Code of Federal Regulations (Last Updated: July 5, 2024) |
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 |
Part 522 - Implantation or Injectable Dosage Form New Animal Drugs |
§ 522.315 - Ceftiofur crystalline free acid.
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(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 withActinobacillus pleuropneumoniae ,Pasteurella multocida ,Haemophilus parasuis , andStreptococcus 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 withMannheimia haemolytica ,Pasteurella multocida , andHaemophilus somnus . For the control of respiratory disease in cattle at high risk of developing BRD associated withM .haemolytica ,P .multocida , andH .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.