21 C.F.R. § 522.914 Fenprostalene solution.
Title 21 - Food and Drugs
(a) Specifications—(1) Cattle. Each milliliter of sterile solution contains 0.5 milligram of fenprostalene. (2) Swine. Each milliliter of sterile solution contains 0.25 milligram of fenprostalene. (b) Sponsor. See 000856 in §510.600(c) of this chapter. (c) Related tolerances. See §556.277 of this chapter. (d) Special considerations. Labeling shall bear the following statements: Women of childbearing age, asthmatics, and persons with bronchial and other respiratory problems should exercise extreme caution when handling this product. It is readily absorbed through the skin and may cause abortion and/or bronchiospasms. Accidental spillage on the skin should be washed off immediately with soap and water. (e) Conditions of use—(1) Cattle—(i) Amount. 1 milligram (2 milliliters) subcutaneously per animal. (ii) Indications for use. For feedlot heifers to induce abortion when pregnant 150 days or less. For beef or nonlactating dairy cattle for estrus synchronization. (iii) Limitations. Subcutaneous use in cattle only. Feedlot heifers to induce abortion, single dose. Beef or nonlactating dairy cattle for estrus synchronization, a single dose or two doses 11 to 13 days apart. Do not use in pregnant animals unless abortion is desired. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (2) Swine—(i) Amount. 0.25 milligram (1 milliliter) subcutaneously once per animal. (ii) Indications for use. For sows and gilts pregnant at least 112 days for the induction of parturition. (iii) Limitations. Subcutaneous use in swine only. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [48 FR 7164, Feb. 18, 1983, as amended at 49 FR 26715, June 29, 1984; 54 FR 400, Jan. 6, 1989; 61 FR 5506, Feb. 13, 1996]
Title 21: Food and Drugs
PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
§ 522.914 Fenprostalene solution.
