Regulations last checked for updates: Nov 22, 2024

Title 21 - Food and Drugs last revised: Nov 19, 2024
§ 520.1855 - Ponazuril.

(a) Specifications. Each gram of paste contains 150 milligrams (mg) ponazuril.

(b) Sponsor. See No. 000010 in § 510.600(c) of this chapter.

(c) Conditions of use in horses—(1) Amount. Administer orally 15 mg per kilogram (kg) (6.81 mg per pound (lb)) body weight as the first dose, followed by 5 mg/kg (2.27 mg/lb) body weight once daily for a period of 27 additional days.

(2) Indications for use. For the treatment of equine protozoal myeloencephalitis caused by Sarcocystis neurona.

(3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[66 FR 43774, Aug. 21, 2001, as amended at 79 FR 28827, May 20, 2014; 80 FR 34278, June 16, 2015; 80 FR 53459, Sept. 4, 2015; 84 FR 39183, Aug. 9, 2019]
authority: 21 U.S.C. 360b.
source: 40 FR 13838, Mar. 27, 1975, unless otherwise noted.
cite as: 21 CFR 520.1855