Group 100
Included is the use of any unsealed radioactive material for
use in uptake, dilution, or excretion studies and not requiring a written
directive: The radioactive material in this group shall be:
1. Obtained from a manufacturer or preparer
licensed under R9-7-703(C)(2)(a), or equivalent NRC or Agreement State
requirements; or
2. Obtained from a
PET radioactive drug producer licensed under R9-7-703 or equivalent NRC or an
Agreement State license excluding production of PET radionuclides prepared by
an authorized nuclear pharmacist who meets the requirements in R9-7-712, a
physician who is an authorized user and who meets the requirements specified in
R9-7-721, or R9-7-723 and
R9-7-721(3)(b)(vii),
or an individual under the supervision of either as specified in R9-7-706;
or
3. If a research protocol:
a. Obtained from and prepared by an Agreement
State or NRC licensee for use in research in accordance with a Radioactive Drug
Research Committee-approved protocol or an Investigational New Drug (IND)
protocol accepted by FDA; or
b.
Prepared by the licensee for use in research in accordance with a Radioactive
Drug Research Committee-approved application or an Investigational New Drug
(IND) protocol accepted by FDA.
Group 200
Included is the use of any unsealed radioactive material for
use in imaging and localization not requiring a written directive. PET
radiopharmaceuticals may be used if the licensee meets the requirements in
R9-7-716. The radioactive material in this group shall be:
1. Obtained from a manufacturer or preparer
licensed under R9-7-703(C)(2)(a), or equivalent NRC or Agreement State
requirements; or
2. Obtained from a
PET radioactive drug producer licensed under R9-7-703 or an equivalent NRC or
Agreement State license excluding production of PET radionuclides prepared by
an authorized nuclear pharmacist who meets the requirements in R9-7-712, a
physician who is an authorized user and who meets the requirements specified in
R9-7-721, or R9-7-723 and
R9-7-721(3)(b)(vii),
or an individual under the supervision of either as specified in R9-7-706;
or
3. If a research protocol:
a. Obtained from and prepared by an Agreement
State or NRC licensee for use in research in accordance with a Radioactive Drug
Research Committee-approved application or an Investigational New Drug (IND)
protocol accepted by FDA; or
b.
Prepared by the licensee for use in research in accordance with a Radioactive
Drug Research Committee-approved application or an Investigational New Drug
(IND) protocol accepted by FDA.
Group 300
Included is the use of any unsealed radioactive material for
medical use (radiopharmaceutical) for which a written directive is required.
The radioactive material in this group shall be:
1. Obtained from a manufacturer or preparer
licensed under R9-7-703(C)(2)(a) or equivalent NRC or Agreement State
requirements; or
2. Obtained from a
PET radioactive drug producer licensed under R9-7-703 or equivalent NRC or an
Agreement State license excluding production of PET radionuclides prepared by
an authorized nuclear pharmacist who meets the requirements in R9-7-712, a
physician who is an authorized user and who meets the requirements specified in
R9-7-721 or R9-7-723, or an individual under the supervision of either as
specified in R9-7-706; or
3. If a
research protocol:
a. Obtained from and
prepared by an Agreement State or NRC licensee for use in research in
accordance with an Investigational New Drug (IND) protocol accepted by FDA;
or
b. Prepared by the licensee for
use in research in accordance with an Investigational New Drug (IND) protocol
accepted by FDA.
Group 400
Included is the use of any brachytherapy source for
therapeutic medical use that is manufactured in accordance with
R9-7-703(C)(2)(b) and:
1. Approved for
therapeutic use in the Sealed Source and Device Registry; or
2. Part of a research protocol that is
approved for therapeutic use under an active Investigational Device Exemption
(IDE) application accepted by the FDA, and meets the requirements of
R9-7-709.
Group 500
Included is the use of any sealed source that is manufactured
in accordance with R9-7-703(C)(2)(b), and is approved for diagnostic use in the
Sealed Source and Device Registry.
Group 600
Included is the use of sealed sources in photon emitting
remote afterloader units, teletherapy units, or gamma stereotactic radiosurgery
units that are manufactured in accordance with R9-7-703(C)(2)(b) and:
1. Approved for therapeutic use in the Sealed
Source and Device Registry; or
2.
Part of a research protocol that is approved for therapeutic use under an
active Investigational Device Exemption (IDE) application accepted by the FDA
and meets the requirements of R9-7-709.
Group 1000
A licensee may use radioactive material or a radiation source
approved for medical use which is not specifically addressed in R9-7-309(4)
if:
1. The applicant or licensee has
submitted the information required by this Article; and
2. The applicant or licensee has received
written approval from the Department in a license or license amendment and uses
the material in accordance with the rules and specific conditions the
Department considers necessary for the medical use of the
material.
