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: 21CFR520.2123c]

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. 520.2123c Spectinomycin solution.

(a) Specifications. Each milliliter of solution contains spectinomycin dihydrochloride pentahydrate equivalent to 50 milligrams (mg) spectinomycin.

(b) Sponsors. See Nos. 016592, 054771, and 061133 in § 510.600(c) of this chapter.

(c) Related tolerances. See § 556.600 of this chapter.

(d) Conditions of use in swine - (1) Amount. Administer 5 mg per pound (lb) of body weight orally twice daily for 3 to 5 days.

(2) Indications for use. For the treatment and control of porcine enteric colibacillosis (scours) caused by E. coli susceptible to spectinomycin in pigs under 4 weeks of age.

(3) Limitations. Do not administer to pigs over 15 lb body weight or over 4 weeks of age. Do not administer within 21 days of slaughter. 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 78 FR 17596, Mar. 22, 2013; 79 FR 28828, May 20, 2014; 81 FR 22523, Apr. 18, 2016; 84 FR 8973, Mar. 13, 2019; 88 FR 14897, Mar. 10, 2023]