---
kind: "section"
citation: "21 C.F.R. § 520.998"
title: "21"
number: "520.998"
heading: "Fluralaner chewable tablets."
url: "https://uscodex.org/cfr/21/520.998"
---

# §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)](/cfr/21/510.600.md?p=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.

## Notes

### Amendments

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

### Authority

Authority: 21 U.S.C. 360b.

### Source

Source: 40 FR 13838, Mar. 27, 1975, unless otherwise noted.

### Amendments

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