Title 21—Food and Drugs--Volume 1
PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
§ 522.1696a   Penicillin G benzathine and penicillin G procaine suspension.
(a) Specifications. Each milliliter of aqueous suspension contains penicillin G benzathine and penicillin G procaine, each equivalent to 150,000 units of penicillin G.
(b) Sponsors. See sponsors in § 510.600(c) of this chapter for the conditions of use in paragraph (d) of this section as follows:
(1) Nos. 054771 and 061133 for use as in paragraph (d)(1) of this section.
(2) Nos. 016592 and 061133 for use as in paragraphs (d)(2)(i), (d)(2)(ii)(A), and (d)(2)(iii) of this section.
(3) No. 054771 for use as in paragraphs (d)(2)(i), (d)(2)(ii)(B), and (d)(2)(iii) of this section.
(c) Related tolerances. See § 556.510 of this chapter.
(d) Conditions of use —(1) Horses, dogs, and beef cattle —(i) Amount —(A) Beef cattle. 2 milliliters per 150 pounds of body weight intramuscularly or subcutaneously. Repeat dosage in 48 hours.
(B) Horses. 2 milliliters per 150 pounds of body weight intramuscularly. Repeat dosage in 48 hours.
(C) Dogs. 1 milliliter per 10 to 25 pounds of body weight intramuscularly or subcutaneously. Repeat dosage in 48 hours.
(ii) Indications for use. Treatment of bacterial infections susceptible to penicillin G.
(iii) Limitations. Not for use in beef cattle within 30 days of slaughter. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) Beef cattle —(i) Amount. 2 milliliters per 150 pounds of body weight subcutaneously. Repeat dosage in 48 hours.
(ii) Indications for use. (A) Treatment of bacterial pneumonia ( Streptococcus spp., Actinomyces pyogenes , Staphylococcus aureus ); upper respiratory infections such as rhinitis or pharyngitis ( A. pyogenes ); blackleg ( Clostridium chauvoei ).
(B) As in paragraph (d)(2)(ii)(A) of this section; and prophylaxis of bovine shipping fever in 300- to 500-pound beef calves.
(iii) Limitations. Not for use within 30 days of slaughter. For No. 016592: A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. For No. 016592: Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.1696b   Penicillin G procaine aqueous suspension.
(a) Specifications. Each milliliter contains penicillin G procaine equivalent to 300,000 units of penicillin G.
(b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter as follows:
(1) Nos. 016592 and 054771 for use as in paragraph (d) of this section.
(2) Nos. 055529 and 061133 for use as in paragraph (d)(2) of this section.
(c) Related tolerances. See § 556.510 of this chapter.
(d) Conditions of use —(1) Dogs and cats —(i) Amount. 10,000 units per pound body weight daily by intramuscular injection.
(ii) Indications for use. Treatment of infections caused by penicillin-sensitive organisms.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) Cattle, sheep, swine, and horses —(i) Amount. 3,000 units per pound body weight (1 milliliter per 100 pounds body weight) daily by intramuscular injection.
(ii) Indications for use. Treatment of cattle and sheep for bacterial pneumonia (shipping fever) caused by Pasteurella multocida ; swine for erysipelas caused by Erysipelothrix rhusiopathiae ; and horses for strangles caused by Streptococcus equi.
(iii) Limitations. Not for use in horses intended for food. Milk that has been taken during treatment and for 48 hours after the last treatment must not be used for food.
(A) For Nos. 054771 and 061133: Do not exceed 7 days of treatment in nonlactating dairy and beef cattle, sheep, and swine, or 5 days in lactating cattle. Discontinue treatment for the following number of days before slaughter: Nonruminating cattle (calves)—7; all other cattle—4; sheep—8; and swine—6.
(B) For Nos. 016592 and 055529: treatment should not exceed 4 consecutive days. A withdrawal period has not been established for this product in pre-ruminating calves. Discontinue treatment for the following number of days before slaughter: cattle—14; sheep—9; and swine—7.
(C) Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.1696c   Penicillin G procaine in oil.
(a) Specifications. Each milliliter contains penicillin G procaine equivalent to 300,000 units of penicillin G.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Conditions of use —(1) Amount. Dogs and cats—10,000 units per pound of body weight once daily. Horses—3,000 units per pound of body weight once daily.
(2) Indications for use. Treatment of infections of dogs, cats, and horses caused by penicillin-susceptible organisms such as Streptococci, Staphylococci, and Corynebacteria.
(3) Limitations. Not for use in food-producing animals. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.1698   Pentazocine.
(a) Specifications. Each milliliter of solution contains pentazocine lactate equivalent to 30 milligrams (mg) of pentazocine base.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Conditions of use —(1) Horses —(i) Amount. Administer 0.15 mg pentazocine base per pound of body weight daily by intravenous or intramuscular injection. In cases of severe pain, a second dose is recommended by intramuscular injection 10 to 15 minutes after the initial dose at the same level.
(ii) Indications for use. For symptomatic relief of pain due to colic.
(iii) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) Dogs —(i) Amount. Administer 0.75 to 1.50 mg of pentazocine base per pound of body weight by intramuscular injection.
(ii) Indications for use. For amelioration of pain accompanying postoperative recovery, fracture, trauma, and spinal disorders.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.1700   Pentobarbital and phenytoin.
(a) Specifications. Each milliliter (mL) of solution contains 390 milligrams (mg) pentobarbital sodium and 50 mg phenytoin sodium.
(b) Sponsors. See Nos. 000061, 051311, 054925, and 086119 in § 510.600(c) of this chapter.
(c) Special considerations. Product labeling shall bear the following warning statements: “ENVIRONMENTAL HAZARD: This product is toxic to wildlife. Birds and mammals feeding on treated animals may be killed. Euthanized animals must be properly disposed of by deep burial, incineration, or other method in compliance with State and local laws, to prevent consumption of carcass material by scavenging wildlife.”
(d) Conditions of use in dogs —(1) Amount. Administer 1 mL per 10 pounds of body weight as a single, bolus intravenous or intracardiac injection.
(2) Indications for use. For humane, painless, and rapid euthanasia.
(3) Limitations. Do not use in animals intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.1703   Pentobarbital.
(a) Specifications. Each milliliter of solution contains 64.8 milligrams (mg) of sodium pentobarbital.
(b) Sponsor. See No. 000061 in § 510.600(c) of this chapter.
(c) Conditions of use —(1) Amount. The drug is administered intravenously “to effect”. For general surgical anesthesia, the usual dose is 11 to 13 mg per pound of body weight. For sedation, the usual dose is approximately 2 mg per pound of body weight. For relieving convulsive seizures caused by strychnine in dogs, the injection should be administered intravenously “to effect”. The drug may be administered intraperitoneally. When given intraperitoneally, it is administered at the same dosage level as for intravenous administration.
(2) Indications for use. The drug is indicated for use as a general anesthetic in dogs and cats. Although it may be used as a general surgical anesthetic for horses, it is usually given at a lower dose to cause sedation and hypnosis and may be supplemented with a local anesthetic. It may also be used in dogs for the symptomatic treatment of strychnine poisoning.
(3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.1704   Pentosan polysulfate sodium.
(a) Specifications. Each milliliter of solution contains 250 milligrams (mg) of pentosan polysulfate sodium.
(b) Sponsor. See No. 043264 in § 510.600(c) of this chapter.
(c) Conditions of use —(1) Amount. Administer 3 mg per kilogram of body weight (1.4 mg per pound) by intramuscular injection once weekly for 4 weeks for a total of four doses.
(2) Indications for use. For the control of clinical signs associated with osteoarthritis in horses.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.1720   Phenylbutazone.
(a) Specifications. (1) Each milliliter of solution contains 100 milligrams (mg) of phenylbutazone.
(2) Each milliliter of solution contains 200 mg of phenylbutazone.
(b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter for use as in paragraph (c) of this section:
(1) No. 054771 for use of product described in paragraph (a)(1) as in paragraph (c) of this section.
(2) Nos. 000061, 054771, 058198, and 061133 for use of product described in paragraph (a)(2) of this section as in paragraph (c) of this section.
(3) Nos. 058005 and 069043 for use of product described in paragraph (a)(2) as in paragraph (c)(2) of this section.
(c) Conditions of use —(1) Dogs —(i) Amount. Administer by intravenous injection 10 mg per pound of body weight daily in three divided doses, not to exceed 800 mg daily regardless of weight. Limit intravenous administration to 2 successive days. Oral medication may follow.
(ii) Indications for use. It is used for the relief of inflammatory conditions associated with the musculoskeletal system.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) Horses —(i) Amount. Administer by intravenous injection 1 to 2 grams (g) per 1,000 pounds of body weight daily in three divided doses, not to exceed 4 g daily. Limit intravenous administration to not more than 5 successive days.
(ii) Indications for use. For the relief of inflammatory conditions associated with the musculoskeletal system.
(iii) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.1820   Pituitary luteinizing hormone powder for injection.
(a) Specifications. The drug is a lyophilized pituitary extract. Each 6-milliliter vial contains an amount equivalent to 25 milligrams of standard pituitary luteinizing hormone and is reconstituted for use by addition of 5 milliliters of 0.9 percent aqueous sodium chloride solution.
(b) Sponsor. No. 000061 in § 510.600(c) of this chapter.
(c) Conditions of use —(1) Amount. Cattle and horses: 25 milligrams; swine: 5 milligrams; sheep: 2.5 milligrams; and dogs: 1.0 milligram. Preferably given by intravenous injection, it may be administered subcutaneously. Treatment may be repeated in 1 to 4 weeks, or as indicated.
(2) Indications for use. As an aid in the treatment of breeding disorders related to pituitary hypofunction in cattle, horses, swine, sheep, and dogs.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.1850   Polysulfated glycosaminoglycan.
(a) Specifications. (1) Each 1-milliliter (mL) ampule of solution contains 250 milligrams (mg) polysulfated glycosaminoglycan.
(2) Each mL of solution packaged in 5-mL ampules or 20-, 30-, or 50-mL vials contains 100 mg polysulfated glycosaminoglycan.
(b) Sponsor. See No. 010797 in § 510.600(c) of this chapter.
(c) Special considerations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(d) Conditions of use —(1) Horses —(i) Indications for use. For the treatment of noninfectious degenerative and/or traumatic joint dysfunction and associated lameness of the carpal and hock joints in horses.
(ii) Amount —(A) Intra-articular use (carpal) : 250 mg once a week for 5 weeks.
(B) Intramuscular use (carpal and hock) : 500 mg every 4 days for 28 days.
(iii) Limitations. Do not use in horses intended for human consumption.
(2) Dogs —(i) Indications for use. For control of signs associated with noninfectious degenerative and/or traumatic arthritis of canine synovial joints.
(ii) Amount. 2 mg per pound of body weight by intramuscular injection twice weekly for up to 4 weeks (maximum of 8 injections).
§ 522.1860   Pradofloxacin.
(a) Specifications. Each milliliter (mL) of solution contains 200 milligrams (mg) pradofloxacin.
(b) Sponsor. See No. 058198 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.530 of this chapter.
(d) Conditions of use —(1) Cattle —(i) Amount. Administer a single dose of 10 mg/kg (2.3 mL/100 lb) body weight by subcutaneous injection.
(ii) Indications for use. Cattle intended for slaughter (beef calves 2 months of age and older, growing beef steers, growing beef heifers, and beef bulls intended for slaughter), and in cattle intended for breeding less than 1 year of age (replacement beef and dairy heifers less than 1 year of age and beef and dairy bulls less than 1 year of age): for the treatment of bovine respiratory disease associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis.
(iii) Limitations. Cattle intended for human consumption must not be slaughtered within 4 days of treatment. Not for use in female dairy cattle 1 year of age and older, including dry dairy cows; use in these cattle may cause drug residues in milk and/or in calves born to these cows. Not for use in beef calves less than 2 months of age, dairy calves, and veal calves. A withdrawal period has not been established for this product in pre-ruminating calves. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits the extralabel use of this drug in food-producing animals.
(2) Swine —(i) Amount. Administer a single dose of 7.5 mg/kg (1.7 mL/100 lb) body weight by intramuscular injection.
(ii) Indications for use. Weaned swine intended for slaughter (nursery, growing, and finishing swine, boars intended for slaughter, barrows, gilts intended for slaughter, and sows intended for slaughter): for the treatment of swine respiratory disease associated with Bordetella bronchiseptica, Glaesserella (Haemophilus) parasuis, Pasteurella multocida, Streptococcus suis, and Mycoplasma hyopneumoniae.
(iii) Limitations. Swine intended for human consumption must not be slaughtered within 2 days of treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits the extralabel use of this drug in food-producing animals.
§ 522.1862   Pralidoxime powder for injection.
(a) Specifications. Each vial contains 1 gram (g) of pralidoxime chloride powder for mixing with 20 cubic centimeters of sterile water for injection. Each milliliter of constituted solution contains 50 milligrams (mg) pralidoxime chloride.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Conditions of use —(1) Amount. Administer as soon as possible after exposure to the poison. Before administration of the sterile pralidoxime chloride, atropine is administered intravenously at a dosage rate of 0.05 mg per pound of body weight, followed by administration of an additional 0.15 mg of atropine per pound of body weight administered intramuscularly. Then the appropriate dosage of sterile pralidoxime chloride is administered slowly intravenously. The dosage rate for sterile pralidoxime chloride when administered to horses is 2 g per horse. When administered to dogs and cats, it is 25 mg per pound of body weight. For small dogs and cats, sterile pralidoxime chloride may be administered either intraperitoneally or intramuscularly. A mild degree of atropinization should be maintained for at least 48 hours. Following severe poisoning, a second dose of sterile pralidoxime chloride may be given after 1 hour if muscle weakness has not been relieved.
(2) Indications for use. It is used in horses, dogs, and cats as an antidote in the treatment of poisoning due to those pesticides and chemicals of the organophosphate class which have anticholinesterase activity in horses, dogs, and cats.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.1870   Praziquantel.
(a) Specifications. Each milliliter (mL) of solution contains 56.8 milligrams of praziquantel.
(b) Sponsors. See Nos. 058198 and 061133 in § 510.600(c) of this chapter.
(c) Conditions of use —(1) Dogs —(i) Amount. Administer by subcutaneous or intramuscular injection for dogs and puppies 5 pounds (lb) and under, 0.3 mL; for 6 to 10 lb, 0.5 mL; for 11 to 25 lb, 1.0 mL; if over 25 lb, 0.2 mL/5 lb body weight to a maximum of 3 mL.
(ii) Indications for use. For removal of canine cestodes Dipylidium caninum, Taenia pisiformis, and Echinococcus granulosus, and removal and control of canine cestode Echinococcus multilocularis.
(iii) Limitations. Federal law restricts the drug to use by or on the order of a licensed veterinarian.
(2) Cats —(i) Amount. Administer by subcutaneous or intramuscular injection for cats and kittens under 5 lb, 0.2 mL; 5 to 10 lb, 0.4 mL; 11 lb and over, 0.6 mL maximum.
(ii) Indications for use. For removal of feline cestodes Dipylidium caninum and Taenia taeniaeformis.
(iii) Limitations. Federal law restricts the drug to use by or on the order of a licensed veterinarian.
§ 522.1881   Prednisolone acetate.
(a) Specifications. Each milliliter of suspension contains 25 milligrams (mg) of prednisolone acetate.
(b) Sponsor. See No. 000061 in § 510.600(c) of this chapter.
(c) Conditions of use —(1) Amount. The drug is administered to horses intra-articularly at a dosage level of 50 to 100 mg. The dose may be repeated when necessary. The drug is administered to dogs and cats intramuscularly at a dosage level of 10 to 50 mg. The dosage may be repeated when necessary. If the condition is of a chronic nature, an oral corticosteroid may be given as a maintenance dosage. The drug may be given intra-articularly to dogs and cats at a dosage level of 5 to 25 mg. The dose may be repeated when necessary after 7 days for two or three doses.
(2) Indications for use. The drug is indicated in the treatment of dogs, cats, and horses for conditions requiring an anti-inflammatory agent. The drug is indicated for the treatment of acute musculoskeletal inflammations such as bursitis, carpitis, and spondylitis. The drug is indicated as supportive therapy in nonspecific dermatosis such as summer eczema and atopy. The drug may be used as supportive therapy pre- and postoperatively and for various stress conditions when corticosteroids are required while the animal is being treated for a specific condition.
(3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.1883   Prednisolone sodium phosphate.
(a) Specifications. Each milliliter of solution contains 20 milligrams (mg) prednisolone sodium phosphate (equivalent to 14.88 mg of prednisolone).
(b) Sponsor. See No. 061133 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs —(1) Amount. Administer intravenously in a dosage of 2 1/2 to 5 mg per pound of body weight, initially for shock and shock-like states, followed by equal maintenance doses at 1-, 3-, 6-, or 10-hour intervals as determined by the condition of the animal.
(2) Indications for use. Administer when a rapid adrenal glucocorticoid and/or anti-inflammatory effect is necessary.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.1884   Prednisolone sodium succinate.
(a) Specifications. Each milliliter of prednisolone sodium succinate injection contains: Prednisolone sodium succinate equivalent in activity to 10, 20, or 50 milligrams (mg) of prednisolone.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter for products containing 10, 20, and 50 mg equivalent prednisolone activity per milliliter for use in horses, dogs, and cats as provided in paragraphs (c)(1)(i), (ii), and (iii) of this section.
(c) Conditions of use —(1) Amount and indications for use —(i) Horses. Administer 50 to 100 mg as an initial dose by intravenous injection over a period of one-half to 1 minute, or by intramuscular injection, and may be repeated in inflammatory, allergic, or other stress conditions at intervals of 12, 24, or 48 hours, depending upon the size of the animal, the severity of the condition and the response to treatment.
(ii) Dogs. Administer by intravenous injection at a range of 2.5 to 5 mg per pound of body weight as an initial dose followed by maintenance doses at 1, 3, 6, or 10 hour intervals, as determined by the condition of the animal, for treatment of shock.
(iii) Dogs and cats. Administer by intramuscular injection for treatment of inflammatory, allergic, and less severe stress conditions, where immediate effect is not required, at 1 to 5 mg ranging upward to 30 to 50 mg in large breeds of dogs. Dosage may be repeated in 12 to 24 hours and continued for 3 to 5 days if necessary. If permanent corticosteroid effect is required, oral therapy with prednisolone tablets may be substituted.
(2) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.1890   Prednisone suspension.
(a) Specifications. Each milliliter of suspension contains 10 to 40 milligrams (mg) of prednisone.
(b) Sponsor. See No. 000061 in § 510.600(c) of this chapter.
(c) Conditions of use —(1) Amount —(i) Horses. Administer 100 to 400 mg by intramuscular injection, repeating if necessary.
(ii) Dogs and cats. Administer 0.25 to 1.0 mg per pound of body weight by intramuscular injection for 3 to 5 days or until a response is noted. Treatment may be continued with an orally administered dose.
(2) Indications for use. It is used for conditions requiring an anti-inflammatory agent.
(3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.1920   Prochlorperazine and isopropamide.
(a) Specifications. Each milliliter of solution contains prochlorperazine edisylate equivalent to 4 milligrams (mg) prochlorperazine and isopropamide iodide equivalent to 0.28 mg of isopropamide.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Conditions of use —(1) Amount. (i) Dosage is administered by subcutaneous injection twice daily as follows:
(ii) Following the last injection, administer prochlorperazine and isopropamide sustained release capsules as indicated.
(2) Indications for use. For use in dogs and cats in which gastrointestinal disturbances are associated with emotional stress.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.1940   Progesterone and estradiol benzoate.
(a) Specifications —(1) Each implant consists of progesterone and estradiol benzoate. (i) 100 mg progesterone and 10 mg estradiol benzoate (one implant consisting of four pellets, each containing 25 mg progesterone and 2.5 mg estradiol benzoate).
(ii) 200 mg progesterone and 20 mg estradiol benzoate (one implant consisting of eight pellets, each containing 25 mg progesterone and 2.5 mg estradiol benzoate).
(2) Each implant consists of progesterone and estradiol benzoate and tylosin tartrate. (i) 100 mg progesterone, 10 mg estradiol benzoate, and 29 mg tylosin tartrate (one implant consisting of four pellets, each containing 25 mg progesterone and 2.5 mg estradiol benzoate, and one pellet containing 29 mg tylosin tartrate).
(ii) 200 mg progesterone, 20 mg estradiol benzoate, and 29 mg tylosin tartrate (one implant consisting of eight pellets, each containing 25 mg progesterone and 2.5 mg estradiol benzoate, and one pellet containing 29 mg tylosin tartrate).
(b) Sponsors. See sponsors in § 510.600(c) of this chapter for use as in paragraph (c) of this section:
(1) No. 054771 for use as in paragraphs (e)(1)(i)(A), (e)(1)(ii), (e)(2)(i)(A), (B), (C), and (e)(2)(ii) of this section.
(2) No. 058198 for use as in paragraphs (e)(1)(i)(A), (e)(1)(i)(B), (e)(1)(ii), and (e)(3) of this section.
(c) Related tolerances. See §§ 556.240 and 556.540 of this chapter.
(d) Special considerations. Labeling of implants described in paragraphs (a)(2)(i) and (a)(2)(ii) for use in paragraphs (e)(1)(i)(B), (e)(1)(ii), (e)(3)(i), and (e)(3)(ii) of this section shall bear the following: “Federal law restricts this drug to use by or on the order of a licensed veterinarian.”
(e) Conditions of use —(1) Beef calves 45 days of age and older and weighing up to 400 lbs —(i) Amounts and indications for use. (A) An implant containing 100 mg progesterone and 10 mg estradiol benzoate as described in paragraph (a)(1)(i) of this section for increased rate of weight gain.
(B) An implant containing 100 mg progesterone, 10 mg estradiol benzoate, and 29 mg tylosin tartrate as described in paragraph (a)(2)(i) of this section for increased rate of weight gain.
(ii) Limitations. Implant pellets subcutaneously in ear only. Other than when used as described in (e)(2)(i)(B) of this section, the implant as described in paragraph (a)(1)(i) of this section is not approved for repeated implantation (reimplantation). The implant as described in paragraph (a)(2)(i) of this section is not approved for repeated implantation (reimplantation) with this or any other cattle ear implant. Do not use in beef calves less than 45 days of age, dairy calves, and veal calves because effectiveness and safety have not been evaluated. Do not use in dairy cows or in animals intended for subsequent breeding. Use in these cattle may cause drug residues in milk and/or calves born to these cows.
(2) Growing beef steers fed in confinement for slaughter —(i) Amounts and indications for use. (A) An implant containing 200 mg progesterone and 20 mg estradiol benzoate as described in paragraph (a)(1)(ii) of this section for increased rate of weight gain and improved feed efficiency.
(B) An implant containing 200 mg progesterone and 20 mg estradiol benzoate as described in paragraph (a)(1)(ii) of this section for increased rate of weight gain in a reimplantation program where an implant as described in paragraph (a)(1)(i) of this section is the first implant and an implant as described in paragraph (a)(1)(ii) of this section is administered approximately 70 days later.
(C) An implant containing 200 mg progesterone and 20 mg estradiol benzoate as described in paragraph (a)(1)(ii) of this section for increased rate of weight gain in a reimplantation program where an implant as described in paragraph (a)(1)(ii) of this section is the first implant and an implant as described in paragraph (a)(1)(ii) of this section is administered approximately 70 days later.
(ii) Limitations. Implant pellets subcutaneously in ear only. Other than when used as described in paragraphs (e)(2)(i)(B) or (C) of this section, the implant described in paragraph (a)(1)(ii) of this section is not approved for repeated implantation (reimplantation) with any other cattle ear implant in growing beef steers and heifers fed in confinement for slaughter as safety and effectiveness have not been evaluated. Do not use in beef calves less than 2 months of age, dairy calves, and veal calves because effectiveness and safety have not been evaluated. Do not use in dairy cows or in animals intended for subsequent breeding. Use in these cattle may cause drug residues in milk and/or calves born to these cows.
(3) Growing beef steers weighing 400 lbs or more —(i) Amounts and indications for use. An implant containing 200 mg progesterone, 20 mg estradiol benzoate, and 29 mg tylosin tartrate as described in paragraph (a)(2)(ii) of this section for increased rate of weight gain and improved feed efficiency.
(ii) Limitations. The implant as described in paragraph (a)(2)(ii) of this section is not approved for repeated implantation (reimplantation) with this or any other cattle ear implant. Do not use in beef calves less than 2 months of age, dairy calves, and veal calves because effectiveness and safety have not been evaluated. Do not use in dairy cows or in animals intended for subsequent breeding. Use in these cattle may cause drug residues in milk and/or calves born to these cows.
§ 522.1962   Promazine.
(a) Specifications. Each milliliter of solution contains 50 milligrams (mg) promazine hydrochloride.
(b) Sponsors. See sponsors in § 510.600(c) of this chapter for use as in paragraph (c) of this section:
(1) No. 054771 for use as in paragraphs (c)(1)(i)(A), (c)(1)(ii)(A), (c)(1)(iii), and (c)(2) of this section.
(2) No. 061133 for use as in paragraphs (c)(1)(i)(B), (c)(1)(ii)(B), and (c)(1)(iii) of this section.
(c) Conditions of use —(1) Horses —(i) Amount. (A) 0.2 to 0.5 milligrams per pounds (mg/lb) body weight intramuscularly or intravenously every 4 to 6 hours.
(B) 0.2 to 0.5 mg/lb body weight intravenously as required.
(ii) Indications for use. (A) For use as a tranquilizer, preanesthetic, or for minor operative procedures in conjunction with local anesthesia; and as adjunctive therapy for tetanus.
(B) For use as a tranquilizer and preanesthetic.
(iii) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) Dogs and cats —(i) Amount. 1 to 2 mg/lb body weight intramuscularly or intravenously every 4 to 6 hours.
(ii) Indications for use. For use as a tranquilizer, preanesthetic, for minor operative procedures in conjunction with local anesthesia, as adjunctive therapy for tetanus, and as an antiemetic prior to worming; or to prevent motion sickness in dogs.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.2002   Propiopromazine.
(a) Specifications. Each milliliter of solution contains 5 or 10 milligrams (mg) propiopromazine hydrochloride.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs and cats —(1) Amounts and indications for use. Administer 0.05 to 0.5 mg per pound of body weight by intravenous or intramuscular injection for tranquilization. Administer 0.25 mg per pound of body weight by intravenous injection as a preanesthetic.
(2) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.2005   Propofol.
(a) Specifications. Each milliliter of emulsion contains 10 milligrams (mg) propofol.
(b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter.
(1) No. 086064 for use as in paragraphs (c)(1), (c)(2)(i), (c)(3), (d)(1), (d)(2)(i), and (d)(3) of this section.
(2) No. 054771 for use as in paragraphs (c)(1), (c)(2)(ii), (c)(3), (d)(1), (d)(2)(ii), and (d)(3) of this section.
(3) Nos. 054771 and 068504 for use as in paragraphs (c)(1), (c)(2)(iii), and (c)(3) of this section.
(c) Conditions of use in dogs —(1) Amount. Administer by intravenous injection according to label directions. The use of preanesthetic medication reduces propofol dose requirements.
(2) Indications for use. (i) As a single injection to provide general anesthesia for short procedures; for induction and maintenance of general anesthesia using incremental doses to effect; and for induction of general anesthesia where maintenance is provided by inhalant anesthetics.
(ii) For induction of general anesthesia; for maintenance of anesthesia for up to 20 minutes; and for induction of general anesthesia followed by maintenance with an inhalant anesthetic.
(iii) For induction and maintenance of general anesthesia; and for induction of general anesthesia followed by maintenance with an inhalant anesthetic.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(d) Conditions of use in cats —(1) Amount. Administer by intravenous injection according to label directions. The use of preanesthetic medication reduces propofol dose requirements.
(2) Indications for use. (i) As a single injection to provide general anesthesia for short procedures; for induction and maintenance of general anesthesia using incremental doses to effect; and for induction of general anesthesia where maintenance is provided by inhalant anesthetics.
(ii) For induction and maintenance of general anesthesia; and for induction of general anesthesia followed by maintenance with an inhalant anesthetic.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.2012   Prostalene.
(a) Specifications. Each milliliter of solution contains 1 milligram of prostalene.
(b) Sponsor. No. 054771 in § 510.600(c) of this chapter.
(c) Conditions of use in horses —(1) Amount. Administer 5 micrograms per kilogram of body weight as a single subcutaneous injection.
(2) Indications for use. For the control of estrus in mares.
(3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.2063   Pyrilamine.
(a) Specifications. Each milliliter of solution contains 20 milligrams (mg) of pyrilamine maleate.
(b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter for uses in paragraph (c) of this section.
(1) No. 000061 for use as in paragraph (c)(1)(i), (2), and (3) of this section.
(2) No. 061133 for use as in paragraph (c)(1)(ii), (2), and (3) of this section.
(c) Conditions of use —(1) Amount. (i) Horses, 40 to 60 mg per 100 pounds (lbs) body weight; foals, 20 mg/100 lbs body weight. Administer by intramuscular, subcutaneous, or intravenous injection. Dosage may be repeated every 6 to 12 hours whenever necessary.
(ii) Horses, 40 to 60 mg/100 lbs body weight; foals, 20 mg/100 lbs body weight. Administer by slow intravenous injection. Dosage may be repeated every 6 to 12 hours if necessary.
(2) Indications for use. It is intended for treating horses in conditions in which antihistaminic therapy may be expected to lead to alleviation of some signs of disease.
(3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.2065   Rabacfosadine.
(a) Specifications. Each vial of powder contains 16.4 milligrams (mg) rabacfosadine. Each milliliter of constituted solution contains 8.2 mg rabacfosadine.
(b) Sponsor. See No. 058198 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs —(1) Amount. Administer rabacfosadine at 1 mg/kilogram body weight as a 30-minute intravenous infusion, once every 3 weeks, for up to 5 doses.
(2) Indications for use. For the treatment of lymphoma in dogs.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.2075   Robenacoxib.
(a) Specifications. Each milliliter of solution contains 20 milligrams (mg) robenacoxib.
(b) Sponsor. See No. 058198 in § 510.600(c) of this chapter.
(c) Conditions of use —(1) Dogs —(i) Amount. Administer 0.91 mg per pound (2 mg/kilogram (kg)) by subcutaneous injection, once daily, for a maximum of 3 days. After the initial subcutaneous dose, subsequent doses can be given by subcutaneous injection or as the oral tablet in dogs weighing at least 5.5 pounds (2.5 kg) and at least 4 months of age, for a maximum of 3 total doses over 3 days, not to exceed 1 dose per day. See § 520.2075(c)(1) of this chapter.
(ii) Indications for use. For the control of postoperative pain and inflammation associated with soft tissue surgery in dogs at least 4 months of age for a maximum of 3 days.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) Cats —(i) Amount. Administer 0.91 mg per pound (2 mg/kg) by subcutaneous injection, once daily, for a maximum of 3 days.
(ii) Indications for use. For the control of postoperative pain and inflammation associated with orthopedic surgery, ovariohysterectomy, and castration in cats at least 4 months of age for a maximum of 3 days.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.2076   Romifidine.
(a) Specifications. Each milliliter of solution contains 10 milligrams (mg) romifidine hydrochloride.
(b) Sponsor. See No. 000010 in § 510.600(c) of this chapter.
(c) Conditions of use in horses —(1) Amount. 40 to 120 micrograms per kilogram of body weight (mcg/kg BW) intravenously for sedation and analgesia; 100 mcg/kg BW intravenously as a preanesthetic.
(2) Indications for use. For use as a sedative and analgesic to facilitate handling, clinical examinations, clinical procedures, and minor surgical procedures in adult horses; and for use as a preanesthetic prior to the induction of general anesthesia in adult horses.
(3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.2092   Secobarbital and dibucaine.
(a) Specifications. Each milliliter (mL) of solution contains 400 milligram (mg) secobarbital sodium and 25 mg dibucaine hydrochloride.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Special considerations. Product labeling shall bear the following warning statements: “ENVIRONMENTAL HAZARD: This product is toxic to wildlife. Birds and mammals feeding on treated animals may be killed. Euthanized animals must be properly disposed of by deep burial, incineration, or other method in compliance with State and local laws, to prevent consumption of carcass material by scavenging wildlife.”
(d) Conditions of use in dogs —(1) Amount. Administer 1 mL per 10 pounds of body weight as a single, bolus intravenous injection.
(2) Indications for use. For humane, painless, and rapid euthanasia.
(3) Limitations. Do not use in animals intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.2100   Selenium and vitamin E.
(a)(1) Specifications. Each milliliter of emulsion contains 5.48 milligrams (mg) sodium selenite (equivalent to 2.5 mg selenium) and 50 mg of vitamin E (68 I.U.) (as d-alpha tocopheryl acetate).
(2) Sponsor. See No. 000061 in § 510.600(c) of this chapter.
(3) Conditions of use in horses —(i) Amount. Administer 1 milliliter (mL) per (/) 100 pounds (lbs) of body weight by intravenous injection or by deep intramuscular injection in divided doses in two or more sites in the gluteal or cervical muscles. Administration may be repeated at 5 to 10 day intervals.
(ii) Indications for use. For the prevention and treatment of selenium-tocopherol deficiency syndrome in horses.
(iii) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(b)(1) Specifications. Each milliliter contains 2.19 mg of sodium selenite (equivalent to 1 mg of selenium), 50 mg of vitamin E (68 I.U.) (as d-alpha tocopheryl acetate).
(2) Sponsor. See No. 000061 in § 510.600(c) of this chapter.
(3) Conditions of use in dogs —(i) Amount. Administer by subcutaneous or intramuscular injection in divided doses in two or more sites at 1 mL/20 lbs of body weight with a minimum dosage of 1/4 mL and a maximum dosage of 5 mL. The dose is repeated at 3-day intervals until a satisfactory therapeutic response is observed. A maintenance regimen is then initiated which consists of 1 mL per 40 lbs of body weight with a minimum dosage of 1/4 mL which is repeated every 3 days or 7 days, or longer, as required to maintain continued improvement or an asymptomatic condition; or the drug may be used in capsule form for oral maintenance therapy.
(ii) Indications for use. As an aid in alleviating and controlling inflammation, pain, and lameness associated with certain arthropathies in dogs.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(c)(1) Specifications. Each milliliter contains 2.19 milligrams of selenite sodium (equivalent to 1 milligram selenium), 50 milligrams vitamin E (68 U.S.P. units).
(2) Sponsor. See No. 000061 in § 510.600(c) of this chapter.
(3) Conditions of use —(i) Dosage. Calves: 2.5 to 3.75 milliliters per 100 pounds of body weight. Lambs 2 weeks of age or older: 1 milliliter per 40 pounds, minimum 1 milliliter. Ewes: 2.5 milliliters per 100 pounds. Sows: 1 milliliter per 40 pounds. Weanling pigs: 1 milliliter per 40 pounds, minimum 1 milliliter.
(ii) Indications for use. Calves, lambs, and ewes: prevention and treatment of white muscle disease (selenium-tocopherol deficiency syndrome). Sows and weanling pigs: an aid in the prevention and treatment of selenium-tocopherol deficiency.
(iii) Limitations. For subcutaneous or intramuscular use. Not for use in newborn pigs. Do not use in pregnant ewes. Calves: Discontinue use 30 days before treated calves are slaughtered for human consumption. Lambs, ewes, sows, or pigs: Discontinue use 14 days before treated lambs, ewes, sows, or pigs are slaughtered for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(d)(1) Specifications. Each milliliter contains 10.95 milligrams selenite sodium (equivalent to 5 milligrams selenium), 50 milligrams vitamin E (68 U.S.P. units).
(2) Sponsors. See Nos. 000061 and 054771 in § 510.600(c) of this chapter.
(3) Conditions of use —(i) Dosage. Breeding beef cows: 1 milliliter per 200 pounds of body weight during the middle third of gestation, and 30 days before calving. Weanling calves: 1 milliliter per 200 pounds of body weight.
(ii) Indications for use. Weanling calves and breeding beef cows: For the prevention and treatment of selenium-tocopherol deficiency syndrome.
(iii) Limitations. For subcutaneous or intramuscular use. Discontinue use 30 days before treated cattle are slaughtered for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(e)(1) Specifications. Each milliliter contains 0.55 milligram selenite sodium (equivalent to 0.25 milligram selenium), 50 milligrams (68 U.S.P. units) vitamin E.
(2) Sponsor. See No. 000061 in § 510.600(c) of this chapter.
(3) Conditions of use —(i) Dosage. Newborn lambs: 1 milliliter. Lambs 2 weeks of age or older: 4 milliliters. Baby pigs: 1 milliliter (or treat the sow during the last week of pregnancy).
(ii) Indications for use. Lambs: for prevention and treatment of white muscle disease (selenium-tocopherol deficiency syndrome). Baby pigs: an aid in the prevention and treatment of selenium-tocopherol deficiency.
(iii) Limitations. For subcutaneous or intramuscular use only. Discontinue use 14 days before treated animals are slaughtered for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.2112   Sometribove zinc suspension.
(a) Specifications. Each single-dose syringe contains 500 milligrams (mg) sometribove zinc in a prolonged-release suspension.
(b) Sponsor. See No. 086106 in § 510.600(c) of this chapter.
(c) Conditions of use —(1) Amount. Inject 500 mg every 14 days starting during the 9th or 10th week (57 to 70 days) after calving and continue until the end of lactation.
(2) Indications for use. To increase production of marketable milk in healthy lactating dairy cows.
(3) Limitations. Use in lactating dairy cows only. Safety to replacement bulls born to treated dairy cows has not been established. Inject subcutaneously. Avoid injections within 2 weeks of expected slaughter to minimize injection site blemishes on carcass. There is no milk discard or preslaughter withdrawal period. Use may reduce pregnancy rates and increase days open. Treated cows are at an increased risk for mastitis and higher milk somatic cell counts. Use care to differentiate increased body temperature due to use of this product from an increased body temperature that may occur due to illness. Cows treated with this product may have more enlarged hocks and disorders of the foot region. Use may reduce hemoglobin and hematocrit values during treatment. Human warning: Avoid prolonged or repeated contact with eyes and skin.
§ 522.2120   Spectinomycin hydrochloride.
(a) Specifications. Each milliliter of solution contains 100 milligrams (mg) spectinomycin hydrochloride (as spectinomycin dihydrochloride pentahydrate).
(b) Sponsors. See sponsors in § 510.600(c) of this chapter:
(1) Nos. 016592 and 054771 for use as in paragraph (d)(1) of this section; and
(2) No. 058198 for use as in paragraph (d)(2) of this section.
(c) Related tolerances. See § 556.600 of this chapter.
(d) Conditions of use. It is administered as follows:
(1) Turkeys (1- to 3-day-old poults) and chickens (newly hatched chicks) —(i) Amounts and indications for use. (A) Administer 5 mg per poult subcutaneously as an aid in the control of chronic respiratory disease (CRD) associated with Escherichia coli in 1- to 3-day-old turkey poults.
(B) Administer 10 mg per poult as a single subcutaneous injection in the nape of the neck as an aid in the control of airsacculitis associated with Mycoplasma meleagridis sensitive to spectinomycin in 1- to 3-day-old turkey poults.
(C) Administer 2.5 to 5 mg per chick as an aid in the control of mortality and to lessen severity of infections caused by M. synoviae, Salmonella typhimurium, S. infantis, and E. coli.
(ii) Limitations. For use only in 1- to 3-day-old turkey poults and newly hatched chicks. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) Dogs —(i) Amount. Administer 2.5 to 5.0 mg per pound of body weight by intramuscular injection twice daily. Treatment may be continued for 4 days.
(ii) Indications for use. For treatment of infections caused by gram-negative and gram-positive organisms susceptible to spectinomycin.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.2121   Spectinomycin sulfate.
(a) Specifications. Each milliliter of solution contains spectinomycin sulfate tetrahydrate equivalent to 100 milligrams (mg) spectinomycin.
(b) Sponsor. See Nos. 054771 and 061133 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.600 of this chapter.
(d) Conditions of use in cattle —(1) Amount. 10 to 15 mg per kilogram of body weight at 24-hour intervals for 3 to 5 consecutive days.
(2) Indications for use. For the treatment of bovine respiratory disease (pneumonia) associated with Mannheimia haemolytica, Pasteurella multocida , and Histophilus somni.
(3) Limitations. Do not slaughter within 11 days of last treatment. Do not use in female dairy cattle 20 months of age or older. Use in this class of cattle may cause residues in milk. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.2150   Stanozolol.
(a) Specifications. Each milliliter of suspension contains 50 milligrams (mg) of stanozolol.
(b) Sponsor. No. 054771 in § 510.600(c) of this chapter.
(c) Conditions of use —(1) Amount —(i) Dogs and cats. For cats and small breeds of dogs: 25 mg. For larger dogs: 50 mg. Administer by deep intramuscular injection in the thigh at weekly intervals, for several weeks.
(ii) Horses. Administer 25 mg per 100 pounds of body weight by deep intramuscular injection in the gluteal region at weekly intervals, for not more than 4 weeks.
(2) Indications for use. For use as an anabolic steroid treatment.
(3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.2220   Sulfadimethoxine.
(a) Specifications. Each milliliter of solution contains:
(1) 100 milligrams (mg) of sulfadimethoxine sodium.
(2) 400 mg of sulfadimethoxine sodium.
(b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter for use as in paragraph (d) of this section.
(1) No. 069043 for use of the product described in paragraph (a)(1) as in paragraph (d)(1) of this section.
(2) No. 054771 for use of the product described in paragraph (a)(2) as in paragraphs (d)(2), (3), and (4) of this section.
(3) Nos. 016592 and 061133 for use of the product described in paragraph (a)(2) as in paragraph (d)(4) of this section.
(c) Related tolerances. See § 556.640 of this chapter.
(d) Conditions of use —(1) Dogs —(i) Amount. Administer by subcutaneous, intramuscular, or intravenous injection at an initial dose of 25 mg per pound of body weight followed by 12.5 mg per pound of body weight every 24 hours thereafter. Continue treatment until the animal is free from symptoms for 48 hours.
(ii) Indications for use. For use in the treatment of sulfadimethoxine-susceptible bacterial infections in dogs.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) Dogs and cats —(i) Amount. Administer by intravenous or subcutaneous injection at an initial dose of 55 mg per kilogram of body weight followed by 27.5 mg per kilogram of body weight every 24 hours.
(ii) Indications for use. For the treatment of respiratory, genitourinary tract, enteric, and soft tissue infections when caused by Streptococci, Staphylococci, Escherichia, Salmonella, Klebsiella, Proteus, or Shigella organisms sensitive to sulfadimethoxine, and in the treatment of canine bacterial enteritis associated with coccidiosis and canine Salmonellosis.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(3) Horses —(i) Amount. Administer by intravenous injection at an initial dose of 55 mg per kilogram of body weight followed by 27.5 mg per kilogram of body weight every 24 hours until the patient is asymptomatic for 48 hours.
(ii) Indications for use. For the treatment of respiratory disease caused by Streptococcus equi (strangles).
(iii) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(4) Cattle —(i) Amount. Administer an initial dose of 25 mg per pound of body weight by intravenous injection followed by 12.5 mg per pound of body weight every 24 hours until the animal is asymptomatic for 48 hours.
(ii) Indications for use. For the treatment of bovine respiratory disease complex (shipping fever complex) and bacterial pneumonia associated with Pasteurella spp. sensitive to sulfadimethoxine; necrotic pododermatitis (foot rot) and calf diphtheria caused by Fusobacterium necrophorum sensitive to sulfadimethoxine.
(iii) Limitations. Milk taken from animals during treatment and for 60 hours (5 milkings) after the latest treatment must not be used for food. Do not administer within 5 days of slaughter. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.2240   Sulfaethoxypyridazine.
(a) Specifications. The drug is an aqueous solution of sulfaethoxypyridazine.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.650 of this chapter.
(d) Conditions of use in cattle —(1) Amount. Administer 2.5 grams per 100 pounds of body weight per day by intravenous injection for not more than 4 days; or first treatment may be followed by 3 days of treatment with sulfaethoxypyridazine in drinking water or tablets in accordance with §§ 520.2240a(e) and 520.2240b(e) of this chapter.
(2) Indications for use. For treatment of respiratory infection (pneumonia, shipping fever), foot rot, calf scours; as adjunctive therapy in septicemia accompanying mastitis and metritis.
(3) Limitations. Do not treat within 16 days of slaughter. Milk that has been taken from animals during treatment and for 72 hours (6 milkings) after the latest treatment must not be used for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.2260   Sulfamethazine.
(a) Specifications. Each milliliter (mL) of solution contains 250 milligrams (mg) sulfamethazine sodium.
(b) Sponsor. See No. 016592 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.670 of this chapter.
(d) Conditions of use in cattle —(1) Amount. Initially administer 20 mL for each 50 pounds (lb) of body weight (100 mg/lb) by intravenous injection, followed by 20 mL per 100 lb of body weight (50 mg/lb) by intravenous injection, daily thereafter. Treatment should not exceed a total of 5 consecutive days.
(2) Indications for use. For cattle for treatment of bacterial pneumonia and bovine respiratory disease complex (shipping fever complex) ( Pasteurella spp.), colibacillosis (bacterial scours) ( Escherichia coli ), necrotic pododermatitis (foot rot) ( Fusobacterium necrophorum ), calf diphtheria ( Fusobacterium necrophorum ), acute mastitis and acute metritis ( Streptococcus spp.) when caused by one or more pathogenic organisms sensitive to sulfamethazine.
(3) Limitations. Withdraw medication from cattle 10 days prior to slaughter. Do not use in female dairy cattle 20 months of age or older. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.2340   Sulfomyxin.
(a) Specifications. Sulfomyxin for injection is sterile. It is derived from the antibiotic substance produced by the growth of Bacillus polymyxa or is the same substance produced by any other means.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Special considerations. The quantities of antibiotic in paragraph (e) of this section refer to the activity of the appropriate standard.
(d) Related tolerances. See § 556.700 of this chapter.
(e) Conditions of use. (1) It is used or intended for use in chickens and turkeys as an aid in the treatment of disease caused or complicated by E. coli, such as colibacillosis and complicated chronic respiratory disease.
(2) It is administered by subcutaneous injection as follows:
(3) A second injection may be given 3 days later if symptoms persist.
(4) Not for use in laying hens; do not treat chickens within 5 days of slaughter. Do not treat turkeys within 7 days of slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.2343   Testosterone propionate and estradiol benzoate.
(a) Sponsors. See sponsors in § 510.600(c) of this chapter for use as in paragraph (d) of this section.
(1) No. 054771 for use as in paragraph (d)(1) of this section.
(2) No. 058198 for use as in paragraph (d)(2) of this section.
(b) Related tolerances. See §§ 556.240 and 556.710 of this chapter.
(c) Special considerations. Labeling of the implants described in paragraph (d)(2) of this section shall bear the following: “Federal law restricts this drug to use by or on the order of a licensed veterinarian.”
(d) Conditions of use —(1) Growing beef heifers fed in confinement for slaughter —(i) Amounts and indications for use. An implant containing 200 mg testosterone propionate and 20 mg estradiol benzoate (one implant consisting of eight pellets, each containing 25 mg testosterone propionate and 2.5 mg estradiol benzoate) for increased rate of weight gain and improved feed efficiency.
(ii) Limitations. Implant pellets subcutaneously in ear only. Not approved for repeated implantation (reimplantation) with this or any other cattle ear implant. Do not use in beef calves less than 2 months of age, dairy calves, and veal calves because safety and effectiveness have not been evaluated. Do not use in dairy cows or in animals intended for subsequent breeding. Use in these cattle may cause drug residues in milk and/or in calves born to these cows.
(2) Growing beef heifers weighing 400 lbs or more —(i) Amounts and indications for use. An implant containing 200 mg testosterone propionate, 20 mg estradiol benzoate, and 29 mg tylosin tartrate (one implant consisting of eight pellets, each containing 25 mg testosterone propionate and 2.5 mg estradiol benzoate, and one pellet containing 29 mg tylosin tartrate) for increased rate of weight gain and improved feed efficiency.
(ii) Limitations. Implant pellets subcutaneously in ear only. Not approved for repeated implantation (reimplantation) with this or any other cattle ear implant. Do not use in beef calves less than 2 months of age, dairy calves, and veal calves because safety and effectiveness have not been evaluated. Do not use in dairy cows or in animals intended for subsequent breeding. Use in these cattle may cause drug residues in milk and/or in calves born to these cows.
§ 522.2404   Thialbarbitone sodium for injection.
(a) Specifications. Thialbarbitone sodium for injection when reconstituted with sterile distilled water provides 94 milligrams of thialbarbitone sodium per milliliter of solution.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Conditions of use. (1) The drug is administered as a general anesthetic in surgical procedures on dogs, cats, swine, sheep, cattle, and horses. The drug is used for procedures of relatively short duration. However, the period of anesthesia can be lengthened by slower initial injection and supplemental administration during surgery.
(2) It is administered intravenously. The drug is injected slowly to dogs, cats, cattle, sheep, and swine. For horses, it is recommended that a pre-anesthetic sedation be administered to the horse 30 minutes before the drug is administered. The drug is then injected rapidly and completely. The drug is used at the following dosage levels:
(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.2424   Thiamylal.
(a) Specifications. The drug is a sterile powder. It is reconstituted with sterile distilled water, water for injection, or sodium chloride injection, to a desired concentration of 0.5 to 4 percent sodium thiamylal.
(b) Sponsors. See Nos. 054771 and 069043 in § 510.600(c) of this chapter.
(c) Conditions of use —(1) Amount. Administer by intravenous injection to effect. The average single dose is:
(i) Dogs and cats: 8 milligrams (mg) per pound of body weight (when used with a preanesthetic, generally one-half the normal dose).
(ii) Swine: 40 mg per 5 pounds (lbs) of body weight.
(iii) Horses: Light anesthesia, 1 gram per 500 lbs to 1,100 lbs of body weight; deep anethesia, 1 gram per 300 lbs of body weight (40 mg/12 lbs of body weight).
(iv) Cattle: Short duration, 20 mg/5 lbs of body weight; longer duration, 40 mg/7 lbs of body weight.
(2) Indications for use. It is used as an ultra-short-acting anesthetic in dogs, cats, swine, horses, and cattle.
(3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.2444   Thiopental injectable dosage forms.
§ 522.2444a   Thiopental powder for injection.
(a) Specifications. The drug contains sodium thiopental powder for constitution with sterile water for injection.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs and cats —(1) Amount. Administer by intravenous injection as follows:
(i) 6 to 9 milligrams (mg) per pound of body weight for brief anesthesia (6 to 10 minutes).
(ii) 10 to 12 mg per pound of body weight for anesthesia of 15 to 25 minutes duration.
(2) Indications for use. It is used as an anesthetic for intravenous administration to dogs and cats during short to moderately long surgical and other procedures. It is also used to induce anesthesia in dogs and cats which then have surgical anesthesia maintained by use of a volatile anesthetic.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.2444b   Thiopental and pentobarbital powder for injection.
(a) Specifications. Each gram of powder contains 750 milligrams (mg) of sodium thiopental and 250 mg of sodium pentobarbital powder for dilution with sterile water for injection.
(b) Sponsor. See No. 061133 in § 510.600(c) of this chapter.
(c) Conditions of use —(1) Amount. For total anesthesia, it is given at approximately 10 to 12 mg per pound of body weight over a period of 3.5 to 5 minutes. When preanesthetic medication is used, wait at least an hour before administering thiopental and sodium pentobarbital for injection, and the dosage necessary for anesthesia is reduced. Usually 1/2 to 2/3 the normal amount is adequate.
(2) Indications for use. It is used as an anesthetic for intravenous administration to dogs and cats during short to moderately long surgical procedures.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.2450   Tigilanol.
(a) Specifications. Each milliliter (mL) of solution contains 1 milligram tigilanol tiglate.
(b) Sponsor. See No. 086132 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs —(1) Amount. Administer as an intratumoral injection at a dose of 0.5 mL per cubic centimeter of tumor volume.
(2) Indications for use. For the treatment of non-metastatic cutaneous mast cell tumors and non-metastatic subcutaneous mast cell tumors located at or distal to the elbow or the hock in dogs.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.2460   Tildipirosin.
(a) Specifications. Each milliliter of solution contains:
(1) 180 milligrams (mg) tildipirosin.
(2) [Reserved]
(b) Sponsor. See No. 000061 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.733 of this chapter.
(d) Conditions of use —(1) Cattle —(i) Amount. Administer 4 mg/kg of bodyweight one time by subcutaneous injection in the neck.
(ii) Indications for use. For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni in beef and non-lactating dairy cattle; and for the control of respiratory disease in beef and non-lactating dairy cattle at high risk of developing BRD associated with M. haemolytica, P. multocida, and H. somni.
(iii) Limitations. Cattle intended for human consumption must not be slaughtered within 21 days from the last treatment. Do not use in female dairy cattle 20 months of age or older. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) [Reserved]
§ 522.2470   Tiletamine and zolazepam.
(a) Specifications. The drug is a sterile powder. Each milliliter of constituted solution contains tiletamine hydrochloride equivalent to 50 milligrams (mg) of tiletamine base and zolazepam hydrochloride equivalent to 50 mg of zolazepam base.
(b) Sponsors. See Nos. 017033, 051311, and 054771 in § 510.600(c) of this chapter.
(c) Conditions of use —(1) Dogs —(i) Amount. Expressed as milligrams of the drug combination:
(A) An initial intramuscular dosage of 3 to 4.5 milligrams per pound (mg/lb) of body weight for diagnostic purposes; 4.5 to 6 mg/lb of body weight for minor procedures of short duration such as repair of lacerations and wounds, castrations, and other procedures requiring mild to moderate analgesia. Supplemental doses when required should be less than the initial dose and the total dose given should not exceed 12 mg/lb of body weight. The maximum total safe dose is 13.6 mg/lb of body weight.
(B) Administer intravenously at 1 to 2 mg/lb (2.2 to 4.4 mg/kg) body weight to effect for induction of anesthesia followed by maintenance with an inhalant anesthetic.
(ii) Indications for use. (A) Intramuscular administration in dogs for restraint and minor procedures of short duration (30 minutes average) requiring mild to moderate analgesia.
(B) Intravenous administration in dogs for induction of anesthesia followed by maintenance with an inhalant anesthetic.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) Cats —(i) Amount. An initial intramuscular dosage of 4.4 to 5.4 mg/lb of body weight is recommended for such procedures as dentistry, treatment of abscesses, foreign body removal, and related types of surgery; 4.8 to 5.7 mg/lb of body weight for minor procedures requiring mild to moderate analgesia, such as repair of lacerations, castrations, and other procedures of short duration. Initial dosages of 6.5 to 7.2 mg/lb of body weight are recommended for ovariohysterectomy and onychectomy. When supplemental doses are required, such individual supplemental doses should be given in increments that are less than the initial dose and the total dose given (initial dose plus supplemental doses) should not exceed the maximum allowable safe dose of 32.7 mg/lb of body weight.
(ii) Indications for use. For restraint or for anesthesia combined with muscle relaxation.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.2471   Tilmicosin.
(a) Specifications. Each milliliter of solution contains 300 milligrams (mg) tilmicosin base as tilmicosin phosphate.
(b) Sponsor. See No. 058198 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.735 of this chapter.
(d) Conditions of use —(1) Cattle —(i) Amount. 10 to 20 milligrams per kilograms (mg/kg) of body weight as a single subcutaneous injection.
(ii) Indications for use. For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica , Pasteurella multocida , and Histophilus somni. For the control of respiratory disease in cattle at high risk of developing BRD associated with M. haemolytica.
(iii) Limitations. Animals intended for human consumption must not be slaughtered within 42 days of last treatment. Do not use in lactating dairy cattle 20 months of age or older. Use of tilmicosin in this class of cattle may cause milk residues. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) Sheep —(i) Amount. 10 mg/kg body weight as a single subcutaneous injection.
(ii) Indications for use. For the treatment of ovine respiratory disease (ORD) associated with Mannheimia ( P.) haemolytica.
(iii) Limitations. Not for use in lactating ewes producing milk for human consumption. Animals intended for human consumption must not be slaughtered within 42 days of last treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.2473   Tiludronate.
(a) Specifications. Each vial of powder contains 500 milligrams (mg) tiludronate disodium. Each milliliter of constituted solution contains 20 mg tiludronate disodium.
(b) Sponsor. See No. 061133 in § 510.600(c) of this chapter.
(c) Conditions of use in horses —(1) Amount. Administer a single dose of 1 mg per kilogram (0.45 mg/pound) of body weight by intravenous infusion.
(2) Indication for use. For the control of clinical signs associated with navicular syndrome.
(3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.2474   Tolazoline.
(a) Specifications. Each milliliter of solution contains tolazoline hydrochloride equivalent to 100 milligrams (mg) of base activity.
(b) Sponsor. See No. 059399 in § 510.600(c) of this chapter.
(c) Conditions of use in horses —(1) Amount. Administer slowly by intravenous injection 4 mg per kilogram of body weight or 1.8 mg per pound (4 milliliters (mL) per 100 kilograms or 4 mL per 220 pounds).
(2) Indications for use. For use in horses when it is desirable to reverse the effects of sedation and analgesia caused by xylazine.
(3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.2476   Trenbolone acetate.
(a) Sponsors. See sponsors in § 510.600(c) of this chapter for use as in paragraph (d) of this section.
(1) No. 000061 for use as in paragraphs (d)(1)(i)(A), (d)(1)(ii) and (iii), (d)(2)(i)(A), and (d)(2)(ii) and (iii) of this section.
(2) No. 058198 for use as in paragraph (d) of this section.
(b) Related tolerances. See § 556.739 of this chapter.
(c) Special considerations. Labeling of implants described in paragraph (d)(1)(i)(B) and (d)(2)(i)(B) of this section shall bear the following: “Federal law restricts this drug to use by or on the order of a licensed veterinarian.”.
(d) Conditions of use —(1) Steers fed in confinement for slaughter —(i) Amount. Use 126 days prior to slaughter; should be reimplanted once after 63 days.
(A) 140 milligrams (mg) trenbolone acetate (one implant consisting of 7 pellets, each pellet containing 20 mg trenbolone acetate) per implant dose.
(B) 140 mg trenbolone acetate (one implant consisting of 8 pellets, each of 7 pellets containing 20 milligrams trenbolone acetate, and 1 pellet containing 29 mg tylosin tartrate) per implant dose.
(ii) Indications for use. For improved feed efficiency.
(iii) Limitations. Implant subcutaneously in ear only. Do not use in animals intended for subsequent breeding or in dairy animals. Safety and effectiveness have not been established in veal calves. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.
(2) Heifers fed in confinement for slaughter —(i) Amount. Use last 63 days prior to slaughter.
(A) 200 mg trenbolone acetate (one implant consisting of 10 pellets, each pellet containing 20 mg trenbolone acetate) per implant dose.
(B) 200 mg of trenbolone acetate (one implant consisting of 11 pellets, each of 10 pellets containing 20 mg of trenbolone acetate, and 1 pellet containing 29 mg of tylosin tartrate) per implant dose.
(ii) Indications for use. For increased rate of weight gain and improved feed efficiency.
(iii) Limitations. Implant subcutaneously in ear only. Do not use in animals intended for subsequent breeding or in dairy animals. Safety and effectiveness have not been established in veal calves. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.
§ 522.2477   Trenbolone acetate and estradiol.
(a) Sponsors. See sponsors in § 510.600(c) of this chapter for uses as in paragraph (d) of this section.
(1) No. 058198 for use in paragraphs (d)(1)(i)(B), (d)(1)(ii), (d)(2)(i)(B), (d)(2)(i)(D), (d)(2)(ii), (d)(3)(i)(B), (d)(3)(i)(D), (d)(3)(ii), (d)(4)(i)(A), (d)(4)(i)(B), and (d)(4)(ii) of this section.
(2) No. 000061 for use in paragraphs (d)(1)(i)(A), (d)(1)(i)(C), (d)(1)(ii), (d)(2)(i)(A), (d)(2)(i)(C), (d)(2)(i)(E), (d)(2)(ii), (d)(3)(i)(A), (d)(3)(i)(C), (d)(3)(i)(E), (d)(3)(ii), (d)(4)(i)(A), and (d)(4)(ii) of this section.
(3) No. 054771 for use in paragraphs (d)(2)(i)(A), (C), (d)(2)(ii), (d)(4)(i)(A), and (d)(4)(ii) of this section.
(b) Related tolerances. See §§ 556.240 and 556.739 of this chapter.
(c) Special considerations. Labeling of implants described in paragraphs (d)(1)(i)(B), (d)(2)(i)(B), (d)(2)(i)(D), (d)(3)(i)(B), (d)(3)(i)(D), and (d)(4)(i)(B) of this section shall bear the following: “Federal law restricts this drug to use by or on the order of a licensed veterinarian.”
(d) Conditions of use —(1) G rowing beef steers and heifers fed in confinement for slaughter —(i) Amounts and indications. (A) An implant containing 200 mg trenbolone acetate and 20 mg estradiol (one implant consisting of 10 pellets each containing 20 mg trenbolone acetate and 2 mg estradiol) for increased rate of weight gain and improved feed efficiency.
(B) An implant containing 200 mg trenbolone acetate, 20 mg estradiol, and 29 mg tylosin tartrate (one implant consisting of 10 pellets, each containing 20 mg trenbolone acetate and 2 mg estradiol, and 1 pellet containing 29 mg tylosin tartrate) for increased rate of weight gain and improved feed efficiency.
(C) An extended- and delayed-release implant containing 200 mg trenbolone acetate and 20 mg estradiol (1 implant consisting of 10 coated pellets, each containing 20 mg trenbolone acetate and 2 mg estradiol) for increased rate of weight gain and improved feed efficiency during 70 to 200 days after implantation.
(ii) Limitations. Implant pellets subcutaneously in ear only. Not approved for repeated implantation (reimplantation) with this or any other cattle ear implant in growing beef steers and heifers fed in confinement for slaughter. Do not use in beef calves less than 2 months of age, dairy calves, and veal calves because safety and effectiveness have not been evaluated. Do not use in dairy cows or in animals intended for subsequent breeding. Use in these cattle may cause drug residues in milk and/or calves born to these cows.
(2) Growing beef steers fed in confinement for slaughter —(i) Amounts and indications. (A) An implant containing 80 mg trenbolone acetate and 16 mg estradiol (one implant consisting of four pellets, each containing 20 mg trenbolone acetate and 4 mg estradiol) for increased rate of weight gain and improved feed efficiency.
(B) An implant containing 80 mg trenbolone acetate, 16 mg estradiol, and 29 mg tylosin tartrate (one implant consisting of four pellets, each containing 20 mg trenbolone acetate and 4 mg estradiol, and one pellet containing 29 mg tylosin tartrate) for increased rate of weight gain and improved feed efficiency.
(C) An implant containing 120 mg trenbolone acetate and 24 mg estradiol (one implant consisting of six pellets, each containing 20 mg trenbolone acetate and 4 mg estradiol) for increased rate of weight gain and improved feed efficiency.
(D) An implant containing 120 mg trenbolone acetate, 24 mg estradiol, and 29 mg tylosin tartrate (one implant consisting of six pellets, each containing 20 mg trenbolone acetate and 4 mg estradiol, and one pellet containing 29 mg tylosin tartrate) for increased rate of weight gain and improved feed efficiency.
(E) An extended-release implant containing 200 mg trenbolone acetate and 40 mg estradiol (one implant consisting of six coated pellets and four uncoated pellets, each containing 20 mg trenbolone acetate and 4 mg estradiol) for increased rate of weight gain and improved feed efficiency for up to 200 days after implantation.
(ii) Limitations. Implant pellets subcutaneously in ear only. Not approved for repeated implantation (reimplantation) with this or any other cattle ear implant in growing beef steers fed in confinement for slaughter. Do not use in beef calves less than 2 months of age, dairy calves, and veal calves because safety and effectiveness have not been evaluated. Do not use in dairy cows or in animals intended for subsequent breeding. Use in these cattle may cause drug residues in milk and/or calves born to these cows.
(3) Growing beef heifers fed in confinement for slaughter —(i) Amounts and indications. (A) An implant containing 80 mg trenbolone acetate and 8 mg estradiol (one implant consisting of four pellets, each containing 20 mg trenbolone acetate and 2 mg estradiol) for increased rate of weight gain.
(B) An implant containing 80 mg trenbolone acetate, 8 mg estradiol, and 29 mg tylosin tartrate (one implant consisting of four pellets, each containing 20 mg trenbolone acetate and 2 mg estradiol, and one pellet containing 29 mg tylosin tartrate) for increased rate of weight gain and improved feed efficiency.
(C) An implant containing 140 mg trenbolone acetate and 14 mg estradiol (one implant consisting of seven pellets, each containing 20 mg trenbolone acetate and 2 mg estradiol) for increased rate of weight gain and improved feed efficiency.
(D) An implant containing 140 mg trenbolone acetate, 14 mg estradiol, and 29 mg tylosin tartrate (one implant consisting of seven pellets, each containing 20 mg trenbolone acetate and 2 mg estradiol, and one pellet containing 29 mg tylosin tartrate) for increased rate of weight gain and improved feed efficiency.
(E) An extended-release implant containing 200 mg trenbolone acetate and 20 mg estradiol (one implant consisting of six coated pellets and four uncoated pellets, each containing 20 mg trenbolone acetate and 2 mg estradiol) for increased rate of weight gain and improved feed efficiency for up to 200 days after implantation.
(ii) Limitations. Implant pellets subcutaneously in ear only. Not approved for repeated implantation (reimplantation) with this or any other cattle ear implant in growing beef heifers fed in confinement for slaughter. Do not use in beef calves less than 2 months of age, dairy calves, and veal calves because safety and effectiveness have not been evaluated. Do not use in dairy cows or in animals intended for subsequent breeding. Use in these cattle may cause drug residues in milk and/or calves born to these cows.
(4) Growing beef steers and heifers on pasture (stocker, feeder, and slaughter) —(i) Amounts and indications for use. (A) An implant containing 40 mg trenbolone acetate and 8 mg estradiol (one implant consisting of two pellets, each containing 20 mg trenbolone acetate and 4 mg estradiol) for increased rate of weight gain.
(B) An implant containing 40 mg trenbolone acetate, 8 mg estradiol, and 29 mg tylosin tartrate (one implant consisting of two pellets, each containing 20 mg trenbolone acetate and 4 mg estradiol, and one pellet containing 29 mg tylosin tartrate) for increased rate of weight gain.
(ii) Limitations. Implant pellets subcutaneously in ear only. Not approved for repeated implantation (reimplantation) with this or any other cattle ear implant in growing beef steers and heifers on pasture (stocker, feeder, and slaughter). Do not use in beef calves less than 2 months of age, dairy calves, and veal calves because safety and effectiveness have not been evaluated. Do not use in dairy cows or in animals intended for subsequent breeding. Use in these cattle may cause drug residues in milk and/or calves born to these cows.
§ 522.2478   Trenbolone acetate and estradiol benzoate.
(a) Specifications. (1) Each implant consists of:
(i) 50 milligrams (mg) trenbolone acetate and 7 mg estradiol benzoate (one implant consisting of two pellets, each pellet containing 25 mg trenbolone acetate and 3.5 mg estradiol benzoate) per implant dose.
(ii) 100 milligrams (mg) trenbolone acetate and 14 mg estradiol benzoate (one implant consisting of four pellets, each pellet containing 25 mg trenbolone acetate and 3.5 mg estradiol benzoate) per implant dose.
(iii) 200 mg trenbolone acetate and 28 mg estradiol benzoate (one implant consisting of eight pellets, each pellet containing 25 mg trenbolone acetate and 3.5 mg estradiol benzoate) per implant dose.
(2) Each extended-release implant consists of:
(i) 150 mg trenbolone acetate and 21 mg estradiol benzoate (one implant consisting of six pellets with a porous polymer film coating, each pellet containing 25 mg trenbolone acetate and 3.5 mg estradiol benzoate) per implant dose.
(ii) 200 mg trenbolone acetate and 28 mg estradiol benzoate (one implant consisting of eight pellets with a porous polymer film coating, each pellet containing 25 mg trenbolone acetate and 3.5 mg estradiol benzoate) per implant dose.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Related tolerances. See §§ 556.240 and 556.739 of this chapter.
(d) Conditions of use —(1) Growing beef steers and heifers fed in confinement for slaughter —(i) Amounts and indications for use .
(A) An implant containing 100 mg trenbolone acetate and 14 mg estradiol benzoate as described in paragraph (a)(1)(ii) of this section for increased rate of weight gain in growing beef steers fed in confinement for slaughter and for increased rate of weight gain and improved feed efficiency in growing beef heifers fed in confinement for slaughter. For increased rate of weight gain for up to 200 days in a reimplantation program where an implant as described in paragraph (a)(1)(ii) of this section is the first implant and an implant as described in paragraph (a)(1)(ii) or (iii) or (a)(2)(ii) of this section is administered 60 to 120 days later.
(B) An implant containing 200 mg trenbolone acetate and 28 mg estradiol benzoate as described in paragraph (a)(1)(iii) of this section for increased rate of weight gain and improved feed efficiency in growing beef steers fed in confinement for slaughter and for increased rate of weight gain in growing beef heifers fed in confinement for slaughter. For increased rate of weight gain for up to 200 days in a reimplantation program where an implant as described in paragraph (a)(1)(ii) of this section is the first implant and an implant as described in paragraph (a)(1)(iii) of this section is administered 60 to 120 days later.
(C) An extended-release implant containing 150 mg trenbolone acetate and 21 mg estradiol benzoate as described in paragraph (a)(2)(i) of this section for increased rate of weight gain for up to 200 days.
(D) An extended-release implant containing 200 mg trenbolone acetate and 28 mg estradiol benzoate as described in paragraph (a)(2)(ii) of this section for increased rate of weight gain and improved feed efficiency for up to 200 days. For increased rate of weight gain for up to 200 days in a reimplantation program where an implant as described in paragraph (a)(1)(ii) of this section is the first implant and an implant as described in paragraph (a)(2)(ii) of this section is administered 60 to 120 days later.
(ii) Limitations. Implant pellets subcutaneously in ear only. Other than as described on the labeling, this implant is not approved for repeated implantation (reimplantation) with any other cattle ear implant in growing beef steers and heifers fed in confinement for slaughter as safety and effectiveness have not been evaluated. Do not use in beef calves less than 2 months of age, dairy calves, and veal calves because effectiveness and safety have not been established. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in dairy cows or in animals intended for subsequent breeding. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. The extended-release implant described in paragraph (a)(2)(i) of this section, used as described in paragraph (d)(1)(i)(C) of this section, is not approved for repeated implantation (reimplantation) with this or any other cattle ear implant.
(2) Growing beef steers and heifers on pasture (stocker, feeder, and slaughter) —(i) Amounts and indications for use. (A) An implant containing 50 mg trenbolone acetate and 7 mg estradiol benzoate as described in paragraph (a)(1)(i) of this section for increased rate of weight gain.
(B) An implant containing 100 mg trenbolone acetate and 14 mg estradiol benzoate as described in paragraph (a)(1)(ii) of this section for increased rate of weight gain.
(C) An extended-release implant containing 150 mg trenbolone acetate and 21 mg estradiol benzoate as described in paragraph (a)(2)(i) of this section for increased rate of weight gain for up to 200 days.
(ii) Limitations. Implant pellets subcutaneously in ear only. Not approved for repeated implantation (reimplantation) with this or any other cattle ear implant in growing beef steers and heifers on pasture (stocker, feeder, and slaughter). Safety and effectiveness following reimplantation have not been evaluated. Do not use in beef calves less than 2 months of age, dairy calves, and veal calves because effectiveness and safety have not been established. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in dairy cows or in animals intended for subsequent breeding. Use in these cattle may cause drug residues in milk and/or in calves born to these cows.
(3) Growing beef steers and heifers in a dry lot —(i) Amount and indications for use. (A) An implant containing 50 mg trenbolone acetate and 7 mg estradiol benzoate as described in paragraph (a)(1)(i) of this section for increased rate of weight gain in growing beef steers and heifers in a dry lot.
(B) An implant containing 100 mg trenbolone acetate and 14 mg estradiol benzoate as described in paragraph (a)(1)(ii) of this section for increased rate of weight gain in growing beef steers and heifers in a dry lot.
(ii) Limitations. Implant pellets subcutaneously in ear only. Not approved for repeated implantation (reimplantation) with this or any other cattle ear implant in growing beef steers and heifers in a dry lot. Safety and effectiveness following reimplantation have not been evaluated. Do not use in beef calves less than 2 months of age, dairy calves, and veal calves because effectiveness and safety have not been established. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in dairy cows or in animals intended for subsequent breeding. Use in these cattle may cause drug residues in milk and/or in calves born to these cows.
§ 522.2483   Triamcinolone.
(a) Specifications. Each milliliter of suspension contains 2 or 6 milligrams (mg) triamcinolone acetonide.
(b) Sponsors. See Nos. 000010 and 069043 in § 510.600(c) of this chapter.
(c) Conditions of use —(1) Dogs and cats —(i) Amount —(A) Intramuscular or subcutaneous. For inflammatory, arthritic, or allergic disorders, administer 0.05 to 0.1 mg per pound (/lb) of body weight as a single injection. For dermatologic disorders, administer 0.1 mg per pound (/lb) of body weight as a single injection. If symptoms recur, the dose may be repeated, or oral corticosteroid therapy may be instituted.
(B) Intralesional. Administer 1.2 to 1.8 mg, divided in several injections around the lesion, spaced 0.5 to 2.5 centimeters apart, depending on lesion size. At any one site, the dose injected should not exceed 0.6 mg. and should be well into the cutis to prevent rupture of the epidermis. When treating animals with multiple lesions, do not exceed a total dose of 6 mg.
(C) Intra-articular and intrasynovial. Administer 1 to 3 mg as a single injection, depending on the size of the joint and severity of symptoms. After 3 or 4 days, repeat dosage if indicated. If initial results are inadequate or too transient, dosage may be increased, not to exceed 3 mg.
(ii) Indications for use. For the treatment of inflammation and related disorders, and the management and treatment of acute arthritis and allergic and dermatologic disorders.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) Horses —(i) Amount —(A) Intramuscular or subcutaneous. Administer 0.01 to 0.02 mg/lb of body weight as a single injection. Usual dose is 12 to 20 mg.
(B) Intra-articular and intrasynovial. Administer 6 to 18 mg as a single injection, depending on the size of the joint and severity of symptoms. After 3 or 4 days, repeat dosage if indicated. If initial results are inadequate or too transient, dosage may be increased, not to exceed 18 mg.
(ii) Indications for use. For the treatment of inflammation and related disorders.
(iii) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.2582   Triflupromazine.
(a) Specifications. Each milliliter of solution contains 20 milligrams (mg) of triflupromazine hydrochloride.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Conditions of use —(1) Amount —(i) Dogs. Administer by intravenous injection at a dosage of 0.5 to 1 mg per pound of body weight daily, or by intramuscular injection at a dosage of 1 to 2 mg per pound of body weight daily.
(ii) Cats. Administer by intramuscular injection at a dosage of 2 to 4 mg per pound of body weight daily.
(iii) Horses. Administer by intravenous or intramuscular injection at a dosage of 10 to 15 mg per 100 pounds of body weight daily to a maximum dose of 100 mg.
(2) Indications for use. For use in dogs, cats, and horses to relieve anxiety and to help control psychomotor overactivity as well as to increase the tolerance of animals to pain and pruritus. The drug is indicated in various office and clinical procedures which require the aid of a tranquilizer, antiemetic, or preanesthetic.
(3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.2610   Trimethoprim and sulfadiazine.
(a) Specifications. Each milliliter (mL) contains:
(1) 40 milligrams (mg) trimethoprim suspended in a solution containing 200 mg sulfadiazine; or
(2) 80 mg trimethoprim suspended in a solution containing 400 mg sulfadiazine (as the sodium salt).
(b) Sponsors. See Nos. 000061 and 054771 in § 510.600(c) of this chapter.
(c) Conditions of use —(1) Dogs —(i) Amount. 1 mL of the product described in paragraph (a)(1) of this section (40 mg trimethoprim and 200 mg sulfadiazine) per 20 pounds (9 kilograms) of body weight per day by subcutaneous injection.
(ii) Indications for use. For the treatment of acute urinary tract infections, acute bacterial complications of distemper, acute respiratory tract infections, acute alimentary tract infections, and acute septicemia due to Streptococcus zooepidemicus.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) Horses —(i) Amount. 2 mL of the product described in paragraph (a)(2) of this section (160 mg trimethoprim and 800 mg sulfadiazine) per 100 pounds (45 kilograms) of body weight per day by intravenous injection as single, daily dose for 5 to 7 days. The daily dose may also be halved and given morning and evening.
(ii) Indications for use. For use where systemic antibacterial action against sensitive organisms is required during treatment of acute strangles, respiratory tract infections, acute urogenital infections, and wound infections and abscesses.
(iii) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.2615   Tripelennamine.
(a) Specifications. Each milliliter of solution contains 20 milligrams (mg) of tripelennamine hydrochloride.
(b) Sponsors. See Nos. 016592 and 051031 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.741 of this chapter.
(d) Conditions of use —(1) Dogs and cats —(i) Amount. Administer 0.5 mg per pound of body weight by intramuscular injection.
(ii) Indications for use. For use in treating conditions in which antihistaminic therapy may be expected to lead to alleviation of some signs of disease.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) Horses —(i) Amount. Administer 0.5 mg per pound of body weight by intramuscular injection.
(ii) Indications for use. For use in treating conditions in which antihistaminic therapy may be expected to lead to alleviation of some signs of disease.
(iii) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(3) Cattle —(i) Amount. Administer 0.5 mg per pound of body weight by intravenous or intramuscular injection.
(ii) Indications for use. For use in treating conditions in which antihistaminic therapy may be expected to lead to alleviation of some signs of disease.
(iii) Limitations. Milk taken during treatment and for 24 hours after the last treatment must not be used for human consumption. Cattle must not be slaughtered for human consumption within 4 days following the last treatment with this drug product. Not for use in beef calves less than 2 months of age, dairy calves, and veal calves. A withdrawal period has not been established for this product in pre-ruminating calves. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.2630   Tulathromycin.
(a) Specifications. Each milliliter of solution contains:
(1) 100 milligrams (mg) tulathromycin
(2) 25 mg tulathromycin
(b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter.
(1) Nos. 000061, 013744, 051311, 054771, 055529, 058198, 061133, 068504, and 069043 for use of product described in paragraph (a)(1) as in paragraphs (d)(1)(i), (d)(1)(ii), (d)(1)(iii)(A), and (d)(2) of this section.
(2) Nos. 013744, 051311, 054771, 058198, 068504, and 069043 for use of product described in paragraph (a)(2) as in paragraphs (d)(1)(i), (d)(1)(ii)(B), (d)(1)(iii)(B), and (d)(2) of this section.
(c) Related tolerances. See § 556.745 of this chapter.
(d) Conditions of use —(1) Cattle —(i) Amount. 2.5 mg per kilogram (/kg) body weight as a single subcutaneous injection in the neck.
(ii) Indications for use —(A) Beef and non-lactating dairy cattle. For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis. For the control of respiratory disease in cattle at high risk of developing BRD associated with M. haemolytica, P. multocida, H. somni, and M. bovis. For the treatment of infectious bovine keratoconjunctivitis (IBK) associated with Moraxella bovis. For the treatment of bovine foot rot (interdigital necrobacillosis) associated with Fusobacterium necrophorum and Porphyromonas levii.
(B) Suckling calves, dairy calves, and veal calves. For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis.
(iii) Limitations. (A) Cattle intended for human consumption must not be slaughtered within 18 days from the last treatment. This drug is not approved for use in female dairy cattle 20 months of age or older, including dry dairy cows. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(B) Calves intended for human consumption must not be slaughtered within 22 days from the last treatment. Not for use in ruminating cattle. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) Swine —(i) Amount. 2.5 mg/kg body weight as a single intramuscular injection in the neck.
(ii) Indications for use. For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae , P. multocida , Bordetella bronchiseptica , Haemophilus parasuis , and Mycoplasma hyopneumoniae ; and for the control of SRD associated with A. pleuropneumoniae , P. multocida , and M. hyopneumoniae in groups of pigs where SRD has been diagnosed.
(iii) Limitations. Swine intended for human consumption must not be slaughtered within 5 days from the last treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.2632   Tulathromycin and ketoprofen.
(a) Specifications. Each milliliter of solution contains 100 milligrams (mg) tulathromycin and 120 milligrams (mg) ketoprofen.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Related tolerances. See §§ 556.345 and 556.745 of this chapter.
(d) Conditions of use —(1) Cattle —(i) Amount. Administer as a single subcutaneous injection 2.5 mg tulathromycin and 3 mg ketoprofen per kilogram (1.1 mL/100 lb) of body weight.
(ii) Indications for use. For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis, and control of pyrexia associated with BRD in beef steers, beef heifers, beef calves 2 months of age and older, beef bulls, dairy bulls, and replacement dairy heifers.
(iii) Limitations. Not for use in reproducing animals over 1 year of age. Cattle must not be slaughtered for human consumption within 18 days following last treatment with this drug product. Not for use in female dairy cattle 1 year of age or older, including dry dairy cows; use in these cattle may cause drug residues in milk and/or in calves born to these cows or heifers. Not for use in beef calves less than 2 months of age, dairy calves, and veal calves. A withdrawal period has not been established for this product in pre-ruminating calves. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) [Reserved]
§ 522.2640   Tylosin.
(a) Specifications. Each milliliter (mL) of solution contains 50 or 200 milligrams (mg) of tylosin activity (as tylosin base).
(b) Sponsors. See sponsors in § 510.600(c) of this chapter as follows:
(1) Nos. 016592 and 058198 for use of 50- or 200-mg/mL solutions as in paragraph (e) of this section.
(2) No. 061133 for use of a 200-mg/mL solution as in paragraphs (e)(1) and (2) of this section.
(c) Related tolerances. See § 556.746 of this chapter.
(d) Special considerations. Labeling must bear the warning statements: “Do not administer to horses or other equines. Injection of tylosin in equines has been fatal.”
(e) Conditions of use —(1) Beef cattle and nonlactating dairy cattle —(i) Amount. Administer 8 mg per pound (mg/lb) of body weight by intramuscular injection once daily for not more than 5 consecutive days. Continue treatment 24 hours after symptoms disappear.
(ii) Indications for use. Treatment of bovine respiratory complex (shipping fever, pneumonia) usually associated with Pasteurella multocida and Arcanobacterium pyogenes; foot rot (necrotic pododermatitis) and calf diphtheria caused by Fusobacterium necrophorum and metritis caused by A. pyogenes.
(iii) Limitations. Cattle intended for human consumption must not be slaughtered within 21 days of the last use of this drug product. This drug product is not approved for use in female dairy cattle 20 months of age or older, including dry dairy cows. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. This product is not approved for use in calves intended to be processed for veal. A withdrawal period has not been established in preruminating calves. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) Swine —(i) Amount. Administer 4 mg/lb of body weight by intramuscular injection twice daily for not more than 3 consecutive days. Continue treatment 24 hours after symptoms disappear. If tylosin medicated drinking water is used as a followup treatment for swine dysentery, the animal should thereafter receive feed containing 40 to 100 grams of tylosin per ton for 2 weeks to assure depletion of tissue residues.
(ii) Indications for use. Treatment of swine arthritis caused by Mycoplasma hyosynoviae; swine pneumonia caused by Pasteurella spp.; swine erysipelas caused by Erysipelothrix rhusiopathiae; swine dysentery associated with Treponema hyodysenteriae when followed by appropriate medication in the drinking water and/or feed.
(iii) Limitations. Swine intended for human consumption must not be slaughtered within 14 days of the last use of this drug product. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(3) Dogs and cats —(i) Amount. Administer 3 to 5 mg/lb of body weight by intramuscular injection at 12- to 24-hour intervals.
(ii) Indications for use —(A) Dogs. Treatment of upper respiratory infections such as bronchitis, tracheobronchitis, tracheitis, laryngitis, tonsillitis, and pneumonia caused by Staphylococci spp., hemolytic Streptococci spp., and Pasteurella multocida.
(B) Cats. Treatment of upper respiratory infections when caused by Staphylococci spp. and hemolytic Streptococci spp. and for feline pneumonitis when caused by tylosin-susceptible organisms.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.2662   Xylazine.
(a) Specifications. Each milliliter (mL) of solution contains xylazine hydrochloride equivalent to:
(1) 20 milligrams (mg) xylazine.
(2) 100 mg xylazine.
(3) 300 mg xylazine.
(b) Sponsors. See sponsors in § 510.600(c) of this chapter for uses as in paragraph (d) of this section.
(1) No. 069043 for use of product described in paragraph (a)(2) of this section as in paragraph (d)(2) of this section.
(2) No. 061133 for use of product described in paragraph (a)(2) of this section as in paragraphs (d)(2), (d)(3)(i), (d)(3)(ii)(A), and (d)(3)(iii) of this section.
(3) Nos. 043264 and 061651 for use of product described in paragraph (a)(1) of this section as in paragraph (d)(1) of this section; and product described in paragraph (a)(2) of this section as in paragraphs (d)(2), (d)(3)(i), (d)(3)(ii)(A), and (d)(3)(iii) of this section.
(4) No. 059399 for use of product described in paragraph (a)(1) of this section as in paragraph (d)(1) of this section; product described in paragraph (a)(2) of this section as in paragraphs (d)(2), (d)(3)(i), (d)(3)(ii)(A), and (d)(3)(iii) of this section; and product described in paragraph (a)(3) of this section as in paragraphs (d)(3)(i), (d)(3)(ii)(B), and (d)(3)(iii) of this section.
(c) Special considerations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(d) Conditions of use —(1) Dogs and cats —(i) Amount. 0.5 mg/pound (lb) intravenously or 1.0 mg/lb subcutaneously.
(ii) Indications for use. To produce sedation, as an analgesic, and as a preanesthetic to local or general anesthesia.
(2) Horses —(i) Amount. 0.5 mg/lb intravenously or 1.0 mg/lb intramuscularly.
(ii) Indications for use. To produce sedation, as an analgesic, and as a preanesthetic to local or general anesthesia.
(iii) Limitations. Do not use in horses intended for human consumption.
(3) Elk and deer —(i) Amount. Administer intramuscularly, by hand syringe, or by syringe dart, in the heavy muscles of the croup or shoulder as follows:
(A) Elk ( Cervus canadensis ): 0.25 to 0.5 mg/lb.
(B) Mule deer ( Odocoileus hemionus ), sika deer ( Cervus nippon ), and white-tailed deer ( Odocoileus virginianus ): 1 to 2 mg/lb.
(C) Fallow deer ( Dama dama ): 2 to 4 mg/lb.
(ii) Indications for use. (A) To produce sedation, as an analgesic, and as a preanesthetic to local anesthesia.
(B) To produce sedation, accompanied by a shorter period of analgesia. May be used to calm and facilitate handling of fractious animals for diagnostic procedures, for minor surgical procedures, for therapeutic medication for sedation and relief of pain following injury or surgery, and as a preanesthetic to local anesthetic. At the recommended dosages, can be used in conjunction with local anesthetics, such as procaine or lidocaine.
(iii) Limitations. Do not use in domestic food-producing animals. Do not use in Cervidae less than 15 days before or during the hunting season.
§ 522.2670   Yohimbine.
(a) Specifications. Each milliliter (mL) of solution contains 2 or 5 milligrams (mg) of yohimbine (as hydrochloride).
(b) Sponsors. See sponsors in § 510.600(c) of this chapter for use as in paragraph (c) of this section.
(1) No. 059399 for use of in 2 mg/mL solution as in paragraph (c)(1) of this section.
(2) No. 053923 for use of in 5 mg/mL solution as in paragraph (c)(2) of this section.
(c) Conditions of use —(1) Dogs —(i) Amount. Administer 0.05 mg per pound (0.11 mg per kilogram) of body weight by intravenous injection.
(ii) Indications for use. To reverse the effects of xylazine in dogs.
(iii) Limitations. Not for use in food-producing animals. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) Deer and elk —(i) Amount. Administer 0.2 to 0.3 mg per kilogram of body weight by intravenous injection.
(ii) Indications for use. A s an antagonist to xylazine sedation in free ranging or confined members of the family Cervidae (deer and elk).
(iii) Limitations. Do not use in domestic food-producing animals. Do not use for 30 days before or during hunting season. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.2680   Zeranol.
(a) Specifications. Each pellet contains 12, 18, or 20 milligrams (mg) zeranol.
(b) Sponsor. See 000061 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.760 of this chapter.
(d) Conditions of use —(1) Beef cattle —(i) Amount. 36 mg zeranol (one implant consisting of 3 pellets, each pellet containing 12 mg zeranol) per implant dose.
(ii) Indications for use. (A) Weaned beef calves, growing beef cattle, feedlot steers, and feedlot heifers: For increased rate of weight gain and improved feed conversion.
(B) Suckling calves: For increased rate of weight gain.
(iii) Limitations. Implant pellets subcutaneously only. Not approved for repeated implantation (reimplantation) with this or any other cattle ear implant within a single production phase as safety and effectiveness have not been evaluated. Do not use in beef calves less than 2 months of age, dairy calves, and veal calves because effectiveness and safety have not been evaluated. A withdrawal period has not been established for this product in preruminating calves. Do not use in replacement beef heifers after weaning or in bulls, dairy cows, or replacement dairy heifers.
(2) Feedlot lambs —(i) Amount. 12 mg zeranol (one implant consisting of 1 pellet containing 12 mg zeranol) per implant dose.
(ii) Indications for use. For increased rate of weight gain and improved feed conversion.
(iii) Limitations. Implant subcutaneously in ear only. Do not use in breeding animals. Do not implant animals within 40 days of slaughter. Safety and effectiveness have not been established in veal calves. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.
(3) Steers fed in confinement for slaughter —(i) Amount. 72 mg zeranol (one implant consisting of 6 pellets, each pellet containing 12 mg zeranol) per implant dose.
(ii) Indications for use. For increased rate of weight gain and improved feed efficiency.
(iii) Limitations. Implant subcutaneously in ear only. Safety and effectiveness have not been established in veal calves. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.
(4) Pasture cattle (slaughter, stocker, feeder steers, and heifers) —(i) Amount. 138 mg zeranol (one implant consisting of 7 pellets, each of 6 pellets containing 20 mg zeranol and a seventh pellet containing 18 mg zeranol) per implant dose.
(ii) Indications for use. For increased rate of weight gain.
(iii) Limitations. Implant subcutaneously in ear only. Safety and effectiveness have not been established in veal calves. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.
§ 522.2690   Zinc gluconate.
(a) Specifications. Each milliliter of solution contains 13.1 milligrams zinc as zinc gluconate neutralized to pH 7.0 with L-arginine.
(b) Sponsor. See No. 011788 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs —(1) Amount. The volume injected into each testicle is based on testicular width as determined by measuring each testicle at its widest point using a metric scale (millimeter) caliper.
(2) Indications for use. Intratesticular injection for chemical sterilization of 3- to 10-month-old male dogs.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.2694   Zinc, copper, manganese, and selenium.
(a) Specifications. Each milliliter (mL) of solution contains 60 milligrams (mg) zinc as zinc oxide, 15 mg copper as copper carbonate, 10 mg manganese as manganese carbonate, and 5 mg selenium as sodium selenite.
(b) Sponsor. See No. 066679 in § 510.600(c) of this chapter.
(c) Conditions of use —(1) Amount. Administer a single dose by subcutaneous injection to cattle up to 1 year of age, 1 mL/100 lb bodyweight; to cattle from 1 to 2 years of age, 1 mL/150 lb bodyweight, and to cattle over 2 years of age, 1 mL/200 lb bodyweight.
(2) Indications for use. As a supplemental source of zinc, copper, manganese, and selenium in cattle.
(3) Limitations. Cattle must not be slaughtered for human food consumption within 14 days of the last treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.