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Electronic Code of Federal Regulations

e-CFR data is current as of December 5, 2019

Title 21Chapter ISubchapter EPart 522 → §522.914


Title 21: Food and Drugs
PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS


§522.914   Fenprostalene.

(a) Specifications. (1) Each milliliter of solution contains 0.5 milligram (mg) fenprostalene.

(2) Each milliliter of solution contains 0.25 mg fenprostalene.

(b) Sponsor. See No. 054771 in §510.600(c) of this chapter for use of product described in paragraph (a)(1) as in paragraph (e)(1) of this section; and for use of product described in paragraph (a)(2) as in paragraph (e)(2) of this section.

(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) Indications for use and amount—(A) For feedlot heifers to induce abortion when pregnant 150 days or less, administer 1 mg (2 milliliter (mL)) subcutaneously.

(B) For beef or nonlactating dairy cattle for estrus synchronization, administer a single or two 1-mg (2-mL) doses subcutaneously, 11 to 13 days apart.

(ii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) Swine—(i) Amount. Administer a single injection of 0.25 mg (1 mL) subcutaneously.

(ii) Indications for use. For the induction of parturition in sows and gilts pregnant at least 112 days.

(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[79 FR 16188, Mar. 25, 2014]

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