21 CFR § 524.2080 - Ropinirole.

---
identifier: "/us/cfr/t21/s524.2080"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 524.2080 - Ropinirole."
title_number: 21
title_name: "Food and Drugs"
section_number: "524.2080"
section_name: "Ropinirole."
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: "524"
part_name: "OPHTHALMIC AND TOPICAL 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 13873, Mar. 27, 1975, unless otherwise noted."
cfr_part: "524"
---


# 524.2080 Ropinirole.

(a) *Specifications.* Each milliliter of solution contains 30 milligrams (mg) ropinirole (equivalent to 34.2 mg ropinirole hydrochloride).

(b) *Sponsor.* See No. 052483 in § 510.600(c) of this chapter.

(c) *Conditions of use*—(1) *Amount.* Using the table provided in labeling, administer the number of eye drops topically, corresponding to body weight, that results in a target dose of 3.75 mg per square meter (mg/m
<sup>2</sup>) (dose band 2.7 to 5.4 mg/m
<sup>2</sup>). If the dog does not vomit within 20 minutes of the first dose, then a second dose may be administered.

(2) *Indications for use.* For the induction of vomiting in dogs.

(3) *Limitations.* Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[86 FR 13185, Mar. 8, 2021]