CFR - Code of Federal Regulations Title 21

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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: 21CFR520.905d]

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. 520.905d Fenbendazole powder.

(a) Specifications. Each 2-ounce packet contains 2.27 grams (4 percent) fenbendazole.

(b) Sponsor. See No. 000061 in § 510.600(c) of this chapter.

(c) Related tolerances. See § 556.275 of this chapter.

(d) Conditions of use. It is administered to swine as follows:

(1) Amount. 3 milligrams fenbendazole per kilogram body weight per day (1.36 milligrams per pound per day).

(2) Indications for use. For removal and control of large roundworms (Ascaris suum ); lungworms (Metastrongylus apri ); nodular worms (Oesophagostomum dentatum, O. quadrispinulatum ); small stomach worms (Hyostrongylus rubidus ); whipworms (Trichuris suis ); and kidneyworms (Stephanurus dentatus - mature and immature).

(3) Limitations. Thoroughly mix the contents of the packet(s) with swine ration and administer according to label directions. Feed as sole ration for 3 consecutive days. Can be fed to pregnant sows. No prior withdrawal of feed or water is necessary. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.

[49 FR 18090, Apr. 27, 1984, as amended at 49 FR 20485, May 15, 1984; 66 FR 47960, Sept. 17, 2001; 70 FR 32489, June 3, 2005; 74 FR 61516, Nov. 25, 2009; 83 FR 48945, Oct. 9, 2018]