[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: 21CFR520.390a]

[Page 113-114]
 
                        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.  520.390a  Chloramphenicol tablets.

    (a)(1) Specifications. Each tablet contains 100, 250, or 500 
milligrams, 1 or 2.5 grams of chloramphenicol.
    (2) Sponsor. In Sec.  510.600(c) of this chapter: No. 000010 for 
100-, 250-, and 500-milligram and 1-gram tablets; No. 000856 for 100-, 
250-. and 500-milligram tablets; No. 017030 for 100-milligram tablets; 
No. 000010 for 100-, 250-, and 500-milligram and 1- and 2.5-gram 
tablets; No. 000069 for 250-milligram tablets.
    (3) Conditions of use. Dogs--(i) Amount. 25 milligrams per pound of 
body weight every 6 hours.
    (ii) Indications for use. Oral treatment of bacterial pulmonary 
infections, bacterial infections of the urinary tract, bacterial 
enteritis, and bacterial infections associated with canine distemper 
caused by susceptible organisms.
    (iii) Limitations. Laboratory tests should be conducted, including 
in vitro culturing and susceptibility tests on samples collected prior 
to treatment. If no response to chloramphenicol therapy is obtained in 3 
to 5 days, discontinue its use and review diagnosis. Not for animals 
which are raised for food production. Chloramphenicol products must not 
be used in meat-, egg-, or milk-producing animals. The length of time 
that residues persist in milk or tissues has not been determined. 
Because of potential antagonism, chloramphenicol should not be 
administered simultaneously with penicillin or streptomycin. Federal law 
restricts this drug to use by or on the order of a licensed 
veterinarian.
    (b)(1) Specifications. Each tablet contains 50, 100, 250, or 500 
milligrams, or 1 gram of chloramphenicol.
    (2) Sponsor. See No. 061623 in Sec.  510.600(c) of this chapter.
    (3) Conditions of use. Dogs--(i) Amount. 25 milligrams per pound of 
body weight every 6 hours.
    (ii) Indications for use. Oral treatment of bacterial 
gastroenteritis associated

[[Page 114]]

with bacterial diarrhea, bacterial pulmonary infections, and bacterial 
infections of the urinary tract caused by susceptible organisms.
    (iii) Limitations. Laboratory tests should be conducted, including 
in vitro culturing and susceptibility tests on samples collected prior 
to treatment. If no response is obtained in 3 to 5 days, discontinue use 
and reevaluate diagnosis. Not for animals that are raised for food 
production. Chloramphenicol products should not be administered in 
conjunction with or 2 hours prior to the induction of general anesthesia 
with pentobarbital because of prolonged recovery. Chloramphenicol should 
not be administered to dogs maintained for breeding purposes. Because of 
potential antagonism, chloramphenicol should not be administered 
simultaneously with penicillin or streptomycin. Federal law restricts 
this drug to use by or on the order of a licensed veterinarian.

[57 FR 37323, Aug. 18, 1992, as amended at 62 FR 35076, June 30, 1997; 
66 FR 14073, Mar. 9, 2001; 68 FR 4914, Jan. 31, 2003]