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Title 21: Food and Drugs
CHAPTER I: FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)
SUBCHAPTER E: ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS
PART 522: IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
522.315 - Ceftiofur crystalline free acid.
(a) Specifications?(1) Each milliliter (mL) of suspension contains 100 milligrams (mg) ceftiofur equivalents (CE).
(2) Each mL of suspension contains 200 mg CE.
(b) Sponsor. See No. 000009 in ? 510.600(c) of this chapter.
(c) Related tolerances. See ? 556.113 of this chapter.
(d) Conditions of use?(1) Swine. The formulation described in paragraph (a)(1) of this section is used as follows:
(i) Amount. 5.0 mg CE per kilogram (kg) of body weight by intramuscular injection in the postauricular region of the neck.
(ii) Indications for use. For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis, and Streptococcus suis.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Following label use as a single treatment, a 14-day preslaughter withdrawal period is required.
(2) Cattle. The formulation described in paragraph (a)(2) of this section is used as follows:
(i) Amount. 6.6 mg CE per kg of body weight by a single, subcutaneous injection in the middle third of the posterior aspect of the ear.
(ii) Indications for use. For the treatment of bovine respiratory disease (BRD), shipping fever, pneumonia) associated with Mannheimia haemolytica, Pasteurella multocida, and Haemophilus somnus. For the control of respiratory disease in cattle at high risk of developing BRD associated with M. haemolytica, P. multocida, and H. somnus.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. A withdrawal period has not been established in preruminating calves. Do not use in calves to be processed for veal.
[68 FR 60296, Oct. 22, 2003, as amended at 69 FR 43892, July 23, 2004]
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