Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-46 - General Licenses and Licenses for Manufacturing and Distribution › Section 3701:1-46-44 - Manufacture and distribution of sources or devices containing radioactive material for medical use

Current through all regulations passed and filed through July 1, 2024
(A) An application for a specific license to
			 manufacture and distribute sources and devices containing radioactive material
			 to persons licensed pursuant to Chapter 3701:1-58 of the Administrative Code or
			 equivalent regulations of the United States nuclear regulatory commission or
			 agreement state for use as a calibration, transmission, or reference source or
			 for the uses listed in rules
			 3701:1-58-43,
			 3701:1-58-53,
			 3701:1-58-55,
			 and
			 3701:1-58-72
			 of the Administrative Code or equivalent regulations of the United States
			 nuclear regulatory commission or agreement state will be approved if:
(1) The applicant satisfies the general
			 requirements in rule
			 3701:1-40-15
			 of the Administrative Code;
(2)
			 The applicant submits sufficient information regarding each type of source or
			 device pertinent to an evaluation of its radiation safety, including:
(a) The radioactive material contained, its
			 chemical and physical form, and amount;
(b) Details of design and construction of the
			 source or device;
(c) Procedures
			 for, and results of, prototype tests to demonstrate that the source or device
			 will maintain its integrity under stresses likely to be encountered in normal
			 use and accidents;
(d) For devices
			 containing radioactive material, the radiation profile of a prototype
			 device;
(e) Details of quality
			 control procedures to assure that production sources and devices meet the
			 standards of the design and prototype tests;
(f) Procedures and standards for calibrating
			 sources and devices;
(g) Legend and
			 methods for labeling sources and devices as to their radioactive
			 content;
(h) Instructions for
			 handling and storing the source or device from the radiation safety standpoint;
			 these instructions are to be included on a durable label attached to the source
			 or device or attached to a permanent storage container for the source or
			 device: provided, that instructions which are too lengthy for such label may be
			 summarized on the label and printed in detail on a brochure which is referenced
			 on the label;
(3) The
			 label affixed to the source or device, or to the permanent storage container
			 for the source or device, contains information on the radionuclide, quantity
			 and date of assay, and a statement that the director has approved distribution
			 of the (name of source or device) to persons licensed to use radioactive
			 material identified in rules
			 3701:1-58-26,
			 3701:1-58-43,
			 3701:1-58-53,
			 and
			 3701:1-58-55
			 of the Administrative Code, as appropriate, and to persons who hold an
			 equivalent license issued by the United States nuclear regulatory commission or
			 an agreement state;and
(4)
									 The source or device has been registered in the sealed
			 source and device registry.