21 CFR 522.1079 - Serum gonadotropin and chorionic gonadotropin.

§ 522.1079 Serum gonadotropin and chorionic gonadotropin.

(a)Specifications. Each dose consists of 400 international units (I.U.) serum gonadotropin and 200 I.U. chorionic gonadotropin as a freeze-dried powder to be reconstituted with 5 milliliters of sterile aqueous diluent.

(b)Sponsor. See No. 000061 in § 510.600(c) of this chapter.

(c)Conditions of use in swine -

(1)Amount. 400 I.U. serum gonadotropin with 200 I.U. chorionic gonadotropin per 5 milliliters dose per animal.

(2)Indications for use.

(i)Gilts. For induction of fertile estrus (heat) in healthy prepuberal (noncycling) gilts.

(ii)Sows. For induction of estrus in healthy weaned sows experiencing delayed return to estrus.

(3)Limitations. For subcutaneous use only.

(i)Gilts. For use only in gilts over 5 1/2 months of age and weighing at least 85 kilograms (187 pounds).

(ii)Sows. Delayed return to estrus is most prevalent after the first litter. The effectiveness has not been established after later litters. Delayed return to estrus often occurs during periods of adverse environmental conditions, and sows mated under such conditions may farrow smaller than normal litters.

[ 55 FR 1405, Jan. 16, 1990, as amended at 58 FR 52222, Oct. 7, 1993; 74 FR 61516, Nov. 25, 2009]

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

Title 21 published on 10-May-2017 03:43

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 522 after this date.

  • 2017-05-10; vol. 82 # 89 - Wednesday, May 10, 2017
    1. 82 FR 21688 - New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsorship
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; correcting amendments.
      This rule is effective May 10, 2017, except for amendatory instruction 3 to 21 CFR 510.600, and amendatory instruction 10 to 21 CFR 522.1002, which are effective May 22, 2017.
      21 CFR Parts 510, 520, 522, 524, and 558