N.M. Admin. Code § 20.3.7.704

Current through Register Vol. 36, No. 1, January 14, 2025

Section 20.3.7.704 - USE OF UNSEALED RADIOACTIVE MATERIAL FOR UPTAKE, DILUTION AND EXCRETION STUDIES FOR WHICH A WRITTEN DIRECTIVE IS NOT REQUIRED

Except for quantities that require a written directive under Paragraph (3) of Subsection G of Section 20.3.7.702 NMAC, a licensee may use any unsealed radioactive material prepared for medical use for uptake, dilution or excretion studies that is:

A. obtained from:

(1) a manufacturer or preparer licensed under Subsection J of 20.3.3.315 NMAC, or equivalent NRC or agreement state requirements; or

(2) a PET radioactive drug producer licensed under Subsection J of 20.3.3.307 NMAC or equivalent NRC or agreement state requirements; or

B. excluding production of PET radionuclides, 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, and Subsection G of 20.3.7.714 NMAC, incorporating 10 CFR 35.290(c)(1)(ii)(G); 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 drug protocol accepted by FDA.

N.M. Admin. Code § 20.3.7.704

20.3.7.704 NMAC - Rp, 20 NMAC 3.1.7.704, 4/30/2009