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e-CFR data is current as of March 4, 2021

Title 21Chapter ISubchapter EPart 522 → §522.1697


Title 21: Food and Drugs
PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS


§522.1697   Pentobarbital and phenytoin.

(a) Specifications. Each milliliter (mL) of solution contains 390 milligrams (mg) pentobarbital sodium and 50 mg phenytoin sodium.

(b) Sponsors. See Nos. 000061, 051311, 054925, and 059399 in §510.600(c) of this chapter.

(c) Special considerations. Product labeling shall bear the following warning statements: “ENVIRONMENTAL HAZARD: This product is toxic to wildlife. Birds and mammals feeding on treated animals may be killed. Euthanized animals must be properly disposed of by deep burial, incineration, or other method in compliance with State and local laws, to prevent consumption of carcass material by scavenging wildlife.”

(d) Conditions of use in dogs—(1) Amount. Administer 1 mL per 10 pounds of body weight as a single, bolus intravenous or intracardiac injection.

(2) Indications for use. For humane, painless, and rapid euthanasia.

(3) Limitations. Do not use in animals intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[85 FR 18120, Apr. 1, 2020, as amended at 85 FR 45308, July 28, 2020]

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