(a) Specifications. Each milliliter of solution contains 7.5 milligrams (mg) luprostiol.

(b) Sponsor. See No. 051311 in §510.600(c) of this chapter.

(c) Special considerations. Labeling shall bear the following statements: Warning: Women of childbearing age, asthmatics, and persons with bronchial and other respiratory problems should exercise extreme caution when handling this product. In the early stages, women may be unaware of their pregnancies. Luprostiol is readily absorbed through the skin and can cause abortion and/or bronchiospasms. Direct contact with the skin should therefore be avoided. Accidental spillage on the skin should be washed off immediately with soap and water.

(d) Conditions of use in horses—(1) Amount. 7.5 mg by intramuscular injection.

(2) Indications for use. For estrus control and termination of pregnancy in mares.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use in horses intended for human consumption.

[55 FR 1185, Jan. 12, 1990, as amended at 56 FR 50653, Oct. 8, 1991; 60 FR 55659, Nov. 2, 1995; 61 FR 66582, Dec. 18, 1996; 74 FR 25146, May 27, 2009]