WAC 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 set forth in chapters 246-233 and 246-235 WAC if the person receives, possesses, uses, transfers, owns, or acquires capsules containing 37 kilobequerels (1 microcurie) 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 shall 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 shall apply for and receive a specific license from the United States Nuclear Regulatory Commission under Section 32.21 of 10 C.F.R. Part 32.

     (4) Nothing in this section relieves persons from complying with applicable United States Food and Drug Administration, other federal, and state requirements governing receipt, administration, and use of drugs.



[Statutory 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.]