Title 21: Food and Drugs
« Home / Title 21 - Food and Drugs--Volume 7 / CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) / SUBCHAPTER F - BIOLOGICS
/ PART 601 - LICENSING
/ Subpart D - Diagnostic Radiopharmaceuticals / § 601.31 Definition.
§ 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) of this section.