---
kind: "section"
citation: "21 C.F.R. § 520.390a"
title: "21"
number: "520.390a"
heading: "Chloramphenicol tablets."
url: "https://uscodex.org/cfr/21/520.390a"
---

# §520.390a. Chloramphenicol tablets.

- (a) **Specifications.** Each tablet contains 50, 100, 250, or 500 milligrams (mg); 1 or 2.5 grams (g) of chloramphenicol.
- (b) **Sponsors.** See [§ 510.600(c)](/cfr/21/510.600.md?p=c) of this chapter:
  - (1) **For use as in paragraphs (c)(1), (c)(2)(i), and (c)(3) of this section—**
    - (i) **No.** 069043 for 100-, 250-, and 500-mg; and 1- and 2.5-g tablets;
    - (ii) **No.** 054771 for 100-, 250-, and 500-mg tablets;
  - (2) **For use as in paragraphs (c)(1), (c)(2)(ii), and (c)(3) of this section—**
    - (i) **No.** 061133 for 50-, 100-, 250-, and 500-mg; and 1-g tablets;
    - (ii) [Reserved]
- (c) **Conditions of use in dogs—**
  - (1) **Amount.** Administer 25 mg per pound of body weight by mouth every 6 hours.
  - (2) **Indications for use—**
    - (i) For the treatment of bacterial pulmonary infections, bacterial infections of the urinary tract, bacterial enteritis, and bacterial infections associated with canine distemper caused by susceptible organisms.
    - (ii) For the treatment of bacterial gastroenteritis associated with bacterial diarrhea, bacterial pulmonary infections, and bacterial infections of the urinary tract caused by susceptible organisms.
  - (3) **Limitations.** Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits the extralabel use of this drug in food-producing animals.

## Notes

### Amendments

[77 FR 4896, Feb. 1, 2012, as amended at 78 FR 21059, Apr. 9, 2013; 79 FR 28819, May 20, 2014; 83 FR 48944, Sept. 28, 2018; 84 FR 8972, Mar. 13, 2019]

### Authority

Authority: 21 U.S.C. 360b.

### Source

Source: 40 FR 13838, Mar. 27, 1975, unless otherwise noted.

### Amendments

[77 FR 4896, Feb. 1, 2012, as amended at 78 FR 21059, Apr. 9, 2013; 79 FR 28819, May 20, 2014; 83 FR 48944, Sept. 28, 2018; 84 FR 8972, Mar. 13, 2019]