21 CFR §522.1820

1. (a)Specifications. The drug is a lyophilized pituitary extract. Each 6-milliliter vial contains an amount equivalent to 25 milligrams of standard pituitary luteinizing hormone and is reconstituted for use by addition of 5 milliliters of 0.9 percent aqueous sodium chloride solution.
2. (b)Sponsor. No. 000061 in § 510.600(c) of this chapter.
3. (c)Conditions of use—(1) Amount. Cattle and horses: 25 milligrams; swine: 5 milligrams; sheep: 2.5 milligrams; and dogs: 1.0 milligram. Preferably given by intravenous injection, it may be administered subcutaneously. Treatment may be repeated in 1 to 4 weeks, or as indicated.
   1. (2)Indications for use. As an aid in the treatment of breeding disorders related to pituitary hypofunction in cattle, horses, swine, sheep, and dogs.
   2. (3)Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.