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: 21CFR520.390a]

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. 520.390a 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) 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.

[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]