CFR - Code of Federal Regulations Title 21

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For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations]

[Title 21, Volume 6]

[CITE: 21CFR522.1083]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER E - ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS

PART 522 -- IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

Sec. 522.1083 Gonadotropin releasing factor analog-diphtheria toxoid conjugate.

(a) Specifications. Each milliliter (mL) of solution contains 0.2 milligrams (mg) gonadotropin releasing factor analog-diphtheria toxoid conjugate.

(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.

(c) Conditions of use in swine - (1) Amount. Each intact male pig or gilt should receive two 2-mL (0.4 mg) doses by subcutaneous injection. Administer the first dose no earlier than 9 weeks of age. Administer the second dose at least 4 weeks after the first dose.

(2) Indications for use - (i) Intact male pigs intended for slaughter: For the temporary immunological castration (suppression of testicular function) and reduction of boar taint.

(ii) Gilts intended for slaughter: For the temporary suppression of estrus.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. For reduction of boar taint, intact male pigs should be slaughtered no earlier than 3 weeks and no later than 10 weeks after the second dose.

[76 FR 27889, May 13, 2011, as amended at 77 FR 4227, Jan. 27, 2012; 79 FR 16189, Mar. 25, 2014; 85 FR 45308, July 28, 2020]