Rhode Island Code of Regulations › Title 216 - Department of health › Chapter 40 - Professional licensing and facility regulation › Subchapter 20 - Radiation › Part 7 - Licensing of Radioactive Material › Section 216-RICR-40-20-7.6 - Specific Licenses

Current through June 14, 2024
7.6.1
Application for Specific Licenses
A. Applications for specific licenses shall
				  be filed in duplicate on a form prescribed by the Agency, and shall include a
				  designated e-mail address for receipt of official Agency correspondence in
				  electronic format.
B. The Agency
				  may at any time after the filing of the original application, and before the
				  expiration of the license, require further statements in order to enable the
				  Agency to determine whether the application should be granted or denied or
				  whether a license should be modified or revoked.
C. Each application shall be signed by the
				  applicant or licensee or a person duly authorized to act on their
				  behalf.
D. An application for a
				  license may include a request for a license authorizing one (1) or more
				  activities.
E. In the application,
				  the applicant shall submit the required information to the Agency without
				  reference to previously submitted documents unless permission has been obtained
				  from the Agency, in advance, to incorporate by reference information contained
				  in previous applications, statements, or reports filed with the Agency. All
				  references shall be clear and specific and shall contain all of the information
				  needed for a particular item on the application.
F. Applications and documents submitted to
				  the Agency may be made available for public inspection except that the Agency
				  may withhold any document or part thereof from public inspection if disclosure
				  of its content is not required in the public interest and would adversely
				  affect the interest of a person concerned.
G. Specific License to Use Radioactive
				  Material in the Form of a Sealed Source or in a Device That Contains the Sealed
				  Source. For the purposes of this Part, requirements for a specific license to
				  use radioactive material in the form of a sealed source or in a device that
				  contains the sealed source are defined by
				   10 C.F.R. §
												30.32(g).
H. Consideration of the Need for an Emergency
				  Plan for Responding to a Release of Radioactive Materials. For the purpose of
				  this Part, requirements for consideration of the need for an emergency plan for
				  responding to a release of radioactive materials are defined by
				   10 C.F.R. §
												30.32(i).
I. Production of PET Radioactive Drugs for
				  Noncommercial Transfer. An application from a medical facility or educational
				  institution to produce Positron Emission Tomography (PET) radioactive drugs for
				  noncommercial transfer to licensees in its consortium authorized for medical
				  use under Part 9 of this Subchapter shall include:
1. A request for authorization for the
				  production of PET radionuclides or evidence of an existing license issued under
				  this Part, or equivalent Regulations of the U.S. Nuclear Regulatory Commission
				  or another Agreement State, for a PET radionuclide production facility within
				  its consortium from which it receives PET radionuclides.
2. Evidence that the applicant is qualified
				  to produce radioactive drugs for medical use by meeting one (1) of the criteria
				  in §7.6.16(B) of this Part.
3.
				  Identification of individual(s) authorized to prepare the PET radioactive drugs
				  if the applicant is a pharmacy, and documentation that each individual meets
				  the requirements of an Authorized Nuclear Pharmacist as specified in
				   10
				  C.F.R. §
													32.72(b)(2)   and §7.6.16(C) of this
				  Part.
4. Information identified in
				   10 C.F.R. §
													32.72(a)(3)  on
				  the PET drugs to be noncommercially transferred to members of its
				  consortium.