21 C.F.R. § 522.1077

Current through October 31, 2024
Section 522.1077 - Gonadorelin
(a)Specifications. Each milliliter (mL) of solution contains:
(1) 43 micrograms ([MICRO]g) of gonadorelin as gonadorelin acetate;
(2) 100 [MICRO]g of gonadorelin as gonadorelin acetate;
(3) 50 [MICRO]g of gonadorelin as gonadorelin diacetate tetrahydrate (equivalent to 43 [MICRO]g gonadorelin); or
(4) 50 [MICRO]g of gonadorelin as gonadorelin hydrochloride.
(b)Sponsors. See sponsor numbers in § 510.600(c) of this chapter.
(1) No. 000061 for use of the 43-[MICRO]g/mL product described in paragraph (a)(1) as in paragraphs (e)(1)(i) and (iii) of this section.
(2) No. 068504 for use of the 100-[MICRO]g/mL product described in paragraph (a)(2) as in paragraphs (d)(1)(i) and (iv) of this section.
(3) Nos. 000010 and 061133 for use of the 50-[MICRO]g/mL product described in paragraph (a)(3) of this section as in paragraphs (e)(1)(i) and (v) of this section.
(4) No. 054771 for use of the 50-[MICRO]g/mL product described in paragraph (a)(4) as in paragraphs (e)(1)(ii) and (vi) of this section.
(c)Related tolerances. See § 556.304 of this chapter.
(d)Special considerations.
(1) Concurrent luteolytic drug use is approved as follows:
(i) Cloprostenol injection for use as in paragraph (e)(1)(iii) of this section as provided by No. 000061 in § 510.600(c) of this chapter.
(ii) Cloprostenol injection for use as in paragraph (e)(1)(iv) of this section as provided by No. 068504 in § 510.600(c) of this chapter.
(iii) Cloprostenol injection for use as in paragraph (e)(1)(v) of this section as provided by Nos. 000010 in § 510.600(c) of this chapter.
(iv) Dinoprost injection for use as in paragraph (e)(1)(vi) of this section as provided by No. 054771 in § 510.600(c) of this chapter.
(2) Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(e)Conditions of use in cattle -
(1)Indications for use and amounts.
(i) For the treatment of ovarian follicular cysts in dairy cattle: Administer 86 [MICRO]g gonadorelin (No. 000061), or 100 [MICRO]g gonadorelin diacetate tetrahydrate (Nos. 000010 and 061133), or 100 [MICRO]g gonadorelin (as gonadorelin acetate; No. 068504) by intramuscular or intravenous injection.
(ii) For the treatment of ovarian follicular cysts in cattle: Administer 100 [MICRO]g gonadorelin hydrochloride by intramuscular injection.
(iii) For use with cloprostenol sodium to synchronize estrous cycles to allow for fixed-time artificial insemination (FTAI) in beef cows and lactating dairy cows: Administer to each cow 86 [MICRO]g gonadorelin by intramuscular injection, followed 6 to 8 days later by 500 [MICRO]g cloprostenol by intramuscular injection, followed 30 to 72 hours later by 86 [MICRO]g gonadorelin by intramuscular injection.
(iv) For use with cloprostenol sodium to synchronize estrous cycles to allow for fixed-time artificial insemination (FTAI) in lactating dairy cows and beef cows: Administer to each cow 100 [MICRO]g gonadorelin by intramuscular injection, followed 6 to 8 days later by 500 [MICRO]g cloprostenol by intramuscular injection, followed 30 to 72 hours later by 100 [MICRO]g gonadorelin by intramuscular injection.
(v) For use with cloprostenol sodium to synchronize estrous cycles to allow for fixed-time artificial insemination (FTAI) in lactating dairy cows and beef cows: Administer to each cow 100 [MICRO]g gonadorelin diacetate tetrahydrate by intramuscular injection, followed 6 to 8 days later by 500 [MICRO]g cloprostenol by intramuscular injection, followed 30 to 72 hours later by 100 [MICRO]g gonadorelin diacetate tetrahydrate by intramuscular injection.
(vi) For use with dinoprost injection to synchronize estrous cycles to allow fixed-time artificial insemination (FTAI) in lactating dairy cows: Administer to each cow 100 to 200 [MICRO]g gonadorelin by intramuscular injection, followed 6 to 8 days later by 25 mg dinoprost by intramuscular injection, followed 30 to 72 hours later by 100 to 200 [MICRO]g gonadorelin by intramuscular injection.
(2) [Reserved]

21 C.F.R. §522.1077

83 FR 64740 , Dec. 18, 2018, as amended at 84 FR 8973 , Mar. 13, 2019; 84 FR 39184 , Aug. 9, 2019; 84 FR 32992 , July 11, 2019; 86 FR 13184 , Mar. 8, 2021; 86 FR 14820 , Mar. 19, 2021; 87 FR 17946 , Mar. 29, 2022; 88 FR 27699 , May 3, 2023
As amended at 81 FR 36789, 6/8/2016; as amended at 81 FR 36789, 6/8/2016; 83 FR 64740, 12/18/2018; as amended at 84 FR 8973, 3/13/2019; 84 FR 39184, 8/9/2019; 84 FR 32992, 9/9/2019; 86 FR 13184, 3/8/2021; 86 FR 14820, 3/19/2021; 87 FR 17946, 3/29/2022; 88 FR 27699, 5/3/2023