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Code · CFR · Title 21 — Food and Drugs · Part 520 — Oral Dosage Form New Animal Drugs · § 520.999

§ 520.999. Fluralaner oral solution.

150 words·~1 min read·/us/cfr/t21/s§ 520.999·

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

(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]
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