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Article 4.6. Sterile Compounding | Midpage
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California Code of Regulations
Title 16
Division 17. California State Board of Pharmacy
Article 4.6. Sterile Compounding
Article 4.6. Sterile Compounding
State of California
1736
Sterile Compounding Definitions.
1736.1
Introduction and Scope.
1736.2
Personnel Training and Evaluation.
1736.3
Personnel Hygiene and Garbing.
1736.4
Facilities and Engineering Controls.
1736.5
Certification and Recertification.
1736.6
Microbiological Air and Surface Monitoring.
1736.7
Cleaning, Disinfecting, and Applying Sporicidal Disinfectants and Sterile 70% IPA.
1736.8
Introducing Items into the SEC and PEC.
1736.9
Equipment, Supplies, and Components.
1736.10
Sterilization and Depyrogenation.
1736.11
Master Formulation and Compounding Records.
1736.12
Release Inspections and Testing.
1736.13
Labeling.
1736.14
Establishing Beyond-Use Dates.
1736.15
Use of Conventionally Manufactured Products as Components.
1736.16
Use of CSPs as Components.
1736.17
Standard Operating Procedures (SOPs).
1736.18
Quality Assurance and Quality Control.
1736.19
CSP Handling, Storage, Packaging, Shipping, and Transport.
1736.20
Documentation.
1736.21
Compounding Allergenic Extracts.