21 CFR § 520.1430 - Mibolerone.

---
identifier: "/us/cfr/t21/s520.1430"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 520.1430 - Mibolerone."
title_number: 21
title_name: "Food and Drugs"
section_number: "520.1430"
section_name: "Mibolerone."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "E"
subchapter_name: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_number: "520"
part_name: "ORAL DOSAGE FORM NEW ANIMAL DRUGS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 360b."
regulatory_source: "40 FR 13838, Mar. 27, 1975, unless otherwise noted."
cfr_part: "520"
---


# 520.1430 Mibolerone.

(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.

[43 FR 15625, Apr. 14, 1978, as amended at 78 FR 28824, May 20, 2014]