21 C.F.R. § 520.390a Chloramphenicol tablets.
Title 21 - Food and Drugs
(a)(1) Specifications. Each tablet contains 100, 250, or 500 milligrams, 1 or 2.5 grams of chloramphenicol. (2) Sponsor. In §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 §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 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]
Title 21: Food and Drugs
PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS
§ 520.390a Chloramphenicol tablets.
