21 CFR 520.43
§ 520.43 Afoxolaner.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 520.43, § 520.43 Afoxolaner, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/87063
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Full text
(a) Specifications. Each chewable tablet contains 11.3, 28.3, 68, or 136 milligrams (mg) afoxolaner.
(b) Sponsor. See No. 000010 in § 510.600(c) of this chapter.
(c) Conditions of use—(1) Amount. Administer orally once a month at a minimum dosage of 1.14 mg/pound (2.5 mg/kilogram).
(2) Indications for use. Kills adult fleas and for the treatment and prevention of flea infestations (Ctenocephalides felis); and the treatment and control of Ixodes scapularis (black-legged tick), Dermacentor variabilis (American dog tick), Amblyomma americanum (lone star tick), Amblyomma maculatum (Gulf Coast tick), Rhipicephalus sanguineus (brown dog tick), and Haemaphysalis longicornis (longhorned tick) infestations in dogs and puppies 8 weeks of age and older, weighing 4 pounds of body weight or greater, for 1 month; and for the prevention of Borrelia burgdorferi infections as a direct result of killing Ixodes scapularis vector ticks.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.