---
kind: "section"
citation: "21 C.F.R. § 522.1077"
title: "21"
number: "522.1077"
heading: "Gonadorelin."
url: "https://uscodex.org/cfr/21/522.1077"
---

# §522.1077. Gonadorelin.

- (a) **Specifications.** Each milliliter (mL) of solution contains:
  - (1) 43 micrograms (µg) of gonadorelin as gonadorelin acetate;
  - (2) 100 µg of gonadorelin as gonadorelin acetate;
  - (3) 50 µg of gonadorelin as gonadorelin diacetate tetrahydrate (equivalent to 43 µg gonadorelin); or
  - (4) 50 µg of gonadorelin as gonadorelin hydrochloride.
- (b) **Sponsors.** See sponsor numbers in [§ 510.600(c)](/cfr/21/510.600.md?p=c) of this chapter.
  - (1) **No.** 000061 for use of the 43-µg/mL product described in [paragraph (a)(1)](#a-1) as in paragraphs [(e)(1)(i)](#e-1-i) and [(iii)](#e-1-iii) of this section.
  - (2) **No.** 068504 for use of the 100-µg/mL product described in [paragraph (a)(2)](#a-2) as in paragraphs [(d)(1)(i)](#d-1-i) and [(iv)](#d-1-iv) of this section.
  - (3) **Nos.** 000010 and 061133 for use of the 50-µg/mL product described in [paragraph (a)(3)](#a-3) of this section as in paragraphs [(e)(1)(i)](#e-1-i) and [(v)](#e-1-v) of this section.
  - (4) **No.** 054771 for use of the 50-µg/mL product described in [paragraph (a)(4)](#a-4) as in paragraphs [(e)(1)(ii)](#e-1-ii) and [(vi)](#e-1-vi) of this section.
- (c) **Related tolerances.** See [§ 556.304](/cfr/21/556.304.md) 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)](/cfr/21/510.600.md?p=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)](/cfr/21/510.600.md?p=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)](/cfr/21/510.600.md?p=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)](/cfr/21/510.600.md?p=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 µg gonadorelin (No. 000061), or 100 µg gonadorelin diacetate tetrahydrate (Nos. 000010 and 061133), or 100 µg gonadorelin (as gonadorelin acetate; No. 068504) by intramuscular or intravenous injection.
    - (ii) **For the treatment of ovarian follicular cysts in cattle—** Administer 100 µg 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 µg gonadorelin by intramuscular injection, followed 6 to 8 days later by 500 µg cloprostenol by intramuscular injection, followed 30 to 72 hours later by 86 µg 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 µg gonadorelin by intramuscular injection, followed 6 to 8 days later by 500 µg cloprostenol by intramuscular injection, followed 30 to 72 hours later by 100 µg 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 µg gonadorelin diacetate tetrahydrate by intramuscular injection, followed 6 to 8 days later by 500 µg cloprostenol by intramuscular injection, followed 30 to 72 hours later by 100 µg 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 µg 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 µg gonadorelin by intramuscular injection.
  - (2) [Reserved]

## Notes

### Amendments

[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]

### Authority

Authority: 21 U.S.C. 360b.

### Source

Source: 40 FR 13858, Mar. 27, 1975, unless otherwise noted.

### Amendments

[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]