Section 246-232-014 - Exemption of C-14 urea diagnostic capsules for human use(1) Except as provided in subsections (2) and (3) of this section, a person is exempt from the requirements for a license and from this chapter and chapters 246-233 and 246-235 WAC if the person receives, possesses, uses, transfers, owns, or acquires, and does not apply radioactive material to, or incorporate radioactive material into, capsules containing 37 kilobecquerels one microcurie) of carbon-14 urea (allowing for nominal variation that may occur during the manufacturing process) each, for "in-vivo" diagnostic use for humans.(2) A person who desires to use the capsules for research involving human subjects must apply for and receive a specific license under chapters 246-240 and 246-235 WAC.(3) A person who desires to manufacture, prepare, process, produce, package, repackage, or transfer for commercial distribution these capsules must do so in accordance with a specific license issued by the NRC, Washington, D.C. 20555.(4) Nothing in this section relieves persons from complying with applicable United States Food and Drug Administration, federal, and state requirements governing receipt, administration, and use of drugs.Wash. Admin. Code § 246-232-014
Amended by WSR 13-24-025, filed 11/22/13, effective 12/23/2013Amended by WSR 16-13-054, Filed 6/10/2016, effective 7/11/2016Amended by WSR 22-19-084, Filed 9/20/2022, effective 10/21/2022Statutory Authority: RCW 70.98.050. 06-05-019, § 246-232-014, filed 2/6/06, effective 3/9/06; 01-02-068, § 246-232-014, filed 12/29/00, effective 1/29/01.