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Electronic Code of Federal Regulations

e-CFR data is current as of December 10, 2019

Title 21Chapter ISubchapter EPart 522 → §522.1664


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


§522.1664   Oxytetracycline and flunixin.

(a) Specifications. Each milliliter (mL) of solution contains 300 milligrams (mg) oxytetracycline base as amphoteric oxytetracycline and 20 mg flunixin base as flunixin meglumine.

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

(c) Related tolerances. See §§556.286 and 556.500 of this chapter.

(d) Conditions of use cattle—(1) Amount. Administer once as an intramuscular or subcutaneous injection of 1 mL per 22 pounds (lb) body weight (BW) (13.6 mg oxytetracycline and 0.9 mg flunixin per lb BW) where retreatment of calves and yearlings for bacterial pneumonia is impractical due to husbandry conditions, such as cattle on range, or where their repeated restraint is inadvisable.

(2) Indications for use. For the treatment of bacterial pneumonia associated with Pasteurella spp. and for the control of associated pyrexia in beef and nonlactating dairy cattle.

(3) Limitations. Discontinue treatment at least 21 days prior to slaughter of cattle. 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. A withdrawal period has not been established 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.

[76 FR 3489, Jan. 20, 2011, as amended at 79 FR 16192, Mar. 25, 2014]

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