Federal regulations · Through 2026-08-25 · Newer source version available

21 CFR 558.348: Mibolerone.

(a) Specifications. Each 6.5 ounce can contains 30 or 60 micrograms (µg) of mibolerone.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs—(1) Amount. 30 µg for animals weighing up to 25 pounds; 60 µg for animals weighing 26 to 50 pounds; 120 µg for animals weighing 51 to 100 pounds; 180 µg for animals weighing over 100 pounds, or German Shepherds or German Shepherd mix weighing 30 to 80 pounds. Administer daily at least 30 days before expected initiation of heat and continue as long as desired, but for not more than 12 months.
(2) Indications for use. For the prevention of estrus (heat) in adult female dogs not intended primarily for breeding purposes.
(3) Limitations. Mibolerone should not be used in bitches before first estrous period or in purebred Bedlington terriers. It is not intended for animals being used primarily for breeding purposes. Use orally in adult female dogs only. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Where this section sits in the code

Title 21—Food and Drugs
CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER E—ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS
PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
Subpart B—Specific New Animal Drugs for Use in Animal Feeds

(a) Specifications. Each 6.5 ounce can contains 30 or 60 micrograms (µg) of mibolerone.

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

(c) Conditions of use in dogs—(1) Amount. 30 µg for animals weighing up to 25 pounds; 60 µg for animals weighing 26 to 50 pounds; 120 µg for animals weighing 51 to 100 pounds; 180 µg for animals weighing over 100 pounds, or German Shepherds or German Shepherd mix weighing 30 to 80 pounds. Administer daily at least 30 days before expected initiation of heat and continue as long as desired, but for not more than 12 months.

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

(3) Limitations. Mibolerone should not be used in bitches before first estrous period or in purebred Bedlington terriers. It is not intended for animals being used primarily for breeding purposes. Use orally in adult female dogs only. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Collected 2026-08-27T02:24:47Z. Source file · JSON

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