eCFR Reference Browser

---

title: "21 CFR §315.1"

source: "https://www.ecfr.gov/current/title-21/section-315.1"

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: "315.1"

section_subject: "Scope."

cfr_reference: "21 CFR 315.1"

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"

---

The regulations in this part apply to radiopharmaceuticals intended for in vivo administration for diagnostic and monitoring use. They do not apply to radiopharmaceuticals intended for therapeutic purposes. In situations where a particular radiopharmaceutical is proposed for both diagnostic and therapeutic uses, the radiopharmaceutical must be evaluated taking into account each intended use.

§315.1 - Scope.