21 CFR § 520.455Chapter I

§ 520.455 Clomipramine.

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Verbatim text below is from the Electronic Code of Federal Regulations (eCFR), a public-domain U.S. government work. Always verify the current version with the eCFR before relying on it for any legal matter.

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Specifications.(a) Each tablet contains 5, 20, 40, or 80 milligrams (mg) clomipramine hydrochloride.

Sponsors.(b) See Nos. 051311, 086039, and 086101 in § 510.600(c) of this chapter.

Conditions of useAmount.(c) —(1) 2 to 4 milligrams of clomipramine hydrochloride per kilogram (0.9 to 1.8 milligrams per pound) of body weight per day, administered as a single daily dose or divided twice daily.

Indications for use.(2) For use as part of a comprehensive behavioral management program to treat separation anxiety in dogs greater than 6 months of age.

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

[64 FR 1762, Jan. 12, 1999, as amended at 72 FR 262, Jan. 4, 2007; 86 FR 57996, Oct. 20, 2021; 91 FR 20340, Apr. 16, 2026]

eCFR data current as of: June 10, 2026

This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.