21 CFR 529.1003 - Flurogestone acetate-impregnated vaginal sponge.

§ 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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United States Code
U.S. Code: Title 21 - FOOD AND DRUGS

Title 21 published on 2015-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 529 after this date.

  • 2015-04-08; vol. 80 # 67 - Wednesday, April 8, 2015
    1. 80 FR 18773 - New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor's Name; Change of Sponsor's Address
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; technical amendments.
      This rule is effective April 8, 2015, except for the amendment to 21 CFR 522.1004, which is effective April 20, 2015.
      21 CFR Parts 510, 520, 522, 524, 529, and 558