[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: 21CFR524.390a]

[Page 294]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS--Table of Contents
 
Sec.  524.390a  Chloramphenicol ophthalmic ointment.

    (a) Specifications. Each gram contains 10 milligrams chloramphenicol 
in a petrolatum base.
    (b) Sponsor. See Nos. 000856 and 025463 in Sec.  510.600(c) of this 
chapter for use as in paragraph (c)(1)(i) of this section. See No. 
017030 for use as in paragraph (c)(1)(ii) of this section.
    (c) Conditions of use. Dogs and cats. (1) Amount. Apply as follows:
    (i) Every 3 hours around the clock for 48 hours after which night 
instillations may be omitted.
    (ii) Four to six times daily to affected eye for the first 72 hours 
depending upon the severity of the condition. A small amount of ointment 
should be placed in the lower conjunctival sac.
    (2) Indications for use. Treatment of bacterial conjunctivitis 
caused by pathogens susceptible to chloramphenicol.
    (3) Limitations. Continue treatment for 48 hours (2 days) after eye 
appears normal. Therapy for cats should not exceed 7 days. Prolonged use 
in cats may produce blood dyscrasias. If improvement is not noted in a 
few days a change of therapy should be considered. When infection may be 
cause of disease, especially in purulent or catarrhal conjunctivitis, 
attempts should be made to determine through susceptibility testing, 
which antibiotics will be effective prior to applying ophthalmic 
preparations. This chloramphenicol product must not be used in animals 
producing meat, eggs, or milk. The length of time that residues persist 
in milk or tissues has not been determined. Federal law restricts this 
drug to use by or on the order of a licensed veterinarian.

[57 FR 37333, Aug. 18, 1992]