21 CFR 516.2106
§ 516.2106 Sirolimus.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 516.2106, § 516.2106 Sirolimus, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/87054
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Full text
(a) Specifications. Each sustained-release tablet contains 0.4, 1.2, or 2.4 milligrams (mg) sirolimus.
(b) Sponsor. See No. 086169 in § 510.600(c) of this chapter.
(c) Conditions of use in cats—(1) Amount. Administer orally once weekly at a dose of 0.3 mg/kilogram of bodyweight.
(2) Indications for use. For the management of ventricular hypertrophy in cats with subclinical hypertrophic cardiomyopathy (HCM).
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. It is a violation of Federal law to use this product other than as directed in the labeling.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.