21 CFR 529.1003 - Flurogestone acetate-impregnated vaginal sponge.

Code of Federal Regulations - Title 21: Food and Drugs (December 2005)


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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 529 - CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

529.1003 - Flurogestone acetate - impregnated vaginal sponge.

  (a) Specifications. Each vaginal sponge contains 20 milligrams of flurogestone acetate.

  (b) Sponsor. See No. 000014 in 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]

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