---
kind: "section"
citation: "21 C.F.R. § 315.2"
title: "21"
number: "315.2"
heading: "Definition."
url: "https://uscodex.org/cfr/21/315.2"
---

# §315.2. Definition.


For purposes of this part, diagnostic radiopharmaceutical means:

- (a) An article that is intended for use in the diagnosis or monitoring of a disease or a manifestation of a disease in humans and that exhibits spontaneous disintegration of unstable nuclei with the emission of nuclear particles or photons; or
- (b) Any nonradioactive reagent kit or nuclide generator that is intended to be used in the preparation of such article as defined in [paragraph (a)](#a) of this section.

## Notes

### Authority

Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 371, 374, 379e; sec. 122, Pub. L. 105-115, 111 Stat. 2322 (21 U.S.C. 355 note).

### Source

Source: 64 FR 26667, May 17, 1999, unless otherwise noted.