Code of Federal Regulations Title 21. Food and Drugs § 21.522.1002 Follicle stimulating hormone

(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.

(i) Single pack. 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 constituted, each milliliter of solution contains 35 IU FSH.

(ii) Dual pack. Each package contains 2 vials. Each vial contains 700 international units (IU) porcine-pituitary-derived FSH equivalent to 400 milligrams NIH–FSH–P1, as a dry powder. Constitute with 20 mL bacteriostatic sodium chloride injection, using strict aseptic technique. When constituted, each milliliter of solution contains 35 IU FSH.

(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.