21 CFR § 520.998 - Fluralaner chewable tablets.

---
identifier: "/us/cfr/t21/s520.998"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 520.998 - Fluralaner chewable tablets."
title_number: 21
title_name: "Food and Drugs"
section_number: "520.998"
section_name: "Fluralaner chewable tablets."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "E"
subchapter_name: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_number: "520"
part_name: "ORAL DOSAGE FORM NEW ANIMAL DRUGS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 360b."
regulatory_source: "40 FR 13838, Mar. 27, 1975, unless otherwise noted."
cfr_part: "520"
---


# 520.998 Fluralaner chewable tablets.

(a) *Specifications.* (1) Each chewable tablet contains 112.5, 250, 500, 1,000, or 1,400 milligrams (mg) fluralaner.

(2) Each chewable tablet contains 45, 100, 200, 400, or 560 mg fluralaner.

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

(c) *Conditions of use in dogs*—(1) *Amount.* Administer orally as a single dose with food:

(i) *Chewable tablets described in paragraph (a)(1) of this section.* Administer every 12 weeks, an appropriate combination of tablets to provide a minimum dose of 11.4 mg per pound (lb) (25 mg per kilogram (kg)) body weight. May be administered every 8 weeks in case of potential exposure to *Amblyomma americanum* ticks.

(ii) *Chewable tablets described in paragraph (a)(2) of this section.* Administer monthly, an appropriate combination of tablets to provide a minimum dose of 4.5 mg/lb (10 mg/kg) body weight.

(2) *Indications for use*—(i) *Chewable tablets described in paragraph (a)(1) of this section.* Kills adult fleas; for the treatment and prevention of flea infestations (*Ctenocephalides felis*), and the treatment and control of tick infestations (*Ixodes scapularis* (black-legged tick), *Dermacentor variabilis* (American dog tick), *Rhipicephalus sanguineus* (brown dog tick), and *Haemaphysalis longicornis* (Asian longhorned tick)) for 12 weeks in dogs and puppies 6 months of age and older, and weighing 4.4 lbs or greater; and for the treatment and control of *Amblyomma americanum* (lone star tick) infestations for 8 weeks in dogs and puppies 6 months of age and older, and weighing 4.4 lbs or greater.

(ii) *Chewable tablets described in paragraph (a)(2) of this section.* Kills adult fleas; for the treatment and prevention of flea infestations (*C. felis*), and the treatment and control of tick infestations (*I. scapularis* (black-legged tick), *D. variabilis* (American dog tick), *R. sanguineus* (brown dog tick), and *H. longicornis* (Asian longhorned tick)) for 1 month in dogs and puppies 8 weeks of age and older, and weighing 4.4 lb or greater; and for the treatment and control of *A. americanum* (lone star tick) infestations for 1 month in dogs and puppies 6 months of age and older, and weighing 4.4 lb or greater.

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

[86 FR 14818, Mar. 19, 2021, as amended at 88 FR 27698, May 3, 2023; 90 FR 6800, Jan. 21, 2025]