21 CFR § 520.292 - Capromorelin.

---
identifier: "/us/cfr/t21/s520.292"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 520.292 - Capromorelin."
title_number: 21
title_name: "Food and Drugs"
section_number: "520.292"
section_name: "Capromorelin."
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"
---


# 520.292 Capromorelin.

(a) *Specifications.* Each milliliter of solution contains:

(1) 30 milligrams (mg) capromorelin; or

(2) 20 mg capromorelin.

(b) *Sponsor.* See No. 058198 in § 510.600(c) of this chapter.

(c) *Conditions of use*—(1) *Dogs.* Use product described in paragraph (a)(1) of this section as follows:

(i) *Amount.* Administer 3 mg/kg once daily by mouth.

(ii) *Indications for use.* For appetite stimulation in dogs.

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

(2) *Cats.* Use product described in paragraph (a)(2) of this section as follows:

(i) *Amount.* Administer 2 mg/kg once daily by mouth.

(ii) *Indications for use.* For management of weight loss in cats with chronic kidney disease.

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

[81 FR 59133, Aug. 29, 2016, as amended at 85 FR 4207, Jan. 24, 2020; 86 FR 17063, Apr. 1, 2021]