[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: 21CFR520.90f]

[Page 105]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS--Table of Contents
 
Sec.  520.90f  Ampicillin trihydrate boluses.

    (a) Specifications. Each bolus contains ampicillin trihydrate 
equivalent to 400 milligrams of ampicillin.
    (b) Sponsor. See No. 055529 in Sec.  510.600(c) of this chapter for 
use as in paragraph (d)(1), 000069 for use as in paragraph (d)(2).
    (c) Related tolerances. See Sec.  556.40 of this chapter.
    (d) Conditions of use. Nonruminating calves--(1) Amount. 5 
milligrams per pound of body weight twice daily for up to 5 days.
    (i) Indications for use. Oral treatment of colibacillosis caused by 
Escherichia coli, bacterial enteritis caused by Salmonella spp., and 
bacterial pneumonia caused by Pasteurella spp.
    (ii) Limitations. Treated calves must not be slaughtered for food 
during treatment and for 15 days after the last treatment. Not for use 
in other animals raised for food production. Federal law restricts this 
drug to use by or on the order of a licensed veterinarian.
    (2) Amount. 5 milligrams per pound of body weight twice daily not to 
exceed 4 days.
    (i) Indications for use. Oral treatment of bacterial enteritis 
(colibacillosis) caused by E. coli.
    (ii) Limitations. Treated calves must not be slaughtered for food 
during treatment and for 7 days after the last treatment. Not for use in 
other animals raised for food production. Federal law restricts this 
drug to use by or on the order of a licensed veterinarian.

[57 FR 37322, Aug. 18, 1992, as amended at 58 FR 61016, Nov. 19, 1993; 
60 FR 55659, Nov. 2, 1995]