---
kind: "section"
citation: "21 C.F.R. § 516.2106"
title: "21"
number: "516.2106"
heading: "Sirolimus."
url: "https://uscodex.org/cfr/21/516.2106"
---

# §516.2106. Sirolimus.

- (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)](/cfr/21/510.600.md?p=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.

## Notes

### Amendments

[90 FR 19624, May 9, 2025]

### Source

Source: 72 FR 57200, Oct. 9, 2007, unless otherwise noted.

### Authority

Authority: 21 U.S.C. 360ccc-1, 360ccc-2, 371.

### Source

Source: 72 FR 41017, July 26, 2007, unless otherwise noted.

### Amendments

[90 FR 19624, May 9, 2025]