Minn. R. agency 144, ch. 4731, MEDICAL USE OF RADIOACTIVE MATERIAL, pt. 4731.4432 - UNSEALED RADIOACTIVE MATERIAL; UPTAKE, DILUTION, AND EXCRETION STUDIES; WRITTEN DIRECTIVE NOT REQUIRED

Except for quantities that require a written directive under part 4731.4408 or 4731.4409, a licensee may use any unsealed radioactive material prepared for medical use for uptake, dilution, or excretion 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 who meets the requirements of 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 for a commissioner, 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.

Notes

Minn. R. agency 144, ch. 4731, MEDICAL USE OF RADIOACTIVE MATERIAL, pt. 4731.4432

29 SR 755; 32 SR 831; 33 SR 1440

Statutory Authority: MS s 144.1202; 144.1203