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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of Mar 22, 2024.

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

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[Code of Federal Regulations]
[Title 21, Volume 6]
[CITE: 21CFR522.1700]



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. 522.1700 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 086119 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. Redesignated at 86 FR 61685, Nov. 8, 2021; 88 FR 84701, Dec. 6, 2023]

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