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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of Oct 17, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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[Code of Federal Regulations]
[Title 21, Volume 6]
[CITE: 21CFR522.1079]



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 522 -- IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

Sec. 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) Related tolerances. See § 556.304 of this chapter.

(d) 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; 84 FR 32992, July 11, 2019]

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