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
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