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§175.104 Specific types of radioactive materials licenses.
(a) Types of license. The requirements specified in this section are in addition to, and not in substitution
for, others in this Article. In particular, the incorporated provisions of 10 CFR Part 30 apply to all
license applications and all specific radioactive materials licenses. For the purposes of this Article,
the following specific license types of radioactive materials apply:
(1) A specific license of limited scope for gamma stereotactic radiosurgery (GSR) or for teletherapy
means a license that authorizes receipt, acquisition, ownership, possession, use and transfer of
specified quantities and types of radioactive material for use in GSR or teletherapy programs.
(2) A specific license of limited scope for medical use means a license that authorizes receipt,
acquisition, ownership, possession, use and transfer of specified quantities and types of
radioactive material for use in or on humans in a medical program, but does not include GSR or
teletherapy.
(3) A specific license of limited scope for other use means a license that authorizes receipt,
production, acquisition, ownership, possession, use and transfer of specified quantities and types
of radioactive material for uses other than in or on humans.
(4) A specific license of broad scope for medical use means a license that authorizes receipt,
acquisition, ownership, possession, use and transfer of any chemical or physical form of the
radioactive materials specified in the license, for use in or on humans in a medical program, but
does not include GSR or teletherapy.
(5) A specific license of broad scope for research and development means a license that authorizes
receipt, acquisition, ownership, possession, use and transfer of any chemical or physical form of
radioactive materials specified in the license, in quantities not exceeding those specified in the
license, for uses other than in or on humans.
(b) Specific licenses for human use of radioactive materials in institutions. An application by a medical
institution for a specific license for medical use of radioactive material may be approved if:
(1) pursuant to §§175.103 and 175.105, the applicant satisfies the requirements specified in the
incorporated provisions of 10 CFR Parts 30 and 35; and
(2) the applicant possesses adequate facilities for the clinical care of patients; and
(3) the physician designated on the application as the individual authorized user has training and
experience as specified in 10 CFR Part 35, in the proposed use, handling and administration of
radionuclides and the clinical management of radioactive patients. The physician must furnish
evidence of such experience with the application. A statement from the physician’s preceptor at
the medical institution where the physician acquired such training and experience, indicating their
amount and nature, may be submitted as evidence of such experience.
(4) The license application is signed by the chairman of the radiation safety committee and an
authorized representative of the medical institution.
(c) Specific licenses to individual physicians for human use of radioactive materials. An application by
an individual physician for a specific license for human use of radioactive material may be approved
if:
(1) pursuant to §§175.103 and 175., the applicant satisfies the requirements specified in the
incorporated provisions of 10 CFR Parts 30 and 35; and
(2) the applicant has training and experience as specified in 10 CFR Part 35 in the proposed use,
handling and administration of radionuclides, and the clinical management of radioactive patients.
The physician must furnish evidence of such training and experience with the application. A
statement from the physician’s preceptor at the institution where the physician acquired such
training and experience, indicating their amount and nature, may be submitted as evidence of such
experience.
(d) Specific licenses of broad scope.
(1) A specific license of broad scope is a specific license authorizing receipt, acquisition, ownership,
possession, use, and transfer of any chemical or physical form of the byproduct material specified
in the license, but not exceeding quantities specified in the license. Approved authorized users do