cfr_sections: 21:21:6.0.1.1.12.0.1.119
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| 21:21:6.0.1.1.12.0.1.119 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | 522.1660a | § 522.1660a Oxytetracycline solution, 200 milligrams/milliliter. | FDA | 21 U.S.C. 360b. | 40 FR 13858, Mar. 27, 1975, unless otherwise noted. | [45 FR 16479, Mar. 14, 1980. Redesignated and amended at 69 FR 31879, June 8, 2004] | (a) Specifications. Each milliliter of sterile solution contains 200 milligrams of oxytetracycline base. (b) Sponsors. See Nos. 000010, 016592, 054771, 055529, 061133, and 069254 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.500 of this chapter; and for No. 061133, see also § 500.1410 of this chapter. (d) Conditions of use —(1) Beef cattle, dairy cattle, and calves including prerumenative (veal) calves —(i) Amounts and indications for use. (A) 3 to 5 mg per pound of body weight (mg/lb BW) per day (/day) intramuscularly, subcutaneously, or intravenously for treatment of pneumonia and shipping fever complex associated with Pasteurella spp. and Haemophilus spp., foot-rot and diphtheria caused by Fusobacterium necrophorum, bacterial enteritis (scours) caused by Escherichia coli, wooden tongue caused by Actinobacillus lignieresii, leptospirosis caused by Leptospira pomona, wound infections and acute metritis caused by Staphylococcus spp. and Streptococcus spp., and anthrax caused by Bacillus anthracis. (B) 5 mg/lb BW/day intramuscularly or intravenously for treatment of anaplasmosis caused by Anaplasma marginale, severe foot-rot, and advanced cases of other indicated diseases. (C) 9 mg/lb BW intramuscularly or subcutaneously as single dosage where retreatment of calves and yearlings for bacterial pneumonia is impractical, for treatment of infectious bovine keratoconjunctivitis (pinkeye) caused by Moraxella bovis, or where retreatment for anaplasmosis is impractical. (ii) Limitations. Discontinue treatment at least 28 days prior to slaughter. Milk taken from animals during treatment and for 96 hours after the last treatment must not be used for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (2) Swine —(i) Amounts and indications for use. (A) Sows: 3 mg/lb BW intramuscularly once, approximately 8 hours before farrowing or immediately after completion of farrowing, as an aid in control of infectious enteritis (baby pig scours, colibacillosis) in suckling pigs caused by E. coli. (B) 3 to 5 mg/lb BW/day intramuscularly for treatment of bacterial enteritis (scours, colibacillosis) caused by E. coli, pneumonia caused by Pasteurella multocida, and leptospirosis caused by Leptospira pomona. (C) 9 mg/lb BW as a single dosage where retreatment for pneumonia is impractical. (ii) Limitations. Administer intramuscularly. Do not inject more than 5 mL per site in adult swine. Discontinue treatment at least 28 days prior to slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian. |