Regulations last checked for updates: Nov 22, 2024

Title 21 - Food and Drugs last revised: Nov 19, 2024
§ 522.995 - Fluprostenol.

(a) Specifications. Each milliliter of solution contains fluprostenol sodium equivalent to 50 micrograms (µg) of fluprostenol.

(b) Sponsor. See No. 058198 in § 510.600(c) of this chapter.

(c) Conditions of use in horses—(1) Amount. Administer 0.55 µg fluprostenol per kilogram of body weight by intramuscular injection.

(2) Indications for use. For use in mares for its luteolytic effect to control the timing of estrus in estrous cycling and in clinically anestrous mares that have a corpus luteum.

(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.

[79 FR 16189, Mar. 25, 2014, as amended at 86 FR 14820, Mar. 19, 2021]
authority: 21 U.S.C. 360b.
source: 40 FR 13858, Mar. 27, 1975, unless otherwise noted.
cite as: 21 CFR 522.995