21 C.F.R. § 524.390b   Chloramphenicol ophthalmic solution.


Title 21 - Food and Drugs


Title 21: Food and Drugs
PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

Browse Previous |  Browse Next

§ 524.390b   Chloramphenicol ophthalmic solution.

(a) Specifications. Each milliliter contains 5 milligrams of chloramphenicol.

(b) Sponsor. See No. 017030 in §510.600(c) of this chapter.

(c) Conditions of use. Dogs and Cats—(1) Amount. Apply one or two drops, 4 to 6 times a day for the first 72 hours, depending upon the severity of the condition. Intervals between applications may be increased after the first 2 days.

(2) Indications for use. Treatment of bacterial conjunctivitis caused by organisms susceptible to chloramphenicol. Therapy should be continued for 48 hours after the eye appears normal.

(3) Limitations. Therapy for cats should not exceed 7 days. As with other antibiotics, prolonged use may result in overgrowth of nonsusceptible organisms. If superinfection occurs, or if clinical improvement is not noted within a reasonable period, discontinue use, and institute appropriate therapy. Prolonged use in cats may produce blood dyscrasias. 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. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[57 FR 37333, Aug. 18, 1992]

Browse Previous |  Browse Next






















chanrobles.com


ChanRobles Legal Resources:

ChanRobles On-Line Bar Review

ChanRobles Internet Bar Review : www.chanroblesbar.com

ChanRobles MCLE On-line

ChanRobles Lawnet Inc. - ChanRobles MCLE On-line : www.chanroblesmcleonline.com