21 C.F.R. § 522.1290 Luprostiol sterile solution.
Title 21 - Food and Drugs
(a) Specifications. Each milliliter of sterile solution contains 7.5 milligrams of luprostiol. (b) Sponsor. See No. 057926 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—(1) Amount. 7.5 milligrams per mare. (2) Indications for use. The drug is used in mares for estrus control and termination of pregnancy. (3) Limitations. Administer by intramuscular injection only. Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [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]
Title 21: Food and Drugs
PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
§ 522.1290 Luprostiol sterile solution.
