21 CFR 315.1

§ 315.1 Scope.

United States · 21 CFR — Food and Drugs · Status: effective

Cite this

Citation: 21 CFR 315.1, § 315.1 Scope, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/86406
Permanent ID: ys:prov:86406@1
SHA-256: 6c32da2dfd0243d6565e9096df013f0aa14428f819796b8e484beeeef9ff00c7

The hash is SHA-256 of this version's text, with every run of whitespace collapsed to a single space and the ends trimmed. The ID always leads back here, and checking it says whether the text you cited is still the current version.

Full text

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.

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.