21 C.F.R. § 862.3645

Neuroleptic drugs radioreceptor assay test system.

Last amended: 2016Year: 2026Length: 77 wordsSubsections: 1Official source

Cite as 21 C.F.R. § 862.3645 (2026)

(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.
21 C.F.R. § 862.3645: Neuroleptic drugs radioreceptor assay test system. | Justis AI