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Electronic Code of Federal Regulations

e-CFR data is current as of December 6, 2019

Title 21Chapter ISubchapter EPart 522 → §522.1014


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


§522.1014   Gamithromycin.

(a) Specifications. Each milliliter (mL) of solution contains 150 milligrams (mg) gamithromycin.

(b) Sponsor. See No. 000010 in §510.600(c) of this chapter.

(c) Related tolerances. See §556.292 of this chapter.

(d) Conditions of use—(1) Cattle—(i) Amount. Administer 6 mg/kilogram of body weight (2 mL per 110 pounds) 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, Histophilus somni, and Mycoplasma bovis 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 and P. multocida.

(iii) Limitations. Cattle intended for human consumption must not be slaughtered within 35 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]

[76 FR 57906, Sept. 19, 2011, as amended at 77 FR 26162, May 3, 2012; 84 FR 39184, Aug. 9, 2019]

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