21 C.F.R. § 522.1002 Follicle stimulating hormone.
Title 21 - Food and Drugs
(a)(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 059521 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. (b)(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. [58 FR 47377, Sept. 9, 1993, as amended at 62 FR 62242, Nov. 21, 1997]
Title 21: Food and Drugs
PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
§ 522.1002 Follicle stimulating hormone.
