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  • 1

    Prepared by

    Nuclear Pharmacy Compounding Practice Committee

    Section on Nuclear Pharmacy Practice

    Academy of Pharmacy Practice and Management (APPM)

    American Pharmaceutical Association (APhA)

    Approved by the APhA Board of TrusteesSeptember 23, 2001

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    TABLE OF CONTENTS

    COMMITTEE MEMBERS .......................................................................................................................................... 4

    ABBREVIATION LIST ............................................................................................................................................... 7

    DEFINITIONS.............................................................................................................................................................. 8

    INTRODUCTION ...................................................................................................................................................... 10

    GENERAL PROVISIONS ......................................................................................................................................... 13

    ORGANIZATION AND PERSONNEL..................................................................................................................... 15

    COMPOUNDING ENVIRONMENT ........................................................................................................................ 17

    Facilities ................................................................................................................................................................. 17

    Equipment .............................................................................................................................................................. 19

    SOURCES OF COMPOUNDING DRUG COMPONENTS...................................................................................... 20

    Bulk Drug Substance.............................................................................................................................................. 20

    Excipient ................................................................................................................................................................ 20

    QUALITY CONTROL............................................................................................................................................... 22

    Compounded Reagent Kits..................................................................................................................................... 22

    Compounded Radiopharmaceuticals ...................................................................................................................... 22

    Quality Control of 99mTc Eluate......................................................................................................................... 22

    Visual Inspection of Product ............................................................................................................................. 22

    Assessment of Radioactivity ............................................................................................................................. 22

    Quality Control of Radionuclide (Dose) Calibrator .......................................................................................... 23

    Radionuclidic Purity.......................................................................................................................................... 23

    Radiochemical Purity ........................................................................................................................................ 23

    pH...................................................................................................................................................................... 23

    Verification of Macroaggregate Particle Size and Number ............................................................................... 23

    Imprinted Labeling ............................................................................................................................................ 23

    Microbiological Control and Bacterial Endotoxin Testing................................................................................ 24

    STABILITY OF COMPOUNDED PREPARATIONS .............................................................................................. 25

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    PRIMARY PACKAGING OF COMPOUNDED PREPARATIONS ........................................................................ 26

    IMPRINTED LABELING FOR COMPOUNDED PREPARATIONS...................................................................... 27

    COMPOUNDING RECORDS AND DOCUMENTS................................................................................................ 28

    STORAGE .................................................................................................................................................................. 29

    REFERENCES ........................................................................................................................................................... 30

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    COMMITTEE MEMBERS

    (The names of the committee members are listed in alphabetical order)

    Samuel C. Augustine, Pharm.D., BCNPAssociate ProfessorCollege of Pharmacy, Department of Pharmacy PracticeCollege of Medicine, Department of Pathology and MicrobiologyDirector of the Antibody LabelingCoordinator of Experiential Training986045 Nebraska Medical CenterOmaha, NE 68198-6045

    Phone: (402) 559-5774Fax: (402) 559-5673E-mail: saugusti@unmc.edu

    Kenneth T. Cheng, Ph.D., BCNP, FAPhAAssociate Professor and Director of Nuclear Pharmacy ProgramDepartment of Pharmaceutical SciencesCollege of PharmacyMedical University of South Carolina171 Ashley AvenueCharleston, SC 29425

    Phone: (843) 792-7458Fax: (843) 792-0759E-mail: chengk@musc.edu

    Richard L. Green, R.Ph., BCNPAdjunct Associate Professor of BionucleonicsButler University College of Pharmacy and Health SciencesProgram Manager Pharmacy PracticeQuality & Regulatory DepartmentSyncor International Corporation6464 Canoga AvenueWoodland Hills, CA 91367

    Phone: (818) 737-4537Fax: (818) 737-4848E-mail: greenr@syncor.com

    mailto:saugusti@unmc.edumailto:chengk@musc.edumailto:GreeR@Syncor.com

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    Wade M. Hopkins, BCNPPharmacy ManagerSyncor International Corporation8389 Almeda, Suite GHouston, TX 77054

    Phone: (713) 748-3303Fax: (713) 748-0029E-mail: hopkinsw@syncor.com

    Joseph C. Hung, Ph.D., BCNP (Chair)Consultant and Professor of PharmacyDirector of Nuclear Pharmacy and PET Radiochemistry FacilityNuclear MedicineDepartment of RadiologyMayo Clinic200 First Street SWRochester, MN 55905

    Phone; (507) 284-4399Fax: (507) 266-4461E-mail: jhung@mayo.edu

    David L. Laven, NPh, CRPh, FASHP, FAPhALead PET Nuclear PharmacistIBA/Eastern Isotopes136 Commerce WaySanford, FL 32771

    Phone: (407) 321-9076Fax: (407) 321-9077E-mail: dlavenrx@earthlink.net

    Brigette R. Robinett, M.S., Pharm.D., R.Ph., BCNPJacksonville Central Pharmacy6950 Phillips Highway, Suite 26Jacksonville, FL 32216

    Phone: (904) 332-0888Fax: (904) 332-0880E-mail: brobinett@medianoe.net

    mailto:hopkinsw@syncor.commailto:jhung@mayo.edumailto:dlavenrx@earthlink.netmailto:brobinett@medianoe.net

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    Neil A. Petry, R.Ph., M.S., BCNP, FAPhAAssistant Professor of RadiologyDirector, Radiopharmacy and Nuclear Medicine LaboratoryDuke University Medical Center133 Bell Building, Box 3304Durham, NC 27710

    Phone: (919) 684-3773Fax: (919) 684-1230E-mail: petry005@mc.duke.edu

    James A. Ponto, M.S., BCNPChief Nuclear Pharmacist and Professor (Clinical)Division of Nuclear MedicineDepartment of RadiologyThe University of Iowa Hospitals and Clinics200 Hawkins Drive 3832 JPPIowa City, IA 52242-1058

    Phone: (319) 356-2741Fax: (319) 384-6389E-mail: james-ponto@uiowa.edu

    Timothy M. Quinton, Pharm.D., M.S., BCNPPresidentRadiopharmacy, Inc.1409 E. Virginia StreetEvansville, IN 47711

    Phone: (812) 421-1002Fax: (812) 421-1004E-mail: quniton@evansville.net

    Dennis P. Swanson, M.S., BCNPSchool of PharmacyUniversity of Pittsburgh1103 Salk HallPittsburgh, PA 15261

    Phone: (412) 648-8584 or 648-8579Fax: (412) 648-1086E-mail: swansondp@msx.upmc.edu

    mailto:petry005@mc.duke.edumailto:james-ponto@uiowa.edumailto:quniton@evansville.netmailto:swansondp@msx.upmc.edu

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    ABBREVIATION LIST

    ACARA: as clean as reasonably achievable

    ACS: American Chemical Society

    ANDA: abbreviated new drug application

    APhA: American Pharmaceutical Association

    APPM: Academy of Pharmacy Practice and Management

    AR: analytical reagent

    ASHP American Society of Health-System Pharmacy

    BET: bacterial endotoxin testing

    CFR: Code of Federal Regulations

    CGMPs: current good manufacturing practices

    FCC: Food Chemicals Codex

    FDA: Food and Drug Administration

    FDAMA: Food and Drug Administration Modernization and Accountability Act of 1997

    FFDCA Federal Food, Drug, and Cosmetic Act

    MOU: memorandum of understanding

    NABP National Association of Boards of Pharmacy

    NDA: new drug application

    NF: National Formulary

    PET: positron emission tomography

    RCP: radiochemical purity

    USP: United States Pharmacopeia

    USPCI United States Pharmacopeial Convention, Inc.

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    DEFINITIONS

    The following selective definitions apply to the Nuclear Pharmacy Compounding Guidelines:

    ACARA (as clean as reasonably achievable) means making every reasonable effort to maintainclean condition

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