CFR - Code of Federal Regulations Title 21

The information on this page is current as of Mar 22, 2024.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations]

[Title 21, Volume 6]

[CITE: 21CFR558.348]

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

Sec. 558.348 Mibolerone.

(a) Specifications. Each 6.5 ounce can contains 30 or 60 micrograms ([micro]g) of mibolerone.

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

(c) Conditions of use in dogs - (1) Amount. 30 [micro]g for animals weighing up to 25 pounds; 60 [micro]g for animals weighing 26 to 50 pounds; 120 [micro]g for animals weighing 51 to 100 pounds; 180 [micro]g 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.

[85 FR 45310, July 28, 2020]