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Medical Products Distribution Licensee Toolkit

This toolkit is designed to help licensees find key information easily.

On this page:

• Regulations
• Guidance
• License Types
• Fees
• Form

Regulations

The 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 contain the requirements most relevant to medical products distribution licensing and possession:

Medical Product Manufacturers and Distributors

• Part 32.72 – Manufacture, preparation, or transfer for commercial distribution of radioactive drugs containing byproduct material for medical use under Part 35, or
• Part 32.74 – Manufacture and distribution of sources or devices containing byproduct material for medical use, and
• Part 32.210 – Registration of product information

Commercial Nuclear Pharmacies

• Part 30 – Rules of general applicability to domestic licensing of byproduct material
• Part 32.72 – Manufacture, preparation, or transfer for commercial distribution of radioactive drugs containing byproduct materia for medical use under Part 35

Note: The commercial nuclear pharmacy license is the only MD-distribution license that includes possession and use of licensed material as well as preparation and distribution of radioactive drugs in the same license. All other MD-distribution licenses prohibit the possession and use of licensed material. This is why on this page Part 30 is only listed as an applicable regulation for the commercial nuclear pharmacy.

See also the Medical, Industrial, Academic Uses of Nuclear Materials Regulations, Guidance, and Communications page.

Guidance

Consolidated materials guidance is published in "Consolidated Guidance About Materials Licenses" (NUREG-1556).

Manufacturers and distributors:

• Volume 12, Program-Specific Guidance About Possession Licenses for Manufacturing and Distribution
• Volume 3, Applications for Sealed Source and Device Evaluation and Registration

Commercial nuclear pharmacies:

• Volume 13, Program-Specific Guidance About Commercial Nuclear Pharmacies, originally published in 1999 and Revision I published in 2007

Regulatory guides (RGs) are issued in 10 divisions and are intended to aid licensees in implementing regulations. The guides most applicable to medical products distribution are—

Manufacturers and distributors

RG 6.9 – Establishing Quality Assurance Programs for the Manufacture and Distribution of Sealed Sources and Devices Containing Byproduct Material

Commercial nuclear pharmacies

• 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.)

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).

License Types

Medical Product Distribution License Types

NRC assigns a five-digit code 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).

Medical Product Manufacturers and Distributors (except commercial nuclear pharmacies)

License Types (Program Codes) for Medical Product Manufacturers and Distributors

*This program code is for drug manufacturers registered with the U.S. Food and Drug Administration (FDA) or the state as a drug manufacturer. It involves manufacturing of drugs in accordance with FDA or state-approved quality assurance systems for a specific FDA- or state-approved drug or biologic. Program code 2500 is used for the preparation of radiopharmaceuticals under the practice of pharmacy.

Commercial Nuclear Pharmacies

License Types (Program Codes) for Commercial Nuclear Pharmacy Use

Additional License Types (Program Codes) associated with commercial nuclear pharmacies. The code used depends upon additional medical product distribution authorizations.

Additional License Types (Program Codes) associated with commercial nuclear pharmacies. The code used depends upon radiation safety program authorizations.

Fees

Medical product manufacturers, distributors, and commercial nuclear pharmacies license applicants are required to pay a fee to the NRC upon application for a new license and are required to pay an annual license fee to the NRC thereafter. 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.

Form

The Application for Material License Form 313 may be used by all medical product manufacturers, distributors, and commercial nuclear pharmacies applicants as a guide to information needed by the NRC. Application checklists are also provided in the appendices to NUREG-1556 guidance so that applicants will better understand the type of information needed for NRC review of the application.

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Wednesday, June 11, 2008