Minnesota Administrative Rules
Agency 144 - Health Department
Chapter 4731 - RADIATION SAFETY
MEDICAL USE OF RADIOACTIVE MATERIAL
Part 4731.4434 - UNSEALED RADIOACTIVE MATERIAL; IMAGING AND LOCALIZATION STUDIES; WRITTEN DIRECTIVE NOT REQUIRED

Universal Citation: MN Rules 4731.4434

Current through Register Vol. 49, No. 13, September 23, 2024

Except for quantities that require a written directive under part 4731.4408, a licensee may use any unsealed radioactive material prepared for medical use for imaging and localization studies that is:

A. obtained from a manufacturer or preparer licensed under part 4731.3395 or equivalent requirements of the NRC or an agreement state or a PET radioactive drug producer licensed according to part 4731.3065, subpart 7, or equivalent requirements of the NRC or an agreement state;

B. excluding production of PET radionuclides, prepared by:

(1) an authorized nuclear pharmacist;

(2) a physician who is an authorized user and meets the requirements specified in part 4731.4436; or parts 4731.4436, subpart 1, item C, subitem (1), unit (b), subunit vii, and 4731.4443; or

(3) an individual under the supervision, according to part 4731.4407, of the authorized nuclear pharmacist in subitem (1) or the physician who is an authorized user in subitem (2);

C. obtained from and prepared by an NRC or agreement state licensee for use in research according to a radioactive drug research committee-approved protocol or an investigational new drug protocol accepted by the Food and Drug Administration; or

D. prepared by the licensee for use in research according to a radioactive drug research committee-approved application or an investigational new drug protocol accepted by the Food and Drug Administration.

Statutory Authority: MS s 144.1202; 144.1203

Disclaimer: These regulations may not be the most recent version. Minnesota may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.