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Electronic Code of Federal Regulations

e-CFR data is current as of December 3, 2019

Title 21Chapter ISubchapter EPart 522 → §522.1660b


Title 21: Food and Drugs
PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS


§522.1660b   Oxytetracycline solution, 300 milligrams/milliliter.

(a) Specifications. Each milliliter (mL) of solution contains 300 milligrams (mg) oxytetracycline base.

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

(c) Related tolerances. See §556.500 of this chapter.

(d) Special considerations. When labeled for use as in paragraph (e)(1)(i)(D) or (e)(1)(i)(E) of this section, labeling shall also 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 cattle, nonlactating dairy cattle, and calves including preruminating (veal) calves—(i) Amounts and indications for use—(A) 3 to 5 mg per pound of bodyweight (mg/lb BW) per day (/day) intramuscularly, subcutaneously, or intravenously for treatment of pneumonia and shipping fever complex associated with Pasteurella spp. and Histophilus 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.

(B) 5 mg/lb BW/day intramuscularly, subcutaneously, or intravenously for treatment of 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 or for treatment of infectious bovine keratoconjunctivitis (pinkeye) caused by Moraxella bovis.

(D) 9 to 13.6 mg/lb BW intramuscularly or subcutaneously as single dosage where retreatment of calves and yearlings for bacterial pneumonia is impractical or for treatment of infectious bovine keratoconjunctivitis (pinkeye) caused by Moraxella bovis.

(E) 13.6 mg/lb BW intramuscularly or subcutaneously as a single dosage for control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia (Pasteurella) haemolytica.

(ii) Limitations. Treatment should be continued 24 to 48 hours following remission of disease signs, however, not to exceed a total of four consecutive days. Do not inject more than 10 mL per site in adult cattle, reducing the volume according to age and body size to 1 to 2 mL in small calves. Exceeding the highest recommended level of drug/lb BW/day, administering more than the recommended number of treatments, and/or exceeding 10 mL intramuscularly or subcutaneously per injection site may result in antibiotic residues beyond the withdrawal time. Rapid intravenous administration may result in animal collapse. Oxytetracycline should be administered intravenously slowly over a period of at least 5 minutes. Discontinue treatment at least 28 days prior to slaughter. Not for use in lactating dairy animals.

(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. Treatment should be continued 24 to 48 hours beyond remission of disease signs, however, not to exceed a total of 4 consecutive days. Exceeding the highest recommended level of drug/lb BW/day, administering more than the recommended number of treatments, and/or exceeding 5 mL intramuscularly per injection site may result in antibiotic residues beyond the withdrawal time. Discontinue treatment at least 28 days prior to slaughter.

[68 FR 54805, Sept. 19, 2003. Redesignated and amended at 69 FR 31879, June 8, 2004; 73 FR 14926, Mar. 20, 2008]

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