64 FR 15684, Apr. 1, 1999; 70 FR 50182, Aug. 26, 2005; 78 FR 14669, Mar. 7, 2013] milligrams or 4.42 grams of n-butyl chloride in each capsule. 1 EDITORIAL NOTE: At 78 FR 14669, Mar. 7, (2) Sponsors. See No. 023851 in 2013, § 520.260 was amended by adding para- § 510.600(c) of this chapter for 221, 442, graphs (b)(1) through (3); however, the amendment could not be incorporated be- 884, or 1,768 milligram or 4.42 gram cap- cause (b)(1) through (3) already exist. sules; No. 038782 for 884 or 1,768 milli- gram or 4.42 gram capsules; and No. § 520.300 Cambendazole oral dosage 000069 for 221 milligram capsules. forms. (3) Conditions of use. (i) It is used for the removal of ascarids (Toxocara canis § 520.300a Cambendazole suspension. and Toxascaris leonina) and hookworms (a) Specifications. Each fluid ounce (Ancylostoma caninum, Ancylostoma contains 0.9 gram of cambendazole. (b) Sponsor. No. 050604 in § 510.600(c) of 1 These conditions are NAS/NRC reviewed this chapter. and deemed effective. Applications for these (c) Conditions of use. (1) It is used in uses need not include effectiveness data as horses for the control of large specified by § 514.111 of this chapter. strongyles (Strongylus vulgaris, S.

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edentatus, S. equinus); small strongyles (5) Caution: Do not administer to (Trichonema, Poteriostomum, pregnant mares during first 3 months Cylicobrachytus, Craterostomum, of pregnancy. Oesophagodontus); roundworms (6) Consult your veterinarian for as- (Parascaris); pinworms. (Oxyuris); and sistance in the diagnosis, treatment, threadworms (Strongyloides). and control of parasitism. (2) It is administered by stomach tube or as a drench at a dose of 0.9 [41 FR 1276, Jan. 7, 1976, as amended at 42 FR 3838, Jan. 21, 1977; 62 FR 63270, Nov. 28, 1997] gram of cambendazole per 100 pounds of body weight (20 milligrams per kilo- § 520.300c Cambendazole paste. gram). (3) For animals maintained on prem- (a) Specifications. The drug is a paste ises where reinfection is likely to containing 45 percent cambendazole. occur, re-treatments may be necessary. (b) Sponsor. No. 050604 in § 510.600(c) of For most effective results, re-treat in 6 this chapter. to 8 weeks. (c) Conditions of use. (1) It is used in (4) Not for use in horses intended for horses for the control of large food. strongyles (Strongylus vulgaris, S. (5) Caution: Do not administer to edentatus, S. equinus); small strongyles pregnant mares during first 3 months (Trichonema, Poteriostomum, of pregnancy. Cylicobrachytus, Craterostomum, (6) Federal law restricts this drug to Oesophagodontus); roundworms use by or on the order of a licensed vet- (Parascaris); pinworms (Oxyuris); and erinarian. threadworms (Strongyloides). (2) Administer 20 milligrams [40 FR 13838, Mar. 27, 1975. Redesignated at 41 cambendazole per kilogram body FR 1276, Jan. 7, 1976, and amended at 42 FR weight (5 grams per 550 pounds (250 3838, Jan. 21, 1977; 62 FR 63270, Nov. 28, 1997] kilograms)) by depositing the paste on the back of the tongue using a dosing § 520.300b Cambendazole pellets. gun. (a) Specifications. The drug is in feed (3) For animals maintained on prem- pellets containing 5.3 percent ises where reinfection is likely to cambendazole. occur, re-treatments may be necessary. (b) Sponsor. No. 050604 in § 510.600(c) of For most effective results, re-treat in 6 this chapter. to 8 weeks. (c) Conditions of use. (1) It is used in (4) Not for use in horses intended for horses for the control of large food. strongyles (Strongylus vulgaris, S. (5) Caution: Do not administer to edentatus, S. equinus); small strongyles pregnant mares during first 3 months (Trichonema, Poteriostomum, of pregnancy. Cylicobrachytus, Craterostomum, (6) Consult your veterinarian for as- Oesophagodontus); roundworms sistance in the diagnosis, treatment, (Parascaris); pinworms (Oxyuris); and and control of parasitism. threadworms (Strongyloides). (2) Administer 20 milligrams [41 FR 1276, Jan. 7, 1976, as amended at 42 FR cambendazole per kilogram body 3838, Jan. 21, 1977; 62 FR 63270, Nov. 28, 1997] weight (6 ounces per 1,000 pounds) by mixing with normal grain ration given § 520.309 Carprofen. at one feeding. Doses for individual (a) Specifications. (1) Each caplet con- horses should be mixed and fed sepa- tains 25, 75, or 100 milligrams (mg) rately to assure that each horse will carprofen. consume the correct amount. (2) Each chewable tablet contains 25, (3) For animals maintained on prem- 75, or 100 mg carprofen. ises where reinfection is likely to (b) Sponsors. See sponsors in occur, re-treatments may be necessary. § 510.600(c) of this chapter for uses as in For most effective results, re-treat in 6 paragraph (d) of this section. to 8 weeks. (1) No. 000069 for use of products de- (4) Not for use in horses intended for scribed in paragraph (a) of this section food. as in paragraph (d) of this section.

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(2) Nos. 000115, 000859, 055529, and (2) Indications for use. For treating 062250 for use of product described in trichomoniasis (canker) in ornamental paragraph (a)(1) as in paragraph (d) of and homing pigeons. this section. (3) Limitations. Not for use in pigeons (c) [Reserved] intended for human food. Consult your (d) Conditions of use in dogs(1) Amount. veterinarian for assistance in the diag- 2 mg per pound (/lb) of body weight nosis, treatment, and control of para- once daily or 1 mg/lb twice daily. For sitism or when severely ill birds do not the control of postoperative pain, ad- respond to treatment. minister approximately 2 hours before the procedure. [54 FR 32336, Aug. 7, 1989] (2) Indications for use. For the relief of § 520.314 Cefadroxil. pain and inflammation associated with osteoarthritis and for the control of (a) Specifications.(1) Each tablet con- postoperative pain associated with soft tains 50, 100, or 200 milligrams (mg) or tissue and orthopedic surgeries. 1 gram of cefadroxil. (3) Limitations. Federal Law restricts (2) Each milliliter of suspension con- this drug to use by or on the order of a stituted from powder contains 50 mg of licensed veterinarian. cefadroxil. (b) Sponsor. See No. 000010 in [61 FR 66581, Dec. 18, 1996, as amended at 64 § 510.600(c) of this chapter. FR 32181, June 16, 1999; 66 FR 63165, Dec. 5, (c) Conditions of use in dogs and cats— 2001; 67 FR 6866, Feb. 14, 2002; 67 FR 65038, Oct. 23, 2002; 67 FR 65697, Oct. 28, 2002; 70 FR (1) Amount—(i) Dogs. Administer 10 mg 30626, May 27, 2005; 71 FR 51995, Sept. 1, 2006; per pound (/lb) body weight twice daily 72 FR 68478, Dec. 5, 2007; 74 FR 21768, May 11, orally. 2009; 78 FR 52853, Aug. 27, 2013; 78 FR 66264, (ii) Cats. Administer 10 mg/lb body Nov. 5, 2013] weight once daily orally. (2) Indications for use—(i) Dogs. For § 520.310 Caramiphen the treatment of skin and soft tissue ethanedisulfonate and ammonium chloride tablets. infections including cellulitis, pyoderma, dermatitis, wound infec- (a) Specifications. Each tablet con- tions, and abscesses due to susceptible tains 10 milligrams of 5st caramiphen strains of Staphylococcus aureus. For ethanedisulfonate and 80 milligrams of the treatment of genitourinary tract 1 ammonium chloride. infections (cystitis) due to susceptible (b) Sponsor. See No. 000856 in strains of Escherichia coli, Proteus § 510.600(c) of this chapter. mirabilis, and S. aureus. (c) Conditions of use in dogs(1) Amount. (ii) Cats. For the treatment of skin One tablet per 15 to 30 pounds of body and soft tissue infections including ab- 1 weight every 4 to 6 hours. scesses, wound infections, cellulitis, (2) Indications for use. For relief of and dermatitis caused by susceptible cough.1 strains of Pasteurella multocida, S. [43 FR 55385, Nov. 28, 1978] aureus, Staphylococcus epidermidis, and Streptococcus spp. § 520.312 Carnidazole tablets. (3) Limitations. Federal law restricts (a) Specifications. Each tablet con- this drug to use by or on the order of a tains 10 milligrams of carnidazole. licensed veterinarian. (b) Sponsor. See 053923 in § 510.600(c) of [75 FR 10165, Mar. 5, 2010] this chapter. (c) Conditions of use(1) Amount. Adult § 520.370 Cefpodoxime tablets. pigeons: 1 tablet (10 milligrams); newly (a) Specifications. Each tablet con- weaned pigeons: 1⁄2 tablet (5 milli- grams). tains cefpodoxime proxetil equivalent to 100 or 200 milligrams (mg) cefpodoxime. 1 These conditions are NAS/NRC reviewed (b) Sponsors. See Nos. 000009 and and deemed effective. Applications for these uses need not include effectiveness data as 026637 in § 510.600(c) of this chapter. specified by § 514.111 of this chapter, but may (c) Conditions of use in dogs(1) Amount. require bioequivalency and safety informa- 5 to 10 mg per kilogram (2.3 to 4.5 mg tion. per pound) body weight daily for 5 to 7

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days, or for 2 to 3 days beyond the ces- (c) Conditions of use in dogs(1) Amount. sation of clinical signs, up to a max- Administer 25 mg per pound of body imum of 28 days. weight by mouth every 6 hours. (2) Indications for use. For the treat- (2) Indications for use—(i) For the ment of skin infections (wounds and treatment of bacterial pulmonary in- abscesses) caused by susceptible strains fections, bacterial infections of the uri- of Staphylococcus intermedius, S. aureus, nary tract, bacterial enteritis, and bac- Streptococcus canis (group G, -hemo- terial infections associated with canine lytic), Escherichia coli, Pasteurella distemper caused by susceptible orga- multocida, and Proteus mirabilis. nisms. (3) Limitations. Federal law restricts (ii) For the treatment of bacterial this drug to use by or on the order of a gastroenteritis associated with bac- licensed veterinarian. terial diarrhea, bacterial pulmonary [69 FR 52815, Aug. 30, 2004, as amended at 78 infections, and bacterial infections of FR 5714, Jan. 28, 2013] the urinary tract caused by susceptible organisms. § 520.376 Cephalexin. (3) Limitations. Federal law restricts (a) Specifications. Each chewable tab- this drug to use by or on the order of a let contains 75, 150, 300, or 600 milli- licensed veterinarian. Federal law pro- grams (mg) cephalexin. hibits the extralabel use of this drug in (b) Sponsor. See No. 051311 in food-producing animals. § 510.600(c) of this chapter. [77 FR 4896, Feb. 1, 2012, as amended at 78 FR (c) Conditions of use—(1) Dogs—(i) 21059, Apr. 9, 2013] Amount. Administer 22 mg per kilo- gram of body weight twice daily for 28 § 520.390b Chloramphenicol capsules. days. (a) Specifications. Each capsule con- (ii) Indications for use. For the treat- tains 50, 100, 250, or 500 milligrams (mg) ment of secondary superficial bacterial chloramphenicol. pyoderma in dogs caused by susceptible (b) Sponsors. See Nos. 000069 and strains of Staphylococcus 050057 in § 510.600(c) of this chapter for pseudintermedius. use as in paragraph (d) of this section. (iii) Limitations. Federal law restricts this drug to use by or on the order of a (c) Special considerations. Federal law licensed veterinarian. prohibits the extralabel use of this (2) [Reserved] product in food-producing animals. (d) Conditions of use in dogs(1) Amount. [77 FR 47512, Aug. 9, 2012] 25 mg per pound of body weight every 6 hours. § 520.390 Chloramphenicol oral dosage (2) Indications for use. For treatment forms. of bacterial pulmonary infections, bac- § 520.390a Chloramphenicol tablets. terial infections of the urinary tract, bacterial enteritis, and bacterial infec- (a) Specifications. Each tablet con- tions associated with canine distemper tains 50, 100, 250, or 500 milligrams caused by susceptible organisms. (mg); 1 or 2.5 grams (g) of chloramphen- (3) Limitations. Federal law restricts icol. this drug to use by or on the order of a (b) Sponsors. See § 510.600(c) of this licensed veterinarian. chapter: (1) For use as in paragraphs (c)(1), [70 FR 75398, Dec. 20, 2005, as amended at 73 (c)(2)(i), and (c)(3) of this section: FR 18442, Apr. 4, 2008; 75 FR 55676, Sept. 14, (i) No. 054628 for 100-, 250-, and 500-mg; 2010] and 1- and 2.5-g tablets; (ii) No. 000856 for 100-, 250-, and 500- § 520.390c Chloramphenicol palmitate mg tablets; oral suspension. (iii) No. 000069 for 250-mg tablets. (a) Specifications. Each milliliter con- (2) For use as in paragraphs (c)(1), tains chloramphenicol palmitate equiv- (c)(2)(ii), and (c)(3) of this section: alent to 30 milligrams of chloramphen- (i) No. 061623 for 50-, 100-, 250-, and icol. 500-mg; and 1-g tablets; (b) Sponsor. See No. 000856 in (ii) [Reserved] § 510.600(c) of this chapter.

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(c) Conditions of use. Dogs(1) Amount. (b) Animals should be regularly and 25 milligrams per pound of body weight carefully observed for early signs of every 6 hours. If no response is ob- fluid and electrolyte imbalance. Take tained in 3 to 5 days, discontinue use appropriate countermeasures if this and reevaluate diagnosis. should occur. In some dogs, (2) Indications for use. Treatment of hypochloremic alkalosis may occur bacterial pulmonary infections, infec- (that is, excretion of chloride in rela- tions of the urinary tract, enteritis, tion to sodium is excessive; the plasma and infections associated with canine bicarbonate level increases and distemper that are caused by orga- alkalosis results). Federal law restricts nisms susceptible to chloramphenicol. this drug to use by or on the order of a 1 (3) Limitations. Not for use in animals licensed veterinarian. that are raised for food production. (b)(1) Specifications. Each bolus con- Must not be used in meat-, egg-, or tains 2 grams of chlorothiazide. milk-producing animals. The length of (2) Sponsor. See No. 000006 in time that residues persist in milk or § 510.600(c) of this chapter. tissues has not been determined. Fed- (3) Conditions of use—(i) Amount. 2 eral law restricts this drug to use by or grams once or twice daily for 3 or 4 1 on the order of a licensed veterinarian. days. (ii) Indications for use. For use in cat- [57 FR 37323, Aug. 18, 1992; 57 FR 42623, Sept. tle as an aid in reduction of 15, 1992] postparturient udder edema. 1 (iii) Limitations. Animals should be § 520.420 Chlorothiazide tablets and regularly and carefully observed for boluses. early signs of fluid and electrolyte im- (a)(1) Specifications. Each tablet con- balance. Take appropriate counter- tains 0.25 gram of chlorothiazide. measures if this should occur. Milk (2) Sponsor. See No. 050604 in taken from dairy animals during treat- § 510.600(c) of this chapter. ment and for 72 hours (six milkings) (3) Conditions of use—(i) Amount. after latest treatment must not be Usual dosage is 5 to 10 milligrams per used for food. Federal law restricts this pound of body weight two or three drug to use by or on the order of a li- times daily. 1 censed veterinarian. 1 (ii) Indications for use. For use in dogs [43 FR 39085, Sept. 1, 1978, as amended at 62 for treatment of congestive heart fail- FR 63270, Nov. 28, 1997] ure and renal edema. 1 (iii) Limitations. (a) Dosage must be § 520.434 Chlorphenesin carbamate adjusted to meet the changing needs of tablets. the individual animal. In mild and re- (a) Specifications. Each tablet con- sponsive cases, it is suggested that a tains 400 milligrams of chlorphenesin dose of 5 milligrams per pound of body carbamate. weight be administered two or three (b) Sponsor. See No. 000009 in times daily. In moderately edematous § 510.600(c) of this chapter. and moderately responsive animals, a (c) Conditions of use in dogs(1) dose of 7.5 to 10 milligrams per pound Amount. 50 milligrams per pound of of body weight may be administered body weight on first day; 25 milligrams three times daily. Severe conditions per pound of body weight each fol- may require higher doses. Certain ani- lowing day. Divide total daily dose into mals may respond adequately to inter- 2 or 3 equal doses—administer at 12- or mittent therapy; in these cases, the 8-hour intervals. drug may be administered either every (2) Indications for use. For use as an other day or for 3 to 5 days each week. adjunct to therapy of acute inflam- matory and traumatic conditions of skeletal muscles. The drug provides re- 1 These conditions are NAS/NRC reviewed lief of the signs of discomfort associ- and deemed effective. Applications for these uses need not include effectiveness data as ated with myositis, muscle sprains, specified by § 514.111 of this chapter, but may traumatic injuries, stifle injuries—es- require bioequivalency and safety informa- pecially when administered before or tion. after surgery—and invertebral disc

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syndrome (can be used concurrently chlortetracycline; administer for not with adrenal corticosteroids). more than 5 days. (3) Limitations. Not recommended for (B) [Reserved] pregnant animals or those with a (ii) [Reserved] known hepatic dysfunction. Periodic (2) Use as chlortetracycline hydro- liver function studies are recommended chloride in a drench or drinking water for animals on prolonged treatment. If as follows: no response is evident within 5 days of (i) Calves—(A) Amount. Ten milli- the beginning of treatment, the diag- grams per pound of body weight daily nosis should be redetermined and ap- in divided doses. propriate therapy instituted. Not rec- (1) Control and treatment of bac- ommended for use with general anes- terial enteritis (scours) caused by E. thetics other than the barbiturates. coli and bacterial pneumonia (shipping Federal law restricts this drug to use fever) associated with Pasteurella spp., by or on the order of a licensed veteri- A. pleuropneumoniae (Hemophilus spp.), narian. and Klebsiella spp. (2) Limitations. Prepare fresh solution [44 FR 16009, Mar. 16, 1979] daily; as sole source of chlortetra- § 520.441 Chlortetracycline powder. cycline; administer for not more than 5 days; do not slaughter animals for food (a) Specifications. Chlortetracycline within 24 hours of treatment; do not powder contains not less than 15 milli- administer this product with milk or grams per gram chlortetracycline hy- milk replacers; administer 1 hour be- drochloride, or chlortetracycline bisul- fore or 2 hours after feeding milk or fate equivalent to 25.6, 64 or 102.4 grams milk replacers; a withdrawal period has per pound (56.4, 141 or 225.6 milligrams not been established in preruminating per gram) chlortetracycline hydro- calves; do not use in calves to be proc- chloride. essed for veal. (b) Sponsors. See sponsors in (B) [Reserved] § 510.600(c) of this chapter for use as in (ii) [Reserved] paragraph (d) of this section. (3) [Reserved] (1) No. 048164 for use as in paragraph (4) The following uses of chlortetra- (d) of this section. cycline hydrochloride or chlortetra- (2) Nos. 046573 and 000010 for use as in cycline bisulfate in drinking water or paragraph (d) of this section. drench were reviewed by the National (3) No. 054628 for use as in paragraphs Academy of Sciences/National Re- (d)(4)(i)(A), (d)(4)(i)(B), and (d)(4)(ii) search Council (NAS/NRC) and found through (d)(4)(iv) of this section. effective: (d)(4)(ii) through (iv) of this section. (i) Chickens—(A) Amount. 200 to 400 (4) Nos. 012286 and 076475 for use as in milligrams per gallon. paragraphs (d)(4)(i)(A), (d)(4)(i)(B), (1) Indications for use. Control of in- (d)(4)(ii), and (d)(4)(iii) of this section. fectious synovitis caused by Myco- (c) Related tolerances. See § 556.150 of plasma synoviae. this chapter. (2) Limitations. Prepare fresh solution (d) Conditions of use. (1) Use as chlor- daily; as sole source of chlortetra- tetracycline hydrochloride in drinking cycline; do not use for more than 14 water as follows: days; do not slaughter animals for food (i) Swine—(A) Amount. Ten milli- within 24 hours of treatment; do not grams per pound of body weight daily use in laying chickens. in divided doses. (B) Amount. 400 to 800 milligrams per (1) Indications for use. Control and gallon. treatment of bacterial enteritis (1) Indications for use. Control of (scours) caused by Escherichia coli and chronic respiratory disease and air-sac bacterial pneumonia associated with infections caused by M. gallisepticum Pasteurella spp., Actinobacillus and E. coli. pleuropneumoniae (Hemophilus spp.), and (2) Limitations. Prepare fresh solution Klebsiella spp. daily; as sole source of chlortetra- (2) Limitations. Prepare a fresh solu- cycline; do not use for more than 14 tion twice daily; as sole source of days; do not slaughter animals for food

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within 24 hours of treatment; do not pleuropneumoniae (Hemophilus spp.), and use in laying chickens. Klebsiella spp. (C) Amount. One thousand milligrams (C) Limitations. Prepare fresh solution per gallon. daily; use as a drench; as sole source of (1) Indications for use. Control of mor- chlortetracycline; do not use for more tality due to fowl cholera caused by than 5 days; do not slaughter animals Pasteurella multocida susceptible to for food within 24 hours of treatment; chlortetracycline. do not use in lactating cattle; do not $(2) Limitations. See paragraph administer this product with milk or (d)(4)(i)(A)(2) of this section. milk replacers; administer 1 hour be- (ii) Growing turkeys—(A) Amount. 400 fore or 2 hours after feeding milk or milligrams per gallon. milk replacers; a withdrawal period has (1) Indications for use. Control of in- not been established in preruminating fectious synovitis caused by M. calves; do not use in calves to be proc- synoviae. essed for veal. (2) Limitations. Prepare fresh solution (5) Use in a drench or drinking water daily; as sole source of chlortetra- as follows: cycline; do not use for more than 14 (i) Chickens—(A) Amount. 200 to 400 days; do not slaughter animals for food mg/gal, for 7 to 14 days. within 24 hours of treatment. (1) Indications for use. Control of in- (B) Amount. 25 milligrams per pound fectious synovitis caused by M. of body weight daily. synoviae susceptible to chlortetra- (1) Indications for use. Control of com- cycline. plicating bacterial organisms associ- (2) Limitations. Prepare fresh solution ated with bluecomb (transmissible en- daily; use as the sole source of chlor- teritis, coronaviral enteritis). tetracycline; do not use for more than (2) Limitations. Prepare fresh solution 14 consecutive days; do not use in lay- daily; as sole source of chlortetra- ing chickens; do not administer to cycline; do not use for more than 14 chickens within 24 hours of slaughter. days; do not slaughter animals for food (B) Amount. 400 to 800 mg/gal, for 7 to within 24 hours of treatment. 14 days. (iii) Swine—(A) Amount. 10 milligrams (1) Indications for use. Control of per pound body weight daily in divided chronic respiratory disease (CRD) and doses. air-sac infections caused by M. (B) Indications for use. Control and gallisepticum and E. coli susceptible to treatment of bacterial enteritis chlortetracycline. (scours) caused by E. coli and Sal- (2) Limitations. As in paragraph monella spp. and bacterial pneumonia (d)(5)(i)(A)(2) of this section. associated with Pasteurella spp., (C) Amount. One thousand mg/gal, for Actinobacillus pleuropneumoniae 7 to 14 days. (Hemophilus spp.), and Klebsiella spp. (1) Indications for use. Control of mor- (C) Limitations. Prepare fresh solution tality due to fowl cholera caused by daily; as sole source of chlortetra- Pasteurella multocida susceptible to cycline; do not use for more than 5 chlortetracycline. days. For Nos. 000010 and 021930, do not (2) Limitations. As in paragraph slaughter animals for food within 5 (d)(5)(i)(A)(2) of this section. days of treatment. For No. 000010, do (ii) Growing Turkeys—(A) Amount. 400 not slaughter animals for food within mg/gal, for 7 to 14 days. 24 hours of treatment. (1) Indications for use. Control of in- (iv) Calves, beef cattle, and nonlac- fectious synovitis caused by Myco- tating dairy cattle—(A) Amount. 10 milli- plasma synoviae susceptible to chlor- grams per pound daily in divided doses. tetracycline. (B) Indications for use. Control and (2) Limitations. Prepare fresh solution treatment of bacterial enteritis daily; use as the sole source of chlor- (scours) caused by E. coli and Sal- tetracycline; do not use for more than monella spp. and bacterial pneumonia 14 consecutive days; do not administer (shipping fever complex) associated to growing turkeys within 24 hours of with Pasteurella spp., A. slaughter.

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(B) Amount. 25 mg/lb body weight (b) Sponsor. See No. 054628 in daily, for 7 to 14 days. § 510.600(c) of this chapter. (1) Indications for use. Control of com- (c) Related tolerances. See § 556.150 of plicating bacterial organisms associ- this chapter. ated with bluecomb (transmissible en- (d) Conditions of use in calves(1) teritis, coronaviral enteritis) suscep- Amount. One 250 milligram bolus per 50 tible to chlortetracycline. pounds of body weight twice a day for (2) Limitations. As in paragraph 3 to 5 days. (d)(5)(ii)(A)(2) of this section. (iii) Swine—(A) Amount. 10 mg/lb body (i) Indications for use. Treatment of weight daily, for 3 to 5 days. bacterial enteritis (scours) caused by (B) Indications for use. Control and Escherichia coli and bacterial pneu- treatment of bacterial enteritis monia associated with Pasteurella spp., (scours) caused by E. coli and Sal- Klesbsiella spp., and Hemophilus spp. monella spp., and bacterial pneumonia (ii) Limitations. Administer bolus di- associated with Pasteurella spp., A. rectly by mouth or crush and dissolve pleuropneumoniae, and Klebsiella spp. in milk or water for drenching or buck- susceptible to chlortetracycline. et feeding; if no improvement is noted (C) Limitations. Prepare fresh solution after 3 days of treatment, consult a daily; use as the sole source of chlor- veterinarian; do not use for more than tetracycline; do not use for more than 5 days; do not administer within 24 5 days; do not administer to swine hours of slaughter. within 24 hours of slaughter. (2) Amount. One 25 milligram tablet (iv) Calves, beef cattle, and nonlac- for each 5 pounds of body weight every —(A) 10 mg/lb tating dairy cattle Amount. 12 hours daily for 3 to 5 days. body weight daily in divided doses, for (i) Indications for use. Control and 3 to 5 days. (B) Indications for use. Control and treatment of bacterial enteritis treatment of bacterial enteritis (scours) caused by E. coli and Sal- (scours) caused by Escherichia coli and monella spp. and bacterial pneumonia Salmonella spp., and bacterial pneu- associated with Pasteurella spp., monia associated with Pasteurella spp., Hemophilus spp., and Klebsiella spp., sus- Histophilus spp., and Klebsiella spp. sus- ceptible to chlortetracycline. ceptible to chlortetracycline. (ii) Limitations. Administer tablet di- (C) Limitations. Prepare fresh solution rectly by mouth or crush and dissolve daily; use as a drench; use as the sole in water for drenching; if no improve- source of chlortetracycline; do not use ment is noted after 3 days of treat- for more than 5 days; do not administer ment, consult a veterinarian; do not to cattle within 24 hours of slaughter; use for more than 5 days; when feeding do not use in lactating dairy cattle; do milk or milk replacer, administration 1 not administer this product with milk hour before or 2 hours after feeding; do or milk replacers; administer 1 hour not administer within 24 hours of before or 2 hours after feeding milk or slaughter. milk replacers; a withdrawal period has (3) Amount. One 500 milligram bolus not been established in preruminating per 100 pounds of body weight twice a calves; do not use in calves to be proc- day for 3 to 5 days. essed for veal. (i) Indications for use. Treatment of [57 FR 37324, Aug. 18, 1992] bacterial enteritis (scours) caused by E. EDITORIAL NOTE: For FEDERAL REGISTER ci- coli and Salmonella spp., and bacterial tations affecting § 520.441, see the List of CFR pneumonia associated with Pasteurella Sections Affected, which appears in the spp., Hemophilus spp., and Klebsiella Finding Aids section of the printed volume spp., susceptible to chlortetracycline. and at www.fdsys.gov. (ii) Limitations. Administer directly § 520.443 Chlortetracycline tablets and by mouth or crush and dissolve in boluses. water for drenching; if no improvement (a) Specifications. Each tablet/bolus is noted after 3 days of treatment, con- contains 25, 250, or 500 milligrams (mg) sult a veterinarian; do not use for more chlortetracycline hydrochloride.

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than 5 days; do not administer within (3) No. 043806 for use of tablets de- 24 hours of slaughter. scribed in paragraph (a)(3) of this sec- tion. [57 FR 37325, Aug. 18, 1992, as amended at 67 FR 78355, Dec. 24, 2002. Redesignated and (c) Conditions of use in dogs(1) Amount. amended at 76 FR 49649, Aug. 11, 2011; 78 FR Wounds, abscesses, and dental infec- 21059, Apr. 9, 2013] tions: 2.5 to 15 mg per pound (/lb) body weight every 12 hours for a maximum § 520.445 Chlortetracycline and of 28 days. Osteomyelitis: 5.0 to 15 mg/ sulfamethazine powder. lb body weight every 12 hours for a (a) Specifications. Each pound of solu- minimum of 28 days. ble powder contains chlortetracycline (2) Indications for use. For the treat- bisulfate equivalent to 102.4 grams (g) ment of skin infections (wounds and of chlortetracycline hydrochloride and abscesses) due to susceptible strains of sulfamethazine bisulfate equivalent to coagulase-positive staphylococci 102.4 g of sulfamethazine. (Staphylococcus aureus or S. (b) Sponsor. See No. 000010 in intermedius), deep wounds and abscesses § 510.600(c) of this chapter. due to susceptible strains of Bacteroides (c) Related tolerances. See §§ 556.150 fragilis, Prevotella melaninogenicus, and 556.670 of this chapter. Fusobacterium necrophorum, and Clos- (d) Conditions of use in swine. Admin- tridium perfringens, dental infections ister in drinking water as follows: due to susceptible strains of S. aureus, (1) Amount. 250 milligrams (mg) of B. fragilis, P. melaninogenicus, F. chlortetracycline and 250 mg of necrophorum, and C. perfringens, and os- sulfamethazine per gallon. teomyelitis due to susceptible strains (2) Indications for use. For the preven- of S. aureus, B. fragilis, P. tion and treatment of bacterial enter- melaninogenicus, F. necrophorum, and C. itis; as an aid in the reduction of the perfringens. incidence of cervical abscesses; and as (3) Limitations. Federal law restricts an aid in the maintenance of weight this drug to use by or on the order of a gains in the presence of bacterial en- licensed veterinarian. teritis and atrophic rhinitis. [67 FR 54954, Aug. 27, 2002, as amended at 68 (3) Limitations. Use as the sole source FR 55824, Sept. 29, 2003; 69 FR 32273, June 9, of chlortetracycline and sulfonamide. 2004; 71 FR 39204, July 12, 2006; 73 FR 4077, Not to be used for more than 28 con- Jan. 24, 2008; 78 FR 17596, Mar. 22, 2013] secutive days. Withdraw 15 days before § 520.447 Clindamycin solution. slaughter. (a) Specifications. Each milliliter of [76 FR 49649, Aug. 11, 2011] solution contains the equivalent of 25 milligrams (mg) clindamycin as the § 520.446 Clindamycin capsules and hydrochloride salt. tablets. (b) Sponsors. See Nos. 000009, 000859, (a) Specifications(1) Each capsule con- 051311, 058829, and 061623 in § 510.600(c) of tains the equivalent of 25, 75, 150, or 300 this chapter. milligrams (mg) clindamycin as the (c) Special considerations. Federal law hydrochloride salt. restricts this drug to use by or on the (2) Each tablet contains the equiva- order of a licensed veterinarian. lent of 25, 75, or 150 mg clindamycin as (d) Conditions of use(1) Dogs—(i) the hydrochloride salt. Amount. Wounds, abscesses, and dental (3) Each capsule contains the equiva- infections: 2.5 to 15 mg per pound (/lb) lent of 25, 75, or 150 mg clindamycin as body weight every 12 hours for a max- the hydrochloride salt. imum of 28 days. Osteomyelitis: 5.0 to (b) Sponsors. See sponsors in 15 mg/lb body weight every 12 hours for § 510.600(c) of this chapter as follows: a minimum of 28 days. (1) Nos. 000009 and 000859 for use of (ii) Indications for use. For the treat- capsules described in paragraph (a)(1) ment of skin infections (wounds and of this section. abscesses) due to susceptible strains of (2) No. 051311 for use of tablets de- coagulase-positive staphylococci scribed in paragraph (a)(2) of this sec- (Staphylococcus aureus or S. tion. intermedius), deep wounds and abscesses

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due to susceptible strains of Bacteroides curs in chronic obstructive pulmonary fragilis, Prevotella melaninogenicus, disease (COPD). Fusobacterium necrophorum, and Clos- (iii) Limitations. Treat at effective tridium perfringens; dental infections dose for 30 days. At the end of the 30- due to susceptible strains of S. aureus, day treatment period, drug should be B. fragilis, P. melaninogenicus, F. withdrawn. If signs return, the 30-day necrophorum, and C. perfringens; and os- treatment period may be repeated. If teomyelitis due to susceptible strains repeating treatment, the step-wise dos- of S. aureus, B. fragilis, P. age schedule should be repeated. The melaninogenicus, F. necrophorum, and C. effect of this drug on breeding stallions perfringens. and brood mares has not been deter- (2) Cats—(i) Amount. 5.0 to 15.0 mg/lb mined. Treatment starting with dos- body weight every 24 hours for a max- ages higher than the initial dose is not imum of 14 days. recommended. Federal law prohibits (ii) Indications for use. For the treat- the extralabel use of this drug in food ment of skin infections (wounds and animals. Federal law restricts this abscesses) due to susceptible strains of drug to use by or on the order of a li- Staphylococcus aureus, S. intermedius, censed veterinarian. Streptococcus spp.; deep wounds and ab- (2) [Reserved] scesses due to susceptible strains of [63 FR 41419, Aug. 4, 1998] Clostridium perfringens and Bacteroides fragilis; and dental infections due to § 520.455 Clomipramine tablets. susceptible strains of S. aureus, S. intermedius, Streptococcus spp., C. (a) Specifications. Each tablet con- perfringens, and B. fragilis. tains 5, 20, 40, or 80 milligrams (mg) clomipramine hydrochloride. [67 FR 54954, Aug. 27, 2002, as amended at 67 (b) Sponsor. See No. 058198 in FR 78684, Dec. 26, 2002; 68 FR 55824, Sept. 29, § 510.600(c) of this chapter. 2003; 69 FR 31734, June 7, 2004; 71 FR 39543, (c) Conditions of use(1) Amount. 2 to 4 July 13, 2006; 72 FR 19796, Apr. 20, 2007; 78 FR 17596, Mar. 22, 2013; 78 FR 30197, May 22, 2013] milligrams of clomipramine hydro- chloride per kilogram (0.9 to 1.8 milli- § 520.452 Clenbuterol syrup. grams per pound) of body weight per day, administered as a single daily dose (a) Specifications. Each milliliter con- or divided twice daily. tains 72.5 micrograms of clenbuterol (2) Indications for use. For use as part hydrochloride. of a comprehensive behavioral manage- (b) Sponsor. See 000010 in § 510.600(c) of ment program to treat separation anx- this chapter. iety in dogs greater than 6 months of (c) [Reserved] age. (d) Conditions of use(1) Horses—(i) (3) Limitations. Federal law restricts Amount. Administer orally twice a day this drug to use by or on the order of a (b.i.d.). Initial dose is 0.5 milliliter per licensed veterinarian. 100 pounds body weight (0.8 micrograms per kilogram) for 3 days (6 treatments). [64 FR 1762, Jan. 12, 1999, as amended at 72 If no improvement, administer 1 milli- FR 262, Jan. 4, 2007] liter per 100 pounds (1.6 micrograms per § 520.462 Clorsulon drench. kilogram) for 3 days (6 treatments). If no improvement, administer 1.5 milli- (a) Specifications. The drug is a sus- liters per 100 pounds (2.4 micrograms pension containing 8.5 percent per kilogram) for 3 days (6 treatments). clorsulon (85 milligrams per milliliter). If no improvement, administer 2.0 mil- (b) Sponsor. See No. 050604 in liliters per 100 pounds (3.2 micrograms § 510.600(c) of this chapter. per kilogram) for 3 days (6 treatments). (c) Conditions of use. Cattle(1) Amount. If no improvement, horse is non- One-quarter fluid ounce per 200 pounds responder to clenbuterol and treatment of body weight (7 milligrams per kilo- should be discontinued. gram or 3.2 milligrams per pound of (ii) Indications for use. Indicated for body weight). the management of horses affected (2) Indications for use. For the treat- with airway obstruction, such as oc- ment of immature and adult liver fluke

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(Fasciola hepatica) infestations in cat- least 6 months of age and weighing at tle. least 3 pounds. (3) Limitations. Using dose syringe, (iii) Limitations. Federal law restricts deposit drench over back of tongue. Do this drug to use by or on the order of a not treat cattle within 8 days of licensed veterinarian. slaughter. Because a withdrawal time in milk has not been established, do [68 FR 54804, Sept. 19, 2003, as amended at 76 not use in female dairy cattle of breed- FR 78815, Dec. 20, 2011] ing age. Consult your veterinarian for assistance in the diagnosis, treatment, § 520.530 Cythioate oral liquid. and control of parasitism. (a) Specifications. Each milliliter con- [50 FR 10221, Mar. 14, 1985, as amended at 62 tains 15 milligrams of cythioate. FR 63270, Nov. 28, 1997] (b) Sponsor. See Nos. 000859 and 053501 in § 510.600 of this chapter. § 520.522 Cyclosporine. (c) Special considerations. Cythioate is (a) Specifications(1) Each cyclosporine a cholinesterase inhibitor. Do not use capsule, USP (MODIFIED) contains 10, this product in animals simultaneously 25, 50, or 100 milligrams (mg) with or within a few days before or cyclosporine. after treatment with or exposure to (2) Each milliliter of cyclosporine cholinesterase-inhibiting drugs, insec- oral solution, USP (MODIFIED) con- ticides, pesticides, or chemicals. tains 100 mg cyclosporine. (d) Conditions of use(1) Amount. 15 mil- (b) Sponsor. See No. 058198 in ligrams cythioate per 10 pounds of body § 510.600(c) of this chapter. weight every third day or twice a week. (c) [Reserved] (2) Indications for use. Dogs, for con- (d) Conditions of use(1) Dogs. Use cap- trol of fleas. sules described in paragraph (a)(1) of (3) Limitations. For oral use in dogs this section as follow: only. Do not use in greyhounds or in (i) Amount. Administer 5 mg per kilo- animals that are pregnant, sick, under gram (mg/kg) of body weight given stress, or recovering from surgery. Fed- orally as a single daily dose for 30 days. eral law restricts this drug to use by or Following this initial daily treatment on the order of a licensed veterinarian. period, the dosage may be tapered by decreasing the frequency of adminis- [49 FR 5614, Feb. 14, 1984, as amended at 67 tration to every other day or two times FR 78355, Dec. 24, 2002] a week, until a minimum frequency is reached which will maintain the de- § 520.531 Cythioate tablets. sired therapeutic effect. (a) [Reserved] (ii) Indications for use. For the control (b) Sponsors. See No. 000859 in of atopic dermatitis in dogs weighing § 510.600(c) of this chapter for use of 30- at least 4 pounds. and 90-milligram (mg) tablets and see (iii) Limitations. Federal law restricts No. 053501 in § 510.600(c) of this chapter this drug to use by or on the order of a for use of 30-mg tablet. licensed veterinarian. (2) Cats. Use the solution described in (c) Special considerations. Cythioate is paragraph (a)(2) of this section as fol- a cholinesterase inhibitor. Do not use low: this product in animals simultaneously (i) Amount. Administer 7 mg/kg of with or within a few days before or body weight orally as a single daily after treatment with or exposure to dose for a minimum of 4 to 6 weeks or cholinesterase-inhibiting drugs, insec- until resolution of clinical signs. Fol- ticides, pesticides, or chemicals. lowing this initial daily treatment pe- (d) Conditions of use(1) Amount. 30 mil- riod, the dosage may be tapered by de- ligrams cythioate per 20 pounds of body creasing the frequency of administra- weight every third day or twice a week. tion to every other day or twice weekly (2) Indications for use. Dogs, for con- to maintain the desired therapeutic ef- trol of fleas. fect. (3) Limitations. For oral use in dogs (ii) Indications for use. For the control only. Do not use in greyhounds or in of feline allergic dermatitis in cats at animals that are pregnant, sick, under

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stress, or recovering from surgery. Fed- (3) Limitations. Federal law restricts eral law restricts this drug to use by or this drug to use by or on the order of a on the order of a licensed veterinarian. licensed veterinarian. [49 FR 5615, Feb. 14, 1984, as amended at 59 [67 FR 68760, Nov. 13, 2002, as amended at 68 FR 26942, May 25, 1994; 67 FR 78355, Dec. 24, FR 18882, Apr. 17, 2003; 72 FR 37437, July 10, 2002] 2007; 73 FR 33692, June 13, 2008; 77 FR 3928, Jan. 26, 2012] § 520.534 Decoquinate. (a) Specifications. The drug is a pow- § 520.540 Dexamethasone oral dosage der containing 0.8 percent decoquinate. forms. (b) Sponsor. See No. 046573 in § 510.600(c) of this chapter. § 520.540a Dexamethasone powder. (c) Related tolerances. See § 556.170 of (a) Specifications. Dexamethasone this chapter. powder is packaged in packets con- (d) Conditions of use. Calves(1) Amount. taining 10 milligrams of dexametha- Feed 22.7 milligrams per 100 pounds of sone. body weight (0.5 milligram per kilo- (b) Sponsor. See No. 000061 in gram) per day. § 510.600(c) of this chapter. (2) Indications for use. For the preven- (c) Conditions of use. (1) Dexametha- tion of coccidiosis in ruminating and sone powder is indicated in cases where nonruminating calves, including veal cattle and horses require additional calves, caused by Eimeria bovis and E. steroid therapy following its parenteral zuernii. administration. The drug is used as (3) Limitations. Feed in whole milk at supportive therapy for management or the rate of 22.7 milligrams per 100 inflammatory conditions such as acute pounds body weight daily (0.5 milli- arthritic lameness, and for various gram per kilogram) for at least 28 days. stress conditions where corticosteroids [64 FR 10103, Mar. 2, 1999, as amended at 64 are required while the animal is being FR 30386, June 8, 1999] treated for a specific condition. (2) The drug is administered at a dos- § 520.538 Deracoxib. age level of 5 to 10 milligrams per ani- (a) Specifications. Each tablet con- mal the first day then 5 milligrams per tains 12, 25, 50, 75, or 100 milligrams day as required by drench or by sprin- (mg) deracoxib. kling on a small amount of feed. (b) Sponsor. See No. 058198 in (3) Clinical and experimental data § 510.600(c) of this chapter. have demonstrated that corticosteroids (c) [Reserved] administered orally or parenterally to (d) Conditions of use in dogs—(1) animals may induce the first stage of Amount. Administer orally as needed, parturition when administered during as a single daily dose based on body the last trimester of pregnancy and weight: may precipitate premature parturition (i) 1 to 2 mg/kilogram (kg) (0.45 to followed by dystocia, fetal death, re- 0.91 mg/pound (lb)), for use as in para- tained placenta, and metritis. graph (d)(2)(i) of this section. (4) Federal law restricts this drug to (ii) 1 to 2 mg/kg (0.45 to 0.91 mg/lb) for use by or on the order of a licensed vet- 3 days, for use as in paragraph (d)(2)(ii) erinarian. A withdrawal period has not of this section. been established for this product in (iii) 3 to 4 mg/kg (1.4 to 1.8 mg/lb) for preruminating calves. Do not use in up to 7 days, for use as in paragraph calves to be processed for veal. (d)(2)(iii) of this section. (2) Indications for use. (i) For the con- [40 FR 13838, Mar. 27, 1975; 41 FR 9149, Mar. 3, trol of pain and inflammation associ- 1976; 52 FR 7832, Mar. 13, 1987; 70 FR 16934, ated with osteoarthritis. Apr. 4, 2005] (ii) For the control of postoperative pain and inflammation associated with § 520.540b Dexamethasone tablets and dental surgery. boluses. (iii) For the control of postoperative (a)(1) Specifications. Each bolus is pain and inflammation associated with half-scored and contains 10 milligrams orthopedic surgery. of dexamethasone.

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(2) Sponsor. See No. 000061 in that corticosteriods administered oral- § 510.600(c) of this chapter. ly or by injection to animals may in- (3) Conditions of use. (i) Dexametha- duce the first stage of parturition when sone bolus is indicated in cases where administered during the last trimester cattle and horses require additional of pregnancy; and they may precipitate steroid therapy following its parenteral premature parturition followed by administration. The drug may be used dystocia, fetal death, retained pla- as supportive therapy for management centa, and metritis. of inflammatory conditions such as (b) Do not use in viral infections. acute arthritic lamenesses, and for var- Anti-inflammatory action of ious stress conditions where corticosteroids may mask signs of in- corticosteroids are required while the fections. Do not use in animals with animal is being treated for a specific tuberculosis, chronic nephritis, condition. cushingoid syndrome, or peptic ulcers, (ii) Administered orally, 5 to 10 milli- except for emergency therapy.1 grams for the first day, then 5 milli- (c) Federal law restricts this drug to grams per day as required. use by or on the order of a licensed vet- (iii) Do not use in viral infections erinarian.1 during the viremic stage. With bac- terial infections, appropriate anti- [40 FR 26273, June 23, 1975, as amended at 44 bacterial therapy should be used. FR 7130, Feb. 6, 1979; 50 FR 49372, Dec. 2, 1985; 52 FR 7832, Mar. 13, 1987; 55 FR 8461, Mar. 8, (iv) Do not use in animals with 1990; 66 FR 14073, Mar. 9, 2001; 68 FR 4914, Jan. chronic nephritis and hypercorticalism 31, 2003; 70 FR 16934, Apr. 4, 2005] (cushingoid syndrome), except for emergency therapy. § 520.540c Dexamethasone chewable (v) Clinical and experimental data tablets. have demonstrated that corticosteroids (a) Specifications. Each half-scored administered orally or by injection to tablet contains 0.25 milligram of dexa- animals may induce the first stage of methasone.1 parturition when administered during (b) Sponsor. See No. 000069 in the last trimester of pregnancy and § 510.600(c) of this chapter. may precipitate premature parturition (c) Conditions of use(1) Amount. 0.25 to followed by dystocia, fetal death, re- 1.25 milligrams per day.1 tained placenta, and metritis. (2) Indications for use. Supportive (vi) Federal law restricts this drug to therapy in nonspecific dermatosis and use by or on the order of a licensed vet- inflammatory conditions in dogs.1 erinarian. A withdrawal period has not (3) Limitations. (i) Administer by free- been established for this product in choice feeding or crumble over food. preruminating calves. Do not use in Administer 0.25 to 1.25 milligrams daily calves to be processed for veal. in single or two divided doses until re- (b)(1) Specifications. Each tablet con- sponse is noted or 7 days have elapsed. tains 0.25 milligram of dexametha- When response is attained, dosage sone.1 (2) Sponsors. See Nos. 000061 and 061623 should be gradually reduced by 0.125 in § 510.600(c) of this chapter. milligram per day until maintenance (3) Conditions of use—(i) Amount. level is achieved. Dogs: Administer orally at 0.25 to 1.25 (ii) Clinical and experimental data milligrams per day for up to 7 days. have demonstrated that corticosteriods Cats: 0.125 to 0.5 milligram per day for administered orally or parenterally to up to 7 days.1 animals may induce the first stage of (ii) Indications for use. In treatment parturition when administered during of dogs and cats as an anti-inflam- the last trimester of pregnancy; and matory agent.1 they may precipitate premature partu- (iii) Limitations. (a) Clinical and ex- rition followed by dystocia, fetal death, perimental data have demonstrated retained placenta, and metritis. (iii) Do not use in viral infections. 1 These conditions are NAS/NRC reviewed Anti-inflammatory action of and deemed effective. Applications for these corticosteriods may mask signs of in- uses need not include effectiveness data as fection. Do not use in animals with tu- specified by § 514.111 of this chapter. berculosis, chronic nephritis,

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cushingoid syndrome, or peptic ulcers, period without the addition of milk or except for emergency therapy.1 milk replacer. (iv) Federal law restricts this drug to [48 FR 38606, Aug. 25, 1983, as amended at 56 use by or on the order of a licensed vet- FR 50653, Oct. 8, 1991; 60 FR 55659, Nov. 2, erinarian. 1995; 76 FR 17336, Mar. 29, 2011] [44 FR 7130, Feb. 6, 1979, as amended at 56 FR § 520.563 Diatrizoate meglumine and 50653, Oct. 8, 1991; 60 FR 55659, Nov. 2, 1995] diatrizoate sodium oral solution. (a) Specifications. Diatrizoate § 520.550 Glucose/glycine/electrolyte. meglumine oral solution is a water (a) Specifications. The product is dis- soluble radiopaque medium containing tributed in packets each of which con- 66 percent diatrizoate meglumine and tains the following ingredients: Sodium 10 percent diatrizoate sodium. chloride 8.82 grams, potassium phos- (b) Sponsor. See No. 053501 in phate 4.20 grams, citric acid anhydrous § 510.600(c) of this chapter. 0.5 gram, potassium citrate 0.12 gram, (c) Conditions of use. (1) It is indicated aminoacetic acid (glycine) 6.36 grams, for radiography of the gastrointestinal and glucose 44.0 grams. tract in dogs and cats. (b) Sponsor. See No. 000069 in (2) It is administered orally at a dos- age level of 0.5 to 1.0 milliliter per § 510.600(c) of this chapter. pound of body weight by gavage or (c) Conditions of use. (1) Glucose/gly- stomach tube. It is administered rec- cine/electrolyte is indicated for use in tally at a dosage level of 0.5 to 1.0 mil- the control of dehydration associated liliter per pound of body weight diluted with diarrhea (scours) in calves. It is with 1 part of the drug to 5 parts of used as an early treatment at the first water. signs of scouring. It may also be used (3) Federal law restricts this drug to as followup treatment following intra- use by or on the order of a licensed vet- venous fluid therapy. erinarian. (2) Dissolve each packet in two [44 FR 12993, Mar. 9, 1979, as amended at 50 quarts of warm water and administer FR 41489, Oct. 11, 1985] to each calf as follows: (i) Scouring and/or dehydrated calves. § 520.580 Dichlorophene and toluene. Feed 2 quarts of solution, twice daily (a) Specifications. Each capsule con- for 2 days (four feedings). No milk or tains 50 milligrams (mg) of milk replacer should be fed during this dichlorophene and 60 mg of toluene, or period. For the next four feedings (days multiples thereof. 3 and 4), use 1 quart of solution to- (b) Sponsors. See sponsors in gether with 1 quart of milk replacer. § 510.600(c) of this chapter for use as in Thereafter, feed as normal. paragraph (c) of this section: (ii) Newly purchased calves. Feed 2 (1) Nos. 017135, 023851, 051311, and quarts of solution instead of milk as 058670 for use only as a single dose. (2) Nos. 000061 and 054628 for use in a the first feed upon arrival. For the next single dose or divided-dosage regimen. scheduled feeding, use 1 quart of solu- (c) Required statement. Consult your tion mixed together with 1 quart of veterinarian for assistance in the diag- milk or milk replacer. Thereafter, feed nosis, treatment, and control of para- as normal. sitism, and before administering to (3) The product should not be used in weak or debilitated animals. animals with severe dehydration (1) Amount. Administer as follows: (down, comatose, or in a state of (i) Single dose: Administer 100 mg of shock). Such animals need intravenous dicholorophene and 120 mg of toluene therapy. A veterinarian should be con- per pound of body weight. sulted in severely scouring calves. The (ii) Divided dose: Administer 100 mg product is not nutritionally complete if of dichlorophene and 120 mg of toluene administered by itself for long periods per 5 pounds of body weight (20 and 24 of time. It should not be administered mg per pound) daily for 6 days. beyond the recommended treatment (2) Indications for use. For the re- moval of ascarids (Toxocara canis and

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Toxascaris leonina) and hookworms lumen of the gastrointestinal tract of (Ancylostoma caninum and Uncinaria pigs, boars, and open or bred gilts and stenocephala); and as an aid in remov- sows. ing tapeworms (Taenia pisiformis, (2) The preparation should be added Dipylidium caninum, and Echinococcus to the indicated amount of feed as set granulosus) from dogs and cats. forth in paragraph (e)(2) of this section (3) Limitations. Withhold solid foods and administered shortly after mixing, and milk for at least 12 hours prior to as follows: medication and for 4 hours afterward. Pounds of Repeat treatment in 2 to 4 weeks in Pounds of mixed feed Number of animals subject to reinfection. feed to be to be admin- pigs to be Weight of ani- mixed with istered to treated per mal in pounds each 0.08 [45 FR 10332, Feb. 15, 1980] ounce of each pig as 0.08 ounce dichlorvos a single of dichlorvos EDITORIAL NOTE: For FEDERAL REGISTER ci- treatment tations affecting § 520.580, see the List of CFR 20–30 ...... 4 0.33 12 Sections Affected, which appears in the 31–40 ...... 5 0.56 9 Finding Aids section of the printed volume 41–60 ...... 6 1.00 6 and at www.fdsys.gov. 61–80 ...... 5 1.00 5 81–100 ...... 4 1.00 4 Adult Gilts, § 520.581 Dichlorophene tablets. Sows, and (a) Specifications. Each tablet con- Boars ...... 16 4.00 4 tains 1 gram of dichlorophene. (b) Sponsor. See 023851 in § 510.600(c) of (3) Do not use this product on ani- this chapter. mals either simultaneously or within a (c) Required statement. Consult your few days before or after treatment with veterinarian for assistance in the diag- or exposure to cholinesterase inhib- nosis, treatment, and control of para- iting drugs, pesticides, or chemicals. sitism, and before administering to The preparation should be mixed thor- weak or debilitated animals. oughly with the feed on a clean, imper- (d) Conditions of use. Dogs(1) Amount. vious surface. Do not allow swine ac- Single dose of 1 tablet (1 gram of cess to feed other than that containing dichlorophene) for each 10 pounds of the preparation until treatment is body weight. complete. Do not treat pigs with signs (2) Indications for use. It is used as an of scours until these signs subside or aid in the removal of tapeworms are alleviated by proper medication. (Taenia pisiformis and Dipylidium Resume normal feeding schedule after- caninum). wards. Swine may be retreated in 4 to (3) Limitations. Withhold solid foods 5 weeks. (f) Conditions of use in dogs. (1) For re- and milk for at least 12 hours prior to moval of Toxocara canis and Toxascaris medication and for 4 hours afterward. leonina (roundworms), Ancylostoma [45 FR 10333, Feb. 15, 1980] caninum and Uncinaria stenocephala (hookworms), and Trichuris vulpis § 520.600 Dichlorvos. (whipworm) residing in the lumen of (a) Chemical name. 2,2-Dichlorvinyl the gastrointestinal tract. dimethyl phosphate. (2) The drug is in capsule form for di- (b) [Reserved] rect administration and in pellet form (c) Sponsor. See No. 054628 in for administration in about one-third § 510.600(c) of this chapter. of the regular canned dog food ration (d) Related tolerances. See § 556.180 of or in ground meat. Dogs may be treat- this chapter. ed with any combination of capsules (e) Conditions of use in swine. (1) It is and/or pellets so that the animal re- recommended for the removal and con- ceives a single dose equaling 12 to 15 trol of sexually mature (adult), sexu- milligrams of the active ingredient per ally immature and/or 4th stage larvae pound of body weight. One-half of the of the whipworm (Trichuris suis), nod- single recommended dosage may be ular worms (Oesophagostomum spp.), given, and the other half may be ad- large round-worm (Ascaris suum), and ministered 8 to 24 hours later. This the mature thick stomach worm split dosage schedule should be used in (Ascarops strongylina) occurring in the animals which are very old, heavily

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parasitized, anemic, or otherwise de- blockage of the intestinal tract, the bilitated. The drug should not be used split dosage should be utilized. in dogs weighing less than 2 pounds. (4) Do not use in horses which are se- (3) In some dogs, efficacy against verely debilitated, suffering from diar- Trichurias vulpis (whipworm) may be er- rhea or severe constipation, infectious ratic. Dogs that do not develop a nega- disease, toxemia or colic. Do not ad- tive stool for Trichuris vulpis ova 10 to minister in conjunction with or within 14 days following initial treatment 1 week of administration of muscle re- should be re-treated. If a negative stool laxant drugs, phenothiazine derived is not obtained in 10 to 14 days fol- tranquilizers or central nervous system lowing re-treatment, alternate means depressant drugs. Horses should not be of therapy should be considered. subjected to insecticide treatment for 5 (4) Do not use in dogs infected with days prior to or after treating with the Dirofilaria immitis. drug. Do not administer to horses af- (5) Do not use with other flicted with chronic alveolar emphy- , taeniacides, antifilarial sema (heaves) or related respiratory agents, muscle relaxants, or tranquil- conditions. The product is a cholin- izers. esterase inhibitor and should not be (6) The drug is a cholinesterase inhib- used simultaneously or within a few itor. Not for use simultaneously or days before or after treatment with or within a few days before or after treat- exposure to cholinesterase inhibiting ment with or exposure to cholin- drugs, pesticides or chemicals. esterase-inhibiting drugs, pesticides, or (5) Do not use in animals other than chemicals. horses, ponies, and mules. Do not use (7) Federal law restricts this drug to in horses, ponies, and mules intended use by or on the order of a licensed vet- for food purposes. Do not allow fowl ac- erinarian. cess to feed containing this preparation (g) Conditions of use in horses when ad- or to fecal excrement from treated ani- ministered in grain. (1) It is rec- mals. ommended for the removal and control (h) Conditions of use in horses when of bots (Gastrophilus intestinalis, G. na- administered orally by syringe. (1) It is salis), large strongyles (Strongylus recommended for the removal and con- vulgaris, S. equinus, S. edentatus), small trol of first, second, and third instar strongyles (of the genera bots (Gastrophilus intestinalis and G. na- Cyathostomum, Cylicocercus, salis), sexually mature and sexually im- Cylicocyclus, Cylicodontophorus, mature (4th stage) ascarids (Parascaris Triodontophorus, Poteriostomum, equorum) in horses and foals. Gyalocephalus), pinworms (Oxyuris (2) The product is in the form of a gel equi), and large roundworm (Parascaris which is administered directly from a equorum) in horses including ponies and syringe onto the horse’s tongue. The mules. Not for use in foals (sucklings product is administered at a dosage and young weanlings). level of 20 milligrams of dichlorvos per (2) For a satisfactory diagnosis, a mi- kilogram of body weight for the re- croscopic fecal examination should be moval of bots and ascarids. The same performed by a veterinarian or a diag- dosage level is repeated every 21 to 28 nostic laboratory prior to worming. days for the control of bots and (3) It is administered in the grain ascarids. For the control of bots only, portion of the ration at a dosage of 14.2 the repeat dosage is 10 milligrams per milligrams to 18.5 milligrams per kilogram of body weight every 21 to 28 pound of body weight as a single dose. days during bot fly season. It may be administered at one-half of (3) Do not use this product in animals the single recommended dosage and re- simultaneously or within a few days peated 8 to 12 hours later in the treat- before or after treatment with or expo- ment of very aged, emaciated or debili- sure to cholinesterase-inhibiting drugs, tated subjects or those reluctant to pesticides or chemicals. Do not admin- consume medicated feed. In suspected ister in conjunction with or within 1 cases of severe ascarid infection suffi- week of administration of muscle-re- cient to cause concern over mechanical laxant drugs, phenothiazine derived

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tranquilizers, or central nervous sys- (b) Sponsor. See No. 000061 in tem depressants. § 510.600(c) of this chapter. (4) Do not use in horses which are (c) Conditions of use in horses(1) severly debilitated or suffering from di- Amount. Administer 1 milligram (mg) arrhea or severe constipation, infec- per kilogram (0.45 mg per pound) of tious disease, toxemia, or colic. Do not body weight in the daily grain ration administer to horses affected with for 28 days. chronic alveolar emphysema (heaves) (2) Indications for use. For the treat- or other respiratory conditions. ment of equine protozoal (5) Do not use in horses intended for myeloencephalitis (EPM) caused by food purposes. Sarcocystis neurona. (6) Federal law restricts this drug to (3) Limitations. Do not use in horses use by or on the order of a licensed vet- intended for human consumption. Fed- erinarian. eral law restricts this drug to use by or (i) Conditions of use in dogs, cats, pup- on the order of a licensed veterinarian. pies, and kittens. (1) Each tablet con- [72 FR 20943, Apr. 27, 2007] tains 2, 5, 10, or 20 milligrams of dichlorvos. § 520.608 Dicloxacillin sodium (2) It is administered orally at 5 mil- monohydrate capsules. ligrams of dichlorvos per pound of body (a) Specifications. Each capsule con- weight. tains dicloxacillin sodium (3) Dogs and puppies: Removal and monohydrate equivalent to 50, 100, 200, control of intestinal roundworms or 500 milligrams of dicloxacillin. (Toxocara canis and Toxascaris leonina) (b) Sponsor. See No. 000856 in § 510.600 and hookworms (Ancylostoma caninum (c) of this chapter. and Uncinaria stenocephala). (c) Conditions of use. Dogs(1) Amount. 5 (4) Cats and kittens: Removal and to 10 milligrams per pound of body control of intestinal roundworms weight, three times daily. In severe ( and Toxascaris leonina) cases, up to 25 milligrams per pound of and hookworms (Ancylostoma body weight three times daily. tubaeforme and Uncinaria stenocephala). (2) Indications for use. Treatment of (5) Dichlorvos is a cholinesterase in- pyoderma (pyogenic dermatitis) due to hibitor. Do not use simultaneously penicillinase-producing staphylococci with or within a few days before or sensitive to the drug. after treatment with or exposure to (3) Limitations. For the treatment of cholinesterase-inhibiting drugs, pes- dogs only. Continue treatment for 24 to ticides, or chemicals. 48 hours after the animal has become (6) Do not use in animals under 10 afebrile or asymptomatic, Administer 1 days of age or 1 pound of body weight. to 2 hours before feeding to ensure (7) Do not administer to animals maximum absorption. Not for use in showing signs of constipation, mechan- animals which are raised for food pro- ical blockage of the intestinal tract, duction. Federal law restricts this drug impaired liver function, or recently ex- to use by or on the order of a licensed posed to or showing signs of infectious veterinarian. disease. [57 FR 37325, Aug. 18, 1992] (8) Do not use in dogs or puppies in- fected with Dirofilaria immitis. § 520.620 Diethylcarbamazine oral dos- (9) Federal law restricts this drug to age forms. use by or on the order of a licensed vet- § 520.622 Diethylcarbamazine citrate erinarian. oral dosage forms. [40 FR 13838, Mar. 27, 1975, as amended at 48 FR 40704, Sept. 9, 1983; 51 FR 28546, Aug. 8, § 520.622a Diethylcarbamazine citrate 1986; 62 FR 35076, June 30, 1997; 64 FR 18571, tablets. Apr. 15, 1999; 78 FR 21059, Apr. 9, 2013] (a) Sponsors. (1) [Reserved] (2) See 053501 in § 510.600(c) of this § 520.606 Diclazuril. chapter for use of 100, 200, and 300 milli- (a) Specifications. Each 100 grams (g) gram tablets for prevention of heart- of pellets contain 1.56 g diclazuril. worm disease in dogs and as an aid in

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the treatment of ascarid infections in (3) Conditions of use. (i) The drug is dogs. indicated for use in dogs for the pre- (3) See 061623 in § 510.600(c) of this vention of infection with Dirofilaria chapter for use of 50, 100, 200, 300, or 400 immitis and T. canis and T. leonina. It is milligram tablets for prevention of also indicated for treatment of ascarid heartworm disease in dogs, as an aid in infections of T. canis and T. leonina in the control of ascarid infections in dogs and T. cati in cats. dogs, and as an aid in the treatment of (ii) For prevention of heartworm and ascarid infections in dogs and cats. ascarid infections in dogs, the drug (4) [Reserved] may be added to the daily diet at a dos- (5) See No. 000061 in § 510.600(c) of this age rate of 3.0 milligrams per pound of chapter for use of 60, 120, or 180 milli- body weight per day or given directly gram tablets for prevention of heart- by mouth at the same dosage rate. For worm disease in dogs, as an aid in the treatment of ascarid infections in dogs control of ascarid infections in dogs, and cats, the drug is administered at a and as an aid in the treatment of asca- dosage level of 25 to 50 milligrams per rid infections in dogs and cats. pound of body weight preferably ad- (6) See No. 054628 in § 510.600(c) of this ministered immediately after feeding. chapter for use of 50, 100, 200, 300, or 400 (iii) Older dogs should be proven neg- milligram tablets for prevention of ative for the presence of Dirofilaria heartworm disease in dogs, as an aid in immitis infection before administration the control of ascarid infections in of the drug. Those with proven infec- dogs, and as an aid in the treatment of tion of Dirofilaria immitis should be ren- ascarid infections in dogs and cats. dered negative using adulticidal and (b) Conditions of use(1) Dosage/indica- microfilaricidal drugs before adminis- tions for use. (i) Three milligrams per pound of body weight daily for preven- tration of this drug. tion of heartworm disease (Dirofilaria (iv) Federal law restricts this drug to immitis) in dogs. use by or on the order of a licensed vet- (ii) Three milligrams per pound of erinarian. body weight daily as an aid in the con- (b) [Reserved] trol of ascarid infections (Toxocara (c)(1) Specifications. Each milliliter of canis) in dogs. syrup contains 60 milligrams of (iii) Twenty-five to 50 milligrams per diethylcarbamazine citrate. pound of body weight as an aid in the (2) Sponsor. See No. 054628 in treatment of ascarid infections in dogs § 510.600(c) of this chapter. (Toxocara canis) and cats (Toxocara (3) Conditions of use. (i) The drug is canis and Toxascaris leonina). used in dogs between 4 weeks and 8 (2) Limitations. Federal law restricts months of age for the removal of this drug to use by or on the order of a ascarids (Toxacara canis) and in ani- licensed veterinarian. mals over 4 weeks of age for the pre- [46 FR 23230, Apr. 24, 1981, as amended at 46 vention of heartworm disease FR 41038, Aug. 14, 1981; 46 FR 46315, Sept. 18, (Dirofilaria immitis). 1981; 46 FR 61653, Dec. 18, 1981; 47 FR 10805, (ii) The drug is administered (a) for Mar. 12, 1982; 47 FR 14150, Apr. 2, 1982; 50 FR removal of ascarids at a dosage of 50 41489, Oct. 11, 1985; 50 FR 49372, Dec. 2, 1985; milligrams per pound of body weight 53 FR 40056, Oct. 13, 1988; 53 FR 40727, Oct. 18, divided into two equal doses and ad- 1988; 55 FR 8461, Mar. 8, 1990; 61 FR 34728, ministered 8 to 12 hours apart (morning July 3, 1996; 62 FR 35076, June 30, 1997; 66 FR 14073, Mar. 9, 2001; 68 FR 4914, Jan. 31, 2003; 76 and night), orally or mixed with either FR 17777, Mar. 31, 2011; 77 FR 4896, Feb. 1, dry or wet food, and (b) for prevention 2012; 78 FR 21059, Apr. 7, 2013] of heartworm disease at a dosage of 3 milligrams per pound of body weight § 520.622b Diethylcarbamazine citrate daily, orally or in food, in heartworm syrup. endemic areas, from the beginning of (a)(1) Specifications. Each milliliter of mosquito activity, during the mosquito syrup contains 60 milligrams of season, and for 2 months following the diethylcarbamazine citrate. end thereof. (2) Sponsor. See No. 053501 in (iii) Dogs older than 8 months of age § 510.600(c) of this chapter. may be infected with Dirofilaria immitis.

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Use of the drug is contraindicated in (3) Limitations. Federal law restricts dogs with active D. immitis infections. this drug to use by or on the order of a (iv) Federal law restricts this drug to licensed veterinarian. use by or on the order of a licensed vet- [43 FR 6941, Feb. 17, 1978] erinarian. EDITORIAL NOTE: For FEDERAL REGISTER ci- [40 FR 13838, Mar. 27, 1975, as amended at 41 tations affecting § 520.622c, see the List of FR 28265, July 9, 1976; 44 FR 3967, Jan. 19, CFR Sections Affected, which appears in the 1979; 47 FR 14150, Apr. 2, 1982; 47 FR 35186, Finding Aids section of the printed volume Aug. 13, 1982; 49 FR 33997, Aug. 28, 1984; 50 FR and at www.fdsys.gov. 41489, Oct. 11, 1985; 53 FR 47027, Oct. 18, 1988; 61 FR 34728, July 3, 1996; 62 FR 35076, June 30, § 520.623 Diethylcarbamazine citrate, 1997; 62 FR 38906, July 21, 1997; 77 FR 4897, oxibendazole chewable tablets. Feb. 1, 2012; 78 FR 21059, Apr. 9, 2013] (a) Specifications. Each tablet con- § 520.622c Diethylcarbamazine citrate tains either 60, 120, or 180 milligrams of chewable tablets. diethylcarbamazine citrate with 45, 91, (a) Specifications. Each chewable tab- or 136 milligrams of oxibendazole, re- let contains 30, 45, 60, 120, 150, or 180 spectively. milligrams of diethylcarbamazine cit- (b) Sponsor. See 000069 in § 510.600(c) of rate. this chapter. (b) Sponsors. See drug listing nos. in (c) Conditions of use in dogs—(1) § 510.600(c) of this chapter for identi- Amount. Administer orally to dogs at a fication of sponsors as follows: dosage level of 6.6 milligrams of (1) [Reserved] diethylcarbamazine citrate per kilo- (2) For 000069, use of 60, 120, or 180 gram of body weight (3 milligrams per milligram tablets as in paragraph pound of body weight) and 5.0 milli- (c)(2)(ii) of this section. grams of oxibendazole per kilogram of (3) For 061690, use of 45 or 150 milli- body weight (2.27 milligrams per pound gram tablets as in paragraph (c)(2)(iii) of body weight). of this section. (2) Indications for use. For prevention (4) For 061133, use of 60-, 120-, or 180- of infection with Dirofilaria immitis milligram tablets as in paragraph (heartworm disease) and Ancylostoma (c)(2)(i) of this section. caninum (hookworm infection) and for (5) For 000061, use of 60-milligram removal and control of Trichuris vulpis tablets as in paragraph (c)(2)(i) of this (whipworm infection) and mature and section. immature stages of intestinal Toxocara (6) For 054628, use of 30, 60, 120, or 180 canis (ascarid infection). milligram tablets as in paragraph (3) Limitations. Orally administer (c)(2)(i) of this section. daily during heartworm season. For (c) Conditions of use(1) Amount. 3 mil- free-choice feeding or broken and ligrams per pound of body weight per placed on or mixed with feed. Do not day for prevention of heartworm dis- use in dogs that may harbor adult ease and control of ascarids; 25 to 50 heartworms. Federal law restricts this milligrams per pound of body weight as drug to use by or on the order of a li- an aid in treatment of ascarid infec- censed veterinarian. tions. [50 FR 28768, July 16, 1985, as amended at 53 (2) Indications for use. (i) For preven- FR 45759, Nov. 14, 1988; 54 FR 3776, Jan. 26, tion of heartworm disease (Dirofilaria 1989; 54 FR 6804, Feb. 14, 1989; 56 FR 50653, immitis) in dogs; as an aid in control of Oct. 8, 1991; 60 FR 55659, Nov. 2, 1995] ascarids (Toxocara canis) in dogs; as an aid in treatment of ascarid (Toxocara § 520.645 Difloxacin. canis and Toxascaris leonina) infections (a) Specifications. Each tablet con- in dogs and cats. tains 11.4, 45.4, or 136 milligrams (mg) (ii) For prevention of infection with of difloxacin hydrochloride. Dirofilaria immitis (heartworm disease) (b) Sponsor. See No. 000010 in in dogs; as an aid in treatment of asca- § 510.600(c) of this chapter. rid (Toxocara canis and Toxascaris (c) [Reserved] leonina) infections in dogs. (d) Conditions of use—(i) Amount. Ad- (iii) For prevention of heartworm dis- minister 5 to 10 mg per kilogram (2.3 to ease (Dirofilaria immitis) in dogs. 4.6 mg per pound) of body weight orally

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once a day for 2 to 3 days beyond ces- Milligrams Length of sation of clinical signs of disease up to per pound of body treatment— a maximum of 30 days. weight days (ii) Indications for use. For manage- Large roundworms (Toxocara ment of diseases in dogs associated canis, Toxascaris leonina) ...... 10 3–5 with bacteria susceptible to difloxacin. Hookworms (Ancylostoma (iii) Limitations. Federal law prohibits caninum, Uncinaria the extra-label use of this drug in food- stenocephala) ...... 10 7 producing animals. Federal law re- Whipworms (Trichuris vulpis) ...... 10 Strongyloides (Strongyloides stricts this drug to use by or on the canis, Strongyloides order of a licensed veterinarian. stercoralis) ...... 10 10–12 (2) [Reserved] Heartworm microfilariae (Dirofilaria immitus) ...... 3–5 7–10 [63 FR 8123, Feb. 18, 1998, as amended at 75 Note: Treatment with dithiazanine iodide for heartworm FR 10165, Mar. 5, 2010] microfilariae should follow 6 weeks after therapy for adult worms. § 520.666 Dirlotapide. (2) The drug is contraindicated in (a) Specifications. Each milliliter animals sensitive to dithiazanine io- (mL) of solution contains 5 milligrams dide and should be used cautiously, if (mg) dirlotapide. at all, in dogs with reduced renal func- (b) Sponsor. See No. 000069 in tion. § 510.600(c) of this chapter. (3) Federal law restricts this drug to (c) Conditions of use in dogs—(1) use by or on the order of a licensed vet- Amount. The initial dosage is 0.01 mL/ erinarian. kg (0.0045 mL/lb) body weight for the (e) Use for treating dogs for large first 14 days. After the first 14 days of roundworms, hookworms, whipworms, treatment, the dose volume is doubled and strongyloides as provided for in to 0.02 mL/kg (0.009 mL/lb) body weight this section has been NAS/NRC re- for the next 14 days (days 15 to 28 of viewed and deemed effective. Applica- treatment). Dogs should be weighed tions for these uses need not include ef- monthly and the dose volume adjusted fectiveness data as specified by § 514.111 every month, as necessary, to maintain of this chapter, but may require bio- a target percent weight loss until the equivalency and safety information. desired weight is achieved. (2) Indications for use. For the man- [40 FR 13838, Mar. 27, 1975, as amended at 47 FR 51564, Nov. 16, 1982; 48 FR 32342, July 15, agement of obesity. 1983; 53 FR 40727, Oct. 18, 1988; 62 FR 35076, (3) Limitations. Federal law restricts June 30, 1997; 78 FR 21059, Apr. 9, 2013] this drug to use by or on the order of a licensed veterinarian. § 520.763b Dithiazanine iodide powder. [72 FR 263, Jan. 4, 2007] (a) [Reserved] (b) Specifications. Dithiazanine iodide § 520.763 Dithiazanine iodide oral dos- powder contains 200 milligrams of age forms. dithiazanine iodide per level standard tablespoon. § 520.763a Dithiazanine iodide tablets. (c) Sponsor. See No. 054628 in (a) [Reserved] § 510.600(c) of this chapter. (b) Specifications. Dithiazanine iodide (d) Conditions of use. (1) Dithiazanine tablets contain 10 milligrams, 50 milli- iodide powder is administered to dogs grams, 100 milligrams, or 200 milli- by mixing the proper dosage in the grams of dithiazanine iodide in each dog’s food, using the following dosage tablet. schedule for various parasite infesta- (c) Sponsor. See No. 054628 in tions: § 510.600(c) of this chapter. (d) Conditions of use. (1) The tablets Milligrams Length of per pound treatment— are administered orally to dogs imme- of body days diately after feeding using the fol- weight lowing dosage schedule for various Large roundworms (Toxocara parasite infestations: canis, Toxascaris leonina) ...... 10 3–5

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gle dose. Treatment is recommended in Milligrams Length of per pound spring and fall. In a heavily infested of body treatment— weight days environment, treatment may be re- peated every 30 days. Not for use in Hookworms (Ancylostoma caninum, Uncinaria horses intended for food purposes. Se- stenocephala) ...... 10 7 verely debilitated animals should not Whipworms (Trichuris vulpis) ...... 10 7 be wormed except on the advice of a Strongyloides (Strongyloides veterinarian. If the drug is for adminis- canis, Strongyloides stercoralis) ...... 10 10–12 tration by stomach tube, it shall be la- Heartworm microfilariae beled: ‘‘Federal law restricts this drug (Dirofilaria immitus) ...... 3–5 7–10 to use by or on the order of a licensed Note: Treatment with dithiazanine iodide for heartworm veterinarian.’’ microfilariae should follow 6 weeks after therapy for adult worms. [47 FR 52696, Nov. 23, 1982, as amended at 48 FR 32342, July 15, 1983; 53 FR 40727, Oct. 18, (2) The drug is contraindicated in 1988; 62 FR 35076, June 30, 1997; 78 FR 21059, animals sensitive to dithiazanine io- Apr. 9, 2013] dide and should be used cautiously, if at all, in dogs with reduced renal func- § 520.766 Domperidone. tion. (a) Specifications. Each milliliter of (3) Federal law restricts this drug to gel contains 110 milligrams (mg) use by or on the order of a licensed vet- domperidone. erinarian. (b) Sponsor. See No. 043264 in § 510.600 (e) Use for treating dogs for large of this chapter. roundworms, hookworms, whipworms, (c) Conditions of use in horses—(1) and strongyloides as provided for in Amount. Administer 0.5 mg per pound this section has been NAS/NRC re- (mg/lb) (1.1 mg/kilogram (kg)) by viewed and deemed effective. Applica- mouth once daily starting 10 to 15 days tions for these uses need not include ef- prior to the expected foaling date. fectiveness data as specified by § 514.111 Treatment may be continued for up to of this chapter, but may require bio- 5 days after foaling if mares are not equivalency and safety information. producing adequate milk. [40 FR 13838, Mar. 27, 1975, as amended at 47 (2) Indications for use. For prevention FR 51564, Nov. 16, 1982; 48 FR 32342, July 15, of fescue toxicosis in periparturient 1983; 53 FR 40727, Oct. 18, 1988; 62 FR 35076, mares. June 30, 1997; 78 FR 21059, Apr. 9, 2013] (3) Limitations. Do not use in horses intended for human consumption. Fed- § 520.763c Dithiazanine iodide and pi- eral law restricts this drug to use by or perazine citrate suspension. on the order of a licensed veterinarian. (a) Specifications. Each milliliter of [75 FR 67031, Nov. 1, 2010] the drug contains 69 milligrams of dithiazanine iodide and 83 milligrams § 520.784 Doxylamine succinate tab- of piperazine base (as piperazine cit- lets. rate). (a) Specifications. The drug is in tab- (b) Sponsor. See 054628 in § 510.600(c) of let form and contains doxylamine suc- this chapter. cinate as the active drug ingredient. (c) [Reserved] (b) Sponsor. See No. 000061 in (d) Conditions of use—(1) Amount. 1 § 510.600(c) of this chapter. ounce (30 milliliters) per 100 pounds of (c) Conditions of use. (1) The drug is body weight for the first 500 pounds; 3⁄4 used in conditions in which antihis- ounce for each 100 pounds thereafter, taminic therapy may be expected to al- up to 1,200 pounds; 101⁄4 ounces to ani- leviate some signs of disease in horses, mals over 1,200 pounds. dogs, and cats. 1 (2) Indications for use. For control of (2) It is administered orally to horses large roundworms, ; at a dosage level of 1 to 2 milligrams small strongyles; large strongyles, Strongylus vulgaris; and pinworms, 1 These conditions are NAS/NRC reviewed Oxyuris equi. and deemed effective. Applications for these (3) Limitations. Administer by drench uses need not include effectiveness data as or mixed with the daily ration as a sin- specified by § 514.111 of this chapter.

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per pound of body weight per day di- (b) Sponsors. See sponsor numbers in vided into 3 or 4 equal doses. It is ad- § 510.600(c) of this chapter for use as in ministered orally to dogs and cats at a paragraph (c) of this section. dosage level of 2 to 3 milligrams per (1) Nos. 000859 and 026637 for use of pound of body weight per day divided product described in paragraph (a)(1) of into 3 or 4 equal doses. 1 this section. (3) Not for use in horses intended for (2) No. 058198 for use of product de- food. 1 scribed in paragraph (a)(2) of this sec- (4) Federal law restricts this drug to tion. use by or on the order of a licensed vet- (c) Conditions of use in dogs and cats— 1 erinarian. (1) Amount. Administer orally as a sin- [40 FR 13838, Mar. 27, 1975, as amended at 42 gle, daily dose or divided into two FR 60140, Nov. 25, 1977; 46 FR 48642, Oct. 2, equal doses at 12-hour intervals. 1981; 61 FR 8873, Mar. 6, 1996; 62 FR 61624, (i) Dogs. 5 to 20 mg per kilogram (/kg) Nov. 19, 1997] (2.27 to 9.07 mg per pound (/lb)) of body § 520.804 Enalapril tablets. weight. (ii) Cats. 5 mg/kg (2.27 mg/lb) of body (a) Specifications. Each tablet con- weight. tains either 1.0, 2.5, 5.0, 10.0, or 20.0 mil- (2) Indications for use. For the man- ligrams of enalapril maleate. agement of diseases associated with (b) Sponsor. See 050604 in § 510.600(c) of bacteria susceptible to enrofloxacin. this chapter. (3) Limitations. Federal law restricts (c) Conditions of use—(1) Dogs—(i) Amount. 0.5 to 1.0 milligram of this drug to use by or on the order of a enalapril maleate per kilogram of body licensed veterinarian. Federal law pro- weight per day. hibits the extralabel use of this drug in (ii) Indications for use. Treatment of food-producing animals. mild, moderate, and severe (modified [78 FR 30197, May 22, 2013, as amended at 78 New York Heart Association Class II, FR 52853, Aug. 27, 2013] III, IV) heart failure in dogs. (iii) Limitations. Use 0.5 milligram per § 520.816 Epsiprantel tablets. kilogram once daily. In the absence of (a) Specifications. Each tablet con- adequate clinical response within a 2- tains either 12.5, 25, 50, or 100 milli- week period, use may be increased to grams of epsiprantel. twice daily (a total of 1.0 milligram per (b) Sponsor. See No. 000069 in kilogram). Enalapril maleate is admin- § 510.600(c) of this chapter. istered as conjunctive therapy with furosemide and digoxin in the treat- (c) Conditions of use—(1) Dogs—(i) ment of dilated cardiomyopathy and Amount. 2.5 milligrams per pound of furosemide with or without digoxin in body weight. the treatment of chronic valvular dis- (ii) Indications for use. Removal of ca- ease. The safety of enalapril for use in nine cestodes Dipylidium caninum and breeding dogs has not been established. Taenia pisiformis. Use in pregnant bitches is not rec- (2) Cats—(i) Amount. 1.25 milligrams ommended. Federal law restricts this per pound of body weight. drug to use by or on the order of a li- (ii) Indications for use. Removal of fe- censed veterinarian. line cestodes D. caninum and T. (2) [Reserved] taeniaeformis. [59 FR 17694, Apr. 14, 1994, as amended at 62 (3) Limitations. For oral use only as a FR 63270, Nov. 28, 1997] single dose. Do not use in animals less than 7 weeks of age. Safety of use in § 520.812 Enrofloxacin. pregnant or breeding animals has not (a) Specifications. Each tablet con- been established. Federal law restricts tains: this drug to use by or on the order of a (1) 22.7, 68.0, or 136.0 milligrams (mg) licensed veterinarian. enrofloxacin; or [54 FR 50615, Dec. 8, 1989, as amended at 56 (2) 22.7, 68.0, 136.0, or 272 mg FR 50653, Oct. 8, 1991; 60 FR 55659, Nov. 2, enrofloxacin. 1995]

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§ 520.823 Erythromycin phosphate. sume enough medicated water to pro- (a) Specifications. Erythromycin phos- vide a therapeutic dosage; solutions phate is the phosphate salt of the anti- older than 3 days should not be used; biotic substance produced by the withdraw 1 day before slaughter. growth of Streptomyces erythreus or the [40 FR 13838, Mar. 27, 1975, as amended at 45 same antibiotic substance produced by FR 56798, Aug. 26, 1980; 66 FR 14073, Mar. 9, any other means. One gram of erythro- 2001; 68 FR 4914, Jan. 31, 2003] mycin phosphate is equivalent to 0.89 gram of erythromycin master stand- § 520.852 Estriol. ard. (a) Specifications. Each tablet con- (b) Sponsor. See No. 061623 in § 510.600(c) of this chapter. tains 1 milligram (mg) estriol. (c) Related tolerances. See § 556.230 of (b) Sponsor. See No. 000061 in this chapter. § 510.600(c) of this chapter. (d) Conditions of use. It is used in (c) Conditions of use in dogs—(1) drinking water as follows: Amount. Administer at an initial dose (1) Broiler and replacement chickens— of 2 mg per dog per day. The dosage (i) Amount. 0.500 gram per gallon. may be titrated to as low as 0.5 mg per (ii) Indications for use. As an aid in dog every second day, depending on re- the control of chronic respiratory dis- sponse. ease due to Mycoplasma gallisepticum (2) Indications for use. For the control susceptible to erythromycin. of estrogen-responsive urinary inconti- (iii) Limitations. Administer for 5 nence in ovariohysterectomized female days; do not use in replacement pullets dogs. over 16 weeks of age; do not use in (3) Limitations. Federal law restricts chickens producing eggs for human this drug to use by or on the order of a consumption; to assure effectiveness, treated birds must consume enough licensed veterinarian. medicated water to provide a thera- [76 FR 78150, Dec. 16, 2011] peutic dosage; solutions older than 3 days should not be used; withdraw 1 § 520.863 Ethylisobutrazine hydro- day before slaughter. chloride tablets. (2) Replacement chickens and chicken (a) Specifications. Each tablet con- breeders—(i) Amount. 0.500 gram per gal- tains either 10 milligrams or 50 milli- lon. grams of ethylisobutrazine hydro- (ii) Indications for use. As an aid in chloride. the control of infectious coryza due to Hemophilus gallinarum susceptible to (b) Sponsor. See No. 000061 in erythromycin. § 510.600(c) of this chapter. (iii) Limitations. Administer for 7 (c) Conditions of use. (1) It is adminis- days; do not use in replacement pullets tered orally to dogs as a tranquilizer.1 over 16 weeks of age; do not use in (2) It is administered once daily at a chickens producing eggs for human dosage level of 2 to 5 milligrams of consumption; to assure effectiveness, ethylisobutrazine hydrochloride per treated birds must consume enough pound of body weight.1 medicated water to provide a thera- (3) It is not to be used in conjunction peutic dosage; solutions older than 3 with organophosphates and/or procaine days should not be used; withdraw 1 hydrochloride because phenothiazine day before slaughter. may potentiate the toxicity of (3) Growing turkeys—(i) Amount. 0.500 organophosphates and the activity of gram per gallon. procaine hydrochloride.1 (ii) Indications for use. As an aid in the control of blue comb (nonspecific infectious enteritis) caused by orga- 1 These conditions are NAS/NRC reviewed nisms susceptible to erythromycin. and deemed effective. Applications for these (iii) Limitations. Administer for 7 uses need not include effectiveness data as days; do not use in turkeys producing specified by § 514.111 of this chapter, but may eggs for human consumption; to assure require bioequivalency and safety informa- effectiveness, treated birds must con- tion.

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(4) Federal law restricts this drug to occur, retreatment may be necessary. use by or on the order of a licensed vet- For most effective results, retreat in 6 erinarian.1 to 8 weeks. [40 FR 13838, Mar. 27, 1975, as amended at 46 (iv) Not for use in horses intended for FR 48642, Oct. 2, 1981; 61 FR 8873, Mar. 6, 1996; food. 62 FR 61624, Nov. 19, 1997] (v) Consult your veterinarian for as- sistance in the diagnosis, treatment, § 520.870 Etodolac. and control of parasitism. (a) Specifications. Each tablet con- tains 150, 300, or 500 milligrams (mg) of [43 FR 8797, Mar. 3, 1978; 43 FR 12311, Mar. 24, etodolac. 1978, as amended at 43 FR 60882, Dec. 29, 1978. Redesignated at 45 FR 8587, Feb. 8, 1980] (b) Sponsor. See No. 000010 in § 510.600(c) of this chapter. § 520.903b Febantel suspension. (c) [Reserved] (d) Conditions of use—(i) Amount. Ad- (a) Specifications. The suspension con- minister 10 to 15 mg per kilogram (4.5 tains 9.3 percent (2.75 grams per ounce) to 6.8 mg per pound) of body weight per febantel. day orally. (b) Sponsor. See 000859 in § 510.600(c) of (ii) Indications for use. For the man- this chapter. agement of pain and inflammation as- (c) Conditions of use—(1) Amount. 3 sociated with osteoarthritis in dogs. milliliters per 100 pounds body weight (iii) Limitations. Federal law restricts or 1 fluid ounce per 1000 pounds (6 mil- this drug to use by or on the order of a ligrams per kilogram body weight). licensed veterinarian. (2) Indications for use. For removal of (2) [Reserved] ascarids (Parascaris equorum—adult and [63 FR 51300, Sept. 25, 1998, as amended at 68 sexually immature), pinworms (Oxyuris FR 51705, Aug. 28, 2003; 75 FR 10166, Mar. 5, equi—adult and 4th stage larvae), large 2010] strongyles (Strongylus vulgaris, S. edentatus, S. equinus), and the various § 520.903 Febantel oral dosage forms. small strongyles in horses, breeding § 520.903a Febantel paste. stallions and mares, pregnant mares, foals, and ponies. (a) Chemical name. Dimethyl [[2- [(methoxyacetyl)amino]-4-(phenyl- (3) Limitations. Administer by stom- thio)phenyl] carbonimidoyl]bis [carba- ach tube or drench, or by mixing well mate]. into a portion of the normal grain ra- (b) Specifications. The drug is a paste tion. For animals maintained on prem- containing 45.5 percent febantel. ises where reinfection is likely to (c) Sponsor. See No. 000859 in occur, retreatment may be necessary. § 510.600(c) of this chapter. For most effective results, retreat in 6 (d) Conditions of use—(1) Amount. Six to 8 weeks. Not for use in horses in- milligrams per kilogram (2.73 milli- tended for food. Federal law restricts grams per pound) of body weight in this drug to use by or on the order of a horses. licensed veterinarian. (2) Indications for use. For removal of (d) Special considerations. Febantel large strongyles (Strongylus vulgaris, S. suspension may be used in combination edentatus, S. equinus); ascarids with trichlorfon oral liquid in accord- (Parascaris equorum— sexually mature ance with the provisions of § 520.2520c, and immature); pinworms (Oxyuris this section, and the following condi- equi— adult and 4th stage larva); and tions: the various small strongyles in horses, (1) Combine 1 part febantel suspen- foals, and ponies. sion with 5 parts trichlorfon liquid. (3) Limitations. (i) The paste may be (2) Allow animal to consume a por- administered on the base of the tongue tion of daily grain ration; administer or well mixed into a portion of the nor- mixture by stomach tube at rate of 18 mal grain ration. milliliters per 100 pounds of body (ii) [Reserved] weight. (iii) For animals maintained on premises where reinfection is likely to [45 FR 8587, Feb. 8, 1980]

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§ 520.903c [Reserved] gram body weight. Administer once daily for 3 consecutive days. § 520.903d Febantel-praziquantel (ii) Puppies and kittens fewer than 6 paste. months of age. Fifteen milligrams per (a) Specifications. Each gram of paste kilogram body weight. Administer once contains 34 milligrams of febantel and daily for 3 consecutive days. 3.4 milligrams of praziquantel. (2) Indications for use. (i) For removal (b) Sponsor. See No. 000859 in of hookworms (Ancylostoma caninum § 510.600(c) of this chapter. and Uncinaria stenocephala), ascarids (c) Conditions of use—(1) Amount—(i) (Toxocara canis and Toxascaris leonina) Dogs and cats (over 6 months of age): 10 and whipworms (Trichuris vulpis) in milligrams of febantel and 1 milligram dogs and puppies. of praziquantel per kilogram of body (ii) For removal of hookworms weight (1 gram of paste per 7.5 pounds () and ascarids body weight) administered by mouth or (Toxocara cati) in cats and kittens. in the food once daily for 3 days. (3) Limitations. Do not use in preg- (ii) Puppies and kittens (less than 6 nant animals. Consider alternative months of age): 15 milligrams of therapy or use with caution in animals febantel and 1.5 milligrams of with preexisting liver or kidney dys- praziquantel per kilogram of body function. Administer to puppies and weight (1 gram of paste per 5 pounds kittens on a full stomach. Federal law body weight) administered by mouth restricts this drug to use by or on the on a full stomach once daily for 3 days. order of a licensed veterinarian. (2) Indications for use. (i) Dogs and [56 FR 50655, Oct. 8, 1991] puppies: For removal of hookworms (Ancylostoma caninum and Uncinaria § 520.905 Fenbendazole oral dosage stenocephala), whipworms (Trichuris forms. vulpis), ascarids (Toxocara canis and § 520.905a Fenbendazole suspension. Toxascaris leonina), and tapeworms (Dipylidium caninum and Taenia (a) Specifications. Each milliliter of pisiformis). suspension contains 100 milligrams (ii) Cats and kittens: For removal of (mg) fenbendazole. hookworms (Ancylostoma tubaeforme), (b) Sponsor. See No. 000061 in ascarids (Toxocara cati) and tapeworms § 510.600(c) of this chapter. (Dipylidium caninum and Taenia (c) Related tolerances. See § 556.275 of taeniaeformis). this chapter. (3) Limitations. Do not use in preg- (d) Special considerations. (1) See nant animals. Federal law restricts § 500.25 of this chapter. this drug to use by or on the order of a (2) Fenbendazole suspension 10 per- licensed veterinarian. cent and approved forms of trichlorfon, when used concomitantly for treating (4) Special considerations. Consider al- the indications provided in paragraph ternative therapy or use with caution (e) of this section and for treating in- in animals with pre-existing liver or fections of stomach bot as provided in kidney dysfunction. § 520.2520, have been shown to be com- [50 FR 19167, May 7, 1985, as amended at 53 patible and not to interfere with one FR 48533, Dec. 1, 1988; 56 FR 50813, Oct. 9, another. 1991] (e) Conditions of use—(1) Horses—(i) Amount. Administer orally 5 mg per § 520.903e Febantel tablets. kilogram (/kg) (2.3 mg per pound (/lb)) (a) Specifications. Each scored tablet for the control of large strongyles, contains 27.2 milligrams of febantel for small strongyles, and pinworms; 10 mg/ use in dogs, puppies, cats, and kittens kg for the control of ascarids. or 163.3 milligrams of febantel for use (ii) Indications for use. For the control in dogs, puppies, and cats. of large strongyles (Strongylus (b) Sponsor. See 000859 in § 510.600(c)(2) edentatus, S. equinus, S. vulgaris), small of this chapter. strongyles (Cyanthostomum spp., (c) Conditions of use—(1) Amount—(i) Cylicocyclus spp., Cylicostephanus spp., Dogs and cats. Ten milligrams per kilo- Triodontophorus spp.), pinworms

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

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

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

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(2) Indications for use. For the control (3) Limitations. Do not use in viral in- of pain and inflammation associated fections. Anti-inflammatory action of with osteoarthritis. corticosteroids may mask signs of in- (3) Limitations. Do not use in horses fection. Do not use in animals with tu- intended for human consumption. Fed- berculosis, chronic nephritis, eral law restricts this drug to use by or cushingoid syndrome, or where peptic on the order of a licensed veterinarian. ulcers occur, except for emergency therapy. Clinical and experimental [71 FR 5788, Feb. 3, 2006] data have demonstrated that § 520.955 Florfenicol. corticosteroids administered orally or parenterally to animals may induce (a) Specifications. Each milliliter the first stage of parturition when ad- (mL) contains 23 milligrams (mg) ministered during last trimester of florfenicol. pregnancy and may precipitate pre- (b) Sponsor. See Nos. 000061 and 058198 mature parturition followed by in § 510.600(c) of this chapter. dystocia, fetal death, retained pla- (c) Related tolerances. See § 556.283 of centa, and metritis. Federal law re- this chapter. stricts this drug to use by or on the (d) Conditions of use in swine—(1) order of a licensed veterinarian. Amount. Administer in drinking water ad libitum at 400 mg per gallon (100 [44 FR 7131, Feb. 6, 1979, as amended at 61 FR parts per million (ppm)) for 5 consecu- 5506, Feb. 13, 1996] tive days. (2) Indications for use. For the treat- § 520.970 Flunixin. ment of swine respiratory disease (a) Specifications. (1) Each 10-gram (g) (SRD) associated with Actinobacillus packet of granules contains flunixin pleuropneumoniae, Pasteurella multocida, meglumine equivalent to 250 milli- Salmonella choleraesuis and Strepto- grams (mg) of flunixin. coccus suis. (2) Each 30-g syringe of paste con- (3) Limitations. Do not slaughter with- tains flunixin meglumine equivalent to in 16 days of last treatment. Federal 1,500 mg of flunixin. law restricts this drug to use by or on (b) Sponsor. See No. 000061 in the order of a licensed veterinarian. § 510.600(c) of this chapter. [67 FR 78357, Dec. 24, 2002, as amended at 72 (c) Conditions of use in horses—(1) FR 262, Jan. 4, 2007; 78 FR 52854, Aug. 27, 2013] Amount. 0.5 mg of flunixin per pound of body weight per day. § 520.960 Flumethasone tablets. (2) Indications for use. For alleviation (a) Specifications. Each tablet con- of inflammation and pain associated tains 0.0625 milligram of flumethasone. with musculoskeletal disorders. (b) Sponsor. See No. 000856 in (3) Limitations. Do not use in horses § 510.600(c) of this chapter. intended for human consumption. Fed- (c) Conditions of use—(1) Amount. (i) eral law restricts this drug to use by or Dogs: Administer orally from 0.0625 to on the order of a licensed veterinarian. 0.25 milligram daily in divided doses. (ii) Cats: Administer orally from [76 FR 53051, Aug. 25, 2011] 0.03125 to 0.125 milligram daily in di- § 520.980 Fluoxetine. vided doses. (2) Indications for use. (i) Dogs: It is (a) Specifications. Each chewable tab- used for musculoskeletal conditions let contains 8, 16, 32, or 64 milligrams due to inflammation of muscles or (mg) fluoxetine hydrochloride. joints and accessory structures, where (b) Sponsor. See No. 000986 in § 510.600 permanent structural changes do not of this chapter. exist, such as arthritis, the disc syn- (c) Conditions of use in dogs—(1) drome, and myositis. Amount. 1 to 2 mg per kilogram body (ii) Dogs and cats: It is used in certain weight once daily. acute and chronic dermatoses of vary- (2) Indications for use. For the treat- ing etiology to help control the pru- ment of canine separation anxiety in ritus, irritation, and inflammation as- conjunction with a behavior modifica- sociated with these conditions. tion plan.

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(3) Limitations. Federal law restricts (2) Dogs—(i) Amount. 1 to 2 mg/lb body this drug to use by or on the order of a weight, once or twice daily. licensed veterinarian. (ii) Indications for use—(A) For treat- ment of edema (pulmonary congestion, [72 FR 6463, Feb. 12, 2007] ascites) associated with cardiac insuffi- § 520.1010 Furosemide. ciency and acute noninflammatory tis- sue edema. (a) Specifications. (1) Each tablet con- (B) For treatment of edema (pul- tains 12.5 or 50 milligrams (mg) monary congestion, ascites) associated furosemide. with cardiac insufficiency. (2) Each bolus contains 2 grams (g) (3) Cats—(i) Amount. 1 to 2 mg/lb body furosemide. weight, once or twice daily. (3) Each packet of powder contains 2 (ii) Indications for use. For treatment g furosemide. of edema (pulmonary congestion, asci- (4) Each milliliter of syrup contains tes) associated with cardiac insuffi- 10 mg furosemide. ciency and acute noninflammatory tis- (b) Sponsors. See sponsor numbers in sue edema. § 510.600(c) of this chapter for use of [66 FR 47960, Sept. 17, 2001, as amended at 69 dosage forms and strengths listed in FR 74419, Dec. 14, 2004; 70 FR 50182, Aug. 26, paragraph (a) of this section for uses as 2005; 70 FR 76396, Dec. 27, 2005; 74 FR 61516, in paragraph (d) of this section. Nov. 25, 2009; 78 FR 17596, Mar. 22, 2013] (1) No. 000010 for tablets in paragraph (a)(1) of this section for conditions of § 520.1044 Gentamicin sulfate oral dos- use in paragraphs (d)(2)(i), (d)(2)(ii)(A), age forms. and (d)(3) of this section. § 520.1044a Gentamicin sulfate oral so- (2) No. 000061 for tablets in paragraph lution. (a)(1) of this section for conditions of (a) Each milliliter of use in paragraphs (d)(2)(i), (d)(2)(ii)(A), Specifications. aqueous solution contains gentamicin and (d)(3) of this section; for boluses in sulfate equivalent to 50 milligrams of paragraph (a)(2) of this section and gentamicin. powder in paragraph (a)(3) of this sec- (b) Sponsor. See Nos. 000061 and 054925 tion for conditions of use in paragraph in § 510.600(c) of this chapter. (d)(1) of this section; and for syrup in (c) Related tolerances. See § 556.300 of paragraph (a)(4) of this section for con- this chapter. ditions of use in paragraphs (d)(2)(i) (d) Conditions of use—(1) Amount. and (d)(2)(ii)(A). Colibacillosis: 1 milliliter per 2 gallons (3) Nos. 000859 and 058829 for use of of drinking water for 3 consecutive syrup in paragraph (a)(4) of this section days, to provide 0.5 milligram/pound/ for conditions of use in paragraph day; swine dysentery: 1 milliliter per 1 (d)(2)(i) and (d)(2)(ii)(A) of this section. gallon of drinking water for 3 consecu- (c) Special considerations. Federal law tive days, to provide 1.0 milligram/ restricts this drug to use by or on the pound/day. order of a licensed veterinarian. (2) Indications for use. In weanling (d) Conditions of use. It is used as fol- swine for control and treatment of lows: colibacillosis caused by strains of E. (1) Cattle—(i) Amount. 1 to 2 mg per coli sensitive to gentamicin, and in pound (/lb) body weight using powder, swine for control and treatment of or one 2-g bolus per animal, per day. swine dysentery associated with (ii) Indications for use. For treatment Treponema hyodysenteriae. of physiological parturient edema of (3) Limitations. For use in swine the mammary gland and associated drinking water only. Do not store or structures. offer medicated drinking water in (iii) Limitations. Treatment not to ex- rusty containers since the drug is ceed 48 hours post-parturition. Milk quickly destroyed in such containers. taken during treatment and for 48 Medicated drinking water should be hours after the last treatment must prepared daily and be the sole source of not be used for food. Cattle must not be drinking water for 3 consecutive days. slaughtered for food within 48 hours Treatment may be repeated if dys- following last treatment. entery recurs. Do not slaughter treated

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swine for food for at least 3 days fol- 0.5 mg per pound of body weight per lowing treatment. day; (ii) For swine dysentery: Gentamicin [48 FR 10302, Mar. 11, 1983. Redesignated at 49 sulfate equivalent to 50 mg of FR 572, Jan. 5, 1984, and amended at 49 FR 14332, Apr. 11, 1984; 52 FR 7832, Mar. 13, 1987; gentamicin per gallon of drinking 62 FR 34169, June 25, 1997; 71 FR 13542, Mar. water to provide 1 mg per pound of 16, 2006] body weight per day. Treatment may be repeated if dysentery recurs. § 520.1044b Gentamicin sulfate pig (2) Indications for use. For control and pump oral solution. treatment of colibacillosis in weanling (a) Specifications. Each milliliter of swine caused by strains of Escherichia pig pump oral solution contains coli sensitive to gentamicin, and for gentamicin sulfate equivalent to 4.35 control and treatment of swine dys- milligrams of gentamicin. entery associated with Treponema (b) Sponsor. See Nos. 000061 and 000859 hyodysenteriae. in § 510.600(c) of this chapter. (3) Limitations. For use in swine (c) Related tolerances. See § 556.300 of drinking water only. Do not store or this chapter. offer medicated drinking water in rusty containers since the drug is (d) Conditions of use—(1) Amount. Ad- quickly destroyed in such containers. minister 1.15 milliliters of pig pump Medicated drinking water should be oral solution (5 milligrams of prepared daily and be the sole source of gentamicin) orally per pig one time. drinking water. (2) Indications for use. In neonatal (4) Withdrawal period. 10 days. swine 1 to 3 days of age for control and treatment of colibacillosis caused by [77 FR 4226, Jan. 27, 2012] strains of E. coli sensitive to gentamicin. § 520.1100 Griseofulvin. (3) Limitations. For use in neonatal (a) Specifications—(1) The powder swine only. Do not slaughter treated complies with U.S.P. for griseofulvin, swine for food for at least 14 days fol- microsize. lowing treatment. (2) Each bolus contains 2.5 grams griseofulvin. [49 FR 572, Jan. 5, 1984, as amended at 52 FR (3) Each tablet contains 125 or 500 7832, Mar. 13, 1987; 62 FR 29011, May 29, 1997; milligrams griseofulvin. 78 FR 17596, Mar. 22, 2013] (b) Sponsors. See sponsors in § 520.1044c Gentamicin sulfate powder. § 510.600(c) of this chapter. (1) No. 000061 for use of products de- (a) Specifications. Each gram of pow- scribed in paragraph (a) for use as in der contains gentamicin sulfate equiv- paragraph (d) of this section. alent to: (2) No. 061623 for use of the powder de- (1) 16.7, 66.7, or 333.3 milligrams (mg) scribed in paragraph (a)(1) for use as in gentamicin. paragraphs (d)(1)(i)(A) and (d)(1)(ii) of (2) 333.3 mg gentamicin. this section. (b) Sponsors. See sponsors in (c) Special considerations. Federal law § 510.600(c) of this chapter for use as in restricts this drug to use by or on the paragraph (d) of this section as follows: order of a licensed veterinarian. (1) No. 000061 for products described (d) Conditions of use—(1) Horses—(i) in paragraph (a)(1) of this section. Amount and indications for use—(A) For (2) Nos. 057561 and 061623 for product equine ringworm infection caused by described in paragraph (a)(2) of this Trichophyton equinum or Microsporum section. gypseum, administer soluble powder de- (c) Related tolerances. See § 556.300 of scribed in paragraph (a)(1) of this sec- this chapter. tion daily as a drench or as a top dress- (d) Conditions of use in swine—(1) ing on feed for not less than 10 days as Amount. Administer in drinking water follows: adults, 2.5 grams; yearlings, for 3 consecutive days as follows: 1.25 to 2.5 grams; and foals, 1.25 grams. (i) For colibacillosis: Gentamicin sul- (B) For treating ringworm infection fate equivalent to 25 mg of gentamicin caused by T. equinum, administer per gallon of drinking water to provide boluses described in paragraph (a)(2) of

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this section daily for not less than 10 (e) Related tolerances. See § 556.310 of days as follows: adults, 1 bolus; year- this chapter. lings, one-half to 1 bolus; and foals, (f) Conditions of use. It is used as a one-half bolus. drench as follows: (ii) Limitations. Not for use in horses (1) Cattle—(i) Amount. 141.5 grams per intended for food. packet. (2) Dogs and cats: (i) Amount. 125- and (ii) Indications for use. Control of gas- 500-milligram tablets administered trointestinal roundworms of the genera orally as follows: Haemonchus, Ostertagia, (A) Daily (single or divided) dose: Trichostrongylus, and Cooperia. (iii) Limitations. (a) Dissolve each Dosage Body weight (pounds) (milli- packet in 32 fluid ounces of water and grams) administer as follows:

Up to 6 ...... 62.5 Dose (fluid 6 to 18 ...... 125 Weight of animal (pounds) ounces) 18 to 36 ...... 250 36 to 48 ...... 375 Up to 100 ...... 1⁄2 48 to 75 ...... 500 100 to 150 ...... 3⁄4 150 to 200 ...... 1 (B) Weekly (single) dose: If experi- 200 to 300 ...... 11⁄2 300 to 450 ...... 2 ence indicates that treatment is more 450 to 700 ...... 3 effective for the drug given in large 700 to 1,000 ...... 4 doses, administer at intervals of 7 to 10 1,000 to 1,200 ...... 5 days, a dose equal to 10 milligrams/ Over 1,200 ...... 6 pound of body weight × body weight × number of days between treatments. (b) Do not treat within 1 week of Dosage should be adjusted according to slaughter; do not treat dairy animals response. Administer additional dose of breeding age; animals should be re- after the animal is free of infection. treated in 3 to 4 weeks. (ii) Indications for use. For treatment [40 FR 13838, Mar. 27, 1975, as amended at 45 of fungal infections of the skin, hair, FR 10333, Feb. 15, 1980; 46 FR 48642, Oct. 2, and claws caused by Trichophyton 1981; 61 FR 8873, Mar. 6, 1996; 62 FR 61624, mentagrophytes, T. rubrum, T. Nov. 19, 1997] schoenleini, T. sulphurem, T. verrucosum, § 520.1120b Haloxon boluses. T. interdigitale, Epidermophyton floccosum, Microsporum gypseum, M. (a) Chemical name. 3-Chloro-7-hy- canis, M. audouini. droxy-4-methylcoumarin bis (2- chloroethyl) phosphate. [40 FR 13838, Mar. 27, 1975, as amended at 41 (b) Specifications. Each bolus contains FR 42948, Sept. 29, 1976; 43 FR 28458, June 30, 1978; 52 FR 7832, Mar. 13, 1987; 54 FR 30205, 10.1 grams of haloxon. July 19, 1989; 71 FR 38073, July 5, 2006; 77 FR (c) Sponsor. See No. 000061 in 28253, May 14, 2012] § 510.600(c) of this chapter. (d) Related tolerances. See § 556.310 of § 520.1120 Haloxon oral dosage forms. this chapter. (e) Conditions of use. (1) Haloxon bolus § 520.1120a Haloxon drench. is an used in cattle for (a) Chemical name. 3-Choloro-7- the control of gastrointestinal hydoxy-4-methylcoumarin bis (2- roundworms of the genera Haemonchus, chloroethyl) phosphate. Ostertagia, Trichostrongylus and (b) Specifications. Haloxon assay of Cooperia. not less than 96 percent by infrared (2) It is administered by giving one spectrum at 8.62 microns. bolus per approximately 500 pounds (c) Sponsor. See No. 000061 in body weight (35 to 50 milligrams per § 510.600(c) of this chapter. kilogram of body weight). (d) Special considerations. Do not use (3) For most effective results, re- any drug, insecticide, pesticide, or treat animals in 3 to 4 weeks. If rein- other chemical having cholinesterase- fection is likely to occur, additional re- inhibiting activity either simulta- treatments may be necessary. neously or within a few days before or (4) Do not use any drug, pesticide or after treatment with haloxon. other chemical having cholinesterase

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inhibiting activity either simulta- of the skin surface, loss of hair, sebor- neously or within a few days before or rhea, thickening of the skin, after treatment with haloxon. hyperpigmentation, and lethargy. (5) Do not treat animals within one (3) Limitations. If no response is ob- week of slaughter. served in 30 to 45 days, the drug should (6) Do not treat dairy animals of be withdrawn and the diagnosis recon- breeding age or older. sidered. Do not use in the presence of [40 FR 13838, Mar. 27, 1975, as amended at 44 cardiac disease, ischemia, adrenal in- FR 61591, Oct. 29, 1979; 46 FR 48642, Oct. 2, sufficiency, or nephrosis. Federal law 1981; 61 FR 8873, Mar. 6, 1996; 62 FR 61625, restricts this drug to use by or on the Nov. 19, 1997] order of a licensed veterinarian. § 520.1130 Hetacillin. [49 FR 22469, May 30, 1984] (a) Specifications.—(1) Each capsule or § 520.1158 Iodochlorhydroxyquin tablet contains hetacillin potassium boluses. equivalent to 50, 100, or 200 milligrams (mg) of ampicillin. (a) Specifications. Each bolus contains (2) Each milliliter of suspension con- 10 grams of iodochlorhydroxyquin. tains hetacillin potassium equivalent (b) Sponsor. See No. 053501 in to 50 mg of ampicillin. § 510.600(c) of this chapter. (b) Sponsor. See No. 000010 in (c) Conditions of use—(1) Amount. 1 § 510.600(c) of this chapter. bolus (10 grams) daily for a 1,000-pound (c) Conditions of use in dogs and cats— horse. (1) Amount—(i) Dogs. Administer 5 mg (2) Indications for use. For treatment per pound (/lb) of body weight orally, of equine diarrhea. twice daily. In severe infections, ad- (3) Limitations. For horses only; not minister 5 mg/lb three times daily, or to be administered to food-producing up to 10 mg/lb twice daily. For stub- animals. Do not administer to horses born urinary tract infections, admin- intended for use as food. Federal law ister up to 20 mg/lb twice daily. restricts this drug to use by or on the (ii) Cats. Administer 50 mg twice order of a licensed veterinarian. daily. (2) Indications for use. For the treat- [48 FR 8054, Feb. 25, 1983, as amended at 50 ment of respiratory tract infections, FR 41489, Oct. 11, 1985] urinary tract infections, gastro- intestinal infections, skin infections, § 520.1182 Iron dextran suspension. soft tissue infections, and postsurgical (a) Specifications. Each milliliter infections associated with strains of or- (mL) of suspension contains 55.56 milli- ganisms susceptible to hetacillin po- grams (mg) iron as ferric hydroxide in tassium. complex with a low molecular weight (3) Limitations. Federal law restricts dextran. this drug to use only by or on the order (b) Sponsor. See No. 051311 in of a licensed veterinarian. § 510.600(c) of this chapter. [75 FR 10166, Mar. 5, 2010] (c) Conditions of use in swine—(1) Amount. Administer 100 mg (1.8 mL) § 520.1157 Iodinated casein tablets. orally by automatic dose dispenser. (a) Specifications. Each 1-gram tablet (2) Indications for use. For the preven- contains 25 milligrams of iodinated ca- tion of iron deficiency anemia in baby sein. pigs. (b) Sponsor. See No. 017762 in (3) Limitations. Treat each pig within § 510.600(c) of this chapter. 24 hours of farrowing. (c) Conditions of use—(1) Amount. 1⁄5 to 1 tablet per 10 pounds of body weight [70 FR 32489, June 3, 2005] (equivalent to 0.5 to 2.5 milligrams of iodinated casein per pound of body § 520.1192 Ivermectin paste. weight). (a) Specifications. Each milligram (2) Indications for use. For dogs for ap- (mg) of paste contains 0.0187 mg (1.87 parent decreased thyroid activity percent) or 0.00153 mg (0.153 percent) of where the signs are alopecia, scaliness ivermectin.

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(b) Sponsors. See sponsors in (iii) Limitations. For oral use only. Do § 510.600(c) of this chapter for use as in not use in horses intended for human paragraph (e) of this section: consumption. (1) No. 050604 for use of a 1.87 percent (2) Cattle—(i) Amount. 23 milligrams paste as in (e)(1) of this section and a per 250 pounds of body weight. 0.153 percent paste for use as in para- (ii) Indications for use. It is used in graph (e)(2) of this section. cattle for the treatment and control of gastrointestinal roundworms (adults (2) Nos. 000859, 051311, 054925, and and fourth-stage larvae) (Ostertagia 061623 for use of a 1.87 percent paste for ostertagi (including inhibited forms), O. use as in paragraph (e)(1) of this sec- lyrata, Haemonchus placei, tion. Trichostrongylus axei, T. colubriformis, (c) Related tolerances. See § 556.344 of Cooperia oncophora, C. punctata, this chapter. Nematodirus helvetianus, Bunostomum (d) Special considerations. See § 500.25 phlebotomum, Strongyloides papillosus of this chapter. (adults only), Oesophagostomum (e) Conditions of use—(1) Horses—(i) radiatum, Trichuris ovis (adults only)); Amount. 200 micrograms per kilogram lungworms (adults and fourth-stage (91 micrograms per pound) of body larvae) (Dictyocaulus viviparus); grubs weight. (first, second, and third instars) (ii) Indications for use. For treatment (Hypoderma bovis, H. lineatum); and and control of Large Strongyles sucking lice (Linognathus vituli, (adults): Strongylus vulgaris (also early Haematopinus eurysternus). forms in blood vessels), S. edentatus (iii) Limitations. For oral use only. Do (also tissue stages), S. equinus, not treat cattle within 24 days of slaughter. Because withdrawal time in Triodontophorus spp. including T. milk has not been established, do not brevicauda and T. serratus, and use in female dairy cattle of breeding Craterostomum acuticaudatum; Small age. Strongyles (adults, including those re- sistant to some class [49 FR 22275, May 29, 1984, as amended at 50 compounds): Coronocyclus spp. includ- FR 27819, July 8, 1985; 51 FR 44449, Dec. 10, 1986; 53 FR 51273, Dec. 21, 1988; 62 FR 63270, ing C. coronatus, C. labiatus, and C. Nov. 28, 1997; 65 FR 70661, Nov. 27, 2000; 67 FR labratus, Cyathostomum spp. including 71820, Dec. 3, 2002; 68 FR 43294, July 22, 2003; C. catinatum and C. pateratum, 69 FR 59131, Oct. 4, 2004; 70 FR 8514, Feb. 22, Cylicocyclus spp. including C. insigne, C. 2005; 71 FR 40010, July 14, 2006; 71 FR 67298, leptostomum, C. nassatus, and C. Nov. 21, 2006; 73 FR 34184, June 17, 2008; 74 FR brevicapsulatus, Cylicodontophorus spp., 6542, Feb. 10, 2009; 78 FR 17596, Mar. 22, 2013] Cylicostephanus spp. including C. § 520.1193 Ivermectin tablets and calicatus, C. goldi, C. longibursatus, and chewables. C. minutus, and Petrovinema poculatum; (a) Specifications. (1) Each tablet or Small Strongyles (fourth-stage larvae); chewable contains 68, 136, or 272 Pinworms (adults and fourth-stage lar- micrograms (mcg) ivermectin. vae): Oxyuris equi; Ascarids (adults and (2) Each chewable contains 55 or 165 third- and fourth-stage larvae): mcg ivermectin. Parascaris equorum; Hairworms (adults): (b) Sponsors. See sponsors in Trichostrongylus axei; Large mouth § 510.600(c) of this chapter for use as in Stomach Worms (adults): Habronema paragraph (d) of this section. muscae; Bots (oral and gastric stages): (1) No. 050604 for use of tablets or Gasterophilus spp. including G. chewables described in paragraph (a)(1) intestinalis and G. nasalis; Lungworms as in paragraph (d)(1) and chewables de- (adults and fourth-stage larvae): scribed in paragraph (a)(2) as in para- Dictyocaulus arnfieldi; Intestinal graph (d)(2) of this section. Threadworms (adults): Strongyloides (2) Nos. 051311 and 059130 for use of westeri; Summer Sores caused by tablets described in paragraph (a)(1) as Habronema and Draschia spp. cutaneous in paragraph (d)(1) of this section. third-stage larvae; Dermatitis caused (c) Special considerations. Federal law by neck threadworm microfilariae, restricts this drug to use by or on the Onchocerca sp. order of a licensed veterinarian.

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(d) Conditions of use—(1) Dogs. For use sistant to some benzimidazole class in dogs 6 weeks of age and older as fol- compounds): Coronocyclus spp. includ- lows: ing C. coronatus, C. labiatus, and C. (i) Amount. 6.0 mcg per kilogram (kg) labratus, Cyathostomum spp. including of body weight (2.72 mcg per pound C. catinatum and C. pateratum, (lb)), minimum. Up to 25 lb, 68 mcg; 26 Cylicocyclus spp. including C. insigne, C. to 50 lb, 136 mcg; 51 to 100 lb, 272 mcg; leptostomum, C. nassatus, and C. over 100 lb, a combination of the appro- brevicapsulatus, Cylicodontophorus spp., priate tablets. Administer at monthly Cylicostephanus spp. including C. dosing intervals. calicatus, C. goldi, C. longibursatus, and (ii) Indications for use. To prevent ca- C. minutus, and Petrovinema poculatum; nine heartworm disease by eliminating Small Strongyles (fourth-stage larvae); the tissue stage of heartworm larvae Pinworms (adults and fourth stage lar- (Dirofilaria immitis) for 1 month (30 vae): Oxyuris equi; Ascarids (adults and days) after infection. third- and fourth-stage larvae): (2) Cats. For use in cats 6 weeks of Parascaris equorum; Hairworms (adults): age and older as follows: Trichostrongylus axei; Large Mouth (i) Amount. Up to 2.3 kilograms (up to Stomach Worms (adults): Habronema 5 lb), 55 mcg; 2.3 to 6.8 kilograms (5 to muscae; Bots (oral and gastric stages): 15 lb), 165 mcg; over 6.8 kilograms (15 Gasterophilus spp. including G. lb), a combination of the appropriate intestinalis and G. nasalis; Lungworms chewables (recommended minimum (adults and fourth-stage larvae): dose of 24 mcg/kg of body weight (10.9 Dictyocaulus arnfieldi; Intestinal mcg/lb)). Administer once a month. Threadworms (adults): Strongyloides (ii) Indications for use. To prevent fe- westeri; Summer Sores caused by line heartworm disease by eliminating Habronema and Draschia spp. cutaneous the tissue stage of heartworm larvae third-stage larvae; Dermatitis caused Dirofilaria immitis for a month (30 days) by neck threadworm microfilariae, after infection, and for removal and Onchocerca sp. control of adult and immature (L4) Limitations. Do not use in horses in- hookworms Ancylostoma tubaeforme and tended for human consumption. A. braziliense. [70 FR 1817, Jan. 11, 2005, as amended at 70 [67 FR 11230, Mar. 13, 2002, as amended at 67 FR 19262, Apr. 13, 2005] FR 21996, May 2, 2002; 69 FR 43735, July 22, 2004] § 520.1195 Ivermectin liquid. § 520.1194 Ivermectin meal. (a) Specifications—(1) Each milliliter (a) Specifications. Each gram of meal (mL) contains 10 milligrams (mg) contains 6 milligrams ivermectin (0.6 ivermectin. percent). (2) Each mL of micellar solution con- (b) Sponsor. See No. 017135 in tains 0.8 mg ivermectin. § 510.600(c) of this chapter. (b) Sponsors. See sponsor numbers in (c) Special considerations. See § 500.25 § 510.600(c) of this chapter. of this chapter. (1) Nos. 000859, 050604, 054925, and (d) Conditions of use in horses—(1) 058005 for use of product described in Amount. Administer 136 micrograms paragraph (a)(1) of this section as in (mcg) ivermectin per pound (/lb) body paragraphs (e)(1)(i), (e)(1)(ii)(A), and weight (300 mcg/kilogram) as a single (e)(1)(iii) of this section. dose on approximately 2 lb grain or (2) No. 058829 for use of product de- sweet feed. scribed in paragraph (a)(1) of this sec- (2) Indications for use. For treatment tion as in paragraphs (e)(1)(i), and control of Large Strongyles (e)(1)(ii)(B), and (e)(1)(iii) of this sec- (adults): Strongylus vulgaris (also early tion. forms in blood vessels), S. edentatus (3) Nos. 050604 and 058829 for use of (also tissue stages), S. equinus, product described in paragraph (a)(2) of Triodontophorus spp. including T. this section as in paragraph (e)(2) of brevicauda and T. serratus, and this section. Craterostomum acuticaudatum; Small (c) Related tolerances. See § 556.344 of Strongyles (adults, including those re- this chapter.

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(d) Special considerations. See § 500.25 (Trichostongylus axei(adult)); Large of this chapter. mouth Stomach Worms (Habronema (e) Conditions of use—(1) Horses—(i) muscae (adult)); Stomach Bots Amount. 200 micrograms (mcg) per kilo- (Gastrophilus spp. (oral and gastric gram (/kg) of body weight as a single stages)); Lungworms (Dictyocaulus dose by stomach tube or as an oral arnfieldi (adult and fourth-stage lar- drench. vae)); intestinal threadworms (ii) Indications for use. For treatment (Strongyloides westeri (adult)); Summer and control of: Sores caused by Habronema and (A) Large Strongyles (adults): Draschia spp. cutaneous third-stage lar- Strongylus vulgaris (also early forms in vae; and Dermatitis caused by neck blood vessels), S. edentatus (also tissue threadworm microfilariae (Onchocerca stages), S. equinus, Triodontophorus spp. spp.). including T. brevicauda and T. serratus, (iii) Limitations. Do not use in horses and Craterostomum acuticaudatum; intended for human consumption. Fed- Small Strongyles (adults, including eral law restricts this drug to use by or those resistant to some benzimidazole on the order of a licensed veterinarian. class compounds): Coronocyclus spp. in- (2) Sheep—(i) Amount. 200 mcg/kg (3 cluding C. coronatus, C. labiatus, and C. mL/26 pounds) of body weight as a sin- labratus, Cyathostomum spp. including gle dose oral drench. C. catinatum and C. pateratum, (ii) Indications for use. For treatment Cylicocyclus spp. including C. insigne, C. and control of the adult and fourth- leptostomum, C. nassatus, and C. stage larvae of gastrointestinal brevicapsulatus, Cylicodontophorus spp., roundworms (Haemonchus contortus, H. Cylicostephanus spp. including C. placei (adults only), Ostertagia calicatus, C. goldi, C. longibursatus, and circumcincta, Trichostrongylus axei, T. C. minutus, and Petrovinema poculatum; colubriformis, Cooperia oncophora Small Strongyles (fourth-stage larvae); (adults only), C. curticei, Pinworms (adults and fourth stage lar- Oesophagostomum columbianum, O. vae): Oxyuris equi; Ascarids (adults and venulosum(adults only), Nematodirus third- and fourth-stage larvae): battus, N. spathiger, S. papillosus (adults Parascaris equorum; Hairworms (adults): only), Chabertia ovina (adult only), Trichostrongylus axei; Large mouth Trichuris ovis (adults only)); lungworms Stomach Worms (adults): Habronema (D. filaria); and all larval stages of the muscae; Bots (oral and gastric stages): nasal bot Oestrus ovis. Gasterophilus spp. including G. (iii) Limitations. For use in sheep intestinalis and G. nasalis; Lungworms only. Do not use in other animal spe- (adults and fourth-stage larvae): cies as severe adverse reactions, in- Dictyocaulus arnfieldi; Intestinal cluding fatalities in dogs, may result. Threadworms (adults), Strongyloides Do not treat sheep within 11 days of westeri; Summer Sores caused by slaughter. Habronema and Draschia spp. cutaneous [67 FR 50597, Aug. 5, 2002, as amended at 69 third-stage larvae; Dermatitis caused FR 57173, Sept. 24, 2004; 71 FR 13542, Mar. 16, by neck threadworm microfilariae, 2006; 71 FR 38072, July 5, 2006; 72 FR 9456, Feb. Onchocerca sp. 21, 2008; 78 FR 17596, Mar. 22, 2013; 79 FR 10964, (B) Large Strongyles (Strongylus Feb. 27, 2014] equinus (adult), S. vulgaris (adult and arterial larval stages), S. endentatus § 520.1196 Ivermectin and pyrantel (adult and migrating tissue stages), pamoate chewable tablets. Triodontophorus spp. (adult)); Small (a) Specifications. Each chewable tab- Strongyles including those resistant to let contains either 68 micrograms (μg) some benzimidazole class compounds of ivermectin and 57 milligrams (mg) of (Cyathostomum spp. (adult and fourth- pyrantel (as pamoate salt), or 136 μg stage larvae), Cylicocyclus spp., and 114 mg, or 272 μg and 227 mg, re- Cylicodontophorus spp., Cylicostephanus spectively. spp.); Pinworms (Oxyuris equi (adult (b) Sponsors. See Nos. 050604, 051311, and fourth-stage larvae)); Ascarids and 063604 in § 510.600(c) of this chapter. (Parascaris equorum (adult and third- (c) Conditions of use—(1) Dogs—(i) and fourth-stage larvae)); Hairworms Amount. A minimum of 6 μg of

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ivermectin and 5 mg of pyrantel (as calves weighing less than 275 lb (125 pamoate salt) per kilogram (2.72 μg and kg). Do not administer a damaged 2.27 mg per pound) of body weight. bolus. Because a milk withdrawal time (ii) Indications for use. To prevent ca- has not been established, do not use in nine heartworm disease by eliminating female dairy cattle of breeding age. Do the tissue larval stages of Dirofilaria not slaughter cattle within 180 days of immitis for up to a month (30 days) after treatment. Consult your veterinarian infection and treatment and control of for assistance in the diagnosis, treat- adult ascarids Toxocara canis and ment, and control of parasitism. Toxascaris leonina, and adult [61 FR 67452, Dec. 23, 1996, as amended at 62 hookworms Ancylostoma caninum, A. FR 63270, Nov. 28, 1997; 65 FR 45876, July 26, braziliense, and Uncinaria stenocephala. 2000] (iii) Limitations. Use monthly. Rec- ommended for dogs 6 weeks of age and § 520.1198 Ivermectin and praziquantel older. Federal law restricts this drug to paste. use by or on the order of a licensed vet- (a) Specifications. Each milligram erinarian. (mg) of paste contains: (2) [Reserved] (1) 0.0155 mg (1.55 percent) ivermectin [58 FR 8542, Feb. 16, 1993, as amended at 61 and 0.0775 mg (7.75 percent) FR 15186, Apr. 5, 1996; 61 FR 59004, Nov. 20, praziquantel. 1996; 62 FR 63270, Nov. 28, 1997; 66 FR 35756, (2) 0.0187 mg (1.87 percent) ivermectin July 9, 2001; 67 FR 21996, May 2, 2002; 68 FR and 0.1403 mg (14.03 percent) 55823, Sept. 29, 2003] praziquantel. (b) Sponsors. See sponsors in § 520.1197 Ivermectin sustained-re- § 510.600(c) of this chapter for uses as in lease bolus. paragraph (d) of this section.— (a) Specifications. Each sustained-re- (1) No. 050604 for use of product de- lease bolus contains 1.72 grams of scribed in paragraph (a)(1) of this sec- ivermectin. tion as in paragraphs (d)(1)(i), (d)(2)(i) (b) Sponsor. See No. 050604 in and (d)(3) of this section. § 510.600(c) of this chapter. (2) No. 051311 for use of product de- (c) Related tolerances. See § 556.344 of scribed in paragraph (a)(2) of this sec- this chapter. tion as in paragraphs (d)(1)(ii), (d) Conditions of use in ruminating (d)(2)(ii), and (d)(3) of this section. calves—(1) Amount. Administer one (c) Special considerations. See § 500.25 bolus per calf weighing at least 275 of this chapter. pounds (lb) (125 kilograms (kg)) and not (d) Conditions of use in horses—(1) more than 660 lb (300 kg) on the day of Amount—(i) 200 micrograms (mcg) per administration. kilogram (/kg) ivermectin (91 mcg per (2) Indications. For treatment and pound (/lb)) and 1 mg/kg praziquantel control, throughout the grazing season (454 mcg/lb) body weight. (approximately 130 days), of gastro- (ii) 200 mcg/kg ivermectin (91 mcg/lb) intestinal roundworms Haemonchus and 1.5 mg/kg praziquantel (681 mcg/lb) placei, Ostertagia ostertagi (including in- body weight. hibited fourth-stage larvae), (2) Indications for use. For treatment Trichostrongylus axei, T. colubriformis, and control of: Cooperia spp., Nematodirus helvetianus, (i) Tapeworms—Anoplocephala Bunostomum phlebotomum, perfoliata; Large strongyles (adults)— Oesophagostomum radiatum; lungworms Strongylus vulgaris (also early forms in Dictyocaulus viviparus; grubs Hypoderma blood vessels), S. edentatus (also tissue spp.; sucking lice Linognathus vituli, stages), S. equinus, Triodontophorus spp. Solenopotes capillatus; mange mites including T. brevicauda and T. serratus, Psoroptes ovis, Sarcoptes scabiei, and and Craterostomum acuticaudatum; ticks Amblyomma americanum. Small Strongyles (adults, including (3) Limitations. The bolus was specifi- those resistant to some benzimidazole cally designed for use in cattle; do not class compounds)—Coronocyclus spp. in- use in other animal species. Calves cluding C. coronatus, C. labiatus, and C. must be ruminating and older than 12 labratus, Cyathostomum spp. including weeks of age. Do not administer to C. catinatum and C. pateratum,

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Cylicocyclus spp. including C. insigne, C. § 520.1199 Ivermectin, pyrantel, and leptostomum, C. nassatus, and C. praziquantel tablets. brevicapsulatus, Cylicodontophorus spp., (a) Specifications. Each chewable tab- Cylicostephanus spp. including C. let contains: calicatus, C. goldi, C. longibursatus, and (1) 34 micrograms (mcg) ivermectin, C. minutus, and Petrovinema poculatum; 28.5 milligrams (mg) pyrantel pamoate, Small Strongyles—fourth-stage larvae; and 28.5 mg praziquantel; Pinworms (adults and fourth-stage lar- (2) 68 mcg ivermectin, 57 mg pyrantel vae)—Oxyuris equi; Ascarids (adults and pamoate, and 57 mg praziquantel; third- and fourth-stage larvae)— (3) 136 mcg ivermectin, 114 mg Parascaris equorum; Hairworms pyrantel pamoate, and 114 mg (adults)—Trichostrongylus axei; Large- praziquantel; or mouth Stomach Worms (adults)— (4) 272 mcg ivermectin, 228 mg Habronema muscae; Bots (oral and gas- pyrantel pamoate, and 228 mg tric stages)—Gasterophilus spp. includ- praziquantel. ing G. intestinalis and G. nasalis; (b) Sponsors. See No. 051311 in Lungworms (adults and fourth-stage § 510.600(c) of this chapter. larvae)—Dictyocaulus arnfieldi; Intes- (c) Conditions of use in dogs—(1) tinal Threadworms (adults)— Amount. Administer monthly according Strongyloides westeri; Summer Sores to body weight as follows: caused by Habronema and Draschia spp. (i) 6 to 12 lb: one tablet as described cutaneous third-stage larvae; Derma- in paragraph (a)(1) of this section. titis caused by neck threadworm (ii) 12.1 to 25 lb: one tablet as de- microfilariae, Onchocerca sp. scribed in paragraph (a)(2) of this sec- (ii) Tapeworms—Anoplocephala tion. perfoliata; Large Strongyles (adults)— (iii) 25.1 to 50 lb: one tablet as de- scribed in paragraph (a)(3) of this sec- Strongylus vulgaris (also early forms in tion. blood vessels), S.edentatus (also tissue (iv) 50.1 to 100 lb: one tablet as de- stages), S. equinus, Triodontophorus scribed in paragraph (a)(4) of this sec- spp.; Small Strongyles (adults, includ- tion. ing those resistant to some benzimid- (v) Greater than 100 lb: use the appro- azole class compounds)—Cyathostomum priate combination of tablets. spp., Cylicocyclus spp., Cylicostephanus (2) Indications for use. Prevents ca- spp., Cylicodontophorus spp.; Small nine heartworm disease by eliminating Strongyles—fourth-stage larvae; the tissue stage of heartworm larvae Pinworms (adults and fourth-stage lar- (Dirofilaria immitis) for 1 month (30 vae)—Oxyuris equi; Ascarids (adults and days) after infection and for the treat- third- and fourth-stage larvae)— ment and control of roundworm Parascaris equorum; Hairworms (Toxocara canis, Toxascaris leonina), (adults)—Trichostrongylus axei; Large- hookworm (Ancylostoma caninum, mouth Stomach Worms (adults)— Uncinaria stenocephala, Ancylostoma Habronema muscae; Bots (oral and gas- braziliense) and tapeworm (Dipylidium tric stages)—Gasterophilus spp.; caninum, Taenia pisiformis) infections. Lungworms (adults and fourth-stage (3) Limitations. Federal law restricts larvae)—Dictyocaulus arnfieldi; Intes- this drug to use by or on the order of a tinal Threadworms (adults)— licensed veterinarian. Strongyloides westeri; Summer Sores [71 FR 65052, Nov. 7, 2006] caused by Habronema and Draschia spp. cutaneous third-stage larvae; Derma- § 520.1200 Ivermectin, fenbendazole, titis caused by neck threadworm and praziquantel tablets. microfilariae, Onchocerca sp. (a) Specifications. Each chewable tab- (3) Limitations. For oral use only. Do let contains either: not use in horses intended for human (1) 68 micrograms (μg) ivermectin, consumption. 1.134 grams fenbendazole, and 57 milli- [68 FR 55309, Sept. 25, 2003, as amended at 69 grams (mg) praziquantel; or FR 49808, Aug. 12, 2004; 70 FR 65835, Nov. 1, (2) 27 μg ivermectin, 454 mg 2005] fenbendazole, and 23 mg praziquantel.

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(b) Sponsor. See No. 000061 in § 520.1242 Levamisole. § 510.600(c) of this chapter. (c) Conditions of use in dogs—(1) § 520.1242a Levamisole powder. Amount. Administer tablets to provide (a) Specifications. Each package of 6 μg per kilogram (/kg) ivermectin, 100 powder contains 9.075, 11.7, 18.15, 46.8, mg/kg fenbendazole, and 5 mg/kg 362.7, or 544.5 grams (g) levamisole hy- praziquantel. drochloride. (2) Indications for use. For the treat- (b) Sponsors. See sponsors in ment and control of adult Toxocara § 510.600(c) for use as follows: canis (roundworm), Ancylostoma (1) No. 000061 for use of 46.8- and 544.5- caninum (hookworm), Trichuris vulpis g packages as in paragraph (e)(1)(i), (whipworm), and Dipylidium caninum (e)(1)(ii)(B), and (e)(1)(iii) of this sec- tion; for 11.7-, 46.8-, and 544.5-g pack- (tapeworm), and for the prevention of ages as in paragraph (e)(2)(i), heartworm disease caused by Dirofilaria (e)(2)(ii)(B), and (e)(2)(iii) of this sec- immitis in adult dogs. tion; and for an 18.15-g package as in (3) Limitations. Federal law restricts paragraph (e)(3) of this section. this drug to use by or on the order of a (2) No. 053501 for use of a 46.8-g pack- licensed veterinarian. age as in paragraph (e)(1)(i), [73 FR 33692, June 13, 2008, as amended at 74 (e)(1)(ii)(A), and (e)(1)(iii) of this sec- FR 61516, Nov. 25, 2009] tion; for 11.7- and 46.8-g packages as in paragraph (e)(2)(i), (e)(2)(ii)(A), and § 520.1204 Kanamycin, bismuth subcar- (e)(2)(iii) of this section; and for 9.075- bonate, activated attapulgite. and 18.15-g packages as in paragraph (a) Specifications—(1) Each 5 milli- (e)(3) of this section. liters (mL) of suspension contains 100 (3) No. 057561 for use of 46.8- and 544.5- g packages as in paragraphs (e)(1)(i), milligrams (mg) kanamycin (as the (e)(1)(ii)(A), and (e)(1)(iii) and (e)(2)(i), sulfate), 250 mg bismuth subcarbonate, (e)(2)(ii)(A), and (e)(2)(iii) of this sec- and 500 mg activated attapulgite (alu- tion. minum magnesium silicate). (4) No. 059130 for use of 46.8-, 362.7-, (2) Each tablet contains 100 mg and 544.5-g packages as in paragraphs kanamycin (as the sulfate), 250 mg bis- (e)(1)(i), (e)(1)(ii)(B), (e)(1)(iii), (e)(2)(i), muth subcarbonate, and 500 mg acti- (e)(2)(ii)(B), and (e)(2)(iii) of this sec- vated attapulgite. tion; and for use of an 18.15-g package (b) Sponsor. See No. 000856 in as in paragraph (e)(3) of this section. § 510.600(c) of this chapter. (c) Related tolerances. See § 556.350 of (c) Conditions of use in dogs—(1) this chapter. Amount. 5 mL of suspension or 1 tablet (d) Special considerations. See § 500.25 per 20 pounds body weight every 8 of this chapter. hours. Maximum dose: 5 mL of suspen- (e) Conditions of use. It is used as an sion or 3 tablets every 8 hours. Dogs anthelmintic as follows: under 10 pounds: 2.5 mL of suspension (1) Cattle—(i) Amount. 8 milligrams or 1⁄2 tablet every 8 hours. A rec- per kilogram (mg/kg) body weight as a ommended initial loading dose should drench. be twice the amount of a single dose. (ii) Indications for use—(A) Effective (2) Indications for use. For the treat- against the following infec- ment of bacterial enteritis caused by tions: Stomach worms (Haemonchus, Trichostrongylus, Ostertagia); intestinal organisms susceptible to kanamycin worms (Trichostrongylus, Cooperia, and the symptomatic relief of the asso- Nematodirus, Bunostomum, ciated diarrhea. Oesophagostomum); and lungworms (3) Limitations. Federal law restricts (Dictyocaulus). this drug to use by or on the order of a (B) Effective against the following licensed veterinarian. adult nematode infections: Stomach [40 FR 13838, Mar. 27, 1975, as amended at 53 worms (Haemonchus placei, Ostertagia FR 27851, July 25, 1988; 56 FR 8710, Mar. 1, ostertagi, Trichostrongylus axei); intes- 1991; 64 FR 403, Jan. 5, 1999; 71 FR 43968, Aug. tinal worms (T. longispicularis, Cooperia 3, 2006] oncophora, C. punctata, Nematodirus

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spathiger, Bunostomum phlebotomum, § 520.1242b Levamisole hydrochloride Oesophagostomum radiatum); and tablet or oblet (bolus). lungworms (Dictyocaulus viviparus). (a) Chemical name. (-)-2,3,5,6- (iii) Limitations. Do not slaughter for Tetrahydro-6-phenylimidazo [2,1-b] thi- food within 48 hours of treatment. Not azole monohydrochloride. for use in dairy animals of breeding (b) Specifications. Assay of not less age. Conditions of constant helminth than 98 percent by nonaqueous titra- exposure may require retreatment 2 to tion with 0.1 N potassium isopropoxide; 4 weeks after the first treatment. Con- 1 isomer minimum 95 percent pure by sult your veterinarian before using in optical rotation. severely debilitated animals. (c) Sponsor. See Nos. 000061 and 053501 (2) Sheep—(i) Amount. 8 mg/kg body in § 510.600(c) of this chapter. weight as a drench. (d) Required labeling. Consult your (ii) Indications for use—(A) Effective veterinarian for assistance in the diag- against the following nematode infec- nosis, treatment, and control of para- tions: Stomach worms (Haemonchus, sitism. Trichostrongylus, Ostertagia); intestinal (e) Related tolerances. See § 556.350 of worms (Trichostrongylus, Cooperia, this chapter. Nematodirus, Bunostomum, (f) Conditions of use. (1) It is used in Oesophagostomum, Chabertia); and an oblet for cattle as follows: lungworms (Dictyocaulus). (i) Amount. 2.19 grams per oblet. (B) Effective against the following (ii) Indications for use. Anthelmintic adult nematode infections: Stomach effective against the following nema- worms (Haemonchus contortus, tode infections: Stomach worms Trichostrongylus axei, Teladorsagia (Haemonchus, Trichostrongylus, circumcincta); intestinal worms Ostertagia), intestinal worms (Trichostrongylus colubriformis, Cooperia (Trichostrongylus, Cooperia, curticei, Nematodirus spathiger, Nematodirus, Bunostomum, Bunostomum trigonocephalum, Oesophagostomum), and lungworms Oesophagostomum columbianum, (Dictyocaulus). Chabertia ovina), and lungworms (iii) Limitations. Administer as a sin- (Dictyocaulus filaria). gle dose as follows: 250 to 450 pounds, 1⁄2 (iii) Limitations. Do not slaughter for oblet; 450 to 750 pounds, 1 oblet; and 750 food within 72 hours of treatment. Con- to 1,050 pounds, 11⁄2 oblets; conditions of ditions of constant helminth exposure constant helminth exposure may re- may require retreatment 2 to 4 weeks quire re-treatment within 2 to 4 weeks after the first treatment. Consult vet- after the first treatment; do not erinarian before using in severely de- slaughter for food within 48 hours of bilitated animals. treatment; not for use in dairy animals (3) Swine—(i) Amount. 8 mg/kg body of breeding age; consult veterinarian weight in drinking water. before using in severely debilitated (ii) Indications for use. Effective animals. against the following nematode infec- (2) It is used in a tablet for sheep as tions: Large roundworms (Ascaris follows: suum), nodular worms (i) Amount. 0.184 gram per tablet. (Oesophagostomum spp.), intestinal (ii) Indications for use. Anthelmintic thread worms (Strongyloides ransomi) effective against the following nema- and lungworms (Metastrongylus spp. ). tode infections: Stomach worms (iii) Limitations. Do not administer (Haemonchus, Trichostrongylus, within 72 hours of slaughter for food. Ostertagia), intestinal worms Pigs maintained under conditions of (Trichostrongylus, Cooperia, constant exposure to worms may re- Nematodirus, Bunostomum, quire retreatment within 4 to 5 weeks Oesophagostomum, Chabertia), and after the first treatment. Consult your lungworms (Dictyocaulus). veterinarian before administering to (iii) Limitations. Administer one tab- sick swine. let for each 50 pounds of body weight; [69 FR 9753, Mar. 2, 2004, as amended at 69 FR conditions of constant helminth expo- 33839, June 17, 2004; 70 FR 2353, Jan. 13, 2005; sure may require re-treatment within 2 77 FR 28253, May 14, 2012] to 4 weeks after the first treatment; do

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

[40 FR 32831, Aug. 5, 1975, as amended at 41 § 520.1242e Levamisole hydrochloride FR 48731, Nov. 5, 1976; 43 FR 11176 Mar. 17, effervescent tablets. 1978; 67 FR 63055, Oct. 10, 2002] (a) Specifications. Each tablet con- § 520.1242d Levamisole resinate. tains 907 milligrams of levamisole hy- (a) Specifications. The drug is drochloride. levamisole adsorbed on a resin, in a (b) Sponsor. See No. 053501 in concentration equivalent to 10 percent § 510.600(c) of this chapter. levamisole hydrochloride. Each 2.05- (c) Related tolerances. See § 556.350 of ounce (58.1 gram) packet contains this chapter. levamisole equivalent to 5.806 grams of (d) Conditions of use. It is used for levamisole hydrochloride. swine as follows:

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

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(Hypoderma), biting lice (Bovicola), and (1) No. 000009 for use as in paragraph sucking lice (Linognathus, Solenoptes). (d) of this section. (3) Limitations. Drug is not effective (2) Nos. 046573, 054925, 061623, and against lice eggs. Conditions of con- 076475 for use as in paragraphs (d)(1) stant helminth and ectoparasitic expo- and (d)(2) of this section. sure may require retreatment within 2 (c) Tolerances. See § 556.360 of this to 4 weeks after first treatment. Do not chapter. administer to cattle within 19 days of (d) Conditions of use—(1) Swine—(i) slaughter. Do not administer to dairy Amount. 250 milligrams per gallon of animals of breeding age. Do not use in drinking water to provide 3.8 milli- calves less than 3 months old, or in de- grams per pound of body weight per bilitated animals. Do not treat Brah- day. man bulls. Consult your veterinarian for assistance in the diagnosis, treat- (ii) Indications for use. For the treat- ment, and control of parasitism. ment of swine dysentery (bloody scours). [53 FR 23757, June 24, 1988, as amended at 54 (iii) Limitations. Discard medicated FR 1353, Jan. 13, 1989; 57 FR 7652, Mar. 4, 1992; drinking water if not used within 2 62 FR 55160, Oct. 23, 1997; 62 FR 61625, Nov. 19, 1997] days. Prepare fresh stock solution daily. Do not use for more than 10 days. § 520.1263 Lincomycin. If clinical signs of disease have not im- proved within 6 days, discontinue § 520.1263a Lincomycin hydrochloride treatment and reevaluate diagnosis. monohydrate tablets and sirup. The safety of lincomycin has not been (a) Specifications. The sirup contains demonstrated in pregnant swine or lincomycin hydrochloride equivalent swine intended for breeding. For No. to either 25 milligrams or 50 milli- 051259: Do not slaughter swine for 6 grams of lincomycin. days following last treatment. (b) Sponsor. See No. 000009 in (2) Chickens—(i) Amount. 64 milli- § 510.600(c) of this chapter. grams per gallon of drinking water. (c) Conditions of use. (1) The drug is (ii) Indications for use. For the control indicated in infections caused by gram- of necrotic enteritis caused by Clos- positive organisms which are sensitive tridium perfringens susceptible to linco- to its action, particularly streptococci mycin in broiler chickens. and staphylococci. (iii) Limitations. Discard medicated (2) It is administered orally to dogs drinking water if not used within 2 and cats at a dosage level of 10 mgs per days. Prepare fresh stock solution pound of body weight every 12 hours, or daily. Administer for 7 consecutive 7 mgs per pound of body weight every 8 hours. Treatment may be continued for days. Do not allow rabbits, hamsters, periods as long as 12 days if clinical guinea pigs, horses, or ruminants ac- judgment indicates. cess to water containing lincomycin. (3) Federal law restricts this drug to Not for use in layer and breeder chick- use by or on the order of a licensed vet- ens. erinarian. (3) Honey bees—(i) Amount. Mix 100 milligrams lincomycin with 20 grams [40 FR 13838, Mar. 27, 1975, as amended at 44 confectioners’/powdered sugar and dust FR 7130, Feb. 6, 1979; 64 FR 403, Jan. 5, 1999] over the top bars of the brood chamber § 520.1263b [Reserved] once weekly for 3 weeks. (ii) Indications for use. For the control § 520.1263c Lincomycin powder. of American foulbrood (Paenibacillus (a) Specifications. Each gram of solu- larvae). ble powder contains lincomycin hydro- (iii) Limitations. The drug should be chloride equivalent to 0.4 grams of lin- fed early in the spring or late in the comycin. fall and consumed by the bees before (b) Sponsors. See sponsor numbers in the main honey flow begins to avoid § 510.600(c) of this chapter for use as in contamination of production honey. paragraph (d) of this section.

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Complete treatments at least 4 weeks contain liothyronine at 60 or 120 before main honey flow. micrograms per tablet, as the sodium [48 FR 3966, Jan. 28, 1983, as amended at 55 salt. FR 3209, Jan. 31, 1990; 60 FR 14217, Mar. 16, (b) Sponsor. See No. 000069 in 1995; 62 FR 65020, Dec. 10, 1997; 64 FR 13341, § 510.600(c) of this chapter. Mar. 18, 1999; 64 FR 13508, Mar. 19, 1999; 64 FR (c) Conditions of use. (1) It is indicated 66382, Nov. 26, 1999; 65 FR 10705, Feb. 29, 2000; in cases of hypothyroidism in dogs. 67 FR 17284, Apr. 10, 2002; 67 FR 71819, Dec. 3, 2002; 67 FR 78356, Dec. 24, 2002; 68 FR 3817, (2) It is administered orally to dogs Jan. 27, 2003; 70 FR 1818, Jan. 11, 2005; 77 FR at levels up to 12.8 micrograms per 20988, Apr. 9, 2012; 77 FR 29217, May 17, 2012] kilogram of body weight per day. Dos- age should be adjusted according to the § 520.1265 Lincomycin and severity of the condition and the re- spectinomycin powder. sponse of the patient. Dosage at the (a) Specifications. The following salts total replacement level (12.8μg per kilo- of lincomycin and spectinomycin are gram of body weight) should be consid- present in a soluble powder in the ratio ered for initiating therapy and then of 1 to 2 on the basis of equivalency of titrated downward for optimum main- lincomycin base to equivalency of tenance effect. Twice daily administra- spectinomycin base: tion is recommended. (1) Lincomycin hydrochloride (3) Federal law restricts this drug to monohydrate and spectinomycin sul- use by or on the order of a licensed vet- fate tetrahydrate. erinarian. (2) Lincomycin hydrochloride monohydrate and spectinomycin [40 FR 13838, Mar. 27, 1975, as amended at 56 dihydrochloride pentahydrate. FR 50653, Oct. 8, 1991; 60 FR 55659, Nov. 2, (b) Sponsors. See sponsors in 1995] § 510.600(c) of this chapter for use as in paragraph (d) of this section. § 520.1288 Lufenuron tablets. (1) No. 000009 for use of product de- (a) Specifications—(1) Tablets con- scribed in paragraph (a)(1) of this sec- taining 45, 90, 204.9, or 409.8 milligrams tion. (mg) lufenuron for use as in paragraphs (2) Nos. 057561, 061623, and 066104 for (c)(1)(i), (c)(1)(ii)(A), (c)(1)(iii), (c)(2)(i), use of product described in paragraph (c)(2)(ii)(A), and (c)(2)(iii) of this sec- (a)(2) of this section. tion. (c) Tolerances. See §§ 556.360 and (2) Flavored tablets containing 45, 90, 556.600 of this chapter. 204.9, or 409.8 milligrams (mg) (d) Conditions of use in chickens—(1) lufenuron for use as in paragraphs Amount. 2 grams of antibiotic activity (c)(1)(i), (c)(1)(ii)(A) or (c)(1)(ii)(B), and per gallon of drinking water; admin- (c)(1)(iii) of this section. ister as the sole source of water for the (3) Flavored tablets containing 90 or first 5 to 7 days of life. (2) Indications for use. As an aid in the 204.9 mg lufenuron for use as in para- control of airsacculitis caused by ei- graphs (c)(2)(i), (c)(2)(ii)(A) or ther Mycoplasma synoviae or M. (c)(2)(ii)(B), and (c)(2)(iii) of this sec- gallisepticum susceptible to lincomycin- tion. spectinomycin and complicated chron- (4) Flavored tablets containing 135 or ic respiratory disease (air sac infec- 270 mg lufenuron for use as in para- tion) caused by Escherichia coli and M. graphs (c)(2)(i), (c)(2)(ii)(A), and gallisepticum susceptible to lincomycin- (c)(2)(iii) of this section. spectinomycin. (b) Sponsor. See No. 058198 in § 510.600(c) of this chapter. [69 FR 13220, Mar. 22, 2004, as amended at 70 FR 40881, July 15, 2005; 71 FR 71038, Dec. 8, (c) Conditions of use—(1) Dogs—(i) 2006; 77 FR 56770, Sept. 14, 2012] Amount. Minimum of 10 mg lufenuron per kilogram (4.5 mg per pound (lb)) of § 520.1284 Sodium liothyronine tablets. body weight, once a month. (a) Specifications. Sodium (ii) Indications for use—(A) For the liothyronine tablets consist of tablets prevention and control of flea popu- intended for oral administration which lations.

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(B) The concurrent use of flavored § 520.1310 Marbofloxacin tablets. lufenuron tablets described in para- (a) Specifications. Each tablet con- graph (a)(2) of this section as in para- tains 25, 50, 100, or 200 milligrams (mg) graph (c)(1)(ii)(A) of this section with marbofloxacin. nitenpyram tablets as in § 520.1510(d)(1) (b) Sponsor. See No. 000069 in of this chapter is indicated to kill § 510.600(c) of this chapter. adult fleas and prevent flea eggs from (c) [Reserved] hatching. (d) Conditions of use—(1) Amount. 1.25 (iii) Limitations. For use in dogs and mg per pound (/lb) of body weight once puppies 4 weeks of age and older. daily, but may be increased to 2.5 mg/ (2) Cats—(i) Amount. Minimum of 30 lb of body weight once daily. mg lufenuron per kilogram (13.6 mg/lb) (2) Indications for use. For the treat- of body weight, once a month. ment of infections in dogs and cats as- (ii) Indications for use—(A) For the sociated with bacteria susceptible to control of flea populations. marbofloxacin. (B) The concurrent use of flavored (3) Limitations. Federal law restricts lufenuron tablets described in para- this drug to use by or on the order of a graph (a)(3) of this section as in para- licensed veterinarian. Federal law pro- graph (c)(2)(ii)(A) of this section with hibits the extralabel use of this drug in nitenpyram tablets as in § 520.1510(d)(2) food-producing animals. of this chapter is indicated to kill [64 FR 39919, July 23, 1999, as amended at 66 adult fleas and prevent flea eggs from FR 46369, Sept. 5, 2001] hatching. (iii) Limitations. For use in cats and § 520.1315 Maropitant. kittens 4 weeks of age and older. (a) Specifications. Each tablet con- [68 FR 51905, Aug. 29, 2003] tains 16, 24, 60, or 160 milligrams (mg) maropitant as maropitant citrate. § 520.1289 Lufenuron suspension. (b) Sponsor. See No. 000069 in § 510.600(c) of this chapter. (a) Specifications. Each individual (c) Conditions of use in dogs—(1) Indi- dose pack contains either 135 or 270 cations for use and amount. For the pre- milligrams of lufenuron. vention of acute vomiting, administer (b) Sponsor. See No. 058198 in a minimum of 2.0 mg per kilogram (/ § 510.600(c) of this chapter. kg) body weight once daily for up to 5 (c) Conditions of use in cats—(1) consecutive days. For the prevention of Amount. Minimum of 13.6 milligrams vomiting due to motion sickness, ad- per pound of body weight (30 milli- minister a minimum of 8.0 mg/kg body grams per kilogram). Recommended weight once daily for up to 2 consecu- dose of 135 milligrams for up to 10 tive days. pounds of body weight or 270 milli- (2) Limitations. Federal law restricts grams for 11 to 20 pounds. Cats over 20 this drug to use by or on the order of a pounds are provided the appropriate licensed veterinarian. combination of packs. [72 FR 9243, Mar. 1, 2007] (2) Indications for use. For control of flea populations. § 520.1320 Mebendazole oral. (3) Limitations. For oral use in cats 6 (a) Chemical name. Methyl 5-benzoyl- weeks of age or older, once a month, benzimindazole-2-carbamate. mixed with food. Administer in con- (b) Specifications. As oral powder: junction with a full meal to ensure ade- Each gram contains either 40 or 166.7 quate absorption. Treat all cats in the milligrams of mebendazole. As oral household to ensure maximum bene- paste: Each gram contains 200 milli- fits. Because the drug has no affect on grams of mebendazole. As oral suspen- adult fleas, the concurrent use of insec- sion: Each milliliter contains 33.3 mil- ticides that kill adults may be nec- ligrams of mebendazole. essary depending on the severity of the (c) Sponsor. See No. 000061 in infestation. § 510.600(c) of this chapter. [60 FR 20402, Apr. 26, 1995, as amended at 62 (d) Conditions of use—(1) Horses—(i) FR 8371, Feb. 25, 1997] Amount. 1 gram of mebendazole per 250

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pounds of body weight per dose, as an drug to use by or on the order of a li- oral powder, paste or suspension. censed veterinarian. (ii) Indications for use. It is used in [42 FR 61255, Dec. 2, 1977, as amended at 43 horses for treatment of infections FR 35686, Aug. 11, 1978; 45 FR 3574, Jan. 18, caused by large roundworms (Parascaris 1980; 46 FR 47218, Sept. 25, 1981; 46 FR 53658, equorum); large strongyles (Strongylus Oct. 30, 1981; 62 FR 61625, Nov. 19, 1997] edentatus, S. equinus, S. vulgaris); small strongyles; and mature and immature § 520.1326 Mebendazole and (4th larval stage pinworms (Oxyuris trichlorfon oral dosage forms. equi)). (iii) Limitations—(a) Oral powder. The § 520.1326a Mebendazole and trichlorfon powder. drug is given by sprinkling directly on the grain portion of the ration or dis- (a) Specifications. Each gram of pow- solving in 2 to 4 pints of water and ad- der contains 83.3 milligrams of ministering by stomach tube. The drug mebendazole and 375.0 milligrams of is compatible with carbon disulfide, trichlorofon. which can be used concurrently for (b) Sponsor. See No. 000061 in both control (Gastrophilus spp. ). Rou- § 510.600(c) of this chapter. tine cautions regarding the use of car- (c) Conditions of use. Horses—(1) bon disulfide must be observed. Do not Amount. 8.8 milligrams of mebendazole administer to horses intended for use and 40 milligrams of trichlorofon per as food. Federal law restricts this drug kilogram of body weight. to use by or on the order of a licensed (2) Indications for use. It is used in veterinarian. horses for the treatment of infections (b) Oral paste. The drug is given by of bots (Gastrophilus intestinalis and G. dosing gun (syringe), inserting the tip nasalis), large roundworms (Parascaris of the gun at the interdental space in equorum), large strongyles (Strongylus the horse’s mouth and depositing the edentatus, S. equinus, S. vulgaris), small paste on the animal’s tongue. The hand strongyles, and pinworms (Oxyuris is placed under the animal’s jaw, and equi.) the head is raised to assure that the (3) Limitations. Administer orally as paste is deposited on the roof of the an individual dose by stomach tube or mouth. Not for use in horses intended throughly mixed in the ground grain for food. Consult your veterinarian for portion of the ration to be consumed in assistance in the diagnosis, treatment, one feeding. Discard treated feed not and control of parasitism. consumed. Do not administer more (c) Oral suspension. The drug is ad- than once every 30 days. Do not treat ministered by stomach tube. Not for sick or debilitated animals, foals under horses intended for food use. Federal 4 months of age, or mares in the last law restricts this drug to use by or on month of pregnancy. Trichlorofon is a the order of a licensed veterinarian. cholinesterase inhibitor. Do not admin- (2) Dogs—(i) Amount. One hundred ister simultaneously or within a few milligrams of mebendazole per 10 days before or after treatment with, or pounds of body weight, once daily for 3 exposure to, cholinesterase-inhibiting days, as an oral powder. drugs, pesticides or chemicals. Do not (ii) Indications for use. The drug is administer intravenous anesthetics, es- used for treatment of infections of pecially muscle relaxants, concur- roundworms (Toxocara canis), rently. Not for horses intended for food hookworms (Ancylostoma caninum, use. Federal law restricts this drug to Uncinaria stenocephala), whipworms use by or on the order of a licensed vet- (Trichuris vulpis), and tapeworms erinarian. (Taenia pisiformis). [45 FR 10759, Feb. 19, 1980, as amended at 46 (iii) Limitations. Administer as an FR 52330, Oct. 27, 1981. Redesignated at 51 FR oral powder by mixing with a small 13212, Apr. 18, 1986, as amended at 62 FR quantity of food, preferably before the 61625, Nov. 19, 1997] regular meal. Federal law restricts this

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§ 520.1326b Mebendazole and tenance dosage level should be individ- trichlorfon paste. ualized for each animal. (a) Specifications. Each gram of paste (4) This drug should not be adminis- contains 100 milligrams of mebendazole tered to horses with active gastro- and 454 milligrams of trichlorfon. intestinal, hepatic, or renal disease. (b) Sponsor. See No. 000061 in (5) Not for use in horses intended for § 510.600(c) of this chapter. food. (c) Conditions of use—(1) Amount. 8.8 (6) Federal law restricts this drug to milligrams of mebendazole and 40 mil- use by or on the order of a licensed vet- ligrams of trichlorfon per kilogram of erinarian. body weight. [41 FR 5632, Feb. 9, 1976, as amended at 53 FR (2) Indications for use. It is used in 23390, June 22, 1988] horses for treatment of infections of bots (Gastrophilus intestinalis and G. na- § 520.1331 Meclofenamic acid tablets. salis), large roundworms (Parascaris (a) Specifications. Each tablet con- equorum), large strongyles (Strongylus tains either 10 or 20 milligrams of edentatus, S. equinus, S. vulgaris), small meclofenamic acid. strongyles, and pinworms (Oxyuris (b) Sponsor. See No. 000856 in equi). § 510.600(c) of this chapter. (3) Limitations. Do not administer (c) Conditions of use in dogs—(1) more than once every 30 days. Do not Amount. 1.1 milligrams per kilogram treat sick or debilitated animals, foals (0.5 milligram per pound) daily for 5 to under 4 months of age, or mares in the 7 days. last month of pregnancy. Trichlorfon is (2) Indications for use. For the relief of a cholinesterase inhibitor. Do not ad- signs and symptoms of chronic inflam- minister simultaneously or within a matory disease involving the musculo- few days before or after treatment skeletal system. with, or exposure to, cholinesterase-in- (3) Limitations. For oral use only. hibiting drugs, pesticides, or chemi- Should not be administered to animals cals. Do not administer intravenous with congestive heart failure or active anesthetics, especially muscle relax- gastrointestinal, hepatic, or renal dis- ants, concurrently. Not for use in ease. Federal law restricts this drug to horses intended for food. Consult your use by or on the order of a licensed vet- veterinarian for assistance in the diag- erinarian. nosis, treatment, and control of para- sitism. [50 FR 43385, Oct. 25, 1985, as amended at 53 FR 23390, June 22, 1988] [51 FR 13212, Apr. 18, 1986, as amended at 62 FR 61625, Nov. 19, 1997] § 520.1341 Megestrol acetate tablets. (a) Specifications. Each tablet con- § 520.1330 Meclofenamic acid granules. tains 5 or 20 milligrams of megestrol (a) Chemical name. N-(2,6-Dichlorom- acetate. tolyl) anthranilic acid. (b) Sponsor. No. 000061 in § 510.600(c) of (b) Specifications. The drug is in this chapter. granular form containing 5 percent (c) Conditions of use. (1) The drug is meclofenamic acid. used in female dogs for the postpone- (c) Sponsor. See No. 000856 in ment of estrus and the alleviation of § 510.600(c) of this chapter. false pregnancy. (d) Conditions of use. (1) The drug is (2) It is administered orally, intact, used in horses for the treatment of or crushed and mixed with food as fol- acute or chronic inflammatory diseases lows: involving the musculoskeletal system. (i) For the postponement of estrus by (2) It is administered orally at a dos- proestrus treatment, 1 milligram per age of 1 milligram per pound of body pound of body weight per day for 8 weight (1 gram per 1,000 pounds) once days. daily for 5 to 7 days by addition to the (ii) For the postponement of estrus daily grain ration. by anestrus treatment, 0.25 milligram (3) Treatment beyond the initial 5- to per pound of body weight per day for 32 7-day period may be indicated. A main- days.

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(iii) For alleviation of false preg- (3) Limitations. Federal law restricts nancy, 1 milligram per pound of body this drug to use by or on the order of a weight per day for 8 days. licensed veterinarian. (3) Full dosage regimen must be com- [68 FR 42968, July 21, 2003, as amended at 69 pleted to produce the desired effect. FR 69523, Nov. 30, 2004. Redesignated and (4) Examination of vaginal smears is amended at 78 FR 57058, Sept. 17, 2013] recommended to confirm detection of proestrus. § 520.1372 Methimazole. (5) Do not administer for more than (a) Specifications. Each tablet con- two consecutive treatments. tains 2.5 or 5 milligrams (mg) (6) Once therapy is started, the ani- methimazole. mal should be confined for 3 to 8 days (b) Sponsor. See No. 043264 in § 510.600 or until cessation of bleeding, since of this chapter. dogs in proestrus accept a male. (c) Conditions of use in cats—(1) (7) Do not use prior to or during first Amount. The starting dose is 2.5 mg estrus cycle. every 12 hours. Following 3 weeks of (8) Do not use in pregnant animals. treatment, the dose should be titrated to effect based on individual serum (9) Do not use in the presence of a total T4 levels and clinical response. disease of the reproductive system or (2) Indications for use. For the treat- with mammary tumors. ment of hyperthyroidism. (10) Should estrus occur within 30 (3) Limitations. Federal law restricts days after cessation of treatment, mat- this drug to use by or on the order of a ing should be prevented. licensed veterinarian. (11) Federal law restricts this drug to use by or on the order of a licensed vet- [74 FR 27707, June 11, 2009] erinarian. § 520.1380 Methocarbamol tablets. [40 FR 13838, Mar. 27, 1975, as amended at 52 (a) Chemical name. 3-(O- FR 7832, Mar. 13, 1987] Methoxyphenoxy)-1,2-propanediol 1- carbamate. § 520.1367 Meloxicam. (b) Specifications. Each tablet con- (a) Specifications—(1) Each milliliter tains 500 milligrams of methocarbamol. of suspension contains 0.5 milligrams (c) Sponsor. See No. 000856 in (mg) meloxicam. § 510.600(c) of this chapter. (2) Each milliliter of suspension con- (d) Conditions of use. (1) The drug is tains 1.5 mg meloxicam. administered to dogs and cats as an ad- (b) Sponsors. See sponsors in junct to therapy for acute inflam- § 510.600(c) of this chapter for uses as in matory and traumatic conditions of paragraph (c) of this section: the skeletal muscles in order to reduce (1) No. 000010 for use of the products muscular spasms. described in paragraph (a) of this sec- (2) Dosage is based upon severity of tion; and symptoms and response noted. The usual initial dose in 60 milligrams per (2) No. 013744 for use of the product pound of body weight in two or three described in paragraph (a)(2) of this equally divided doses followed by 30 to section. 60 milligrams per pound of body weight (c) Conditions of use in dogs—(1) each following day, usually not to ex- Amount. Administer orally as a single ceed 14 to 21 days. dose at 0.09 mg per pound (mg/lb) body (3) For use only by or on the order of weight (0.2 mg per kilogram (mg/kg)) a licensed veterinarian. on the first day of treatment. For all treatment after day 1, administer 0.045 [40 FR 13838, Mar. 27, 1975, as amended at 67 FR 67521, Nov. 6, 2002] mg/lb (0.1 mg/kg) body weight once daily. § 520.1408 Methylprednisolone tablets. (2) Indications for use. For the control (a) Specifications. Each table contains of pain and inflammation associated 1, 2, or 4 milligrams of with osteoarthritis. methylprednisolone.

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(b) Sponsor. See No. 000009 in methylprednisolone and 300 milligrams § 510.600(c) of this chapter for use of 1- of aspirin. and 4-milligram tablets; see No. 054628 (b) Sponsor. See No. 000009 in for use of 1- and 2-milligram tablets. § 510.600(c) of this chapter. (c) [Reserved] (c) NAS/NRC status. The conditions of (d) Special consideration. (1) Clinical use have been NAS/NRC reviewed and and experimental data have dem- found effective. New animal drug appli- onstrated that corticosteroids adminis- cations for approval of drugs for these tered orally or parenterally to animals conditions of use need not include ef- may induce the first stage of parturi- fectiveness data specified by § 514.111 of tion when administered during the last this chapter, but may require bio- trimester of pregnancy and may pre- equivalency and safety information. cipitate premature parturition fol- (d) Special considerations. (1) Clinical lowed by dystocia, fetal death, retained and experimental data have dem- placenta, and metritis. onstrated that corticosteroids adminis- (2) Systemic therapy with tered orally or parenterally to animals methylprednisolone is contraindicated may induce the first stage of parturi- in animals with arrested tuberculosis, tion when administered during the last peptic ulcer, acute psychoses, or trimester of pregnancy and may pre- cushingoid syndrome. The presence of cipitate premature parturition fol- active tuberculosis, diabetes, lowed by dystocia, fetal death, retained osteoporosis, chronic psychotic reac- placenta, and metritis. tions, predisposition to (2) Systemic therapy with thrombophlebitis, hypertension, con- methylprednisolone is contraindicated gestive heart failure, or renal insuffi- in animals with tuberculosis, chronic ciency necessitates carefully con- nephritis, peptic ulcer, or Cushingoid trolled use of corticosteroids. Some of syndrome. The presence of diabetes these conditions occur only rarely in mellitus, osteoporosis, predisposition dogs and cats but should be kept in to thrombophlebitis, hypertension, mind. congestive heart failure, or renal insuf- (3) Anti-inflammatory action of ficiency necessitates carefully con- corticosteroids may mask signs of in- trolled use of corticosteroids. fection. (3) Anti-inflammatory action of (e) Conditions of use—(1) Amount. Dogs corticosteroids may mask signs of in- and cats: 5 to 15 pounds, 2 milligrams; fection. 15 to 40 pounds, 2 to 4 milligrams; 40 to (e) Conditions of use—(1) Amount. Dogs 80 pounds, 4 to 8 milligrams. 1 under 15 pounds, ⁄4 to 1 tablet daily; 15 (2) Indications for use. For use in dogs to 60 pounds, 1 to 2 tablets daily; 60 and cats as an anti-inflammatory pounds and over, 2 tablets daily. agent. (2) Indications for use. As an anti-in- (3) Limitations. Administer total daily flammatory and analgesic agent in dose orally in equally divided doses 6 to dogs. 10 hours apart until response is noted (3) Limitations. Administer total daily or 7 days have elapsed. When response dose in divided doses 6 to 10 hours is attained, dosage should be gradually apart, with a light feeding. When re- reduced until maintenance level is sponse is attained, dosage should be achieved. Hazardous for human use. gradually reduced until maintenance Federal law restricts this drug to use level is achieved. Do not administer to by or on the order of a licensed veteri- cats. Do not overdose. Federal law re- narian. stricts this drug to use by or on the [47 FR 52697, Nov. 23, 1982, as amended at 49 order of a licensed veterinarian. FR 20810, May 17, 1984; 50 FR 32844, Aug. 15, 1985; 53 FR 40727, Oct. 18, 1988; 62 FR 35076, [48 FR 21566, May 13, 1983] June 30, 1997; 78 FR 21059, Apr. 9, 2013] § 520.1422 Metoserpate hydrochloride. § 520.1409 Methylprednisolone, aspirin (a) Chemical name. Methyl-o-methyl- tablets. 18-epireserpate hydrochloride. (a) Specifications. Each tablet con- (b) Sponsor. See No. 053501 in tains 0.5 milligram of § 510.600(c) of this chapter.

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(c) Related tolerances. See § 556.410 of (3) Limitations. Administer daily, this chapter. orally or in a small amount of food, at (d) Conditions of use. It is used in least 30 days before expected initiation drinking water for replacement chick- of heat, and continue daily as long as ens as follows: desired, but not for more than 24 (1) Amount. 568.5 milligrams per gal- months. Mibolerone should not be used lon (0.015 percent). in bitches before the first estrous pe- (i) Indications for use. As a tranquil- riod. It is not intended for animals izer for flock treatment of chickens being used primarily for breeding pur- prior to handling. poses. Use orally in adult female dogs (ii) Limitations. To be used one time only. Federal law restricts this drug to as a treatment for replacement chick- use by or on the order of a licensed vet- ens up to 16 weeks of age; usual drink- erinarian. ing water should be withheld prior to [43 FR 15625, Apr. 14, 1978] treatment to provide adequate con- sumption of medicated drinking water; § 520.1441 Milbemycin oxime. not for use in laying chickens; chick- (a) Specifications—(1) Dogs. Each tab- ens slaughtered within 72 hours fol- let contains 2.3, 5.75, 11.5, or 23.0 milli- lowing treatment must not be used for grams of milbemycin oxime. food. (2) Cats. Each tablet contains 5.75, (2) Amount. 2 to 4 milligrams per 2.2 11.5, or 23.0 milligrams of milbemycin pounds of body weight. oxime. (i) Indications for use. As an aid in (b) Sponsor. See 058198 in § 510.600(c) of control of hysteria. this chapter. (ii) Limitations. To be used as a treat- (c) [Reserved] ment for replacement chickens up to 16 (d) Conditions of use—(1) Dogs and weeks of age; usual drinking water puppies—(i) Amount. For hookworm, should be withheld prior to treatment roundworm, and whipworm, use 0.23 to provide adequate consumption of milligram per pound of body weight (0.5 medicated drinking water; the drug milligram per kilogram). For heart- should be administered at a dosage worm, use 0.05 milligram per pound of level of 4 milligrams per 2.2 pounds of body weight (0.1 milligram per kilo- body weight followed by 2 treatments gram). at 4-day intervals of 2 milligrams per (ii) Indications for use. For prevention 2.2 pounds of body weight; not for use of heartworm disease caused by in laying chickens; chickens slaugh- Dirofilaria immitis, control of hookworm tered within 72 hours following treat- infections caused by Ancylostoma ment must not be used for food. caninum, and removal and control of adult roundworm infections caused by [40 FR 13838, Mar. 27, 1975, as amended at 76 Toxocara canis and Toxascaris leonina FR 17337, Mar. 29, 2011] and whipworm infections caused by Trichuris vulpis in dogs and in puppies 4 § 520.1430 Mibolerone. weeks of age or greater and 2 pounds of (a) Specifications. Each milliliter con- body weight or greater. tains 100 micrograms of mibolerone. (iii) Limitations. Do not use in puppies (b) Sponsor. See No. 000009 in less than 4 weeks of age and less than § 510.600(c) of this chapter. 2 pounds of body weight. Administer (c) Conditions of use—(1) Amount. 30 once a month. First dose given within micrograms for animals weighing 1 to 1 month after first exposure to mosqui- 25 pounds; 60 micrograms for animals toes and continue regular use until at weighing 26 to 50 pounds; 120 least 1 month after end of mosquito micrograms for animals weighing 51 to season. Federal law restricts this drug 100 pounds; 180 micrograms for animals to use by or on the order of a licensed weighing over 100 pounds, German veterinarian. Shepherds, or German Shepherd mix. (2) Cats and kittens—(i) Amount. 0.91 (2) Indications for use. For the preven- milligram per pound of body weight (2.0 tion of estrus (heat) in adult female milligrams per kilogram). dogs not intended primarily for breed- (ii) Indications for use. For prevention ing purposes. of heartworm disease caused by

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Dirofilaria immitis and the removal of indicated to kill adult fleas and pre- adult Toxocara cati (roundworm) and vent flea eggs from hatching. Ancylostoma tubaeforme (hookworm) in- (iii) Limitations. Federal law restricts fections in cats 6 weeks of age or great- this drug to use by or on the order of a er and 1.5 pounds body weight or great- licensed veterinarian. er. (2) [Reserved] (iii) Limitations. Do not use in kittens [62 FR 28629, May 27, 1997, as amended at 63 less than 6 weeks of age or 1.5 pounds FR 41190, Aug. 3, 1998; 68 FR 51905, Aug. 29, body weight. Administer once a month. 2003. Redesignated at 77 FR 47512, Aug. 9, Federal law restricts this drug to use 2012] by or on the order of a licensed veteri- narian. § 520.1445 Milbemycin oxime and praziquantel. [55 FR 25301, June 21, 1990, as amended at 55 (a) Specifications. Each chewable tab- FR 49888, Dec. 3, 1990; 58 FR 5608, Jan. 22, 1993; 60 FR 50097, Sept. 28, 1995; 61 FR 43654, let contains: Aug. 26, 1996; 63 FR 29352, May 29, 1998; 63 FR (1) 2.3 milligrams (mg) milbemycin 41189, Aug. 3, 1998. Redesignated at 77 FR oxime and 22.8 mg praziquantel; 47512, Aug. 9, 2012] (2) 5.75 mg milbemycin oxime and 57 mg praziquantel; § 520.1443 Milbemycin oxime and (3) 11.5 mg milbemycin oxime and 114 lufenuron. mg praziquantel; or (a) Specifications—(1) Tablets con- (4) 23 mg milbemycin oxime and 228 taining: 2.3 milligrams (mg) mg praziquantel. milbemycin oxime and 46 mg (b) Sponsor. See No. 058198 in lufenuron, 5.75 mg milbemycin oxime § 510.600(c) of this chapter. and 115 mg lufenuron, 11.5 mg (c) Conditions of use—(1) Dogs—(i) milbemycin oxime and 230 mg Amount. Administer orally, once a lufenuron, or 23 mg milbemycin oxime month, a minimum dosage of 0.23 mg and 460 mg lufenuron. per pound (mg/lb) of body weight (0.5 (2) Flavored tablets containing: 2.3 mg per kilogram (mg/kg)) milbemycin mg milbemycin oxime and 46 mg oxime and 2.28 mg/lb of body weight (5 lufenuron, 5.75 mg milbemycin oxime mg/kg) praziquantel. and 115 mg lufenuron, 11.5 mg (ii) Indications for use. For the pre- milbemycin oxime and 230 mg vention of heartworm disease caused lufenuron, or 23 mg milbemycin oxime by Dirofilaria immitis and for the treat- and 460 mg lufenuron. ment and control of adult roundworm (b) Sponsor. See No. 058198 in (Toxocara canis, Toxascaris leonina), § 510.600(c) of this chapter. adult hookworm (Ancylostoma (c) [Reserved] caninum), adult whipworm (Trichuris (d) Conditions of use—(1) Dogs—(i) vulpis), and adult tapeworm (Taenia Amount. 0.5 mg milbemycin oxime and pisiformis, Echinococcus multilocularis, 10 mg lufenuron per kilogram of body and E. granulosus) infections in dogs weight, once a month. and puppies 2 pounds of body weight or (ii) Indications for use—(A) For use in greater and 6 weeks of age and older. dogs and puppies for the prevention of (iii) Limitations. Federal law restricts heartworm disease caused by Dirofilaria this drug to use by or on the order of a immitis, for prevention and control of licensed veterinarian. flea populations, for control of adult (2) [Reserved] Ancylostoma caninum (hookworm), and [77 FR 47512, Aug. 9, 2012] for removal and control of adult Toxocara canis, Toxascaris leonina § 520.1447 Milbemycin oxime, (roundworm), and Trichuris vulpis lufenuron, and praziquantel tablets. (whipworm) infections. (a) Specifications. Each tablet con- (B) The concurrent use of flavored tains: milbemycin oxime and lufenuron tab- (1) 2.3 milligrams (mg) milbemycin lets described in paragraph (a)(2) of oxime, 46 mg lufenuron, and 22.8 mg this section as in paragraph (d)(1)(ii)(A) praziquantel; of this section with nitenpyram tablets (2) 5.75 mg milbemycin oxime, 115 mg as in § 520.1510(d)(1) of this chapter is lufenuron, and 57 mg praziquantel;

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(3) 11.5 mg milbemycin oxime, 230 mg spp.), and worms of the large intestine lufenuron, and 114 mg praziquantel; or (Oesophagostomum radiatum). (4) 23 mg milbemycin oxime, 460 mg (3) Limitations. Conditions of constant lufenuron, and 228 mg praziquantel. worm exposure may require retreat- (b) Sponsor. See No. 058198 in ment in 2 to 4 weeks. Consult your vet- § 510.600(c) of this chapter. erinarian before administering to se- (c) [Reserved] verely debilitated animals and for as- (d) Conditions of use—(1) Dogs—(i) sistance in the diagnosis, treatment, Amount. 0.5 mg milbemycin oxime, 10 and control of parasitism. Do not treat mg lufenuron, and 5 mg of praziquantel within 14 days of slaughter. per kilogram of body weight, once a month. [46 FR 50949, Oct. 16, 1981. Redesignated at 49 (ii) Indications for use. For the pre- FR 47831, Dec. 7, 1984, and amended at 51 FR vention of heartworm disease caused 9005, Mar. 17, 1986] by Dirofilaria immitis; for the prevention and control of flea populations § 520.1450b Morantel tartrate car- (Ctenocephalides felis); and for the treat- tridge. ment and control of adult roundworm (a) Specifications. The drug product (Toxocara canis, Toxascaris leonina), consists of a stainless-steel cylinder adult hookworm (Ancylostoma having both ends closed with poly- caninum), adult whipworm (Trichuris ethylene diffusing discs and containing vulpis), and adult tapeworm (Taenia a morantel tartrate paste. The paste pisiformis, Echinococcus multilocularis, contains 22.7 grams of morantel tar- and E. granulosus) infections in dogs trate equivalent to 13.5 grams of and puppies 2 pounds of body weight or morantel base. greater and 6 weeks of age and older. (iii) Limitations. Federal law restricts (b) Sponsor. See No. 000069 in this drug to use by or on the order of a § 510.600(c) of this chapter. licensed veterinarian. (c) Related tolerances. See § 556.425 of (2) [Reserved] this chapter. (d) Conditions of use—(1) Amount. [77 FR 4225, Jan. 27, 2012] Grazing cattle: Administer 1 cartridge § 520.1450 Morantel tartrate oral dos- to each animal at the start of the graz- age forms. ing season. (2) Indications for use. For control of § 520.1450a Morantel tartrate bolus. the adult stage of the following gastro- (a) Specifications. Each bolus contains intestinal nematode infections in 2.2 grams morantel tartrate equivalent weaned calves and yearling cattle to 1.3 grams of morantel base. weighing a minimum of 200 pounds: (b) Sponsor. See No. 000069 in Ostertagia spp., Trichostrongylus axei, § 510.600(c) of this chapter. Cooperia spp., and Oesophagostomum (c) Related tolerances. See § 556.425 of radiatum. this chapter. (3) Limitations. Administer orally (d) Conditions of use—(1) Amount. One with the dosing gun to all cattle that bolus per 500 pounds of body weight (4.4 will be grazing the same pasture. Effec- milligrams per pound of body weight) tiveness of the drug product is depend- as a single oral dose. Boluses may be ent upon continuous control of the gas- divided in half for more accurate dos- trointestinal parasites for approxi- ing as follows: up to 325 pounds, 1⁄2 bolus; 326 to 600 pounds, 1 bolus; 601 to mately 90 days following administra- tion. Therefore, treated cattle should 900 pounds, 11⁄2 boluses; and 901 to 1,200 pounds, 2 boluses. not be moved to pastures grazed in the (2) Indications for use. For removal same grazing season/calendar year by and control of mature gastrointestinal untreated cattle. Do not administer to nematode infections of cattle including cattle within 106 days of slaughter. stomach worms (Haemonchus spp., Ostertagia spp., Trichostrongylus spp.), worms of the small intestine (Cooperia spp., Trichostrongylus spp., Nematodirus

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Consult your veterinarian before ad- (b) Sponsor. See No. 000856 in ministering to severely debilitated ani- § 510.600(c) of this chapter. mals and for assistance in the diag- (c) [Reserved] nosis, treatment, and control of para- (d) Conditions of use—(1) Amount. 3 sitism. micrograms per kilogram (1.36 [49 FR 47831, Dec. 7, 1984, as amended at 51 micrograms per pound) of body weight. FR 23415, June 27, 1986; 51 FR 41081, Nov. 13, (2) Indications for use. To prevent in- 1986] fection by the canine heartworm Dirofilaria immitis and the subsequent § 520.1450c Morantel tartrate sus- development of canine heartworm dis- tained-release trilaminate cylinder/ ease. sheet. (3) Limitations. Use once-a-month in (a) Specifications. The drug product dogs at 8 weeks of age or older. Federal consists of a trilaminated, perforated, law restricts this drug to use by or on plastic sheet formed into a cylinder the order of a licensed veterinarian. having plastic plugs in its ends. The [62 FR 37713, July 15, 1997] core lamina contains 19.8 grams of morantel tartrate equivalent to 11.8 § 520.1452 Moxidectin gel. grams of morantel base. (b) Sponsor. See 000069 in § 510.600(c) of (a) Specifications. Each milliliter of this chapter. gel contains 20 milligrams (2 percent) (c) Related tolerances. See § 556.425 of moxidectin. this chapter. (b) Sponsor. See No. 000856 in (d) Conditions of use—(1) Amount. § 510.600(c) of this chapter. Grazing cattle: Administer 1 cartridge (c) Special considerations. See § 500.25 to each animal at the start of the graz- of this chapter. ing season. (d) Conditions of use in horses and (2) Indications for use. For control of ponies—(1) Amount. 0.4 milligram the adult stage of the following gastro- moxidectin per kilogram (2.2 pounds) of intestinal nematode infections in body weight. weaned calves and yearling cattle (2) Indications for use. For the treat- weighing a minimum of 200 pounds: ment and control of large strongyles: Ostertagia spp., Trichostrongylus axei, Strongylus vulgaris (adults and L4/L5 ar- Cooperia spp., and Oesophagostomum terial stages), S. edentatus (adult and radiatum. tissue stages), Triodontophorus (3) Limitations. Administer orally brevicauda (adults), and T. serratus with the dosing gun to all cattle that (adults); small strongyles (adults): will be grazing the same pasture. Effec- Cyathostomum spp., including C. tiveness of the drug product is depend- catinatum and C. pateratum; ent upon continuous control of the gas- Cylicocyclus. spp., including C. insigne, trointestinal parasites for approxi- C. leptostomum, C. nassatus, and C. mately 90 days following administra- radiatus; Cyliocostephanus spp., includ- tion. Therefore, treated cattle should ing C. calicatus, C. goldi, C. not be moved to pastures grazed in the longibursatus, and C. minutus; same grazing season/calendar year by Coronocyclus spp., including C. untreated cattle. Do not administer to coronatus, C. labiatus, and C. labratus; cattle within 102 days of slaughter. Gyalocephalus capitatus; and Consult your veterinarian before ad- Petrovinema poculatus; small ministering to severely debilitated ani- strongyles: undifferentiated lumenal mals and for assistance in the diag- larvae; encysted cyathostomes (late L3 nosis, treatment, and control of para- and L4 mucosal cyathostome larvae); sitism. ascarids: Parascaris equorum (adults and L4 larval stages); pinworms: Oxyuris [56 FR 13396, Apr. 2, 1991] equi (adults and L4 larval stages); hairworms: Trichostrongylus axei § 520.1451 Moxidectin tablets. (adults); large-mouth stomach worms: (a) Specifications. Each tablet con- Habronema muscae (adults); and horse tains 30, 68, or 136 micrograms of stomach bots: Gasterophilus intestinalis moxidectin. (2nd and 3rd instars) and G. nasalis (3rd

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instars). One dose also suppresses (3) Limitations. For oral use in horses strongyle egg production for 84 days. and ponies 6 months of age and older. (3) Limitations. For oral use in horses Not for use in horses and ponies in- and ponies 6 months of age and older. tended for food. Not for use in horses and ponies in- [68 FR 51446, Aug. 27, 2003, as amended at 69 tended for food. FR 21956, Apr. 23, 2004; 70 FR 75017, Dec. 19, [62 FR 42902, Aug. 11, 1997, as amended at 64 2005] FR 66105, Nov. 24, 1999; 68 FR 51445, Aug. 27, 2003; 69 FR 24959, May 5, 2004; 70 FR 75017, § 520.1454 Moxidectin solution. Dec. 19, 2005] (a) Specifications. Each milliliter (mL) of solution contains 1 milligram § 520.1453 Moxidectin and (mg) moxidectin. praziquantel gel. (b) Sponsor. See No. 000010 in (a) Specifications. Each milliliter of § 510.600(c) of this chapter. gel contains 20 milligrams (mg) (2.0 (c) Related tolerances. See § 556.426 of percent) moxidectin and 125 mg (12.5 this chapter. percent) praziquantel. (d) Special considerations. See § 500.25 (b) Sponsor. See No. 000856 in of this chapter. § 510.600(c) of this chapter. (e) Conditions of use in sheep—(1) (c) Special considerations. See § 500.25 Amount. Administer 1 mL per 11 pounds of this chapter. body weight (1 mL per 5 kilograms) by (d) Conditions of use in horses and mouth. ponies—(1) Amount. Administer by (2) Indications for use. For the treat- mouth as a single dose: 0.4 mg ment and control of the adult and L4 moxidectin per kilogram and 2.5 mg larval stages of Haemonchus contortus, praziquantel per kilogram (2.2 pounds) Teladorsagia circumcincta, T. trifurcata, body weight. Trichostrongylus axei, T. colubriformis, T. (2) Indications for use. For the treat- vitrinus, Cooperia curticei, C. oncophora, ment and control of large strongyles: Oesophagostomum columbianum, O. Strongylus vulgaris (adults and L4/L5 ar- venulosum, Nematodirus battus, N. terial stages), S. edentatus (adult and filicollis, and N. spathiger. tissue stages), Triodontophorus (3) Limitations. Sheep must not be brevicauda (adults), and T. serratus slaughtered for human consumption (adults); small strongyles (adults): within 7 days of treatment. Because a (Cyathostomum spp., including C. withholding time in milk has not been catinatum and C. pateratum; Cylicocyclus established for this product, do not use spp., including C. insigne, C. in female sheep providing milk for leptostomum, C. nassatus, and C. human consumption. radiatus; Cylicostephanus spp., including [70 FR 76163, Dec. 23, 2005, as amended at 76 C. calicatus, C. goldi, C. longibursatus, FR 48714, Aug. 9, 2011] and C. minutus; Coronocyclus spp., in- cluding C. coronatus, C. labiatus, and C. § 520.1468 Naproxen granules. labratus; Gyalocephalus capitatus; and (a) Specifications. Naproxen granules Petrovinema poculatus; small contain 50 percent naproxen. strongyles: undifferentiated lumenal (b) Sponsor. No. 000856 in § 510.600(c) of larvae; encysted cyathostomes (late L3 this chapter. and L4 mucosal cyathostome larvae); (c) Conditions of use—(1) Horses. The ascarids: Parascaris equorum (adults and drug is used for the relief of inflamma- L4 larval stages); pinworms: Oxyuris tion and associated pain and lameness equi (adults and L4 larval stages); exhibited with arthritis, as well as my- hairworms: Trichostrongylus axei ositis and other soft tissue diseases of (adults); large-mouth stomach worms: the musculoskeletal system of the Habronema muscae (adults); horse stom- horse. ach bots: Gasterophilus intestinalis (2nd (2)(i) For oral maintenance therapy and 3rd instars) and G. nasalis (3rd following initial intravenous dosage, instars); and tapeworms: Anoplocephala administer 10 milligrams naproxen per perfoliata (adults). One dose also sup- kilogram of animal body weight twice presses strongyle egg production for 84 daily as top dressing in the animal’s days. feed for up to 14 consecutive days. The

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initial intravenous dosage is 5 milli- terial enteritis) caused by Escherichia grams per kilogram of body weight. coli susceptible to neomycin sulfate. (ii) For oral dosage only, administer (iii) Limitations. Add powder to drink- 10 milligrams naproxen per kilogram of ing water or milk; not for use in liquid animal body weight twice daily as a supplements. Administer solution undi- top dressing in the animal’s feed for up luted or in drinking water. Prepare a to 14 consecutive days. fresh solution in drinking water daily. (3) Not for use in horses intended for If symptoms persist after using this food. preparation for 2 or 3 days, consult a (4) Federal law restricts this drug to veterinarian. Treatment should con- use by or on the order of a licensed vet- tinue 24 to 48 hours beyond remission erinarian. of disease symptoms, but not to exceed a total of 14 consecutive days. Dis- [41 FR 14188, Apr. 2, 1976, as amended at 51 continue treatment prior to slaughter FR 24525, July 7, 1986; 61 FR 5506, Feb. 13, as follows: Cattle, 1 day; sheep, 2 days; 1996] swine and goats, 3 days. § 520.1484 Neomycin. (2) Turkeys—(i) Amount. 10 mg/lb of body weight per day (22 mg/kg) for 5 (a) Specifications—(1) Each ounce of days. powder contains 20.3 grams (g) neomy- (ii) Indications for use. For the control cin sulfate (equivalent to 14.2 g neomy- of mortality associated with E. coli sus- cin base). ceptible to neomycin sulfate in grow- (2) Each milliliter of solution con- ing turkeys. tains 200 milligrams (mg) neomycin (iii) Limitations. Add to drinking sulfate (equivalent to 140 mg neomycin water; not for use in liquid supple- base). ments. Prepare a fresh solution daily. (b) Sponsors. See sponsors in If symptoms persist after using this § 510.600(c) of this chapter for use as in preparation for 2 or 3 days, consult a paragraph (e) of this section. veterinarian. Treatment should con- (1) Nos. 000069 and 054925 for use of tinue 24 to 48 hours beyond remission product described in paragraph (a)(1) as of disease symptoms, but not to exceed in paragraph (e)(1) of this section. a total of 5 consecutive days. (2) Nos. 000009, 046573, 058005, and [71 FR 56866, Sept. 28, 2006, as amended at 71 061623 for use of product described in FR 68738, Nov. 28, 2006; 78 FR 17596, Mar. 22, paragraph (a)(1) as in paragraphs (e)(1) 2013] and (e)(2) of this section. (3) Nos. 000009, 000859, 054925, and § 520.1510 Nitenpyram tablets. 058005 for use of product described in (a) Specifications. Each tablet con- paragraph (a)(2) as in paragraph (e)(1) tains 11.4 or 57 milligrams (mg) of this section. nitenpyram. (c) Related tolerances. See § 556.430 of (b) Sponsor. See No. 058198 in this chapter. § 510.600(c) of this chapter. (d) Special labeling considerations. La- (c) Special considerations. The concur- beling shall bear the following warning rent use of nitenpyram tablets and fla- statements: ‘‘A withdrawal period has vored milbemycin/lufenuron tablets as not been established for use in in paragraph (d)(1)(ii)(B) of this section preruminating calves. Do not use in shall be by or on the order of a licensed calves to be processed for veal. Use of veterinarian. more than one product containing neo- (d) Conditions of use—(1) Dogs—(i) mycin or failure to follow withdrawal Amount—(A) One 11.4-mg tablet for times may result in illegal drug resi- dogs weighing less than 25 pounds (lb) dues.’’ or one 57-mg tablet for dogs weighing (e) Conditions of use—(1) Cattle, swine, more than 25 lb, as needed, for use as in sheep, and goats—(i) Amount. 10 mg per paragraph (d)(1)(ii)(A) of this section. pound (/lb) of body weight per day (22 (B) One 11.4-mg tablet for dogs weigh- mg per kilogram (/kg)) in divided doses ing less than 25 lb or one 57 mg tablet for a maximum of 14 days. for dogs weighing more than 25 lbs, (ii) Indications for use. For the treat- once or twice weekly, for use as in ment and control of colibacillosis (bac- paragraph (d)(1)(ii)(B) of this section.

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(ii) Indications for use—(A) For the (c) Special considerations. When la- treatment of flea infestations on dogs beled for use as in paragraph (d)(2)(i) of and puppies 4 weeks of age and older this section, product labeling shall and 2 lbs of body weight or greater. bear: ‘‘Federal law restricts this drug (B) The concurrent use of nitenpyram to use by or on the order of a licensed tablets as in paragraph (d)(1)(i)(B) of veterinarian.’’ this section with either flavored (d) Conditions of use in horses—(1) lufenuron tablets as in § 520.1288(c)(1) of Amount—(i) For treatment of gastric this chapter or flavored milbemycin ulcers, 1.8 milligrams per pound (mg/lb) and lufenuron tablets as in of body weight (4 milligrams per kilo- § 520.1446(d)(1) of this chapter is indi- gram (mg/kg)) once daily for 4 weeks. cated to kill adult fleas and prevent For prevention of recurrence of gastric flea eggs from hatching. ulcers, 0.9 mg/lb of body weight (2 mg/ (2) Cats—(i) Amount—(A) One 11.4-mg kg) once daily for at least an addi- tablet, as needed, for use as in para- tional 4 weeks. graph (d)(2)(ii)(A) of this section. (ii) For prevention of gastric ulcers (B) One 11.4-mg tablet, once or twice using the premarked syringe, one dose weekly, for use as in paragraph per day for 8 or 28 days. Each dose de- (d)(2)(ii)(B) of this section. livers at least 1 mg/kg of body weight. (ii) Indications for use—(A) For the Horses over 1,200 lb body weight should treatment of flea infestations on cats receive two doses per day. and kittens 4 weeks of age and older (2) Indications for use. (i) For treat- and 2 lbs of body weight or greater. ment and prevention of recurrence of (B) The concurrent use of nitenpyram gastric ulcers in horses and foals 4 tablets as in paragraph (d)(2)(i)(B) of weeks of age and older. this section with flavored lufenuron (ii) For prevention of gastric ulcers tablets as in § 520.1288(c)(2) of this chap- in horses. ter is indicated to kill adult fleas and (3) Limitations. Do not use in horses prevent flea eggs from hatching. intended for human consumption. [68 FR 51906, Aug. 29, 2003] [69 FR 13220, Mar. 22, 2004, as amended at 71 FR 59374, Oct. 10, 2006] § 520.1604 Oclacitinib. § 520.1616 Orbifloxacin tablets. (a) Specifications. Each tablet con- (a) Specifications. Each tablet con- tains 3.6, 5.4, or 16 milligrams (mg) of tains 5.7, 22.7, or 68 milligrams (mg) oclacitinib as oclacitinib maleate. orbifloxacin. (b) Sponsor. See No. 054771 in (b) Sponsor. See No. 000061 in § 510.600(c) of this chapter. § 510.600(c) of this chapter. (c) Conditions of use—(1) Amount. Ad- (c) Conditions of use in dogs and cats— minister orally 0.18 to 0.27 mg/per (1) Amount. 2.5 to 7.5 mg per kilogram pound of body weight (0.4 to 0.6 mg/kg body weight once daily. body weight) twice daily for up to 14 (2) Indications for use. For manage- days; then administered once daily for ment of diseases associated with bac- maintenance therapy. teria susceptible to orbifloxacin. (2) Indications for use. For control of (3) Limitations. Federal law restricts pruritus associated with allergic der- this drug to use by or on the order of a matitis and control of atopic derma- licensed veterinarian. Federal law pro- titis in dogs at least 12 months of age. hibits the extralabel use of this drug in (3) Limitations. Federal law restricts food producing animals. this drug to use by or on the order of a licensed veterinarian. [71 FR 14643, Mar. 23, 2006, as amended at 75 FR 26646, May 12, 2010] [78 FR 42007, July 15, 2013] § 520.1618 Orbifloxacin suspension. § 520.1615 Omeprazole. (a) Specifications. Each milliliter of (a) Specifications. Each gram of paste suspension contains 30 milligrams (mg) contains 0.37 gram omeprazole. orbifloxacin. (b) Sponsor. See No. 050604 in (b) Sponsor. See No. 000061 in § 510.600(c) of this chapter. 510.600(c) of this chapter.

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(c) Special considerations. Federal law ringe. Discard unused portions of sus- restricts this drug to use by or on the pension after 24 hours. Mix drug ac- order of a licensed veterinarian. Fed- cording to directions prior to use. Ad- eral law prohibits the extralabel use of minister drug with caution to sick or this drug in food-producing animals. debilitated horses. Not for use in (d) Conditions of use—(1) Dogs—(i) horses intended for food. Federal law Amount. 1.1 to 3.4 mg/lb (2.5 to 7.5 mg/ restricts this drug to use by or on the kg) of body weight once daily. order of a licensed veterinarian. (ii) Indications for use. For the treat- (ii) Pellets. The drug is given by sprin- ment of urinary tract infections (cys- kling on the grain portion of the ra- titis) in dogs caused by susceptible tion. Withholding feed or water prior strains of Staphylococcus to administration is not necessary. Ad- pseudintermedius, Proteus mirabilis, Esch- minister drug with caution to sick or erichia coli, and Enterococcus faecalis debilitated horses. Not for use in and skin and soft tissue infections (wounds and abscesses) in dogs caused horses intended for food. Consult your by susceptible strains of Staphylococcus veterinarian for assistance in the diag- pseudintermedius, Staphylococcus aureus, nosis, treatment, and control of para- coagulase-positive staphylococci, sitism. Pasteurella multocida, Proteus mirabilis, [44 FR 35211, June 19, 1979, as amended at 46 Pseudomonas spp., Klebsiella FR 26301, May 12, 1981; 46 FR 60570, Dec. 11, pneumoniae, E. coli, Enterobacter spp., 1981; 49 FR 28549, July 13, 1984; 61 FR 5506, Citrobacter spp., E. faecalis, b-hemolytic Feb. 13, 1996] streptococci (Group G), and Strepto- coccus equisimilis. § 520.1629 Oxfendazole paste. (2) Cats—(i) Amount. 3.4 mg/lb (7.5 mg/ (a)(1) Specifications. Each gram of kg) of body weight once daily. paste contains 0.375 gram oxfendazole (ii) Indications for use. For the treat- (37.5 percent). ment of skin infections (wounds and (2) Sponsor. See No. 000856 in abscesses) in cats caused by susceptible § 510.600(c) of this chapter. strains of S. aureus, E. coli, and P. (3) Conditions of use—(i) Amount. 10 multocida. milligrams per kilogram (2.2 pounds) of [75 FR 26646, May 12, 2010] body weight. (ii) Indications for use. The drug is § 520.1628 Oxfendazole powder and used in horses for removal of the fol- pellets. lowing gastrointestinal worms: Large (a) Specifications—(1) Powder for sus- roundworms (Parascaris equorum), ma- pension. Each gram of powder contains ture and 4th stage larvae pinworms 7.57 percent oxfendazole. (Oxyuris equi), large strongyles (2) Pellets. Each gram of pellets con- (Strongylus edentatus, S. vulgaris, and S. tains 6.49 percent oxfendazole. equinus), and small strongyles. (b) Sponsor. See No. 000856 in (iii) Limitations. Horses maintained § 510.600(c) of this chapter. on premises where reinfection is likely (c) Conditions of use—(1) Amount. 10 milligrams per kilogram of body to occur should be retreated in 6 to 8 weight. weeks. Withholding feed or water prior (2) Indications for use. The drug is to use is unnecessary. Administer drug used in horses for removal of the fol- with caution to sick or debilitated lowing gastrointestinal worms: Large horses. Not for use in horses intended roundworms (Parascaris equorum), ma- for food. Consult your veterinarian for ture and immature pinworms (Oxyuris assistance in the diagnosis, treatment, equi), large strongyles (Strongylus and control of parasitism. edentatus, Strongylus vulgaris, and (b)(1) Specifications. Each gram of Strongylus equinus), and small paste contains 185 milligrams of strongyles. oxfendazole (18.5 percent). (3) Limitations—(i) Powder for suspen- (2) Sponsor. See No. 000856 in sion. For gravity administration via § 510.600(c) of this chapter. stomach tube or for positive adminis- (3) Related tolerances. See § 556.495 of tration via stomach tube and dose sy- this chapter.

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(4) Conditions of use—(i) Amount. 4.5 (Strongylus edentatus, S. vulgaris, and S. milligrams per kilogram of body equinus), and small strongyles. weight (2.05 milligrams per pound). (iii) Limitations. Withholding feed or (ii) Indications for use. The drug is water prior to use is unnecessary. Ad- used in cattle for the removal and con- minister drug with caution to sick or trol of the following worms: lungworms debilitated horses. Do not use in horses (Dictyocaulus viviparus—adult, L4); intended for human consumption. stomach worms: barberpole worms (2) Cattle. Use the products described (Haemonchus contortus and H. placei— in paragraphs (a)(1) and (a)(2) of this adult), small stomach worms section as follows: (Trichostrongylus axei—adult), brown (i) Amount. 4.5 mg/kg of body weight stomach worms (Ostertagia ostertagi— by dose syringe. Treatment may be re- adult, L4, inhibited L4); intestinal peated in 4 to 6 weeks. worms; nodular worms (ii) Indications for use. For the re- (Oesophagostomum radiatum—adult), moval and control of: lungworms hookworms (Bunostomum (Dictyocaulus viviparus—adult, L4); phlebotomum—adult), small intestinal stomach worms: barberpole worms worms (Cooperia punctata, C. oncophora, (Haemonchus contortus and H. placei— and C. mcmasteri—adult, L4); and tape- adult), small stomach worms worms (Moniezia benedeni—adult). (Trichostrongylus axei—adult), brown (iii) Limitations. For use in cattle stomach worms (Ostertagia ostertagi— only. Treatment may be repeated in 4 adult, L4, inhibited L4); intestinal to 6 weeks. Cattle must not be slaugh- worms; nodular worms tered until 11 days after treatment. Do (Oesophagostomum radiatum—adult), not use in female dairy cattle of breed- hookworms (Bunostomum ing age. Consult a veterinarian for as- phlebotomum—adult), small intestinal sistance in the diagnosis, treatment, worms (Cooperia punctata, C. oncophora, and control of parasitism. and C. surnabada—adult, L4), and tape- [49 FR 38250, Sept. 28, 1984, as amended at 58 worms (Moniezia benedeni—adult). FR 39443, July 23, 1993; 61 FR 5506, Feb. 13, (iii) Limitations. Cattle must not be 1996] slaughtered until 7 days after treat- ment. Because a withdrawal time in § 520.1630 Oxfendazole suspension. milk has not been established, do not (a) Specifications. Each milliliter of use in female dairy cattle of breeding suspension contains: age. (1) 90.6 milligrams (mg) oxfendazole [55 FR 46943, Nov. 8, 1990, as amended at 56 (9.06 percent). FR 8710, Mar. 1, 1991; 61 FR 5506, Feb. 13, 1996; (2) 225.0 mg oxfendazole (22.5 percent). 72 FR 10596, Mar. 9, 2007; 73 FR 45610, Aug. 6, (b) Sponsor. See No. 000010 in 2008; 75 FR 10166, Mar. 5, 2010] § 510.600(c) of this chapter. (c) Related tolerances. See § 556.495 of § 520.1631 Oxfendazole and trichlorfon this chapter. paste. (d) Special considerations. See § 500.25 (a) Specifications. Each gram of paste of this chapter. If labeled for adminis- contains 28.5 milligrams oxfendazole tration by stomach tube: Federal law and 454.5 milligrams trichlorfon. restricts this drug to use by or on the (b) Sponsor. See 000856 in § 510.600(c) of order of a licensed veterinarian. this chapter. (e) Conditions of use—(1) Horses. Use (c) Conditions of use—(1) Amount. 2.5 the product described in paragraph milligrams of oxfendazole and 40 milli- (a)(1) of this section as follows: grams of trichlorfon per kilogram of (i) Amount. 10 mg per kilogram (/kg) body weight. of body weight by stomach tube or dose (2) Indications for use. The drug is syringe. Horses maintained on prem- used in horses for removal of bots ises where reinfection is likely to occur (Gasterophilus intestinalis, 2nd and 3rd should be retreated in 6 to 8 weeks. instars; G. nasalis, 3rd instar) and the (ii) Indications for use. For removal of following gastrointestinal worms: large roundworms (Parascaris equorum), Large roundworms (Parascaris mature and 4th stage larvae pinworms equorum), pinworms (Oxyuris equi), (Oxyuris equi), large strongyles adult and 4th stage larvae; large

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strongyles (Strongylus edentatus, S. § 520.1640 Oxibendazole suspension. vulgaris, and S. equinus); and small (a) Specifications. The suspension con- strongyles. tains 10 percent oxibendazole. (3) Limitations. Horses maintained on (b) Sponsor. See 000069 in § 510.600(c) of premises where reinfection is likely to this chapter. occur should be retreated in 6 to 8 (c) Conditions of use in horses—(1) weeks. Withholding feed or water be- Amount. For use other than fore use is unnecessary. Administer threadworms (Strongyloides westeri), 10 with caution to sick or debilitated milligrams of oxibendazole per kilo- horses. Not for use in horses intended gram of body weight; for threadworms, for food. Do not administer to mares 15 milligrams per kilogram of body during the last month of pregnancy. weight. Trichlorfon is a cholinesterase inhib- (2) Indications for use. For removal itor. Do not use this product in ani- and control of large strongyles mals simultaneously with, or within a (Strongylus edentatus, S. equinus, S. few days before or after treatment with vulgaris); small strongyles (species of or exposure to, cholinesterase-inhib- the genera Cylicostephanus Cylicocyclus, iting drugs, pesticides, or chemicals. Cyathostomum, Triodontophorus, Consult your veterinarian for assist- Cylicodontophorus, and Gyalocephalus); ance in the diagnosis, treatment, and large roundworms (Parascaris equorum); control of parasitism. pinworms (Oxyuris equi) including var- [50 FR 50291, Dec. 10, 1985, as amended at 61 ious larval stages; and threadworms FR 5506, Feb. 13, 1996] (Strongyloides westeri). (3) Limitations. Administer by stom- § 520.1638 Oxibendazole paste. ach tube in 3 to 4 pints of warm water, (a) Specifications. The paste contains or by top dressing or mixing into a por- 22.7 percent oxibendazole. tion of the normal grain ration. Pre- (b) Sponsor. See 000069 in § 510.600(c) of pare individual doses to ensure that this chapter. each animal receives the correct (c) Conditions of use in horses—(1) amount. Horses maintained on prem- Amount. For uses other than for ises where reinfection is likely to occur threadworms (Strongyloides westeri), 10 should be re-treated in 6 to 8 weeks. milligrams of oxibendazole per kilo- Not for use in horses intended for gram of body weight; for threadworms human consumption. Federal law re- (Strongyloides westeri), 15 milligrams stricts this drug to use by or on the per kilogram. order of a licensed veterinarian. (2) Indications for use. For removal and control of large strongyles [45 FR 78119, Nov. 28, 1980, as amended at 47 (Strongylus edentatus, S. equinus, S. FR 39812, Sept. 10, 1982; 56 FR 50653, Oct. 8, vulgaris); small strongyles (genera 1991; 60 FR 55659, Nov. 2, 1995; 71 FR 33237, June 8, 2006] Cylicostephanus, Cylicocyclus, Cyathostomum, Triodontophorus, § 520.1660 Oxytetracycline. Cylicodontophorus, and Gyalocephalus); large roundworms (Parascaris equorum); § 520.1660a Oxytetracycline and pinworms (Oxyuris equi) including var- carbomycin in combination. ious larval stages; and threadworms (a) Specifications. (1) Oxytetracycline: (Strongyloides westeri). The antibiotic substance produced by (3) Limitations. Administer orally by growth of Streptomyces rimosus or the syringe. Horses maintained on prem- same antibiotic substance produced by ises where reinfection is likely to occur any other means. should be re-treated in 6 to 8 weeks. (2) Carbomycin: The antibiotic sub- Not for use in horses intended for stance produced by growth of human consumption. Consult a veteri- Streptomyces halstedii or the same anti- narian for assistance in the diagnosis, biotic substance produced by any other treatment, and control of parasitism. means. [46 FR 50948, Oct. 16, 1981, as amended at 47 (b) Sponsor. See No. 000069 in FR 36418, Aug. 20, 1982; 56 FR 50653, Oct. 8, § 510.600(c) of this chapter. 1991; 60 FR 55659, Nov. 2, 1995; 71 FR 33237, (c) Special considerations. The quan- June 8, 2006] tities of oxytetracycline in paragraph

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(e) of this section refer to the activity tinuation of compatible antibiotic of oxytetracycline hydrochloride and therapy following parenteral oxytetra- the quantities of carbomycin listed cycline administration where rapidly refer to the activity of an appropriate attained, sustained antibiotic blood standard. levels are required. The duration of (d) Related tolerances. See §§ 556.110 treatment required to obtain favorable and 556.500 of this chapter. response will depend to some extent on (e) Conditions of use. It is used as oxy- the severity and degree of involvement tetracycline hydrochloride plus and the susceptibility of the infectious carbomycin base in drinking water of agent. Clinical response to antibiotic chickens as follows: therapy usually occurs within 48 to 72 (1) Amount. 1.0 gram of oxytetra- hours. If improvement is not observed cycline and 1.0 gram carbomycin per gallon. within that period, the diagnosis and (2) Indications for use. As an aid in the course of treatment should be reconsid- prevention and treatment of com- ered. To assure adequate treatment, plicated chronic respiratory disease administration of the drug should con- (air-sac infection) caused by Myco- tinue for at least 48 hours following fa- plasma gallisepticum and secondary bac- vorable clinical response.1 terial organisms associated with chron- (3) Federal law restricts this drug to ic respiratory disease such as E. coli. use by or on the order of a licensed vet- (3) Limitations. Administer for not erinarian.1 more than 5 days; not for use in chick- ens producing eggs for human con- § 520.1660c Oxytetracycline hydro- sumption; withdraw 24 hours before chloride tablets/boluses. slaughter. (a) Specifications. Each tablet or bolus contains 250, 500, or 1,000 milligrams of § 520.1660b Oxytetracycline hydro- chloride capsules. oxytetracycline hydrochloride. (b) Sponsors. For sponsors in (a) Specifications. The drug is in cap- § 510.600(c) of this chapter: See 000010 sule form with each capsule containing for use of 500 and 1,000 milligram 125 or 250 milligrams of oxytetracycline boluses. See 000069 for use of 250 and 500 hydrochloride. Oxytetracycline is the milligram tablets. antibiotic substance produced by growth of Streptomyces rimosus or the (c) Tolerances. See § 556.500 of this same antibiotic substance produced by chapter. any other means. (d) Conditions of use in beef and dairy (b) Sponsor. See No. 000069 in cattle—(1)(i) Amount. 250 milligrams per § 510.600(c) of this chapter. 100 pounds of body weight every 12 (c) Conditions of use. (1) It is used in hours (5 milligrams per pound of body dogs and cats for the treatment of bac- weight daily in two doses). terial pneumonia caused by Brucella (ii) Indications for use. For control of bronchiseptica, tonsilitis caused by bacterial enteritis caused by Salmonella Streptococcus hemolyticus, bacterial en- typhimurium and Escherichia coli teritis caused by Escherichia coli, uri- (colibacillosis) and bacterial pneu- nary tract infections caused by Esch- monia (shipping fever complex, erichia coli, and wound infections pasteurellosis) caused by Pasteurella caused by Staphylococcus aureus. 1 multocida. (2) The drug is administered orally to (2)(i) Amount. 500 milligrams per 100 dogs and cats at a dosage level of 25–50 pound of body weight every 12 hours (10 milligrams per pound of body weight milligrams per pound of body weight per day in divided doses at 12-hour in- daily in two doses). tervals. The drug can be used for con- (ii) Indications for use. For treatment of bacterial enteritis caused by Sal- 1 These conditions are NAS/NRC reviewed monella typhimurium and Escherichia coli and deemed effective. Applications for these uses need not include effectiveness data as (colibacillosis) and bacterial pneu- specified by § 514.111 of this chapter, but may monia (shipping fever complex, require bioequivalency and safety informa- pasteurellosis) caused by Pasteurella tion. multocida.

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(3) Limitations. Dosage should con- (9) Each 2.73 grams of powder con- tinue until the animal returns to nor- tains 1 gram of OTC HCl (packets: 9.87 mal and for 24 hours to 48 hours after and, 19.75 oz, and 3.91 lb; pails: 3.09 and symptoms have subsided. Treatment 5 lb). should not exceed 4 consecutive days. (10) Each 2.73 grams of powder con- Do not exceed 500 milligrams per 100 tains 1 gram of OTC HCl (packets: 9.87 pounds of body weight every 12 hours and 19.74 oz; pails: 5 lb). (10 milligrams per pound daily). For (b) Sponsor. See sponsor numbers in sponsor 000069: Discontinue treatment 7 § 510.600(c) of this chapter as follows: days prior to slaughter. Not for use in (1) No. 000069 for use of OTC HCl con- lactating dairy cattle. A withdrawal centrations in paragraphs (a)(1), (a)(2), period has not been established for this and (a)(3) of this section in chickens, product in preruminating calves. Do turkeys, swine, cattle, sheep, and not use in calves to be processed for honey bees. veal. (2) No. 046573 for use of OTC HCl con- centration in paragraph (a)(4) of this [46 FR 32440, June 23, 1981, as amended at 50 FR 1045, Jan. 9, 1985; 63 FR 70334, Dec. 21, section in chickens, turkeys, and 1998; 70 FR 16394, Apr. 4, 2005] swine. (3) No. 054628 for use of OTC HCl con- § 520.1660d Oxytetracycline powder. centration in paragraph (a)(5) of this section in turkeys and chickens. (a) Specifications. The drug is a solu- (4) No. 057561 for use of OTC HCl con- ble powder distributed in packets or centration in paragraph (a)(6) of this pails having several concentrations of section in chickens, turkeys, and oxytetracycline hydrochloride (inde- swine. pendent of the various net weights) as (5) No. 061623 for use of OTC HCl con- follows: centration in paragraph (a)(7) of this (1) Each 18.14 grams of powder con- section in chickens, turkeys, swine, tains 1 gram of oxytetracycline hydro- cattle, sheep, and honeybees. chloride (OTC HCl) (packets: 4, 6.4, and (6) No. 048164 for use of OTC HCl con- 16 oz.). centrations in paragraph (a)(8) of this (2) Each 4.43 grams of powder con- section in chickens, turkeys, swine, tains 1 gram of OTC HCl (packets: 4 cattle, sheep, and honey bees. and 16 oz.). (7) No. 061623 for use of OTC HCl con- (3) Each 1.32 grams of powder con- centration in paragraph (a)(9) of this tains 1 gram of OTC HCl (packets: 2.39, section in chickens, turkeys, and 4.78, and 9.55 oz.; jars: 2.25 lbs.; and swine. pails: 4.5 lbs.). (8) No. 059320 for use of OTC con- (4) Each 2.73 grams of powder con- centration in paragraph (a)(10) of this tains 1 gram of OTC HCl (packets: 2.46 section in chickens, turkeys, and swine and 9.87 oz; pail: 3.09 lb). as in paragraph (d) of this section. (5) Each 4.2 grams of powder contains (c) Related tolerances. See § 556.500 of 1 gram of OTC HCl (packets: 3.8 and this chapter. 15.2 oz; pails: 4.74 and 23.7 lb). (d) Conditions of use. (1) It is used in (6) Each 1.32 grams of powder con- drinking water as follows: tains 1 gram of OTC HCl (packet: 4.78 (i) Chickens—(A)(1) Amount per gallon. oz.; pail: 5 lb). Each 2.73 grams of pow- 200 to 400 milligrams. der contains 1 gram of OTC HCl (pack- (2) Indications for use. Control of in- et: 9.87 oz). fectious synovitis caused by Myco- (7) Each 1.32 grams of powder con- plasma synoviae susceptible to oxytet- tains 1 gram of OTC HCl (packet: 4.78 racycline. and 9.6 oz.; pails: 2 and 5 lb); each 18.1 (3) Limitations. Prepare a fresh solu- grams of powder contains 1 gram of tion daily. Administer 7 to 14 days. Not OTC HCl (packet: 6.4 oz.; pails: 2 and 5 to be used for more than 14 consecutive lb). days. Use as sole source of drinking (8) Each 135.5-gram packet (4.78 water. Do not use in birds producing ounce) contains 102.4 grams of OTC eggs for human consumption. HCl. Each 677.5-gram packet (23.9 (B)(1) Amount per gallon. 400 to 800 ounce) contains 512 grams of OTC HCl. milligrams.

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(2) Indications for use. Control of (transmissible enteritis, coronaviral chronic respiratory disease (CRD) and enteritis) susceptible to oxytetra- air sac infections caused by Myco- cycline. plasma gallisepticum and E. coli suscep- (3) Limitations. Prepare a fresh solu- tible to oxytetracycline; control of tion daily. Administer 7 to 14 days. Not fowl cholera caused by Pasteurella to be used for more than 14 consecutive multocida susceptible to oxytetra- days. Use as sole source of drinking cycline. water. Do not use in birds producing (3) Limitations. Prepare a fresh solu- eggs for human consumption. With- tion daily. Administer 7 to 14 days. Not draw 5 days prior to slaughter those to be used for more than 14 consecutive products sponsored by Nos. 000069, and days. Use as sole source of drinking 061623 in § 510.600(c) of this chapter. water. Do not use in birds producing Withdraw 4 days prior to salughter eggs for human consumption. those products sponsored by No. 054628. (ii) Turkeys—(A)(1) Amount per gallon. Zero-day withdrawal for those products 200 to 400 milligrams. sponsored by Nos. 046573, 053389, 057561, (2) Indications for use. Control of 059320, and 061133. hexamitiasis caused by Hexamita (iii) Swine—(A) Amount. 10 milligrams meleagridis susceptible to oxytetra- per pound of body weight daily. cycline. (B) Indications for use. Control and (3) Limitations. Prepare a fresh solu- treatment of bacterial enteritis caused tion daily. Administer 7 to 14 days. Not by Escherichia coli and Salmonella to be used for more than 14 consecutive choleraesuis and bacterial pneumonia days. Use as sole source of drinking caused by Pasteurella multocida suscep- water. Do not use in birds producing tible to oxytetracycline. For breeding eggs for human consumption. With- swine: Control and treatment of lepto- draw 5 days prior to slaughter those spirosis (reducing the incidence of products sponsored by Nos. 000069, and abortions and shedding of leptospira) 061623 in § 510.600(c) of this chapter. caused by Leptospira pomona suscep- Withdraw 4 days prior to slaughter tible to oxytetracycline. those products sponsored by No. 054628. (C) Limitations. Prepare a fresh solu- Zero-day withdrawal for those products tion daily. Use as sole source of OTC. sponsored by Nos. 046573, 053389, 057561, Administer up to 14 days; do not use for 059320, and 061133. more than 14 consecutive days; with- (B)(1) Amount per gallon. 400 milli- draw zero days prior to slaughter those grams. products sponsored by Nos. 000069 and (2) Indications for use. Control of in- 061623. Administer up to 5 days; do not fectious synovitis caused by Myco- use for more than 5 consecutive days; plasma synoviae susceptible to oxytet- withdraw zero days prior to slaughter racycline. those products sponsored by Nos. (3) Limitations. Prepare a fresh solu- 046573, 053389, 057561, 059320, and 061133. tion daily. Administer 7 to 14 days. Not (iv) Calves, beef cattle, and nonlac- to be used for more than 14 consecutive tating dairy cattle—(A) Amount. 10 milli- days. Use as sole source of drinking grams per pound of body weight daily. water. Do not use in birds producing (B) Indications for use. Control and eggs for human consumption. With- treatment of bacterial enteritis caused draw 5 days prior to slaughter those by E. coli and bacterial pneumonia products sponsored by Nos. 000069, and (shipping fever complex) caused by P. 061623 in § 510.600(c) of this chapter. multocida susceptible to oxytetra- Withdraw 4 days prior to slaughter cycline. those products sponsored by No. 054628. (C) Limitations. Prepare a fresh solu- Zero-day withdrawal for those products tion daily. Administer up to 14 days. sponsored by Nos. 046573, 053389, 057561, Do not use for more than 14 consecu- 059320, and 061133. tive days. Use as sole source of oxytet- (C)(1) Amount. 25 milligrams per racycline. Do not administer this prod- pound of body weight. uct with milk or milk replacers. Ad- (2) Indications for use. Growing tur- minister 1 hour before or 2 hours after keys. Control of complicating bacterial feeding milk or milk replacers. With- organisms associated with bluecomb draw 5 days prior to slaughter. A milk

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discard period has not been established (c) Conditions of use in turkeys— (1) for this product in lactating dairy cat- Amount. 1,500,000 units per gallon tle. Do not use in female dairy cattle 20 drinking water for 5 days. months of age or older. (2) Indications for use. Treatment of (v) Sheep—(A) Amount. 10 milligrams erysipelas caused by Erysipelothrix per pound of body weight daily. rhusiopathiae. (B) Indications for use. Control and (3) Limitations. Prepare concentrated treatment of bacterial enteritis caused stock solution for use with medication by E. coli and bacterial pneumonia proportioners fresh every 24 hours. Pre- (shipping fever complex) caused by P. pare recommended use levels for grav- multocida susceptible to oxytetra- ity flow watering system fresh every 12 cycline. hours. For best results, treatment (C) Limitations. Prepare a fresh solu- should be started at the first sign of in- tion daily. Administer up to 14 days. fection. Discontinue treatment at least Do not use for more than 14 consecu- 1 day prior to slaughter. Not for use in tive days. Use as sole source of oxytet- turkeys producing eggs for human con- racycline. Withdraw 5 days prior to sumption. slaughter. [57 FR 37326, Aug. 18, 1992, as amended at 59 (2) It is used in the food of honey bees FR 42493, Aug. 18, 1994; 60 FR 26359, May 17, as follows: 1995; 62 FR 55160, Oct. 23, 1997; 65 FR 10705, (i) Amount. 200 milligrams per colony, Feb. 29, 2000; 66 FR 14073, Mar. 9, 2001; 68 FR administered via either a 1:1 sugar 4914, Jan. 31, 2003; 68 FR 26204, May 15, 2003; syrup (equal parts of sugar and water 69 FR 9946, Mar. 3, 2004; 69 FR 41428, July 9, weight to weight) or dusting with a 2004; 77 FR 20988, Apr. 9, 2012] powdered sugar mixture. § 520.1696c Penicillin V powder. (ii) Indications for use. For control of American foulbrood caused by (a) Specifications. When reconstituted, Paenibacillus larvae and European each milliliter contains 25 milligrams foulbrood caused by Streptococcus (40,000 units) of penicillin V. pluton susceptible to oxytetracycline. (b) Sponsor. See No. 050604 in (iii) Limitations. The drug is adminis- § 510.600(c) of this chapter. tered in 3 applications of sugar syrup (c) [Reserved] or 3 dustings at 4- to 5-day intervals. (d) Conditions of use. Dogs and cats— The drug should be fed early in the (1) Amount. 10 to 15 milligrams per spring or fall and consumed by the bees pound of body weight every 6 to 8 before main honey flow begins to avoid hours. contamination of production honey. (2) Indications for use. Treatment of Remove at least 6 weeks prior to main respiratory, urogenital, skin, and soft honey flow. tissue infections and septicemia caused by pathogens susceptible to penicillin [50 FR 32694, Aug. 14, 1985] V potassium. EDITORIAL NOTE: For FEDERAL REGISTER ci- (3) Limitations. Administer orally 1 to tations affecting § 520.1660d, see the List of 2 hours prior to feeding for maximum CFR Sections Affected, which appears in the absorption. Federal law restricts this Finding Aids section of the printed volume drug to use by or on the order of a li- and at www.fdsys.gov. censed veterinarian. § 520.1696 Penicillin. [57 FR 37326, Aug. 18, 1992; 57 FR 42623, Sept. 15, 1992; 77 FR 20988, Apr. 9, 2012] § 520.1696a [Reserved] § 520.1696d Penicillin V tablets. § 520.1696b Penicillin G powder. (a) Specifications. Each tablet con- (a) Specifications. Each gram of pow- tains penicillin V potassium equivalent der contains penicillin G potassium to 125 milligrams (200,000 units) or 250 equivalent to 1.54 million units of peni- milligrams (400,000 units) of penicillin cillin G. V. (b) Sponsors. See Nos. 010515, 046573, (b) Sponsors. See Nos. 050604 and 053501, 059320, 061623 and 076475 in 053501 in § 510.600(c) of this chapter. § 510.600(c) of this chapter. (c) [Reserved]

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(d) Conditions of use. Dogs and Cats— (5) No. 000143 for use of 1-g tablets in (1) Amount. 10 to 15 milligrams per horses. pound of body weight every 6 to 8 (6) No. 058829 for use of 100-mg or 1-g hours. tablets in dogs and horses. (2) Indications for use. Treatment of (c) Conditions of use—(1) Dogs—(i) respiratory, urogenital, skin and soft Amount. 20 mg per pound of body tissue infections and septicemia caused weight daily. by pathogens susceptible to penicillin (ii) Indications for use. For the relief V potassium. of inflammatory conditions associated (3) Limitations. Administer orally 1 to with the musculoskeletal system. 2 hours prior to feeding for maximum absorption. Federal law restricts this (iii) Limitations. Federal law restricts drug to use by or on the order of a li- this drug to use by or on the order of a censed veterinarian. licensed veterinarian. (2) Horses—(i) Amount. 1 to 2 g per 500 [57 FR 37327, Aug. 18, 1992, as amended at 59 pounds of body weight daily. FR 58775, Nov. 15, 1994] (ii) Indications for use. For the relief § 520.1705 Pergolide. of inflammatory conditions associated with the musculoskeletal system. (a) Specifications. Each tablet con- tains 1 milligram (mg) pergolide (iii) Limitations. Do not use in horses mesylate. intended for human consumption. Fed- (b) Sponsor. See No. 000010 in eral law prohibits the use of this drug § 510.600(c) of this chapter. in female dairy cattle 20 months of age (c) Conditions of use in horses—(1) or older. Federal law restricts this drug Amount. Administer orally at a start- to use by or on the order of a licensed ing dose of 2 micrograms/kilograms (μ/ veterinarian. kg) once daily. Dosage may be adjusted [73 FR 8192, Feb. 13, 2008, as amended at 74 to effect, not to exceed 4 μg/kg daily. FR 1146, Jan. 12, 2009; 76 FR 11331, Mar. 2, (2) Indications for use. For the control 2011; 76 FR 17777, Mar. 31, 2011; 78 FR 21060, of clinical signs associated with Pitui- Apr. 9, 2013] tary Pars Intermedia Dysfunction (Equine Cushing’s Disease). § 520.1720b Phenylbutazone granules. (3) Limitations. Federal law restricts (a) Specifications. The drug is in this drug to use by or on the order of a granular form. It is packaged to con- licensed veterinarian. tain either 8 grams of phenylbutazone [77 FR 15960, Mar. 19, 2012] per package or 1 gram of phenylbutazone per package. § 520.1720 Phenylbutazone oral dosage (b) Sponsor. See 000061 in § 510.600(c) forms. for 8-gram package, see 059320 for 1- gram package. § 520.1720a Phenylbutazone tablets and boluses. (c) NAS/NRC status. The conditions of use have been NAS/NRC reviewed and (a) Specifications. Each tablet con- found effective. NADA’s for approval of tains 100, 200, or 400 milligrams (mg), or drugs for these conditions of use need 1 gram (g) of phenylbutazone. Each not include effectiveness data specified bolus contains 1, 2, or 4 gram g of by § 514.111 of this chapter, but may re- phenylbutazone. quire bioequivalency and safety infor- (b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter, as follows: mation. (1) No. 000061 for use of 100- or 400-mg (d) Conditions of use—(1) Horses—(i) or 1-g tablets, or 2- or 4-g boluses, in Amount. 1 to 2 grams per 500 pounds of dogs and horses. body weight, not to exceed 4 grams, (2) Nos. 000859 and 054628 for use of daily, as required. 100- or 200-mg or 1-g tablets in dogs and (ii) Indications. For the treatment of horses. inflammatory conditions associated (3) Nos. 000856 and 061623 for use of with the musculoskeletal system. 100-mg or 1-g tablets in dogs and (iii) Limitations. Administer orally by horses. adding to a portion of the usual grain (4) [Reserved] ration. Use a relatively high dose for

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the first 48 hours, then gradually re- may require bioequivalency and safety duce to a maintenance level at the low- information. est level capable of producing the de- (d) Conditions of use in horses—(1) sired clinical response. Treated ani- Amount. 1 to 2 grams of phenylbutazone mals should not be slaughtered for food per 500 pounds of body weight, not to use. Federal law restricts this drug to exceed 4 grams daily. use by or on the order of a licensed vet- (2) Indications for use. For relief of in- erinarian. flammatory conditions associated with [46 FR 18960, Mar. 27, 1981, as amended at 46 the musculoskeletal system of horses. FR 48642, Oct. 2, 1981; 57 FR 2836, Jan. 24, 1992; (3) Limitations. Use a relatively high 61 FR 8873, Mar. 6, 1996; 62 FR 61625, Nov. 19, dose for the first 48 hours, then gradu- 1997; 65 FR 20731, Apr. 18, 2000] ally reduce to a maintenance level at the lowest level capable of producing § 520.1720c Phenylbutazone paste. the desired clinical response. Not for (a) Specifications—(1) Each gram of use in horses intended for food. Federal paste contains 0.2 grams law restricts this drug to use by or on phenylbutazone. the order of a licensed veterinarian. (2) Each gram of paste contains 0.35 [50 FR 13561, Apr. 5, 1985, as amended at 50 grams phenylbutazone. FR 49372, Dec. 2, 1985; 55 FR 8462, Mar. 8, 1990; (b) Sponsors. See sponsor numbers in 66 FR 14073, Mar. 9, 2001; 68 FR 4915, Jan. 31, § 510.600(c) of this chapter. 2003] (1) No. 000061 for use of product de- scribed in paragraph (a)(1) of this sec- § 520.1720e Phenylbutazone powder. tion. (a) Specifications—(1) Each 1.15 grams (2) No. 064847 for use of product de- (g) of powder contains 1 g scribed in paragraph (a)(2) of this sec- phenylbutazone. tion. (2) Each 10 g of powder contains 1 g (c) Conditions of use in horses—(1) phenylbutazone. Amount. 1 to 2 grams of phenylbutazone (b) Sponsors. See sponsor numbers in per 500 pounds of body weight, not to § 510.600(c) of this chapter. exceed 4 grams daily. (1) No. 027053 for use of product de- (2) Indications for use. For relief of in- scribed in paragraph (a)(1) of this sec- flammatory conditions associated with tion. the musculoskeletal system. (2) No. 057699 for use of product de- (3) Limitations. Use a relatively high scribed in paragraph (a)(2) of this sec- dose for the first 48 hours, then gradu- tion. ally reduce to a maintenance level of (c) Conditions of use in horses—(1) the lowest level capable of producing Amount. Administer 1 to 2 g (1 to 2 level the desired clinical response. Do not scoops, using the scoop provided) per use in horses intended for human con- 500 pounds of body weight on a small sumption. Federal law restricts this amount of palatable feed, not exceed 4 drug to use by or on the order of a li- g per animal daily. censed veterinarian. (2) Indications for use. For the relief of [45 FR 84762, Dec. 23, 1980, as amended at 58 inflammatory conditions associated FR 29777, May 24, 1993; 61 FR 8873, Mar. 6, with the musculosketetal system. 1996; 62 FR 61625, Nov. 19, 1997; 68 FR 43926, (3) Limitations. Do not use in horses July 25, 2003; 72 FR 60550, Oct. 25, 2007; 77 FR intended for human consumption. Fed- 4897, Feb. 1, 2012] eral law prohibits the extralabel use of § 520.1720d Phenylbutazone gel. this product in female cattle 20 months of age or older. Federal law restricts (a) Specifications. Each 30 grams of gel this drug to use by or on the order of a contains 4 grams of phenylbutazone. licensed veterinarian. (b) Sponsor. See No. 061623 in § 510.600(c) of this chapter. [72 FR 27956, May 18, 2007] (c) NAS/NRC status. The conditions of use are NAS/NRC reviewed and found § 520.1760 Phenylpropanolamine. effective. Applications for these uses (a) Specifications. Each chewable tab- need not include effectiveness data as let contains 25, 50, or 75 milligram (mg) specified in § 514.111 of this chapter, but phenylpropanolamine hydrochloride.

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(b) Sponsors. See No. 055246 in (c) Conditions of use. Horses and § 510.600(c) of this chapter. ponies—(1) Amount. One fluid ounce per (c) Conditions of use in dogs—(1) 100 pounds of body weight.1 Amount. Administer 2 mg/kg of body (2) Indications for use. For removing weight twice daily. ascarids (large roundworms, Parascaris (2) Indications for use. For the control equorum), bots (Gastrophilus spp.), small of urinary incontinence due to urethral strongyles, large strongyles (Strongyles sphincter hypotonus in dogs. spp.), and pinworms (Oxyuris equi).1 (3) Limitations. Federal law restricts (3) Limitations. Administer by stom- this drug to use by or on the order of a ach tube or dose syringe after with- licensed veterinarian. holding feed overnight or for 8 to 10 hours. Provide water as usual. Resume [77 FR 15961, Mar. 19, 2012] regular feeding 4 to 6 hours after treat- § 520.1780 Pimobendan. ment. Treatment of debilitated or ane- mic animals is contraindicated. Do not (a) Specifications. Each chewable tab- administer to animals that are or were let contains 1.25, 2.5, 5, or 10 milligrams recently affected with colic, diarrhea, (mg) pimobendan. or infected with a serious infectious (b) Sponsor. See No. 000010 in disease. As with most anthelmintics, § 510.600(c) of this chapter. drastic cathartics and other gastro- (c) Conditions of use in dogs—(1) intestinal irritants should not be ad- Amount. Administer orally at a total ministered in conjunction with this daily dose of 0.23 mg per pound (0.5 mg drug. Animals in poor condition or per kilogram) body weight, using a heavily parasitized should be given one suitable combination of whole or half half the recommended dose and treated tablets. The total daily dose should be again in 2 or 3 weeks. Federal law re- divided into two portions administered stricts this drug to use by or on the approximately 12 hours apart. order of a licensed veterinarian.1 (2) Indications for use. For the man- agement of the signs of mild, mod- [45 FR 52781, Aug. 8, 1980] erate, or severe (modified New York Heart Association Class II, III, or IV) § 520.1802b Piperazine-carbon disul- fide complex boluses. congestive heart failure due to atrio- ventricular valvular insufficiency or (a) Specifications. Each bolus contains dilated cardiomyopathy; for use with 20 grams of piperazine-carbon disulfide concurrent therapy for congestive complex. heart failure as appropriate on a case- (b) Sponsor. See 000009 in § 510.600(c) of by-case basis. this chapter. (3) Limitations. Federal law restricts (c) Conditions of use: Horses and this drug to use by or on the order of a ponies—(1) Amount. For removal of licensed veterinarian. ascarids and small strongyles, 1 bolus (20 grams) per 500 pounds body weight; [72 FR 27733, May 17, 2007, as amended at 79 removal of large strongyles, pinworms, FR 18158, Apr. 1, 2014] and bots, 1 bolus per 250 pounds body weight.1 § 520.1802 Piperazine-carbon disulfide complex oral dosage forms. (2) Indications for use. For removing ascarids (large roundworms, Parascaris § 520.1802a Piperazine-carbon disul- equorum), large strongyles (Strongylus fide complex suspension. spp.) bots (Gastrophilus spp.), small (a) Specifications. Each fluid ounce of strongyles, and pinworms (Oxyuris 1 suspension contains 7.5 grams of piper- equi). azine-carbon disulfide complex. The pi- (3) Limitations. Withhold feed over- perazine-carbon disulfide complex con- night or for 8 to 10 hours. Give water tains equimolar parts of piperazine and carbon disulfide (1 gram contains 530 1 These conditions are NAS/NRC reviewed mgs of piperazine and 470 mgs of carbon and found effective. Applications for these disulfide). uses need not include effectiveness data as specified by § 514.111 of this chapter, but may (b) Sponsor. See 000009 in § 510.600(c) of require bioequivalency and safety informa- this chapter. tion.

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just before and/or after treatment. Re- the animal has finished eating the sume regular feeding 4 to 6 hours after dosed food, the remainder of the food treatment. Treatment of debilitated or may be given. Dogs and cats may be anemic animals is contraindicated. Do wormed at 6 to 8 weeks of age. The first not administer to animals that are or treatment should be repeated 10 days were recently affected with colic, diar- later. Reinfection may occur. Repeat rhea, or infected with a serious infec- treatment if indicated. tious disease. As with most (3) Severely debilitated animals anthelmintics, drastic cathartics or should not be wormed except on the ad- other gastrointestinal irritants should vice of a veterinarian. not be administered in conjunction with this drug. Animals in poor condi- [40 FR 13838, Mar. 27, 1975, as amended at 54 FR 38515, Sept. 19, 1989] tion or heavily parasitized should be given one half the recommended dose § 520.1804 Piperazine phosphate cap- and treated again in 2 or 3 weeks. Con- sules. sult your veterinarian for assistance in the diagnosis, treatment, and control (a) Specifications. Each capsule con- tains 120, 300, or 600 milligrams of pi- of parasitism.1 perazine phosphate monohydrate. [45 FR 52782, Aug. 8, 1980] (b) Sponsor. See No. 051311 in § 510.600(c) of this chapter. § 520.1802c Piperazine-carbon disul- (c) Conditions of use—(1) Amount. 60 fide complex with phenothiazine suspension. milligrams of piperazine phosphate monohydrate per pound of body (a) Specifications. Each fluid ounce weight.1 contains 5 grams of piperazine-carbon (2) Indications for use—(i) Dogs. It is disulfide complex and 0.83 gram of used for the removal of large phenothiazine. roundworms (ascarids) Toxocara canis (b) Sponsor. See 000009 in § 510.600(c) of and Toxascaris leonina. 1 this chapter. (ii) Cats. It is used for the removal of (c) Conditions of use: Horses and large roundworms (ascarids) Toxocara ponies—(1) Amount. One fluid ounce per mystax and Toxacaris leonina. 1 100 pounds of body weight. (3) Limitations. Administer in ani- (2) Indications for use. For removing mal’s food or milk. For animals up to ascarids (large roundworms, Parascaris 1 year of age administer every 2 or 3 equorum), bots (Gastrophilus spp.), small months; for animals over 1 year old, strongyles, and large strongyles administer periodically as necessary. (Strongylus spp.). Consult your veterinarian for assist- (3) Limitations. See § 520.1802a(c)(3). ance in the diagnosis, treatment, and [45 FR 52782, Aug. 8, 1980] control of parasitism.1

§ 520.1803 Piperazine citrate capsules. [43 FR 6941, Feb. 17, 1978; 43 FR 9804, Mar. 10, 1978, as amended at 46 FR 20158, Apr. 3, 1981; (a) Specifications. Piperazine citrate 69 FR 31878, June 8, 2004] capsules contain piperazine citrate equivalent to 140 milligrams of piper- § 520.1805 Piperazine phosphate with azine base in each capsule. thenium closylate tablets. (b) Sponsor. See No. 021091 in (a) Specifications. Each scored tablet § 510.600(c) of this chapter. contains the equivalent of 250 milli- (c) Conditions of use. (1) It is used in grams piperazine hexahydrate (as pi- dogs and cats for the removal of large perazine phosphate) and 125 milligrams roundworms (Toxocara canis and thenium (as thenium closylate) or 500 Toxascaris leonina). milligrams piperazine hexahydrate (as (2) The contents of 1 capsule should be mixed with the food of the animal 1 for each 5 pounds, or fraction thereof of These conditions are NAS/NRC reviewed and deemed effective. Applications for these body weight, except dogs weighing over uses need not include effectiveness data as 25 pounds should be given the contents specified by § 514.111 of this chapter, but may of 6 capsules. The drug should be mixed require bioequivalency and safety informa- in 1⁄2 of the regular feeding and when tion.

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piperazine phosphate) and 250 milli- (2) Dosage. Administer 20 to 30 mg pi- grams thenium (as thenium closylate). perazine base per pound body weight as (b) Sponsor. See No. 000061 in a single dose. § 510.600(c) of this chapter. (3) Limitations. Administer by mixing (c) Conditions of use—(1) Amount. Ad- into the animal’s ration to be con- minister orally to dogs as follows: sumed at one feeding. For animals in heavily contaminated areas, reworm at NUMBER OF TABLETS AT EACH OF THE TWO monthly intervals. Not for use in DOSES unweaned pups or animals less than 3 weeks of age. Animal weight (lb) 375 mg 750 mg [70 FR 17319, Apr. 6, 2005]

2 but less than 5 ...... 1⁄2 ...... 5 but less than 10 ...... 1 1⁄2 § 520.1807 Piperazine. 10 or heavier ...... 2 1 (a) Specifications. A soluble powder or liquid containing piperazine (2) Indications for use. For removal of dihydrochloride or dipiperazine sulfate, immature (fourth stage larvae) and equivalent to 17, 34, or 230 grams of pi- adult hookworms (Ancylostoma perazine per pound or 100 milliliters. caninum, A. braziliense, and Uncinaria (b) Sponsor. See 015565 in § 510.600(c) of stenocephala) and ascarids (Toxocara this chapter. canis) from weaned pups and adult (c) Related tolerances. See § 556.513 of dogs. this chapter. (3) Limitations. Do not use this prod- (d) Conditions of use—(1) Chickens—(i) uct to treat dogs weighing less than 2 Amount. 50 milligrams per bird under 6 pounds, unweaned pups, or pups under 5 weeks, 100 milligrams per bird over 6 weeks of age. Maximum efficacy weeks. against hookworms necessitates two (ii) Indications for use. For removal of doses in 1 day of treatment. The inter- large roundworm (Ascaridia spp.). val between the doses should be not (iii) Limitations. For use in drinking less than 4 hours or more than 24 water or feed. Use as sole source of hours. Administer the first dose in the drinking water. Prepare fresh solution morning before feeding. Do not permit daily. Use as 1-day single treatment. dog to chew tablet. Feed the dog be- Withdraw 14 days prior to slaughter. tween doses. Do not feed milk or other Do not use for chickens producing eggs fatty foods during treatment. Retreat- for human consumption. Consult your ment may be needed in 7 to 28 days as veterinarian for assistance in the diag- determined by laboratory fecal exami- nosis, treatment, and control of para- nations or in animals kept in known sitism. contaminated quarters. Federal law re- (2) Turkeys—(i) Amount. 100 milli- stricts this drug to use by or on the grams per bird up to 12 weeks and 200 order of a licensed veterinarian. milligrams per bird over 12 weeks. (ii) Indications for use. For removal of [43 FR 32747, July 28, 1978, as amended at 47 large roundworm (Ascaridia spp.). FR 55476, Dec. 10, 1982; 61 FR 8873, Mar. 6, 1996; 62 FR 61625, Nov. 19, 1997] (iii) Limitations. For use in drinking water or feed. Use as sole source of § 520.1806 Piperazine suspension. drinking water. Prepare fresh solution daily. Use as 1-day single treatment. (a) Specifications. Each milliliter of Withdraw 14 days prior to slaughter. suspension contains piperazine Consult your veterinarian for assist- monohydrochloride equivalent to 33.5 ance in the diagnosis, treatment, and milligrams (mg) piperazine base. control of parasitism. (b) Sponsor. See No. 017135 in (3) Swine—(i) Amount. 50 milligrams § 510.600(c) of this chapter. per pound of body weight. (c) Special considerations. See (ii) Indications for use. For removal of § 500.25(c) of this chapter. large roundworm (Ascaris suum) and (d) Conditions of use in dogs—(1) Indi- nodular worms (Oesophagostomum spp.). cations for use. For the removal of (iii) Limitations. For use in drinking roundworms (Toxocara canisand water or feed. Use as sole source of Toxascaris leonina). drinking water. Prepare fresh solution

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daily. Use as 1-day single treatment. blocks at least 7 days before exposure Withdraw 21 days prior to slaughter. to bloat-producing conditions. Consult your veterinarian for assist- [40 FR 13838, Mar. 27, 1975, as amended at 40 ance in the diagnosis, treatment, and FR 39857, Aug. 29, 1975; 42 FR 41854, Aug. 19, control of parasitism. 1977; 50 FR 5385, Feb. 8, 1985; 54 FR 33501, Aug. [64 FR 23018, Apr. 29, 1999] 15, 1989; 56 FR 50653, Oct. 8, 1991; 58 FR 26523, May 4, 1993; 60 FR 55659, Nov. 2, 1995; 66 FR § 520.1840 Poloxalene. 47963, Sept. 17, 2001; 69 FR 62811, Oct. 28, 2004; 70 FR 32489, June 3, 2005] (a) Specifications. Polyoxypropylene- polyoxyethylene glycol nonionic block § 520.1846 Polyoxyethylene (23) lauryl polymer. ether blocks. (b) Sponsors. See sponsors in (a) Specifications. Each molasses- § 510.600(c) of this chapter for use as in based block contains 2.2 percent paragraph (d) of this section. polyoxyethylene (23) lauryl ether. (1) No. 000069 for use as in paragraphs (b) Sponsor. See No. 067949 in (d)(1) and (d)(3) of this section. § 510.600(c) of this chapter. (2) No. 051311 for use as in paragraph (c) Conditions of use—(1) Amount. 2 (d)(4) of this section. grams of polyoxyethylene (23) lauryl (3) No. 067949 for use as in paragraph ether per 100 kilograms of body weight (d)(2) of this section. per day (1 pound of block per 500 kilo- (4) No. 066104 for use as in paragraph gram (1,100 pound) animal per day). (d)(3) of this section. (2) Indications for use. For reduction (c) [Reserved] of the incidence of bloat (alfalfa and (d) Conditions of use. (1) For treat- clover) in pastured cattle. ment of legume (alfalfa, clover) bloat (3) Limitations. Administer free- in cattle. Administer as a drench at the choice to beef cattle and nonlactating rate of 25 grams for animals up to 500 dairy cattle only. Initially, provide one pounds and 50 grams for animals over block per five head of cattle. Start 500 pounds of body weight. treatment 10 to 14 days before exposure (2) For control of legume (alfalfa, clo- to bloat-producing pastures. Do not ver) bloat in cattle. Administer, in mo- allow cattle access to other sources of lasses block containing 6.6 percent salt while being fed this product. Do poloxalene, at the rate of 0.8 oz. of not feed this product to animals with- block (1.5 grams poloxalene) per 100 lbs. out adequate forage/roughage consump- of body weight per day. tion. (3) For prevention of legume (alfalfa, [50 FR 48189, Nov. 22, 1985, as amended at 56 clover) and wheat pasture bloat in cat- FR 9841, Mar. 8, 1991; 69 FR 62811, Oct. 28, tle. A 53-percent poloxalene top dress- 2004] ing on individual rations of ground feed. Dosage is 1 gram of poloxalene § 520.1855 Ponazuril. per 100 pounds of body weight daily. If (a) Specifications. Each gram of paste bloating conditions are severe, the dose contains 150 milligrams (mg) ponazuril. is doubled. Treatment should be start- (b) Sponsor. See No. 000859 in ed 2 to 3 days before exposure to bloat- § 510.600(c) of this chapter. producing conditions. Repeat use of the (c) Conditions of use in horses—(1) drug if animals are exposed to bloat- Amount. 5 mg per kilogram body producing conditions for more than 12 weight, daily for 28 days. hours after the last treatment. Do not (2) Indications for use. For the treat- exceed the double dose in any 24-hour ment of equine protozoal period. myeloencephalitis caused by Sarcocystis (4) For control of legume (alfalfa, clo- neurona. ver) and wheat pasture bloat in cattle. (3) Limitations. Not for use in horses Administer in molasses block con- intended for food. Federal law restricts taining 6.6 percent poloxalene, at the this drug to use by or on the order of a rate of 0.8 ounce of block (1.5 grams of licensed veterinarian. poloxalene) per 100 pounds of body weight per day. Provide access to [66 FR 43774, Aug. 21, 2001]

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§ 520.1860 Pradofloxacin. (iii) Limitations—(A) If labeled only for use as in paragraph (c)(1)(ii)(A) of (a) Specifications. Each milliliter of suspension contains 25 milligrams (mg) this section: Not intended for use in pradofloxacin. puppies less than 4 weeks of age. Con- sult your veterinarian before admin- (b) Sponsor. See No. 000859 in § 510.600(c) of this chapter. istering tablets to weak or debilitated animals and for assistance in the diag- (c) Special considerations. Federal law restricts this drug to use by or on the nosis, treatment, and control of para- order of a licensed veterinarian. Fed- sitism. (B) If labeled for use as in paragraph eral law prohibits the extralabel use of (c)(1)(ii)(B) of this section: Federal law this drug in food-producing animals. restricts this drug to use by or on the (d) Conditions of use in cats—(1) order of a licensed veterinarian. Amount. Administer 3.4 mg/lb (7.5 mg/ (2) Cats—(i) Indications for use. For re- kg) body weight once daily for 7 con- moval of feline cestodes Dipylidium secutive days. caninum and Taenia taeniaeformis. (2) Indications for use. For the treat- (ii) Dosage. Cats 4 pounds and under, ment of skin infections (wounds and 11.5 mg; 5 to 11 pounds, 23 mg; over 11 abscesses) in cats caused by susceptible pounds, 34.5 mg. strains of Pasteurella multocida, Strepto- (iii) Limitations. Administer directly coccus canis, Staphylococcus aureus, by mouth or crumbled and in feed. Not Staphylococcus felis, and Staphylococcus intended for use in kittens less than 6 pseudintermedius. weeks of age. For OTC use: Consult [77 FR 76863, Dec. 31, 2012] your veterinarian before administering tablets to weak or debilitated animals, § 520.1870 Praziquantel tablets. and for assistance in the diagnosis, (a) Specifications. Each tablet con- treatment, and control of parasitism. tains: [46 FR 60570, Dec. 11, 1981, as amended at 47 (1) 34 milligrams (mg) praziquantel. FR 26377, June 18, 1982; 55 FR 2234, Jan. 23, (2) 11.5 or 23 mg praziquantel. 1990; 58 FR 7864, Feb. 10, 1993; 58 FR 42853, (b) Sponsors. See sponsors in Aug. 12, 1993; 68 FR 57351, Oct. 3, 2003; 69 FR § 510.600(c) of this chapter: 62181, Oct. 25, 2004; 78 FR 17596, Mar. 22, 2013] (1) No. 000859 for use of the product described in paragraph (a)(1) of this § 520.1871 Praziquantel and pyrantel. section, as in paragraph (c)(1) of this (a) Specifications. (1) Each tablet con- section; and for use of the product de- tains 13.6 milligrams (mg) praziquantel scribed in paragraph (a)(2) of this sec- and 54.3 mg pyrantel base (as pyrantel tion, as in paragraph (c)(2) of this sec- pamoate), 18.2 mg praziquantel and 72.6 tion. mg pyrantel base (as pyrantel (2) No. 000859 for use of the product pamoate), or 27.2 mg praziquantel and described in paragraph (a)(1) of this 108.6 mg pyrantel base (as pyrantel section, as in paragraph (c)(1) of this pamoate). section. (2) Each chewable tablet contains 30 (c) Conditions of use—(1) Dogs—(i) mg praziquantel and 30 mg pyrantel Amount. 5 pounds (lb) and under, 1⁄2 tab- pamoate or 114 mg praziquantel and 114 let (17 mg); 6 to 10 lb, 1 tablet (34 mg); mg pyrantel pamoate. 11 to 15 lb, 11⁄2 tablets (51 mg); 16 to 30 (b) Sponsors. See sponsors in lb, 2 tablets (68 mg); 31 to 45 lb, 3 tab- § 510.600(c) for use as in paragraph (d) of lets (102 mg); 46 to 60 lb, 4 tablets (136 this chapter. mg); over 60 lb, 5 tablets maximum (170 (1) See No. 000859 for use of tablets mg). Administer directly by mouth or described in paragraph (a)(1) of this crumbled and in feed. section for use as in paragraph (d)(1) of (ii) Indications for use—(A) For re- this section. moval of canine cestodes Dipylidium (2) See No. 051311 for use of tablets caninum and Taenia pisiformis. described in paragraph (a)(2) of this (B) For removal of the canine cestode section for use as in paragraph (d)(2) of Echinococcus granulosus, and for re- this section. moval and control of the canine (c) Special considerations. See § 500.25 cestode Echinococcus multilocularis. of this chapter.

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(d) Conditions of use—(1) Cats—(i) Dos- Weight of animal Number of tablets per dose age. Administer a minimum dose of 2.27 Tablet Tablet Tablet mg praziquantel and 9.2 mg pyrantel Kilograms Pounds no. 1 no. 2 no. 3 pamoate per pound of body weight ac- 0.9 to 1.8 ...... 2 to 4 ...... 1/2. cording to the dosing tables on label- 2.3 to 3.2 ...... 5 to 7 ...... 1. ing. May be given directly by mouth or 3.6 to 5.4 ...... 8 to 12 ..... 1 1/2. in a small amount of food. Do not with- 5.9 to 8.2 ...... 13 to 18 ... 2. 8.6 to 11.4 .... 19 to 25 ... 2 1/2. hold food prior to or after treatment. If 11.8 to 13.6 .. 26 to 30 ...... 1. reinfection occurs, treatment may be 14.1 to 20.0 .. 31 to 44 ...... 1 1/2. repeated. 20.4 to 27.2 .. 45 to 60 ...... 2 ...... 1 27.7 to 40.9 .. 61 to 90 ...... 1 1/2 (ii) Indications for use. For removal of 41.3 to 54.5 .. 91 to 120 ...... 2 tapeworms (Dipylidium caninum and Taenia taeniaeformis), hookworms (ii) Indications for use. For the re- (Ancylostoma tubaeforme), and large moval of tapeworms (Dipylidium roundworms (Toxocara cati) in cats and caninum, Taenia pisiformis, Echinococcus kittens. granulosus); hookworms (Ancylostoma (iii) Limitations. Not for use in kit- caninum, Uncinaria stenocephala); tens less than 2 months of age or ascarids (Toxocara canis, Toxascaris weighing less than 2.0 pounds. Consult leonina); and whipworms (Trichuris your veterinarian before giving to sick vulpis) and for the removal and control or pregnant animals. of tapeworm Echinococcus multilocularis (2) Dogs—(i) Amount. Administer a in dogs. minimum dose of 5 mg praziquantel (iii) Limitations. Do not use in preg- and 5 mg pyrantel pamoate per kilo- nant animals. Do not use in dogs gram body weight (2.27 mg praziquantel weighing less than 0.9 kilogram (2 and 2.27 mg pyrantel pamoate per pounds) or puppies less than 3 weeks of pound body weight) according to the age. Federal law restricts this drug to dosing tables on labeling. use by or on the order of a licensed vet- (ii) Indications for use. For the treat- erinarian. ment and control of roundworms [59 FR 33908, July 1, 1994, as amended at 61 (Toxocara canis and Toxascaris leonina), FR 29651, June 12, 1996; 68 FR 22293, Apr. 28, hookworms (Ancylostoma caninum, 2003; 71 FR 6677, Feb. 9, 2006] , and Uncinaria stenocephala), and tapeworms § 520.1880 Prednisolone tablets. (Dipylidium caninum and Taenia (a) Specifications. Each tablet con- pisiformis) in dogs and puppies. tains 5 or 20 milligrams prednisolone. [58 FR 58652, Nov. 3, 1993, as amended at 72 (b) Sponsor. See No. 061690 in FR 16270, Apr. 4, 2007; 75 FR 54018, Sept. 3, § 510.600(c)(2) of this chapter. 2010] (c) Special considerations. (1) Clinical and experimental data have dem- § 520.1872 Praziquantel, pyrantel onstrated that corticosteroids adminis- pamoate, and febantel tablets. tered orally or parenterally to animals (a) Specifications. Each tablet or may induce the first stage of parturi- chewable tablet contains either: tion when administered during the last (1) Tablet No. 1: 22.7 milligrams trimester of pregnancy and may pre- praziquantel, 22.7 milligrams pyrantel cipitate parturition followed by base, and 113.4 milligrams febantel; or dystocia, fetal death, retained pla- (2) Tablet No. 2: 68 milligrams centa, and metritis. praziquantel, 68 milligrams pyrantel (2) Do not use in viral infections. base, and 340.2 milligrams febantel. Systemic therapy with prednisolone is (3) Tablet No. 3: 136 milligrams (mg) contraindicated in animals with peptic praziquantel, 136 mg pyrantel base, and ulcer, corneal ulcer, and Cushingoid 680.4 mg febantel. syndrome. The presence of diabetes, (b) Sponsor. See 000859 in § 510.600(c) of osteoporosis, predisposition to this chapter. thrombophlebitis, hypertension, con- (c) Conditions of use—(1) Dogs—(i) gestive heart failure, renal insuffi- Amount. Administer as a single dose di- ciency, and active tuberculosis neces- rectly by mouth or in a small amount sitates carefully controlled use. Some of food as follows: of the above conditions occur only

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rarely in dogs but should be kept in stricts this drug to use by or on the mind. order of a licensed veterinarian. (3) Anti-inflammatory action of [42 FR 61594, Dec. 6, 1977, as amended at 43 corticosteroids may mask signs of in- FR 55386, Nov. 28, 1978; 46 FR 8467, Jan. 27, fection. 1981; 46 FR 57477, Nov. 24, 1981; 53 FR 40727, (d) Conditions of use—(1) Amount. Oct. 18, 1988; 56 FR 37473, Aug. 7, 1991; 62 FR Dogs: 2.5 milligrams per 4.5 kilograms 35076, June 30, 1997; 78 FR 21060, Apr. 9, 2013] (10 pounds) body weight per day. Ad- § 520.1920 Prochlorperazine, minister total daily dose orally in isopropamide sustained release equally divided doses 6 to 10 hours capsules. apart until response is noted or 7 days (a) Specifications. Prochlorperazine, have elapsed. When response is at- isopropamide sustained release cap- tained, dosage should be gradually re- sules contain either: duced until maintenance level is (1) 3.33 milligrams of achieved. prochlorperazine (as the dimaleate) (2) Indications for use. For use in dogs and 1.67 milligrams of isopropamide (as as an anti-inflammatory agent. the iodide), or (3) Limitations. Federal law restricts (2) 10 milligrams of prochlorperazine this drug to use by or on the order of a (as the dimaleate) and 5 milligrams of licensed veterinarian. isopropamide (as the iodide). [57 FR 4718, Feb. 7, 1992, as amended at 60 FR (b) Sponsor. See No. 000069 in 57832, Nov. 22, 1995; 63 FR 148, Jan. 5, 1998] § 510.600(c) of this chapter. (c) Conditions of use. (1) The drug is § 520.1900 Primidone tablets. used for the treatment of dogs in which (a) Specifications. Each tablet con- gastrointestinal disturbances are asso- tains 50 or 250 milligrams of primidone. ciated with emotional stress. (b) Sponsor. See No. 054628 in (2)(i) Capsules described in paragraph (a)(1) of this section are administered § 510.600(c) of this chapter for use of 250 orally to dogs weighing from 4 to 15 milligram tablets; see No. 000856 in pounds at the rate of 1 capsule twice § 510.600(c) of this chapter for use of 50 daily. These capsules are administered and 250 milligram tablets. orally to dogs weighing from 16 to 30 (c) Conditions of use in dogs—(1) pounds at the rate of 1 or 2 capsules Amount. Twenty-five milligrams of twice daily. For dogs weighing less primidone per pound of body weight (55 than 4 pounds, administer orally an ap- milligrams per kilogram of body propriate fraction of the contents of weight) daily. one of these capsules. (2) Indications for use. For the control (ii) Capsules described in paragraph of convulsions associated with idio- (a)(2) of this section are given to dogs pathic epilepsy, epileptiform convul- weighing 30 pounds and over at the rate sions, viral encephalitis, distemper, of 1 capsule twice daily. and hardpad disease that occurs as a (3) For use only by or on the order of clinically recognizable lesion in certain a licensed veterinarian. entities in dogs. [40 FR 13838, Mar. 27, 1975, as amended at 56 (3) Limitations. The tablets may be FR 50653, Oct. 8, 1991; 60 FR 55659, Nov. 2, administered whole or crushed and 1995] mixed with the food. When convulsions are frequent, the dosage should be di- § 520.1921 Prochlorperazine, vided and administered at intervals. isopropamide, with neomycin sus- Reduction in dosage should be made tained-release capsules. gradually and never be abruptly dis- (a) Specifications. Each capsule con- continued. Do not use in feline species, tains either: as primidone appears to have a specific (1) Capsule No. 1: 3.33 milligrams of neurotoxicity in cats. Federal law re- prochlorperazine (as the dimaleate), 1.67 milligrams of isopropamide (as the iodide), and 25 milligrams of neomycin base (as the sulfate); or

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(2) Capsule No. 3: 10 milligrams of (iii) Federal law restricts this drug to prochlorperazine (as the dimaleate), 5 use by or on the order of a licensed vet- milligrams of isopropamide (as the io- erinarian. dide), and 75 milligrams of neomycin (b) [Reserved] base (as the sulfate). [40 FR 13838, Mar. 27, 1975, as amended at 43 (b) Sponsor. See No. 000069 in FR 55386, Nov. 28, 1978; 59 FR 5705, Feb. 8, § 510.600(c) of this chapter. 1994] (c) Conditions of use—(1) Amount. Ad- minister capsules orally twice daily to § 520.2002 Propiopromazine hydro- dogs as follows: chloride. (a) Chemical name. 1-Propanone, 1-[10- Number of cap- [3-(dimethylamino) propyl] sules per dose Animal weight (pounds) phenothiazine-2-yl]-, Capsule Capsule monohydrochloride. No. 1 No. 3 (b) Specifications. The drug is admin- 10 to 20 ...... 1 istered in a chewable tablet containing 20 to 30 ...... 2 10 to 20 milligrams of propiopromazine Over 30 ...... 3 1 hydrochloride. Over 60 ...... 2 (c) Sponsor. See No. 000856 in § 510.600(c) of this chapter. (2) Indications for use. For treatment (d) Conditions of use. (1) The drug is of dogs in which infectious bacterial intended for oral administration to gastroenteritis is associated with emo- dogs as a tranquilizer. It is used as an tional stress. aid in handling difficult, excited, and (3) Limitations. Do not continue medi- unruly dogs, and in controlling exces- cation longer than 5 days. Overdosage sive kennel barking, car sickness, and or prolonged administration may severe dermatitis. It is also indicated produce nephrotoxicity as manifested for use in minor surgery and prior to by albuminuria, presence of granular routine examinations, laboratory pro- casts and depressed urinary output. If cedures, and diagnostic procedures. it is desirable to administer a vasocon- (2) It is administered at the rate of strictor, norepinephrine is the drug of 0.5 to 2 milligrams of propiopromazine choice. Federal law restricts this drug hydrochloride per pound of body weight to use by or on the order of a licensed once or twice daily depending upon the veterinarian. degree of tranquilization desired. [49 FR 14103, Apr. 10, 1984, as amended at 56 NOTE: Not for use with organophosphates FR 50653, Oct. 8, 1991; 60 FR 55659, Nov. 2, and/or procaine hydrochloride, as 1995] phenothiazine may potentiate the toxicity of organophosphates and the activity of pro- § 520.1962 Promazine hydrochloride. caine hydrochloride. Overdosage may produce significant depression. (a)(1) Chemical name. 10-[3- (3) For use only by or on the order of (Dimethylamino)propyl]phenothiazine a licensed veterinarian. monohydrochloride. (2) Specifications. Conforms to N.F. [40 FR 13838, Mar. 27, 1975, as amended at 46 XII. FR 60570, Dec. 11, 1981; 61 FR 5506, Feb. 13, 1996] (3) Sponsor. See No. 000856 in § 510.600(c) of this chapter. § 520.2041 Pyrantel pamoate chewable (4) [Reserved] tablets. (5) Conditions of use. (i) The drug is (a) Specifications. Each tablet con- used for quieting excitable, unruly, or tains pyrantel pamoate equivalent to intractable horses. It is administered 22.7 or 113.5 milligrams pyrantel base. at a dosage level of 0.45 to 0.9 milli- (b) Sponsor. See Nos. 017135 and 051311 grams of promazine hydrochloride per in § 510.600(c) of this chapter. pound of body weight mixed with an (c) Conditions of use—(1) Amount. Pro- amount of feed that will be readily con- vides at least 2.27 milligrams pyrantel sumed. base per pound body weight for dogs (ii) Do not use in horses intended for weighing more than 5 pounds, and at food. least 4.54 milligrams of pyrantel base

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per pound body weight for dogs weigh- fecal examination should be conducted ing 5 pounds or less. 2 to 4 weeks after first treatment regi- (2) Indications for use—(i) In dogs and men to determine the need for re-treat- puppies. For removal of ascarids ment. Consult your veterinarian for as- (Toxocara canis; Toxascaris leonina) and sistance in the diagnosis, treatment, hookworms (Ancylostoma caninum; and control of parasitism. Uncinaria stenocephala). [43 FR 52700, Nov. 14, 1978, as amended at 49 (ii) In puppies and adult dogs and in FR 22073, May 25, 1984; 57 FR 48163, Oct. 22, lactating bitches after whelping. To 1992; 58 FR 44611, Aug. 24, 1993] prevent reinfection of Toxocara canis. (3) Limitations. Administer to puppies § 520.2043 Pyrantel pamoate suspen- at 2, 3, 4, 6, 8, and 10 weeks of age. Ad- sion. minister to lactating bitches 2 to 3 (a) Specifications. (1) Each milliliter weeks after whelping. Retreatment of (mL) contains pyrantel pamoate equiv- adult dogs may be necessary at month- alent to 50 milligrams (mg) pyrantel ly intervals as determined by labora- base. tory fecal examinations. Consult your (2) Each mL contains pyrantel veterinarian for assistance in the diag- pamoate equivalent to 2.27 or 4.54 mg nosis, treatment, and control of para- pyrantel base. sitism. (3) Each mL contains pyrantel [52 FR 37937, Oct. 13, 1987, as amended at 57 pamoate equivalent to 4.54 mg pyrantel FR 48163, Oct. 22, 1992; 58 FR 44611, Aug. 24, base. 1993; 66 FR 9650, Feb. 9, 2001; 67 FR 21996, May (b) Sponsors. See sponsors in 2, 2002] § 510.600(c) of this chapter for uses as in paragraph (d) of this section. § 520.2042 Pyrantel pamoate tablets. (1) Nos. 000069, 000859, and 058829 for (a) Specifications. Each tablet con- use of the product described in para- tains pyrantel pamoate equivalent to graph (a)(1) as in paragraph (d)(1) of 22.7, 45.4, or 113.5 milligrams of this section. pyrantel base. (2) Nos. 000069, 055246, 058829, and (b) Sponsor. See No. 017135 in 059130 for use of the products described § 510.600(c) of this chapter. in paragraph (a)(2) as in paragraph (c) Conditions of use. It is used for (d)(2) of this section. dogs as follows: (3) No. 023851 for use of the product (1) Amount. For dogs weighing over 5 described in paragraph (a)(3) as in para- pounds, use at least 2.27 milligrams of graph (d)(2) of this section. pyrantel base per pound of body (c) Special considerations. See § 500.25 weight; for dogs weighing 5 pounds or of this chapter. less, use at least 4.54 milligrams of (d) Conditions of use—(1) Horses and pyrantel base per pound of body ponies. It is used as follows: weight. (i) Amount. 3 mg per pound (/lb) body (2) Indications for use. For removal weight as a single dose mixed with the and control of large roundworms usual grain ration, or by stomach tube (ascarids) (Toxocara canis and or dose syringe. Toxascaris leonina), and hookworms (ii) Indications for use. For the re- (Ancylostoma caninum and Uncinaria moval and control of mature infections stenocephala). of large strongyles (Strongylus vulgaris, (3) Limitations. Administer orally di- S. edentatus, S. equinus); pinworms rectly or in a small amount of food. To (Oxyuris equi); large roundworms prevent reinfection of T. canis in pup- (Parascaris equorum); and small pies, lactating bitches after whelping, strongyles. and adult dogs; treat puppies 2, 3, 4, 6, (iii) Limitations. Do not use in horses 8, and 10 weeks of age; treat lactating intended for human consumption. bitches 2 to 3 weeks after whelping; When the drug is for administration by routinely treat adult dogs monthly. Do stomach tube, it shall be labeled: not withhold food prior to or after ‘‘Federal law restricts this drug to use treatment. The presence of these by or on the order of a licensed veteri- parasites should be confirmed by lab- narian.’’ oratory fecal examination. A followup (2) Dogs. It is used as follows:

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(i) Dogs and puppies—(A) Amount. 2.27 parasites: large strongyles (Strongylus mg/lb body weight as a single dose in vulgaris, S. edentatus, S. equinus); small the animal’s feed bowl by itself or strongyles; pinworms (Oxyuris equi); mixed in a small quantity of food. and large roundworms (Parascaris (B) Indications for use. For the re- equorum). moval of large roundworms (Toxocara (ii) 6 mg/lb body weight as single oral canis and Toxascaris leonina) and dose for the removal and control of ma- hookworms (Ancylostoma caninum and ture infections of tapeworms Uncinaria stenocephala). (Anoplocephala perfoliata). (C) Limitations. Additional treatment (2) Limitations. Do not use in horses may be required and should be con- intended for human consumption. firmed by fecal examination within 2 [70 FR 29447, May 23, 2005, as amended at 76 to 4 weeks. FR 17337, Mar. 29, 2011; 78 FR 17596, Mar. 22, (ii) Dogs, puppies, and lactating bitches 2013] after whelping—(A) Amount. 2.27 mg/lb body weight. § 520.2045 Pyrantel tartrate powder; (B) Indications for use. To prevent re- pyrantel tartrate pellets. infections of T. canis. (a) Specifications. (1) Pyrantel tar- (C) Limitations. Administer to puppies trate powder horse wormer contains at 2, 3, 4, 6, 8, and 10 weeks of age. Ad- 11.3 percent and swine wormer 10.6 per- minister to lactating bitches 2 to 3 cent pyrantel tartrate. weeks after whelping. Adult dogs kept (2) Pyrantel tartrate pellets colt and in heavily contaminated quarters may horse wormer contains 1.25 percent be treated at monthly intervals. pyrantel tartrate. [67 FR 43248, June 27, 2002, as amended at 68 (b) Sponsor. (1) See No. 000069 in FR 54803, Sept. 19, 2003; 68 FR 55199, Sept. 23, § 510.600(c) of this chapter for condi- 2003; 68 FR 55825, Sept. 29, 2003; 75 FR 52622, tions of use provided for in paragraphs Aug. 27, 2010; 76 FR 17337, Mar. 29, 2011; 78 FR (d) (1) and (2) of this section. 17596, Mar. 22, 2013] (2) See No. 061623 in § 510.600(c) of this chapter, for conditions of use provided § 520.2044 Pyrantel pamoate paste. for in paragraph (d)(3) of this section. (a) Specifications—(1) Each milliliter (c) Related tolerances. See § 556.560 of (mL) contains 180 milligrams (mg) this chapter. pyrantel base (as pyrantel pamoate). (d) Conditions of use. It is used in: (1) (2) Each mL contains 226 mg pyrantel Horses and ponies: base (as pyrantel pamoate). (i) For the removal and control of in- (3) Each mL contains 171 mg pyrantel fections from the following mature base (as pyrantel pamoate). parasites: Large strongyles (Strongylus (b) Sponsors. See sponsors in vulgaris, Strongylus edentatus, § 510.600(c) of this chapter. Strongylus equinus), small strongyles (1) No. 000069 for use of product de- (Trichonema spp., Triodontophorus), scribed in paragraph (a)(1) of this sec- pinworms (Oxyuris), and large tion as in paragraph (d)(1)(i) and (d)(2) roundworms (Parascaris). of this section. (ii) It is administered as a single dose (2) No. 000859 for use of product de- at 0.57 gram of pyrantel tartrate per 100 scribed in paragraph (a)(2) of this sec- pounds of body weight mixed with the tion as in paragraph (d) of this section. usual grain ration. (3) No. 061623 for use of product de- (iii) It is recommended that severely scribed in paragraph (a)(3) of this sec- debilitated animals not be treated with tion as in paragraph (d)(1)(i) and (d)(2) this drug. Do not administer by stom- of this section. ach tube or dose syringe. The drug (c) Special considerations. See § 500.25 should be used immediately after the of this chapter. package is opened. (d) Conditions of use. It is used in (iv) Warning: Not for use in horses horses and ponies as follows: and ponies to be slaughtered for food (1) Amounts and indications for use—(i) purposes. 3 mg per pound (/lb) body weight as sin- (2) Swine: gle oral dose for removal and control of (i) For the removal and control of infections from the following mature large roundworms (Ascaris suum) and

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nodular worm (Oesophagostomum) infec- (3) Limitations. Federal law restricts tions. this drug to use by or on the order of a (ii) It is added to feed at 0.4 gram licensed veterinarian. pyrantel tartrate per pound of [76 FR 18648, Apr. 5, 2011, as amended at 79 nonpelleted ration. The ration is ad- FR 10964, Feb. 27, 2014] ministered as a single treatment as the sole ration at the rate of 1 pound per 40 § 520.2098 Selegiline hydrochloride pounds of animal weight for animals up tablets. to 200 pounds. Animals 200 pounds and (a) Specifications. Each tablet con- over are administered 5 pounds of ra- tains either 2, 5, 10, 15, or 30 milligrams tion per animal. of selegiline hydrochloride. (iii) Fast pigs over night for optimum (b) Sponsor. See No. 000069 in results. Water should be made avail- § 510.600(c) of this chapter. able to animals during fasting and (c) [Reserved] treatment periods. Consult veteri- (d) Conditions of use—Dogs—(1) Dos- narian before using in severely debili- age. 1 milligram per kilogram (0.45 mil- tated animals. The drug should be used ligram per pound) of body weight. immediately after the package is (i) Indications for use. For control of opened. clinical signs associated with uncom- (iv) Warning: Do not treat within 24 plicated pituitary-dependent hours of slaughter. hyperadrenocorticism in dogs. (3) Horses and colts: (ii) Limitations. Administer orally (i) For the removal and control of in- once daily. If no improvement in clin- fections from the following mature ical signs or physical examination find- parasites: Large strongyles (Strongylus ings after 2 months of therapy, in- vulgaris, Strongylus edentatus, crease dose to a maximum of 2 milli- Strongylus equinus), small strongyles grams per kilogram once daily. Federal (Trichonema spp., Triodontophorus), law restricts this drug to use by or on pinworms (Oxyuris), and large the order of a licensed veterinarian. roundworms (Parascaris). (2) Dosage. 0.5 to 1.0 milligram per (ii) It is administered as a single dose kilogram of body weight once daily. at 12.5 milligrams of pyrantel tartrate (i) Indications for use. For the control per 2.2 pounds of body weight mixed of clinical signs associated with canine with the usual grain ration. cognitive dysfunction syndrome. (iii) It is recommended that severely (ii) Limitations. Federal law restricts debilitated animals not be treated with this drug to use by or on the order of a this drug. licensed veterinarian. (iv) Warning: Do not use in horses or colts intended for food. [62 FR 34632, June 27, 1997; 62 FR 55159, Oct. 23, 1997, as amended at 63 FR 29551, June 1, [40 FR 13838, Mar. 27, 1975, as amended at 59 1998; 64 FR 2122, Jan. 13, 1999] FR 28769, June 3, 1994; 69 FR 41427, July 9, 2004; 76 FR 40229, July 8, 2011] § 520.2100 Selenium, vitamin E cap- sules. § 520.2075 Robenacoxib. (a) Specifications. The capsules con- (a) Specifications. Each tablet con- tain 2.19 milligrams of sodium selenite tains 6 milligrams (mg) robenacoxib. (equivalent to 1 milligram of selenium) (b) Sponsors. See No. 058198 in and 56.2 milligrams of vitamin E (68 § 510.600(c) of this chapter. I.U.) (as d-alpha tocopheryl acid succi- (c) Conditions of use in cats—(1) nate) or 0.548 milligram of sodium sele- Amount. Administer 0.45 mg per pound nite (equivalent to .25 milligram of se- (/lb) (1 mg/kilogram (kg)) once daily. lenium and 14 milligrams of vitamin E (2) Indications for use. For the control (17 I.U.) (as d-alpha tocopheryl acid of postoperative pain and inflamma- succinate.) tion associated with orthopedic sur- (b) Sponsor. See No. 000061 in gery, ovariohysterectomy, and castra- § 510.600(c) of this chapter. tion in cats weighing at least 5.5 lb (2.5 (c) Conditions of use. (1) The drug is kg) and at least 4 months of age; for up intended for use as an aid in alleviating to a maximum of 3 days. and controlling inflammation, pain,

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and lameness associated with certain (3) Limitations. Federal law restricts arthropathies in dogs. this drug to use by or on the order of a (2) The capsules are administered licensed veterinarian. orally with the larger capsules admin- [73 FR 6607, Feb. 5, 2008] istered at a dosage level of 1 capsule per 20 pounds of body weight to a max- § 520.2123b Spectinomycin powder. imum of 5 capsules with the dosage re- (a) Specifications. Each gram (g) of peated at 3 day intervals until a satis- powder contains spectinomycin factory therapeutic response is ob- dihydrochloride pentahydrate equiva- served. A maintenance dosage is then lent to 0.5 g spectinomycin. administered consisting of 1 capsule (b) Sponsor. See No. 061623 in per 40 pounds of body weight, with a § 510.600(c) of this chapter. minimum of 1 capsule per 40 pounds of (c) Related tolerances. See § 556.600 of body weight, with a minimum of 1 cap- this chapter. sule, given every 3 days, or 7 days, or (d) Conditions of use in chickens. It is longer, as required to maintain im- administered in the drinking water of provement or an asymptomatic condi- growing chickens as follows: tion. For dogs under 20 pounds of body (1) Indications for use and amounts—(i) weight, the small capsules are adminis- For increased rate of weight gain and tered orally at a dosage level of 1 per 5 improved feed efficiency in broiler chickens, administer 0.5 g per gallon of pounds of body weight with a minimum water as the only source of drinking of 1 capsule which dosage is repeated at water for the first 3 days of life and for 3 day intervals until a satisfactory re- 1 day following each vaccination. sponse is observed then a maintenance (ii) As an aid in controlling infec- regimen is initiated with 1 capsule per tious synovitis due to Mycoplasma 10 pounds of body weight, minimum of synoviae in broiler chickens, admin- 1 capsule, every 3 days, or 7 days, or ister 1 g per gallon of water as the only longer as required to maintain contin- source of drinking water for the first 3 ued improvement or an asymptomatic to 5 days of life. condition. (iii) As an aid in the prevention or (3) Federal law restricts this drug to control of losses due to CRD associated use by or on the order of a licensed vet- with M. gallisepticum (PPLO) in grow- erinarian. ing chickens, administer 2 g per gallon of water as the only source of drinking [40 FR 13838, Mar. 27, 1975, as amended at 52 water for the first 3 days of life and for FR 7832, Mar. 13, 1987; 52 FR 9756, Mar. 26, 1 day following each vaccination. 1987] (2) Limitations. Do not administer to § 520.2123 Spectinomycin oral dosage laying chickens. Do not administer forms. within 5 days of slaughter. [73 FR 6607, Feb. 5, 2008] § 520.2123a Spectinomycin tablets. (a) Specifications. Each tablet con- § 520.2123c Spectinomycin solution. tains spectinomycin dihydrochloride (a) Specifications. Each milliliter of pentahydrate equivalent to 100 milli- solution contains spectinomycin grams (mg) spectinomycin. dihydrochloride pentahydrate equiva- (b) Sponsor. See No. 061623 in lent to 50 milligrams (mg) § 510.600(c) of this chapter. spectinomycin. (c) Conditions of use in dogs—(1) (b) Sponsors. See Nos. 000856, 000859, Amount. Administer orally to provide and 061623 in § 510.600(c) of this chapter. 10 mg per pound (lb) of body weight (c) Related tolerances. See § 556.600 of this chapter. twice daily. Dosage may be continued (d) Conditions of use in swine—(1) for 4 consecutive days. Amount. Administer 5 mg per pound (lb) (2) Indications for use. For the treat- of body weight orally twice daily for 3 ment of infectious diarrhea and to 5 days. gastroenteritis caused by organisms (2) Indications for use. For the treat- susceptible to spectinomycin. ment and control of porcine enteric

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colibacillosis (scours) caused by E. coli spinosad and 0.2 mg/lb (0.5 mg/kg) of susceptible to spectinomycin in pigs body weight milbemycin oxime. under 4 weeks of age. (2) Indications for use. To kill fleas; (3) Limitations. Do not administer to for the prevention and treatment of pigs over 15 lb body weight or over 4 flea infestations (Ctenocephalides felis); weeks of age. Do not administer within for the prevention of heartworm dis- 21 days of slaughter. ease (Dirofilaria immitis); and for the treatment and control of adult [73 FR 6607, Feb. 5, 2008] hookworm (Ancylostoma caninum), adult roundworm (Toxocara canis and § 520.2130 Spinosad. Toxascaris leonina), and adult (a) Specifications. Each chewable tab- whipworm (Trichuris vulpis) infections let contains 90, 140, 270, 560, 810, or 1620 in dogs and puppies 8 weeks of age or milligrams (mg) spinosad. older and 5 lbs of body weight or great- (b) Sponsor. See No. 000986 in § 510.600 er. of this chapter. (3) Limitations. Federal law restricts (c) Special considerations. Federal law this drug to use by or on the order of a restricts this drug to use by or on the licensed veterinarian. order of a licensed veterinarian. [76 FR 12563, Mar. 8, 2011] (d) Conditions of use—(1) Dogs—(i) Amount. Administer tablets once a § 520.2150 Stanozolol oral dosage month at a recommended minimum forms. dosage of 13.5 mg per pound (30 mg per kilogram) of body weight. § 520.2150a Stanozolol tablets. (ii) Indications for use. To kill fleas (a) Specifications. Each tablet con- and for the prevention and treatment tains 2 milligrams of stanozolol. of flea infestations (Ctenocephalides (b) Sponsor. No. 000009 in § 510.600(c) of felis) for 1 month on dogs and puppies this chapter. 14 weeks of age and older and 3.3 (c) Conditions of use. (1) Used as an pounds of body weight or greater. anabolic steroid treatment in dogs and (2) Cats—(i) Amount. Administer tab- cats. lets once a month at a minimum dos- (2) Administered orally to cats and age of 22.5 mg per pound (50 mg per small breeds of dogs, 1⁄2 to 1 tablet kilogram) of body weight. twice daily for several weeks; to large (ii) Indications for use. To kill fleas breeds of dogs, 1 to 2 tablets twice and for the prevention and treatment daily for several weeks. The tablets of flea infestations (C. felis) for 1 month may be crushed and administered in on cats and kittens 14 weeks of age and feed. older and 2 pounds of body weight or (3) Federal law restricts this drug to greater. use by or on the order of a licensed vet- erinarian. [77 FR 60623, Oct. 4, 2012] [40 FR 46101, Oct. 6, 1975, as amended at 42 FR § 520.2134 Spinosad and milbemycin. 36995, July 19, 1977. Redesignated at 50 FR 38114, Sept. 20, 1985, and amended at 55 FR (a) Specifications. Each chewable tab- 23076, June 6, 1990] let contains 140 milligrams (mg) spinosad and 2.3 mg milbemycin oxime, § 520.2150b Stanozolol chewable tab- 270 mg spinosad and 4.5 mg milbemycin lets. oxime, 560 mg spinosad and 9.3 mg (a) Specifications. Each chewable tab- milbemycin oxime, 810 mg spinosad let contains 2 milligrams of stanozolol. and 13.5 mg milbemycin oxime, or 1,620 (b) Sponsor. No. 000009 in § 510.600(c) of mg spinosad and 27 mg milbemycin this chapter. oxime. (c) Conditions of use. (1) Used as an (b) Sponsor. See No. 000986 in § 510.600 anabolic steroid treatment in dogs. of this chapter. (2) Administered orally to small (c) Conditions of use in dogs—(1) breeds of dogs, 1⁄2 to 1 tablet twice daily Amount. Administer once a month at a for several weeks; to large breeds of minimum dosage of 13.5 mg/pound (lb) dogs, 1 to 2 tablets twice daily for sev- (30 mg/kilogram (kg)) of body weight eral weeks.

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(3) Federal law restricts this drug to § 520.2158b Dihydrostreptomycin tab- use by or on the order of a licensed vet- lets. erinarian. (a) Specifications. Each tablet con- [50 FR 38114, Sept. 20, 1985, as amended at 55 tains 37.5 milligrams dihydrostrepto- FR 23076, June 6, 1990] mycin (as the sulfate) with 375 milli- grams chlorhexidine dihydrochloride. § 520.2158 Streptomycin/dihydro- (b) Sponsor. See No. 000856 in streptomycin oral dosage forms. § 510.600(c) of this chapter. (c) Related tolerances. See §§ 556.120 § 520.2158a Streptomycin sulfate oral and 556.200 of this chapter. solution. (d) Conditions of use. Calves—(1) (a) Specifications. Solution containing Amount. 150 milligrams of dihydro- 25 percent streptomycin sulfate. streptomycin and 1.5 grams of (b) Sponsor. See Nos. 033008 and 055462 chlorhexidine dihydrochloride per 100 in § 510.600(c) of this chapter. pounds of body weight per day. (c) Related tolerances. See § 556.610 of (2) Indications for use. Treatment of this chapter. bacterial scours in calves. (d) Conditions of use. Use in drinking (3) Limitations. Administer orally water as follows: once a day for 5 days; withdraw 3 days (1) Calves and swine—(i) Amount. 10 to before slaughter. 15 milligrams per pound (mg/pound) of [57 FR 37327, Aug. 18, 1992; 57 FR 42623, Sept. body weight (1.0 to 1.5 grams per gal- 15, 1992] lon). (ii) Indications for use. Treatment of § 520.2158c Dihydrostreptomycin oral suspension. bacterial enteritis caused by Esch- erichia coli and Salmonella spp. suscep- (a) Specifications. Each milliliter con- tible to streptomycin. tains 1.25 milligrams dihydrostrepto- (iii) Limitations. Calves: Do not ad- mycin (as the sulfate) with 12.5 milli- minister for more than 5 days. Swine: grams chlorhexidine dihydrochloride. Do not administer for more than 4 (b) Sponsor. See No. 000856 in days. Prepare fresh solution daily. § 510.600(c) of this chapter. Calves: Withdraw 2 days before slaugh- (c) Related tolerances. See §§ 556.120 ter. As sole source of streptomycin. and 556.200 of this chapter. Warning: Certain strains of bacteria (d) Conditions of use. Calves—(1) may develop a tolerance for strepto- Amount. 150 milligrams of dihydro- mycin. Consult a veterinarian or ani- streptomycin and 1.5 grams of mal pathologist for diagnosis. chlorhexidine dihydrochloride per 100 (2) Chickens—(i) Amount. 10 to 15 mg/ pounds of body weight per day. pound of body weight (0.6 to 0.9 grams (2) Indications for use. Treatment of per gallon). bacterial scours in calves. (3) Limitations. Administer orally (ii) Indications for use. Treatment of once a day for 5 days; withdraw 3 days nonspecific infectious enteritis caused before slaughter. by organisms susceptible to strepto- mycin. [57 FR 37327, Aug. 18, 1992] (iii) Limitations. Chickens: Do not ad- minister for more than 5 days. With- § 520.2160 Styrylpyridinium, diethylcarbamazine oral dosage draw 4 days before slaughter. Do not forms. administer to chickens producing eggs for human consumption. Prepare fresh § 520.2170 Sulfabromomethazine so- solution daily. As sole source of strep- dium boluses. tomycin. Warning: Certain strains of (a) Specifications. Each bolus contains bacteria may develop a tolerance for 15 grams of sulfabromomethazine so- streptomycin. Consult a veterinarian dium. or animal pathologist for diagnosis. (b) Related tolerance. See § 556.620 of [57 FR 37327, Aug. 18, 1992, as amended at 58 this chapter. FR 47211, Sept. 8, 1993; 63 FR 51821, Sept. 29, (c) Sponsor. See No. 050604 in 1998] § 510.600(c) of this chapter.

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(d) NAS/NRC status. These conditions § 520.2200 Sulfachlorpyridazine. of use are NAS/NRC reviewed and found effective. NADA’s for these uses need (a) Specifications.—(1) Sodium not include effectiveness data as speci- sulfachlorpyridazine powder. fied by § 514.111 of this chapter, but (2) Each bolus contains 2 grams may require bioequivalency and safety sulfachlorpyridazine. information. (3) Each tablet contains 250 milli- (e) Conditions of use. Cattle—(1) grams (mg) sulfachlorpyridazine. Amount. 90 milligrams per pound body (b) Sponsor. See No. 000010 in weight. § 510.600(c) of this chapter. (2) Indications for use. Treatment of (c) Related tolerances. See § 556.630 of necrotic pododermatitis (foot rot) and this chapter. calf diphtheria caused by Fusobacterium (d) Conditions of use. It is used as fol- necrophorum; colibacillosis (scours) lows: caused by Escherichia coli; bacterial (1) Calves—(i) Amount. Administer 30 pneumonia and bovine respiratory dis- to 45 mg sulfachlorpyridazine powder ease complex (shipping fever complex) per pound (/lb) of body weight per day associated with Pasteurella spp.; acute metritis and acute mastitis caused by in milk or milk replacer, or in a bolus, Streptococcus spp. in divided doses twice daily for 1 to 5 (3) Limitations. Administer orally; re- days. peat in 48 hours if necessary; milk (ii) Indications for use. For the treat- taken from animals within 96 hours (8 ment of diarrhea caused or complicated milkings) of latest treatment must not by Escherichia coli (colibacillosis). be used for food; do not administer (iii) Limitations. Treated ruminating within 18 days of slaughter; dis- calves must not be slaughtered for food continue use if hematuria, crystalluria during treatment or for 7 days after or severe depression are noticed; if the last treatment. A withdrawal pe- signs persist after 2 or 3 days consult a riod has not been established for this veterinarian. product in preruminating calves. Do [47 FR 30243, July 13, 1982, as amended at 62 not use in calves to be processed for FR 63270, Nov. 28, 1997] veal. (2) Swine—(i) Amount. Administer 20 § 520.2184 Sodium sulfachloropyrazine to 35 mg/lb body weight per day, in di- monohydrate. vided doses twice daily for 1 to 5 days: (a) Chemical name. 2-Sulfamido-6- (A) In drinking water or chloroxyrazine, sodium. (B) For individual treatment, in an (b) Sponsor. See Nos. 053501 in oral suspension containing 50 mg per § 510.600(c) of this chapter. milliliter. (c) Related tolerances. See § 556.625 of (ii) Indications for use. For the treat- this chapter. ment of diarrhea caused or complicated (d) Conditions of use. It is used in the by E. coli (colibacillosis). drinking water of broilers, breeder flocks, and replacement chickens as (iii) Limitations. Treated swine must follows: not be slaughtered for food during (1) Amount. 0.03 percent. treatment or for 4 days after the last (2) Indications for use. Treatment of treatment. coccidiosis. (3) Dogs—(i) Amount. Administer tab- (3) Limitations. Administer in drink- lets orally at 500 mg per 10 to 15 lb of ing water for 3 days as sole source of body weight daily, in two or three di- drinking water and sulfonamide medi- vided doses. cation; withdraw 4 days prior to (ii) Indications for use. As an aid in slaughter; not to be administered to the treatment of infectious chickens producing eggs for human tracheobronchitis and infections consumption. caused by E. coli, and in the treatment [40 FR 13838, Mar. 27, 1975, as amended at 50 of infections caused by other Gram- FR 41489, Oct. 11, 1985; 54 FR 12188, Mar. 24, positive and Gram-negative organisms 1989; 55 FR 8460, Mar. 8, 1990; 64 FR 15684, Apr. that are susceptible to sulfonamide 1, 1999; 67 FR 78355, Dec. 24, 2002] therapy.

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(iii) Limitations. Federal law restricts solution) for 2 to 3 days. If disease re- this drug to use only by or on the order curs, repeat treatment. of a licensed veterinarian. (ii) Limitations. Make fresh solution [75 FR 10166, Mar. 5, 2010] daily. Do not treat chickens within 14 days of slaughter for food. Do not § 520.2215 Sulfadiazine/pyrimethamine medicate chickens producing eggs for suspension. human consumption. (a) Specifications. Each milliliter (2) Turkeys—(i) Amounts and indica- (mL) of suspension contains 250 milli- tions for use—(A) As an aid in the con- grams (mg) sulfadiazine (as the sodium trol of coccidiosis caused by Eimeria salt) and 12.5 mg pyrimethamine. meleagrimitis and E. adenoeides suscep- (b) Sponsor. See No. 055246 in tible to sulfamerazine, sulfamethazine, § 510.600(c) of this chapter. and sulfaquinoxaline: provide medi- (c) Conditions of use in horses—(1) cated water (0.25 percent solution) for 2 Amount. Administer orally 20 mg sulfa- days, then plain water for 3 days, then diazine per kilogram (kg) body weight medicated water (0.25 percent solution) and 1 mg/kg pyrimethamine daily. for 2 days, then plain water for 3 days, (2) Indications for use. For the treat- then medicated water (0.25 percent so- ment of equine protozoal lution) for 2 days. Repeat if necessary. myeloencephalitis (EPM) caused by Do not change litter. Sarcocystis neurona. (B) As an aid in the control of acute (3) Limitations. Do not use in horses fowl cholera caused by Pasteurella intended for human consumption. Fed- multocida susceptible to sulfamerazine, eral law restricts this drug to use by or sulfamethazine, and sulfaquinoxaline: on the order of a licensed veterinarian. provide medicated water (0.4 percent [69 FR 70054, Dec. 2, 2004, as amended at 73 solution) for 2 to 3 days. If disease re- FR 53686, Sept. 17, 2008; 75 FR 69586, Nov. 15, curs, repeat treatment. 2010] (ii) Limitations. Make fresh solution daily. Do not treat turkeys within 14 § 520.2218 Sulfamerazine, days of slaughter for food. Do not sulfamethazine, and medicate turkeys producing eggs for sulfaquinoxaline powder. human consumption. (a) Specifications. Each 195-gram (g) packet of powder contains 78 g sulfa- [71 FR 13001, Mar. 14, 2006] merazine, 78 g sulfamethazine, and 39 g § 520.2220 Sulfadimethoxine oral dos- sulfaquinoxaline. age forms. (b) Sponsor. See No. 046573 in § 510.600(c) of this chapter. § 520.2220a Sulfadimethoxine oral so- (c) Related tolerances. See §§ 556.670 lution and soluble powder. and 556.685 of this chapter. (a) Approvals. (1) For oral solution (d) Conditions of use—(1) Chickens—(i) containing 12.5 percent (3.75 grams per Amounts and indications for use—(A) As ounce) sulfadimethoxine, see Nos. an aid in the control of coccidiosis 000069, 000859, 054628, 054925, and 057561 caused by Eimeria tenella and E. necatrix susceptible to sulfamerazine, in § 510.600(c). sulfamethazine, and sulfaquinoxaline: (2) For soluble powder, each 107 provide medicated water (0.4 percent grams contain the equivalent of 94.6 solution) for 2 to 3 days, then plain grams of sulfadimethoxine (as the so- water for 3 days, then medicated water dium salt); see Nos. 000069, 054925, (0.25 percent solution) for 2 days. If 057561, 058829, 061623, and 066104 in bloody droppings appear, repeat at 0.25 § 510.600(c) of this chapter. percent level for 2 more days. Do not (b) Special considerations. Federal law change litter. prohibits the extralabel use of this (B) As an aid in the control of acute product in lactating dairy cattle. fowl cholera caused by Pasteurella (c) Related tolerances. See § 556.640 of multocida susceptible to sulfamerazine, this chapter. sulfamethazine, and sulfaquinoxaline: (d) Conditions of use. The oral solu- provide medicated water (0.4 percent tion is administered as a cattle drench

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or diluted as directed to prepare drink- preruminating calves. Do not use in ing water. The powder is used to pre- calves to be processed for veal. pare a drench or drinking water. The [40 FR 13838, Mar. 27, 1975, as amended at 58 concentrations and uses of the various FR 6092, Jan. 26, 1993; 59 FR 56000, Nov. 10, solutions are as follows: 1994; 61 FR 4875, Feb. 9, 1996; 62 FR 8371, Feb. (1) Broiler and replacement chickens 25, 1997; 62 FR 23357, Apr. 30, 1997; 62 FR 35076, only—(i) Amount. 1.875 (0.05 percent) June 30, 1997; 62 FR 40932, July 31, 1997; 63 FR grams per gallon. 59714, Nov. 5, 1998; 64 FR 18572, Apr. 15, 1999; (ii) Indications for use. Treatment of 70 FR 73137, Dec. 9, 2005; 71 FR 13542, Mar. 16, disease outbreaks of coccidiosis, fowl 2006; 74 FR 60156, Nov. 20, 2009; 76 FR 17337, Mar. 29, 2011; 77 FR 56770, Sept. 14, 2012; 78 FR cholera, and infectious coryza. 17596, Mar. 22, 2013; 78 FR 21060, Apr. 9, 2013] (iii) Limitations. Administer for 6 con- secutive days; do not administer to § 520.2220b Sulfadimethoxine tablets chickens over 16 weeks of age; as sole and boluses. source of drinking water and sul- (a) Sponsors. Approval to firms iden- fonamide medication; as tified in § 510.600(c) of this chapter as sulfadimethoxine solution or follows: sulfadimethoxine soluble sodium salt; (1) To 000069, approval for use as in withdraw 5 days before slaughter. paragraphs (d)(1), (d)(2), and (d)(3) of (2) Meat-producing turkeys only—(i) this section. Amount. 0.938 (0.025 percent) grams per (2) To 000061, approval for use as in gallon. paragraph (d)(2). (ii) Indications for use. Treatment of (b) Related tolerances. See § 556.640 of disease outbreaks of coccidiosis and this chapter. fowl cholera. (c) [Reserved] (iii) Limitations. Administer for 6 con- (d) Conditions of use—(1) Cattle—(i) secutive days; do not administer to Amount. Administer 2.5 grams per 100 turkeys over 24 weeks of age; as sole pounds body weight for 1 day followed source of drinking water and sul- by 1.25 grams per 100 pounds body fonamide medication; as weight per day; treat for 4 to 5 days. sulfadimethoxine solution or (ii) Indications for use. For the treat- sulfadimethoxine soluble sodium salt; ment of shipping fever complex and withdraw 5 days before slaughter. bacterial pneumonia associated with (3) Dairy calves, dairy heifers, and beef Pasteurella spp. sensitive to cattle only—(i) Amount. 1.18 to 2.36 (0.031 sulfadimethoxine; and calf diphtheria to 0.062 percent) grams per gallon. and foot rot associated with (ii) Indications for use. For the treat- Fusobacterium necrophorum sensitive to ment of shipping fever complex and sulfadimethoxine. bacterial pneumonia associated with (iii) Limitations. Do not administer Pasteurella spp. sensitive to within 7 days of slaughter; milk that sulfadimethoxine; and calf diphtheria has been taken from animals during and foot rot associated with treatment and 60 hours (5 milkings) Fusobacterium necrophorum after the latest treatment must not be (Sphaerophorus necrophorus) sensitive used for food. A withdrawal period has to sulfadimethoxine. not been established for this product in (iii) Administer 2.5 grams per 100 preruminating calves. Do not use in pounds of body weight for first day, calves to be processed for veal. then 1.25 grams per 100 pounds of body (2) Dogs and cats—(i) Amount. Admin- weight per day for the next 4 consecu- ister 25 milligrams per pound of body tive days; in drinking water or drench; weight on the first day followed by 12.5 available as a sulfadimethoxine soluble milligrams per pound of body weight powder or a 12.5 percent per day until the animal is free of sulfadimethoxine sodium solution (3.75 symptoms for 48 hours. grams sulfadimethoxine per fluid (ii) Indications for use. Treatment of ounce); if no improvement within 2 to 3 sulfadimethoxine-susceptible bacterial days, reevaluate diagnosis; do not treat infections. beyond 5 days; withdraw 7 days before (iii) Limitations. Federal law restricts slaughter. A withdrawal period has not this drug to use by or on the order of a been established for this product in licensed veterinarian.

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(3) Beef cattle and nonlactating dairy § 520.2220d Sulfadimethoxine- cattle—(i) Amount. Administer one 12.5- ormetoprim tablets. gram-sustained-release bolus for the (a) Specifications. Each tablet con- nearest 200 pounds of body weight, i.e., tains 120 milligrams (100 milligrams of 62.5 milligrams per pound of body sulfadimethoxine and 20 milligrams of weight. Do not repeat treatment for 7 ormetoprim), 240 milligrams (200 milli- days. grams of sulfadimethoxine and 40 milli- (ii) Indications for use. Treatment of grams of ormetoprim), 600 milligrams shipping fever complex and bacterial (500 milligrams of sulfadimethoxine pneumonia associated with organisms and 100 milligrams of ormetoprim), or such as Pasteurella spp. sensitive to 1200 milligrams (1,000 milligrams of sulfadimethoxine; calf diphtheria and sulfadimethoxine and 200 milligrams of foot rot associated with Fusobacterium ormetoprim). necrophorum sensitive to (b) Sponsor. See No. 000069 in sulfadimethoxine. § 510.600(c) of this chapter. (iii) Limitations. Do not use in female (c) Conditions of use—(1) Amount. On dairy cattle 20 months of age or older. the first day of treatment, administer Do not administer within 12 days of 25 milligrams per pound (55 milligrams slaughter. Federal law restricts this per kilogram) of body weight. Then fol- drug to use by or on the order of a li- low with a daily dosage of 12.5 milli- censed veterinarian. grams per pound (27.5 milligrams per kilogram) of body weight. [40 FR 13838, Mar. 27, 1975, as amended at 40 (2) Indications of use. Treatment of FR 43488, Sept. 22, 1975; 49 FR 36830, Sept. 20, 1984; 59 FR 56000, Nov. 10, 1994; 61 FR 4875, skin and soft tissue infections (wounds Feb. 9, 1996; 62 FR 61625, Nov. 19, 1997; 64 FR and abscesses) in dogs caused by 15684, Apr. 1, 1999; 70 FR 16934, Apr. 4, 2005; 76 strains of Staphylococcus aureus and FR 17337, Mar. 29, 2011] Escherichia coli and urinary tract infec- tions caused by Escherichia coli, § 520.2220c Sulfadimethoxine oral sus- Staphlococcus spp., and Proteus mirabilus pension. susceptible to ormetoprim-potentiated (a) Chemical name. N′-(2,6-Dimethoxy- sulfadimethoxine. 4-pyrimidinyl) sulfanilamide. (3) Limitations. Continue treatment (b) Specifications. Each milliliter of until patient is asymptomatic for 48 the drug contains 50 milligrams of hours, but do not exceed a total of 21 sulfadimethoxine. consecutive days. Maintain adequate water intake during the treatment pe- (c) Sponsor. See Nos. 000061 and 000069 riod. Safety in breeding animals has in § 510.600(c) of this chapter. not been established. Federal law re- (1) It is intended for use in the treat- stricts this drug to use by or on the ment of sulfonamide susceptible bac- order of a licensed veterinarian. terial infections in dogs and cats and enteritis associated with coccidiosis in [54 FR 48593, Nov. 24, 1989, as amended at 59 dogs. FR 56000, Nov. 10, 1994; 61 FR 4875, Feb. 9, 1996; 61 FR 46719, Sept. 5, 1996] (2) On the first day of treatment ad- minister an oral dose of 25 milligrams § 520.2240 Sulfaethoxypyridazine. per pound of body weight, then follow with a daily dosage of 12.5 milligrams § 520.2240a Sulfaethoxypyridazine per pound of body weight. Length of drinking water. treatment will depend upon clinical re- (a) Chemical name. N′-(6-Ethoxy-3- sponse. Continue treatment until pa- pyridazinyl) sulfanilamide. tient is asymptomatic for 48 hours. (b) Specifications. Melting point range Maintain adequate water intake during of 180 °C. to 186 °C. the treatment period. (c) Sponsor. See No. 053501 in (3) For use only by or on the order of § 510.600(c) of this chapter. a licensed veterinarian. (d) Related tolerances. See § 556.650 of [40 FR 13838, Mar. 27, 1975, as amended at 59 this chapter. FR 56000, Nov. 10, 1994; 61 FR 4875, Feb. 9, (e) Conditions of use. It is used as fol- 1996; 62 FR 61625, Nov. 19, 1997] lows:

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(1) Swine—(i) Amount. 1.9 to 3.8 grams 72 hours (6 milkings) after the latest per gallon (0.05 percent to 0.1 percent). treatment must not be used for food; (ii) Indications for use. Treatment of for use only by or on the order of a li- bacterial scours pneumonia enteritis, censed veterinarian. bronchitis, septicemia accompanying (2) Amount. 15-gram controlled re- Salmonella cholerasuis infection. lease tablets. (iii) Limitations. Administer 3.8 grams (i) Indications for use. Treatment of per gallon for first day followed by 1.9 foot rot and respiratory infections grams per gallon for not less than 3 (shipping fever and pneumonia) caused days nor more than 9 days as sodium by sulfonamide-susceptible pathogens sulfaethoxypyridazine; do not treat (E. coli, streptococci, staphylococci, within 10 days of slaughter; as sole Sphaerophorus necrophorus and Gram- source of sulfonamide; for use by or on negative rods including Pasteurella); for the order of a licensed veterinarian. use prophylactically in cattle during (2) Cattle—(i) Amount. 2.5 grams per periods of stress for reducing losses due gallon (0.066 percent). to sulfonamide sensitive disease condi- (ii) Indications for use. Treatment of tions. respiratory infections (pneumonia, (ii) Limitations. Administer 100 milli- shipping fever), foot rot, calf scours; as grams per pound of body weight; do not adjunctive therapy in septicemia ac- treat within 16 days of slaughter; as companying mastitis and metritis. sole source of sulfonamide; not for use (iii) Limitations. Administer at the in lactating dairy cows; Federal law re- rate of 1 gallon per 100 pounds of body stricts this drug to use by or on the weight per day for 4 days; as sodium order of a licensed veterinarian. sulfaethoxypyridazine; do not treat within 16 days of slaughter; as sole [40 FR 13838, Mar. 27, 1975, as amended at 67 source of sulfonamide; for use by or on FR 78355, Dec. 24, 2002] the order of a licensed veterinarian; milk that has been taken from animals § 520.2260 Sulfamethazine oral dosage during treatment and for 72 hours (6 forms. milkings) after latest treatment must § 520.2260a Sulfamethazine oblet, tab- not be used for food. let, and bolus. [40 FR 13838, Mar. 27, 1975, as amended at 67 (a)(1) Sponsor. See No. 000010 in FR 78355, Dec. 24, 2002] § 510.600(c) of this chapter for use of 2.5- § 520.2240b Sulfaethoxypyridazine tab- , 5-, and 15-gram sulfamethazine oblet lets. in beef cattle, nonlactating dairy cat- tle, and horses. See No. 061690 in (a) Chemical name. N′-(6-Ethoxy-3- § 510.600(c) of this chapter for use of 5- pyridazinyl) sulfanilamide. , 15-, and 25-gram tablet in beef and (b) Specifications. Melting point range nonlactating dairy cattle. of 180 °C to 186 °C. (c) Sponsor. See No. 053501 in (2) Related tolerance in edible products. § 510.600(c) of this chapter. See § 556.670 of this chapter. (d) Related tolerances. See § 556.650 of (3) Conditions of use—(i) Amount. Ad- this chapter. minister as a single dose 100 milligrams (e) Conditions of use. It is used for cat- of sulfamethazine per pound of body tle as follows: weight the first day and 50 milligrams (1) Amount. 2.5 or 15 grams per tablet. per pound of body weight on each fol- (i) Indications for use. Treatment of lowing day. respiratory infections (pneumonia, (ii) Indications for use. For treatment shipping fever), foot rot, calf scours; as of diseases caused by organisms suscep- adjunctive therapy in septicemia ac- tible to sulfamethazine. companying mastitis and metritis. (A) Beef cattle and nonlactating dairy (ii) Limitations. Administer 25 milli- cattle. Treatment of bacterial pneu- grams per pound of animal weight per monia and bovine respiratory disease day for 4 days; do not treat within 16 complex (shipping fever complex) days of slaughter; as sole source of sul- (Pasteurella spp.), colibacillosis (bac- fonamide; milk that has been taken terial scours) (Escherichia coli), necrotic from animals during treatment and for pododermatitis (foot rot)

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(Fusobacterium necrophorum), calf diph- months of age or older; such use may theria (Fusobacterium necrophorum), cause drug residues in milk. Admin- acute mastitis (Streptococcus spp.), ister with adequate supervision. Fol- acute metritis (Streptococcus spp.), coc- lows recomended dosages carefully. cidiosis (Eimeria bovis and Eimeria Fluid intake must be adequate. If zurnii). symptoms persist after 2 or 3 days, con- (B) Horses. Treatment of bacterial sult a veterinarian. pneumonia (secondary infections asso- [54 FR 15751, Apr. 19, 1989; 54 FR 19283, May 4, ciated with Pasteurella spp.), strangles 1989, as amended at 56 FR 50653, Oct. 8, 1991; (Streptococcus equi), and bacterial en- 59 FR 22754, May 3, 1994; 61 FR 4875, Feb. 9, teritis (Escherichia coli). 1996; 64 FR 66383, Nov. 26, 1999; 67 FR 78355, (iii) Limitations. Administer daily Dec. 24, 2002; 75 FR 10166, Mar. 5, 2010; 76 FR until animal’s temperature and appear- 17337, Mar. 29, 2011] ance are normal. If symptoms persist after using for 2 or 3 days consult a § 520.2260b Sulfamethazine sustained- veterinarian. Fluid intake must be ade- release boluses. quate. Treatment should continue 24 to (a)(1) Sponsor. See No. 000859 in 48 hours beyond the remission of dis- § 510.600(c) of this chapter for use of a ease symptoms, but not to exceed 5 22.5-gram sulfamethazine prolonged-re- consecutive days. Follow dosages care- lease bolus. fully. Do not treat cattle within 10 (2) Conditions of use—(i) Amount. De- days of slaughter. Do not use in female pending on the duration of therapeutic dairy cattle 20 months of age or older. levels desired, administer boluses as a Use of sulfamethazine in this class of single dose as follows: 31⁄2 days—1 bolus cattle may cause milk residues. A (22.5 grams) per 200 pounds of body withdrawal period has not been estab- weight; 5 days—1 bolus per 100 pounds lished in preruminating calves. Do not of body weight. use in calves to be processed for veal. (ii) Indications for use. Beef and non- Do not use in horses intended for lactating cattle for sustained treat- human consumption. ment of shipping fever pneumonia (b)(1) Sponsor. See No. 053501 in caused or complicated by Pasteurella § 510.600(c) of this chapter for use of 5- multocida; as an aid in the treatment of gram sulfamethazine bolus. foot rot, mastitis, pneumonia, metritis, (2) Related tolerances in edible prod- bacterial enteritis, calf diphtheria, and ucts. See § 556.670 of this chapter. septicemia when caused or complicated (3) Conditions of use—(i) Amount. Ad- by bacteria susceptible to minister 10 grams (2 boluses) of sulfamethazine. sulfamethazine per 100 pounds of body (iii) Limitations. Cattle that are weight the first day, then 5 grams (1 acutely ill should be treated bolus) of sulfamethazine per 100 pounds parenterally with a suitable anti- of body weight daily for up to 4 addi- bacterial product to obtain immediate tional consecutive days. therapeutic blood levels; do not slaugh- (ii) Indications for use. Ruminating ter animals for food within 16 days of beef and dairy calves. For treatment of treatment; do not use in lactating the following diseases caused by orga- dairy cattle; Federal law restricts this nisms susceptible to sulfamethazine: drug to use by or on the order of a li- bacterial scours (colibacilloosis) caused censed veterinarian. by E. coli; necrotic pododermatitis (foot (b)(1) Sponsor. See No. 053501 in rot) and calf diphtheria caused by F. § 510.600(c) of this chapter for use of a necrophorum; bacterial pneumonia asso- 27-gram sulfamethazine sustained-re- ciated with Pasteurella spp.; and coc- lease bolus. cidiosis caused by E. bovis and E. zurnii. (2) Conditions of use—(i) Amount. 27 (iii) Limitations. Do not administer grams (1 bolus) for each 150 pounds of for more than 5 consecutive days. Do body weight as a single dose. not treat calves within 11 days of (ii) Indications for use. For nonlac- slaughter. Do not use in calves to be tating cattle for the treatment of in- slaughtered under 1 month of age or in fections caused by organisms sensitive calves being fed an all milk diet. Do to sulfamethazine such as hemorrhagic not use in female dairy cattle 20 septicemia (shipping fever complex),

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bacterial pneumonia, foot rot, and calf (d)(1) Sponsor. See 000859 in § 510.600(c) diphtheria and as an aid in the control of this chapter for use of a 22.5-gram of bacterial diseases usually associated sulfamethazine sustained release bolus. with shipping and handling of cattle. (2) Conditions of use—(i) Amount. Ad- (iii) Limitations. If no response within minister 1 bolus (22.5 grams) per 200 2 to 3 days, reevaluate therapy; do not pounds of body weight, as a single dose. crush tablets; treated animals must (ii) Indications for use. Beef and non- not be slaughtered for food within 28 lactating dairy cattle for the prolonged days after the latest treatment; Fed- treatment of the following diseases eral law restricts this drug to use by or when caused by one or more of the list- on the order of a licensed veterinarian. (c)(1) Sponsor. See No. 061623 in ed pathogenic organisms sensitive to § 510.600(c) of this chapter for use of a sulfamethazine: bovine respiratory dis- 32.1-gram sustained-release bolus. ease complex (shipping fever complex) (2) Conditions of use—(i) Amount. 32.1 (Pasteurella spp.), bacterial pneumonia grams (1 bolus) per 200 pounds of body (Pasteurella spp.), necrotic weight.1 pododermatitis (foot rot) (ii) Indications for use. For beef and (Fusobacterium necrophorum), nonlactating dairy cattle for the treat- colibacillosis (bacterial scours) ment of diseases caused by (Escherichia coli), calf diphtheria sulfamethazine-sensitive organisms as (Fusobacterium necrophorum), acute follows: bacterial pneumonia and bo- mastitis (Streptococcus spp.) and acute vine respiratory disease complex (ship- metritis (Streptococcus spp.). ping fever complex) caused by (iii) Limitations. Cattle that are Pasteurella spp., colibacillosis (bac- acutely ill should be treated by injec- terial scours) caused by E. coli, necrotic tion with a suitable antibacterial prod- pododermatitis (foot rot) and calf diph- uct to obtain immediate therapeutic theria caused by Fusobacterium blood levels; do not slaughter animals necrophorum, and acute mastitis and for food within 16 days of treatment; do acute metritis caused by Streptococcus not use in lactating dairy cattle; if spp.)1 treated animals do not respond within (iii) Limitations. After 72 hours, all animals should be reexamined for per- 2 to 3 days, consult a veterinarian. sistence of observable disease signs. If (e)(1) Sponsor. See No. 061623 in signs are present, consult a veteri- § 510.600(c) of this chapter for use of an narian. It is strongly recommended 8.02-gram sulfamethazine sustained-re- that a second dose be given to provide lease bolus. for an additional 72 hours of therapy, (2) Conditions of use—(i) Amount. Ad- particularly in more severe cases. The minister 2 boluses (8.02 grams per dosage schedule should be used at each bolus) per 100 pounds of body weight, as 72-hour interval. Animals should not a single dose. receive more than 2 doses because of (ii) Indications for use. Administer the possibility of incurring residue vio- orally to ruminating calves for the pro- lations. This drug, like all longed treatment of the following dis- sulfonamides, may cause toxic reac- eases when caused by one or more of tions and irreparable injury unless ad- the listed pathogenic organisms sen- ministered with adequate and contin- sitive to sulfamethazine: bacterial uous supervision; follow dosages care- pneumonia (Pasteurella spp.), fully. Fluid intake must be adequate at colibacillosis (bacterial scours) (E. all times throughout the 3-day ther- coli), and calf diptheria (Fusobacterium apy, Do not use in lactating dairy cat- necrophorum). tle. Do not treat animals within 12 (iii) Limitations. For use in rumi- days of slaughter. nating replacement calves only; 72 hours after dosing all animals should 1 These conditions are NAS/NRC reviewed be reexamined for persistence of dis- and found effective. Applications for these uses need not inlcude effectiveness data as ease signs; if signs are present, consult specified by § 514.111 of this chapter, but may a veterinarian; do not slaughter ani- require bioequivalency and safety informa- mals for food for at least 12 days after tion. the last dose; this product has not been

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shown to be effective for nonrumi- ceptible to sulfamethazine: bacterial nating calves; exceeding two consecu- pneumonia associated with Pasteurella tive doses may cause violative tissue spp.; colibacillosis (bacterial scours) residue to remain beyond the with- caused by Escherichia coli; coccidiosis drawal time; do not use in calves under caused by Eimeria bovis and E. zurnii; 1 month of age or calves being fed an and calf diphtheria caused by all milk diet. Fusobacterium necrophorum. (f)(1) Sponsor. See No. 000859 in (iii) Limitations. Do not use in calves § 510.600(c) of this chapter for use of a to be slaughtered under 1 month of age 30-gram sulfamethazine sustained-re- or calves being fed an all milk diet. Do lease bolus. not use in female dairy cattle 20 (2) Conditions of use—(i) Amount. Ad- months of age or older. If symptoms minister at the rate of 1 bolus (30 grams per bolus) per 200 pounds of body persist after 3 days, consult a veteri- weight, as a single dose. narian. Do not administer more than 2 (ii) Indications for use. Administer consecutive doses. Do not slaughter orally to beef cattle and nonlactating animals for food for at least 8 days dairy cattle for the treatment of the after the last dose. Do not crush bolus. following diseases when caused by one [46 FR 36132, July 14, 1981, as amended at 48 or more of the listed pathogenic orga- FR 18803, Apr. 26, 1983; 48 FR 32760, July 19, nisms sensitive to sulfamethazine: bo- 1983; 49 FR 29057, July 18, 1984; 50 FR 49372, vine respiratory disease complex (ship- Dec. 2, 1985; 51 FR 30212, Aug. 25, 1986; 53 FR ping fever complex) associated with 40727, Oct. 18, 1988; 54 FR 14341, Apr. 11, 1989; Pasteurella spp.; bacterial pneumonia 55 FR 8462, Mar. 8, 1990; 56 FR 50653, Oct. 8, associated with Pasteurell spp.; necrotic 1991; 59 FR 22754, May 3, 1994; 61 FR 4875, Feb. pododermatitis (foot rot) and calf diph- 9, 1996; 62 FR 35076, June 30, 1997; 66 FR 14073, theria caused by Fusobacterium Mar. 9, 2001; 68 FR 4915, Jan. 31, 2003; 70 FR necrophorum; colibacillosis (bacterial 8290, Feb. 18, 2005; 78 FR 17596, Mar. 22, 2013] scours) caused by Escherichia coli; coc- cidiosis caused by Eimeria bovis and E. § 520.2260c Sulfamethazine sustained- release tablets. zurnii; acute mastitis and metritis caused by Streptococcus spp. (a) Sponsor. See No. 053501 in (iii) Limitations. For use in beef cattle § 510.600(c) of this chapter for use of an and nonlactating dairy cattle only; if 8-gram sulfamethazine sustained-re- symptoms persist for 2 or 3 days after lease tablet. use, consult a veterinarian; do not (b) Conditions of use—(1) Amount. 8 slaughter animals for food for at least grams (1 tablet) per 45 pounds of body 8 days after the last dose; do not use in weight as a single dose. lactating dairy cattle; do not admin- (2) Indications for use. In calves for ister more than two consecutive doses. sustained treatment of pneumonia (g) Related tolerances. See § 556.670 of caused by Pasteurella spp., this chapter. colibacillosis (bacterial scours) caused (h)(1) Sponsor. See No. 000010 in by Escherichia coli; and calf diptheria § 510.600(c) of this chapter for use of an caused by Fusobacterium necrophorum. 8.25-gram sulfamethazine sustained-re- lease bolus. (3) Limitations. If there is no response (2) Conditions of use—(i) Amount. Ad- within 2 to 3 days, reevaluate therapy. minister at the rate of 1 bolus (8.25 Do not crush tablets. Treated animals grams per bolus) per 50 pounds of body must not be slaughtered for food with- weight, as a single dose. If signs of dis- in 18 days after the latest treatment. ease are significantly reduced, it is rec- Federal law restricts this drug to use ommended that a second dose be given by or on the order of a licensed veteri- to provide an additional 72 hours of narian. therapy. [48 FR 26763, June 10, 1983, as amended at 56 (ii) Indications for use. Administer FR 50653, Oct. 8, 1991; 59 FR 22754, May 3, 1994; orally to ruminating beef and dairy 61 FR 4875, Feb. 9, 1996] calves for treatment of the following diseases when caused by one or more of the listed pathogenic organisms sus-

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§ 520.2261 Sulfamethazine sodium oral amount of medication to one-half for 4 dosage forms. additional days. (3) Limitations. Add the required dose § 520.2261a Sulfamethazine solution. to that amount of water that will be (a) Sponsors. See Nos. 000010 and consumed in 1 day. Consumption 061623 in § 510.600(c) of this chapter for should be carefully checked. Have only use of a 12.5-percent sulfamethazine so- medicated water available during dium solution. treatment. Withdraw medication from (b) Related tolerances in edible prod- cattle, chickens, and turkeys 10 days ucts. See § 556.670 of this chapter. prior to slaughter for food. Withdraw (c) Conditions of use—(1) Amount. Ad- medication from swine 15 days before minister in drinking water to provide: slaughter for food. Do not medicate Cattle and swine 112.5 milligrams of chickens or turkeys producing eggs for sulfamethazine sodium per pound of human consumption. Treatment of all body weight per day on the first day diseases should be instituted early. and 56.25 milligrams per pound of body Treatment should continue 24 to 48 weight on subsequent days; Chickens, hours beyond the remission of disease 61 to 89 milligrams of sulfamethazine symptoms, but not to exceed a total of sodium per pound of body weight per 5 consecutive days in cattle or swine. day, and turkeys 53 to 130 milligrams Medicated cattle, swine, chickens, and of sulfamethazine sodium per pound of turkeys must actually consume enough body weight per day, depending upon medicated water which provides the the dosage, age, and class of chickens recommended dosages. Do not use in fe- or turkeys, ambient temperature, and male dairy cattle 20 months of age or other factors. older. Use of sulfamethazine in this (2) Indications for use. For treatment class of cattle may cause milk resi- and control of diseases caused by orga- dues. A withdrawal period has not been nisms sensitive to sulfamethazine. established in preruminating calves. (i) Beef and nonlactating dairy cattle. Do not use in calves to be processed for Treatment of bacterial pneumonia and veal. bovine respiratory disease complex (d) NAS/NRC status. The conditions of (shipping fever complex) (Pasteurella use specified in this section have been spp.), colibacillosis (bacterial scours) reviewed by NAS/NRC and are found ef- (Escherichia coli), necrotic fective. Applications for these uses pododermatitis (foot rot) need not include effectiveness data as (Fusobacterium necrophorum), calf diph- specified by § 514.111 of this chapter, theria (Fusobacterium necrophorum), but may require bioequivalency and acute mastitis (Streptococcus spp.), and safety information. acute metritis (Streptococcus spp.). [47 FR 25322, June 11, 1982, as amended at 47 (ii) Swine. Treatment of porcine FR 25735, June 15, 1982; 67 FR 78355, Dec. 24, colibacillosis (bacterial scours) 2002; 70 FR 32489, June 3, 2005; 74 FR 36112, (Escherichia coli), and bacterial pneu- July 22, 2009; 75 FR 10166, Mar. 5, 2010; 76 FR monia (Pasteurella spp.). 17337, Mar. 29, 2011] (iii) Chickens and turkeys. In chickens for control of infectious coryza § 520.2261b Sulfamethazine powder. (Avibacterium paragallinarum), coccidi- (a) Specifications. A soluble powder osis (Eimeria tenella, Eimeria necatrix), composed of 100 percent sulfamethazine acute fowl cholera (Pasteurella sodium. multocida), and pullorum disease (b) Sponsors. See Nos. 000010 and (Salmonella pullorum). In turkeys for 061623 in § 510.600(c) of this chapter. control of coccidiosis (Eimeria (c) Related tolerances. See § 556.670 of meleagrimitis, Eimeria adenoeides). Medi- this chapter. cate as follows: Infectious coryza in (d) Conditions of use—(1) Chickens—(i) chickens, medicate for 2 consecutive Amount. Administer in drinking water days; acute fowl cholera and pullorum to provide 58 to 85 milligrams (mg) per disease, in chickens, medicate for 6 pound (/lb) of body weight per day. consecutive days; coccidiosis, in chick- (ii) Indications for use. For control of ens and turkeys, medicate as in para- infectious coryza (Haemophilus graph (c) of this section, then reduce gallinarum), coccidiosis (Eimeria tenella,

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E. necatrix), acute fowl cholera tuted early. Treatment should con- (Pasteurella multocida), and pullorum tinue 24 to 48 hours beyond the remis- disease (Salmonella pullorum). sion of disease symptoms, but not to (iii) Limitations. Add the required exceed a total of 5 consecutive days. dose to that amount of water that will Medicated swine must actually con- be consumed in 1 day. Consumption sume enough medicated water which should be carefully checked. Have only provides the recommended dosages. medicated water available during (4) Cattle—(i) Amount. Administer in treatment. Withdraw medication 10 drinking water, or as a drench, to pro- days prior to slaughter for food. Do not vide 108 mg/lb of body weight on the medicate chickens producing eggs for first day and 54 mg/lb of body weight human consumption. Treatment of all per day on the second, third, and fourth diseases should be instituted early. days of administration. Treatment should continue 24 to 48 (ii) Indications for use in beef and non- hours beyond the remission of disease lactating dairy cattle. Treatment of bac- symptoms. Medicated chickens must terial pneumonia and bovine res- actually consume enough medicated piratory disease complex (shipping water which provides the recommended fever complex) (Pasteurella spp.), dosages. colibacillosis (bacterial scours) (E. (2) Turkeys—(i) Amount. Administer coli), necrotic pododermatitis (foot rot) in drinking water to provide 50 to 124 (Fusobacterium necrophorum), calf diph- mg/lb of body weight per day theria (F. necrophorum), acute mastitis (ii) Indications for use. For control of (Streptococcus spp.), and acute metritis coccidiosis (E. meleagrimitis, E. (Streptococcus spp.) adenoeides). (iii) Limitations. Add the required (iii) Limitations. Add the required dose to that amount of water that will dose to that amount of water that will be consumed in 1 day. Consumption be consumed in 1 day. Consumption should be carefully checked. Have only should be carefully checked. Have only medicated water available during medicated water available during treatment. Withdraw medication 10 treatment. Withdraw medication 10 days prior to slaughter for food. Treat- days prior to slaughter for food. Do not ment of all diseases should be insti- medicate turkeys producing eggs for tuted early. Treatment should con- human consumption. Treatment of all tinue 24 to 48 hours beyond the remis- diseases should be instituted early. sion of disease symptoms, but not to Treatment should continue 24 to 48 exceed a total of 5 consecutive days. hours beyond the remission of disease Medicated cattle must actually con- symptoms. Medicated turkeys must ac- sume enough medicated water which tually consume enough medicated provides the recommended dosages. water which provides the recommended [71 FR 70303, Dec. 4, 2006, as amended at 75 dosages. FR 10166, Mar. 5, 2010] (3) Swine—(i) Amount. Administer in drinking water, or as a drench, to pro- § 520.2280 Sulfamethizole and methe- vide 108 mg/lb of body weight on the namine mandelate tablets. first day and 54 mg/lb of body weight (a) Specifications. Each tablet con- per day on the second, third, and fourth tains 250 milligrams of sulfamethizole days of administration. and 250 milligrams of methenamine (ii) Indications for use. For treatment mandelate. of porcine colibacillosis (bacterial (b) Sponsor. See No. 000856 in scours) (E. coli), and bacterial pneu- § 510.600(c) of this chapter. monia (Pasteurella spp.). (c) Conditions of use. (1) The drug is (iii) Limitations. Add the required indicated for the treatment of urinary dose to that amount of water that will tract infections in dogs and cats such be consumed in 1 day. Consumption as cystitis, nephritis, prostatitis, ure- should be carefully checked. Have only thritis, and pyelonephritis. It is also medicated water available during used as an aid in the management of treatment. Withdraw medication 15 complications resulting from surgical days prior to slaughter for food. Treat- manipulations of the urinary tract ment of all diseases should be insti- such as removal of calculi from the

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bladder, in ureterostomies, and in in- change litter unless absolutely nec- strumentation of the urethra and blad- essary. Do not give flushing mashes. der. (2) Turkeys. (i) As an aid in the con- (2) It is administered at a dosage trol of outbreaks of coccidiosis caused level of one tablet for each 20 pounds of by Eimeria meleagrimitis and E. body weight given three times per day. adenoeides. The drug should be given until all signs (ii) Administer at the 0.025 percent are alleviated. To reduce the possi- level for 2 days, skip 3 days, give for 2 bility of a relapse, it is suggested that days, skip 3 days and give for 2 more therapy be continued for a further pe- days. Repeat if necessary. Do not riod of a week to 10 days. change litter unless absolutely nec- (3) Federal law restricts this drug to essary. Do not give flushing mashes. use by or on the order of a licensed vet- (3) Chickens and turkeys. (i) As an aid erinarian. in the control of acute fowl cholera caused by Pasteurella multocida suscep- [40 FR 13838, Mar. 27, 1975, as amended at 50 tible to sulfaquinoxaline and fowl ty- FR 13561, Apr. 5, 1985] phoid caused by Salmonella gallinarum susceptible to sulfaquinoxaline. § 520.2325 Sulfaquinoxaline oral dos- age forms. (ii) Administer at the 0.04 percent level for 2 or 3 days. Move birds to § 520.2325a Sulfaquinoxaline drinking clean ground. If disease recurs, repeat water. treatment. If cholera has become es- tablished as the respiratory or chronic (a) Sponsor. See § 510.600(c) of this form, use feed medicated with chapter for identification of the spon- sulfaquinoxaline. Poultry which have sors. survived typhoid outbreaks should not (1) To No. 000859 for use of a 25-per- be kept for laying house replacements cent sulfaquinoxaline soluble powder or breeders unless tests show they are and a 20-percent sulfaquinoxaline so- not carriers. dium solution as provided for in para- (4) Cattle and calves. (i) For the con- graph (c) of this section. trol and treatment of outbreaks of coc- (2) To No. 061623 for use of 3.44- and cidiosis caused by Eimeria bovis or E. 12.85-percent sulfaquinoxaline sodium zurnii. solutions as provided for in paragraphs (ii) Administer at the 0.015-percent (c)(1), (c)(2), (c)(3), (c)(4)(i), and (c)(4)(ii) level for 3 to 5 days in drinking water of this section. medicated with sulfaquinoxaline solu- (3) To No. 046573 for use of a 31.92-per- tion. cent sulfaquinoxaline solution (sodium (iii) In lieu of treatment as provided and potassium salts) as provided for in in paragraph (e)(4)(ii) of this section, paragraphs (c)(1), (c)(2), (c)(3), (c)(4)(i), administer 1 teaspoon of 25-percent and (c)(4)(ii) of this section. sulfaquinoxaline soluble powder per (4) No. 053501 for use of a 28.62-percent day for each 125 pounds of body weight sulfaquinoxaline sodium solution as for 3 to 5 days in drinking water. provided in paragraphs (c)(1), (c)(2), and (d) Limitations. Consult a veterinarian (c)(3) of this section. or poultry pathologist for diagnosis. (b) Related tolerances. See § 556.685 of May cause toxic reactions unless the this chapter. drug is evenly mixed in water at dos- (c) Conditions of use. It is used in ages indicated and used according to drinking water as follows: directions. For control of outbreaks of (1) Chickens. (i) As an aid in the con- disease, medication should be initiated trol of outbreaks of coccidiosis caused as soon as the diagnosis is determined. by Eimeria tenella, E. necatrix, E. Medicated chickens, turkeys, cattle, acervulina, E. maxima, and E. brunetti. and calves must actually consume (ii) Administer at the 0.04 percent enough medicated water which pro- level for 2 or 3 days, skip 3 days then vides a recommended dosage of ap- administer at the 0.025 percent level for proximately 10 to 45 milligrams per 2 more days. If bloody droppings ap- pound per day in chickens, 3.5 to 55 pear, repeat treatment at the 0.025 per- milligrams per pound per day in tur- cent level for 2 more days. Do not keys, and approximately 6 milligrams

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per pound per day in cattle and calves § 520.2330 Sulfisoxazole tablets. depending on the age, class of animal, (a) Specifications. Each tablet con- ambient temperature, and other fac- tains 260 milligrams (4 grains) of tors. A withdrawal period has not been sulfisoxazole. established for sulfaquinoxaline in (b) Sponsor. See No. 000856 in preruminating calves. Do not use in § 510.600(c) of this chapter. calves to be processed for veal. Not for (c) Conditions of use—(1) Amount. Ad- use in lactating dairy cattle. Do not minister one tablet orally per 4 pounds give to chickens, turkeys or cattle of body weight. 1 within 10 days of slaughter for food. Do (2) Indications for use. Use in dogs and not medicate chickens or turkeys pro- cats as an aid in treatment of bacterial ducing eggs for human consumption. pneumonia and bacterial enteritis Make fresh drinking water daily. when caused by organisms sensitive to sulfisoxazole. 1 [48 FR 3964, Jan. 28, 1983, as amended at 48 (3) Limitations. Repeat dosage at 24- FR 26762, June 10, 1983; 55 FR 29843, July 23, hour intervals until 2 to 3 days after 1990; 59 FR 28769, June 3, 1994; 59 FR 33197, disappearance of clinical symptoms. June 28, 1994; 61 FR 24443, May 15, 1996; 61 FR 63711, Dec. 2, 1996; 62 FR 37712, July 15, 1997; (Administration of one-half daily dos- 65 FR 10705, Feb. 29, 2000; 69 FR 41427, July 9, age at 12-hour intervals or one-third 2004; 69 FR 60547, Oct. 12, 2004; 74 FR 36112, daily dosage at 8-hour intervals will July 22, 2009; 78 FR 17596, Mar. 22, 2013] provide a more constant blood level.) Provide adequate supply of drinking § 520.2325b Sulfaquinoxaline drench. water. If symptoms persist after using this preparation for 2 or 3 days, consult (a)–(b) [Reserved] a veterinarian. 1 (c) Sponsor. See No. 050749 in § 510.600(c) of this chapter. [43 FR 60895, Dec. 29, 1978] (d) NAS/NRC status. The conditions of § 520.2340 Tepoxalin. use specified in this section have been reviewed by NAS/NRC and are found ef- (a) Specifications. Each tablet con- fective. Applications for these uses tains 30, 50, 100, or 200 milligrams (mg) need not include effectiveness data as tepoxalin. specified by § 514.111 of this chapter, (b) Sponsor. See No. 000061 in but may require bioequivalency infor- § 510.600(c) of this chapter. mation. Applications must be accom- (c) Conditions of use in dogs—(1) panied by a written commitment to un- Amount. 10 mg per kilogram (/kg) daily; or 20 mg/kg on the initial day of treat- dertake the human safety studies re- ment, followed by 10 mg/kg daily. quired by FDA. (2) Indications for use. For the control (e) Conditions of uses. As a 25-percent of pain and inflammation associated sulfaquinoxaline soluble powder. with osteoarthritis. (1) For the control and treatment of (3) Limitations. Federal law restricts outbreaks of coccidiosis in cattle and this drug to use by or on the order of a calves caused by Eimeria bovis or E. licensed veterinarian. zurnii. [68 FR 34795, June 11, 2003] (2) Give one teaspoon of 25 percent sulfaquinoxaline soluble powder for § 520.2345 Tetracycline. each 125 pounds of body weight for 3 to 5 days as a drench. § 520.2345a Tetracycline hydrochloride (f) Limitations. For control of out- capsules. breaks of disease, medication should be (a) Specifications. Each capsule con- initiated as soon as the diagnosis is de- tains 50, 100, 125, 250, or 500 milligrams termined. Consult a veterinarian for di- (mg) tetracycline hydrochloride. agnosis. Do not give to cattle within 10 days of slaughter for food. Not for use 1 These conditions are NAS/NRC reviewed in lactating dairy cattle. and deemed effective. Applications for these uses need not include effectiveness data as [48 FR 3964, Jan. 28, 1983, as amended at 55 specified by § 514.111 of this chapter, but may FR 29843, July 23, 1990; 59 FR 33197, June 28, require bioequivalency and safety informa- 1994] tion.

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(b) Sponsor. See sponsors in 000009 in § 510.600(c) of this chapter for § 510.600(c) of this chapter for use as in use as in paragraph (d)(2) of this sec- paragraph (c) of this section: tion. (1) No. 000009: 250 mg per capsule. (c) Related tolerances. See § 556.720 of (2) No. 000069: 125, 250, or 500 mg per this chapter. capsule. (d) Conditions of use. Calves—(1) (c) Conditions of use in dogs—(1) Amount. 10 milligrams per pound of Amount. 25 mg per pound of body body weight per day in divided doses. weight per day in divided doses every 6 (i) Indications for use. Control and hours. treatment of bacterial enteritis (2) Indications for use. For treatment (scours) caused by E. coli and bacterial of infections caused by organisms sen- pneumonia caused by Pasteurella spp., sitive to tetracycline hydrochloride, Hemophilus spp., and Klebsiella spp. such as bacterial gastroenteritis due to (ii) Limitations. Administer orally for E. coli and urinary tract infections due 3 to 5 days; do not slaughter animals to Staphylococcus spp. and E. coli. for food within 14 days of treatment; (3) Limitations. Federal law restricts use as sole source of tetracycline. this drug to use by or on the order of a (iii) National Academy of Sciences/Na- licensed veterinarian. tional Research Council (NAS/NRC) sta- [70 FR 50182, Aug. 26, 2005, as amended at 73 tus. The conditions of use specified in FR 18442, Apr. 4, 2008] paragraph (d)(1)(i) of this section were NAS/NRC reviewed and found effective. § 520.2345b Tetracycline tablets. Applications for these uses need not in- (a) Specifications. Each tablet con- clude effectiveness data as specified in tains 100, 250, or 500 milligrams of tet- § 514.111 of this chapter, but may re- racycline (as the hydrochloride). quire bioequivalency and safety infor- (b) Sponsor. For 100, 250, or 500 milli- mation. grams per tablet, see No. 000069 in (2) Amount. 10 milligrams per pound § 510.600(c) of this chapter. For 250 mil- of body weight per day in two divided ligrams per tablet, see No. 000009 in doses. § 510.600(c) of this chapter. (i) Indications for use. Treatment of (c) Conditions of use. Dogs—(1) bacterial pneumonia caused by orga- Amount. 25 milligrams per pound of nisms susceptible to tetracycline, bac- body weight per day in divided doses terial enteritis caused by E. coli, and every 6 hours. salmonella organisms susceptible to (2) Indications for use. Treatment of tetracycline. infections caused by organisms sen- (ii) Limitations. Administer orally for sitive to tetracycline hydrochloride, not more than 5 days; do not slaughter such as bacterial gastroenteritis due to animals for food within 12 days of E. coli and urinary tract infections due treatment; use as sole source of tetra- to Staphylococcus spp. and E. coli. cycline. (3) Limitations. Administer orally; [57 FR 37328, Aug. 18, 1992, as amended at 67 continue treatment until symptoms of FR 78355, Dec. 24, 2002] the disease have subsided and tempera- ture is normal for 48 hours; not for use § 520.2345d Tetracycline powder. in animals raised for food production; (a) Specifications. Each pound of pow- Federal law restricts this drug to use der contains 25, 102.4, or 324 grams tet- by or on the order of a licensed veteri- racycline hydrochloride. narian. (b) Sponsors. See sponsors listed in [57 FR 37327, Aug. 18, 1992] § 510.600(c) of this chapter for condi- tions of use as in paragraph (d) of this § 520.2345c Tetracycline boluses. section: (a) Specifications. Each bolus contains (1) No. 000069: 25 grams per pound as 500 milligrams of tetracycline (as the in paragraphs (d)(3) and (d)(4) of this hydrochloride). section. (b) Sponsors. See No. 053501 in (2) No. 054628: 25, 102.4, and 324 grams § 510.600(c) of this chapter for use as in per pound as in paragraph (d) of this paragraph (d)(1) of this section. See No. section.

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(3) No. 046573: 25, 102.4, and 324 grams (iii) Limitations. Administer for 7 to per pound as in paragraph (d) of this 14 days; do not slaughter for food with- section. in 4 days of treatment; not for use in (4) Nos. 054925, 057561, 061623, and chickens producing eggs for human 076475: 324 grams per pound as in para- consumption; prepare a fresh solution graph (d) of this section. daily; use as the sole source of tetra- (c) Related tolerances. See § 556.720 of cycline. this chapter. (4) Turkeys—(i) Amount. For infec- (d) Conditions of use. It is adminis- tious synovitis: 400 milligrams per gal- tered in drinking water as follows: lon. For complicating bacterial orga- (1) Calves—(i) Amount. 10 milligrams nisms associated with bluecomb (trans- per pound of body weight per day in di- missible enteritis or coronaviral enter- vided doses. itis): 25 milligrams per pound of body (ii) Indications for use. Control and weight per day. treatment of bacterial enteritis (ii) Indications for use. Control of in- (scours) caused by and Escherichia coli fectious synovitis caused by M. bacterial pneumonia (shipping fever synoviae; control of bluecomb com- complex) associated with Pasteurella plicated by organisms sensitive to tet- spp., Actinobacillus pleuropneumoniae racycline. (Hemophilus spp.), and Klebsiella spp., susceptible to tetracycline. (iii) Limitations. Administer for 7 to (iii) Limitations. Administer for 3 to 5 14 days; do not slaughter for food with- days; do not slaughter animals for food in 4 days of treatment; not for use in within 4 days of treatment for No. turkeys producing eggs for human con- 000010 and within 5 days of treatment sumption; prepare a fresh solution for Nos. 046573, 054925, 057561, 059130, and daily; use as the sole source of tetra- 061623; prepare a fresh solution daily; cycline. use as the sole source of tetracycline. [59 FR 17693, Apr. 14, 1994, as amended at 59 A withdrawal period has not been es- FR 19133, Apr. 22, 1994; 62 FR 5319, Feb. 5, tablished for this product in 1997; 62 FR 35076, June 30, 1997; 62 FR 46668, preruminating calves. Do not use in Sept. 4, 1997; 62 FR 55160, Oct. 23, 1997; 64 FR calves to be processed for veal. 37673, July 13, 1999; 67 FR 78355, Dec. 24, 2002; (2) Swine—(i) Amount. 10 milligrams 70 FR 16934, Apr. 4, 2005; 70 FR 67353, Nov. 7, per pound of body weight per day in di- 2005; 71 FR 13542, Mar. 16, 2006; 75 FR 10166, Mar. 5, 2010; 75 FR 12981, Mar. 18, 2010; 76 FR vided doses. 17338, Mar. 29, 2011; 77 FR 20988, Apr. 9, 2012; (ii) Indications for use. Control and 78 FR 21060, Apr. 9, 2013] treatment of bacterial enteritis (scours) caused by E. coli and bacterial § 520.2345e Tetracycline oral liquid. pneumonia associated with Pasteurella (a) Specifications. Each milliliter con- spp., A. pleuropneumoniae (Hemophilus spp.), and Klebsiella spp., susceptible to tains the equivalent of either 25 or 100 tetracycline. milligrams of tetracycline hydro- (iii) Limitations. Administer for 3 to 5 chloride. days; do not slaughter animals for food (b) Sponsor. See No. 000069, in within 7 days of treatment for No. § 510.600(c) of this chapter for use of 25 000010 and within 4 days of treatment or 100 milligrams per milliliter liquid for Nos. 046573, 054925, 057561, 059130, and in dogs as in paragraph (c)(1) of this 061623; prepare a fresh solution daily; section; see No. 000009 in § 510.600(c) of use as the sole source of tetracycline. this chapter for use of 100 milligrams (3) Chickens—(i) Amount. Chronic res- per milliliter liquid in dogs and cats as piratory disease: 400 to 800 milligrams in paragraph (c)(2). per gallon. Infectious synovitis: 200 to (c) Conditions of use—(1) Dogs—(i) 400 milligrams per gallon. Amount. 25 milligrams per pound of (ii) Indications for use. Control of body weight per day in divided doses chronic respiratory disease (CRD or every 6 hours. air-sac disease) caused by Mycoplasma (ii) Indications for use. Treatment of gallisepticum and E. coli; control of in- infections caused by organisms sen- fectious synovitis caused by M. sitive to tetracycline hydrochloride, synoviae susceptible to tetracycline. such as bacterial gastroenteritis due to

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Escherichia coli and urinary tract infec- evidence of infection has disappeared. tions due to Staphylococcus spp. and E. As with all antibiotics, appropriate in coli. vitro culturing and susceptibility tests (iii) Limitations. Administer orally; of samples taken before treatment continue treatment until symptoms should be conducted. Federal law re- have subsided and the temperature is stricts this drug to use by or on the normal for 48 hours; not for use in ani- order of a licensed veterinarian. mals which are raised for food produc- tion; Federal law restricts this drug to [57 FR 37329, Aug. 18, 1992] use by or on the order of a licensed vet- erinarian. § 520.2345g Tetracycline hydrochloride and sodium novobiocin tablets. (iv) National Academy of Sciences/Na- tional Research Council (NAS/NRC) sta- (a) Specifications. Each tablet con- tus. These conditions were NAS/NRC tains the equivalent of 60 milligrams of reviewed and found effective. Applica- tetracycline hydrochloride and 60 mil- tions for these uses need not include ef- ligrams of novobiocin, or 180 milli- fectiveness data as specified by § 514.111 grams of tetracycline hydrochloride of this chapter, but may require bio- and 180 milligrams of novobiocin. equivalency and safety information. (b) Sponsor. No. 000009 in § 510.600(c) of (2) Dogs and cats—(i) Amount. 25 milli- this chapter. grams per pound of body weight per (c) Conditions of use. Dogs—(1) day in divided doses every 6 hours. Amount. 10 milligrams of each anti- (ii) Indications for use. Treatment of biotic per pound of body weight (one infections caused by organisms suscep- single-strength tablet for each 6 pounds tible to tetracycline hydrochloride, or one triple-strength tablet for each 18 such as bacterial gastroenteritis due to pounds). E. coli and urinary tract infections due (2) Indications for use. Treatment of to Staphylococcus spp. and E. coli. acute or chronic canine respiratory in- (iii) Limitations. Administer orally; fections such as tonsillitis, bronchitis, continue treatment until the tempera- and tracheobronchitis when caused by ture has been normal for 48 hours; not pathogens susceptible to tetracycline for use in food-producing animals; Fed- and/or novobiocin, such as Staphy- eral law restricts this drug to use by or lococcus spp. and Escherichia coli. on the order of a licensed veterinarian. (3) Limitations. Continue treatment [57 FR 37329, Aug. 18, 1992] for at least 48 hours after the tempera- ture has returned to normal and all § 520.2345f Tetracycline phosphate evidence of infection has disappeared. complex and sodium novobiocin As with all antibiotics, appropriate in capsules. vitro culturing and susceptibility tests (a) Specifications. Each capsule con- of samples taken before treatment tains the equivalent of 60 milligrams of should be conducted. Federal law re- tetracycline hydrochloride and 60 mil- stricts this drug to use by or on the ligrams of novobiocin. order of a licensed veterinarian. (b) Sponsor. No. 000009 in § 510.600(c) of this chapter. [57 FR 37329, Aug. 18, 1992] (c) Conditions of use. Dogs—(1) Amount. 10 milligrams of each anti- § 520.2345h Tetracycline hydro- biotic per pound of body weight (1 cap- chloride, sodium novobiocin, and prednisolone tablets. sule for each 6 pounds) every 12 hours. (2) Indications for use. Treatment of (a) Specifications. Each tablet con- acute or chronic canine respiratory in- tains the equivalent of 60 milligrams of fections such as tonsillitis, bronchitis, tetracycline hydrochloride, 60 milli- and tracheobronchitis when caused by grams of novobiocin, and 1.5 milli- pathogens susceptible to tetracycline grams of prednisolone or 180 milli- and/or novobiocin, such as Staphy- grams of tetracycline hydrochloride, lococcus spp. and Escherichia coli. 180 milligrams of novobiocin, and 4.5 (3) Limitations. Continue treatment milligrams of prednisolone. for at least 48 hours after the tempera- (b) Sponsor. See No. 000009 in ture has returned to normal and all § 510.600(c) of this chapter.

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(c) Conditions of use. Dogs—(1) cies Ancylostoma caninum and Uncinaria Amount. 10 milligrams of each anti- stenocephala (hookworms). Dogs weigh- biotic and 0.25 milligram of prednis- ing 10 pounds and over are adminis- olone per pound of body weight (one tered 1 tablet as a single dose. Dogs single-strength tablet for each 6 pounds weighing 5 to 10 pounds are adminis- or one triple-strength tablet for each 18 tered one-half tablet twice during a pounds) every 12 hours for 48 hours. single day. All dosages are given for 1 Treatment is to be continued with day only. The treatment should be re- novobiocin and tetracycline alone at peated after 2 or 3 weeks. the same dose schedule for an addi- (2) Suckling puppies or recently tional 3 days or longer as needed. weaned puppies weighing less than 5 (2) Indications for use. Treatment of pounds should not be treated with the acute and chronic canine respiratory drug. Animals that are severely in- infections such as tonsillitis, bron- fected, exhibiting evidence of intes- chitis, and tracheobronchitis when tinal hemorrhage, debilitation, and caused by pathogens susceptible to tet- anemia, should be given supportive racycline and/or novobiocin, such as treatment. Staphylococcus spp. and Escherichia coli, (3) Federal law restricts this drug to when it is necessary to initially reduce use by or on the order of a licensed vet- the severity of associated clinical erinarian. signs. (3) Limitations. As with all anti- [40 FR 13838, Mar. 27, 1975, as amended at 41 biotics, appropriate in vitro culturing FR 53477, Dec. 7, 1976; 46 FR 48642, Oct. 2, 1981; and susceptibility tests of samples 61 FR 8873, Mar. 6, 1996; 62 FR 61625, Nov. 19, 1997] taken before treatment should be con- ducted. Administer for 48 hours only. § 520.2380 Thiabendazole oral dosage Continue treatment if needed with tet- forms. racycline/novobiocin alone. The prod- uct is contraindicated in animals with § 520.2380a Thiabendazole top dress- tuberculosis, hyperadrenocorticalism, ing and mineral protein block. or peptic ulcers. Clinical and experi- (a) Chemical name. 2-(4-Thiazolyl)- mental data have demonstrated that benzimidazole. corticosteroids administered orally or (b) Specifications. Conforms to N.F. parenterally to animals may induce XII. the first stage of parturition when ad- (c) Sponsors. See sponsors in ministered during the last trimester of § 510.600(c) of this chapter for use as in pregnancy and may precipitate pre- paragraph (e) of this section. mature parturition followed by (1) No. 051311 for use as in paragraph dystocia, fetal death, retained pla- (e)(1)(i) of this section. centa, and metritis. Federal law re- (2) No. 050604 for use as in paragraph stricts this drug to use by or on the (e)(1)(ii) of this section. order of a licensed veterinarian. (3) No. 012286 for use as in paragraph [57 FR 37329, Aug. 18, 1992] (e)(2) of this section. (d) Related tolerances. See § 556.730 of § 520.2362 Thenium closylate tablets. this chapter. (a) Chemical name. (N,N-Dimethyl-N- (e) Conditions of use. It is used as fol- 2-phenoxyethyl-N-2′-thenylammo- lows: nium)-p-chlorobenzene-sulfonate. (1) Horses—(i) Route of administration. (b) Specifications. Thenium closylate In feed, as a top dressing. tablets contain thenium closylate (a) Amount. 2 grams per 100 pounds of equivalent to 500 milligrams thenium body weight. as base in each tablet. (b) Indications for use. For control of (c) Sponsor. See No. 000061 in large strongyles, small strongyles, § 510.600(c) of this chapter. pinworms, and threadworms (including (d) Conditions of use. (1) The tablets members of the genera Strongylus, are administered orally to dogs as a Cyathostomum, Cylicobrachytus, and re- single day treatment of canine ancylo- lated genera, Craterostomum, stomiasis by the removal from the in- Oesophagodontus, Poteriostomum, testines of the adult forms of the spe- Oxyuris, and Strongyloides).

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(c) Limitations. Add to the usual feed narian consulted for advice concerning of horses mixed into that amount of treatment. the feed normally consumed at one [40 FR 13838, Mar. 27, 1975, as amended at 41 feeding. Warning: Not for use in horses FR 9149, Mar. 3, 1976; 62 FR 63271, Nov. 28, intended for food. 1997; 70 FR 32489, June 3, 2005; 73 FR 35340, (ii) Route of administration. In feed. June 23, 2008] (a) Amount. 2 grams per 100 pounds of body weight. § 520.2380b Thiabendazole drench or oral paste. (1) Indications for use. For control of large and small strongyles, (a) Chemical name. 2-(4-Thiazolyl) Strongyloides, and pinworms of the gen- benzimidazole. era Strongylus, Cyathostomum, (b) Specifications. Conforms to N.F. Cylicobrachytus and related genera, XII. Craterostomum, Oesophagodontus, (c) Sponsor. See No. 050604 in Poteriostomum, Oxyuris, and § 510.600(c) of this chapter for the spon- Strongyloides. sor of the usages provided for by para- graph (e) of this section. (2) Limitations. Administer in a single dosage mixed with the normal grain ra- (d) Related tolerances. See § 556.730 of this chapter. tion given at one feeding. Warning: Not (e) Conditions of use. It is used as fol- for use in horses intended for food. lows: (b) Amount. 4 grams per 100 pounds of (1) Horses. As a single liquid oral body weight. dose, administered as a drench or by (1) Indications for use. For control of stomach tube; or as an oral paste. ascarids of the genus Parascaris. (i) Amount. 2 grams per 100 pounds of (2) Limitations. Administer in a single body weight. dosage mixed with the normal grain ra- (a) Indications for use. For the control tion given at one feeding. Warning: Not of infections of large strongyles for use in horses intended for food. (Strongylus vulgaris, Strongylus (2) Cattle—(i) Route of administration. endentatus), small strongyles In feed block. (Cyathastomum, Cylicobrachytus and re- (ii) Amount. 3.3 percent block con- lated genera, Craterostomum, sumed at the recommended level of 0.11 Oesophagodontus, Poteriostomum), pound per 100 pounds of body weight pinworms (Oxyuris), and threadworms per day. (Strongyloides). (iii) Indications for use. For control of (b) Limitations. Not for use in horses infections of gastrointestinal to be slaughtered for food purposes. roundworms (Trichostrongylus, When administered by stomach tube, Haemonchus, Ostertagia and Cooperia). for use only by or on the order of a li- (iv) Limitations. Administer to cattle censed veterinarian. When for use as a on pasture or range accustomed to liquid oral drench or an oral paste, con- sult your veterinarian for assistance in mineral protein block feeding for 3 the diagnosis, treatment, and control days. Milk taken from animals during of parasitism. treatment and within 96 hours (8 (ii) Amount. 4 grams per 100 pounds of milkings) after the latest treatment body weight. must not be used for food. Do not treat (a) Indications for use. For control of cattle within 3 days of slaughter. For a infections of ascardis (Parascaris). satisfactory diagnosis, a microscopic (b) Limitations. Not for use in horses fecal examination should be performed to be slaughtered for food purposes. by a veterinarian or diagnostic labora- When administered by stomach tube, tory prior to worming. Animals main- use only by or on the order of a li- tained under conditions of constant censed veterinarian. When for use as a worm exposure may require re-treat- liquid oral drench or an oral paste, con- ment within 2 to 3 weeks. Animals that sult your veterinarian for assistance in are severely parasitized, sick, or off the diagnosis, treatment, and control feed should be isolated and a veteri- of parasitism. (2) Pigs. As an oral paste.

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(i) Amount. 200 milligrams for each 5 (ii) Indications for use. Control of in- to 7 pounds of body weight per dose. fections of gastrointestinal (ii) Indications for use. For control of roundworms in sheep and goats. infections with Strongyloides ransomi. (Trichostrongylus spp., Haemonchus spp., These infections are commonly found Ostertagia spp., Cooperia spp., in Southeastern United States. Nematodirus spp., Bunostomum spp., (iii) Limitations. Administer to baby Strongyloides spp., Chabertia spp., and pigs (1 to 8 weeks of age). Treatment Oesophagostomum spp. ); also active may be repeated in 5 to 7 days if nec- from 3 hours to 3 days following treat- essary. Before treatment, obtain an ac- ment against ova and larvae passed by curate diagnosis from a veterinarian or sheep (good activity against diagnostic laboratory. Do not treat Trichostrongylus colubriformis and axei, within 30 days of slaughter. Ostertagia spp., Bunostomum spp., (3) Cattle. Orally as a drench and in Nematodirus spp., and Strongyloides spp.; paste form using a dosing gun designed less effective against Haemonchus for the product. contortus and Oesophagostomum spp. ). (i) Amount. 3 grams per 100 pounds of (iii) Limitations. As a single oral dose; body weight. do not treat animals within 30 days of (a) Indications for use. Control of in- slaughter; milk taken from treated fections of gastrointestinal animals within 96 hours (8 milkings) roundworms (Trichostrongylus spp., after the latest treatment must not be Haemonchus spp., Nematodirus spp., used for food; in severe infections in Ostertagia spp., and Oesophagostomum sheep, treatment should be repeated in radiatum). 2 to 3 weeks. (5) Orally, as a drench. (b) Limitations. For most effective re- Goats. sults, severely parasitized animals or (i) Amount. 3 grams per 100 pounds of those constantly exposed to helminth body weight. infection should be re-treated every 2 (ii) Indications for use. Control of se- to 3 weeks. Milk taken from treated vere infections of gastrointestinal animals within 96 hours (8 milkings) roundworms (Trichostrongylus spp., after the latest treatment must not be Haemonchus spp., Ostertagia spp., used for food. Do not treat cattle with- Cooperia spp., Nematodirus spp., in 3 days of slaughter. For a satisfac- Bunostomum spp., Strongyloides spp., tory diagnosis, a microscopic fecal ex- Chabertia spp., and Oesophagostomum amination should be performed prior to spp. ). worming. (iii) Limitations. As a single oral dose; (ii) Amount. 5 grams per 100 pounds of do not treat animals within 30 days of body weight. slaughter; milk taken from treated animals within 96 hours (8 milkings) (a) Indications for use. Control of in- after the latest treatment must not be fections of Cooperia spp. or severe infec- used for food; treatment should be re- tions of other species in paragraph peated in 2 to 3 weeks. (e)(3)(i)(a) of this section. (b) Limitations. For most effective re- [40 FR 13838, Mar. 27, 1975, as amended at 41 sults, severely parasitized animals or FR 9149, Mar. 3, 1976; 41 FR 47424, Oct. 29, those constantly exposed to helminth 1976; 62 FR 63271, Nov. 28, 1997] infection should be re-treated every 2 to 3 weeks. Milk taken from treated § 520.2380c Thiabendazole bolus. animals within 96 hours (8 milkings) (a) Chemical name. 2-(4-Thiazolyl) after the latest treatment must not be benzimidazole. used for food. Do not treat cattle with- (b) Specifications. Conforms to N.F. in 3 days of slaughter. For a satisfac- XII. tory diagnosis, a microscopic fecal ex- (c) Sponsor. See No. 050604 in amination should be performed prior to § 510.600(c) of this chapter. worming. (d) Related tolerances. See § 556.730 of (4) Sheep and goats. Orally, as a this chapter. drench. (e) Conditions of use. It is used as fol- (i) Amount. 2 grams per 100 pounds of lows: body weight. (1) Cattle. In a bolus.

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(i) Amount. 3 grams per 100 pounds of (i) Amount. 3 grams per 100 pounds of body weight. body weight. (a) Indications for use. Control of in- (ii) Indications for use. Control of se- fections of gastrointestinal vere infections of gastrointestinal roundworms (general Trichostrongylus roundworms (genera Trichostrongylus spp., Haemonchus spp., Nematodirus spp., spp., Haemonchus spp., Ostertagia spp., Ostertagia spp., and Oesophagostomum Cooperia spp., Nematodirus spp., radiatum). Bunostomum spp., Strongyloides spp., (b) Limitations. As a single oral dose; Chabertia spp., and Oesophagostomum may repeat once in 2 to 3 weeks; do not spp. ). treat animals within 3 days of slaugh- (iii) Limitations. As a single oral dose; ter; milk taken from treated animals do not treat animals within 30 days of within 96 hours (8 milkings) after the slaughter; milk taken from treated latest treatment must not be used for animals within 96 hours (8 milkings) food. after the latest treatment must not be (ii) Amount. 5 grams per 100 pounds of used for food; treatment should be re- body weight. peated in 2 to 3 weeks. (a) Indications for use. Control of se- vere infections of gastrointestinal [40 FR 13838, Mar. 27, 1975, as amended at 41 FR 9149, Mar. 3, 1976; 62 FR 63271, Nov. 28, roundworms (genera Trichostrongylus 1997] spp., Haemonchus spp., Nematodirus spp., Ostertagia spp., and Oesophagostomum § 520.2380d Thiabendazole, piperazine radiatum). Control of infections with citrate suspension. Cooperia spp. (a) Specifications. Each fluid ounce of (b) Limitations. As a single oral dose; suspension contains 2 grams of as a drench or bolus; may repeat once thiabendazole and 2.5 grams of piper- in 2 to 3 weeks; do not treat animals azine (from piperazine citrate). within 3 days of slaughter; milk taken (b) Sponsor. See No. 050604 in from treated animals within 96 hours (8 § 510.600(c) of this chapter. milkings) after the latest treatment (c) Conditions of use. (1) It is adminis- must not be used for food. tered to horses by stomach tube or as a (2) Sheep and goats. In a bolus. drench at the rate of 1 fluid ounce of (i) Amount. 2 grams per 100 pounds of suspension per 100 pounds of body body weight. weight for the control of large (ii) Indications for use. Control of in- strongyles, small strongyles, fections of gastrointestinal pinworms, Strongyloides and ascarids roundworms in sheep and goats (gen- (including members of the genera eral Trichostrongylus spp., Haemonchus Strongylus spp., Cyathostomum spp., spp., Ostertagia spp., Cooperia spp., Cylicobrachytus spp. and related genera Nematodirus spp., Bunostomum spp., Craterostomum spp., Oesophagodontus Strongyloides spp., Chabertia spp., and spp., Poteriostomum spp., Oxyuris spp., Oesophagostomum spp. ); also active Strongyloides spp., and Parascaris spp. ). from 3 hours to 3 days following treat- (2) Do not use in horses intended to ment against ova and larvae passed by be used for food purposes. sheep (good activity against T. (3) For use by or on the order of a li- colubriformis and axei, Ostertagia spp., censed veterinarian. Bunostomum spp., Nematodirus spp., and Strongyloides spp.; less effective against [40 FR 13838, Mar. 27, 1975, as amended at 62 Haemonchus contortus and FR 63271, Nov. 28, 1997] Oesophagostomum spp. ). (iii) Limitations. As a single oral dose; § 520.2380e Thiabendazole with do not treat animals within 30 days of trichlorfon. slaughter; milk taken from treated (a) Specifications. The drug contains 5 animals within 96 hours (8 milkings) grams of thiabendazole with 4.5 grams after the latest treatment must not be of trichlorfon, or 20 grams of used for food; in severe infections in thiabendazole with 18 grams of sheep, treatment should be repeated in trichlorfon. 2 to 3 weeks. (b) Sponsor. See No. 017135 in (3) Goats. In a bolus. § 510.600(c) of this chapter.

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(c) Conditions of use. (1) Used for the (Strongyloides), and ascarids (Parascaris) treatment and control of bots in horses. (Gasterophilus spp. ), large strongyles (3) Limitations. Use a single oral dose. (Strongylus spp. ), small strongyles Administer as a drench or by stomach (genera Cyathostomum, Cylicobrachytus, tube suspended in 1 pint of warm Craterostomum, Oesophagodontus, water; by dose syringe suspended in 1⁄2 Poteriostomum), pinworms (Oxyuris spp., ounce of water for each 100 pounds of Strongyloides spp. ), and ascarids body weight; or sprinkled over a small (Parascaris spp. ) in horses. amount of daily feed. Not for animals (2) Administer 2 grams of intended for food use. If the label bears thiabendazole with 1.8 grams of directions for administration by stom- trichlorfon per 100 pounds of body ach tube or drench, it shall also bear weight sprinkled on the animals’ usual the statement ‘‘Caution: Federal law daily ration of feed, or may be mixed in restricts this drug to use by or on the 5 to 10 fluid ounces of water and admin- order of a licensed veterinarian;’’ if not istered by stomach tube or drench. labeled for use by stomach tube or (3) Do not re-treat more than once drench, the label shall bear the state- every 30 days, preferably every 6 to 8 ment, ‘‘Consult your veterinarian for weeks. assistance in the diagonosis, treat- (4) Do not treat animals if sick or de- ment, and control of parasitism.’’ bilitated; less than 4 months of age; or mares in last month of pregnancy. [46 FR 18963, Mar. 27, 1981, as amended at 46 (5) Do not administer intravenous an- FR 52330, Oct. 27, 1981; 62 FR 63271, Nov. 28, 1997] esthetics, especially muscle relaxants, within 2 weeks of use. § 520.2455 Tiamulin. (6) Not for animals intended for food use. (a) Specifications. (1) Each gram of (7) Do not use within a few days be- soluble powder contains 450 milligrams fore or after treatment with or expo- (mg) tiamulin hydrogen fumarate. sure to cholinesterase-inhibiting drugs, (2) Each milliliter (mL) of solution pesticides, or chemicals. contains 125 mg (12.5 percent) tiamulin (8) If the label bears directions for ad- hydrogen fumarate. ministration of the drug by stomach (3) Each mL of solution contains 123 tube or drench it shall also bear the mg (12.3 percent) tiamulin hydrogen fu- statement: Caution; Federal law re- marate. stricts this drug to use by or on the (b) Sponsors. See sponsor numbers in order of a licensed veterinarian. § 510.600(c) of this chapter for use as in paragraph (d) of this section. [40 FR 23071, May 28, 1975, as amended at 48 FR 48229, Oct. 18, 1983] (1) No. 058198 for products described in paragraphs (a)(1) and (a)(2) of this § 520.2380f Thiabendazole, piperazine section. phosphate powder. (2) No. 066104 for the product de- (a) Specifications. Each ounce of water scribed in paragraph (a)(1) of this sec- dispersible powder contains 6.67 grams tion. of thiabendazole and 8.33 grams of pi- (3) No. 000859 for the product de- perazine (as piperazine phosphate). scribed in paragraph (a)(3) of this sec- (b) Sponsor. See No. 050604 in tion. § 510.600(c) of this chapter. (c) Related tolerances. See § 556.738 of (c) Conditions of use—(1) Amount. 2 this chapter. grams of thiabendazole and 2.5 grams (d) Conditions of use in swine—(1) of piperazine (0.3 ounce of powder) per Amounts and indications for use. Admin- 100 pounds of body weight. ister in drinking water for 5 consecu- (2) Indications for use. Treatment of tive days: infections of large strongyles (genus (i) 3.5 mg per (/) lb of body weight Strongylus), small strongyles (genera daily for treatment of swine dysentery Cyathostomum, Cylicobrachytus, and re- associated with Brachyspira lated genera Craterostomum, hyodysenteriae susceptible to tiamulin. Oesophagodontus, Poteriostomum), (ii) 10.5 mg/lb of body weight daily for pinworms (Oxyuris), threadworms treatment of swine pneumonia due to

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Actinobacillus pleuropneumoniae suscep- (c) Conditions of use—(1) Horses—(i) tible to tiamulin. Amount. 5 milligrams per pound of body (2) Limitations. Use as only source of weight as a single dose. drinking water. Prepare fresh medi- (ii) Indications for use. Removal of cated water daily. Withdraw medica- mature large strongyles (Strongylus tion 3 days before slaughter following edentatus, S. equinus, and S. vulgaris), treatment at 3.5 mg/lb and 7 days be- mature ascarids (Parascaris equorum), fore slaughter following treatment at mature and immature (4th larval 10.5 mg/lb of body weight. Swine being stage) pinworms (Oxyuris equi), and ma- treated with tiamulin should not have ture small strongyles (Triodontophorus access to feeds containing polyether spp.). ionophores (e.g., , monensin, (iii) Limitations. For administration narasin, salinomycin, or with feed: Sprinkle required amount of semduramycin) as adverse reactions granules on a small amount of the may occur. The effects of tiamulin on usual grain ration and mix. Prepare for swine reproductive performance, preg- each horse individually. Withholding of nancy, and lactation have not been de- feed or water not necessary. Not for termined. use in horses intended for food. The re- productive safety of tioxidazole in [70 FR 75017, Dec. 19, 2005, as amended at 74 FR 7180, Feb. 13, 2009; 75 FR 54492, Sept. 8, breeding animals has not been deter- 2010; 77 FR 56770, Sept. 14, 2012; 78 FR 17596, mined. Consult your veterinarian for Mar. 22, 2013] assistance in the diagnosis, treatment, and control of parasitism. It is rec- § 520.2471 Tilmicosin. ommended that this drug be adminis- (a) Specifications. Each milliliter of tered with caution to sick or debili- concentrate solution contains 250 milli- tated horses. grams (mg) tilmicosin as tilmicosin (2) [Reserved] phosphate. [50 FR 52772, Dec. 26, 1985; 51 FR 2693, Jan. 21, (b) Sponsor. See No. 000986 in 1986, as amended at 52 FR 7832, Mar. 13, 1987] § 510.600(c) of this chapter. (c) Tolerances. See § 556.735 of this § 520.2473b Tioxidazole paste. chapter. (a) Specifications. Each plastic syringe (d) Conditions of use in swine—(1) contains 6.25 grams of tioxidazole. Amount. Administer in drinking water (b) Sponsor. See No. 000061 in at a concentration of 200 mg per liter § 510.600(c) of this chapter. for 5 consecutive days. (c) Conditions of use—(1) Horses—(i) (2) Indication for use. For the control Amount. 5 milligrams of tioxidazole per of swine respiratory disease associated pound of body weight as a single dose. with Pasteurella multocida and (ii) Indications for use. Removal of Haemophilus parasuis in groups of swine mature large strongyles (Strongylus in buildings where a respiratory dis- edentatus, S. equinus, and S. vulgaris), ease outbreak is diagnosed. mature ascarids (Parascaris equorum), (3) Limitations. Swine intended for mature and immature (4th larval human consumption must not be stage) pinworms (Oxyuris equi), and ma- slaughtered within 7 days of the last ture small strongyles (Triodontophorus treatment with this product. Federal spp.). law restricts this drug to use by or on (iii) Limitations. Administer orally by the order of a licensed veterinarian. inserting the nozzle of the syringe [79 FR 18158, Apr. 1, 2014] through the space between front and back teeth and deposit the required § 520.2473 Tioxidazole oral dosage dose on the base of the tongue. Before forms. dosing, make sure the horse’s mouth contains no feed. Not for use in horses § 520.2473a Tioxidazole granules. intended for food. The reproductive (a) Specifications. Each gram of gran- safety of tioxidazole in breeding ani- ules contains 200 milligrams of mals has not been determined. Consult tioxidazole. your veterinarian for assistance in the (b) Sponsor. See No. 000061 in diagnosis, treatment, and control of § 510.600(c) of this chapter. parasitism. It is recommended that

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this drug be administered with caution (2) Horses. Use oral powder described to sick or debilitated horses. in paragraph (a)(2) of this section as (2) [Reserved] follows: (i) Amount. Administer 0.005 to 0.01 [52 FR 43059, Nov. 9, 1987] mg/lb of body weight twice daily, sprin- kled (top-dressed) on a small portion of § 520.2475 Toceranib. feed. Therapy may be initiated with a (a) Specifications. Each tablet con- single injection of triamcinolone tains 10, 15, or 50 milligrams (mg) acetonide suspension as in § 522.2483 of toceranib as toceranib phosphate. this chapter, in which case (b) Sponsor. See No. 000009 in § 510.600 triamcinolone acetonide oral powder of this chapter. should be administered beginning 3 or 4 (c) Conditions of use—(1) Dogs—(i) days after the injection. Amount. Administer an initial dose of (ii) Indications for use. As an anti-in- 3.25 mg per kilogram (1.48 mg per flammatory agent. pound) body weight, orally every other (iii) Limitations. Federal law restricts day. this drug to use by or on the order of a (ii) Indications for use. For the treat- licensed veterinarian. Do not use in ment of Patnaik grade II or III, recur- horses intended for human consump- rent, cutaneous mast cell tumors with tion. or without regional lymph node in- [75 FR 10166, Mar. 5, 2010] volvement. (iii) Limitations. Federal law restricts § 520.2520 Trichlorfon oral dosage this drug to use by or on the order of a forms. licensed veterinarian. (2) [Reserved] § 520.2520b Trichlorfon and atropine. (a) Chemical name. (1) For trichlorfon: [74 FR 28875, June 18, 2009] O,O-Dimethyl 2,2,2-trichloro-1-hy- § 520.2483 Triamcinolone. droxyethyl phosphonate. (2) For atropine: Atropine N.F. (a) Specifications.—(1) Each tablet (b) Sponsor. See No. 000856 in contains 0.5 milligram (mg) or 1.5 mg § 510.600(c) of this chapter. triamcinolone acetonide. (c) Conditions of use. (1) The drug is (2) Each 15 grams of powder contains used for the treatment of Syphacia 10 mg triamcinolone acetonide. obvelata (pinworm) in laboratory mice. (b) Sponsor. See No. 000010 in (2) It is administered in distilled § 510.600(c) of this chapter. water as sole source of drinking water (c) Special considerations. See § 510.410 continuously for 7 to 14 days at 1.67 of this chapter. grams of trichlorfon and 7.7 milligrams (d) Conditions of use—(1) Dogs and of atropine per liter. cats. Use tablets described in paragraph (3) Prepare fresh solution every 3 (a)(1) of this section as follows: days. Do not use simultaneously with (i) Amount. Administer 0.05 mg per other drugs, insecticides, pesticides, or pound (/lb) of body weight daily by chemicals having cholinesterase activ- mouth; up to 0.1 mg per pound (/lb) of ity, nor within 7 days before or after body weight daily, if response to the treatment with any other cholin- smaller dose is inadequate. Therapy esterase inhibitor. may be initiated with a single injec- (4) Restricted to use by or on the tion of triamcinolone acetonide sus- order of a licensed veterinarian. pension as in § 522.2483 of this chapter, in which case triamcinolone acetonide § 520.2520e Trichlorfon boluses. tablets should be administered begin- (a) Specifications. Each bolus contains ning 5 to 7 days after the injection. either 7.3, 10.9, 14.6, or 18.2 g of (ii) Indications for use. As an anti-in- trichlorfon. flammatory agent. (b) Sponsor. See 000856 in § 510.600(c) of (iii) Limitations. Federal law restricts this chapter. this drug to use by or on the order of a (c) Special considerations. Trichlorfon licensed veterinarian. is a cholinesterase inhibitor. Do not

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use this product on animals simulta- Gastrophilus intestinalis), large neously with, or within 2 weeks, before roundworms (ascarids, Parascaris or after treatment with or exposure to, equorum), and pinworms (Oxyuris equi). neuromuscular depolarizing agents (3) Limitations. Do not fast horses be- (i.e., succinylcholine) or to cholin- fore or after treatment. Treatment of esterase-inhibiting drugs, pesticides, or mares in late pregnancy is not rec- chemicals. ommended. Surgery or any severe (d) NAS/NRC status. Use of this drug stress should be avoided for at least 2 has been NAS/NRC reviewed and found weeks before or after treatment. Do effective. Applications for these uses not administer to sick, toxic, or debili- need not include effectiveness data as tated horses. Not to be used in horses specified by § 514.111 of this chapter. intended for use as food. Federal law (e) Conditions of use—(1) Amount. 18.2 restricts this drug to use by or on the milligrams per pound of body weight, order of a licensed veterinarian. except for strongyles use 36.4 milli- [45 FR 48128, July 18, 1980] grams per pound of body weight. (2) Indications for use. For horses for § 520.2520g Trichlorfon, phenothiazine, removal of bots (Gastrophilus nasalis, and piperazine dihydrochloride Gastrophilus intestinalis), large powder. strongyles (Strongylus vulgaris), small (a) Specifications. Each 54.10 grams strongyles, large roundworms (1.91 ounces) of water dispersible pow- (ascarids, Parascaris equorum), and der contains 9.10 grams of trichlorfon, pinworms (Oxyuris equi). 6.25 grams of phenothiazine, and the (3) Limitations. Do not fast horses be- equivalent of 20.0 grams of piperazine fore or after treatment. Treatment of base (as piperazine dihydrochloride). mares in late pregnancy is not rec- (b) Sponsor. See No. 000856 in ommended. Surgery or any severe § 510.600(c) of this chapter. stress should be avoided for at least 2 (c) Special considerations. Labeling weeks before or after treatment. Do shall bear the following statements: not administer to sick, toxic, or debili- The drug is a cholinesterase inhibitor. tated horses. Not to be used in horses Do not use this product in horses si- intended for use as food. Federal law multaneously with, or within 2 weeks restricts this drug to use by or on the before or after treatment with, or expo- order of a licensed veterinarian. sure to, neuromuscular depolarizing [45 FR 48127, July 18, 1980] agents (e.g., succinylcholine) or to cho- linesterase-inhibiting drugs, pesticides, § 520.2520f Trichlorfon granules. or chemicals. (a) Specifications. Each package con- (d) Conditions of use—(1) Amount. 18.2 tains either 18.2 or 36.4 g of trichlorfon. milligrams of trichlorfon, 12.5 milli- (b) Sponsor. See 000856 in § 510.600(c) of grams of phenothiazine, and 40.0 milli- this chapter. grams of piperazine base per pound of (c) Special considerations. Trichlorfon body weight. is a cholinesterase inhibitor. Do not (2) Indications for use. For horses for use this product on animals simulta- removal of bots (Gastrophilus nasalis, neously with, or within 2 weeks before Gastrophilus intestinalis), large or after treatment with or exposure to strongyles (Strongylus vulgaris), small neuromuscular depolarizing agents strongyles, large roundworms (i.e., succinylcholine) or to cholin- (ascarids, Parascaris equorum), and esterase-inhibiting drugs, pesticides, or pinworms (Oxyuris equi). chemicals. (3) Limitations. Mix powder and vial (d) NAS/NRC status. Use of this drug contents together in warm water to has been NAS/NRC reviewed and found form suspension. Administer by stom- effective. Applications for these uses ach tube. Do not fast horses before or need not include effectiveness data as after treatment. Treatment of mares in specified by § 514.111 of this chapter. late pregnancy is not recommended. (e) Conditions of use—(1) Amount. 18.2 Surgery or any severe stress should be milligrams per pound of body weight. avoided for at least 2 weeks before or (2) Indications for use. For horses for after treatment. Do not administer to removal of bots (Gastrophilus nasalis, sick, toxic, or debilitated horses. Not

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to be used in horses intended for use as of hyperadrenocorticism due to food. Federal law restricts this drug to adrenocortical tumor. use by or on the order of a licensed vet- (3) Limitations. Federal law restricts erinarian. this drug to use by or on the order of a licensed veterinarian. [48 FR 2757, Jan. 21, 1983] [74 FR 21767, May 11, 2009, as amended at 74 § 520.2582 Triflupromazine hydro- FR 30464, June 26, 2009] chloride tablets. § 520.2604 Trimeprazine tartrate and (a) Specifications. Each tablet con- prednisolone tablets. tains either 10 milligrams or 25 milli- (a) Specifications. Each tablet con- grams of triflupromazine hydro- tains: trimeprazine tartrate, 5 milli- chloride. grams; and prednisolone, 2 milligrams. (b) Sponsor. See No. 053501 in (b) Sponsor. See No. 000069 in § 510.600(c) of this chapter. § 510.600(c) of this chapter. (c) Conditions of use. (1) The drug is (c) Conditions of use. (1) The drug is used in dogs and cats to relieve anxiety administered orally to dogs for the re- and to help control psychomotor over- lief of itching regardless of cause; re- activity as well as to increase the tol- duction of inflammation commonly as- erance of animals to pain and pruritus. sociated with most skin disorders of The drug is indicated in various office dogs such as eczema, caused by inter- and clinical procedures which require nal disorders, otitis, and dermatitis, al- the aid of a tranquilizer, antiemetic, or lergic, parasitic, pustular and nonspe- preanesthetic.1 cific. It is also used in dogs as adjunc- (2) The drug is administered orally to tive therapy in various cough condi- dogs and cats at a dosage level of 1 to tions including treatment of ‘‘kennel 2 milligrams per pound of body weight cough’’ or tracheobronchitis, bron- daily; an initial dosage at the 2-milli- chitis including allergic bronchitis, in grams level is suggested followed by tonsillitis, acute upper respiratory in- daily doses at the 1-milligram level. fections and coughs of nonspecific ori- Frequently, the drug may be with- gin. The product may also be adminis- drawn after 4 to 5 days, with drug ef- tered to dogs suffering from acute or fect continuing after withdrawal.1 chronic bacterial infections, provided (3) Do not use in conjunction with the infection is controlled by appro- organophosphates and/or procaine hy- priate antibiotic or chemotherapeutic drochloride, because phenothiazines agents.1 may potentiate the toxicity of (2) The drug is administered orally at organophosphates and the activity of an initial dosage level of 1⁄2 tablet procaine hydrochloride.1 twice daily to dogs weighing up to 10 (4) Federal law restricts this drug to pounds, one tablet twice daily to dogs use by or on the order of a licensed vet- weighing 11 to 20 pounds, two tablets erinarian.1 twice daily to dogs weighing 21 to 40 pounds, and three tablets twice daily [40 FR 13838, Mar. 27, 1975, as amended at 50 to dogs weighing over 40 pounds. After FR 41489, Oct. 11, 1985] 4 days, the dosage is reduced to ap- 1 § 520.2598 Trilostane. proximately ⁄2 the initial dosage or to an amount just sufficient to maintain (a) Specifications. Each capsule con- remission of symptoms. Dosages in in- tains 10, 30, or 60 milligrams (mg) dividual cases may vary and should be trilostane. adjusted until proper response is ob- (b) Sponsor. See No. 043264 in § 510.600 tained.1 of this chapter. (3) Do not use the drug in cases of (c) Conditions of use in dogs—(1) viral infections involving corneal ul- Amount. The starting dose is 1.0 to 3.0 ceration or dendritic ulceration of the milligrams per pound (2.2 to 6.7 milli- cornea.1 grams per kilogram) once a day. (4) Clinical and experimental data (2) Indications for use. For treatment have demonstrated that corticosteroids of pituitary-dependent administered orally or parenterally to hyperadrenocorticism. For treatment animals may induce the first stage of

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parturition when administered during terial infections, provided the infection the last trimester of pregnancy and is controlled by appropriate antibiotic may precipitate premature parturition or chemotherapeutic agents. followed by dystocia, fetal death, re- (3) Limitations. After 4 days, reduce tained placenta, and metritis.1 dosage to one-half the initial dose or to (5) Federal law restricts this drug to an amount sufficient to maintain re- use by or on the order of a licensed vet- mission of symptoms. Dosages in indi- erinarian.1 vidual cases may vary and should be [40 FR 13838, Mar. 27, 1975, as amended at 56 adjusted until proper response is ob- FR 50653, Oct. 8, 1991; 60 FR 55659, Nov. 2, tained. Do not use the drug in cases of 1995] viral infections involving corneal ul- ceration or dendritic ulceration of the § 520.2605 Trimeprazine tartrate and cornea. Clinical and experimental data prednisolone capsules. have demonstrated that corticosteroids (a) Specifications. Each capsule con- administered orally or parenterally to tains 3.75 milligrams of trimeprazine in animals may induce the first stage of sustained released form (as the tar- parturition when administered during trate) and 1 milligram of prednisolone the last trimester of pregnancy and (capsule no. 1) or 7.5 milligrams of may precipitate premature parturition trimeprazine in sustained release form followed by dystocia, fetal death, re- (as the tartrate) and 2 milligrams of tained placenta, and metritis. Federal prednisolone (capsule no. 2). law restricts this drug to use by or on (b) Sponsor. See 000069 in § 510.600(c) of the order of a licensed veterinarian. this chapter. (c) Conditions of use—(1) Amount. Ad- [48 FR 19367, Apr. 29, 1983, as amended at 56 FR 50653, Oct. 8, 1991; 60 FR 55659, Nov. 2, minister either capsule orally once 1995] daily to dogs as follows:

Number of capsules § 520.2610 Trimethoprim and sulfa- per dose diazine tablets. Animal weight (pounds) Capsule Capsule (a) Specifications. Each tablet con- No. 1 No. 2 tains 30 milligrams (5 milligrams of Up to 10 ...... 1 ...... trimethoprim and 25 milligrams of sul- 11 to 20 ...... 2 1 fadiazine), 120 milligrams (20 milli- 21 to 40 ...... 4 2 grams of trimethoprim and 100 milli- Over 40 ...... 6 3 grams of sulfadiazine), 480 milligrams (80 milligrams of trimethoprim and 400 (2) Indications for use. For the relief of milligrams of sulfadiazine) or 960 milli- itching regardless of cause, reduction grams (160 milligrams of trimethoprim of inflammation commonly associated and 800 milligrams of sulfadiazine). with most skin disorders of dogs such as eczema caused by internal disorders, (b) Sponsor. See Nos. 000061 and 000856 otitis, and dermatitis (allergic, para- in § 510.600(c) of this chapter. sitic, pustular, and nonspecific). It is (c) Conditions of use. (1) The drug is also used in dogs as adjunctive therapy used in dogs where systemic anti- in various cough conditions including bacterial action against sensitive orga- treatment of ‘‘kennel cough’’ or nisms is required, either alone or as an tracheobronchitis, bronchitis including adjunct to surgery or debridement with allergic bronchitis, tonsillitis, acute associated infection. The drug is indi- upper respiratory infections, and cated where control of bacterial infec- coughs of nonspecific origin. The prod- tion is required during the treatment uct may also be administered to dogs of acute urinary tract infections, acute suffering from acute or chronic bac- bacterial complications of distemper, acute respiratory tract infections, acute alimentary tract infections, 1 These conditions are NAS/NRC reviewed wound infections, and abscesses. and deemed effective. Applications for these uses need not include effectiveness data as (2) The drug is given orally at 30 mil- specified by § 514.111 of this chapter, but may ligrams per kilogram of body weight require bioequivalency and safety informa- per day (14 milligrams per pound per tion. day), or as follows:

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(2) No. 000061 for product adminis- Animal body weight (pounds) Number of tablets tered as in paragraph (c)(1)(ii) of this

30 MG TABLETS section. (c) Conditions of use in horses—(1) 2.2 ...... 1 Amount. Administer orally as a single 4.4 ...... 2 daily dose for 5 to 7 days: 6.6 ...... 3 (i) 5 g of paste (335 mg trimethoprim 8.8 ...... 4 and 1,665 mg sulfadiazine) per 150 120 MG TABLETS pounds (68 kilograms) of body weight per day. Up to 9 ...... 1 (ii) 3.75 g of paste (250 mg 10 to 19 ...... 2 trimethoprim and 1,250 mg sulfa- 20 to 29 ...... 3 30 to 40 ...... 4 diazine) per 110 pounds (50 kilograms) of body weight per day. 480 MG TABLETS (2) Indications for use. For use where systemic antibacterial action against 30 to 40 ...... 1 40 to 60 ...... 11⁄2 sensitive organisms is required during 60 to 80 ...... 2 treatment of acute strangles, res- 80 to 110 ...... 3 piratory infections, acute urogenital Over 110 ...... 4 infections, and wound infections and abscesses. (3) The drug is given once daily. Al- (3) Limitations. Not for use in horses ternatively, especially in severe infec- intended for human consumption. Fed- tions, the initial dose may be followed eral law restricts this drug to use by or by one-half the recommended daily on the order of a licensed veterinarian. dose every 12 hours. If no improvement is seen in 3 days, discontinue therapy [71 FR 30802, May 31, 2006] and reevaluate diagnosis. § 520.2612 Trimethoprim and sulfa- (4) Administer for 2 to 3 days after diazine suspension. symptoms have subsided. Do not treat for more than 14 consecutive days. (a) Specifications. Each milliliter (mL) of suspension contains: (5) During long term treatment, peri- (1) 10 milligrams (mg) trimethoprim odic platelet counts and white and red and 50 mg sulfadiazine; or blood cell counts are recommended. (2) 400 mg combined active ingredi- (6) The drug should not be used in pa- ents (67 mg trimethoprim and 333 mg tients showing marked liver paren- sulfadiazine). chymal damage or blood dyscrasia, nor (b) Sponsors. See sponsor numbers in in those with a history of sulfonamide § 510.600 of this chapter: sensitivity. (1) No. 000061 for use of product de- (7) Federal law restricts this drug to scribed in paragraph (a)(1) for use as in use by or on the order of a licensed vet- paragraph (c)(1) of this section. erinarian. (2) No. 051072 for use of product de- [41 FR 3853, Jan. 27, 1976, as amended at 44 scribed in paragraph (a)(2) for use as in FR 32214, June 5, 1979; 46 FR 23231, Apr. 24, paragraph (c)(2) of this section. 1981; 47 FR 36814, Aug. 24, 1982; 50 FR 9800, (c) Conditions of use—(1) Dogs—(i) Mar. 12, 1985; 50 FR 11852, Mar. 26, 1985; 61 FR Amount. Administer 1 mL (10 mg 5506, Feb. 13, 1996; 61 FR 8873, Mar. 6, 1996; 62 trimethoprim and 50 mg sulfadiazine) FR 61625, Nov. 19, 1997] per 5 pounds (lb) of body weight once daily, or one-half the recommended § 520.2611 Trimethoprim and sulfa- diazine paste. daily dose every 12 hours, for up to 14 consecutive days. (a) Specifications. Each gram (g) of (ii) Indications for use. The drug is paste contains 67 milligrams (mg) used in dogs where systemic anti- trimethoprim and 333 mg sulfadiazine. bacterial action against sensitive orga- (b) Sponsors. See sponsors in nisms is required, either alone or as an § 510.600(c) of this chapter: adjunct to surgery or debridement with (1) No. 000856 for product adminis- associated infection. The drug is indi- tered as in paragraph (c)(1)(i) of this cated where control of bacterial infec- section. tion is required during the treatment

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of acute urinary tract infections, acute trate equivalent to either 100 or 256 bacterial complications of distemper, grams tylosin base. acute respiratory tract infections, (b) Sponsors. See Nos. 000986, 016592, acute alimentary tract infections, and 061623 in § 510.600(c) of this chapter. wound infections, and abscesses. (1) No. 000986 for use of a 100-gram jar (iii) Limitations. Federal law restricts as in paragraph (d) of this section. this drug to use by or on the order of a (2) No. 016592 for use of a 100-gram jar licensed veterinarian. or pouch as in paragraphs (d)(1), (d)(2), (2) Horses—(i) Amount. Administer 24 (d)(3)(i), (d)(3)(ii)(B), (d)(3)(iii), and mg combined active ingredients per (d)(4) of this section. kilogram of body weight (2.7 mL/100 lb) (3) No. 061623 for use of a 100- or 256- twice daily for 10 days. gram jar or pouch as in paragraphs (ii) Indications for use. For the treat- (d)(1), (d)(2), (d)(3)(i), (d)(3)(ii)(B), ment of lower respiratory tract infec- (d)(3)(iii), and (d)(4) of this section. tions in horses caused by susceptible (c) Related tolerances. See § 556.740 of strains of Streptococcus equi subsp. this chapter. zooepidemicus. (d) Conditions of use—(1) Chickens—(i) (iii) Limitations. Do not use in horses Amount. 2 grams per gallon for 1 to 5 intended for human consumption. Fed- days as the sole source of drinking eral law restricts this drug to use by or water. Treated chickens should con- on the order of a licensed veterinarian. sume enough medicated drinking water [78 FR 63872, Oct. 25, 2013] to provide 50 milligrams (mg) tylosin per pound of body weight per day. § 520.2613 Trimethoprim and sulfa- (ii) Indications for use. For maintain- diazine powder. ing weight gain and feed efficiency in the presence of infectious sinusitis as- (a) Specifications. Each gram of pow- sociated with Mycoplasma gallisepticum der contains 67 milligrams of sensitive to tylosin. trimethoprim and 333 milligrams of sulfadiazine. (iii) Limitations. Prepare a fresh solu- tion every 3 days. Do not use in layers (b) Sponsor. See No. 000009 and 058711 producing eggs for human consump- in § 510.600(c) of this chapter. tion. Do not administer within 24 hours (c) Conditions of use: Horses—(1) Dos- of slaughter. age. 3.75 grams of powder per 110 pounds (2) Turkeys—(i) Amount. 2 grams per (50 kilograms) of body weight per day. gallon for 2 to 5 days as the sole source (2) Indications for use. For control of of drinking water. Treated turkeys bacterial infections of horses during should consume enough medicated treatment of acute strangles, res- drinking water to provide 60 mg tylosin piratory tract infections, acute uro- per pound of body weight per day. genital infections, wound infections, (ii) Indications for use. For maintain- and abscesses. ing weight gains and feed efficiency in (3) Limitations. Administer orally in a the presence of infectious sinusitis as- small amount of feed, as a single daily sociated with Mycoplasma gallisepticum dose, for 5 to 7 days. Continue therapy sensitive to tylosin. for 2 to 3 days after clinical signs have (iii) Limitations. Prepare a fresh solu- subsided. If no improvement is seen in tion every 3 days. Do not use in layers 3 to 5 days, reevaluate diagnosis. A producing eggs for human consump- complete blood count should be done tion. Do not administer within 5 days periodically with prolonged use. Not of slaughter. for use in horses intended for food. Fed- eral law restricts this drug to use by or (3) Swine—(i) Amount. 250 mg per gal- on the order of a licensed veterinarian. lon as the only source of drinking water for 3 to 10 days, depending on the [58 FR 36135, July 6, 1993, as amended at 64 severity of the condition being treated. FR 68289, Dec. 7, 1999] (ii) Indications for use. (A) For the treatment and control of swine dys- § 520.2640 Tylosin. entery associated with Brachyspira (a) Specifications. Each container of hyodysenteriae when followed imme- soluble powder contains tylosin tar- diately by tylosin phosphate medicated

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feed; and for the control of porcine pro- (3) Limitations. Federal law restricts liferative enteropathies (PPE, ileitis) this drug to use by or on the order of a associated with Lawsonia intracellularis licensed veterinarian. when followed immediately by tylosin [77 FR 55415, Sept. 10, 2012] phosphate medicated feed. (B) For the treatment and control of PART 522—IMPLANTATION OR swine dysentery associated with Brachyspira hyodysenteriae. INJECTABLE DOSAGE FORM NEW (iii) Limitations. Prepare a fresh solu- ANIMAL DRUGS tion daily. Do not administer within 48 Sec. hours of slaughter. As indicated in 522.23 Acepromazine. paragraph (d)(3)(ii)(A) of this section, 522.52 Alfaxalone. follow with tylosin phosphate medi- 522.56 Amikacin. cated feed as in § 558.625(f)(1)(vi)(c) of 522.62 Aminopentamide. this chapter. 522.82 Aminopropazine. (4) Honey bees—(i) Amount. Mix 200 522.84 Beta-aminopropionitrile. milligrams tylosin in 20 grams confec- 522.88 Amoxicillin. 522.90 Ampicillin injectable dosage forms. tioners’/powdered sugar. Use imme- 522.90a Ampicillin trihydrate suspension. diately. Apply (dust) this mixture over 522.90b Ampicillin trihydrate powder for in- the top bars of the brood chamber once jection. weekly for 3 weeks. 522.90c Ampicillin sodium. (ii) Indications for use. For the control 522.144 Arsenamide. of American foulbrood (Paenibacillus 522.147 Atipamezole. 522.150 Azaperone. larvae). 522.161 Betamethasone. (iii) Limitations. The drug should be 522.163 Betamethasone dipropionate and fed early in the spring or fall and con- betamethasone sodium phosphate aque- sumed by the bees before the main ous suspension. honey flow begins, to avoid contamina- 522.204 Boldenone. tion of production honey. Complete 522.234 Butamisole. 522.246 Butorphanol. treatments at least 4 weeks before 522.275 N-Butylscopolammonium. main honey flow. 522.300 Carfentanil. 522.304 Carprofen. [40 FR 13838, Mar. 27, 1975, as amended at 50 522.311 Cefovecin. FR 49841, Dec. 5, 1985; 59 FR 14365, Mar. 28, 522.313 Ceftiofur injectable dosage forms. 1994; 62 FR 39443, July 23, 1997; 68 FR 24879, 522.313a Ceftiofur crystalline free acid. May 9, 2003; 70 FR 69439, Nov. 16, 2005; 73 FR 522.313b Ceftiofur hydrochloride. 76946, Dec. 18, 2008; 75 FR 76259, Dec. 8, 2010; 522.313c Ceftiofur sodium. 76 FR 59024, Sept. 23, 2011; 77 FR 29217, May 522.380 Chloral hydrate, pentobarbital, and 17, 2012] magnesium sulfate. 522.390 Chloramphenicol. § 520.2645 Tylvalosin. 522.460 Cloprostenol. (a) Specifications. Granules containing 522.468 Colistimethate sodium powder for 62.5 percent tylvalosin (w/w) as injection. 522.480 Corticotropin. tylvalosin tartrate. 522.518 Cupric glycinate injection. (b) Sponsor. See No. 066916 in 522.522 Danofloxacin. § 510.600(c) of this chapter. 522.533 Deslorelin. (c) Related tolerances. See § 556.748 of 522.535 Desoxycorticosterone. this chapter. 522.536 Detomidine. 522.540 Dexamethasone solution. (d) Conditions of use in swine—(1) 522.542 Dexamethasone suspension. Amount. Administer 50 parts per mil- 522.558 Dexmedetomidine. lion tylvalosin in drinking water for 5 522.563 Diatrizoate. consecutive days. 522.650 Dihydrostreptomycin sulfate injec- (2) Indications for use. For the control tion. of porcine proliferative enteropathy 522.690 Dinoprost solution. 522.723 Diprenorphine. (PPE) associated with Lawsonia 522.770 . intracellularis infection in groups of 522.775 Doxapram. swine in buildings experiencing an out- 522.784 Doxylamine. break of PPE. 522.800 Droperidol and .

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