Section 180-3-006 - RADIOACTIVE DRUG: CAPSULES CONTAINING CARBON-14 UREA FOR "IN VIVO" DIAGNOSTIC USE FOR HUMANS This section addresses radioactive drugs containing carbon-14 urea for "in vivo" diagnostic use for humans.
006.01EXEMPTIONS. Other than as provided in 180 NAC 3-006.02, any person is exempt from the requirements for a license set forth in the Act and from the regulations in 180 NAC 3 and 7 provided that such person receives, possesses, uses, transfers, owns or acquires capsules containing 37 kBq (1 µCi) Carbon-14 urea, allowing for nominal variation that may occur during the manufacturing process, each for "in vivo" diagnostic use for humans.006.02RESEARCH INVOLVING HUMAN SUBJECTS. Any person who desires to use the capsules for research involving human subjects must apply for and receive a specific license according to 180 NAC 7.006.03COMMERCIAL DISTRIBUTION. Any person who desires to manufacture, prepare, process, produce, package, repackage, or transfer for commercial distribution such capsules must apply for and receive a specific license from the U.S. Nuclear Regulatory Commission (NRC) according to 10 CFR 32.21.006.04ADDITIONAL REQUIREMENTS. Nothing in 180 NAC 3-006 relieves persons from complying with applicable U.S. Food and Drug Administration (FDA), other Federal, and State requirements governing receipt, administration, and use of drugs.180 Neb. Admin. Code, ch. 3, § 006
Amended effective 6/15/2021