Section 30180.6 - Radioactive Drug: Capsules Containing Carbon-14 Urea for "In Vivo" Diagnostic Use for Humans(a) A person who receives, possesses, uses, transfers, owns, or acquires capsules containing urea impregnated with carbon-14, which are manufactured for "in vivo" diagnostic use in humans, is exempt from the requirements for a license specified in section 30190 and sections 30191 through 30237, and from Group 3 of this subchapter, provided that each capsule does not exceed one microcurie (allowing for nominal variation that may occur during the manufacturing process) of carbon-14.(b) Any person who desires to use a capsule described in subsection (a) for research involving human subjects shall hold a specific license issued pursuant to section 30195 authorizing the medical use of radioactive material.(c) This section shall not be deemed to authorize the manufacturing, preparation, processing, producing, packaging, repackaging, or transferring for commercial distribution of such capsules.(d) Nothing in this section relieves persons from complying with applicable U.S. Food and Drug Administration requirements, or other Federal and State requirements, governing the receipt, administration, and use of drugs.Cal. Code Regs. Tit. 17, § 30180.6
1. New section filed 12-30-2014; operative 4-1-2015 (Register 2015, No. 1). Note: Authority cited: Sections 114975, 115000 and 131200, Health and Safety Code. Reference: Sections 114965, 114970, 115000, 115060, 115165, 115230, 115235, 131050, 131051 and 131052, Health and Safety Code.
1. New section filed 12-30-2014; operative 4/1/2015 (Register 2015, No. 1).