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21 C.F.R. § 520.390b   Chloramphenicol capsules.

Title 21 - Food and Drugs

Title 21: Food and Drugs
PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS

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§ 520.390b   Chloramphenicol capsules.

(a) Specifications. Each capsule contains 50, 100, 250, or 500 milligrams (mg) chloramphenicol.

(b) Sponsors. See sponsors in §510.600(c) of this chapter for use as in paragraph (d) of this section.

(1) Nos. 000069, 000185, and 050057 for capsules containing 50, 100, 250, or 500 mg chloramphenicol.

(2) No. 058034 for capsules containing 100 or 250 mg chloramphenicol.

(c) Special considerations. Federal law prohibits the extralabel use of this product in food-producing animals.

(d) Conditions of use in dogs—(1) Amount. 25 mg per pound of body weight every 6 hours.

(2) Indications for use. For treatment of bacterial pulmonary infections, bacterial infections of the urinary tract, bacterial enteritis, and bacterial infections associated with canine distemper caused by susceptible organisms.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[70 FR 75398, Dec. 20, 2005]

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