CFR - Code of Federal Regulations Title 21

The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations]

[Title 21, Volume 6]

[CITE: 21CFR520.390c]

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

Sec. 520.390c Chloramphenicol palmitate oral suspension.

(a) Specifications. Each milliliter contains chloramphenicol palmitate equivalent to 30 milligrams of chloramphenicol.

(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.

(c) Conditions of use. Dogs - (1) Amount. 25 milligrams per pound of body weight every 6 hours. If no response is obtained in 3 to 5 days, discontinue use and reevaluate diagnosis.

(2) Indications for use. Treatment of bacterial pulmonary infections, infections of the urinary tract, enteritis, and infections associated with canine distemper that are caused by organisms susceptible to chloramphenicol.

(3) Limitations. Not for use in animals that are raised for food production. 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 37323, Aug. 18, 1992; 57 FR 42623, Sept. 15, 1992, as amended at 79 FR 28819, May 20, 2014]