MINNESOTA DEPARTMENT OF HEALTH REGULATORY GUIDE FOR NUCLEAR PHARMACIES Radioactive Materials Unit Minnesota Department of Health 625 Robert Street North P.O. Box 64975 St. Paul, Minnesota 55164-0975 (651) 201-4545 April 2, 2007 TABLE OF CONTENTS INTRODUCTION.........................................................................................................................................................5 AS LOW AS REASONABLY ACHIEVABLE (ALARA) PHILOSOPHY............................................................5 TIMELY NOTIFICATION OF TRANSFER OF CONTROL ..................................................................................5 TIMELY NOTIFICATION OF BANKRUPTCY PROCEEDINGS .........................................................................6 RECORDKEEPING FOR DECOMMISSIONING AND FINANCIAL ASSURANCE ........................................6 DETERMINING NEED FOR FINANCIAL ASSURANCE FOR DECOMMISSIONING...........................................................7 FILING AN APPLICATION .......................................................................................................................................7 ITEM 1: LICENSE ACTION TYPE ...............................................................................................................................8 ITEM 2: NAME AND MAILING ADDRESS OF APPLICANT ...........................................................................................8 ITEM 3: ADDRESS(ES) WHERE LICENSED MATERIAL WILL BE USED OR POSSESSED ..........................................8 ITEM 4: PERSON TO BE CONTACTED ABOUT THIS APPLICATION...........................................................................9 ITEM 5: RADIOACTIVE MATERIAL.............................................................................................................................9 Unsealed and/or Sealed Radioactive Material..............................................................................................9 ITEM 6: PURPOSE(S) FOR WHICH LICENSED MATERIAL WILL BE USED ..............................................................11 Distribution and Redistribution of Sealed and Unsealed Materials..........................................................11 Preparation of Radiopharmaceuticals ..........................................................................................................13 Sealed Sources for Calibration and Checks................................................................................................13 Service Activities .............................................................................................................................................13 ITEM 7: INDIVIDUAL(S) RESPONSIBLE FOR RADIATION SAFETY PROGRAM..........................................................13 MANAGEMENT RESPONSIBILITIES ..........................................................................................................................13 Radiation Safety Officer..................................................................................................................................14 Authorized Nuclear Pharmacist (ANP).........................................................................................................15 Authorized Users (AU)....................................................................................................................................16 ITEM 8: TRAINING FOR INDIVIDUALS WORKING IN OR FREQUENTING RESTRICTED AREAS.................................17 Occupationally Exposed Workers and Ancillary Personnel ......................................................................17 Personnel Involved in Hazardous Materials Package Preparation and Transport................................18 Instruction for Supervised Individuals Preparing Radiopharmaceuticals................................................19 ITEM 9: FACILITIES AND EQUIPMENT .....................................................................................................................19 Radiation Monitoring Equipment...................................................................................................................20 Dosage Measurement Systems ....................................................................................................................21 ITEM 10: RADIATION SAFETY PROGRAM...............................................................................................................22 Audit Program ..................................................................................................................................................22 Material Receipt and Accountability .............................................................................................................22 Occupational Dose..........................................................................................................................................24 Public Dose ......................................................................................................................................................25 General Safety Procedures............................................................................................................................26 Emergency Procedures..................................................................................................................................26 Surveys .............................................................................................................................................................27 Leak Testing of Sealed Sources ...................................................................................................................27 Undetected Contamination and Loss of Control of Licensed Material ....................................................28 Transportation..................................................................................................................................................28 Minimization of Contamination ......................................................................................................................29 Radioactive Drug Labeling for Distribution ..................................................................................................29 Radioactive Drug Shielding for Distribution.................................................................................................30 ITEM 11: WASTE MANAGEMENT............................................................................................................................30 Disposal by Decay-in-Storage.......................................................................................................................31 Transfer to an Authorized Recipient.............................................................................................................32 Release into Sanitary Sewerage...................................................................................................................32 Returned Wastes from Customers ...............................................................................................................32 3 ITEM 12: LICENSE FEE............................................................................................................................................33 ITEM 13: CERTIFICATION .......................................................................................................................................33 AMENDMENTS TO A LICENSE............................................................................................................................34 RENEWAL OF A LICENSE....................................................................................................................................34 IMPLEMENTATION .................................................................................................................................................34 INSPECTIONS ..........................................................................................................................................................34 APPENDICES ...........................................................................................................................................................35 APPENDIX A: TYPICAL DUTIES AND RESPONSIBILITIES OF THE RADIATION SAFETY OFFICER (RSO) ..............35 APPENDIX B: MODEL DOSE CALIBRATOR TESTING PROGRAM............................................................................36 APPENDIX C: SUGGESTED NUCLEAR PHARMACY AUDIT CHECKLIST ..................................................................41 APPENDIX D: ORDERING AND RECEIVING RADIOACTIVE MATERIAL....................................................................50 APPENDIX E: SAFELY OPENING PACKAGES .........................................................................................................51 APPENDIX F: PERSONNEL EXPOSURE MONITORING PROGRAM ..........................................................................53 External Exposure...........................................................................................................................................53 Investigational Levels - External Exposure..................................................................................................55 Declared Pregnancy And Dose To The Embryo/Fetus .............................................................................56 Internal Exposure ............................................................................................................................................56