Except for quantities that require a written directive under Paragraph (3) of Subsection G of 20.3.7.702 NMAC, a licensee may use any unsealed radioactive material prepared for medical for imaging and localization studies use that is:

1. A. obtained from:

   1. (1) a manufacturer or preparer licensed pursuant to Subsection J of 20.3.3.315 NMAC or equivalent NRC or agreement state requirements; or
   2. (2) a PET radioactive drug producer licensed under Subsection J of 20.3.3.307 NMAC or equivalent NRC or agreement state requirements; 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 in either Subsection G of 20.3.7.714 NMAC, incorporating 10 CFR 35.290, or Subsection H of 20.3.7.714 NMAC, incorporating 10 CFR 35.390, and Subsection G of 20.3.7.714 NMAC, incorporating 10 CFR 35.290(c)(1)(ii)(G); or
   3. (3) an individual under the supervision, as specified in Subsection F of 20.3.7.702 NMAC, of the authorized nuclear pharmacist in Paragraph (1) of this subsection or the physician who is an authorized user in Paragraph (2) of this subsection; or
3. C. obtained from and prepared by a department, NRC or agreement state licensee for use in research in accordance with a radioactive drug research committee-approved protocol or an investigational new drug protocol accepted by FDA; or
4. D. prepared by the licensee for use in research in accordance with a radioactive drug research committee-approved application or an investigational new drug protocol accepted by FDA.

[20.3.7.705 NMAC - Rp, 20 NMAC 3.1.7.705, 4/30/2009]