Product Manufacturing and Distribution of Radioactive Material
On this page:
- Medical Products Distribution (description, toolkit)
- Exempt Distribution (description, toolkit)
- Generally Licensed Products Distribution (description, toolkit)
- Specifically Licensed Products Distribution (description, toolkit)
Licensees in this category are involved in manufacturing or distributing radioactive materials (sealed sources, radiochemicals, etc.) or products containing radioactive materials (gauges, radiography cameras, smoke detectors, etc.) to other specific licensees (industrial, academic, or medical), general licensees, or persons exempt from the requirements for a license. The following major categories are within product manufacturing and distribution. Each has an associated licensee toolkit with links to specific regulations and guidance as well as information about license types, forms, and fees. In addition, the toolkit provides answers to some frequently asked questions.
Medical Products Distribution
Medical Products Distribution involves radioactive drugs, sources, and devices containing byproduct materials that are distributed to limited specific medical use licensees. The radioactive drugs may be prepared by commercial nuclear pharmacies or manufactured by radioactive drug manufacturers regulated by the U.S. Food and Drug Administration or State Agencies. The radioactive sources and devices include calibration or reference sources, brachytherapy sources and devices, diagnostic bone mineral analysis, and portable imaging devices.
Look up information in the Medical Products Distribution Licensee Toolkit.
The requirements for licenses authorizing the commercial distribution of products containing byproduct
material to persons who are exempt from licensing are provided in Subpart A of 10 CFR Part 32. Examples of these products include exempt concentrations, luminous watches and gun sights, electron tubes, check sources, irradiated gemstones, and smoke detectors. The requirements for licenses authorizing the commercial distribution of products containing source material to persons who are exempt from licensing are provided in 10 CFR 40.52 and 40.53. Examples of these products include incandescent gas mantles, vacuum tubes, welding rods, and electric lamps.
Look up information in the Exempt Distribution Licensee Toolkit.
Generally Licensed Products Distribution
Specific licenses are issued that authorize the commercial distribution of byproduct material to general licensees. The requirements for this type of distribution license are provided in Subpart B of 10 CFR Part 32. Examples of these products include sealed sources contained in devices designated for detecting, measuring, gauging, or controlling density, thickness, radiation leakage, or chemical composition or for producing light or an ionized atmosphere; tritium or promethium-147 contained in luminous aircraft safety devices; americium-241 in calibration and reference sources; and certain byproduct material in prepackaged units for use in certain in vitro clinical or laboratory tests. These products are used under general licenses that are provided by the regulations in 10 CFR Part 31.
Some source material licensees may manufacture or distribute industrial products and devices containing depleted uranium for the purpose of providing a concentrated mass in a small volume of the product or device. Requirements for this type of license are in 10 CFR Part 40.34; the products are used under a general license provided in 10 CFR Part 40.25.
Some special nuclear material licensees may manufacture or distribute plutonium calibration or reference sources. Requirements for this type of license are found in in 10 CFR Part 70.39; the products are used under a general license provided in 10 CFR Part 70.19.
Look up information in the Generally Licensed Products Distribution Licensee Toolkit.
Specifically Licensed Products Distribution
Licenses are issued for the manufacturing and distribution of products containing byproduct, source, and special nuclear material in various forms for a number of purposes. The products are distributed to persons specifically licensed by NRC or an Agreement State. Medical products distributed under such a license may include radiochemicals that may be distributed to manufacturers, radiopharmacies, veterinarians, and broadscope medical use licensees for the production of radioactive drugs, as well as gamma steriotactical and teletherapy devices for radiation therapy use, and plutonium-powered cardiac pacemakers. Other licensees include suppliers who process, package, encapsulate, and distribute sealed sources for use in gamma radiography, irradiation, well logging, and gauges. Licensees are also involved in the manufacture, assembly, and distribution of various other products that contain radionuclides or radiochemicals for non-medical research.
Look up information in the Specifically Licensed Products Distribution Licensee Toolkit.