(a) Specifications. Each milliliter contains 100 micrograms of mibolerone.

(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.

(c) Conditions of use in dogs—(1) Amount. 30 micrograms for animals weighing 1 to 25 pounds; 60 micrograms for animals weighing 26 to 50 pounds; 120 micrograms for animals weighing 51 to 100 pounds; 180 micrograms for animals weighing over 100 pounds, German Shepherds, or German Shepherd mix. Administer daily, orally or in a small amount of food, at least 30 days before expected initiation of heat, and continue daily as long as desired, but not for more than 24 months.

(2) Indications for use. For the prevention of estrus (heat) in adult female dogs not intended primarily for breeding purposes.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.