CFR - Code of Federal Regulations Title 21

The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations]

[Title 21, Volume 6]

[CITE: 21CFR522.2450]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER E - ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS

PART 522 -- IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

Sec. 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]