---
kind: "section"
citation: "21 C.F.R. § 601.31"
title: "21"
number: "601.31"
heading: "Definition."
url: "https://uscodex.org/cfr/21/601.31"
---

# §601.31. 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

### Source

Source: 64 FR 26668, May 17, 1999, unless otherwise noted.

### Authority

Authority: 15 U.S.C. 1451-1561; 21 U.S.C. 321, 351, 352, 353, 355, 356b, 360, 360c-360f, 360h-360j, 371, 374, 379e, 381; 42 U.S.C. 216, 241, 262, 263, 264; sec 122, Pub. L. 105-115, 111 Stat. 2322 (21 U.S.C. 355 note), sec 7002(e), Pub. L. 111-148, 124 Stat. 817, as amended by sec. 607, Division N, Pub. L. 116-94, 133 Stat. 3127.

### Source

Source: 38 FR 32052, Nov. 20, 1973, unless otherwise noted.