Minn. R. agency 144, ch. 4731, MEDICAL USE OF RADIOACTIVE MATERIAL, pt. 4731.4440 - UNSEALED RADIOACTIVE MATERIAL; WRITTEN DIRECTIVE REQUIRED
A licensee may use any unsealed radioactive material identified in part 4731.4443, subpart 1, item B, subitem (1), unit (b), subunit vi, prepared for medical use and for which a written directive is required 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 an authorized nuclear pharmacist,
a physician who is an authorized user and meets the requirements under part
4731.4436 or 4731.4443, or an individual under the supervision of either, as
specified under part 4731.4407;
C.
obtained from and prepared by a commissioner, NRC, or agreement state licensee
for use in research according to an investigational new drug protocol accepted
by the Food and Drug Administration; or
D. prepared by the licensee for use in
research according to an investigational new drug protocol accepted by the Food
and Drug Administration.
Notes
Statutory Authority: MS s 144.1202; 144.1203
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