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Electronic Code of Federal Regulations

e-CFR data is current as of December 9, 2019

Title 21Chapter ISubchapter EPart 522 → §522.533


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


§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. 051311 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, as amended at 79 FR 18158, Apr. 1, 2014]

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