Kan. Admin. Regs. § 28-35-178j - General license for use of radioactive material for certain in vivo clinical or laboratory testing
(a) Except as provided in subsections (b) and
(c), each person shall be exempt from the license requirements in part 3 and
part 6 of these regulations if the person receives, possesses, uses, transfers,
owns, or acquires any capsules containing 37 kBq (1 laCi) of carbon-14 urea,
allowing for nominal variation that may occur during the manufacturing process
for in vivo diagnostic use for humans.
(b) Before using the capsules specified in
subsection (a) for research involving human subjects, each person shall apply
and shall be considered for approval for a specific license. Each person shall
be required to have a specific license before engaging in the research
specified in this subsection.
(c)
Before manufacturing, preparing, processing, producing, packaging, repackaging,
or transferring the capsules specified in subsection (a) for commercial
distribution, each person shall apply and shall be considered for approval for
a specific license. Each person shall be required to have a specific license
before performing any of the actions specified in this subsection.
(d) Nothing in this regulation shall exempt
any person from applicable FDA requirements, other federal requirements, and
state requirements governing receipt, administration, and use of drugs.
Notes
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