21 CFR 522.1002 - Follicle stimulating hormone.

§ 522.1002 Follicle stimulating hormone.


(1)Specifications. Each package contains 2 vials. One vial contains dry, powdered, porcine pituitary gland equivalent to 75 units (NIH-FSH-S1) of follicle stimulating hormone. The other vial contains 10 milliliters of aqueous diluent.

(2)Sponsor. See No. 052923 in § 510.600(c) of this chapter.

(3)Conditions of use.

(i)Dosage. 12.5 units of follicle stimulating hormone twice a day for 3 days (a total of 75 units). To effect regression of the corpus luteum, prostaglandin should be given with the 5th dose.

(ii)Indications for use. For induction of superovulation in cows for procedures requiring the production of multiple ova at a single estrus.

(iii)Limitations. For intramuscular use in cows that are not pregnant and have a normal corpus luteum. Federal law restricts this drug to use by or on the order of a licensed veterinarian.


(1)Specifications. The drug is a lyophilized pituitary extract material. Each 10-milliliter vial contains an amount equivalent to 50 milligrams of standard porcine follicle stimulating hormone and is reconstituted for use by addition of 10 milliliters of 0.9 percent aqueous sodium chloride solution.

(2)Sponsor. See 063112 in § 510.600(c) of this chapter.

(3)Conditions of use.

(i)Dosage. Cattle and horses, 10-50 milligrams; sheep and swine, 5-25 milligrams; dogs, 5-15 milligrams.

(ii)Indications for use. The drug is used as a supplemental source of follicle stimulating hormone where there is a general deficiency in cattle, horses, sheep, swine, and dogs.

(iii)Limitations. Administer intramuscularly, subcutaneously, or intravenously. Federal law restricts this drug to use by or on the order of a licensed veterinarian.


(1)Specifications. Each package contains 2 vials. One vial contains 700 international units (IU) porcine-pituitary derived follicle stimulating hormone (FSH) equivalent to 400 milligrams NIH-FSH-P1, as a dry powder. The other vial contains 20 milliliters (mL) of bacteriostatic sodium chloride injection. When reconstituted, each milliliter of constituted solution contains 35 IU FSH.

(2)Sponsor. See No. 017030 in § 510.600(c) of this chapter.

(3)Conditions of use -

(i)Dosage. Administer 2.5 mL (87.5 IU) intramuscularly, twice daily at 12-hour intervals, for 4 consecutive days. In conjunction with the 6th dose, administer an approved prostaglandin product for cattle (cloprostenol sodium or dinoprost tromethamine), using the labeled dosage and administration instructions to cause luteolysis and induce estrus. See § 522.460 for use of cloprostenol sodium or § 522.690 for use of dinoprost tromethamine.

(ii)Indications for use. For the induction of superovulation in beef and dairy heifers and cows.

(iii)Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[ 58 FR 47377, Sept. 9, 1993, as amended at 62 FR 62242, Nov. 21, 1997; 76 FR 2808, Jan. 18, 2011; 79 FR 53136, Sept. 8, 2014; 79 FR 74020, Dec. 15, 2014]

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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