Medical Products Distribution Licensee Toolkit

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

On this page:

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.

Page Last Reviewed/Updated Friday, March 27, 2020