A licensee may use any unsealed byproduct material identified in 10 CFR 35.390(b)(1)(ii)(G) prepared for medical use and for which a written directive is required that is:

1. A. Obtained from a manufacturer or preparer licensed under Subsection J of 20.3.3.315 NMAC or equivalent agreement state or NRC requirements; or

2. B. 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; 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 protocol accepted by FDA.

[20.3.7.708 NMAC - Rp, 20 NMAC 3.1.7.708, 04/30/2009, A, 02/14/2023]