eCFR Reference Browser

---

title: "21 CFR §315.2"

source: "https://www.ecfr.gov/current/title-21/section-315.2"

title_number: "21"

volume_number: "5"

chapter_number: "Unknown"

subchapter_code: "D"

subchapter_subject: "DRUGS FOR HUMAN USE"

part_code: "315"

part_subject: "DIAGNOSTIC RADIOPHARMACEUTICALS"

subpart_code: "B"

subpart_subject: "Combination Drugs"

section_number: "315.2"

section_subject: "Definition."

cfr_reference: "21 CFR 315.2"

title_name: "Title 21"

title_subject: "Food and Drugs"

parts_covered: "Parts 300 to 499"

revised_date: "Revised as of April 1, 2019"

publication_date: "As of April 1, 2019"

contains_description: "Containing a codification of documents of general applicability and future effect"

publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"

---

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.

§315.2 - Definition.