§ 315.2 Definition.

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Title 21—Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER D—DRUGS FOR HUMAN USE > PART 315—DIAGNOSTIC RADIOPHARMACEUTICALS

This text was captured on Sep 22, 2026. It is a snapshot, not a live feed, so check the official code before relying on it.

Text

Link to an amendment published at 91 FR 60004, Sept. 22, 2026.

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.

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