21 CFR § 520.390b - Chloramphenicol capsules.

---
identifier: "/us/cfr/t21/s520.390b"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 520.390b - Chloramphenicol capsules."
title_number: 21
title_name: "Food and Drugs"
section_number: "520.390b"
section_name: "Chloramphenicol capsules."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "E"
subchapter_name: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_number: "520"
part_name: "ORAL DOSAGE FORM NEW ANIMAL DRUGS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 360b."
regulatory_source: "40 FR 13838, Mar. 27, 1975, unless otherwise noted."
cfr_part: "520"
---


# 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]