[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR558.348]

[Page 421]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES--(Continued)
 
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS--Table of Contents
 
      Subpart B--Specific New Animal Drugs for Use in Animal Feeds
 
Sec. 558.348  Mibolerone.

    (a) Approvals. To No. 000009 in Sec. 510.600(c) of this chapter for 
a canned dog food, each 6\1/2\ ounce can containing 30 or 60 micrograms 
of mibolerone.
    (b) Conditions of use--(1) Amount. 30 micrograms for animals 
weighing up 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, or German Shepherds or 
German Shepherd mix weighing 30 to 80 pounds.
    (2) Indications for use. For the prevention of estrus (heat) in 
adult female dogs not intended primarily for breeding purposes.
    (3) Limitations. Administer daily at least 30 days before expected 
initiation of heat and continue as long as desired, but for not more 
than 12 months. 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.

[47 FR 6617, Feb. 16, 1982]