242 Part 522—Implantation Or Injectable Dosage Form

Pt. 522 21 CFR Ch. I (4–1–11 Edition)

PART 522—IMPLANTATION OR 522.723 Diprenorphine hydrochloride injection. INJECTABLE DOSAGE FORM NEW 522.770 Doramectin. ANIMAL DRUGS 522.775 Doxapram. 522.778 Doxycycline hyclate. Sec. 522.784 Doxylamine succinate injection. 522.23 Acepromazine. 522.800 Droperidol and fentanyl citrate in- 522.44 Sterile sodium acetazolamide. jection. 522.46 Alfaprostol. 522.810 Embutramide, chloroquine, and lido- 522.56 Amikacin. caine solution. 522.62 Aminopentamide hydrogen sulfate in- 522.812 Enrofloxacin. jection. 522.820 Erythromycin. 522.82 Aminopropazine fumarate sterile so- 522.840 Estradiol. lution injection. 522.842 Estradiol benzoate and testosterone 522.84 Beta-aminopropionitrile fumarate. propionate. 522.88 Sterile amoxicillin trihydrate for sus- 522.850 Estradiol valerate and norgestomet pension. in combination. 522.90 Ampicillin implantation and 522.863 Ethylisobutrazine hydrochloride in- injectible dosage forms. jection. 522.90a Ampicillin trihydrate sterile suspen- 522.870 Etodolac. sion. 522.883 Etorphine hydrochloride injection. 522.900 Euthanasia solution. 522.90b Ampicillin trihydrate. 522.914 Fenprostalene solution. 522.90c Ampicillin sodium. 522.930 Firocoxib. 522.144 Arsenamide sodium aqueous injec- 522.955 Florfenicol. tion. 522.956 Florfenicol and flunixin. 522.147 Atipamezole. 522.960 Flumethasone implantation or 522.150 Azaperone. injectable dosage forms. 522.161 Betamethasone acetate and 522.960a Flumethasone suspension. betamethasone disodium phosphate aque- 522.960b Flumethasone acetate injection. ous suspension. 522.960c Flumethasone solution. 522.163 Betamethasone dipropionate and 522.970 Flunixin. betamethasone sodium phosphate aque- 522.995 Fluprostenol sodium injection. ous suspension. 522.1002 Follicle stimulating hormone. 522.204 Boldenone. 522.1004 Fomepizole. 522.234 Butamisole hydrochloride. 522.1010 Furosemide. 522.246 Butorphanol. 522.1020 Gelatin solution. 522.275 N-Butylscopolammonium bromide. 522.1044 Gentamicin. 522.300 Carfentanil citrate injection. 522.1066 Glycopyrrolate. 522.304 Carprofen. 522.1077 Gonadorelin injectable. 522.311 Cefovecin. 522.1078 Gonadorelin diacetate tetra- 522.313 Ceftiofur injectable dosage forms. hydrate. 522.313a Ceftiofur crystalline free acid. 522.1079 Serum gonadotropin and chorionic 522.313b Ceftiofur hydrochloride. gonadotropin. 522.313c Ceftiofur sodium. 522.1081 Chorionic gonadotropin for injec- 522.380 Chloral hydrate, pentobarbital, and tion; chorionic gonadotropin suspension. magnesium sulfate sterile aqueous solu- 522.1085 Guaifenesin sterile powder. tion. 522.1086 Guaifenesin injection. 522.390 Chloramphenicol injection. 522.1125 Hemoglobin glutamer-200 (bovine). 522.460 Cloprostenol sodium. 522.1145 Hyaluronate sodium. 522.468 Colistimethate sodium powder for 522.1150 Hydrochlorothiazide injection. injection. 522.1155 Imidocarb dipropionate sterile pow- 522.480 Repository corticotropin injection. der. 522.518 Cupric glycinate injection. 522.1156 Imidocarb dipropionate solution. 522.522 Danofloxacin. 522.1160 Insulin. 522.533 Deslorelin. 522.1182 Iron injection. 522.535 Desoxycorticosterone pivalate. 522.1192 Ivermectin. 522.536 Detomidine hydrochloride injection. 522.1193 Ivermectin and clorsulon. 522.540 Dexamethasone injection. 522.1204 Kanamycin sulfate injection. 522.542 Dexamethasone-21-isonicotinate sus- 522.1222 Ketamine hydrochloride injectable pension. dosage forms. 522.558 Dexmedetomidine. 522.1222a Ketamine. 522.563 Diatrizoate meglumine and dia- 522.1222b Ketamine hydrochloride with trizoate sodium injection. promazine hydrochloride and 522.650 Dihydrostreptomycin sulfate injec- aminopentamide hydrogen sulfate injection. tion. 522.690 Dinoprost solution. 522.1225 Ketoprofen solution.

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522.1228 [Reserved] 522.1920 Prochlorperazine, isopropamide for 522.1244 Levamisole phosphate injection. injection. 522.1260 Lincomycin. 522.1940 Progesterone and estradiol ben- 522.1289 Lufenuron suspension. zoate. 522.1290 Luprostiol. 522.1962 Promazine hydrochloride. 522.1315 Maropitant. 522.2002 Propiopromazine hydrochloride in- 522.1335 Medetomidine hydrochloride injec- jection. tion. 522.2005 Propofol. 522.1350 Melatonin implant. 522.2012 Prostalene solution. 522.1362 Melarsomine dihydrochloride for 522.2063 Pyrilamine maleate injection. injection. 522.2076 Romifidine. 522.1367 Meloxicam. 522.2100 Selenium, vitamin E injection. 522.1372 Mepivacaine. 522.2112 Sometribove zinc suspension. 522.1380 Methocarbamol injection. 522.2120 Spectinomycin dihydrochloride in- 522.1410 Sterile methylprednisolone acetate jection. suspension. 522.2121 Spectinomycin sulfate. 522.1450 Moxidectin solution. 522.2150 Stanozolol sterile suspension. 522.1451 Moxidectin for suspension. 522.2200 Sulfachlorpyridazine. 522.1452 Nalorphine hydrochloride injection. 522.2220 Sulfadimethoxine injection. 522.1462 Naloxone hydrochloride injection. 522.2240 Sulfaethoxypyridazine. 522.1465 Naltrexone hydrochloride injection. 522.2260 Sulfamethazine. 522.1468 Naproxen for injection. 522.2340 Sulfomyxin. 522.1484 Neomycin sulfate sterile solution. 522.2404 Thialbarbitone sodium for injec- 522.1503 Neostigmine methylsulfate injection. tion. 522.2424 Sodium thiamylal for injection. 522.1610 Oleate sodium solution. 522.2444 Sodium thiopental implantation or 522.1620 Orgotein for injection. injectable dosage forms. 522.1642 Oxymorphone hydrochloride injec- 522.2444a Sodium thiopental for injection. tion. 522.2444b Sodium thiopental, sodium pento- 522.1660 Oxytetracycline injectable dosage barbital for injection. forms. 522.2470 Tiletamine hydrochloride and 522.1660a Oxytetracycline solution, 200 mil- zolazepam hydrochloride for injection. ligrams/milliliter. 522.2471 Tilmicosin. 522.2474 Tolazoline hydrochloride injection. 522.1660b Oxytetracycline solution, 300 mil- 522.2476 Trenbolone acetate. ligrams/milliliter. 522.2477 Trenbolone acetate and estradiol. 522.1662 Oxytetracycline hydrochloride im- 522.2478 Trenbolone acetate and estradiol plantation or injectable dosage forms. benzoate. 522.1662a Oxytetracycline hydrochloride in- 522.2483 Triamcinolone. jection. 522.2582 Triflupromazine hydrochloride in- 522.1662b Oxytetracycline hydrochloride jection. with lidocaine injection. 522.2610 Trimethoprim and sulfadiazine. 522.1662 Oxytetracycline and flunixin. 522.2615 Tripelennamine hydrochloride in- 522.1680 Oxytocin injection. jection. 522.1696 Penicillin G procaine implantation 522.2630 Tulathromycin. and injectable dosage forms. 522.2640 Tylosin. 522.1696a Penicillin G benzathine and peni- 522.2662 Xylazine. cillin G procaine suspension. 522.2670 Yohimbine injectable. 522.1696b Penicillin G procaine aqueous sus- 522.2680 Zeranol. pension. 522.2690 Zinc gluconate. 522.1696c Penicillin G procaine in oil. 522.1698 Pentazocine lactate injection. AUTHORITY: 21 U.S.C. 360b. 522.1704 Sodium pentobarbital injection. SOURCE: 40 FR 13858, Mar. 27, 1975, unless 522.1720 Phenylbutazone injection. otherwise noted. 522.1820 Pituitary luteinizing hormone for injection. 522.1850 Polysulfated glycosaminoglycan. § 522.23 Acepromazine. 522.1862 Sterile pralidoxime chloride. (a) Specifications. Each milliliter of 522.1870 Praziquantel injectable solution. solution contains 10 milligrams (mg) 522.1881 Sterile prednisolone acetate aque- acepromazine maleate. ous suspension. (b) Sponsors. See sponsors in 522.1883 Prednisolone sodium phosphate. § 510.600(c) of this chapter: 522.1884 Prednisolone sodium succinate injection. (1) No. 000010 for use as in paragraphs 522.1885 Prednisolone tertiary butylacetate (d) and (e) of this section. suspension. (2) No. 059130 for use as in paragraph 522.1890 Sterile prednisone suspension. (d) of this section.

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(c) Special considerations. Federal law (c) Conditions of use. It is used in restricts this drug to use by or on the horses as follows: order of a licensed veterinarian. (1) Amount. For average mature (d) Conditions of use. It is used in mares, 6.0 micrograms per kilogram of dogs, cats, and horses as follows: body weight. (1) Amount. Dogs: 0.25 to 0.5 mg per (2) Indications for use. To cause pound (/lb) of body weight; Cats: 0.5 to luteolysis in mares with active corpora 1.0 mg/lb of body weight; Horses: 2.0 to lutea. 4.0 mg per 100 lbs of body weight. (3) Limitations. For intramuscular or (2) Indications for use. As a tranquil- subcutaneous use as a single injection. izer. Not for horses intended for food. (e) Conditions of use. It is used in dogs Alfaprostol is readily absorbed through as follows: the skin and can cause abortion and/or (1) Amount. Dogs: 0.25 to 0.5 mg/lb of bronchial spasms. Women of child- body weight. bearing age, asthmatics, and persons (2) Indications for use. As an aid in with bronchial and other respiratory tranquilization and as a preanesthetic problems should exercise extreme cau- agent. tion when handling this product. Fed- [75 FR 10167, Mar. 5, 2010] eral law restricts this drug to use by or on the order of a licensed veterinarian. § 522.44 Sterile sodium acetazolamide. [48 FR 43300, Sept. 23, 1983, as amended at 53 (a) Specifications. Sterile sodium acet- FR 40057, Oct. 13, 1988] azolamide contains acetazolamide sodium complying with United States § 522.56 Amikacin. Pharmacopeia as a sterile powder with (a) Specifications. Each milliliter of directions for reconstituting the prod- solution contains 50 milligrams (mg) of uct with sterile distilled water to fur- amikacin as amikacin sulfate. nish a product having a concentration (b) Sponsors. See Nos. 000856 and of 100 milligrams acetazolamide activ- 059130 in § 510.600(c) of this chapter. ity per milliliter. (c) Conditions of use in dogs—(1) (b) Sponsor. See No. 010042 in Amount. 5 mg/pound (lb) of body weight § 510.600(c) of this chapter. twice daily by intramuscular or sub- (c) Conditions of use. (1) It is used as cutaneous injection. an aid in the treatment of dogs with (2) Indications for use. For treatment mild congestive heart failure and for of genitourinary tract infections (cys- rapid reduction of intraocular pres- titis) caused by susceptible strains of sure.1 Escherichia coli and Proteus spp. and (2) It is administered skin and soft tissue infections caused intramuscularly or intraperitoneally by susceptible strains of Pseudomonas to dogs at a level of 5 to 15 milligrams spp. and E. coli. per pound of body weight daily pref- (3) Limitations. Do not use in horses erably administered in two or more di- intended for human consumption. Fed- vided doses.1 eral law restricts this drug to use by or (3) For use only by or on the order of on the order of a licensed veterinarian. a licensed veterinarian.1 [76 FR 17338, Mar. 29, 2011] § 522.46 Alfaprostol. § 522.62 Aminopentamide hydrogen (a) Specifications. Each milliliter of sulfate injection. sterile solution contains 1 milligram of alfaprostol. (a) Chemical name. 4- (b) Sponsor. No. 055882 in § 510.600(c) of (Dimethylamino)-2,2- this chapter. diphenylvaleramide hydrogen sulfate. (b) Specifications. It is sterile and each milliliter of aqueous solution con- 1 These conditions are NAS/NRC reviewed tains 0.5 milligram of the drug. and deemed effective. Applications for these uses need not include effectiveness data as (c) Sponsor. See No. 000856 in specified by § 514.111 of this chapter, but may § 510.600(c) of this chapter. require bioequivalency and safety informa- (d) Conditions of use. (1) It is intended tion. for use in dogs and cats only for the

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treatment of vomiting and/or diarrhea, (3) Not for use in animals intended nausea, acute abdominal visceral for food purposes.1 spasm, pylorospasm, or hypertrophic (4) For use only by or on the order of gastritis. a licensed veterinarian.1

NOTE: Not for use in animals with glau- [40 FR 13858, Mar. 27, 1975, as amended at 46 coma because of the occurrence of mydriasis. FR 48642, Oct. 2, 1981; 61 FR 8873, Mar. 6, 1996; 62 FR 61625, Nov. 19, 1997] (2) Dosage is administered by subcutaneous or intramuscular injection § 522.84 Beta-aminopropionitrile fuma- every 8 to 12 hours, as follows: rate.

Dosage in (a) Specifications. Each vial contains Weight of animal in pounds milligrams 7.0 milligrams of beta- aminopropionitrile fumarate sterile Up to 10 ...... 0.1 11 to 20 ...... 0.2 lyophilized powder which is reconsti- 21 to 50 ...... 0.3 tuted for injection with 10 milliliters of 51 to 100 ...... 0.4 sterile physiologic saline, USP. Over 100 ...... 0.5 (b) Sponsor. See No. 064146 in § 510.600(c) of this chapter. Dosage may be gradually increased up (c) [Reserved] to a maximum of five times the sug- (d) Conditions of use—(1) Horses—(i) gested dosage. Following parenteral Amount. 7 milligrams (10 milliliters) use dosage may be continued by oral intralesionally every other day for 5 administration of tablets. treatments beginning about 30 days (3) For use only by or on the order of after initial injury. a licensed veterinarian. (ii) Indications for use. For treatment of tendinitis of the superficial digital [40 FR 13858, Mar. 27, 1975, as amended at 53 FR 27851, July 25, 1988] flexor tendon (SDFT) in the adult horse where there is sonographic evi- § 522.82 Aminopropazine fumarate dence of fiber tearing. sterile solution injection. (iii) Limitations. Single dose con- (a) Specifications. Each milliliter of tainer for intralesional injection. Do aminopropazine fumarate sterile aque- not use in horses with dermal irrita- ous solution, veterinary, contains tion or open skin lesions in the injec- aminopropazine fumarate equivalent to tion area. Do not administer 25 milligrams of aminopropazine base. intraarticularly, into the tendon sheath, or in the presence of concur- (b) Sponsor. See No. 000061 in rent limb fractures. Do not use in § 510.600(c) of this chapter. breeding animals since the effects on (c) Conditions of use. (1) The drug is fertility, pregnancy, or fetal health used for reducing excessive smooth have not been determined. Not for use muscle contractions, such as occur in in horses intended for food. Federal law urethral spasms associated with uroli- restricts this drug to use by or on the thiasis in cats and dogs and in colic order of a licensed veterinarian. spasms in horses.1 (2) [Reserved] (2) It is administered intramuscularly or intravenously to [63 FR 44382, Aug. 19, 1998] dogs and cats at a level of 1 to 2 milligrams per pound of body weight. It is § 522.88 Sterile amoxicillin trihydrate administered intramuscularly or intra- for suspension. venously to horses at a level of 0.25 (a)(1) Specifications. Each vial con- milligrams per pound of body weight. tains 3 grams of amoxicillin as the tri- Dosage can be repeated every 12 hours, hydrate. The powder is reconstituted as indicated.1 with sterile water for injection USP to a concentration of 100 or 250 milligrams per milliliter for use as in paragraph 1 These conditions are NAS/NRC reviewed (d) of this section. and deemed effective. Applications for these uses need not include effectiveness data as (2) Each vial contains 25 grams of specified by § 514.111 of this chapter, but may amoxicillin as the trihydrate. The pow- require bioequivalency and safety informa- der is reconstituted with sterile water tion. for injection USP to a concentration of

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250 milligrams per milliliter for use as (e) Condition of use. Cattle—(1) in paragraph (e). Amount. 3 to 5 milligrams per pound of (b) Sponsor. See 000069 in § 510.600(c) of body weight once a day according to this chapter. the animal being treated, the severity (c) Related tolerance. See § 556.38 of of infection, and the animal’s response. this chapter. (2) Indications for use. Treatment of (d) Conditions of use in dogs and cats— diseases due to amoxicillin-susceptible (1) Amount. 5 milligrams per pound of organisms as follows: Respiratory tract body weight daily. infections (shipping fever, pneumonia) (2) Indications for use—(i) Dogs. Treat- due to P. multocida, P. hemolytica, ment of infections caused by suscep- Hemophilus spp., Staphylococcus spp., tible strains of organisms as follows: and Streptococcus spp. and acute necrot- Respiratory infections (tonsillitis, ic pododermatitis (foot rot) due to tracheobronchitis) due to Staphy- Fusobacterium necrophorum. lococcus aureus, Streptococcus spp., Esch- (3) Limitations. Administer once daily erichia coli, and Proteus mirabilis; geni- for up to 5 days by intramuscular or tourinary infections (cystitis) due to S. subcutaneous injection. Continue aureus, Streptococcus spp., E. coli, and P. treatment for 48 to 72 hours after the mirabilis; gastrointestinal infections animal has become afebrile or asymp- (bacterial gastroenteritis) due to S. tomatic. Do not continue treatment aureus, Streptococcus spp., E. coli, and P. beyond 5 days. Treated animals must mirabilis; bacterial dermatitis due to S. not be slaughtered for food during aureus, Streptococcus spp., and P. treatment and for 25 days after the last mirabilis; soft tissue infections (ab- treatment. As with all antibiotics, ap- scesses, lacerations, and wounds), due propriate in vitro culturing and suscep- to S. aureus, Streptococcus spp., E. coli, tibility testing of samples taken before and P. mirabilis. treatment should be conducted. Milk (ii) Cats. Treatment of infections from treated cows must not be used for caused by susceptible strains of orga- human consumption during treatment nisms as follows: Upper respiratory in- or for 96 hours (8 milkings) after last fections due to S. aureus, Staphy- treatment. Maximum volume per injec- lococcus spp., Streptococcus spp., tion should not exceed 30 milliliters. Hemophilus spp., E. coli, Pasteurella spp., Federal law restricts this drug to use and P. mirabilis; genitourinary infec- by or on the order of a licensed veteri- tions (cystitis) due to S. aureus, Strepto- narian. coccus spp., E. coli, P. mirabilis, and Corynebacterium spp.; gastrointestinal [57 FR 37330, Aug. 18, 1992; 60 FR 55659, Nov. infections due to E. coli, Proteus spp., 2, 1995] Staphylococcus spp., and Streptococcus spp.; skin and soft tissue infections (ab- § 522.90 Ampicillin implantation and injectible dosage forms. scesses, lacerations, and wounds) due to S. aureus, Staphylococcus spp., Strep- § 522.90a Ampicillin trihydrate sterile tococcus spp., E. coli, and Pasteurella suspension. multocida. (a) Each milliliter con- (3) Limitations. For use in dogs and Specifications. cats only. Administer once daily for up tains ampicillin trihydrate equivalent to 5 days by intramuscular or subcuta- to 200 milligrams of ampicillin. neous injection. Continue treatment (1) Sponsor. See No. 053501 in for 48 hours after the animal has be- § 510.600(c) of this chapter. come afebrile or asymptomatic. If no (2) Related tolerances. See § 556.40 of improvement is seen within 5 days, re- this chapter. view the diagnosis and change therapy. (3) Conditions of use—(i) Calves. (A) As with all antibiotics, appropriate in Amount. For enteritis: 3 milligrams per vitro culturing susceptibility testing of pound of body weight, intramuscularly, samples taken before treatment should once or twice daily, for up to 3 days. be conducted. Federal law restricts this For pneumonia: 3 milligrams per pound drug to use by or on the order of a li- of body weight, intramuscularly, twice censed veterinarian. daily, for up to 3 days.

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(B) Indications for use. Treatment of monia caused by Pasteurella spp. sus- bacterial enteritis caused by Esch- ceptible to ampicillin. erichia coli and bacterial pneumonia (C) Limitations. Treated animals must caused by Pasteurella spp. susceptible not be slaughtered for food use during to ampicillin. treatment or for 15 days after the last (C) Limitations. Not for use in other treatment. Federal law restricts this animals raised for food production. drug to use by or on the order of a li- Treated animals must not be slaugh- censed veterinarian. tered for food use during treatment or (b) Specifications. Each milliliter con- for 9 days after the last treatment. tains ampicillin trihydrate equivalent Federal law restricts this drug to use to 150 milligrams of ampicillin. by or on the order of a licensed veteri- (1) Sponsor. See No. 000069 in narian. § 510.600(c) of this chapter. (ii) Dogs. (A) Amount. 3 to 6 milli- (2) Related tolerances. See § 556.40 of grams per pound of body weight this chapter. intramuscularly, once or twice daily. (3) Conditions of use. Dogs—(i) Amount. (B) Indications for use. Treatment of 3 to 5 milligrams of ampicillin per respiratory tract infections due to E. pound of body weight, once a day for up coli, Pseudomonas spp., Proteus spp., to 4 days. Staphylococcus spp., and Streptococcus (ii) Indications for use. Treatment of spp.; tonsillitis due to E. coli, bacterial infections of the upper res- Pseudomonas spp., Streptococcus spp., piratory tract (tonsillitis) due to Strep- and Staphylococcus spp.; generalized in- tococcus spp., Staphylococcus spp., E. fections (septicemia) associated with coli, Proteus spp., and Pasteurella spp., abscesses, lacerations, and wounds due and soft tissue infections (abscesses, to Staphylococcus spp. and Streptococcus lacerations, and wounds) due to Staphy- spp. lococcus spp., Streptococcus spp., and E. (C) Limitations. Continue treatment coli, when caused by susceptible orga- at least 48 hours after the animal’s nisms. temperature has returned to normal (iii) Limitations. Administer and other signs of infection have sub- intramuscularly. If continued treat- sided. Usual treatment is 3 to 5 days. ment is indicated, oral dosage is rec- Federal law restricts this drug to use ommended. As with all antibiotics, ap- by or on the order of a licensed veteri- propriate in vitro culturing and suscep- narian. tibility tests of samples taken before (iii) Cats. (A) Amount. 5 to 10 milli- treatment are recommended. Federal grams per pound of body weight law restricts this drug to use by or on intramuscularily or subcutaneously, the order of a licensed veterinarian. once or twice daily. [57 FR 37330, Aug. 18, 1992, as amended at 60 (B) Indications for use. Treatment of FR 55659, Nov. 2, 1995] generalized infections (septicemia) associated with abscesses, lacerations, § 522.90b Ampicillin trihydrate. and wounds due to Staphylococcus spp., (a) Specifications. Each milliliter of Streptococcus spp., and Pasteurella spp. aqueous suspension constituted from (C) Limitations. Continue treatment ampicillin trihydrate powder contains at least 48 hours after the animal’s 50, 100, or 250 milligrams (mg) ampi- temperature has returned to normal cillin equivalents. and other signs of infection have sub- (b) Sponsors. See Nos. 000010 and sided. Usual treatment is 3 to 5 days. 010515 in § 510.600(c) of this chapter. Federal law restricts this drug to use (c) Related tolerances. See § 556.40 of by or on the order of a licensed veteri- this chapter. narian. (d) Conditions of use—(1) Dogs and (iv) Swine. (A) Amount. 3 milligrams cats—(i) Amount. 3 mg/pound (lb) of per pound of body weight, body weight twice daily by subcuta- intramuscularily, once or twice daily, neous or intramuscular injection. for up to 3 days. (ii) Indications for use. For treatment (B) Indications for use. Treatment of of strains of organisms susceptible to bacterial enteritis (colibacillosis) ampicillin and associated with res- caused by E. coli and bacterial pneu- piratory tract infections, urinary tract

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infections, gastrointestinal infections, eral law restricts this drug to use by or skin infections, soft tissue infections, on the order of a licensed veterinarian. and postsurgical infections. [72 FR 45158, Aug. 13, 2007] (iii) Limitations. Federal law restricts this drug to use by or on the order of a § 522.144 Arsenamide sodium aqueous licensed veterinarian. injection. (2) Cattle—(i) Amount. 2 to 5 mg/lb of (a) Chemical name. [[(p- body weight once daily by Carbamoylphenyl) arsylene]dithio di- intramuscular injection. acetic acid, sodium salt. (ii) Indications for use. For treatment of respiratory tract infections caused (b) Specifications. The drug is a sterile by organisms susceptible to ampicillin, aqueous solution and each milliliter bacterial pneumonia (shipping fever, contains 10.0 milligrams of arsenamide calf pneumonia, and bovine pneu- sodium. monia) caused by Aerobacter spp., (c) Sponsor. See No. 050604 in Klebsiella spp., Staphylococcus spp., § 510.600(c) of this chapter. Streptococcus spp., Pasteurella multocida, (d) Conditions of use. (1) For the treat- and Escherichia coli. ment and prevention of canine heart- (iii) Limitations. Do not treat cattle worm disease caused by Dirofilaria for more than 7 days. Milk from treat- immitis. ed cows must not be used for food dur- (2) It is administered intravenously ing treatment or for 48 hours (4 at 0.1 milliliter per pound of body milkings) after the last treatment. weight (1.0 milliliter for every 10 Cattle must not be slaughtered for food pounds) twice a day for 2 days. For during treatment or for 144 hours (6 dogs in poor condition, particularly days) after the last treatment. Federal those with evidence of reduced liver law restricts this drug to use by or on function, a more conservative dosage the order of a licensed veterinarian. schedule of 0.1 milliliter per pound of body weight daily for 15 days is rec- [57 FR 37331, Aug. 18, 1992; 57 FR 42623, Sept. 15, 1992; 58 FR 18304, Apr. 8, 1993; 63 FR 41420, ommended. Aug. 4, 1998; 75 FR 10167, Mar. 5, 2010; 76 FR (3) Restricted to use only by or on 17338, Mar. 29, 2011] the order of a licensed veterinarian.

§ 522.90c Ampicillin sodium. [40 FR 13858, Mar. 27, 1975, as amended at 43 FR 27785, June 27, 1978; 45 FR 56798, Aug. 26, (a) Specifications. Each milliliter of 1980; 55 FR 26683, June 29, 1990] aqueous solution constituted from ampicillin sodium powder contains 300 § 522.147 Atipamezole. milligrams (mg) ampicillin equiva- (a) Specifications. Each milliliter of lents. solution contains 5.0 milligrams (b) Sponsors. See Nos. 000069 and atipamezole hydrochloride. 010515 in § 510.600(c) of this chapter. (b) Sponsor. See No. 052483 in (c) Conditions of use in horses—(1) § 510.600(c) of this chapter. Amount: 3 mg per pound of body weight (c) Conditions of use in dogs—(1) twice daily by intravenous or Amount. Inject intramuscularly the intramuscular injection. same volume as that of (2) Indications for use. For the treat- dexmedetomidine or medetomidine ment of respiratory tract infections used. (pneumonia and strangles) due to (2) Indications for use. For reversal of Staphylococcus spp., Streptococcus spp. the sedative and analgesic effects of (including S. equi), Escherichia coli, and dexmedetomidine hydrochloride or Proteus mirabilis, and skin and soft tis- medetomidine hydrochloride. sue infections (abscesses and wounds) due to Staphylococcus spp., Streptococcus (3) Limitations. Federal law restricts spp., E. coli, and P. mirabilis, when this drug to use by or on the order of a caused by susceptible organisms. licensed veterinarian. (3) Limitations. Do not use in horses [61 FR 48830, Sept. 17, 1996, as amended at 64 intended for human consumption. Fed- FR 71640, Dec. 22, 1999; 72 FR 264, Jan. 4, 2007]

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§ 522.150 Azaperone. use in horses intended for food. For use only by or on the order of a licensed (a) Specifications. Each milliliter of solution contains 40 milligrams (mg) veterinarian. azaperone. [40 FR13858, Mar. 27, 1975, as amended at 52 (b) Sponsor. See No. 012578 in FR 7832, Mar. 13, 1987] § 510.600(c) of this chapter. (c) Conditions of use—(1) Indications § 522.163 Betamethasone dipropionate for use. For control of aggressiveness and betamethasone sodium phos- when mixing or regrouping weanling or phate aqueous suspension. feeder pigs weighing up to 80 pounds. (a) Specifications. Betamethasone (2) Dosage. 2.2 mg per kilogram (1 mg dipropionate and betamethasone so- per pound) by deep intramuscular in- dium phosphate aqueous suspension is jection. a sterile aqueous suspension. Each mil- (3) Limitations. Federal law restricts liliter of the suspension contains the this drug to use by or on the order of a equivalent of 5 milligrams of licensed veterinarian. betamethasone as betamethasone [74 FR 65689, Dec. 11, 2009] dipropionate and 2 milligrams of betamethasone as betamethasone so- § 522.161 Betamethasone acetate and dium phosphate. betamethasone disodium phosphate (b) Sponsor. See No. 000061 in aqueous suspension. § 510.600(c) of this chapter. (a) Chemical names. Betamethasone (c) Conditions of use—(1) Dogs. (i) It is acetate: 9-a-Fluoro-16-b- used as an aid in the control of pru- methylprednisolone - 21 - acetate ritus associated with dermatoses. (C24H31FO6). Betamethasone disodium (ii) It is administered by phosphate: 9-a-Fluoro-16-b- intramuscular injection at a dosage of methylprednisolone-21-disodium phos- 0.25 to 0.5 milliliter per 20 pounds of phate (C22H28FNa2O8P). body weight, depending on the severity (b) Specifications. The drug is a sterile of the condition. Frequency of dosage aqueous suspension and each cubic cen- depends on recurrence of pruritic timeter contains: 12 milligrams of symptoms. Dosage may be repeated betamethasone acetate (equivalent to every 3 weeks or when symptoms recur, 10.8 milligrams of betamethasone), 3.9 not to exceed a total of 4 injections. milligrams of betamethasone disodium (2) Horses. (i) It is used as an aid in phosphate (equivalent to 3 milligrams the control of inflammation associated of betamethasone), 2 milligrams of di- with various arthropathies. basic sodium phosphate, 5 milligrams of sodium chloride, 0.1 milligram of di- (ii) It is administered aseptically by sodium EDTA, 0.5 milligram of poly- intraarticular injection at a dosage of sorbate 80, 9 milligrams of benzyl alco- 2.5 to 5 milliliters per joint, depending hol, 5 milligrams of sodium on the severity of the condition and carboxymethylcellulose, 1.8 milligrams the joint size. Dosage may be repeated of methylparaben, 0.2 milligram of upon recurrence of clinical signs. Injec- propylparaben, hydrochloric acid and/ tion into the joint cavity should be or sodium hydroxide to adjust pH, and preceded by withdrawal of synovial water for injection q.s. fluid. (c) Sponsor. See No. 000061 in (iii) Not for use in horses intended for § 510.600(c) of this chapter. food. (d) Conditions of use. It is used or in- (3) Clinical and experimental data. It tended for use by intra-articular injec- has been demonstrated that tion of horses for the treatment of var- corticosteroids administered orally or ious inflammatory joint conditions; for parenterally to animals may induce example, acute and traumatic lame- the first stage of parturition when ad- ness involving the carpel and fetlock ministered during the last trimester of joints. Administer from 2.5 to 5 cubic pregnancy and may precipitate pre- centimeters per dose. Dose may be re- mature parturition followed by peated when necessary depending upon dystocia, fetal death, retained pla- the duration of relief obtained. Not for centa, and metritis.

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(4) Restrictions. Federal law restricts § 522.246 Butorphanol. this drug to use by or on the order of a (a) Specifications. Each milliliter of licensed veterinarian. solution contains butorphanol (as [40 FR 13858, Mar. 27, 1975, as amended at 41 butorphanol tartrate) in the following FR 27316, July 2, 1976; 52 FR 7832, Mar. 13, amounts: 1987] (1) 0.5 milligrams (mg); (2) 2 mg; or § 522.204 Boldenone. (3) 10 mg (a) Specifications. Each milliliter of (b) Sponsors. See sponsors in solution contains 25 or 50 milligrams § 510.600(c) of this chapter as follows: (mg) boldenone undecylenate. (1) No. 000856 for use of the product (b) Sponsor. See No. 053501 in described in paragraph (a)(1) as in para- § 510.600(c) of this chapter. graph (d)(1) of this section; for use of (c) Conditions of use in horses—(1) the product described in paragraph (a)(2) as in paragraph (d)(2) of this sec- Amount. 0.5 mg per pound body weight tion; and for use of the product de- by intramuscular injection. Treatment scribed in paragraph (a)(3) as in para- may be repeated at 3-week intervals. graph (d)(3) of this section. (2) Indications for use. As an aid for (2) Nos. 015914 and 059130 for use of treating debilitated horses when an im- the product described in paragraph provement in weight, hair coat, or gen- (a)(2) as in paragraph (d)(2) of this sec- eral physical condition is desired. tion. (3) Limitations. Do not administer to (3) Nos. 000061, 059130, and 061690 for horses intended for human consump- use of the product described in para- tion. Federal law restricts this drug to graph (a)(3) as in paragraph (d)(3) of use by or on the order of a licensed vet- this section. erinarian. (c) Special considerations. Federal law [70 FR 70998, Nov. 25, 2005] restricts this drug to use by or on the order of a licensed veterinarian. § 522.234 Butamisole hydrochloride. (d) Conditions of use—(1) Dogs—(i) Amount. Administer 0.025 mg per pound (a) Specifications. The drug contains of body weight by subcutaneous injec- 11 milligrams of butamisole per milli- tion at intervals of 6 to 12 hours, as re- liter in a solution consisting of 70 per- quired. If necessary, increase dose to a cent propylene glycol, 4 percent benzyl maximum of 0.05 mg per pound of body alcohol and distilled water. weight. Treatment should not nor- (b) Sponsor. See Nos. 000859 and 053501 mally be required for longer than 7 in § 510.600(c) of this chapter. days. (c) Conditions of use. (1) The drug is (ii) Indications for use. For the relief administered by subcutaneous injec- of chronic nonproductive cough associ- tion to dogs for the treatment of infec- ated with tracheo-bronchitis, trations with whipworms (Trichuris cheitis, tonsillitis, laryngitis, and vulpis), and the hookworm (Ancylostoma pharyngitis associated with inflam- caninum). matory conditions of the upper res- (2) The drug is administered piratory tract. subcutaneously at the rate of 0.1 milli- (2) Cats—(i) Amount. Administer 0.2 liter per pound of body weight. In prob- mg per pound of body weight by sub- lem cases, retreatment for whipworms cutaneous injection. Dose may be re- may be necessary in approximately 3 peated up to 4 times per day. Do not months. For hookworms, a second in- treat for more than 2 days. jection should be given 21 days after (ii) Indications for use. For the relief the initial treatment. of pain in cats caused by major or (3) Federal law restricts this drug to minor trauma, or pain associated with use by or on the order of a licensed vet- surgical procedures. erinarian. (3) Horses—(i) Amount. Administer [43 FR 15625, Apr. 14, 1978. Redesignated at 43 0.05 mg per pound of body weight by in- FR 60883, Dec. 29, 1978, and amended at 45 FR travenous injection. Dose may be re- 29789, May 6, 1980; 51 FR 19329, May 29, 1986; peated within 3 to 4 hours. Treatment 67 FR 63055, Oct. 10, 2002] should not exceed 48 hours.

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(ii) Indications for use. For the relief are inadequate to recommend use in of pain associated with colic and pregnant animals. Avoid use during postpartum pain in adult horses and breeding season. Federal law restricts yearlings. this drug to use by or on the order of a (iii) Limitations. Do not use in horses licensed veterinarian. The licensed vet- intended for human consumption. erinarian shall be a veterinarian engaged in zoo and exotic animal prac- [72 FR 27957, May 18, 2007, as amended at 73 FR 31358, June 2, 2008; 74 FR 61516, Nov. 25, tice, wildlife management programs, or 2009; 75 FR 22524, Apr. 29, 2010] research. [53 FR 40057, Oct. 13, 1988. Redesignated at 73 § 522.275 N-Butylscopolammonium bro- FR 29685, May 22, 2008] mide. (a) Specifications. Each milliliter of § 522.304 Carprofen. solution contains 20 milligrams (mg) (a) Specifications. Each milliliter of N-butylscopolammonium bromide. solution contains 50 milligrams (mg) (b) Sponsor. See No. 000010 in carprofen. § 510.600(c) of this chapter. (b) Sponsor. See No. 000069 in (c) Conditions of use in horses—(1) § 510.600(c) of this chapter. Amount. 0.3 mg per kilogram of body (c) [Reserved] weight (0.14 mg per pound) slowly in- (d) Conditions of use in dogs—(1) travenously. Amount. 2 mg/lb (4.4 mg/kg) body (2) Indications for use. For the control weight once daily or 1 mg/lb (2.2 mg/kg) of abdominal pain (colic) associated twice daily, by subcutaneous injection. with spasmodic colic, flatulent colic, For the control of postoperative pain, and simple impactions. administer approximately 2 hours be- (3) Limitations. Federal law restricts fore the procedure. this drug to use by or on the order of a (2) Conditions of use. For the relief of licensed veterinarian. pain and inflammation associated with [69 FR 35512, June 25, 2004] osteoarthritis and for the control of postoperative pain associated with soft § 522.300 Carfentanil citrate injection. tissue and orthopedic surgeries. (a) Specifications. Each milliliter of (3) Limitations. Federal law restricts sterile aqueous solution contains 3 mil- this drug to use by or on the order of a ligrams of carfentanil citrate. licensed veterinarian. (b) Sponsor. See No. 053923 in [68 FR 26205, May 15, 2003, as amended at 68 § 510.600(c) of this chapter. FR 34796, June 11, 2003; 68 FR 49351, Aug. 18, (c) Conditions of use—(1) Amount. 5 to 2003. Redesignated at 73 FR 29685, May 22, 20 micrograms per kilogram (.005 to 2008] .020 milligram per kilogram) of body weight. § 522.311 Cefovecin. (2) Indications for use. For immo- (a) Specifications. Each milliliter of bilizing free ranging and confined constituted solution contains 80 milli- members of the family Cervidae (deer, grams (mg) cefovecin as the sodium elk, and moose). salt. (3) Limitations. Inject into large mus- (b) Sponsor. See No. 000069 in cle of neck, shoulder, back, or hind- § 510.600(c) of this chapter. quarter. Avoid intrathoracic, intra-ab- (c) Special considerations. Federal law dominal, or subcutaneous injection. To restricts this drug to use by or on the reverse effect, use 7 milligrams of order of a licensed veterinarian. diprenorphine for each milligram of (d) Conditions of use—(1) Dogs—(i) carefentanil citrate, given intra- Amount. Administer 3.6 mg/pound (lb) (8 venously or one-half intravenously and mg/kilograms (kg)) body weight as a one-half intramuscularly or single subcutaneous injection. A sec- subcutaneously. Do not use in domestic ond subcutaneous injection of 3.6 mg/lb animals intended for food. Do not use (8 mg/kg) may be administered if re- 30 days before or during hunting sea- sponse to therapy is not complete. son. Do not use in animals that display (ii) Indications for use. For the treat- clinical signs of severe cardiovascular ment of skin infections (secondary su- or respiratory disease. Available data perficial pyoderma, abscesses, and

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wounds) in dogs caused by susceptible pect of the ear where it attaches to the strains of Staphylococcus intermedius head (base of the ear) in beef and non- and Streptococcus canis (Group G). lactating dairy cattle. For subcuta- (2) Cats—(i) Amount. Administer 3.6 neous injection in the posterior aspect mg/lb (8 mg/kg) body weight as a sin- of the ear where it attaches to the head gle, one-time subcutaneous injection. (base of the ear) in lactating dairy cat- (ii) Indications for use. For the treat- tle. ment of skin infections (wounds and (ii) Indications for use. For the treat- abscesses) in cats caused by susceptible ment of bovine respiratory disease strains of Pasteurella multocida. (BRD, shipping fever, pneumonia) associated with Mannheimia haemolytica, [73 FR 29685, May 22, 2008] Pasteurella multocida, and Histophilus § 522.313 Ceftiofur injectable dosage somni in beef, non-lactating dairy, and forms. lactating dairy cattle. For the control of respiratory disease in beef and non- § 522.313a Ceftiofur crystalline free lactating dairy cattle which are at acid. high risk of developing BRD associated (a) Specifications. The product is a with M. haemolytica, P. multocida, and suspension of ceftiofur crystalline free H. somni. For the treatment of bovine acid. foot rot (interdigital necrobacillosis) (1) Each milliliter (mL) contains 100 associated with Fusobacterium milligrams (mg) ceftiofur equivalents. necrophorum and Porphyromonas levii in (2) Each mL contains 200 mg ceftiofur beef, non-lactating dairy, and lactating equivalents. dairy cattle. (b) Sponsor. See No. 000009 in (iii) Limitations. Following label use § 510.600(c) of this chapter. as a single treatment, a 13-day pre- (c) Related tolerances. See § 556.113 of slaughter withdrawal period is re- this chapter. quired. A withdrawal period has not (d) Special considerations. Federal law been established in preruminating restricts this drug to use by or on the calves. Do not use in calves to be proc- order of a licensed veterinarian. essed for veal. (e) Conditions of use—(1) Swine. The (3) Horses. The formulation described formulation described in paragraph in paragraph (a)(2) of this section is (a)(1) of this section is used as follows: used as follows: (i) Amount. 5.0 mg CE per kilogram (i) Amount. Two intramuscular injec- (kg) of body weight by intramuscular tions, 4 days apart, at a dose of 3.0 mg/ injection in the postauricular region of lb (6.6 mg/kg) body weight. the neck. (ii) Indications for use. For the treat- (ii) Indications for use. For the treatment of lower respiratory tract infec- ment of swine respiratory disease tions in horses caused by susceptible (SRD) associated with Actinobacillus strains of Streptococcus equi ssp. pleuropneumoniae, Pasteurella multocida, zooepidemicus. Haemophilus parasuis, and Streptococcus (iii) Limitations. Do not use in horses suis. For the control of SRD associated intended for human consumption. with A. pleuropneumoniae, P. multocida, [68 FR 60296, Oct. 22, 2003, as amended at 69 H. parasuis, and S. suis in groups of pigs FR 43892, July 23, 2004. Redesignated and where SRD has been diagnosed. amended at 71 FR 39546, July 13, 2006; 73 FR (iii) Limitations. Following label use 58872, Oct. 8, 2008; 75 FR 4692, Jan. 29, 2010; 75 as a single treatment, a 14-day pre- FR 62468, Oct. 12, 2010] slaughter withdrawal period is required. § 522.313b Ceftiofur hydrochloride. (2) Cattle. The formulation described (a) Specifications. Each milliliter of in paragraph (a)(2) of this section is ceftiofur hydrochloride suspension con- used as follows: tains 50 milligrams (mg) ceftiofur (i) Amount. 6.6 mg ceftiofur equiva- equivalents. lents per kg of body weight as a single (b) Sponsor. See No. 000009 in injection. For subcutaneous injection § 510.600(c) of this chapter. in the middle third of the posterior as- (c) Related tolerances. See § 556.113 of pect of the ear or in the posterior as- this chapter.

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(d) Special considerations. Federal preruminating calves. Do not use in law restricts this drug to use by or on calves to be processed for veal. the order of a licensed veterinarian. [61 FR 29479, June 11, 1996, as amended at 63 (e) Conditions of use. (1) Swine—(i) FR 53578, Oct. 6, 1998; 67 FR 45901, July 11, Amount. 3 to 5 mg per kilogram (/kg) of 2002; 69 FR 47362, Aug. 5, 2004. Redesignated body weight by intramuscular injec- and amended at 71 FR 39544, July 13, 2006; 73 tion. Treatment should be repeated at FR 45612, Aug. 6, 2008; 76 FR 17338, Mar. 29, 24-hour intervals for a total of 3 con- 2011] secutive days. § 522.313c Ceftiofur sodium. (ii) Indications for use. For treatment and control of swine bacterial res- (a) Specifications. Each milliliter of piratory disease (swine bacterial pneu- aqueous solution constituted from monia) associated with Actinobacillus ceftiofur sodium powder contains 50 pleuropneumoniae, Pasteurella multocida, milligrams (mg) ceftiofur equivalents. Salmonella Choleraesuis, and Strepto- (b) Sponsors. See Nos. 000009 and coccus suis. 068330 in § 510.600(c) of this chapter. (iii) Limitations. Treated swine must (c) Related tolerances. See § 556.113 of not be slaughtered for 4 days following this chapter. the last treatment. (d) Special considerations. Federal law (2) Cattle—(i) Amount. For bovine res- restricts this drug to use by or on the piratory disease and acute bovine order of a licensed veterinarian. interdigital necrobacillosis, administer (e) Conditions of use—(1) Swine—(i) 1.1 to 2.2 mg/kg of body weight at 24- Amount. 3 to 5 mg per kilogram (/kg) hour intervals for 3 to 5 consecutive body weight by intramuscular injec- days. For bovine respiratory disease tion for 3 consecutive days. only, 2.2 mg/kg of body weight may be (ii) Indications for use. For treatment administered twice at a 48-hour inter- and control of swine bacterial res- val. For acute metritis only, admin- piratory disease (swine bacterial pneu- ister 2.2 mg/kg of body weight at 24- monia) associated with Actinobacillus hour intervals for 5 consecutive days. pleuropneumoniae, Pasteurella multocida, Product in peanut oil suspension may Salmonella choleraesuis, and Strepto- be administered by either coccus suis. intramuscular or subcutaneous injec- (iii) Limitations. Treated pigs must tion. Product in caprylic/capric not be slaughtered for 4 days following triglyceride suspension may be admin- the last treatment. istered by subcutaneous injection only. (2) Cattle—(i) Amount. 0.5 to 1.0 mg/lb (ii) Indications for use. For treatment body weight by intramuscular or sub- of bovine respiratory disease (BRD, cutaneous injection for 3 days. Addi- shipping fever, pneumonia) associated tional treatments may be given on days 4 and 5 for animals which do not with Mannheimia haemolytica, P. show satisfactory response. multocida, and Histophilus somni; acute bovine interdigital necrobacillosis (ii) Indications for use. For treatment (foot rot, pododermatitis) associated of bovine respiratory disease (shipping fever, pneumonia) associated with with Fusobacterium necrophorum and Mannheimia haemolytica, P. multocida, Bacteroides melaninogenicus; and acute and Histophilus somni in beef and dairy metritis (0 to 14 days post-partum) as- cattle; and for treatment of acute bo- sociated with bacteria susceptible to vine interdigital necrobacillosis (foot ceftiofur. rot, pododermatitis) associated with (iii) Limitations. Treated cattle must Fusobacterium necrophorum and not be slaughtered for 3 days following Bacteroides melaninogenicus. the last treatment. A withdrawal pe- (iii) Limitations. Treated cattle must riod has not been established in not be slaughtered for 4 days following the last treatment. (3) Sheep—(i) Amount. 0.5 to 1.0 mg/lb body weight by intramuscular injection for 3 days. Additional treatments

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may be given on days 4 and 5 for ani- (ii) Indications for use. For treatment mals which do not show satisfactory of canine urinary tract infections asso- response. ciated with E. coli and Proteus mirabilis. (ii) Indications for use. For treatment [53 5369, Feb. 24, 1988, as amended at 55 FR of sheep respiratory disease (pneu- 13768, Apr. 12, 1990; 56 FR 12119, Mar. 22, 1991; monia) associated with M. haemolytica 57 FR 41862, Sept. 14, 1992; 59 FR 41666, Aug. and P. multocida. 15, 1994; 59 FR 54518, Nov. 1, 1994; 60 FR 51719, (4) Goats—(i) Amount. 0.5 to 1.0 mg/lb Oct. 3, 1995; 61 FR 35130, July 5, 1996; 61 FR body weight by intramuscular injec- 66583, Dec. 18, 1996; 66 FR 21283, Apr. 30, 2001; tion for 3 days. Additional treatments 66 FR 32540, June 15, 2001; 69 FR 47362, Aug. 5, may be given on days 4 and 5 for ani- 2004. Redesignated and amended at 71 FR 39544, July 13, 2006; 74 FR 34236, July 15, 2009] mals which do not show satisfactory response. § 522.380 Chloral hydrate, pento- (ii) Indications for use. For treatment barbital, and magnesium sulfate of caprine respiratory disease (goat sterile aqueous solution. pneumonia) associated with M. (a) [Reserved] haemolytica and P. multocida. (b)(1) Specifications. Chloral hydrate, (5) —(i) . 0.08 to 0.20 Chickens Amount pentobarbital, and magnesium sulfate mg as a single subcutaneous injection sterile aqueous solution contains 42.5 in the neck. milligrams of chloral hydrate, 8.86 mil- (ii) Indications for use. For control of ligrams of pentobarbital, and 21.2 milli- early mortality associated with Esch- grams of magnesium sulfate in each erichia coli organisms susceptible to milliliter of sterile aqueous solution ceftiofur in day-old chicks. containing water, 33.8 percent pro- (6) Turkeys—(i) Amount. 0.17 to 0.5 mg pylene glycol, and 14.25 percent ethyl as a single subcutaneous injection in alcohol. the neck. (2) Sponsor. See No. 000856 in (ii) Indications for use. For control of § 510.600(c) of this chapter. early mortality associated with E. coli (3) Conditions of use. (i) It is used for organisms susceptible to ceftiofur in general anesthesia and as a sedative-re- day-old poults. laxant in cattle and horses. (7) Horses—(i) Amount. 2.2 to 4.4 mg/kg (ii) For intravenous use only. The (1.0 to 2.0 mg/lb) body weight by drug is administered at a dosage level intramuscular injection. Treatment of 20 to 50 milliliters per 100 pounds of should be repeated every 24 hours, con- body weight for general anesthesia tinued for 48 hours after clinical signs until the desired effect is produced. have disappeared, and should not ex- Cattle usually require a lower dosage ceed 10 days. A maximum of 10 mL on the basis of body weight. When used should be administered per injection as a sedative-relaxant, it is adminis- site. tered at a level of one-fourth to one- (ii) Indications for use. For treatment half of the anesthetic dosage level. of respiratory infections in horses asso- (iii) Federal law restricts this drug to ciated with Streptococcus zooepidemicus. use by or on the order of a licensed vet- (iii) Limitations. Do not use in horses erinarian. intended for human consumption. (8) Dogs—(i) Amount. 1.0 mg/lb (2.2 mg/ [40 FR 13858, Mar. 27, 1975, as amended at 45 kg) body weight by subcutaneous injec- FR 16482, Mar. 14, 1980] tion. Treatment should be repeated at § 522.390 Chloramphenicol injection. 24-hour intervals, continued for 48 hours after clinical signs have dis- (a) Specifications. Each milliliter con- appeared, for 5 to 14 days. tains 100 milligrams of chloramphenicol. (b) Sponsor. See Nos. 000069 and 059130 in § 510.600(c) of this chapter. (c) Conditions of use. Dogs—(1) Amount. 5 to 15 milligrams per pound of

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body weight, intramuscularly or intra- (b) Single cloprostenol injection for venously, every 6 hours. In severe in- terminating unwanted pregnancies fections, use 4 to 6 hour treatment in- from mismatings from 1 week after tervals the first day. If no response is mating until 5 months after concep- obtained in 3 to 5 days, discontinue use tion, or for treating unobserved (non- and reevaluate diagnosis. detected) estrus, mummified fetus, and (2) Indications for use. Treatment of luteal cysts. infections of the respiratory tract, the (c) Single cloprostenol injection for urinary tract, and enteritis and tonsil- the treatment of pyometra. litis caused by organisms susceptible (iii) Do not administer to pregnant to chloramphenicol. animals where the calf is not to be (3) Limitations. Not for use in animals aborted. raised for food production. Federal law (iv) Women of childbearing age, restricts this drug to use by or on the asthmatics, and persons with bronchial order of a licensed veterinarian. and other respiratory problems should [57 FR 37331, Aug. 18, 1992, as amended at 65 exercise extreme caution when han- FR 45877, July 26, 2000] dling this product. Cloprostenol is readily absorbed through the skin and § 522.460 Cloprostenol sodium. may cause abortion and/or (a)(1) Specifications. Each milliliter of bronchiospasms. Accidental spillage on the aqueous solution contains 263 the skin should be washed off imme- micrograms of cloprostenol sodium diately with soap and water. (equivalent to 250 micrograms of (v) Federal law restricts this drug to cloprostenol) in a sodium citrate, an- use by or on the order of a licensed vet- hydrous citric acid and sodium chloride erinarian. buffer containing 0.1 percent w/v (b)(1) Specifications. Each milliliter of chlorocresol B.P. as a bactericide. sterile aqueous solution contains 131.5 (2) Sponsor. See Nos. 000061 and 068504 micrograms of cloprostenol sodium in § 510.600(c) of this chapter. (equivalent to 125 micrograms of (3) Conditions of use. For cloprostenol). intramuscular use in beef and dairy (2) Sponsor. See No. 000061 in cattle to induce luteolysis. § 510.600(c) of this chapter. (i) Amount. 2 milliliters (equivalent (3) Special considerations. Labeling to 500 micrograms of cloprostenol). shall bear the statements prescribed in (ii) Indications. (a) For scheduling paragraphs (a)(3) (iii) and (iv) of this estrus and ovulation to control the section. time at which cycling cows or heifers (4) Conditions of use—(i) Amount. 3 can be bred. milliliters (equivalent to 375 (1) Single cloprostenol injection. micrograms of cloprostenol) Treat only animals with a mature cor- intramuscularly per animal as a single pus luteum. Estrus should occur in 2 to dose. 5 days, and cattle should be insemi- (ii) Indications for use. To induce nated at the usual time relative to the abortion in pregnant feedlot heifers detection of estrus. If estrus is not ob- from 1 week after mating until 41⁄2 served, treated animals may be insemi- months of gestation. nated either once at 72 hours post in- (iii) Limitations. Federal law restricts jection or twice at 72 and 96 hours post this drug to use by or on the order of a injection. licensed veterinarian. (2) Double cloprostenol injection. [47 FR 4678, Feb. 2, 1982, as amended at 48 FR Give cattle a second injection 11 days 15619, Apr. 12, 1983; 49 FR 5100, Feb. 10, 1984; after the first injection. Estrus should 49 FR 29957, July 25, 1984; 65 FR 6892, Feb. 11, occur 2 to 5 days after the second injec- 2000; 69 FR 40766, July 7, 2004] tion, and cattle should be inseminated at the usual time relative to the detec- § 522.468 Colistimethate sodium pow- tion of estrus. If estrus is not observed, der for injection. treated animals may be inseminated (a) Specifications. Each vial contains either once at about 72 hours post in- colistimethate sodium equivalent to 10 jection or twice at 72 and 96 hours fol- grams colistin activity and mannitol lowing the second injection. to be reconstituted with 62.5 milliliters

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sterile saline or sterile water for injec- jection U.S.P. It contains 40 or 80 tion. The resulting solution contains U.S.P. units per milliliter. colistimethate sodium equivalent to (2) Sponsor. See No. 061623 in 133 milligrams per milliliter colistin § 510.600(c) of this chapter. activity. (3) Conditions of use. (i) For (b) Sponsor. See 046573 in § 510.600(c) of intramuscular injection in dogs as a di- this chapter. agnostic aid to test for adrenal dys- (c) [Reserved] function. For intramuscular or sub- (d) Conditions of use. (1) 1- to 3-day- cutaneous injection in dogs and cats old chickens. for stimulation of the adrenal cortex (i) Dosage. 0.2 milligram colistin ac- where there is a general deficiency of tivity per chicken. ACTH. (ii) Indications for use. Control of (ii) For diagnostic use: Administer at early mortality associated with Esch- one unit per pound of body weight erichia coli organisms susceptible to colistin. intramuscularly. For therapeutic use: (iii) Limitations. For subcutaneous in- Administer at one unit per pound of jection in the neck of 1- to 3-day-old body weight intramuscularly or chickens. Not for use in laying hens subcutaneously, initially, to be reproducing eggs for human consump- peated as indicated. tion. Do not use in turkeys. Federal (iii) Federal law restricts this drug to law restricts this drug to use by or on use by or on the order of a licensed vet- the order of a licensed veterinarian. erinarian. (2) [Reserved] (c) National Academy of Sciences/Na- tional Reserach Council (NAS/NRC) sta- [63 FR 13123, Mar. 18, 1998] tus. The therapeutic indication for use § 522.480 Repository corticotropin in- has been reviewed by NAS/NRC and jection. found to be effective. Applications for (a)(1) Specifications. The drug con- this use need not include effectiveness forms to repository corticotropin injec- data as specified in § 514.111 of this tion U.S.P. It contains 40 or 80 U.S.C. chapter, but may require bioequiva- (I.U.) units per cubic centimeter. lency and safety information. (2) Sponsor. See No. 026637 in [40 FR 13858, Mar. 27, 1985, as amended at 50 § 510.600(c) of this chapter. FR 40966, Oct. 8, 1985; 53 FR 45760, Nov. 14, (3) Special considerations. The drug 1988; 68 FR 59881, Oct. 20, 2003; 74 FR 20582, should be refrigerated. With prolonged May 5, 2009] use supplement daily diet with potassium chloride at one gram for small § 522.518 Cupric glycinate injection. animals and from 5 to 10 grams for (a) Specifications. Each milliliter large animals. (mL) of sterile aqueous suspension con- (4) Conditions of use. (i) It is used as tains 200 milligrams of cupric glycinate an intramuscular or subcutaneous in- (equivalent to 60 milligrams of copper). jection in cattle and small animals for (b) Sponsor. See No. 049185 in stimulation of the adrenal cortex § 510.600(c) of this chapter. where there is a general deficiency of corticotropin (ACTH). It is also a (c) Conditions of use—(1) Amount. 200 therapeutic agent for primary bovine milligrams (1 mL) for calves 300 pounds ketosis. and under; 400 milligrams (2 mL) for (ii) It is administered to cattle ini- calves over 300 pounds and adult cattle. tially at 200 to 600 units followed by a (2) Indications for use. For beef calves dose daily or every other day of 200 to and beef cattle for the prevention of 300 units and to small animals at one copper deficiency, or when labeled for unit per pound of body weight to be re- veterinary prescription use, for the peated as indicated. prevention and/or treatment of copper (iii) For use only by or on the order deficiency alone or in association with of a licensed veterinarian. molybdenum toxicity. (b)(1) Specifications. The drug con- (3) Limitations. For subcutaneous use forms to respository corticotropin in- only; repeat dose in 3 months in young

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calves, in 6 months in cattle; dis- (c) Conditions of use—(1) Horses and continue use 30 days before treated ani- ponies—(i) Amount. One implant per mals are slaughtered for food use; Fed- mare subcutaneously in the neck. eral law restricts this drug to use by or (ii) Indications for use. For inducing on the order of a licensed veterinarian. ovulation within 48 hours in estrous [46 FR 20159, Apr. 3, 1981, as amended at 52 mares with an ovarian follicle greater FR 7832, Mar. 13, 1987; 62 FR 28630, May 27, than 30 mL in diameter. 1997] (iii) Limitations. Do not use in horses or ponies intended for human consump- § 522.522 Danofloxacin. tion. Federal law restricts this drug to (a) Specifications. Each milliliter of use by or on the order of a licensed vet- solution contains 180 milligrams (mg) erinarian. danofloxacin as the mesylate salt. (2) Horses—(i) Amount. Administer 1.8 (b) Sponsor. See No. 000069 in mg (1 mL) by intramuscular injection § 510.600(c) of this chapter. in the neck. (c) Related tolerances. See § 556.169 of (ii) Indications for use. For inducing this chapter. ovulation within 48 hours in cyclic es- (d) Conditions of use in cattle—(1) trous mares with an ovarian follicle be- Amount. 6 mg per kilogram of body tween 30 and 40 mL in diameter. weight by subcutaneous injection. (iii) Limitations. Do not use in horses Treatment should be repeated approxi- intended for human consumption. Fed- mately 48 hours following the first in- eral law restricts this drug to use by or jection. on the order of a licensed veterinarian. (2) Indications for use. For the treat- [75 FR 81456, Dec. 28, 2010] ment of bovine respiratory disease (BRD) associated with Mannheimia § 522.535 Desoxycorticosterone (Pasteurella) haemolytica and Pasteurella pivalate. multocida. (3) Limitations. Animals intended for (a) Specifications. Each milliliter of human consumption should not be sterile aqueous suspension contains 25 slaughtered within 4 days from the last milligrams of desoxycorticosterone treatment. Do not use in cattle in- pivalate. tended for dairy production. A with- (b) Sponsor. See No. 058198 in drawal period has not been established § 510.600(c) of this chapter. for this product in pre-ruminating (c) [Reserved] calves. Do not use in calves to be proc- (d) Conditions of use—(1) Dogs—(i) essed for veal. Federal law restricts Amount. Dosage requirements are vari- this drug to use by or on the order of a able and must be individualized on the licensed veterinarian. Federal law pro- basis of the response of the patient to hibits the extra-label use of this drug therapy. Initial dose of 1 milligram per in food-producing animals. pound (0.45 kilogram) of body weight every 25 days, intramuscularly. Usual [67 FR 78972, Dec. 27, 2002] dose is 0.75 to 1.0 milligram per pound § 522.533 Deslorelin. of body weight every 21 to 30 days. (ii) Indications for use. For use as re- (a) Specifications—(1) Each implant placement therapy for the contains 2.1 milligrams (mg) deslorelin mineralocorticoid deficit in dogs with acetate. primary adrenocortical insufficiency. (2) Each milliliter (mL) of suspension (iii) Limitations. For intramuscular contains 1.8 mg deslorelin acetate. use only. Do not use in pregnant dogs, (b) Sponsors. See sponsor numbers in dogs suffering from congestive heart § 510.600(c) of this chapter as follows: disease, severe renal disease, or edema. (1) No. 043246 for use of product de- Federal law restricts this drug to use scribed in paragraph (a)(1) as in para- by or on the order of a licensed veteri- graph (c)(1) of this section. narian. (2) No. 051330 for use of product de- (2) [Reserved] scribed in paragraph (a)(2) as in paragraph (c)(2) of this section. [63 FR 13122, Mar. 18, 1998]

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§ 522.536 Detomidine hydrochloride in- (A) For the treatment of primary bo- jection. vine ketosis and as an anti-inflam- (a) Specification. Each milliliter of matory agent in cattle and horses; sterile aqueous solution contains 10 (B) As an anti-inflammatory agent in milligrams of detomidine hydro- dogs and cats. chloride. (iii) Limitations. Federal law restricts (b) Sponsor. See 052483 in § 510.600(c) of this drug to use by or on the order of a this chapter. licensed veterinarian. (c) Conditions of use—(1) Amount. For (b)(1) Specifications. The drug is a sedation, analgesia, or sedation and an- sterile aqueous solution. Each milli- algesia: 20 or 40 micrograms per kilo- liter contains either 2.0 milligrams of gram (0.2 or 0.4 milliliter per 100 kilo- dexamethasone or 4.0 milligrams of gram or 220 pounds) by body weight, dexamethasone sodium phosphate depending on depth and duration re- (equivalent to 3.0 milligrams dexa- quired. methasone). (2) Indication for use. As a sedative (2) Sponsor. See number in § 510.600(c) and analgesic to facilitate minor sur- of this chapter as follows: gical and diagnostic procedures in ma- (i) No. 061623 for use of 2.0 milligrams ture horses and yearlings. dexamethasone or 4.0 milligrams dexa- (3) Limitations. For sedation admin- methasone sodium phosphate injec- ister intraveneously (IV) or intramuscularly (IM); for analgesia by tions. IV; for both sedation and analgesia by (ii) No. 000402 for use of 2.0 milli- IV. Do not use in horses with pre-exist- grams dexamethasone or 4.0 milligrams ing atrioventricular or sinoauricular dexamethasone sodium phosphate in- block, with severe coronary insuffi- jections. ciency, cerebrovascular disease, res- (3) Conditions of use. (i) The drug is piratory disease, or chronic renal fail- used in dogs for the treatment of in- ure. Do not use in breeding animals. flammatory conditions, as supportive Not for use in horses intended for food. therapy in canine posterior paresis, as Federal law restricts this drug to use supportive therapy before or after sur- by or on the order of a licensed veteri- gery to enhance recovery of poor sur- narian. gical risks, and as supportive therapy in nonspecific dermatosis. 1 [54 FR 50365, Dec. 6, 1989; 54 FR 51551, Dec. 15, 1989] (ii) The drug is administered intravenously at 0.25 to 1 milligram ini- § 522.540 Dexamethasone injection. tially. The dose may be repeated for 3 (a)(1) Specifications. Each milliliter of to 5 days or until a response is noted. solution contains 2 milligrams (mg) If continued treatment is required, oral dexamethasone. therapy may be substituted. When (2) Sponsors. See sponsors in therapy is withdrawn after prolonged § 510.600(c) of this chapter: use, the daily dose should be reduced (i) Nos. 000061, 059130, and 061623 for gradually over several days. 1 use as in paragraph (a)(3) of this sec- (iii) Clinical and experimental data tion. have demonstrated that corticosteroids (ii) No. 058005 for use as in paragraphs administered orally or parenterally to (a)(3)(i)(C), (a)(3)(i)(D), (a)(3)(ii)(A), and animals may induce the first stage of (a)(3)(iii) of this section. parturition when administered during (3) Conditions of use—(i) Amount. The the last trimester of pregnancy and drug is administered intravenously or may precipitate premature parturition intramuscularly and dosage may be re- followed by dystocia, fetal death, repeated if necessary, as follows: tained placenta, and metritis. (A) Dogs. 0.25 to 1 mg. (B) Cats. 0.125 to 0.5 mg. 1 These conditions are NAS/NRC-reviewed (C) Horses. 2.5 to 5 mg. and deemed effective. Applications for these (D) Cattle. 5 to 20 mg, depending on uses need not include effectiveness data as the severity of the condition. specified by § 514.111 of this chapter, but may (ii) Indications for use. The drug is in- require bioequivalency and safety informa- dicated: tion.

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(iv) Federal law restricts this drug to 0.25 to 1 milligram; cats—0.125 to 0.5 use by or on the order of a licensed vet- milligram; horses—2.5 to 5 milligrams. erinarian. (iii) Clinical and experimental data (c)(1) Specifications. The drug is a have demonstrated that corticosteroids sterile aqueous solution. Each milli- administered orally or by injection to liter contains 2.0 milligrams of dexa- animals may induce the first stage of methasone or 4.0 milligrams of dexa- parturition when administered during methasone sodium phosphate (equiva- the last trimester of pregnancy and lent to 3.0 milligrams of dexametha- may precipitate premature parturition sone). followed by dystocia, fetal death, re- (2) Sponsor. See Nos. 000402 and 061623 tained placenta, and metritis. in § 510.600(c) of this chapter. (iv) Not for use in horses intended for (3) Conditions of use. (i) The drug is food. used as a rapid adrenal glucocorticoid (v) Federal law restricts this drug to and/or anti-inflammatory agent in use by or on the order of a licensed vet- horses. 1 erinarian. (ii) The drug is administered intravenously at a dosage of 2.5 to 5.0 milli- (e)(1) Specifications. The drug is a grams. If permanent corticosteroid ef- sterile aqueous solution. Each milli- fect is required, oral therapy may be liter contains 4.0 milligrams of dexa- substituted. When therapy is with- methasone sodium phosphate (equiva- drawn after prolonged use, the daily lent to 3 milligrams of dexametha- dose should be reduced gradually over sone). several days. 1 (2) Sponsor. See No. 059130 in (iii) Clinical and experimental data § 510.600(c) of this chapter. have demonstrated that corticosteroids (3) Conditions of use. (i) The drug is administered orally or parenterally to given for glucocorticoid and anti-in- animals may induce the first stage of flammatory effect in dogs and horses. parturition when administered during (ii) Administer intravenously as fol- the last trimester of pregnancy and lows: Dogs—0.25 to 1 milligram ini- may precipitate premature parturition tially; may be repeated for 3 to 5 days followed by dystocia, fetal death, re- or until response is noted. Horses—2.5 tained placenta, and metritis. to 5 milligrams. If permanent (iv) Not for use in horses intended for glucocorticoid effect is required, oral food. therapy may be substituted. When (v) Federal law restricts this drug to therapy is to be withdrawn after pro- use by or on the order of a licensed vet- longed use, the daily dose should be re- erinarian. duced gradually over several days. (d)(1) Specifications. The drug is a (iii) Clinical and experimental data sterile aqueous solution. Each milli- have demonstrated that corticosteroids liter contains 2.0 milligrams of dexa- administered orally or by injection methasone or 4.0 milligrams of dexa- may induce the first stage of parturi- methasone sodium phosphate (equiva- tion when administered during the last lent to 3.0 milligrams of dexamethasone). trimester of pregnancy and may pre- (2) Sponsors. See the following num- cipitate premature parturition fol- bers in § 510.600(c) of this chapter: lowed by dystocia, fetal death, retained (i) Nos. 000069 and 059130 for intra- placenta, and metritis. venous or intramuscular use of 2.0 mil- (iv) Do not use in viral infections. ligrams dexamethasone injection. Anti-inflammatory action of (ii) No. 000069 for intravenous use of corticosteroids may mask signs of in- 2.0 milligrams dexamethasone injec- fections. Except when used for emer- tion. gency therapy, the product is contra- (3) Conditions of use. (i) The drug is indicated in animals with tuberculosis, used as an anti-inflammatory agent in chronic nephritis, cushingoid syn- dogs, cats, and horses. drome, or peptic ulcers. (ii) It is administered intravenously (v) Not for use in horses intended for or intramuscularly as follows: dogs— food.

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(vi) Federal law restricts this drug to surface area by intramuscular injec- use by or on the order of a licensed vet- tion. erinarian. (B) For use as a preanesthetic to gen- μ 2 [41 FR 28265, July 9, 1976] eral anesthesia, administer 125 g/m of body surface area or 375 μg/m2 of body EDITORIAL NOTE: For FEDERAL REGISTER ci- surface area by intramuscular injec- tations affecting § 522.540, see the List of CFR Sections Affected, which appears in the tion. Finding Aids section of the printed volume (ii) Limitations. Federal law restricts and at www.fdsys.gov. this drug to use by or on the order of a licensed veterinarian. § 522.542 Dexamethasone-21- (2) Cats—(i) Amount. 40 μg/killogram isonicotinate suspension. by intramuscular injection. (a) Specifications. Each milliliter of (ii) Indications for use. For use as a sterile suspension contains 1 milligram sedative and analgesic to facilitate of dexamethasone-21-isonicotinate. clinical examinations, clinical proce- (b) Sponsor. No. 000010 in § 510.600(c) of dures, minor surgical procedures, and this chapter. minor dental procedures; and as a (c) Conditions of use. (1) The drug is preanesthetic to general anesthesia. used in the treatment of various in- (iii) Limitations. Federal law restricts flammatory conditions associated with this drug to use by or on the order of a the musculoskeletal system in dogs, licensed veterinarian. cats, and horses. (2) It is recommended for [72 FR 263, Jan. 4, 2007, as amended at 72 FR intramuscular administration as fol- 19797, Apr. 20, 2007; 72 FR 51365, Sept. 7, 2007; lows: Dogs—0.25 to 1 milligram; cats— 75 FR 60308, Sept. 30, 2010] 0.125 to 0.5 milligram; horses—5 to 20 milligrams. Dosage may be repeated. § 522.563 Diatrizoate meglumine and diatrizoate sodium injection. (3) Clinical and experimental data have demonstrated that corticosteriods (a) Specifications. Diatrizoate administered orally or parenterally to meglumine and diatrizoate sodium in- animals may induce the first stage of jection contains 34.3 percent dia- parturition when administered during trizoate meglumine and 35 percent dia- the last trimester of pregnancy and trizoate sodium, or 66 percent dia- may precipitate premature parturition trizoate meglumine and 10 percent dia- following by dystocia, fetal death, re- trizoate sodium, in sterile aqueous so- tained placenta, and metritis. lution. (4) Not for use in horses intended for (b) Sponsor. See No. 053501 in food. § 510.600(c) of this chapter. (5) Federal law restricts this drug to (c) Conditions of use. (1) It is indicated use by or on the order of a licensed vet- for use in dogs and cats for visualiza- erinarian. tion in excretion urography, including [42 FR 37543, July 22, 1977, as amended at 47 renal angiography, uretography, FR 14703, Apr. 6, 1982] cystography, and urethrography; aortography; angiocardiography, pe- § 522.558 Dexmedetomidine. ripheral arteriography, and (a) Specifications. Each milliliter of venography; selective coronary arteri- solution contains 0.5 milligram (mg) of ography; cerebral angiography; dexmedetomidine hydrochloride. lymphography; arthrography; discog- (b) Sponsor. See No. 052483 in raphy; and sialography. It is also useful § 510.600(c) of this chapter. as an aid in delineating peritoneal her- (c) Conditions of use—(1) Dogs—(i) In- nias and fistulous tracts. dications for use and amount. (A) For (2) For excretion urography admin- use as a sedative and analgesic to fa- ister 0.5 to 1.0 milliliter per pound of cilitate clinical examinations, clinical body weight to a maximum of 30 milli- procedures, minor surgical procedures, liters intravenously. For cystography and minor dental procedures, admin- remove urine, administer 5 to 25 milli- ister 375 micrograms (μg) per square liters directly into the bladder via meter (/m2) of body surface area by in- catheter. For urethrography admin- travenous injection or 500 μg/m2 of body ister 1.0 to 5 milliliters via catheter

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into the urethra to provide desired con- (3) Limitations. Administer by deep trasts delineation. For angiocardiog- intramuscular injection only. Treat- raphy (including aortography) rapidly ment should be continued for 3 to 5 inject 5 to 10 milliliters directly into days or until the urine is free of the heart via catheter or leptospira for at least 72 hours as meas- intraventricular puncture. For cerebral ured by darkfield microscopic examina- angiography rapid injection of 3 to 10 tion. Treatment with subtherapeutic milliliters via carotid artery. For pe- dosages, excessive duration of therapy, ripheral arteriography and/or or inappropriate use of this antibiotic venography and selective coronary ar- may lead to the emergence of strepto- teriography rapidly inject 3 to 10 milli- mycin or dihydrostreptomycin resist- liters intravascularly into the vascular ant organisms. Discontinue use 30 days bed to be delineated. For before slaughter for food. Not for use in lymphography slowly inject 1.0 to 10 animals producing milk because use of milliliters directly into the lymph ves- the drug will contaminate the milk. sel to be delineated. For arthrography Federal law restricts this drug to use slowly inject 1.0 to 5 milliliters di- by or on the order of a licensed veteri- rectly into the joint to be delineated. narian. For discography slowly inject 0.5 to 1.0 [57 FR 37331, Aug. 18, 1992; 57 FR 42623, Sept. milliliter directly into the disc to be 15, 1992] delineated. For sialography slowly inject 0.5 to 1.0 milliliter into the duct to § 522.690 Dinoprost solution. be delineated. For delineation of fis- (a) Specifications. Each milliliter tulous tracts slowly inject quantity (mL) of solution contains dinoprost necessary to fill the tract. For delinea- tromethamine equivalent to 5 milli- tion of peritoneal hernias inject 0.5 to grams (mg) dinoprost. 1.0 milliliter per pound of body weight (b) Sponsors. See Nos. 000009 and directly into the peritoneal cavity. 059130 in § 510.600(c) of this chapter. (3) Federal law restricts this drug to (c) Special considerations. (1) Federal use by or on the order of a licensed vet- law restricts this drug to use by or on erinarian. the order of a licensed veterinarian. [44 FR 12993, Mar. 9, 1979, as amended at 50 (2) Women of child-bearing age, FR 41489, Oct. 11, 1985] asthmatics, and persons with bronchial and other respiratory problems should § 522.650 Dihydrostreptomycin sulfate exercise extreme caution when han- injection. dling this product. Dinoprost (a) Specifications. Each milliliter con- tromethamine is readily absorbed tains dihydrostreptomycin sulfate through the skin and can cause abor- equivalent to 500 milligrams of dihy- tion and bronchiospasms. Accidental drostreptomycin. spillage on the skin should be washed (b) Sponsor. See Nos. 000069 and 055529 off immediately with soap and water. in § 510.600(c) of this chapter. (d) Conditions of use—(1) Horses—(i) (c) National Academy of Sciences/Na- Amount. 1 mg per 100 pounds of body tional Research Council (NAS/NRC) sta- weight as a single intramuscular injec- tus. The conditions of use were NAS/ tion. NRC reviewed and found effective. Ap- (ii) Indications. For its luteolytic ef- plications for these uses need not in- fect to control timing of estrus in clude effectiveness data as specified by estrus cycling mares and in clinically § 514.111 of this chapter but may require anestrous mares that have a corpus bioequivalency and safety information. luteum. (d) Conditions of use—(1) Amount. 5 (iii) Limitations. Not for use in horses milligrams per pound of body weight intended for food. every 12 hours. (2) Cattle—(i) Beef cattle and nonlac- (2) Indications for use. Treatment of tating dairy heifers—(A) Amount. 25 mg leptospirosis in dogs and horses due to as an intramuscular injection either Leptospira canicola, L. once or twice at a 10- to 12-day inter- icterohemorrhagiae, and L. pomona; in val. cattle due to L. pomona; and in swine (B) Indications. For its luteolytic ef- due to L. pomona; and L. grippotyphosa. fect to control timing of estrus and

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ovulation in estrous cycling cattle that free-ranging wild animals that might have a corpus luteum. be used for food. (ii) Beef cattle and nonlactating dairy (4) Federal law restricts this drug to heifers—(A) Amount. 25 mg as a single use by or on the order of a licensed vet- intramuscular injection. erinarian. Distribution is restricted to (B) Indications. For treatment of veterinarians engaged in zoo and exotic pyometra (chronic endometritis). animal practice, wildlife management (iii) Nonlactating cattle—(A) Amount. programs and researchers. 25 mg as a single intramuscular injec- [40 FR 13858, Mar. 27, 1975, as amended at 48 tion during the first 100 days of gesta- FR 16241, Apr. 15, 1983; 60 FR 39847, Aug. 4, tion. 1995; 64 FR 15684, Apr. 1, 1999] (B) Indications. For its abortifacient effect in nonlactating cattle. § 522.770 Doramectin. (iv) Lactating dairy cattle—(A) (a) Specifications. Each milliliter of Amount. 25 mg as a single sterile aqueous solution contains 10 intramuscular injection. milligrams of doramectin. (B) Indications. For treatment of (b) Sponsor. See No. 000069 in § 510.600 unobserved (silent) estrus in lactating (c) of this chapter. dairy cattle that have a corpus luteum. (c) Related tolerances. See § 556.225 of (v) Dinoprost solution as provided by this chapter. No. 000009 in § 510.600(c) of this chapter (d) Conditions of use—(1) Cattle—(i) may be used concurrently with pro- Amount. 200 micrograms per kilogram gesterone intravaginal inserts as in (10 milligrams per 110 pounds). § 529.1940 of this chapter. (ii) Indications for use. For treatment (3) Swine—(i) Amount. 10 mg as a sin- and control of gastrointestinal gle intramuscular injection. roundworms, lungworms, eyeworms, (ii) Indications. For parturition induc- grubs, sucking lice, and mange mites. tion in swine when injected within 3 To control infections and to protect days of normal predicted farrowing. from reinfection with Cooperia [67 FR 41824, June 20, 2002] oncophora and Haemonchus placei for 14 days, Ostertagia ostertagi for 21 days, § 522.723 Diprenorphine hydrochloride and C. punctata, Oesophagostomum injection. radiatum, and Dictyocaulus viviparus for (a) Chemical name. N-(Cyclopropyl- 28 days after treatment. methyl)-6,7,8,14-tetrahydro-7-alpha-(1- (iii) Limitations. Administer as a sin- hydroxy - 1 - methylethyl) - 6,14 - gle subcutaneous or intramuscular in- endoethanonororipavine hydrochloride. jection. Do not slaughter cattle within (b) Specifications. Each milliliter of 35 days of treatment. Not for use in fe- diprenorphine hydrochloride injection, male dairy cattle 20 months of age or veterinary, contains 2 mg of older. Do not use in calves to be proc- diprenorphine hydrochloride in sterile essed for veal. aqueous solution. (2) Swine—(i) Amount. 300 micrograms (c) Sponsors. See No. 053923 in per kilogram (10 milligrams per 75 § 510.600(c) of this chapter. pounds). (d) Conditions of use. (1) The drug is (ii) Indications for use. For treatment used for reversing the effects of and control of gastrointestinal etorphine hydrochloride injection, vet- roundworms, lungworms, kidney erinary, the use of which is provided worms, sucking lice, and mange mites. for in § 522.883, in wild and exotic ani- (iii) Limitations. Administer as a sin- mals. gle intramuscular injection. Do not (2) It is administered slaughter swine within 24 days of treat- intramuscularly or intravenously at a ment. Consult your veterinarian for as- suitable dosage level depending upon sistance in the diagnosis, treatment, the species. and control of parasitism. (3) For use in wild or exotic animals [61 FR 53321, Oct. 11, 1996, as amended at 62 only. Do not use in domestic food-pro- FR 44410, Aug. 21, 1997; 62 FR 62242, Nov. 21, ducing animals. Do not use 30 days be- 1997; 63 FR 68183, Dec. 10, 1998; 64 FR 13509, fore, or during, the hunting season in Mar. 19, 1999]

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§ 522.775 Doxapram. nent discoloration of teeth. Do not use in pregnant bitches. Use in breeding (a) Specifications. Each milliliter of dogs has not been evaluated. Federal solution contains 20 milligrams (mg) law restricts this drug to use by or on doxapram hydrochloride. the order of a licensed veterinarian. (b) Sponsor. See Nos. 000010 and 015914 in § 510.600(c) of this chapter. [63 FR 8349, Feb. 19, 1998, as amended at 65 (c) Conditions of use—(1) Amount. For FR 45878, July 26, 2000] intravenous use in dogs and cats at a § 522.784 Doxylamine succinate injec- dose of 21⁄2 to 5 mg per pound (/lb) body tion. weight in barbiturate anesthesia, 0.5 mg/lb in inhalation anesthesia; for in- (a) Specifications. Each milliliter of travenous use in horses at 0.25 mg/lb the drug contains 11.36 mg of body weight in barbiturate anesthesia, doxylamine succinate. 0.2 mg/lb in inhalation anesthesia, 0.25 (b) Sponsor. See No. 000061 in mg/lb with chloral hydrate with or § 510.600(c) of this chapter. without magnesium sulfate; for sub- (c) Conditions of use. (1) The drug is cutaneous, sublingual, or umbilical used in conditions in which antihis- vein administration in neonate puppies taminic therapy may be expected to al- at a dose rate of 1 to 5 mg; for subcuta- leviate some signs of disease in horses, neous or sublingual use in neonate kit- dogs, and cats. 1 tens at 1 to 2 mg. Dosage may be re- (2) It is administered to horses at a peated in 15 to 20 minutes if necessary. dosage level of 25 mg per hundred (2) Indications for use. Administer to pounds of body weight. It is adminis- dogs, cats, and horses to stimulate res- tered to dogs and cats at a dosage level piration during and after general anes- of 0.5 to 1 mg per pound of body weight. thesia; or to speed awakening and re- Doses may be repeated at 8 to 12 hours, turn of reflexes after anesthesia. Ad- if necessary, to produce desired effect. minister to neonate dogs and cats to Intravenous route is not recommended initiate respiration following dystocia for dogs and cats and should be in- or caesarean section; or to stimulate jected slowly in horses. Intramuscular respiration following dystocia or cae- and subcutaneous administration sarean section. should be by divided injection sites. 1 (3) Limitations. Federal law restricts (3) Not for use in horses intended for 1 this drug to use by or on the order of a food. licensed veterinarian. (4) Federal law restricts this drug to use by or on the order of a licensed vet- [72 FR 261, Jan. 4, 2007, as amended at 75 FR erinarian. 1 10167, Mar. 5, 2010] [40 FR 13858, Mar. 27, 1975, as amended at 42 § 522.778 Doxycycline hyclate. FR 60140, Nov. 25, 1977; 46 FR 48642, Oct. 2, 1981; 61 FR 8873, Mar. 6, 1996; 62 FR 61625, (a) Specifications. Doxycycline Nov. 19, 1997] hyclate solution contains 8.5 percent doxycycline activity. A syringe of N- § 522.800 Droperidol and fentanyl cit- methyl-2-pyrrolidone and poly (DL- rate injection. lactide) mixed with a syringe of (a) Specifications. Droperidol and doxycycline produces 0.5 milliliter of fentanyl citrate injection is a sterile solution. solution containing 20 milligrams of (b) Sponsor. See 000009 in § 510.600(c) of droperidol and 0.4 milligram of this chapter. fentanyl citrate per cubic centimeter. (c) [Reserved] (b) Sponsor. See No. 000061 in (d) Conditions of use—(1) Dogs—(i) § 510.600(c) of this chapter. Amount. Apply subgingivally to peri- (c) Conditions of use. (1) It is used in odontal pocket(s) of affected teeth. dogs as an analgesic and tranquilizer (ii) Indications for use. For treatment and for general anesthesia. and control of periodontal disease. (iii) Limitations. Do not use in dogs 1 These conditions are NAS/NRC reviewed less than 1-year old. Use of and deemed effective. Applications for these tetracyclines during tooth develop- uses need not include effectiveness data as ment has been associated with perma- specified by § 514.111 of this chapter.

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(2) It is administered as follows: this drug to use by or on the order of a (i) For analgesia and tranquilization licensed veterinarian. administer according to response de- [70 FR 36337, June 23, 2005] sired, as follows: (a) Intramuscularly at the rate of 1 § 522.812 Enrofloxacin. cubic centimeter per 15 to 20 pounds of (a) Specifications. Each milliliter body weight in conjunction with atro- (mL) of solution contains: pine sulfate administered at the rate of (1) 22.7 milligrams (mg) enrofloxacin 0.02 milligram per pound of body or weight, or (2) 100 mg enrofloxacin. (b) Intravenously at the rate of 1 (b) Sponsor. See No. 000859 in cubic centimeter per 25 to 60 pounds of § 510.600(c) of this chapter. body weight in conjunction with atro- (c) Related tolerance. See § 556.226 of pine sulfate administered at the rate of this chapter. 0.02 milligram per pound of body (d) Special considerations. Federal law weight. restricts this drug to use by or on the (ii) For general anesthesia admin- order of a licensed veterinarian. Fed- ister according to response desired, as eral law prohibits the extra-label use of follows: this drug in food-producing animals. (a) Intramuscularly at the rate of 1 (e) Conditions of use—(1) Dogs. Use the cubic centimeter per 40 pounds of body product described in paragraph (a)(1) of weight in conjunction with atropine this section as follows: sulfate administered at the rate of 0.02 (i) Amount. 2.5 mg per kilogram (/kg) of body weight (1.13 mg per pound) as a milligram per pound of body weight single, intramuscular, initial dose fol- and followed in 10 minutes by an intra- lowed by use of tablets twice daily for venous administration of sodium pen- 2 to 3 days beyond cessation of clinical tobarbital at the rate of 3 milligrams signs to a maximum of 10 days. per pound of body weight, or (ii) Indications for use. For the man- (b) Intravenously at the rate of 1 agement of diseases associated with cubic centimeter per 25 to 60 pounds of bacteria susceptible to enrofloxacin. body weight in conjunction with atro- (2) Cattle. Use the product described pine sulfate administered at the rate of in paragraph (a)(2) of this section as 0.02 milligram per pound of body follows: weight and followed within 15 seconds (i) Amount. Single-dose therapy: 7.5 by an intravenous administration of to 12.5 mg/kg of body weight by sub- sodium pentobarbital at the rate of 3 cutaneous injection. Multiple-day ther- milligrams per pound of body weight. apy: 2.5 to 5.0 mg/kg of body weight by (3) For use only by or on the order of subcutaneous injection. Treatment a licensed veterinarian. should be repeated at 24-hour intervals for 3 days. Additional treatments may [40 FR 13858, Mar. 27, 1975, as amended at 64 FR 15684, Apr. 1, 1999] be given on days 4 and 5 to animals that have shown clinical improvement § 522.810 Embutramide, chloroquine, but not total recovery. and lidocaine solution. (ii) Indications for use. For the treatment of bovine respiratory disease (a) Specifications. Each milliliter (BRD) associated with Mannheimia (mL) of solution contains 135 milli- haemolytica, Pasteurella multocida, and grams (mg) embutramide; 45 mg Histophilus somni (previously chloroquine phosphate, U.S.P.; and 1.9 Haemophilus somnus) in beef and non- mg lidocaine, U.S.P. lactating dairy cattle. (b) Sponsor. See No. 059130 in (iii) Limitations. Animals intended for § 510.600(c) of this chapter. human consumption must not be (c) Conditions of use in dogs—(1) slaughtered within 28 days from the Amount. One mL per 5 pounds of body last treatment. Do not use in female weight. dairy cattle 20 months of age or older. (2) Indications for use. For euthanasia. Use of enrofloxacin in this class of cat- (3) Limitations. Not for use in animals tle may cause milk residues. A with- intended for food. Federal law restricts drawal period has not been established

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for this product in pre-ruminating respiratory infections (rhinitis, bron- calves. Do not use in calves to be proc- chitis), secondary infections associated essed for veal. with panleukopenia, and bacterial (3) Swine. Use the product described wound infections caused by Staphy- in paragraph (a)(2) of this section as lococcus spp. and Streptococcus spp., sus- follows: ceptible to erythromycin. (i) Amount. Administer 7.5 mg/kg of (iii) Limitations. Federal law restricts body weight once, by subcutaneous in- this drug to use by or on the order of a jection behind the ear. licensed veterinarian. (ii) Indications for use. For the treat- (3) Cattle. Administer products de- ment and control of swine respiratory scribed in paragraph (b) of this section disease (SRD) associated with as follows: Actinobacillus pleuropneumoniae, (i) Amount. 4 mg/lb body weight by Pasteurella multocida, Haemophilus deep intramuscular injection once parasuis, and Streptococcus suis. daily for up to 5 days. (iii) Limitations. Animals intended for (ii) Indications for use. For the treat- human consumption must not be ment of bovine respiratory disease slaughtered within 5 days of receiving (shipping fever complex and bacterial a single-injection dose. pneumonia) associated with Pasteurella multocida susceptible to erythromycin. [72 FR 10597, Mar. 9, 2007, as amended by 73 (iii) Limitations. Do not use in female FR 17890, Apr. 2, 2008; 73 FR 21819, Apr. 23, 2008] dairy cattle over 20 months of age. Do not slaughter treated animals within 6 § 522.820 Erythromycin. days of last treatment. A withdrawal period has not been established for this (a) Sponsor. See No. 061623 in product in pre-ruminating calves. Do § 510.600(c) of this chapter. not use in calves to be processed for (b) Specifications—(1) Each milliliter veal. To avoid excess trim, do not (mL) of solution contains 100 milli- slaughter within 21 days of last injec- grams (mg) erythromycin base. tion. (2) Each mL of solution contains 200 mg erythromycin base. [72 FR 69142, Dec. 7, 2007] (c) Related tolerances. See § 556.230 of this chapter. § 522.840 Estradiol. (d) Conditions of use—(1) Dog. Admin- (a) Specifications. Each silicone rub- ister product described in paragraph ber implant contains 25.7 or 43.9 milli- (b)(1) of this section as follows: grams (mg) estradiol and is coated with (i) Amount. 3 to 5 mg per pound (/lb) not less than 0.5 mg oxytetracycline body weight, intramuscularly, two to powder. three times daily, for up to 5 days. (b) Sponsor. See No. 021641 in (ii) Indications for use. For the treat- § 510.600(c) of this chapter. ment of bacterial pneumonia, upper (c) Related tolerances. See § 556.240 of respiratory infections (tonsillitis, this chapter. bronchitis, tracheitis, pharyngitis, (d) Conditions of use. For implanta- pleurisy), endometritis and metritis, tion in steers and heifers as follows: and bacterial wound infections caused (1) Amount. Insert one 25.7-mg im- by Staphylococcus spp., Streptococcus plant every 200 days; insert one 43.9-mg spp., and Corynebacterium spp., sen- implant every 400 days. sitive to erythromycin. (2) Indications for use. For increased (iii) Limitations. Federal law restricts rate of weight gain in suckling and this drug to use by or on the order of a pastured growing steers; for improved licensed veterinarian. feed efficiency and increased rate of (2) Cats. Administer product de- weight gain in confined steers and heif- scribed in paragraph (b)(1) of this sec- ers. No additional effectiveness may be tion as follows: expected from reimplanting in less (i) Amount. 3 to 5 mg/lb body weight, than 200 days for the 25.7-mg implant intramuscularly, two to three times or 400 days for the 43.9-mg implant. daily, for up to 5 days. (3) Limitations. For subcutaneous ear (ii) Indications for use. For the treat- implantation in steers and heifers only. ment of bacterial pneumonia, upper Safety and effectiveness have not been

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established in veal calves. A with- norgestomet and 5.0 milligrams of es- drawal period has not been established tradiol valerate per 2 milliliters. for this product in preruminating (b) Sponsor. See 050604 in § 510.600(c) of calves. Do not use in calves to be proc- this chapter. essed for veal. (c) Conditions of use—(1) Amount. One [69 FR 67818, Nov. 22, 2004] implant and 2 milliliters of injection at time of implantation. § 522.842 Estradiol benzoate and tes- (2) Indications for use. For synchroni- tosterone propionate. zation of estrus/ovulation in cycling (a) Sponsors. See sponsors in beef cattle and non-lactating dairy § 510.600(c) of this chapter for use as in heifers. paragraph (c) of this section. (3) Limitations. Insert implant (1) No. 000856 for use as in paragraph subcutaneously in the ear only; then (c)(1)(i), (c)(2), and (c)(3) of this section. immediately inject solution (2) No. 021641 for use as in paragraph intramuscularly only. Counting the (c) of this section. day of implantation as day 1, remove (b) Related tolerances. See §§ 556.240 the implant on day 10. Collect all im- and 556.710 of this chapter. plants as they are removed and burn (c) Conditions of use. For implanta- them. While animals are restrained for tion in heifers as follows: artificial insemination, avoid other (1) Amount. (i) 20 milligrams (mg) es- treatments such as vaccinations, dip- tradiol benzoate and 200 mg testos- ping, pour-on grub and louse preven- terone propionate (one implant con- tion, spraying, etc. When inseminating sisting of 8 pellets, each pellet con- without estrus detection, the entire taining 2.5 mg estradiol benzoate and treated group should be started at 48 25 mg testosterone propionate) per im- hours after the last implant has been plant dose. removed and should be completed with- (ii) 20 mg estradiol benzoate and 200 in 6 hours. Where estrus detection is mg testosterone propionate (one im- preferred, insemination should be ap- plant consisting of 9 pellets, each of 8 proximately 12 hours after first detec- pellets containing 2.5 mg estradiol ben- tion of estrus. Those that do not con- zoate and 25 mg testosterone propio- ceive can be re-bred when they return nate, and 1 pellet containing 29 mg to estrus approximately 17 to 25 days tylosin tartrate) per implant dose. after implant removal. Do not use in (2) Indications for use. For increased cows producing milk for human con- rate of weight gain and improved feed sumption. efficiency. (3) Limitations. For heifers weighing [47 FR 55477, Dec. 10, 1982, as amended at 48 400 pounds or more; for subcutaneous FR 49656, Oct. 27, 1983; 51 FR 33592, Sept. 22, ear implantation, one dose per animal; 1986; 54 FR 1165, Jan. 12, 1989] not for use in dairy or beef replacement heifers. Safety and effectiveness have § 522.863 Ethylisobutrazine hydrochloride injection. not been established in veal calves. A withdrawal period has not been estab- (a) Specifications. The drug is a sterile lished for this product in aqueous solution. Each milliliter con- preruminating calves. Do not use in tains 50 milligrams of calves to be processed for veal. ethylisobutrazine hydrochloride. (b) Sponsor. See No. 000061 in [69 FR 68252, Nov. 24, 2004] § 510.600(c) of this chapter. § 522.850 Estradiol valerate and (c) Conditions of use. (1) It is used in norgestomet in combination. dogs as a tranquilizer.1 (a) Specifications. The product is a (2) It is administered two-component drug consisting of the intramuscularly at a dosage level of 2 following: to 5 milligrams of ethylisobutrazine (1) An implant containing 6.0 milli- hydrochloride per pound of body weight grams of norgestomet. for profound tranquilization. It is ad- (2) An injectable solution (sesame ministered intravenously at a dosage oil) containing 3.0 milligrams of level of 1 to 2 milligrams of

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ethylisobutrazine hydrochloride per (2) It is administered pound of body weight to effect.1 intramuscularly by hand syringe or sy- (3) It is not to be used in conjunction ringe dart at a suitable dosage level de- with organophosphates and/or procaine pending upon the species. hydrochloride because phenothiazines (3) Do not use the drug unless may potentiate the toxicity of diprenorphine hydrochloride injection, organophosphates and the activity of veterinary, as provided for in § 522.723, procaine hydrochloride.1 is available for use in reversing the ef- (4) Federal law restricts this drug to fects of etorphine hydrochloride injec- use by or on the order of a licensed vet- tion, veterinary. erinarian.1 (4) For use in wild or exotic animals [40 FR 13858, Mar. 27, 1975, as amended at 46 only. Do not use in domestic food-pro- FR 48642, Oct. 2, 1981; 61 FR 8873, Mar. 6, 1996; ducing animals. Do not use 30 days be- 62 FR 61625, Nov. 19, 1997] fore, or during, the hunting season in free-ranging wild animals that might § 522.870 Etodolac. be used for food. (a) Specifications. Each milliliter con- (5) Federal law restricts this drug to tains 100 milligrams (mg) etodolac. use by or on the order of a licensed vet- (b) Sponsor. See No. 000010 in § 510.600 erinarian. Distribution is restricted to of this chapter. veterinarians engaged in zoo and exotic (c) Conditions of use in dogs—(1) animal practice, wildlife management Amount. Administer 4.5 to 6.8 mg/pound programs, and researchers. (10 to 15 mg/kilogram) body weight as a [40 FR 13858, Mar. 27, 1975, as amended at 48 single, dorsoscapular subcutaneous in- FR 16241, Apr. 15, 1983; 61 FR 260, Jan. 4, 1996] jection. If needed, the daily dose of etodolac tablets as in § 520.870 of this § 522.900 Euthanasia solution. chapter may be given 24 hours after the (a) Specifications. Each milliliter injection. (mL) of solution contains: (2) Indications for use. For the control of pain and inflammation associated (1) 390 milligrams (mg) of pento- with osteoarthritis. barbital sodium and 50 mg phenytoin (3) Limitations. Federal law restricts sodium. this drug to use by or on the order of a (2) 400 mg secobarbital sodium and 25 licensed veterinarian. mg dibucaine hydrochloride. (b) Sponsors. See sponsors in [72 FR 51365, Sept. 7, 2007, as amended at 75 § 510.600(c) of this chapter: FR 10167, Mar. 5, 2010] (1) Nos. 000061, 051311, and 054925 for § 522.883 Etorphine hydrochloride in- use of product described in paragraph jection. (a)(1) of this section. (2) No. 000856 for use of product de- (a) Chemical name. 6,7,8,14 - scribed in paragraph (a)(2) of this sec- tetrahydro - alpha - methyl - alpha - tion. propyl - 6,14 - endo-ethenooripavine- (c) Special considerations. Product la- alpha-methanol hydrochloride. beling shall bear the following warning (b) Specifications. Each milliliter of statements: ENVIRONMENTAL HAZ- etorphine hydrochloride injection, vet- ‘‘ ARD: This product is toxic to wildlife. erinary, contains 1 mg of etorphine hy- Birds and mammals feeding on treated drochloride in sterile aqueous solution. animals may be killed. Euthanized ani- (c) Sponsors. See No. 053923 in mals must be properly disposed of by § 510.600(c) of this chapter. deep burial, incineration, or other (d) Conditions of use. (1) The drug is method in compliance with state and used for the immobilization of wild and local laws, to prevent consumption of exotic animals. carcass material by scavenging wildlife.’’ 1 These conditions are NAS/NRC reviewed (d) Conditions of use in dogs—(1) Indi- and deemed effective. Applications for these uses need not include effectiveness data as cations for use. For humane, painless, specified by § 514.111 of this chapter, but may and rapid euthanasia. require bioequivalency and safety informa- (2) Amount. One mL per 10 pounds of tion. body weight.

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(3) Limitations. Do not use in animals drug to use by or on the order of a li- intended for food. Federal law restricts censed veterinarian. this drug to use by or on the order of a [48 FR 7164, Feb. 18, 1983, as amended at 49 licensed veterinarian. FR 26715, June 29, 1984; 54 FR 400, Jan. 6, 1989; [68 FR 42969, July 21, 2003, as amended at 68 61 FR 5506, Feb. 13, 1996] FR 55824, Sept. 29, 2003; 70 FR 8929, Feb. 24, 2005; 71 FR 13542, Mar. 16, 2006] § 522.930 Firocoxib. (a) Specifications. Each milliliter of § 522.914 Fenprostalene solution. solution contains 20 milligrams (mg) (a) Specifications—(1) Cattle. Each mil- firocoxib. liliter of sterile solution contains 0.5 (b) Sponsors. See No. 050604 in milligram of fenprostalene. § 510.600(c) of this chapter. (2) Swine. Each milliliter of sterile (c) Conditions of use in horses—(1) solution contains 0.25 milligram of Amount. Administer 0.04 mg/pound (lb) fenprostalene. (0.09 mg/kilogram (kg)) of body weight (BW) intravenously, once daily, for up (b) Sponsor. See 000856 in § 510.600(c) of to 5 days. If further treatment is need- this chapter. ed, firocoxib oral paste can be adminis- (c) Related tolerances. See § 556.277 of tered at a dosage of 0.045 mg/lb (0.1 mg/ this chapter. kg) of BW for up to an additional 9 (d) Special considerations. Labeling days of treatment. shall bear the following statements: (2) Indications for use. For the control Women of childbearing age, of pain and inflammation associated asthmatics, and persons with bronchial with osteoarthritis. and other respiratory problems should (3) Limitations. Do not use in horses exercise extreme caution when han- intended for human consumption. Fed- dling this product. It is readily ab- eral law restricts this drug to use by or sorbed through the skin and may cause on the order of a licensed veterinarian. abortion and/or bronchiospasms. Acci- dental spillage on the skin should be [75 FR 59611, Sept. 28, 2010] washed off immediately with soap and § 522.955 Florfenicol. water. (e) Conditions of use—(1) Cattle—(i) (a) Specifications. Each milliliter Amount. 1 milligram (2 milliliters) (mL) of solution contains: subcutaneously per animal. (1) 300 milligrams (mg) florfenicol in the inactive vehicles 2-pyrrolidone and (ii) Indications for use. For feedlot triacetin. heifers to induce abortion when preg- (2) 300 mg florfenicol in the inactive nant 150 days or less. For beef or non- vehicle n-methyl-2-pyrrolidone. lactating dairy cattle for estrus syn- (b) Sponsor. See No. 000061 in chronization. § 510.600(c) of this chapter for use of (iii) Limitations. Subcutaneous use in product described in paragraph (a)(1) as cattle only. Feedlot heifers to induce in paragraph (d)(1)(i) and for use of abortion, single dose. Beef or nonlac- product described in paragraph (a)(2) as tating dairy cattle for estrus synchro- in paragraph (d)(1)(ii). nization, a single dose or two doses 11 (c) Related tolerance. See § 556.283 of to 13 days apart. Do not use in preg- this chapter. nant animals unless abortion is de- (d) Conditions of use—(1) Cattle—(i) 300 sired. Federal law restricts this drug to mg/mL florfenicol in 2-pyrrolidone and use by or on the order of a licensed vet- triacetin (inactive vehicles). erinarian. (A) Amount. 40 mg/kilogram (kg) body (2) Swine—(i) Amount. 0.25 milligram weight as a single subcutaneous injec- (1 milliliter) subcutaneously once per tion. animal. (B) Indications for use. For treatment (ii) Indications for use. For sows and of bovine respiratory disease (BRD) as- gilts pregnant at least 112 days for the sociated with Mannheimia haemolytica, induction of parturition. Pasteurella multocida, Histophilus somni, (iii) Limitations. Subcutaneous use in and Mycoplasma bovis in beef and non- swine only. Federal law restricts this lactating dairy cattle.

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(C) Limitations. Do not slaughter (c) Tolerances. See §§ 556.283 and within 44 days of treatment. Do not use 556.286 of this chapter. in female dairy cattle 20 months of age (d) Conditions for use in cattle—(1) or older. Use may cause milk residues. Amount. 40 mg florfenicol/kg body A withdrawal period has not been es- weight (BW) and 2.2 mg flunixin/kg BW tablished in preruminating calves. Do (equivalent to 2 mL/15 kg BW or 6 mL/ not use in calves to be processed for 100 lbs) once, by subcutaneous injec- veal. Federal law restricts this drug to tion. use by or on the order of a licensed vet- (2) Indications for use. For treatment erinarian. of bovine respiratory disease (BRD) as- (ii) 300 mg/mL florfenicol in n-meth- sociated with Mannheimia haemolytica, yl-2-pyrrolidone (inactive vehicle). Pasteurella multocida, Histophilus somni, (A)(1) Amount. 20 mg/kg of body and Mycoplasma bovis, and control of weight as an intramuscular injection. BRD-associated pyrexia in beef and A second dose should be administered non-lactating dairy cattle. 48 hours later. Alternatively, 40 mg/kg (3) Limitations. Federal law restricts of body weight as a single subcuta- this drug to use by or on the order of a neous injection may be used. licensed veterinarian. Animals in- (2) Indications for use. For treatment tended for human consumption must of BRD associated with Mannheimia not be slaughtered within 38 days of (Pasteurella) haemolytica, P. multocida, treatment. Do not use in female dairy and Haemophilus somnus. For treatment cattle 20 months of age or older. Use of of bovine interdigital phlegmon (foot florfenicol in this class of cattle may rot, acute interdigital necrobacillosis, cause milk residues. A withdrawal pe- infectious pododermatitis) associated riod has not been established in with Fusobacterium necrophorum and preruminating calves. Do not use in Bacteroides melaninogenicus. calves to be processed for veal. (B)(1) Amount. 40 mg/kg of body weight as a single subcutaneous injec- [75 FR 1275, Jan. 11, 2010, as amended at 75 FR 54018, Sept. 3, 2010] tion. (2) Indications for use. For control of § 522.960 Flumethasone implantation respiratory disease in cattle at high or injectable dosage forms. risk of developing BRD associated with Mannheimia (Pasteurella) haemolytica, P. § 522.960a Flumethasone suspension. multocida, and Haemophilus somnus. (a) Chemical name. 6a,9a-Difluoro- (C) Limitations. Do not slaughter 11b,17,21 - trihydroxy - 16a - within 28 days of last intramuscular methylpregna - 1,4 - diene - 3,20 - dione. treatment or within 38 days of subcuta- (b) Specifications. Flumethasone sus- neous treatment. Do not use in female pension is sterile and each milliliter of dairy cattle 20 months of age or older. the drug contains: 2 milligrams of Use may cause milk residues. A with- flumethasone, 20 milligrams of pro- drawal period has not been established pylene glycol, 9 milligrams of benzyl in preruminating calves. Do not use in alcohol (as preservative), 8 milligrams calves to be processed for veal. Federal of sodium chloride, 0.02 milligram of law restricts this drug to use by or on polysorbate-80, 0.1 milligram of citric the order of a licensed veterinarian. acid, and water for injection q.s. (2) [Reserved] (c) Sponsor. See No. 000856 in [73 FR 21041, Apr. 18, 2008, as amended by 74 § 510.600(c) of this chapter. FR 66574, Dec. 16, 2009] (d) Conditions of use. (1) It is recommended in the various disease states § 522.956 Florfenicol and flunixin. involving synovial structures (joints) (a) Specifications. Each milliliter of horses where excessive synovial fluid (mL) of solution contains 300 milli- of inflammatory origin is present and grams (mg) florfenicol and 16.5 mg where permanent structural changes do flunixin (27.37 mg flunixin meglumine). not exist. Such conditions include ar- (b) Sponsor. See No. 000061 in thritis, carpitis, and osselets. § 510.600(c) of this chapter for use as in (2) The drug is administered paragraph (d) of this section. intraarticularly at a dosage level of 6

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to 10 milligrams per injection. The dos- exceed 3 days of therapy. With chronic age level is dependent upon the size of conditions intramuscular therapy may the involved synovial structure and the be followed by oral administration of degree of severity of the condition flumethasone tablets at a daily dose of under treatment. The dosage is limited from 0.0625 to 0.25 milligram per ani- to a single injection per week in any mal. one synovial structure. (3) For use only by or on the order of (3) Clinical and experimental data a licensed veterinarian. have demonstrated that corticosteroids [40 FR 13858, Mar. 27, 1975. Redesignated at 44 administered orally and parenterally FR 16011, Mar. 16, 1979, as amended at 61 FR to animals during the last trimester of 5507, Feb. 13, 1996] pregnancy may induce the first stage of parturition and may precipitate pre- § 522.960c Flumethasone solution. mature parturition followed by (a) Specifications. Each milliliter of dystocia, fetal death, retained pla- sterile aqueous solution contains 0.5 centa, and metritis. The drug is not to milligram flumethasone. be used in horses intended for slaugh- (b) Sponsor. See No. 000856 in ter for food purposes. § 510.600(c) of this chapter. (4) For use only by or on the order of (c) Conditions of use. It is used as fol- a licensed veterinarian. lows: [40 FR 13858, Mar. 27, 1975. Redesignated at 44 (1) Horses—(i) Amount. 1.25 to 2.5 mil- FR 16011, Mar. 16, 1979, as amended at 61 FR ligrams daily, intravenously, 5506, Feb. 13, 1996] intramuscularly, or intra-articularly. (ii) Indications for use. It is used for § 522.960b Flumethasone acetate injec- the treatment of musculoskeletal con- tion. ditions due to inflammation, where (a) Chemical name. 6-alpha,9-alpha- permanent structural changes do not difluoro - 16 - alpha - exist, e.g., bursitis, carpitis, osselets, methylprednisolone 21-acetate. and myositis; and allergic states, e.g., (b) Specifications. Flumethasone in- hives, urticaria, and insect bites. jection is sterile and contains per cubic (iii) Limitations—(a) Clinical and ex- centimeter: 2 milligrams of perimental data have demonstrated flumethasone acetate; 20 milligrams of that corticosteroids administered oral- propylene glycol; 9 milligrams of ben- ly or parenterally to animals may in- zyl alcohol (as preservative); 8 milli- duce the first stage of parturition when grams of sodium chloride; 1 milligram administered during the last trimester of polysorbate 80; 0.1 milligram of cit- of pregnancy and may precipitate pre- ric acid; water for injection q.s. mature parturition followed by (c) Sponsor. See No. 000856 in dystocia, fetal death, retained pla- § 510.600(c) of this chapter. centa, and metritis. (d) Conditions of use. (1) It is rec- (b) When a long-term therapy is used, ommended in certain acute and chronic the dose should be individually ad- canine dermatoses of varying etiology justed to the minimum maintenance to help control the pruritus, irritation, dose. A protein-rich diet is useful in and inflammation associated with dogs and cats on long-term therapy to these conditions. counteract nitrogen loss if it should (2) The drug is administered occur. A small amount of potassium intramuscularly at the following rec- chloride daily in the diet will counter- ommended daily dosage: act excessive potassium loss if this is Dosage in present. Weight of animal in pounds milligrams (c) It has been demonstrated that Up to 10 ...... 1.0 corticosteroids, especially at high dose 10 to 25 ...... 2.0 levels, may result in delayed wound 25 and over ...... 4.0 and fracture healing. (d) Flumethasone may be adminis- Dosage should be adjusted according to tered to animals with bacterial dis- the weight of the animal, the severity eases provided appropriate anti- of the symptoms, and the response bacterial therapy is administered si- noted. Dosage by injection should not multaneously.

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(e) The drug is not to be used in (2) See No. 000856 for use as in para- horses intended for slaughter for food graph (e)(1) of this section. purposes. (3) See Nos. 057561 and 059130 for use (f) Federal law restricts this drug to as in paragraphs (e)(1) and (2) of this use by or on the order of a licensed vet- section. erinarian. (c) Related tolerances. See § 556.286 of (2) Dogs—(i) Amount. 0.0625 to 0.25 this chapter. milligram daily, intravenously, (d) Special considerations. Federal law intramuscularly, or subcutaneously; restricts this drug to use by or on the 0.125 to 1.0 milligram daily, order of a licensed veterinarian. intralesionally, depending on the size (e) Conditions of use—(1) Horses—(i) and location of the lesion; 0.166 to 1.0 Amount. 0.5 mg per pound (/lb) of body milligram daily, intra-articularly, de- weight per day, intravenously or pending on the severity of the condi- intramuscularly, for up to 5 days. tion and the size of the involved joint. (ii) Indications for use. It is used for (ii) Indications for use. For alleviation the treatment of musculoskeletal con- of inflammation and pain associated ditions due to inflamation of muscles with musculoskeletal disorders, and al- or joints and accessory structures leviation of visceral pain associated where permanent structural changes do with colic. not exist, e.g., arthritis, osteoarthritis, (iii) Limitations. Do not use in horses disc syndrome, and myositis (in septic intended for human consumption. arthritis, appropriate antibacterial (2) Cattle—(i) Amounts and indications therapy should be concurrently admin- for use—(A) Administer 1.1 to 2.2 mg/ istered); certain acute and chronic kilogram (kg) (0.5 to 1.0 mg/lb) of body dermatoses of varying etiology to help weight per day intravenously, as a sin- control associated pruritus, irritation, gle dose or divided into two doses ad- and inflammation; otitis externa in ministered at 12-hour intervals, for up conjunction with topical medication; to 3 days for control of pyrexia associ- allergic states, e.g., hives, urticaria, ated with bovine respiratory disease and insect bites; and shock and shock- and endotoxemia or for control of in- like states by intravenous administra- flammation in endotoxemia. tion. (B) Administer 2.2 mg/kg (1.0 mg/lb) (iii) Limitations. See paragraph of body weight once intravenously for (c)(1)(iii) of this section. control of pyrexia associated with (3) Cats—(i) Amount. 0.03125 to 0.125 acute bovine mastitis. milligram daily intravenously, (ii) Limitations. Cattle must not be intramuscularly, or subcutaneously. slaughtered for human consumption (ii) Indications for use. It is used for within 4 days of last treatment. Milk the treatment of certain acute and that has been taken during treatment chronic dermatoses of varying etiology and for 36 hours after the last treat- to help control associated pruritus, ir- ment must not be used for food. Do not ritation, and inflammation. use in dry dairy cows. A withdrawal pe- (iii) Limitations. See paragraph riod has not been established for use in (c)(1)(iii) of this section. preruminating calves. Do not use in [44 FR 16011, Mar. 16, 1978, as amended at 61 calves to be processed for veal. FR 5507, Feb. 13, 1996] (B) For control of pyrexia associated with acute bovine mastitis. § 522.970 Flunixin. (iii) Limitations. Do not slaughter for (a) Specifications. Each milliliter of food use within 4 days of last treat- solution contains flunixin meglumine ment. A withdrawal period has not equivalent to 50 milligrams (mg) been established for use in flunixin. preruminating calves. Do not use in (b) Sponsors. See sponsors in calves to be processed for veal. For § 510.600(c) of this chapter for use as in Nos. 000061, 055529, 059130, and 061623: Do paragraph (e) of this section. not use in dry dairy cows. Milk that (1) See Nos. 000061, 055529, and 061623 has been taken during treatment and for use as in paragraph (e) of this sec- for 36 hours after the last treatment tion. must not be used for food. For No.

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057561: Not for use in lactating or dry skin should be washed off immediately dairy cows. with soap and water. (3) Swine—(i) Amount. Administer 2.2 [44 FR 52191, Sept. 7, 1979, as amended at 47 mg/kg (1.0 mg/lb) of body weight as a FR 22092, May 21, 1982] single intramuscular injection. (ii) Indications for use. For the control § 522.1002 Follicle stimulating hor- of pyrexia associated with swine res- mone. piratory disease. (a)(1) Specifications. Each package (iii) Limitations. Swine must not be contains 2 vials. One vial contains dry, slaughtered for human consumption powdered, porcine pituitary gland within 12 days of last treatment. equivalent to 75 units (NIH-FSH-S1) of follicle stimulating hormone. The [42 FR 39103, Aug. 2, 1977, as amended at 52 other vial contains 10 milliliters of FR 7832, Mar. 13, 1987; 60 FR 54942, Oct. 27, 1995; 62 FR 22888, Apr. 28, 1997; 63 FR 38749, aqueous diluent. July 20, 1998; 67 FR 9400, Mar. 1, 2002; 68 FR (2) Sponsor. See No. 052923 in 70701, Dec. 19, 2003; 69 FR 53618, Sept. 2, 2004; § 510.600(c) of this chapter. 69 FR 60308, Oct. 8, 2004; 70 FR 48868, Aug. 22, (3) Conditions of use. (i) Dosage. 12.5 2005; 70 FR 70998, Nov. 25, 2005; 71 FR 15564, units of follicle stimulating hormone Mar. 29, 2006; 71 FR 16222, Mar. 31, 2006; 73 FR twice a day for 3 days (a total of 75 2809, Jan. 16, 2008; 73 FR 28037, May 15, 2008; units). To effect regression of the cor- 74 FR 6994, Feb. 12, 2009; 74 FR 34236, July 15, pus luteum, prostaglandin should be 2009; 75 FR 13225, Mar. 19, 2010; 75 FR 76260, given with the 5th dose. Dec. 8, 2010] (ii) Indications for use. For induction § 522.995 Fluprostenol sodium injec- of superovulation in cows for proce- tion. dures requiring the production of multiple ova at a single estrus. (a) Specifications. Each milliliter of (iii) Limitations. For intramuscular sterile aqueous solution contains use in cows that are not pregnant and fluprostenol sodium equivalent to 50 have a normal corpus luteum. Federal micrograms of fluprostenol. law restricts this drug to use by or on (b) Sponsor. See 000859 in § 510.600(c) of the order of a licensed veterinarian. this chapter. (b)(1) Specifications. The drug is a (c) Conditions of use—(1) Amount. 0.55 lyophilized pituitary extract material. microgram fluprostenol per kilogram Each 10-milliliter vial contains an of body weight. amount equivalent to 50 milligrams of (2) Indications for use. The drug is standard porcine follicle stimulating used in mares for its luteolytic effect hormone and is reconstituted for use to control the timing of estrus in es- by addition of 10 milliliters of 0.9 per- trous cycling and in clinically cent aqueous sodium chloride solution. anestrous mares that have a corpus (2) Sponsor. See 063112 in § 510.600(c) of luteum. this chapter. (3) Limitations. Administer by (3) Conditions of use. (i) Dosage. Cattle intramuscular injection only. Warning: and horses, 10–50 milligrams; sheep and Not for use in horses intended for food. swine, 5–25 milligrams; dogs, 5–15 milli- For veterinary use only. Federal law grams. restricts this drug to use by or on the (ii) Indications for use. The drug is order of a licensed veterinarian. used as a supplemental source of fol- Women of childbearing age, licle stimulating hormone where there asthmatics, and persons with bronchial is a general deficiency in cattle, and other respiratory problems should horses, sheep, swine, and dogs. exercise extreme caution when han- (iii) Limitations. Administer dling this product. In the early stages, intramuscularly, subcutaneously, or women may be unaware of their preg- intravenously. Federal law restricts nancies. Fluprostenol is readily ab- this drug to use by or on the order of a sorbed through the skin and can cause licensed veterinarian. abortion and/or bronchiospasms. Direct [58 FR 47377, Sept. 9, 1993, as amended at 62 contact with the skin should therefore FR 62242, Nov. 21, 1997; 76 FR 2808, Jan. 18, be avoided. Accidental spillage on the 2011]

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§ 522.1004 Fomepizole. ascites) associated with cardiac insuffi- (a) Specifications. Each vial contains ciency and acute noninflammatory tis- 1.5 grams fomepizole (1.5 milliliter sue edema. (mL) of 1.0 gram per mL solution). (2) Horses—(i) Amount. 250 to 500 mg (b) Sponsors. See Nos. 068727 and per animal once or twice daily, 068882 in § 510.600(c) of this chapter. intramuscularly or intravenously. (c) Conditions of use in dogs—(1) (A) Indications for use. For the treat- Amount. 20 milligrams per kilogram ment of edema (pulmonary congestion, (mg/kg) of body weight intravenously ascites) associated with cardiac insuffi- initially, followed by 15 mg/kg at 12 ciency, and acute noninflammatory tis- and 24 hours, and 5 mg/kg at 36 hours. sue edema. (2) Indications for use. As an antidote (B) Limitations. Do not use in horses for ethylene glycol (antifreeze) poi- intended for food. soning in dogs who have ingested or are (ii) Amount. 0.5 mg/lb body weight suspected of having ingested ethylene once or twice daily, intramuscularly or glycol. intravenously. (3) Limitations. Federal law restricts (A) Indications for use. For treatment this drug to use by or on the order of a of acute noninflammatory tissue licensed veterinarian. edema. (B) Limitations. Do not use in horses [61 FR 68147, Dec. 27, 1996, as amended at 71 intended for food. FR 28266, May 16, 2006; 74 FR 26952, June 5, (iii) Amount. 250 to 500 mg/animal 2009; 74 FR 47725, Sept. 17, 2009] once or twice daily, intramuscularly or § 522.1010 Furosemide. intravenously. (A) Indications for use. For the treat- (a) Specifications—(1) Each milliliter ment of edema (pulmonary congestion, (mL) of solution contains 50 milligrams ascites) associated with cardiac insuffi- (mg) furosemide monoethanolamine. ciency, and acute noninflammatory tis- (2) Each mL of solution contains 50 sue edema. mg furosemide diethanolamine. (B) Limitations. Do not use in horses (b) Sponsors. See sponsors in intended for human consumption. § 510.600(c) of this chapter for use of (3) —(i) . 500 mg/animal products described in paragraph (a) of Cattle Amount this section for use as in paragraph (d) once daily, intramuscularly or intra- of this section. venously; or 250 mg/animal twice daily (1) No. 000010 as described in para- at 12-hour intervals, intramuscularly graph (a)(1) of this section for use as in or intravenously. paragraphs (d)(1) and (d)(2)(ii) of this (ii) Indications for use. For the treat- section. ment of physiological parturient (2) No. 061623 as described in para- edema of the mammary gland and asso- graph (a)(2) of this section for use as in ciated structures. paragraph (d)(2)(ii) of this section. (iii) Limitations. Treatment not to ex- (3) No. 059130 as described in para- ceed 48 hours post-parturition. Milk graph (a)(2) for use as in paragraphs taken during treatment and for 48 (d)(1), (d)(2)(i), and (d)(3) of this sec- hours (four milkings) after the last tion. treatment must not be used for food. (4) No. 000061 as described in para- Cattle must not be slaughtered for food graph (a)(2) for use as in paragraphs within 48 hours following last treat- (d)(1), (d)(2)(iii), and (d)(3) of this sec- ment. tion. [66 FR 47961, Sept. 17, 2001, as amended at 67 (c) Special considerations. Federal law FR 18086, Apr. 15, 2002; 68 FR 59881, Oct. 20, restricts this drug to use by or on the 2003; 69 FR 17585, Apr. 5, 2004; 71 FR 39548, order of a licensed veterinarian. July 13, 2006; 74 FR 61516, Nov. 25, 2009; 76 FR (d) Conditions of use—(1) Dogs and 17338, Mar. 29, 2011] cats—(i) Amount. 1.25 to 2.5 mg per pound (/lb) body weight once or twice § 522.1020 Gelatin solution. daily, intramuscularly or intra- (a) Specifications. It is sterile and venously. each 100 cubic centimeters contains 8 (ii) Indications for use. For the treat- grams of gelatin in an 0.85 percent so- ment of edema (pulmonary congestion, dium chloride solution.

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(b) Sponsor. See No. 000856 in and in chickens as in paragraph (d)(3) § 510.600(c) of this chapter. of this section. (c) Conditions of use. (1) It is used to (c) Related tolerances. See § 556.300 of restore circulatory volume and main- this chapter. tain blood pressure in animals being (d) Conditions of use—(1) Dogs and treated for shock. cats—(i) Amount. Two milligrams of (2) The exact dosage to be adminis- gentamicin per pound of body weight, tered must be determined after evalu- twice daily on the first day, once daily ating the animal’s condition and will thereafter, using a 50 milligram-per- vary according to the size of the ani- milliliter solution. mal and the degree of shock. A sug- (ii) Indications for use—(a) Dogs. For gested dosage range for small animals the treatment of infections of urinary such as dogs is 4 to 8 cubic centimeters tract (cystitis, nephritis), respiratory per pound body weight. The suggested tract (tonsillitis, pneumonia, dosage range for large animals such as tracheobronchitis), skin and soft tissue sheep, calves, cows, or horses is 2 to 4 (pyodermatitis, wounds, lacerations, cubic centimeters per pound of body peritonitis). weight. It is administered intra- (b) Cats. For the treatment of infec- venously at a rate of 10 cubic centi- tions of urinary tract (cystitis, nephri- meters per minute in small animals tis), respiratory tract (pneumonitis, and 20 to 30 cubic centimeters per pneumonia, upper respiratory tract in- minute in large animals. The solution fections), skin and soft tissue (wounds, is administered aseptically and must lacerations, peritonitis), and as sup- be between 50 to 70 °F. when injected. portive therapy for secondary bacterial (3) A few animals will exhibit signs of infections associated with allergic reaction. This solution can panleucopenia. cause transient reversible nephrosis. (iii) Limitations. Administer This product is not intended to replace intramuscularly or subcutaneously. If whole blood in cases of anemia and response is not noted after 7 days, the should not be used in the presence of antibiotic sensitivity of the infecting renal dysfunction. Unused portions re- organism should be retested. Federal maining in bottles should be discarded. law restricts this drug to use by or on (4) For use only by or on the order of the order of a licensed veterinarian. a licensed veterinarian. (2) Turkeys—(i) Amount. One milligram of gentamicin per 0.2 milliliter § 522.1044 Gentamicin. dose, using the 50- or 100-milligrams- (a) Specifications. Each milliliter of per-milliliter product diluted with solution contains gentamicin sulfate sterile saline to a concentration of 5 equivalent to 5, 50, or 100 milligrams milligrams-per-milliliter. (mg) gentamicin. (ii) Indications for use. As an aid in (b) Sponsors. See sponsors in the prevention of early mortality due § 510.600(c) of this chapter for use as in to Arizona paracolon infections suscep- paragraph (d) of this section. tible to gentamicin. (1) No. 000061 for use of 5 mg per mil- (iii) Limitations. For 1- to 3-day old liliter (/mL) solution in swine as in turkey poults. Administer paragraph (d)(4), 50 mg/mL solution in subcutaneously in the neck. Injected dogs and cats as in paragraph (d)(1), 50 poults must not be slaughtered for food mg/mL and 100 mg/mL solution in for at least 9 weeks after treatment. chickens and turkeys as in paragraphs (3) Chickens—(i) Amount. 0.2 milli- (d)(2) and (d)(3) of this section. gram of gentamicin per 0.2 milliliter (2) No. 058005 for use of 5 mg/mL solu- dose, using the 50- or 100-milligrams- tion in swine as in paragraph (d)(4) of per-milliliter product diluted with this section. sterile saline to a concentration of 1.0 (3) No. 000010 for use of 50 mg/mL so- milligram-per-milliliter. lution in dogs as in paragraph (d)(5) of (ii) Indications for use. In day-old this section. chickens, for prevention of early mor- (4) No. 059130 for use of 100 mg/mL so- tality caused by Escherichia coli. Sal- lution in turkeys as in paragraph (d)(2) monella typhimurium, and Pseudomonas

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aeruginosa that are susceptible to (2) Indications for use. As a gentamicin. preanesthetic agent. (iii) Limitations. For use in day-old (3) Limitations. Federal law restricts chickens only. Administer aseptically, this drug to use by or on the order of a injecting the diluted product licensed veterinarian. subcutaneously in the neck. Do not slaughter treated animals for food for [71 FR 64451, Nov. 2, 2006] at least 5 weeks after treatment. § 522.1077 Gonadorelin injectable. (4) Swine—(i) Amount. 5 milligrams of gentamicin as a single intramuscular (a) Specifications. Each milliliter ster- dose using 5 milligram-per-milliliter ile aqueous solution contains 50 solution. micrograms of gonadorelin (as hydro- (ii) Indications for use. In piglets up to chloride). 3 days old for treatment of porcine (b) Sponsor. See No. 000856 in colibacillosis caused by strains of E. § 510.600(c) of this chapter. coli sensitive to gentamicin. (c) Conditions of use in cattle—(1) (iii) Limitations. For single Amount. 100 micrograms per cow intramuscular dose in pigs up to 3 days intramuscularly. of age only. Do not slaughter treated (2) Indications for use. For the treat- animals for food for at least 40 days fol- ment of cystic ovaries (ovarian following treatment. licular cysts) in cattle to reduce the (5) Dogs—(i) Amount. 2 milligrams of time to first estrus. gentamicin per pound of body weight, (3) Limitations. For intramuscular use twice daily on the first day, then once only. Federal law restricts this drug to daily. use by or on the order of a licensed vet- (ii) Indications for use. For use in the erinarian. treatment of urinary tract infections (cystitis) caused by Proteus mirabilis, [54 FR 50235, Dec. 5, 1989] Escherichia coli, and Staphylococcus § 522.1078 Gonadorelin diacetate tetra- aureus. hydrate. (iii) Limitations. Administer intramuscularly or subcutaneously. If (a) Specifications. Each milliliter of no improvement is seen after 3 days, solution contains 50 micrograms (μg) of treatment should be discontinued and gonadorelin diacetate tetrahydrate. the diagnosis reevaluated. Treatment (b) Sponsors. See Nos. 000061, 050604, not to exceed 7 days. Federal law re- and 059130 in § 510.600(c) of this chapter. stricts this drug to use by or on the (c) Conditions of use in cattle. It is order of a licensed veterinarian. used as follows: (1) Amount. 100 μg per cow as a single [43 FR 1942, Jan. 13, 1978, as amended at 48 FR 791, Jan. 7, 1983; 51 FR 15606, Apr. 25, 1986; intramuscular or intravenous injec- 52 FR 7832, Mar. 13, 1987; 53 FR 40727, Oct. 18, tion. 1988; 60 FR 29985, June 7, 1995; 61 FR 24441, (2) Indications for use. For the treat- May 15, 1996; 62 FR 45157, Aug. 26, 1997; 63 FR ment of ovarian cysts in dairy cattle. 59714, Nov. 5, 1998; 63 FR 68182, Dec. 10, 1998; (3) Limitations. Federal law restricts 65 FR 45877, July 26, 2000; 71 FR 76901, Dec. 22, this drug to use by or on the order of a 2006] licensed veterinarian. § 522.1066 Glycopyrrolate. [67 FR 68759, Nov. 13, 2002, as amended at 74 (a) Specifications. Each milliliter of FR 61516, Nov. 25, 2009] solution contains 0.2 milligram glycopyrrolate. § 522.1079 Serum gonadotropin and chorionic gonadotropin. (b) Sponsors. See Nos. 000856 and 059130 in § 510.600(c) of this chapter. (a) Specifications. Each dose consists (c) Conditions of use in dogs and cats— of 400 international units (I.U.) serum (1) Amount. 5 micrograms per pound of gonadotropin and 200 I.U. chorionic body weight (0.25 milliliter per 10 gonadotropin as a freeze-dried powder pounds of body weight) by intravenous, to be reconstituted with 5 milliliters of intramuscular, or subcutaneous injec- sterile aqueous diluent. tion in dogs or by intramuscular injec- (b) Sponsor. See No. 000061 in tion in cats. § 510.600(c) of this chapter.

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(c) Conditions of use in swine—(1) (ii) Indications for use. For parenteral Amount. 400 I.U. serum gonadotropin use in cows for treatment of nympho- with 200 I.U. chorionic gonadotropin mania (frequent or constant heat) due per 5 milliliters dose per animal. to cystic ovaries. (2) Indications for use. (i) Gilts. For in- (iii) Limitations. Federal law restricts duction of fertile estrus (heat) in this drug to use by or on the order of a healthy prepuberal (noncycling) gilts. licensed veterinarian. (ii) Sows. For induction of estrus in (2) Finfish—(i) Amount. 50 to 510 IU healthy weaned sows experiencing de- per pound of body weight for males, 67 layed return to estrus. to 1,816 IU per pound of body weight for (3) Limitations. For subcutaneous use females, by intramuscular injection. only. Up to three doses may be administered. (i) Gilts. For use only in gilts over 5 (ii) Indications for use. An aid in im- 1/2 months of age and weighing at least proving spawning function in male and 85 kilograms (187 pounds). female brood finfish. (ii) Sows. Delayed return to estrus is (iii) Limitations. In fish intended for most prevalent after the first litter. human consumption, the total dose ad- The effectiveness has not been estab- ministered per fish (all injections com- lished after later litters. Delayed re- bined) should not exceed 25,000 IU turn to estrus often occurs during peri- chorionic gonadotropin. Federal law re- ods of adverse environmental condi- stricts this drug to use by or on the tions, and sows mated under such con- order of a licensed veterinarian. ditions may farrow smaller than nor- [74 FR 61516, Nov. 25, 2009] mal litters. EFFECTIVE DATE NOTE: At 76 FR 17778, Mar. [55 FR 1405, Jan. 16, 1990, as amended at 58 31, 2011, § 522.1081 was amended by removing FR 52222, Oct. 7, 1993; 74 FR 61516, Nov. 25, ‘‘Nos. 058639 and 063323’’ and in its place add 2009] ‘‘No. 058639’’, effective April 11, 2011.

§ 522.1081 Chorionic gonadotropin. § 522.1085 Guaifenesin sterile powder. (a) Specifications. Each vial contains (a) Specifications. It is a sterile pow- 5,000, 10,000 or 20,000 USP units of der containing guaifenesin. lyophilized powder for constitution (b) Sponsor. See Nos. 000856 and 037990 with accompanying diluent to a 10-mil- in § 510.600(c) of this chapter. liliter solution. (c) Conditions of use. (1) It is indicated (b) Sponsors. See sponsors in for intravenous use as a muscle relax- § 510.600(c) of this chapter for use as in ant in horses. paragraph (d) of this section. (2) A solution is prepared by dis- (1) Nos. 000402 and 053501 for use as in solving the drug in sterile water for in- paragraphs (d)(1)(i)(A), (d)(1)(i)(B) and jection to make a solution containing (d)(1)(i)(C) of this section. 50 milligrams of guaifenesin per milli- (2) Nos. 058639 and 063323 for use as in liter of solution. It is administered by paragraphs (d)(1)(i)(A) and (d)(1)(i)(B) rapid intravenous infusion at a fixed of this section. dosage of 1 milliliter of prepared solu- (3) No. 000061 for use as in paragraphs tion per pound of body weight. (d)(1)(i)(A) and (d)(2) of this section. (3) Not to be used in horses intended (c) Related tolerances. See § 556.304 of for food. this chapter. (4) Federal law restricts this drug to (d) Conditions of use—(1) Cattle—(i) use by or on the order of a licensed vet- Amount. As a single dose. Dosage may erinarian. be repeated in 14 days if the animal’s [49 FR 48039, Dec. 10, 1984, as amended at 60 behavior or examination of the ovaries FR 27223, May 23, 1995; 67 FR 67521, Nov. 6, per rectum indicates retreatment. 2002] (A) 10,000 USP units by intramuscular injection. § 522.1086 Guaifenesin injection. (B) 500 to 2,500 USP units by (a) Specifications. Each milliliter of intrafollicular injection. sterile aqueous solution contains 50 (C) 2,500 to 5,000 USP units by intra- milligrams of guaifenesin and 50 milli- venous injection. grams of dextrose.

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(b) Sponsor. See Nos. 037990 and 059130 (ii) Indications for use. Treatment of in § 510.600(c) of this chapter. joint dysfunction in horses due to non- (c) [Reserved] infectious synovitis associated with (d) Conditions of use. (1) The drug is equine osteoarthritis. used intravenously in horses as a skel- (iii) Limitations. For intra-articular etal muscle relaxant. injection in horses only. Treatment (2) Administer rapidly at a dosage of may be repeated at weekly intervals 1 milliliter per pound of body weight. for a total of three treatments. Do not (3) No to be used in horses intended use in horses intended for human con- for food. sumption. Federal law restricts this (4) Federal law restricts this drug to drug to use by or on the order of a li- use by or on the order of a licensed vet- censed veterinarian. erinarian. (b)(1) Specifications. Each milliliter of [60 FR 27223, May 23, 1995, as amended at 63 sterile aqueous solution contains 5 mil- FR 29352, May 29, 1998] ligrams of hyaluronate sodium. (2) Sponsor. See 053501 in § 510.600(c) of § 522.1125 Hemoglobin glutamer-200 this chapter. (bovine). (3) Conditions of use—(i) Amount. (a) Specifications. Each 125 milliliter Small and medium-size joints (carpal, bag contains 13 grams per deciliter of fetlock)—10 milligrams; larger joint polymerized hemoglobin of bovine ori- (hock)—20 milligrams. gin in modified Lactated Ringer’s Solu- (ii) Indications for use. Treatment of tion. It is a sterile, clear, dark purple joint dysfunction in horses due to non- solution. infectious synovitis associated with (b) Sponsor. See No. 063075 in equine osteoarthritis. § 510.600(c) of this chapter. (iii) Limitations. For intraarticular (c) [Reserved] injection in horses only. Treatment (d) Conditions of use—(1) Amount. One- may be repeated at weekly intervals time dose of 10 to 30 milliliters per kilogram of body weight administered for a total of four treatments. Not for intravenously at a rate of up to 10 mil- use in horses intended for food. Federal liliters per kilogram per hour. law restricts this drug to use by or on (2) Indications for use. For the treat- the order of a licensed veterinarian. ment of anemia in dogs by increasing (c)(1) Specifications. Each milliliter of systemic oxygen content (plasma he- sterile aqueous solution contains 10 moglobin concentration) and improv- milligrams of hyaluronate sodium. ing the clinical signs associated with (2) Sponsor. See No. 000010 in anemia, regardless of the cause of ane- § 510.600(c) of this chapter. mia (hemolysis, blood loss, or ineffec- (3) Conditions of use—(i) Amount. tive erythropoiesis). Small and medium-size joints (carpal, (3) Limitations. For intravenous use fetlock)—20 milligrams. only. Overdosage or an excessive rate (ii) Indications for use. Treatment of of administration (greater than 10 mil- carpal or fetlock joint dysfunction in liliters per kilogram per hour) may re- horses due to acute or chronic non- sult in circulatory overload. Federal infectious synovitis associated with law restricts this drug to use by or on equine osteoarthritis. the order of a licensed veterinarian. (iii) Limitations. For intraarticular [63 FR 11598, Mar. 10, 1998, as amended at 65 injection in horses only. Treatment FR 20732, Apr. 18, 2000] may be repeated after 1 or more weeks but not to exceed 2 injections per week § 522.1145 Hyaluronate sodium. for a total of 4 weeks. Not for use in (a)(1) Specifications. Each milliliter of horses intended for food. Federal law sterile aqueous solution contains 10 restricts this drug to use by or on the milligrams of hyaluronate sodium. order of a licensed veterinarian. (2) Sponsor. See 000009 in § 510.600(c). (d)(1) Specifications. Each milliliter of (3) Conditions of use—(i) Amount. sterile aqueous solution contains 10 Small and medium-size joints (carpal, milligrams of hyaluronate sodium. fetlock)—20 milligrams; larger joint (2) Sponsor. See 000061 in § 510.600(c) of (hock)—40 milligrams. this chapter.

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(3) Conditions of use—(i) Amount. 50 drug to use by or on the order of a li- milligrams in carpal and fetlock joints. censed veterinarian. (ii) Indications for use. For treatment [49 FR 45124, Nov. 15, 1984, as amended at 51 of equine carpal and fetlock joint dys- FR 11438, Apr. 3, 1986; 51 FR 25032, July 10, function caused by traumatic and/or 1986; 53 FR 19773, May 31, 1988; 53 FR 22297, degenerative joint disease of mild to June 15, 1988; 56 FR 50814, Oct. 9, 1991; 57 FR moderate severity. 2837, Jan. 24, 1992; 59 FR 33198, June 28, 1994; (iii) Limitations. For intraarticular 61 FR 59003, Nov. 20, 1996; 63 FR 59216, Nov. 3, 1998; 71 FR 1689, Jan. 11, 2006; 71 FR 39204, injection in horses only. Not for use in July 12, 2006; 75 FR 1274, Jan. 11, 2010; 75 FR horses intended for food. Not intended 10167, Mar. 5, 2010] for use in breeding animals. Federal law restricts this drug to use by or on § 522.1150 Hydrochlorothiazide injec- the order of a licensed veterinarian. tion. (e)(1) Specifications. Each milliliter of (a) Specifications. Each milliliter con- solution contains: tains 25 milligrams of (i) 10 milligrams (mg) hyaluronate hydrochlorothiazide. sodium; or (b) Sponsor. See No. 050604 in (ii) 10 mg hyaluronate sodium with § 510.600(c) of this chapter. benzyl alcohol as a preservative. (c) Conditions of use—(1) Amount. 5 to (2) Sponsor. See No. 000859 in 10 milliliters (125 to 250 milligrams) in- § 510.600(c) of this chapter. travenously or intramuscularly once or (3) Conditions of use in horses—(i) twice a day. After onset of diuresis, Amount. 20 mg of the product described treatment may be continued with an in paragraph (e)(1)(i) of this section by orally administered maintenance dose. intra-articular injection into the car- (2) Indications for use. For use in cat- pus or fetlock; or 40 mg of the product tle as an aid in the treatment of 1 described in paragraph (e)(1)(i) or postparturient udder edema. (e)(1)(ii) of this section by slow intra- (3) Limitations. Animals should be venous injection into the jugular vein. regularly and carefully observed for Treatment may be repeated at weekly early signs of fluid and electrolyte im- intervals for a total of three treat- balance. Take appropriate counter- ments. measures if this should occur. Milk (ii) Indications for use. For treatment taken from dairy animals during treat- of carpal or fetlock joint dysfunction ment and for 72 hours (6 milkings) after due to noninfectious synovitis associ- the latest treatment must not be used ated with equine osteoarthritis. for food. Federal law restricts this drug to use by or on the order of a licensed (iii) Limitations. Do not use in horses veterinarian.1 intended for human consumption. Fed- eral law restricts this drug to use by or [43 FR 59058, Dec. 19, 1978, as amended at 62 on the order of a licensed veterinarian. FR 63271, Nov. 28, 1997] (f)(1) Specifications. Each milliliter of § 522.1155 Imidocarb dipropionate sterile aqueous solution contains 11 sterile powder. milligrams of hyaluronate sodium. (2) Sponsor. See 060865 in § 510.600(c). (a) Specifications. Imidocarb (3) Conditions of use—(i) Amount. dipropionate powder is reconstituted Small and medium-size joints (carpal, with sterile water. Each milliliter of fetlock)—22 milligrams; larger joint solution contains 100 milligrams of (hock)—44 milligrams. imidocarb base. (b) Sponsor. No. 000061 in § 510.600(c) of (ii) Indications for use. Treatment of this chapter. joint dysfunction in horses due to non- (c) Conditions of use. The drug is used infectious synovitis associated with in horses and zebras as follows: equine osteoarthritis. (iii) Limitations. For intra-articular 1 injection in horses only. Treatment These conditions are NAS/NRC reviewed and deemed effective. Applications for these may be repeated at weekly intervals uses need not include effectiveness data as for a total of three treatments. Do not specified by § 514.111 of this chapter, but may use in horses intended for human con- require bioequivalency and safety informa- sumption. Federal law restricts this tion.

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(1) Amount. For Babesia caballi infec- Imidocarb is a cholinesterase inhibitor. tions, use intramuscularly 2 milli- Do not use simultaneously with or a grams of imidocarb base per kilogram few days before or after treatment with of body weight, repeating dosage once or exposure to cholinesterase-inhib- after 24 hours. For Babesia equi infec- iting drugs, pesticides, or chemicals. tions, use 4 milligrams of imidocarb Federal law restricts this drug to use base per kilogram of body weight, re- by or on the order of a licensed veteri- peating dosage four times at 72-hour narian. intervals. (2) [Reserved] (2) Indications for use. For the treat- [62 FR 66984, Dec. 23, 1997] ment of babesiosis (piroplasmosis) caused by Babesia caballi and Babesia § 522.1160 Insulin. equi. (a) Specifications—(1) Each milliliter (3) Limitations. Administer (mL) of porcine insulin zinc suspension intramuscularly in the neck region. Do contains 40 international units (IU) of not inject intravenously. Do not use insulin. for other equidae or for animals of (2) Each mL of protamine zinc recom- other species. Do not use in horses less binant human insulin suspension con- than 1 year old. Do not use for animals tains 40 IU of insulin. in near-term pregnancies. Imidocarb (b) Sponsors. See sponsors in § 510.600 dipropionate is a cholinesterase inhib- of this chapter for use as in paragraph itor. Do not use this product simulta- (c) of this section. neously with or a few days before or (1) No. 000061 for use of product de- after treatment with or exposure to scribed in paragraph (a)(1) of this sec- cholinesterase-inhibiting drugs, pes- tion as in paragraphs (c)(1), (c)(2)(i)(A), ticides, or chemicals. Do not use in (c)(2)(ii), and (c)(2)(iii) of this section. horses intended for food. Federal law (2) No. 000010 for use of product de- restricts this drug to use by or on the scribed in paragraph (a)(2) of this sec- order of a licensed veterinarian. tion as in paragraphs (c)(2)(i)(B), Imidocarb dipropionate is sold only (c)(2)(ii), and (c)(2)(iii) of this section. under permit issued by the Director of (c) Conditions of use—(1) Dogs—(i) the National Program Planning Staff, Amount. Administer an initial once- Veterinary Services, APHIS, USDA, to daily dose of 0.5 IU per kilogram of licensed or full-time State, Federal, or body weight by subcutaneous injection military veterinarians. concurrently with or right after a [43 FR 40455, Sept. 12, 1978, as amended at 46 meal. Adjust this once-daily dose at ap- FR 48642, Oct. 2, 1981; 61 FR 8873, Mar. 6, 1996; propriate intervals based on clinical 62 FR 61625, Nov. 19, 1997] signs, urinalysis results, and glucose curve values until adequate glycemic § 522.1156 Imidocarb dipropionate so- control has been attained. Twice-daily lution. therapy should be initiated if the dura- (a) Specifications. Each milliliter of tion of insulin action is determined to injectable solution contains 120 milli- be inadequate. If twice-daily treatment grams of imidocarb. is initiated, the two doses should be 25 (b) Sponsor. See No. 000061 in percent less than the once daily dose § 510.600(c) of this chapter. required to attain an acceptable nadir. (c) [Reserved] (ii) Indications for use. For the reduc- (d) Conditions of use—(1) Dogs—(i) tion of hyperglycemia and hyper- Amount. 6.6 milligrams imidocarb per glycemia-associated clinical signs in kilogram (3 milligrams per pound) of dogs with diabetes mellitus. body weight. (iii) Limitations. Federal law restricts (ii) Indications for use. Treatment of this drug to use by or on the order of a clinical signs of babesiosis and/or dem- licensed veterinarian. onstrated Babesia organisms in the (2) Cats—(i) Amount—(A) Porcine insu- blood. lin zinc. Administer an initial dose of 1 (iii) Limitations. Use subcutaneously to 2 IU by subcutaneous injection. In- or intramuscularly. Not for intra- jections should be given twice daily at venous use. Repeat the dose after 2 approximately 12-hour intervals. For weeks for a total of two treatments. cats fed twice daily, the injections

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should be concurrent with or right tial intramuscular injection of 100 mg after a meal. For cats fed ad libitum, at 2 to 4 days of age. Dosage may be re- no change in feeding is needed. Adjust peated in 14 to 21 days. the dose at appropriate intervals based (ii) For the treatment of anemia due on clinical signs, urinalysis results, to iron deficiency, administer an and glucose curve values until ade- intramuscular injection of 200 mg. quate glycemic control has been at- (3) Nos. 000061 and 062408 for use of tained. product described in paragraph (a)(1)(i) (B) Protamine zinc recombinant human of this section as follows: insulin. Administer an initial dose of (i) For the prevention of iron defi- 0.1 to 0.3 IU/pound of body weight (0.2 ciency anemia, administer to 0.7 IU/kilogram) every 12 hours. The intramuscularly an amount of drug dose should be given concurrently with containing 100 to 150 mg of elemental or right after a meal. Re-evaluate the iron to animals from 1 to 3 days of age. cat at appropriate intervals and adjust (ii) For the treatment of iron defi- the dose based on both clinical signs ciency anemia, administer and glucose nadirs until adequate gly- intramuscularly an amount of drug cemic control has been attained. containing 100 to 200 mg of elemental (ii) Indications for use. For the reduc- iron per animal. Dosage may be re- tion of hyperglycemia and hyper- peated in 10 days to 2 weeks. glycemia-associated clinical signs in (4) Nos. 051311 and 053501 for use of cats with diabetes mellitus. product described in paragraph (iii) Limitations. Federal law restricts (a)(1)(ii) of this section as follows: this drug to use by or on the order of a (i) For prevention of iron deficiency licensed veterinarian. anemia, administer 1 mL by [69 FR 25827, May 10, 2004, as amended at 73 intramuscular injection at 2 to 5 days FR 21042, Apr. 18, 2008; 74 FR 61517, Nov. 25, of age. Dosage may be repeated at 2 2009; 74 FR 66048, Dec. 14, 2009] weeks of age. (ii) For treatment of iron deficiency § 522.1182 Iron injection. anemia, administer 1 to 2 mL by (a) Specifications. See § 510.440 of this intramuscular injection at 5 to 28 days chapter. Each milliliter (mL) of solu- of age. tion contains the equivalent of: (5) No. 053501 for use of product de- (1) 100 milligrams (mg) of elemental scribed in paragraph (a)(1)(iii) of this iron derived from: section as follows: (i) Ferric hydroxide; (i) For prevention of anemia due to (ii) Ferric oxide; or iron deficiency, administer 100 mg by (iii) Elemental iron. intramuscular or subcutaneous injec- (2) 200 mg of elemental iron derived tion at 2 to 4 days of age. from ferric hydroxide. (ii) For treatment of anemia due to (b) Sponsors and conditions of use. It is iron deficiency, administer 100 mg by used in baby pigs by sponsors in intramuscular or subcutaneous injec- § 510.600(c) of this chapter as follows: tion up to 4 weeks of age. (1) Nos. 042552 and 059130 for use of (6) Nos. 058005 and 059130 for use of product described in paragraph (a)(1)(i) product described in paragraph of this section as follows: (a)(1)(iii) of this section as follows: (i) For prevention of iron deficiency (i) For prevention of anemia due to anemia, inject 100 mg (1 mL) by iron deficiency, administer 100 mg by intramuscular injection at 2 to 4 days intramuscular injection at 2 to 4 days of age. of age. (ii) For treatment of iron deficiency (ii) For treatment of anemia due to anemia, inject 100 mg (1 mL) by iron deficiency, administer 100 mg by intramuscular injection. Dosage may intramuscular injection. Treatment be repeated in approximately 10 days. may be repeated in 10 days. (2) No. 000856 for use of product de- (7) Nos. 042552 and 059130 for use of scribed in paragraph (a)(1)(i) of this product described in paragraph (a)(2) of section as follows: this section as follows: (i) For the prevention of anemia due (i) For prevention of baby pig anemia to iron deficiency, administer an ini- due to iron deficiency, intramuscularly

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inject 200 mg of elemental iron (1 mL) (ii) Indications for use. For the treat- at 1 to 3 days of age. ment and control of large strongyles (ii) For treatment of baby pig anemia (adult) (Strongylus vulgaris, S. edentatus, due to iron deficiency, intramuscularly Triodontophorus spp.), small strongyles inject 200 mg of elemental iron at the (adult and fourth stage larvae) first sign of anemia. (Cyathostomum spp., Cylicocyclus spp., (8) No. 062408 for use of product de- Cylicostephanus spp.), pinworms (adult scribed in paragraph (a)(2) of this sec- and fourth-stage larvae) (Oxyuris equi), tion as follows: large roundworms (adult) (Parascaris (i) For prevention of iron deficiency equorum), hairworms (adult) anemia, administer 200 mg (Trichostrongylus axei), large mouth intramuscularly on or before 3 days of stomach worms (adult) (Habronema age. muscae), neck threadworms (ii) For treatment of iron deficiency (microfilariae) (Onchocerca spp.), and anemia, administer 200 mg stomach bots (Gastrophilus spp.). intramuscularly. (iii) Limitations. Not for use in horses [73 FR 12635, Mar. 10, 2008, as amended at 73 intended for human consumption. Fed- FR 14385, Mar. 18, 2008] eral law restricts this drug to use by or on the order of a licensed veterinarian. § 522.1192 Ivermectin. (2) Cattle—(i) Amount. 200 μg/kg of (a) Specifications—(1) Each milliliter body weight by subcutaneous injection. (mL) of solution contains 20 milligrams (ii) Indications for use. For the treat- (mg) ivermectin. ment and control of gastrointestinal (2) Each mL of solution contains 10 nematodes (adults and fourth-stage lar- mg ivermectin. vae) (Haemonchus placei, Ostertagia (3) Each mL of solution contains 2.7 ostertagi (including inhibited larvae), O. mg ivermectin. lyrata, Trichostrongylus axei, T. (b) Sponsors. See sponsors in colubriformis, Cooperia oncophora, C. § 510.600(c) of this chapter for use as in punctata, C. pectinata, Oesophagostomum paragraph (e) of this section. radiatum, Nematodirus helvetianus (1) No. 050604 for use of the product (adults only), N. spathiger (adults only), described in paragraph (a)(1) of this Bunostomum phlebotomum); lungworms section as in paragraph (e)(1) of this (adults and fourth-stage larvae) section; the product described in para- (Dictyocaulus viviparus); grubs (paragraph (a)(2) of this section as in parasitic stages) (Hypoderma bovis, H. graphs (e)(2), (e)(3), (e)(4), and (e)(5) of lineatum); sucking lice (Linognathus this section; and the product described vituli, Haematopinus eurysternus, in paragraph (a)(3) of this section as in Solenopotes capillatus); mites (scabies) paragraphs (e)(3) and (e)(6) of this sec- (Psoroptes ovis (syn. P. communis var. tion. bovis), Sarcoptes scabiei var. bovis). For (2) Nos. 055529, 058005, and 059130 for control of infections and to protect use of the product described in para- from reinfection with D. viviparus and graph (a)(2) of this section as in para- O. radiatum for 28 days after treatment; graphs (e)(2), (e)(3), (e)(4), and (e)(5) of O. ostertagi, T. axei, and C. punctata for this section. 21 days after treatment; H. placei and (c) Related tolerances. See § 556.344 of C. oncophora for 14 days after treat- this chapter. ment. (d) Special considerations—(1) See (iii) Limitations. Do not treat cattle § 500.25 of this chapter. within 35 days of slaughter. Because a (2) Labeling shall bear the following withdrawal time in milk has not been precaution: ‘‘This product should not be established, do not use in female dairy used in other animal species as severe cattle of breeding age. A withdrawal adverse reactions, including fatalities period has not been established for this in dogs, may result.’’ product in pre-ruminating calves. Do (e) Conditions of use—(1) Horses—(i) not use in calves to be processed for Amount. 200 micrograms per kilogram veal. (μg/kg) of body weight by (3) Swine—(i) Amount. 300 μg/kg of intramuscular injection. body weight by subcutaneous injection.

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(ii) Indications for use. For the treat- ostertagi (including inhibited larvae), O. ment and control of gastrointestinal lyrata, Trichostrongylus axei, T. roundworms (adults and fourth-stage colubriformis, Cooperia oncophora, C. larvae) (large roundworm, Ascaris suum; punctata, C. pectinata, Oesophagostomum red stomach worm, Hyostrongylus radiatum, Nematodirus helvetianus rubidus; nodular worm, (adults only), N. spathiger (adults only), Oesophagostomum spp.; threadworm, Bunostomum phlebotomum; lungworms Strongyloides ransomi (adults only)); so- (adults and fourth-stage larvae) matic roundworm larvae (threadworm, (Dictyocaulus viviparus); liver flukes S. ransomi (somatic larvae)); lungworms (adults only) (Fasciola hepatica); grubs ( spp. (adults only)); lice Metastrongylus (parasitic stages) (Hypoderma bovis, H. (H. suis); and mites (S. scabiei var. suis). lineatum); lice (Linognathus vituli, (iii) Limitations. Do not treat swine within 18 days of slaughter. Haematopinus eurysternus, Solenopotes (4) American bison—(i) Amount. 200 μg/ capillatus); mites (Psoroptes ovis (syn. P. kg of body weight by subcutaneous in- communis var. bovis), Sarcoptes scabiei jection. var. bovis); and for control of infections (ii) Indications for use. For the treat- of D. viviparus and O. radiatum for 28 ment and control of grubs (H. bovis). days afer treatment; O. ostertagi, T. (iii) Limitations. Do not slaughter axei, and C. punctata for 21 days after within 56 days of last treatment. treatment; and H. placei and C. (5) Reindeer—(i) Amount. 200 μg/kg of oncophora for 14 days after treatment. body weight by subcutaneous injection. (3) Limitations. For subcutaneous use (ii) Indications for use. For the treat- only. Not for intravenous or ment and control of warbles intramuscular use. Do not treat cattle (Oedemagena tarandi). within 49 days of slaughter. Because a (iii) Limitations. Do not treat reindeer withdrawal time in milk has not been within 56 days of slaughter. established, do not use in female dairy (6) Ranch-raised foxes—(i) Amount. 200 cattle of breeding age. Do not use in μg/kg of body weight by subcutaneous other animal species because severe ad- injection. Repeat in 3 weeks. verse reactions, including fatalities in (ii) Indications for use. For treatment and control of ear mites (Otodectes dogs, may result. A withdrawal period cynotis). has not been established for this product in preruminating calves. Do not [72 FR 27735, May 17, 2007, as amended at 72 use in calves to be processed for veal. FR 62771, Nov. 7, 2007; 74 FR 9049, Mar. 2, 2009; 75 FR 26647, May 12, 2010] [55 FR 38984, Sept. 24, 1990, as amended at 62 FR 14302, Mar. 26, 1997; 62 FR 63271, Nov. 28, § 522.1193 Ivermectin and clorsulon. 1997; 64 FR 26671, May 17, 1999; 69 FR 31735, (a) Specifications. Each milliliter June 7, 2004; 72 FR 27734, May 17, 2007] (mL) of solution contains 10 milligrams (mg) (1 percent) ivermectin and 100 mg § 522.1204 Kanamycin sulfate injection. (10 percent) clorsulon. (a) Specifications. Each milliliter of (b) Sponsors. See Nos. 050604 and kanamycin sulfate injection veterinary 055529 in § 510.600(c) of this chapter for contains either 50 or 200 milligrams of use as in paragraph (e) of this section. kanamycin. (c) Related tolerances. See §§ 556.163 (b) Sponsor. See No. 000856 in and 556.344 of this chapter. § 510.600(c) of this chapter. (d) Special considerations. See § 500.25 (c) Conditions of use. (1) It is used in of this chapter. the treatment of bacterial infections (e) Conditions of use in cattle—(1) Amount. Administer 1 mL (10 mg due to kanamycin sensitive organisms ivermectin and 100 mg clorsulon) per 50 in dogs and cats. kilograms (110 pounds) by subcuta- (2) It is administered subcutaneously neous injection. or intramuscularly at 5 milligrams per (2) Indications for use. For the treat- pound of body weight per day in equal- ment and control of gastrointestinal ly divided doses at 12-hour intervals. nematodes (adults and fourth-stage lar- (3) Its label shall bear an appropriate vae) (Haemonchus placei, Ostertagia expiration date.

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(4) Restricted to use by or on the (c) Sponsor. See Code No. 000856 in order of a licensed veterinarian. § 510.600(c) of this chapter. [40 FR 13858, Mar. 27, 1975, as amended at 53 (d) Special considerations. Store in a FR 27851, July 25, 1988; 64 FR 403, Jan. 5, 1999] cool place. Protect from light. Do not use if precipitate appears. § 522.1222 Ketamine hydrochloride (e) Conditions of use. (1) It is used in injectable dosage forms. cats as the sole anesthetic agent for ovariohysterectomy and general sur- § 522.1222a Ketamine. gery. (a) Specifications. Each milliliter con- (2) It is administered tains ketamine hydrochloride equiva- intramuscularly at a recommended lent to 100 milligrams (mg) ketamine dose from 15 to 20 milligrams ketamine base activity. base per pound of body weight, depend- (b) Sponsors. See Nos. 000010, 059130, ing on the effect desired. 061690, 026637, and 063286 in § 510.600(c) of (3) Federal law restricts this drug to this chapter. use by or on the order of a licensed vet- (c) Special considerations. Federal law erinarian. restricts this drug to use by or on the order of a licensed veterinarian. [40 FR 59342, Dec. 23, 1975, as amended at 42 (d) Conditions of use—(1) Cats—(i) FR 3838, Jan. 21, 1977; 53 FR 27851, July 25, Amount. 5 to 15 mg/pound body weight 1988] intramuscularly, depending on the ef- § 522.1225 Ketoprofen solution. fect desired. (ii) Indications for use. For restraint (a) Specifications. Each milliliter of or as the sole anesthetic agent in diag- sterile aqueous solution contains 100 nostic or minor, brief surgical proce- milligrams of ketoprofen. dures that do not require skeletal mus- (b) Sponsor. See 000856 in 21 CFR cle relaxation. 510.600(c) of this chapter. (2) Subhuman primates—(i) Amount. 3 (c) Conditions of use in horses—(1) to 15 mg/kilogram body weight Amount. 1.0 milligram per pound of intramuscularly, depending upon the body weight once daily for up to 5 days. species, general condition, and age of (2) Indications for use. For alleviation the subject. of inflammation and pain associated (ii) Indications for use. For restraint. with musculoskeletal disorders in [67 FR 17283, Apr. 10, 2002, as amended at 73 horses. FR 8192, Feb. 13, 2008; 74 FR 36111, July 22, (3) Limitations. For intravenous use 2009; 74 FR 66573, Dec. 16, 2009; 75 FR 10167, only. Do not use in breeding animals. Mar. 5, 2010] Effects on fertility, pregnancy, or fetal health have not been determined. Not § 522.1222b Ketamine hydrochloride for use in horses intended for food. Fed- with promazine hydrochloride and eral law restricts this drug to use by or aminopentamide hydrogen sulfate injection. on the order of a licensed veterinarian. (a) Chemical name. Ketamine hydro- [55 FR 40653, Oct. 4, 1990] chloride, (±),-2-(o-chlorophenyl)-2- (methylamino) cyclohexanone hydro- § 522.1228 [Reserved] chloride, with promazine hydrochloride, 10-[3-(dimethylamino) propyl] § 522.1244 Levamisole phosphate injection. phenothiazine monohydrochloride, and aminopentamide hydrogen sulfate. (a) Specifications. Each milliliter of (b) Specifications. The drug is a sterile sterile aqueous solution contains aqueous solution and each milliliter levamisole phosphate equivalent to contains: Ketamine hydrochloride 136.5 or 182 milligrams of levamisole equivalent to 100 milligrams ketamine hydrochloride (13.65 or 18.2 percent). base activity, 7.5 milligrams of (b) Sponsor. See Nos. 000061 and 057561 promazine hydrochloride, and 0.0625 in § 510.600 of this chapter for use of milligram of aminopentamide hydro- 13.65 percent injection, and see No. gen sulfate, with 1:10,000 benzethonium 053501 for use of 13.65 and 18.2 percent chloride. injection.

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(c) Conditions of use—(1) Amount. 2 (2) Nos. 058005 and 059130 for use of milliliters per 100 pounds of body concentrations in paragraph (a)(2) of weight, subcutaneously in the neck. this section as in paragraph (e)(2) of (2) Indications for use. (i) The 13.65 this section. percent injection is used as an anthel- (3) No. 046573 for use of concentration mintic in cattle for treatment of the in paragraph (a)(3) of this section as in following parasites: stomach worms paragraph (e)(2) of this section. (Haemonchus, Trichostrongylus, (4) No. 061623 for use of concentra- Ostertagia), intestinal worms tions in paragraph (a)(4) of this section (Trichostrongylus, Cooperia, as in paragraph (e)(2) of this section. Nematodirus, Bunostomum, (c) Special considerations. When com- Oesophagostomum, Chabertia), and mon labeling for use of the drug in lungworms (Dictyocaulus). dogs, cats, and swine is included with (ii) The 18.2 percent injection is used the drug, all such uses are subject to as an anthelmintic in cattle for treat- the labeling requirements of § 201.105 of ment of the following parasites: stom- this chapter. ach worms (Haemonchus, (d) Related tolerances. See § 556.360 of Trichostrongylus, Ostertagia), intestinal this chapter. worms (Trichostrongylus, Cooperia, (e) Conditions of use. It is used for ani- Nematodirus, Bunostomum, mals as follows: Oesophagostomum) and lungworms (1) Dogs and cats—(i) Amount. 5 mg (Dictyocaulus). per pound (/lb) of body weight twice (3) Limitations. Do not administer daily or 10 mg/lb body weight once more than 10 milliliters per site. Cattle daily by intramuscular injection; 5 to that are severely parasitized or main- 10 mg/lb body weight one or two times tained under conditions of constant daily by slow intravenous injection. helminth exposure may require re- (ii) Indications for use. Infections treatment within 2 to 4 weeks after caused by Gram-positive organisms, first treatment. Consult your veteri- particularly streptococci and narian for assistance in the diagnosis, staphylococci. treatment, and control of parasitism. (iii) Limitations. Federal law restricts Consult your veterinarian before using this drug to use by or on the order of a in severely debilitated animals or ani- licensed veterinarian. mals under severe stress. Do not ad- (2) Swine—(i) Amount. 5 mg/lb body minister to cattle within 7 days of weight once daily by intramuscular in- slaughter. Do not administer to dairy jection for 3 to 7 days. animals of breeding age. (ii) Indications for use. Treatment of infectious arthritis and mycoplasma [43 FR 20489, May 12, 1978, as amended at 43 pneumonia. FR 29289, July 7, 1978; 43 FR 60895, Dec. 29, (iii) Limitations. Do not treat within 1978; 47 FR 10807, Mar. 12, 1982; 62 FR 61625, 48 hours of slaughter. Nov. 19, 1997; 65 FR 61090, Oct. 16, 2000; 67 FR 63055, Oct. 10, 2002] [40 FR 13858, Mar. 27, 1975, as amended at 50 FR 31351, Aug. 2, 1985; 67 FR 34388, May 14, § 522.1260 Lincomycin. 2002; 68 FR 51705, Aug. 28, 2003; 69 FR 11507, Mar. 11, 2004; 69 FR 47361, Aug. 5, 2004; 71 FR (a) Specifications. Each milliliter of 51996, Sept. 1, 2006] solution contains lincomycin hydrochloride monohydrate equivalent to: § 522.1289 Lufenuron suspension. (1) 25, 50, 100, or 300 milligrams (mg) (a) Specifications. Each milliliter of lincomycin. sterile aqueous suspension contains 10 (2) 25, 100, or 300 mg lincomycin. milligrams of lufenuron. (3) 300 mg lincomycin. (b) Sponsor. See No. 058198 in (4) 100 or 300 mg lincomycin. § 510.600(c) of this chapter. (b) Sponsors. See sponsors in (c) [Reserved] § 510.600(c) of this chapter for uses as in (d) Conditions of use—(1) Cats—(i) paragraph (e) of this section. Amount. 10 milligrams per kilogram (1) No. 000009 for use of concentra- (4.5 milligrams per pound) of body tions in paragraph (a)(1) of this section weight every 6 months, as in paragraph (e) of this section. subcutaneously.

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(ii) Indications for use. For use in cats § 522.1315 Maropitant. 6 weeks of age and older, for control of (a) Specifications. Each milliliter of flea populations. Lufenuron controls solution contains 10 milligrams (mg) flea populations by preventing the de- maropitant as maropitant citrate. velopment of flea eggs and does not (b) Sponsor. See No. 000069 in kill adult fleas. Concurrent use of in- § 510.600(c) of this chapter. secticides may be necessary for ade- (c) Conditions of use in dogs—(1) quate control of adult fleas. Amount. Administer 1.0 mg per kilo- (iii) Limitations. For subcutaneous gram body weight by subcutaneous in- use in cats only. The safety of this jection once daily for up to 5 consecu- product in reproducing animals has not tive days. been established. Do not use in dogs. (2) Indications for use. For the preven- Federal law restricts this drug to use tion and treatment of acute vomiting. by or on the order of a licensed veterinarian. (3) Limitations. Federal law restricts this drug to use by or on the order of a (2) [Reserved] licensed veterinarian. [63 FR 29552, June 1, 1998] [72 FR 9243, Mar. 1, 2007] § 522.1290 Luprostiol. § 522.1335 Medetomidine hydro- (a) Specifications. Each milliliter of chloride injection. solution contains 7.5 milligrams (mg) (a) Specifications. Each milliliter of luprostiol. sterile aqueous solution contains 1.0 (b) Sponsor. See No. 051311 in milligram of medetomidine hydro- § 510.600(c) of this chapter. chloride. (c) Special considerations. Labeling (b) Sponsor. See 052483 in § 510.600(c) of shall bear the following statements: this chapter. Warning: Women of childbearing age, (c) Conditions of use—(1) Amount. 750 asthmatics, and persons with bronchial micrograms intravenously (IV) or 1,000 and other respiratory problems should micrograms intramuscularly per exercise extreme caution when han- square meter of body surface. The IV dling this product. In the early stages, route is more efficacious for dental women may be unaware of their preg- care. nancies. Luprostiol is readily absorbed (2) Indications for use. As a sedative through the skin and can cause abor- and analgesic in dogs over 12 weeks of tion and/or bronchiospasms. Direct age to facilitate clinical examinations, contact with the skin should therefore clinical procedures, minor surgical pro- be avoided. Accidental spillage on the cedures not requiring muscle relax- skin should be washed off immediately ation, and minor dental procedures not with soap and water. requiring intubation. The intravenous (d) Conditions of use in horses—(1) route of administration is more effica- Amount. 7.5 mg by intramuscular injec- cious for dental care. tion. (3) Limitations. Do not use in dogs (2) Indications for use. For estrus with cardiac disease, respiratory dis- control and termination of pregnancy orders, liver or kidney diseases, dogs in in mares. shock, dogs which are severly debili- (3) Limitations. Federal law restricts tated, or dogs which are stressed due to this drug to use by or on the order of a extreme heat, cold, or fatigue. Allow licensed veterinarian. Do not use in agitated dogs to rest quietly before ad- horses intended for human consump- ministration. Do not repeat dosing in tion. dogs not responding satisfactorily to [55 FR 1185, Jan. 12, 1990, as amended at 56 treatment. Do not use in breeding or FR 50653, Oct. 8, 1991; 60 FR 55659, Nov. 2, pregnant animals. Federal law restricts 1995; 61 FR 66582, Dec. 18, 1996; 74 FR 25146, this drug to use by or on the order of a May 27, 2009] licensed veterinarian. [61 FR 21075, May 9, 1996]

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§ 522.1350 Melatonin implant. dogs with class 4 (very severe) heartworm disease (Caval Sydrome). Not for (a) Specifications. The drug is a sili- use in breeding animals and lactating cone rubber elastomer implant con- or pregnant bitches. Federal law re- taining 2.7 milligrams of melatonin. stricts this drug to use by or on the (b) Sponsor. See No. 053923 in order of a licensed veterinarian. § 510.600(c) of this chapter. (c) Conditions of use—(1) Amount. One [60 FR 49340, Sept. 25, 1995] implant per mink. (2) Indications for use. For use in § 522.1367 Meloxicam. healthy male and female kit and adult (a) Specifications. Each milliliter of female mink (Mustela vison) to accel- solution contains 5.0 milligrams (mg) erate the fur priming cycle. meloxicam. (3) Limitations. For subcutaneous im- (b) Sponsor. See No. 000010 in plantation in mink only. Do not im- § 510.600(c) of this chapter. plant potential breeding stock. Do not (c) Conditions of use—(1) Dogs—(i) use in food-producing animals. Amount. Administer 0.09 mg per pound [59 FR 37422, July 22, 1994] (mg/lb) body weight (0.2 mg per kilogram (mg/kg)) by intravenous or sub- § 522.1362 Melarsomine cutaneous injection on the first day of dihydrochloride for injection. treatment. For treatment after day 1, (a) Specifications. The drug consists of administer meloxicam suspension oral- a vial of lyophilized powder containing ly at 0.045 mg/lb (0.1 mg/kg) body 50 milligrams of melarsomine weight once daily as in § 520.1350(c) of dihydrochloride which is reconstituted this chapter. with the provided 2 milliliters of ster- (ii) Indications for use. For the control ile water for injection. of pain and inflammation associated (b) Sponsor. See No. 050604 in with osteoarthritis. § 510.600(c) of this chapter. (iii) Limitations. Federal law restricts (c) Conditions of use—(1) Amount. For this drug to use by or on the order of a asymptomatic to moderate (class 1 to licensed veterinarian. class 2) heartworm disease: 2.5 milli- (2) Cats—(i) Amount. Administer 0.14 grams per kilogram of body weight (1.1 mg/lb (0.3 mg/kg) body weight as a sin- milligram per pound) twice, 24 hours gle, one-time subcutaneous injection. apart. The series can be repeated in 4 (ii) Indications for use. For the control months depending on the response to of postoperative pain and inflamma- the first treatment and the condition, tion associated with orthopedic sur- age, and use of the dog. For severe gery, ovariohysterectomy, and castra- (class 3) heartworm disease: Single in- tion when administered prior to sur- jection of 2.5 milligrams per kilogram gery. followed, approximately 1 month later, (iii) Limitations. Federal law restricts by 2.5 milligrams per kilogram admin- this drug to use by or on the order of a istered twice, 24 hours apart. licensed veterinarian. (2) Indications. Treatment of sta- bilized, class 1, 2, and 3 heartworm dis- [68 FR 68724, Dec. 10, 2003, as amended at 69 ease (asymptomatic to mild, moderate, FR 69523, Nov. 30, 2004] and severe, respectively) caused by im- § 522.1372 Mepivacaine. mature (4 month-old, stage L5) to mature adult infections of Dirofilaria (a) Specifications. Each milliliter immitis in dogs. (mL) of solution contains 20 milligrams (3) Limitations. Administer only by mepivacaine hydrochloride. deep intramuscular injection in the (b) Sponsor. See No. 000009 in lumbar muscles (L3-L5). Use a 23 gauge § 510.600(c) of this chapter. 1 inch needle for dogs less than or (c) Conditions of use in horses—(1) equal to 10 kilograms (22 pounds) and a Amount. For nerve block, 3 to 5 mL; for 22 gauge 1 1/2 inch needle for dogs epidural anesthesia, 5 to 20 mL; for greater than 10 kilograms (22 pounds). intra-articular anesthesia, 10 to 15 mL; Use alternate sides with each adminis- for infiltration, as required; for anes- tration. The drug is contraindicated in thesia of the laryngeal mucosa prior to

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ventriculectomy, by topical spray, 25 § 522.1410 Sterile methylprednisolone to 40 mL, by infiltration, 20 to 50 mL. acetate suspension. (2) Indications for use. For use as a (a) Specifications. Each milliliter of local anesthetic for infiltration, nerve aqueous suspension contains 20 or 40 block, intra-articular and epidural an- milligrams of methylprednisolone ace- esthesia, and topical and/or infiltration tate.1 anesthesia of the laryngeal mucosa (b) Sponsors. See Nos. 000009 and prior to ventriculectomy. 000010 in § 510.600(c) of this chapter. (3) Limitations. Not for use in horses (c) Special considerations. (1) Clinical intended for human consumption. Fed- and experimental data have dem- eral law restricts this drug to use by or onstrated that corticosteroids adminis- on the order of a licensed veterinarian. tered orally or parenterally to animals may induce the first stage of parturi- [71 FR 39547, July 13, 2006] tion when administered during the last § 522.1380 Methocarbamol injection. trimester of pregnancy and may precipitate premature parturition fol- (a) Specifications. The product is a lowed by dystocia, fetal death, retained sterile, pyrogen-free solution, each placenta, and metritis. milliliter containing 100 milligrams of (2) Systemic therapy with methocarbamol, 0.5 milliliter of poly- methylprednisolone acetate, as with ethylene glycol 300, and water for in- other corticoids, is contraindicated in jection q.s. Its pH is 3.5 to 6.0. animals with arrested tuberculosis, (b) Sponsor. See No. 000856 in peptic ulcer, and Cushing’s syndrome. § 510.600(c) of this chapter. The presence of active tuberculosis, di- (c) Conditions of use—(1) Amount—(i) abetes mellitus, osteoporosis, renal in- Dogs and cats. 20 milligrams per pound sufficiency, predisposition to of body weight for moderate condi- thrombophlebitis, hypertension, or tions, 25 to 100 milligrams per pound of congestive heart failure necessitates body weight for severe conditions (tet- carefully controlled use of anus and strychnine poisoning), total corticosteroids. Intrasynovial, cumulative dose not to exceed 150 mil- intratendinous, or other injections of ligrams per pound of body weight. corticosteroids for local effect are con- (ii) Horses. 2 to 10 milligrams per traindicated in the presence of acute pound of body weight for moderate con- infectious conditions. Exacerbation of ditions, 10 to 25 milligrams per pound pain, further loss of joint motion, with of body weight for severe conditions fever and malaise following injection (tetanus), additional amounts may be may indicate that the condition has be- needed to relieve residual effects and come septic. Appropriate antibacterial therapy should be instituted imme- to prevent recurrence of symptoms. diately. (2) Indications for use. As an adjunct (d) Conditions of use—(1) Amount—(i) for treating acute inflammatory and Intramuscular. Dosage may be repeated traumatic conditions of the skeletal when necessary, as follows: dogs—2 to muscles and to reduce muscular 40 milligrams (up to 120 milligrams in spasms. extremely large breeds or dogs with se- (3) Limitations. For intravenous use vere involvement); cats—10 to 20 milli- only. For dogs, administer rapidly half grams; horses—200 milligrams. 1 the estimated dose, pause until the ani- (ii) Intrasynovial. Dosage may be re- mal starts to relax, then continue ad- peated when necessary, as follows: ministration to effect. For horses, ad- horses—40 to 240 milligrams; dogs—up minister rapidly to effect. Not for to 20 milligrams.1 horses intended for food use. Federal law restricts this drug to use by or on 1 These conditions are NAS/NRC reviewed the order of a licensed veterinarian. and deemed effective. Applications for these uses need not include effectiveness data as [45 FR 79758, Dec. 2, 1980, as amended at 46 specified by § 514.111 of this chapter, but may FR 18964, Mar. 27, 1981; 67 FR 67521, Nov. 6, require bioequivalency and safety informa- 2002] tion.

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(2) Indications for use. Treatment of (3) Limitations. Do not slaughter cat- inflammation and related disorders in tle within 21 days of treatment. Be- dogs, cats, and horses; 1 treatment of cause a withholding time for milk has allergic and dermatologic disorders in not been established, do not use in fe- dogs and cats; and as supportive ther- male dairy cattle of breeding age. A apy to antibacterial treatment of se- withdrawal period has not been estab- vere infections in dogs and cats. lished for preruminating calves. Do not (3) Limitations. Not for use in horses use in calves to be processed for veal. intended for food. Not for human use. [70 FR 36337, June 23, 2005, as amended at 71 Federal law restricts this drug to use FR 7414, Feb. 13, 2006] by or on the order of a licensed veterinarian. § 522.1451 Moxidectin for suspension. [43 FR 59058, Dec. 19, 1978, as amended at 51 (a) Specifications. The drug product FR 741, Jan. 8, 1986; 53 FR 40728, Oct. 18, 1988; consists of two separate vials. One con- 62 FR 35076, June 30, 1997] tains 10 percent moxidectin microspheres, and the other contains a vehi- § 522.1450 Moxidectin solution. cle for constitution of the moxidectin (a) Specifications. Each milliliter of microspheres. Each milliliter of con- solution contains 10 milligrams (mg) stituted, sustained-release suspension moxidectin. contains 3.4 milligrams (mg) of (b) Sponsor. See No. 000856 in moxidectin. § 510.600(c) of this chapter. (b) Sponsor. See No. 000856 in (c) Related tolerances. See § 556.426 of § 510.600(c) of this chapter. this chapter. (c) [Reserved] (d) Conditions of use in beef and non- (d) Conditions of use; dogs—(1) Amount. lactating dairy cattle—(1) Amount. 0.2 0.17 mg per kilogram body weight mg/kilogram body weight (0.2 mg/2.2 (0.0773 mg per pound) as a single sub- pound) as a single subcutaneous injec- cutaneous injection. tion. (2) Indications for use. For prevention (2) Indications for use. For treatment of heartworm disease caused by and control of gastrointestinal Dirofilaria immitis; for treatment of ex- roundworms: Ostertagia ostertagi isting larval and adult hookworm (adults, fourth-stage larvae, and inhib- (Ancylostoma caninum) and Uncinaria ited larvae), Haemonchus placei stenocephala infections. (adults), Trichostrongylus axei (adults (3) Limitations. Federal law restricts and fourth-stage larvae), this drug to use by or on the order of a Trichostrongylus colubriformis (adults licensed veterinarian. and fourth-stage larvae), Cooperia [66 FR 35756, July 9, 2001, as amended at 67 oncophora (adults), Cooperia pectinata FR 57944, Sept. 13, 2002] (adults), Cooperia punctata (adults and fourth-stage larvae), Cooperia spatulata § 522.1452 Nalorphine hydrochloride (adults), Cooperia surnabada (adults and injection. fourth-stage larvae), Nematodirus (a) Specifications. Each milliliter of helvetianus (adults), Oesophagostomum aqueous solution contains 5 milligrams radiatum (adults and fourth-stage lar- of nalorphine hydrochloride. vae), Trichuris spp. (adults); (b) Sponsor. See No. 050604 in lungworms: Dictyocaulus viviparus § 510.600(c) of this chapter. (adults and fourth-stage larvae); grubs: (c) Conditions of use—(1) Amount. One Hypoderma bovis and Hypoderma milligram per 5 pounds; intravenously, lineatum; mites: Psoroptes ovis intramuscularly, or subcutaneously. (Psoroptes communis var. bovis); lice: (2) Indications for use. Respiratory Linognathus vituli and Solenopotes and circulatory depression in dogs re- capillatus; for protection of cattle from sulting from overdosage of, or unusual reinfection with D. viviparus and O. sensitivity to, morphine and certain radiatum for 42 days after treatment, other narcotics. Not for depression due with H. placei for 35 days after treat- to any other cause. ment, and with O. ostertagi and T. axei (3) Limitations. Successive doses of for 14 days after treatment. the drug gradually lose their analeptic

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effect and eventually induce res- (3) Limitations. Available data are in- piratory depression equal to that of adequate to recommend use in preg- opiates. Therefore, do not exceed thera- nant animals. Avoid using during peutic dosage. Do not mix drug with breeding season. Do not use in domes- meperidine solutions because the buff- tic food-producing animals. Do not use er will cause precipitation. Federal law in free-ranging animals for 45 days be- restricts this drug to use by or on the fore or during hunting season. Federal order of a licensed veterinarian. law restricts this drug to use by or on the order of a licensed veterinarian. [44 FR 6707, Feb. 2, 1979, as amended at 47 FR 36418, Aug. 20, 1982; 62 FR 63271, Nov. 28, 1997] [62 FR 5320, Feb. 5, 1997]

§ 522.1462 Naloxone hydrochloride in- § 522.1468 Naproxen for injection. jection. (a) Specifications. The drug is a (a) Specifications. Naloxone hydro- lyophilized powder which is reconsti- chloride injection is an aqueous sterile tuted with sterile water for injection solution containing 0.4 milligram of to form a 10 percent sterile aqueous so- naloxone hydrochloride per milliliter. lution (100 milligrams per milliliter). (b) Sponsor. See No. 060951 in (b) Sponsor. See 000856 in § 510.600(c) of § 510.600(c) of this chapter. this chapter. (c) Conditions of use. (1) It is used as (c) Conditions of use in horses—(1) Dos- a narcotic antagonist in dogs. age. Five milligrams per kilogram of (2) It is administered by intravenous, body weight intravenously followed by intramuscular, or subcutaneous injec- maintenance oral therapy of 10 milli- tion at an initial dose of 0.04 milligram grams per kilogram of body weight per kilogram of body weight. When twice daily for up to 14 consecutive given intravenously, the dosage may be days. repeated at 2- to 3-minute intervals as (2) Indications for use. For the relief of necessary. Onset of action by inflammation and associated pain and intramuscular or subcutaneous injec- lameness exhibited with arthritis, as tion is slightly longer than it is by in- well as myositis and other soft tissue travenous injection, and repeated dos- diseases of the musculoskeletal system ages must be administered accordingly. of the horse. (3) For use only by or on the order of (3) Limitations. Not for use in horses a licensed veterinarian. intended for food. Federal law restricts [40 FR 13858, Mar. 27, 1975, as amended at 47 this drug to use by or on the order of a FR 20757, May 14, 1982; 54 FR 32632, Aug. 9, licensed veterinarian. 1989; 63 FR 7701, Feb. 17, 1998] [46 FR 26763, May 15, 1981. Redesignated and amended at 51 FR 24525, July 7, 1986; 61 FR § 522.1465 Naltrexone hydrochloride 5507, Feb. 13, 1996] injection. (a) Specifications. Each milliliter of § 522.1484 Neomycin sulfate sterile so- sterile aqueous solution contains 50 lution. milligrams of naltrexone hydro- (a) Specifications. Each milliliter of chloride. sterile aqueous solution contains 50 (b) Sponsor. See 053923 in § 510.600(c) of milligrams of neomycin sulfate (equiv- this chapter. alent to 35 milligrams of neomycin (c) Conditions of use in elk and moose— base).1 (1) Amount. 100 milligrams of (b) Sponsor. See No. 000009 in naltrexone hydrochloride for each mil- § 510.600(c) of this chapter. ligram of carfentanil citrate adminis- (c) Conditions of use—(1) Amount. 5 tered. One-quarter of the dose should milligrams per pound of body weight be administered intravenously and daily divided into portions adminis- three-quarters of the dose should be ad- tered every 6 to 8 hours for 3 to 5 days.1 ministered subcutaneously. (2) Indications for use. As an antago- 1 These claims are NAS/NRC reviewed and nist to carfentanil citrate immobiliza- deemed effective. Applications for these uses tion in free-ranging or confined elk and need not include effectiveness data as speci- moose (Cervidae). fied by § 514.111 of this chapter.

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(2) Indications for use. Administer to § 522.1610 Oleate sodium solution. dogs and cats for the treatment of (a) Specifications. Each milliliter of acute and chronic bacterial infections sterile aqueous solution contains 50 due to organisms susceptible to neomy- milligrams of sodium oleate. 1 cin. (b) Sponsor. See No. 037990 in (3) Limitations. For intramuscular or § 510.600(c) of this chapter. intravenous use only. Neomycin is not (c) Conditions of use—(1) It is used in for use parenterally in food-producing horses to stimulate infiltration of cel- animals because of prolonged residues lular blood components that subse- in edible tissues. Labeling shall bear an quently differentiate into fibrous and/ appropriate expiration date. For use by or fibrocartilagenous tissue. or on the order of a licensed veteri- (2) The drug is administered by par- narian.1 enteral injection dependent upon the area of response desired. An injection [43 FR 48996, Oct. 20, 1978, as amended at 64 of 1 milliliter will produce a response FR 403, Jan. 5, 1999] of approximately 15 square centi- § 522.1503 Neostigmine methylsulfate meters. Do not inject more than 2 mil- injection. liliters per injection site. Regardless of the number of injection sites, the total (a) Specifications. Neostigmine volume used should not exceed 10 milli- methylsulfate injection contains two liters. milligrams of neostigmine methyl- (3) Not for use in horses intended for sulfate in each milliliter of sterile food. aqueous solution. (4) Federal law restricts this drug to (b) Sponsor. See No. 000061 in use by or on the order of a licensed vet- § 510.600(c) of this chapter. erinarian. (c) Conditions of use. (1) The drug is [41 FR 27034, July 1, 1976, as amended at 50 intended for use for treating rumen FR 40966, Oct. 8, 1985] atony; initiating peristalsis which causes evacuation of the bowel; § 522.1620 Orgotein for injection. emptying the urinary bladder; and (a) Specifications. Orgotein for injec- stimulating skeletal muscle contrac- tion is packaged in a vial containing 5 tions. It is a curare antagonist. milligrams of orgotein and 10 milli- (2) It is administered to cattle and grams of sucrose as lyophilized sterile horses at a dosage level of 1 milligram nonpyrogenic powder with directions per 100 pounds of body weight for dissolving the contents of the vial subcutaneously. It is administered to in 2 milliliters of diluent which is so- sheep at a dosage level of 1 to 11⁄2 milli- dium chloride injection, U.S.P. grams per 100 pounds body weight (b) Sponsor. See No. 024991 in subcutaneously. It is administered to § 510.600(c) of this chapter. swine at a dosage level of 2 to 3 milli- (c) Conditions of use—(1) Horses. (i) It grams per 100 pounds body weight is used in the treatment of soft tissue intramuscularly. These doses may be inflammation associated with the mus- repeated as indicated. culoskeletal system. (3) The drug is contraindicated in me- (ii) It is administered by deep chanical, intestinal or urinary obstruc- intramuscular injection at a dosage tion, late pregnancy, and in animals level of 5 milligrams every other day treated with other cholinesterase infor 2 weeks and twice weekly for 2 to 3 hibitors. more weeks. Severe cases, both acute (4) Not for use in animals producing and chronic, may benefit more from milk, since this use will result in con- daily therapy initially. Dosage may be tamination of the milk. continued beyond 5 weeks if satisfactory improvement has not been (5) Federal law restricts this drug to achieved. use by or on the order of a licensed vet- (iii) Not for use in horses intended for erinarian. food. [40 FR 13858, Mar. 27, 1975, as amended at 62 (2) Dogs. (i) It is used for the relief of FR 61625, Nov. 19, 1997] inflammation associated with

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ankylosing spondylitis, spondylosis, § 522.1660 Oxytetracycline injectable and disc disease. When severe nerve dosage forms. damage is present, response will occur much more slowly, if at all. § 522.1660a Oxytetracycline solution, 200 milligrams/milliliter. (ii) It is administered by subcutaneous injection at a dosage level of 5 (a) Specifications. Each milliliter of milligrams every day for 6 days, and sterile solution contains 200 milligrams thereafter, every other day for 8 days. of oxytetracycline base. In less severe conditions, shorter (b) Sponsors. See Nos. 000010, 000069, courses of therapy may be indicated. 048164, 055529, 057561, 059130, and 061623 in § 510.600(c) of this chapter. (3) Federal law restricts this drug to (c) Related tolerances. See § 556.500 of use by or on the order of a licensed vet- this chapter. erinarian. (d) Special considerations. When la- [40 FR 13858, Mar. 27, 1975, as amended at 41 beled for the treatment of FR 32583, Aug. 4, 1976] anaplasmosis or anthrax, labeling shall also bear the following: ‘‘Federal law § 522.1642 Oxymorphone hydro- restricts this drug to use by or on the chloride injection. order of a licensed veterinarian.’’ (a) Specifications. The drug contains 1 (e) Conditions of use—(1) Beef cattle, or 1.5 milligrams of oxymorphone hy- dairy cattle, and calves including drochloride per milliliter of aqueous prerumenative (veal) calves—(i) Amounts solution containing 0.8 percent sodium and indications for use—(A) 3 to 5 mg per pound of body weight (mg/lb BW) chloride. per day (/day) intramuscularly, (b) Sponsor. See No. 060951 in subcutaneously, or intravenously for § 510.600(c) of this chapter. treatment of pneumonia and shipping (c) Conditions of use. (1) The drug is a fever complex associated with narcotic analgesic, preanesthetic, anes- Pasteurella spp. and Haemophilus spp., thetic, and substitute anesthetic adju- foot-rot and diphtheria caused by vant for intramuscular, subcutaneous Fusobacterium necrophorum, bacterial or intravenous administration to cats enteritis (scours) caused by Escherichia and dogs as follows: coli, wooden tongue caused by Actinobacillus lignieresii, leptospirosis Dosage Animal Body weight (pounds) (milligram) caused by Leptospira pomona, wound infections and acute metritis caused by Dogs ...... 2 to 5 ...... 0.75 Staphylococcus spp. and Streptococcus 5 to 15 ...... 0.75–1.5 spp., and anthrax caused by Bacillus 15 to 30 ...... 1.5–2.5 anthracis. 30 to 60 ...... 2.5–4.0 Over 60 ...... 4.0 (B) 5 mg/lb BW/day intramuscularly Cats ...... Small ...... 0.4–0.75 or intravenously for treatment of Large ...... 0.75–1.5 anaplasmosis caused by Anaplasma marginale, severe foot-rot, and ad- (2) Do not mix with a barbiturate in vanced cases of other indicated dis- the same syringe to preclude precipita- eases. tion. (C) 9 mg/lb BW intramuscularly or (3) It tends to depress respiration. subcutaneously as single dosage where Naloxone hydrochloride and other nar- retreatment of calves and yearlings for cotic antagonists are used to counter bacterial pneumonia is impractical, for over-dosing. treatment of infectious bovine (4) Federal law restricts this drug to keratoconjunctivitis (pinkeye) caused by Moraxella bovis, or where retreat- use by or on the order of a licensed vet- ment for anaplasmosis is impractical. erinarian. (ii) Limitations. Exceeding the highest [40 FR 13858, Mar. 27, 1975, as amended at 63 recommended level of drug per pound FR 7701, Feb. 17, 1998] of bodyweight per day, administering more than the recommended number of treatments, and/or exceeding 10 mL intramuscularly or subcutaneously per

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injection site may result in antibiotic 5 mg per pound of bodyweight (mg/lb residues beyond the withdrawal time. BW) per day (/day) intramuscularly, Rapid intravenous administration in subcutaneously, or intravenously for cattle may result in animal collapse. treatment of pneumonia and shipping Oxytetracycline should be adminis- fever complex associated with tered intravenously slowly over a pe- Pasteurella spp. and Histophilus spp., riod of at least 5 minutes. Discontinue foot-rot and diphtheria caused by treatment at least 28 days prior to Fusobacterium necrophorum, bacterial slaughter. Not for use in lactating enteritis (scours) caused by Escherichia dairy animals. coli, wooden tongue caused by (2) Swine—(i) Amounts and indications Actinobacillus lignieresii, leptospirosis for use—(A) Sows: 3 mg/lb BW caused by Leptospira pomona, wound in- intramuscularly once, approximately 8 fections and acute metritis caused by hours before farrowing or immediately Staphylococcus spp. and Streptococcus after completion of farrowing, as an aid spp. in control of infectious enteritis (baby pig scours, colibacillosis) in suckling (B) 5 mg/lb BW/day intramuscularly, pigs caused by E. coli. subcutaneously, or intravenously for (B) 3 to 5 mg/lb BW/day treatment of severe foot-rot, and ad- intramuscularly for treatment of bac- vanced cases of other indicated dis- terial enteritis (scours, colibacillosis) eases. caused by E. coli, pneumonia caused by (C) 9 mg/lb BW intramuscularly or Pasteurella multocida, and leptospirosis subcutaneously as single dosage where caused by Leptospira pomona. retreatment of calves and yearlings for (C) 9 mg/lb BW as a single dosage bacterial pneumonia is impractical or where retreatment for pneumonia is for treatment of infectious bovine impractical. keratoconjunctivitis (pinkeye) caused (ii) Limitations. Administer by Moraxella bovis. intramuscularly. Do not inject more (D) 9 to 13.6 mg/lb BW than 5 mL per site in adult swine. Dis- intramuscularly or subcutaneously as continue treatment at least 28 days single dosage where retreatment of prior to slaughter. calves and yearlings for bacterial pneu- [45 FR 16479, Mar. 14, 1980. Redesignated and monia is impractical or for treatment amended at 69 FR 31879, June 8, 2004] of infectious bovine EDITORIAL NOTE: For FEDERAL REGISTER ci- keratoconjunctivitis (pinkeye) caused tations affecting § 522.1660a, see the List of by Moraxella bovis. CFR Sections Affected, which appears in the (E) 13.6 mg/lb BW intramuscularly or Finding Aids section of the printed volume subcutaneously as a single dosage for and at www.fdsys.gov. control of respiratory disease in cattle § 522.1660b Oxytetracycline solution, at high risk of developing BRD associ- 300 milligrams/milliliter. ated with Mannheimia (Pasteurella) haemolytica. (a) Specifications. Each milliliter (mL) of solution contains 300 milli- (ii) Limitations. Treatment should be grams (mg) oxytetracycline base. continued 24 to 48 hours following re- (b) Sponsor. See No. 055529 in mission of disease signs, however, not § 510.600(c) of this chapter. to exceed a total of four consecutive (c) Related tolerances. See § 556.500 of days. Do not inject more than 10 mL this chapter. per site in adult cattle, reducing the (d) Special considerations. When la- volume according to age and body size beled for use as in paragraph (e)(1)(i)(D) to 1 to 2 mL in small calves. Exceeding or (e)(1)(i)(E) of this section, labeling the highest recommended level of drug/ shall also bear the following: ‘‘Federal lb BW/day, administering more than law restricts this drug to use by or on the recommended number of treat- the order of a licensed veterinarian.’’. ments, and/or exceeding 10 mL (e) Conditions of use—(1) Beef cattle, intramuscularly or subcutaneously per nonlactating dairy cattle, and calves in- injection site may result in antibiotic cluding preruminating (veal) calves—(i) residues beyond the withdrawal time. Amounts and indications for use—(A) 3 to Rapid intravenous administration may

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result in animal collapse. Oxytetra- pathogens listed as follows: pneumonia cycline should be administered intra- and shipping fever complex (Pasteurella venously slowly over a period of at spp.; Hemophilis spp.; Klebsiella spp. ), least 5 minutes. Discontinue treatment bacterial enteritis (scours) (E. coli), at least 28 days prior to slaughter. Not foot-rot (Spherophorus necrophorus), for use in lactating dairy animals. diphtheria (Spherophorus necrophorus), (2) Swine—(i) Amounts and indications wooden tongue (Actinobacillus for use—(A) Sows: 3 mg/lb BW lignieresi), leptospirosis (Leptospira po- intramuscularly once, approximately 8 mona), and wound infections; acute me- hours before farrowing or immediately tritis; traumatic injury (caused by a after completion of farrowing, as an aid variety of bacterial organisms (such as in control of infectious enteritis (baby streptococcal and staphylococcal orga- pig scours, colibacillosis) in suckling nisms).) pigs caused by E. coli. (ii) It is administered by (B) 3 to 5 mg/lb BW/day intramuscular injection of 3 to 5 milli- intramuscularly for treatment of bac- grams of oxytetracycline hydro- terial enteritis (scours, colibacillosis) chloride per pound of body weight per caused by E. coli, pneumonia caused by day. Leptospirosis, severe foot-rot and Pasteurella multocida, and leptospirosis severe forms of the indicated diseases caused by Leptospira pomona. should be treated with 5 milligrams per (C) 9 mg/lb BW as a single dosage pound of body weight per day. Treat- where retreatment for pneumonia is ment should be continued for 24 to 48 impractical. hours following remission of disease (ii) Limitations. Administer symptoms; however, not to exceed a intramuscularly. Treatment should be total of 4 consecutive days. Only 2 mil- continued 24 to 48 hours beyond remis- liliters of the drug should be injected sion of disease signs, however, not to per site in case of calves weighing 100 exceed a total of 4 consecutive days. pounds or less and not more than 10 Exceeding the highest recommended milliliters should be injected per site level of drug/lb BW/day, administering in adult cattle. more than the recommended number of (iii) Discontinue treatment with the treatments, and/or exceeding 5 mL drug at least 20 days prior to slaughter intramuscularly per injection site may of the animal. When administered to result in antibiotic residues beyond the animals within 30 days of slaughter, withdrawal time. Discontinue treat- muscle discoloration may necessitate ment at least 28 days prior to slaugh- trimming of injection site and sur- ter. rounding tissues. (iv) For use only in beef cattle, beef [68 FR 54805, Sept. 19, 2003. Redesignated and calves, nonlactating dairy cattle, and amended at 69 FR 31879, June 8, 2004; 73 FR 14926, Mar. 20, 2008] dairy calves. (b)(1) Specifications. Each milliliter of § 522.1662 Oxytetracycline hydro- sterile solution contains 50 or 100 milli- chloride implantation or injectable grams of oxytetracycline (as oxytetra- dosage forms. cycline hydrochloride). (2) Sponsor. See 000010 in § 510.600(c) of § 522.1662a Oxytetracycline hydro- this chapter. chloride injection. (3) Conditions of use—(i) Beef cattle (a)(1) Specifications. The drug con- and nonlactating dairy cattle—(a) tains 50 milligrams of oxytetracycline Amount. Three to 5 milligrams of oxy- hydrochloride in each milliliter of ster- tetracycline per pound of body weight ile solution. per day; 5 milligrams per pound of body (2) Sponsor. See No. 000010 in weight per day for the treatment of § 510.600(c) of this chapter. anaplasmosis, severe foot-rot, and se- (3) Conditions of use. (i) The drug is vere cases of other indicated diseases. intended for use in beef cattle, beef (b) Indications for use. Treatment of calves, nonlactating dairy cattle, and diseases due to oxytetracycline-suscep- dairy calves for treatment of disease tible organisms as follows: Pneumonia conditions caused by one or more of and shipping fever complex associated the following oxytetracycline sensitive with Pasteurella spp., Hemophilus spp.,

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and Klebsiella spp., foot-rot and diph- for more than 4 consecutive days. Dis- theria caused by Spherophorus continue treatment at least 26 days be- necrophorus, bacterial enteritis (scours) fore slaughter. caused by Escherichia coli, wooden (c)(1) Specifications. The drug con- tongue caused by Actinobacillus tains 50 or 100 milligrams of oxytetra- lignieresi, leptospirosis caused by cycline hydrochloride in each milliliter Leptospira pomona, and wound infec- of sterile solution. tions and acute metritis caused by (2) Sponsor. See No. 000069 in Staphylococcus spp. and Streptococcus § 510.600(c) of this chapter. spp. If labeled for use by or on the (3) Conditions of use. (i) The drug is order of a licensed veterinarian, it may intended for use in the treatment of be used for the treatment of disease due to oxytetracycline-suscep- anaplasmosis caused by Anaplasma tible organisms in beef cattle and non- marginale. lactating dairy cattle. It is indicated in (c) Limitations. For 50-milligram-per- the treatment of pneumonia and ship- milliliter solution, administer ping fever complex associated with intramuscularly or intravenously; for Pasteurella spp., Hemophilus spp., 100-milligram-per-milliliter solution, Klebsiella spp., foot-rot and diphtheria administer intramuscularly only. caused by Spherophorus necrophorus, Treatment of all diseases should be in- bacterial enteritis (scours) caused by stituted early and continue for 24 to 48 Escherichia coli, wooden tongue caused hours beyond remission of disease by Actinobacillus lignieresi, acute metri- symptoms, but not to exceed a total of tis, and wound infections caused by 4 consecutive days. Consult your vet- staphylococcal and streptococcal orga- erinarian if no improvement is noted nisms. within 48 hours. Do not inject more than 10 milliliters per site in adult cat- (ii) It is administered to cattle at a tle, reducing the volume according to dosage level of 3 to 5 milligrams per age and body size to 0.5 to 2 milliliters pound of body weight per day. It may in small calves. Exceeding the highest be administered intramuscularly or in- recommended dose of 5 milligrams per travenously from a 50 milligram per pound of body weight, administering at milliliter solution. It is administered recommended levels for more than 4 intravenously from a 100 milligram per consecutive days, and/or exceeding 10 milliliter solution. Severe foot-rot and milliliters intramuscularly per injec- the severe forms of the indicated dis- tion site may result in antibiotic resi- eases should be treated with 5 milli- dues beyond the withdrawal time. Dis- grams per pound of body weight. Treat- continue treatment at least 18 days ment should be continued 24 to 48 prior to slaughter. Not for use in lac- hours following remission of disease tating dairy cattle. symptoms, however, not to exceed a (ii) Swine—(a) Amount. Three to 5 total of 4 consecutive days. If no im- milligrams of oxytetracycline per provement is noted within 24 hours, pound of body weight per day. Sows: 3 consult a veterinarian. When injecting milligrams of oxytetracycline per the drug intramuscularly, do not inject pound of body weight, approximately 8 more than 10 milliliters per site in hours before farrowing or immediately adult cattle. Reduce the amount in- after completion of farrowing. jected at each site according to the size (b) Indications for use. For treatment of the animal. For very small calves do of bacterial enteritis (scours, not use more than 2 milliliters per in- colibacillosis) caused by Escherichia jection site. coli, pneumonia caused by Pasteurella (iii) Not for use in lactating dairy multocida, and leptospirosis caused by cattle. Discontinue treatment at least Leptospira pomona. Sows: as an aid in 19 days prior to slaughter. When ad- control of infectious enteritis (baby pig ministered intramuscularly within 30 scours, colibacillosis) in suckling pigs days of slaughter, muscle discoloration caused by Escherichia coli. may necessitate trimming of the injec- (c) Limitations. Administer tion site and surrounding tissues. intramuscularly. Do not inject more (d)(1) Specifications. The drug con- than 5 milliliters per site. Do not use tains 50 milligrams of oxytetracycline

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hydrochloride in each milliliter of ster- hours before farrowing or immediately ile solution. after farrowing. (2) Sponsor. See No. 000069 in (iii) In poultry (broilers, turkeys, and § 510.600(c) of this chapter. breeding chickens) as follows: (3) Conditions of use. (i) In beef cattle (a) It is used for the treatment of air and nonlactating dairy cattle as fol- sacculitis (air-sac disease, chronic res- lows: piratory disease) caused by Mycoplasma (a) It is used for the treatment of gallisepticum and Escherichia coli; fowl pneumonia and shipping fever complex cholera caused by Pasteurella multocida; associated with Pasteurella spp. and infectious sinusitis caused by Myco- Hemophilus spp.; foot-rot and diph- plasma gallisepticum; and infectious syn- theria caused by Spherophorus ovitis caused by Mycoplasma synoviae. necrophorus; bacterial enteritis (scours) (b) Administered subcutaneously to caused by Escherichia coli; wooden chickens 1 day to 2 weeks of age at 6.25 tongue caused by Actinobacillus milligrams of oxytetracycline per bird lignieresi; leptospirosis caused by per day diluted with 1 part of the drug Leptospira pomona; wound infections to 3 parts of sterile water; to chickens and acute metritis caused by staphy- 2 to 4 weeks of age using the same di- lococcal and streptococcal organisms. luted product at 12.5 milligrams of oxytetracycline per bird; to chickens 4 to 8 (b) Administer by intravenous or weeks of age without dilution at 25 intramuscular injection at 3 to 5 milli- milligrams of oxytetracycline per bird; grams of oxytetracycline per pound of to chickens 8 weeks of age (broilers and body weight per day. In the treatment light pullets) at 50 milligrams of oxy- of severe foot-rot and severe forms of tetracycline per bird; to adult chickens the indicated diseases, a dosage level of at 100 milligrams of oxytetracycline 5 milligrams per pound of body weight per bird. per day is recommended. (c) Administered subcutaneously to (c) If the labeling of the drug bears turkeys 1 day to 2 weeks of age and 2 to the statement ‘‘Federal law restricts 4 weeks of age at the same dosage as this drug to use by or on the order of a chickens; to turkeys 4 to 6 weeks of age licensed veterinarian,’’ it may include at 50 milligrams of oxytetracycline as additional directions for use in beef the undiluted product per bird; to tur- cattle and nonlactating dairy cattle for keys 6 to 9 weeks of age at 100 milli- the treatment of anaplasmosis caused grams of oxytetracycline per bird; to by Anaplasma marginale, and anthrax turkeys 9 to 12 weeks of age at 150 mil- caused by Bacillus anthracis in which ligrams of oxytetracycline per bird; to case the drug is given at 3 to 5 milli- turkeys 12 weeks of age and older at 200 grams of oxytetracycline per pound of milligrams of oxytetracycline per bird. body weight per day for anthrax, and at In light turkey breeds, no more than 25 5 milligrams per pound of body weight milligrams per pound of body weight is per day for anaplasmosis. administered. For the treatment of in- (ii) In swine as follows: fectious sinusitis in turkeys, 1⁄4 to 1⁄2 (a) It is used for the treatment of milliliter of the drug is injected di- bacterial enteritis (scours, rectly into each swollen sinus depend- colibacillosis) caused by Escherichia ing upon the age of the bird and the se- coli; pneumonia caused by Pasteurella verity of the condition. At the time multocida; and leptospirosis caused by that the sinuses are treated, the drug Leptospira pomona. Administered to should also be administered sows as an aid in the control of infec- subcutaneously to the birds according tious enteritis (baby pig scours, to the dosage schedule given in para- colibacillosis) in suckling pigs caused graph (d)(3)(iii)(c) of this section. If re- by Escherichia coli. filling of the sinuses occurs, the treat- (b) Administer by intramuscular in- ment may be repeated in 5 to 7 days. jection at 3 to 5 milligrams of oxytet- (iv) Treatment of all diseases should racycline per pound of body weight per be instituted early. Treatment should day to swine. Administered to sows at continue for 24 to 48 hours beyond the 3 milligrams of oxytetracycline per remission of disease symptoms, but not pound of body weight approximately 8 exceed a total of 4 consecutive days. If

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no improvement is noted within 24 to marginale and anthrax caused by Bacil- 48 hours, diagnosis and therapy should lus anthracis. be reevaluated. (c) Limitations. Administer (v) When injecting intramuscularly intramuscularly. Treatment of all dis- in adult livestock, do not inject more eases should be instituted early and than 10 milliliters at any one site. The continue for 24 to 48 hours beyond re- volume administered per injection site mission of disease symptoms, but not should be reduced according to age and to exceed a total of 4 consecutive days. body size so that 1 or 2 milliliters are Consult your veterinarian if no im- injected in smaller animals such as provement is noted within 48 hours. Do small calves and young pigs. Intra- not inject more than 10 milliliters per venous administration is recommended site in adult cattle, reducing the vol- in cattle when daily dosage exceeds 50 ume according to age and body size to milliliters. 1 to 2 milliliters in small calves. Ex- (vi) Treatment must be discontinued ceeding the highest recommended dose at least 5 days prior to slaughter for of 5 milligrams per pound of body chickens and turkeys and at least 22 weight, administering at recommended days prior to slaughter for cattle and levels for more than 4 consecutive swine. When administered days, and/or exceeding 10 milliliters intramuscularly to animals within 30 intramuscularly per injection site may days of slaughter, muscle discoloration result in antibiotic residues beyond the may necessitate trimming of the injection site(s) and surrounding tissues withdrawal time. Discontinue treat- during the dressing procedure. ment at least 15 days prior to slaugh- (vii) Not for use in lactating dairy ter. Not for use in lactating dairy cat- animals. Do not administer to laying tle. hens unless the eggs are used for hatch- (ii) Swine—(a) Amount. 3 to 5 milli- ing only. grams of oxytetracycline per pound of (e)(1) Specifications. Each milliliter of body weight per day. Sows: 3 milli- sterile solution contains 100 milligrams grams of oxytetracycline per pound of of oxytetracycline hydrochloride. body weight, administered once, ap- (2) Sponsor. See No. 000069 in proximately 8 hours before farrowing § 510.600(c) of this chapter. or immediately after completion of (3) Conditions of use—(i) Beef cattle farrowing. and nonlactating dairy cattle—(a) (b) Indications for use. For treatment Amount. 3 to 5 milligrams of oxytetra- of bacterial enteritis (scours, cycline per pound of body weight per colibacillosis) caused by Escherichia day; 5 milligrams per pound of body coli, pneumonia caused by Pasteurella weight per day for treatment of multocida, and leptospirosis caused by anaplasmosis, severe foot-rot, and se- Leptospira pomona. Sows: as an aid in vere cases of other indicated diseases. control of infections enteritis (baby pig (b) Indications for use. Treatment of scours, colibacillosis) in suckling pigs diseases due to oxytetracycline-suscep- caused by Escherichia coli. tible organisms as follows: Pneumonia (c) Limitations. Administer and shipping fever complex associated intramuscularly. Do not inject more with Pasteurella spp. and Hemophilus than 5 milliliters per site in adult spp., foot-rot and diphtheria caused by swine, reducing the volume according Fusobacterium necrophorum, bacterial to age and body size to 1 to 2 milliliters enteritis (scours) caused by Escherichia in young pigs. Discontinue treatment coli, wooden tongue caused by at least 22 days prior to slaughter. Actinobacillus lignieresii, leptospirosis (f) [Reserved] caused by Leptospira pomona, and (g)(1) Specifications. Each milliliter of wound infections and acute metritis sterile solution contains 100 milligrams caused by Staphylococcus spp. and Strep- tococcus spp. If labeled for use by or on of oxytetracycline as oxytetracycline the order of a licensed veterinarian, it hydrochloride. may be used for the treatment of (2) Sponsor. See No. 000010 in anaplasmosis caused by Anaplasma § 510.600(c) of this chapter.

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(3) Conditions of use. The drug is used noted within 24 hours, consult a veteri- for the treatment of diseases due to ox- narian. Do not inject more than 5 mil- ytetracycline-susceptible organisms as liliters per site. Discontinue treatment follows: at least 20 days prior to slaughter. (i) Beef cattle, beef calves, nonlactating (h)(1) Specifications. Each milliliter of dairy cattle, and dairy calves—(a) sterile solution contains 50 or 100 milli- Amount. 3 to 5 milligrams of oxytetra- grams of oxytetracycline hydro- cycline per pound of body weight per chloride. day. (2) Sponsors. See No. 000010 in (b) Indications for use. For the treat- § 510.600(c) of this chapter for use of 50 ment of pneumonia and shipping fever and 100 milligrams per milliliter solu- complex associated with Pasteurella tion; and Nos. 055529 and 059130 in spp., Hemophilus spp., or Klebsiella spp. § 510.600(c) for use of 100 milligrams per (c) Limitations. Administer by milliliter solution. intramuscular, intravenous, or sub- (3) Conditions of use—(i) Amount. The cutaneous injection. In severe forms of drug is used in beef cattle, beef calves, the indicated diseases, administer 5 nonlactating dairy cattle, and dairy milligrams of oxytetracycline per calves as follows: 3 to 5 milligrams of pound of body weight per day. Continue oxytetracycline hydrochloride per treatment 24 to 48 hours following re- pound of body weight per day; 5 milli- mission of disease symptoms, not to grams per pound of body weight per exceed a total of 4 consecutive days. If day for treatment of severe forms of no improvement is noted within 48 the indicated diseases. hours, consult a veterinarian. Do not (ii) Indications for use. The drug is inject more than 10 milliliters per in- used for treatment of bacterial pneu- jection site intramuscularly in adult monia and shipping fever complex asso- cattle; no more than 1 milliliter per ciated with Pasteurella spp.; foot-rot site in calves weighing 100 pounds or and calf diphtheria caused by less. Do not slaughter cattle for 13 days Spherophorus necrophorus; bacterial after intramuscular or intravenous enterities (scours) caused by Esch- treatment, or 2 days after subcuta- erichia coli; wooden tongue caused by neous treatment. Exceeding the high- Actinobacillus lignieresi; wound infec- est recommended dosage or duration of tions, acute metrities, and traumatic treatment (not more than 4 consecu- injury caused by staphylococcal and tive days) may result in residues be- streptococcal organisms. yond the withdrawal period. A with- (iii) Limitations. Administer 50-milli- drawal period has not been established gram-per-milliliter solution for use of this product in intramuscularly; administer 100-milli- preruminating calves. Do not use in gram-per-milliliter solution intra- calves to be processed for veal. venously. Continue treatment 24 to 48 (ii) Swine—(a) Amount. 3 to 5 milli- hours following remission of disease grams of oxytetracycline per pound of symptoms, not to exceed a total of 4 body weight per day. Sows: Administer consecutive days. If no improvement is once 3 milligrams of oxytetracycline noted within 24 to 48 hours, consult a per pound of body weight, approxi- veterinarian for diagnosis and therapy. mately 8 hours before farrowing or im- When injecting the drug mediately after completion of intramuscularly, do no inject more farrowing. than 10 milliliters per site in adult cat- (b) Indications for use. For treatment tle. Reduce the volume administered of bacterial enteritis (scours, per injection site according to age and colibacillosis) caused by Escherichia body size. In calves weighing 100 coli, pneumonia caused by Pasteurella pounds or less, do no inject more than multocida, and leptospirosis caused by 2 milliliters intramuscularly per site. Leptospira pomona. Sows: As an aid in Discontinue treatment at least 22 days control of infectious enteritis (baby pig before slaughter. Not for use in lac- scours, colibacillosis) in suckling pigs tating dairy animals. caused by Escherichia coli. (i)(1) Specifications. Each milliliter of (c) Limitations. Administer sterile solution contains 50 milligrams intramuscularly. If no improvement is of oxytetracycline hydrochloride.

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(2) Sponsor. See No. 059130 in Fusobacterium necrophorum; bacterial § 510.600(c) of this chapter. enteritis (scours) caused by Escherichia (3) Conditions of use—(i) Amount. The coli; wooden tongue caused by drug is used in beef cattle, beef calves, Actinobacillus lignieresii; leptospirosis nonlactating dairy cattle, and dairy caused by Leptospira pomona; acute me- calves as follows: Administer 3 to 5 tritis and wound infections caused by milligrams of the oxytetracycline hy- staphylococcal and streptococcal orga- drochloride intramuscularly per pound nisms; if labeled for use by or on the of body weight per day. order of a licensed veterinarian, it may (ii) Indications for use. The drug is be used for treatment of anaplasmosis used for treatment of bacterial pneu- caused by Anaplasma marginale and an- monia and shipping fever complex asso- thrax caused by Bacillus anthracis. ciated with Pasteurella spp.; foot-rot (iii) Limitations. Administer by intra- and diptheria caused by Spherophorus venous injection. Treatment should be necrophorus; bacterial enteritis (scours) continued 24 to 48 hours following re- caused by Escherichia coli; wooden mission of disease symptoms, but not tongue caused by Actinobacillus to exceed a total of 4 consecutive days. lignieresi; wound infections and acute If no improvement occurs within 24 to metritis caused by staphylococcal and 48 hours, reevaluate diagnosis and ther- streptococcal organisms susceptible to apy. Discontinue use at least 19 days oxytetracycline. prior to slaughter. Not for use in lac- (iii) Limitations. In severe forms of tating dairy cattle. the indicated diseases, administer the equivalent of 5 milligrams of oxytetra- [40 FR 13858, Mar. 27, 1975] cycline hydrochloride per pound of EDITORIAL NOTE: For FEDERAL REGISTER ci- body weight per day. Continue treat- tations affecting § 522.1662a, see the List of ment 24 to 48 hours following remission CFR Sections Affected, which appears in the of disease symptoms, not to exceed a Finding Aids section of the printed volume total of 4 consecutive days. If no im- and at www.fdsys.gov. provement is noted within 24 to 48 § 522.1662b Oxytetracycline hydro- hours, consult a veterinarian for diag- chloride with lidocaine injection. nosis and therapy. In adult livestock, do not inject more than 10 milliliters (a) Specifications. The drug contains at any one site. Reduce the volume ad- 50 or 100 milligrams of oxytetracycline ministered per injection site according hydrochloride and 2 percent lidocaine to age and body size. In calves weigh- in each milliliter of sterile aqueous so- ing 100 pounds or less inject only 2 mil- lution. liliters per site. Discontinue treatment (b) Sponsor. See No. 000069 in at least 18 days before slaughter. Not § 510.600(c) of this chapter. for use in lactating dairy cattle. (c) Conditions of use. (1) The drug is (j) [Reserved] indicated for use in the treatment of (k)(1) Specifications. Each milliliter of diseases of dogs caused by pathogens sterile solution contains either 50 or sensitive to oxytetracycline hydro- 100 milligrams of oxytetracycline hy- chloride including treatment for the drochloride. following conditions in dogs caused by (2) Sponsor. See No. 061623 in susceptible microorganisms: Bacterial § 510.600(c) of this chapter. infections of the urinary tract caused (3) Conditions of use in beef cattle and by Hemolytic staphylococcus, Strepto- nonlactating dairy cattle—(i) Amount. 3 coccus spp., Bacterial pulmonary infec- to 5 milligrams per pound of body tions caused by Brucella bronchiseptica, weight daily, 5 milligrams per pound Streptococcus pyogenes, Staphylococcus for anaplasmosis, severe foot rot, and aureus, secondary bacterial infections severe forms of other diseases. caused by Micrococcus pyogenes var. (ii) Indications for use. Treatment of albus, Brucella bronchiseptica, Strepto- diseases due to oxytetracycline-suscep- coccus spp. tible organisms as follows: pneumonia (2) The drug is administered and shipping fever complex associated intramuscularly at a recommended with Pasteurella spp. and Hemophilus daily dosage to dogs at 5 milligrams spp.; foot rot and diphtheria caused by per pound of body weight administered

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in divided doses at 6 to 12 hour inter- (b) Sponsors. See Nos. 000010, 000856, vals. Therapy should be continued for 059130, 058639, 059130, and 061623 in at least 24 hours after all symptoms § 510.600(c) of this chapter. have subsided. (c) Conditions of use—(1) Amount—(i) (3) Federal law restricts this drug to Obstetrical. Administer drug intra- use by or on the order of a licensed vet- venously, intramuscularly, or erinarian. subcutaneously under aseptic conditions as indicated. The following dos- [40 FR 13858, Mar. 27, 1975, as amended at 48 ages are recommended and may be re- FR 30615, July 5, 1983] peated as conditions require:

§ 522.1664 Oxytetracycline and mL U.S.P. units flunixin. Cats ...... 0.25 to 0.5 ...... 5 to 10. (a) Specifications. Each milliliter Dogs ...... 0.25 to 1.5 ...... 5 to 30. (mL) of solution contains 300 milli- Ewes, Sows ...... 1.5 to 2.5 ...... 30 to 50. Cows, Horses ...... 5.0 ...... 100. grams (mg) oxytetracycline base as amphoteric oxytetracycline and 20 mg (ii) Milk letdown. Intravenous admin- flunixin base as flunixin meglumine. istration is desirable. The following (b) Sponsor. See No. 055529 in dosage is recommended and may be re- § 510.600(c) of this chapter. peated as conditions require: (c) Related tolerances. See §§ 556.286 and 556.500 of this chapter. mL U.S.P. units (d) Conditions of use cattle—(1) Cows ...... 0.5 to 1.0 ...... 10 to 20. Amount. Administer once as an Sows ...... 0.25 to 1.0 ...... 5 to 20. intramuscular or subcutaneous injection of 1 mL per 22 pounds (lb) body (2) Indications for use. Oxytocin may weight (BW) (13.6 mg oxytetracycline be used as a uterine contractor to precipitate and accelerate normal parturi- and 0.9 mg flunixin per lb BW) where tion and postpartum evacuation of retreatment of calves and yearlings for uterine debris. In surgery it may be bacterial pneumonia is impractical due used postoperatively following cesar- to husbandry conditions, such as cattle ean section to facilitate involution and on range, or where their repeated re- resistance to the large inflow of blood. straint is inadvisable. It will contract smooth muscle cells of (2) Indications for use. For the treat- the mammary gland for milk letdown ment of bacterial pneumonia associ- if the udder is in proper physiological ated with Pasteurella spp. and for the state. control of associated pyrexia in beef (3) Limitations. Federal law restricts and nonlactating dairy cattle. this drug to use by or on the order of a (3) Limitations. Federal law restricts licensed veterinarian. this drug to use by or on the order of a licensed veterinarian. Discontinue [44 FR 63097, Nov. 2, 1979; 45 FR 1019, Jan. 4, 1980, as amended at 52 FR 18691, May 19, 1987; treatment at least 21 days prior to 52 FR 25212, July 6, 1987; 52 FR 36023, Sept. 25, slaughter of cattle. Do not use in fe- 1987; 53 FR 32610, Aug. 26, 1988; 53 FR 40728, male dairy cattle 20 months of age or Oct. 18, 1988; 54 FR 41442, Oct. 10, 1989; 55 FR older. Use in this class of cattle may 8462, Mar. 8, 1990; 56 FR 14642, Apr. 11, 1991, 56 cause milk residues. A withdrawal pe- FR 16002, Apr. 19, 1991; 59 FR 31139, June 17, riod has not been established in 1994; 62 FR 35076, June 30, 1997; 62 FR 38906, preruminating calves. Do not use in July 21, 1997; 65 FR 45877, July 26, 2000; 66 FR 22117, May 3, 2001; 68 FR 36913, June 20, 2003] calves to be processed for veal. Use of dosages other than those indicated § 522.1696 Penicillin G procaine im- may result in residue violations. plantation and injectable dosage forms. [76 FR 3489, Jan. 20, 2011] § 522.1696a Penicillin G benzathine § 522.1680 Oxytocin injection. and penicillin G procaine suspen- (a) Specifications. Each milliliter sion. (mL) of solution contains 20 USP units (a) Specifications. Each milliliter of oxytocin. aqueous suspension contains penicillin

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G benzathine and penicillin G procaine, slaughter. For Nos. 049185, 055529, each equivalent to 150,000 units of peni- 059130, and 061623: A withdrawal period cillin G. has not been established for this prod- (b) Sponsors. See sponsors in uct in preruminating calves. Do not § 510.600(c) of this chapter for the condi- use in calves to be processed for veal. tions of use in paragraph (d) of this sec- [66 FR 711, Jan. 4, 2001, as amended at 68 FR tion as follows: 34534, June 10, 2003; 70 FR 21947, Apr. 28, 2005; (1) Nos. 000856, 049185, 055529, and 70 FR 50182, Aug. 26, 2005; 73 FR 16754, Mar. 061623 for use as in paragraph (d)(1) of 31, 2008; 75 FR 54017, Sept. 3, 2010] this section. (2) Nos. 055529, 059130, and 061623 for § 522.1696b Penicillin G procaine aque- use as in paragraphs (d)(2)(i), ous suspension. (d)(2)(ii)(A), and (d)(2)(iii) of this sec- (a) Specifications. Each milliliter con- tion. tains penicillin G procaine equivalent (3) Nos. 000856 and 049185 for use as in to 300,000 units of penicillin G. paragraphs (d)(2)(i), (d)(2)(ii)(B), and (b) Sponsors. See sponsor numbers in (d)(2)(iii) of this section. § 510.600(c) of this chapter as follows: (c) . See § 556.510 of Related tolerances (1) Nos. 053501, 055529, and 059130 for this chapter. use as in paragraph (d) of this section. (d) Conditions of use—(1) Horses, dogs, (2) No. 061623 for use as in paragraph and beef cattle—(i) Amount—(A) Beef (d)(2) of this section. cattle. 2 milliliters per 150 pounds of body weight intramuscularly or (c) Related tolerances. See § 556.510 of subcutaneously. Repeat dosage in 48 this chapter. hours. (d) Conditions of use—(1) Dogs and (B) Horses. 2 milliliters per 150 pounds cats—(i) Amount. 10,000 units per pound of body weight intramuscularly. Re- body weight daily by intramuscular in- peat dosage in 48 hours. jection at 24-hour intervals. Continue (C) Dogs. 1 milliliter per 10 to 25 treatment at least 48 hours after symp- pounds of body weight intramuscularly toms disappear. or subcutaneously. Repeat dosage in 48 (ii) Indications for use. Treatment of hours. infections caused by penicillin-sen- (ii) Conditions of use. Treatment of sitive organisms. bacterial infections susceptible to peni- (iii) Limitations. Federal law restricts cillin G. this drug to use by or on the order of a (iii) Limitations. In beef cattle, treat- licensed veterinarian. ment should be limited to two doses. (2) Cattle, sheep, swine, and horses—(i) Not for use in beef cattle within 30 Amount. 3,000 units per pound body days of slaughter. Do not use in horses weight (1 milliliter per 100 pounds body intended for food purposes. Federal law weight) daily by intramuscular injec- restricts this drug to use by or on the tion. order of a licensed veterinarian. (A) For Nos. 053501, 055529, 059130, and (2) Beef cattle—(i) Amount. 2 milli- 061623: Continue treatment at least 48 liters per 150 pounds of body weight hours after symptoms disappear. subcutaneously. Repeat dosage in 48 (B) For No. 055529: Continue treat- hours. ment at least 1 day after symptoms (ii) Conditions of use. disappear (usually 2 or 3 days). (A) Treatment of bacterial pneu- (ii) Indications for use. Treatment of monia (Streptococcus spp., Actinomyces cattle and sheep for bacterial pneu- pyogenes, Staphylococcus aureus); upper monia (shipping fever) caused by respiratory infections such as rhinitis Pasteurella multocida; swine for erysipe- or pharyngitis (A. pyogenes); blackleg las caused by Erysipelothrix (Clostridium chauvoei). rhusiopathiae; and horses for strangles (B) As in paragraph (d)(2)(ii)(A) of caused by Streptococcus equi. this section; and prophylaxis of bovine (iii) Limitations. Not for use in horses shipping fever in 300- to 500-pound beef intended for food. Milk that has been calves. taken during treatment and for 48 (iii) Limitations. Limit treatment to hours after the last treatment must two doses. Not for use within 30 days of not be used for food.

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(A) For Nos. 053501 and 061623: Do not (c) Conditions of use—(1) Horses—(i) exceed 7 days of treatment in nonlac- Amount. 0.15 milligram of pentazocine tating dairy and beef cattle, sheep, and base per pound of body weight per day. swine, or 5 days in lactating cattle. (ii) Indications for use. For sympto- Discontinue treatment for the fol- matic relief of pain due to colic. lowing number of days before slaugh- (iii) Limitations. Administer intra- ter: Nonruminating cattle (calves)—7; venously or intramuscularly. Intra- all other cattle—4; sheep—8; and venous injections are given slowly in swine—6. the jugular vein. In cases of severe (B) For Nos. 055529 and 059130: Con- pain, a second dose is recommended tinue treatment at least 1 day after intramuscularly 10 to 15 minutes after symptoms disappear (usually 2 or 3 the initial dose at the same level. Not days). for use in horses intended for food. Fed- [66 FR 712, Jan. 4, 2001, as amended at 68 FR eral law restricts this drug to use by or 34534, June 10, 2003; 68 FR 42589, July 18, 2003; on the order of a licensed veterinarian. 69 FR 17586, Apr. 5, 2004; 70 FR 16935, Apr. 4, (2) Dogs—(i) Amount. 0.75 to 1.50 milli- 2005; 73 FR 14177, Mar. 17, 2008; 75 FR 54017, grams of pentazocine base per pound of Sept. 3, 2010] body weight. (ii) Indications for use. For ameliora- § 522.1696c Penicillin G procaine in tion of pain accompanying post- oil. operative recovery, fracture, trauma, (a) Specifications. Each milliliter con- and spinal disorders. tains penicillin G procaine equivalent (iii) Limitations. Administer to 300,000 units of penicillin G. intramuscularly only. Federal law re- (b) Sponsor. See No. 053501 in stricts this drug to use by or on the § 510.600(c) of this chapter. order of a licensed veterinarian. (c) National Academy of Sciences/Na- tional Research Council (NAS/NRC) sta- [42 FR 31450, June 21, 1977, as amended at 42 FR 36995, July 19, 1977; 47 FR 5409, Feb. 5, tus. The conditions of use were NAS/ 1982; 55 FR 23076, June 6, 1990] NRC reviewed and found effective. Ap- plications for these uses need not in- § 522.1704 Sodium pentobarbital injec- clude effectiveness data as specified by tion. § 514.111 of this chapter, but may re- (a)(1) Specifications. Sodium pento- quire bioequivalency and safety infor- barbital injection is sterile and con- mation. tains in each milliliter 64.8 milligrams (d) Conditions of use—(1) Amount. of sodium pentobarbital. Dogs and cats—10,000 units per pound (2) Sponsor. See No. 000061 in of body weight once daily. Horses— § 510.600(c) of this chapter. 3,000 units per pound of body weight (3) Conditions of use. (i) The drug is once daily. indicated for use as a general anes- (2) Indications for use. Treatment of thetic in dogs and cats. Although it infections of dogs, cats, and horses may be used as a general surgical anes- caused by penicillin-susceptible orga- thetic for horses, it is usually given at nisms such as Streptococci, a lower dose to cause sedation and hyp- Staphylococci, and Corynebacteria. nosis and may be supplemented with a (3) Limitations. Not for use in food- local anesthetic. It may also be used in producing animals. Federal law re- dogs for the symptomatic treatment of stricts this drug to use by or on the strychnine poisoning. order of a licensed veterinarian. (ii) The drug is administered intra- [57 FR 37333, Aug. 18, 1992] venously ‘‘to effect’’. For general surgical anesthesia, the usual dose is 11 to § 522.1698 Pentazocine lactate injec- 13 milligrams per pound of body tion. weight. For sedation, the usual dose is (a) Specifications. Each milliliter of approximately 2 milligrams per pound sterile aqueous solution contains of body weight. For relieving convul- pentazocine lactate equivalent to 30 sive seizures in dogs, when caused by milligrams of pentazocine base. strychnine, the injection should be ad- (b) Sponsor. See No. 000009 in ministered intravenously ‘‘to effect’’. § 510.600(c) of this chapter. The drug may be given

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intraperitoneally if desired. However, tion to not more than 5 successive the results of such injections are less days. uniform. When given intraperitoneally, (3) Not for use in animals intended it is administered at the same dosage for food. level as for intravenous administra- (4) Federal law restricts this drug to tion. The dose must be reduced for ani- use by or on the order of a licensed vet- mals showing under-nourishment, tox- erinarian. emia, shock and similar conditions. [40 FR 13858, Mar. 27, 1975] (iii) Federal law restricts this drug to use by or on the order of a licensed vet- EDITORIAL NOTE: For FEDERAL REGISTER ci- tations affecting § 522.1720, see the List of erinarian. CFR Sections Affected, which appears in the (b) [Reserved] Finding Aids section of the printed volume and at www.fdsys.gov. [40 FR 13858, Mar. 27, 1975, as amended at 45 FR 83483, Dec. 19, 1980; 52 FR 25212, July 6, § 522.1820 Pituitary luteinizing hor- 1987; 62 FR 61625, Nov. 19, 1997; 66 FR 23588, mone for injection. May 9, 2001] (a) Specifications. The drug is a § 522.1720 Phenylbutazone injection. lyophilized pituitary extract. Each 6- milliliter vial contains an amount (a) Specifications. The drug contains equivalent to 25 milligrams of standard 100 or 200 milligrams of phenylbutazone pituitary luteinizing hormone and is in each milliliter of sterile aqueous so- reconstituted for use by addition of 5 lution. milliliters of 0.9 percent aqueous so- (b) Sponsors. (1) Approval for use of dium chloride solution. the 200 milligrams per milliliter drug (b) Sponsor. No. 000061 in § 510.600(c) of in dogs and horses: See sponsor Nos. this chapter. 000061, 000856, 059130, and 061623 in (c) Conditions of use. (1) The drug is § 510.600(c) of this chapter. an aid in the treatment of breeding dis- (2) Approval for use of the 200 milli- orders related to pituitary grams per milliliter drug for use in hypofunction in cattle, horses, swine, horses: See sponsor Nos. 000010 and sheep, and dogs. 058005 in § 510.600(c) of this chapter. (2) Preferably given by intravenous (3) Approval for use of the 100 milli- injection, it may be administered grams per milliliter drug in dogs and subcutaneously; dosage is as follows: horses: See sponsor No. 000856 in Cattle and horses, 25 mg; swine, 5 mg; § 510.600(c) of this chapter. sheep, 2.5 mg, and dogs, 1.0 mg. Treat- (c) Conditions of use for dogs. (1) It is ment may be repeated in 1 to 4 weeks, used for the relief of inflammatory or as indicated. conditions associated with the mus- (3) Federal law restricts this drug to culoskeletal system. use by or on the order of a licensed vet- (2) It is administered intravenously erinarian. at a dosage level of 10 milligrams per [40 FR 13858, Mar. 27, 1975, as amended at 52 pound of body weight daily in 3 divided FR 7832, Mar. 13, 1987] doses, not to exceed 800 milligrams daily regardless of weight. Limit intra- § 522.1850 Polysulfated venous administration to 2 successive glycosaminoglycan. days. Oral medication may follow. (a) Specifications. (1) Each 1-milliliter (3) Federal law restricts this drug to (mL) ampule of solution contains 250 use by or on the order of a licensed vet- milligrams (mg) polysulfated erinarian. glycosaminoglycan. (d) Conditions of use for horses. (1) It is (2) Each mL of solution packaged in used for the relief of inflammatory 5-mL ampules or 20-, 30-, or 50-mL vials conditions associated with the mus- contains 100 mg polysulfated culoskeletal system. glycosaminoglycan. (2) It is administered intravenously (b) Sponsor. See No. 010797 in at a dosage level of 1 to 2 grams per § 510.600(c) of this chapter. 1,000 pounds of body weight daily in 3 (c) Special considerations. Federal law divided doses, not to exceed 4 grams restricts this drug to use by or on the daily. Limit intravenous administra- order of a licensed veterinarian.

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(d) Conditions of use—(1) Horses—(i) administered to horses is 2 grams per Indications for use. For the treatment of horse. When administered to dogs and noninfectious degenerative and/or trau- cats, it is 25 milligrams per pound of matic joint dysfunction and associated body weight. For small dogs and cats, lameness of the carpal and hock joints sterile pralidoxime chloride may be ad- in horses. ministered either intraperitoneally or (ii) Amount—(A) Intra-articular use intramuscularly. A mild degree of (carpal): 250 mg once a week for 5 atropinization should be maintained weeks. for at least 48 hours. Following severe (B) Intramuscular use (carpal and poisoning, a second dose of sterile hock): 500 mg every 4 days for 28 days. pralidoxime chloride may be given (iii) Limitations. Do not use in horses after 1 hour if muscle weakness has not intended for human consumption. been relieved. (2) Dogs—(i) Indications for use. For (3) For use only by or on the order of control of signs associated with non- a licensed veterinarian. infectious degenerative and/or traumatic arthritis of canine synovial [40 FR 13858, Mar. 27, 1975, as amended at 49 joints. FR 32061, Aug. 10, 1984] (ii) Amount. 2 mg per pound of body weight by intramuscular injection § 522.1870 Praziquantel injectable so- twice weekly for up to 4 weeks (max- lution. imum of 8 injections). (a) Specification. Each milliliter con- [72 FR 56896, Oct. 5, 2007, as amended at 74 FR tains 56.8 milligrams of praziquantel. 67816, Dec. 21, 2009] (b) Sponsors. See 000859 and 059130 in § 510.600(c) of this chapter. § 522.1862 Sterile pralidoxime chlo- (c) Conditions of use—(1) Dogs—(i) ride. Amount. For dogs 5 pounds and under, (a) Chemical name. 2-Formyl-1- 0.3 milliliter (17.0 milligrams); for 6 to methylpyridinium chloride oxime. 10 pounds, 0.5 milliliter (28.4 milli- (b) Specifications. Sterile pralidoxime grams); for 11 to 25 pounds, 1.0 milli- chloride is packaged in vials. Each vial liter (56.8 milligrams); if over 25 contains 1 gram of sterile pralidoxime Pounds, 0.2 milliliter (11.4 milligrams) chloride powder and includes directions per 5 pounds body weight to a max- for mixing this gram with 20 cubic cen- imum of 3 milliliters (170.4 milligrams). timeters of sterile water for injection (ii) Indications for use. For removal of prior to use. canine cestodes Dipylidium caninum, (c) Sponsor. See No. 000856 in Taenia pisiformis, and Echinococcus § 510.600(c) of this chapter. granulosus, and removal and control of (d) Conditions of use. (1) It is used in canine cestode Echinococcus horses, dogs, and cats as an antidote in multilocularis. the treatment of poisoning due to those pesticides and chemicals of the (iii) Limitations. For subcutaneous or organophosphate class which have intramuscular use; not intended for use anticholinesterase activity in horses, in puppies less than 4 weeks of age; dogs, and cats. Federal law restricts the drug to use by (2) It is administered as soon as pos- or on the order of a licensed veteri- sible after exposure to the poison. Be- narian. fore administration of the sterile (2) Cats—(i) Amount. For cats under 5 pralidoxime chloride, atropine is ad- pounds, 0.2 milliliter (11.4 milligrams); ministered intravenously at a dosage 5 to 10 pounds, 0.4 milliliter (22.7 milli- rate of 0.05 milligram per pound of grams); 11 pounds and over, 0.6 milli- body weight, followed by administra- liter (34.1 milligrams) maximum. tion of an additional 0.15 milligram of (ii) Indications for use. For removal of atropine per pound of body weight ad- feline cestodes Dipylidium caninum and ministered intramuscularly. Then the Taenia taeniaeformis. appropriate dosage of sterile (iii) Limitations. For subcutaneous or pralidoxime chloride is administered intramuscular injection only. Not in- slowly intravenously. The dosage rate tended for use in kittens less than 6 for sterile pralidoxime chloride when weeks of age. Federal law restricts this

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drug to use by or on the order of a li- (4) Not for use in horses intended for censed veterinarian. food. (5) Federal law restricts this drug to [46 FR 10464, Feb. 3, 1981, as amended at 47 use by or on the order of a licensed vet- FR 6617, Feb. 16, 1982; 58 FR 42853, Aug. 12, 1993; 67 FR 79853, Dec. 31, 2002] erinarian. [52 FR 23032, June 17, 1987] § 522.1881 Sterile prednisolone acetate aqueous suspension. § 522.1883 Prednisolone sodium phosphate. (a) Specifications. Each milliliter of sterile aqueous suspension contains 25 (a) Specifications. Each milliliter of milligrams of prednisolone acetate. solution contains 20 milligrams (mg) (b) Sponsor. See No. 000061 in prednisolone sodium phosphate (equiv- § 510.600(c) of this chapter. alent to 14.88 mg of prednisolone). (b) Sponsor. See No. 061623 in (c) NAS/NRC status. The conditions of § 510.600(c) of this chapter. use are NAS/NRC reviewed and found (c) Conditions of use in dogs—(1) effective. Applications for these uses Amount. Administer intravenously in a need not include effectiveness data as dosage of 2 1/2 to 5 mg per pound of specified in § 514.111 of this chapter but body weight, initially for shock and may require bioequivalency and safety shock-like states, followed by equal information. maintenance doses at 1-, 3-, 6-, or 10- (d) Conditions of use. (1) The drug is hour intervals as determined by the indicated in the treatment of dogs, condition of the animal. cats, and horses for conditions requir- (2) Indications for use. Administer ing an anti-inflammatory agent. The when a rapid adrenal glucocorticoid drug is indicated for the treatment of and/or anti-inflammatory effect is nec- acute musculoskeletal inflammations essary. such as bursitis, carpitis, and spondy- (3) Limitations. Federal law restricts litis. The drug is indicated as sup- this drug to use by or on the order of a portive therapy in nonspecific der- licensed veterinarian. matosis such as summer eczema and atopy. The drug may be used as sup- [68 FR 59881, Oct. 20, 2003] portive therapy pre- and post-opera- § 522.1884 Prednisolone sodium succi- tively and for various stress conditions nate injection. when corticosteroids are required while the animal is being treated for a spe- (a) Chemical name. 11 beta, 17, 21- cific condition. Trihydroxypregna-1, 4-diene-3, 20-dione 21-succinate sodium salt. (2) The drug is administered to horses (b) Specifications. Each milliliter of intra-articularly at a dosage level of 50 prednisolone sodium succinate injec- to 100 milligrams. The dose may be re- tion contains: Prednisolone sodium peated when necessary. If no response succinate equivalent in activity to 10, is noted after 3 or 4 days, the possi- 20, or 50 milligrams of prednisolone. bility must be considered that the con- (c) Sponsor. See No. 000009 in dition is unresponsive to prednisolone § 510.600(c) of this chapter for products therapy. The drug is administered to containing 10, 20, and 50 milligrams dogs and cats intramuscularly at a dos- equivalent prednisolone activity per age level of 10 to 50 milligrams. The milliliter for use in horses, dogs, and dosage may be repeated when nec- cats as provided in paragraphs (d)(1), essary. If the condition is of a chronic (2) (i), (ii), and (iii) of this section. nature, an oral corticosteroid may be (d) Conditions of use. (1) The drug is given as a maintenance dosage. The intended for the treatment of horses, drug may be given intra-articularly to dogs, and cats.1 dogs and cats at a dosage level of 5 to 25 milligrams. The dose may be repeated when necessary after 7 days for 1 These conditions are NAS/NRC reviewed two or three doses. and found effective. Applications for these uses need not include effectiveness data as (3) The labeling shall comply with specified by § 514.111 of this chapter, but may the requirements of § 510.410 of this require bioequivalency and safety informa- chapter for corticosteroids. tion.

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(2)(i) The dosage for horses is 50 to to 20 milligrams. Intramuscular re- 100 milligrams as an initial dose given treatment of horses in 24 to 48 hours intravenously over a period of one-half may be necessary, depending on the to 1 minute, or intramuscularly, and general condition of the animal and the may be repeated in inflammatory, al- severity and duration of the disease.1 lergic, or other stress conditions at in- (3) Clinical and experimental data tervals of 12, 24, or 48 hours, depending have demonstrated that corticosteroids upon the size of the animal, the sever- administered orally or parenterally to ity of the condition and the response to animals may induce the first stage of treatment. 1 parturition when administered late in (ii) In dogs, the drug is administered pregnancy and may precipitate pre- intravenously at a range of 2.5 to 5 mil- mature parturition followed by ligrams per pound of body weight as an dystocia, fetal death, retained pla- initial dose followed by maintenance centa, and metritis.1 doses at 1, 3, 6, or 10 hour intervals, as (4) Federal law restricts this drug to determined by the condition of the ani- use by or on the order of a licensed vet- mal, for treatment of shock. erinarian.1 (iii) In dogs and cats, the drug may [40 FR 13858, Mar. 27, 1975, as amended at 62 be given intramuscularly for treatment FR 63271, Nov. 28, 1997] of inflammatory, allergic and less severe stress conditions, where imme- § 522.1890 Sterile prednisone suspen- diate effect is not required, at 1 to 5 sion. milligrams ranging upward to 30 to 50 (a) [Reserved] milligrams in large breeds of dogs. Dos- (b)(1) Specifications. Each milliliter of age may be repeated in 12 to 24 hours sterile aqueous suspension contains 10 and continued for 3 to 5 days if nec- to 40 milligrams of prednisone. essary. If permanent corticosteroid ef- (2) Sponsor. See 000061 in § 510.600(c) of fect is required oral therapy with pred- this chapter. nisolone tablets may be substituted. (3) Conditions of use—(i) Amount. Ad- (3) Federal law restricts this drug to minister intramuscularly as follows: use by or on the order of a licensed vet- (a) Horses. 100 to 400 milligrams, re- 1 erinarian. peating if necessary. If no response is [40 FR 13858, Mar. 27, 1975, as amended at 46 observed after 3 to 4 days of therapy, FR 13215, Feb. 20, 1981; 46 FR 33513, June 30, reevaluate diagnosis.1 1981; 52 FR 25212, July 6, 1987; 66 FR 23588, (b) Dogs and cats. 0.25 to 1.0 milligram May 9, 2001] per pound of body weight for 3 to 5 days or until a response is noted. Treatment § 522.1885 Prednisolone tertiary butylacetate suspension. may be continued with an orally administered dose.1 (a) Specifications. Prednisolone ter- (ii) Indications for use. It is used for tiary butylacetate (Pregna-1,4-diene-3, conditions requiring an anti-inflam- 20-dione-11B, 17a 21-triol 21-(3,3, di- matory agent.1 methyl butyrate) suspension contains (iii) Limitations. 1 Do not use in viral 20 milligrams of prednisolone tertiary infections. Except in emergency ther- butylacetate per milliliter. It is sterile. apy, do not use in animals with tuber- (b) Sponsor. See No. 050604 in culosis, chronic nephritis, or § 510.600(c) of this chapter. Cushings’s disease. With infections, use (c) Conditions of use. (1) It is used as appropriate antibacterial therapy with an anti-inflammatory agent in horses, and for at least 3 days after discontinu- 1 dogs, and cats. ance of use and disappearance of all (2) It is administered to horses signs of infection. Clinical and experi- intramuscularly at a dosage level of 100 mental data have demonstrated that to 300 milligrams and intrasynovially at a dosage level of 50 to 100 milli- 1 grams. It is administered These conditions are NAS/NRC reviewed and deemed effective. Applications for these intramuscularly to dogs and cats at a uses need not include effectiveness data as dosage level of 1 milligram per 5 specified by § 514.111 of this chapter, but may pounds of body weight and require bioequivalency and safety informa- intrasynovially at a dosage level of 10 tion.

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corticosteroids administered orally or (1) No. 000856 for use as in paragraphs parenterally to animals may induce (c)(1)(i)(A), (c)(1)(ii), (c)(1)(iii), the first stage of parturition when ad- (c)(2)(i)(A), (c)(2)(ii), (c)(2)(iii), and ministered during the last trimester of (c)(3) of this section. pregnancy and may precipitate pre- (2) No. 021641 for use as in paragraphs mature parturition followed by (c)(1) and (c)(2) of this section. dystocia, fetal death, retained pla- (b) Related tolerances. See §§ 556.240 centa, and metritis. Not for use in and 556.540 of this chapter. horses intended for food. Federal law (c) Conditions of use in cattle. It is restricts this drug to use by or on the used for implantation as follows: order of a licensed veterinarian. (1) Suckling beef calves—(i) Amount— [45 FR 13446, Feb. 29, 1980, as amended at 50 (A) 100 milligrams (mg) progesterone FR 6160, Feb. 14, 1985; 52 FR 7832, Mar. 13, and 10 mg estradiol benzoate (one im- 1987] plant consisting of 4 pellets, each pellet containing 25 mg progesterone and § 522.1920 Prochlorperazine, 2.5 mg estradiol benzoate) per implant isopropamide for injection. dose. (a) Specifications. Prochlorperazine, (B) 100 mg progesterone and 10 mg es- isopropamide for injection, veterinary, tradiol benzoate (one implant con- contains in each milliliter, 6 milli- sisting of 5 pellets, each of 4 pellets grams of prochlorperazine edisylate containing 25 mg progesterone and 2.5 (equivalent to 4 milligrams mg estradiol benzoate, and 1 pellet con- prochlorperazine), and 0.38 milligrams taining 29 mg tylosin tartrate) per im- of isopropamide iodide (equivalent to plant dose. 0.28 milligrams of isopropamide) in (ii) Indications for use. For increased buffered aqueous solution. rate of weight gain. (b) Sponsor. See No. 000069 in (iii) Limitations. For use in suckling § 510.600(c) of this chapter. beef calves (at least 45 days of age) up (c) Conditions of use. (1) The drug is to 400 pounds (lb) of body weight. For used in dogs and cats in which gastro- subcutaneous ear implantation, one intestinal disturbances are associated dose per animal. Do not use in bull with emotional stress. calves intended for reproduction. Safe- (2) Dosage is administered by sub- ty and effectiveness have not been es- cutaneous injection twice daily as fol- tablished in veal calves. A withdrawal lows: period has not been established for this product in preruminating calves. Do Weight of animal in pounds Dosage in Milliliters not use in calves to be processed for Up to 4 ...... 0.25 veal. 5 to 14 ...... 0.5–1 (2) Steers—(i) Amount—(A) 200 mg pro- 15 to 30 ...... 2–3 gesterone and 20 mg estradiol benzoate 30 to 45 ...... 3–4 45 to 60 ...... 4–5 (one implant consisting of 8 pellets, Over 60 ...... 6 each pellet containing 25 mg progesterone and 2.5 mg estradiol benzoate) per Following the last injection, admin- implant dose. ister prochlorperazine and (B) 200 mg progesterone and 20 mg es- isopropamide sustained release cap- tradiol benzoate (one implant con- sules as indicated. sisting of 9 pellets, each of 8 pellets (3) For use only by or on the order of containing 25 mg progesterone and 2.5 a licensed veterinarian. mg estradiol benzoate, and 1 pellet con- [40 FR 13858, Mar. 27, 1975, as amended at 56 taining 29 mg tylosin tartrate) per im- FR 50653, Oct. 8, 1991; 60 FR 55659, Nov. 2, plant dose. 1995] (ii) Indications for use. For increased rate of weight gain and improved feed § 522.1940 Progesterone and estradiol efficiency. benzoate. (iii) Limitations. For animals weigh- (a) Sponsors. See sponsors in ing 400 lb or more; for subcutaneous ear § 510.600(c) of this chapter for use as in implantation, one dose per animal. paragraph (c) of this section: Safety and effectiveness have not been

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established in veal calves. A with- (ii) Indications for use. For use as a drawal period has not been established tranquilizer, preanesthetic, for minor for this product in preruminating operative procedures in conjunction calves. Do not use in calves to be proc- with local anesthesia, as adjunctive essed for veal. therapy for tetanus, and as an (3) Steers fed in confinement for slaugh- antiemetic prior to worming; or to pre- ter—(i) Amount. Reimplant 200 mg pro- vent motion sickness in dogs. gesterone and 20 mg estradiol benzoate (iii) Limitations. Federal law restricts on approximately day 70 following an this drug to use by or on the order of a initial implant of 100 mg progesterone licensed veterinarian. and 10 mg estradiol benzoate or 200 mg progesterone and 20 mg estradiol ben- [46 FR 18962, Mar. 27, 1981, as amended at 68 zoate. FR 59881, Oct. 20, 2003; 70 FR 50183, Aug. 26, 2005] (ii) Indications for use. For additional improvement in rate of weight gain. § 522.2002 Propiopromazine hydro- (iii) Limitations. For subcutaneous ear chloride injection. implantation. Safety and effectiveness have not been established in veal (a) Chemical name. 1-Propanone, 1-[10- calves. A withdrawal period has not [3-(dimethylamino) propyl] been established for this product in phenothiazine-2-yl]-, preruminating calves. Do not use in monohydrochloride. calves to be processed for veal. (b) Specifications. Propiopromazine hydrochloride injection contains 5 or 10 [69 FR 70055, Dec. 2, 2004] milligrams of the drug in each milliliter of sterile aqueous solution. § 522.1962 Promazine hydrochloride. (c) Sponsor. See No. 000856 in (a) Specifications. Each milliliter of § 510.600(c) of this chapter. solution contains 50 milligrams (mg) (d) Conditions of use. (1) It is adminis- promazine hydrochloride. tered either intravenously or (b) Sponsors. See sponsors in intramuscularly to dogs and cats for § 510.600(c) of this chapter for use as in tranquilization at a dosage level of paragraph (c) of this section: 0.05–0.5 milligram per pound of body (1) No. 000856 for use as in paragraphs weight and is also administered intra- (c)(1)(i)(A), (c)(1)(ii)(A), (c)(1)(iii), and venously to dogs and cats as a (c)(2) of this section. preanesthetic at a dosage level of 0.25 (2) No. 061623 for use as in paragraphs milligram per pound of body weight. (c)(1)(i)(B), (c)(1)(ii)(B), and (c)(1)(iii) of (2) It is not to be used in conjunction this section. with organophosphates and/or procaine (c) Conditions of use—(1) Horses—(i) hydrochloride since phenothiazines Amount—(A) 0.2 to 0.5 milligrams per may potentiate the toxicity of pounds (mg/lb) body weight organophosphates and the activity of intramuscularly or intravenously procaine hydrochloride. every 4 to 6 hours. (3) For use only by or on the order of (B) 0.2 to 0.5 mg/lb body weight intra- a licensed veterinarian. venously as required. (ii) Indications for use—(A) For use as [40 FR 13858, Mar. 27, 1975, as amended at 46 a tranquilizer, preanesthetic, or for FR 60570, Dec. 11, 1981; 61 FR 5507, Feb. 13, 1996] minor operative procedures in conjunction with local anesthesia; and as ad- § 522.2005 Propofol. junctive therapy for tetanus. (B) For use as a tranquilizer and (a) Specifications. Each milliliter of preanesthetic. emulsion contains 10 milligrams (mg) (iii) Limitations. Not for use in horses propofol. intended for food. Federal law restricts (b) Sponsors. See sponsor numbers in this drug to use by or on the order of a § 510.600(c) of this chapter. licensed veterinarian. (1) No. 059130 for use as in paragraphs (2) Dogs and cats—(i) Amount. 1 to 2 (c)(1), (c)(2)(i), and (c)(3) of this section. mg/lb body weight intramuscularly or (2) No. 000074 for use as in paragraphs intravenously every 4 to 6 hours. (c)(1), (c)(2)(i), and (c)(3) of this section.

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(3) No. 000856 for use as in paragraphs expected to lead to alleviation of some (c)(1), (c)(2)(ii), and (c)(3) of this sec- signs of disease.1 tion. (2)(i) It is administered (c) Conditions of use in dogs and cats— intramuscularly, subcutaneously, or (1) Amount. Administer by intravenous intravenously. Local injection at the injection according to label directions. site of insect bites may be indicated in The use of preanesthetic medication severe cases. Intravenous injections reduces propofol dose requirements. must be given slowly to avoid symp- (2) Indications for use—(i) As a single toms of overdosage. Dosage may be re- injection to provide general anesthesia peated every 6 to 12 hours whenever for short procedures; for induction and necessary. Horses, 40 to 60 milligrams maintenance of general anesthesia per 100 pounds body weight; foals, 20 using incremental doses to effect; for milligrams per 100 pounds body induction of general anesthesia where weight.1 maintenance is provided by inhalant (ii) It is administered intravenously. anesthetics. Intravenous injections must be given (ii) For the induction and mainte- slowly to avoid symptoms of over- nance of anesthesia and for induction dosage. Dosage may be repeated every 6 of anesthesia followed by maintenance to 12 hours if necessary. Horses, 40 to 60 with an inhalant anesthetic. milligrams per 100 pounds body weight; foals, 20 milligrams per 100 pounds [75 FR 20269, Apr. 19, 2010, as amended at 75 body weight.1 FR 38700, July 6, 2010] (3) Do not use in horses intended for food purposes.1 § 522.2012 Prostalene solution. (4) Federal law restricts this drug to (a) Specifications. Each milliliter of use by or on the order of a licensed vet- sterile solution contains 1 milligram of erinarian.1 prostalene. (b) Sponsor. No. 000856 in § 510.600(c) of [40 FR 13858, Mar. 27, 1975; 41 FR 9150, Mar. 3, 1976, as amended at 42 FR 13549, Mar. 11, 1977; this chapter. 42 FR 61256, Dec. 2, 1977; 51 FR 41477, Nov. 17, (c) Conditions of use—Horses. (1) It is 1986; 52 FR 7832, Mar. 13, 1987; 54 FR 1164, Jan. used in mares for the control of estrus. 12, 1989; 68 FR 59881, Oct. 20, 2003] (2) It is administered at a dose of 5 micrograms per kilogram of body § 522.2076 Romifidine. weight as a single subcutaneous injec- (a) Specifications. Each milliliter of tion. solution contains 10 milligrams (mg) (3) Not for use in horses intended for romifidine hydrochloride. food. (b) Sponsor. See No. 000010 in (4) Federal law restricts this drug to § 510.600(c) of this chapter. use by or on the order of a licensed vet- (c) Conditions of use in horses—(1) erinarian. Amount. 40 to 120 micrograms per kilo- [41 FR 26854, June 30, 1976, as amended at 61 gram of body weight (mcg/kg BW) in- FR 5507, Feb. 13, 1996] travenously for sedation and analgesia; 100 mcg/kg BW intravenously as a § 522.2063 Pyrilamine maleate injec- preanesthetic. tion. (2) Indications for use. For use as a (a) Specifications. The drug is a sterile sedative and analgesic to facilitate aqueous solution with each milliliter handling, clinical examinations, clin- containing 20 milligrams of pyrilamine ical procedures, and minor surgical maleate. procedures in adult horses; and for use (b) Sponsors. See No. 000061 in as a preanesthetic prior to the induc- § 510.600(c) of this chapter for uses in tion of general anesthesia in adult paragraph (c)(2)(i) of this section; see horses. No. 061623 in § 510.600(c) of this chapter for uses in paragraph (c)(2)(ii) of this 1 These conditions are NAS/NRC reviewed section. and found effective. Applications for these (c) Conditions of use. (1) It is intended uses need not include effectiveness data as specified by § 514.111 of this chapter, but may for treating horses in conditions in require bioequivalency and safety informa- which antihistaminic therapy may be tion.

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(3) Limitations. Federal law restricts longer, as required to maintain contin- this drug to use by or on the order of a ued improvement or an asymptomatic licensed veterinarian. Not for horses condition; or the drug may be used in intended for human consumption. capsule form for oral maintenance [69 FR 47363, Aug. 5, 2004] therapy. (iii) Federal law restricts this drug to § 522.2100 Selenium, vitamin E injec- use by or on the order of a licensed vet- tion. erinarian. (a)(1) Specifications. The drug is an (c)(1) Specifications. Each milliliter emulsion containing in each milliliter, contains 2.19 milligrams of selenite so- 5.48 milligrams sodium selenite (equiv- dium (equivalent to 1 milligram sele- alent to 2.5 milligrams selenium), 50 nium), 50 milligrams vitamin E (68 milligrams of vitamin E (68 I.U.) (as d- U.S.P. units). alpha tocopheryl acetate). (2) Sponsor. See No. 000061 in (2) Sponsor. See No. 000061 in § 510.600(c) of this chapter. § 510.600(c) of this chapter. (3) Conditions of use—(i) Dosage. (3) Conditions of use. (i) The drug is Calves: 2.5 to 3.75 milliliters per 100 intended for use for the prevention and pounds of body weight. Lambs 2 weeks treatment of selenium-tocopherol defi- of age or older: 1 milliliter per 40 ciency syndrome in horses. pounds, minimum 1 milliliter. Ewes: 2.5 (ii) The drug is administered by in- milliliters per 100 pounds. Sows: 1 mil- travenous or deep intramuscular injec- liliter per 40 pounds. Weanling pigs: 1 tion in divided doses in 2 or more sites milliliter per 40 pounds, minimum 1 in the gluteal or cervical muscles at a milliliter. dosage level of 1 milliliter per 100 (ii) Indications for use. Calves, lambs, pounds of body weight and may be re- and ewes: prevention and treatment of peated at 5 to 10 day intervals. white muscle disease (selenium-tocoph- (iii) Do not use in horses intended for erol deficiency syndrome). Sows and food. weanling pigs: an aid in the prevention (iv) Federal law restricts this drug to and treatment of selenium-tocopherol use by or on the order of a licensed vet- deficiency. erinarian. (b)(1) Specifications. The drug con- (iii) Limitations. For subcutaneous or tains in each milliliter 2.19 milligrams intramuscular use. Not for use in new- of sodium selenite (equivalent to 1 mil- born pigs. Do not use in pregnant ewes. ligram of selenium), 50 milligrams of Calves: Discontinue use 30 days before vitamin E (68 I.U.) (as d-alpha treated calves are slaughtered for tocopheryl acetate). human consumption. Lambs, ewes, (2) Sponsor. See No. 000061 in sows, or pigs: Discontinue use 14 days § 510.600(c) of this chapter. before treated lambs, ewes, sows, or (3) Conditions of use. (i) The drug is pigs are slaughtered for human con- intended for use as an aid in alleviating sumption. Federal law restricts this and controlling inflammation, pain and drug to use by or on the order of a li- lameness associated with certain censed veterinarian. arthropathies in dogs. (d)(1) Specifications. Each milliliter (ii) The drug is administered contains 10.95 milligrams selenite so- subcutaneously or intramuscularly in dium (equivalent to 5 milligrams sele- divided doses in 2 or more sites at a nium), 50 milligrams vitamin E (68 dosage level of 1 milliliter per 20 U.S.P. units). pounds of body weight with a minimum (2) Sponsor. See Nos. 000061 and 000856 dosage of 1⁄4 milliliter and a maximum in § 510.600(c) of this chapter. dosage of 5 milliliters. The dosage is (3) Conditions of use—(i) Dosage. repeated at 3 day intervals until a sat- Breeding beef cows: 1 milliliter per 200 isfactory therapeutic response is ob- pounds of body weight during the mid- served. A maintenance regimen is then dle third of gestation, and 30 days be- initiated which consists of 1 milliliter fore calving. Weanling calves: 1 milli- per 40 pounds of body weight with a liter per 200 pounds of body weight. minimum dosage of 1⁄4 milliliter which (ii) Indications for use. Weanling is repeated every 3 days or 7 days, or calves and breeding beef cows: For the

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prevention and treatment of selenium- pected slaughter to minimize injection tocopherol deficiency syndrome. site blemishes on carcass. There is no (iii) Limitations. For subcutaneous or milk discard or preslaughter with- intramuscular use. Discontinue use 30 drawal period. Use may reduce preg- days before treated cattle are slaugh- nancy rates and increase days open. tered for human consumption. Federal Treated cows are at an increased risk law restricts this drug to use by or on for mastitis and higher milk somatic the order of a licensed veterinarian. cell counts. Use care to differentiate (e)(1) Specifications. Each milliliter increased body temperature due to use contains 0.55 milligram selenite sodium of this product from an increased body (equivalent to 0.25 milligram sele- temperature that may occur due to ill- nium), 50 milligrams (68 U.S.P. units) ness. Cows treated with this product vitamin E. may have more enlarged hocks and dis- (2) Sponsor. See No. 000061 in orders of the foot region. Use may re- § 510.600(c) of this chapter. duce hemoglobin and hematocrit val- (3) Conditions of use—(i) Dosage. New- ues during treatment. Human warning: born lambs: 1 milliliter. Lambs 2 weeks Avoid prolonged or repeated contact of age or older: 4 milliliters. Baby pigs: with eyes and skin. 1 milliliter (or treat the sow during the [58 FR 59947, Nov. 12, 1993, as amended at 67 last week of pregnancy). FR 18085, Apr. 15, 2002; 68 FR 62006, Oct. 31, (ii) Indications for use. Lambs: for pre- 2003; 74 FR 53164, Oct. 16, 2009] vention and treatment of white muscle disease (selenium-tocopherol deficiency § 522.2120 Spectinomycin syndrome). Baby pigs: an aid in the dihydrochloride injection. prevention and treatment of selenium- (a) Specifications. The spectinomycin tocopherol deficiency. dihydrochloride pentahydrate used in (iii) Limitations. For subcutaneous or manufacturing the drug is the anti- intramuscular use only. Discontinue biotic substance produced by the use 14 days before treated animals are growth of Streptomyces flavopersicus slaughtered for human consumption. (var. Abbott) or the same antibiotic Federal law restricts this drug to use substance produced by any other by or on the order of a licensed veteri- means. Each milliliter of the drug con- narian. tains the following amount of [40 FR 13858, Mar. 27, 1975, as amended at 52 spectinomycin activity from FR 7832, Mar. 13, 1987; 57 FR 21209, May 19, spectinomycin dihydrochloride 1992; 58 FR 57556, Oct. 26, 1993; 60 FR 57833, pentahydrate: Nov. 22, 1995; 64 FR 27916, May 24, 1999] (1) 5 milligrams when used as provided in paragraph (d)(1) of this sec- § 522.2112 Sometribove zinc suspen- tion. sion. (2) [Reserved] (a) Specifications. Each single-dose sy- (3) 100 milligrams when used as pro- ringe contains 500 milligrams (mg) vided in paragraphs (d) (2), (3), and (4) sometribove zinc in a prolonged-release of this section. suspension. (b) Sponsor. In § 510.600 of this chap- (b) Sponsor. See No. 000986 in ter, see No. 059130 for conditions of use § 510.600(c) of this chapter. as in paragraph (d) of this section, and (c) Conditions of use—(1) Amount. In- see No. 000009 for conditions of use as ject 500 mg every 14 days starting dur- in paragraph (d)(2) and (d)(4) of this ing the 9th or 10th week (57 to 70 days) section. after calving and continue until the (c) Special considerations. The quan- end of lactation. tity of spectinomycin referred to in (2) Indications for use. To increase this section refers to the equivalent production of marketable milk in weight of base activity for the drug. healthy lactating dairy cows. (d) Conditions of use. It is adminis- (3) Limitations. Use in lactating dairy tered as spectinomycin dihydrochloride cows only. Safety to replacement bulls pentahydrate as follows: born to treated dairy cows has not been (1) Subcutaneously in the treatment established. Inject subcutaneously. of 1-to-3-day-old turkey poults at the Avoid injections within 2 weeks of ex- rate of 1 to 2 milligrams per poult as an

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aid in the prevention of mortality asso- in female dairy cattle 20 months of age ciated with Arizona group infection. or older. Use in this class of cattle may (2) Subcutaneously in the treatment cause residues in milk. A withdrawal of 1-to-3-day old: period has not been established for this (i) Turkey poults at the rate of 5 mil- product in preruminating calves. Do ligrams per poult as an aid in the con- not use in calves to be processed for trol of chronic respiratory disease veal. Federal law restricts this drug to (CRD) associated with E. coli. use by or on the order of a licensed vet- (ii) Baby chicks at the rate of 2.5 to erinarian. 5 milligrams per chick as an aid in the [72 FR 31178, June 6, 2007] control of mortality and to lessen severity of infections caused by M. § 522.2150 Stanozolol sterile suspen- synoviae, S. typhimurium, S. infantis, sion. and E. coli. (a) Specifications. Each milliliter of (3) Intramuscularly in the treatment sterile suspension contains 50 milli- of dogs: grams of stanozolol. (i) At a dosage level of 2.5 milligrams (b) Sponsor. No. 000009 in § 510.600(c) of to 5.0 milligrams per pound of body this chapter. weight twice daily. Treatment may be continued for 4 days. For treatment of (c) Conditions of use. (1) Used as an infections caused by gram-negative and anabolic steroid treatment in dogs, gram-positive organisms susceptible to cats, and horses. spectinomycin. (2) Administered to dogs and cats by (ii) Federal law restricts this drug to deep intramuscular injection in the use by or on the order of a licensed vet- thigh at weekly intervals, for several erinarian. weeks. For cats and small breeds of (4) Administer single injection of 0.1 dogs, 25 milligrams. For larger dogs, 50 milliliter (10 milligrams) milligrams. subcutaneously in nape of neck of 1- to (3) Administered to horses by deep 3-day-old turkey poults as an aid in intramuscular injection in the gluteal control of airsacculitis associated with region at weekly intervals, for not M. meleagridis sensitive to more than 4 weeks; 25 milligrams per spectinomycin. 100 pounds of body weight. (4) Not for use in horses intended for [40 FR 13858, Mar. 27, 1975, as amended at 43 food. FR 9273, Mar. 7, 1978; 46 FR 18964, Mar. 27, (5) Federal law restricts this drug to 1981; 47 FR 14149, Apr. 2, 1982; 61 FR 5507, Feb. use by or on the order of a licensed vet- 13, 1996; 61 FR 31028, June 19, 1996; 65 FR 45877, July 26, 2000; 66 FR 22118, May 3, 2001] erinarian. [40 FR 46101, Oct. 6, 1975, as amended at 42 FR § 522.2121 Spectinomycin sulfate. 36995, July 19, 1977; 55 FR 23076, June 6, 1990] (a) Specifications. Each milliliter of solution contains spectinomycin sul- § 522.2200 Sulfachlorpyridazine. fate tetrahydrate equivalent to 100 mil- (a) Specifications. Each milliliter of ligrams (mg) spectinomycin. solution contains sodium (b) Sponsor. See No. 000009 in sulfachlorpyridazine equivalent to 200 § 510.600(c) of this chapter. milligrams (mg) sulfachlorpyridazine. (c) Related tolerances. See § 556.600 of (b) Sponsor. See No. 000010 in this chapter. § 510.600(c) of this chapter. (d) Conditions of use in cattle—(1) (c) Related tolerances. See § 556.630 of Amount. 10 to 15 mg per kilogram of this chapter. body weight at 24-hour intervals for 3 (d) Conditions of use in calves. It is to 5 consecutive days. used as follows: (2) Indications for use. For the treat- (1) Amount. Administer 30 to 45 mg ment of bovine respiratory disease per pound (/lb) of body weight in di- (pneumonia) associated with vided doses by twice daily injection for Mannheimia haemolytica, Pasteurella 1 to 5 days. multocida, and Histophilus somni. (2) Indications for use. For the treat- (3) Limitations. Do not slaughter with- ment of diarrhea caused or complicated in 11 days of last treatment. Do not use by Escherichia coli (colibacillosis).

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(3) Limitations. Treated calves must (d) Federal law restricts this drug to not be slaughtered for food during use by or on the order of a licensed vet- treatment or for 5 days after the last erinarian. treatment. A withdrawal period has (iii) It is used or intended for use in not been established for this product in cattle as follows: preruminating calves. Do not use in (a) For the treatment of shipping calves to be processed for veal. fever complex, bacterial pneumonia, calf diphtheria, and foot-rot. [75 FR 10167, Mar. 5, 2010] (b) It is administered by intravenous injection at an initial dose of 25 milli- § 522.2220 Sulfadimethoxine injection. grams per pound of body weight fol- (a)(1) Specifications. Sulfadimethoxine lowed by 12.5 milligrams per pound of injection containing 400 milligrams per body weight every 24 hours until the milliliter. animal is asymptomatic for 48 hours. (2) Sponsor. (i) See No. 000069 in (c) Milk taken from animals during § 510.600(c) of this chapter for condi- treatment and for 60 hours (5 milkings) tions of use as in paragraphs (a)(3)(i) after the latest treatment must not be through (a)(3)(iii) of this section. used for food. Do not administer within (ii) See No. 057561 for conditions of 5 days of slaughter. A withdrawal pe- use as in paragraph (a)(3) of this sec- riod has not been established for this tion. product in preruminating calves. Do (iii) See No. 059130 for use as in para- not use in calves to be processed for graph (a)(3)(iii) of this section. veal. (3) Conditions of use. (i) It is used or (d) Tissue damage may result from intended for use in dogs and cats as fol- perivascular infiltration. lows: (b) [Reserved] (a) For the treatment of respiratory, (c)(1) Specifications. Sulfadimethoxine genitourinary tract, enteric, and soft containing 100 milligrams per milli- tissue infections when caused by liter. Streptococci, Staphylococci, Esch- (2) Sponsor. See No. 000010 in erichia, Salmonella, Klebsiella, Pro- § 510.600(c) of this chapter. teus, or Shigella organisms sensitive to (3) Conditions of use. (i) It is used or sulfadimethoxine, and in the treatment intended for use in the treatment of of canine bacterial enteritis associated sulfadimethoxine-susceptible bacterial with coccidiosis and canine Salmonel- infections in dogs. losis. (ii) It is administered by subcuta- (b) It is administered by intravenous neous, intramuscular, or intravenous or subcutaneous injection at an initial injection at an initial dose of 25 milli- dose of 55 milligrams per kilogram of grams per pound of body weight fol- body weight followed by 27.5 milli- lowed by 12.5 milligrams per pound of grams per kilogram of body weight body weight every 24 hours thereafter. every 24 hours. Continue treatment until the animal is free from symptoms for 48 hours. (c) Federal law restricts this drug to (iii) For use by or on the order of a li- use by or on the order of a licensed vet- censed veterinarian. erinarian. (d) Related tolerances. See § 556.640 of (ii) It is used or intended for use in this chapter. horses as follows: (a) For the treatment of respiratory [40 FR 13858, Mar. 27, 1975, as amended at 40 disease caused by Streptococcus equi FR 34112, Aug. 14, 1975; 40 FR 42007, Sept. 10, (strangles). 1975; 50 FR 254, Jan. 3, 1985; 53 FR 40728, Oct. 18, 1988; 54 FR 30205, July 19, 1989; 58 FR 38972, (b) It is administered by intravenous July 21, 1993; 59 FR 56000, Nov. 10, 1994; 61 FR injection at an initial dose of 55 milli- 4875, Feb. 9, 1996; 62 FR 23128, Apr. 29, 1997; 62 grams per kilogram of body weight fol- FR 35076, June 30, 1997; 70 FR 16935, Apr. 4, lowed by 27.5 milligrams per kilogram 2005] of body weight every 24 hours until the patient is asymptomatic for 48 hours. § 522.2240 Sulfaethoxypyridazine. (c) Not for use in horses intended for (a) Chemical name. N1-(6-Ethoxy-3- food. pyridazinyl) sulfanilamide.

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(b) Specifications. Melting point range acute mastitis and acute metritis of 180 °C to 186 °C. (Streptococcus spp.) when caused by one (c) Sponsor. See No. 053501 in or more pathogenic organisms sen- § 510.600(c) of this chapter. sitive to sulfamethazine. (d) Related tolerances. See § 556.650 of (3) Limitations. For intravenous use this chapter. only. Not for use in lactating dairy ani- (e) Conditions of use. It is used for in- mals. Withdraw medication from cattle jection into cattle as follows: 10 days prior to slaughter for food. If (1) Amount. 2.5 grams per 100 pounds symptoms persist for 2 or 3 days, con- of body weight per day. sult a veterinarian. Adequate water in- (2) Indications for use. Treatment of take is important for animals treated respiratory infection (pneumonia, shipping fever), foot rot, calf scours; as ad- with sulfonamides. Treatment should junctive therapy in septicemia accom- continue 24 to 48 hours beyond the re- panying mastitis and metritis. mission of disease symptoms, but not (3) Limitations. Administer intra- to exceed a total of 5 consecutive days. venously for not more than 4 days; or [46 FR 62055, Dec. 22, 1981, as amended at 67 first treatment may be followed by 3 FR 78355, Dec. 24, 2002; 75 FR 10167, Mar. 5, days of treatment with 2010] sulfaethoxypyridazine in drinking water or tablets in accordance with § 522.2340 Sulfomyxin. §§ 520.2240a(e) and 520.2240b(e) of this (a) Specifications. Sulfomyxin for in- chapter; as sodium jection is sterile. It is derived from the sulfaethoxypyridazine; do not treat antibiotic substance produced by the within 16 days of slaughter; as sole growth of Bacillus polymyxa or is the source of sulfonamide; milk that has same substance produced by any other been taken from animals during treat- means. ment and for 72 hours (6 milkings) after (b) Sponsor. See No. 000069 in the latest treatment must not be used § 510.600(c) of this chapter. for food. Federal law restricts this drug to use by or on the order of a licensed (c) Special considerations. The quan- veterinarian. tities of antibiotic in paragraph (e) of this section refer to the activity of the [40 FR 13858, Mar. 27, 1975, as amended at 41 appropriate standard. FR 11011, Mar. 15, 1976; 67 FR 78355, Dec. 24, 2002; 76 FR 17027, Mar. 28, 2011] (d) Related tolerances. See § 556.700 of this chapter. § 522.2260 Sulfamethazine. (e) Conditions of use. (1) It is used or (a) Specifications. Each milliliter of intended for use in chickens and tur- solution contains 250 milligrams keys as an aid in the treatment of dis- sulfamethazine sodium. ease caused or complicated by E. coli, (b) Sponsor. See No. 000010 in such as colibacillosis and complicated § 510.600(c) of this chapter. chronic respiratory disease. (c) Related tolerances. See § 556.670 of (2) It is administered by subcuta- this chapter. neous injection as follows: (d) Conditions of use in cattle—(1) Amount. 20 milliliters for each 50 Antibiotic activity pounds of body weight (100 milligrams Age of birds in days Chickens Turkeys per pound) initially; 20 milliliters per (units) (units) 100 pounds of body weight (50 milli- 1 to 14 ...... 12,500 12,500 grams per pound) daily, thereafter. 15 to 28 ...... 25,000 25,000 (2) Indications for use. For cattle for 29 to 63 ...... 50,000 50,000 treatment of bacterial pneumonia and Over 63 ...... 50,000 100,000 bovine respiratory disease complex (shipping fever complex) (Pasteurella (3) A second injection may be given 3 spp.), colibacillosis (bacterial scours) days later if symptoms persist. (Escherichia coli), necrotic (4) Not for use in laying hens; do not pododermatitis (foot rot) treat chickens within 5 days of slaugh- (Fusobacterium necrophorum), calf diph- ter; do not treat turkeys within 7 days theria (Fusobacterium necrophorum), of slaughter.

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§ 522.2404 Thialbarbitone sodium for (i) Dogs and cats: 8 milligrams per injection. pound of body weight (when used with (a) Specifications. Thialbarbitone so- a preanesthetic, generally one-half the dium for injection when reconstituted normal dose). with sterile distilled water provides 94 (ii) Swine: 40 milligrams per 5 pounds milligrams of thialbarbitone sodium of body weight. per milliliter of solution. (iii) Horses: Light anesthesia, 1 gram (b) Sponsor. See No. 000856 in per 500 pounds to 1,100 pounds of body § 510.600(c) of this chapter. weight; deep anethesia, 1 gram per 300 (c) Conditions of use. (1) The drug is pounds of body weight (40 milligrams administered as a general anesthetic in per 12 pounds of body weight). surgical procedures on dogs, cats, (iv) Cattle: Short duration, 20 milli- swine, sheep, cattle, and horses. The grams per 5 pounds of body weight; drug is used for procedures of rel- longer duration, 40 milligrams per 7 atively short duration. However, the pounds of body weight. period of anesthesia can be lengthened (3) Federal law restricts this drug to by slower initial injection and supple- use by or on the order of a licensed vet- mental administration during surgery. erinarian. (2) It is administered intravenously. (4) NAS/NRC status: The conditions The drug is injected slowly to dogs, of use specified in this paragraph are cats, cattle, sheep, and swine. For NAS/NRC reviewed and found effective. horses, it is recommended that a pre- Applications for these uses need not in- anesthetic sedation be administered to clude effectiveness data as specified in the horse 30 minutes before the drug is § 514.111 of this chapter, but may re- administered. The drug is then injected quire bioequivalency and safety infor- rapidly and completely. The drug is mation. used at the following dosage levels: [40 FR 25812, June 19, 1975, as amended at 49 Weight of animal Dosage in FR 8434, Mar. 7, 1984; 53 FR 23390, June 22, Species milligrams 1988; 53 FR 40728, Oct. 18, 1988; 62 FR 35076, in pounds per pound June 30, 1997] Dog ...... Over 50 ...... 14.1 Do ...... 30–50 ...... 18.8 § 522.2444 Sodium thiopental implan- Do ...... 10–30 ...... 23.5 tation or injectable dosage forms. Do ...... Under 10 ...... 28.2 Cat ...... 31.3–37.6 Horse ...... 6.3–7.8 § 522.2444a Sodium thiopental for in- Cattle and swine ...... 6.7–9.4 jection. Calves and sheep ...... 9.4–11.8 (a) Specifications. The drug contains (3) Federal law restricts this drug to sodium thiopental sterile powder for use by or on the order of a licensed vet- dilution with sterile water for injec- erinarian. tion. (b) Sponsor. See No. 000856 in § 522.2424 Sodium thiamylal for injec- § 510.600(c) of this chapter. tion. (c) Conditions of use. (1) It is used as (a) Specifications. The drug is a sterile an anesthetic for intravenous adminis- dry powder. It is reconstituted tration to dogs and cats during short to aseptically with sterile distilled water, moderately long surgical and other water for injection, or sodium chloride procedures. It is also used to induce an- injection, to a desired concentration of esthesia in dogs and cats which then 0.5 to 4 percent sodium thiamylal. have surgical anesthesia maintained by (b) Sponsors. See code Nos. 000010 and use of a volatile anesthetic. 000856 in § 510.500(c) of this chapter. (2) It is administered as follows: (c) Conditions of use. (1) It is used as (i) For brief anesthesia (6 to 10 min- an ultra-short-acting anesthetic in utes) a dosage of 6 to 9 milligrams per dogs, cats, swine, horses, and cattle. pound of body weight is suggested. (2) When diluted aseptically to the (ii) To obtain anesthesia of 15 to 25 desired concentration and adminis- minutes duration the suggested dosage tered intravenously to effect, the aver- is 10 to 12 milligrams per pound of body age single dose is: weight.

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(iii) Use of a preanesthetic tranquil- milligrams of zolazepam base per milli- izer or morphine will decrease the dos- liter of solution. age of sodium thiopental required, pro- (b) Sponsor. See No. 000856 in vide for smoother induction and § 510.600(c) of this chapter. smoother recovery, and sometimes pro- (c) Conditions of use—(1) Indications long the recovery period. If morphine is for use. It is used for restraint or for used as a preanesthetic agent the dose anesthesia combined with muscle re- of the barbiturate can be reduced as laxation in cats and in dogs for re- much as 40 to 50 percent. When a tran- straint and minor procedures of short quilizer is administered the barbitu- duration (30 minutes) requiring mild to rate dosage can be reduced 10 to 25 per- moderate analgesia. cent. (2) Amount. Expressed as milligrams (3) Federal law restricts this drug to of the drug combination: use by or on the order of a licensed vet- (i) In healthy dogs: An initial erinarian. intramuscular dosage of 3 to 4.5 milligrams per pound of body weight for di- § 522.2444b Sodium thiopental, sodium agnostic purposes; 4.5 to 6 milligrams pentobarbital for injection. per pound of body weight for minor (a) Specifications. Each gram of the procedures of short duration such as drug contains 750 milligrams of sodium repair of lacerations and wounds, cas- thiopental and 250 milligrams of so- trations, and other procedures requir- dium pentobarbital sterile powder for ing mild to moderate analgesia. Sup- dilution with sterile water for injec- plemental doses when required should tion. be less than the initial dose and the (b) Sponsor. See No. 061623 in total dose given should not exceed 12 § 510.600(c) of this chapter. milligrams per pound of body weight. (c) Conditions of use. (1) It is used as The maximum total safe dose is 13.6 an anesthetic for intravenous adminis- milligrams per pound of body weight. tration to dogs and cats during short to (ii) In healthy cats: An initial moderately long surgical procedures. intramuscular dosage of 4.4 to 5.4 milli- (2) It is administered as follows: grams per pound of body weight is rec- (i) For total anesthesia, it is given at ommended for such procedures as den- approximately 10 to 12 milligrams per tistry, treatment of abscesses, foreign pound of body weight over a period of body removal, and related types of sur- 3.5 to 5 minutes. gery; 4.8 to 5.7 milligrams per pound of (ii) When preanesthetic medication is body weight for minor procedures re- used, it is important to wait at least an quiring mild to moderate analgesia, hour before administering thiopental such as repair of lacerations, castra- and sodium pentobarbital for injection, tions, and other procedures of short du- and the dosage necessary for anes- ration. Initial dosages of 6.5 to 7.2 mil- thesia is reduced. Usually 1⁄2 to 2⁄3 the ligrams per pound of body weight are normal amount is adequate. recommended for ovariohysterectomy (3) Federal law restricts this drug to and onychectomy. When supplemental use by or on the order of a licensed vet- doses are required, such individual sup- erinarian. plemental doses should be given in in- [40 FR 13858, Mar. 27, 1975, as amended at 47 crements that are less than the initial FR 14149, Apr. 2, 1982; 66 FR 14073, Mar. 9, dose and the total dose given (initial 2001; 68 FR 4915, Jan. 31, 2003] dose plus supplemental doses) should not exceed the maximum allowable § 522.2470 Tiletamine hydrochloride safe dose of 32.7 milligrams per pound and zolazepam hydrochloride for of body weight. injection. (3) Limitations. Discard unused recon- (a) Specifications. Tiletamine hydro- stituted solution after 48 hours. Not for chloride and zolazepam hydrochloride use in dogs and cats with pancreatic for injection when reconstituted with disease, or with severe cardiac or pul- sterile distilled water provides monary dysfunction. Not for use in tiletamine hydrochloride and pregnant animals. Not for use in cats zolazepam hydrochloride equivalent to suffering with renal insufficiency. The 50 milligrams of tiletamine base and 50 dosage should be reduced in geriatric

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dogs and cats. Federal law restricts (b) Sponsor. See No. 061690 in this drug to use by or on the order of a § 510.600(c) of this chapter. licensed veterinarian. (c) Conditions of use. It is used as fol- [47 FR 15328, Apr. 9, 1982, as amended at 51 lows: FR 24142, July 2, 1986; 67 FR 67521, Nov. 6, (1) Horses—(i) Amount. Administer 2002] slowly by intravenous injection 4 milligrams per kilogram of body weight or § 522.2471 Tilmicosin. 1.8 milligrams per pound (4 milliliters (a) Specifications. Each milliliter of per 100 kilograms or 4 milliliters per solution contains 300 milligrams (mg) 220 pounds). tilmicosin base as tilmicosin phos- (ii) Indications for use. For use in phate. horses when it is desirable to reverse (b) Sponsor. See No. 000986 in the effects of sedation and analgesia § 510.600(c) of this chapter. caused by xylazine. (c) Related tolerances. See § 556.735 of (iii) Limitations. The safety of this chapter. TolazineTM has not been established in (d) Special considerations. (1) Not for pregnant mares, lactating mares, human use. Use of this antibiotic in horses intended for breeding, foals, or humans may prove fatal. Do not use in horses with metabolically unstable automatically powered syringes. conditions. The safety of TolazineTM (2) Federal law restricts this drug to has not been evaluated for reversing use by or on the order of a licensed vet- xylazine used as a preanesthetic to a erinarian. general anesthetic. This drug is for use (e) Conditions of use—(1) Cattle—(i) in horses only and not for use in food- Amount. 10 to 20 milligrams per kilo- producing animals. Users with cardio- grams (mg/kg) of body weight as a sin- vascular disease (for example, hyper- gle subcutaneous injection. tension or ischemic heart disease) (ii) Indications for use. For the treat- should take special precautions to ment of bovine respiratory disease avoid accidental exposure to this prod- (BRD) associated with Mannheimia uct. haemolytica, Pasteurella multocida, and Accidental spillage on the skin should Histophilus somni. For the control of be washed off immediately with soap respiratory disease in cattle at high and water. Federal law restricts this risk of developing BRD associated with drug to use by or on the order of a li- M. haemolytica. censed veterinarian. (iii) Limitations. Do not use in female (2) [Reserved] dairy cattle 20 months of age or older. Use of this antibiotic in this class of [61 FR 25785, May 23, 1996] cattle may cause milk residues. Do not slaughter within 42 days of last treat- § 522.2476 Trenbolone acetate. ment. (a) Sponsors. See sponsors in (2) Sheep—(i) Amount. 10 mg/kg body § 510.600(c) of this chapter for use as in weight as a single subcutaneous injec- paragraph (d) of this section. tion. (1) No. 021641 for use as in paragraph (ii) Indications for use. For the treat- (c) of this section. ment of ovine respiratory disease (2) No. 000061 for use as in paragraphs (ORD) associated with Mannheimia (P.) (c)(1)(i)(A), (c)(1)(ii), (c)(1)(iii), haemolytica. (c)(2)(i)(A), (c)(2)(ii), and (c)(2)(iii) of (iii) Limitations. Do not slaughter this section. within 28 days of last treatment. (b) Related tolerances. See § 556.739 of [67 FR 72367, Dec. 5, 2002, as amended at 75 this chapter. FR 9334, Mar. 2, 2010] (c) Conditions of use—(1) Steers fed in confinement for slaughter—(i) Amount. § 522.2474 Tolazoline hydrochloride in- Use 126 days prior to slaughter; should jection. be reimplanted once after 63 days. (a) Specifications. Each milliliter of (A) 140 milligrams (mg) trenbolone sterile aqueous solution contains acetate (one implant consisting of 7 tolazoline hydrochloride equivalent to pellets, each pellet containing 20 mg 100 milligrams of base activity. trenbolone acetate) per implant dose.

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(B) 140 mg trenbolone acetate (one (2) No. 000061 for use as in paragraphs implant consisting of 8 pellets, each of (d)(1)(i)(A), (d)(1)(i)(C), (d)(1)(i)(D), 7 pellets containing 20 milligrams (d)(1)(i)(G), (d)(1)(ii), (d)(1)(iii), trenbolone acetate, and 1 pellet con- (d)(2)(i)(A), (d)(2)(i)(C), (d)(2)(i)(D), taining 29 mg tylosin tartrate) per im- (d)(2)(ii), (d)(2)(iii), (d)(3)(i)(A), plant dose. (d)(3)(ii), and (d)(3)(iii) of this section. (ii) Indications for use. For improved (3) No. 000856 for use as in paragraphs feed efficiency. (d)(1)(i)(A), (d)(1)(i)(D), (d)(1)(ii), (iii) Limitations. Implant (d)(1)(iii), (d)(3)(i)(A), (d)(3)(ii), and subcutaneously in ear only. Do not use (d)(3)(iii) of this section. in animals intended for subsequent (d) Conditions of use—(1) Steers fed in breeding or in dairy animals. Safety confinement for slaughter—(i) Amount. and effectiveness have not been estab- (A) 120 milligrams (mg) trenbolone ace- lished in veal calves. A withdrawal pe- tate and 24 mg estradiol (one implant riod has not been established for this product in preruminating calves. Do consisting of 6 pellets, each pellet con- not use in calves to be processed for taining 20 mg trenbolone acetate and 4 veal. mg estradiol) per implant dose. (2) Heifers fed in confinement for (B) 120 mg trenbolone acetate and 24 slaughter—(i) Amount. Use last 63 days mg estradiol (one implant consisting of prior to slaughter. 7 pellets, each of 6 pellets containing 20 (A) 200 mg trenbolone acetate (one mg trenbolone acetate and 4 mg estra- implant consisting of 10 pellets, each diol, and 1 pellet containing 29 mg pellet containing 20 mg trenbolone ace- tylosin tartrate) per implant dose. tate) per implant dose. (C) 200 mg trenbolone acetate and 20 (B) 200 mg of trenbolone acetate (one mg estradiol (one implant consisting of implant consisting of 11 pellets, each of 10 pellets, each pellet containing 20 mg 10 pellets containing 20 mg of trenbolone acetate and 2 mg estradiol) trenbolone acetate, and 1 pellet con- per implant dose. taining 29 mg of tylosin tartrate) per (D) 80 mg trenbolone acetate and 16 implant dose. mg estradiol (one implant consisting of (ii) Indications for use. For increased 4 pellets, each pellet containing 20 mg rate of weight gain and improved feed trenbolone acetate and 4 mg estradiol) efficiency. per implant dose. (iii) Limitations. Implant (E) 200 mg trenbolone acetate and 20 subcutaneously in ear only. Do not use mg estradiol (one implant consisting of in animals intended for subsequent 11 pellets, each of 10 pellets containing breeding or in dairy animals. Safety 20 mg trenbolone acetate and 2 mg es- and effectiveness have not been estab- tradiol, and 1 pellet containing 29 mg lished in veal calves. A withdrawal pe- tylosin tartrate) per implant dose. riod has not been established for this product in preruminating calves. Do (F) 80 mg trenbolone acetate and 16 not use in calves to be processed for mg estradiol (one implant consisting of veal. 5 pellets, each of 4 pellets containing 20 mg trenbolone acetate and 4 mg estra- [66 FR 47961, Sept. 17, 2001, as amended at 69 diol, and 1 pellet containing 29 mg FR 70056, Dec. 2, 2004; 74 FR 61517, Nov. 25, tylosin tartrate) per implant dose. 2009] (G) 200 milligram (mg) trenbolone ac- § 522.2477 Trenbolone acetate and es- etate and 40 mg estradiol (one implant tradiol. consisting of 10 pellets, each pellet con- (a) [Reserved] taining 20 mg trenbolone acetate and 4 (b) Sponsors. See sponsors in mg estradiol) per implant dose. § 510.600(c) of this chapter for uses as in (ii) Indications for use. For increased paragraph (d) of this section. rate of weight gain and improved feed (1) No. 021641 for use as in paragraphs efficiency. (d)(1)(i)(A), (d)(1)(i)(B), (d)(1)(i)(C), (iii) Limitations. Implant (d)(1)(i)(D), (d)(1)(i)(E), (d)(1)(i)(F), subcutaneously in ear only. Do not use (d)(1)(ii), (d)(1)(iii), (d)(2), and (d)(3) of in animals intended for subsequent this section. breeding or in dairy animals. Safety

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and effectiveness have not been estab- product in preruminating calves. Do lished in veal calves. A withdrawal pe- not use in calves to be processed for riod has not been established for this veal. product in preruminating calves. Do (3) Pasture cattle (slaughter, stocker, not use in calves to be processed for and feeder steers and heifers)—(i) veal. Amount. (A) 40 mg trenbolone acetate (2) Heifers fed in confinement for and 8 mg estradiol (one implant con- slaughter—(i) Amount. (A) 140 mg sisting of 2 pellets, each pellet con- trenbolone acetate and 14 mg estradiol taining 20 mg trenbolone acetate and 4 (one implant consisting of 7 pellets, mg estradiol) per implant dose. each pellet containing 20 mg (B) 40 mg trenbolone acetate and 8 trenbolone acetate and 2 mg estradiol) mg estradiol (one implant consisting of per implant dose for use as in para- 3 pellets, each of 2 pellets containing 20 graph (d)(2)(ii)(A) of this section. mg trenbolone acetate and 4 mg estra- (B) 140 mg trenbolone acetate and 14 diol, and 1 pellet containing 29 mg mg estradiol (one implant consisting of tylosin tartrate) per implant dose. 8 pellets, each of 7 pellets containing 20 (ii) Indications for use. For increased mg trenbolone acetate and 2 mg estra- rate of weight gain. diol, and 1 pellet containing 29 mg (iii) Limitations. Implant tylosin tartrate) per implant dose for subcutaneously in ear only. Do not use use as in paragraphs (d)(2)(ii)(A) of this in animals intended for subsequent section. breeding or in dairy animals. Safety (C) 80 mg trenbolone acetate and 8 and effectiveness have not been estab- mg estradiol (one implant consisting of lished in veal calves. A withdrawal pe- 4 pellets, each pellet containing 20 mg riod has not been established for this trenbolone acetate and 2 mg estradiol) product in preruminating calves. Do per implant dose for use as in para- not use in calves to be processed for graph (d)(2)(ii)(B) of this section. veal. (D) 200 mg trenbolone acetate and 20 mg estradiol (one implant consisting of [60 FR 4376, Jan. 23, 1995] 10 pellets, each pellet containing 20 mg EDITORIAL NOTE: For FEDERAL REGISTER ci- trenbolone acetate and 2 mg estradiol) tations affecting § 522.2477, see the List of per implant dose for use as in para- CFR Sections Affected, which appears in the graph (d)(2)(ii)(A) of this section. Finding Aids section of the printed volume (E) 80 mg trenbolone acetate and 8 and at www.fdsys.gov. mg estradiol (one implant consisting of 5 pellets, each of 4 pellets containing 20 § 522.2478 Trenbolone acetate and estradiol benzoate. mg trenbolone acetate and 2 mg estradiol, and 1 pellet containing 29 mg (a) Specifications. Each implant dose tylosin tartrate) per implant dose for consists of: use as in paragraph (d)(2)(ii)(B) of this (1) 8 pellets, each pellet containing 25 section. milligrams (mg) trenbolone acetate (F) 200 mg trenbolone acetate and 20 and 3.5 mg estradiol benzoate. mg estradiol (one implant consisting of (2) 4 pellets, each pellet containing 25 11 pellets, each of 10 pellets containing mg trenbolone acetate and 3.5 mg es- 20 mg trenbolone acetate and 2 mg estradiol benzoate. tradiol, and 1 pellet containing 29 mg (b) Sponsor. See No. 000856 in tylosin tartrate) per implant dose. § 510.600(c) of this chapter. (ii) Indications for use. (A) For in- (c) Related tolerances. See §§ 556.240 creased rate of weight gain and im- and 556.739 of this chapter. proved feed efficiency. (d) Conditions of use—(1) Steers fed in (B) For increased rate of weight gain. confinement for slaughter. (i) For an im- (iii) Limitations. Implant plant as described in paragraph (a)(1) of subcutaneously in ear only. Do not use this section: in animals intended for subsequent (A) Amount. 200 mg trenbolone ace- breeding or in dairy animals. Safety tate and 28 mg estradiol benzoate. and effectiveness have not been estab- (B) Indications for use. For increased lished in veal calves. A withdrawal pe- rate of weight gain and improved feed riod has not been established for this efficiency.

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(C) Limitations. Implant around the lesion, spaced 0.5 to 2.5 cen- subcutaneously in ear only. Safety and timeters apart, depending on lesion effectiveness have not been established size. At any one site, the dose injected in veal calves. A withdrawal period has should not exceed 0.6 mg. and should be not been established for this product in well into the cutis to prevent rupture preruminating calves. Do not use in of the epidermis. When treating ani- calves to be processed for veal. mals with multiple lesions, do not ex- (ii) For an implant as described in ceed a total dose of 6 mg. paragraph (a)(2) of this section: (C) Intra-articular and intrasynovial. (A) Amount. 100 mg trenbolone ace- Administer 1 to 3 mg as a single injec- tate and 14 mg estradiol benzoate. tion, depending on the size of the joint (B) Indications for use. For increased and severity of symptoms. After 3 or 4 rate of weight gain. days, repeat dosage if indicated. If ini- (C) Limitations. Implant tial results are inadequate or too tran- subcutaneously in ear only. Safety and sient, dosage may be increased, not to effectiveness have not been established exceed 3 mg. in veal calves. A withdrawal period has not been established for this product in (ii) Indications for use. For the treat- preruminating calves. Do not use in ment of inflammation and related dis- calves to be processed for veal. orders, and the management and treat- (2) Heifers fed in confinement for ment of acute arthritis and allergic slaughter—(i) Amount. 200 mg and dermatologic disorders. trenbolone acetate and 28 mg estradiol (iii) Limitations. Federal law restricts benzoate (as described in paragraph this drug to use by or on the order of a (a)(1) of this section). licensed veterinarian. (ii) Indications for use. For increased (2) Horses—(i) Amount—(A) rate of weight gain. Intramuscular or subcutaneous. Admin- (iii) Limitations. Implant ister 0.01 to 0.02 mg/lb of body weight as subcutaneously in ear only. Not for a single injection. Usual dose is 12 to 20 subsequent breeding dairy or beef re- mg. placement heifers. Safety and effec- (B) Intra-articular and intrasynovial. tiveness have not been established in Administer 6 to 18 mg as a single injec- veal calves. A withdrawal period has tion, depending on the size of the joint not been established for this product in and severity of symptoms. After 3 or 4 preruminating calves. Do not use in days, repeat dosage if indicated. If ini- calves to be processed for veal. tial results are inadequate or too tran- [67 FR 78972, Dec. 27, 2002, as amended at 69 sient, dosage may be increased, not to FR 67818, Nov. 22, 2004] exceed 18 mg. (ii) Indications for use. For the treat- § 522.2483 Triamcinolone. ment of inflammation and related dis- (a) Specifications. Each milliliter of orders. suspension contains 2 or 6 milligrams (iii) Limitations. Do not use in horses (mg) triamcinolone acetonide. intended for human consumption. Fed- (b) Sponsor. See No. 000010 in eral law restricts this drug to use by or § 510.600(c) of this chapter. on the order of a licensed veterinarian. (c) Conditions of use—(1) Dogs and cats—(i) Amount—(A) Intramuscular or [75 FR 10167, Mar. 5, 2010] subcutaneous. For inflammatory, ar- § 522.2582 Triflupromazine hydro- thritic, or allergic disorders, admin- chloride injection. ister 0.05 to 0.1 mg per pound (/lb) of body weight as a single injection. For (a) Specifications. Triflupromazine hy- dermatologic disorders, administer 0.1 drochloride injection contains 20 milli- mg per pound (/lb) of body weight as a grams of triflupromazine hydrochloride single injection. If symptoms recur, the in each milliliter of sterile aqueous so- dose may be repeated, or oral lution. corticosteroid therapy may be insti- (b) Sponsor. See No. 053501 in tuted. § 510.600(c) of this chapter. (B) Intralesional. Administer 1.2 to 1.8 (c) Conditions of use. (1) The drug is mg, divided in several injections used in dogs, cats, and horses to relieve

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anxiety and to help control psycho- in paragraph (a)(1) of this section (40 motor overactivity as well as to in- mg trimethoprim and 200 mg sulfa- crease the tolerance of animals to pain diazine) per 20 pounds (9 kilograms) of and pruritus. The drug is indicated in body weight per day by subcutaneous various office and clinical procedures injection. which require the aid of a tranquilizer, (ii) Indications for use. For the treat- antiemetic, or preanesthetic.1 ment of acute urinary tract infections, (2) The drug is administered to dogs acute bacterial complications of dis- either intravenously at a dosage level temper, acute respiratory tract infec- of 0.5 to 1 milligram per pound of body tions, acute alimentary tract infec- weight daily, or intramuscularly at a tions, and acute septicemia due to dosage level of 1 to 2 milligrams per Streptococcus zooepidemicus. pound of body weight daily. It is ad- (2) Horses—(i) Amount. 2 mL of the ministered to cats intramuscularly at product described in paragraph (a)(2) of a dosage level of 2 to 4 milligrams per this section (160 mg trimethoprim and pound of body weight daily. It is ad- 800 mg sulfadiazine) per 100 pounds (45 ministered to horses intravenously or kilograms) of body weight per day by intramuscularly at a dosage level of 10 intravenous injection as single, daily to 15 milligrams per 100 pounds of body dose for 5 to 7 days. The daily dose may weight daily to a maximum dose of 100 also be halved and given morning and milligrams. 1 evening. (3) Not for use in horses intended for (ii) Indications for use. For use where food. 1 systemic antibacterial action against (4) Do not use in conjunction with sensitive organisms is required during organophosphates and/or procaine hy- treatment of acute strangles, res- drochloride, because phenothiazines piratory tract infections, acute uro- may potentitate the toxicity of genital infections, and wound infec- organophosphates and the activity of tions and abscesses. procaine hydrochloride. 1 (iii) Limitations. Not for use in horses (5) Federal law restricts this drug to intended for human consumption. use by or on the order of a licensed vet- [71 FR 30803, May 31, 2006] erinarian.1 § 522.2615 Tripelennamine hydro- [40 FR 13858, Mar. 27, 1975, as amended at 50 chloride injection. FR 41490, Oct. 11, 1985] (a) Specifications. Each milliliter of § 522.2610 Trimethoprim and sulfa- aqueous solution contains 20 milli- diazine. grams of tripelennamine hydro- (a) Specifications. Each milliliter chloride. (mL) contains: (b) Sponsor. See Nos. 053501 and 059130 (1) 40 milligrams (mg) trimethoprim in § 510.600(c) of this chapter. suspended in a solution containing 200 (c) Related tolerances. See § 556.741 of mg sulfadiazine; or this chapter. (2) 80 mg trimethoprim suspended in (d) Conditions of use—(1) Amount—(i) a solution containing 400 mg sulfa- Dogs, cats, and horses. For diazine (as the sodium salt). intramuscular use only at a dose of 0.5 (b) Sponsors. See Nos. 000061 and milligram per pound of body weight. 000856 in § 510.600(c) of this chapter. (ii) Cattle. Administer intravenously (c) Special considerations. Federal law or intramuscularly at a dose of 0.5 mil- restricts this drug to use by or on the ligram per pound of body weight. order of a licensed veterinarian. (2) Indications for use. For use in (d) Conditions of use—(1) Dogs—(i) treating conditions in which antihis- Amount. 1 mL of the product described taminic therapy may be expected to lead to alleviation of some signs of disease. 1 These conditions are NAS/NRC reviewed (3) Limitations. Do not use in horses and are deemed effective. Applications for these uses need not include the effectiveness intended for food purposes. Treated data specified by § 514.111 of this chapter, but cattle must not be slaughtered for food may require bioequivalency and safety infor- during treatment and for 4 days fol- mation. lowing the last treatment. Milk that

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has been taken during treatment and pleuropneumoniae, P. multocida, for 24 hours (two milkings) after the Bordetella bronchiseptica, Haemophilus last treatment must not be used for parasuis, and Mycoplasma food. A withdrawal period has not been hyopneumoniae; and for the control of established for this product in SRD associated with A. preruminating calves. Do not use in pleuropneumoniae, P. multocida, and M. calves to be processed for veal. Federal hyopneumoniae in groups of pigs where law restricts this drug to use by or on SRD has been diagnosed. the order of a licensed veterinarian. (iii) Limitations. Swine intended for [51 FR 44450, Dec. 10, 1986, as amended at 61 human consumption must not be FR 29480, June 11, 1996; 62 FR 4164, Jan. 29, slaughtered within 5 days from the last 1997] treatment. Federal law restricts this drug to use by or on the order of a li- § 522.2630 Tulathromycin. censed veterinarian. (a) Specifications. Each milliliter of [70 FR 39918, July 12, 2005, as amended at 71 solution contains 100 milligrams (mg) FR 57416, Sept. 29, 2006; 72 FR 54540, Sept. 26, tulathromycin. 2007; 73 FR 6018, Feb. 1, 2008; 73 FR 58872, Oct. (b) Sponsor. See No. 000069 in 8, 2008; 74 FR 53165, Oct. 16, 2009] § 510.600(c) of this chapter. (c) Related tolerances. See § 556.745 of § 522.2640 Tylosin. this chapter. (a) Specifications. Each milliliter of (d) Conditions of use—(1) Beef and non- sterile solution of 50 percent propylene lactating dairy cattle—(i) Amount. 2.5 mg glycol with 4 percent benzyl alcohol per kilogram (/kg) body weight as a contains 50 to 200 milligrams of tylosin single subcutaneous injection in the activity (as tylosin base). Tylosin con- neck. forms to the appropriate antibiotic (ii) Indications for use. For the treat- standard. Tylosin contains at least 95 ment of bovine respiratory disease percent tylosin as a combination of (BRD) associated with Mannheimia tylosin A, tylosin B, tylosin C, and haemolytica, Pasteurella multocida, tylosin D of which at least 80 percent is Histophilus somni, and Mycoplasma bovis. tylosin A as determined by a method For the control of respiratory disease entitled Determination of Factor Con- in cattle at high risk of developing ‘‘ tent in Tylosin by High Performance BRD associated with M. haemolytica, P. Liquid Chromatography, which is in- multocida, H. somni, and M. bovis. For ’’ corporated by reference. Copies are the treatment of infectious bovine available from the Division of Dockets keratoconjunctivitis associated with Management (HFA–305), Food and Drug Moraxella bovis. For the treatment of Administration, 5630 Fishers Lane, rm. bovine foot rot (interdigital 1061, Rockville, MD 20852, or at the Na- necrobacillosis) associated with tional Archives and Records Adminis- Fusobacterium necrophorum and tration (NARA). For information on Porphyromonas levii. the availability of this material at (iii) Limitations. Cattle intended for NARA, call 202–741–6030, or go to: http:// human consumption must not be www.archives.gov/federal register/ slaughtered within 18 days from the l code of federal regulations/ last treatment. Do not use in female l l l ibr locations.html. dairy cattle 20 months of age or older. l A withdrawal period has not been es- (b) Sponsors. (1) See No. 000986 in tablished for this product in § 510.600(c) of this chapter for use in preruminating calves. Do not use in paragraphs (e)(1), (2), and (3) of this calves to be processed for veal. Federal section. law restricts this drug to use by or on (2) See No. 000010 in § 510.600(c) of this the order of a licensed veterinarian. chapter for use as in paragraphs (e)(1) (2) Swine—(i) Amount. 2.5 mg/kg body and (2) of this section. weight as a single intramuscular injec- (c) [Reserved] tion in the neck. (d) Related tolerances. See § 556.740 of (ii) Indications for use. For the treat- this chapter. ment of swine respiratory disease (e) Conditions of use—(1) Beef cattle (SRD) associated with Actinobacillus and nonlactating dairy cattle—(i)

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Amount. 8 milligrams per pound of body (b) Cats. Treatment of upper res- weight once daily. piratory infections when caused by (ii) Indications for use. Treatment of Staphylococci spp. and hemolytic bovine respiratory complex (shipping Streptococci spp. and for feline pneumo- fever, pneumonia) usually associated nitis when caused by tylosin suscep- with Pasteurella multocida and tible organisms. Arcanobacterium pyogenes; foot rot (ne- (iii) Limitations. For intramuscular crotic pododermatitis) and calf diph- use only. If there is no response to theria caused by Fusobacterium therapy in 5 days, diagnosis and treat- necrophorum and metritis caused by ment should be reassessed. Use a 50- Arcanobacterium pyogenes. milligram-per-milliliter solution only. (iii) Limitations. Administer Dogs and cats receiving a dose of less intramuscularly for not more than 5 than 50 milligrams (1 milliliter) should consecutive days. Continue treatment be dosed with a tuberculin syringe. 24 hours after symptoms disappear. Do Federal law restricts this drug to use not inject more than 10 milliliters per by or on the order of a licensed veteri- site. Do not use in lactating dairy cat- narian. tle. Use a 50-milligram-per-milliliter [46 FR 48643, Oct. 2, 1981, as amended at 47 FR solution for calves weighing less than 9398, Mar. 5, 1982; 50 FR 49841, Dec. 5, 1985; 50 200 pounds. Do not administer within 21 FR 50292, Dec. 10, 1985; 53 FR 40728, Oct. 18, days of slaughter. A withdrawal period 1988; 59 FR 14365, Mar. 28, 1994; 62 FR 35077, has not been established for this prod- June 30, 1997; 68 FR 24879, May 9, 2003; 70 FR uct in preruminating calves. Do not 16935, Apr. 4, 2005. Redesignated and amended use in calves to be processed for veal. at 74 FR 11644, Mar. 19, 2009] (2) Swine—(i) Amount. 4 milligrams per pound of body weight twice daily. § 522.2662 Xylazine. (ii) Indications for use. Treatment of (a) Specifications. Each milliliter swine arthritis caused by Mycoplasma (mL) of solution contains xylazine hy- hyosynoviae; swine pneumonia caused drochloride equivalent to: by Pasteurella spp.; swine erysipelas (1) 20 milligrams (mg) xylazine. caused by Erysipelothrix rhusiopathiae; (2) 100 mg xylazine. swine dysentery associated with (3) 300 mg xylazine. Treponema hyodysenteriae when fol- (b) Sponsors. See sponsors in lowed by appropriate medication in the § 510.600(c) of this chapter for uses as in drinking water and/or feed. paragraph (d) of this section. (iii) Limitations. Administer (1) No. 000010 for use of product de- intramuscularly for not more than 3 scribed in paragraph (a)(2) of this sec- consecutive days. Continue treatment tion as in paragraph (d)(2) of this sec- 24 hours after symptoms disappear. Do tion. not inject more than 5 milliliters per (2) No. 000010 for use of product de- site. Do not administer within 14 days scribed in paragraph (a)(2) of this sec- of slaughter. If tylosin medicated tion as in paragraphs (d)(2), (d)(3)(i), drinking water is used as followup (d)(3)(ii)(A), and (d)(3)(iii) of this sec- treatment for swine dysentery, the ani- tion. mal should thereafter receive feed con- (3) Nos. 000859 and 061651 for use of taining 40 to 100 grams of tylosin per product described in paragraph (a)(1) of ton for 2 weeks to assure depletion of this section as in paragraph (d)(1); and tissue residues. product described in paragraph (a)(2) of (3) Dogs and cats—(i) Amount. 3 to 5 this section as in paragraphs (d)(2), milligrams per pound of body weight at (d)(3)(i), (d)(3)(ii)(A), and (d)(3)(iii) of 12- to 24-hour intervals. this section. (ii) Indications for use—(a) Dogs. (4) No. 061690 for use of product de- Treatment of upper respiratory infec- scribed in paragraph (a)(1) of this sections such as bronchitis, tion as in paragraph (d)(1) of this sec- tracheobronchitis, tracheitis, laryn- tion; product described in paragraph gitis, tonsillitis, and pneumonia caused (a)(2) of this section as in paragraphs by Staphylococci spp., hemolytic (d)(2), (d)(3)(i), (d)(3)(ii)(A), and Streptococci spp., and Pasteurella (d)(3)(iii) of this section; and product multocida. described in paragraph (a)(3) of this

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section as in paragraphs (d)(3)(i), ther 2 or 5 milligrams of yohimbine (as (d)(3)(ii)(B), and (d)(3)(iii) of this sec- hydrochloride). tion. (b) Sponsor. See 061690 in § 510.600(c) of (c) Special considerations. Federal law this chapter for use of 2 milligrams per restricts this drug to use by or on the milliliter solution in dogs. order of a licensed veterinarian. (1) Amount. 0.05 milligram per pound (d) Conditions of use—(1) Dogs and (0.11 milligram per kilogram) of body cats—(i) Amount. 0.5 mg/pound (lb) in- weight. travenously or 1.0 mg/lb (2) Indications for use. To reverse the subcutaneously. effects of xylazine in dogs. (ii) Indications for use. To produce se- (3) Limitations. For intravenous use in dation, as an analgesic, and as a dogs only. Not for use in food-pro- preanesthetic to local or general anes- ducing animals. Safety of use in preg- thesia. nant dogs or in dogs intended for breed- (2) Horses—(i) Amount. 0.5 mg/lb intra- ing has not been established. Federal venously or 1.0 mg/lb intramuscularly. law restricts this drug to use by or on (ii) Indications for use. To produce se- the order of a licensed veterinarian. dation, as an analgesic, and as a (c) Sponsor. See 053923 in § 510.600(c) of preanesthetic to local or general anes- this chapter for use of 5 milligrams per thesia. milliliter solution in deer and elk. (iii) Limitations. Not for use in horses (1) Amount. 0.2 to 0.3 milligram per intended for food. kilogram of body weight. (3) Elk and deer—(i) Amount. Admin- (2) Indications for use. As an antago- ister intramuscularly, by hand syringe, nist to xylazine sedation in free rang- or by syringe dart, in the heavy mus- ing or confined members of the family cles of the croup or shoulder as follows: Cervidae (deer and elk). (A) Elk (Cervus canadensis): 0.25 to 0.5 (3) Limitations. For intravenous use mg/lb. only. Do not use in domestic food-pro- (B) Mule deer (Odocoileus hemionus), ducing animals. Do not use for 30 days sika deer (Cervus nippon), and white- before or during hunting season. Fed- tailed deer (Odocoileus virginianus): 1 to eral law restricts this drug to use by or 2 mg/lb. on the order of a licensed veterinarian. (C) Fallow deer (Dama dama): 2 to 4 [58 FR 8543, Feb. 16, 1993, as amended at 60 mg/lb. FR 57832, Nov. 22, 1995] (ii) Indications for use. (A) To produce sedation, as an analgesic, and as a § 522.2680 Zeranol. preanesthetic to local anesthesia. (a) Specifications. Each pellet con- (B) To produce sedation, accom- tains 12, 18, or 20 milligrams (mg) panied by a shorter period of analgesia. zeranol. May be used to calm and facilitate han- (b) Sponsor. See 000061 in § 510.600(c) of dling of fractious animals for diag- this chapter. nostic procedures, for minor surgical (c) Related tolerances. See § 556.760 of procedures, for therapeutic medication this chapter. for sedation and relief of pain following (d) Conditions of use—(1) Beef cattle— injury or surgery, and as a (i) Amount. 36 mg zeranol (one implant preanesthetic to local anesthetic. At consisting of 3 pellets, each pellet con- the recommended dosages, can be used taining 12 mg zeranol) per implant in conjunction with local anesthetics, dose. such as procaine or lidocaine. (ii) Indications for use—(A) For in- (iii) Limitations. Do not use in domes- creased rate of weight gain and im- tic food-producing animals. Do not use proved feed conversion in weaned beef in Cervidae less than 15 days before or calves, growing beef cattle, feedlot during the hunting season. steers, and feedlot heifers. [68 FR 26206, May 15, 2003, as amended at 75 (B) For increased rate of weight gain FR 10167, Mar. 5, 2010] in suckling calves. (iii) Limitations. Implant § 522.2670 Yohimbine injectable. subcutaneously in ear only. Do not use (a) Specifications. Each milliliter of in bulls intended for reproduction or in sterile aqueous solution contains ei- dairy animals. Do not use before 1

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month of age or after weaning in heif- preruminating calves. Do not use in ers intended for reproduction. Safety calves to be processed for veal. and effectiveness have not been estab- [59 FR 19639, Apr. 25, 1994; 60 FR 26360, May lished in veal calves. A withdrawal pe- 17, 1995, as amended at 62 FR 61625, Nov. 19, riod has not been established for this 1997; 64 FR 46840, Aug. 27, 1999; 67 FR 6867, product in preruminating calves. Do Feb. 14, 2002; 70 FR 6764, Feb. 9, 2005] not use in calves to be processed for veal. § 522.2690 Zinc gluconate. (2) Feedlot lambs—(i) Amount. 12 mg (a) Specifications. Each milliliter of zeranol (one implant consisting of 1 solution contains 13.1 milligrams zinc pellet containing 12 mg zeranol) per as zinc gluconate neutralized to pH 7.0 implant dose. with L-arginine. (ii) Indications for use. For increased (b) Sponsor. See No. 067647 in rate of weight gain and improved feed § 510.600(c) of this chapter. (c) Conditions of use in dogs—(1) conversion. Amount. The volume injected into each (iii) Limitations. Implant testicle is based on testicular width as subcutaneously in ear only. Do not use determined by measuring each testicle in breeding animals. Do not implant at its widest point using a metric scale animals within 40 days of slaughter. (millimeter) caliper. Safety and effectiveness have not been (2) Indications for use. Intratesticular established in veal calves. A with- injection for chemical sterilization of drawal period has not been established 3- to 10-month-old male dogs. for this product in preruminating (3) Limitations. Federal law restricts calves. Do not use in calves to be proc- this drug to use by or on the order of a essed for veal. licensed veterinarian. (3) Steers fed in confinement for slaugh- [68 FR 26995, May 19, 2003] ter—(i) Amount. 72 mg zeranol (one implant consisting of 6 pellets, each pel- PART 524—OPHTHALMIC AND TOP- let containing 12 mg zeranol) per implant dose. ICAL DOSAGE FORM NEW ANI- (ii) Indications for use. For increased MAL DRUGS rate of weight gain and improved feed Sec. efficiency. 524.86 Amitraz liquid. (iii) Limitations. Implant 524.154 Bacitracin or bacitracin zinc-neomy- subcutaneously in ear only. Safety and cin sulfate-polymyxin B sulfate oph- effectiveness have not been established thalmic ointment. in veal calves. A withdrawal period has 524.155 Bacitracin zinc-polymyxin B sulfate- not been established for this product in neomycin sulfate-hydrocortisone or hydrocortisone acetate ophthalmic oint- preruminating calves. Do not use in ment. calves to be processed for veal. 524.390 Chloramphenicol ophthalmic and (4) Pasture cattle (slaughter, stocker, topical dosage forms. feeder steers, and heifers)—(i) Amount. 524.390a Chloramphenicol ophthalmic oint- 138 mg zeranol (one implant consisting ment. 524.390b Chloramphenicol ophthalmic solu- of 7 pellets, each of 6 pellets containing tion. 20 mg zeranol and a seventh pellet con- 524.390d Chloramphenicol-prednisolone oph- taining 18 mg zeranol) per implant thalmic ointment. dose. 524.402 Chlorhexidine. (ii) Indications for use. For increased 524.450 Clotrimazole cream. 524.463 Copper naphthenate. rate of weight gain. 524.520 Cuprimyxin cream. (iii) Limitations. Implant 524.575 Cyclosporine ophthalmic ointment. subcutaneously in ear only. Safety and 524.590 Diclofenac. effectiveness have not been established 524.660 Dimethyl sulfoxide ophthalmic and in veal calves. A withdrawal period has topical dosage forms. not been established for this product in 524.660a Dimethyl sulfoxide solution. 524.660b Dimethyl sulfoxide gel. 524.770 Doramectin. 524.775 Emodepside and praziquantel.

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