[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: 21CFR529.1003]

[Page 324]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES--(Continued)
 
PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS--Table of Contents
 
Sec. 529.1003  Flurogestone acetate-impregnated vaginal sponge.

    (a) Specifications. Each vaginal sponge contains 20 milligrams of 
flurogestone acetate.
    (b) Sponsor. See No. 000014 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Indications for use. For synchronizing 
estrus/ovulation in cycling adult ewes during their normal breeding 
season.
    (2) Limitations. Using applicator provided, insert sponge into ewe's 
vagina 13 days before desired start of breeding. For intravaginal use in 
sheep only. Do not use in young ewes that have not had lambs. Use 
plastic or rubber gloves when handling large numbers of sponges to 
minimize exposure to drug. Do not leave sponge in the vagina for more 
than 21 days. Ewes must not be slaughtered for food within 30 days of 
sponge removal.

[49 FR 45420, Nov. 16, 1984]