10 CFR 30.21 - Radioactive drug: Capsules containing carbon-14 urea for “in vivo” diagnostic use for humans.
(a) Except as provided in paragraphs (b) and (c) of this section, any person is exempt from the requirements for a license set forth in Section 81 of the Act and from the regulations in this part and part 35 of this chapter provided that such person receives, possesses, uses, transfers, owns, or acquires capsules containing 37 kBq (1 µCi) carbon-14 urea (allowing for nominal variation that may occur during the manufacturing process) each, for “in vivo” diagnostic use for humans.
(c) Any person who desires to manufacture, prepare, process, produce, package, repackage, or transfer for commercial distribution such capsules shall apply for and receive a specific license pursuant to § 32.21 of this chapter.
Title 10 published on 2015-12-04
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 10 CFR Part 30 after this date.
Title 10 published on 2015-12-04.
The following are only the Rules published in the Federal Register after the published date of Title 10.
For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.