Generally Licensed Products Distribution Licensee Toolkit

This toolkit has been designed to help licensees find key information easily.

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See also Frequently Asked Questions.

Note that generally-licensed product distribution licenses for products containing source or special nuclear materials include possession and use as well as manufacture and distribution authorizations. However, these licenses do not cover the possession and use of byproduct material. A separate license is needed for possession and use of byproduct material (see 10 CFR Part 32).

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Regulations

NRC's regulations are found in Chapter I of Title 10, "Energy," of the Code of Federal Regulations (CFR). Chapter I is divided into Parts 1 through 199. The following parts set forth additional provisions regarding generally licensed products distribution licensing and possession.

  • Part 32.51 – Byproduct Material Contained in Devices for Use under § 31.5; Requirements for License to Manufacture, or Initially Transfer
  • Part 32.53 – Luminous Safety Devices for Use in Aircraft: Requirements for License to Manufacture, Assemble, Repair or Initially Transfer
  • Part 32.57 – Calibration or Reference Sources Containing Americium-241 or Radium-226: Requirements for License to Manufacture or Initially Transfer
  • Part 32.61 – Ice Detection Devices Containing Strontium-90; Requirements for License to Manufacture or Initially Transfer
  • Part 32.71 – Manufacture and Distribution of Byproduct Material for Certain in Vitro Clinical or Laboratory Testing under General License
  • Part 40.34 – Special Requirements for Issuance of Specific Licenses
  • Part 70.39 – Specific Licenses for the Manufacture or Initial Transfer of Calibration or Reference Sources
  • Part 31.5 – Certain Detecting, Measuring, Gauging, or Controlling Devices for Producing Light or an Ionized Atmosphere
  • Part 31.6 – General License to Install Devices Generally Licensed in § 31.5
  • Part 31.7 – Luminous Safety Devices for Use in Aircraft
  • Part 31.8 – Americium-241 and Radium-226 in the Form of Calibration or Reference Sources
  • Part 31.10 – General License for Strontium 90 in Ice Detection Devices
  • Part 31.11 – General License for Use of Byproduct Material for Certain in Vitro Clinical or Laboratory Testing
  • Part 31.12 – General License for Certain Items and Self-luminous Products Containing Radium-226
  • Part 40.25 – General License for Use of Certain Industrial Products or Devices
  • Part 70.19 – General License for Calibration or Reference Sources

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Guidance

Consolidated guidance is published in "Consolidated Guidance About Materials Licenses" (NUREG-1556). The volumes most applicable to generally licensed products distribution are–

  • Volume 3, Applications for Sealed Source and Device Evaluation and Registration
  • Volume 16, Program-Specific Guidance About Licenses Authorizing Distribution to General Licensees
  • Volume 17, Program-Specific Guidance About Licenses for Special Nuclear Material of Less than Critical Mass

Regulatory guides (RGs) are issued in 10 divisions and are intended to aid licensees in implementing regulations. The guide most applicable to generally licensed products distribution is RG 6.9 – Establishing Quality Assurance Programs for the Manufacture and Distribution of Sealed Sources and Devices Containing Byproduct Material.

Web (HTML) versions of some regulatory guides are available for viewing or downloading at this site. In the index for each division of guides, the number of each guide available at this site is underscored. All active final and draft guides are also available in NRC's Agencywide Documents Access and Management System (ADAMS).

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License Types

Licensees who manufacture or distribute sources or devices to general licensees are identified by the license type G Distribution.

NRC assigns five-digit program code number(s) to each license according to the principal activities authorized in the license. NRC uses approximately 100 program codes to classify the activities of thousands of active licenses. The program codes that are assigned to a license may be used to identify the applicable fee categories in the schedules in 10 CFR Part 170 and 10 CFR Part 171. To learn more about program codes and their descriptions and the associated fee and inspection categories, see "Office of Nuclear Materials Safety and Safeguards Program Code Descriptions and Inspection Priorities."

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Fees

Generally licensed products distribution licensees are required to pay an annual license fee to the NRC. Refer to the schedule of materials fees for the fees required for each category of license and each type of fee.

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Form

The Application for Material License Form 313 is to be used by all generally licensed products distribution licensees.

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