CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER E—ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS (parts 500 to 590) > PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS > 522.2630—Tulathromycin.

522.2630—Tulathromycin.

(a) Specifications. Each milliliter of solution contains 100 milligrams (mg) tulathromycin.
(b) Sponsor. See No. 000069 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.745 of this chapter.
(d) Conditions of use— (1) Beef and nonlactating dairy cattle— 2.5 mg per kilogram (/kg) body weight as a single 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. For the control of respiratory disease in cattle at high risk of developing BRD associated with M. haemolytica, P. multocida, H. somni, and M. bovis. For the treatment of infectious bovine keratoconjunctivitis associated with Moraxella bovis. For the treatment of bovine foot rot (interdigital necrobacillosis) associated with Fusobacterium necrophorum and Porphyromonas levii.
(iii) Limitations. Cattle intended for human consumption must not be slaughtered within 18 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) Swine— (i) Amount. 2.5 mg/kg body weight as a single intramuscular injection in the neck.
(ii) Indications for use. For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, P. multocida, Bordetella bronchiseptica, Haemophilus parasuis, and Mycoplasma hyopneumoniae; and for the control of SRD associated with A. pleuropneumoniae, P. multocida, and M. hyopneumoniae in groups of pigs where SRD has been diagnosed.
(iii) Limitations. Swine intended for human consumption must not be slaughtered within 5 days from the last treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Code of Federal Regulations

[70 FR 39918, July 12, 2005, as amended at 71 FR 57416, Sept. 29, 2006; 72 FR 54540, Sept. 26, 2007; 73 FR 6018, Feb. 1, 2008; 73 FR 58872, Oct. 8, 2008; 74 FR 53165, Oct. 16, 2009]