21 CFR 522.2450
§ 522.2450 Tigilanol.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 522.2450, § 522.2450 Tigilanol, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/87547
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Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.