[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: 21CFR522.90a]

[Page 218-219]
 
                        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. 522.90a  Ampicillin trihydrate sterile suspension.

    (a) Specifications. Each milliliter contains ampicillin trihydrate 
equivalent to 200 milligrams of ampicillin.
    (1) Sponsor. See No. 053501 in Sec. 510.600(c) of this chapter.
    (2) Related tolerances. See Sec. 556.40 of this chapter.
    (3) Conditions of use--(i) Calves.
    (A) Amount. For enteritis: 3 milligrams per pound of body weight, 
intramuscularly, once or twice daily, for up to 3 days. For pneumonia: 3 
milligrams per pound of body weight, intramuscularly, twice daily, for 
up to 3 days.
    (B) Indications for use. Treatment of bacterial enteritis caused by 
Escherichia coli and bacterial pneumonia caused by Pasteurella spp. 
susceptible to ampicillin.
    (C) Limitations. Not for use in other animals raised for food 
production. Treated animals must not be slaughtered for food use during 
treatment or for 9 days after the last treatment. Federal law restricts 
this drug to use by or on the order of a licensed veterinarian.
    (ii) Dogs. (A) Amount. 3 to 6 milligrams per pound of body weight 
intramuscularly, once or twice daily.
    (B) Indications for use. Treatment of respiratory tract infections 
due to E. coli, Pseudomonas spp., Proteus spp., Staphylococcus spp., and 
Streptococcus spp.; tonsillitis due to E. coli, Pseudomonas spp., 
Streptococcus spp., and Staphylococcus spp.; generalized infections 
(septicemia) associated with abscesses, lacerations, and wounds due to 
Staphylococcus spp. and Streptococcus spp.
    (C) Limitations. Continue treatment at least 48 hours after the 
animal's temperature has returned to normal and other signs of infection 
have subsided. Usual treatment is 3 to 5 days. Federal law restricts 
this drug to use

[[Page 219]]

by or on the order of a licensed veterinarian.
    (iii) Cats. (A) Amount. 5 to 10 milligrams per pound of body weight 
intramuscularily or subcutaneously, once or twice daily.
    (B) Indications for use. Treatment of generalized infections 
(septicemia) associated with abscesses, lacerations, and wounds due to 
Staphylococcus spp., Streptococcus spp., and Pasteurella spp.
    (C) Limitations. Continue treatment at least 48 hours after the 
animal's temperature has returned to normal and other signs of infection 
have subsided. Usual treatment is 3 to 5 days. Federal law restricts 
this drug to use by or on the order of a licensed veterinarian.
    (iv) Swine. (A) Amount. 3 milligrams per pound of body weight, 
intramuscularily, once or twice daily, for up to 3 days.
    (B) Indications for use. Treatment of bacterial enteritis 
(colibacillosis) caused by E. coli and bacterial pneumonia caused by 
Pasteurella spp. susceptible to ampicillin.
    (C) Limitations. Treated animals must not be slaughtered for food 
use during treatment or for 15 days after the last treatment. Federal 
law restricts this drug to use by or on the order of a licensed 
veterinarian.
    (b) Specifications. Each milliliter contains ampicillin trihydrate 
equivalent to 150 milligrams of ampicillin.
    (1) Sponsor. See No. 000069 in Sec. 510.600(c) of this chapter.
    (2) Related tolerances. See Sec. 556.40 of this chapter.
    (3) Conditions of use. Dogs--(i) Amount. 3 to 5 milligrams of 
ampicillin per pound of body weight, once a day for up to 4 days.
    (ii) Indications for use. Treatment of bacterial infections of the 
upper respiratory tract (tonsillitis) due to Streptococcus spp., 
Staphylococcus spp., E. coli, Proteus spp., and Pasteurella spp., and 
soft tissue infections (abscesses, lacerations, and wounds) due to 
Staphylococcus spp., Streptococcus spp., and E. coli, when caused by 
susceptible organisms.
    (iii) Limitations. Administer intramuscularly. If continued 
treatment is indicated, oral dosage is recommended. As with all 
antibiotics, appropriate in vitro culturing and susceptibility tests of 
samples taken before treatment are recommended. Federal law restricts 
this drug to use by or on the order of a licensed veterinarian.

[57 FR 37330, Aug. 18, 1992, as amended at 60 FR 55659, Nov. 2, 1995]