21 CFR § 520.766 - Domperidone.

---
identifier: "/us/cfr/t21/s520.766"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 520.766 - Domperidone."
title_number: 21
title_name: "Food and Drugs"
section_number: "520.766"
section_name: "Domperidone."
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: "520"
part_name: "ORAL 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 13838, Mar. 27, 1975, unless otherwise noted."
cfr_part: "520"
---


# 520.766 Domperidone.

(a) *Specifications.* Each milliliter of gel contains 110 milligrams (mg) domperidone.

(b) *Sponsor.* See No. 043264 in § 510.600 of this chapter.

(c) *Conditions of use in horses*—(1) *Amount.* Administer 0.5 mg per pound (mg/lb) (1.1 mg/kilogram (kg)) by mouth once daily starting 10 to 15 days prior to the expected foaling date. Treatment may be continued for up to 5 days after foaling if mares are not producing adequate milk.

(2) *Indications for use.* For prevention of fescue toxicosis in periparturient mares.

(3) *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 67031, Nov. 1, 2010]