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24 Allergenic Extracts

Mary C. McManamon and Matthew Madurski

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8 Ancillary Equipment and Supplies

Ashley Duty

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15 Aseptic Technique

Linda F. McElhiney

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28 Batch Compounding

Matthew M. Brown

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26 Biologicals, Biosimilars, and Vaccines

Hallie Barr and Ben Lopez

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14 Cleaning and Disinfecting

Erich Brechtelsbauer

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Cover Compounding Sterile Preparations

Compounding Sterile Preparations

Ryan A. Forrey, Lindsey B. Amerine, and Angela W. Yaniv

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Section 5 Considerations for Specialized Products and Populations

Ryan A. Forrey, Lindsey B. Amerine, and Angela W. Yaniv

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32 Corrective and Preventative Action (CAPA) Plans

Varsha Gaitonde and David Short

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29 Dealing with Latex Allergies

Lynda Kiliany

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30 Documentation of Compounded Sterile Preparations

David A. South

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Section 3 Engineering Controls and Equipment

Ryan A. Forrey, Lindsey B. Amerine, and Angela W. Yaniv

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31 Environmental Quality and Control

Patricia C. Kienle

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16 Establishing Beyond-Use Dates

Kevin N. Hansen

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18 Finished Preparation Release Checks and Tests

Angela W. Yaniv

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27 Handling and Compounding of Hazardous Drugs

Nicholas A. Link and Patricia A. Roberts

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1 Imperative for Change: Adverse Sterile Compounding Events

Christina Michalek

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Section 1 Introduction to Sterile Compounding

Ryan A. Forrey, Lindsey B. Amerine, and Angela W. Yaniv

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17 Labeling Sterile Preparations

Joshua S. Ilenin

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20 Maintaining Sterility, Purity, and Stability of Dispensed and Distributed CSPs

Kevin N. Hansen

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11 Microbiological Issues in Compounding Sterile Preparations

Abby Roth

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34 Outsourcing the Compounding of Sterile Preparations

Angela T. Cassano

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22 Parenteral Nutrition Compounding

Todd W. Canada

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23 Pediatric Compounding

Kathleen M. Gura

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13 Personnel Cleansing and Garbing

Patricia A. Roberts

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5 Personnel Training and Competency Evaluation of Garbing and Aseptic Work Practices

Linda F. McElhiney

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3 Pharmacist Education

Joyce S. Jih and Robert P. Shrewsbury

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4 Pharmacy Technician Education, Certification, Training, Evaluation, and Regulation

Mary Ann Stuhan

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21 Point of Care Compounding and Preparation for Administration

Ashley Duty

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33 Policies, Procedures, and Quality Assurance Programs

Patricia C. Kienle

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6 Primary Engineering Controls

Richard C. Capps

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Section 4 Principles and Work Practices of Sterile Compounding

Ryan A. Forrey, Lindsey B. Amerine, and Angela W. Yaniv

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Section 6 Quality Management

Ryan A. Forrey, Lindsey B. Amerine, and Angela W. Yaniv

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25 Radiopharmaceuticals

George H. Hinkle

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19 Receipt, Storage, Movement, and Disposal of Compounded Sterile Preparation Components and Finished Preparations in the Pharmacy

Joshua S. Ilenin

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7 Secondary Engineering Controls and Cleanroom Design

Elaine Strauss, Chuck Gaziano, and F. Kurt Last

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2 Standards for Compounded Sterile Preparations

Ryan A. Forrey

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9 Sterile Compounding Technology

Craig A. Boyce and Bruce A. Erickson

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Section 2 Sterile Compounding Training and Competency

Ryan A. Forrey, Lindsey B. Amerine, and Angela W. Yaniv

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10 Sterile Preparation Formulation

Paul M. Baker

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12 Sterility Assurance of Compounded Sterile Preparations

Angela W. Yaniv

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20 ADMINISTERING HAZARDOUS DRUGS

(See Section 14 in <800>.)

Patricia C. Kienle

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ANSWER KEY

Patricia C. Kienle

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APPENDIX

COMPOUNDING HAZARDOUS DRUGS

Patricia C. Kienle

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6 ASSESSMENT OF RISK

Patricia C. Kienle

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16 BEYOND-USE DATES

Patricia C. Kienle

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Cover The Chapter <800> Answer Book

The Chapter <800> Answer Book

Patricia C. Kienle

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13 CLOSED SYSTEM DRUG-TRANSFER DEVICES

(See Sections 5 and 14 in USP <800>.)

Patricia C. Kienle

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COMPETENCE CHECKLIST

Patricia C. Kienle

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COMPETENCY ASSESSMENT EXAM

Patricia C. Kienle