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Medical Products Distribution Licensee ToolkitThis toolkit is designed to help licensees find key information easily. On this page: RegulationsThe 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
Commercial Nuclear Pharmacies
See also the Medical, Industrial, Academic Uses of Nuclear Materials Regulations, Guidance, and Communications page. GuidanceConsolidated materials guidance is published in "Consolidated Guidance About Materials Licenses" (NUREG-1556). Manufacturers and distributors:
Commercial nuclear pharmacies:
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
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 TypesMedical Product Distribution License TypesNRC 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.
FeesMedical 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. FormThe 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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