N.M. Admin. Code § 20.3.7.708 - USE OF UNSEALED RADIOACTIVE MATERIAL FOR WHICH A WRITTEN DIRECTIVE IS REQUIRED

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:

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

B. Prepared by:

(1) an authorized nuclear pharmacist;

(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) 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

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

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.

Notes

N.M. Admin. Code § 20.3.7.708

20.3.7.708 NMAC - Rp, 20 NMAC 3.1.7.708, 4/30/2009, Amended by New Mexico Register, Volume XXXIV, Issue 03, February 14, 2023, eff. 2/14/2023