657.13.1 Purpose and scope. |
|
|
|
657.13.2 Definitions. |
|
|
|
657.13.3 Responsibilities. |
|
|
|
657.13.4 Reserved |
|
|
|
657.13.5 References required. |
|
|
|
657.13.6 Policies and procedures. |
|
|
|
657.13.7 Labeling requirements. |
|
|
|
657.13.8 Reserved |
|
|
|
657.13.9 Reserved |
|
|
|
657.13.10 Microbial contamination risk levels. |
|
|
|
657.13.11 Low-risk preparations. |
|
|
|
657.13.12 Medium-risk preparations. |
|
|
|
657.13.13 High-risk preparations. |
|
|
|
657.13.14 Immediate-use preparations. |
|
|
|
657.13.15 Utilization of single-dose and multiple-dose containers. |
|
|
|
657.13.16 Utilization of proprietary bag and vial systems. |
|
|
|
657.13.17 Reserved |
|
|
|
657.13.18 Reserved |
|
|
|
657.13.19 Reserved |
|
|
|
657.13.20 Sterile preparation of hazardous drugs. |
|
|
|
657.13.21 Reserved |
|
|
|
657.13.22 Reserved |
|
|
|
657.13.23 Verification of compounding accuracy and sterility. |
|
|
|
657.13.24 Sterilization methods. |
|
|
|
657.13.25 Media-fill testing by personnel. |
|
|
|
657.13.26 Reserved |
|
|
|
657.13.27 Physical environment requirements. |
|
|
|
657.13.28 Cleaning, maintenance, and supplies. |
|
|
|
657.13.29 Environmental monitoring requirements. |
|
|
|
657.13.30 Reserved |
|
|
|
657.13.31 Quality assurance (QA). |
|
|
|
657.13.32 Patient or caregiver education and training. |
|
|
|
657.13.33 Storage and delivery of sterile preparations. |
|
|
|