CFR - Code of Federal Regulations Title 21

The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations]

[Title 21, Volume 6]

[CITE: 21CFR520.292]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER E - ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS

PART 520 -- ORAL DOSAGE FORM NEW ANIMAL DRUGS

Sec. 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]