21 CFR 522.914 - Fenprostalene.

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There are 5 Updates appearing in the Federal Register for 21 CFR 522. View below or at eCFR (GPOAccess)
§ 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]

Title 21 published on 2014-04-01

The following are only the Rules published in the Federal Register after the published date of Title 21.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2014-10-28; vol. 79 # 208 - Tuesday, October 28, 2014
    1. 79 FR 64114 - New Animal Drugs; Alfaxalone; Dinoprost; Ivermectin and Clorsulon; Nitrofurazone; Trenbolone and Estradiol Benzoate; Trimethoprim and Sulfadiazine; Tylosin; Change of Sponsor
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule, technical amendment.
      This rule is effective October 28, 2014.
      21 CFR Parts 510, 520, 522, 524, and 556

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United States Code
U.S. Code: Title 21 - FOOD AND DRUGS

Title 21 published on 2014-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 522 after this date.

  • 2014-10-28; vol. 79 # 208 - Tuesday, October 28, 2014
    1. 79 FR 64114 - New Animal Drugs; Alfaxalone; Dinoprost; Ivermectin and Clorsulon; Nitrofurazone; Trenbolone and Estradiol Benzoate; Trimethoprim and Sulfadiazine; Tylosin; Change of Sponsor
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule, technical amendment.
      This rule is effective October 28, 2014.
      21 CFR Parts 510, 520, 522, 524, and 556