CORAR

Council on Radionuclides and Radiopharmaceuticals, Inc.

CORAR advocates for public policies that impact health care, transportationsafety, homeland security, and manufacturing in an effort to expandaccess to safe and affordable health care treatments for all.

Transportation
The Transportation Committee is tasked with activities uniquely associated with the movement of radioactive material from one location to another (domestic or international) including but not limited to packaging, monitoring, loading, carriage by all modes, interim storage, unloading, and receipt. Includes the physical movement of materials across borders.

Import/Export regulations, licenses, permits and conditions that allow or inhibit radioactive materials to be imported and exported.  

Areas of Interest:

  • Domestic transport regulations
  • International transport regulations
  • Modal transport regulations
  • Transport security
  • Carrier availability
  • Carrier qualifications
  • Carrier/shipper training
  • Radiation Protection Programs for the transport of radioactive material
  • Shipment denials
  • Package/container approval
  • CVSA Level VI Inspections
  • Supply Chain restrictions (routes. Class 7 carriage capability / acceptance, etc.)
  • US / Canada Border Contingency Planning
  • HMTA Reauthorization Legation
  • Proposed legislation to increase nuclear security (with MQS Comm)
  • 100 percent screening of cargo carried on passenger aircraft

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Manufacturing, Health, Safety (MHS)
The Manufacturing, Health, Safety (MHS) Committee considers everything that is required at a licensed manufacturing facility to receive, possess, handle, store, utilize, manufacture, process, secure, and dispose of radioactive materials. MHS activities encompass issues such as Environmental Health and Safety programs which include “in-house” cyclotron or accelerator production facilities that are integral to a broader manufacturing operation.

Areas of Interest:

  • Site security
  • Radiation Protection Standards
  • Environmental Protection
  • Radioactive waste
  • Quality Standards (ISO)
  • National Source tracking
  • Regulatory Harmonization and Simplification
  • Occupational Safety
  • Decommissioning
  • Clearance of Materials
  • Sewer disposal
  • Licensing, Inspection and Enforcement (Fees)
  • cGMPs
  • Radiological Emergency Plans and Programs
  • Radiation Safety Consensus Standards
  • NCRP and ICRP Recommendations
  • Low level Rad Waste Imports
  • Proposed legislation to increase nuclear security (with Trans Comm)
  • EPA radiation standards
  • NRC patient release criteria  (with HCP Comm)
  • FDA efforts to reduce radiation exposure  (with HCP Comm)
 

Isotope Supply   
The Isotope Supply Committee evaluates strategic and tactical issues that are specific to the availability of radioactive and stable isotopes used by a majority of the CORAR member companies to manufacture radionuclide and radiopharmaceutical products.  Includes reactor isotope production and “contract” cyclotron or accelerator facilities.

Areas of Interest:

  • Strategic isotope supply
  • Reactor availability
  • “Contract” cyclotron availability
  • Radioisotope and stable isotope production
  • Isotope production facility security
  • Import/export
  • Non-proliferation policies (Mo-99 HEU/LEU)
  • Medical Isotope Legislation (e.g. S.99)
  • DOE Isotope Program
 

Health Care Policy    
The Health Care Policy Committee is tasked with proactive and/or reactive activities to all proposed, pending or in-force federal and/or state medical-reimbursement legislations and regulations, and other related activities pertaining to radiopharmaceuticals and nuclear medicine procedures.  In addition, the committee considers issues involving quality of products and materials used to manufacture radiopharmaceuticals.  The primary focus is on purity, sterility, concentration and size, etc. specifications and cGMP regulations.

Areas of Interest:

  • Federal, state, and private reimbursement coverage, coding and payment
  • Diagnosis, procedure, and product coding
  • Utilization and quality of medical imaging (reimbursement impact)
  • Congressional education and outreach
  • Regulation of pharmacy compounding
  • Drug review, approval, and process optimization
  • Critical path initiative
  • FDA user fees
  • Re-establishment of Medical Imaging Drug Advisory Committee
  • cGMPs
  • Quality standards (ISO)
  • Exploratory INDs
  • FDA Drug User Fees and FDA Establishment Fees to for PET isotope manufacturing facilities
  • Medicaid Rebates and application to radiopharmaceuticals (including SPECT and PET radiopharmaceuticals)
  • Medicare payment reductions to the technical component payment for medical imaging procedures
  • Medicare separate payment of radiopharmaceuticals in the hospital outpatient setting
  • Establishing a methodology for the optional reporting of average selling price (ASP) of radiopharmaceuticals
  • New Indications for FDG
  • Drug Safety/Import legislation
  • NRC patient release criteria  (with MHS Comm)
  • FDA efforts to reduce radiation exposure  (with MHS Comm)
 

Nuclear Pharmacy     
The Nuclear Pharmacy Committee is tasked with proactive and/or reactive activities to all proposed, pending or in-force federal and/or state nuclear pharmacy issues, legislation, and regulations, and other related activities pertaining to radiopharmaceuticals and nuclear pharmacy regulations.

Areas of Interest:

  • Extremity dose monitoring
  • Regulation of pharmacy compounding
  • The Joint Commission (fka JCAHO) regulations
  • Harmonization of State pharmacy regulations
  • USP issues
  • Application of FDA Establishment Fees to Nuclear Pharmacies Providing PET isotopes
  • Application of federal health information technology (HIT) rules
 

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