21 CFR 522.533 - Deslorelin.

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There are 12 Updates appearing in the Federal Register for 21 CFR 522. View below or at eCFR (GPOAccess)
§ 522.533 Deslorelin.
(a) Specifications—
(1) Each implant contains 2.1 milligrams (mg) deslorelin acetate.
(2) Each milliliter (mL) of suspension contains 1.8 mg deslorelin acetate.
(b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter as follows:
(1) No. 043246 for use of product described in paragraph (a)(1) as in paragraph (c)(1) of this section.
(2) No. 051330 for use of product described in paragraph (a)(2) as in paragraph (c)(2) of this section.
(c) Conditions of use—
(1) Horses and ponies—
(i) Amount. One implant per mare subcutaneously in the neck.
(ii) Indications for use. For inducing ovulation within 48 hours in estrous mares with an ovarian follicle greater than 30 mL in diameter.
(iii) Limitations. Do not use in horses or ponies intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) Horses—
(i) Amount. Administer 1.8 mg (1 mL) by intramuscular injection in the neck.
(ii) Indications for use. For inducing ovulation within 48 hours in cyclic estrous mares with an ovarian follicle between 30 and 40 mL in diameter.
(iii) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[75 FR 81456, Dec. 28, 2010]

Title 21 published on 2013-04-01

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.

  • 2014-04-15; vol. 79 # 72 - Tuesday, April 15, 2014
    1. 79 FR 21126 - New Animal Drugs; Ceftiofur Sodium; Gentamicin; Xylazine
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; technical amendment.
      This rule is effective April 15, 2014.
      21 CFR Part 522

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

Title 21 published on 2013-04-01

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

  • 2014-04-15; vol. 79 # 72 - Tuesday, April 15, 2014
    1. 79 FR 21126 - New Animal Drugs; Ceftiofur Sodium; Gentamicin; Xylazine
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; technical amendment.
      This rule is effective April 15, 2014.
      21 CFR Part 522