New Hampshire Code of Administrative Rules
He - Department of Health and Human Services
Subtitle He-P - Former Division of Public Health Services
Chapter He-P 4000 - NEW HAMPSHIRE RULES FOR THE CONTROL OF RADIATION
Part He-P 4030 - LICENSING OF RADIOACTIVE MATERIAL
Section He-P 4030.05 - Radioactive Drug: Capsules Containing Carbon-14 Urea for "In Vivo" Diagnostic Use for Humans

Universal Citation: NH Admin Rules He-P 4030.05

Current through Register No. 12, March 21, 2024

(a) Except as provided in He-P 4030.05(b) and (c), any person is exempt from the requirements for a license set forth in He-P 4030 and He-P 4035, provided that such person receives, possesses, uses, transfers, owns, or acquires capsules containing 37 kilobecquerels (1microcurie) of carbon-14 urea each, allowing for nominal variation that may occur during the manufacturing process, for "in vivo" diagnostic use for humans.

(b) Any person who desires to use the capsules for research involving human subjects shall apply for and receive a specific license pursuant to He-P 4035.

(c) Nothing in this section shall relieve persons from complying with applicable FDA, federal, and other state requirements governing receipt, administration, and use of drugs.

(See Revision Note at part heading for He-P 4030) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07

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