21 CFR § 529.2620 - Triptorelin.

---
identifier: "/us/cfr/t21/s529.2620"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 529.2620 - Triptorelin."
title_number: 21
title_name: "Food and Drugs"
section_number: "529.2620"
section_name: "Triptorelin."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "E"
subchapter_name: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_number: "529"
part_name: "CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 360b."
regulatory_source: "40 FR 13881, Mar. 27, 1975, unless otherwise noted."
cfr_part: "529"
---


# 529.2620 Triptorelin.

(a) *Specifications.* Each milliliter of gel contains 100 micrograms (mcg) triptorelin as triptorelin acetate.

(b) *Sponsor.* See No. 051072 in § 510.600(c) of this chapter.

(c) *Conditions of use in swine*—(1) *Amount.* Administer 200 mcg intravaginally approximately 96 hours after weaning.

(2) *Indications for use.* For the synchronization of time of insemination in weaned sows to facilitate a single fixed-time artificial insemination.

(3) *Limitations.* Not approved for use in gilts. Safety and effectiveness have not been evaluated in these animals. Should not be used in sows with obvious reproductive tract abnormalities.

[77 FR 64717, Oct. 23, 2012, as amended at 90 FR 6801, Jan. 21, 2025]