GroundRules
21 CFR 520.999: Fluralaner oral solution.
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER E—ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS
- PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS
(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.
Collected 2026-08-27T02:24:47Z. Source file · JSON