21 CFR § 520.999 - Fluralaner oral solution.

---
identifier: "/us/cfr/t21/s520.999"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 520.999 - Fluralaner oral solution."
title_number: 21
title_name: "Food and Drugs"
section_number: "520.999"
section_name: "Fluralaner oral solution."
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"
---


# 520.999 Fluralaner oral solution.

(a) *Specifications.* Each milliliter (mL) of solution contains 10 milligrams (mg) fluralaner.

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

(c) *Conditions of use in laying hens and replacement chickens*—(1) *Amount.* Administer orally to chickens via the drinking water as 2 single doses, spaced 7 days apart, with each dose consumed over a period of 6 to 24 hours. Each dose is 0.5 mg fluralaner/kilogram (kg) (0.227 mg/pound (mg/lb)) body weight, equivalent to 0.05 mL fluralaner oral solution/kg body weight (0.023 mL/lb).

(2) *Indications for use.* For the treatment and control of northern fowl mites (*Ornithonyssus sylviarum*).

(3) *Limitations.* Federal law restricts this drug to use by or on the order of a licensed veterinarian. Chickens must not be slaughtered for human consumption for 11 days after the last treatment. No egg discard is required when used according to the labeling.

[91 FR 5300, Feb. 6, 2026]