1. (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).
2. (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.
3. (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.

4. (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. (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. (2) The licensee has:

      1. a. Applied for and received approval of a specific amendment to its license prior to conducting such research; and
      2. b. 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.
5. (e) Nothing in He-P 4035.04(d) relieves licensees from complying with other requirements in He-P 4035.

Source. (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; ss by #10897, INTERIM, eff 7-22-15, EXPIRES: 1-18-16; ss by #11011, eff 1-15-16; ss by #13048, eff 6-2-20; ss by #13473, eff 10-25-22