21 CFR § 315.2 - Definition.

---
identifier: "/us/cfr/t21/s315.2"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 315.2 - Definition."
title_number: 21
title_name: "Food and Drugs"
section_number: "315.2"
section_name: "Definition."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "D"
subchapter_name: "DRUGS FOR HUMAN USE"
part_number: "315"
part_name: "DIAGNOSTIC RADIOPHARMACEUTICALS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
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)."
regulatory_source: "64 FR 26667, May 17, 1999, unless otherwise noted."
cfr_part: "315"
---


# 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) of this section.