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: 21CFR520.2123a]

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. 520.2123a Spectinomycin tablets.

(a) Specifications. Each tablet contains spectinomycin dihydrochloride equivalent to 100 milligrams (mg) spectinomycin.

(b) Sponsors. See Nos. 054771 and 061133 in § 510.600(c) of this chapter.

(c) Conditions of use in dogs - (1) Amount. Administer orally to provide 10 mg per pound (lb) of body weight twice daily. Dosage may be continued for 4 consecutive days.

(2) Indications for use. For the treatment of infectious diarrhea and gastroenteritis caused by organisms susceptible to spectinomycin.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[73 FR 6607, Feb. 5, 2008, as amended at 79 FR 28828, May 20, 2014; 84 FR 8973, Mar. 13, 2019]