Section He-P 4030.05 - Radioactive Drug: Capsules Containing Carbon-14 Urea for "In Vivo" Diagnostic Use for Humans(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.N.H. Admin. Code § He-P 4030.05
(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
Amended by Volume XXXV, Number 32 Filed August 13, 2015, Proposed by #10896, Effective 7/22/2015, Expires1/18/2016.Amended by Volume XXXVI Number 01, Filed January 7, 2016, Proposed by #11006, Effective 1/15/2016, Expires 1/15/2026.Amended by Volume XL Number 24, Filed June 11, 2020, Proposed by #13047, Effective 6/2/2020, Expires 6/2/2030.