StacksVerified U.S. regulatory reference

21 CFR §522.995

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
  1. (a)Specifications. Each milliliter of solution contains fluprostenol sodium equivalent to 50 micrograms (µg) of fluprostenol.
  2. (b)Sponsor. See No. 058198 in § 510.600(c) of this chapter.
  3. (c)Conditions of use in horses—(1) Amount. Administer 0.55 µg fluprostenol per kilogram of body weight by intramuscular injection.
    1. (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.
    2. (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.