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: 21CFR520.903d]

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. 520.903d Febantel tablets.

(a) Specifications. Each scored tablet contains 27.2 milligrams of febantel for use in dogs, puppies, cats, and kittens or 163.3 milligrams of febantel for use in dogs, puppies, and cats.

(b) Sponsor. See No. 058198 in § 510.600(c) of this chapter.

(c) Conditions of use - (1) Amount - (i) Dogs and cats. Ten milligrams per kilogram body weight. Administer once daily for 3 consecutive days.

(ii) Puppies and kittens fewer than 6 months of age. Fifteen milligrams per kilogram body weight. Administer once daily for 3 consecutive days.

(2) Indications for use. (i) For removal of hookworms (Ancylostoma caninum and Uncinaria stenocephala ), ascarids (Toxocara canis and Toxascaris leonina ) and whipworms (Trichuris vulpis ) in dogs and puppies.

(ii) For removal of hookworms (Ancylostoma tubaeforme ) and ascarids (Toxocara cati ) in cats and kittens.

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

[56 FR 50655, Oct. 8, 1991, as amended at 79 FR 28821, May 20, 2014. Redesignated at 85 FR 18119, Apr. 1, 2020, as amended at 86 FR 14818, Mar. 19, 2021]