21 CFR § 524.998 - Fluralaner.

---
identifier: "/us/cfr/t21/s524.998"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 524.998 - Fluralaner."
title_number: 21
title_name: "Food and Drugs"
section_number: "524.998"
section_name: "Fluralaner."
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: "524"
part_name: "OPHTHALMIC AND TOPICAL 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 13873, Mar. 27, 1975, unless otherwise noted."
cfr_part: "524"
---


# 524.998 Fluralaner.

(a) *Specifications.* Each milliliter of solution contains 280 milligrams (mg) fluralaner.

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

(c) *Conditions of use*—(1) *Dogs*—(i) *Amount.* Administer topically as a single dose every 12 weeks according to the label dosage schedule to provide a minimum dose of 11.4 mg/lb (25 mg/kg) body weight. May be administered every 8 weeks in case of potential exposure to *Amblyomma americanum* ticks.

(ii) *Indications for use.* 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), and *Rhipicephalus sanguineus* (brown dog tick)) for 12 weeks in dogs and puppies 6 months of age and older, and weighing 4.4 lb or greater; for the treatment and control of *A. americanum* (lone star tick) infestations for 8 weeks in dogs and puppies 6 months of age and older, and weighing 4.4 lb or greater.

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

(2) *Cats*—(i) *Amount.* Administer topically as a single dose every 12 weeks according to the label dosage schedule to provide a minimum dose of 18.2 mg/lb (40 mg/kg) body weight. May be administered every 8 weeks in case of potential exposure to *D. variabilis* ticks.

(ii) *Indications for use.* Kills adult fleas; for the treatment and prevention of flea infestations (*C. felis*) and the treatment and control of *I. scapularis* (black-legged tick) and *Haemaphysalis longicornis* (Asian longhorned tick) infestations for 12 weeks in cats and kittens 6 months of age and older, and weighing 2.6 lb or greater; for the treatment and control of *D. variabilis* (American dog tick) infestations for 8 weeks in cats and kittens 6 months of age and older, and weighing 2.6 lb or greater.

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

[81 FR 67152, Sept. 30, 2016, as amended at 82 FR 43485, Sept. 18, 2017; 88 FR 14901, Mar. 10, 2023]