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24 Allergenic Extracts

8 Ancillary Equipment and Supplies

15 Aseptic Technique

28 Batch Compounding

26 Biologicals, Biosimilars, and Vaccines

14 Cleaning and Disinfecting

Section 5 Considerations for Specialized Products and Populations

32 Corrective and Preventative Action (CAPA) Plans

29 Dealing with Latex Allergies

30 Documentation of Compounded Sterile Preparations

Section 3 Engineering Controls and Equipment

31 Environmental Quality and Control

16 Establishing Beyond-Use Dates

18 Finished Preparation Release Checks and Tests

27 Handling and Compounding of Hazardous Drugs

Section 1 Introduction to Sterile Compounding

17 Labeling Sterile Preparations

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

11 Microbiological Issues in Compounding Sterile Preparations

34 Outsourcing the Compounding of Sterile Preparations

22 Parenteral Nutrition Compounding

23 Pediatric Compounding

13 Personnel Cleansing and Garbing

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

3 Pharmacist Education

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

21 Point of Care Compounding and Preparation for Administration

33 Policies, Procedures, and Quality Assurance Programs

6 Primary Engineering Controls

Section 4 Principles and Work Practices of Sterile Compounding

Section 6 Quality Management

25 Radiopharmaceuticals

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

7 Secondary Engineering Controls and Cleanroom Design

2 Standards for Compounded Sterile Preparations

9 Sterile Compounding Technology

Section 2 Sterile Compounding Training and Competency

10 Sterile Preparation Formulation

12 Sterility Assurance of Compounded Sterile Preparations

20 ADMINISTERING HAZARDOUS DRUGS

(See Section 14 in <800>.)

ANSWER KEY

APPENDIX

COMPOUNDING HAZARDOUS DRUGS

6 ASSESSMENT OF RISK

16 BEYOND-USE DATES

13 CLOSED SYSTEM DRUG-TRANSFER DEVICES

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

COMPETENCE CHECKLIST

COMPETENCY ASSESSMENT EXAM