---
kind: "section"
citation: "21 C.F.R. § 862.3645"
title: "21"
number: "862.3645"
heading: "Neuroleptic drugs radioreceptor assay test system."
url: "https://uscodex.org/cfr/21/862.3645"
---

# §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.

## Notes

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 52 FR 16122, May 1, 1987, unless otherwise noted.