21 CFR 315.2
§ 315.2 Definition.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 315.2, § 315.2 Definition, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/86407
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Full text
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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.