[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR522.90b]

[Page 219-220]
 
                        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. 522.90b  Ampicillin trihydrate for sterile suspension.

    (a) Specifications. When reconstituted, each milliliter contains 
ampicillin trihydrate equivalent to 50, 100, or 250 milligrams of 
ampicillin.
    (b) Sponsor. (1) See 000856 in Sec. 510.600(c) of this chapter for 
use of 50, 100, and 250 milligrams per milliliter ampicillin suspension.
    (2) See 010515 in Sec. 510.600(c) of this chapter for use of 100 and 
250 milligrams per milliliter ampicillin suspension.
    (c) Related tolerances. See Sec. 556.40 of this chapter.
    (d) Conditions of use. (1) Dogs--(i) Amount. 3 milligrams per pound 
of body weight twice daily.
    (ii) Indications for use. Treatment against strains of organisms 
susceptible to ampicillin and associated with respiratory tract 
infections, urinary tract infections, gastrointestinal infections, skin 
infections, soft tissue infections, and postsurgical infections.
    (iii) Limitations. Administer by subcutaneous or intramuscular 
injection. Treatment should be continued for 48 to 72 hours after the 
animal has become afebrile or asymptomatic. Federal law restricts this 
drug to use by or on the order of a licensed veterinarian.
    (2) Cats--(i) Amount. 3 milligrams per pound of body weight twice 
daily.
    (ii) Indications for use. Treatment against strains of organisms 
susceptible to ampicillin and associated with respiratory tract 
infections, urinary tract infections, gastrointestinal infections, skin 
infections, soft tissue infections, and postsurgical infections.
    (iii) Limitations. Administer by subcutaneous or intramuscular 
injection. Treatment should be continued for 48 to 72 hours after the 
animal has become afebrile or asymptomatic. Federal law restricts this 
drug to use by or on the order of a licensed veterinarian.

[[Page 220]]

    (3) Cattle--(i) Amount. 2 to 5 milligrams per pound of body weight 
once daily by intramuscular injection.
    (ii) Indications for use. Treatment of respiratory tract infections 
caused by organisms susceptible to ampicillin, bacterial pneumonia 
(shipping fever, calf pneumonia, and bovine pneumonia) caused by 
Aerobacter spp., Klebsiella spp., Staphylococcus spp., Streptococcus 
spp., Pasteurella multocida, and Escherichia coli.
    (iii) Limitations. Do not treat cattle for more than 7 days. Milk 
from treated cows must not be used for food during treatment and for 48 
hours (4 milkings) after the last treatment. Cattle must not be 
slaughtered for food during treatment and for 144 hours (6 days) after 
the last treatment. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[57 FR 37331, Aug. 18, 1992; 57 FR 42623, Sept. 15, 1992; 58 FR 18304, 
Apr. 8, 1993; 63 FR 41420, Aug. 4, 1998]