1. (a) Except for quantities that require a written directive under He-P 4035.13(c), a licensee may use any unsealed byproduct material prepared for medical use for uptake, dilution, or excretion studies that is:

   1. (1) Obtained from:

      1. a. A manufacturer or preparer licensed under He-P 4032.05, or the equivalent requirements of an agreement state, or the Nuclear Regulatory Commission;
      2. b. 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.

   2. (2) Prepared by, excluding production of PET radionuclides:

      1. a. An authorized nuclear pharmacist;
      2. b. A physician who is an authorized user and who meets the requirements specified in He-P 4035.64, or He-P 4035.65 and He-P 4035.64(c)(1)b.7;
      3. c. An individual under the supervision, as specified in He-P 4035.11, of the authorized nuclear pharmacist in He-P 4035.27(a)(2)a. or the physician who is an authorized user in He-P 4035.27(a)(2)b.; or
   3. (3) Obtained from and prepared by a DHHS/RHS, or an agreement state, or the Nuclear Regulatory Commission licensee for use in research in accordance with a Radioactive Drug Research Committee-approved protocol or an Investigational New Drug (IND) protocol accepted by FDA; or
   4. (4) Prepared by the licensee for use in research in accordance with a Radioactive Drug Research Committee-approved application or 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; ss by #13048, eff 6-2-20; ss by #13473, eff 10-25-22