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Medical Isotope Production Without Highly Enriched Uranium (2009) / Chapter Skim
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8 Conversion to LEU-Based Production of Molybdenum-99: Regulatory Considerations
Pages 101-107

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From page 101...
... Civilian nuclear fuel cycle facilities that handle Formula Quantities of Special Nuclear ­Materials   Special Nuclear Material is defined in Title 1 of the Atomic Energy Act of 1954. It includes plutonium, uranium-233, or uranium enriched in the isotopes uranium-233 or uranium-235.
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From page 102...
... and promulgated in part or in whole in regulations by national authorities. In the United States, for example, civilian facilities possessing formula quantities of ­special ­nuclear materials fall under the authority of the Nuclear Regulatory Commission and must meet the requirements in Title 10, Part 73 of the Code of Federal Regulations (10 CFR Part 73)
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From page 103...
... The targets can be shipped to the reactors in less-than-formula quantities. 3. The security requirements for all nuclear facilities, including the research and test reactors that are used to irradiate targets for medical isotope production, were raised in many countries, including the United States, following the September 11, 2001, terrorist attacks on the United States.
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From page 104...
... The total concentrations of alpha-emitting isotopes are not appreciably different in either target type, and both uranium and plutonium isotopes can be effectively removed during target processing. COMMERCIAL SALE OF RADIOPHARMACEUTICALS The third issue of concern to producers involves regulatory approvals for commercial sale of radiopharmaceuticals manufactured from Mo-99.
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From page 105...
... The DMF describes the facil ity in which the Mo-99 is made; the production process itself, including any raw materials used in production; and product test methods, specifications, stability, and release criteria. The DMF is not approved by the FDA; instead, it is used as a source of information when FDA approval is sought to sell Tc-99m radiolabeled compounds made with that producer's Mo-99.
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From page 106...
... If LEU-based Mo-99 can be produced with similar chemical characteristics similar to HEU-based Mo-99 -- and current experience in Argentina and Australia indicates that it can -- it is hard for the committee to see any rational basis for expectations of substantial delays in FDA approvals if producers submit high-quality sNDAs and work with FDA staff throughout the approval process. It is especially difficult for the committee to see how the FDA would ever require clinical trials as part of an sNDA for a new Mo-99 source.
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From page 107...
... It is important to recognize that these cost estimates represent only the direct costs for regulatory approvals. There are also likely to be ­ indirect costs for such approvals, including, for example, any opportunity costs associated with lost sales of Mo-99, technetium generators, or radio­ pharmaceutical kits as a result of the regulatory process.
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Key Terms

  • regulatory considerations
  • approval process
  • fda approval
  • heu targets
  • medical isotope

  • percent leu
  • formula quantities
  • isotope production
  • fda approvals
  • clinical trials

  • special nuclear
  • radiolabeled compounds
  • commercial sale
  • technetium generator
  • security costs

  • production facilities
  • fda presenter
  • nuclear materials
  • security requirements
  • regulatory approvals

  • physical security
  • obtain fda
  • radiopharmaceuticals manufactured
  • compounds intended
  • research reactor

  • committee hypothesized
  • require clinical
  • industry representatives
  • generator producer
  • substantial savings


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