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Specifically Licensed Products Distribution Licensee Toolkit

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

On this page:

• Regulations
• Guidance
• Inspection Guidance
• License Types
• Fees
• Forms

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. This type of manufacture and distribution license authorizes the possession and use of licensed material but prohibits distribution persuant to 32.72 or 32.74 or distribution to general licensees or to persons exempt froml licensing. The following parts set forth additional provisions regarding specifically licensed products distribution licensing and possession.

• Part 30 – Rules of General Applicability to Domestic Licensing of Byproduct Material
• Part 32.210 – Registration of Product Information
• Part 30.32 – Application for Specific Licenses
• Part 34.20 – Performance Requirements for Industrial Radiography Equipment
• Part 36.21 – Performance Criteria for Sealed Sources
• Part 39.41 – Design and Performance Criteria for Sealed Sources
• Part 40 – Domestic Licensing of Source Material
• Part 70 – Domestic Licensing of Special Nuclear Material

For additional references, see the Medical, Industrial, Academic Uses of Nuclear Materials Regulations, Guidance, and Communications page.

Guidance

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

• Volume 3, Applications for Sealed Source and Device Evaluation and Registration
• Volume 12, Program-Specific Guidance About Possession Licenses for Manufacturing and Distribution (Final Report)
• Vol. 17, Program-Specific Guidance About Licenses for Special Nuclear Material of Less Than Critical Mass

Web (HTML) versions of some NUREG-series publications are available in our NUREG-Series Document Collection. Some are also available in ADAMS (see our table listing their availability).

For additional references, see the Medical, Industrial, Academic Uses of Nuclear Materials Regulations, Guidance, and Communications page.

Regulatory guides are issued in 10 divisions and are intended to aid licensees in implementing regulations. The guides most applicable to specifically licensed products distribution are the following:

• Division 8, Occupational Health series (See the detailed list of Division 8 regulatory guides in Medical, Industrial, and Academic Uses of Nuclear Materials Regulations, Guidance, and Communications for the most applicable guides for commercial nuclear pharmacies.)
• Regulatory Guide 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).

Inspection Guidance

NRC's regional offices (Region I - Northeast, Region II - Southeast, Region III - Midwest, and Region IV - West/Southwest) conduct typically unannounced, periodic inspection of licensed activities using guidance from Inspection Manual, Chapter 2800. The frequency of inspection is based on the hazard of materials used. The following addresses inspections directly related to specifically licensed products distribution:

• IP 87125 – Materials Processor/Manufacture Programs

For additional references, see the Inspection of Inspection of Medical, Industrial, and Academic Uses of Nuclear Materials page.

License Types

Licensees who manufacture or distribute sealed sources to specific licensees are identified by the license type S Distribution

NRC assigns a five-digit program code number to each license to designate the major activity or principal use authorized in the license. These codes may be used to identify the appropriate NUREG-1556 guidance documents and secondary activities or uses authorized in the license. NRC uses approximately 100 program codes to classify the primary and secondary activities of thousands of active licenses. Additional information provided in the description of each license type may be used to identify the fee categories information in the schedules in 10 CFR Part 170 and 10 CFR Part 171. To learn more about the license category and the associated fee and inspection categories, see "Consolidated Guidance About Materials Licenses: Guidance About Administrative Licensing Procedures" (NUREG-1556, Vol. 20), Appendix G: LTS Program Code Descriptions.

Program Codes Used in Materials and Fuel Licensing and Inspection Programs

Fees

Specifically licensed products distribution licensees are required to pay an annual license fee to the NRC. These fees are explained in our Materials Fee Billing Handbook. Refer to the schedule of materials fees for the fees required for each category of license and each type of fee.

Forms

The following forms are to be used by all specifically licensed products distribution licensees.

• Application for Materials License Form 313
• Disposition of Materials Form 314
• NRC Form 3
• NRC Form 4
• NRC Form 5

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Thursday, February 28, 2008