Section He-P 4035.04 - License Required(a) No person shall manufacture, produce, prepare, compound, acquire, receive, possess, use, or transfer byproduct material for medical use except in accordance with a specific license issued by DHHS/RHS, or an agreement state, or the Nuclear Regulatory Commission, or as allowed in He-P 4035.04(b) or (c).(b) A person shall receive, possess, use, or transfer byproduct material in accordance with He-P 4035 under the supervision of an authorized user as provided in He-P 4035.11 unless prohibited by license condition.(c) A person shall prepare unsealed byproduct material for medical use in accordance with He-P 4035 under the supervision of an authorized nuclear pharmacist, or authorized user as provided in He-P 4035.11, unless prohibited by license condition.(d) A person shall conduct research involving human subjects using byproduct materials specified on a license for the uses authorized on the license provided that: (1) The research is conducted, funded, supported, or regulated by a federal agency which has implemented the Federal Policy for the Protection of Human Subjects and in accordance with He-P 4035.04(d)(2)b.; or(2) The licensee has: a. Applied for and received approval of a specific amendment to its license prior to conducting such research; andb. Obtained informed consent from the human subjects and has obtained prior review and approval of the research activities by an "Institutional Review Board" in accordance with the meaning of these terms as defined and described in the Federal Policy for the Protection of Human Subjects.(e) Nothing in He-P 4035.04(d) relieves licensees from complying with other requirements in He-P 4035.N.H. Admin. Code § He-P 4035.04
(See Revision Note at part heading for He-P 4035) #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 #10897, Effective 7/22/2015, Expires1/18/2016.Amended by Volume XXXVI Number 01, Filed January 7, 2016, Proposed by #11011, Effective 1/15/2016, Expires 1/15/2026.Amended by Volume XL Number 24, Filed June 11, 2020, Proposed by #13048, Effective 6/2/2020, Expires 6/2/2030.Amended by Volume XLII Number 45, Filed November 10, 2022, Proposed by #13473, Effective 10/25/2022, Expires 10/25/2032