Regulations last checked for updates: May 07, 2025

Title 21 - Food and Drugs last revised: Apr 28, 2025
§ 862.3645 - Neuroleptic drugs radioreceptor assay test system.

(a) Identification. A neuroleptic drugs radioceptor assay test system is a device intended to measure in serum or plasma the dopamine receptor blocking activity of neuroleptic drugs and their active metabolites. A neuroleptic drug has anti-psychotic action affecting principally psychomotor activity, is generally without hypnotic effects, and is a tranquilizer. Measurements obtained by this device are used to aid in determining whether a patient is taking the prescribed dosage level of such drugs.

(b) Classification. Class II.

authority: 21 U.S.C. 351,360,360c,360e,360j,360l,371
source: 52 FR 16122, May 1, 1987, unless otherwise noted.
cite as: 21 CFR 862.3645