Regulations last checked for updates: Feb 12, 2026

Title 21 - Food and Drugs last revised: Dec 18, 2026
§ 862.3660 - Phenobarbital test system.

(a) Identification. A phenobarbitol test system is a device intended to measure phenobarbital, an antiepileptic and sedative-hypnotic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of phenobarbital use or overdose and in monitoring levels of phenobarbital to ensure appropriate therapy.

(b) Classification. Class II.

authority: 21 U.S.C. 351,360,360c,360e,360j,360
source: 52 FR 16122, May 1, 1987, unless otherwise noted.
cite as: 21 CFR 862.3660