Code of Federal Regulations (Last Updated: July 5, 2024) |
Title 21 - Food and Drugs |
Chapter I - Food and Drug Administration, Department of Health and Human Services |
SubChapter E - Animal Drugs, Feeds, and Related Products |
Part 520 - Oral Dosage Form New Animal Drugs |
§ 520.390b - Chloramphenicol capsules.
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§ 520.390b Chloramphenicol capsules.
(a) Specifications. Each capsule contains 50, 100, 250, or 500 milligrams (mg) chloramphenicol.
(b) Sponsors. See Nos. 050057 and 054771 in § 510.600(c) of this chapter for use as in paragraph (d) of this section.
(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, as amended at 73 FR 18442, Apr. 4, 2008; 75 FR 55676, Sept. 14, 2010; 79 FR 28819, May 20, 2014]