Minn. R. agency 144, ch. 4731, DOMESTIC LICENSING OF RADIOACTIVE MATERIALS, pt. 4731.3055
Except as provided in subparts 2 and 3, a person is exempt from parts 4731.3000 to 4731.3245 and 4731.4400 to 4731.4527, if the person receives, possesses, uses, transfers, owns, or acquires capsules containing one µCi (37 kBq) carbon-14 urea (allowing for nominal variation that may occur during the manufacturing process) each, for in vivo diagnostic use for humans.
A person who desires to use the capsules under subpart 1 for research involving human subjects must apply for and receive a specific license according to parts 4731.4400 to 4731.4527.
A person who desires to manufacture, prepare, process, produce, package, repackage, or transfer for commercial distribution the capsules under subpart 1 must apply for and receive a specific license under Code of Federal Regulations, title 10, section 32.21.
Nothing in this part relieves a person from complying with applicable United States Food and Drug Administration or other federal and state requirements governing receipt, administration, and use of drugs.
Minn. R. agency 144, ch. 4731, DOMESTIC LICENSING OF RADIOACTIVE MATERIALS, pt. 4731.3055
Statutory Authority: MS s 144.1202; 144.1203