[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR522.314]

[Page 226]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS--Table of Contents
 
Sec.  522.314  Ceftiofur hydrochloride.

    (a) Specifications. Each milliliter of suspension contains ceftiofur 
hydrochloride equivalent to 50 milligrams (mg) of ceftiofur.
    (b) Sponsor. See No. 000009 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.113 of this chapter.
    (d) Conditions of use. (1) Swine--(i) Amount. 3 to 5 mg per kilogram 
(/kg) of body weight by intramuscular injection. Treatment should be 
repeated at 24-hour intervals for a total of 3 consecutive days.
    (ii) Indications for use. For treatment and control of swine 
bacterial respiratory disease (swine bacterial pneumonia) associated 
with Actinobacillus (Haemophilus) pleuropneumoniae, Pastureurella 
multocida, Salmonella choleraesuis, and Streptococcus suis Type 2.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) Cattle--(i) Dosage. 1.1 to 2.2 mg/kg of body weight by 
intramuscular or subcutaneous injection, at 24-hour intervals for 3 to 5 
consecutive days. For bovine respiratory disease, 2.2 mg/kg of body 
weight may be administered twice at a 48-hour interval. For acute 
metritis, administer 2.2 mg/kg of body weight daily for 5 consecutive 
days.
    (ii) Indications for use. For treatment of bovine respiratory 
disease (BRD, shipping fever, pneumonia) associated with Mannheimia spp. 
(Pasteurella haemolytica), P. multocida, and Haemophilus somnus; acute 
bovine interdigital necrobacillosis (foot rot, pododermatitis) 
associated with Fusobacterium necrophorum and Bacteroides 
melaninogenicus; and acute metritis (0 to 14 days post partum) 
associated with bacteria susceptible to ceftiofur.
    (iii) Limitations. Do not slaughter treated cattle for 48 hours (2 
days) after last treatment. A withdrawal period has not been established 
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.

[61 FR 29479, June 11, 1996, as amended at 63 FR 53578, Oct. 6, 1998; 67 
FR 45901, July 11, 2002]