A licensee shall use any unsealed byproduct material identified in He-P 4035.65(b)(2)b., prepared for medical use and for which a written directive is required that is:

1. (a) Obtained from one of the following:

   1. (1) A manufacturer or preparer licensed under He-P 4032.05, or the equivalent requirements of an agreement state, or the Nuclear Regulatory Commission; or
   2. (2) A PET radioactive drug producer licensed under He-P 4030.07(k), or the equivalent requirements of an agreement state, or the Nuclear Regulatory Commission; or

2. (b) Excluding production of PET radionuclides, prepared by:

   1. (1) An authorized nuclear pharmacist;
   2. (2) A physician who is an authorized user and who meets the requirements specified under He-P 4035.64 or He-P 4035.65; or
   3. (3) An individual under the supervision, as specified in He-P 4035.11, of the authorized nuclear pharmacist in He-P 4035.35(b)(1) or the physician who is an authorized user in He-P 4035.35(b)(2); or
3. (c) Obtained from and prepared by a DHHS/RHS licensee, or an equivalent agreement state, or a Nuclear Regulatory Commission licensee for use in research in accordance with an Investigational New Drug (IND) protocol accepted by FDA; or
4. (d) Is prepared by the licensee for use in research in accordance with an Investigational New Drug (IND) protocol accepted by FDA.

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; amd by #12054, eff 11-19-16; ss by #13048, eff 6-2-20; ss by #13473, eff 10-25-22