Minnesota Administrative Rules
Agency 144 - Health Department
Chapter 4731 - RADIATION SAFETY
DOMESTIC LICENSING OF RADIOACTIVE MATERIALS
Part 4731.3245 - GENERAL LICENSE; IN VITRO CLINICAL OR LABORATORY TESTING USE
Current through Register Vol. 49, No. 13, September 23, 2024
Subpart 1. License issued.
A physician, veterinarian in the practice of veterinary medicine, clinical laboratory, or hospital is issued a general license to receive, acquire, possess, transfer, or use, according to this part, the following radioactive materials in prepackaged units for use in in vitro clinical or laboratory tests not involving internal or external administration of radioactive material, or the radiation therefrom, to human beings or animals:
Subp. 2. License requirements.
A person must not receive, acquire, possess, use, or transfer radioactive material under the general license issued under subpart 1 unless the person:
Subp. 3. Additional requirements.
A person who receives, acquires, possesses, or uses radioactive material under the general license issued under subpart 1 must:
Subp. 4. Limitation.
A general licensee under this part must not receive, acquire, possess, or use radioactive material:
"This radioactive material may be received, acquired, possessed, and used only by physicians, veterinarians in the practice of veterinary medicine, clinical laboratories, or hospitals and only for in vitro clinical or laboratory tests not involving internal or external administration of the material, or the radiation therefrom, to human beings or animals. Its receipt, acquisition, possession, use, and transfer are subject to the rules of and a general license issued by the Nuclear Regulatory Commission or a state with which the Nuclear Regulatory Commission has entered into an agreement for the exercise of regulatory authority.
(Name of manufacturer)"
Subp. 5. Changes in registration.
A registrant possessing or using radioactive material under the general license issued under subpart 1 must report in writing to the commissioner any changes in the information provided in the form under subpart 2, item A. The report must be furnished within 30 days after the effective date of the change.
Subp. 6. Exemptions.
A person using radioactive material under the general license issued under subpart 1 is exempt from parts 4731.1000 to 4731.2950 and Code of Federal Regulations, title 10, part 21, with respect to radioactive material covered by the general license, except that persons using mock iodine-125 under subpart 1, item G, must comply with parts 4731.2400, 4731.2600, and 4731.2610.
Statutory Authority: MS s 144.1202; 144.1203