21 CFR § 516.1760 - Phenobarbital.

---
identifier: "/us/cfr/t21/s516.1760"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 516.1760 - Phenobarbital."
title_number: 21
title_name: "Food and Drugs"
section_number: "516.1760"
section_name: "Phenobarbital."
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: "516"
part_name: "NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES"
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. 360ccc-1, 360ccc-2, 371."
regulatory_source: "72 FR 41017, July 26, 2007, unless otherwise noted."
cfr_part: "516"
---


# 516.1760 Phenobarbital.

(a) *Specifications.* Each tablet contains 15, 16.2, 30, 32.4, 60, 64.8, 97.2 or 100 milligrams (mg) phenobarbital.

(b) *Sponsor.* See No. 064950 in § 510.600(c) of this chapter.

(c) *Conditions of use*—(1) *Amount.* Administer phenobarbital as tablets given orally twice a day at the minimum dosage of 2.5 mg per kilogram of body weight (mg/kg) and may be titrated to effect to a maximum dosage of 5 mg/kg. The dosage of phenobarbital tablets should be adjusted based on monitoring the clinical response of the individual patient.

(2) *Indications for use.* For the control of seizures associated with idiopathic epilepsy in dogs.

(3) *Limitations.* Federal law restricts this drug to use by or on the order of a licensed veterinarian. It is a violation of Federal law to use this product other than as directed in the labeling.

[88 FR 84699, Dec. 6, 2023; 89 FR 85426, Oct. 28, 2024]