21 CFR § 201.129 - Drugs; exemption for radioactive drugs for research use.

---
identifier: "/us/cfr/t21/s201.129"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 201.129 - Drugs; exemption for radioactive drugs for research use."
title_number: 21
title_name: "Food and Drugs"
section_number: "201.129"
section_name: "Drugs; exemption for radioactive drugs for research use."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "C"
subchapter_name: "DRUGS: GENERAL"
part_number: "201"
part_name: "LABELING"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 321, 331, 343, 351, 352, 353, 355, 358, 360, 360b, 360ccc, 360ccc-1, 360ddd, 360ddd-1, 360ee, 360gg-360ss, 371, 374, 379e; 42 U.S.C. 216, 241, 262, 264."
regulatory_source: "40 FR 13998, Mar. 27, 1975, unless otherwise noted."
cfr_part: "201"
---


# 201.129 Drugs; exemption for radioactive drugs for research use.

A radioactive drug intended for administration to human research subjects during the course of a research project intended to obtain basic research information regarding metabolism (including kinetics, distribution, and localization) of a radioactively labeled drug or regarding human physiology, pathophysiology, or biochemistry (but not intended for immediate therapeutic, diagnostic, or similar purposes), under the conditions set forth in § 361.1 of this chapter, shall be exempt from section 502(f)(1) of the act if the packaging, label, and labeling are in compliance with § 361.1(f) of this chapter.

[41 FR 6911, Feb. 13, 1976]