Regulatory and Legislative Priorities

• Advocate for Appropriate Medicare Payment for Diagnostic Radiopharmaceuticals:

  • Advocate for separate payment legislation for certain diagnostic radiopharmaceuticals under the Medicare Hospital Outpatient Prospective Payment System (OPPS)

• Promote Safety of Radiopharmaceuticals Dispensed and Administered to Patients:

  • Continue advocacy with the U.S. Food and Drug Administration (FDA) and State Board of Pharmacies (BOPs) regarding the compounding of essential copies of radiopharmaceuticals

• Foster Good Manufacturing and Nuclear Pharmacy Preparation Practices for Positron Emission Tomography (PET) Drugs:

  • Monitor potential changes and updates to FDA PET drug manufacturing regulations under 21 CFR Part 212

  • Monitor and inform regulations pertaining to the use of Ge-68/Ga-68 generators in preparation of FDA approved PET drugs

• Support Regulations that Expand Patient Access to Therapeutic Radiopharmaceuticals:

  • Advocate for U.S. Nuclear Regulatory Commission (NRC) staff recommendations for rule making to revise training & experience (T&E) requirements for Authorized Users (AUs) under 10 CFR 35.300

• Maintain Safe Transportation of Medical and Industrial Radioisotopes:

  • Monitor and inform the U.S. Department of Transportation (DOT) harmonization of regulations for the safe transport of hazardous material with NRC and International Atomic Energy Agency (IAEA) regulations

• Ensure Reliable and Sustainable Domestic Supply of Medical and Industrial isotopes:

  • Advocate for U.S. legislation, policies, and programs to support a resilient and sustainable supply chain of medical and industrial isotopes, including increasing domestic production of essential radioactive and enriched stable isotopes used in U.S. healthcare and industry