21 CFR § 522.2450 - Tigilanol.

---
identifier: "/us/cfr/t21/s522.2450"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 522.2450 - Tigilanol."
title_number: 21
title_name: "Food and Drugs"
section_number: "522.2450"
section_name: "Tigilanol."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "E"
subchapter_name: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_number: "522"
part_name: "IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 360b."
regulatory_source: "40 FR 13858, Mar. 27, 1975, unless otherwise noted."
cfr_part: "522"
---


# 522.2450 Tigilanol.

(a) *Specifications.* Each milliliter (mL) of solution contains 1 milligram tigilanol tiglate.

(b) *Sponsor.* See No. 086132 in § 510.600(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.

[86 FR 17064, Apr. 1, 2021]