---
kind: "section"
citation: "21 C.F.R. § 522.2450"
title: "21"
number: "522.2450"
heading: "Tigilanol."
url: "https://uscodex.org/cfr/21/522.2450"
---

# §522.2450. Tigilanol.

- (a) **Specifications.** Each milliliter (mL) of solution contains 1 milligram tigilanol tiglate.
- (b) **Sponsor.** See No. 086132 in [§ 510.600(c)](/cfr/21/510.600.md?p=c) of this chapter.
- (c) **Conditions of use in dogs—**
  - (1) **Amount.** Administer as an intratumoral injection at a dose of 0.5 mL per cubic centimeter of tumor volume.
  - (2) **Indications for use.** For the treatment of non-metastatic cutaneous mast cell tumors and non-metastatic subcutaneous mast cell tumors located at or distal to the elbow or the hock in dogs.
  - (3) **Limitations.** Federal law restricts this drug to use by or on the order of a licensed veterinarian.

## Notes

### Amendments

[86 FR 17064, Apr. 1, 2021]

### Authority

Authority: 21 U.S.C. 360b.

### Source

Source: 40 FR 13858, Mar. 27, 1975, unless otherwise noted.

### Amendments

[86 FR 17064, Apr. 1, 2021]