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Electronic Code of Federal Regulations

e-CFR data is current as of December 12, 2019

Title 21Chapter ISubchapter EPart 522 → §522.2460


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


§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]

[77 FR 39391, July 3, 2012]

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